August 8, 2012Journal of the American College of Cardiology
Vascular Complications After Transcatheter Aortic Valve Replacement
Key result
Major vascular complications after transfemoral TAVR linked to ~131% greater 1-year mortality risk.
- HR 2.31
- 95% CI 1.20-4.43
- P=0.012
- n=419
Why the study?
Vascular complications after transfemoral TAVR are frequent and may be associated with unfavorable prognosis.
Key Points
- The study aims to identify the incidence, predictors, and impact of vascular complications following transfemoral transcatheter aortic valve replacement.
- Randomized controlled trial using data from the PARTNER trial with 419 patients assigned to transfemoral TAVR.
- Evaluated 30-day rates of major and minor vascular complications and assessed their impact on 1-year mortality.
- Utilized first-generation Edwards-Sapien valves and delivery systems via a 22- or 24-F sheath.
- Fifteen point three percent (15.3%) of patients had major vascular complications, and eleven point nine percent (11.9%) had minor vascular complications within 30 days.
- Only female gender was identified as an independent predictor of major vascular complications (HR: 2.31, 95% CI: 1.08 to 4.98, p = 0.03).
- Major vascular complications were linked to higher rates of major bleeding, renal failure, and increased mortality at 30 days and 1 year (HR: 2.31, p = 0.012).
Study Design
Type
RCT (n=419)
Randomization
Randomized
Structured PICO
P
Population
419 patients from the PARTNER trial (177 inoperable [cohort B] and 242 operable high-risk [cohort A]) who were randomly assigned to and received transfemoral transcatheter aortic valve replacement (TF-TAVR)
I
Intervention
Transfemoral transcatheter aortic valve replacement (TF-TAVR) using first-generation Edwards-Sapien valves and delivery systems via a 22- or 24-F sheath
O
Outcome
30-day rates of major and minor vascular complications (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortalitysafety
Main Result
Effect estimate: HR 2.31 (95% CI 1.20-4.43)
p-value: p=0.012
Major vascular complications are frequent after transfemoral TAVR with first-generation devices and are independently associated with increased 1-year mortality.
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The improvement was partly due to better patient selection, partly better techniques, partly smaller catheters, and maybe a little luck. All were important.”
“I think that the growing experience with transcatheter aortic valve replacement...”
TATobias A. RheudeInterventional cardiologist, Deutsches Herzzentrum München
“Constant refinements of procedural techniques as well as device iterations resulted in improved outcomes after TAVI procedures over the years. Nevertheless, access-related vascular complications after TAVI remain common.”
Implication
Warrants meticulous access planning in TF-TAVR to curb mortality; leaves open impact with smaller contemporary delivery systems.
Abstract
OBJECTIVES: This study sought to identify incidence, predictors, and impact of vascular complications (VC) after transfemoral (TF) transcatheter aortic valve replacement (TAVR). BACKGROUND: VC after TF-TAVR are frequent and may be associated with unfavorable prognosis. METHODS: From the randomized controlled PARTNER (Placement of AoRTic TraNscathetER Valve) trial, a total of 419 patients (177 from cohort B [inoperable] and 242 from cohort A [operable high-risk]) were randomly assigned to TF-TAVR and actually received the designated treatment. First-generation Edwards-Sapien valves and delivery systems were used, via a 22- or 24-F sheath. The 30-day rates of major and minor VC (modified Valve Academic Research Consortium definitions), predictors, and effect on 1-year mortality were assessed. RESULTS: Sixty-four patients (15.3%) had major VC and 50 patients (11.9%) had minor VC within 30 days of the procedure. Among patients with major VC, vascular dissection (62.8%), perforation (31.3%), and access-site hematoma (22.9%) were the most frequent modes of presentation. Major VC, but not minor VC, were associated with significantly higher 30-day rates of major bleeding, transfusions, and renal failure requiring dialysis, and with a significantly higher rate of 30-day and 1-year mortality. The only identifiable independent predictor of major VC was female gender (hazard ratio [HR]: 2.31 [95% confidence interval (CI): 1.08 to 4.98], p = 0.03). Major VC (HR: 2.31 [95% CI: 1.20 to 4.43], p = 0.012), and renal disease at baseline (HR: 2.26 [95% CI: 1.34 to 3.81], p = 0.002) were identified as independent predictors of 1-year mortality. CONCLUSIONS: Major VC were frequent after TF-TAVR in the PARTNER trial using first-generation devices and were associated with high mortality. However, the incidence and impact of major VC on 1-year mortality decreased with lower-risk populations.
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Cite This Study
Généreux et al. (2012) conducted an RCT in Aortic stenosis (inoperable or high-risk) (n=419). Transfemoral transcatheter aortic valve replacement (TF-TAVR) was evaluated on 1-year mortality associated with major vascular complications (HR 2.31, 95% CI 1.20-4.43, p=0.012). Major vascular complications occurred in 15.3% of patients after transfemoral TAVR and independently predicted 1-year mortality (HR 2.31; 95% CI 1.20-4.43; p=0.012).