Twelfth Interagency Registry for Mechanically Assisted Circulatory Support Report: Readmissions After Left Ventricular Assist Device

Shah, Palak; Yuzefpolskaya, M.; Hickey, Gavin; Breathett, Khadijah; Wever‐Pinzon, Omar; Khue-Ton, Van; Hiesinger, William; Koehl, Devin; Kirklin, James K.; Cantor, Ryan S.; Jacobs, Jeffrey P.; Habib, Robert H.; Pagani, Francis D.; Goldstein, Daniel J.

doi:10.1016/j.athoracsur.2021.12.011

Cited by 97 publications

(88 citation statements)

References 27 publications

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“…The overall rate of cardiac recovery leading to device weaning in the Interagency Registry for Mechanically Assisted Circulatory Support (INERMACS) database has consistently been low, occurring in less than 5% of the implant cases by five years [ 33 ]. Topkara et al, however, studied 13,454 patients implanted with a continuous flow LVAD from 2006 to 2015 using the INTERMACS registry [ 34 ].…”

Section: Incidence Magnitude and Time Course Of Cardiac Recoverymentioning

confidence: 99%

“…The overall rate of cardiac recovery leading to device weaning in the INTERMACS database has consistently been low, occurring in less than 5% of advanced HF patients receiving LVADs [ 33 ]. On the contrary, institutions who have focused on promoting cardiac recovery, prospectively monitoring the underlying cardiac function and weaning the LVAD when patients show a significant improvement, consistently report rates of LVAD weaning that are much higher than those reported in INTERMACS [ 4 , 5 , 6 , 7 , 22 , 23 , 27 , 30 , 31 , 36 , 37 , 38 , 39 , 40 ].…”

Section: Current and Future Opportunities For Improvementmentioning

confidence: 99%

“…Retrospective studies employing registry data have identified clinical characteristics associated with a higher probability for significant reverse cardiac remodeling and LVAD weaning [ 25 , 34 , 35 ]. A younger age, shorter duration of HF, underlying non-ischemic cardiomyopathy and less dilated left ventricle have consistently been identified as the predictors of native heart function recovery on LVAD support [ 25 , 32 , 33 , 34 , 90 ]. The Utah group studied patients in the INTERMACS database and six independent predictors of LVAD weaning were identified: age < 50 years, non-ischemic HF etiology, <2 years from cardiac diagnosis, no implantable cardioverter defibrillator (likely a surrogate of a short duration of HF), a serum creatinine level < 1.2 mg/dL, and LVEDD < 6.5 cm [ 35 ].…”

Section: Current and Future Opportunities For Improvementmentioning

confidence: 99%

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LVAD as a Bridge to Remission from Advanced Heart Failure: Current Data and Opportunities for Improvement

Kyriakopoulos

Kapelios

Stauder

et al. 2022

JCM

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Left ventricular assist devices (LVADs) are an established treatment modality for advanced heart failure (HF). It has been shown that through volume and pressure unloading they can lead to significant functional and structural cardiac improvement, allowing LVAD support withdrawal in a subset of patients. In the first part of this review, we discuss the historical background, current evidence on the incidence and assessment of LVAD-mediated cardiac recovery, and out-comes including quality of life after LVAD support withdrawal. In the second part, we discuss current and future opportunities to promote LVAD-mediated reverse remodeling and improve our pathophysiological understanding of HF and recovery for the benefit of the greater HF population.

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Section: Incidence Magnitude and Time Course Of Cardiac Recoverymentioning

confidence: 99%

Section: Current and Future Opportunities For Improvementmentioning

confidence: 99%

Section: Current and Future Opportunities For Improvementmentioning

confidence: 99%

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LVAD as a Bridge to Remission from Advanced Heart Failure: Current Data and Opportunities for Improvement

Kyriakopoulos

Kapelios

Stauder

et al. 2022

JCM

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“…After continuous-flow LVADs were first approved for destination and bridge to transplantation strategies, the fourth annual Interagency Registry of Mechanical Circulatory Support (INTERMACS) in 2012 concluded that RHF “represents a major challenge to the successful application of continuous-flow technology and constitutes a major thrust of future INTERMACS research” ( 2 ). This declaration continues to hold true in 2022 despite improved VAD technology with 2-year survival nearing that of heart transplantation ( 3 , 4 ). In fact, the most recent INTERMACS annual reports omitted the RHF post-LVAD in their outcomes, noting varying definitions and lack of consistency making an analysis unreliable ( 4 – 7 ).…”

Section: Introductionmentioning

confidence: 99%

“…This declaration continues to hold true in 2022 despite improved VAD technology with 2-year survival nearing that of heart transplantation ( 3 , 4 ). In fact, the most recent INTERMACS annual reports omitted the RHF post-LVAD in their outcomes, noting varying definitions and lack of consistency making an analysis unreliable ( 4 – 7 ). Herein, we propose that the latest definition proposed by the Mechanical Circulatory Support Academic Research Consortium (MCS-ARC) to diagnose RHF-LVAD will help mitigate the ongoing challenges encountered by the heart failure community in this decade-long quest to find the right definition for RHF post-LVAD.…”

Section: Introductionmentioning

confidence: 99%

The “Right” Definition for Post–Left Ventricular Assist Device Right Heart Failure: The More We Learn, the Less We Know

Hall

Copeland

Alam

et al. 2022

Front. Cardiovasc. Med.

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Right heart failure is a major cause of morbidity and mortality following left ventricular assist device implantation. Over the past few decades, the definition proposed by the Interagency Registry of Mechanical Circulatory Support and Society of Thoracic Surgeons has continually evolved to better identify this complex pathology. We propose that the latest definition proposed by the Mechanical Circulatory Support Academic Research Consortium in 2020 will increase our recognition and understanding of this complex disease phenomenon.

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Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial

Mehra

Goldstein

Cleveland

et al. 2022

JAMA

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180

126

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ImportanceAlthough durable left ventricular assist device (LVAD) therapy has emerged as an important treatment option for patients with advanced heart failure refractory to pharmacological support, outcomes, including survival, beyond 2 years remain poorly characterized.ObjectiveTo report the composite end point of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Scale score &gt;3) or reoperation to replace the pump 5 years after the implant in participants who received the fully magnetically levitated centrifugal-flow HeartMate 3 or axial-flow HeartMate II LVAD in the MOMENTUM 3 randomized trial and were still receiving LVAD therapy at the 2-year follow-up.Design, Setting, and ParticipantsThis observational study was a 5-year follow-up of the MOMENTUM 3 trial, conducted in 69 US centers, that demonstrated superiority of the centrifugal-flow LVAD to the axial-flow pump with respect to survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump at 2 years. A total of 295 patients were enrolled between June 2019 to April 2021 in the extended-phase study, with 5-year follow-up completed in September 2021.ExposuresOf 1020 patients in the investigational device exemption per-protocol population, 536 were still receiving LVAD support at 2 years, of whom 289 received the centrifugal-flow pump and 247 received the axial-flow pump.Main Outcomes and MeasuresThere were 10 end points evaluated at 5 years in the per-protocol population, including a composite of survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump between the centrifugal-flow and axial-flow pump groups and overall survival between the 2 groups.ResultsA total of 477 patients (295 enrolled and 182 provided limited data) of 536 patients still receiving LVAD support at 2 years contributed to the extended-phase analysis (median age, 62 y; 86 [18%] women). The 5-year Kaplan-Meier estimate of survival to transplant, recovery, or LVAD support free of debilitating stroke or reoperation to replace the pump in the centrifugal-flow vs axial-flow group was 54.0% vs 29.7% (hazard ratio, 0.55 [95% CI, 0.45-0.67]; P &lt; .001). Overall Kaplan-Meier survival was 58.4% in the centrifugal-flow group vs 43.7% in the axial-flow group (hazard ratio, 0.72 [95% CI, 0.58-0.89]; P = .003). Serious adverse events of stroke, bleeding, and pump thrombosis were less frequent in the centrifugal-flow pump group.Conclusions and RelevanceIn this observational follow-up study of patients from the MOMENTUM 3 randomized trial, per-protocol analyses found that receipt of a fully magnetically levitated centrifugal-flow LVAD vs axial-flow LVAD was associated with a better composite outcome and higher likelihood of overall survival at 5 years. These findings support the use of the fully magnetically levitated LVAD.Trial RegistrationClinicalTrials.gov Identifier: NCT02224755 and NCT03982979

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Twelfth Interagency Registry for Mechanically Assisted Circulatory Support Report: Readmissions After Left Ventricular Assist Device

Cited by 97 publications

References 27 publications

LVAD as a Bridge to Remission from Advanced Heart Failure: Current Data and Opportunities for Improvement

LVAD as a Bridge to Remission from Advanced Heart Failure: Current Data and Opportunities for Improvement

The “Right” Definition for Post–Left Ventricular Assist Device Right Heart Failure: The More We Learn, the Less We Know

Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial

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