Transradial Route Gains Support as Default for Secondary TAVR Access

For secondary access in TAVR, using a transradial instead of a transfemoral approach is associated with significantly fewer vascular and bleeding complications and improved 30-day outcomes, a new observational study suggests.

Much research has been dedicated to improving the percutaneous closure and hemostasis of the primary access sites for TAVR procedures—usually transfemoral—but a second access point is necessary to ensure angiographic guidance during the procedure. Many operators use the contralateral femoral artery for this but must manage the risk of vascular complications.

“It's the forgotten access,” senior study author Josep Rodés-Cabau, MD (Quebec Heart & Lung Institute/Laval University, Quebec City, Canada), told TCTMD, referring to the radial artery. “It's something that, . . . even if the data is not definitive because it's not randomized, people should think about. When you have retroperitoneal hematoma due to secondary access issue, it's a pity. You could have avoided that by using the transradial, and sometimes this can [otherwise] be life-threatening.”

Fewer Complications With Radial

For the study, published online ahead of print in Circulation: Cardiovascular Interventions last week, Lucía Junquera, MD (Quebec Heart & Lung Institute/Laval University), Rodés-Cabau, and colleagues looked at 4,949 TAVR patients from 10 centers in Canada and Europe treated between 2007 and 2018. Primary access was transfemoral in 83.3% of patients, while the transradial route was used for secondary access in 18.9% of patients (59.1% on the right side) and the other transfemoral artery in 81.1%.

A total of 18.3% of patients had a vascular complication, with nearly 38% of these events deemed to be major. Complications were mostly related to the primary access point (84.5%); however, of those related to secondary access, 95% occurred in those treated transfemorally compared with only 5% treated transradially (P < 0.001). Overall, 1.3% of the population had a major vascular complication related to secondary access, with no cases occurring in the transradial group (P < 0.001).

In those receiving transfemoral secondary access, 23.5% of access-related vascular complications were related to the secondary access, accounting for 25.8% and 22.3% of major and minor vascular access-site complications, respectively. On the other hand, only 5.9% of vascular access-site complications were related to radial secondary access, with all classified as minor.

As for bleeding, 9.1% of the overall population developed major/life-threatening events, including 5.1% related to an access-site complication. Of these, 18.1% were related to secondary access, all of them occurring in those receiving transfemoral secondary access (P < 0.001). Additionally, more minor bleeding events occurred in the transfemoral arm than in the transradial (1.6% vs 0.8%; P = 0.048).

The researchers also conducted a propensity-matched analysis of 2,978 and 928 patients treated with transfemoral and transradial secondary access, respectively. Here, rates of vascular complications (4.7% vs 0.9%; P < 0.001) and major/life-threatening bleeding events (1.0% vs 0; P < 0.001) related to secondary access remained higher for those treated transfemorally compared with transradially. Also, rates of stroke (3.1% vs 1.6%; P = 0.043), acute kidney injury (9.9% vs 5.7%; P < 0.001), and mortality (4.0% vs 2.4%; P = 0.047) at 30 days were all higher, and hospital stays were longer (mean 7.9 vs 6.5 days; P < 0.001) for transfemoral secondary access.

Radial as Default Secondary Access?

The results are not surprising, according to Rodés-Cabau, given all the literature showing the advantages of radial over femoral access in PCI. Because of this, transradial secondary access for TAVR should be the “default strategy” going forward, he said. “For sure you have to evaluate every case and maybe you can find the cases where transfemoral can [offer] a potential advantage, but otherwise . . . the data is quite convincing.”

Pointing to the propensity-matched analysis specifically, Rodés-Cabau cited the fact that the two cohorts had “exactly the same rate of primary vascular complications—this means that the matching was really good. It was really, really good.”

Even so, he advised caution interpreting the decreases in stroke, mortality, and acute kidney injury with transradial access because of the observational nature of the study. “These need to be further demonstrated,” he said. “But it's not surprising that if you prevent major vascular issues, life threatening bleeding issues, you can reduce mortality, acute kidney injury, and transfusions. . . . When you start this vicious circle of vascular issues, bleeding, et cetera, many things can happen, and this is why I think at least partially we have been able to show a decrease in other complications other than vascular and bleeding complications with the radial approach.”

Commenting on the study for TCTMD, Mauricio Cohen, MD (University of Miami Miller School of Medicine, FL), said using transradial secondary access “adds an additional layer of safety to TAVR.” It’s a practice he defaults to, although not every operator at his institution does, he said.

“The same way the world is shifting from transfemoral to transradial in percutaneous coronary interventions, I think that the same concerns can be raised about the safety of secondary access in TAVR procedures,” Cohen observed. “We know that with transradial we don't get vascular complications, period, [and] you just don't get major vascular complications. You're not going to have surgery for a vascular complication. You're not going to be transfused 3 or 5 units or die because of a vascular complication in the arm.”

It mostly comes down to operator comfort, he said. “The practice is variable, and there are people who feel more comfortable with radial and there are people who feel less comfortable. The most innovative operators always like to look at ways to make the procedure safer.”

Still, because the study is retrospective and observational, Cohen pointed to its inherent limitations. “If you look at the time period when the data was collected, it's 2007 to 2018. In 2007, TAVR was in its infancy and the types of complications we used to have with TAVR were much, much worse,” he said. “Transradial came later as a refinement of the technique when the devices used for TAVR were more refined and better. So that could create a possible selection bias that is difficult to adjust for.”

Cohen said a randomized trial may not be needed to demonstrate a benefit of radial over femoral in this setting. “Nowadays, femoral access with ultrasound has improved significantly, so it's become safer, and I think that with safe femoral access you would need lots of patients to demonstrate a difference between radial and femoral secondary access,” he observed. Still, Cohen said he would like to see more-contemporary data for both approaches, especially in low-risk TAVR patients.

Rodés-Cabau said his team is currently brainstorming a randomized trial to have a better answer to this question. “For sure you could say well, the results are quite, I would say, strong in terms of protection and we know that radial is better in coronaries,” he said. “You can maybe have some doubts about the need for a randomized trial, but we are thinking about it. We are thinking about really doing a trial and providing a definite response and showing really that the secondary access in TAVR should be radial and not femoral.”