麻豆传媒

Transcatheter aortic valve replacement (TAVR) can be made more user-friendly by placing both arterial sheaths on the same side of the body, according to a center that has made unilateral access the default approach for the procedure without sacrificing patient outcomes.

Since the first unilateral transfemoral TAVR was performed at the Cleveland Clinic in September 2014, its adoption had grown to 43.7% of total cases in 2017, a trend coinciding with a numerical decline in access site-related vascular complications (13.7% in 2014 to 7.4% in 2017, P=0.082).

Bilateral and unilateral access were associated with similar rates of peripheral vascular complications (10.8% vs 8.6%, P=0.543), including delivery sheath-site stenosis, dissection, and pseudoaneurysm, according to Samir Kapadia, MD, and colleagues of the Cleveland Clinic in .

Standard procedure is to place a second arterial sheath in the contralateral femoral artery in order to perform aortic root angiography, and potentially to intervene in case of a vascular complication during TAVR.

Unilateral access, on the other hand, allows for an easier way to manage complications at the access site, Kapadia's group said.

"For the most part, the inferior sheath is already across the delivery sheath access point, making balloon dilation or stent placement quite straightforward. As such, the time spent in managing peripheral complications is also substantially less," the authors said.

"Furthermore, the use of a guide catheter and wire (as needed to cross over) is not necessary for intervention and therefore is more cost efficient," they continued. "In addition, about 30% of the complications following TAVR are shown to be due to the contralateral access site; therefore, by using only unilateral access, complications from the contralateral site may be prevented."

Enhanced comfort may be a benefit to the patient as all lower limb sheaths will be in the same lower limb, the authors suggested.

Operators started out selecting only patients with common femoral arteries of at least 7 mm for unilateral access. By 2017, this was the default approach regardless of iliofemoral size, tortuosity, or calcification, according to Kapadia and colleagues.

Their retrospective study used records from the Cleveland Clinic's TAVR database. They identified 1,208 people who'd undergone transfemoral TAVR in 2014-2017. Median age was 83 and 58% were men. Four in five patients received a Sapien device.

Bilateral femoral access was chosen in 83.36% of cases, with the unilateral approach accounting for the remainder. There was zero conversion from unilateral to bilateral access during the procedure.

New permanent pacemakers were required for 12% and 7% of the bilateral and unilateral groups, respectively.

Researchers could not identify a single risk factor that could independently predict vascular complications. To do so might take a large randomized trial, they suggested.

Other study limitations were the low event rates and the relatively small sample for the unilateral group.

Moreover, men had been significantly more likely to undergo single-side access, while patients requiring valve delivery sheaths greater than 16F still had operators resorting to bilateral access, pointed out J. Kevin Harrison, MD, of Duke University Medical Center in Durham, North Carolina.

On the rare occasions when his own institution employs unilateral dual arterial access for TAVR, operators have encountered increased catheter interaction between the pigtail catheter and the valve delivery catheter, Harrison wrote in an accompanying editorial.

Nevertheless, "The investigators are to be congratulated on their attention to detail with respect to vascular access, and their continued analysis of vascular complications in an effort to improve the clinical outcomes of patients being treated with TAVR," he said.

"The reduction of vascular complications continues to be an important goal of TAVR in 2019, just as it was a decade ago, as we move to treating patients with lower surgical risk, including those individuals with standard risk for open surgical valve replacement," Harrison emphasized.