GARY: Majority of Patients Do Well With TAVR or Surgery at 1 Year

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Regardless of whether patients undergo surgery or an interventional procedure for aortic stenosis, most report their general health to be the same or better at 1 year, according to data from a German registry. The study, published July 30, 2014, in the European Journal of Cardio-Thoracic Surgery, found 1-year mortality to be lower with surgery than transcatheter aortic valve replacement (TAVR), but few other differences in complication rates between the therapies. 

Mortality Lower for Surgery Within Risk Parameters

Patients in the SAVR groups (with and without CABG) had lower 1-year mortality rates compared with those undergoing transapical or transvascular TAVR. However, when the EuroSCORE-predicted risk of mortality exceeded 20% and German AV Score exceeded 6, survival was no longer different between the SAVR and TAVR groups (table 1).

Table 1. Mortality at 1 Year

Patients with severe aortic regurgitation post-TAVR had worse long-term survival compared with those with no or trace insufficiency, while those with mild aortic insufficiency had a tendency toward worse survival.

At 1 year, new pacemaker implantation rates were highest in the transvascular and transapical TAVR groups (26.2% and 14.1%, respectively). PCI was required in 1.9% of transvascular TAVR, 1.5% of transapical TAVR, 1.1% of SAVR + CABG, and 0.5% of conventional SAVR patients. The rate of new stroke was similar across groups: 3.0% for SAVR alone, 4.5% for SAVR + CABG, 4.8% for transvascular TAVR, and 3.6% for transapical TAVR patients, with most occurring during the initial hospitalization. The same was true for reoccurrences of MI, which were less than 1% in all groups at 1 year.

More than 80% of patients in all groups reported that they were in the same or better health at 1 year than they were prior to intervention. In all except the transapical TAVR patients, 50% or more reported ‘very good’ satisfaction with the procedure. More than 70% of patients in all groups were in NYHA class I or II, with the highest proportion (85%) observed in the SAVR groups.

Surgery the ‘Gold Standard’ for Low/Intermediate-Risk Patients

“Considering that all comers were included in the GARY registry, including emergency and active endocarditis patients, the low mortality and stroke rates we observed support the position of conventional [SAVR] being the gold standard for patients with aortic stenosis at low and intermediate risk,” Dr. Mohr and colleagues write.

The investigators observe that the low rates of many procedural complications “reflect the growing experience in transcutaneous aortic valve therapy.” However, they add, TAVR is associated with a “not inconsequential risk of serious complications requiring immediate surgical or interventional therapy,” and attention should be focused on improving survival by having surgeons and perfusionists on standby.

The study authors conclude that the 1-year results “confirm in a large, ‘real-world,’ all-comer patient population that conventional surgery in operable patients yields excellent results in all risk groups. TAVR is being performed in a significant proportion of cases and is a good alternative for high-risk patients.   

“Continuation of the registry and long-term follow-up will help to develop robust future risk models to predict patient outcomes for each treatment option in patients with aortic stenosis.” they add.  

Source:
 Mohr FW, Holzhey D, Möllmann H, et al. The German Aortic Valve Registry: 1-year results from 13,680 patients with aortic valve disease. Eur J Cardiothorac Surg. 2014;Epub ahead of print. 

Disclosures:

• Dr. Mohr reports no relevant conflicts of interest. 

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