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Vascular complications (VCs) after transfemoral transcatheter aortic valve replacement (TAVR) have historically been common and associated with significant morbidity and mortality. We evaluated our large multicenter experience to provide new insight on the incidence, predictors, management, and clinical impact of VCs after TAVR.
Retrospective TVT registry and chart review was performed for 1573 patients undergoing commercial transfemoral TAVR across seven centers within our hospital network between 2012 and 2016. VCs and bleeding complications (BCs) were defined by Valve Academic Research Consortium-2 definitions. Incidence of 30-day VCs and BCs, treatment strategy, and outcomes were reported. A mixed-effects model with hospital as a random effect was used to assess predictors of major VCs. Kaplan-Meier survival analysis and log-rank test were used to compare 30-day and 1-year survival for minor, major, and no VC groups.
There were 182 VCs that occurred in 173 patients (11.0%) within 30 days of TAVR, including 95 patients (6.0%) with major and 78 (5.0%) with minor VCs. Forty-four cases (2.8%) were complicated by life-threatening bleeding, within an additional 48 (3.1%) major and 22 (1.4%) minor BCs (Table). Percutaneous closure device failure (n = 19 [19.8%]), access site hematoma (n = 17 [17.7%]), ventricular perforation (n = 16 [16.7%]), retroperitoneal hemorrhage (n = 11 [11.5%]), and pseudoaneurysm (n = 11 [11.5%]) were the most common forms of major VCs. Seventy-one major VCs (74.0%) required intervention. Independent predictors of major VC included female sex (odds ratio [OR], 2.95; 95% confidence interval [CI], 1.87-4.65; P < .001), Hispanic ethnicity (OR, 3.79; 95% CI, 1.37-10.46; P = .01), and prior PCI (OR, 1.96; 95% CI, 1.27-3.03; P = .002). Compared with 2013 to 2016, procedures performed in 2012 had a higher likelihood of major VCs (OR, 2.73; 95% CI, 1.02-7.27; P = .045). Patients who had a major VC were more likely to require blood transfusion (P < .001), to have longer intensive care unit and overall length of stay (P < .001), to develop stroke (P = .027), and to be readmitted for a vascular reason within 30 days (P = .020). Patients with major VC, minor VC, or no VC had 30-day survival of 84.2% (95% CI, 75.2%-90.2%), 97.4% (95% CI, 90.0%-99.3%), and 98.3% (95% CI, 97.4%-98.8%), respectively, and 1-year survival of 78.4% (95% CI, 68.5%-85.5%), 91.6% (95% CI, 82.2%-96.1%), and 88.5% (95% CI, 86.6%-90.1%), respectively (P < .001; Fig).
Despite a reduction in the incidence of VCs in our multicenter experience, major VCs continue to be associated with significant morbidity and mortality. These findings reinforce the importance of patient selection and consideration of TAVR with alternative access for those with challenging iliofemoral access.
TableIncidence of vascular complications (VCs) and bleeding complications (BCs) after transfemoral transcatheter aortic valve replacement (TAVR)
Overall, No. (%)
Overall, No. (%)
Values correspond to number of patients experiencing a VC or BC. In patients with more than one complication, the highest severity VC or BC was counted.
Author Disclosures: J. Brevig: Nothing to Disclose; R. W. Hodson: Nothing to Disclose; R. Jin: Nothing to Disclose; E. B. Kirker: Nothing to Disclose; P. Ryan: Nothing to Disclose; L. Siwek: Nothing to Disclose; K. Spinelli: Nothing to Disclose; B. W. Ullery: Cook Medical: Speakers Bureau, Endologix, Inc: Consulting Fees (eg, advisory boards), Speakers Bureau, Medtronic: Consulting Fees (eg, advisory boards), Speakers Bureau, Silk Road Medical: Other Financial or Material Support.