When an older patient with some medical problems and a medium level of surgical risk needed to have a leaky heart valve repaired, they weighed their options with the care team at Atrium Health Sanger Heart & Vascular Institute.
The patient was diagnosed with severe symptomatic degenerative mitral regurgitation (DMR) (more information below), evaluated by Sanger Heart & Vascular Institute’s multidisciplinary heart team and given a choice between either open heart cardiac surgery, the standard of care, or a new, investigational technology, the CardioMech MVRS, which involved enrolling in a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approved Early Feasibility Study.
This decision meant trying a new heart valve repair technology that had never been done on a human before. The patient chose to try the new technology and the procedure was conducted in early September 2021. As it turned out, the patient became the first person in the world to receive a transcatheter transseptal chordal mitral valve repair with the CardioMech MVRS technology, repairing the leaky heart valve without surgery.
The patient could feel confident in the capable hands of the experienced care team at Atrium Health Sanger Heart & Vascular Institute. “For over a decade, we’ve been a leader and innovator in transcatheter mitral valve therapies,” said Michael Rinaldi, MD, interventional cardiologist and medical director of the Structural Heart Program at Sanger Heart & Vascular Institute. “This was such an exciting opportunity to be part of the very first human clinical trial of a technology that may prove to be an alternative therapy to other therapies we’ve worked with and developed.”
About Mitral Regurgitation (MR)
MR is the third most common cardiovascular disease with a prevalence of over 4 million people afflicted in the U.S. each year. 1 It is the backward flow of blood from the left ventricle into the left atrium, reducing flow to the rest of the body. MR occurs when the mitral valve leaflets do not close properly or when the heart is enlarged.2
The signs and symptoms of MR may be shortness of breath, fatigue, heart murmur or palpitations which can cause heart failure, pulmonary hypertension, stroke and even death.3
Degenerative Mitral Regurgitation (DMR)
Most of the patients that suffer from MR have DMR (56%),1 a type of MR caused by a structural defect with the mitral valve chords (chordae tendinea) such as a floppy leaflet, called prolapse, or ruptured native chord, called flail.4 This was the case for Dr. Rinaldi’s patient.
Mitral valve surgery
“Traditionally, mitral valve repair using open-heart surgery has been the standard of care,” said Dr. Rinaldi. “At the hands of excellent, high-volume surgeons, the results can be both life-changing and life-saving.”
However, some patients aren’t ideal candidates for open-heart surgery. For example, some patients have other medical problems or age-related factors that increase the risk of complications from surgery.
CardioMech Mitral Valve Repair System (MVRS)
CardioMech is developing a catheter-based mitral valve repair technology designed to treat patients suffering from moderate to severe or severe, symptomatic DMR due to prolapse or flail.
The CardioMech technology is designed to provide a catheter-based therapy for the placement of artificial chord(s) to reduce or eliminate MR as an alternative to surgical mitral valve repair.
The CardioMech MVRS procedure implants an artificial chord(s) with anchors on each end, one for the mitral valve leaflet, the other for the left ventricle wall. Once the anchors are placed, the artificial chord is adjusted on a beating heart with the goal of reducing or eliminating the regurgitation.
History of innovative valve repair
In 2005, Sanger Heart & Vascular Institute was among the first 10 centers in the world to pioneer another transcatheter mitral valve repair using the Abbott MitraClip.
In addition to valve repair, Sanger Heart & Vascular Institute was also among the first centers in the world to perform transcatheter repair and mitral valve replacement using a variety of technologies.
Catheter-based valve repair
“This procedure allows the surgeon to pull the floppy mitral leaflet down in real time, while the valve is opening and closing, attempting to bring the valve back to its natural form,” Dr. Rinaldi explained. “If the procedure doesn’t work, “the surgeon can simply repair the valve surgically or add a catheter-based clip to further minimize leaking.”
Advantages of minimally invasive techniques
According to Dr. Rinaldi, a typical patient has a 1%-2% risk of complications from surgery. “However, the sicker you are and the older you are, the higher your risk of complications and the longer your recovery will be,” he revealed.
With traditional heart surgery, patients are usually in the hospital for 3 to 5 days, with a total recovery time of over a month. Older patients may have to finish their recovery in a rehab or nursing facility.
“For older patients with extensive medical problems, the potential for low complication rates and quick recoveries are especially appealing,” Dr. Rinaldi noted. “Young, healthy patients may prefer surgical valve repair, since it yields durable results.”
Multidisciplinary team of experts
“When it comes to treating patients with valvular heart disease, we’re happy to offer expertise in multiple areas,” Dr. Rinaldi said. “We’re experts in medical management, surgical therapies and catheter-based techniques. This allows us to offer patients multiple options and tailor the treatment plan to meet their unique needs.”
The multidisciplinary valve repair team includes the following experts:
- Advanced imagers: Specialists who take pictures that guide the care team and who use medical imaging techniques, including computed tomography and magnetic resonance imaging, to define problems in the patient’s heart.
- Surgeons: Doctors who are skilled in surgical techniques.
- Catheter-based physicians: Doctors who are trained and experienced in using catheters to treat patients without surgery.
“Our valve repair experts work together in a collaborative environment in order to improve patient care,” said Dr. Rinaldi. “Each of our own abilities is enhanced because we feed off each other.”
Clinical research
Sanger Heart & Vascular Institute’s clinical research team conducts both sponsored and outcomes studies in collaboration with experts from structural heart, electrophysiology, vascular, heart failure and cardiothoracic surgery clinics. Outcomes studies are also referred to as investigator-initiated studies, which are requested by a physician. The team currently has over 60 sponsored trials and over 50 outcomes trials.
“It’s an amazing feeling to be able to offer cutting-edge research in the form of procedures, devices, and medications to patients who would have few other options available for treatment,” says Dana Amaro, MSN, RN, program coordinator for Atrium Health Sanger Heart & Vascular Institute – Clinical Research. “To be ‘first in human’ further instills in our team a sense of pride to be part of an institution that has our exceptional level of knowledge, experience and competence.”
Positive outcome, quick recovery
How did things turn out for the world’s first catheter-based mitral valve repair patient? “It was a complete win and a clinical success acutely,” explained Dr. Rinaldi. “The care team was able to take the patient’s mitral valve leak from severe down to mild. The patient did really well during the procedure and went home the next day.”
Ultimately, durability for this technique still poses challenges and the research work and innovation continue. While this procedure is investigative and not yet a standard modality of care, the acute outcomes are promising. Ongoing studies will indicate whether these results are repeatable.
“When we’re caring for patients, we don’t want to just offer good care; we want to offer the best science-based medicine available,” Dr. Rinaldi said. “Our goal is to provide the latest techniques and technology to our patients. That’s why we’re continuing to pioneer these technologies through clinical trials.”
To learn more about heart care at Sanger Heart & Vascular Institute, visit online.
Caution: CardioMech MVRS is an investigational device in the United States. CardioMech MVRS is limited by federal (or United States) law to investigational use. It is not available for sale in the United States. The CardioMech MVRS is not available for sale in any region and has not received any regulatory approvals.
1 Leon, Martin B., (2017). What is Structural Heart Intervention Today [PowerPoint] London: PCR London Valves 2017.
2 Columbiasurgery. (2020). Mitral Valve Regurgitation. https://columbiasurgery.org/conditions-and-treatments/mitral-valve-regurgitation.
3 Hanson, Ivan. (2018). Mitral Regurgitation. https://emedicine.medscape.com/article/155618-overview.
4 Pellerin D, Brecker S, Veyrat C. Degenerative mitral valve disease with emphasis on mitral valve prolapse. Heart. 2002;88 Suppl 4(Suppl 4):iv20-iv28. doi:10.1136/heart.88.suppl_4.iv20.
