FRANCE 2: Prior CABG Does Not Influence Mortality After TAVR

Having undergone CABG does not appear to worsen outcomes in patients receiving TAVR, according to a registry study published online May 8, 2015, ahead of print in the American Journal of Cardiology.

Martine Gilard, MD, PhD, of Centre Hospitalier Universitaire de la Cavale Blanch (Brest, France), and colleagues looked at data from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry. The study included 3,761 patients selected for TAVR at 33 centers in France and 1 center in Monaco in 2010 or 2011; 18% of patients had a history of CABG.

First- or second-generation Sapien valves (Edwards Lifesciences) were used in about two-thirds of patients, and the CoreValve device (Medtronic) was used in the rest. Operators used a transfemoral-first approach; ultimately, access was transfemoral in 73.0%, transapical in 17.9%, transsubclavian in 5.6%, and other in 3.0%.

There were numerous baseline differences between patients with or without prior CABG. Those with such a history were younger and more often male; had a higher mean logistic EuroSCORE; and had higher rates of CAD, diabetes, prior MI, abdominal aortic aneurysm, and peripheral vascular disease. They also were less likely to have chronic obstructive pulmonary disease or pulmonary hypertension or to have NYHA class III or IV symptoms. Aortic valve area was larger and LVEF and aortic valve gradient were lower in the patients who had undergone bypass surgery.

In terms of procedural characteristics, prior CABG patients were more likely to receive general anesthesia during TAVR and to have the transapical approach used.

All-cause mortality (primary endpoint) occurred at similar rates in the patients with vs without a history of CABG for up to 1 year following TAVR (table 1).

There were also no differences in cardiovascular mortality; the percentage of patients in NYHA class III or IV; or most VARC-defined procedural complications, including MI, stroke, or vascular and bleeding complications. Prior CABG patients, however, were less likely to have moderate-to-severe aortic regurgitation after TAVR (11.8% vs 15.1%; P = .04).

On multivariate analysis, several factors were associated with a higher or lower risk of 1-year mortality (table 2). History of CABG was not one of them (HR 1.06; 95% CI 0.64-1.76).

At 1 year, the vast majority of surviving patients (89.5%) were in NYHA class I or II.

Trends Toward Better Survival After CABG

According to the authors, the current dataset is the largest to explore the impact of prior CABG on TAVR outcomes. Previous studies, including subanalyses of RCTs, have demonstrated trends toward a lower mortality risk in patients who have undergone CABG. And in 1 study from 2012, a history of bypass surgery was an independent predictor of better 2-year survival.

“These findings… suggest that [TAVR] has the potential to be an attractive option in high-risk patients with severe aortic stenosis and previous CABG,” the authors write.

However, they acknowledge some limitations of the study, noting that the observational design precludes definitive conclusions. In addition, it was unknown whether patients with prior CABG had patent arteries, and there was no information on the interval between CABG and TAVR.

Source:
Castellant P, Didier R, Bezon E, et al. Comparison of outcome of transcatheter aortic valve implantation with- versus-without previous coronary artery bypass grafting (from the FRANCE 2 registry). Am J Cardiol. 2015;Epub ahead of print.

Disclosures:

• Dr. Gilard reports no relevant conflicts of interest.

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