今日の臨床サポート

ペースメーカ植え込み、フォローアップ

著者: 中井俊子 日本大学板橋病院循環器内科

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/監修レビュー済:2021/12/01
患者向け説明資料

概要・推奨   

  1. ペースメーカ治療は、日本循環器学会の「不整脈の非薬物治療ガイドライン」の指針に従い適応を判断するが、原則、有症状の徐脈性不整脈においてペースメーカが推奨される(推奨度1)。
  1. 閉塞性肥大型心筋症において有意な流出路圧格差があり圧格差による症状によりQOL低下を呈する症例では、ベータ遮断薬など薬剤による徐脈を呈する場合においても、ペースメーカ治療が推奨される(推奨度1)。
 
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:
中井俊子 : 講演料(日本メドトロニック,アボットメディカル,バイオトロニックジャパン),企業などが提供する寄付講座(バイオトロニックジャパン,アボットメディカル,日本メドトロニック,日本ライフライン,ボストンサイエンティフィック)[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. 2021年 JCS/JHRS ガイドライン フォーカスアップデート版 不整脈非薬物治療に基づき確認を行った。

まとめ・診察

手技のまとめ  
  1. ペースメーカは当初、高度な 徐脈 による生命の危険や血行動態の改善を目的として開発された。
  1. 近年では生命維持のみならず、生活の質(QOL)の向上を目指して、より生理的な作動設定が可能なシステムになってきている[1][2]
  1. ペースメーカ治療は、変性疾患、炎症性疾患など不可逆性の原因による徐脈性不整脈に対して行われる。
  1. 日本循環器学会の「不整脈の非薬物治療ガイドライン」の指針に従い、適応を判断する[3][4]
  1. 通常、左右いずれかの鎖骨下静脈からのアプローチにて、ペースメーカリードを挿入する。小児症例、あるいは経静脈アクセスが困難な症例においては、外科的アプローチにて心外膜リードを使用して植込みを行う。
  1. ペースメーカの植込みは通常、局所麻酔で行う。手術時間は症例によるが、1時間半程度である。
  1. リードレスペースメーカは、ポケット感染リスクの高い症例や経静脈アクセスが困難な症例に使用される。ただし、現時点では心室ペーシングのみ(VVIモード)のため、適応は慎重に検討する。
  1. リードレスペースメーカの植込みについては、右(または左)大腿静脈から経カテーテル的に行うため、手技時間は通常のペースメーカより短い。
  1. His束ペーシング:近年、刺激伝導系のHis束を直接あるいはHis束および周囲の心筋をペーシングする「His束ペーシング」が行われるようになり、話題を呼んでいる。しかし、ペーシング閾値が4-5V程度に上昇してしまったという報告もあり、長期的に安全な閾値を得ることが今後の課題である。確立された手技となるには、しばらく時間を要すると思われる。
問診・診察のポイント  
  1. 初診時の問診: 徐脈 によると思われる症状の有無を確認する。

これより先の閲覧には個人契約のトライアルまたはお申込みが必要です。

最新のエビデンスに基づいた二次文献データベース「今日の臨床サポート」。
常時アップデートされており、最新のエビデンスを各分野のエキスパートが豊富な図表や処方・検査例を交えて分かりやすく解説。日常臨床で遭遇するほぼ全ての症状・疾患から薬剤・検査情報まで瞬時に検索可能です。

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文献 

著者: Justin D Shaber, John D Fisher, Indiresha Ramachandra, Christian Gonzalez, Lauren Rosenberg, Kevin J Ferrick, Jay N Gross, Soo G Kim
雑誌名: Pacing Clin Electrophysiol. 2008 Feb;31(2):192-7. doi: 10.1111/j.1540-8159.2007.00968.x.
Abstract/Text BACKGROUND: Rate responsive (RR) pacemakers are commonly implanted with nominal conservative factory-set responsiveness, which is usually accepted because established exercise protocols are time-consuming. We aimed for efficient assessment of RR pacemaker settings.
METHODS: We tested exercise heart rates in controls and paced patients using a brief exercise test that approximates real-life levels of exertion. The test used a nonmotorized treadmill: 30 seconds walking at patient-determined speed followed by 15 seconds brisk exertion. Subjects totaled 110: 26 with RR pacemakers; 22 with non-RR pacers; 27 "sick" nonpaced control patients; and 35 healthy controls. Heart rate (HR) was measured prior to exercise, after 30 seconds of casual walk, after 15 seconds of brisk walk, and 1 minute into recovery. Testing required <5 minutes from set-up to recovery.
RESULTS: The 26 RR pacer patients had a mean HR at rest = 74 +/- 10 beats per minute (bpm), walk = 87 +/- 14, and brisk = 94 +/- 18 (increase 27%). Non-RR pacer patients (n = 22): rest = 73 +/- 12 bpm, walk = 88 +/- 14, and brisk = 94 +/- 17 (increase 24.3%, P = 0.60 vs RR patients). "Sick" controls (n = 27): rest = 78 +/- 14 bpm, walk = 102 +/- 17, and brisk = 117 +/- 18 (increase 51.9%, P< 0.001 vs RR pts). For the healthy controls, HRs were at rest 83+/11 bpm, walk = 104 +/- 12, and brisk = 117 +/- 13 (P< 0.001 compared to both paced groups; P = NS vs sick controls).
CONCLUSIONS: Nominal RR settings may be suboptimal for many patients. The nonmotorized treadmill test allows quick and inexpensive assessment of RR programming, with the potential for efficient RR optimization.

PMID 18233972  Pacing Clin Electrophysiol. 2008 Feb;31(2):192-7. doi: ・・・
著者: D P Lipkin, N Buller, M Frenneaux, L Ludgate, T Lowe, S C Webb, D M Krikler
雑誌名: Br Heart J. 1987 Dec;58(6):613-6.
Abstract/Text Atrial tracking pacemakers may improve exercise capacity and symptoms because they maintain atrioventricular synchrony and preserve the physiological response of heart rate to exercise. A rate responsive pacemaker which reacts to physical activity may be effective in patients with sinus node disease who are unsuitable for VDD pacing. At least three months after implant a double blind randomised short and long term crossover study was performed in ten patients with complete heart block: block was present at rest and during exercise on a modified Bruce protocol. Symptoms were assessed on a visual analogue scale and exercise capacity (maximal oxygen consumption and anaerobic threshold) was measured during rate responsive (peak rate 125/min) and conventional fixed rate (VVI) pacing (70/min). One month after randomisation treadmill exercise was performed. The mode was then changed to the other pacing mode and exercise was repeated three hours later. After another month the process was repeated but in the reverse order. During long term assessment there was subjective improvement in the sensation of breathlessness with rate responsive pacing. During short term assessment maximal oxygen consumption increased and the benefit was maintained during long term rate responsive compared with long term VVI pacing; oxygen consumption at the anaerobic threshold was similarly improved. Activity detecting rate responsive pacing is better than fixed rate ventricular pacing in patients with complete atrioventricular block.

PMID 3322351  Br Heart J. 1987 Dec;58(6):613-6.
著者: R K Aggarwal, D T Connelly, S G Ray, J Ball, R G Charles
雑誌名: Br Heart J. 1995 Jun;73(6):571-5.
Abstract/Text OBJECTIVE: To evaluate the incidence of intraoperative and early postoperative complications (up to two months after implant) of endocardial permanent pacemaker insertion in all patients under-going a first implant at a referral centre.
METHODS: Prospective evaluation of all endocardial pacemaker implantation procedures performed from April 1992 to January 1994 carried out by completion of standard audit form at implant. Patients' demographic data, medical history, details of pacemaker hardware used, and any complications were noted. Follow up information was also collected prospectively onto standard forms at pacemaker outpatient clinic.
SETTING: United Kingdom tertiary referral cardiothoracic centre.
PATIENTS: 1088 consecutive patients underwent implantation of their first endocardial permanent pacemaker from April 1992 to January 1994. Implant and follow up data were available for 1059 (97.3%) patients at analysis. The median (range) age was 77 years (16-99); 51.2 % were male.
RESULTS: Dual chamber units were implanted in 54.1% of patients, single chamber atrial in 5.2%, and ventricular in 40.7%. A temporary pacing lead was present at implant in 22.9% of patients. Most (93.6%) implants were performed via the subclavian vein. Immediate complications were rare: eight (0.8%) patients developed pneumothorax requiring medical treatment and 11 (1.0%) an insignificant pneumothorax. There was no significant difference in the pneumothorax rate for dual chamber (DDD) compared with single chamber systems. Arterial puncture without sequelae was documented in 2.7% of attempts at subclavian vein cannulation. A total of 35 patients (3.3%) required reoperation; the reoperation rate for dual chamber (3.5%) was similar to that for single chamber (3.1%) systems. Electrode displacement (n = 15, 1.4%) was the most common reason for reoperation. Atrial lead displacement (n = 10, 1.6% of atrial leads) was significantly more common than ventricular lead displacement (n = 5, 0.5% of ventricular leads, P = 0.047). There was no difference in electrode displacement rates for dual (1.6%) compared with single (1.2%) chamber systems. Pacemaker pocket infection led to reoperation in 10 patients (six dual, four single chamber, P = not significant) and was significantly more common in patients who had a temporary pacing lead in place at implant (2.9%) than in those who did not (0.4%, P = 0.0014). Five patients (0.5%) required reoperation for generator erosion (two dual, three single chamber, P = not significant). and a further five for drainage of haematoma or a serous fluid collection (three dual, two single chamber, P = not significant). Complications that did not require reoperation were also rare. Undersensing occurred in 10 patients (0.9%). Atrial undersensing (n = 8) was significantly more common than ventricular undersensing (n = 2, P = 0.017). All patients were successfully treated by reprogramming of sensitivity. Superficial wound infection was treated successfully with antibiotics in nine patients (six dual, three single chamber, P = not significant). Three patients with DDD generators developed sustained atrial fibrillation: two required reprogramming to VVI mode and one required cardioversion.
CONCLUSIONS: Permanent pacing in a large tertiary referral centre with experienced operators carries a low risk. Infection rates are low, < 1% overall but significantly higher in patients who undergo temporary pacing before implantation. Lead displacement and undersensing are more likely to occur with atrial than ventricular leads. The overall complication rate for dual chamber pacing, however, is no higher than for single chamber pacing.

PMID 7626359  Br Heart J. 1995 Jun;73(6):571-5.
著者: David A Hirschl, Vineet R Jain, Hugo Spindola-Franco, Jay N Gross, Linda B Haramati
雑誌名: Pacing Clin Electrophysiol. 2007 Jan;30(1):28-32. doi: 10.1111/j.1540-8159.2007.00575.x.
Abstract/Text BACKGROUND: Pacemakers and implantable cardiac defibrillators (ICDs) are widely used for the management of cardiac arrhythmias and congestive heart failure (CHF). Acute implantation complication rates range from 3% to 7%. The aim of this study is to describe the incidence of lead perforation on computed tomography (CT), and correlate these findings with electrophysiologic data.
METHODS: Images of 100 consecutive patients with permanent pacemakers (n = 72) or ICDs (n = 28) who underwent multidetector CTs of the chest were identified. Cases were reviewed by 2 cardiothoracic radiologists, and a third if there was disagreement. Each CT was reviewed for device and fixation type, tip position, and presence of pericardial effusion. Results were correlated with lead impedance and pacing threshold, when available [79% (79/100)]. A cardiac electrophysiologist interpreted device data.
RESULTS: All 100 patients had right ventricular leads (58 passive, 42 active) and 61 had right atrial leads (12 passive, 49 active). 15% (15/100) of patients had a lead perforation. Perforation rates were 15% (9/61) for atrial and 6% (6/100) for ventricular leads (P < 0.05, chi square). Four of 28 (14%) right ventricular ICD leads and 2 of 72 (3%)right ventricular pacemaker leads were perforated (P < 0.05, chi square). 12% (6/49) of active right atrial leads, and 25% (3/12) of passive right atrial leads perforated (P = NS, chi square). 7% (3/42) of active right ventricular leads, and 5% (3/58) of passive ventricular leads perforated (P = NS, chi square). Electrophysiologic parameters did not differ significantly between perforated and nonperforated leads.
CONCLUSION: Asymptomatic perforation is a common phenomenon and rarely resulting in electrophysiologic consequences. Atrial leads perforated more frequently than ventricular leads, and ventricular ICD leads perforated more frequently than ventricular pacemaker leads.

PMID 17241311  Pacing Clin Electrophysiol. 2007 Jan;30(1):28-32. doi: ・・・
著者: M S Kiviniemi, M A Pirnes, H J Eränen, R V Kettunen, J E Hartikainen
雑誌名: Pacing Clin Electrophysiol. 1999 May;22(5):711-20.
Abstract/Text This study evaluates complications related to permanent endocardial pacing in the era of modern pacemaker therapy. There is only limited information available about the complications related to modern cardiac pacing. Most of the existing data are based on the 1970s and are no longer valid for current practice. The recent reports on pacemaker complications are focused on some specific complication or are restricted to early complications. Thus, there are no reports available providing a comprehensive view of complications related to modern cardiac pacing. Four hundred forty-six patients, who received permanent endocardial pacemakers between January 1990 and December 1995 at Kuopio University Hospital, were reviewed retrospectively using patient records. Attention was paid to the occurrence of any complication during the implantation or follow-up. An early complication was detected in 6.7%, and 4.9% of patients were treated invasively due to the early complication. Late complication developed in 7.2% and reoperation was required in 6.3% of the patients. Complications related to the implantation procedure occurred in 3.1%. Inadequate capture or sensing was observed in 7.4% of the patients. Pacemaker infection was detected in 1.8% and erosion in 0.9% of the patients. An AV block developed in 3.6% (1.6%/year) patients who received an AAI(R)-pacemaker due to sick sinus syndrome. There was no mortality attributable to pacemaker therapy. A great majority (68%) of the complications occurred within the first 3 months after the implantation. Complications associated to modern permanent endocardial pacemaker therapy are not infrequent. Eleven percent of patients needed an invasive procedure due to an early or late complication.

PMID 10353129  Pacing Clin Electrophysiol. 1999 May;22(5):711-20.
著者: Daniel Z Uslan, Muhammad R Sohail, Jennifer L St Sauver, Paul A Friedman, David L Hayes, Sarah M Stoner, Walter R Wilson, James M Steckelberg, Larry M Baddour
雑誌名: Arch Intern Med. 2007 Apr 9;167(7):669-75. doi: 10.1001/archinte.167.7.669.
Abstract/Text BACKGROUND: The incidence of cardiac device infection is not well understood. Bloodstream infection (BSI) in patients with permanent pacemakers or implantable cardioverter-defibrillators (hereafter, defibrillators) may reflect device infection.
METHODS: Retrospective, population-based cohort study of all adult patients with cardiac devices who resided in Olmsted County, Minnesota, from 1975 to 2004. The medical linkage-system of the Rochester Epidemiology Project and standardized criteria were used to identify all cases of BSI and device infection. The incidence of device infection was calculated with person-years of follow-up after device implantation.
RESULTS: A total of 1524 patients with cardiac devices were included in the cohort. Total person-time of follow-up was 7578 years. The incidence of definite device infection was 1.9 per 1000 device-years (95% confidence interval [CI], 1.1-3.1). The incidence of pocket infection without BSI was 1.37 per 1000 device-years (95% CI, 0.62-3.05), and pocket infection with BSI or device-related endocarditis 1.14 per 1000 device years (95% CI, 0.47-2.74). The cumulative probability of device infection was higher among patients with defibrillators compared with those with pacemakers, P<.001. Twelve (54.6%) of 22 cases of Staphylococcus aureus BSI had definite or possible cardiac device infection vs 3 (12.0%) of 25 cases of bloodstream infection due to gram-negative bacilli (P = .004).
CONCLUSIONS: To our knowledge, this is the first population-based study to describe the incidence of cardiac device infection. Device infection was common during episodes of S aureus BSI. The rate of cardiac device infection was higher in patients with defibrillators than in those with pacemakers.

PMID 17420425  Arch Intern Med. 2007 Apr 9;167(7):669-75. doi: 10.1001・・・
著者: M R Sohail
雑誌名: Intern Med J. 2007 Jul;37(7):509-10; author reply 510. doi: 10.1111/j.1445-5994.2007.01415.x.
Abstract/Text
PMID 17547736  Intern Med J. 2007 Jul;37(7):509-10; author reply 510. ・・・
著者: D M Jacobs, A S Fink, R P Miller, W R Anderson, R D McVenes, J F Lessar, K E Cobian, D B Staffanson, J E Upton, M P Bubrick
雑誌名: Pacing Clin Electrophysiol. 1993 Mar;16(3 Pt 1):434-44.
Abstract/Text In recent years, pacemaker lead failure due to compressive damage has been reported with increasing frequency. To document the mechanism of this failure, we evaluated explanted mechanically damaged leads with electrical testing, optical microscopy, and in some cases, scanning electron microscopy (SEM). In addition, we performed an autopsy study to measure the compressive loads on catheters placed percutaneously through the costoclavicular angle, as well as by cephalic cutdown. Of the 49 explanted compression damaged leads with enough clinical data for analysis, all had been placed by percutaneous subclavian puncture. Our autopsy data confirmed the significant increase in pressures generated in the costoclavicular angle for medial percutaneous subclavian catheterization (126 +/- 26 mmHg) compared to a more lateral percutaneous subclavian puncture (63 +/- 15 mmHg) or a cephalic cutdown (38 +/- 13 mmHg) (P < 0.01). In vivo coil compression testing documented loads up to 100 pounds per linear inch of coil and a compressive morphology by SEM identical to that seen in the clinical explants. Pacemaker leads appear to be susceptible to compression damage when placed by subclavian venipuncture. When possible, leads should be placed such that they avoid the tight costoclavicular angle.

PMID 7681195  Pacing Clin Electrophysiol. 1993 Mar;16(3 Pt 1):434-44.・・・
著者: M Roelke, S S O'Nunain, S Osswald, H Garan, J W Harthorne, J N Ruskin
雑誌名: Pacing Clin Electrophysiol. 1995 May;18(5 Pt 1):973-9.
Abstract/Text UNLABELLED: Subclavian crush syndrome, described with pacemaker leads implanted via subclavian puncture, may occur when conductor fractures and insulation breaches develop by compression of a lead between the first rib and clavicle. We reviewed our experience in 164 patients who underwent intended implantation of transvenous defibrillator systems to determine the clinical relevance of subclavian crush syndrome in defibrillator patients. Venous access was obtained via subclavian puncture in 114 patients (70%) and via cephalic cut-down in 50 patients (30%). Nonthoracotomy lead systems, with or without subcutaneous patch, were successfully implanted in 131 of 164 patients (79.9%). Thoracotomy was required in 32 patients (19.5%) and subxiphoid patch in 1 patient (0.6%). Over a mean of 12.9 months (range 1-62 months), 3 patients (1.8%) required revision of the rate sensing lead/coil or superior vena cava coil after development of lead compression fractures in the region of the clavicle and first rib. In all 3 patients the leads had been implanted via subclavian puncture (2.6% of patients in whom the subclavian technique was utilized). Two patients presented with spurious shocks. One patient was asymptomatic.
CONCLUSIONS: When venous access is obtained via subclavian puncture, subclavian crush syndrome may develop in patients with transvenous defibrillator systems. Patients may be asymptomatic and lead fractures may go unrecognized. When implanting transvenous defibrillator systems, strong consideration should be given to obtaining venous access primarily via the cephalic cut-down technique.

PMID 7659570  Pacing Clin Electrophysiol. 1995 May;18(5 Pt 1):973-9.
著者: Won Ho Kim, Boyoung Joung, Jaemin Shim, Jong Sung Park, Eui-Seock Hwang, Hui-Nam Pak, Sungsoon Kim, Moonhyoung Lee
雑誌名: Yonsei Med J. 2010 Nov;51(6):832-7. doi: 10.3349/ymj.2010.51.6.832.
Abstract/Text PURPOSE: The optimal pacing mode with either single chamber atrial pacemaker (AAI or AAIR) or dual chamber pacemaker (DDD or DDDR) is still not clear in sinus-node dysfunction (SND) and intact atrioventricular (AV) conduction.
MATERIALS AND METHODS: Patients who were implanted with permanent pacemaker using AAI(R) (n = 73) or DDD(R) (n = 113) were compared.
RESULTS: The baseline characteristics were comparable between the two groups, with a mean follow-up duration of 69 months. The incidence of death did not show statistical difference. However, the incidence of hospitalization for congestive heart failure (CHF) was significantly lower in the AAI(R) group (0%) than the DDD(R) group (8.8%, p = 0.03). Also, atrial fibrillation (AF) was found in 2.8% in the AAI(R) group, which was statistically different from 15.2% of patients in the DDD(R) group (p = 0.01). Four patients (5.5%) with AAI(R) developed AV block, and subsequently switched to DDD(R) pacing. The risk of AF was lower in the patients implanted with AAI(R) than those with DDD(R) [hazard ratio (HR), 0.84; 95% confidence interval, 0.72 to 0.97, p = 0.02].
CONCLUSION: In patients with SND and intact AV conduction, AAI(R) pacing can achieve a better clinical outcome in terms of occurrence of CHF and AF than DDD(R) pacing. These findings support AAI(R) pacing as the preferred pacing mode in patients with SND and intact AV conduction.

PMID 20879047  Yonsei Med J. 2010 Nov;51(6):832-7. doi: 10.3349/ymj.20・・・
著者: Rikke Esberg Kirkfeldt, Henning Rud Andersen, Jens Cosedis Nielsen, DANPACE Investigators
雑誌名: Europace. 2013 Aug;15(8):1166-73. doi: 10.1093/europace/eut039. Epub 2013 Feb 28.
Abstract/Text AIMS: To investigate the indications for system upgrade with single lead atrial pacing (AAIR), complications associated with these re-interventions, and possible predictors for system upgrade among patients included in the Danish Multicenter Randomized Trial on AAIR vs. dual-chamber pacing (DDDR) in sick sinus syndrome (DANPACE).
METHODS AND RESULTS: A total of 707 of 1415 patients were randomized to AAIR pacing. Mean follow-up was 5.5 ± 2.6 years. Information on indications for system upgrade and complications were collected by reviewing patient charts. Multiple logistic regression was used to estimate adjusted odds ratios (aOR) with 95% confidence intervals (CI) for the association between predictors and system upgrade. Sixty-six patients (9.3%) in the AAIR group underwent system upgrade. Fifty-nine of these patients (89.3%) had a documented class I indication for system upgrade. Age (aOR 0.98 for each 1-year increase in age; 95% CI 0.6-1.0), and left atrial enlargement (aOR 1.9; 95% CI 1.0-3.8) were predictors for system upgrade. No single clinically applicable predictor for upgrade was identified. A total of 11 patients (16.7%) experienced at least one major complication after system upgrade.
CONCLUSION: The majority of patients with AAIR pacing who underwent system upgrade had a class I indication. The incidence of major complications after system upgrade was high. The present data support the use of DDDR pacing rather than AAIR pacing in sick sinus syndrome.

PMID 23449923  Europace. 2013 Aug;15(8):1166-73. doi: 10.1093/europace・・・
著者: Michael O Sweeney, Julie B Shea, Victoria Fox, Stuart Adler, Linda Nelson, Thomas J Mullen, Paul Belk, David Casavant, Todd Sheldon
雑誌名: Heart Rhythm. 2004 Jul;1(2):160-7. doi: 10.1016/j.hrthm.2004.03.059.
Abstract/Text OBJECTIVE: We hypothesized that a new minimal ventricular pacing mode (MVP) that provides AAI/R pacing with ventricular monitoring and back-up DDD/R pacing as needed during AV block (AVB) would significantly reduce cumulative percent ventricular pacing compared to DDD/R.
BACKGROUND: Conventional DDD/R mode often results in high cumulative percent ventricular pacing that may adversely affect ventricular function and increase risk of heart failure and atrial fibrillation.
METHODS: MVP was made operational in 30 patients with DDD/R implantable cardioverter-defibrillators (ICDs) and no history of AVB. Patients were randomized to one week each in DDD/R and MVP. Holter monitor recordings (ECG, intracardiac electrograms, and event markers) and device diagnostics were analyzed for cumulative % atrial paced (Cum%AP), cumulative percent ventricular pacing, and frequency and duration of DDD/R pacing back-up. Diaries were used to report symptoms.
RESULTS: Age of the study population was 61 years +/- 12 years and 83% were male. Baseline PR interval was 204 ms +/- 32 ms and programmed AV intervals (DDD/R) were 200 ms +/- 50 ms (paced)/167 ms +/- 54 ms (sensed). Cum%AP was similar between MVP and DDD/R (47.9 +/- 37 vs 46.3 +/- 36). Cumulative percent ventricular pacing was significantly lower in MVP vs DDD/R (3.79 +/- 16.3 vs 80.6 +/- 33.8, P < .0001). Back-up DDD/R pacing during MVP operation due to transient AVB occurred in 10% of patients (9.3 +/- 7.4 [range 1-15] episodes/patient-day, duration 39.7 minutes +/- 156 minutes). Fifteen percent of AV intervals during MVP operation exceeded 300 ms. No significant symptoms were reported during MVP operation.
CONCLUSIONS: MVP dramatically reduced cumulative percent ventricular pacing compared to DDD/R while maintaining AV synchrony and providing sensor-modulated atrial pacing support. Intermittent oscillations between MVP and DDD/R during transient AV block appeared safe and well tolerated.

PMID 15851147  Heart Rhythm. 2004 Jul;1(2):160-7. doi: 10.1016/j.hrthm・・・
著者: Anne M Gillis, Helmut Pürerfellner, Carsten W Israel, Henri Sunthorn, Salem Kacet, Michael Anelli-Monti, Feng Tang, Martin Young, Giuseppe Boriani, Medtronic Enrhythm Clinical Study Investigators
雑誌名: Pacing Clin Electrophysiol. 2006 Jul;29(7):697-705. doi: 10.1111/j.1540-8159.2006.00422.x.
Abstract/Text BACKGROUND: Frequent and unnecessary right ventricular apical pacing increases the risk of atrial fibrillation or congestive heart failure. We evaluated a new pacing algorithm, managed ventricular pacing (MVP) which automatically changes modes between AAI/R and DDD/R in patients receiving pacemakers for symptomatic bradycardia.
METHODS: Patients were randomized to the MVP mode or DDD/R mode for 1 month and then crossed over to the alternate pacing modality for an additional month. On completion of the crossover phase, the pacing mode selected was individualized and patients were followed for an additional 4 months.
RESULTS: Of the 129 patients who successfully completed the crossover study, the cumulative percent ventricular pacing was significantly reduced in the MVP mode (median 1.4%) compared to the DDD/R mode (median 89.6%, 94.0% relative reduction; 95% CI 89.3-98.8%, P < 0.001). Patients with sinus node disease (SND, n = 51) when compared to patients with AV block (AVB) (n = 68) experienced a greater reduction in ventricular pacing with the MVP mode compared to the DDD/R mode (median relative reduction 99.1%; 95% CI 97.5-99.9% vs median relative reduction 60.1%; 95% CI 16.7-93.9% P < 0.001). The reduced percent ventricular pacing during MVP was sustained over longer term follow-up.
CONCLUSIONS: The majority of patients with a bradycardia indication for cardiac pacing do not require ventricular pacing most of the time. The MVP mode significantly reduces unnecessary right ventricular pacing. This mode benefits even patients with intermittent AVB and is sustained over longer term follow-up.

PMID 16884504  Pacing Clin Electrophysiol. 2006 Jul;29(7):697-705. doi・・・
著者: Silin Chen, Keping Chen, Qianmin Tao, Liangrong Zheng, Farong Shen, Shulin Wu, Jie Fan, Geng Xu, Li Wang, Xiaohong Zhou, Shu Zhang, COMPARE Study Investigators
雑誌名: Europace. 2014 Nov;16(11):1595-602. doi: 10.1093/europace/euu055. Epub 2014 Apr 4.
Abstract/Text AIMS: The present study was to assess the reduction of right ventricular pacing (RVP) by pacemaker algorithms of Managed Ventricular Pacing (MVP) and Search AV+ (SAV+) interval over a period of 12 months.
METHODS AND RESULTS: A total of 385 patients indicated for a dual-chamber pacemaker (DC-PM) were enrolled in the prospective, randomized COMPARE study at 29 centres in China between June 2009 and April 2011. Patients implanted with DC-PMs were randomized in a 1 : 1 ratio to the MVP group or the SAV+ group. The percentage of VP (%VP) was obtained from the device diagnostic data at 1-, 6-, and 12-month follow-ups and was expressed as the median %VP over all beats in patients with sinus node dysfunction (SND) and atrioventricular block (AVB) excluding persistent third-degree AVB. Of 385 enrolled patients, 253 had SND and 72 had AVB. The %VP in the MVP group was significantly lower than that in the SAV+ group at 1-, 6-, and 12-month follow-ups, respectively. At 12-month follow-up, the median %VP in SND patients was 0.20% in the MVP group and 1.4% in the SAV+ group (P < 0.0001) and the median %VP in AVB patients was 11.8% in the MVP group and 98.1% in the SAV+ group (P < 0.001). There was no statistical difference in %VP from 1- to 12-month follow-up. A trend in the correlation between %VP and AT/AF burden was observed.
CONCLUSION: Over 12-month follow-up, the %VP was lower for MVP than SAV+ in patients with either SND or AVB. The sustainable %VP reduction has potential implications in reducing the development of heart failure and/or atrial arrhythmia morbidity.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.
PMID 24706091  Europace. 2014 Nov;16(11):1595-602. doi: 10.1093/europa・・・
著者: Renato P Ricci, Giovanni Luca Botto, Juan M Bénézet, Jens Cosedis Nielsen, Luc De Roy, Olivier Piot, Aurelio Quesada, Raffaele Quaglione, Diego Vaccari, Lorenza Mangoni, Andrea Grammatico, Milan Kozák, PreFER MVP Investigators
雑誌名: Heart Rhythm. 2015 Nov;12(11):2239-46. doi: 10.1016/j.hrthm.2015.06.041. Epub 2015 Jun 30.
Abstract/Text BACKGROUND: Pacing in the right ventricle can cause a variety of detrimental effects, including atrial tachyarrhythmias (atrial tachycardia [AT]/atrial fibrillation [AF]).
OBJECTIVE: The purpose of this study was to evaluate the incidence and predictors of persistent AT/AF in patients with long-term exposure to ventricular pacing.
METHODS: In a multicenter international trial, 605 patients (age 75 ± 11 years, 240 women) referred for replacement of an implanted pacemaker or implantable cardioverter-defibrillator (ICD), with a history of high-percentage (>40%) ventricular pacing, were randomly allocated to standard dual-chamber pacing or managed ventricular pacing (MVP), a pacing modality that minimizes ventricular pacing. The main end-point of this secondary analysis of the PreFER MVP randomized study was persistent AT/AF, defined as ≥7 consecutive days with AT/AF or AT/AF interrupted by atrial cardioversion or AT/AF present during 2 consecutive follow-up visits.
RESULTS: Persistent AT/AF was observed in 71 patients (11.7%) after 2 years of follow-up. At multivariable Cox regression analysis, prior AT/AF (hazard ratio [HR] 2.85, 95% confidence interval [CI] 1.20-6.22, P = .017) and ventricular pacing percentage, estimated in the first 3 months, ≥10% (HR 3.24, 95% 95% CI 1.13-9.31, P = .029) were independent predictors for persistent AT/AF. MVP was associated with persistent AT/AF risk (HR 3.41, 95% 95% CI 1.10-10.6, P = .024) in the subgroup of patients with baseline long PR interval (PR >230 ms) but not in the whole population.
CONCLUSION: In pacemaker and ICD replacement patients, a high percentage of ventricular pacing is associated with higher risk of persistent AT/AF. Use of algorithms that minimize right ventricular pacing may benefit patients with normal spontaneous AV conduction but should be evaluated with caution in patients with long PR interval.

Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
PMID 26142300  Heart Rhythm. 2015 Nov;12(11):2239-46. doi: 10.1016/j.h・・・
著者: H R Andersen, L Thuesen, J P Bagger, T Vesterlund, P E Thomsen
雑誌名: Lancet. 1994 Dec 3;344(8936):1523-8.
Abstract/Text In patients with sick-sinus syndrome, single-chamber atrial pacing has been reported, in retrospective studies, to be associated with lower frequencies of atrial fibrillation, thromboembolism, heart failure, and mortality than ventricular pacing; although single-chamber ventricular pacing is most commonly used. We did a prospective randomised trial in 225 consecutive patients (142 women, 83 men; mean age 76 years) with the sick-sinus syndrome, randomised to atrial (n = 110) or ventricular (n = 115) pacing and followed for up to 5 years (mean 40 [SD 18] months). During follow-up, the frequency of atrial fibrillation was higher in the ventricular group, except at the first follow-up at 3 months. Thromboembolic events (stroke or peripheral arterial embolus) occurred in 20 patients in the ventricular group and in 6 patients in the atrial group (p = 0.0083). 25 patients died in the ventricular group compared with 21 in the atrial group (p = 0.74). Heart failure estimated by the New York Heart Association classification and by the daily doses of diuretics did not differ between the two groups. Atrioventricular block occurred in 2 patients in the atrial group. Patients with sick-sinus syndrome should be treated with atrial pacing rather than ventricular pacing because atrial pacing is associated with lower frequencies of atrial fibrillation, thromboembolic complications, and a low risk of atrioventricular block.

PMID 7983951  Lancet. 1994 Dec 3;344(8936):1523-8.
著者: H R Andersen, J C Nielsen, P E Thomsen, L Thuesen, P T Mortensen, T Vesterlund, A K Pedersen
雑誌名: Lancet. 1997 Oct 25;350(9086):1210-6. doi: 10.1016/S0140-6736(97)03425-9.
Abstract/Text BACKGROUND: In a previous study of 225 patients with sick-sinus syndrome randomised to either single-chamber atrial pacing (n=110) or single-chamber ventricular pacing (n=115), we found that after a mean follow-up of 3.3 years, atrial pacing was associated with significantly less atrial fibrillation and thromboembolism whereas there was no significant difference in mortality and heart failure between the two groups. We aimed to find out whether this beneficial effect of atrial pacing is maintained during extended follow-up of up to 8 years.
METHODS: Follow-up visits for all patients were at 3 months, 12 months, then once a year at which patients had a physical examination, ECG recording, and pacemaker check-up. Endpoints were mortality, cardiovascular death, atrial fibrillation, thromboembolic events, heart failure, and atrioventricular block. Data was analysed on Dec 31, 1996.
FINDINGS: At long-term follow-up, 39 patients from the atrial group had died versus 57 from the ventricular group (relative risk 0.66 [95% CI 0.44-0.99]; p=0.045). 19 patients from the atrial group and 39 patients from the ventricular group died from a cardiovascular cause (0.47 [0.27-0.82]; p=0.0065). The cumulative incidences of atrial fibrillation and chronic atrial fibrillation were also significantly lower in the atrial group than in the ventricular group (0.54 [0.33-0.89], p=0.012 and 0.35 [0.16-0.76], p=0.004, respectively). Thromboembolic events occurred in 13 patients in the atrial group and 26 in the ventricular group (0.47 [0.24-0.92], p=0.023). Heart failure was less severe in the atrial group than in the ventricular group (p<0.05). In multivariate analysis, atrial pacing was significantly associated with freedom from thromboembolic events (0.47 [0.24-0.92], p=0.028) and survival from cardiovascular death (0.52 [0.30-0.91], p=0.022), but no longer with overall survival (0.71 [0.46-1.08], p=0.11) or chronic atrial fibrillation (0.45 [0.20-1.05], p=0.063). Atrioventricular block occurred in four patients in the atrial group (0.6% annual risk).
INTERPRETATION: The beneficial effect of atrial pacing found in our previous study is enhanced substantially over time. Patients with sick-sinus syndrome should be treated with an atrial rather than ventricular-pacing system because after long-term follow-up, atrial pacing is associated with a significantly higher survival, less atrial fibrillation, fewer thromboembolic complications, less heart failure, and a low-risk of atrioventricular block.

PMID 9652562  Lancet. 1997 Oct 25;350(9086):1210-6. doi: 10.1016/S014・・・
著者: G A Lamas, E J Orav, B S Stambler, K A Ellenbogen, E B Sgarbossa, S K Huang, R A Marinchak, N A Estes, G F Mitchell, E H Lieberman, C M Mangione, L Goldman
雑誌名: N Engl J Med. 1998 Apr 16;338(16):1097-104. doi: 10.1056/NEJM199804163381602.
Abstract/Text BACKGROUND: Standard clinical practice permits the use of either single-chamber ventricular pacemakers or dual-chamber pacemakers for most patients who require cardiac pacing. Ventricular pacemakers are less expensive, but dual-chamber pacemakers are believed to be more physiologic. However, it is not known whether either type of pacemaker results in superior clinical outcomes.
METHODS: The Pacemaker Selection in the Elderly study was a 30-month, single-blind, randomized, controlled comparison of ventricular pacing and dual-chamber pacing in 407 patients 65 years of age or older in 29 centers. Patients received a dual-chamber pacemaker that had been randomly programmed to either ventricular pacing or dual-chamber pacing. The primary end point was health-related quality of life as measured by the 36-item Medical Outcomes Study Short-Form General Health Survey.
RESULT: The average age of the patients was 76 years (range, 65 to 96), and 60 percent were men. Quality of life improved significantly after pacemaker implantation (P<0.001), but there were no differences between the two pacing modes in either the quality of life or prespecified clinical outcomes (including cardiovascular events or death). However, 53 patients assigned to ventricular pacing (26 percent) were crossed over to dual-chamber pacing because of symptoms related to the pacemaker syndrome. Patients with sinus-node dysfunction, but not those with atrioventricular block, had moderately better quality of life and cardiovascular functional status with dual-chamber pacing than with ventricular pacing. Trends of borderline statistical significance in clinical end points favoring dual-chamber pacing were observed in patients with sinus-node dysfunction, but not in those with atrioventricular block.
CONCLUSION: The implantation of a permanent pacemaker improves health-related quality of life. However, the quality-of-life benefits associated with dual-chamber pacing as compared with ventricular pacing are observed principally in the subgroup of patients with sinus-node dysfunction.

PMID 9545357  N Engl J Med. 1998 Apr 16;338(16):1097-104. doi: 10.105・・・
著者: S J Connolly, C R Kerr, M Gent, R S Roberts, S Yusuf, A M Gillis, M H Sami, M Talajic, A S Tang, G J Klein, C Lau, D M Newman
雑誌名: N Engl J Med. 2000 May 11;342(19):1385-91. doi: 10.1056/NEJM200005113421902.
Abstract/Text BACKGROUND: Evidence suggests that physiologic pacing (dual-chamber or atrial) may be superior to single-chamber (ventricular) pacing because it is associated with lower risks of atrial fibrillation, stroke, and death. These benefits have not been evaluated in a large, randomized, controlled trial.
METHODS: At 32 Canadian centers, patients without chronic atrial fibrillation who were scheduled for a first implantation of a pacemaker to treat symptomatic bradycardia were eligible for enrollment. We randomly assigned patients to receive either a ventricular pacemaker or a physiologic pacemaker and followed them for an average of three years. The primary outcome was stroke or death due to cardiovascular causes. Secondary outcomes were death from any cause, atrial fibrillation, and hospitalization for heart failure.
RESULTS: A total of 1474 patients were randomly assigned to receive a ventricular pacemaker and 1094 to receive a physiologic pacemaker. The annual rate of stroke or death due to cardiovascular causes was 5.5 percent with ventricular pacing, as compared with 4.9 percent with physiologic pacing (reduction in relative risk, 9.4 percent; 95 percent confidence interval, -10.5 to 25.7 percent [the negative value indicates an increase in risk]; P=0.33). The annual rate of atrial fibrillation was significantly lower among the patients in the physiologic-pacing group (5.3 percent) than among those in the ventricular-pacing group (6.6 percent), for a reduction in relative risk of 18.0 percent (95 percent confidence interval, 0.3 to 32.6 percent; P=0.05). The effect on the rate of atrial fibrillation was not apparent until two years after implantation. The observed annual rates of death from all causes and of hospitalization for heart failure were lower among the patients with a physiologic pacemaker than among those with a ventricular pacemaker, but not significantly so (annual rates of death, 6.6 percent with ventricular pacing and 6.3 percent with physiologic pacing; annual rates of hospitalization for heart failure, 3.5 percent and 3.1 percent, respectively). There were significantly more perioperative complications with physiologic pacing than with ventricular pacing (9.0 percent vs. 3.8 percent, P<0.001).
CONCLUSIONS: Physiologic pacing provides little benefit over ventricular pacing for the prevention of stroke or death due to cardiovascular causes.

PMID 10805823  N Engl J Med. 2000 May 11;342(19):1385-91. doi: 10.1056・・・
著者: A C Skanes, A D Krahn, R Yee, G J Klein, S J Connolly, C R Kerr, M Gent, K E Thorpe, R S Roberts, Canadian Trial of Physiologic Pacing
雑誌名: J Am Coll Cardiol. 2001 Jul;38(1):167-72.
Abstract/Text OBJECTIVES: This study examined the effect of physiologic pacing on the development of chronic atrial fibrillation (CAF) in the Canadian Trial Of Physiologic Pacing (CTOPP).
BACKGROUND: The role of physiologic pacing to prevent CAF remains unclear. Small randomized studies have suggested a benefit for patients with sick sinus syndrome. No data from a large randomized trial are available.
METHODS: The CTOPP randomized patients undergoing first pacemaker implant to ventricular-based or physiologic pacing (AAI or DDD). Patients who were prospectively found to have persistent atrial fibrillation (AF) lasting greater than or equal to one week were defined as having CAF. Kaplan-Meier plots for the development of CAF were compared by log-rank test. The effect of baseline variables on the benefit of physiologic pacing was evaluated by Cox proportional hazards modeling.
RESULTS: Physiologic pacing reduced the development of CAF by 27.1%, from 3.84% per year to 2.8% per year (p = 0.016). Three clinical factors predicted the development of CAF: age > or =74 years (p = 0.057), sinoatrial (SA) node disease (p < 0.001) and prior AF (p < 0.001). Subgroup analysis demonstrated a trend for patients with no history of myocardial infarction or coronary disease (p = 0.09) as well as apparently normal left ventricular function (p = 0.11) to derive greatest benefit.
CONCLUSIONS: Physiologic pacing reduces the annual rate of development of chronic AF in patients undergoing first pacemaker implant. Age > or =74 years, SA node disease and prior AF predicted the development of CAF. Patients with structurally normal hearts appear to derive greatest benefits.

PMID 11451268  J Am Coll Cardiol. 2001 Jul;38(1):167-72.
著者: Michael O Sweeney, Alan J Bank, Emmanuel Nsah, Maria Koullick, Qian Cathy Zeng, Douglas Hettrick, Todd Sheldon, Gervasio A Lamas, Search AV Extension and Managed Ventricular Pacing for Promoting Atrioventricular Conduction (SAVE PACe) Trial
雑誌名: N Engl J Med. 2007 Sep 6;357(10):1000-8. doi: 10.1056/NEJMoa071880.
Abstract/Text BACKGROUND: Conventional dual-chamber pacing maintains atrioventricular synchrony but results in high percentages of ventricular pacing, which causes ventricular desynchronization and has been linked to an increased risk of atrial fibrillation in patients with sinus-node disease.
METHODS: We randomly assigned 1065 patients with sinus-node disease, intact atrioventricular conduction, and a normal QRS interval to receive conventional dual-chamber pacing (535 patients) or dual-chamber minimal ventricular pacing with the use of new pacemaker features designed to promote atrioventricular conduction, preserve ventricular conduction, and prevent ventricular desynchronization (530 patients). The primary end point was time to persistent atrial fibrillation.
RESULTS: The mean (+/-SD) follow-up period was 1.7+/-1.0 years when the trial was stopped because it had met the primary end point. The median percentage of ventricular beats that were paced was lower in dual-chamber minimal ventricular pacing than in conventional dual-chamber pacing (9.1% vs. 99.0%, P<0.001), whereas the percentage of atrial beats that were paced was similar in the two groups (71.4% vs. 70.4%, P=0.96). Persistent atrial fibrillation developed in 110 patients, 68 (12.7%) in the group assigned to conventional dual-chamber pacing and 42 (7.9%) in the group assigned to dual-chamber minimal ventricular pacing. The hazard ratio for development of persistent atrial fibrillation in patients with dual-chamber minimal ventricular pacing as compared with those with conventional dual-chamber pacing was 0.60 (95% confidence interval, 0.41 to 0.88; P=0.009), indicating a 40% reduction in relative risk. The absolute reduction in risk was 4.8%. The mortality rate was similar in the two groups (4.9% in the group receiving dual-chamber minimal ventricular pacing vs. 5.4% in the group receiving conventional dual-chamber pacing, P=0.54).
CONCLUSIONS: Dual-chamber minimal ventricular pacing, as compared with conventional dual-chamber pacing, prevents ventricular desynchronization and moderately reduces the risk of persistent atrial fibrillation in patients with sinus-node disease. (ClinicalTrials.gov number, NCT00284830 [ClinicalTrials.gov].).

Copyright 2007 Massachusetts Medical Society.
PMID 17804844  N Engl J Med. 2007 Sep 6;357(10):1000-8. doi: 10.1056/N・・・
著者: Michael O Sweeney, Anne S Hellkamp, Kenneth A Ellenbogen, Arnold J Greenspon, Roger A Freedman, Kerry L Lee, Gervasio A Lamas, MOde Selection Trial Investigators
雑誌名: Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/01.CIR.0000072769.17295.B1. Epub 2003 Jun 2.
Abstract/Text BACKGROUND: Dual-chamber (DDDR) pacing preserves AV synchrony and may reduce heart failure (HF) and atrial fibrillation (AF) compared with ventricular (VVIR) pacing in sinus node dysfunction (SND). However, DDDR pacing often results in prolonged QRS durations (QRSd) as the result of right ventricular stimulation, and ventricular desynchronization may result. The effect of pacing-induced ventricular desynchronization in patients with normal baseline QRSd is unknown.
METHODS AND RESULTS: Baseline QRSd was obtained from 12-lead ECGs before pacemaker implantation in MOST, a 2010-patient, 6-year, randomized trial of DDDR versus VVIR pacing in SND. Cumulative percent ventricular paced (Cum%VP) was determined from stored pacemaker data. Baseline QRSd <120 ms was observed in 1339 patients (707 DDDR, 632 VVIR). Cum%VP was greater in DDDR versus VVIR (90% versus 58%, P=0.001). Cox models demonstrated that the time-dependent covariate Cum%VP was a strong predictor of HF hospitalization in DDDR (hazard ratio [HR], 2.99 [95% CI, 1.15 to 7.75] for Cum%VP >40%) and VVIR (HR 2.56 [95% CI, 1.48 to 4.43] for Cum%VP >80%). The risk of AF increased linearly with Cum%VP from 0% to 85% in both groups (DDDR, HR 1.36 [95% CI, 1.09, 1.69]; VVIR, HR 1.21 [95% CI 1.02, 1.43], for each 25% increase in Cum%VP). Model results were unaffected by adjustment for known baseline predictors of HF hospitalization and AF.
CONCLUSIONS: Ventricular desynchronization imposed by ventricular pacing even when AV synchrony is preserved increases the risk of HF hospitalization and AF in SND with normal baseline QRSd.

PMID 12782566  Circulation. 2003 Jun 17;107(23):2932-7. doi: 10.1161/0・・・
著者: A J Mangram, T C Horan, M L Pearson, L C Silver, W R Jarvis
雑誌名: Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620.
Abstract/Text
PMID 10219875  Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; q・・・
著者: Jose M Tolosana, Paola Berne, Lluis Mont, Magda Heras, Antonio Berruezo, Joan Monteagudo, David Tamborero, Begoña Benito, Josep Brugada
雑誌名: Eur Heart J. 2009 Aug;30(15):1880-4. doi: 10.1093/eurheartj/ehp194. Epub 2009 May 31.
Abstract/Text AIMS: Current guidelines recommend stopping oral anticoagulation (OAC) and starting heparin infusion before implanting/replacing a pacemaker/implantable cardioverter-defibrillator (ICD) in patients with high risk for thrombo-embolic events. The aim of this study was to demonstrate that the maintenance of OAC during device implantation/replacement is as safe as bridging to intravenous heparin and shortens in-hospital stay.
METHODS AND RESULTS: A cohort of 101 consecutive patients with high risk for embolic events and indication for implant/replacement of a pacemaker/ICD were randomized to two anticoagulant strategies: bridging from OAC to heparin infusion (n = 51) vs. maintenance of OAC to reach an INR = 2 +/- 0.3 at the day of the procedure (n = 50). Haemorrhagic and thrombo-embolic complications were evaluated at discharge, 15 and 45 days after the procedure. A total of 4/51 patients (7.8%) from heparin group and 4/50 (8.0%) from the OAC group developed pocket haematoma following the implant (P = 1.00). One haematoma in each group required evacuation (1.9 vs. 2%, P = 1.00). No other haemorrhagic events or embolic complications developed during the follow-up. Duration of the hospital stay was longer in the heparin group [median of 5 (4-7) vs. 2 (1-4) days; P < 0.001].
CONCLUSION: Implant of devices maintaining OAC is as safe as bridging to heparin infusion and allows a significant reduction of in-hospital stay.

PMID 19487235  Eur Heart J. 2009 Aug;30(15):1880-4. doi: 10.1093/eurhe・・・
著者: A Da Costa, G Kirkorian, M Cucherat, F Delahaye, P Chevalier, A Cerisier, K Isaaz, P Touboul
雑誌名: Circulation. 1998 May 12;97(18):1796-801.
Abstract/Text BACKGROUND: Infection remains a serious complication after permanent pacemaker implantation. Antibiotic prophylaxis is frequently prescribed at the time of insertion to reduce its incidence, although results of well-designed, controlled studies are lacking.
METHODS AND RESULTS: We performed a meta-analysis of all available randomized trials to evaluate the effectiveness of antibiotic prophylaxis to reduce infection rates after permanent pacemaker implantation. Reports of trials were identified through a Medline, Embase, Current Contents, and an extensive bibliography search. Trials that met the following criteria were included: (1) prospective, randomized, controlled, open or blind trials; (2) patients assigned to a systemic antibiotic group or a control group; (3) end point events related to any infection after pacemaker implantation: wound infection, septicemia, pocket abscess, purulent secretion, right infective endocarditis, inflammatory signs, a positive culture, septic pulmonary embolism, or repeat operation for an infective complication. Seven trials met the inclusion criteria. They included 2023 patients with established permanent pacemaker implantation (new implants or replacements). The incidence of end point events in control groups ranged from 0% to 12%. The meta-analysis suggested a consistent protective effect of antibiotic pretreatment (P=.0046; common odds ratio: 0.256, 95% confidence interval: 0.10 to 0.656).
CONCLUSIONS: Results of the present meta-analysis suggest that systemic antibiotic prophylaxis significantly reduces the incidence of potentially serious infective complications after permanent pacemaker implantation. They support the use of prophylactic antibiotics at the time of pacemaker insertion to prevent short-term pocket infection, skin erosion or septicemia.

PMID 9603534  Circulation. 1998 May 12;97(18):1796-801.
著者: Muhammad R Sohail, Daniel Z Uslan, Akbar H Khan, Paul A Friedman, David L Hayes, Walter R Wilson, James M Steckelberg, Sarah M Stoner, Larry M Baddour
雑誌名: Clin Infect Dis. 2007 Jul 15;45(2):166-73. doi: 10.1086/518889. Epub 2007 Jun 6.
Abstract/Text Background. Several host- and procedure-related factors have been reported to increase the risk of permanent pacemaker (PPM) infection on the basis of descriptive analyses of case series. The purpose of this study is to assess the risk factors for PPM infection using case-control study methods.Methods. All patients who had a PPM implanted at our institution from January 1991 to December 2003 were retrospectively reviewed. Each patient who experienced a PPM infection was matched with 2 control subjects by age, sex, year of implantation, and duration of follow-up. Univariate and multivariable analyses were performed to identify significant risk factors for PPM infection.Results. Twenty-nine case patients and 58 control subjects met inclusion criteria. The majority (83%) of case patients presented with a pocket infection; a minority (10%) had PPM-related endocarditis. Staphylococcus species (69%) were the most common pathogens. On univariate analysis, previous PPM infection, malignancy, long-term corticosteroid use, multiple device revisions, a permanent central venous catheter, the presence of >2 pacing leads, and a lack of antibiotic prophylaxis at the time of PPM placement were associated with an increased risk of PPM infection. A multivariable logistic regression model identified long-term corticosteroid use (odds ratio [OR], 13.90; 95% confidence interval [CI], 1.27-151.7; P=.03) and the presence of >2 pacing leads versus 2 leads (OR, 5.41; 95% CI, 1.44-20.29; P=.01) as independent risk factors for PPM infection. In contrast, use of antibiotic prophylaxis prior to PPM implantation had a protective effect (OR, 0.087; 95% CI, 0.016-0.48; P=.005).Conclusions. These findings should assist clinicians in identifying patients who are at increased risk of PPM infection, as well as in developing strategies to minimize the modifiable risks.

PMID 17578774  Clin Infect Dis. 2007 Jul 15;45(2):166-73. doi: 10.1086・・・
著者: Dale W Bratzler, E Patchen Dellinger, Keith M Olsen, Trish M Perl, Paul G Auwaerter, Maureen K Bolon, Douglas N Fish, Lena M Napolitano, Robert G Sawyer, Douglas Slain, James P Steinberg, Robert A Weinstein, American Society of Health-System Pharmacists, Infectious Disease Society of America, Surgical Infection Society, Society for Healthcare Epidemiology of America
雑誌名: Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568.
Abstract/Text
PMID 23327981  Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: ・・・
著者: Niraj Varma, Andrew E Epstein, Anand Irimpen, Robert Schweikert, Charles Love, TRUST Investigators
雑誌名: Circulation. 2010 Jul 27;122(4):325-32. doi: 10.1161/CIRCULATIONAHA.110.937409. Epub 2010 Jul 12.
Abstract/Text BACKGROUND: Monitoring implantable cardiac device function and patient condition is important. The Lumos-T Safely Reduces Routine Office Device Follow-Up (TRUST) trial tested the hypothesis that remote home monitoring with automatic daily surveillance (HM) is safe and effective for implantable cardioverter-defibrillator follow-up for 1 year and enables rapid physician evaluation of significant events.
METHODS AND RESULTS: In total, 1339 patients were randomized 2:1 to HM or conventional follow-up. Follow-up checks occurred at 3, 6, 9, 12, and 15 months after implantation. HM was used before office visits at 3 and 15 months in the HM group. At 6, 9, and 12 months, HM only was used but was followed by office visits if necessary. Conventional patients were evaluated with office visits only. Scheduled office visits and unscheduled evaluations, incidence of morbidity, and time elapsed from first event occurrence in each patient to physician evaluation were tracked for each group. HM and conventional patients were similar (age, 63.3+/-12.8 versus 64.0+/-12.1 years; gender, 72.0% versus 73.1% male; New York Heart Association class II, 55.9% versus 60.4%; pathology: left ventricular ejection fraction, 29.0+/-10.7% versus 28.5+/-9.8%; coronary artery disease, 64.8% versus 71.7%; primary prevention indication, 72.2% versus 73.8%; and dual-chamber implants, 57.8% versus 56.6%). HM reduced total in-hospital device evaluations by 45% without affecting morbidity. In the HM group, 85.8% of all 6-, 9-, and 12-month follow-ups were performed remotely only, indicating that HM provided sufficient assessment in the majority. Median time to evaluation was <2 days in the HM group compared with 36 days in the conventional group (P<0.001) for all arrhythmic events.
CONCLUSIONS: HM is safe and allows more rapid detection of actionable events compared with conventional monitoring in patients with implantable electronic cardiac devices.

PMID 20625110  Circulation. 2010 Jul 27;122(4):325-32. doi: 10.1161/CI・・・
著者: George H Crossley, Andrew Boyle, Holly Vitense, Yanping Chang, R Hardwin Mead, CONNECT Investigators
雑誌名: J Am Coll Cardiol. 2011 Mar 8;57(10):1181-9. doi: 10.1016/j.jacc.2010.12.012. Epub 2011 Jan 20.
Abstract/Text OBJECTIVES: The primary objective was to determine if wireless remote monitoring with automatic clinician alerts reduces the time from a clinical event to a clinical decision in response to arrhythmias, cardiovascular (CV) disease progression, and device issues compared to patients receiving standard in-office care. A secondary objective was to compare the rates of CV health care utilization between patients in the remote and in-office arms.
BACKGROUND: In addition to providing life-saving therapy, implantable cardioverter-defibrillators collect advanced diagnostics on the progression of the patient's heart disease. Device technology has progressed to allow wireless remote monitoring with automatic clinician alerts to replace some scheduled in-office visits.
METHODS: The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) study was a multicenter, prospective, randomized evaluation involving 1,997 patients from 136 clinical sites who underwent insertion of an implantable cardioverter-defibrillator (including cardiac resynchronization therapy devices) and were followed up for 15 months. Health care utilization data included all CV-related hospitalizations, emergency department visits, and clinic office visits.
RESULTS: The median time from clinical event to clinical decision per patient was reduced from 22 days in the in-office arm to 4.6 days in the remote arm (p < 0.001). The health care utilization data revealed a decrease in mean length of stay per CV hospitalization visit from 4.0 days in the in-office arm to 3.3 days in the remote arm (p = 0.002).
CONCLUSIONS: Wireless remote monitoring with automatic clinician alerts as compared with standard in-office follow-up significantly reduced the time to a clinical decision in response to clinical events and was associated with a significant reduction in mean length of CV hospital stay. (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision [CONNECT]; NCT00402246).

Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
PMID 21255955  J Am Coll Cardiol. 2011 Mar 8;57(10):1181-9. doi: 10.10・・・
著者: Gerhard Hindricks, Milos Taborsky, Michael Glikson, Ullus Heinrich, Burghard Schumacher, Amos Katz, Johannes Brachmann, Thorsten Lewalter, Andreas Goette, Michael Block, Josef Kautzner, Stefan Sack, Daniela Husser, Christopher Piorkowski, Peter Søgaard, IN-TIME study group*
雑誌名: Lancet. 2014 Aug 16;384(9943):583-590. doi: 10.1016/S0140-6736(14)61176-4.
Abstract/Text BACKGROUND: An increasing number of patients with heart failure receive implantable cardioverter-defibrillators (ICDs) or cardiac resynchronisation defibrillators (CRT-Ds) with telemonitoring function. Early detection of worsening heart failure, or upstream factors predisposing to worsening heart failure, by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes, but the evidence is weak. We investigated this possibility in IN-TIME, a clinical trial.
METHODS: We did this randomised, controlled trial at 36 tertiary clinical centres and hospitals in Australia, Europe, and Israel. We enrolled patients with chronic heart failure, NYHA class II-III symptoms, ejection fraction of no more than 35%, optimal drug treatment, no permanent atrial fibrillation, and a recent dual-chamber ICD or CRT-D implantation. After a 1 month run-in phase, patients were randomly assigned (1:1) to either automatic, daily, implant-based, multiparameter telemonitoring in addition to standard care or standard care without telemonitoring. Investigators were not masked to treatment allocation. Patients were masked to allocation unless they were contacted because of telemonitoring findings. Follow-up was 1 year. The primary outcome measure was a composite clinical score combining all-cause death, overnight hospital admission for heart failure, change in NYHA class, and change in patient global self-assessment, for the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT00538356.
FINDINGS: We enrolled 716 patients, of whom 664 were randomly assigned (333 to telemonitoring, 331 to control). Mean age was 65·5 years and mean ejection fraction was 26%. 285 (43%) of patients had NYHA functional class II and 378 (57%) had NYHA class III. Most patients received CRT-Ds (390; 58·7%). At 1 year, 63 (18·9%) of 333 patients in the telemonitoring group versus 90 (27·2%) of 331 in the control group (p=0·013) had worsened composite score (odds ratio 0·63, 95% CI 0·43-0·90). Ten versus 27 patients died during follow-up.
INTERPRETATION: Automatic, daily, implant-based, multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure. Such telemonitoring is feasible and should be used in clinical practice.
FUNDING: Biotronik SE & Co. KG.

Copyright © 2014 Elsevier Ltd. All rights reserved.
PMID 25131977  Lancet. 2014 Aug 16;384(9943):583-590. doi: 10.1016/S01・・・

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