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TAVR linked to improved QOL, higher mortality in patients with HF
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Data from a real-world registry showed high procedural success rates and early improvement in functional status after transcatheter aortic valve replacement among patients with severe reduced left ventricular ejection function, but an increased rate of postprocedural mortality.
Researchers analyzed data from the prospective, multicenter German Transcatheter Aortic Valve Interventions (German-TAVI) registry for outcomes in patients with severe depressed LVEF. Their analysis included outcomes on 1,432 patients who underwent TAVR (LVEF ≤30%, n=169; LVEF >30%, n=1,263). Most patients received Corevalve (Medtronic; 84.6% LVEF ≤30%, 81% LVEF >30%) or Sapien (Edwards Lifesciences; 15.4% LVEF ≤30%, 18.9% LVEF >30%) valves. Transfemoral TAVR was the most common approach.
Researchers examined procedural success, NYHA class and quality of life at 30 days and 1 year.
The technical success rate was 95.9% in patients with LVEF ≤30% vs. 97.6% in patients with LVEF >30% (P=.17). The rate of procedure abortion was 3.6% vs. 1.1%, respectively (P=.05). Both groups also had a low rate of conversion to open-heart surgery (0.6% vs. 1.3%, respectively; P=.45). Documented severe procedural complications were low and similar between both groups.
At 30 days, estimated cumulative mortality was 14.2% in patients with LVEF ≤30% vs. 7.3% in patients with LVEF >30 (P<.0001). Rates of stroke, systemic embolism, MI and severe bleeding were similar between the groups, but patients with LVEF ≤30% had higher rates of the combined endpoints of major adverse cardiac events including death and MI (16.6% vs. 8.4%; P<.001) and major adverse cardiac and cerebrovascular events including death, MI and stroke (16.6% vs. 8.1%; P<.001) at 30 days postprocedure. The researchers also reported significant improvement in functional status according to NYHA HF classification and Canadian Cardiovascular Society classification and QOL as assessed by EuroQol-5D.
At 1 year, estimated cumulative mortality was 33.7% in patients with LVEF ≤30% vs. 18.1% in patients with LVEF >30% (P<.001). Again, rates of stroke, systemic embolism, MI and severe bleeding were similar between the groups, and the combined endpoints of MACE (36.1% vs. 21.3%; P<.001) and MACCE (36.7% vs. 22.4%; P<.01) were higher in patients with LVEF ≤30%. Functional status was similarly improved in all patients. However, QOL, as assessed by EURO-Qol 5d, was larger at 1 year in patients with LVEF ≤30% (gain, 0.22 vs. 0.05).
According to the researchers, patients with LVEF ≤30% more frequently had low cardiac output syndrome (12.3% vs. 5.9%; P<.01) and resuscitation (10.4% vs. 5.6%; P<.05), which may have contributed to the higher mortality at 30 days and 1 year.
“These observations demonstrate that TAVR is a feasible and safe therapy even under conditions of depressed LVEF, despite the fact that many hospitals were still in the beginning of their learning curves,” the researchers wrote.
Disclosure: The researchers report no relevant financial disclosures.
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