PMID- 19766801
OWN - NLM
STAT- MEDLINE
DCOM- 20091008
LR  - 20211020
IS  - 1552-6259 (Electronic)
IS  - 0003-4975 (Print)
IS  - 0003-4975 (Linking)
VI  - 88
IP  - 4
DP  - 2009 Oct
TI  - Incidence and patterns of adverse event onset during the first 60 days after 
      ventricular assist device implantation.
PG  - 1162-70
LID - 10.1016/j.athoracsur.2009.06.028 [doi]
AB  - 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.
FAU - Genovese, Elizabeth A
AU  - Genovese EA
AD  - Artificial Heart Program, University of Pittsburgh Medical Center, Pittsburgh, 
      Pennsylvania 15213, USA.
FAU - Dew, Mary Amanda
AU  - Dew MA
FAU - Teuteberg, Jeffrey J
AU  - Teuteberg JJ
FAU - Simon, Marc A
AU  - Simon MA
FAU - Kay, Joy
AU  - Kay J
FAU - Siegenthaler, Michael P
AU  - Siegenthaler MP
FAU - Bhama, Jay K
AU  - Bhama JK
FAU - Bermudez, Christian A
AU  - Bermudez CA
FAU - Lockard, Kathleen L
AU  - Lockard KL
FAU - Winowich, Steve
AU  - Winowich S
FAU - Kormos, Robert L
AU  - Kormos RL
LA  - eng
GR  - R01 MH072718/MH/NIMH NIH HHS/United States
GR  - R01 MH072718-04/MH/NIMH NIH HHS/United States
GR  - KL2 RR024154/RR/NCRR NIH HHS/United States
GR  - KL2 TR000146/TR/NCATS NIH HHS/United States
GR  - K12 RR024154/RR/NCRR NIH HHS/United States
GR  - KL2 RR024154-03/RR/NCRR NIH HHS/United States
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - Netherlands
TA  - Ann Thorac Surg
JT  - The Annals of thoracic surgery
JID - 15030100R
SB  - IM
MH  - Acute Disease
MH  - Female
MH  - Heart Failure/*surgery
MH  - *Heart-Assist Devices
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - Pennsylvania/epidemiology
MH  - Postoperative Complications/*epidemiology/etiology
MH  - Prosthesis Failure
MH  - Prosthesis Implantation/*adverse effects
MH  - Retrospective Studies
MH  - Time Factors
PMC - PMC2763436
MID - NIHMS131555
EDAT- 2009/09/22 06:00
MHDA- 2009/10/09 06:00
PMCR- 2010/10/01
CRDT- 2009/09/22 06:00
PHST- 2009/02/08 00:00 [received]
PHST- 2009/06/04 00:00 [revised]
PHST- 2009/06/09 00:00 [accepted]
PHST- 2009/09/22 06:00 [entrez]
PHST- 2009/09/22 06:00 [pubmed]
PHST- 2009/10/09 06:00 [medline]
PHST- 2010/10/01 00:00 [pmc-release]
AID - S0003-4975(09)01263-6 [pii]
AID - 10.1016/j.athoracsur.2009.06.028 [doi]
PST - ppublish
SO  - Ann Thorac Surg. 2009 Oct;88(4):1162-70. doi: 10.1016/j.athoracsur.2009.06.028.