• ‘First In-Heart Microcomputer,’ EVAR Suture-Delivery Catheter Named Top CRT Innovations

    The “world’s first in-heart microcomputer” and an endovascular aortic repair (EVAR) suture-delivery catheter were recognized Saturday as the best innovations of CRT 2021 Virtual.

    The judges chose the V-LAP implantable microcomputer (Vectorious Medical Technologies Ltd.), presented by Tal Hasin, MD, of Shaare Zedek Medical Center, Jerusalem. CRT audience members voted for Vesteck Suture-Tight (Vesteck Inc.), a catheter that delivers nitinol sutures to secure EVAR grafts to the aorta at initial implant or during a subsequent repair procedure, presented by William A. Gray, MD, of Lankenau Heart Institute, Wynnewood, Pennsylvania.

    V-LAP

    Hasin said the V-LAP measures left atrial pressure (LAP) when the patient pushes a button on an external belt, data from the VLAP is sent to a cloud. In real time, a physician can remotely adjust the patient’s medication based on the data.

    The device is the subject of the VECTOR-HF study, which is designed to enroll 45 patients with chronic New York Heart Association heart failure class III, hospitalization for worsening heart failure, or elevated ambulatory B-type natriuretic peptide (BNP) or N-terminal-pro hormone BNP. Eleven sites in Europe and Israel are participating.

    Hasin said 24 patients have been enrolled so far with follow-up as long as 28 months. The procedure in which the device is implanted takes an average 1 hour, 20 minutes, and the device is deployed in 6 minutes or less.

    In the first 21 patients, the device demonstrated LAP accuracy at 3-month follow-up when compared to the gold-standard measurement, pulmonary capillary wedge pressure, Hasin said.

    Suture-Tight

    In presenting the Suture-Tight device, Gray noted that the two current options for patients with aortic aneurysm, open surgical repair and EVAR, have issues. Surgery is durable but carries a 4.8% perioperative mortality rate and a 19.2% mortality rate in high-risk patients. EVAR is not as durable, and while mortality is lower, it is still high at 4.7% in high-risk patients, he said.

    Gray pointed to Medtronic’s postmarket Anchor Registry, which includes more than 1,800 patients and shows that endoanchors work by providing proximal sealing after EVAR, which leads to a shrinkage of the aneurysm sac, which increases long-term survival and leads to fewer cardiac events. Suture-Tight, he said, is the next-generation technology, building on the anchor.

    Gray said Suture-Tight delivers nitinol sutures and secures the endovascular graft to the aorta at initial implant or for a subsequent procedure.

    “The theme here is that we don’t sell endovascular grafts,” he said. “We’re selling the suture catheter that makes the grafts last longer.”

    Gray said that 16-French over-the-wire 0.035-inch prototypes of Suture-Tight demonstrated the proof of concept in preclinical cases. Each device is preloaded with four sets of sutures. He also played a video during his presentation showing that if a suture happens to be deployed in the wrong position, it is easily retractable and repositioned.

    Other innovations

    The other innovations presented Saturday were:

    • A device designed to leverage interaction with the heart by the Impella transvalvular pump to manage treatment of critically ill patients, presented by Steven Keller, MD, PhD, of Brigham and Women’s Hospital, Boston.
    • A novel extravascular temporary pacing lead system, presented by Gary Gerhsony, MD, of John Muir Health Cardiovascular Institute, San Francisco.
    • A transcatheter antiembolic filter, designed to capture debris and protect both the cerebral and peripheral vessels, presented by Filippo Scalise, MD, of Policlinico di Monza, Italy.

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