St. Michael’s cardiologist performs successful world first, using a novel Canadian-invented device

TORONTO, May 24, 2017—When Dr. Neil Fam examined his 86-year-old patient with severe mitral regurgitation—a condition in which the blood flows backward into the heart after it contracts—his options for treating her were limited.

Because of her age and overall health, Ortensia Aceti of Sault Ste. Marie, Ont., was not a good candidate for surgery to repair her mitral valve, the flap between the two left chambers of her heart. She had been in and out of hospital with heart failure, and medication was no longer controlling her symptoms.

Instead, Dr. Fam decided on a catheter-based treatment to guide a MitraClip® device to the heart and clamp the leaky valve. The catheter would usually be inserted through the femoral vein in the leg, but her vein was blocked.

“We were locked out, blocked from accessing her heart,” said Dr. Fam, an interventional cardiologist and director of the Cardiac Intensive Care Unit of St. Michael’s Hospital in Toronto.

Dr. Fam recalled a conversation he had about a year previously with Baylis Medical Company, Inc., a Canadian supplier of high-tech cardiology equipment, about their SupraCross® RF Solution, which includes a steerable sheath and radiofrequency wire that were designed to achieve transseptal access to the heart from alternative approaches. These devices can enter the body through the jugular vein in the neck, enabling access to the leaky valve despite the blockage in her leg.

For the first time in the world, Dr. Fam successfully used the SupraCross® RF Solution to guide a MitraClip® device through the jugular vein into the heart and successfully repair a leaking mitral valve.

Dr. Fam said this was possible, despite the awkward angle of the jugular vein in relation to the heart, because the tip of the sheath is steerable and the wire is equipped to deliver radiofrequency energy to puncture the septum of the heart. This allows the physician to position the system appropriately from this challenging angle, and puncture the septum in a precise and controlled manner without using excessive force. The septum is the dividing wall between the left and right sides of the heart and it’s the last barrier to getting to the mitral valve, which sits between the left ventricle and the left atrium.

Dr. Fam said that Mrs. Aceti had no complications and that her condition improved, allowing her to be discharged to her home. At a follow-up appointment, the patient was doing well with no further heart failure.

Sue Carlucci, one of Mrs. Aceti’s three daughters, said that Dr. Fam explained the novel procedure to the family carefully in advance.

“If Dr. Fam hadn’t suggested this procedure, we probably would have lost our mom,” she said.

“He’s our angel,” she said, referring to St. Michael’s nickname, the Urban Angel.

Dr. Fam said that while this procedure would be appropriate for only selected patients, they are high-risk patients for which there may be no other treatment options.

“Given the success of this procedure, the door is open for future studies of the jugular approach for treating the mitral valve,” he said.

Dr. Fam published a report of this procedure in the journal Eurointervention on May 9.

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 Center, 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.

For more information, or to interview Dr. Fam please contact:
Leslie Shepherd
Manager, Media Strategy
Phone: 1-416-864-6094
shepherdl@smh.ca
St. Michael’s Hospital
Inspired Care. Inspiring Science.

About Baylis Medical
Baylis Medical develops and markets high-technology medical devices used in the fields of interventional cardiology, interventional radiology, and spinal procedures. Our vision is to develop and market innovative medical therapies while Improving the Lives of People Around the World. The company has offices in Montreal and Toronto (Canada), Boston (USA), London (U.K.) and Munich (Germany). For more information, visit www.baylismedical.com.

© Baylis Medical Company Inc., 2017. The Baylis Medical logo and SupraCross are trademarks and/or registered trademarks of Baylis Medical Company Inc. in the USA and/or other countries. All other trademarks are the property of their respective owners. CAUTION: Federal Law (USA) restricts the use of these devices to or by the order of a physician. Before use, consult product labels and Instructions for Use for Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Directions for Use.