Vascular Complications After Transcatheter Aortic Valve Replacement: Insights From the PARTNER (Placement of AoRTic TraNscathetER Valve) Trial

Aug 08, 2012
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Authors:
Généreux P, Webb JG, Svensson LG, et al.
Citation:
J Am Coll Cardiol 2012;Aug 8:[Epub ahead of print].
Summary By:
Hitinder S. Gurm, MBBS, FACC

Study Questions:

What are the incidence, predictors, and impact of vascular complications (VCs) after transfemoral transcatheter aortic valve replacement (TAVR)?

Methods:

The authors assessed the predictors and impact of VCs among patients undergoing TAVR via the femoral approach in the PARTNER trial. The study cohort was comprised of a total of 419 patients (177 from cohort B [inoperable] and 242 from cohort A [operable high-risk]) who were randomly assigned to and actually received TAVR. The study deployed the first-generation Edwards-Sapien valves via a 22- or 24-F sheath. The outcomes of interest were 30-day rates of major and minor VC, as defined by the modified Valve Academic Research Consortium.

Results:

A major VC occurred in 64 patients (15.3%), whereas 11.9% had a minor VC within 30 days of the procedure. Among patients with a major VC, the specific complications were vascular dissection (62.8%), perforation (31.3%), and access-site hematoma (22.9%). Major VCs 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 (14.1% vs. 3.1%) and 1-year mortality (39.4% vs. 22.8%). The only identifiable independent predictor of major VC was female gender (hazard ratio [HR], 2.31; 95% confidence interval [CI], 1.08-4.98; p = 0.03). Major VCs (HR, 2.31; 95% CI, 1.20-4.43; p = 0.012) and renal disease at baseline (HR, 2.26; 95% CI, 1.34-3.81; p = 0.002) were independent predictors of 1-year mortality.

Conclusions:

The authors concluded that major VCs were common after transfemoral TAVR in the PARTNER trial, and were associated with high mortality.

Perspective:

The first-generation TAVR required large bulky sheaths and the occurrence of vascular complications in a large proportion of patients is not surprising. Ongoing improvement in device design and increasing clinical experience will help reduce both the occurrence and the impact of vascular complications in patients undergoing TAVR.

Keywords: Blood Transfusion, Incidence, Heart Valve Prosthesis, Bioprosthesis, Cardiology, Hematoma, Heart Valve Prosthesis Implantation, Angioplasty, Hemorrhage


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