A Lifesaving “Knife to the Heart”- Performing a Heart Operation Without Surgical Intervention

 

Jerusalem’s Shaare Zedek Medical Center Becomes First in the World to Perform Procedure Designed by Pi-Cardia Ltd. Using  a tiny knife Inserted to the Heart Via Catheterization.

The Catheterization Unit of the Jesselson Integrated Heart Center at Shaare Zedek Medical Center in Israel recorded a historic first in the world heart landmark procedure inserting a tiny knife into the heart of a patient to prevent blockage, without performing open heart surgery. The technology called ShortCut and developed by the Rehovot, Israel based Pi-Cardia Ltd. is the world’s first dedicated device designed to split the leaflets of a pre-existing valve to enable safe Transcatheter Aortic Valve Replacement (TAVR) in patients at risk for coronary obstruction or compromised coronary access. Pi-Cardia Ltd. is a global leader in the development of non-implant, catheter-based solutions for treating heart valves.

The patient, 96 year-old Annette Chron, was diagnosed with a valve blockage that had significantly affected her overall functioning and was deemed life-threatening.

Numerous experts told her that an open-chest surgery would be extremely dangerous and that traditional valve replacement catheterization techniques were not suitable for her condition. “I realized that whatever options I might have had earlier in life would be increasingly difficult. I consulted with several doctors around the country but every one told me the same thing; you’re better off living with the blockage and not taking the risk,” she says.

The new approach advanced at Shaare Zedek relied on a recent Israeli development, a tiny knife, only millimeters long, that can be maneuvered into the heart by catheterization through the body vessels, without stopping the functioning of the organ. The procedure performed by a team led by Dr. Danny Dvir, Director of the Catheterization Unit at Shaare Zedek, utilizing the technology developed by Pi-Cardia Israel.

“We are very excited about this key milestone of demonstrating clinical feasibility with ShortCut, which allows us to move forward with our clinical plan in the US and Europe,” said Erez Golan, Pi-Cardia’s Chief Executive Officer. “As the number of patients with aortic stenosis continues to grow, Shortcut may offer important new treatment options for both physicians and patients.”

Dr. Dvir explained that in cath-lab valve replacement procedures, the leaflets of the existing valve are pushed aside by the new valve. In certain patients and in certain conditions these leaflets are positioned in such a way that they may impact the blood flow and increase the risk of fatal heart attacks after valve replacement. Traditionally this condition presented a situation where many patients had poor options for effective treatment.

“Our goal became to find a method where we could lacerate the problematic leaflet but to do so without performing open-heart surgery. This tiny knife that is only millimeters long, with extreme caution can be entered the heart through the blood vessels,” Dr. Dvir explained. “This new method joins many other remarkable innovations in the field of interventional cardiology and significantly expands our possibilities. We can say that we are able to perform real surgical procedures, without opening the patient chest or stopping the heart function.”

Annette was released from the hospital few days after the procedure and was able to shortly return to a high level of functioning.

Annette says that this innovation represents a significant step forward for her and many others, “Medicine has grown so much in recent years,” she says. “In my thirties, I began working as a nurse and many different fields of medicine were managed similarly with very basic methods. Nowadays you can do all sorts of things without opening up the patient and it’s simply incredible! Thanks to this new approach I can go back to doing what I am used to like swimming and light walks. I very much look forward to being able to be with my grandchildren and their children. I feel great. I’ve already gotten vaccinated and invite everyone to vaccinate so we can get back to our normal lives.”

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