Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial

Nir Uriel; Valluvan Jeevanandam; Teruhiko Imamura; David Onsager; Tae Song; Takeyoshi Ota; Colleen Juricek; Pamela Combs; Thomas Lammy; Sonna Patel-Raman; Joshua R. Woolley; Gabriel Sayer; Carmelo Milano; Jacob Schroder; Ezequiel Molina; Jonathan Grinstein; Erik Suarez; Jerry D. Estep; Sanjeev Aggarwal; Scott Silvestry; Nirav Raval

doi:10.1161/CIRCHEARTFAILURE.119.006666

Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial

Nir Uriel, Valluvan Jeevanandam, Teruhiko Imamura, David Onsager, Tae Song, Takeyoshi Ota, Colleen Juricek, Pamela Combs, Thomas Lammy, Sonna Patel-Raman, Joshua R. Woolley, Gabriel Sayer, Carmelo Milano, Jacob Schroder, Ezequiel Molina, Jonathan Grinstein, Erik Suarez, Jerry D. Estep, Sanjeev Aggarwal, Scott SilvestryNirav Raval

Research output: Contribution to journal › Article › peer-review

12 Scopus citations

Abstract

BACKGROUND: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery.

METHODS: We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial.

RESULTS: Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support.

CONCLUSIONS: This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02645539.

Original language	English (US)
Pages (from-to)	E006666
Journal	Circulation: Heart Failure
Volume	13
Issue number	4
DOIs	https://doi.org/10.1161/CIRCHEARTFAILURE.119.006666
State	Published - Apr 1 2020

Keywords

cardiomyopathies
counterpulsation
heart failure
quality of life
subclavian artery
Stroke/mortality
Prospective Studies
United States
Humans
Middle Aged
Male
Prosthesis Design
Recovery of Function
Feasibility Studies
Heart Failure/diagnosis
Time Factors
Female
Heart-Assist Devices
Risk Factors
Heart Transplantation
Treatment Outcome
Counterpulsation/adverse effects
Exercise Tolerance
Quality of Life
Aged

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1161/CIRCHEARTFAILURE.119.006666

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Uriel, N., Jeevanandam, V., Imamura, T., Onsager, D., Song, T., Ota, T., Juricek, C., Combs, P., Lammy, T., Patel-Raman, S., Woolley, J. R., Sayer, G., Milano, C., Schroder, J., Molina, E., Grinstein, J., Suarez, E., Estep, J. D., Aggarwal, S., ... Raval, N. (2020). Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial. Circulation: Heart Failure, 13(4), E006666. https://doi.org/10.1161/CIRCHEARTFAILURE.119.006666

Uriel, N, Jeevanandam, V, Imamura, T, Onsager, D, Song, T, Ota, T, Juricek, C, Combs, P, Lammy, T, Patel-Raman, S, Woolley, JR, Sayer, G, Milano, C, Schroder, J, Molina, E, Grinstein, J, Suarez, E, Estep, JD, Aggarwal, S, Silvestry, S & Raval, N 2020, 'Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial', Circulation: Heart Failure, vol. 13, no. 4, pp. E006666. https://doi.org/10.1161/CIRCHEARTFAILURE.119.006666

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title = "Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial",

abstract = "BACKGROUND: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery.METHODS: We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial.RESULTS: Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support.CONCLUSIONS: This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02645539.",

keywords = "cardiomyopathies, counterpulsation, heart failure, quality of life, subclavian artery, Stroke/mortality, Prospective Studies, United States, Humans, Middle Aged, Male, Prosthesis Design, Recovery of Function, Feasibility Studies, Heart Failure/diagnosis, Time Factors, Female, Heart-Assist Devices, Risk Factors, Heart Transplantation, Treatment Outcome, Counterpulsation/adverse effects, Exercise Tolerance, Quality of Life, Aged",

author = "Nir Uriel and Valluvan Jeevanandam and Teruhiko Imamura and David Onsager and Tae Song and Takeyoshi Ota and Colleen Juricek and Pamela Combs and Thomas Lammy and Sonna Patel-Raman and Woolley, {Joshua R.} and Gabriel Sayer and Carmelo Milano and Jacob Schroder and Ezequiel Molina and Jonathan Grinstein and Erik Suarez and Estep, {Jerry D.} and Sanjeev Aggarwal and Scott Silvestry and Nirav Raval",

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doi = "10.1161/CIRCHEARTFAILURE.119.006666",

language = "English (US)",

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T1 - Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients

T2 - Results of the Multicenter Feasibility Trial

AU - Uriel, Nir

AU - Jeevanandam, Valluvan

AU - Imamura, Teruhiko

AU - Onsager, David

AU - Song, Tae

AU - Ota, Takeyoshi

AU - Juricek, Colleen

AU - Combs, Pamela

AU - Lammy, Thomas

AU - Patel-Raman, Sonna

AU - Woolley, Joshua R.

AU - Sayer, Gabriel

AU - Milano, Carmelo

AU - Schroder, Jacob

AU - Molina, Ezequiel

AU - Grinstein, Jonathan

AU - Suarez, Erik

AU - Estep, Jerry D.

AU - Aggarwal, Sanjeev

AU - Silvestry, Scott

AU - Raval, Nirav

PY - 2020/4/1

Y1 - 2020/4/1

N2 - BACKGROUND: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery.METHODS: We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial.RESULTS: Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support.CONCLUSIONS: This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02645539.

AB - BACKGROUND: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery.METHODS: We performed a prospective, single-arm, multicenter, US Food and Drug Administration-approved feasibility trial of iVAS therapy as a bridge to transplant or decision following the FIH (First-In-Human) trial.RESULTS: Forty-seven patients were enrolled, and 45 patients (median 61 years old, 37 males, and 30 listed on United Network of Organ Sharing) received iVAS support for median 44 (25-87) days. There were no intraoperative complications. Success was defined as survival or transplant on iVAS therapy free from disabling stroke. Outcome success at 30 days (the primary end point of this study) and at 6 months was 89% and 80%, respectively. During 6 months of iVAS support, 2 patients died and 2 patients experienced disabling neurological dysfunction. Six-minute walk distance, 2-minute step test, and Kansas City Cardiomyopathy Questionnaire score improved during 4-week iVAS support.CONCLUSIONS: This feasibility trial demonstrated promising short-term outcomes of iVAS therapy with improved functional capacity and quality of life during the therapy. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02645539.

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KW - Prospective Studies

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KW - Humans

KW - Middle Aged

KW - Male

KW - Prosthesis Design

KW - Recovery of Function

KW - Feasibility Studies

KW - Heart Failure/diagnosis

KW - Time Factors

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KW - Heart-Assist Devices

KW - Risk Factors

KW - Heart Transplantation

KW - Treatment Outcome

KW - Counterpulsation/adverse effects

KW - Exercise Tolerance

KW - Quality of Life

KW - Aged

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Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial

Abstract

Keywords

ASJC Scopus subject areas

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