BACKGROUND: To evaluate whether the Alfieri technique improves clinical and haemodynamic results and compare it with transaortic mitral valve secondary cord cutting in patients scheduled for septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy. METHODS:Forty-eight (48) patients with moderate-to-severe systolic anterior motion (SAM)-mediated mitral regurgitation were randomly assigned to the Alfieri or Cutting groups in addition to septal myectomy. The primary endpoint was postoperative mean transmitral pressure gradient (TPG). The secondary endpoints were residual left ventricular outflow tract (LVOT) gradient after procedure, residual mitral regurgitation (MR), postoperative SAM, repeating bypass, and survival. RESULTS: There were no 30-day mortality and ventricular septal defects. The postoperative LVOT gradient was 15.4±7.6 mmHg and 11.1±4.9 mmHg (p=0.078) in the Alfieri and Cutting groups, respectively. The Alfieri technique was associated with higher peak (7.8±3.3 vs 4.7±2.8 mmHg; p=0.014) and mean (3.9±1.7 vs 2.1±1.6 mmHg; p=0.013) TPG. The Cutting group was associated with higher mild MR rate at discharge (six vs no patients; p=0.009). One (1) patient (4.2%) in the Alfieri group required pacemaker implantation owing to conduction disturbances (p=0.312). Two-year (2-year) freedom from late mortality and sudden cardiac death rates were 95.5%±4.4% and 100% for the Alfieri and Cutting groups, respectively (log rank, p=0.317). No patients had New York Heart Association functional class III or IV or moderate or severe MR. The maximum LVOT gradient was 20.4±15.2 mmHg and 16.7±10.4 mmHg, respectively (p=0.330). There were no reoperations during follow-up. CONCLUSIONS: Both techniques with septal myectomy effectively eliminated SAM-induced MR and LVOT obstructions in hypertrophic cardiomyopathy patients.
RCT Entities:
BACKGROUND: To evaluate whether the Alfieri technique improves clinical and haemodynamic results and compare it with transaortic mitral valve secondary cord cutting in patients scheduled for septal myectomy for severely symptomatic hypertrophic obstructive cardiomyopathy. METHODS: Forty-eight (48) patients with moderate-to-severe systolic anterior motion (SAM)-mediated mitral regurgitation were randomly assigned to the Alfieri or Cutting groups in addition to septal myectomy. The primary endpoint was postoperative mean transmitral pressure gradient (TPG). The secondary endpoints were residual left ventricular outflow tract (LVOT) gradient after procedure, residual mitral regurgitation (MR), postoperative SAM, repeating bypass, and survival. RESULTS: There were no 30-day mortality and ventricular septal defects. The postoperative LVOT gradient was 15.4±7.6 mmHg and 11.1±4.9 mmHg (p=0.078) in the Alfieri and Cutting groups, respectively. The Alfieri technique was associated with higher peak (7.8±3.3 vs 4.7±2.8 mmHg; p=0.014) and mean (3.9±1.7 vs 2.1±1.6 mmHg; p=0.013) TPG. The Cutting group was associated with higher mild MR rate at discharge (six vs no patients; p=0.009). One (1) patient (4.2%) in the Alfieri group required pacemaker implantation owing to conduction disturbances (p=0.312). Two-year (2-year) freedom from late mortality and sudden cardiac death rates were 95.5%±4.4% and 100% for the Alfieri and Cutting groups, respectively (log rank, p=0.317). No patients had New York Heart Association functional class III or IV or moderate or severe MR. The maximum LVOT gradient was 20.4±15.2 mmHg and 16.7±10.4 mmHg, respectively (p=0.330). There were no reoperations during follow-up. CONCLUSIONS: Both techniques with septal myectomy effectively eliminated SAM-induced MR and LVOT obstructions in hypertrophic cardiomyopathypatients.