今日の臨床サポート

周術期マネジメント/周術期内科コンサルト

著者: 加藤良太朗 板橋中央総合病院 総合診療科

監修: 徳田安春 一般社団法人 群星沖縄臨床研修センター

著者校正/監修レビュー済:2020/02/19
参考ガイドライン:
  1. 米国心臓病学会(ACC)・米国心臓協会(AHA):非心臓手術患者の周術期の心血管疾患の評価および管理に関するガイドライン 2014年版

概要・推奨   

  1. コンサルタントと主治医が円滑なコミュニケーションをとりながら、効果的な並診を行っていくためには、守るべきマナーがある。
  1. 内科コンサルタントに期待される最も重要な役割の一つは周術期のリスク評価である。2014年に米国心臓病学会(American College of Cardiology、以下「ACC」)と米国心臓協会(American Heart Association、以下「AHA」)が共同で発表した「非心臓手術患者の周術期の心血管疾患の評価および管理に関するガイドライン」は熟知しておく必要がある。
  1. 周術期に起こる合併症のほとんどは内科疾患であるため、内科コンサルタントへの期待は大きく、治療方法のみならず患者のモニタリングまで幅広い役割が求められる。
  1. 閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約が必要となります。閲覧にはご契約
薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、
著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適用の査定において保険適用及び保険適用外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適用の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
加藤良太朗 : 特に申告事項無し[2021年]
監修:徳田安春 : 特に申告事項無し[2021年]

病態・疫学・診察

コンサルタントの心得  
  1. わが国では、主治医が他科のコンサルタントと一緒に一人の患者を診ていくという文化が十分に根付いていない。それには、例えば米国のように、コンサルトそのものに対して診療報酬が支払われるような仕組みがないことも影響しているかもしれない。
  1. しかし、患者層が急速に高齢化し、慢性疾患を複数持つ患者も増え、もはや主治医一人では対応できないのが最近の医療現場である。必然的に手術患者もリスクの高い高齢患者が増え、周術期マネジメントは複雑化し、内科コンサルトの役割も増しつつある。主治医との潤滑な並診を可能にするために、コンサルタントが心得ておくべきマナーがいくつかある。ここでは、1980年代にリー・ゴールドマン等が提唱した、「コンサルタントの十戒[1]」を日本の医療に則した形で紹介する。
  1. 目的を明確にする:
  1. せっかく詳細なコンサルトを行なっても、それが主治医の質問に答えていないと全く意味がない。コンサルタントは可能な限り主治医と直接話して、コンサルトの目的を明確にするべきである。それが難しい場合には、紹介状や他科依頼、診療録等に具体的に何について知りたいのかを記載してもらう必要がある。
  1. ときに主治医が患者の状態を十分に把握できず、助けては欲しいけれど、具体的に何を質問したら良いのかということすら分かっていない場合がある。そのようなときでも、決して主治医を非難したり、コンサルトを拒否したりしてはいけない。主治医が途方にくれているときこそ、コンサルタントの出番である。
  1. なお、診療録記載をする際には、「○○で入院中の●●さん、△△の管理について主治科よりコンサルトを依頼された」というように、コンサルトの理由を明記しておくことも、後々のトラブル回避のためには重要である。
  1. 緊急性を把握する:
  1. 外来や病棟、他院など、コンサルトは様々な形で依頼される。全てのコンサルトは速やかに対応されるべきであるが、コンサルトの中には、明らかに急ぐ場合と、待っても良い場合がある。コンサルトを依頼されたら、緊急なのか、至急なのか、あるいは待機的でよいのか、まず緊急性を明確にすることが大切である。緊急や至急の場合には、主治医と直接話しておくことが極めて大事である。
  1. 緊急性が高い場合、コンサルタントを依頼する主治医も、そして依頼されたコンサルタントも、要領を得たプレゼンテーションをするべきである。効率的なコミュニケーションのためには、米国海軍が開発したSBAR法が有用である[2]。すなわち、まず主治医はコンサルトが必要となった状況(situation)を一言で述べ、次にコンサルタントにとって有用と思われる追加情報あるいは背景(background)を説明し、主治医自身の評価(assessment)を共有した上で、推奨(recommendation)を仰ぐ、というコミュニケーション様式である。例えば、主治医からは以下のような依頼を期待したい。
  1. 「救急外来担当医の○○です。胸痛で来院した55歳の男性についてコンサルトさせて下さい。もともと糖尿病と高血圧の既往があり、3時間前から前胸部に締め付けられるような痛みが出現したそうです。発汗もだいぶしております。胸痛はニトログリセリン2錠で消失しました。心電図上は変化ないのですが、私は不安定狭心症を疑っています。評価をお願いできますでしょうか?」
  1. 依頼を受けたコンサルタントも、SBAR法で答えると以下のようになる。
  1. 「先ほどの患者さんですが、急性心筋梗塞だと思いますので、これからカテーテル検査の準備をします。糖尿病と高血圧の既往がある55歳男性で、胸痛も典型的です。よく見ると心電図にも微妙な変化があり、トロポニンも上昇しています。アスピリンの投与とヘパリンの持続点滴を開始して下さい。」
  1. 百聞は一見にしかず:
  1. コンサルタントは他人の書いた診療録に依存するのではなく、可能な限り、自分自身で患者の話を聴き、診察をすることが大事である。ときには自分で他院や他施設に電話する必要もあり、自らグラム染色を再検する、画像を読影する、というような執着心が求められる。ちょっとした努力が、患者にとって大きな恩恵に繋がるからである。
  1. 可能な限り簡潔に答える:
  1. 診療録は医学的にも法的にも大変重要な記録であり、漏れのないコンサルト記載が必要である。しかし、コンサルト記載が過剰に長いと、大事な推奨事項が埋もれてしまい、主治医に伝わらないことにもなりうる。したがって、病歴や処方薬のリストなど、主治医がすでに記載していることを繰り返す必要はない。
  1. 可能な限り具体的に答える:
  1. 薬剤の用量や頻度、投与ルートなどは、できる限り詳細に伝え、診療録にも記載することが大切である。薬剤については誤解が大変多いからである。また、研修医から依頼されたコンサルテーションには教育の意味も兼ねているため、推奨の根拠となる参考文献などを記載しておくことも有用である。
  1. 不用意の用意:
  1. かつて勝海舟は、あらゆる準備をしてなお、不測の事態が起こりうることを想定した柔軟な対応をとることの重要性を説いた。コンサルテーションもしかりである。患者の容態が急変する、数日後に予期せぬ検査結果が返ってくる、ということは臨床現場では珍しくない。代替えプランを用意するなど、推奨事項は変わるかもしれないという意識を持って対応する必要がある。
  1. 身の丈を知る:
  1. コンサルタントは、決して出しゃばってはいけない。医療においては、正解が一つとは限らない場合が多い。たとえ主治医の取った選択が、自分が推奨したものでなかったとしても、そこには様々な理由が関与している場合が多い。医学的あるいは倫理的に明らかに問題がある場合を除いては、主治医の判断を尊重すべきである。逆に、主治医は患者管理をコンサルタントに丸投げしてもいけない。コンサルタントはあくまで補助的な役割に徹するべきであり、中長期的な管理は主治医の仕事である。
  1. 決して相手を辱めない:
  1. 主治医を見下したような対応、あるいは主治医に失礼な対応は絶対にしてはいけない。例えば、「こんなことも知らないのですか?」といったような発言は避けるべきであるし、勝手に検査をオーダーする、処方内容を変えてしまう、といったような行動もあってはならない。ただし、無用に主治医に忖度する必要もない。例えば、細菌感染は否定的であるにも関わらず、主治医の顔色を伺って広域抗菌薬を継続させるというような配慮は不要である。
  1. 言うは易く、効果的である:
  1. コンサルテーションを行なったら、推奨事項を診療録に記載するだけではなく、必ず主治医に電話等で直接伝えること。主治医が推奨事項を遂行してくれる可能性が増す一方、後々のトラブル回避にも繋がるからである。例えば、外科からコンサルトされた後に、主治医に相談もせずに「手術を延期すべきである」と診療録に記載してしまったとする。それに気づかずに外科医が手術をしてしまうと、患者ばかりか主治医も不利益を被る可能性がある。
  1. フォローアップを忘れずに:
  1. コンサルタントは、質問に答えて終わりではなく、推奨事項が実際に遂行されたか、そしてその結果患者がどのような転機を辿ったかをフォローする必要がある。主治医が忙しくて指示を入れ忘れることもあるかもしれないし、検査結果が出るまで数日かかることもある。丁寧なコンサルタントは、主治医が助けを求めてきた問題点が解決するまでフォローする。
  1. 以上が、リー・ゴールドマン等が提唱するコンサルタント全般についてのマナーであるが、繰り返し強調されているのはコミュニケーションの重要性である。周術期も例外ではない。コンサルタントは、「自分の専門性を期待されているのだ」と前向きに捉え、積極的に主治医と対話することによって、お互いにとって、そして何よりも患者にとって実りある診療を提供することができるのである。
周術期の疫学  
  1. 世界中で毎年2億件の手術が行われているが、そのうち100万人が周術期(術後30日以内)に死亡している[3]。全世界で行われている手術の半分に当たる1億件以上の手術は米国で行われているが、注目すべきは外来で行われる手術の件数が過去10年で3倍増加している点である。全米医療の質フォーラム(National Quality Forum、以下「NQF」)のデータによると、米国では年間約5,330万件の手術が外来患者に対して、そして約5,140万件の手術が入院患者に対して行われている[4]
  1. 全ての手術はリスクを伴う。実際、米国では術後患者の7人に1人は退院後30日以内に再入院しており、待機的手術後に退院した患者1,000人中14人以上が敗血症になっている[4]。わが国でも、毎年膨大な数の手術や手技が行われていることを考えると、周術期のリスク管理は医療全体、ひいては社会全体にとって関心の対象となるべきである。

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文献 

著者: L Goldman, T Lee, P Rudd
雑誌名: Arch Intern Med. 1983 Sep;143(9):1753-5.
Abstract/Text If internists are not explicitly instructed in how to perform consultations, the outcome of their consultative efforts may be suboptimal. We suggest that consultations will be more helpful if the following principles are followed: the consultant should determine the question that is being asked, establish the urgency of the consultation, gather primary data, communicate as briefly as appropriate, make specific recommendations, provide contingency plans, understand his own role in the process, offer educational information, communicate recommendations directly to the requesting physician, and provide appropriate follow-up. If these ten "commandments" are followed, the consultation is more likely to be effective and satisfactory for all the participants.

PMID 6615097  Arch Intern Med. 1983 Sep;143(9):1753-5.
著者: Thomas G Weiser, Scott E Regenbogen, Katherine D Thompson, Alex B Haynes, Stuart R Lipsitz, William R Berry, Atul A Gawande
雑誌名: Lancet. 2008 Jul 12;372(9633):139-44. doi: 10.1016/S0140-6736(08)60878-8. Epub 2008 Jun 24.
Abstract/Text BACKGROUND: Little is known about the amount and availability of surgical care globally. We estimated the number of major operations undertaken worldwide, described their distribution, and assessed the importance of surgical care in global public-health policy.
METHODS: We gathered demographic, health, and economic data for 192 member states of WHO. Data for the rate of surgery were sought from several sources including governmental agencies, statistical and epidemiological organisations, published studies, and individuals involved in surgical policy initiatives. We also obtained per-head total expenditure on health from analyses done in 2004. Major surgery was defined as any intervention occurring in a hospital operating theatre involving the incision, excision, manipulation, or suturing of tissue, usually requiring regional or general anaesthesia or sedation. We created a model to estimate rates of major surgery for countries for which such data were unavailable, then used demographic information to calculate the total worldwide volume of surgery.
FINDINGS: We obtained surgical data for 56 (29%) of 192 WHO member states. We estimated that 234.2 (95% CI 187.2-281.2) million major surgical procedures are undertaken every year worldwide. Countries spending US$100 or less per head on health care have an estimated mean rate of major surgery of 295 (SE 53) procedures per 100 000 population per year, whereas those spending more than $1000 have a mean rate of 11 110 (SE 1300; p<0.0001). Middle-expenditure ($401-1000) and high-expenditure (>$1000) countries, accounting for 30.2% of the world's population, provided 73.6% (172.3 million) of operations worldwide in 2004, whereas poor-expenditure (INTERPRETATION: Worldwide volume of surgery is large. In view of the high death and complication rates of major surgical procedures, surgical safety should now be a substantial global public-health concern. The disproportionate scarcity of surgical access in low-income settings suggests a large unaddressed disease burden worldwide. Public-health efforts and surveillance in surgery should be established.

PMID 18582931  Lancet. 2008 Jul 12;372(9633):139-44. doi: 10.1016/S014・・・
著者: Lee A Fleisher, Kirsten E Fleischmann, Andrew D Auerbach, Susan A Barnason, Joshua A Beckman, Biykem Bozkurt, Victor G Davila-Roman, Marie D Gerhard-Herman, Thomas A Holly, Garvan C Kane, Joseph E Marine, M Timothy Nelson, Crystal C Spencer, Annemarie Thompson, Henry H Ting, Barry F Uretsky, Duminda N Wijeysundera
雑誌名: Circulation. 2014 Dec 9;130(24):e278-333. doi: 10.1161/CIR.0000000000000106. Epub 2014 Aug 1.
Abstract/Text
PMID 25085961  Circulation. 2014 Dec 9;130(24):e278-333. doi: 10.1161/・・・
著者: Judith A R van Waes, Hendrik M Nathoe, Jurgen C de Graaff, Hans Kemperman, Gert Jan de Borst, Linda M Peelen, Wilton A van Klei, Cardiac Health After Surgery (CHASE) Investigators
雑誌名: Circulation. 2013 Jun 11;127(23):2264-71. doi: 10.1161/CIRCULATIONAHA.113.002128. Epub 2013 May 10.
Abstract/Text BACKGROUND: To identify patients at risk for postoperative myocardial injury and death, measuring cardiac troponin routinely after noncardiac surgery has been suggested. Such monitoring was implemented in our hospital. The aim of this study was to determine the predictive value of postoperative myocardial injury, as measured by troponin elevation, on 30-day mortality after noncardiac surgery.
METHODS AND RESULTS: This observational, single-center cohort study included 2232 consecutive intermediate- to high-risk noncardiac surgery patients aged ≥60 years who underwent surgery in 2011. Troponin was measured on the first 3 postoperative days. Log binomial regression analysis was used to estimate the association between postoperative myocardial injury (troponin I level >0.06 μg/L) and all-cause 30-day mortality. Myocardial injury was found in 315 of 1627 patients in whom troponin I was measured (19%). All-cause death occurred in 56 patients (3%). The relative risk of a minor increase in troponin (0.07-0.59 μg/L) was 2.4 (95% confidence interval, 1.3-4.2; P<0.01), and the relative risk of a 10- to 100-fold increase in troponin (≥0.60 μg/L) was 4.2 (95% confidence interval, 2.1-8.6; P<0.01). A myocardial infarction according to the universal definition was diagnosed in 10 patients (0.6%), of whom 1 (0.06%) had ST-segment elevation myocardial infarction.
CONCLUSIONS: Postoperative myocardial injury is an independent predictor of 30-day mortality after noncardiac surgery. Implementation of postoperative troponin monitoring as standard of care is feasible and may be helpful in improving the prognosis of patients undergoing noncardiac surgery.

PMID 23667270  Circulation. 2013 Jun 11;127(23):2264-71. doi: 10.1161/・・・
著者: Masha Livhits, Clifford Y Ko, Michael J Leonardi, David S Zingmond, Melinda Maggard Gibbons, Christian de Virgilio
雑誌名: Ann Surg. 2011 May;253(5):857-64. doi: 10.1097/SLA.0b013e3182125196.
Abstract/Text OBJECTIVE: We aimed to assess the impact of recent myocardial infarction (MI) on outcomes after subsequent surgery in the contemporary clinical setting.
BACKGROUND: Prior work shows that a history of a recent MI is a risk factor for complications following noncardiac surgery. However, this data does not reflect current advances in clinical management.
METHODS: Using the California Patient Discharge Database, we retrospectively analyzed patients undergoing hip surgery, cholecystectomy, colectomy, elective abdominal aortic aneurysm repair, and lower extremity amputation from 1999 to 2004 (n = 563,842). Postoperative 30-day MI rate, 30-day mortality, and 1-year mortality were compared for patients with and without a recent MI using univariate analyses and multivariate logistic regression. Relative risks (RR) with 95% confidence intervals were estimated using bootstrapping with 1000 repetitions.
RESULTS: Postoperative MI rate for the recent MI cohort decreased substantially as the length of time from MI to operation increased (0-30 days = 32.8%, 31-60 days = 18.7%, 61-90 days = 8.4%, and 91-180 days = 5.9%), as did 30-day mortality (0-30 days = 14.2%, 31-60 days = 11.5%, 61-90 days = 10.5%, and 91-180 days = 9.9%). MI within 30 days of an operation was associated with a higher risk of postoperative MI (RR range = 9.98-44.29 for the 5 procedures), 30-day mortality (RR range, 1.83-3.84), and 1-year mortality (RR range, 1.56-3.14).
CONCLUSIONS: A recent MI remains a significant risk factor for postoperative MI and mortality following surgery. Strategies such as delaying elective operations for at least 8 weeks and medical optimization should be considered.

(C) 2011 Lippincott Williams & Wilkins, Inc.
PMID 21372685  Ann Surg. 2011 May;253(5):857-64. doi: 10.1097/SLA.0b01・・・
著者: Willem-Jan Flu, Jan-Peter van Kuijk, Sanne E Hoeks, Ruud Kuiper, Olaf Schouten, Dustin Goei, Abdou Elhendy, Hence J M Verhagen, Ian R Thomson, Jeroen J Bax, Lee A Fleisher, Don Poldermans
雑誌名: Anesthesiology. 2010 Jun;112(6):1316-24. doi: 10.1097/ALN.0b013e3181da89ca.
Abstract/Text BACKGROUND: The prognostic value of heart failure symptoms on postoperative outcome is well acknowledged in perioperative guidelines. The prognostic value of asymptomatic left ventricular (LV) dysfunction remains unknown. This study evaluated the prognostic implications of asymptomatic LV dysfunction in vascular surgery patients assessed with routine echocardiography.
METHODS: Echocardiography was performed preoperatively in 1,005 consecutive vascular surgery patients. Systolic LV dysfunction was defined as LV ejection fraction less than 50%. Ratio of mitral-peak velocity during early and late filling, pulmonary vein flow, and deceleration time was used to diagnose diastolic LV dysfunction. Troponin-T measurements and electrocardiograms were performed routinely perioperatively. Multivariate regression analyses evaluated the relation between LV function and the study endpoints, 30-day cardiovascular events, and long-term cardiovascular mortality.
RESULTS: Left ventricular dysfunction was diagnosed in 506 (50%) patients of which 80% were asymptomatic. In open vascular surgery (n = 649), both asymptomatic systolic and isolated diastolic LV dysfunctions were associated with 30-day cardiovascular events (odds ratios 2.3, 95% confidence interval [CI] 1.4-3.6 and 1.8, 95% CI 1.1-2.9, respectively) and long-term cardiovascular mortality (hazard ratios 4.6, 95% CI 2.4-8.5 and 3.0, 95% CI 1.5-6.0, respectively). In endovascular surgery (n = 356), only symptomatic heart failure was associated with 30-day cardiovascular events (odds ratio 1.8, 95% CI 1.1-2.9) and long-term cardiovascular mortality (hazard ratio 10.3, 95% CI 5.4-19.3).
CONCLUSIONS: This study demonstrated that asymptomatic LV dysfunction is predictive for 30-day and long-term cardiovascular outcome in open vascular surgery patients. These data suggest that preoperative risk stratification should include not only solely heart failure symptoms but also routine preoperative echocardiography to risk stratify open vascular surgery patients.

PMID 20502115  Anesthesiology. 2010 Jun;112(6):1316-24. doi: 10.1097/A・・・
著者: E Mahla, B Rotman, P Rehak, J L Atlee, H Gombotz, J Berger, W F List, W Klein, H Metzler
雑誌名: Anesth Analg. 1998 Jan;86(1):16-21. doi: 10.1097/00000539-199801000-00004.
Abstract/Text UNLABELLED: Noncardiac surgical patients with preoperative ventricular dysrhythmias and structural heart disease may be at increased risk of adverse cardiac outcome. We evaluated how anesthesia and surgery affect the course of ventricular dysrhythmias (premature ventricular beats [PVB] and repetitive forms of ventricular beats [RFVB]: couplets and nonsustained ventricular tachycardia) noted preoperatively in patients with structural heart disease and whether the frequency of ventricular dysrhythmias affects cardiac outcome. In a prospective study, 70 patients scheduled for noncardiac surgery with structural heart disease and RFVB on preoperative Holter electrocardiogram were continuously monitored intraoperatively and for 3 days postoperatively. Holter tracings were analyzed for rhythm, medians of total PVB and RFVB per hour. Preoperative RFVB recurred intraoperatively in 35% and postoperatively in 87% of patients. There was a significant intra- and postoperative decrease of total PVB per hour (P < 0.05) and RFVB per hour (P < 0.01). Frequency of ventricular dysrhythmias in the five patients suffering adverse outcome (unstable angina, n = 1; congestive heart failure, n = 4) did not significantly differ from those with good outcome. We conclude that in noncardiac surgical patients with structural heart disease and RFVB, the frequency of ventricular dysrhythmias is not associated with adverse cardiac outcome.
IMPLICATIONS: Using continuous electrocardiogram monitoring, we investigated whether the frequency of perioperative ventricular dysrhythmias independently affects outcome in patients with structural heart disease undergoing noncardiac surgery. The incidence of perioperative dysrhythmia in patients with an adverse outcome (8%) did not differ from those with a good outcome.

PMID 9428844  Anesth Analg. 1998 Jan;86(1):16-21. doi: 10.1097/000005・・・
著者: Shikhar Agarwal, Anitha Rajamanickam, Navkaranbir S Bajaj, Brian P Griffin, Thadeo Catacutan, Lars G Svensson, Abdel G Anabtawi, E Murat Tuzcu, Samir R Kapadia
雑誌名: Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):193-200. doi: 10.1161/CIRCOUTCOMES.111.000091. Epub 2013 Mar 12.
Abstract/Text BACKGROUND: Preoperative management of patients with aortic stenosis (AS) who need noncardiac surgery (NCS) remains controversial. We sought to determine the impact of AS on the postoperative outcomes after NCS.
METHODS AND RESULTS: Patients undergoing NCS with moderate AS (valve area: 1.0-1.5 cm(2)) or severe AS (valve area: <1.0 cm(2)) were identified using the surgical and the echocardiographic databases. Using propensity score analysis, we obtained 4 matched control patients without AS for each patient with AS undergoing NCS. The propensity score matching used the 6 revised cardiac risk index criteria, in addition to age and sex. Primary outcome was a composite of 30-day mortality and postoperative myocardial infarction. We matched 634 patients with AS undergoing NCS to 2536 controls. There were 244 patients with severe AS and 390 patients with moderate AS. Thirty-day mortality was 2.1% for AS patients compared with 1.0% in non-AS controls (P=0.036). Postoperative myocardial infarction was more frequent in patients with AS compared with controls (3.0% versus 1.1%; P=0.001). Combined primary outcome was significantly worse for both moderate and severe AS patients compared with respective controls (4.4% versus 1.7%; P=0.002; and 5.7% versus 2.7%; P=0.02, respectively). High-risk surgery, symptomatic severe AS, coexisting mitral regurgitation, and preexisting coronary disease were significant predictors of primary outcome in patients with AS.
CONCLUSION: Presence of AS adversely affects postoperative outcomes among patients undergoing NCS, evidenced by a higher 30-day mortality and postoperative myocardial infarction after NCS.

PMID 23481524  Circ Cardiovasc Qual Outcomes. 2013 Mar 1;6(2):193-200.・・・
著者: T H Lee, E R Marcantonio, C M Mangione, E J Thomas, C A Polanczyk, E F Cook, D J Sugarbaker, M C Donaldson, R Poss, K K Ho, L E Ludwig, A Pedan, L Goldman
雑誌名: Circulation. 1999 Sep 7;100(10):1043-9. doi: 10.1161/01.cir.100.10.1043.
Abstract/Text BACKGROUND: Cardiac complications are important causes of morbidity after noncardiac surgery. The purpose of this prospective cohort study was to develop and validate an index for risk of cardiac complications.
METHODS AND RESULTS: We studied 4315 patients aged > or = 50 years undergoing elective major noncardiac procedures in a tertiary-care teaching hospital. The main outcome measures were major cardiac complications. Major cardiac complications occurred in 56 (2%) of 2893 patients assigned to the derivation cohort. Six independent predictors of complications were identified and included in a Revised Cardiac Risk Index: high-risk type of surgery, history of ischemic heart disease, history of congestive heart failure, history of cerebrovascular disease, preoperative treatment with insulin, and preoperative serum creatinine >2.0 mg/dL. Rates of major cardiac complication with 0, 1, 2, or > or = 3 of these factors were 0.5%, 1.3%, 4%, and 9%, respectively, in the derivation cohort and 0.4%, 0.9%, 7%, and 11%, respectively, among 1422 patients in the validation cohort. Receiver operating characteristic curve analysis in the validation cohort indicated that the diagnostic performance of the Revised Cardiac Risk Index was superior to other published risk-prediction indexes.
CONCLUSIONS: In stable patients undergoing nonurgent major noncardiac surgery, this index can identify patients at higher risk for complications. This index may be useful for identification of candidates for further risk stratification with noninvasive technologies or other management strategies, as well as low-risk patients in whom additional evaluation is unlikely to be helpful.

PMID 10477528  Circulation. 1999 Sep 7;100(10):1043-9. doi: 10.1161/01・・・
著者: Prateek K Gupta, Himani Gupta, Abhishek Sundaram, Manu Kaushik, Xiang Fang, Weldon J Miller, Dennis J Esterbrooks, Claire B Hunter, Iraklis I Pipinos, Jason M Johanning, Thomas G Lynch, R Armour Forse, Syed M Mohiuddin, Aryan N Mooss
雑誌名: Circulation. 2011 Jul 26;124(4):381-7. doi: 10.1161/CIRCULATIONAHA.110.015701. Epub 2011 Jul 5.
Abstract/Text BACKGROUND: Perioperative myocardial infarction or cardiac arrest is associated with significant morbidity and mortality. The Revised Cardiac Risk Index is currently the most commonly used cardiac risk stratification tool; however, it has several limitations, one of which is its relatively low discriminative ability. The objective of the present study was to develop and validate a predictive cardiac risk calculator.
METHODS AND RESULTS: Patients who underwent surgery were identified from the American College of Surgeons' 2007 National Surgical Quality Improvement Program database, a multicenter (>250 hospitals) prospective database. Of the 211 410 patients, 1371 (0.65%) developed perioperative myocardial infarction or cardiac arrest. On multivariate logistic regression analysis, 5 predictors of perioperative myocardial infarction or cardiac arrest were identified: type of surgery, dependent functional status, abnormal creatinine, American Society of Anesthesiologists' class, and increasing age. The risk model based on the 2007 data set was subsequently validated on the 2008 data set (n=257 385). The model performance was very similar between the 2007 and 2008 data sets, with C statistics (also known as area under the receiver operating characteristic curve) of 0.884 and 0.874, respectively. Application of the Revised Cardiac Risk Index to the 2008 National Surgical Quality Improvement Program data set yielded a relatively lower C statistic (0.747). The risk model was used to develop an interactive risk calculator.
CONCLUSIONS: The cardiac risk calculator provides a risk estimate of perioperative myocardial infarction or cardiac arrest and is anticipated to simplify the informed consent process. Its predictive performance surpasses that of the Revised Cardiac Risk Index.

PMID 21730309  Circulation. 2011 Jul 26;124(4):381-7. doi: 10.1161/CIR・・・
著者: D F Reilly, M J McNeely, D Doerner, D L Greenberg, T O Staiger, M J Geist, P A Vedovatti, J E Coffey, M W Mora, T R Johnson, E D Guray, G A Van Norman, S D Fihn
雑誌名: Arch Intern Med. 1999 Oct 11;159(18):2185-92. doi: 10.1001/archinte.159.18.2185.
Abstract/Text BACKGROUND: Impaired exercise tolerance during formal testing is predictive of perioperative complications. However, for most patients, formal exercise testing is not indicated, and exercise tolerance is assessed by history.
OBJECTIVE: To determine the relationship between self-reported exercise tolerance and serious perioperative complications.
METHODS: Our study group consisted of 600 consecutive outpatients referred to a medical consultation clinic at a tertiary care medical center for preoperative evaluation before undergoing 612 major noncardiac procedures. Patients were asked to estimate the number of blocks they could walk and flights of stairs they could climb without experiencing symptomatic limitation. Patients who could not walk 4 blocks and climb 2 flights of stairs were considered to have poor exercise tolerance. All patients were evaluated for the development of 26 serious complications that occurred during hospitalization.
RESULTS: Patients reporting poor exercise tolerance had more perioperative complications (20.4% vs 10.4%; P<.001). Specifically, they had more myocardial ischemia (P = .02) and more cardiovascular (P = .04) and neurologic (P = .03) events. Poor exercise tolerance predicted risk for serious complications independent of all other patient characteristics, including age (adjusted odds ratio, 1.94; 95% confidence interval, 1.19-3.17). The likelihood of a serious complication occurring was inversely related to the number blocks that could be walked (P = .006) or flights of stairs that could be climbed (P = .01). Other patient characteristics predicting serious complications in multivariable regression analysis included history of congestive heart failure, dementia, Parkinson disease, and smoking greater than or equal to 20 pack-years.
CONCLUSION: Self-reported exercise tolerance can be used to predict in-hospital perioperative risk, even when using relatively simple and familiar measures.

PMID 10527296  Arch Intern Med. 1999 Oct 11;159(18):2185-92. doi: 10.1・・・
著者: M A Hlatky, R E Boineau, M B Higginbotham, K L Lee, D B Mark, R M Califf, F R Cobb, D B Pryor
雑誌名: Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/0002-9149(89)90496-7.
Abstract/Text To develop a brief, self-administered questionnaire that accurately measures functional capacity and assesses aspects of quality of life, 50 subjects undergoing exercise testing with measurement of peak oxygen uptake were studied. All subjects were questioned about their ability to perform a variety of common activities by an interviewer blinded to exercise test findings. A 12-item scale (the Duke Activity Status Index) was then developed that correlated well with peak oxygen uptake (Spearman correlation coefficient 0.80). To test this new index, an independent group of 50 subjects completed a self-administered questionnaire to determine functional capacity and underwent exercise testing with measurement of peak oxygen uptake. The Duke Activity Status Index correlated significantly (p less than 0.0001) with peak oxygen uptake (Spearman correlation coefficient 0.58) in this independent sample. The Duke Activity Status Index is a valid measure of functional capacity that can be obtained by self-administered questionnaire.

PMID 2782256  Am J Cardiol. 1989 Sep 15;64(10):651-4. doi: 10.1016/00・・・
著者: Duminda N Wijeysundera, Rupert M Pearse, Mark A Shulman, Tom E F Abbott, Elizabeth Torres, Althea Ambosta, Bernard L Croal, John T Granton, Kevin E Thorpe, Michael P W Grocott, Catherine Farrington, Paul S Myles, Brian H Cuthbertson, METS study investigators
雑誌名: Lancet. 2018 Jun 30;391(10140):2631-2640. doi: 10.1016/S0140-6736(18)31131-0.
Abstract/Text BACKGROUND: Functional capacity is an important component of risk assessment for major surgery. Doctors' clinical subjective assessment of patients' functional capacity has uncertain accuracy. We did a study to compare preoperative subjective assessment with alternative markers of fitness (cardiopulmonary exercise testing [CPET], scores on the Duke Activity Status Index [DASI] questionnaire, and serum N-terminal pro-B-type natriuretic peptide [NT pro-BNP] concentrations) for predicting death or complications after major elective non-cardiac surgery.
METHODS: We did a multicentre, international, prospective cohort study at 25 hospitals: five in Canada, seven in the UK, ten in Australia, and three in New Zealand. We recruited adults aged at least 40 years who were scheduled for major non-cardiac surgery and deemed to have one or more risk factors for cardiac complications (eg, a history of heart failure, stroke, or diabetes) or coronary artery disease. Functional capacity was subjectively assessed in units of metabolic equivalents of tasks by the responsible anaesthesiologists in the preoperative assessment clinic, graded as poor (<4), moderate (4-10), or good (>10). All participants also completed the DASI questionnaire, underwent CPET to measure peak oxygen consumption, and had blood tests for measurement of NT pro-BNP concentrations. After surgery, patients had daily electrocardiograms and blood tests to measure troponin and creatinine concentrations until the third postoperative day or hospital discharge. The primary outcome was death or myocardial infarction within 30 days after surgery, assessed in all participants who underwent both CPET and surgery. Prognostic accuracy was assessed using logistic regression, receiver-operating-characteristic curves, and net risk reclassification.
FINDINGS: Between March 1, 2013, and March 25, 2016, we included 1401 patients in the study. 28 (2%) of 1401 patients died or had a myocardial infarction within 30 days of surgery. Subjective assessment had 19·2% sensitivity (95% CI 14·2-25) and 94·7% specificity (93·2-95·9) for identifying the inability to attain four metabolic equivalents during CPET. Only DASI scores were associated with predicting the primary outcome (adjusted odds ratio 0·96, 95% CI 0·83-0·99; p=0·03).
INTERPRETATION: Subjectively assessed functional capacity should not be used for preoperative risk evaluation. Clinicians could instead consider a measure such as DASI for cardiac risk assessment.
FUNDING: Canadian Institutes of Health Research, Heart and Stroke Foundation of Canada, Ontario Ministry of Health and Long-Term Care, Ontario Ministry of Research, Innovation and Science, UK National Institute of Academic Anaesthesia, UK Clinical Research Collaboration, Australian and New Zealand College of Anaesthetists, and Monash University.

Copyright © 2018 Elsevier Ltd. All rights reserved.
PMID 30070222  Lancet. 2018 Jun 30;391(10140):2631-2640. doi: 10.1016/・・・
著者: Edward O McFalls, Herbert B Ward, Thomas E Moritz, Steven Goldman, William C Krupski, Fred Littooy, Gordon Pierpont, Steve Santilli, Joseph Rapp, Brack Hattler, Kendrick Shunk, Connie Jaenicke, Lizy Thottapurathu, Nancy Ellis, Domenic J Reda, William G Henderson
雑誌名: N Engl J Med. 2004 Dec 30;351(27):2795-804. doi: 10.1056/NEJMoa041905.
Abstract/Text BACKGROUND: The benefit of coronary-artery revascularization before elective major vascular surgery is unclear.
METHODS: We randomly assigned patients at increased risk for perioperative cardiac complications and clinically significant coronary artery disease to undergo either revascularization or no revascularization before elective major vascular surgery. The primary end point was long-term mortality.
RESULTS: Of 5859 patients scheduled for vascular operations at 18 Veterans Affairs medical centers, 510 (9 percent) were eligible for the study and were randomly assigned to either coronary-artery revascularization before surgery or no revascularization before surgery. The indications for a vascular operation were an expanding abdominal aortic aneurysm (33 percent) or arterial occlusive disease of the legs (67 percent). Among the patients assigned to preoperative coronary-artery revascularization, percutaneous coronary intervention was performed in 59 percent, and bypass surgery was performed in 41 percent. The median time from randomization to vascular surgery was 54 days in the revascularization group and 18 days in the group not undergoing revascularization (P<0.001). At 2.7 years after randomization, mortality in the revascularization group was 22 percent and in the no-revascularization group 23 percent (relative risk, 0.98; 95 percent confidence interval, 0.70 to 1.37; P=0.92). Within 30 days after the vascular operation, a postoperative myocardial infarction, defined by elevated troponin levels, occurred in 12 percent of the revascularization group and 14 percent of the no-revascularization group (P=0.37).
CONCLUSIONS: Coronary-artery revascularization before elective vascular surgery does not significantly alter the long-term outcome. On the basis of these data, a strategy of coronary-artery revascularization before elective vascular surgery among patients with stable cardiac symptoms cannot be recommended.

Copyright 2004 Massachusetts Medical Society.
PMID 15625331  N Engl J Med. 2004 Dec 30;351(27):2795-804. doi: 10.105・・・
著者: Peter K Lindenauer, Penelope Pekow, Kaijun Wang, Dheeresh K Mamidi, Benjamin Gutierrez, Evan M Benjamin
雑誌名: N Engl J Med. 2005 Jul 28;353(4):349-61. doi: 10.1056/NEJMoa041895.
Abstract/Text BACKGROUND: Despite limited evidence from randomized trials, perioperative treatment with beta-blockers is now widely advocated. We assessed the use of perioperative beta-blockers and their association with in-hospital mortality in routine clinical practice.
METHODS: We conducted a retrospective cohort study of patients 18 years of age or older who underwent major noncardiac surgery in 2000 and 2001 at 329 hospitals throughout the United States. We used propensity-score matching to adjust for differences between patients who received perioperative beta-blockers and those who did not receive such therapy and compared in-hospital mortality using multivariable logistic modeling.
RESULTS: Of 782,969 patients, 663,635 (85 percent) had no recorded contraindications to beta-blockers, 122,338 of whom (18 percent) received such treatment during the first two hospital days, including 14 percent of patients with a Revised Cardiac Risk Index (RCRI) score of 0 and 44 percent with a score of 4 or higher. The relationship between perioperative beta-blocker treatment and the risk of death varied directly with cardiac risk; among the 580,665 patients with an RCRI score of 0 or 1, treatment was associated with no benefit and possible harm, whereas among the patients with an RCRI score of 2, 3, or 4 or more, the adjusted odds ratios for death in the hospital were 0.88 (95 percent confidence interval, 0.80 to 0.98), 0.71 (95 percent confidence interval, 0.63 to 0.80), and 0.58 (95 percent confidence interval, 0.50 to 0.67), respectively.
CONCLUSIONS: Perioperative beta-blocker therapy is associated with a reduced risk of in-hospital death among high-risk, but not low-risk, patients undergoing major noncardiac surgery. Patient safety may be enhanced by increasing the use of beta-blockers in high-risk patients.

Copyright 2005 Massachusetts Medical Society.
PMID 16049209  N Engl J Med. 2005 Jul 28;353(4):349-61. doi: 10.1056/N・・・
著者: POISE Study Group, P J Devereaux, Homer Yang, Salim Yusuf, Gordon Guyatt, Kate Leslie, Juan Carlos Villar, Denis Xavier, Susan Chrolavicius, Launi Greenspan, Janice Pogue, Prem Pais, Lisheng Liu, Shouchun Xu, German Málaga, Alvaro Avezum, Matthew Chan, Victor M Montori, Mike Jacka, Peter Choi
雑誌名: Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S0140-6736(08)60601-7. Epub 2008 May 12.
Abstract/Text BACKGROUND: Trials of beta blockers in patients undergoing non-cardiac surgery have reported conflicting results. This randomised controlled trial, done in 190 hospitals in 23 countries, was designed to investigate the effects of perioperative beta blockers.
METHODS: We randomly assigned 8351 patients with, or at risk of, atherosclerotic disease who were undergoing non-cardiac surgery to receive extended-release metoprolol succinate (n=4174) or placebo (n=4177), by a computerised randomisation phone service. Study treatment was started 2-4 h before surgery and continued for 30 days. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary endpoint was a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal cardiac arrest. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00182039.
FINDINGS: All 8351 patients were included in analyses; 8331 (99.8%) patients completed the 30-day follow-up. Fewer patients in the metoprolol group than in the placebo group reached the primary endpoint (244 [5.8%] patients in the metoprolol group vs 290 [6.9%] in the placebo group; hazard ratio 0.84, 95% CI 0.70-0.99; p=0.0399). Fewer patients in the metoprolol group than in the placebo group had a myocardial infarction (176 [4.2%] vs 239 [5.7%] patients; 0.73, 0.60-0.89; p=0.0017). However, there were more deaths in the metoprolol group than in the placebo group (129 [3.1%] vs 97 [2.3%] patients; 1.33, 1.03-1.74; p=0.0317). More patients in the metoprolol group than in the placebo group had a stroke (41 [1.0%] vs 19 [0.5%] patients; 2.17, 1.26-3.74; p=0.0053).
INTERPRETATION: Our results highlight the risk in assuming a perioperative beta-blocker regimen has benefit without substantial harm, and the importance and need for large randomised trials in the perioperative setting. Patients are unlikely to accept the risks associated with perioperative extended-release metoprolol.

PMID 18479744  Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S01・・・
著者: Martin J London, Kwan Hur, Gregory G Schwartz, William G Henderson
雑誌名: JAMA. 2013 Apr 24;309(16):1704-13. doi: 10.1001/jama.2013.4135.
Abstract/Text IMPORTANCE: The effectiveness of perioperative β-blockade in patients undergoing noncardiac surgery remains controversial.
OBJECTIVE: To determine the associations of early perioperative exposure to β-blockers with 30-day postoperative outcome in patients undergoing noncardiac surgery.
DESIGN, SETTING, AND PATIENTS: A retrospective cohort analysis evaluating exposure to β-blockers on the day of or following major noncardiac surgery among a population-based sample of 136,745 patients who were 1:1 matched on propensity scores (37,805 matched pairs) treated at 104 VA medical centers from January 2005 through August 2010.
MAIN OUTCOMES AND MEASURES: All cause 30-day mortality and cardiac morbidity (cardiac arrest or Q-wave myocardial infarction).
RESULTS: Overall 55,138 patients (40.3%) were exposed to β-blockers. Exposure was higher in the 66.7% of 13,863 patients undergoing vascular surgery (95% CI, 65.9%-67.5%) than in the 37.4% of 122,882 patients undergoing nonvascular surgery (95% CI, 37.1%-37.6%; P < .001). Exposure increased as Revised Cardiac Risk Index factors increased, with 25.3% (95% CI, 24.9%-25.6%) of those with no risk vs 71.3% (95% CI, 69.5%-73.2%) of those with 4 risk factors or more exposed to β-blockers (P < .001). Death occurred among 1.1% (95% CI, 1.1%-1.2%) and cardiac morbidity occurred among 0.9% (95% CI, 0.8%-0.9%) of patients. In the propensity matched cohort, exposure was associated with lower mortality (relative risk [RR], 0.73; 95% CI, 0.65-0.83; P < .001; number need to treat [NNT], 241; 95% CI, 173-397). When stratified by cumulative numbers of Revised Cardiac Risk Index factors, β-blocker exposure was associated with significantly lower mortality among patients with 2 factors (RR, 0.63 [95% CI, 0.50-0.80]; P < .001; NNT, 105 [95% CI, 69-212]), 3 factors (RR, 0.54 [95% CI, 0.39-0.73]; P < .001; NNT, 41 [95% CI, 28-80]), or 4 factors or more (RR, 0.40 [95% CI, 0.25-0.73]; P < .001; NNT, 18 [95% CI, 12-34]). This association was limited to patients undergoing nonvascular surgery. β-Blocker exposure was also associated with a lower rate of nonfatal Q-wave infarction or cardiac arrest (RR, 0.67 [95% CI, 0.57-0.79]; P < .001; NNT, 339 [95% CI, 240-582]), again limited to patients undergoing nonvascular surgery.
CONCLUSIONS AND RELEVANCE: Among propensity-matched patients undergoing noncardiac, nonvascular surgery, perioperative β-blocker exposure was associated with lower rates of 30-day all-cause mortality in patients with 2 or more Revised Cardiac Risk Index factors. Our findings support use of a cumulative number of Revised Cardiac Risk Index predictors in decision making regarding institution and continuation of perioperative β-blockade. A multicenter randomized trial involving patients at a low to intermediate risk by these factors would be of interest to validate these observational findings.

PMID 23613075  JAMA. 2013 Apr 24;309(16):1704-13. doi: 10.1001/jama.20・・・
著者: Anai E S Durazzo, Fábio S Machado, Dimas T Ikeoka, Cláudia De Bernoche, Maristela C Monachini, Pedro Puech-Leão, Bruno Caramelli
雑誌名: J Vasc Surg. 2004 May;39(5):967-75; discussion 975-6. doi: 10.1016/j.jvs.2004.01.004.
Abstract/Text OBJECTIVES: This prospective, randomized, placebo-controlled, double-blind clinical trial was performed to analyze the effect of atorvastatin compared with placebo on the occurrence of a 6-month composite of cardiovascular events after vascular surgery. Cardiovascular complications are the most important cause of perioperative morbidity and mortality among patients undergoing vascular surgery. Statin therapy may reduce perioperative cardiac events through stabilization of coronary plaques.
METHODS: One hundred patients were randomly assigned to receive 20 mg atorvastatin or placebo once a day for 45 days, irrespective of their serum cholesterol concentration. Vascular surgery was performed on average 30 days after randomization, and patients were prospectively followed up over 6 months. The cardiovascular events studied were death from cardiac cause, nonfatal myocardial infarction, unstable angina, and stroke.
RESULTS: Fifty patients received atorvastatin, and 50 received placebo. During the 6-month follow-up primary end points occurred in 17 patients, 4 in the atorvastatin group and 13 in the placebo group. The incidence of cardiac events was more than three times higher with placebo (26.0%) compared with atorvastatin (8.0%; P =.031). The risk for an event was compared between the groups with the Kaplan-Meier method, as event-free survival after vascular surgery. Patients given atorvastatin exhibited a significant decrease in the rate of cardiac events, compared with the placebo group, within 6 months after vascular surgery (P =.018).
CONCLUSION: Short-term treatment with atorvastatin significantly reduces the incidence of major adverse cardiovascular events after vascular surgery.

PMID 15111846  J Vasc Surg. 2004 May;39(5):967-75; discussion 975-6. d・・・
著者: Duminda N Wijeysundera, Jennifer S Naik, W Scott Beattie
雑誌名: Am J Med. 2003 Jun 15;114(9):742-52. doi: 10.1016/s0002-9343(03)00165-7.
Abstract/Text PURPOSE: To investigate the effects of alpha(2)-adrenergic agonists on perioperative mortality and cardiovascular complications in adults undergoing surgery.
METHODS: MEDLINE (1966 to May 2002), EMBASE (1980 to May 2002), the Cochrane Clinical Trials Register, the Science Citation Index, and bibliographies of included articles were searched without language restriction. Randomized trials comparing preoperative, intraoperative, or postoperative (first 48 hours) administration of clonidine, dexmedetomidine, or mivazerol with controls were included. Studies had to report any of the following outcomes: mortality, myocardial infarction, ischemia, or supraventricular tachyarrhythmia. Treatment effects were calculated using the fixed-effects model. Heterogeneity was assessed using the Q test.
RESULTS: Twenty-three trials comprising 3395 patients were included. Overall, alpha(2)-adrenergic agonists reduced mortality (relative risk [RR] = 0.64; 95% confidence interval [CI]: 0.42 to 0.99; P = 0.05) and ischemia (RR = 0.76; 95% CI: 0.63 to 0.91; P = 0.003) significantly. They also reduced mortality (RR = 0.47; 95% CI: 0.25 to 0.90; P = 0.02) and myocardial infarction (RR = 0.66; 95% CI: 0.46 to 0.94; P = 0.02) during vascular surgery. During cardiac surgery, alpha(2)-adrenergic agonists reduced ischemia (RR = 0.71; 95% CI: 0.54 to 0.92; P = 0.01) and were associated with trends toward lower mortality (RR = 0.49; 95% CI: 0.12 to 1.98; P = 0.3) and a reduced risk of myocardial infarction (RR = 0.83; 95% CI: 0.35 to 1.96; P = 0.7).
CONCLUSION: Alpha-2 adrenergic agonists reduce mortality and myocardial infarction following vascular surgery. During cardiac surgery, they reduce ischemia and may also have effects on mortality and myocardial infarction. Large randomized trials are needed to evaluate these agents during cardiac and vascular surgery.

PMID 12829201  Am J Med. 2003 Jun 15;114(9):742-52. doi: 10.1016/s0002・・・
著者: Arthur W Wallace, Daniel Galindez, Ali Salahieh, Elizabeth L Layug, Eleanor A Lazo, Kathy A Haratonik, Denis M Boisvert, David Kardatzke
雑誌名: Anesthesiology. 2004 Aug;101(2):284-93. doi: 10.1097/00000542-200408000-00007.
Abstract/Text BACKGROUND: Perioperative myocardial ischemia occurs in 20-40% of patients at risk for cardiac morbidity and is associated with a ninefold increase in risk of cardiac morbidity.
METHODS: In a prospective, double-blinded, clinical trial, we studied 190 patients with or at risk for coronary artery disease in two study groups with a 2:1 ratio (clonidine, n = 125 vs. placebo, n = 65) to test the hypothesis that prophylactic clonidine reduces the incidence of perioperative myocardial ischemia and postoperative death in patients undergoing noncardiac surgery. Clonidine (0.2 mg orally as well as a patch) or placebo (tablet and patch) was administered the night before surgery, and clonidine (0.2 mg orally) or placebo (tablet) was administered on the morning of surgery. The patch or placebo remained on the patient for 4 days and was then removed.
RESULTS: The incidence of perioperative myocardial ischemia was significantly reduced with clonidine (intraoperative and postoperative, 18 of 125, 14% vs. placebo, 20 of 65, 31%; P = 0.01). Prophylactic clonidine administration had minimal hemodynamic effects. Clonidine reduced the incidence of postoperative mortality for up to 2 yr (clonidine, 19 of 125 [15%] vs. placebo, 19 of 65 [29%]; relative risk = 0.43 [confidence interval, 0.21-0.89]; P = 0.035).
CONCLUSIONS: Perioperative administration of clonidine for 4 days to patients at risk for coronary artery disease significantly reduces the incidence of perioperative myocardial ischemia and postoperative death.

PMID 15277909  Anesthesiology. 2004 Aug;101(2):284-93. doi: 10.1097/00・・・
著者: P J Devereaux, Marko Mrkobrada, Daniel I Sessler, Kate Leslie, Pablo Alonso-Coello, Andrea Kurz, Juan Carlos Villar, Alben Sigamani, Bruce M Biccard, Christian S Meyhoff, Joel L Parlow, Gordon Guyatt, Andrea Robinson, Amit X Garg, Reitze N Rodseth, Fernando Botto, Giovanna Lurati Buse, Denis Xavier, Matthew T V Chan, Maria Tiboni, Deborah Cook, Priya A Kumar, Patrice Forget, German Malaga, Edith Fleischmann, Mohammed Amir, John Eikelboom, Richard Mizera, David Torres, C Y Wang, Tomas VanHelder, Pilar Paniagua, Otavio Berwanger, Sadeesh Srinathan, Michelle Graham, Laura Pasin, Yannick Le Manach, Peggy Gao, Janice Pogue, Richard Whitlock, André Lamy, Clive Kearon, Colin Baigent, Clara Chow, Shirley Pettit, Susan Chrolavicius, Salim Yusuf, POISE-2 Investigators
雑誌名: N Engl J Med. 2014 Apr 17;370(16):1494-503. doi: 10.1056/NEJMoa1401105. Epub 2014 Mar 31.
Abstract/Text BACKGROUND: There is substantial variability in the perioperative administration of aspirin in patients undergoing noncardiac surgery, both among patients who are already on an aspirin regimen and among those who are not.
METHODS: Using a 2-by-2 factorial trial design, we randomly assigned 10,010 patients who were preparing to undergo noncardiac surgery and were at risk for vascular complications to receive aspirin or placebo and clonidine or placebo. The results of the aspirin trial are reported here. The patients were stratified according to whether they had not been taking aspirin before the study (initiation stratum, with 5628 patients) or they were already on an aspirin regimen (continuation stratum, with 4382 patients). Patients started taking aspirin (at a dose of 200 mg) or placebo just before surgery and continued it daily (at a dose of 100 mg) for 30 days in the initiation stratum and for 7 days in the continuation stratum, after which patients resumed their regular aspirin regimen. The primary outcome was a composite of death or nonfatal myocardial infarction at 30 days.
RESULTS: The primary outcome occurred in 351 of 4998 patients (7.0%) in the aspirin group and in 355 of 5012 patients (7.1%) in the placebo group (hazard ratio in the aspirin group, 0.99; 95% confidence interval [CI], 0.86 to 1.15; P=0.92). Major bleeding was more common in the aspirin group than in the placebo group (230 patients [4.6%] vs. 188 patients [3.8%]; hazard ratio, 1.23; 95% CI, 1.01, to 1.49; P=0.04). The primary and secondary outcome results were similar in the two aspirin strata.
CONCLUSIONS: Administration of aspirin before surgery and throughout the early postsurgical period had no significant effect on the rate of a composite of death or nonfatal myocardial infarction but increased the risk of major bleeding. (Funded by the Canadian Institutes of Health Research and others; POISE-2 ClinicalTrials.gov number, NCT01082874.).

PMID 24679062  N Engl J Med. 2014 Apr 17;370(16):1494-503. doi: 10.105・・・
著者: Duminda N Wijeysundera, W Scott Beattie
雑誌名: Anesth Analg. 2003 Sep;97(3):634-41. doi: 10.1213/01.ane.0000081732.51871.d2.
Abstract/Text Cardiac complications are the leading cause of death after noncardiac surgery. Despite theoretical benefits, calcium channel blockers (CCB) are not widely used in the perioperative setting. This systematic review assessed the efficacy of CCBs during noncardiac surgery. MEDLINE, EMBASE, Science Citation Index, PubMed, and reference lists were searched without language restriction for randomized controlled trials (RCT) evaluating CCBs during noncardiac surgery. Two reviewers independently abstracted data on death, myocardial infarction (MI), ischemia, supraventricular tachyarrhythmia (SVT), and congestive heart failure (CHF). Treatment effects were calculated as relative risks (RR) with 95% confidence intervals (CI). Eleven studies (1007 patients) were included. CCBs significantly reduced ischemia (RR, 0.49; 95% CI, 0.30-0.80; P = 0.004) and SVT (RR, 0.52; 95% CI, 0.37-0.72; P < 0.0001). CCBs were associated with trends towards reduced death and MI. In post hoc analyses, CCBs significantly reduced death/MI (RR, 0.35; 95% CI, 0.15-0.86; P = 0.02) and major morbid events (MME), defined as death, MI, or CHF (RR, 0.39; 95% CI, 0.17-0.89; P = 0.02). In subgroup analyses, diltiazem significantly reduced ischemia, SVT, death/MI, and MMEs. This meta-analysis shows CCBs significantly reduced ischemia, SVT, and combined end-points in the setting of noncardiac surgery. The majority of these benefits are attributable to diltiazem, suggesting the need for further evaluation of this drug in a large RCT.

PMID 12933374  Anesth Analg. 2003 Sep;97(3):634-41. doi: 10.1213/01.an・・・
著者: David J Rosenman, Furman S McDonald, Jon O Ebbert, Patricia J Erwin, Matthew LaBella, Victor M Montori
雑誌名: J Hosp Med. 2008 Jul;3(4):319-25. doi: 10.1002/jhm.323.
Abstract/Text BACKGROUND: Hospitalists involved in perioperative care either stop or continue until the day of surgery renin-angiotensin-aldosterone system antagonists (either angiotensin-converting enzyme inhibitors [ACEI] or angiotensin II receptor subtype 1 antagonists [ARA]) in patients who use these agents chronically. This practice variation reflects uncertainty regarding the risks and benefits of either approach.
PURPOSE: The purpose of this study was to assess the clinical consequences of preoperatively continuing versus withholding ACEI/ARAs in patients treated chronically with these agents.
DATA SOURCES AND STUDY SELECTION: We comprehensively searched 7 major electronic databases, considered references from selected reviews, hand-searched journals, and communicated with experts. We included randomized trials and observational studies.
DATA EXTRACTION: We evaluated the relative risk (RR) of hypotension requiring vasopressors and of myocardial infarction in patients who did or did not receive an immediate preoperative dose of ACEI or ARA.
DATA SYNTHESIS: Random-effects meta-analysis from 5 studies totaling 434 patients suggested that patients receiving an immediate preoperative ACEI/ARA dose were more likely (RR 1.50, 95% CI 1.15-1.96) to develop hypotension requiring vasopressors at or shortly after induction of anesthesia. Sufficient data were not available to assess other outcomes.
CONCLUSION: Preoperative administration of ACEI/ARAs increases intraoperative hypotension. The long-term clinical consequences of continuing versus withholding preoperative ACEI/ARAs are unknown. This uncertainty stems in part from the absence to date of randomized trials designed specifically to examine patient-important consequences of this decision.

Copyright 2008 Society of Hospital Medicine.
PMID 18698608  J Hosp Med. 2008 Jul;3(4):319-25. doi: 10.1002/jhm.323.・・・
著者: M Bertrand, G Godet, K Meersschaert, L Brun, E Salcedo, P Coriat
雑誌名: Anesth Analg. 2001 Jan;92(1):26-30. doi: 10.1097/00000539-200101000-00006.
Abstract/Text UNLABELLED: Angiotensin II antagonists (AIIA) are part of a new rational treatment of hypertension. Because adverse circulatory effects during anesthesia can occur in patients chronically treated with angiotensin-converting enzyme inhibitors, some clinicians discontinue them at least 24 h before operation. No data are available concerning AIIA administration in patients scheduled for vascular surgery performed under general anesthesia. The aim of this prospective randomized study was to compare hemodynamics during induction of anesthesia in patients chronically treated with AIIA and those of patients not receiving this drug on the morning before operation. Thirty-seven patients chronically treated with AIIA for hypertension were randomly assigned to two groups: Group I: AIIA discontinued on the day before surgery (n = 18); Group II: AIIA given 1 h before anesthesia (n = 19). Patients received sufentanil 0.4 microg/kg, propofol 1.5 mg/kg, and atracurium 0.5 mg/kg. During the procedure, the anesthesiologist was required to maintain systolic blood pressure and heart rate within 30% of baseline values using intravascular fluid administration and vasoconstric- tors (e.g. , ephedrine, phenylephrine, or terlipressin). Hemodynamic variables were recorded each 1 min. Hemodynamic study ended at incision. The number and duration of hemodynamic events were collected, and total doses of vasoactive drugs were noted in each group. Systolic arterial pressure was significantly decreased in Group II at 5, 15 and 23 min after induction of anesthesia (*P < 0.05). In this group, the decrease in systolic arterial pressure was associated with more frequent episodes of hypotension (AIIA withdrawn: 1 +/- 1; AIIA given: 2 +/- 1; P < 0.01), with a larger number of patients developing at least 1 episode of hypotension (AIIA withdrawn: 12; AIIA given: 19; P < 0.01), and a longer duration of an episode of hypotension (AIIA withdrawn: 3 +/- 4 min; AIIA given: 8 +/- 7 min; P < 0.01), and an increased need for vasoactive drugs. In conclusion, blockade of the renin-angiotensin system increases the potential hypotensive effect of anesthetic induction. A severe hypotensive episode, requiring vasoconstrictor treatment, occurs after induction of general anesthesia in patients chronically treated with AIIA. Recommendations to discontinue AIIA drugs on the day before the surgery may be justified.
IMPLICATIONS: This prospective randomized study demonstrated that more severe hypotensive episodes, requiring vasoconstrictor treatment, occur after induction of general anesthesia in patients chronically treated with AIIA and receiving this drug on the morning before operation, in comparison with those in whom AIIA were discontinued on the day before operation. Recommendations to discontinue these drugs on the day before the surgery may be justified.

PMID 11133595  Anesth Analg. 2001 Jan;92(1):26-30. doi: 10.1097/000005・・・
著者: Mary T Hawn, Laura A Graham, Joshua S Richman, Kamal M F Itani, William G Henderson, Thomas M Maddox
雑誌名: JAMA. 2013 Oct 9;310(14):1462-72. doi: 10.1001/jama.2013.278787.
Abstract/Text IMPORTANCE: Guidelines recommend delaying noncardiac surgery in patients after coronary stent procedures for 1 year after drug-eluting stents (DES) and for 6 weeks after bare metal stents (BMS). The evidence underlying these recommendations is limited and conflicting.
OBJECTIVE: To determine risk factors for adverse cardiac events in patients undergoing noncardiac surgery following coronary stent implantation.
DESIGN, SETTING, AND PARTICIPANTS: A national, retrospective cohort study of 41,989 Veterans Affairs (VA) and non-VA operations occurring in the 24 months after a coronary stent implantation between 2000 and 2010. Nonlinear generalized additive models examined the association between timing of surgery and stent type with major adverse cardiac events (MACE) adjusting for patient, surgery, and cardiac risk factors. A nested case-control study assessed the association between perioperative antiplatelet cessation and MACE.
MAIN OUTCOMES AND MEASURES: A composite 30-day MACE rate of all-cause mortality, myocardial infarction, and cardiac revascularization.
RESULTS: Within 24 months of 124,844 coronary stent implantations (47.6% DES, 52.4% BMS), 28,029 patients (22.5%; 95% CI, 22.2%-22.7%) underwent noncardiac operations resulting in 1980 MACE (4.7%; 95% CI, 4.5%-4.9%). Time between stent and surgery was associated with MACE (<6 weeks, 11.6%; 6 weeks to <6 months, 6.4%; 6-12 months, 4.2%; >12-24 months, 3.5%; P < .001). MACE rate by stent type was 5.1% for BMS and 4.3% for DES (P < .001). After adjustment, the 3 factors most strongly associated with MACE were nonelective surgical admission (adjusted odds ratio [AOR], 4.77; 95% CI, 4.07-5.59), history of myocardial infarction in the 6 months preceding surgery (AOR, 2.63; 95% CI, 2.32-2.98), and revised cardiac risk index greater than 2 (AOR, 2.13; 95% CI, 1.85-2.44). Of the 12 variables in the model, timing of surgery ranked fifth in explanatory importance measured by partial effects analysis. Stent type ranked last, and DES was not significantly associated with MACE (AOR, 0.91; 95% CI, 0.83-1.01). After both BMS and DES placement, the risk of MACE was stable at 6 months. A case-control analysis of 284 matched pairs found no association between antiplatelet cessation and MACE (OR, 0.86; 95% CI, 0.57-1.29).
CONCLUSIONS AND RELEVANCE: Among patients undergoing noncardiac surgery within 2 years of coronary stent placement, MACE were associated with emergency surgery and advanced cardiac disease but not stent type or timing of surgery beyond 6 months after stent implantation. Guideline emphasis on stent type and surgical timing for both DES and BMS should be reevaluated.

PMID 24101118  JAMA. 2013 Oct 9;310(14):1462-72. doi: 10.1001/jama.201・・・
著者:
雑誌名: Lancet. 2000 Apr 15;355(9212):1295-302.
Abstract/Text BACKGROUND: Previous trials of antiplatelet therapy for the prevention of venous thromboembolism have individually been inconclusive, but a meta-analysis of their results indicated reductions in the risks of deep-vein thrombosis and of pulmonary embolism in various high-risk groups. The aim of this large randomised placebo-controlled trial was to confirm or refute these apparent benefits.
METHODS: During 1992-1998, 148 hospitals in Australia, New Zealand, South Africa, Sweden and the UK randomised 13,356 patients undergoing surgery for hip fracture, and 22 hospitals in New Zealand randomised a further 4088 patients undergoing elective arthroplasty. Study treatment was 160 mg daily aspirin or placebo, started preoperatively and continued for 35 days. Patients received any other thromboprophylaxis thought necessary. Follow-up was of mortality and of in-hospital morbidity up to day 35.
FINDINGS: Among the patients with hip fracture, allocation to aspirin produced proportional reductions in pulmonary embolism of 43% (95% CI 18-60; p=0.002) and in symptomatic deep-vein thrombosis of 29% (3-48; p=0.03). Pulmonary embolism or deep-vein thrombosis was confirmed in 105 (1.6%) of 6679 patients assigned aspirin compared with 165 (2.5%) of 6677 assigned placebo, which represents an absolute reduction of 9 (SE 2) per 1000 and a proportional reduction of 36% (19-50; p=0.0003). Similar proportional effects were seen in all major subgroups, including patients receiving subcutaneous heparin. Aspirin prevented 4 (1) fatal pulmonary emboli per 1000 patients (18 aspirin-group vs 43 placebo-group deaths), representing a proportional reduction of 58% (27-76; p=0.002), with no apparent effect on deaths from any other vascular cause (hazard ratio 1.04 [95% CI 0.86-1.26]) or non-vascular cause (1.01 [0.84-1.23]). Deaths due to bleeding were few (13 aspirin vs 15 placebo), but there was an excess of 6 (3) postoperative transfused bleeding episodes per 1000 patients assigned aspirin (p=0.04). Among elective-arthroplasty patients, rates of venous thromboembolism were lower, but the proportional effects of aspirin were compatible with those among patients with hip fracture.
INTERPRETATION: These results, along with those of the previous meta-analysis, show that aspirin reduces the risk of pulmonary embolism and deep-vein thrombosis by at least a third throughout a period of increased risk. Hence, there is now good evidence for considering aspirin routinely in a wide range of surgical and medical groups at high risk of venous thromboembolism.

PMID 10776741  Lancet. 2000 Apr 15;355(9212):1295-302.
著者: James D Douketis, Alex C Spyropoulos, Scott Kaatz, Richard C Becker, Joseph A Caprini, Andrew S Dunn, David A Garcia, Alan Jacobson, Amir K Jaffer, David F Kong, Sam Schulman, Alexander G G Turpie, Vic Hasselblad, Thomas L Ortel, BRIDGE Investigators
雑誌名: N Engl J Med. 2015 Aug 27;373(9):823-33. doi: 10.1056/NEJMoa1501035. Epub 2015 Jun 22.
Abstract/Text BACKGROUND: It is uncertain whether bridging anticoagulation is necessary for patients with atrial fibrillation who need an interruption in warfarin treatment for an elective operation or other elective invasive procedure. We hypothesized that forgoing bridging anticoagulation would be noninferior to bridging with low-molecular-weight heparin for the prevention of perioperative arterial thromboembolism and would be superior to bridging with respect to major bleeding.
METHODS: We performed a randomized, double-blind, placebo-controlled trial in which, after perioperative interruption of warfarin therapy, patients were randomly assigned to receive bridging anticoagulation therapy with low-molecular-weight heparin (100 IU of dalteparin per kilogram of body weight) or matching placebo administered subcutaneously twice daily, from 3 days before the procedure until 24 hours before the procedure and then for 5 to 10 days after the procedure. Warfarin treatment was stopped 5 days before the procedure and was resumed within 24 hours after the procedure. Follow-up of patients continued for 30 days after the procedure. The primary outcomes were arterial thromboembolism (stroke, systemic embolism, or transient ischemic attack) and major bleeding.
RESULTS: In total, 1884 patients were enrolled, with 950 assigned to receive no bridging therapy and 934 assigned to receive bridging therapy. The incidence of arterial thromboembolism was 0.4% in the no-bridging group and 0.3% in the bridging group (risk difference, 0.1 percentage points; 95% confidence interval [CI], -0.6 to 0.8; P=0.01 for noninferiority). The incidence of major bleeding was 1.3% in the no-bridging group and 3.2% in the bridging group (relative risk, 0.41; 95% CI, 0.20 to 0.78; P=0.005 for superiority).
CONCLUSIONS: In patients with atrial fibrillation who had warfarin treatment interrupted for an elective operation or other elective invasive procedure, forgoing bridging anticoagulation was noninferior to perioperative bridging with low-molecular-weight heparin for the prevention of arterial thromboembolism and decreased the risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health; BRIDGE ClinicalTrials.gov number, NCT00786474.).

PMID 26095867  N Engl J Med. 2015 Aug 27;373(9):823-33. doi: 10.1056/N・・・
著者: A C Spyropoulos, A G G Turpie, A S Dunn, J Spandorfer, J Douketis, A Jacobson, F J Frost, REGIMEN Investigators
雑誌名: J Thromb Haemost. 2006 Jun;4(6):1246-52. doi: 10.1111/j.1538-7836.2006.01908.x.
Abstract/Text BACKGROUND: Patients who receive long-term oral anticoagulant (OAC) therapy often require interruption of OAC for an elective surgical or an invasive procedure. Heparin bridging therapy has been used in these situations, although the optimal method has not been established. No large prospective studies have compared unfractionated heparin (UFH) with low-molecular-weight heparin (LMWH) for the perioperative management of patients at risk of thromboembolism requiring temporary interruption of long-term OAC therapy.
PATIENTS/METHODS: This multicenter, observational, prospective registry conducted in North America enrolled 901 eligible patients on long-term OAC who required heparin bridging therapy for an elective surgical or invasive procedure. Practice patterns and clinical outcomes were compared between patients who received either UFH alone (n = 180) or LMWH alone (n = 721).
RESULTS: Overall, the majority of patients (74.5%) requiring heparin bridging therapy had arterial indications for OAC. LMWH, in mostly twice-daily treatment doses, represented approximately 80% of the study population. LMWH-bridged patients had significantly fewer arterial indications for OAC, a lower mean Charlson comorbidity score, and were less likely to undergo major or cardiothoracic surgery, receive intraprocedural anticoagulants or thrombolytics, or receive general anesthesia than UFH-bridged patients (all P < 0.05). The LMWH group had significantly more bridging therapy completed in an outpatient setting or with a < 24-h hospital stay vs. the UFH group (63.6% vs. 6.1%, P < 0.001). In the LMWH and UFH groups, similar rates of overall adverse events (16.2% vs. 17.1%, respectively, P = 0.81), major composite adverse events (arterial/venous thromboembolism, major bleed, and death; 4.2% vs. 7.9%, respectively, P = 0.07) and major bleeds (3.3% vs. 5.5%, respectively, P = 0.25) were observed. The thromboembolic event rates were 2.4% for UFH and 0.9% for LMWH. Logistic regression analysis revealed that for postoperative heparin use a Charlson comorbidity score > 1 was an independent predictor of a major bleed and that vascular, general, and major surgery were associated with non-significant trends towards an increased risk of major bleed.
CONCLUSIONS: Treatment-dose LMWH, mostly in the outpatient setting, is used substantially more often than UFH as bridging therapy in patients with predominately arterial indications for OAC. Overall adverse events, including thromboembolism and bleeding, are similar for patients treated with LMWH or UFH. Postoperative heparin bridging should be used with caution in patients with multiple comorbidities and those undergoing vascular, general, and major surgery. These findings need to be confirmed using large randomized trials for specific patient groups undergoing specific procedures.

PMID 16706967  J Thromb Haemost. 2006 Jun;4(6):1246-52. doi: 10.1111/j・・・
著者: J R Balser, E A Martinez, B D Winters, P W Perdue, A W Clarke, W Huang, G F Tomaselli, T Dorman, K Campbell, P Lipsett, M J Breslow, B A Rosenfeld
雑誌名: Anesthesiology. 1998 Nov;89(5):1052-9. doi: 10.1097/00000542-199811000-00004.
Abstract/Text BACKGROUND: Postoperative supraventricular tachyarrhythmia is a common complication of surgery. Because chemical cardioversion is often ineffective, ventricular rate control remains a principal goal of therapy. The authors hypothesized that patients with supraventricular tachyarrhythmia after major noncardiac surgery who receive intravenous beta-adrenergic blockade for ventricular rate control would experience conversion to sinus rhythm at a rate that differs from those receiving intravenous calcium channel blockade.
METHODS: The rate of conversion to sinus rhythm at 2 and 12 h after treatment was examined in 64 cases of postoperative supraventricular tachyarrhythmia. After adenosine administration, patients who remained in supraventricular tachyarrhythmia were prospectively randomized to receive either intravenous diltiazem or intravenous esmolol for ventricular rate control (unblinded). Loading and infusion rates were adjusted to achieve equivalent degrees of ventricular rate control.
RESULTS: Patients were similar with regard to age and Apache III score. Most patients in both groups had atrial fibrillation (esmolol, 79%; diltiazem, 81%), and none experienced stable conversion with adenosine. Patients randomized to receive esmolol experienced a 59% rate of conversion to sinus rhythm within 2 h of treatment, compared with only 33% for patients randomized to receive diltiazem (intention to treat, P = 0.049; odds ratio, 2.9; 95% confidence interval, 1.046 to 7.8). After 12 h of therapy, the number of patients converting to sinus rhythm increased in both groups (esmolol, 85%; diltiazem, 62%), and the rates of conversion no longer differed significantly. Ventricular rates when supraventricular tachyarrhythmia began and after 2 and 12 h of rate control therapy were similar in the two treatment groups. The in-hospital mortality rate and length of stay in the intensive care unit were not significantly influenced by treatment group.
CONCLUSIONS: Among adenosine-resistant patients in the intensive care unit with atrial fibrillation after noncardiac surgery, intravenous esmolol produced a more rapid (2-h) conversion to sinus rhythm than did intravenous diltiazem.

PMID 9821992  Anesthesiology. 1998 Nov;89(5):1052-9. doi: 10.1097/000・・・
著者: Daniel I Sessler, P J Devereaux
雑誌名: Anesth Analg. 2016 Aug;123(2):359-60. doi: 10.1213/ANE.0000000000001450.
Abstract/Text Myocardial injury is the most common cause of death during the 30 days after noncardiac surgery. Only 14% of patients who are experiencing a perioperative myocardial infarction will have chest pain, and 65% are entirely clinically silent, which means that they will go undetected without routine troponin screening. Although it is tempting to dismiss asymptomatic troponin elevation, mortality is similar with and without symptoms. Furthermore, mortality at 30 days in patients who have postoperative troponin elevation is a concerning 10%, which represents a 5-fold increase from background risk. Among inpatients ≥45 years of age who are having noncardiac surgery, the number necessary to screen to detect myocardial injury after noncardiac surgery, that would otherwise be missed, is only about 15 patients. Thus, troponin screening seems appropriate for most surgical inpatients who are ≥45 years of age. Potential acute interventions include initiating therapy such as aspirin, statins, and angiotensin-converting enzyme (ACE) inhibitor antihypertensives, along with chronic lifestyle improvements such as smoking cessation, healthful eating, and exercise.

PMID 27331782  Anesth Analg. 2016 Aug;123(2):359-60. doi: 10.1213/ANE.・・・
著者: S K Epstein, L J Faling, B D Daly, B R Celli
雑誌名: Chest. 1993 Sep;104(3):694-700. doi: 10.1378/chest.104.3.694.
Abstract/Text Recent studies have used preoperative cardiopulmonary exercise testing to improve risk assessment of pulmonary resection for lung cancer. These studies have demonstrated inconsistent correlation between peak oxygen uptake (VO2) and postoperative complications but have not systematically examined other methods of risk stratification. We analyzed the findings in 42 patients who had cardiopulmonary exercise testing prior to lung cancer resection. Preoperative clinical data combining pulmonary factors (obesity, productive cough, wheezing, tobacco use, ratio of the forced expiratory volume in 1 s over the forced vital capacity [FEV1/FVC] < 70 percent, and PaCO2 > 45 mm Hg), and an established cardiac risk index were used to generate a cardiopulmonary risk index (CPRI). When analyzed using the risk index, the incidence of postoperative complications increased with higher CPRI scores. Those with a CPRI of 4 or greater were 22 times more likely to develop a complication, compared to a CPRI of less than 4 (p < 0.0001). We found that patients with a peak VO2 less than 500 ml/m2/min (body surface area) were 6 times more likely to experience a cardiopulmonary complication (p < 0.05). With multiple logistic regression analysis, peak VO2 was not an independent predictor of postoperative complications. Analysis also demonstrated that a CPRI of 4 or greater was associated with significant reductions in peak VO2. We conclude that both the peak VO2 during cardiopulmonary exercise testing and a multifactorial CPRI are highly predictive of complications after lung resection. Adding the peak VO2 did not enhance the risk estimation generated by the CPRI. The association between postoperative complications and peak VO2 may be explained by the correlation between identifiable cardiopulmonary disease (CPRI) and reduced oxygen uptake with exercise.

PMID 8365278  Chest. 1993 Sep;104(3):694-700. doi: 10.1378/chest.104.・・・
著者: G W Smetana
雑誌名: N Engl J Med. 1999 Mar 25;340(12):937-44. doi: 10.1056/NEJM199903253401207.
Abstract/Text
PMID 10089188  N Engl J Med. 1999 Mar 25;340(12):937-44. doi: 10.1056/・・・
著者: Gerald W Smetana, Valerie A Lawrence, John E Cornell, American College of Physicians
雑誌名: Ann Intern Med. 2006 Apr 18;144(8):581-95. doi: 10.7326/0003-4819-144-8-200604180-00009.
Abstract/Text BACKGROUND: The importance of clinical risk factors for postoperative pulmonary complications and the value of preoperative testing to stratify risk are the subject of debate.
PURPOSE: To systematically review the literature on preoperative pulmonary risk stratification before noncardiothoracic surgery.
DATA SOURCES: MEDLINE search from 1 January 1980 through 30 June 2005 and hand search of the bibliographies of retrieved articles.
STUDY SELECTION: English-language studies that reported the effect of patient- and procedure-related risk factors and laboratory predictors on postoperative pulmonary complication rates after noncardiothoracic surgery and that met predefined inclusion criteria.
DATA EXTRACTION: The authors used standardized abstraction instruments to extract data on study characteristics, hierarchy of research design, study quality, risk factors, and laboratory predictors.
DATA SYNTHESIS: The authors determined random-effects pooled estimate odds ratios and, when appropriate, trim-and-fill estimates for patient- and procedure-related risk factors from studies that used multivariable analyses. They assigned summary strength of evidence scores for each factor. Good evidence supports patient-related risk factors for postoperative pulmonary complications, including advanced age, American Society of Anesthesiologists class 2 or higher, functional dependence, chronic obstructive pulmonary disease, and congestive heart failure. Good evidence supports procedure-related risk factors for postoperative pulmonary complications, including aortic aneurysm repair, nonresective thoracic surgery, abdominal surgery, neurosurgery, emergency surgery, general anesthesia, head and neck surgery, vascular surgery, and prolonged surgery. Among laboratory predictors, good evidence exists only for serum albumin level less than 30 g/L. Insufficient evidence supports preoperative spirometry as a tool to stratify risk.
LIMITATIONS: For certain risk factors and laboratory predictors, the literature provides only unadjusted estimates of risk. Prescreening, variable selection algorithms, and publication bias limited reporting of risk factors among studies using multivariable analysis.
CONCLUSIONS: Selected clinical and laboratory factors allow risk stratification for postoperative pulmonary complications after noncardiothoracic surgery.

PMID 16618956  Ann Intern Med. 2006 Apr 18;144(8):581-95. doi: 10.7326・・・
著者: M Nakagawa, H Tanaka, H Tsukuma, Y Kishi
雑誌名: Chest. 2001 Sep;120(3):705-10. doi: 10.1378/chest.120.3.705.
Abstract/Text STUDY OBJECTIVE: To examine the relationship between the duration of the preoperative smoke-free period and the development of postoperative pulmonary complications (PPCs) in patients who underwent pulmonary surgery, and the optimal timing of quitting smoking.
DESIGN: Retrospective cohort study.
SETTING: Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
PATIENTS: Two hundred eighty-eight consecutive patients who underwent pulmonary surgery between January 1997 and December 1998.
MEASUREMENTS AND RESULTS: We collected information on the preoperative characteristics, intraoperative conditions, and occurrence of PPCs by reviewing the medical records. Study subjects were classified into four groups based on their smoking status. A current smoker was defined as one who smoked within 2 weeks prior to the operation. Recent smokers and ex-smokers were defined as those whose duration of abstinence from smoking was 2 to 4 weeks and > 4 weeks prior to the operation, respectively. A never-smoker was defined as one who had never smoked. The incidence of PPCs among the current smokers and recent smokers was 43.6% and 53.8%, respectively, and each was higher than that in the never-smokers (23.9%; p < 0.05). The moving average of the incidence of PPCs gradually decreased in patients whose smoke-free period was 5 to 8 weeks or longer. After controlling for sex, age, results of pulmonary function tests, and duration of surgery, the odds ratios for PPCs developing in current smokers, recent smokers, and ex-smokers in comparison with never-smokers were 2.09 (95% confidence interval [CI], 0.83 to 5.25), 2.44 (95% CI, 0.67 to 8.89), and 1.03 (95% CI, 0.47 to 2.26), respectively.
CONCLUSIONS: These findings indicate that preoperative smoking abstinence of at least 4 weeks is necessary for patients who undergo pulmonary surgery, to reduce the incidence of PPCs.

PMID 11555496  Chest. 2001 Sep;120(3):705-10. doi: 10.1378/chest.120.3・・・
著者: J C Hall, R Tarala, J Harris, J Tapper, K Christiansen
雑誌名: Lancet. 1991 Apr 20;337(8747):953-6. doi: 10.1016/0140-6736(91)91580-n.
Abstract/Text We entered 876 patients into a clinical trial aimed at preventing pulmonary complications after abdominal surgery. Patients either received conventional chest physiotherapy or were encouraged to perform maximal inspiratory manoeuvres for 5 min during each hour while awake, using an incentive spirometer. The incidence of pulmonary complications did not differ significantly between the groups: incentive spirometry 68 of 431 (15.8%, 95% CI 14.0-17.6%), and chest physiotherapy 68 of 445 (15.3%, CI 13.6-17.0%). Nor was there a difference between the groups in the incidence of positive clinical signs, pyrexia, abnormal chest radiographs, pathogens in sputum, respiratory failure (PO2 less than 60 mm Hg), or length of stay in hospital. We conclude that prophylactic incentive spirometry and chest physiotherapy are of equivalent clinical efficacy in the general management of patients undergoing abdominal surgery.

PMID 1678039  Lancet. 1991 Apr 20;337(8747):953-6. doi: 10.1016/0140-・・・
著者: J C Hall, R A Tarala, J Tapper, J L Hall
雑誌名: BMJ. 1996 Jan 20;312(7024):148-52; discussion 152-3. doi: 10.1136/bmj.312.7024.148.
Abstract/Text OBJECTIVE: To evaluate the prevention of respiratory complications after abdominal surgery by a comparison of a global policy of incentive spirometry with a regimen consisting of deep breathing exercises for low risk patients and incentive spirometry plus physiotherapy for high risk patients.
DESIGN: Stratified randomised trial.
SETTING: General surgical service of an urban teaching hospital.
PATIENTS: 456 patients undergoing abdominal surgery. Patients less than 60 years of age with an American Society of Anesthesia classification of 1 were considered to be at low risk.
OUTCOME MEASURES: Respiratory complications were defined as clinical features consistent with collapse or consolidation, a temperature above 38 degrees C, plus either confirmatory chest radiology or positive results on sputum microbiology. We also recorded the time that staff devoted to prophylactic respiratory therapy.
RESULTS: There was good baseline equivalence between the groups. The incidence of respiratory complications was 15% (35/231) for patients in the incentive spirometry group and 12% (28/225) for patients in the mixed therapy group (P = 0.40; 95% confidence interval -3.6% to 9.0%). It required similar amounts of staff time to provide incentive spirometry and deep breathing exercises for low risk patients. The inclusion of physiotherapy for high risk patients, however, resulted in the utilisation of an extra 30 minutes of staff time per patient.
CONCLUSIONS: When the use of resources is taken into account, the most efficient regimen of prophylaxis against respiratory complications after abdominal surgery is deep breathing exercises for low risk patients and incentive spirometry for high risk patients.

PMID 8563533  BMJ. 1996 Jan 20;312(7024):148-52; discussion 152-3. do・・・
著者: L G Bluman, L Mosca, N Newman, D G Simon
雑誌名: Chest. 1998 Apr;113(4):883-9. doi: 10.1378/chest.113.4.883.
Abstract/Text OBJECTIVE: To examine the effect of preoperative smoking behavior on postoperative pulmonary complications.
DESIGN: Prospective cohort study.
SETTING: The Veterans Administration Medical Center, Syracuse, NY.
PARTICIPANTS: Patients scheduled for noncardiac elective surgery (n=410).
MEASUREMENTS AND RESULTS: Smoking status was determined by self-report. Postoperative pulmonary complications were determined by systematic extraction of medical record data. Postoperative pulmonary complications occurred in 31 of 141 (22.0%) current smokers, 24 of 187 (12.8%) past smokers, and 4 of 82 (4.9%) never smokers. The odds ratio (OR) for developing a postoperative pulmonary complication for current smokers vs never smokers was 5.5 (95% confidence interval [CI], 1.9 to 16.2) and 4.2 (95% CI, 1.2 to 14.8) after adjustment for type of surgery, type of anesthesia, abnormal chest radiograph, chronic cough, history of pulmonary disease, history of cardiac disease, history of COPD, education level, pulmonary function, body mass index, and age. Current smokers who reported reducing cigarette consumption prior to surgery were more likely to develop a complication compared with those who did not (adjusted OR=6.7, 95% CI, 2.6 to 17.1).
CONCLUSIONS: Current smoking was associated with a nearly sixfold increase in risk for a postoperative pulmonary complication. Reduction in smoking within 1 month of surgery was not associated with a decreased risk of postoperative pulmonary complications.

PMID 9554620  Chest. 1998 Apr;113(4):883-9. doi: 10.1378/chest.113.4.・・・
著者: Magdy Selim
雑誌名: N Engl J Med. 2007 Feb 15;356(7):706-13. doi: 10.1056/NEJMra062668.
Abstract/Text
PMID 17301301  N Engl J Med. 2007 Feb 15;356(7):706-13. doi: 10.1056/N・・・
著者: T L Janssen, A R Alberts, L Hooft, Fus Mattace-Raso, C A Mosk, L van der Laan
雑誌名: Clin Interv Aging. 2019;14:1095-1117. doi: 10.2147/CIA.S201323. Epub 2019 Jun 19.
Abstract/Text Introduction: Vulnerable or "frail" patients are susceptible to the development of delirium when exposed to triggers such as surgical procedures. Once delirium occurs, interventions have little effect on severity or duration, emphasizing the importance of primary prevention. This review provides an overview of interventions to prevent postoperative delirium in elderly patients undergoing elective surgery. Methods: A literature search was conducted in March 2018. Randomized controlled trials (RCTs) and before-and-after studies on interventions with potential effects on postoperative delirium in elderly surgical patients were included. Acute admission, planned ICU admission, and cardiac patients were excluded. Full texts were reviewed, and quality was assessed by two independent reviewers. Primary outcome was the incidence of delirium. Secondary outcomes were severity and duration of delirium. Pooled risk ratios (RRs) were calculated for incidences of delirium where similar intervention techniques were used. Results: Thirty-one RCTs and four before-and-after studies were included for analysis. In 19 studies, intervention decreased the incidences of postoperative delirium. Severity was reduced in three out of nine studies which reported severity of delirium. Duration was reduced in three out of six studies. Pooled analysis showed a significant reduction in delirium incidence for dexmedetomidine treatment, and bispectral index (BIS)-guided anaesthesia. Based on sensitivity analyses, by leaving out studies with a high risk of bias, multicomponent interventions and antipsychotics can also significantly reduce the incidence of delirium. Conclusion: Multicomponent interventions, the use of antipsychotics, BIS-guidance, and dexmedetomidine treatment can successfully reduce the incidence of postoperative delirium in elderly patients undergoing elective, non-cardiac surgery. However, present studies are heterogeneous, and high-quality studies are scarce. Future studies should add these preventive methods to already existing multimodal and multidisciplinary interventions to tackle as many precipitating factors as possible, starting in the pre-admission period.

PMID 31354253  Clin Interv Aging. 2019;14:1095-1117. doi: 10.2147/CIA.・・・
著者: Robert L Schiff, Gail A Welsh
雑誌名: Med Clin North Am. 2003 Jan;87(1):175-92. doi: 10.1016/s0025-7125(02)00150-5.
Abstract/Text Whenever possible, endocrine disorders should be identified and evaluated prior to surgery. A plan for perioperative management of diabetes should be based on the type of diabetes, what diabetes medications are taken, the status of diabetes control, and what type of surgery is planned. Perioperative management of diabetes must include bedside glucose monitoring. Patients with mild hypothyroidism can safely proceed with elective surgery. Elective surgery should be postponed for patients with moderate or severe hypothyroidism. Patients who have mild hyperthyroidism can undergo elective surgery with preoperative beta blockade. Elective surgery should not be done on patients with moderate or severe hyperthyroidism until they are euthyroid. Patients with pheochromocytoma need to be identified and properly treated before surgery to prevent perioperative cardiovascular complications. Patients who take endogenous steroids should have the status of their HPA axis determined prior to surgery. If the patient is undergoing moderate or major surgical stress and has documented or presumed HPA suppression, then stress doses of steroids should be give perioperatively.

PMID 12575889  Med Clin North Am. 2003 Jan;87(1):175-92. doi: 10.1016/・・・
著者: Douglas B Coursin, Kenneth E Wood
雑誌名: JAMA. 2002 Jan 9;287(2):236-40. doi: 10.1001/jama.287.2.236.
Abstract/Text
PMID 11779267  JAMA. 2002 Jan 9;287(2):236-40. doi: 10.1001/jama.287.2・・・
著者: Joseph T King, Joseph L Goulet, Melissa F Perkal, Ronnie A Rosenthal
雑誌名: Ann Surg. 2011 Jan;253(1):158-65. doi: 10.1097/SLA.0b013e3181f9bb3a.
Abstract/Text OBJECTIVE: Examine the relationship between perioperative glucose control and postoperative infections in a nationwide sample of diabetic patients undergoing a wide variety of surgical procedures.
SUMMARY OF BACKGROUND DATA: Perioperative glucose control has been linked to postoperative infections after selected surgical procedures.
METHODS: Retrospective analysis of surgical outcomes data from 1999 to 2004 on 55,408 patients with diabetes undergoing a variety of noncardiac operations contained in the Veterans Heath Administration National Surgical Quality Improvement Program database, supplemented with the Veterans Heath Administration Decision Support Services hemoglobin A1c (HbA(₁c)) and serum glucose data. Multivariate Poisson regression model of postoperative infection including demographics, comorbidities, functional status, preoperative laboratories, surgical data, and glucose control (diabetes medications, serum glucose, HbA(₁c), mean serum glucose within 24 hours after surgery).
RESULTS: The most common procedures were herniorrhaphy (10%), carotid endarterectomy (6.6%), and open colectomy (5.6%). Mean (SD) preoperative HbA1c concentration was 7.9% (2.3); 51% of patients had preoperative serum glucose concentrations more than 150 mg/dL; and 72% of patients had a mean 24 hour postoperative glucose concentration at least 150 mg/dL. The overall postoperative infection rate was 8.0%. Higher rates of postoperative infection were associated with mean 24 hour postoperative serum glucose concentrations of 150 to 250 mg/dL (incidence rate ratio 1.22, 95% confidence interval, 1.04-1.43; P = 0.01) and more than 250 mg/dL (incidence rate ratio: 1.43; 95% confidence interval, 1.19-1.71; P < 0.001). Preoperative HbA1c and glucose concentrations were not associated with increased infection rates.
CONCLUSIONS: In a large nationwide sample of diabetic patients undergoing a variety of noncardiac surgical procedures, glucose control in the first 24 hours after surgery was poor, and mean serum glucose concentrations of 150 mg/dL and higher during this time period were associated with increased rates of postoperative infectious complications.

PMID 21135698  Ann Surg. 2011 Jan;253(1):158-65. doi: 10.1097/SLA.0b01・・・
著者: NICE-SUGAR Study Investigators, Simon Finfer, Dean R Chittock, Steve Yu-Shuo Su, Deborah Blair, Denise Foster, Vinay Dhingra, Rinaldo Bellomo, Deborah Cook, Peter Dodek, William R Henderson, Paul C Hébert, Stephane Heritier, Daren K Heyland, Colin McArthur, Ellen McDonald, Imogen Mitchell, John A Myburgh, Robyn Norton, Julie Potter, Bruce G Robinson, Juan J Ronco
雑誌名: N Engl J Med. 2009 Mar 26;360(13):1283-97. doi: 10.1056/NEJMoa0810625. Epub 2009 Mar 24.
Abstract/Text BACKGROUND: The optimal target range for blood glucose in critically ill patients remains unclear.
METHODS: Within 24 hours after admission to an intensive care unit (ICU), adults who were expected to require treatment in the ICU on 3 or more consecutive days were randomly assigned to undergo either intensive glucose control, with a target blood glucose range of 81 to 108 mg per deciliter (4.5 to 6.0 mmol per liter), or conventional glucose control, with a target of 180 mg or less per deciliter (10.0 mmol or less per liter). We defined the primary end point as death from any cause within 90 days after randomization.
RESULTS: Of the 6104 patients who underwent randomization, 3054 were assigned to undergo intensive control and 3050 to undergo conventional control; data with regard to the primary outcome at day 90 were available for 3010 and 3012 patients, respectively. The two groups had similar characteristics at baseline. A total of 829 patients (27.5%) in the intensive-control group and 751 (24.9%) in the conventional-control group died (odds ratio for intensive control, 1.14; 95% confidence interval, 1.02 to 1.28; P=0.02). The treatment effect did not differ significantly between operative (surgical) patients and nonoperative (medical) patients (odds ratio for death in the intensive-control group, 1.31 and 1.07, respectively; P=0.10). Severe hypoglycemia (blood glucose level, < or = 40 mg per deciliter [2.2 mmol per liter]) was reported in 206 of 3016 patients (6.8%) in the intensive-control group and 15 of 3014 (0.5%) in the conventional-control group (P<0.001). There was no significant difference between the two treatment groups in the median number of days in the ICU (P=0.84) or hospital (P=0.86) or the median number of days of mechanical ventilation (P=0.56) or renal-replacement therapy (P=0.39).
CONCLUSIONS: In this large, international, randomized trial, we found that intensive glucose control increased mortality among adults in the ICU: a blood glucose target of 180 mg or less per deciliter resulted in lower mortality than did a target of 81 to 108 mg per deciliter. (ClinicalTrials.gov number, NCT00220987.)

2009 Massachusetts Medical Society
PMID 19318384  N Engl J Med. 2009 Mar 26;360(13):1283-97. doi: 10.1056・・・
著者: Guillermo E Umpierrez, Dawn Smiley, Ariel Zisman, Luz M Prieto, Andres Palacio, Miguel Ceron, Alvaro Puig, Roberto Mejia
雑誌名: Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10.2337/dc07-0295. Epub 2007 May 18.
Abstract/Text OBJECTIVE: We sought to study the optimal management of hyperglycemia in non-intensive care unit patients with type 2 diabetes, as few studies thus far have focused on the subject.
RESEARCH DESIGN AND METHODS: We conducted a prospective, multicenter, randomized trial to compare the efficacy and safety of a basal-bolus insulin regimen with that of sliding-scale regular insulin (SSI) in patients with type 2 diabetes. A total of 130 insulin-naive patients were randomized to receive glargine and glulisine (n = 65) or a standard SSI protocol (n = 65). Glargine was given once daily and glulisine before meals at a starting dose of 0.4 units x kg(-1) x day(-1) for blood glucose 140-200 mg/dl or 0.5 units x kg(-1) x day(-1) for blood glucose 201-400 mg/dl. SSI was given four times per day for blood glucose >140 mg/dl.
RESULTS: The mean admission blood glucose was 229 +/- 6 mg/dl and A1C 8.8 +/- 2%. A blood glucose target of <140 mg/dl was achieved in 66% of patients in the glargine and glulisine group and in 38% of those in the SSI group. The mean daily blood glucose between groups ranged from 23 to 58 mg/dl, with an overall blood glucose difference of 27 mg/dl (P < 0.01). Despite increasing insulin doses, 14% of patients treated with SSI remained with blood glucose >240 mg/dl. There were no differences in the rate of hypoglycemia or length of hospital stay.
CONCLUSIONS: Treatment with insulin glargine and glulisine resulted in significant improvement in glycemic control compared with that achieved with the use of SSI alone. Our study indicates that a basal-bolus insulin regimen is preferred over SSI in the management of non-critically ill, hospitalized patients with type 2 diabetes.

PMID 17513708  Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10.2337/dc07・・・
著者: Gavin J Murphy, Katie Pike, Chris A Rogers, Sarah Wordsworth, Elizabeth A Stokes, Gianni D Angelini, Barnaby C Reeves, TITRe2 Investigators
雑誌名: N Engl J Med. 2015 Mar 12;372(11):997-1008. doi: 10.1056/NEJMoa1403612.
Abstract/Text BACKGROUND: Whether a restrictive threshold for hemoglobin level in red-cell transfusions, as compared with a liberal threshold, reduces postoperative morbidity and health care costs after cardiac surgery is uncertain.
METHODS: We conducted a multicenter, parallel-group trial in which patients older than 16 years of age who were undergoing nonemergency cardiac surgery were recruited from 17 centers in the United Kingdom. Patients with a postoperative hemoglobin level of less than 9 g per deciliter were randomly assigned to a restrictive transfusion threshold (hemoglobin level <7.5 g per deciliter) or a liberal transfusion threshold (hemoglobin level <9 g per deciliter). The primary outcome was a serious infection (sepsis or wound infection) or an ischemic event (permanent stroke [confirmation on brain imaging and deficit in motor, sensory, or coordination functions], myocardial infarction, infarction of the gut, or acute kidney injury) within 3 months after randomization. Health care costs, excluding the index surgery, were estimated from the day of surgery to 3 months after surgery.
RESULTS: A total of 2007 patients underwent randomization; 4 participants withdrew, leaving 1000 in the restrictive-threshold group and 1003 in the liberal-threshold group. Transfusion rates after randomization were 53.4% and 92.2% in the two groups, respectively. The primary outcome occurred in 35.1% of the patients in the restrictive-threshold group and 33.0% of the patients in the liberal-threshold group (odds ratio, 1.11; 95% confidence interval [CI], 0.91 to 1.34; P=0.30); there was no indication of heterogeneity according to subgroup. There were more deaths in the restrictive-threshold group than in the liberal-threshold group (4.2% vs. 2.6%; hazard ratio, 1.64; 95% CI, 1.00 to 2.67; P=0.045). Serious postoperative complications, excluding primary-outcome events, occurred in 35.7% of participants in the restrictive-threshold group and 34.2% of participants in the liberal-threshold group. Total costs did not differ significantly between the groups.
CONCLUSIONS: A restrictive transfusion threshold after cardiac surgery was not superior to a liberal threshold with respect to morbidity or health care costs. (Funded by the National Institute for Health Research Health Technology Assessment program; Current Controlled Trials number, ISRCTN70923932.).

PMID 25760354  N Engl J Med. 2015 Mar 12;372(11):997-1008. doi: 10.105・・・
著者: Jeffrey L Carson, Michael L Terrin, Helaine Noveck, David W Sanders, Bernard R Chaitman, George G Rhoads, George Nemo, Karen Dragert, Lauren Beaupre, Kevin Hildebrand, William Macaulay, Courtland Lewis, Donald Richard Cook, Gwendolyn Dobbin, Khwaja J Zakriya, Fred S Apple, Rebecca A Horney, Jay Magaziner, FOCUS Investigators
雑誌名: N Engl J Med. 2011 Dec 29;365(26):2453-62. doi: 10.1056/NEJMoa1012452. Epub 2011 Dec 14.
Abstract/Text BACKGROUND: The hemoglobin threshold at which postoperative red-cell transfusion is warranted is controversial. We conducted a randomized trial to determine whether a higher threshold for blood transfusion would improve recovery in patients who had undergone surgery for hip fracture.
METHODS: We enrolled 2016 patients who were 50 years of age or older, who had either a history of or risk factors for cardiovascular disease, and whose hemoglobin level was below 10 g per deciliter after hip-fracture surgery. We randomly assigned patients to a liberal transfusion strategy (a hemoglobin threshold of 10 g per deciliter) or a restrictive transfusion strategy (symptoms of anemia or at physician discretion for a hemoglobin level of <8 g per deciliter). The primary outcome was death or an inability to walk across a room without human assistance on 60-day follow-up.
RESULTS: A median of 2 units of red cells were transfused in the liberal-strategy group and none in the restrictive-strategy group. The rates of the primary outcome were 35.2% in the liberal-strategy group and 34.7% in the restrictive-strategy group (odds ratio in the liberal-strategy group, 1.01; 95% confidence interval [CI], 0.84 to 1.22), for an absolute risk difference of 0.5 percentage points (95% CI, -3.7 to 4.7). The rates of in-hospital acute coronary syndrome or death were 4.3% and 5.2%, respectively (absolute risk difference, -0.9%; 99% CI, -3.3 to 1.6), and rates of death on 60-day follow-up were 7.6% and 6.6%, respectively (absolute risk difference, 1.0%; 99% CI, -1.9 to 4.0). The rates of other complications were similar in the two groups.
CONCLUSIONS: A liberal transfusion strategy, as compared with a restrictive strategy, did not reduce rates of death or inability to walk independently on 60-day follow-up or reduce in-hospital morbidity in elderly patients at high cardiovascular risk. (Funded by the National Heart, Lung, and Blood Institute; FOCUS ClinicalTrials.gov number, NCT00071032.).

PMID 22168590  N Engl J Med. 2011 Dec 29;365(26):2453-62. doi: 10.1056・・・
著者: P C Hébert, G Wells, M A Blajchman, J Marshall, C Martin, G Pagliarello, M Tweeddale, I Schweitzer, E Yetisir
雑誌名: N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601.
Abstract/Text BACKGROUND: To determine whether a restrictive strategy of red-cell transfusion and a liberal strategy produced equivalent results in critically ill patients, we compared the rates of death from all causes at 30 days and the severity of organ dysfunction.
METHODS: We enrolled 838 critically ill patients with euvolemia after initial treatment who had hemoglobin concentrations of less than 9.0 g per deciliter within 72 hours after admission to the intensive care unit and randomly assigned 418 patients to a restrictive strategy of transfusion, in which red cells were transfused if the hemoglobin concentration dropped below 7.0 g per deciliter and hemoglobin concentrations were maintained at 7.0 to 9.0 g per deciliter, and 420 patients to a liberal strategy, in which transfusions were given when the hemoglobin concentration fell below 10.0 g per deciliter and hemoglobin concentrations were maintained at 10.0 to 12.0 g per deciliter.
RESULTS: Overall, 30-day mortality was similar in the two groups (18.7 percent vs. 23.3 percent, P= 0.11). However, the rates were significantly lower with the restrictive transfusion strategy among patients who were less acutely ill -- those with an Acute Physiology and Chronic Health Evaluation II score of < or =20 (8.7 percent in the restrictive-strategy group and 16.1 percent in the liberal-strategy group; P=0.03) -- and among patients who were less than 55 years of age (5.7 percent and 13.0 percent, respectively; P=0.02), but not among patients with clinically significant cardiac disease (20.5 percent and 22.9 percent, respectively; P=0.69). The mortality rate during hospitalization was significantly lower in the restrictive-strategy group (22.3 percent vs. 28.1 percent, P=0.05).
CONCLUSIONS: A restrictive strategy of red-cell transfusion is at least as effective as and possibly superior to a liberal transfusion strategy in critically ill patients, with the possible exception of patients with acute myocardial infarction and unstable angina.

PMID 9971864  N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/N・・・
著者: Joseph A Caprini
雑誌名: Am J Surg. 2010 Jan;199(1 Suppl):S3-10. doi: 10.1016/j.amjsurg.2009.10.006.
Abstract/Text BACKGROUND: Approximately 900,000 cases of deep vein thrombosis and pulmonary embolism occur annually in the United States, and one-third lead to the patient's death. A variety of surgical factors contribute to Virchow's triad of venous stasis, vascular injury, and hypercoagulability, including intraoperative venous distension and microvascular endothelial damage. Patients also may have individual risk factors such as a history of thromboembolism, cancer, advanced age, or a genetic trait linked to hypercoagulation. This article discusses recent trends in the development and validation of venous thromboembolism risk scores, including the results of a large validation study.
DATA SOURCES: A Medline literature search was performed to identify original studies.
CONCLUSIONS: Venous thromboembolism risk scores have been developed for groups of patients based on a few broad risk categories, but a more accurate, individualized risk score can be obtained using a recently validated risk scoring system, which can be used to determine the type and length of prophylaxis to administer. Further studies are under way to refine this system.

Copyright 2010 Elsevier Inc. All rights reserved.
PMID 20103082  Am J Surg. 2010 Jan;199(1 Suppl):S3-10. doi: 10.1016/j.・・・
著者: Yngve Falck-Ytter, Charles W Francis, Norman A Johanson, Catherine Curley, Ola E Dahl, Sam Schulman, Thomas L Ortel, Stephen G Pauker, Clifford W Colwell
雑誌名: Chest. 2012 Feb;141(2 Suppl):e278S-e325S. doi: 10.1378/chest.11-2404.
Abstract/Text BACKGROUND: VTE is a serious, but decreasing complication following major orthopedic surgery. This guideline focuses on optimal prophylaxis to reduce postoperative pulmonary embolism and DVT.
METHODS: The methods of this guideline follow those described in Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines in this supplement.
RESULTS: In patients undergoing major orthopedic surgery, we recommend the use of one of the following rather than no antithrombotic prophylaxis: low-molecular-weight heparin; fondaparinux; dabigatran, apixaban, rivaroxaban (total hip arthroplasty or total knee arthroplasty but not hip fracture surgery); low-dose unfractionated heparin; adjusted-dose vitamin K antagonist; aspirin (all Grade 1B); or an intermittent pneumatic compression device (IPCD) (Grade 1C) for a minimum of 10 to 14 days. We suggest the use of low-molecular-weight heparin in preference to the other agents we have recommended as alternatives (Grade 2C/2B), and in patients receiving pharmacologic prophylaxis, we suggest adding an IPCD during the hospital stay (Grade 2C). We suggest extending thromboprophylaxis for up to 35 days (Grade 2B). In patients at increased bleeding risk, we suggest an IPCD or no prophylaxis (Grade 2C). In patients who decline injections, we recommend using apixaban or dabigatran (all Grade 1B). We suggest against using inferior vena cava filter placement for primary prevention in patients with contraindications to both pharmacologic and mechanical thromboprophylaxis (Grade 2C). We recommend against Doppler (or duplex) ultrasonography screening before hospital discharge (Grade 1B). For patients with isolated lower-extremity injuries requiring leg immobilization, we suggest no thromboprophylaxis (Grade 2B). For patients undergoing knee arthroscopy without a history of VTE, we suggest no thromboprophylaxis (Grade 2B).
CONCLUSIONS: Optimal strategies for thromboprophylaxis after major orthopedic surgery include pharmacologic and mechanical approaches.

PMID 22315265  Chest. 2012 Feb;141(2 Suppl):e278S-e325S. doi: 10.1378/・・・
著者: Konstantinos C Siontis, Xiaosong Zhang, Ashley Eckard, Nicole Bhave, Douglas E Schaubel, Kevin He, Anca Tilea, Austin G Stack, Rajesh Balkrishnan, Xiaoxi Yao, Peter A Noseworthy, Nilay D Shah, Rajiv Saran, Brahmajee K Nallamothu
雑誌名: Circulation. 2018 Oct 9;138(15):1519-1529. doi: 10.1161/CIRCULATIONAHA.118.035418.
Abstract/Text BACKGROUND: Patients with end-stage kidney disease (ESKD) on dialysis were excluded from clinical trials of direct oral anticoagulants for atrial fibrillation (AF). Recent data have raised concerns regarding the safety of dabigatran and rivaroxaban, but apixaban has not been evaluated despite current labeling supporting its use in this population. The goal of this study was to determine patterns of apixaban use and its associated outcomes in dialysis-dependent patients with ESKD and AF.
METHODS: We performed a retrospective cohort study of Medicare beneficiaries included in the United States Renal Data System (October 2010 to December 2015). Eligible patients were those with ESKD and AF undergoing dialysis who initiated treatment with an oral anticoagulant. Because of the small number of dabigatran and rivaroxaban users, outcomes were only assessed in patients treated with apixaban or warfarin. Apixaban and warfarin patients were matched (1:3) based on prognostic score. Differences between groups in survival free of stroke or systemic embolism, major bleeding, gastrointestinal bleeding, intracranial bleeding, and death were assessed using Kaplan-Meier analyses. Hazard ratios (HRs) and 95% CIs were derived from Cox regression analyses.
RESULTS: The study population consisted of 25 523 patients (45.7% women; 68.2±11.9 years of age), including 2351 patients on apixaban and 23 172 patients on warfarin. An annual increase in apixaban prescriptions was observed after its marketing approval at the end of 2012, such that 26.6% of new anticoagulant prescriptions in 2015 were for apixaban. In matched cohorts, there was no difference in the risks of stroke/systemic embolism between apixaban and warfarin (HR, 0.88; 95% CI, 0.69-1.12; P=0.29), but apixaban was associated with a significantly lower risk of major bleeding (HR, 0.72; 95% CI, 0.59-0.87; P<0.001). In sensitivity analyses, standard-dose apixaban (5 mg twice a day; n=1034) was associated with significantly lower risks of stroke/systemic embolism and death as compared with either reduced-dose apixaban (2.5 mg twice a day; n=1317; HR, 0.61; 95% CI, 0.37-0.98; P=0.04 for stroke/systemic embolism; HR, 0.64; 95% CI, 0.45-0.92; P=0.01 for death) or warfarin (HR, 0.64; 95% CI, 0.42-0.97; P=0.04 for stroke/systemic embolism; HR, 0.63; 95% CI, 0.46-0.85; P=0.003 for death).
CONCLUSIONS: Among patients with ESKD and AF on dialysis, apixaban use may be associated with a lower risk of major bleeding compared with warfarin, with a standard 5 mg twice a day dose also associated with reductions in thromboembolic and mortality risk.

PMID 29954737  Circulation. 2018 Oct 9;138(15):1519-1529. doi: 10.1161・・・
著者: Brandon R Hood, Mark E Cowen, Huiyong T Zheng, Richard E Hughes, Bonita Singal, Brian R Hallstrom
雑誌名: JAMA Surg. 2019 Jan 1;154(1):65-72. doi: 10.1001/jamasurg.2018.3858.
Abstract/Text Importance: There has been significant debate in the surgical and medical communities regarding the appropriateness of using aspirin alone for venous thromboembolism (VTE) prophylaxis following total knee arthroplasty (TKA).
Objective: To determine the acceptability of aspirin alone vs anticoagulant prophylaxis for reducing the risk of postoperative VTE in patients undergoing TKA.
Design, Setting, and Participants: Noninferiority study of a retrospective cohort of TKA cases submitted to the Michigan Arthroplasty Registry Collaborative Quality Initiative at 29 member hospitals, ranging from small community hospitals to large academic and nonacademic medical centers in Michigan. The study included 41 537 patients who underwent primary TKA between April 1, 2013, and October 31, 2015. Clinical events were monitored for 90 days after surgery. Data were analyzed between September and October 2016.
Exposures: The method of pharmacologic prophylaxis: neither aspirin nor anticoagulants for 668 patients (1.6%), aspirin only for 12 831 patients (30.9%), anticoagulant only (eg, low-molecular-weight heparin, warfarin, and Xa inhibitors) for 22 620 patients (54.5%), and both aspirin/anticoagulant for 5418 patients (13.0%). Most patients were also using intermittent pneumatic compression stockings.
Main Outcome and Measures: The primary composite outcome was the first occurrence of VTE or death. The noninferiority margin was specified as 0.3. The secondary outcome was bleeding events.
Results: Of the 41 537 patients, 14 966 were men (36%), and the mean age was 65.8 years. A VTE event occurred in 573 of 41 537 patients (1.38%); 32 of 668 (4.79%) who received no pharmacologic prophylaxis, 149 of 12 831 (1.16%) treated with aspirin alone, 321 of 22 620 (1.42%) with anticoagulation alone, and 71 of 5418 (1.31%) prescribed both aspirin and anticoagulation. Aspirin only was noninferior for the composite VTE outcome compared with those receiving other chemoprophylaxis (adjusted odds ratio, 0.85; 95% CI, 0.68-1.07, P for inferiority = .007). Bleeding occurred in 457 of 41 537 patients (1.10%), 10 of 668 (1.50%) without prophylaxis, 116 of 12 831 (0.90%) in the aspirin group, 258 of 22 620 (1.14%) with anticoagulation, and 73 of 5418 (1.35%) of those receiving both. Aspirin alone was also noninferior for bleeding complications (adjusted odds ratio, 0.80; 95% CI, 0.63-1.00, P for inferiority <.001).
Conclusions and Relevance: In this study of patients undergoing TKA, aspirin was not inferior to other anticoagulants in the postoperative rate of VTE or death. Aspirin alone may provide similar protection from postoperative VTE compared with other anticoagulation treatments.

PMID 30347089  JAMA Surg. 2019 Jan 1;154(1):65-72. doi: 10.1001/jamasu・・・

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