The William Harvey Distinguished Chair in Advanced Cardiovascular Medicine at Brigham and Women's Hospital
Do data from clinical trials translate into real world evidence? An overwhelming YES from the ELEVATE pivotal study which once again shows the transformative benefit of chronic LVAD support in Advanced Heart Failure - A median survival in excess of 5 years, a tripling in 6 minute walk distance and near doubling in QOL achieved. Adding life to years and not just years to life. The findings are also echoed by the recent INTERMACS real world analysis (Ann Thorac Surg. 2023 Nov 8:S0003-4975(23)01155-4.). We MUST move to better implementation of the findings of these studies by proving these life saving opportunities to our patients. Finn Gustafsson Javed Butler Prof. Dr. J. D. Schmitto, MD, PhD, MBA, FRCS(Glasg) FACS Arjang Ruhparwar Daniel Goldstein, MD Manreet Kanwar Andrew J. Sauer, MD Robert Kormos
It was funny this past week at our selection meeting the tone of discussion regarding lvad utilization has changed so dramatically. I got this feeling that we were talking about it like we talk about doing valve replacements on patients with a history of ivdu endocarditis. It was more about timing and ethical considerations. Our cardiologists see it as an on the shelf therapy. Gone is the let’s try everything else first approach. I’m old enough to appreciate what a change that is now. It was very encouraging.
Great results. We have to challenge the narrative that transplant is the golden standard. There has to be a discussion on quality of life and time spend on waiting lists. In the UK the average waiting time is 2.5 years. The HM3 can be taken from the shelf any time, does not fail, there is literally no early mortality and all you need is a bit of anticoagulation. I think we have managed during the last decade of intense work to turn LVAD therapy into a pacemaker like procedure for patients with end stage heart failure.
Clinical trials are conducted in the real world with real patients, real treatments, and real outcomes. So why are we surprised?
Thank you Mandeep and others who see this data as a critical advance in the evolution of therapeutic options for patients dying with advanced heart failure. Death should not be an option.
Indeed Mandeep. We NOW need to “elevate” the discussion to seriously talk about “net prolongation of life” for younger patients as we do when we think about aortic valve replacement.
This is amazingly consistent data and excellent presentation in an easy to understand visual. I want to say this level of similarity between RWE and Clinical trials maybe unique to this therapy.
Imagine the excellent results if MOMENTUM 3 and ELEVATE once we get rid of the driveline. This will gain more acceptance among patients and referring cardiologists
Amazing
Solid work, Dr. Chairman!
Professor and Consultant, Transplant Institute and Dept Cardiothoracic Surg, Sahlgrenska University Hospital
10moWell done Mandeep and all, keep hammering on the message, there are still a lot of disbelief among cardiologists regarding LVAD therapy, despite improving technology, better results and great trials. Ignorance or disinterest? Whatever it is, needs to be adressed by sustained dissemination of information and knowledge......