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The ShortCut Pivotal Trial: A Dedicated Valve Leaflet Splitting Device
As TAVR’s procedural reach continues to expand into younger populations, there has been a rise in focus around lifetime management of aortic stenosis. Bioprosthetic heart valves, whether TAVR or surgical AVR, do not last a lifetime, and “there are likely to be multiple interventions,” said Dr. Susheel Kodali, noting “there’s a clear need” for a transcatheter solution. As patients receive multiple interventions for their aortic valve across their life, a rise in valve-in-valve procedures will occur in less than 5 years, Dr. Kodali said, according to as-yet unpublished data shown from Généreux, Dvir, and colleagues.
Challenges for valve-in-valve procedures include coronary obstruction. “The leaflet of the bioprosthetic valve, if there isn’t room, can come in front of the coronary artery, and occlude it,” said Dr. Kodali. The ShortCut (PiCardia) is a dedicated leaflet splitting device with a cutting element. The operator opens a positioning arm of the ShortCut and moves it over the leaflet they want to split, depending on which coronary artery is at risk. “If it’s a low left main with a short sinus, you favor that leaflet,” said Dr. Kodali. “If it’s the right coronary, sometimes you do both.” After the positioning arm is in place, the cutting arm is engaged, and as the ShortCut device is retracted, the cutting element splits the leaflet. At that point, a valve can be placed, so an advantage of the ShortCut device is that the operator can orient the cut in the leaflet so that it is in front of the coronary artery, remove the device, and proceed with the TAVR as planned.
Dr. Kodali shared a case performed by Dr. Benjamin Seguy at CHU Bordeaux Hospital in France demonstrating modification of leaflets in front of both the right and left coronary arteries, with a valve then being placed and resulting good flow into both coronary arteries. The ShortCut leaflet splitting procedure can be done in anywhere from five to 10 minutes, noted Dr. Kodali, and patients typically remain stable during the procedure.
The ShortCut pivotal approval trial sought to assess the safety and effectiveness of the ShortCut device for splitting bioprosthetic aortic valve leaflets in patients at risk for valve-in-valve induced coronary obstruction. The primary endpoint was ShortCut procedure-related mortality and assessment for stroke at 7 days. Secondary and tertiary endpoints were assessed for safety through 30 days and 90 days, respectively. Effectiveness endpoints included intraprocedural evaluation of leaflet splitting success (primarily evaluated by transesophageal echocardiogram or by the presence of worsening aortic regurgitation [AR] by angiography) and freedom from coronary obstruction related to the split leaflet. Technical success was also assessed.
The ShortCut pivotal trial was a global study with sites across the United States, Europe, and Israel. The main inclusion criteria were patients who needed a valve-in-valve procedure due to a failed bioprosthetic valve, had AS or aortic insufficiency, and were at risk for TAVR-induced coronary obstruction. Exclusion criteria included excessive leaflet calcium or anatomy not suited for the ShortCut, among other criteria, mostly based around certain anatomic and clinical-based limitations of the device. The trial enrolled 60 patients, with an average age of 77 years, and were a majority female —typically at higher risk due to smaller valve sizing, at high risk for surgery, and had typical comorbidities for a high-risk population. The majority of patients (58%) had AS, 12% had AR, and the remainder had a mix of AS and AR. The breakdown of bioprosthetic valve type included 2 TAVR patients, with the remainder being surgical AVR patients, and in general patients had small valves, with 43% having 21 mm and 13% having 19 mm valve sizes. Fifty percent were left coronary leaflets that underwent laceration, and 37% had both left and right coronary leaflet lacerations. The degenerated valves treated with ShortCut included stented, stentless, stented with externally mounted leaflets, and sutureless surgical valves, and TAVR valves.
Dr. Kodali concluded by noting that the pivotal study has completed enrollment and has shown that the ShortCut allows for an effective, controlled, and simple splitting of single or double leaflets, with short procedural times. “As we expand TAVI into younger populations and multiple valve interventions may be required, and there is a real need for a leaflet-splitting device,” he said.
Data collection for the ShortCut Pivotal study (ClinicalTrials.gov NCT04952909) is ongoing and full data will be presented in the beginning of 2024.
During the post-presentation discussion, lead moderator Dr. Nicolas Dumonteil sought to place the trial in perspective, considering daily practice. He noted that the risk of coronary obstruction during TAVI-in-TAVI or TAVI-in-SAVR is a “highly predictable complication; the mechanisms are well understood — you are pushing the leaflet of the first valve that is going to seal either directly the coronary ostium or to sequestrate the Valsalva sinus. So, therefore, it is something that you can totally predict at the time of preoperative […] interpretation and you can adopt preventative strategies.” Currently the choices are between chimney or snorkel stenting, which he noted is simple and safe, but “makes coronary reaccess unlikely”. The other option is the BASILICA procedure, which is “more technically demanding”. The goal for the ShortCut device in the current environment, Dr. Dumonteil said, is to show that its leaflet splitting is “simpler, easier, faster, standardized, [and] reproducible.”
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