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TAVR With Evolut PRO vs. Acurate neo
Study Questions:
What are the outcomes of transcatheter aortic valve replacement (TAVR) with the Acurate neo (NEO) device as compared to the Evolut PRO (PRO) device?
Methods:
The investigators conducted a multicenter, retrospective, propensity-matched comparison of the NEO and the PRO device using the NEOPRO (A Multicenter Comparison of Acurate NEO Versus Evolut PRO Transcatheter Heart Valves) registry. This registry retrospectively included patients who underwent transfemoral TAVR with either NEO or PRO valves at 24 centers between January 2012 and March 2018. One-to-one propensity-score (PS) matching resulted in 251 pairs. Predischarge and 30-day Valve Academic Research Consortium (VARC)-2 defined outcomes were evaluated. Binary logistic regression was performed to adjust the treatment effect for PS quintiles. PS matching was used to adjust for differences in baseline characteristics and potential confounders that may lead to biased estimates of treatment outcomes.
Results:
A total of 1,551 patients (n = 1,263 NEO; n = 288 PRO) were included. The mean age was 82 years, and the mean Society of Thoracic Surgeons score was 5.1%. After PS matching (n = 502), VARC-2 device success (90.6% vs. 91.6%; p = 0.751) and pre-discharge moderate to severe (II+) paravalvular aortic regurgitation (7.3% vs. 5.7%; p = 0.584) were comparable between the NEO and PRO groups. Furthermore, there were no significant differences in any 30-day clinical outcome between matched NEO and PRO pairs, including all-cause mortality (3.2% vs. 1.2%; p = 0.221), stroke (2.4% vs. 2.8%; p = 1.000), new permanent pacemaker implantation (11.0% vs. 12.8%; p = 0.565), and VARC-2 early safety endpoint (10.6% vs. 10.4%; p = 1.000). Logistic regression on the unmatched cohort confirmed a similar risk of VARC-2 device success, paravalvular aortic regurgitation II+, and 30-day clinical outcomes after NEO and PRO implantation.
Conclusions:
The authors concluded that transfemoral TAVR with the NEO and PRO bioprostheses was associated with high device success, acceptable rates of paravalvular aortic regurgitation II+, and good 30-day clinical outcomes.
Perspective:
This multicenter registry reports that transfemoral TAVR with the NEO and PRO devices were associated with high device success, acceptable rates of moderate-to-severe paravalvular aortic regurgitation, and good 30-day clinical outcomes. After adjustment for potential confounders by means of propensity matched analysis, short-term outcomes were similar between the two next-generation self-expanding devices. Additional comparative studies are indicated to assess procedural short- and long-term success and outcomes after TAVR with self-expanding devices and durability, as well as to help potentially identify the patients gaining the most benefit from implantation of a specific self-expanding device for targeted device therapy.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Prevention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Aortic Valve Insufficiency, Bioprosthesis, Cardiovascular Surgical Procedures, Geriatrics, Heart Valve Diseases, Heart Valve Prosthesis, Pacemaker, Artificial, Secondary Prevention, Stroke, Transcatheter Aortic Valve Replacement, Treatment Outcome, Vascular Diseases
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