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TVT registry: TAVR mortality risk, observed mortality show a decrease
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In patients who underwent transcatheter aortic valve replacement, both the projected risk for mortality and observed in-hospital mortality have decreased since 2012, according to the annual report of the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry.
The societies issue annual reports on procedures tracked through the Transcatheter Valve Therapy (TVT) registry, including TAVR, transcatheter mitral leaflet clip and transcatheter valve-in-valve therapy/transcatheter valve-in-ring therapy, with a registry module designated for each procedure. Each module records demographic information, comorbidities, aortic- and mitral-specific baseline criteria, procedural details, outcomes (mortality and morbidity in-hospital, at 30 days and at 1 year) and quality of life.
Data for all patients undergoing procedures with commercially approved devices were recorded from 2012 to 2015.
The researchers found that, among the 54,782 documented patients who underwent TAVR, a decrease was seen in the expected risk for 30-day operative mortality (STS predicted risk of mortality [PROM]), from 7% to 6%, and a decrease in TAVR PROM was also seen, from 4% to 3% (both P < .001).
In terms of observed outcomes, there was a decrease in TAVR in-hospital deaths, from 5.7% in 2012 to 2.9% in 2015 (P < .0001), and the rate of 30-day mortality was reduced from 7.5% in 2012 to 4.6% in 2015 (P < .0001), equaling an overall 4-year average of 5.7%.
There was an overall 22.6% 1-year mortality rate, and this rate decreased from 25.8% in 2012 to 21.6% in 2014 (P < .0001). The overall rate of in-hospital stroke was 2.1%, and a slight decrease was observed during the 4-year period, from 2.2% to 2% (P < .05). The overall 30-day rate of stroke was 2.1%, decreasing from 2.3% to 1.9% in 2015 (P = .03).
A decrease was also seen in postoperative atrial fibrillation during the study period, from 6.9% in 2012-2013 to 3.7% in 2015. However, new pacemaker insertion at 30 days showed an increase, from 8.8% in 2013 to 12% in 2015 (P < .0001). The overall rate of new pacemaker insertion was 11.8%.
The rate of acute kidney injury requiring dialysis was 1.4% overall, and showed a reduction from 1.7% in 2012 to 0.9% in 2015 (P < .0001). No major bleeding was seen in 91.6% of patients overall, and this outcome showed an improvement from 87.1% in 2012 to 93.1% in 2015 (P < .001).
Overall, of the 90% of patients for whom echocardiographic data were available, 64.1% had no or trace aortic regurgitation at discharge or 30 days, 29% had mild aortic regurgitation and 6.9% had moderate/severe aortic regurgitation.
A decrease was seen in in-hospital length of stay, from 6 days in 2012 to 4 days in 2015 (P < .0001).
Of the 2,556 patients who underwent a mitral leaflet clip procedure in 2015, the outcomes were similar to those seen in 2013-2014 patients, with hospital mortality of 2% and mitral regurgitation decreased to gradient ≤ 2% in 87% of patients (P < .0001). Of the 349 patients who underwent valve-in-valve and valve-in-ring procedures, the observed hospital mortality was 7.2% and the 30-day mortality rate was 8.5%.
“The rapid launch and progress of the TVT Registry has yielded important trends forpatient outcomes and clinical care of TAVR patients,” the researchers wrote. “Importantly, actual TAVR in-hospital, 30-day and 1-year mortality significantly decreased over time. One-year mortality continues to be high, and further investigation into the predictors of patients who are unlikely to benefit from the procedure both in terms of survival and quality of life needs to occur.” – by Jennifer Byrne
Disclosure: The researchers report no relevant financial disclosures.
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