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

MedStar author(s):
Citation: Circulation: Heart Failure. 13(4):e006666, 2020 04.PMID: 32264715Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal ArticleSubject headings: *Counterpulsation/is [Instrumentation] | *Exercise Tolerance | *Heart Failure/th [Therapy] | *Heart-Assist Devices | *Quality of Life | Aged | Counterpulsation/ae [Adverse Effects] | Counterpulsation/mo [Mortality] | Feasibility Studies | Female | Heart Failure/di [Diagnosis] | Heart Failure/mo [Mortality] | Heart Failure/pp [Physiopathology] | Heart Transplantation | Humans | Male | Middle Aged | Prospective Studies | Prosthesis Design | Recovery of Function | Risk Factors | Stroke/mo [Mortality] | Time Factors | Treatment Outcome | United StatesYear: 2020Local holdings: Available online from MWHC library: 2008 - presentISSN:
  • 1941-3289
Name of journal: Circulation. Heart failureAbstract: BACKGROUND: The NuPulseCV intravascular ventricular assist system (iVAS) provides extended duration ambulatory counterpulsation via a durable pump placed through the distal subclavian artery.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.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.All authors: Aggarwal S, Combs P, Estep JD, Grinstein J, Imamura T, iVAS Investigators, Jeevanandam V, Juricek C, Lammy T, Milano C, Molina E, Onsager D, Ota T, Patel-Raman S, Raval N, Sayer G, Schroder J, Silvestry S, Song T, Suarez E, Uriel N, Woolley JROriginally published: Circulation: Heart Failure. 13(4):e006666, 2020 Apr.Fiscal year: FY2020Digital Object Identifier: Date added to catalog: 2020-07-09
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 32264715 Available 32264715

Available online from MWHC library: 2008 - present

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

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.

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.

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