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

Forrest, John K.; Mangi, Abeel A.; Popma, Jeffrey J.; Khabbaz, Kamal R.; Reardon, Michael J.; Kleiman, Neal S.; Yakubov, Steven J.; Watson, Daniel R.; Kodali, Susheel; George, Isaac; Tadros, Peter; Zorn, George L.; Brown, John; Kipperman, Robert; Saul, Sara; Qiao, Hongyan; Oh, Jae K.; Williams, Mathew

doi:10.1016/j.jcin.2017.10.014

Cited by 159 publications

(93 citation statements)

References 26 publications

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“…The improvement in device success was driven by a significant reduction in moderate paravalvular regurgitation (1.7%). These findings are in keeping with the low incidence of moderate paravalvular regurgitation (0.0%) reported in the Evolut PRO US clinical study …”

Section: Discussionsupporting

confidence: 89%

“…The outer pericardial wrap could also potentially lead to an increase in conduction disturbance. 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 .…”

Section: Discussionsupporting

confidence: 87%

“…The Evolut PRO transcatheter aortic valve (Medtronic, Minneapolis, MN) is a third‐generation self‐expanding transcatheter aortic valve. The key design changes from the second‐generation Evolut R have been described previously . In brief, the valve has an external pericardial wrap, designed to increase surface contact with the native anatomy and minimize paravalvular regurgitation.…”

Section: Introductionmentioning

confidence: 99%

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

Dowling

Firoozi

Panoulas

et al. 2019

Cathet Cardio Intervent

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Objectives The United Kingdom and Ireland Implanters' registry is a multicenter registry which reports on real‐world experience with new transcatheter heart valves. Background The Evolut PRO (Medtronic, Minneapolis, MN) transcatheter aortic valve is a self‐expanding transcatheter aortic valve with an outer pericardial wrap, designed to minimize paravalvular regurgitation. Methods Between July 2017 and December 2018, clinical, procedural, and 30‐day outcome data were prospectively collected from all patients receiving the Evolut PRO valve across nine 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 317 patients underwent implantation. Mean age was 81.8 ± 6.4 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.5 ± 1.8%. Iliofemoral access was used in 99.1% of patients. Device success was 91.2%. Mean gradient was 7.6 ± 4.7 mmHg and effective orifice area 1.9 ± 0.7 cm2. The incidence of moderate paravalvular regurgitation was 1.7% and there was no severe paravalvular regurgitation. A new permanent pacemaker was implanted in 17.8% of patients without a pacemaker at baseline. Early safety was demonstrated in 92.7%. At 30 days, all‐cause mortality was 0.6%, stroke 3.8%, and major vascular complication 2.8%. Conclusions Real‐world experience of the Evolut PRO transcatheter aortic valve demonstrated favorable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

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

Dowling

Firoozi

Panoulas

et al. 2019

Cathet Cardio Intervent

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“…These findings represent a definite improvement on the outcomes seen with the first‐generation CoreValve in the ADVANCE clinical study (15.0%) . However, incidence of more than mild paravalvular regurgitation was not as low as has been recently reported in the Evolut R FORWARD clinical study (1.9%), Evolut R 34 mm U.S. clinical study (1.7%), Evolut PRO U.S. clinical study (0.0%) and other 34 mm Evolut R registry data (0.0%–5.0%) . The average implant depth in our study (5.6 ± 3.1 mm) was outside the manufacturer recommendations (3–5 mm), which may explain the higher incidence of more than mild paravalvular regurgitation that we have reported.…”

Section: Discussionmentioning

confidence: 53%

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

Dowling

Firoozi

Doyle

et al. 2018

Cathet Cardio Intervent

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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.

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“…In addition, 4 THVs, Evolut PRO, Edwards Centera, SAPIEN 3 Ultra and Myval, received CE mark approval in 2017, 2018, 2018 and 2019 respectively. Clinical endpoints are reviewed in a few articles [11][12][13] and studies showed 30-day mortality rates of 1.7% (Evolut PRO [14,15]) and 1% (Centera [14,15]) and 9.1% 1-year mortality rate for Centera [11][12][13][14][15]. Articles describing clinical endpoints of Myval were not identified.…”

Section: Transcatheter Heart Valvesmentioning

confidence: 99%

Transcatheter aortic valve replacement: clinical safety and performance data

Baal

Roszek

Elk

et al. 2019

Expert Review of Medical Devices

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Introduction: Patients with severe aortic stenosis and regurgitation who are inoperable or at high-risk for surgery can be treated with transcatheter aortic valve replacement (TAVR). The aim of this study was to provide a comprehensive overview of the literature of TAVR and reported clinical and performance outcomes. Areas covered: A total of 16 devices, described in 204 articles describing clinical and performance outcomes, were included. The most frequently observed outcome was 30-day mortality, ranging between 0-23%. Other commonly reported clinical outcomes were 30-day stroke, ranging between 0-14.3% and pacemaker implantation, ranging from 0-44.9%. The most common valve performance outcome was aortic valve regurgitation, however, mostly reported at 7 days follow-up. Next to a followup period of 30 days, numerous articles reported outcomes at 6 months and 1 year. The numbers of articles describing outcomes with a longer follow-up as well as including intermediate and low-risk patients were limited. Expert commentary: This literature review provided a clear overview of the reported clinical and performance outcomes of TAVR devices. Despite the frequently used VARC-2 definitions, we identified a huge variation across studies. Future studies using standardized definitions of study setups and outcomes are essential and might lead to better insights of TAVR.

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

Cited by 159 publications

References 26 publications

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

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

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

Transcatheter aortic valve replacement: clinical safety and performance data

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