CRT 2019 finished strong with the final set of late-breaking trial results, the announcement of the Best Innovation for CRT 2019, more live cases and the Drug-Coated Balloon Safety Town Hall.
The Lutonix paclitaxel-coated balloon demonstrated excellent safety and freedom from revascularization at 1 year, according to SAFE-DCB registry results presented by Nicolas W. Shammas, MD, MS, FACC, FSCAI, president and research director of the Midwest Cardiovascular Research Foundation.
A novel device successfully closed transcaval access in the setting of transcatheter aortic valve replacement in all study patients, according to trial results presented by Toby Rogers, MD, PhD, of the National Institutes of Health’s National Heart, Lung and Blood Institute and MedStar Washington Hospital Center (MWHC).
The Eximo Medical B-Laser is safe and effective at reducing residual diameter stenosis in all infrainguinal lesion subtypes, according to another trial presented by Shammas.
Toby Rogers, MD, PhD, capped off his conference by winning the Best Innovation for CRT 2019 with Transcatheter Mitral Cerclage Annuloplasty. Rogers offered the following explanation:
Mitral cerclage is intended to treat patients with symptomatic severe functional mitral valve regurgitation. Functional mitral valve regurgitation is caused by left ventricle dilation, which results in mitral valve annular dilation and map-coaptation of the otherwise normal mitral valve leaflets. The resulting mitral regurgitation leads to heart failure symptoms.
Mitral cerclage annuloplasty is a catheter procedure performed under X-ray and ultrasound guidance without surgery. The cerclage device compresses the mitral valve like a purse-string to affect circumferential annuloplasty and reduce the septal-lateral dimension of the mitral annulus. The cerclage device partially lies within the coronary sinus and incorporates a rigid bridge-shaped element that prevents coronary artery compression as the device is tightened to treat mitral regurgitation.
Importantly, cerclage does not preclude other transcatheter mitral valve therapies in the future, including edge-to-edge mitral valve repair (e.g., MitraClip), transcatheter mitral valve replacement, or surgery. This stands in stark contrast with edge-to-edge repair, which is commonly performed outside the U.S. for functional mitral regurgitation.
Clinical testing outside the U.S. has shown early promise: Cerclage is a simple right-sided technique performed under mostly fluoroscopic guidance. In a first-in-human study in South Korea, dramatic cardiac chamber reverse remodeling and electrical remodeling was observed.
The latest-generation Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA) device, developed in collaboration with physicians from the National Heart Lung and Blood Institute, is a fully percutaneous, reversible (even after tensioning and release), right-sided, fully circumferential mitral annuloplasty system that is implanted via the right jugular vein. The U.S. Food and Drug Administration granted an investigational device exemption for the Transmural Systems TMCA device in February 2019. Rogers led the pre-clinical development of the TMCA device
"We are excited to announce that we will be enrolling into an Early Feasibility Study (EFS) for Mitral Cerclage Annuloplasty here in the United States in April 2019,” he said after winning the CRT Best Innovation Award.
The runner-up was Azeem Latib, MD, of San Raffaele Scientific Institute, Milan, Italy, for his innovation, “Reproducible and Controlled Transseptal Puncture System.”
The Best Innovation competition had a new two-day format this year. The initial entries were presented Monday, and the top five advanced to Tuesday.
Latib had a second entry in the top five, “Controlled Flow Infusion: A New Approach to Measure dynamic Microvascular Resistance (dMVR) and to Treat Microvascular Obstruction (MVO) in Acute Heart Attack Patients in the Cath Lab.” The rest of the top entries were “Heartflow Planner: Pre-procedural Planning to Optimize Treatment,” by Charles Taylor, PhD, founder and chief technology officer of HeartFlow, Redwood City, Calif.; and “Second Heart: A Minimally Invasive Cardiac Assist Device,” by Leslie Miller, MD, of chief medical officer of Second Heart Assist Inc., of Salt Lake City, Utah.
DCB Safety Town Hall
A new feature at CRT this year, the Drug-Coated Balloon (DCB) Safety Town Hall packed the Empire Ballroom. The focus was on the scrutiny that paclitaxel-coated devices have received since a meta-analysis by Konstantinos Katsanos, MD, PhD, MSc, EBIR, of Patras University Hospital, Greece, and colleagues, published Dec. 6, 2018, in the Journal of the American Heart Association. Katsanos and colleagues’ manuscript reported higher all-cause mortality in patients undergoing treatment of femoropopliteal disease with paclitaxel-coated devices compared to control groups in 28 randomized controlled trials.
Katsanos himself was at the town hall Tuesday. He explained and defended the paper under some intense questioning about statistical methods used in reporting the meta-analysis.
The panel and presenters represented interventional cardiologists, researchers, biostatisticians and industry. At the end, panelists voted on four questions and discussed them.
The first was, “Given the data from the meta-analysis and other data that was presented today, is there a safety signal for paclitaxel DCB in the SFA (superficial femoral artery)?” The tally of votes, taken anonymously, was 10 yes, zero no and four “I don’t know.”
The second was, “Should the current labeling for DCB and DES (drug-eluting stent) with paclitaxel be restricted, changed or unchanged?” The tally was three votes for restricted, three for changed and eight for unchanged.
“Changed” was indefinite, CRT Course Chairman Ron Waksman, MD, FSCAI, of MWHC, pointed out, as it could include expanding or restricting the use.
The third question was, “Should patients be informed about the paclitaxel controversy prior to intervention with a paclitaxel device?” Jeffrey J. Popma, MD, FSCAI, of Beth Israel Deaconess Medical Center, Boston, who was a co-moderator of the town hall, polled the audience. Nearly all audience members raised their hands to indicate that patients should be informed. Popma said the vote was similar with the panel: 10 voted yes, patients should be informed, and one voted “I don’t know.”
The fourth and final question was, “Is the patient-level data of all paclitaxel systems poolable for definitive analysis?” The tally was nine yes, one no and four “I don’t know.”
After the daylong town hall, Popma summed up the current state of the paclitaxel device debate: “I came in with uncertainty, and now I’m going away with uncertainty, but we made tremendous progress.”
Town hall co-moderator David E. Kandzari, MD, FSCAI, of Piedmont Heart Institute, Atlanta, added: “I know I don’t know, and I want to thank everybody, our audience, for attending and staying with us for a full day of terrific presentations.”
The live cases continued through CRT’s last day.
In one case from MWHC, a peripheral vascular intervention was performed on a patient who presented with numbness of the right arm, forearm and fingers. On diagnostic angiography, he was noted to have severely calcified lesion at the ostium of the brachiocephalic trunk with significant gradient requiring endovascular intervention. Nelson L. Bernardo, MD, FSCAI, utilized the Shockwave IVL (Shockwave Medical Inc., Fremont, Calif.) device to disrupt the calcium to facilitate stent delivery with excellent final angiographic results.
In another case, from MWHC, during the Complex Coronary session, a 65-year-old male who came in for treatment of in-stent restenosis of a proximal right coronary artery (RCA) lesion. Invasive physiologic lesion assessment confirmed ischemia, with an abnormal Pd/Pa and fractional flow reserve. The RCA stent extended beyond the ostium, protruding into the aorta. Itsik Ben-Dor, MD, used The FLASH™ Ostial System Dual-Balloon Angioplasty Catheter system (Ostial Corporation). Post-percutaneous coronary intervention intravascular ultrasound confirmed an optimal result.
That’s it for CRT 2019. We wish you safe travels home, and we will see you next year at a new venue, the Gaylord National Resort & Convention Center in National Harbor, Md., for CRT 2020!