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Medtronic Low Risk Trial

By Joan Jennings RN MA, Research Nurse Specialist 

Posted April 1, 2019

Transcatheter Aortic Valve Replacement (TAVR) has developed into the standard of care for patients with severe aortic stenosis who are inoperable or at extreme or high risk for conventional surgical aortic valve replacement. St. Francis Hospital was a leader in the early Medtronic CoreValve clinical trials and was instrumental in gaining FDA approval for high risk populations.

In April 2016, St. Francis Hospital embarked on the Medtronic CoreValve Low Risk TAVR trial (EVOLUT) which is seeking expansion of the approved indication for patients who are at low risk for surgical aortic valve replacement (SAVR). In coordination with the John Brancaccio Heart Valve Center, the St. Francis Research team consented 53 patients for this randomized trial and 37 patients were deemed eligible to participate. Fifteen patients were randomized to SAVR and 22 received the CoreValve TAVR.

St. Francis Hospital continues to provide TAVR for patients with low surgical risk through the Medtronic CoreValve Low Risk TAVR Continued Access trial. Eight patients have received TAVR implant in this non-randomized protocol. Patients in both Low Risk studies will be followed for 10 years.

The results of the low risk Trials, both PARTNER 3 and EVOLUT were released at 2019 ACC held in New Orleans on March 16-18. TAVR for low risk patients with severe aortic stenosis is safe and effective. The death and stroke risks are at least comparable if not lower than surgery. The findings are now published in March issues of NEJM. Dr. Newell Robinson and Dr. George Petrossian were coauthors for EVOLUT trial.

“Our participation in the Medtronic Low Risk TAVR trial was an opportunity to be involved in research that will have a huge impact in how cardiology is practiced. TAVR was non inferior to surgical aortic valve replacement and TAVR will become the main form of therapy for aortic stenosis moving forward”, said George A. Petrossian, M.D., Co-Director of the Heart Valve Center.

“The results of the Low Risk Trials, both Medtronic and Edwards, were very provocative in that they suggest that a patient with any risk is a candidate for TAVR. This will likely change the way we treat aortic valve disease forever”, observed Newell B. Robinson, M.D., Chairman of Cardiothoracic Surgery and Co-Director of the Heart Valve Center.

“The opportunity to offer patients with aortic stenosis additional options for treatment has been extremely rewarding”, commented Patricia Krug, RN, CCRC, Research Nurse Specialist.

“Our experience at St. Francis with the early TAVR trials has given us a unique perspective on the evolution and advances of this technology that we can share with our patients”, observed Joan Jennings, RN, MA, Research Nurse Specialist.