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TVT Registry: Positive outcomes of TAVR increasing over time
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Over time, transcatheter aortic valve replacement has become more streamlined and the rate of positive outcomes after replacement has increased, according to an update from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.
The report characterized demographics, in-hospital procedural characteristics and outcomes of 26,414 patients who underwent TAVR with the Sapien (Edwards Lifesciences), Sapien XT (Edwards Lifesciences) or CoreValve (Medtronic) systems at 348 U.S. centers between 2012 and 2014.
Patient characteristics
In the overall cohort, mean patient age was 82 years (91% aged at least 70 years; 68% aged at least 80 years), 50.5% of patients were men and fewer than 5% of patients were black. Age differences over time were not clinically significant.
Patients tended to have multiple comorbidities, including prior revascularization, prior stroke, diabetes and peripheral artery disease; frequently had chronic lung disease and prior MI; had a high rate of NYHA Class III or IV HF (82.5%); were frail (81.6% with slow 5 m walk test score); and had poor self-reported health status (median Kansas City Cardiomyopathy Questionnaire score at baseline, 39.1), according to the report.
Mean STS predicted risk of mortality for surgical AVR was 8.34%, while median STS PROM score declined between 2012 and 2014 (P for trend < .0001).
David R. Holmes Jr.
“This is probably related in part to the expansion of TAVR to high-risk patients, from its initial restriction to inoperable or prohibitive-risk patients,” David R. Holmes Jr., MD, from Mayo Clinic, and colleagues wrote in the Journal of the American College of Cardiology and the Annals of Thoracic Surgery.
The primary indication for TAVR was severe native aortic stenosis in more than 90% of patients, while 2.2% underwent a valve-in-valve procedure for a degenerated biologic prosthesis; this indication was off-label during the study period.
Compared with 2012-2013, procedures in 2014 were more likely to be elective (91.5% vs. 89.5%; P < .0001), less likely to be aborted (1.3% vs. 2.9%; P < .0001) and less likely to require performance of cardiopulmonary bypass (2.9% vs. 4.1%; P < .0001), though rates of conversion to open-heart surgery were similar (2014, 1.3%; 2012-2013, 1.4%; P = .4507), Holmes and colleagues wrote.
Over time, there has been an increased use of moderate sedation, rising to 5.1% in 2014 (P for trend < .0001), and of transfemoral access, rising to 66.8% in 2014 (P for trend < .0001), the authors wrote.
Success rates high
Implant success rate was 97.3% and device success rate was 92.7% during the study period, while the rate of procedure-related cardiac complications was 1.9%.
Compared with 2012-2013, in 2014 there were fewer cases of MI (0.4% vs. 0.6%; P = .0316), cardiac arrest (4.3% vs. 5.5%; P < .0001) and atrial fibrillation (5.7% vs. 6.9%; P = .0001) prior to discharge, though more cases of needing a new pacemaker or implantable cardioverter defibrillator (11% vs. 6.8%; P < .0001), according to the authors.
Rates of vascular complications, most commonly bleeding, dropped to 4.2% from 5.6%, and rates of site-reported stroke were unchanged over time (2014, 2.2%; 2012-2013, 2.1%), they wrote.
Unadjusted in-hospital mortality was 4.4% in 2014 compared with 5.3% in 2012-2013.
Michael J. Reardon
“The most important takeaway is the fact that the TAVR procedure continues to change since its initial approval by the FDA in 2011,” Holmes, a member of the Cardiology Today Editorial Board, said in a press release. “Patients undergoing TAVR remain primarily elderly and high-risk for surgical replacement, but the predicted risk of mortality has declined over the course of time. This is the result of changes in regulatory instructions for use and approval of alternative access points.”
Patient selection reasonable
In a related editorial, Michael J. Reardon, MD, and Neal S. Kleiman, MD, noted that “these observations suggest that patient selection for TAVR in the United States has remained reasonable, with excellent efficacy and continued safety.”
Reardon and Kleiman, both from Houston Methodist DeBakey Heart and Vascular Center, added that “important questions remain to be resolved, particularly in regard to antithrombotic therapies, in patients who have undergone TAVR. Use of the registry is likely to become a useful mechanism to resolve these questions in broad national population.” – by Erik Swain
Disclosures: Holmes reports no relevant financial disclosures. See the full article for a list of the other authors’ relevant financial disclosures. Reardon reports serving on an advisory board for Medtronic. Kleiman reports providing educational services for Medtronic.
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