Coronary Access More Challenging With Self-Expanding Valves: SCAAR/SWENTRY

PARIS, France—Fluoroscopy times and the amount of contrast needed during coronary angiography are significantly higher in patients with a prior TAVI, with the self-expanding transcatheter heart valves posing the biggest challenges for coronary access, new data from Sweden confirm.

Investigators say that as TAVI is now approved for treating lower-risk patients, operators should consider valve type when treating younger people expected to live long enough to potentially need treatment for coronary artery disease.

“The design of the transcatheter heart valve may influence the procedure complexity of a coronary angiography after a TAVI implant,” said Oskar Angeräs, MD, PhD (Sahlgrenska University Hospital, Gothenburg, Sweden), during his presentation at EuroPCR 2024. “As we are now moving into treating patients with longer life expectancy, we will end up with more patients where we’re doing a coronary angiography after a TAVI implant.”

As TAVI is now approved for patients across the risk spectrum, lifetime management of patients is an important clinical consideration. This means not just managing the need for a second valve should the first fail over time, but also ensuring that operators can access the coronary arteries.

In a 2020 study, RE-ACCESS investigators led by Marco Barbanti, MD (Policlinico-Vittorio Emanuele Hospital, University of Catania, Italy), found coronary access following TAVI wasn’t possible in nearly 8% of patients, and that this failure rate was almost exclusive to the Evolut (Medtronic) platform.

In RE-ACCESS 2, researchers looked at coronary access after TAVI with the self-expanding Evolut and Acurate (Boston Scientific) devices, this time after the valves had been implanted using commissural alignment techniques. While unsuccessful coronary cannulation was down a little—just 5.5% of cases—the problem again remained mostly with Evolut valves.

Mohamed Abdel-Wahab, MD (University of Leipzig, Germany), who wasn’t involved with either study, said the new Swedish results confirm what operators have long known. “Regardless of the type of valve present, it takes a bit longer and it's a bit more difficult than in people without a valve, which is logical,” he told TCTMD. “Looking at the valve types, they’ve seen exactly the same thing that Marco showed in the prospective studies.”

Clinically speaking, though, Abdel-Wahab said it’s not possible to say that all younger patients should get a particular valve type.

“This is a difficult decision-making process,” he told TCTMD. “Anatomies do differ—it's not only the prosthesis that hinders access. It's also the aortic root anatomy.” With some patients, you can implant any valve and not have a future problem accessing the coronary arteries whereas with others it’s going to be a challenge. Valve positioning also impacts future access, he said.

“So, we integrate all this and then try to decide on the prothesis for this patient,” he said. “For example, if it's a small annulus, we want to have good hemodynamics, so we tend to use the self-expanding valve. But then we’ll ask, will coronary access be fine, is the sinus big enough, is the sinotubular junction big enough? Maybe we need to implant a little bit deeper and align it?”

SCAAR and SWENTRY Registries

In this analysis, fluoroscopic times during angiography stood as a surrogate of the complexity for accessing the coronary arteries in those with a prior TAVI.

In Sweden, there are 30 hospitals capable of performing coronary angiography and eight TAVI centers. Using national reporting from two registries (SCAAR for angiography/PCI and SWENTRY for TAVI), they analyzed data from 245,000 coronary angiographies and 9,806 TAVI procedures performed between 2008 and 2022. During that time, 5.8% of patients with a prior TAVI underwent coronary angiography.

The need for coronary angiography increased over time, with 2.7% of patients undergoing coronary angiography 1 year out from TAVI. Five and 10 years after the TAVI procedure, 7.3% and 9.1% of patients alive had undergone angiography, respectively. The most common indication for coronary angiography was unstable angina/NSTEMI (42%), followed by symptomatic chronic coronary syndrome. Just 5.7% of angiographies performed after TAVI were for STEMI.

“STEMI is still quite rare,” said Angeräs.

Compared with the control group who underwent coronary angiography, patients with a preexisting transcatheter valve had longer fluoroscopy times. In the control arm, fluoroscopy times were a mean of 3.2 minutes, but were 6.83 minutes with a self-expanding valve and 5.22 minutes with a balloon-expandable valve.

Looking at valve design and placement a, Angeräs said those with an intra-annular design had lower fluoroscopic times than those with a supra-annular placement.

With regard to specific devices, the Sapien (Edwards Lifesciences) and Evolut family of valves were mostly used in Sweden during the study period, but operators also have access to self-expanding devices from Boston Scientific and Abbott. Fluoroscopy times required to access the coronary arteries with the Edwards, Medtronic, Boston Scientific, and Abbott devices in place were 4.2, 6.1, 5.3, and 5.5 minutes, respectively. The corresponding amount of contrast used with those preexisting devices was 72, 82, 72, and 80 minutes.

Angeräs said that in a head-to-head comparison between the Sapien and Evolut series of valves, the difference in fluoroscopy time and contrast amount was significantly higher with Medtronic’s self-expanding device.

To TCTMD, Abdel-Wahab pointed out that the RE-ACCESS studies found that the Sapien and Acurate neo valves were mostly equivalent with respect to access, and that the problem lay with Evolut, not with the supra-annular placement. “It's more or less the amount of metal you have,” he said. “Acurate is a supra-annular valve, but it’s mostly naked in the upper part, only the leaflets, not a lot of metal.” While you can improve coronary access with Evolut using commissural alignment, you can’t eliminate the problem altogether, he added. “That’s why it’s important to reduce the amount of metal.”

In late March, the US Food and Drug Administration approved the Evolut FX+, and it’s designed to improve coronary access with larger access windows, said Abdel-Wahab. “If you align the valve, and put these windows in front of the coronaries, it should be easier,” he said. “It should be similar to Acurate.”

The longer fluoroscopy times seen in the Swedish registry study are unlikely to have clinical implications, but what matters most to operators is whether or not they can ultimately cannulate the coronary ostia should patients need to undergo angiography or PCI, he said.

“Even if I take some time to access, I don’t care,” said Abdel-Wahab. “Unsuccessful access could be problematic.”