Two new codes for transcatheter aortic valve implantation (TAVI) have been added to the ICD-9 by CMS, becoming effective October 1st. The addition comes prior to the FDA's circulatory system devices panel meeting scheduled for next week, where it will review Edwards Lifesciences' premarket approval application for its Sapien transcatheter valve.
Currently approved for use in Europe, the Sapien valve was used in the PARTNER trials, comparing outcomes between a cohort of patients undergoing TAVI versus those receiving the more traditional open heart valve replacement. Preliminary results of the trial showed a lower rate of all-cause death for TAVI patients (30.7%) as compared with the open heart cohort. (50.7%)
Edwards is not the only player in the market. Medtronic is also a producer of transcatheter valves, which are currently being tested in the CoreValve U.S. Clinical Trial. Positive results stemming from PARTNER as well as from the SOURCE registry have attributed to growing interest in the device and procedure, which offers the possibility of treating a growing number of patients by providing a treatment option to those too ill to be eligible for open heart. In fact, analysts expect the number of heart valve procedures to grow at an annual rate of 6% through 2015, pushing the total value of the market to $1.25 billion.
Interest in the CV community is so strong that despite the technology not yet receiving FDA approval, the STS and ACC released a consensus paper in late June, as blogged about my colleague Brian Maher earlier this week.
For those interested in the multidisciplinary requirements of TAVI procedures, including hybrid ORs, the Cardiovascular Roundtable's 2011 study, Heart and Vascular Service Line Integration, offers both strategic and implementation guidance on the major components heart and vascular collaboration. (Heartwire, 9/10; Heartwire, 7/2011; Businesswire 6/11; CMS)