Initial experience of a large, self‐expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters’ registry

Abstract

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.

Early clinical and procedural outcomes in large series of 34‐mm self‐expanding transcatheter aortic valve replacement

“…Only one patient had a peak AV velocity > 3 m/s postprocedure. These success rates by VARC‐2 criteria are comparable to recently published results of similar prostheses …”

Initial experience of a self‐expanding transcatheter aortic valve with an outer pericardial wrap: The United Kingdom and Ireland Implanters' registry

“…However, we demonstrated a similar incidence of new permanent pacemaker implantation (17.8% of patients without a pacemaker at baseline) to previous studies of self‐expanding prostheses (11.8–19.7%) . Preexisting right bundle branch block was identified as a strong risk factor for new permanent pacemaker (57.1%), as has been previously been described . Consideration should therefore be made for prophylactic pacemaker insertion in this patient subset.…”

“…The United Kingdo and Ireland Implanters' registry is a multicenter registry which reports on real‐world experience with new transcatheter heart valves. Our group has previously reported on the procedural, clinical, and 30‐day outcome data of the Evolut R valve . Here, we describe our initial experience with the Evolut PRO valve.…”

Transcatheter aortic valve replacement versus surgery for symptomatic severe aortic stenosis: A reconstructed individual patient data meta‐analysis

“…This is an important observation, as with reduced sheath profiles in current-generation TAVR systems, transfemoral TAVR is now feasible in the vast majority of patients. 44,45 Cox proportional-hazards regression analysis of the primary and secondary end points did not show any significant interactions by baseline surgical risk or the type of TAVR system used, suggesting that the lower risk of death and disabling stroke associated with TAVR is not dependent on patient surgical risk, nor is it dependent on the type of TAVR system used. These observation suggests broad applicability of the findings of the primary and secondary end points.…”