Ejection Fraction Improvement Following Contemporary High-Risk Percutaneous Coronary Intervention: RESTORE EF Study Results

Wollmuth, Jason; Patel, Mitul; Dahle, Thom G.; Bharadwaj, Aditya; Waggoner, Thomas; Chambers, Jeffrey W.; Ruiz-Rodriguez, Ernesto; Mahmud, Ehtisham; Thompson, Craig A.; Morris, D Lynn

doi:10.1016/j.jscai.2022.100350

Cited by 11 publications

(11 citation statements)

References 26 publications

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“…Patienten mit komplexer koronarer Mehrgefäßerkrankung werden zunehmend älter und weisen teils multiple Komorbiditäten auf. Insbesondere bei parallel bestehender signifikanter Einschränkung der linksventrikulären Ejektionsfraktion bietet hier die Impella die Möglichkeit einer periprozeduralen Unterstützung [8,9]. Im Unterschied zur komplexen, aber elektiven Koronarintervention, bei der die Impella in der Regel nach abgeschlossener PCI primär wieder entfernt werden kann, sollte das Device bei der Versorgung von Patienten im kardiogenen Schock auch noch für die intensivmedizinische Anschlusstherapie belassen werden, um die weitere Erholung zu unterstützen.…”

Section: Grundlegende Funktionsweiseunclassified

Die Rolle der perkutanen Impella-Pumpe in der Anästhesie und Intensivmedizin

Ott¹,

Notz²,

Menger³

et al. 2023

Anästhesiol Intensivmed Notfallmed Schmerzther

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Section: Grundlegende Funktionsweiseunclassified

Die Rolle der perkutanen Impella-Pumpe in der Anästhesie und Intensivmedizin

Ott¹,

Notz²,

Menger³

et al. 2023

Anästhesiol Intensivmed Notfallmed Schmerzther

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“…Mechanical circulatory support devices may improve patient outcomes by promoting complete revascularization of all angiographically significant lesions. 11 , 12 The RESTORE EF study, 13 a multicentre, non-randomized trial of 406 patients in the USA treated with Impella during elective HR-PCI, reported increased LVEF in patients with complete revascularization after 90 days, with the greatest improvement in patients with a residual SYNTAX score of 0 or LVEF <20% at baseline. Moreover, recent studies, including a meta-analysis of over 17 000 patients, have demonstrated that PCI guided by intravascular imaging (via ultrasound or optical coherence tomography) is associated with improved patient outcomes.…”

Section: Introductionmentioning

confidence: 99%

“… 18 In the PROTECT II study, 18 the use of rotational atherectomy was 9% in the IABP group and 14.2% in the Impella group, which was further increased to 52% in the RESTORE EF population. 13 However, the use of MCS devices has a higher rate of vascular bleeding and is known to be a predictor for in-hospital MACCE. 19 …”

Section: Introductionmentioning

confidence: 99%

The use of mechanical circulatory support in elective high-risk percutaneous coronary interventions: a literature-based review

Geppert,

Mashayekhi,

Huber

2024

European Heart Journal Open

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Contemporary medical practices allow complete percutaneous coronary intervention (PCI) in a considerable number of patients who previously would have been considered too “high-risk” for such procedures. Use of mechanical circulatory support (MCS) devices during these high-risk PCIs (HR-PCIs) is thought to reduce the potential risk for major adverse events during and after revascularization. The Intra-aortic balloon pump (IABP), veno-arterial extracorporal membrane oxygenation (V-A ECMO), and the Impella are the most common MCS devices in use. This review aims to summarize the clinical evidence for each of these devices and the potential mechanisms for the improvement in patient outcomes in HR-PCI. IABP use has rapidly declined in recent years due to no evidence of benefit in HR-PCI and cardiogenic shock. V-A ECMO results in low rates of major adverse cardiac and cerebrovascular events (MACCEs) but higher rates of acute kidney injury and increased need for transfusions. In initial studies, Impella resulted in a reduced need for repeat interventions and reduced rates of hypotension, but no benefit in mortality. However, MACCE rates with Impella have gradually declined over the last ten years, reflecting increased operator experience and technical improvements. Thus, a large, randomized trial is needed to assess the efficacy of Impella in HR-PCI with contemporary standards of care. There is currently no individual parameter that can identify patients who would benefit from MCS use in elective HR-PCI. To address this gap, we propose an algorithm that combines anatomical complexity, co-morbidities, and clinical presentation to accurately identify candidates for MCS-assisted HR-PCI.

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“…9 Finally, 2 upcoming randomized trials (REVIVED-BCIS2 [NCT01920048] and the ISCHEMIA-Heart Failure Planning Study) will address the value of PCI in patients with left ventricular dysfunction. While we eagerly await the results of these trials, based on the encouraging report from Wollmuth et al, 10 a heart team-based recommendation for PCI in CABG-ineligible patients appears reasonable for patients with ICM.…”

mentioning

confidence: 99%

“…However, clinical data demonstrating the benefits of MCS-based revascularization on mortality and key surrogates such as LVEF improvement remain limited. 6,7 Excitingly, in the current issue of JSCAI, Wollmuth et al 10 present the results of the RESTORE EF study, a single-arm observational study of 495 patients who underwent upfront Impella-supported nonemergent PCI at 22 sites in the United States. Most of the patients had impaired left ventricular dysfunction, required multivessel and/or atherectomy PCI, and were surgical turndowns.…”

mentioning

confidence: 99%