今日の臨床サポート

人工心臓弁植込み患者のフォローアップ

著者: 小野稔 東京大学 心臓外科

監修: 今井靖 自治医科大学 薬理学講座臨床薬理学部門・内科学講座循環器内科学部門

著者校正済:2021/07/21
現在監修レビュー中
患者向け説明資料

概要・推奨   

  1. 人工弁(機械弁・生体弁ともに)置換術後3カ月未満の症例に対しては、PT-INR 2.0~3.0になるようにワーファリンコントロールを行う(推奨度1)
  1. 低リスクの大動脈機械弁置換術後3カ月以降の症例に対しては、PT-INR 2.0~2.5になるようにワーファリンコントロールを行う(推奨度1)
  1. 僧帽弁位機械弁置換術後3カ月以降の症例に対しては、PT-INR 2.0~3.0になるようにワーファリンコントロールを行う(推奨度1)
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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:
小野稔 : 講演料(日本メドトロニック),奨学(奨励)寄付など(エドワーズライフサイエンス,アボットメディカルジャパン)[2021年]
監修:今井靖 : 講演料(第一三共株式会社)[2021年]

改訂のポイント:
  1. 「2020年改訂版弁膜症のガイドライン」に基づいて改訂を行った。
  1. 生体弁による弁置換術後で血栓塞栓症の危険因子を持つ場合、術後3カ月以降もPT-INR 2.0~2.5を目標にワーファリン投与を考慮するが、アスピリンの併用については削除した。
  1. 「TAVI後6カ月未満におけるアスピリン75~100㎎およびクロピドグレル75mgの併用投与の後、アスリピンまたはクロピドグレルの単独投与の続行について」、推奨度2として新規追加した。
  1. 手術症例数を更新した。

まとめ・診察

手術のまとめ  
  1. 日本胸部外科学会2017年学術調査によると、弁膜症手術(31,608弁23,312手術)の方法は形成術が43.9%、生体弁置換術が45.1%、機械弁置換術が11.0%であり、機械弁使用症例が減少している。
  1. 治療対象の弁は、大動脈弁が43.9%、僧帽弁が35.5%とほぼ同数であった。
  1. 機械弁は炭素合金を中心とした人工材料から成り、最近の弁はすべて二葉弁であるが、かつて傾斜ディスク弁を使用された患者もわずかに通院している。機械弁は抗凝固療法が必須となる。
  1. 生体弁はブタ大動脈弁やウシ・ブタの心膜弁から成っている。生体弁は心機能、手術時期、不整脈や合併疾患の有無などを加味して抗凝固療法が行われる。
問診・診察のポイント  
  1. 以下の要因を考慮しながら人工弁植込み後の外来通院の間隔を決める。

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文献 

著者: Helmut Baumgartner, Volkmar Falk, Jeroen J Bax, Michele De Bonis, Christian Hamm, Per Johan Holm, Bernard Iung, Patrizio Lancellotti, Emmanuel Lansac, Daniel Rodriguez Muñoz, Raphael Rosenhek, Johan Sjögren, Pilar Tornos Mas, Alec Vahanian, Thomas Walther, Olaf Wendler, Stephan Windecker, Jose Luis Zamorano, ESC Scientific Document Group
雑誌名: Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391.
Abstract/Text
PMID 28886619  Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093・・・
著者: John Puskas, Marc Gerdisch, Dennis Nichols, Reed Quinn, Charles Anderson, Birger Rhenman, Lilibeth Fermin, Michael McGrath, Bobby Kong, Chad Hughes, Gulshan Sethi, Michael Wait, Tomas Martin, Allen Graeve, PROACT Investigators
雑誌名: J Thorac Cardiovasc Surg. 2014 Apr;147(4):1202-1210; discussion 1210-1. doi: 10.1016/j.jtcvs.2014.01.004. Epub 2014 Jan 12.
Abstract/Text OBJECTIVE: Under Food and Drug Administration investigational device exemption, the Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT) has been testing the safety of less aggressive anticoagulation than recommended by the American College of Cardiology/American Heart Association guidelines after implantation of an approved bileaflet mechanical valve.
METHODS: In this first limb of the PROACT, patients with elevated risk factors for thromboembolism were randomized at 33 US centers to receive lower dose warfarin (test international normalized ratio [INR], 1.5-2.0) or continue standard warfarin (control INR, 2.0-3.0), 3 months after mechanical aortic valve replacement. The INR was adjusted by home monitoring; all patients received 81 mg aspirin daily. Adverse events were independently adjudicated.
RESULTS: A total of 375 aortic valve replacement patients were randomized into control (n = 190) and test (n = 185) groups from September 2006 to December 2009. The mean age ± standard deviation was 55.2 ± 12.5 years; 79% were men; and 93% were in sinus rhythm preoperatively. Calcific degeneration was present in 67%; active endocarditis was excluded. Concomitant procedures included coronary artery bypass grafting (27%), aortic aneurysm repair (14%), and other (25%). The follow-up duration averaged 3.82 years (755.7 patient-years [pt-yrs] for control; 675.2 pt-yrs for test). The mean INR was 2.50 ± 0.63 for the control and 1.89 ± 0.49 for the test groups (P < .0001). The test group experienced significantly lower major (1.48% vs 3.26%/pt-yr; P = .047) and minor (1.32% vs 3.41%/pt-yr; P = .021) bleeding rates. The incidence of stroke, transient ischemic attack, total neurologic events, and all-cause mortality were similar between the 2 groups.
CONCLUSIONS: INR can be safely maintained between 1.5 and 2.0 after aortic valve replacement with this approved bileaflet mechanical prosthesis. With low-dose aspirin, this resulted in a significantly lower risk of bleeding, without a significant increase in thromboembolism.

Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.
PMID 24512654  J Thorac Cardiovasc Surg. 2014 Apr;147(4):1202-1210; di・・・
著者: Gregor Pache, Simon Schoechlin, Philipp Blanke, Stephan Dorfs, Nikolaus Jander, Chesnal D Arepalli, Michael Gick, Heinz-Joachim Buettner, Jonathon Leipsic, Mathias Langer, Franz-Josef Neumann, Philipp Ruile
雑誌名: Eur Heart J. 2016 Jul 21;37(28):2263-71. doi: 10.1093/eurheartj/ehv526. Epub 2015 Oct 7.
Abstract/Text AIMS: We sought to evaluate the frequency of early hypo-attenuated leaflet thickening (HALT) of the SAPIEN 3 transcatheter aortic valve (S3).
METHODS AND RESULTS: Of 249 patients who had undergone S3 implantation, we studied 156 consecutive patients (85 women, median age 82.2 ± 5.5 years) by electrocardiogram (ECG)-triggered dual-source computed tomography angiography (CTA) after a median of 5 days post-transcatheter aortic valve implantation. The prosthesis was assessed for HALT. Apart from heparin, peri-interventional antithrombotic therapy consisted of single- (aspirin 29%) or dual- (aspirin plus clopidogrel 71%) antiplatelet therapy. Hypo-attenuated leaflet thickening was found in 16 patients [10.3% (95% confidence interval (CI) 5.5-15.0%)] of the patients. None of the baseline and procedural variables were significantly associated with HALT, nor did we find a significant association with the antithrombotic regimen, either peri-interventionally or at the time of CTA. Hypo-attenuated leaflet thickening was found in 6 of 45 patients with peri-interventional single-antiplatelet therapy and in 10 of 111 patients with dual-antiplatelet therapy at the time of intervention [13.3% (95% CI 3.4-23.3%) vs. 9% (95% CI 3.7-14.3%), P = 0.42]. Hypo-attenuated leaflet thickening was not associated with clinical symptoms, but a small, albeit significant difference in mean pressure gradient at the time of CTA (11.6 ± 3.4 vs. 14.9 ± 5.3 mmHg, P = 0.026). Full anticoagulation led to almost complete resolution of HALT in 13 patients with follow-up CTA.
CONCLUSION: Irrespective of the antiplatelet regimen, early HALT occurred in 10% of our patients undergoing transcatheter aortic S3 implantation. Early HALT is clinically inapparent and reversible by full anticoagulation.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.
PMID 26446193  Eur Heart J. 2016 Jul 21;37(28):2263-71. doi: 10.1093/e・・・
著者: Nicolaj C Hansson, Erik L Grove, Henning R Andersen, Jonathon Leipsic, Ole N Mathiassen, Jesper M Jensen, Kaare T Jensen, Philipp Blanke, Tina Leetmaa, Mariann Tang, Lars R Krusell, Kaj E Klaaborg, Evald H Christiansen, Kim Terp, Christian J Terkelsen, Steen H Poulsen, John Webb, Hans Erik Bøtker, Bjarne L Nørgaard
雑誌名: J Am Coll Cardiol. 2016 Nov 8;68(19):2059-2069. doi: 10.1016/j.jacc.2016.08.010. Epub 2016 Aug 28.
Abstract/Text BACKGROUND: There are limited data on the incidence, clinical implications, and predisposing factors of transcatheter heart valve (THV) thrombosis following transcatheter aortic valve replacement (TAVR).
OBJECTIVES: The authors assessed the incidence, potential predictors, and clinical implications of THV thrombosis as determined by contrast-enhanced multidetector computed tomography (MDCT) after TAVR.
METHODS: Among 460 consecutive patients who underwent TAVR with the Edwards Sapien XT or Sapien 3 (Edwards Lifesciences, Irvine, California) THV, 405 (88%) underwent MDCT in addition to transthoracic and transesophageal echocardiography 1 to 3 months post-TAVR. MDCT scans were evaluated for hypoattenuated leaflet thickening that indicated THV thrombosis.
RESULTS: MDCT verified THV thrombosis in 28 of 405 (7%) patients. A total of 23 patients had subclinical THV thrombosis, whereas 5 (18%) patients experienced clinically overt obstructive THV thrombosis. THV thrombosis risk did not differ among different generations of THVs (8% vs. 6%; p = 0.42). The risk of THV thrombosis in patients who did not receive warfarin was higher compared with patients who received warfarin (10.7% vs. 1.8%; risk ratio [RR]: 6.09; 95% confidence interval [CI]: 1.86 to 19.84). A larger THV was associated with an increased risk of THV thrombosis (p = 0.03). In multivariable analysis, a 29-mm THV (RR: 2.89; 95% CI: 1.44 to 5.80) and no post-TAVR warfarin treatment (RR: 5.46; 95% CI: 1.68 to 17.7) independently predicted THV thrombosis. Treatment with warfarin effectively reverted THV thrombosis and normalized THV function in 85% of patients as documented by follow-up transesophageal echocardiography and MDCT.
CONCLUSIONS: Incidence of THV thrombosis in this large study was 7%. A larger THV size may predispose to THV thrombosis, whereas treatment with warfarin appears to have a protective effect. Although often subclinical, THV thrombosis may have important clinical implications.

Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
PMID 27580689  J Am Coll Cardiol. 2016 Nov 8;68(19):2059-2069. doi: 10・・・
著者: Raj R Makkar, Gregory Fontana, Lars Søndergaard
雑誌名: N Engl J Med. 2016 Apr 21;374(16):1591-2. doi: 10.1056/NEJMc1600179.
Abstract/Text
PMID 27096589  N Engl J Med. 2016 Apr 21;374(16):1591-2. doi: 10.1056/・・・
著者: Ryo Yanagisawa, Makoto Tanaka, Fumiaki Yashima, Takahide Arai, Masahiro Jinzaki, Hideyuki Shimizu, Keiichi Fukuda, Yusuke Watanabe, Toru Naganuma, Akihiro Higashimori, Kazuki Mizutani, Motoharu Araki, Norio Tada, Futoshi Yamanaka, Toshiaki Otsuka, Masanori Yamamoto, Kentaro Hayashida
雑誌名: Circ Cardiovasc Interv. 2019 Feb;12(2):e007349. doi: 10.1161/CIRCINTERVENTIONS.118.007349.
Abstract/Text BACKGROUND: The occurrence and clinical impact of untreated subclinical leaflet thrombosis beyond 1 year after transcatheter aortic valve replacement still remain unclear.
METHODS AND RESULTS: In a multicenter transcatheter aortic valve replacement registry, we analyzed data from 485 patients who underwent 4-dimensional multidetector computed tomography posttranscatheter aortic valve replacement performed to survey hypoattenuated leaflet thickening with reduced leaflet motion compatible with thrombus at a median of 3 days, 6 months, 1 year, 2 years, and 3 years. Incidence, predictors, and clinical outcomes of early (median 3 days) and late (>30 days) leaflet thrombosis were assessed. Additional anticoagulation was not administered because of subclinical findings at the time of computed tomography in all patients. Early leaflet thrombosis occurred in 45 (9.3%) of 485 patients. Mean pressure gradient at discharge was higher in patients with early leaflet thrombosis than in those without. Independent predictors of early leaflet thrombosis in balloon-expandable prostheses were low-flow, low-gradient aortic stenosis, severe prosthesis-patient mismatch, and 29-mm prostheses. No predictors could be identified for self-expanding prosthesis. Cumulative event rates of death, stroke, or rehospitalization for heart failure over 2 years were 10.7% and 16.9% in patients with and without early leaflet thrombosis, respectively ( P=0.63). Late leaflet thrombosis occurred late up to 3 years, and male sex and paravalvular leak less than mild were independent predictors.
CONCLUSIONS: Untreated early leaflet thrombosis did not affect the cumulative event rates of death, stroke, and rehospitalization for heart failure. Late leaflet thrombosis was newly detected during 3-year follow-up. Visual Overview: A visual overview is available for this article.

PMID 30732472  Circ Cardiovasc Interv. 2019 Feb;12(2):e007349. doi: 10・・・
著者: M J Wahl
雑誌名: Arch Intern Med. 1998 Aug 10-24;158(15):1610-6.
Abstract/Text Continuous oral anticoagulant therapy has been used to decrease the risk of thromboembolism for more than half a century, prolonging the lives of thousands of patients. Many physicians recommend interrupting continuous anticoagulant therapy for dental surgery to prevent hemorrhage. In reviewing the available literature, there are no well-documented cases of serious bleeding problems from dental surgery in patients receiving therapeutic levels of continuous warfarin sodium therapy, but there were several documented cases of serious embolic complications in patients whose warfarin therapy was withdrawn for dental treatment. Many authorities state that dental extractions can be performed with minimal risk in patients who are at or above therapeutic levels of anticoagulation. There are sound legal reasons to continue therapeutic levels of warfarin for dental treatment. Although there is a theoretical risk of hemorrhage after dental surgery in patients who are at therapeutic levels of anticoagulation, the risk appears to be minimal, the bleeding usually can be easily treated with local measures, and this risk may be greatly outweighed by the risk of thromboembolism after withdrawal of anticoagulant therapy.

PMID 9701094  Arch Intern Med. 1998 Aug 10-24;158(15):1610-6.
著者: P Devani, K M Lavery, C J Howell
雑誌名: Br J Oral Maxillofac Surg. 1998 Apr;36(2):107-11. doi: 10.1016/s0266-4356(98)90177-2.
Abstract/Text Various clinical protocols for the management of warfarinised patients needing dental extractions have been suggested. This study was designed to compare two approaches in the management of these patients. A control group of 32 patients had their warfarin treatment stopped for 2-3 days prior to having dental extractions, resulting in a reduction in the average preoperative international normalised ratio (INR) from 2.6 to 1.6. The study group of 33 patients did not have their anticoagulant treatment altered before extractions, and had an average preoperative INR of 2.7. All patients were treated under local analgesia on an outpatient basis, and local measures-consisting of Surgicel pack and sutures-were used in all cases to control postoperative bleeding from extraction sockets. None of the patients had any immediate postoperative bleeding, and only 1 patient from each group had mild delayed haemorrhage, which was easily controlled with local measures. It is proposed that, provided the INR is within the therapeutic range of 2.0 to 4.0 and local measures are used to control postoperative bleeding, there is no justification in altering warfarin treatment prior to dental extractions in these patients, and thereby exposing them to the risk of thromboembolism.

PMID 9643595  Br J Oral Maxillofac Surg. 1998 Apr;36(2):107-11. doi: ・・・
著者: E A Loeliger, A W Broekmans
雑誌名: Haemostasis. 1985;15(4):283-92. doi: 10.1159/000215161.
Abstract/Text The relevant literature on the intensity of anticoagulation needed to prevent the development or growth of thrombi in patients at risk is reviewed. In case of elective surgery, prevention of venous thrombosis is easily attained with heparin or with coumarin alone, at levels of anticoagulation involving only a minor risk of bleeding complications. For posttraumatic prophylaxis, more intensive oral anticoagulation is required, similar to that for the management of active venous thrombosis, for which a combined heparin/coumarin regimen is proposed. A 90% reduction of the incidence of systemic emboli in patients with a high risk of developing intracardiac thrombosis requires high-intensity treatment with a target INR of 4. More intensive anticoagulation would be needed to obtain the same 90% protection in case of arterial (coronary) thrombosis. This is prohibited, however, by the rapidly increasing bleeding risk in cases with INR values greater than 5. With a target INR of 3.5 (sixty-Plus patients), the reinfarction rate will not be lowered by more than two thirds. Antiplatelet drugs given alone or in combination with anticoagulants have not been convincingly successful thus far in the prevention and treatment of thrombosis.

PMID 4043830  Haemostasis. 1985;15(4):283-92. doi: 10.1159/000215161.・・・

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