Valve-in-valve technique fixes leaks after TAVI

Catania, Italy - Italian registry data confirm the so-called "valve-in-valve" technique for repairing malpositioned CoreValve (Medtronic, Minneapolis, MN) transcatheter aortic valves is a good option for patients with significant paraprosthetic leaks without recourse to surgery [1]. Dr Gian Paolo Ussia (University of Catania, Italy) and colleagues reviewed 663 consecutive patients who underwent transcatheter aortic-valve implantation (TAVI) with the 18-F CoreValve ReValving System at 14 centers across Italy and analyzed the clinical and echocardiographic outcomes of the 24 patients in that group who underwent a valve-in-valve intervention for severe paraprosthetic leaks. Alternatives to the valve-in-valve approach include postdilation with balloons, repositioning the valve with a snare catheter, or just observation. The physician decides which approach to use based on hemodynamic parameters, echo, and the clinical response of the patient, according to Ussia. "We found that a second appropriately placed device served as a good bailout method and effectively managed the hemodynamic instability," Ussia told heartwire. "Communication and sharing of experience between implanting physicians and proctors was instrumental in understanding that this could be a very effective and safe maneuver, which then was utilized routinely." Their study was published in the March 1, 2011 issue of the Journal of the American College of Cardiology. In the 3.6% of patients undergoing the valve-in-valve procedure to fix a leak, the most common type of device malposition was deployment that was too low inside the left ventricular outflow tract (75% of cases). The only statistically significant baseline difference between the patients needing a second valve and those who did not is that the former group had a slightly larger average annulus diameter (23.6 mm vs 22.1, p=0.010). In most cases, balloon dilation was necessary to optimize the expansion of the second device, but this did not damage the leaflets or aortic root structures. There were no major adverse cerebrovascular and cardiac events within 30 days for the patients undergoing the a second valve implant, and the procedural, 30-day, and 12-month outcomes of the valve-in-valve group, including survival and major adverse events, were statistically equivalent to the outcomes of those who did not require a second intervention (95.5% for the valve-in-valve patients and 86.3% for the patients who did not need a second procedure). Procedural success was obtained in 100% of the valve-in-valve patients, with no periprocedural death. There were no cases of valve deterioration or new onset of central or perivalvular regurgitation observed or any reports of thrombotic or embolic events in the valve-in-valve group, "which reflects well on the design features and the endothelialization of the [CoreValve] device," according to the authors. "The valve-in-valve technique can be used readily in the catheterization laboratory as bailout therapy for a failed implantation resulting from a malpositioned valve with severe paraprosthetic leak when the attempt of reposition with the snare technique fails, preventing conversion to emergency open-heart surgery," the authors explain. "The availability of a bailout provides a margin of safety and enhances operator confidence. This is important for a nascent technology like TAVI to gain widespread clinical acceptance." This margin of safety is important because which patients will develop a leak is difficult to predict prior to their initial valve-replacement procedure, Ussia told heartwire. Ussia said Medtronic's ADVANCE registry may answer more questions about the long-term durability of valves implanted in other prosthetic valves as well as their effects on coronary perfusion.