TY  - BOOK
AU  - Grinstein, Jonathan
AU  - Molina, Ezequiel J
TI  - Clinical Outcomes and Quality of Life With an Ambulatory Counterpulsation Pump in Advanced Heart Failure Patients: Results of the Multicenter Feasibility Trial
SN  - 1941-3289
PY  - 2020///
KW  - *Counterpulsation/is [Instrumentation]
KW  - *Exercise Tolerance
KW  - *Heart Failure/th [Therapy]
KW  - *Heart-Assist Devices
KW  - *Quality of Life
KW  - Aged
KW  - Counterpulsation/ae [Adverse Effects]
KW  - Counterpulsation/mo [Mortality]
KW  - Feasibility Studies
KW  - Female
KW  - Heart Failure/di [Diagnosis]
KW  - Heart Failure/mo [Mortality]
KW  - Heart Failure/pp [Physiopathology]
KW  - Heart Transplantation
KW  - Humans
KW  - Male
KW  - Middle Aged
KW  - Prospective Studies
KW  - Prosthesis Design
KW  - Recovery of Function
KW  - Risk Factors
KW  - Stroke/mo [Mortality]
KW  - Time Factors
KW  - Treatment Outcome
KW  - United States
KW  - MedStar Heart & Vascular Institute
KW  - Journal Article
N1  - Available online from MWHC library: 2008 - present
N2  - 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
UR  - https://dx.doi.org/10.1161/CIRCHEARTFAILURE.119.006666
ER  -