The Corval Valve Trials - A Brief History

CardioNerds, Daniel Ambinder and CardioNerds Academy Program Director, Dr. Tommy Das (Cardiology fellow, Cleveland Clinic), Dr. Jacqueline Latina (Structural heart fellow, Johns Hopkins) discuss aortic stenosis and the story of TAVR from both the historical perspective and in terms of future directions with Dr. Jon Resar, Professor of Medicine and Director of the Adult Catheterization Laboratory and Interventional Cardiology at the Johns Hopkins Hospital. This episode is brought to you for Heart Valve Disease Awareness Day. Audio editing by CardioNerds Academy Intern, Shivani Reddy. As many as 11 million Americans have heart valve disease (HVD)—a potentially disabling and deadly disease—yet 3 out of 4 Americans know little to nothing about heart valve disease. Learn more about valve disease. Pearls • Notes • References • Guest Profiles • Production Team CardioNerds Aortic Stenosis SeriesCardioNerds Episode PageCardioNerds AcademyCardionerds Healy Honor Roll CardioNerds Journal ClubSubscribe to The Heartbeat Newsletter!Check out CardioNerds SWAG!Become a CardioNerds Patron! Pearls and Quotes - Aortic Stenosis and the Story of TAVR In the previous century, patients with severe aortic stenosis who were treated “medically” had 50% mortality over 2 years after developing symptoms. Balloon aortic valvuloplasty was initially touted as extremely “efficacious” for aortic stenosis but follow-up studies showed that the improvement in symptoms were not durable, and long-term prognosis was dismal. The PARTNER Trial started enrolling in 2007 in extreme risk patients – patients who were not surgical candidates. In 2010, the PARTNER trial was published and TAVR blew away the “standard of care” in inoperable patients at the time, cutting outcomes in half (composite of death and repeat hospitalization). The PARTNER trial studied balloon expandable intra-annular valve implantation. The CoreValve trial studied self-expanding supra-annular valve implantation and was published in 2014. The “Heart Team” approach entails collaborative decision making between cardiologists and cardiac surgeons to personalize management for patients. Both intra-annular and supra-annular valves show non-inferior outcomes to surgery in intermediate and low risk patients. Revascularization prior to TAVR is an evolving arena; the trend has been interventionalists performing fewer PCIs prior to TAVR given the benefit is not clear if angina is not a prominent symptom. Show notes - Aortic Stenosis and the Story of TAVR (TAVR/TAVI are using interchangeably) CardioNerds Aortic Stenosis, updated 1.20.21 1. In the 1990s, patients with severe aortic stenosis (AS) who were deemed to be at high surgical risk would weigh the risks of surgery and prolonged recovery. Balloon Aortic Valvuloplasty (BAV) was first performed by Dr. Alain Cribier in 1986. The technique was based on the foundation of pulmonary valvuloplasty performed initially in 1982 by Drs. Jean Kan and Bob White, and mitral valvuloplasty in 1984. BAV was initially touted as an efficacious cure for aortic stenosis, but unfortunately it had a high restenosis rate as well as high risks for stroke and vascular complications (no closure devices at that time) with an overall poor long-term prognosis. Balloon aortic valvuloplasty was primarily used for decompensated Class IV heart failure in non-surgical candidates. 2. Transcatheter aortic valve replacement (TAVR/TAVI) was developed and first performed in human in 2002.(1) This was performed by Dr. Alain Cribier in France in 2002, initially by trans-septal approach and then by retroaortic approach. Here is a representative diagram of the procedure. Figure: Transcatheter Aortic-Valve Replacement. The transcatheter valve is positioned at the level of the native aortic valve during the final step of valve replacement, when the balloon is inflated within the native valve during a brief period of rapid ven...