ABSTRACT
BACKGROUND: Very little is known about long-term valve durability after transcatheter aortic valve replacement (TAVR). OBJECTIVES: This study sought to evaluate the incidence of structural valve degeneration (SVD) 5 to 10 years post-procedure. METHODS: Demographic, procedural, and in-hospital outcome data on patients who underwent TAVR from 2007 to 2011 were obtained from the U.K. TAVI (United Kingdom Transcatheter Aortic Valve Implantation) registry. Patients in whom echocardiographic data were available both at baseline and ≥5 years post-TAVR were included. Hemodynamic SVD was determined according to European task force committee guidelines. RESULTS: A total of 241 patients (79.3 ± 7.5 years of age; 46% female) with paired post-procedure and late echocardiographic follow-up (median 5.8 years, range 5 to 10 years) were included. A total of 149 patients (64%) were treated with a self-expandable valve and 80 (34.7%) with a balloon-expandable valve. Peak aortic valve gradient at follow-up was lower than post-procedure (17.1 vs. 19.1 mm Hg; p = 0.002). More patients had none/trivial aortic regurgitation (AR) (47.5% vs. 33%), and fewer had mild AR (42.5% vs. 57%) at follow-up (p = 0.02). There was 1 case (0.4%) of severe SVD 5.3 years after implantation (new severe AR). There were 21 cases (8.7%) of moderate SVD (mean 6.1 years post-implantation; range 4.9 to 8.6 years). Twelve of these (57%) were due to new AR and 9 (43%) to restenosis. CONCLUSIONS: Long-term transcatheter aortic valve function is excellent. In the authors' study, 91% of patients remained free of SVD between 5 and 10 years post-implantation. The incidence of severe SVD was <1%. Moderate SVD occurred in 1 in 12 patients.
Subject(s)
Aortic Valve Insufficiency , Aortic Valve Stenosis , Aortic Valve , Heart Valve Prosthesis , Postoperative Complications , Transcatheter Aortic Valve Replacement/adverse effects , Aged , Aged, 80 and over , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve/surgery , Aortic Valve Insufficiency/diagnosis , Aortic Valve Insufficiency/epidemiology , Aortic Valve Insufficiency/etiology , Aortic Valve Stenosis/epidemiology , Aortic Valve Stenosis/surgery , Echocardiography/methods , Female , Hemodynamics , Humans , Long Term Adverse Effects/diagnosis , Long Term Adverse Effects/epidemiology , Male , Outcome and Process Assessment, Health Care , Postoperative Complications/diagnosis , Postoperative Complications/epidemiology , Prosthesis Design , Prosthesis Failure , Transcatheter Aortic Valve Replacement/instrumentation , Transcatheter Aortic Valve Replacement/methods , United Kingdom/epidemiologyABSTRACT
OBJECTIVES: The UK & Ireland Implanters' registry is a multicenter registry which reports on real-world experience with novel transcatheter heart valves. BACKGROUND: The 34 mm Evolut R transcatheter aortic valve is a self-expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus. METHODS: Between January 2017 and April 2018, clinical, procedural and 30-day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2(VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. RESULTS: A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm2 . Paravalvular regurgitation was more than mild in 7.2%. A new permanent pacemaker was implanted in 15.7%. Early safety was demonstrated in 91.2%. At 30 days, all-cause mortality was 3.2%, stroke 3.7%, and major vascular complication 2.3%. CONCLUSIONS: Real-world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.
