Results from TVT Registry Analysis Presented at TCT and Published Simultaneously in the Journal of the American College of Cardiology

BOSTON – September 17, 2022 – An analysis from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) TVT Registry found that most patients with severe mitral regurgitation (MR) and cardiogenic shock (CS) who underwent mitral transcatheter edge-to-edge repair (TEER) in the United States achieved successful MR reduction, and that successful repair was associated with lower mortality and heart failure (HF) hospitalizations at one year post-procedure compared with unsuccessful repair.

Findings were reported today at TCT 2022, the 34th annual scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

TEER is an increasingly adopted treatment option for high-risk patients with severe symptomatic MR in the United States. One high-risk group that might benefit from TEER but has been understudied are those patients with CS in addition to severe MR. CS has a persistently high mortality and few interventions have improved its prognosis. In addition, moderate to severe MR is present in up to one in five patients admitted with CS and increases mortality risk by 60%.

Researchers utilized data from the STS/ACC TVT Registry from November 22, 2013 to December 31, 2021. A total of 3,797 patients undergoing TEER in the United States met at least one of the pre-specified inclusion criteria for CS due to the presence of cardiogenic shock, inotrope-use, or mechanical circulatory support prior to TEER. Among this group, 3,249 (85.6%) patients achieved device success defined as MR reduction of ≥1 grade and a final MR ≤ moderate (2+).

The primary endpoint was the impact of device success on clinical outcomes – specifically, mortality and HF admissions at one year. At one-year post procedure, device success was associated with significantly lower all-cause mortality (34.6% vs. 55.5%, adjusted-HR 0.49, 95%CI 0.41-0.59, p<0.001), and a composite of mortality and HF admissions (29.6% vs. 45.2%, adjusted HR 0.51, 95%CI 0.42-0.62, p<0.001).

“This analysis examined the characteristics and outcomes of TEER in patients with cardiogenic shock,” said Mohamad A. Alkhouli, MD, Chair of Research and Innovation, Division of Interventional Cardiology, Mayo Clinic and Professor of Medicine, Mayo Clinic College of Medicine. “Our findings not only show that TEER in patients with CS can achieve successful MR reduction the majority of the time, but also that device success in this high-risk population is associated with a better one-year survival rate as well as fewer heart failure hospitalizations. Randomized trials on the role of TEER in patients with cardiogenic shock are needed to establish this as a potential therapeutic option.”

This research was supported by the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR) and The Society of Thoracic Surgeons National Database.

Dr. Alkhouli reported the following disclosures: grant/research support from Boston Scientific and Philips in addition to consultation fees from Abbott, Biosense Webster, Boston Scientific, and Philips.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is one of the world’s leading nonprofit organizations specializing in interventional cardiology innovation, research, and education. CRF is dedicated to helping doctors improve survival and quality of life for people suffering from heart and vascular disease. For over 30 years, CRF has helped accelerate medical breakthroughs and educated doctors on the latest treatments for heart disease. CRF’s centers of excellence include the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the premier educational meeting specializing in interventional cardiovascular medicine. Now in its 34th year, TCT features major medical research breakthroughs and gathers leading researchers and clinicians from around the world to present and discuss the latest evidence-based research in the field.

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