TCT Presents Studies of Medtronic's CoreValve

September 22, 2009—Medtronic, Inc. (Minneapolis, MN) announced that data on the Medtronic CoreValve percutaneous aortic valve system were presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2009 scientific symposium in San Francisco. Medtronic acquired CoreValve, Inc., in April. The CoreValve system device is commercially available internationally but is an investigational device in the United States.

According to the company, the clinical performance of the Medtronic CoreValve system was highlighted in 13 scientific presentations at TCT's Valvular Heart Disease Summit on September 21. Presentation of the European/Canadian 18-F safety and efficacy study included 2-year patient follow-up data supporting the safety, efficacy, and durability of the CoreValve.

According to the conference's newspaper, TCT Daily, on September 22, data from several ongoing registries suggest that use of the CoreValve transcatheter aortic valve is safe and efficacious in elderly patients with severe aortic stenosis. Eberhard Grube, MD, presented single-center approval data from the Seigburg CoreValve experience beginning in 2004. Several clinical endpoints decreased with subsequent generations of the CoreValve device. The in-hospital mortality rate decreased from 40% in the 25-F group (n = 10) to 3% in the most recent 18-F group (n = 130). The in-hospital stroke rate also decreased from 10% in the 25-F group to 1.5% in the (2009) 18-F group. The Karnofsky index was 33.3 in the 25-F group, increasing to 40.7 in the 21-F group and 44.9 in the 18-F safety and efficacy study.

TCT Daily also reported that Gerhard Schuler, MD, presented post-CE Mark–approval results from the CoreValve-initiated, 18-F expanded evaluation registry. Dr. Schuler noted that more than 5,000 CoreValve devices have been implanted since the CE Mark approval. Follow-up status at 30 days, including implantation and procedural results, was available for 1,483 patients. Dr. Schuler reported a procedural success rate of 98.5% in the expanded evaluation registry. The total 24-hour mortality rate was 2.4%, and the 30-day mortality rate was 10.3%. In addition, 30-day New York Heart Association functional class improved by one or two levels in the majority of registry patients after device implantation.

The most common 24-hour adverse events were permanent pacemaker requirement (7.2%), major arrhythmias (5%), major bleeding (5%), and cardiac tamponade. The most common 30-day adverse events were permanent pacemaker requirement (25%), major arrhythmias (15.7%), major bleeding (6.9%), and cardiac death (6.7%). Mean peak gradient decreased from 78.1 mm Hg to 17.1 mm Hg, and the mean gradient decreased from 48.1 mm Hg to 8.9 mm Hg. Dr. Schuler concluded that available data indicate that procedural success rate is higher than 98%, and the 30-day mortality rate is approximately 10%; however, data regarding mortality and clinical status are far from complete, despite a large number of implant devices, the TCT Daily reported.