TVT Registry Analysis Assesses Use of TEER in Severe MR and Cardiogenic Shock

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. Additionally, successful repair was associated with lower mortality and heart failure (HF) hospitalizations at 1-year postprocedure compared with unsuccessful repair.

The findings were reported at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts. The study was published by Trevor Simard, MD, et al in the Journal of the American College of Cardiology.

According to the TCT, patients with CS in addition to severe MR is a high-risk group that might benefit from TEER but has been understudied. 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%.

As summarized in the TCT press release, the investigators utilized TVT Registry data 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 prespecified inclusion criteria for CS caused by the presence of cardiogenic shock, inotrope use, or mechanical circulatory support before TEER. Among this group, 3,249 (85.6%) patients achieved device success defined as MR reduction of ≥ 1 grade and final MR ≤ moderate (2+).

The primary endpoint was the impact of device success on clinical outcomes—specifically, mortality and HF admissions at 1 year.

At 1 year postprocedure, device success was associated with significantly lower all-cause mortality (34.6% vs 55.5%; adjusted hazard ratio [HR], 0.49; 95% CI, 0.41-0.59; P < .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 < .001).

"This analysis examined the characteristics and outcomes of TEER in patients with CS," commented Mohamad A. Alkhouli, MD, in the TCT press release. "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 1-year survival rate as well as fewer HF hospitalizations."

Dr. Alkhouli, who is Chair of Research and Innovation, Division of Interventional Cardiology, Mayo Clinic and Professor of Medicine, Mayo Clinic College of Medicine in Rochester, Minnesota, further stated, "Randomized trials on the role of TEER in patients with CS are needed to establish this as a potential therapeutic option."

The research was supported by the ACC Foundation’s National Cardiovascular Data Registry and the STS National Database, noted the TCT press release.