今日の臨床サポート

経皮的心肺補助の概要・適応

著者: 今村輝彦 富山大学 第二内科

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:2021/03/10
参考ガイドライン:
  1. 日本循環器学会:急性・慢性心不全診療ガイドライン(2017年改訂版)

概要・推奨   

  1. 内科治療に抵抗性を示す急性心不全に際しては速やかに機械的補助循環を考慮すべきである(推奨度2)
  1. ただし機械的補助循環を行う際には同時に出口戦略も模索する必要がある(推奨度2)
  1. 併存疾患のために中長期的な予後が見込めない患者に対して機械的補助循環治療を行うべきではない(推奨度4)
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:
今村輝彦 : 未申告[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. 心不全診療ガイドラインが改訂されたため、その内容を踏まえて改訂した。
  1. わが国でも経皮的LVAD治療としてのImpellaが使用可能になったため、実臨床におけるこの治療の立ち位置を改訂した。

まとめ・診察

まとめ  
機械的補助循環
  1. 「心不全に対して、一次的に心臓のポンプ機能を補助・代行し、心臓のポンプ失調の回復を待つ方法」を循環補助という。
  1. 循環補助の第1選択は薬物療法であるが、心原性ショックを含む重症心不全が薬物治療抵抗性となった場合には、機械的補助循環(assisted circulation)を速やかに導入する必要となる。
  1. 機械的補助循環法の中には、圧補助法であるIABP(Intra-aortic balloon pumping)と流量補助法である静-動脈バイパス(veno-arterial bypass、VAB)や補助人工心臓(ventricular assist system、VAS)などがある。
  1. 機械的補助循環を心原性ショック症例に対して行った場合の治療成績は、補助開始前の状態で大きく異なる。院外心肺停止例におけるPCPS補助の生存率は14~40%であり、多くの報告は20%程度である。
 
重症心不全におけるVAD 治療のアルゴリズム

日本循環器学会の急性・慢性心不全診療ガイドライン(2017年改訂版)の「急性心不全患者における機械的補助循環装置の選択と治療体系」アルゴリズム。
新規発症の重症心不全において、強心薬やIABPでも血行動態が不安定であれば、PCPSやImpellaを検討する。離脱困難である一方で他臓器障害を認めなければ体外式VADの植え込みを行い、必要に応じて心臓移植適応を検討する。慢性心不全の急性増悪に対しても、強心薬、IABP、Impella、PCPSなどを組み合わせて血行動態の立ち上げを目指したのち、心臓移植適応取得の可能性を検討しながら体外式または植込型LVAD治療を目指す。

 
世界的にみた重症心不全患者における機械的補助循環治療体系

世界水準のAHA Statements 2013 Recommendations for MCSにおける「重症心不全患者における機械的補助循環治療体系」アルゴリズム
BTT:心臓移植へのbridge(橋渡し)(bridge to transplantation)
DT:永久使用(destination therapy)
BTD:心臓移植(bridge to decision)
(※)わが国では現在DT適応が議論されている最中であり、まだ認められていない。

出典

img1:  Recommendations for the use of mechanical circulatory support: device strategies and patient selection: a scientific statement from the American Heart Association.
 
 Circulation. 2012 Nov 27;126(22):2648-67・・・
 
経皮的心肺補助
  1. 経皮的心肺補助(Percutaneous Cardio-Pulmonary Support、PCPS)はVABを経皮的カニュレーションにより行うシステムであり、機械的補助循環を簡便かつ迅速に実施できるシステムであり、循環補助のみではなく呼吸補助が可能である。
  1. 海外でECMO(Extra-Corporeal Membrane Oxygenation)と呼称されているものとほぼ同義であり、わが国でもECMOと呼称されることが多くなってきた。呼吸補助のみを行うためのVV ECMOや心肺両方の補助を行うためのVA ECMOなど様々な回路が使用されている。

今なら12か月分の料金で14ヶ月利用できます(個人契約、期間限定キャンペーン)

11月30日(火)までにお申込みいただくと、
通常12ヵ月の使用期間が2ヶ月延長となり、14ヵ月ご利用いただけるようになります。

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文献 

著者: J H STUCKEY, M M NEWMAN, C DENNIS, E H BERG, S E GOODMAN, C C FRIES, K E KARLSON, M BLUMENFELD, S W WEITZNER, L S BINDER, A WINSTON
雑誌名: Surg Forum. 1957;8:342-4.
Abstract/Text
PMID 13529624  Surg Forum. 1957;8:342-4.
著者: A Kantrowitz, S Tjonneland, P S Freed, S J Phillips, A N Butner, J L Sherman
雑誌名: JAMA. 1968 Jan 8;203(2):113-8.
Abstract/Text
PMID 5694059  JAMA. 1968 Jan 8;203(2):113-8.
著者: D LIOTTA, C W HALL, W S HENLY, D A COOLEY, E S CRAWFORD, M E DEBAKEY
雑誌名: Am J Cardiol. 1963 Sep;12:399-405.
Abstract/Text
PMID 14064861  Am J Cardiol. 1963 Sep;12:399-405.
著者: F C SPENCER, B EISEMAN, J K TRINKLE, N P ROSSI
雑誌名: J Thorac Cardiovasc Surg. 1965 Jan;49:56-73.
Abstract/Text
PMID 14261875  J Thorac Cardiovasc Surg. 1965 Jan;49:56-73.
著者: M E DeBakey
雑誌名: Am J Cardiol. 1971 Jan;27(1):3-11. doi: 10.1016/0002-9149(71)90076-2.
Abstract/Text
PMID 5538711  Am J Cardiol. 1971 Jan;27(1):3-11. doi: 10.1016/0002-91・・・
著者: J G Copeland, M M Levinson, R Smith, T B Icenogle, C Vaughn, K Cheng, R Ott, R W Emery
雑誌名: JAMA. 1986 Dec 5;256(21):2991-5.
Abstract/Text In 1985, at the University of Arizona, Tucson, two attempts were made to "bridge" patients from impending death to heart transplantation, using orthotopically positioned total artificial hearts. The first attempt, using an unapproved device on an emergency basis, failed after transplantation because of severe pulmonary edema and Pseudomonas pneumonia and the apparent transmission of a Pseudomonas infection from donor to recipient. The second experience, using a Jarvik-7 device, led to stable support for nine days with one major complication, a reversible neurologic deficit with no associated computed tomographic scan abnormality. This patient survived cardiac transplantation and, after being successfully treated for complications, has made a full recovery and returned to full-time work.

PMID 3534340  JAMA. 1986 Dec 5;256(21):2991-5.
著者: J C Norman, M I Brook, D A Cooley, T Klima, B D Kahan, O H Frazier, A S Keats, J Hacker, E K Massin, J M Duncan, R T Solis, C C Dacso, W E Luper, D S Winston, G J Reul
雑誌名: Lancet. 1978 May 27;1(8074):1125-7.
Abstract/Text A patient with acute bacterial endocarditis in whom ischaemic contracture of the left ventricle (stone-heart syndrome) developed during aortic and mitral valve replacement had an emergency implantation of an intracorporeal partial artificial heart (an abdominal left-ventricular assist device of ALVAD). This device functioned as a total artificial heart for nearly 6 days, while a donor heart for transplantation was sought. The ALVAD was then removed, and the patient received allografts of a heart and a kidney. The transplanted heart functioned well, but the patient died 15 days later from gram-negative sepsis. There was no evidence of cardiac or renal allograft rejection.

PMID 77417  Lancet. 1978 May 27;1(8074):1125-7.
著者: E A Rose, A C Gelijns, A J Moskowitz, D F Heitjan, L W Stevenson, W Dembitsky, J W Long, D D Ascheim, A R Tierney, R G Levitan, J T Watson, P Meier, N S Ronan, P A Shapiro, R M Lazar, L W Miller, L Gupta, O H Frazier, P Desvigne-Nickens, M C Oz, V L Poirier, Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group
雑誌名: N Engl J Med. 2001 Nov 15;345(20):1435-43. doi: 10.1056/NEJMoa012175.
Abstract/Text BACKGROUND: Implantable left ventricular assist devices have benefited patients with end-stage heart failure as a bridge to cardiac transplantation, but their long-term use for the purpose of enhancing survival and the quality of life has not been evaluated.
METHODS: We randomly assigned 129 patients with end-stage heart failure who were ineligible for cardiac transplantation to receive a left ventricular assist device (68 patients) or optimal medical management (61). All patients had symptoms of New York Heart Association class IV heart failure.
RESULTS: Kaplan-Meier survival analysis showed a reduction of 48 percent in the risk of death from any cause in the group that received left ventricular assist devices as compared with the medical-therapy group (relative risk, 0.52; 95 percent confidence interval, 0.34 to 0.78; P=0.001). The rates of survival at one year were 52 percent in the device group and 25 percent in the medical-therapy group (P=0.002), and the rates at two years were 23 percent and 8 percent (P=0.09), respectively. The frequency of serious adverse events in the device group was 2.35 (95 percent confidence interval, 1.86 to 2.95) times that in the medical-therapy group, with a predominance of infection, bleeding, and malfunction of the device. The quality of life was significantly improved at one year in the device group.
CONCLUSIONS: The use of a left ventricular assist device in patients with advanced heart failure resulted in a clinically meaningful survival benefit and an improved quality of life. A left ventricular assist device is an acceptable alternative therapy in selected patients who are not candidates for cardiac transplantation.

PMID 11794191  N Engl J Med. 2001 Nov 15;345(20):1435-43. doi: 10.1056・・・
著者: D Bregman, W J Casarella
雑誌名: Ann Thorac Surg. 1980 Feb;29(2):153-5.
Abstract/Text A new intraaortic balloon is described that can be inserted percutaneously through a 12F sheath by the standard Seldinger technique. Insertion and removal are rapid, and the hemodynamics of balloon pumping are similar to our previous clinical experience with standard single- and dual-chambered intraaortic balloons. The initial clinical experience is detailed.

PMID 7356366  Ann Thorac Surg. 1980 Feb;29(2):153-5.
著者: S J Phillips, B Ballentine, D Slonine, J Hall, J Vandehaar, C Kongtahworn, R H Zeff, J R Skinner, K Reckmo, D Gray
雑誌名: Ann Thorac Surg. 1983 Aug;36(2):223-5.
Abstract/Text Improved technology has allowed us to develop support pumps that can be applied rapidly and safely. A system utilizing thin-walled (4 mm inner diameter) percutaneously inserted sheaths has been designed for rapid bedside arterial and central venous cannulation to establish femoral arterial and venous cardiopulmonary bypass. The system utilizes two 30-cm-long large-bore, thin-walled (end and side holes) venous cannulas and a single 15-cm-long (end hole) arterial reperfusion cannula, which is connected to a pediatric oxygenator and a vortex pump head. Five patients with refractory cardiac arrest who could not be resuscitated by conventional means were revived with this system. Application time was approximately five minutes. This system appears to be an easily applied and reliable short-term mechanical support device.

PMID 6882082  Ann Thorac Surg. 1983 Aug;36(2):223-5.
著者: K E Alcan, S H Stertzer, E Wallsh, N P DePasquale, M S Bruno
雑誌名: Am Heart J. 1983 Mar;105(3):527-30.
Abstract/Text Between June, 1979, and July, 1982, 14 patients required an IABP in conjunction with PTCA. The clinical indications for balloon counterpulsation, in the performance of PTCA were (1) clinically unstable situations where PTCA might otherwise be contraindicated, e.g., left main stem disease, multivessel coronary artery disease, unstable anginal syndromes, and cardiogenic shock; (2) preoperative insertion of an IABP for added safety following unsuccessful angioplasty; (3) abrupt vessel closure during a PTCA procedure in which the patient becomes hemodynamically unstable; and (4) late vessel closure following an initially successful angioplasty resulting in hemodynamic compromise. Of the 14 cases requiring balloon counterpulsation, 13 survived hospitalization and were alive at the time this report was submitted. We conclude that IABP is a useful adjunct to PTCA in a variety of clinical circumstances.

PMID 6219566  Am Heart J. 1983 Mar;105(3):527-30.
著者: C DENNIS, E CARLENS, A SENNING, D P HALL, J R MORENO, R R CAPPELLETTI, S A WESOLOWSKI
雑誌名: Ann Surg. 1962 Oct;156:623-37. doi: 10.1097/00000658-196210000-00009.
Abstract/Text
PMID 14027026  Ann Surg. 1962 Oct;156:623-37. doi: 10.1097/00000658-19・・・
著者: Pascal Vranckx, David P Foley, Pim J de Feijter, Jeroen Vos, Peter Smits, Patrick W Serruys
雑誌名: Int J Cardiovasc Intervent. 2003;5(1):35-9.
Abstract/Text BACKGROUND: In patients with poor left ventricular function and high-risk coronary lesions, prolonged ischemia during percutaneous coronary intervention (PCI) may have major hemodynamic consequences. The Tandemheart is a percutaneous left ventricular assist device intended for short-term circulatory support.
METHODS AND RESULTS: The Tandem-heart incorporates 9-17 F. arterial cannulae and a unique 21 F. transseptal cannula and centrifugal bloodpump. Operating at 7500 rpm, the pump withdraws oxygenated blood from the left atrium and delivers up to 4 liters/min to the arterial circulation. As of May 2001, the Tandem-heart was electively employed in three male patients (ages 52, 54 and 56) scheduled for high-risk PCI. The mean time to initial circulatory support was less than 30 minutes. Systemic hemodynamics significantly improved prior to PCI in two patients. Pump flow after one hour ranged from 2.43 to 3.8 liters/min (mean 3.17 liters/min) and duration of support from 23 to 49 hours (mean 33 hours). Procedural success was 100%, with no significant hemolysis or bleeding. Successful weaning was completed in all patients, who have remained free of major cardiac events up to seven months post-PCI.
CONCLUSIONS: In this first clinical experience of elective use of Tandem-heart for circulatory support during high-risk PCI, the device was easily inserted and preserved hemodynamic stability, regardless of the intrinsic cardiac function, creating optimism for more widespread use for this and other indications.

PMID 12623563  Int J Cardiovasc Intervent. 2003;5(1):35-9.
著者: O H Frazier, R K Wampler, J M Duncan, W E Dear, M P Macris, S M Parnis, J M Fuqua
雑誌名: Ann Thorac Surg. 1990 Feb;49(2):299-304.
Abstract/Text The Hemopump, a catheter-mounted, temporary ventricular assist device, consists of an external electromechanical drive console and a disposable, intraarterial axial-flow pump (21F). Power is transmitted percutaneously to the pump by a flexible drive shaft within the catheter. The device is positioned in the left ventricle by way of the femoral artery approach or through the ascending aorta. Blood is drawn from the left ventricle through the transvalvular inlet cannula and pumped into the aorta. As of December 1988, the Hemopump had successfully supported the circulation of 7 patients (5 men, 2 women) ranging in age from 44 to 72 years (mean age, 59 years) and suffering from cardiogenic shock (cardiac index less than 2.0 L/min/m2). Indications for use included failure to be weaned from cardiopulmonary bypass in 4 patients, acute myocardial infarction in 1, severe cardiac allograft rejection in 1, and donor heart failure in 1. Duration of support ranged from 26 to 113 hours (mean, 66 hours). Although 5 patients demonstrated transient hemolysis, none experienced infection, thrombosis, or vascular injury. Hemodynamic variables improved in all patients during support by the device. As of December 1988, 5 of the 7 patients were alive more than 30 days after support had been discontinued, and 3 of these patients were discharged from the hospital. On the basis of our initial clinical results, the Hemopump, which does not require a major surgical procedure for insertion, provides effective, temporary circulatory support in patients with potentially reversible cardiac failure.

PMID 2306152  Ann Thorac Surg. 1990 Feb;49(2):299-304.
著者: B Meyns, J Dens, P Sergeant, P Herijgers, W Daenen, W Flameng
雑誌名: Thorac Cardiovasc Surg. 2003 Dec;51(6):312-7. doi: 10.1055/s-2003-45422.
Abstract/Text BACKGROUND: We planned a study to assess the safety, feasibility, and efficacy of the Impella micro-axial blood pump in patients with cardiogenic shock.
METHODS: From January 2001 to September 2002 inclusive, 16 patients in cardiogenic shock (maximal inotropic support and with IABP in 11 cases) underwent left ventricle unloading with the Impella pump. 6 were placed via the femoral artery (patients in the coronary care unit) and 10 directly through the aorta (postcardiotomy heart failure). In three patients, the device was used in combination with ECMO. Mean age was 60 years (range 43 - 75), 11 were male.
RESULTS: A stable pump flow of 4.24 +/- 0.28 l/min was reached (3.3 +/- 1.9 l/min in patients with ECMO and Impella). Mean blood pressure before Impella) support was 57.4 +/- 13 mmHg, which increased to 74.9 +/- 13 mmHg after 6 hours and 80.6 +/- 17 mmHg (p = 0.003) after 24 hours. Cardiac output increased from 4.1 +/- 1.3 l/min to 5.5 +/- 1.3 (p = 0.003) and 5.9 +/-1.9 l/min (p = 0.01) at 6 and 24 hours. Mean pulmonary wedge pressure decreased from 29 +/- 10 mmHg to 17 +/- 5 mmHg and 18 +/- 7 mmHg at 6 (p = 0.04) and 24 hours. Blood lactate levels decreased significantly after 6 hours of support (from 2.7 +/- 1 to 1.3 +/- 0.5 mmol/l, p = 0.004). Device-related complications included three sensor failures (no clinical action), one pump displacement (replacement) and six incidences of haemolysis (peak free plasma haemoglobin > 100 mg/dl, no clinical action). Eleven patients (68 %) were weaned, six (37 %) survived.
CONCLUSIONS: Left ventricular unloading with the Impella pump via the transthoracic or femoral approach is feasible and safe. Support led to a decrease in pulmonary capillary wedge pressure, increase in cardiac output and mean blood pressure, and improved organ perfusion in patients with severe cardiogenic shock.

PMID 14669126  Thorac Cardiovasc Surg. 2003 Dec;51(6):312-7. doi: 10.1・・・
著者: Asmir I Syed, Amit Kakkar, Amit Karkar, Rebecca Torguson, Yanlin Li, Itsik Ben-Dor, Sara D Collins, Gilles Lemesle, Gabriel Maluenda, Zhenyi Xue, Mickey Scheinowitz, Kimberly Kaneshige, Lowell F Satler, Kenneth M Kent, William O Suddath, Augusto D Pichard, Joseph Lindsay, Ron Waksman
雑誌名: Cardiovasc Revasc Med. 2010 Apr-Jun;11(2):91-7. doi: 10.1016/j.carrev.2009.07.006.
Abstract/Text OBJECTIVES: This study aimed to report the in-hospital and 30-day event rates in patients undergoing non-emergent, high-risk percutaneous coronary intervention (PCI) and to evaluate whether the Impella Recover LP 2.5 device (Abiomed, Danvers, MA) demonstrates superiority over intra-aortic balloon pump (IABP) in the Protect II (A Prospective Feasibility Trial Investigating the Use of the Impella Recover LP 2.5 System in Patients Undergoing High Risk Percutaneous Coronary Intervention) study.
BACKGROUND: Patients undergoing non-emergent, high-risk PCI are often treated with prophylactic IABP for hemodynamic support.
METHODS: A cohort of 85 patients who met the inclusion/exclusion criteria of the Protect II study was included in this retrospective analysis. High-risk PCI was defined as intervention to the last patent coronary conduit or to an unprotected left main or in a patient with three-vessel disease with an ejection fraction of RESULTS: The overall in-hospital and 30-day event rates were low (15.3% and 21.3%, respectively) with a low major vascular complication rate (5.9%). Therefore, for the Impella Recover LP 2.5 device to demonstrate superiority over IABP with a treatment effect of 33.3% and 80% power, the Protect II trial will require a total of 908 patients. With the current sample size of 654 patients, the Protect II trial is underpowered, with only 66% power.
CONCLUSION: These data question the clinical benefit of the Protect II study, which is evaluating the relatively high-profile Impella LP 2.5 device over IABP for this high-risk population.

PMID 20347798  Cardiovasc Revasc Med. 2010 Apr-Jun;11(2):91-7. doi: 10・・・
著者: Melchior Seyfarth, Dirk Sibbing, Iris Bauer, Georg Fröhlich, Lorenz Bott-Flügel, Robert Byrne, Josef Dirschinger, Adnan Kastrati, Albert Schömig
雑誌名: J Am Coll Cardiol. 2008 Nov 4;52(19):1584-8. doi: 10.1016/j.jacc.2008.05.065.
Abstract/Text OBJECTIVES: The aim of this study was to test whether the left ventricular assist device (LVAD) Impella LP2.5 (Abiomed Europe GmbH, Aachen, Germany) provides superior hemodynamic support compared with the intra-aortic balloon pump (IABP).
BACKGROUND: Cardiogenic shock caused by left ventricular failure is associated with high mortality in patients with acute myocardial infarction (AMI). An LVAD may help to bridge patients to recovery from left ventricular failure.
METHODS: In a prospective, randomized study, 26 patients with cardiogenic shock were studied. The primary end point was the change of the cardiac index (CI) from baseline to 30 min after implantation. Secondary end points included lactic acidosis, hemolysis, and mortality after 30 days.
RESULTS: In 25 patients the allocated device (n = 13 IABP, n = 12 Impella LP2.5) could be safely placed. One patient died before implantation. The CI after 30 min of support was significantly increased in patients with the Impella LP2.5 compared with patients with IABP (Impella: DeltaCI = 0.49 +/- 0.46 l/min/m(2); IABP: DeltaCI = 0.11 +/- 0.31 l/min/m(2); p = 0.02). Overall 30-day mortality was 46% in both groups.
CONCLUSIONS: In patients presenting with cardiogenic shock caused by AMI, the use of a percutaneously placed LVAD (Impella LP 2.5) is feasible and safe, and provides superior hemodynamic support compared with standard treatment using an intra-aortic balloon pump. (Efficacy Study of LV Assist Device to Treat Patients With Cardiogenic Shock [ISAR-SHOCK]; NCT00417378).

PMID 19007597  J Am Coll Cardiol. 2008 Nov 4;52(19):1584-8. doi: 10.10・・・
著者: Jin M Cheng, Corstiaan A den Uil, Sanne E Hoeks, Martin van der Ent, Lucia S D Jewbali, Ron T van Domburg, Patrick W Serruys
雑誌名: Eur Heart J. 2009 Sep;30(17):2102-8. doi: 10.1093/eurheartj/ehp292. Epub 2009 Jul 18.
Abstract/Text AIMS: Studies have compared safety and efficacy of percutaneous left ventricular assist devices (LVADs) with intra-aortic balloon pump (IABP) counterpulsation in patients with cardiogenic shock. We performed a meta-analysis of controlled trials to evaluate potential benefits of percutaneous LVAD on haemodynamics and 30-day survival.
METHODS AND RESULTS: Two independent investigators searched Medline, Embase, and Cochrane Central Register of Controlled Trials for all controlled trials using percutaneous LVAD in patients with cardiogenic shock, where after data were extracted using standardized forms. Weighted mean differences (MDs) were calculated for cardiac index (CI), mean arterial pressure (MAP), and pulmonary capillary wedge pressure (PCWP). Relative risks (RRs) were calculated for 30-day mortality, leg ischaemia, bleeding, and sepsis. In main analysis, trials were combined using inverse-variance random effects approach. Two trials evaluated the TandemHeart and a recent trial used the Impella device. After device implantation, percutaneous LVAD patients had higher CI (MD 0.35 L/min/m(2), 95% CI 0.09-0.61), higher MAP (MD 12.8 mmHg, 95% CI 3.6-22.0), and lower PCWP (MD -5.3 mm Hg, 95% CI -9.4 to -1.2) compared with IABP patients. Similar 30-day mortality (RR 1.06, 95% CI 0.68-1.66) was observed using percutaneous LVAD compared with IABP. No significant difference was observed in incidence of leg ischaemia (RR 2.59, 95% CI 0.75-8.97) in percutaneous LVAD patients compared with IABP patients. Bleeding (RR 2.35, 95% CI 1.40-3.93) was significantly more observed in TandemHeart patients compared with patients treated with IABP.
CONCLUSION: Although percutaneous LVAD provides superior haemodynamic support in patients with cardiogenic shock compared with IABP, the use of these more powerful devices did not improve early survival. These results do not yet support percutaneous LVAD as first-choice approach in the mechanical management of cardiogenic shock.

PMID 19617601  Eur Heart J. 2009 Sep;30(17):2102-8. doi: 10.1093/eurhe・・・

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