Percutaneous mechanical mitral commissurotomy with a newly designed metallic valvulotome - Immediate results of the initial experience in 153 patients

Background-Percutaneous balloon valvotomy has become a common treatment of mitral stenosis, but the cost of the procedure remains a limitation in coun tries with restricted financial resources, leading to a frequent reuse of t he disposable catheters, To overcome this limitation, a reusable metallic v alvotomy device has been developed with the goals of both improving the mit ral valvotomy results and decreasing the cost of the procedure. Methods and Results-The device consists of a detachable metallic cylinder w ith 2 articulated bars screwed onto the distal end of a disposable catheter whose proximal end is connected to an activating pliers. By the transsepta l route, the device is advanced across the valve over a traction guidewire, Squeezing the pliers opens the bars up to a maximum extent of 40 mm, The c linical experience consisted of 153 patients with a broad spectrum of mitra l valve deformities. The procedure was successful in 92% of cases and resul ted in a significant increase in mitral valve area, from 0.95+/-0.2 to 2.16 +/-0.4 cm(2). No increase in mitral regurgitation was noted in 80% of cases . Bilateral splitting of the commissures was observed in 87%, Complications were 2 cases of severe mitral regurgitation (1 requiring surgery), 1 peric ardial tamponade, and 1 transient cerebrovascular embolic event. In this se ries, the maximum number of consecutive patients treated with the same devi ce was 35. Conclusions-The results obtained with this new device are encouraging and a t least comparable to those of current balloon techniques. Multiple uses af ter sterilization should markedly decrease the procedural cost, a major adv antage in countries with limited resources and high incidence of mitral ste nosis.