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  • ShortCut Device Successfully Splits Failed Bioprosthetic Valve Leaflets in ViV TAVR – First-in-Human Study

    The first dedicated transcatheter leaflet-splitting device demonstrated safety and successfully prevented coronary obstruction after transcatheter aortic valve replacement (TAVR) in a first-in-human trial of patients with failed bioprosthetic valves.

    These findings were reported in a manuscript written by Danny Dvir, MD, of Shaare Zedek Medical Center and Hebrew University of Jerusalem, and colleagues that was published Monday online and in the Jan. 9 issue of JACC: Cardiovascular Interventions.

    Coronary artery obstruction is a rare but potentially life-threatening complication after valve-in-valve (ViV) TAVR. Preventive strategies include stenting designed to deflect the valve leaflets from the coronary ostia and a leaflet-splitting technique known as BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction).

    The stenting techniques, Dvir and colleagues wrote, are not ideal because of the risk of stent deformation and thrombosis because they are placed in a compressed space between the coronary ostium and the TAVR valve, and patients must take antiplatelet medications indefinitely. BASILICA, they added, is effective, but “it requires highly skilled and experienced operators using this uncommon method and is performed with off-label tools that are not indicated for leaflet laceration.”

    The ShortCut device, manufactured by PiCardia, is designed to split one or more bioprosthetic leaflets to prevent post-TAVR coronary obstruction. The device is introduced through a 16-French sheath via the femoral artery and delivered over a 0.035-inch guidewire using standard catheterization.

    Study setup

    The device was tested in vitro and in a porcine model and then offered to patients at high risk for coronary obstruction, which was determined using computed tomography-based anatomical characteristics. Procedural success was defined as patient survival at 30 days with the new valve functioning and without stroke or coronary obstruction.

    After bench testing and the preclinical trial, the device was used in eight patients with failed bioprosthetic valves at two medical centers: Shaare Zedek in Jerusalem and the German Heart Institute in Berlin. The patients’ median age was 81 years (interquartile ratio: 72-85 years), and three were men.

    Clinicians split 11 leaflets. Five of the eight patients were considered to be at risk for obstruction of the left main coronary artery alone, and three were considered at risk for  obstruction of both the left and right coronary arteries. Before the ShortCut device was placed, each patient received the Sentinel cerebral embolic protection device (Boston Scientific) via the right radial artery.

    All patients underwent successful ViV TAVR, with the ShortCut device as an adjunct, and showed no evidence of coronary obstruction. All eight patients were discharged from the hospital in good clinical condition with no adverse neurological events.

    The authors noted that the small sample size is the main limitation of the first-in-human study of the device.

    “In the current limited experience, it seems that the device provides a faster and easier to control method for splitting of bioprosthetic aortic valve leaflets prior to TAVR in patients at high risk for coronary obstruction,” the authors concluded. “There was no stroke or coronary obstruction when using this approach, and there was no evidence for any device-related adverse events.”

    Future of leaflet splitting

    In an accompanying editorial, Toby Rogers, MD, PhD, of MedStar Washington Hospital Center and the National Heart, Lung, and Blood Institute, pointed out several differences between mechanical leaflet splitting with the ShortCut device and electrosurgical leaflet splitting with the BASILICA technique.

    Mechanical splitting may only partially split the leaflet and may be associated with an increased risk of leaflet avulsion compared to BASILICA. Additionally, splitting degenerated native or bioprosthetic leaflets may increase the risk of embolic debris and stroke. Rogers noted that in the BASILICA trial, one definite and two possible strokes occurred, but he added that it was not possible to determine whether the stroke was related to the BASILICA technique or TAVR.

    Rogers predicted that treating failing bioprosthetic valves “will likely be associated with even higher risk for coronary obstruction, because TAVR leaflets commonly extend above the coronary ostia.” He added that leaflet splitting might not be enough in some redo TAVR procedures “because the commissures may be misaligned and because the splay achieved in contemporary transcatheter heart valves which have long redundant leaflets may not be adequate.”

    Having said that, the editorialist concluded that whether mechanical or electrosurgical, “leaflet modification is likely to become commonplace when treating patients with failing bioprostheses, surgical or transcatheter, and having dedicated catheter tools to accomplish leaflet laceration safely, effectively, and reproducibly is imperative.”

    Sources:

    Dvir D, Leon MB, Abdel-Wahab M, et al. First-in-Human Dedicated Leaflet Splitting Device for Prevention of Coronary Obstruction in Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv 2023;16:94–102.

    Rogers T. Is There a Shortcut to Leaflet Splitting? JACC Cardiovasc Interv 2023;16:103–105.

    Image Credit: Damian – stock.adobe.com

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