A clinical study is ongoing within the United States to evaluate the use of the NeoChord DS1000.
Mount Sinai Heart is leading a multicenter clinical trial of a minimally invasive mitral valve prolapse repair technology that has the potential to transform the standard of care for the disorder. The ReChord Trial is a randomized U.S. Food and Drug Administration study exploring the NeoChord DS1000 system in treating patients with degenerative mitral valve regurgitation. Ahmed El-Eshmawi, MD, Assistant Professor of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai, says the appeal of the device is that it enables surgeons to replace damaged chordae tendineae with artificial chordae without using cardiopulmonary bypass or cutting the sternum.
“While the heart is beating, you make a small incision under the patient’s left nipple, insert the device, and implant the artificial chords to the mitral valve,” says Dr. El-Eshmawi, the site Principal Investigator for the study. “Under normal physiological conditions, you can use transesophageal echocardiography to control the length of these chords to ensure the mitral regurgitation is corrected and the patient is cured.”
David H. Adams, MD, Cardiac Surgeon-in-Chief of the Mount Sinai Health System, and the Marie-Josée and Henry R. Kravis Professor and Chair of Cardiovascular Surgery, Icahn School of Medicine at Mount Sinai, is National Co-Principal Investigator of the trial. In November 2016, Dr. Adams led a team at The Mount Sinai Hospital that performed the first surgery in the national ReChord Trial.
Thirty medical centers and 585 patients with single-segment mitral valve prolapse will participate in the seven year clinical trial, which is to be completed in July 2023. Dr. El-Eshmawi says half of the subjects will receive a mitral valve repair with the NeoChord device and the control group will receive repair using standard surgical techniques with cardiopulmonary bypass.
Although data on the clinical trial are not yet available, Dr. El-Eshmawi says, “At Mount Sinai, we have noticed that patients in the device group progress sooner following the procedure than those in the surgical control group. In almost all cases, they leave the operating room already extubated. This suggests the technology might lead to a faster recovery rate with a shorter hospital stay than the current standard of care.”
After their procedures, all patients in the trial are monitored through consultations, phone surveys, and echocardiograms to determine the durability of the NeoChord repair compared with the standard of care. Dr. El-Eshmawi says the technology does not use an annuloplasty ring to support the repaired valve, so follow-up is needed to determine the long-term durability. He is optimistic that the NeoChord technology, which has received European Union clearance, could achieve outcomes comparable to standard surgery in well-selected patients.
“I think it will prove to be a safe and effective technology,” he says. “Patients are certainly interested in it as a treatment option. We are getting phone calls from across the country about this trial, so it is gaining popularity very quickly.”
CAUTION: The NeoChord DS1000 is an investigational device limited by federal (United States) law to investigational use.