ACC's NCDR suite of registries is a robust source of data for researchers, and a critical component in continuing to help hospitals, practices and clinicians advance the quality of cardiovascular care and improve patient outcomes for all.

The real-world evidence from recent NCDR research using data from the STS/ACC TVT Registry provides new understanding about the role of patient and procedural factors in improving outcomes after TAVR; the safety and effectiveness of TAVR in patients who have suffered cardiogenic shock (CS); and the low use of guideline-directed medical therapy (GDMT) in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER).

Patient, Procedural Factors Impacting TAVR Outcomes Over Time

Among patients undergoing TAVR, advances in device technology and procedural factors contributed to the majority of observed improvement in short-term outcomes, while changing patient characteristics had an increased impact on improved outcomes at one year, according to a study published in Circulation: Cardiovascular Interventions.

Using data captured by the STS/ACC TVT Registry, Suzanne V. Arnold, MD, et al., looked at 161,196 patients undergoing TAVR at 596 sites over a six-year period to determine the impact of demographics, noncardiovascular comorbidities, cardiovascular comorbidities, device-related factors and nondevice-related procedural factors on improved TAVR outcomes over time.

Results showed that outcomes improved steadily from 2012 to 2018, including 30-day mortality (6.7% to 2.4%), 30-day composite adverse events (25.3% to 10.5%) and one-year mortality (19.9% to 10.1%; p< 0.001 for all).

Most improvement in 30-day mortality was attributable to device factors and nondevice procedural factors, with similar results for 30-day composite adverse events. However, not all improvement was explainable by factors included in the analysis, indicating improved technical skill likely contributed. When looking at one-year outcomes, patient and procedural factors exhibited similar contributions on improvement over time, pointing to patient characteristics like younger age, healthier status and lower risk having greater impact on longer term outcomes.

"As structural cardiology expands into the treatment of other forms of valvular heart disease, following this paradigm – identifying the complications with the greatest negative impact on survival and health status and adapting devices and procedural care to reduce these – is likely to remain an effective approach for quickly improving both short- and long-term outcomes of these procedures," state Arnold, et al.

TAVR Found Safe and Effective in Patients With Cardiogenic Shock

Patients with CS who survived the first 30 days following TAVR had similar mortality rates as those without CS, and reported improved symptoms and quality of life, demonstrating the safety and efficacy of the procedure in this population, according to a study published in the European Heart Journal.

Kashish Goel, MD, FACC, et al., used data from the STS/ACC TVT Registry to examine outcomes in 309,505 patients undergoing TAVR with balloon-expandable valves (SAPIEN 3 and SAPIEN 3 Ultra bioprosthesis) between June 2015 and September 2022, of whom 5,006 (1.6%) presented with CS before TAVR.

Successful valve implantation was reported in 97.9% of patients, with technical success according to Valve Academic Research Consortium-3 criteria achieved in 94.5% of cases. CS, compared with no CS, was associated with a higher rate of mortality in-hospital (9.9% vs. 2.7%), at 30 days (12.9% vs. 4.9%) and one year (29.7% vs. 22.6%). Notably, the landmark analysis after 30 days revealed the risk of mortality at one year was similar in the CS and non-CS groups (hazard ratio [HR], 1.07; 95% CI, 0.95-1.21). At one-year, patients reported significant improvements in functional class (Class I/II 89%) and quality of life (change in KCCQ] score +50).

Factors independently associated with one-year mortality were: older age (HR, 1.02), peripheral artery disease (HR, 1.25), prior ICD implantation (HR, 1.37), dialysis (HR, 2.07), immunocompromised (HR, 1.33), NYHA Class III/IV symptoms (HR, 1.50), as well as lower aortic valve mean gradient and lower levels of albumin, hemoglobin and KCCQ scores.

"One-year mortality in the present study was 29%, which is lower than the previously reported mortality rate of 35%-50% after TAVR in [cardiogenic shock]," write the authors.

GDMT Use Low in Patients Undergoing M-TEER

Before undergoing M-TEER for functional mitral regurgitation (MR), less than one-fifth of patients were prescribed comprehensive GDMT, according to a study published in European Heart Journal. Furthermore, the study found the risk of death or heart failure (HF) hospitalization at one year was lower among those on triple or double GDMT, compared with single or no therapy, before M-TEER.

Using data from the STS/ACC TVT Registry, Anubodh S. Varshney, MD, et al., identified 4,199 patients from 449 sites with left ventricular ejection fraction <50% undergoing M-TEER for functional MR between July 23, 2019 and March 31, 2022. Researchers determined rates of GDMT use before intervention and then evaluated associations between preprocedure therapy – none, single, double or triple therapy – with risk of mortality or HF hospitalization at one year.

Before M-TEER, beta-blockers, ACE inhibitors/ARBs, mineralocorticoid receptor antagonists and angiotensin receptor-neprilysin inhibitors were prescribed in 85.1%, 44.4%, 28.6% and 19.9% of patients respectively. Triple therapy was prescribed for 19.2% of patients, double therapy for 38.2%, single therapy for 36.0% and no therapy in 6.5%. Significant center-level variation was seen in the proportion of patients on triple therapy (0-61%; adjusted median odds ratio, 1.48; p<0.001).

At one year, among patients with follow-up data (n=2,014 across 341 sites), the composite rate of mortality or HF hospitalization was lowest with triple therapy at 23.1%, vs. 24.8%, 35.7% and 41.1% respectively for double, single and no therapy (p<0.01). The adjusted hazard ratio for triple and double therapy was 0.73 and 0.69, respectively.

"These findings reinforce guideline recommendations to optimize [GDMT] prior to [M-TEER] in a broad and generalizable real-world patient population," write the authors. "Notably, in patients who cannot tolerate triple therapy, double therapy appears to be associated with substantial benefit over more limited regimens."