Percutaneous transvenous mitral commissurotomy: with or without heparin? A randomised double blind study

Abstract

Background: Percutaneous transvenous mitral commissurotomy (PTMC) is an alternative approach to open heart surgery in patients with symptomatic mitral stenosis (MS). Aim: To compare the outcome of performing PTMC with or without heparin administration. Methods: In this randomised clinical trial, 480 patients with symptomatic MS were randomly allocated to one of two groups, with or without heparin administration as part of the procedure. Echocardiographic and clinical outcomes of PTMC assessed before the procedure, during hospitalisation, and after the one-month follow-up, were compared between the two groups. Results: Baseline demographic and clinical characteristics were similar in the 240 patients with heparin administration (the Hep [+] group) and the 240 patients without heparin administration (the Hep [-] group) during the procedure. In the whole study group mitral valve area (MVA) was 0.94 +/- 0.03 cm(2) prior to PTMC, and increased to 1.85 +/- 0.06 cm(2) after the procedure (p = 0.0001). The mean increase in MVA was 0.85 +/- 0.27 cm(2) in the Hep (+) group and 0.88 +/- 0.2 cm(2) in the Hep (-) group (NS). During the procedure, or immediately after PTMC, embolic events were recorded in two (0.83%) Hep (+) patients and one (0.42%) Hep (-) patient (NS). The frequency of haematoma at puncture site (three 11.25%) Hep [+] vs two 10.83%) Hep [-]), and the need for urgent surgery (two [0.83%] Hep [+] vs five [2.1%] Hep [-]), were similar in both groups. There were no embolic events after discharge or during the one month follow-up period. Conclusions: Our study revealed that in high volume centres and in selected patients without left atrial thrombus, heparin administration during PTMC is not associated with any additional protective effect against embolic events during short-term follow-up.