James M McCabe (University of Washington, Seattle, USA) and others report in The American Journal of Cardiology that surgical access for transfemoral transcatheter aortic valve implantation (TAVI) is not associated with a significant reduction in major vascular complications compared with percutaneous access. The authors claim that this finding is counterintuitive because one might expect surgical access to be the superior approach for reducing vascular complications.
According to McCabe et al, surgical access and percutaneous access are both “routinely employed” techniques during transfemoral TAVI. However, they add few data exist for which technique is the optimum approach—noting that, to date, no multicentre studies have compared in-hospital and intermediate-term outcomes or quality of life to inform decisions regarding access strategies for large calibre catheter-based procedures. Therefore, the aim of the present study was, using data from the PARTNER (Placement of aortic transcatheter valve) trial, to evaluate differences in outcomes and quality of life following such procedures performed using surgical access vs. percutaneous access.
Reviewing data for 1,416 patients who underwent transfemoral TAVI in the PARTNER trial (cohorts A and B and the continued access registry), McCabe et al identified 292 well-matched pairs (52% of potential matches). They comment: “The percutaneous and open surgical patients demonstrate multiple baseline differences. Notably, a larger percentage of patients who received percutaneous access had significant peripheral arterial disease, documented frailty and had larger valves implanted, requiring the larger size sheath. Conversely fewer patients underwent percutaneous access had ‘normal’ iliac arteries (defined as >8mm without calcification or tortuosity).”
The primary endpoint was the 30-day rate of major vascular complications (eg. thoracic dissections). Quality of life was an additional endpoint and was evaluated with the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Short-Form-12 (SF-12) Health Survey.
At 30 days, after propensity matched scoring, there were no significant differences in the rate of major vascular complications between surgical and percutaneous access: 9.6% for surgical vs. 7.5% for percutaneous (p=0.37). McCabe et al write: “Surgical arterial exposure and repair has long been a de facto treatment strategy for significant vascular access complications following endovascular procedures. One, therefore, might intuitively expect surgical access to be a superior strategy for avoiding vascular complications. We did not find this to be true, however.” They add that percutaneous access was associated with a reduced total vascular complication rate, shorter median procedural duration, and shorter median length of stay.
The authors report that while the KCCQ Summary Score significantly improved in both groups, there were no significant differences in this score at 30 days between groups. “It is worth noting, however, that both the KCCQ and SF-12 were included in the PARTNER trial primarily to investigate differences in health status between those receiving TAVI and medical therapy or surgical aortic valve replacement. As such, neither instrument was specifically designed to detect more subtle differences associated with alternative approaches to femoral artery access,” they comment.
McCabe et al state that “current and future improvements” in delivery systems and access sheath technologies are expected to reduce the calibre of femoral access systems specific to TAVI but add that “even the smallest” currently available TAVI delivery system is “many fold larger” than a standard angiographic or interventional catheter, “meaning that centres currently developing structural heart programmes will still need to develop expertise with large bore access methods”. They conclude: “Surgical access for large-bore femoral access does not appear to confer any advantages over percutaneous access and may be associated with more minor vascular complications.”
McCabe told Cardiovascular News: “TAVI sheath sizes have obviously gotten smaller and the vast majority of high-volume TAVI operators routinely employ a fully percutaneous approach in 2016. However, we used the early PARTNER data—when 24Fr and 26Fr sheaths were still required—to explore large bore catheter access strategies in general. We found that there was a very steep learning curve for both percutaneous and surgically exposed large-bore catheter access but there did not appear to be any advantage gained by surgically exposing the femoral artery. In fact, there were some signals for advantage to percutaneous access even with 26Fr sheaths. Of course, one could wonder if patient selection plays into these data—and I am sure it did insofar as the worst cases probably moved to transapical or other approaches—but among femoral access patients, our data actually suggest that the percutaneous group had smaller, more tortuous and more diseased vessels yet, on average, still faired just as well if not slightly better than the surgical exposure group. These data are really germane to other large bore catheter-based procedures such as thoracic endovascular aortic repair (TEVAR) or mechanical circulatory support devices and newly developing technologies, among others.”