Journal and News Scan

The ISCHEMIA trial has caused heated discussion in the cardiovascular field, with its results being used to downgrade coronary artery bypass grafting (CABG) recommendations in recent guidelines. The authors of this paper performed a detailed re-analysis of the ISCHEMIA trial and critically examined its findings. Several factors are judged likely to have diluted the potential survival advantage associated with CABG. The authors concluded that the results of ISCHEMIA have been misinterpreted, that they are aligned with previous evidence and should not be used to downgrade recommendations for CABG.

Non-inferiority study designs are frequently used in randomized controlled trials (RCT) comparing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). However, the long-term outcomes of TAVR are unknown, and the concept of non-inferiority is challenging to define and assess. This systematic review and meta-analysis published in Interdisciplinary Cardiovascular and Thoracic Surgery (ICVTS) compares TAVR and SAVR, specifically emphasizing the non-inferiority margin for five-year all-cause mortality. To this end, the authors performed a systematic search in three electronic databases. A total of eight RCTs (n = 8,698 patients) comparing TAVR and SAVR were included. Bayesian methods were implemented to evaluate the posterior probability of non-inferiority at different trial non-inferiority margins. The primary study outcomes were five-year actuarial all-cause mortality and the probability of non-inferiority at various transformed trial non-inferiority margins. Kaplan-Meier-derived five-year survival was 61.6 percent (95 percent CI 59.8–63.5 percent) for TAVR and 63.7 percent (95 percent CI 61.9–65.6 percent) for SAVR. The posterior median relative risk for all-cause mortality of TAVR was 1.14 compared to SAVR. The posterior probability of a mortality difference in favor of SAVR was 99.9 percent. The authors concluded that the non-inferiority of TAVR compared to SAVR is unlikely after five years in terms of all-cause mortality.

Degenerative aortic valve stenosis is the most frequent valvular heart disease in western countries, and valve replacement is the gold standard for symptomatic severe cases. In addition to the two established procedures (surgical aortic valve replacement [SAVR] and transcatheter aortic valve implantation [TAVI]), the last decade showed the rising of a third way, which is based on the concept of the surgical replacement but takes some advantages of the TAVI prosthesis's design, such as the faster and simpler anchoring mechanism. This category includes the interventions performed with the sutureless and the rapid deployment prostheses. Sutureless and rapid-deployment (SURD-AVR) has been applied to high- and intermediate-risk populations with good clinical results. However, concerns were raised because of the incidence of postprocedural permanent pacemaker implantation (PPI), which was higher than in conventional SAVR and similar to that observed following TAVI. Possible factors associated with this complication have been assessed only in single-center studies with small sample populations. Moreover, recent analyses reported a reduction of this complication over time, suggesting the possible role of a time bias or learning curve effect. For these reasons, the authors aimed to investigate the need for PPI following SURD-AVR in a large cohort using a progress report approach.

In this mandatory national clinical registry analysis of acute aortic dissections, in-hospital mortality was 18 percent in 859 patients who underwent repair of type A dissections vs. 52 percent in 298 unoperated-on type A patients, and 13 percent in 122 patients who underwent surgical or endovascular repair of type B dissections vs. 13 percent in 434 unoperated-on type B patients. Unadjusted three-year survival in patients discharged alive was 91 percent after type A dissection repair vs. 78 percent without surgery, and 83 percent after type B repair vs. 77 percent without surgery.