Effect of Impella 5.5 on Preexisting Functional Mitral Regurgitation in Patients with Heart Failure–Related Cardiogenic Shock

Kataria, Rachna; Khalil, Abdurrahman; Coglianese, Erin; Crowley, Jerome; Silverman, Michael G.; Shelton, Kenneth; Michel, Eriberto; D’Alessandro, David A.; Ton, Van-Khue

doi:10.1016/j.shj.2022.100072

Cited by 4 publications

(4 citation statements)

References 18 publications

(35 reference statements)

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“…In a recent study evaluating the impact of Impella 5.5 hemodynamics on patients with moderate to severe functional mitral regurgitation, Kataria and colleagues found that Impella 5.5 improved hemodynamic response 24 h postimplant with increased cardiac index and decreased CVP, dPAP, and systemic vascular resistance. 17 There was also a significant decrease in serum lactate, and although nonsignificant, all other laboratory values (serum creatinine, alanine aminotransferase, aspartate aminotransferase, and bilirubin) showed improvement after 24 h on Impella 5.5. In the present study, hemodynamic and laboratory data were similar between the prolonged and short-term cohorts on POD1 and POD5, and at the time of explant, and there was a trend toward improved hemodynamics and laboratory values in the prolonged cohort.…”

Section: Discussionmentioning

confidence: 81%

Reconsidering FDA Guidelines: A Single-Center Experience of Prolonged Impella 5.5 Support

Valdes,

Stinson,

Sharaf

et al. 2023

Innovations�(Phila)

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Objective: Impella 5.5 (Abiomed, Danvers, MA, USA) is approved by the US Food and Drug Administration (FDA) for mechanical circulatory support for ≤14 days. It is unknown whether prolonged support is associated with worse outcomes. We sought to review our single-center experience with Impella 5.5 and compare outcomes based on support duration. Methods: We retrospectively reviewed adult patients (≥18 years old) supported with Impella 5.5 at our institution (May 2020 to April 2023). Patients on prolonged support (>14 days) were compared with those supported for ≤14 days. Results: There were 31 patients supported with Impella 5.5 including 14 (45.2%) supported >14 days. Median support duration for those on prolonged support was 43.5 (interquartile range [IQR] 25 to 63.5) days versus 8 (IQR 6, 13) days for those who were not ( P < 0.001). Overall, the device-related complication rate was 9.7% and did not differ between groups ( P = 0.08). Overall, 30-day postimplant survival was 71% and did not differ by support duration ( P = 0.2). In-hospital mortality was 32% and did not differ between cohorts ( P > 0.99). Among those surviving to explant ( n = 22), long-term strategy included bridge to durable ventricular assist device (18%, n = 4), cardiac transplant (55%, n = 12), and cardiac recovery (27%, n = 6). Conclusions: High-risk patients with cardiogenic shock may be supported with Impella 5.5 beyond the FDA-approved duration without increased risk of complications or mortality.

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Section: Discussionmentioning

confidence: 81%

Reconsidering FDA Guidelines: A Single-Center Experience of Prolonged Impella 5.5 Support

Valdes,

Stinson,

Sharaf

et al. 2023

Innovations�(Phila)

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“…Kataria et al . 9 reported 24 patients with functional mitral regurgitation treated with Impella 5.5. Salas De Armas et al .…”

Section: Resultsmentioning

confidence: 99%

“…Five studies described selected populations treated with Impella devices. Kataria et al 9 reported 24 patients with functional mitral regurgitation treated with Impella 5.5. Salas De Armas et al 15 reported eight patients with refractory hemolysis on Impella CP support who were upgraded to Impella 5.0 or 5.5.…”

Section: Baseline Characteristicsmentioning

confidence: 99%

Patient Characteristics and Early Clinical Outcomes With Impella 5.5: A Systematic Review and Meta-Analysis

Kwon,

Bentley,

Cevasco

et al. 2024

ASAIO Journal

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Data regarding outcomes with Impella 5.5 are limited. The aim of this systematic review and meta-analysis was to summarize patient and treatment characteristics and early clinical outcomes among patients supported by Impella 5.5. A systematic literature search was conducted in PubMed, Scopus, and Cochrane databases from September 2019 to March 2023. Studies reporting outcomes in greater than or equal to 5 patients were included for review. Patient characteristics, treatment characteristics, and early clinical outcomes were extracted. Outcomes included adverse events, survival to hospital discharge, and 30 day survival. Random-effect models were used to estimate pooled effects for survival outcomes. Assessment for bias was performed using funnel plots and Egger’s tests. Fifteen studies were included for qualitative review, representing 707 patients. Mean duration of support was 9.9 ± 8.2 days. On meta-analysis of 13 studies reporting survival outcomes, survival to hospital discharge was 68% (95% confidence interval [CI], 58–78%), and 30 day survival was 65% (95% CI, 56–74%) among patients with Impella devices predominantly supported by Impella 5.5 (>60%). There was significant study heterogeneity for these outcomes. Among 294 patients with Impella 5.5 only, survival to discharge was 78% (95% CI, 72–82%) with no significant study heterogeneity. This data present early benchmarks for outcomes with Impella 5.5 as clinical experience with these devices accrues.

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“…Care was later withdrawn due to inability to wean from mechanical support [47]. Kataria and colleagues described three cases of successful use of ProtekDuo® for acute right heart failure in patients with Impella 5.5 placed for heart failure-related cardiogenic shock, though specific outcomes of these patients were not discussed [48]. See Figure 3.…”

Section: Protekduo® With Temporary Lvadsmentioning

confidence: 99%

Perspective Chapter: The ProtekDuo® Cannula for Acute Mechanical Circulatory Support

Brewer¹,

Sharif²,

Maybauer³

2023

Ventricular Assist Devices - Advances and Applications in Heart Failure

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The ProtekDuo® is a dual lumen cannula that can be used in numerous configurations to treat cardiogenic shock and hypotension. Its default function is as a temporary percutaneous right ventricular assist device (RVAD) system, however, other configurations both alone and with other mechanical circulatory support (MCS) devices have evolved. In addition to its use as a component of a ventricular assist device (VAD), it can be used as a cannula for extracorporeal membrane oxygenation (ECMO) and may serve as double lumen drainage cannula on cardiopulmonary bypass (CPB). The role of the cannula in ECMO has been described in multiple configurations including traditional veno-pulmonary (V-P) or “oxygenated RVAD” (oxyRVAD), veno-venopulmonary (V-VP), or venopulmonary-arterial (VP-A). This book chapter summarizes various configurations and technical aspects of the ProtekDuo(R) cannula in the management of hypotension and cardiogenic shock.

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Effect of Impella 5.5 on Preexisting Functional Mitral Regurgitation in Patients with Heart Failure–Related Cardiogenic Shock

Cited by 4 publications

References 18 publications

Reconsidering FDA Guidelines: A Single-Center Experience of Prolonged Impella 5.5 Support

Reconsidering FDA Guidelines: A Single-Center Experience of Prolonged Impella 5.5 Support

Patient Characteristics and Early Clinical Outcomes With Impella 5.5: A Systematic Review and Meta-Analysis

Perspective Chapter: The ProtekDuo® Cannula for Acute Mechanical Circulatory Support

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