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TAVR survival rate similar in patients with aortic stenosis, cancer vs. no cancer
Patients with severe aortic stenosis and active cancer who undergo transcatheter aortic valve replacement had comparable survival rates compared with patients with severe aortic stenosis but no cancer, independent of cancer status, according to results from the OCEAN-TAVI registry.
In the Japanese, multicenter, prospective registry, researchers evaluated 749 consecutive high-risk patients with severe, symptomatic aortic stenosis who underwent TAVR with the Sapien XT prosthesis (Edwards Lifesciences). Participants were enrolled from eight Japanese hospitals between October 2013 and October 2015. The Valve Academic Research Consortium-2 criteria were used to evaluate procedure success and other procedural factors during TAVR. The researchers defined late mortality as any cause of death after 30 days.
Postprocedural follow-up was conducted on an outpatient basis through in-person visits or telephone interviews at 30 days, 6 months, and then annually.
Forty-seven patients (44.7% men; median age, 83 years) had active cancer. The researchers defined advanced cancer as stage greater than T2, N1 or M1, along with any malignancy considered recalcitrant, relapsing or recurrent. The researchers acquired all data regarding cancers, including the type of cancer, advanced cancer or cancer metastasis from outpatient visits or telephone interviews with patients.
Survival analyses
The researchers used Kaplan-Meier analysis using the log-rank test to compare survival rates between patients with active cancer vs. those without cancer, patients with active cancer vs. those with limited cancer, and patients with metastatic cancer vs. nonmetastatic cancer. ORs for late mortality were calculated using univariate logistic regression analysis.
The transfemoral approach was utilized in 85% of patients in the cancer cohort and in 78% of the patients without cancer. Compared with the noncancer group, the cancer group was implanted with a larger valve size.
The researchers found comparable rates of major vascular complication (4.3% vs. 7.5%; P = .24), life-threatening bleeding (2.1% vs. 7.1%; P = .15) and major bleeding (8.5% vs. 13%; P = .38) between the cancer and noncancer groups. There were no cancer-related bleeding or thrombosis events.
No significant differences were seen between the cancer and noncancer groups in terms of device success (100% vs. 96.2%; P = .17) or 30-day survival (95.7% vs. 97.3%; P = .38). Kaplan-Meier analysis revealed no significant difference in overall survival probability between patients with and without cancer (log-rank P = .42). This finding appeared to be independent of cancer status (limited cancer, log-rank P = .68; advanced cancer, log-rank P = .36; metastatic cancer, log-rank P = .12).
No mortality differences
The overall rate of late mortality was 7%, with five deaths (10.6%) in the cancer group and 45 deaths (6.4%) in the noncancer group. In the multivariate Cox regression analysis, NYHA class III or IV (HR = 2.16; 95% CI, 1.15-4.07), prior cerebrovascular disease (HR = 2.19; 95% CI, 1.15-4.15), EuroSCORE II (per 1 increase; HR = 1.04; 95% CI, 1-1.06) and cancer metastasis (HR = 4.73; 95% CI, 1.12-20) as the only factors independently predictive of late mortality.
“As a clinical implication of this study, patients with active cancer and severe [aortic stenosis] with high operative risk should undergo [TAVR], not based on the presence of local or advanced cancer but on the metastatic status of the cancer,” the researchers wrote. – by Jennifer Byrne
Disclosure: Five researchers report being proctors for transfemoral TAVR for Edwards Lifesciences.