Use of an Intrapericardial, Continuous-Flow, Centrifugal Pump in Patients Awaiting Heart Transplantation

• Published in: Circulation (New York, N.Y.) Vol. 125; no. 25; pp. 3191 - 3200
• Main Authors: AARONSON, Keith D, SLAUGHTER, Mark S, JEEVANANDAM, Valluvan, ANDERSON, Allen S, KORMOS, Robert L, TEUTEBERG, Jeffrey J, LEVY, Wayne C, NAFTEL, David C, BITTMAN, Richard M, PAGANI, Francis D, HATHAWAY, David R, BOYCE, Steven W, MILLER, Leslie W, MCGEE, Edwin C, COTTS, William G, ACKER, Michael A, JESSUP, Mariell L, GREGORIC, Igor D, LOYALKA, Pranav, FRAZIER, O. H
• Format: Journal Article
• Language: English
• Published: Hagerstown, MD Lippincott Williams & Wilkins 26-06-2012
• Subjects: Adult; Aged; Biological and medical sciences; Blood and lymphatic vessels; Cardiology. Vascular system; Cardiovascular system; Diseases of the peripheral vessels. Diseases of the vena cava. Miscellaneous; Female; Follow-Up Studies; Heart Failure - mortality; Heart Failure - physiopathology; Heart Failure - surgery; Heart Transplantation - mortality; Heart Transplantation - trends; Heart-Assist Devices - trends; Humans; Male; Medical sciences; Middle Aged; Pericardium - physiopathology; Pharmacology. Drug treatments; Prospective Studies; Surveys and Questionnaires; Survival Rate - trends; Treatment Outcome; Vasodilator agents. Cerebral vasodilators; Ventricular Dysfunction, Left - mortality; Ventricular Dysfunction, Left - physiopathology; Ventricular Dysfunction, Left - surgery; Waiting Lists - mortality; Human; Heart failure; Centrifugal pump; ventricular assist device; heart surgery; Heart disease; Surgery; Cardiovascular disease; Survival; Quality of life
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/circulationaha.111.058412

Contemporary ventricular assist device therapy results in a high rate of successful heart transplantation but is associated with bleeding, infections, and other complications. Further reductions in pump size, centrifugal design, and intrapericardial positioning may reduce complications and improve outcomes.
We studied a small, intrapericardially positioned, continuous-flow centrifugal pump in patients requiring an implanted ventricular assist device as a bridge to heart transplantation. The course of investigational pump recipients was compared with that of patients implanted contemporaneously with commercially available devices. The primary outcome, success, was defined as survival on the originally implanted device, transplantation, or explantation for ventricular recovery at 180 days and was evaluated for both noninferiority and superiority. Secondary outcomes included a comparison of survival between groups and functional and quality-of-life outcomes and adverse events in the investigational device group. A total of 140 patients received the investigational pump, and 499 patients received a commercially available pump implanted contemporaneously. Success occurred in 90.7% of investigational pump patients and 90.1% of controls, establishing the noninferiority of the investigational pump (P<0.001; 15% noninferiority margin). At 6 months, median 6-minute walk distance improved by 128.5 m, and both disease-specific and global quality-of-life scores improved significantly.
A small, intrapericardially positioned, continuous-flow, centrifugal pump was noninferior to contemporaneously implanted, commercially available ventricular assist devices. Functional capacity and quality of life improved markedly, and the adverse event profile was favorable.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00751972.