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NEW ORLEANS -- In a real world registry trial comparing transcatheter aortic valve replacement (TAVR) to surgical aortic valve replacement (SAVR) in intermediate risk patients, the mortality at one year was nearly twice as high in the TAVR group, but those patients were also older and more frail than the surgery patients.
One-year mortality was 16.9% with TAVR versus 8.9 for SAVR (P<0.001), said Nicolas Werner, MD, of Medical Clinic B in Ludwigshafen, Germany. Werner reported results from the German Aortic Valve Registry at an American Heart Association late-breaking clinical trials presentation.
Mortality rates in-hospital and at 30 days also favored SAVR over TAVR, 3.8% versus 2.6% (P=0.02) and 4.6% versus 3.2% (P=0.01), respectively.
The all-comers registry enrolled 49,660 patients from January 2011 through December 2013. Werner reported on 5,997 patients with isolated TAVR or SAVR for the analysis. A majority of patients, 4,101, received TAVR.
The most common reason for selecting TAVR was age -- the average age for TAVR patients was 82 versus 76 in the SAVR group -- followed by frailty, Werner said. TAVR patients were also more likely to be female.
Roughly 75% of the TAVR procedures were transfemoral.
, a cardiothoracic surgeon from Columbia University, said the mortality results surprised him. Smith, who was a principal investigator of the PARTNER II trial, said the higher mortality probably reflects the difference between a clinical trial and real world experience.
"The 'intermediate' risk patients in the TAVR arm were really at the very high end of the intermediate risk and probably would not be included in an RCT," he commented.
But even with the increased mortality, the results were still very encouraging for TAVR, said of Christiana Care, who moderated a press conference where the results were reported. "Before TAVR, these patients would not have had an option for valve replacement. They would not have gotten surgery," Gardner told 51˶.
TAVR patients were more likely to require a pacemaker (19.1% versus 5.3%), to have vascular complications (7.7% versus o.4%), and had a higher risk for aortic regurgitation of grade II or greater (4.7% versus o.4%) and all of those differences were statistically significant (P<0.001).
On the flip side, major bleeding (51.5% versus 25%), reintervention for bleeding (4.5% versus 1.3%) and pericardial tamponade (1.1% versus 0.3%) were more common with surgery and those differences were also highly significant (P<0.001), Werner said.
Disclosures
Werner declared no conflict of interest.
Primary Source
American Heart Association Scientific Sessions
Werner, N et al "Patients at intermediate surgical risk undergoing isolated interventional or surgical aortic valve replacement for severe symptomatic aortic valve stenosis. One year results from the German Aortic Valve Registry (GARY)" AHA 2016; Abstract LBCT 2.