Early Clinical Outcomes After Transcatheter Aortic Valve Replacement Using a Novel Self-Expanding Bioprosthesis in Patients With Severe Aortic Stenosis Who Are Suboptimal for Surgery: Results of the Evolut R U.S. Study.

This study sought to evaluate this transcatheter aortic valve (TAV) bioprosthesis in patients who are poorly suitable for surgical aortic valve (AV) replacement. A novel self-expandable TAV bioprosthesis was designed to provide a low-profile delivery system, conformable annular sealing, and the ability to resheath and reposition during deployment. The Evolut R U.S. study included 241 patients with severe aortic stenosis who were deemed to be at least high risk for surgery treated at 23 clinical sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. An independent echocardiography laboratory was used to evaluate hemodynamic outcomes. Patients were elderly (83.3 ± 7.2 years of age) and had high surgical risk (Society of Thoracic Surgeons predicted risk of mortality of 7.4 ± 3.4%). The majority of patients (89.5%) were treated by iliofemoral access. Resheathing or recapturing was performed in 22.6% of patients; more than 1 valve was required in 3 patients (1.3%). The 30-day outcomes included all-cause mortality (2.5%), disabling stroke (3.3%), major vascular complications (7.5%), life-threatening or disabling bleeding (7.1%), and new permanent pacemaker (16.4%). AV hemodynamics were markedly improved at 30 days: the mean AV gradient was reduced from 48.2 ± 13.0 mm Hg to 7.8 ± 3.1 mm Hg (p < 0.001) and AV area increased from 0.6 ± 0.2 cm2 to 1.9 ± 0.5 cm2 (p < 0.001). Moderate residual paravalvular leak was identified in 5.3% of patients. We conclude that this novel self-expanding TAV bioprosthesis is safe and effective for the treatment of patients with severe aortic stenosis who are suboptimal for surgery. (Medtronic CoreValve Evolut R U.S. Clinical Study; NCT02207569).

Popma JJ ，Reardon MJ ，Khabbaz K ，Harrison JK ，Hughes GC ，Kodali S ，George I ，Deeb GM ，Chetcuti S ，Kipperman R ，Brown J ，Qiao H ，Slater J ，Williams MR ... -  《-》

Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap.

This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments. All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm2 at 30 days. The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853).

Forrest JK ，Mangi AA ，Popma JJ ，Khabbaz K ，Reardon MJ ，Kleiman NS ，Yakubov SJ ，Watson D ，Kodali S ，George I ，Tadros P ，Zorn GL 3rd ，Brown J ，Kipperman R ，Saul S ，Qiao H ，Oh JK ，Williams MR ... -  《-》

Three Generations of Self-Expanding Transcatheter Aortic Valves: A Report From the STS/ACC TVT Registry.

The aim of this study was to assess the evolution of early outcomes for 3 iterative self-expanding transcatheter aortic valves. Over the past decade there have been rapid advancements in transcatheter aortic valve replacement (TAVR) technologies, including 3 generations of supra-annular self-expanding transcatheter systems. Data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry for patients undergoing TAVR with CoreValve, Evolut R, or Evolut PRO valves to treat tricuspid aortic stenosis between January 2014 and September 2017 were obtained. Patient risk and echocardiographic data are site reported. Valves analyzed included 23-, 26-, and 29-mm sizes to fit 18- to 26-mm annular diameters. Propensity score matching was performed using the Evolut PRO group as the common reference. Of 18,874 patients undergoing TAVR at 381 centers, 5,514 patients were implanted with CoreValve, 11,295 with Evolut R, and 2,065 with Evolut PRO valves. At 30 days, there were significantly fewer patients with more than mild aortic regurgitation for the unmatched (7.8% CoreValve, 5.2% Evolut R, and 2.8% Evolut PRO; p < 0.001) and matched populations (8.3% CoreValve, 5.4% Evolut R, and 3.4% Evolut PRO; p = 0.032). The mean aortic valve gradients at 30 days in the matched populations were <8 mm Hg for all 3 valves (7.3 mm Hg CoreValve, 7.5 mm Hg Evolut R, 7.2 mm Hg Evolut PRO). Advancements in transcatheter valve technologies and expanding indications for TAVR have resulted in improved outcomes for patients undergoing TAVR in the United States with self-expanding, supra-annular valves. In particular, the addition of an outer pericardial tissue wrap designed to enhance sealing at the level of the aortic annulus has resulted in very low rates of significant aortic regurgitation while maintaining excellent hemodynamic status.

Forrest JK ，Kaple RK ，Tang GHL ，Yakubov SJ ，Nazif TM ，Williams MR ，Zhang A ，Popma JJ ，Reardon MJ ... -  《-》

Implantation and 30-Day Follow-Up on All 4 Valve Sizes Within the Portico Transcatheter Aortic Bioprosthetic Family.

The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system. The Portico transcatheter aortic heart valve is a fully resheathable, repositionable, and self-expanding bioprosthesis designed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances. Patients (n = 222) with symptomatic (New York Heart Association functional class ≥II) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospective, nonrandomized, multicenter study. Patients were implanted with the full range of Portico heart valves (23, 25, 27, and 29 mm) using the transfemoral approach. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included valve performance, improvement in functional class, and procedural outcomes as defined by Valve Academic Research Consortium criteria. A total of 220 patients (mean age 83.0 ± 4.6 years, 74.3% women, mean Society of Thoracic Surgeons score 5.8%) had valves implanted. All resheathing and repositioning attempts (n = 72) were successful. At 30 days, all-cause mortality was 3.6%. Procedural outcomes included disabling (major) stroke (3.2%), major vascular complications (7.2%), and permanent pacemaker implantation (13.5%). Compared with baseline, 75.8% of patients improved by ≥1 New York Heart Association functional class at 30 days. The rate of moderate paravalvular leak was 5.7%, with no severe paravalvular leak reported. No differences in paravalvular leak incidence and severity were observed among valve sizes (p = 0.24). Across all valve sizes, use of the repositionable Portico transcatheter aortic valve replacement system resulted in safe and effective treatment of aortic stenosis in high-risk patients.

Möllmann H ，Linke A ，Holzhey DM ，Walther T ，Manoharan G ，Schäfer U ，Heinz-Kuck K ，Van Boven AJ ，Redwood SR ，Kovac J ，Butter C ，Søndergaard L ，Lauten A ，Schymik G ，Worthley SG ... -  《-》

Comparison of Self-Expanding Bioprostheses for Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis: SCOPE 2 Randomized Clinical Trial.

Tamburino C ，Bleiziffer S ，Thiele H ，Scholtz S ，Hildick-Smith D ，Cunnington M ，Wolf A ，Barbanti M ，Tchetchè D ，Garot P ，Pagnotta P ，Gilard M ，Bedogni F ，Van Belle E ，Vasa-Nicotera M ，Chieffo A ，Deutsch O ，Kempfert J ，Søndergaard L ，Butter C ，Trillo-Nouche R ，Lotfi S ，Möllmann H ，Joner M ，Abdel-Wahab M ，Bogaerts K ，Hengstenberg C ，Capodanno D ... -  《-》