Insights from the investigational device exemption (IDE) pivotal study of the Shortcut (Pi-Cardia) leaflet modification system have been shared for the first time at EuroPCR 2024 (14–17 May, Paris, France).
“TAVI is the preferred treatment for patients with failed bioprosthetic valves—valve-in-valve—but the risk for coronary obstruction is a significant concern and it is associated with a high-risk of mortality of around 50%,” explained Danny Dvir (Sha’are Zedek, Jerusalem, Israel), an investigator in the study, describing the current need for leaflet modification techniques and technologies to facilitate coronary access after TAVI.
With a projected increase in valve-in-valve procedures, the incidence of coronary obstruction and challenging coronary access after TAVI is expected to rise, Dvir commented.
An existing technique that has been developed to avoid coronary obstruction is BASILICA, a transcatheter electrosurgical procedure whereby catheters and guidewires are used to traverse and lacerate the aortic leaflet in front of the threatened coronary artery to preserve perfusion. Dvir told Cardiovascular News that typically a BASILICA may take between one and two hours to perform, and is a challenging procedure to learn and teach.
The ShortCut device is designed to simplify the leaflet splitting process and can be delivered transfemorally using a left ventricular wire. When the device is delivered to the target area at the base of the leaflet, a small blade is advanced into the leaflet which, once manually pulled through, creates a split.
The IDE study of the device, which was awarded US Food and Drug Administration (FDA) breakthrough device designation in January 2024, enrolled 60 patients undergoing valve-in-valve procedures, in whom ShortCut was used as a preceding step to TAVI implantation. The primary safety endpoint was procedure-related mortality or stroke assessed within seven days of hospital stay, and the primary effectiveness endpoint was per-patient leaflet splitting success.
Dvir reported a 0% rate of mortality within 30 days of the Shortcut procedure, and 5% within 90 days. There was a 1.7% stroke rate within 90 days. The primary efficacy endpoint was met, with successful leaflet splitting achieved in all patients.
There were three cases of post-TAVI coronary obstruction that required intervention, Dvir reported, but no procedural mortality. “The use of Shortcut facilitated straightforward access with optimal stenting without bioprotection,” he reported.
Leaflet splitting was achieved efficiently, with a single attempt in all cases despite being performed by first-time users, and a median of only two cases per site.
“Really this was the beginning of the learning curve at all sites, but the procedure time was only 27 minutes for [a] single split, including TEE [transoesophageal echocardiography] verification of the split, so these are short procedures,” Dvir commented of the efficiency of the procedure. “It seems that Shortcut addresses an unmet need and will be important for the lifetime management of patients requiring multiple valve interventions.”
