Registry Study: One-Year Outcomes Similar for TAVR, Surgery

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Transcatheter aortic valve replacement (TAVR) is a relatively safe procedure compared with the surgical gold standard, with similar 1-year rates of hard outcomes such as death, myocardial infarction (MI) and stroke but a lower rate of life-threatening bleeding, according to results from a large observational registry published online February 23, 2012, in the American Journal of Cardiology. On the other hand, TAVR patients had higher rates of aortic regurgitation and unexplained late death, possibly owing to more comorbidities.

Davide Capodanno, MD, of Ferrarotto Hospital (Catania, Italy), and colleagues evaluated early and midterm outcomes of 618 patients who underwent successful TAVR (n = 218) or surgical aortic valve replacement (n = 400) at their institution and another Italian hospital between January 2005 and March 2011. In 89% of patients, TAVR was performed with either the 26-mm or 29-mm self-expanding CoreValve ReValving System (Medtronic, Minneapolis, MN). The remaining patients received the balloon-expandable Edwards Sapien XT (Edwards LifeSciences, Irvine, CA).

No Difference in Most Early Complications

The procedural success rate for TAVR was 99.1%. Procedural death occurred in 1 patient (0.2%) with no significant differences between TAVR and the surgical group (0.4% vs. 0.0%; P = 0.353). In addition, there were no differences between groups for in-hospital outcomes, including mortality, cardiovascular death, stroke, and stage 3 acute kidney injury (AKI). However, there was a trend toward a lower incidence of life-threatening bleeding in the TAVR group (table 1).

Table 1. In-Hospital Outcomes

Compared with surgical patients, TAVR patients also had shorter stays in the hospital (5 ± 4 days vs. 11 ± 6 days; P < 0.001) and intensive care unit (2 ± 2 days vs. 4 ± 3 days; P = 0.009).

At 30 days, there were no significant differences in the primary endpoint of Valve Academic Research Consortium–defined major adverse cardiac and cerebrovascular events (MACCE; composite of death from any cause, spontaneous MI, stroke, urgent or emergency conversion to surgery, or life-threatening/disabling bleeding) or in mortality rates between the 2 groups. The trend toward a higher incidence of life-threatening bleeding persisted in the surgical group (9.3% vs. 5.5% for TAVR; P = 0.093), which also showed a higher rate of reintervention/new cardiac surgery compared with the TAVR group (5.8% vs. 0.9%; P = 0.004).

Bleeding an Independent Predictor of Mortality

While Kaplan-Meier analysis showed no differences between the TAVR and surgery groups for the primary endpoint at 12 months, there was a higher risk of all-cause mortality in the TAVR group (table 2).

Table 2. Twelve-Month Outcomes

Using several methods of adjusting for potential confounders, the researchers found that surgical aortic valve replacement was consistently associated with a higher risk of MACCE than TAVR (RR 2.2-2.6 at 30 days, 2.3-2.5 at 6 months, and 2.0-2.2 at 12 months). This difference was driven by an adjusted increased risk of life-threatening bleeding with surgery at 6 (OR 3.03; P = 0.040) and 12 months (OR 2.90; P = 0.043). No differences in adjusted risk of death, MI, or stroke were seen between the 2 groups at either time point.

Logistic EuroScore (HR 1.03; 95% CI 1.00-1.06; P = 0.034), age (adjusted HR 1.05; 95% CI 1.00-1.11; P = 0.037), chronic renal failure (adjusted HR 2.26; 95% CI 1.01-5.09, P = 0.048), and in-hospital life-threatening bleeding (adjusted HR 6.76; 95% CI 3.46-13.21, P = 0.001) were found to be independent predictors of 12-month all-cause mortality.

Acute improvements in mean pressure gradients were maintained over 1 year for both therapies. A higher incidence of regurgitation at 1 year was reported in the TAVR group, specifically regurgitation ≥ grade 2 (12.6% vs. 1.3%; P < 0.001).

In an e-mail communication with TCTMD, Dr. Capodanno noted that his group previously showed that postprocedural paravalvular leak grade ≥ 2 is an independent predictor of 1-year mortality (Tamburino C, et al. Circulation. 2011;23:299-308).

“In this regard, the fact that we observed a higher percentage of ≥ 2 aortic regurgitation in [TAVR] patients raises some concerns,” he said. “However, these suboptimal results occurred especially at the beginning of our [TAVR] program and are now seen much less, [due in part] to the availability of new delivery systems and improved skills of the operators in optimizing postprocedural outcomes.”

Consistent with PARTNER

Dr. Capodanno also commented that although the nonrandomized nature of the study warrants caution in interpreting the findings, “the consistency of our results with those of PARTNER cohort A should be noted.”

He added that while the registry study found a lower incidence of stroke in the TAVR group than PARTNER cohort A, this may be explained by the lack of follow-up cerebral MRI in the registry and the use of first-generation devices characterized by a larger diameter and minor flexibility in the PARTNER trial. He and his study authors also point out that the higher prevalence of preexisting cerebral vascular disease in the PARTNER population (almost 28%) may help explain the higher incidence of postprocedural stroke reported in the TAVR cohort.

“Finally, differently from the PARTNER trial, we used the VARC definitions for stroke,” Dr. Capodanno said. “That being said, we did not find an increased risk of stroke with [TAVR] compared with surgery, which we believe is partly reassuring.”

As for the higher rate of death at 12 months in the TAVR group, the study authors say recent observational studies suggest these deaths are more likely patient-related than procedure-related, likely stemming from the high-risk profile of the TAVR population.

Source:

Tamburino C, Barbanti M, Capodanno D, et al. Comparison of complications and outcomes to one year of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis. Am J Cardiol. 2012;Epub ahead of print.

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