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Significantly Improved Results for Medtronic's Evolut TAVR seen in the Optimize PRO Study
Use of the Cusp Overlap Technique Brought Pacemaker Rates Down to Single Digits
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Medtronic's Evolut Pro TAVR
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May 21, 2022 -- Not long ago, the only option for patients with symptomatic severe aortic stenosis required major open heart surgery, days in-hospital, and many days of rehabilitation. At this year's EuroPCR meeting in Paris (their first in-person conference since the pandemic began), the 20th anniversary of the first transcatheter aortic valve implantation (TAVI) was celebrated. Dr. Alain Cribier, the interventional cardiologist who performed the first TAVI, was honored and many seminars and live cases were presented, showcasing the valves from several device manufacturers. In the U.S., the procedure is called transcatheter aortic valve replacement or TAVR. But whether you call it TAVI or TAVR, this procedure has revolutionized the treatment of aortic stenosis.
The two main devices worldwide remain the Sapien, a balloon-expandable valve manufactured by Edwards, and the CoreValve/Evolut, a self-expanding valve manufactured by Medtronic. The valves from all manufacturers normally evolve as more is learned and most recently, several of the valves have had a "skirt" added, which has helped to reduce the paravalvular leak (PVL).
But in the case of the Evolut valve, it was not a change in the design of the device, but a new method of implantation that achieved dramatic improvements. At this year's EuroPCR meeting, the interim results of the Optimize PRO study of Medtronic's Evolut™ PRO and PRO+ TAVR systems in 400 patients were presented as a Hotline Trial. And the results were excellent: permanent pacemaker rates dropped to single digits (9.2%) and the number of patients with moderate or severe paravalvular leak (PVL) was zero (78% of patients had no or only trace PVL). Moreover, the median length of hospital stay was one day.
The important take-away was that the improved results were not due to a change in the device, but in the technique used to implant it: called the cusp overlap technique. This technique was discussed at last year's virtual EuroPCR and you can learn more about it by watching this video discussion between Drs. Darren Mylotte, Steven Yakubov, and Douglas Fraser.
Dr. Kendra Grubb |
The Optimize PRO interim results were presented at this year's EuroPCR meeting by Dr. Kendra Grubb, surgical director of the Structural Heart and Valve Center at Emory University in Atlanta and co-principal investigator in the Optimize PRO study. During the discussion, Dr. Grubb stated, "For this particular valve...and I think that's the point of this study, is that you've made no changes in the valve...but just the technique in and of itself: landing the valve higher, away from the membranous septum, away from the conduction system. Most of this has to do with taking a valve we were already using and getting better results by using a stepwise approach that's reproducible to be really able to understand where we are in space and get excellent outcomes.
"You don't need separate protocols for balloon expanding or self-expanding.... I believe that this technique will be helpful for all valves.... I see that as an advantage for any type of TAVR valve, not unique to this, but certainly this valve is becoming the way to do it."
The press release from Medtronic follows:
Optimized Procedure and Care Pathway with Medtronic Evolut™ TAVR System Demonstrates Excellent Valve Performance and Procedural Outcomes
Mid-term Results of Optimize PRO Clinical Study Reinforces Benefits of Predictability and Control Using Cusp Overlap Technique
May 17, 2022 -- Dublin -- Medtronic today announced results of 400 patients treated in the United States and Canada from the main cohort of the Optimize PRO clinical study evaluating valve performance and procedural outcomes associated with an “optimized” pre- and post-procedural TAVR care pathway, utilizing the cusp overlap technique to deploy the Evolut valves. The cusp overlap technique is designed to help implanters assess and achieve the target implant depth to reduce interaction with the conduction system. Findings were presented as a featured Hotline Trial at EuroPCR 2022.
The study results show that the cusp overlap technique led to more predictability and control resulting in a single-digit pacemaker implantation rate (9.2%1), a low 30-day mortality rate (0.8%), median length of hospital stay of one day, and upon discharge, no cases of moderate/severe paravalvular leak (PVL) (0%) and 78% of patients had none/trace PVL. The lowest pacemaker implantation rates were observed when all steps of the cusp overlap technique were followed.
Dr. Kendra Grubb |
"The results demonstrate significant improvement for TAVR with the Evolut valve, some of the best results in an Evolut trial we have ever seen," said Kendra Grubb, M.D., surgical director of the Structural Heart and Valve Center at Emory University in Atlanta, and co-principal investigator in the Optimize PRO study who presented the data at the meeting. “Adopting the cusp overlap technique and clinical pathways resulted in single-digit pacemaker rates out to 30 days, next-day discharge in the majority of the patients, and remarkably low rates of paravalvular leak.”
adding value
The Optimize PRO study utilizes a TAVR care pathway to evaluate common practices and shared experiences such as conscious sedation and early mobilization. A conduction disturbance pathway evaluates efficiencies and heart team considerations for monitoring and managing patients with conduction disturbance who might be considered for a pacemaker post TAVR.
“We are committed to improving the TAVR care pathway with simple and repeatable techniques that implanting centers can use to help improve procedure efficiencies and success,” said Neil Yanke, vice president and general manager of the Structural Heart business, which is part of the Cardiovascular Portfolio at Medtronic. “The findings presented today – coupled with our recent data presented at ACC 2022 establishing the CoreValve/Evolut TAVR systems as the first and only TAVR platform to demonstrate significantly lower rates of structural valve deterioration (SVD) vs. SAVR at five years – help to further establish the robust clinical evidence physicians need to make the best decisions for their patients.”
The post-market, prospective, multi-center study is evaluating outcomes associated with procedure-related techniques and post-procedure transcatheter aortic valve replacement (TAVR) when using the self-expanding, supra-annular Evolut™ PRO and PRO+ TAVR systems in patients with symptomatic severe aortic stenosis. The current interim analysis includes 400 main cohort patients and 104 roll-in patients at up to 46 sites in the United States and Canada. The primary endpoint includes the rate of all-cause mortality or all-stroke at 30 days with secondary endpoints of discharge time, percent of patients with more than moderate aortic regurgitation, and the rate of pacemaker implant for new-onset or worsening conduction disturbance at 30 days. The study will also evaluate rehospitalization rates and discharge time at 30 days and one year.
The Medtronic CoreValve™ Evolut™ R, CoreValve™ Evolut™ PRO, and Evolut™ PRO+ systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn.
Reported by Burt Cohen, May 21, 2022
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