Health Status After Transcatheter Aortic Valve Replacement in Patients at Extreme Surgical Risk

Abstract

Objectives To characterize health status outcomes after transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis among patients at extreme surgical risk and to identify pre-procedural patient characteristics associated with a poor outcome. Background For many patients considering TAVR, improvement in quality of life may be of even greater importance than prolonged survival. Methods Patients with severe, symptomatic aortic stenosis who were considered to be at prohibitive risk for surgical aortic valve replacement were enrolled in the single-arm CoreValve U.S. Extreme Risk Study. Health status was assessed at baseline and at 1, 6, and 12 months after TAVR using the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Short-Form-12 (SF-12), and the EuroQol-5D. The overall summary scale of the KCCQ (range 0-100; higher scores = better health) was the primary health status outcome. A poor outcome after TAVR was defined as either death, a KCCQ-overall summary score (KCCQ-OS) <45 or a decline in KCCQ-OS of 10 points at 6-month follow-up. Results A total of 471 patients underwent TAVR via the transfemoral approach, of whom 436 (93%) completed the baseline health status survey. All health status measures demonstrated considerable impairment at baseline. After TAVR, there was substantial improvement in both disease-specific and generic health status measures, with an increase in the KCCQ-OS of 23.9 points (95% confidence interval [CI] 20.3-27.5) at 1 month, 27.4 points (95% CI 24.2-30.6) at 6 months, 27.4 points (95% CI 24.1-30.8) at 12 months, along with substantial increases in SF-12 scores and EQ-5D utilities as well (all p<0.003 compared with baseline). Nonetheless, 39% of patients had a poor outcome after TAVR. Baseline factors independently associated with poor outcome included wheelchair dependency, lower mean aortic valve gradient, prior CABG, oxygen dependency, very high predicted mortality with surgical AVR, and low serum albumin. Conclusions Among patients with severe aortic stenosis, TAVR with a self-expanding bioprosthesis resulted in substantial improvements in both disease-specific and generic health-related quality of life, but there remained a large minority of patients who died or had very poor quality of life despite TAVR. Predictive models based on a combination of clinical factors as well as disability and frailty may provide insight into the optimal patient population for which TAVR is beneficial.

Permanent pacemaker insertion in patients with conduction abnormalities post transcatheter aortic valve replacement: a review and proposed guidelines

“…Importantly, the pacemaker implantation was 14.7%. Similar outcomes were reported with 16.4% of patients requiring PPM in the Evolut R U.S. Study (18); and in 13.3% of patients requiring PPM in the Evolut R US IFU trial (19).…”

Advances in Transcatheter Aortic Valve Replacement

“…The improvement in quality of life (QoL) was very large in the extreme-risk trials 12,13 and in the randomized trials at 1 year was equal between TAVR and SAVR, although transfemoral TAVR had a more rapid attainment of this improved QoL.…”

Can We Predict Quality of Life and Survival After Transcatheter Aortic Valve Replacement?

“…[1][2][3][4][5] In fact, recent analyses from 2 separate randomized controlled trials have reported that healthrelated quality of life improves earlier and faster among highrisk patients assigned to transfemoral TAVR, as compared with surgical aortic valve replacement. 6,7 Nevertheless, it is becoming increasingly clear that not all patients assigned to TAVR benefit from the procedure.…”

“…For example, in the CoreValve US Pivotal trial, extreme risk cohort (mean Society of Thoracic Surgeons [STS] score 10.4±5.6%), 39% of patients were deemed to have had a poor outcome after TAVR (22% death, 16% poor quality of life, and 1.4% quality of life decline). 5 Similarly, in the Placement of Aortic Transcatheter Valves (PARTNER) trial (including both cohorts), 35% of patients were categorized as having a poor outcome after the procedure (19% death, 16% poor quality of life). 8 In the recently published STS/American College of Cardiology/Transcatheter Valve Therapy (ACC/TVT) registry, patients with the combination of advanced age (85-94 years), dialysis dependency, and STS score ≥15% (n=77 patients) had a 1-year mortality rate of 54%.…”

“…Therefore, health-related quality of life may serve as a useful surrogate marker for the combined effect of a patient's age, AS severity, comorbidities, and frailty parameters. Although there have been several studies quantifying improvements in health-related quality of life as compared with baseline following TAVR, [4][5][6][7][8] it remains unclear whether the status of baseline health-related quality of life per se may serve as a useful parameter for further risk stratification of patients before the procedure.…”