Adult: Aortic Valve
Outcomes of procedural complications in transfemoral transcatheter aortic valve replacement

Accepted for the 46th Annual Meeting of the Western Thoracic Surgical Association.
https://doi.org/10.1016/j.jtcvs.2021.04.082Get rights and content

Abstract

Objectives

As the application of transcatheter aortic valve replacement (TAVR) expands, the longitudinal implications of periprocedural complications are increasingly relevant. We examine the influence of TAVR complications on midterm survival.

Methods

Patients undergoing transfemoral TAVR at our institution between November 2011 and June 2018 were reviewed. Stroke severity was classified according to the National Institutes of Health stroke score. Kaplan-Meier analysis was used to assess survival, and a Cox proportional hazards model was created to examine independent associations with survival. The median follow-up time was 36 months for a total of 2789 patient-years.

Results

Overall, 866 patients were included. The mean age was 80 ± 9.5 years and mean Society of Thoracic Surgeons score was 4.8% ± 2.7%. The mortality rate at 30-days was 2.8% and 11.8% at 1 year. In-hospital left bundle branch block and 30-day permanent pacemaker insertion occurred in 14.8% and 7.9%, respectively. Postprocedural greater-than-mild paravalvular leak was present in 4.4% and stroke occurred in 3.8% at 30-days. Greater-than-mild paravalvular leak was associated with decreased survival at 2 years (P = .02), but not at 5 years. Severe stroke was independently associated with decreased survival at 5 years (hazard ratio, 5.73; 95% confidence interval, 2.29-14.36; P ≤ .001); however, the effect of nonsevere stroke did not reach significance (hazard ratio, 1.69; 95% confidence interval, 0.82-3.47; P = .152).

Conclusions

Severe stroke was independently associated with decreased 5-year survival and initial risks associated with paravalvular leak may be attenuated over the midterm following transfemoral TAVR. Strategies to minimize the incidence of stroke and paravalvular leak must be prioritized to improve longitudinal outcomes after TAVR.

Section snippets

Patient Selection

All patients undergoing TAVR at our institution between November 2011 and June 2018 were reviewed. Patients with alternate access TAVR, other than transfemoral, and those with concomitant percutaneous mitral intervention were excluded. This research was approved by our institutional review board with waived patient consent (protocol #2010P000292, initial approval February 11, 2010).

Data Sources and Variables of Interest

Patient demographic characteristics, laboratory values, operative details, and in-hospital outcomes were obtained

Study Population and Perioperative Outcomes

Overall, 866 patients were included in the final analysis. The mean age was 80 ± 9.5 and 458 patients (52.9%) were women (Table 1). The mean STS PROM in this group was 4.8% ± 2.7%, and 128 (14.8%) patients had a pacemaker in place before TAVR. The median preprocedural ejection fraction was 60% (IQR, 55%-65%). The majority of patients had primary pathology of aortic stenosis (80.1%). The mean preoperative aortic valve gradient was 43 ± 9.5 mm Hg and the mean aortic valve area was 0.7 ± 0.2 cm2.

Discussion

Our 5-year study of 866 patients undergoing transfemoral TAVR between 2011 and 2018 had several important findings (Figure 6). First, PVL was the most common complication studied (23%), followed by LBBB (15%), PPM (8%), and stroke (4%). Second, severe stroke was the only complication associated with a survival penalty over the 5-year follow-up period, and severe stroke was independently associated with reduced mid-term survival. Third, although greater-than-mild PVL was associated with

Conclusions

This real-world, longitudinal study of TAVR complications provides important information regarding midterm significance of stroke, PVL, LBBB, and PPM. Severe stroke following TAVR is associated with poor longitudinal survival. Additionally, initial mortality risks associated with greater-than-mild PVL may be attenuated over time. Our findings highlight the importance of complication prevention in the application of TAVR to patients with long life expectancy.

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