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QUARTERLY FOCUS ISSUE: HEART RHYTHM DISORDER: CLINICAL RESEARCH: IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR

Evaluation of Early Complications Related to De Novo Cardioverter Defibrillator Implantation

Insights From the Ontario ICD Database

Douglas S. Lee, MD, PhD^_*,,_*, Andrew D. Krahn, MD^¶, Jeffrey S. Healey, MD, MSc^||, David Birnie, MBChB^#, Eugene Crystal, MD, Paul Dorian, MD, Christopher S. Simpson, MD^_**, Yaariv Khaykin, MD, Douglas Cameron, MD, Amir Janmohamed, MD, Raymond Yee, MD^¶, Peter C. Austin, PhD^_*, Zhongliang Chen, MD, MSc^_*, Judy Hardy, RN^_*, Jack V. Tu, MD, PhD^_*, for the Investigators of the Ontario ICD Database

^_* Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada
Toronto General Hospital, Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
St. Michael's Hospital, Toronto, Ontario, Canada
^|| Hamilton Health Sciences Centre, Hamilton, Ontario, Canada
^¶ London Health Sciences Centre, London, Ontario, Canada
^# University of Ottawa Heart Institute, Ottawa, Ontario, Canada
^_** Kingston General Hospital, Kingston, Ontario, Canada
Southlake Regional Health Centre, Newmarket, Ontario, Canada
Rouge Valley Health System, Scarborough, Ontario, Canada

Manuscript received September 12, 2009; revised manuscript received November 9, 2009, accepted November 18, 2009.

^_* Reprint requests and correspondence: Dr. Douglas S. Lee, Institute for Clinical Evaluative Sciences, Room G-106, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada (Email: dlee{at}ices.on.ca).

Objectives: This study examined the predictors of early complications after defibrillator implantation.

Background: Although implantable cardioverter-defibrillators are widely used, predictors of procedural complications and the consequences of these events have not been determined.

Methods: In a prospective, multicenter, population-based clinical outcomes registry of all newly implanted defibrillator patients at 18 centers in Ontario, Canada, we examined 45-day complications and all-cause mortality from February 2007 to May 2009. Complications were determined longitudinally and were categorized as direct implant-related or indirect events.

Results: Among 3,340 patients (mean age 63.8 ± 12.5 years, 78.5% men), major complications occurred in 4.1% of de novo procedures. Compared with those undergoing a single-chamber device, implantation of a cardiac resynchronization defibrillator (adjusted hazard ratio [HR]: 2.17, 95% confidence interval [CI]: 1.38 to 3.43, p < 0.001) or dual-chamber device (adjusted HR: 1.82, 95% CI: 1.19 to 2.79, p = 0.006) was associated with increased risk of major complications. Major complications were increased in women (adjusted HR: 1.49, 95% CI: 1.02 to 2.16, p = 0.037) and when left ventricular end-systolic dimension exceeded 45 mm (adjusted HR: 1.54, 95% CI: 1.08 to 2.20, p = 0.018). Major complications (excluding death) occurring early after defibrillator implantation were associated with increased adjusted risk of subsequent death up to 180 days after defibrillator implant (adjusted HR: 3.70, 95% CI: 1.64 to 8.33, p = 0.002). Direct implant-related complications were associated with increased risk of early death (adjusted HR: 24.89, p = 0.01), whereas indirect clinical complications conferred increased risk of near-term death (adjusted HR: 12.35, p < 0.001) after defibrillator implantation.

Conclusions: Complications after de novo defibrillator implantation were strongly associated with device type. Major complications were associated with increased risk of mortality.

Key Words: implantable defibrillators • complications • outcomes research • mortality • quality of care

Abbreviations and Acronyms   CI = confidence interval   HR = hazard ratio   CRT-D = cardiac resynchronization therapy defibrillator   ICD = implantable cardioverter-defibrillator

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