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Investigational device offers hope of a ‘shortcut’ to prevent coronary obstruction after TAVI

Ngày 23/07/2022 01:40 | Lượt xem: 795

Preventing coronary obstruction after transcatheter aortic valve implantation (TAVI) becomes increasingly important as the procedure moves into a lower-risk patient population. According to researchers in Europe and Israel, a new device may offer a simple solution to preventing this complication in TAVI patients.

“With valve-in-valve procedures and as we go to a younger population and are treating [more] failed transcatheter heart valve devices, we may see the risk of having coronary obstruction increasing dramatically. We need to find tools to prevent coronary obstruction,” Danny Dvir (Shaare Zedek Medical Center, Jerusalem, Israel) told attendees of TVT 2022 (The Structural Heart Summit, 8–10 June, Chicago, USA). “We know how to identify cases at risk for coronary obstruction and we just need a safe, simple and effective leaflet splitting tool that will enable TAVI expansion into the younger population.”

Dvir was presenting insights from the first-in-human use of the dedicated transcatheter leaflet splitting device—the ShortCut catheter (Pi-Cardia)—a tool designed for potential uses including leaflet splitting to enable valve-in-valve procedures, splitting of native leaflets to avoid coronary impairment, or “tricuspidisation” of bicuspid valves prior to TAVI.

ShortCut was among the headline innovations to emerge from two of the summer’s major conferences in the structural heart and interventional cardiology, TVT and EuroPCR 2022 (17–20 May, Paris, France). At EuroPCR, Didier Tchétché (Clinique Pasteur, Toulouse, France) also delivered early insights into the use of the device.

Coronary artery obstruction occurs in around 0.7% of TAVI cases, and is thought to carry around 50% mortality, previous study has suggested. One technique that has been developed to avoid this complication is BASILICA, a transcatheter electrosurgical procedure performed before TAVI in which catheters and guidewires are used to traverse and lacerate the aortic leaflet in front of the threatened coronary artery to preserve perfusion.

Five years have passed since we performed the first BASILICA cases, Dvir noted in his presentation at TVT, but the technique is far from widespread, he added, possibly due to its complexity. Having a dedicated tool that replicates the outcome of the BASILICA technique, albeit via a much simpler method, may offer a more accessible option for retaining coronary flow that can be compromised post-TAVI or in some native valves.

At TVT, Dvir described the design and use of the ShortCut device, as well as detailing outcomes in the first eight patients to have undergone leaflet splitting with ShortCut on a compassionate-use basis.

ShortCut is delivered transfemorally using a 16Fr sheath over a routine left ventricular wire, Dvir explained in his presentation, where he walked through the steps of the procedure. Once 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 in the leaflet.

“It is quite straightforward,” Dvir commented, noting that the procedure can be completed in around 20 minutes, significantly shorter than the time needed to perform a BASILCIA laceration and does not require electrification.

Of the eight patients to have undergone the procedure at the time of the presentation, Dvir noted that there had been no incidences of coronary obstruction, mortality or stroke to date. “The cases were quick and effective and I think it is generalisable to the population,” he commented. A prospective study of the device began enrolment in 2022.

Source CardiovascularNews

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