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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、またはこれらの組み合わせを検討する。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。心臓移植適応を取得できれば、心臓移植までの橋渡し治療(BTT)として植込型LVAD治療が可能になる。心臓移植の適応にない場合は、中長期的な予後や治療戦略、患者や介護者の状況などを総合的に加味した後に、恒久的な植込型LVAD治療(destination therapy:DT)を検討する。
出典
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1: 日本循環器学会他編:日本心不全学会合同ガイドライン 急性・慢性心不全診療ガイドライン(2017年改訂版)https://www.j-circ.or.jp/cms/wp-content/uploads/2017/06/JCS2017_tsutsui_h_190830.pdf(2020年9月閲覧)班長:筒井裕之、p100、図13 重症心不全におけるVAD 治療のアルゴリズム

各種補助循環治療の創成期と経皮的補助循環の歴史

出典
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1: 許俊鋭先生ご提供

PCPSの適応・禁忌

出典
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1: 許俊鋭先生ご提供

臨床的に用いられている経皮的補助循環法のシェーマ

RA:右房
LA:左房
IABP:大動脈バルーンパンピング
Outlet Area:出口部
Inlet Area:入口部
出典
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1: Clinical introduction of the Tandemheart, a percutaneous left ventricular assist device, for circulatory support during high-risk percutaneous coronary intervention.
著者: Vranckx P, Foley DP, de Feijter PJ, Vos J, Smits P, Serruys PW.
雑誌名: Int J Cardiovasc Intervent. 2003;5(1):35-9. doi: 10.1080/14628840304611.
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.
Int J Cardiovasc Intervent. 2003;5(1):35-9. doi: 10.1080/1462884030461...
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2: Initial experiences with the Impella device in patients with cardiogenic shock - Impella support for cardiogenic shock.
著者: Meyns B, Dens J, Sergeant P, Herijgers P, Daenen W, Flameng W.
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.
Thorac Cardiovasc Surg. 2003 Dec;51(6):312-7. doi: 10.1055/s-2003-4542...
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3: Prophylactic use of intra-aortic balloon pump for high-risk percutaneous coronary intervention: will the Impella LP 2.5 device show superiority in a clinical randomized study?
著者: Syed AI, Kakkar A, Torguson R, Li Y, Ben-Dor I, Collins SD, Lemesle G, Maluenda G, Xue Z, Scheinowitz M, Kaneshige K, Satler LF, Kent KM, Suddath WO, Pichard AD, Lindsay J, Waksman R.
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.
Cardiovasc Revasc Med. 2010 Apr-Jun;11(2):91-7. doi: 10.1016/j.carrev....
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4: A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction.
著者: Seyfarth M, Sibbing D, Bauer I, Fröhlich G, Bott-Flügel L, Byrne R, Dirschinger J, Kastrati A, Schömig A.
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).
J Am Coll Cardiol. 2008 Nov 4;52(19):1584-8. doi: 10.1016/j.jacc.2008....

PCPSの適応(2005年)

2005年のPCPS研究会の700例の集計によれば、66%の適応が心肺蘇生であり、23%が心原性ショックであった。
呼吸補助は7%と少ないが、欧米ではECMOとして小児IRDS、成人ARDS、インフルエンザなどによる呼吸不全できわめて重要な治療手段となっている。今後、日本でもECMOの適応比率は、急性心不全適応が減少し、呼吸不全に対する適応が拡大していくものと予測される。COVID-19に関連する急性呼吸不全に対するECMOの有効性が期待された。一方でその限界も知られるようになり、その適正使用が議論されている。
 
参考文献:JAMA. 2011 Oct 19;306(15):1659-68. doi: 10.1001/jama.2011.1471. Epub 2011 Oct 5.

日本におけるPCPS治療症例数(2008-2010年)

2010 年循環器疾患診療実態調査報告書でみる過去3年間(2008~10年)の日本におけるPCPS症例数。
治療成績は調査されていないが、鹿野の調査によると、院外心肺停止例に対する世界の治療成績は14~40%で、多くの報告は20%程度である。しかし、鹿野自身の経験した院外心肺停止例174例の生存率は40%と良好だが、意識回復率は26%、社会復帰率は21%であったと報告しており、真の意味での救命率は想像以上に低いと予測される。
 
参考文献:
  1. 2010年(2011年度実施・公表)循環器疾患診療実態調査 報告書、p15
  1. 鹿野 恒: 心肺停止症例と人工心肺(PCPS).人工臓器 2008;37:38-43.

PCPS治療成績の推移

PCPS装着例の1997~2005年の死亡率の変化。
全体の死亡率は減ってきている。
出典
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1: 経皮的心肺補助(PCPS)研究会:日本PCPS研究会全国集計調査結果(2003-2005)

Impella 急性心筋梗塞心原性ショック臨床試験結果

高リスクPCIにおける予防的IABPとPCPS補助効果。死亡、脳合併症、心筋梗塞、再冠血行再建の頻度はIABPのほうが有意に高かった。特に重症な心原性ショック症例に対しては、実臨床においてはImpellaが積極的に用いられるようになってきている。
出典
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1: Prophylactic use of intra-aortic balloon pump for high-risk percutaneous coronary intervention: will the Impella LP 2.5 device show superiority in a clinical randomized study?
著者: Syed AI, Kakkar A, Torguson R, Li Y, Ben-Dor I, Collins SD, Lemesle G, Maluenda G, Xue Z, Scheinowitz M, Kaneshige K, Satler LF, Kent KM, Suddath WO, Pichard AD, Lindsay J, Waksman R.
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.
Cardiovasc Revasc Med. 2010 Apr-Jun;11(2):91-7. doi: 10.1016/j.carrev....

Impella 急性心筋梗塞心原性ショック臨床試験

Impella LP2.5(Abiomed Europe GmbH, Aachen, Germany)を用いた心原性ショック症例に対する前向き無作為割り付け試験。
急性心筋梗塞に起因した心原性ショック治療におけるIABPとImpella比較でも、血行動態の改善効果は優れていたものの、救命率には有意な差はみられなかった。IABPとImpellaそれぞれをどのような患者群に用いればより良い結果が得られるのか、最適な患者選択方法が現在模索されている。
出典
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1: A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction.
著者: Seyfarth M, Sibbing D, Bauer I, Fröhlich G, Bott-Flügel L, Byrne R, Dirschinger J, Kastrati A, Schömig A.
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).
J Am Coll Cardiol. 2008 Nov 4;52(19):1584-8. doi: 10.1016/j.jacc.2008....

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、またはこれらの組み合わせを検討する。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。心臓移植適応を取得できれば、心臓移植までの橋渡し治療(BTT)として植込型LVAD治療が可能になる。心臓移植の適応にない場合は、中長期的な予後や治療戦略、患者や介護者の状況などを総合的に加味した後に、恒久的な植込型LVAD治療(destination therapy:DT)を検討する。
出典
img
1: 日本循環器学会他編:日本心不全学会合同ガイドライン 急性・慢性心不全診療ガイドライン(2017年改訂版)https://www.j-circ.or.jp/cms/wp-content/uploads/2017/06/JCS2017_tsutsui_h_190830.pdf(2020年9月閲覧)班長:筒井裕之、p100、図13 重症心不全におけるVAD 治療のアルゴリズム

各種補助循環治療の創成期と経皮的補助循環の歴史

出典
img
1: 許俊鋭先生ご提供