MedicalResearch.com Interview with:
Dr. Shazia Afzal MD
University Hospital Düsseldorf, Medical Faculty, Division of Cardiology, Pulmonology and Vascular Medicine, Düsseldorf, Germany
MedicalResearch.com: What is the background for this study?
Response: Since its introduction in 2002, transcatheter aortic valve replacement (TAVR) emerged to an increasingly important interventional procedure in the field of structural heart disease. Widespread use in Europe, the USA and Canada lead to continuous technological development and improved patient’s safety, procedural success and clinical outcome.
In 08/2017 one of the market leaders introduced its latest generation valve model -the CoreValve Evolut PROTM– which was especially designed to mitigate paravalvular leakage after valve deployment. We conducted the first prospective study which directly compares the Evolut PROTM with its direct predecessor the Evolut RTM as a head-to-head analysis especially focusing on hemodynamic performance and clinical outcome in a real-world setting. To ensure comparability between groups, we performed propensity score matching with special interest in CT-derived data to guarantee equitable anatomical conditions.
Since both valves are on the market but sold at different prices the pivotal question is whether the Evolut PROTM reaches its target. In a highly budget restricted health care system with limited refunding cost-effectiveness evolves to a substantial discussion point in daily clinical practice. Our results may not be marketing friendly but we think of relevance for the interventional community.
MedicalResearch.com: What are the main findings?
Response: The major findings of our study are:
1) Both prostheses provide sophisticated technology with excellent hemodynamic performance
2) The occurrence and degree of PVL after TAVR is similar in both groups.
3) No differences between the two prostheses could be observed regarding major vascular and bleeding complications.
MedicalResearch.com: What should readers take away from your report?
Response: The Evolut RTM TAVR valve is as effective as the Evolut PROTM in treating significant aortic valve stenosis.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Larger multicenter trials are needed to confirm our findings. The post-market, prospective interventional Forward PRO study (NCT03417011) is conducted right now and already recruits fast. It is a single-arm, multi-center trial with 600 planned patients.
JACC Cardiovascular Interventions
The Latest Evolution of the Medtronic CoreValve System in the Era of Transcatheter Aortic Valve Replacement
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