April 1, 2011Open Access
Event‐Free Survival Following CRT with Surgically Implanted LV Leads Versus Standard Transvenous Approach
Key Result
Isolated surgical LV lead placement was associated with a higher early risk of events in the first 3 months compared to transvenous placement (HR 1.8; 95% CI 1.1-2.7; P=0.02).
Study Design
Type
Cohort (n=480)
Multicenter
No
Structured PICO
Does surgical epicardial LV lead placement compared to transvenous placement affect event-free survival in patients undergoing CRT?
P
Population
480 consecutive patients undergoing surgical or percutaneous left ventricle lead placement for cardiac resynchronization therapy.
E
Exposure
Surgical epicardial LV lead placement (n=48, including 28 with isolated surgical lead placement)
C
Comparator
Standard transvenous (percutaneous) LV lead placement (n=432)
O
Outcome
Long-term event-free survivalhard clinical
Isolated surgical LV lead placement for CRT carries a significant early mortality risk compared to the transvenous approach, though long-term survival is similar.
Main Result
Hazard Ratio: 1.3 (95% CI 1–1.7)
p-value: p=0.07
Abstract
BACKGROUND: While surgical epicardial lead placement is performed in a subset of cardiac resynchronization therapy patients, data comparing survival following surgical versus transvenous lead placement are limited. We hypothesized that surgical procedures would be associated with increased mortality risk. METHODS: Long-term event-free survival was assessed for 480 consecutive patients undergoing surgical (48) or percutaneous (432) left ventricle (LV) lead placement at our institution from January 2000 to September 2008. RESULTS: Baseline clinical and demographic characteristics were similar between groups. While there was no statistically significant difference in overall event-free survival (P = 0.13), when analysis was restricted to surgical patients with isolated surgical lead placement (n = 28), event-free survival was significantly lower in surgical patients (P = 0.015). There appeared to be an early risk (first approximately 3 months postimplantation) with surgical lead placement, primarily in LV lead-only patients. Event rates were significantly higher in LV lead-only surgical patients than in transvenous patients in the first 3 months (P = 0.006). In proportional hazards analysis comparing isolated surgical LV lead placement to transvenous lead placement, adjusted hazard ratios were 1.8 (1.1,2.7 P = 0.02) and 1.3 (1.0,1.7 P = 0.07) for the first 3 months and for the full duration of follow-up, respectively. CONCLUSIONS: Isolated surgical LV lead placement appears to carry a small but significant upfront mortality cost, with risk extending beyond the immediate postoperative period. Long-term survival is similar, suggesting those surviving beyond this period of early risk derive the same benefit as coronary sinus lead recipients. Further work is needed to identify risk factors associated with early mortality following surgical lead placement.