‘The beginning of the story’: TAVR pioneers highlight 20 years of intervention history
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WASHINGTON — There have been many changes in intervention since Alain Cribier, MD, FASC, FESC, performed the first-in-human transcatheter aortic valve replacement in a patient with severe aortic stenosis who was not a candidate for surgery.
Cribier recalled feeling a mix of emotions as he prepared for what would be the world’s first TAVR in April 2002. At the time, he tried to think of words to characterize what would happen — “crazy,” “stupid” and “courageous” came to mind, he said.
“The night before, I did not sleep at all,” Cribier, emeritus professor of medicine and director of cardiology at the University of Rouen's Charles Nicolle Hospital, said while speaking at the “Disruptive Innovation: TAVR 20 Years Later” panel discussion, held at the American College of Cardiology Scientific Session. “I was just rehearsing what I had been doing on the last sheep, which was just before this patient.”
The first TAVR patient, a man aged 57 years, had severe aortic stenosis and presented in cardiogenic shock. He had major left ventricular dysfunction, an ejection fraction of just 12% and multiple comorbidities contraindicating surgery. After failed balloon aortic valvuloplasty, TAVR was the patient’s only option.
The procedure was successfully performed using a challenging approach: the antegrade transseptal approach via the femoral vein. The transcatheter heart valve was accurately deployed in the middle of the valvular calcification.
“After the case, we watched the clock,” Cribier said. “We decided if the patient survived for 30 minutes, we would say the procedure was a success. In 30 minutes, the patient was smiling, moving his hands, thanking everyone for what we did. Five hours later, we drank champagne in his room. It was the beginning of the story.”
The TAVR anniversary panel at the ACC Scientific Session was led by Michael J. Mack, MD, FACC, cardiothoracic surgeon at Baylor Scott & White Health, and Cardiology Today Editorial Board Member Dipti Itchhaporia, MD, FACC, FESC, president of the ACC; the Eric & Sheila Samson Endowed Chair in Cardiovascular Health and director of disease management for Jeffrey M. Carlton Heart and Vascular Institute at Hoag Memorial Hospital, Newport Beach, California; and assistant clinical professor of medicine at University of California, Irvine.
‘This ... is going to work’
The first TAVR, watched by hundreds of cardiologists and surgeons, would forever change practice.
In the years since, TAVR has moved from a curiosity that drew excited crowds to become the standard of care for patients with symptomatic heart disease due to severe aortic stenosis. Procedural expertise and equipment have markedly improved; subsequent clinical trials, including PARTNER, have validated the clinical use of TAVR in a variety of patient settings.
“When we unblinded the PARTNER trial with almost 400 of the worst-case-scenario patients, randomized to TAVR or control therapy, and we printed the first Kaplan-Meier curves and saw a 20% difference in absolute mortality, that was shocking,” Martin B. Leon, MD, FACC, professor of medicine at Columbia University Irving Medical Center, director of Columbia Interventional Cardiovascular Care and director of the Cardiac Catheterization Laboratories, said during the panel discussion. “Then, in New Orleans, presenting the PARTNER 3 and Evolut Low Risk trials with Eugene Braunwald, MD, the low-risk data demonstrating at least the equivalent of surgery with over 2,000 patients, using two different platforms in well-conducted clinical trials. Those were my moments where I realized this thing is going to work, work in high-risk patients and actually be a workhorse therapy in low-risk patients, too.”
Michael J. Reardon, MD, FACC, co-investigator for the Evolut Low Risk Trial, the Allison Family Distinguished Chair of Cardiovascular Research and professor of cardiovascular surgery at Houston Methodist Hospital, said he did not embrace TAVR initially.
The successes in high-risk patients changed his mind.
“I began to embrace it when we did our first extreme-risk cases,” Reardon recalled. “They were all intubated, they all went to an ICU. I have learned that if you want to find out how a surgeon’s case is going, you do not ask the surgeon. You go to the ICU and you ask the nurses. After the third case, I found out the nurses were begging to have the TAVR patients placed in their beds. Not because it was an exciting new technology, but because they did so well they required no care. The nurses were the ones that convinced me these patients are doing great, and if it works in these people, the sickest patients, it is going to work in other people.”
Today, the Society of Thoracic Surgeons/ACC Transcatheter Valve Therapy (TVT) Registry continues to monitor patient safety and real-world outcomes related to TAVR.
Roxana Mehran, MD, FACC, professor of medicine and director of interventional cardiology research at the Zena and Michael A. Wiener Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai, called the collection of TAVR randomized controlled trials an “incredible model” for how trialists should be gathering evidence.
“Every single clinical trial in TAVR has been prospective, well controlled, randomized, powered for the endpoint in the patients that needed it most, against the best possible therapy available to them,” Mehran said during the discussion. “The number of articles [on TAVR] published in The New England Journal of Medicine speaks for the fantastic work that has been done by the investigators. To me, this technology now comes complemented by the TVT Registry for all.
“We now have data in randomized controlled trials, in real-world patient populations, for extended periods of time, not just 1 year but going out to 5 years, from SURTAVI. A tremendous body of evidence is being built here,” Mehran said. “I cannot imagine any other technology where researchers have put more effort into this kind of work with large clinical trials. That is why TAVR now is TAVR-first. Patients want it because the evidence is so strong.”
Future of TAVR
Guidelines no longer use risk as a standalone reason to choose TAVR over surgery, Reardon said. Ongoing studies will focus on long-term outcomes data related to durability and valve deterioration in the younger, low-risk patient population. Trialists are also assessing TAVR intervention in asymptomatic patients; results from the EARLY TAVR trial are expected in early 2024.
Cribier said two decades of TAVR procedures have demonstrated the importance of putting the patient at the center of every decision.
“The patient is the heart of the problem,” Cribier said. “Now, for TAVR, we must work on how to create a valve that will have a very long durability. This is the goal. TAVR has brought some new concepts for how to practice medicine, and I am glad for that.”
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Mack MJ, et al. Disruptive Innovation: TAVR 20 Years Later. Presented at: American College of Cardiology Scientific Session; April 2-4, 2022; Washington, D.C. (hybrid meeting).
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