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Comorbidities predicted mortality in high-risk patients undergoing TAVR
Researchers of a recent study have found that one-half of high-risk patients who underwent transcatheter aortic valve replacement for the treatment of severe symptomatic aortic stenosis died by 3.5 years of follow-up, and more than one-half died of non-cardiac comorbidities.
Researchers from three provinces in Canada evaluated long-term outcomes after TAVR with a balloon-expandable valve (Cribier-Edwards, Sapien or Sapien XT; Edwards Lifesciences). The multicenter study included 339 patients who were nonoperable or considered at very high surgical risk (mean age, 81 ± 8 years; Society of Thoracic Surgeons score, 9.8 ± 6.4%).
In all, 188 patients (55.5%) died at a mean follow-up of 42 ± 15 months. Predictors of late mortality included chronic obstructive pulmonary disease (HR=2.18; 95% CI, 1.53-3.11), chronic kidney disease (HR=1.08 for each decrease of 10 mL/min in estimated glomerular filtration rate; 95% CI, 1.01-1.19), chronic atrial fibrillation (HR=1.44; 95% CI, 1.02-2.03) and frailty (HR=1.52; 95% CI, 1.07-2.17).
Researchers noted a mild, nonclinically significant decrease in valve area at 2 years of follow-up, but no further valve area reduction occurred by 4 years. There were no changes in residual aortic regurgitation and no cases of structural valve failure.
More careful evaluation and follow-up of patients with comorbidities might translate into better mid- to long-term outcomes, researchers wrote.
“Also, cardiac mortality was mostly related to the presence of pulmonary hypertension [PH] and chronic kidney disease at the time of the TAVR procedure,” they said. “The presence of these entities, especially of PH, might reflect an overly advanced CVD condition, and the potential role of staged procedures (balloon aortic valvuloplasty before TAVR) in these patients might merit further evaluation.”
Disclosure: Rodés-Cabau is a consultant for Edwards Lifesciences and St. Jude Medical. The study was supported in part by a grant from Edwards Lifesciences.
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It’s important to note that these are registry data, which need to be interpreted with caution, but it seems like it was a well-conducted, real-world registry. The findings seem fairly consistent with most of the other TAVR trials that have come along in recent years. The new findings were that AF seems to be a risk factor for not doing well in this study and it hasn’t been found to be a big predictor in other studies, and aortic insufficiency didn’t turn out to be a risk factor, which is also different from other studies. But this registry did not have very large numbers, which may explain some of the differences. In addition, the only valves used in this study were balloon-expandable, which may also explain some of the differences.
This study reinforces the notion that patients can have a good hemodynamic response and functional improvement, but still have a high mortality rate over 3.5 years of follow-up. This is important because it shows that these patients aren’t dying from their valve disease, but from comorbidities. So even better valves and techniques aren’t going to reduce the number very much because most of these deaths occurred after 30 days. Another important point is that it lends some insight into who we shouldn’t be treating. This is what the community needs to get a handle on, because you can fix these valves and get a good response and a lot of patients will still die from other causes. The other good thing about this study is that it showed that the valves are durable up to 4 years, which is important. They title it long-term follow-up, but in terms of other surgical valves they use, this really isn’t long-term but rather mid-term results; however, it’s encouraging at least out to four years that the valve function appears to durable.