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PARIS -- For people undergoing valve-in-valve transcatheter aortic valve replacement (TAVR), a dedicated bioprosthetic leaflet splitting device produced better-than-expected results preventing coronary obstruction, and is now poised for FDA approval.

The ShortCut device demonstrated safety -- freedom from all-cause mortality within 7 days being 100% and freedom from stroke 98.3% -- among 60 people undergoing transfemoral valve-in-valve TAVR for a failed bioprosthetic aortic valve deemed at risk of coronary obstruction due to their anatomy.

As for effectiveness, inexperienced operators were able to split leaflets on all first attempts. One patient had cardiac tamponade caused by the left ventricular guidewire, resulting in a technical success of 98.3% for the ShortCut, according to Danny Dvir, MD, of Shaare Zedek Medical Center in Jerusalem, Israel, at the EuroPCR meeting this year.

"ShortCut addresses an unmet need and will be important for the lifetime management of patients requiring multiple valve interventions," he told the audience at EuroPCR. The ShortCut pivotal study was simultaneously published in the .

ShortCut is the first dedicated leaflet splitting device for people at risk of TAVR-induced coronary obstruction. It can split single or double leaflets with a single rotating positioning arm. After such splitting, the ShortCut device is removed and TAVR is performed over the same guidewire.

Dvir reported that the ShortCut splitting device was used on the left leaflet in half of cases, right leaflet in 13.3% of cases, and both leaflets in 36.7%. A single split took nearly 27 minutes, and a double split 37 minutes.

Three people (5%) still had coronary obstruction (two partial and one complete) despite the ShortCut procedure.

"Clearly you've targeted one of the most complex populations in TAVR," said session panelist Philippe Genereux, MD, of Atlantic Health System in Morristown, New Jersey. A participant in the study, Genereux expressed his enthusiasm for the device, highlighting zero cardiovascular mortality and only one stroke in the study -- both "unheard of."

Coronary obstruction is a complication of TAVR that is associated with significant mortality. It is becoming more relevant with TAVR shifting toward younger patients with aortic stenosis (AS), who are expected to need repeat procedures over their lifetimes.

Meanwhile, an existing manual leaflet splitting technique, BASILICA, has not been able to reach the mainstream due to its difficulty for even "super experienced" operators, Dvir said. "We started with BASILICA 7 years ago, but unfortunately, not many sites are independent in doing BASILICA procedures ... I think that with dedicated devices it will be much easier."

He contrasted BASILICA taking on average of an hour, hour and a half, against ShortCut's under-40-minute double splits.

During a press conference, Dvir said the ShortCut device may get FDA approved within a couple of months.

"So we know now the [ShortCut] device is safe and the device is effective. And it makes me think, why shouldn't we use it for other indications? Should we use it for enabling better coronary access? Should we use it in natives in some cases, should we use it in bicuspids? I think probably yes," Dvir suggested.

"The concept of maybe to prevent or to allow future coronary access, I think for me is the next one because a lot of these young patients will need a TAV [transcatheter aortic valve]-in-TAV in the future," Genereux agreed.

The pivotal study was an international report from 22 sites.

Participants were 60 people with a failed bioprosthetic valve requiring a percutaneous valve-in-valve procedure. They were judged to be at risk for coronary obstruction due to high-risk anatomical characteristics such as low coronary height relative to the annular plane and narrow sinuses of Valsalva.

The investigators had excluded people with certain calcification patterns or certain anatomies, coronary disease requiring treatment soon after TAVR, and hemodynamic or respiratory instability.

Dvir's group wound up with participants that were age 77 years on average, 70% women, and at high surgical risk with a mean STS score of 4.5%. Mean left ventricular ejection fraction was 54% and two-thirds of people fell within New York Heart Association class III and IV.

Dvir noted over 43% of people had coronary artery disease. Nearly 60% had isolated AS, and 30% a mix of AS and aortic regurgitation. Nearly all patients went into the study with a failed stented surgical valve.

Transesophageal echocardiography was conducted during the ShortCut procedure in order to acquire images before and after leaflet splitting. Following TAVR, coronary artery patency was assessed using angiography and color Doppler echocardiography.

Operators put in a self-expanding TAVR valve in two-thirds of cases, the rest receiving balloon-expandable valves.

Patients were given post-procedure antiplatelets and/or anticoagulation at the operator's discretion.

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