Toronto: St. Michael’s Cardiology Team Performs World`s First Implantation of Pascal System From Edwards Lifesciences to Treat Tricuspid Regurgitation

March 12, 2020 — Interventional cardiologist Dr. Neil Fam and the valve team at St. Michael’s Hospital have performed yet another world-first procedure.

Dr. Fam and the team implanted a new device called the Pascal system in a patient with tricuspid regurgitation – a condition in which the valve separating the two right chambers of the heart is leaking. This can cause the heart to enlarge, eventually leading to symptoms of heart failure such as shortness of breath, fatigue and leg swelling.

Until now there have been few minimally invasive treatment options for people with tricuspid regurgitation, which affects about 5 per cent of people over age 75 and has a high mortality rate.

Dr. Fam has been among the first interventional cardiologists using the Pascal system, developed by Edwards Lifesciences originally to treat patients with mitral regurgitation who might otherwise have no other treatment options.

The current standard minimally invasive treatment for mitral regurgitation is Mitraclip, where a catheter inserted in the femoral vein guides the device to the heart where it clamps the leaky valve. But a considerable number of patients are not eligible for a MitraClip for anatomical reasons.

The Pascal system uses a spacer, a device to fill the space between the leaflets, or doors, of the heart valve that are not closing together as tightly as they should. The leaflets of the valves are then clamped onto the spacer. Dr. Fam said the features of the Pascal system may be better tailored for patients with complex anatomy.

Edwards has been working with physicians on developing the Pascal procedure to address people with tricuspid regurgitation. Dr. Fam and the valve team, consisting of echocardiographers, anesthesiologists, nurses and technicians, successfully performed this procedure for the first time in 2017 and several times since.

Dr. Fam described the first procedure in a case study published Feb. 26 in the Journal of the American College of Cardiology: Cardiovascular Interventions and presented Feb. 27 at the international Mitral Valve Meeting in Zurich, Switzerland.

The first patient was an 82-year-old woman who had been hospitalized five times for heart failure and was too high risk for conventional surgery. After the Pascal system was inserted, her tricuspid regurgitation was mild and her condition improved so much that she was discharged from hospital three days later. Dr. Fam said her quality of life has improved dramatically and she has had no further hospitalizations.

Dr. Fam said the ability to use the Pascal system, in addition to Mitraclips, reinforces St. Michael’s national leadership in this field.

“Most importantly, we are giving these sick patients more treatment options, with improved quality of life and less time in hospital,” he said.

About St. Michael's Hospital

St. Michael’s Hospital provides compassionate care to all who enter its doors. The hospital also provides outstanding medical education to future health care professionals in more than 29 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, care of the homeless and global health are among the Hospital’s recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing International Healthcare Education Centre, which make up the Li Ka Shing Knowledge Institute, research and education at St. Michael’s Hospital are recognized and make an impact around the world. Founded in 1892, the hospital is fully affiliated with the University of Toronto.