Early procedure-related adverse events by gender in MADIT-CRT.

Background: Whether gender differences exist in procedure-related adverse events following cardiac resynchronization therapy (CRT-D) implantation is unknown. We investigated the type and frequency of procedure-related adverse events among those enrolled in MADIT-CRT and identified clinical predictors for gender-specific events.

Methods: We compared differences in the rate of procedure-related adverse events by gender (444 females and 1,346 males) that occurred ≤30 days after the index procedure in the implantable cardioverter defibrillator (ICD) and CRT-D groups. Eight types of major adverse events were identified, defined as procedure-related complications deemed potentially life-threatening. Best subset regression analysis (P < 0.10) was performed to identify baseline clinical factors associated with procedure-related adverse events that differed by gender.

Results: Women randomized to CRT-D received a greater reduction in the risk of heart failure or death versus men (P < 0.001). Women were twice as likely as men to experience a major procedure-related adverse event (6.3% vs. 2.7%; P < 0.001), including pneumothorax/hemothorax (3% vs. 1%; P < 0.001). Women were more likely to experience a major adverse event related to CRT-D than ICD implantation (7.7% vs. 2.9%; P = 0.018). Clinical predictors of major adverse events in females were smaller body mass index (BMI), elevated blood urea nitrogen, and elevated creatinine. The main predictor for pneumothorax/hemothorax was reduced BMI for women and men.

Conclusion: Women demonstrate greater clinical benefit from CRT than men but are more likely to experience adverse procedure-related events within the first 30 days after device implantation. A smaller BMI seems to be a major factor associated with pneumothorax/hemothorax in both females and males.