HACKENSACK, N.J. — Doctors at Hackensack University Medical Center performed the first commercial procedure in the United States using a newly approved catheter-delivered device to seal leaks around replacement heart valves, Hackensack Meridian Health said Monday.
The hospital said Dr. Ryan Kaple, director of its Structural & Congenital Heart Program, and Dr. Craig Basman, the program’s associate director, performed the procedure last week using the Abbott Amplatzer Paraclose PVL Occluder. According to the hospital, the device was recently approved by the FDA and is the first and only transcatheter device in the U.S. designed specifically for these leaks.
The condition, called a paravalvular leak, occurs when a small gap forms between a patient’s own heart tissue and a replacement valve, allowing blood to flow backward. The hospital said such leaks occur in up to 17% of mitral valve replacements and 10% of aortic valve replacements, and left untreated can cause anemia, shortness of breath, swollen legs and eventually heart failure.
Until now, the hospital said, repairing these leaks often meant a second open-heart surgery. In the new approach, doctors thread the small device through a catheter inserted into a blood vessel in the leg and guide it to the heart, where it expands to seal the gap. Dr. Perry Wengrofsky, the hospital’s director of interventional and structural echocardiography, helped guide the procedure with ultrasound.
“For years, patients suffering from a paravalvular leak had very limited, highly invasive options,” Kaple said. “Being able to seal this leak through a simple catheter procedure is a profound step forward.”
“Paravalvular leaks can be difficult to treat, and for many patients a second open-heart surgery carries significant risk,” Basman said. “The Amplatzer Paraclose occluder gives us a purpose-built, precise way to close these leaks through a catheter, so patients can recover faster and return to the lives they want to lead.”
The hospital said it was a participant in the PARADIGM clinical trial, the study used to show the FDA the device’s safety and effectiveness. It added that heart valve disease and valve replacements are increasing, particularly among women and younger, active adults.
Patients who previously had a valve replaced and now have unexplained fatigue, shortness of breath or swelling may have such a leak, the hospital said.
This report is based on a press release from Hackensack Meridian Health.
Leave a Reply