Experts trace history of TAVR, heart team approach

SAN FRANCISCO — A presentation at TCT 2013 chronicled the evolution of transcatheter aortic valve replacement and the importance of a multidisciplinary heart team.

Alain Cribier, MD, of the University of Rouen in France, discussed the 25-year evolution of TAVR from the first balloon aortic valvuloplasty to the 2011 FDA approval in nonsurgical patients in the wake of the PARTNER B trial.

“The technique was extremely difficult to imagine at first,” he said. “People said, first of all, it’s dangerous; second of all, it’s impossible.”

Cribier summarized some of the fears voiced early on.

“We learned many lessons from those first experiences with TAVR,” Cribier said. This allowed the community to move into the transseptal era, which occurred between 2002 and 2005 on the heels of the I-REVIVE and RECAST studies.

“This approach was associated with an 85% success rate,” Cribier said. “It was unbelievable that five patients survived 5 years without any device dysfunction.”

In 2004, the next phase came with the 23-mm and 26-mm Edwards Sapien devices.

“This was the start of a new era of remarkable partnership between surgeons, cardiologists and other specialists,” Cribier said, noting that there are now more than 80,000 devices implanted worldwide. “TAVR should assume a dominant role in the management of degenerative aortic stenosis in the future.”

Heart teams and multidisciplinary registries

E. Murat Tuzcu, MD, of the Cleveland Clinic, said evolving patient needs helped bring about the development of multidisciplinary heart teams.

“Many of the patients we saw were neither purely surgical nor purely medical,” he said. “Patient expectations were different.”

Tuzcu highlighted difficulties in decision-making and changing funding mechanisms as other reasons for the development of heart teams.

“With limited resources, teamwork can be more efficient,” he said. “By the late 2000s, people were thinking more about teams in general, and a heart team was No. 1 on everybody’s agenda.”

Regulatory agencies soon took notice, according to Tuzcu. The 2012 European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) guidelines for the management of valvular heart disease noted an absolute contraindication for the absence of a heart team. The FDA mentioned a heart team in the indications for the Edwards Sapien device, and the CMS covers TAVR with the condition that the patient is under the care of a heart team.

“The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care,” Tuzcu read from the CMS guideline.

The current focus is on clinical research, TVT registries and post-marketing studies to improve quality assurance, according to Tuzcu.

“The vision is to create a research engine for quality improvement,” he said. “I’m proud to tell you that the great majority of TAVR cases in the United States are captured.”

For more information:

Cribier AG. The odyssey of TAVR: From concept to clinical reality.

Tuzcu EM. Emerging paradigms: Multidisciplinary heart teams and society-based registries. Both presented at: TCT 2013; Oct. 27-Nov. 1, 2013; San Francisco.

Disclosure: Cribier reports receiving consulting fees/honoraria from Edwards Lifesciences. Tuzcu reports no relevant financial disclosures.