News Article Title

December 14, 2011

Doctors at Holy Spirit Hospital perform United States’ first non-trial TAVR procedure using the SAPIEN device

Rajesh Dave, MD, FACC, FSCAI, Chief Medical Executive, Holy Spirit Cardiovascular Institute, and Director, Cardiac Catheterization Laboratories at The Ortenzio Heart Center at Holy Spirit, and Vincent Park, MD, Cardiovascular Surgical Institute, together successfully performed the United States’ first (non-trial, commercial use) transcatheter aortic valve replacement (TAVR) using the Edwards Lifesciences’ SAPIEN device at Holy Spirit Hospital. The U.S. Food and Drug Administration (FDA) approved the Edwards SAPIEN Transcatheter Heart Valve Model 9000TFX and accessories for commercial use on November 2, 2011.

The TAVR procedure allows doctors to implant an artificial heart valve as they would a coronary stent without opening the chest or using heart and lung bypass machines. This procedure is especially beneficial to patients who are too sick to undergo conventional open heart surgery. “With TAVR we can now significantly improve life expectancy and quality of life for patients who have very limited treatment options,” says Dr. Dave.  “When patients are treated with medical therapy alone, because they cannot have surgery or are at a high risk for open heart surgery, we’ve seen very poor outcomes—in recent trials and clinical practice. “TAVR represents one of the greatest advances in treating cardiovascular disease.”

Dr. Park, a cardiovascular surgeon, makes a small incision into the patient’s groin, allowing access into the artery for Dr. Dave to implant the SAPIEN device using a balloon catheter.

Two TAVR procedures were performed on Monday, December 12, and one was performed today. The first patient, a 93-year-old male, was discharged today, two days after undergoing this procedure.

Capital Cardiovascular Associates has offices on the East and West Shores, including 5 Capital Drive, Harrisburg, and 101 Erford Road, Camp Hill. The phone number is 724-6450. Cardiovascular Surgical Institute is located a 423 North 21st Street, Camp Hill. Both practices are services of Holy Spirit Health System.