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Left and right atrial transport function after the maze procedure for atrial fibrillation: An echocardiographic Doppler follow-up study
Objectives: We evaluated atrial transport function after the Maze procedure in long-term follow-up and compared left and right atrial function in Maze patients with that of healthy age-matched controls using echo Doppler techniques. Background: The Maze procedure is designed to eliminate atrial fibrillation, restore normal sinus rhythm, and preserve atrial contraction. Initial data indicate that atrial transport function is restored in most patients undergoing the Maze procedure. The long-term echo Doppler evaluation of patients after the Maze procedure has not been well described. Methods: We performed pulsed-wave Doppler and two-dimensional echocardiographic studies on 31 patients (24 men, mean age 53.8 years) who underwent the Maze procedure and who had a follow-up study greater than 3 months (mean 16.5 months) after the procedure. Measurements included peak left ventricular and right ventricular inflow A-wave velocity, maximum and minimum left atrial and right atrial areas, and fractional area change of the left and right atria. Results were compared with those obtained from 15 age-matched control subjects (11 men, mean age 53.8 years). Results: Twenty-two patients (71%) had left atrial function shown by the presence of left ventricular inflow A-wave, and 25 patients (81%) had right atrial function shown by the presence of right ventricular inflow A-wave on Doppler echocardiography. The left ventricular inflow A-wave velocity was significantly lower than that of age-matched controls (37.5±15.5 versus 61.0±13.9 cm/sec;
p<0.001), whereas the right ventricular inflow A-wave velocity did not significantly differ between patients and control subjects (35.4±9.9 versus 35.3±4.9 cm/sec;
p=Not significant). Although left and right atrial areas decreased significantly after the procedure, there was no significant change in the fractional area change which was smaller in Maze patients than control individuals. Conclusions: (1) In long-term follow-up of 16.5 months after the Maze procedure, left atrial systolic function was preserved in 71% of our patients and right atrial systolic function was preserved in 81%; (2) the left ventricular inflow peak A-wave velocity after Maze is considerably less than that in age-matched controls; and (3) left and right atrial sizes decreased after the procedure with no change in the fractional area change. These findings suggest that the Maze procedure is effective in restoring atrial function in the majority of patients; however, restored function is less than in control individuals
Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial
International audienceBackground: The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction) was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms. Methods: Primary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and <250 beats per minute. Patients were followed for 18 months. The primary end point was the IAS-free rate compared with a 91.6% performance goal, derived from the results for the ICD-only patients in the MADIT-RIT study (Multicenter Automatic Defibrillator Implantation Trial–Reduce Inappropriate Therapy). Kaplan-Meier analyses were performed to evaluate event-free rates for IAS, all-cause shock, and complications. Multivariable proportional hazard analysis was performed to determine predictors of end points. Results: S-ICD implant was attempted in 1116 patients, and 1111 patients were included in postimplant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% were women, 23.4% were Black, 53.5% had ischemic heart disease, 87.7% had symptomatic heart failure, and the mean left ventricular ejection fraction was 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (lower confidence limit, 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the 3-incision technique, no history of atrial fibrillation, and ischemic cause. The 18-month all-cause shock-free rate was 90.6% (lower confidence limit, 89.0%), meeting the prespecified performance goal of 85.8%. Conversion success rate for appropriate, discrete episodes was 98.4%. Complication-free rate at 18 months was 92.7%. Conclusions: This study demonstrates high efficacy and safety with contemporary S-ICD devices and programming despite the relatively high incidence of comorbidities in comparison with earlier S-ICD trials. The inappropriate shock rate (3.1% at 1 year) is the lowest reported for the S-ICD and lower than many transvenous ICD studies using contemporary programming to reduce IAS. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02433379
Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial
International audienceBackground: The subcutaneous (S) implantable cardioverter-defibrillator (ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, had less left ventricular dysfunction, and received more inappropriate shocks (IAS) than in typical transvenous ICD trials. The UNTOUCHED trial (Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction) was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms. Methods: Primary prevention patients with left ventricular ejection fraction ≤35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥250 beats per minute and morphology discrimination for rates ≥200 and <250 beats per minute. Patients were followed for 18 months. The primary end point was the IAS-free rate compared with a 91.6% performance goal, derived from the results for the ICD-only patients in the MADIT-RIT study (Multicenter Automatic Defibrillator Implantation Trial–Reduce Inappropriate Therapy). Kaplan-Meier analyses were performed to evaluate event-free rates for IAS, all-cause shock, and complications. Multivariable proportional hazard analysis was performed to determine predictors of end points. Results: S-ICD implant was attempted in 1116 patients, and 1111 patients were included in postimplant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% were women, 23.4% were Black, 53.5% had ischemic heart disease, 87.7% had symptomatic heart failure, and the mean left ventricular ejection fraction was 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (lower confidence limit, 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the 3-incision technique, no history of atrial fibrillation, and ischemic cause. The 18-month all-cause shock-free rate was 90.6% (lower confidence limit, 89.0%), meeting the prespecified performance goal of 85.8%. Conversion success rate for appropriate, discrete episodes was 98.4%. Complication-free rate at 18 months was 92.7%. Conclusions: This study demonstrates high efficacy and safety with contemporary S-ICD devices and programming despite the relatively high incidence of comorbidities in comparison with earlier S-ICD trials. The inappropriate shock rate (3.1% at 1 year) is the lowest reported for the S-ICD and lower than many transvenous ICD studies using contemporary programming to reduce IAS. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02433379