Incidence and patterns of adverse event onset during the first 60 days after ventricular assist device implantation.
BACKGROUND
Although ventricular assist devices (VADs) provide effective treatment for end-stage heart failure, VAD support remains associated with significant risk for adverse events (AEs). To date there has been no detailed assessment of the incidence of a full range of AEs using standardized event definitions. We sought to characterize the frequency and timing of AE onset during the first 60 days of VAD support, a period during which clinical observation suggests the risk of incident AEs is high.


METHODS
A retrospective analysis was performed utilizing prospectively collected data from a single-site clinical database including 195 patients aged 18 or greater receiving VADs between 1996 and 2006. Adverse events were coded using standardized criteria. Cumulative incidence rates were determined, controlling for competing risks (death, transplantation, recovery-wean).


RESULTS
During the first 60 days after implantation, the most common AEs were bleeding, infection, and arrhythmias (cumulative incidence rates, 36% to 48%), followed by tamponade, respiratory events, reoperations, and neurologic events (24% to 31%). Other events (eg, hemolysis, renal, hepatic events) were less common (rates <15%). Some events (eg, bleeding, arrhythmias) showed steep onset rates early after implantation. Others (eg, infections, neurologic events) had gradual onsets during the 60-day period. Incidence of most events did not vary by implant era (1996 to 2000 vs 2001 to 2006) or by left ventricular versus biventricular support.


CONCLUSIONS
Understanding differential temporal patterns of AE onset will allow preventive strategies to be targeted to the time periods when specific AE risks are greatest. The AE incidence rates provide benchmarks against which future studies of VAD-related risks may be compared.
Genovese
Elizabeth A
EA
Artificial Heart Program, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, USA.
Dew
Mary Amanda
MA
Teuteberg
Jeffrey J
JJ
Simon
Marc A
MA
Kay
Joy
J
Siegenthaler
Michael P
MP
Bhama
Jay K
JK
Bermudez
Christian A
CA
Lockard
Kathleen L
KL
Winowich
Steve
S
Kormos
Robert L
RL
D000208:Acute Disease; D005260:Female; D006333:Heart Failure / Q000601:surgery*; D006353:Heart-Assist Devices; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010414:Pennsylvania / Q000453:epidemiology; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology; D011475:Prosthesis Failure; D019919:Prosthesis Implantation / Q000009:adverse effects*; D012189:Retrospective Studies; D013997:Time Factors