The registry, a joint project of the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC), reflects the inherently multidisciplinary nature of advanced structural heart services.
Programs are required by the CMS National Coverage Determination to input information on all patients who are not in clinical trials and receive new transcatheter structural heart technologies—including TAVR and transcatheter mitral valve repair—for approved indications. Therefore, the registry provides a comprehensive lens into the national landscape for structural heart.
Here are four important findings from the latest report, which covers 2012 to 2015:
1. TAVR mortality rates are improving, but pacemakers remain a challenge
TAVR outcomes are generally improving over time. For example, the in-hospital morality rate for patients who underwent TAVR declined from 3.9% in 2012 to 2.9% in 2015, while the 30-day morality rate declined from 5.7% to 4.6% over that time period. Other outcomes, such as acute kidney injury, post-operative atrial fibrillation, and major bleeding also improved.
At the same time, the need for post-TAVR pacemaker implantation continues to be an issue, with 12% of TAVR patients receiving a pacemaker in 2015. Pacemaker rates actually began to increase in 2014, over the 2013 rate of 8.8%. As a result, mitigating conduction disorder complications post-TAVR has been a key area of focus for many programs.
Finally, 30-day valve-related readmission was relatively stable from 2012 to 2015, at 0.9%.
2. The risk level of TAVR patients is shifting downward
Interestingly, the operative risk level for TAVR patients decreased over the four-year period. The median STS PROM (Society of Thoracic Surgeons Predicted Risk of Mortality) score—which estimates expected risk of 30-day operative mortality of patients undergoing TAVR—decreased from 7% in 2012 to 6% in 2015.
This shift indicates that as TAVR techniques and outcomes have advanced, the procedure has begun moving into the intermediate-risk population. Note that select TAVR devices were FDA-approved in intermediate-risk patients in summer 2016. It's therefore likely that patients with lower STS PROM who received TAVR commercially prior to 2016 had other documented risk factors contributing toward eligibility.
3. Moderate sedation is becoming a more common anesthesia choice
In recent years, there's been a debate over the appropriate anesthesia modality for TAVR—general anesthesia (GA) or moderate sedation (MS)—with some progressive programs shifting to MS to reduce complications and streamline care.
The registry report indicates that while GA is still the predominant choice, MS is gaining in popularity, with use increasing from 2.2% of TAVR cases in 2012 to 16.6% in 2015.
4. The registry is also reporting on transcatheter mitral repair
The report also features updates on several mitral valve therapies, including transcatheter mitral valve repair (for which MitraClip is the only currently approved device). Since this therapy has been commercially available for a shorter time period, there are lower volumes for analysis. However, between 2014 and 2015, patient characteristics and outcomes among the 3,697 included cases remained relatively stable.
Additionally, the report noted that early outcomes in transcatheter mitral valve-in-valve (TMViV) and transcatheter mitral valve-in-ring (TMViR) are encouraging, particularly compared with the high risk level of many patients, suggesting that they "appear to be an attractive treatment option for this group of patients."
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