Patients with severe mitral regurgitation (MR) and cardiogenic shock (CS) who underwent mitral transcatheter edge-to-edge repair (TEER) achieved successful MR reduction, new study findings suggest. The analysis concluded that successful repair was associated with lower mortality and heart failure (HF) hospitalizations at 1-year post-procedure compared with unsuccessful repair. “This analysis examined the characteristics and outcomes of TEER in patients with cardiogenic shock,” said Mohamad A. Alkhouli, MD, study author and 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 1-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.” TCT 2022 presentation The findings from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve (STS/ACC TVT) Registry were reported Saturday at Transcatheter Cardiovascular Therapeutics (TCT) 2022 in Boston. The study, which was also simultaneously published online in the Journal of the American College of Cardiology, discusses TEER’s emergence as an effective treatment for high-risk patients with severe symptomatic MR. TEER’s clinical benefit has been documented with MR etiologies across a range of high-risk populations including patients with chronic renal insufficiency, severe ventricular dysfunction, pulmonary hypertension, tricuspid regurgitation and obstructive lung disease. One high-risk group of patients that may benefit from TEER are those with CS in addition to severe MR. CS has persistently high mortality and few interventions have improved its prognosis. In addition, moderate to severe MR is present in up to 1 in 5 patients admitted with CS and increases mortality risk by 60%. Study methodology Researchers used data from the STS/ACC TVT Registry from Nov. 22, 2013, to Dec. 31, 2021. A total of 3,797 patients were included with a mean age of 73.0±11.9 and 59.5% were male. These patients underwent TEER in the United States and met at least one of the pre-specified inclusion criteria for CS due to the presence of inotrope use or mechanical circulatory support prior to TEER. The primary endpoint was the impact of device success on clinical outcomes – specifically, mortality and HF admissions at 1 year. Device success was defined as MR reduction of ≥1 grade and a final MR ≤ moderate (2+). Secondary analysis included durability of MR reduction in follow-up, assessment of observed vs. expected STS score in predicting mortality after mitral valve repair. Main findings The patients’ mean STS score (MV repair) was 14.9±15.3, 53.4% had degenerative MR and 27.5% had functional MR. Device success was achieved in 3,249 (85.6%) patients, with 91.4% achieving an MR reduction >1 absolute grade score and 88.2% registering a final MR grade <2+ score. At 1-year post-procedure, device success was associated with significantly lower all-cause mortality (34.6% vs. 55.5%, adjusted hazard ratio (HR) 0.49, 95% confidence interval [CI] 0.41-0.59, p<0.001). Device success was also associated with 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). “Our study leveraged the TVT registry which includes virtually all TEER cases performed in the US, providing evidence of efficacy across a broad range of centers,” stated the study. “The study’s findings corroborate earlier reports by documenting a device success rate of 85.6% in this large nationwide cohort of patients with CS and severe MR. “These rates are comparable with device success rates of TEER overall suggesting that the presence of CS does not necessarily impede the ability to achieve technical success with the TEER procedure.” Commenting on the consistency of device success and its association with improved outcomes, the researchers admitted it was possible the study’s improved outcomes may be, “partially related to milder degrees of CS, different types of CS presentation, or to a specific MR etiology.” “Our extensive sensitivity analyses showed consistent associations of device success with better 1-year survival regardless of MR mechanism, acute coronary syndrome, defining criterion of CS, or the degree of left ventricular dysfunction,” said the study team. “Nonetheless, given the non-remediable effect of various confounders in this observational study, a randomized clinical trial is warranted.” Image Credit: Jason Wermers/CRTonline.org