Pavol Tomašov

Alcohol septal ablation for obstructive hypertrophic cardiomyopathy: ultra-low dose of alcohol (1 ml) is still effective

Echo-guided alcohol septal ablation (ASA) is an alternative treatment for highly symptomatic patients with obstructive hypertrophic cardiomyopathy (HOCM). Previous reports suggest that a low dose of alcohol (1.5–2 ml) is as effective as the classic dose (2–4 ml) used in the past. Because a larger infarct might be associated with a potential long-term risk, in this pilot study we wanted to determine whether an ultra-low dose of alcohol (1 ml) would be effective in the mid-term follow-up. Seventy patients (55 ± 13 years, range 24–81 years, septum thickness <31 mm) with a highly symptomatic HOCM receiving maximum medical therapy were enrolled. Thirty-five consecutive patients (group I) have been treated with an ultra-low alcohol dose (1.0 ± 0.1 ml) and compared with a control group II of 35 patients treated by the same medical team using the classic alcohol dose (2.5 ± 0.8 ml) in the past. At 6-month follow-up, both groups of patients improved in dyspnea (2.9 ± 0.6 vs 1.5 ± 0.5 New York Heart Association [NYHA] class for group I; P < 0.01, and 2.5 ± 0.7 vs 1.4 ± 0.4 NYHA class for group II; P < 0.01) and angina (2.1 ± 1 vs 0.6 ± 0.8 Canadian Cardiovascular Society [CCS] class for group I; P < 0.01, and 2.1 ± 0.9 vs 0.7 ± 0.7 CCS class for group II; P < 0.01). There was a significant decrease in left ventricular (LV) ejection fraction (P < 0.05), septum thickness (P < 0.01), and LV outflow gradient (P < 0.01) in both groups of patients. However, there was no significant difference with regard to the extent of symptomatic or echocardiographic changes and complications between both groups. These results suggest that the ultra-low dose of alcohol (1 ml) is still effective in the treatment of the majority of HOCM patients without extreme septum hypertrophy (<31 mm).

Long-term clinical outcome after alcohol septal ablation for obstructive hypertrophic cardiomyopathy: results from the Euro-ASA registry

AIMSnThe first cases of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy (HCM) were published two decades ago. Although the outcomes of single-centre and national ASA registries have been published, the long-term survival and clinical outcome of the procedure are still debated.nnnMETHODS AND RESULTSnWe report long-term outcomes from the as yet largest multinational ASA registry (the Euro-ASA registry). A total of 1275 (58 ± 14 years, median follow-up 5.7 years) highly symptomatic patients treated with ASA were included. The 30-day post-ASA mortality was 1%. Overall, 171 (13%) patients died during follow-up, corresponding to a post-ASA all-cause mortality rate of 2.42 deaths per 100 patient-years. Survival rates at 1, 5, and 10 years after ASA were 98% (95% CI 96-98%), 89% (95% CI 87-91%), and 77% (95% CI 73-80%), respectively. In multivariable analysis, independent predictors of all-cause mortality were age at ASA (P < 0.01), septum thickness before ASA (P < 0.01), NYHA class before ASA (P = 0.047), and the left ventricular (LV) outflow tract gradient at the last clinical check-up (P = 0.048). Alcohol septal ablation reduced the LV outflow tract gradient from 67 ± 36 to 16 ± 21 mmHg (P < 0.01) and NYHA class from 2.9 ± 0.5 to 1.6 ± 0.7 (P < 0.01). At the last check-up, 89% of patients reported dyspnoea of NYHA class ≤2, which was independently associated with LV outflow tract gradient (P < 0.01).nnnCONCLUSIONSnThe Euro-ASA registry demonstrated low peri-procedural and long-term mortality after ASA. This intervention provided durable relief of symptoms and a reduction of LV outflow tract obstruction in selected and highly symptomatic patients with obstructive HCM. As the post-procedural obstruction seems to be associated with both worse functional status and prognosis, optimal therapy should be focused on the elimination of LV outflow tract gradient.

Long-term survival after alcohol septal ablation for hypertrophic obstructive cardiomyopathy: a comparison with general population

AIMSnWe decided to determine the long-term survival of patients after alcohol septal ablation (ASA) for hypertrophic obstructive cardiomyopathy (HOCM) and compare this with the general population.nnnMETHODS AND RESULTSnA total of 178 highly symptomatic, consecutive patients (58 ± 12 years, 53% women) were treated by ASA between April 1998 and April 2013 and followed-up for 4.8 years (IQR 2.1-7.5). At baseline, 155 patients (87%) suffered from dyspnoea ≥3 class of NYHA; at the most recent examination, 87 patients (49%) and 23 patients (13%) reported dyspnoea of NYHA class 1 and ≥3, respectively. The left ventricular outflow gradient was significantly reduced (68 ± 42 vs. 20 ± 25 mmHg; P < 0.01). A total of 19 deaths (11%) occurred during 925 patient-years, which means an overall mortality rate of 2.1% per year. Survival free of all-cause mortality at 1, 5, and 10 years was 97% (95% CI, 93-99%), 92% (95% CI, 87-96%), and 82% (95% CI, 70-90%), respectively. This observed mortality was comparable to the expected survival for age- and sex-comparable general population (P = 0.34). According to multivariate analysis, the only independent predictor of all-cause mortality was age at ASA (hazard ratio 1.09, 95% CI 1.04-1.14; P < 0.01).nnnCONCLUSIONSnThis study suggests that in patients with HOCM and important symptoms who underwent ASA, long-term survival after the procedure did not differ significantly from that of the general population.

Long-Term Effects of Varying Alcohol Dosing in Percutaneous Septal Ablation for Obstructive Hypertrophic Cardiomyopathy: A Randomized Study With a Follow-up up to 11 Years

BACKGROUNDnHighly symptomatic patients with obstructive hypertrophic cardiomyopathy (HCM) are candidates for alcohol septal ablation (ASA). We wanted to determine long-term (>60 months) clinical and echocardiographic outcomes of patients treated with low (1-2 mL) or high (>2 mL) doses of alcohol.nnnMETHODSnSeventy-six patients were randomized into 2 arms in a 1:1 ratio, and subsequently were treated by ASA with a low (1-2 mL) or high (>2 mL) dose of alcohol. Clinical and echocardiographic examinations were performed at baseline, 1 year after the procedure, and at the end of follow-up (at least 60 months after ASA).nnnRESULTSnBoth groups of patients matched in all baseline clinical and echocardiographic data. In a total of 76 patients, 86 septal branches were ablated in 80 ASA procedures (2 repeat procedures in each group). There were no differences in postprocedural complications. Seven patients (4 vs 3 patients; not significant) died during follow-up (60-138 months; median 85 months). Pressure gradients decreased significantly in both groups (from 74±36 to 24±32 mm Hg in the low-dose group and from 74±39 mm Hg to 18±20 mm Hg in the high-dose group). There were no significant differences between the groups, and all main hemodynamic and echocardiographic changes occurred in the first postprocedural year. At final examination, there were no patients with New York Heart Association class>2 dyspnea in either group.nnnCONCLUSIONSnThis study demonstrates that ASA for obstructive hypertrophic cardiomyopathy is safe and effective in long-term follow-up. No differences in long-term efficacy and safety were found between low and high doses of alcohol.

Outcome of patients after alcohol septal ablation with permanent pacemaker implanted for periprocedural complete heart block

Highly symptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM) irresponsive to medical therapy are treated with surgical myectomy, dual-chamber pacing or alcohol septal ablation(ASA). Based on single-center studies or national registries it seems that both short- and long-term outcomes of ASA are acceptable. The most frequent major complication associated with ASA is the mostly self-terminating complete heart block (CHB) that occurs in 20–50% of patients and requires permanent pacemaker implantation in 9–20% of all ASA patients [2,3]. Accordingly, this retrospective study was undertaken to evaluate the long-term outcome of patients who underwent early permanent pacemaker implantation due to post-ASA CHB.

Complications of low-dose, echo-guided alcohol septal ablation†

Background: Alcohol septal ablation (ASA) is a catheter‐based intervention that has been used as an alternative to surgical myectomy in highly symptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM). Methods: This retrospective study was designed to evaluate the incidence of major complications in the mid‐term follow‐up of low‐dose (1–2.5 ml of ethanol), echo‐guided alcohol septal ablation. Results: A total of 101 consecutive patients (56 ± 15 years) with highly symptomatic HOCM were enrolled. At 6 months, there was a significant decrease in resting outflow gradient accompanied by reduction in basal septal diameter and improvement in symptoms (P < 0.01). Two patients (2%) experienced procedural ventricular tachycardias terminated by electrical cardioversion. A total of 87 patients (86%) underwent an uneventful postprocedural hospital stay. The postprocedural complete heart block occurred in 10 patients (10%), and subsequent permanent pacemaker was implanted in four cases (4%). Sustained ventricular arrhythmias requiring electrical cardioversion occurred in four patients (4%) within postprocedural hospital stay. Subsequently, ICD was not implanted in any of these cases. The patients were repeatedly examined by Holter ECG monitoring, and in the mid‐term follow‐up (6–50 months), they stayed asymptomatic and without any ventricular arrhythmias. Conclusion: This study demonstrates the same early incidence of complete heart block requiring permanent pacemaker implantation (4%) and sustained ventricular arrhythmias following low‐dose, echo‐guided ASA.

Survival of Patients 50 Years of Age After Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy

BACKGROUNDnThe long-term efficacy and safety of alcohol septal ablation (ASA) has recently been demonstrated. However, there is still debate about the outcome of younger patients who should be treated using myectomy, according to American College of Cardiology Foundation/American Heart Association guidelines. The aim of this study was to evaluate the long-term outcome of patients ≤ 50 years of age after ASA for hypertrophic obstructive cardiomyopathy (HOCM).nnnMETHODSnWe retrospectively evaluated consecutive, highly symptomatic patients aged ≤ 50 years with HOCM who underwent ASA.nnnRESULTSnInstitutional databases of 3 cardiovascular centres identified 290 patients with HOCM who underwent ASA; 75 (26%) of them were aged ≤ 50 years at the time of their first ASA. Median duration of follow-up was 5.1 years (range, 0.1-15.4 years). Four patients (5%) died during the study period (438 patient-years; the annual mortality rate was 0.91%; 95% confidence interval [CI], 0.25-2.34%; the annual mortality rate combined with the first appropriate implantable cardioverter-defibrillator discharge was 1.43%; 95% CI, 0.52-3.10%). Survival free of all-cause mortality at 1, 5, and 10 years was 97% (95% CI, 89-99%), 94% (95% CI, 84-98%), and 94% (95% CI, 84-98%), respectively.nnnCONCLUSIONSnResults of this first study focused on HOCM patients aged ≤ 50 years who underwent ASA suggest a low risk of all-cause death or appropriate implantable cardioverter-defibrillator discharge in the long-term follow-up.

Effect of Two-Day Atorvastatin Pretreatment on Long-Term Outcome of Patients With Stable Angina Pectoris Undergoing Elective Percutaneous Coronary Intervention

Several randomized studies and meta-analyses have suggested that pretreatment with statins may decrease periprocedural myocardial infarction (MI) in patients undergoing percutaneous coronary intervention (PCI). The purpose of this randomized study was to investigate the effect of a 2-day atorvastatin therapy before PCI on long-term clinical outcome. Two hundred statin-naive patients with stable angina pectoris referred for PCI were enrolled and randomized (ratio 1:1) to 2-day pretreatment with atorvastatin 80 mg/day and subsequent PCI (atorvastatin group), or immediate PCI (control group). The registry group comprised 182 consecutive patients on long-term statin therapy referred for immediate PCI during the same period as randomized patients. We compared the first occurrence of MI or death during long-term follow-up. There were no significant differences in most clinical characteristics and early results among the 3 groups. Median follow-up was 45 months (1 to 59). Incidences of death/MI were 11.4%, 12.9%, and 13.8% in the atorvastatin, control, and registry groups, respectively. In the same groups, age-adjusted estimated 4-year freedom from death/MI was 0.78 versus 0.75 versus 0.80, respectively (p=0.882, log-rank test). In multivariate analysis, only age of patients (odds ratio 1.04, 95% confidence interval 1.02 to 1.07, p<0.001) was identified as a significant predictor of death or MI during follow-up. In conclusion, these results suggest that 2-day therapy with high-dose atorvastatin before PCI did not influence occurrence of periprocedural MI or long-term clinical outcomes.

Effect of seven-day atorvastatin pretreatment on the incidence of periprocedural myocardial infarction following percutaneous coronary intervention in patients receiving long-term statin therapy. A randomized study☆

BACKGROUNDnThe aim of this randomized study was to investigate the effect of seven-day high-dose atorvastatin therapy on the incidence of peri-procedural myocardial infarction (PMI) in patients receiving long-term statin therapy.nnnMETHODSnThe patients with stable angina receiving statin therapy and referred for percutaneous coronary intervention (PCI) were randomized (ratio 1:1) to a 7-day pre-treatment with atorvastatin of 80 mg daily and subsequent PCI (Atorvastatin group), or immediate PCI (Control group). The incidence of PMI was based on serum concentration of creatine kinase myocardial band (CK-MB) mass and troponin I (TnI), which were measured prior to and between 16 and 24h post PCI. The values were considered as positive if they were elevated ≥ 3 times the upper limit normal.nnnRESULTSnWe randomized 202 patients (male 67%, 65.5 ± 9.2 years; 100 vs. 102 pts.). There were no significant differences in the baseline characteristics among the randomized groups. The incidence of PMI, based on post-interventional release of TnI and/or CK-MB mass was 15% in the Atorvastatin group vs. 14% in the Control group (p=0.80). One patient (3%) in Atorvastatin group suffered from MI between randomization and PCI.nnnCONCLUSIONSnThese results suggest that 7-day pre-PCI therapy with high-dose atorvastatin did not reduce the occurrence of PMI in patients receiving chronic statin therapy.

Obstruction after alcohol septal ablation is associated with cardiovascular mortality events

Background Left ventricular outflow tract obstruction (≥30u2005mmu2005Hg at rest; LVOTO) is considered a possible risk of long-term outcomes in patients with hypertrophic cardiomyopathy (HCM). However, the influence of LVOTO on the occurrence of cardiovascular mortality events in patients after alcohol septal ablation (ASA) for obstructive HCM remains unresolved. Methods We compared the outcomes of patients treated with ASA with residual LVOTO <30u2005mmu2005Hg with those with residual LVOTO ≥30u2005mmu2005Hg at the first postdischarge check-up (1–6u2005months after the procedure). Results A total of 270 patients (60±12 years, median follow-up 5.1 years; 95% CI 4.5 to 5.9 years) treated with a single ASA were included; 208 (77%) and 62 (23%) patients had post-ASA LVOTO <30 and ≥30u2005mmu2005Hg at the first postdischarge clinical check-up, respectively (LVOTO 13±6 vs 50±27u2005mmu2005Hg; p<0.01). Freedom from cardiovascular mortality events at 1, 5 and 10u2005years were 99% (95% CI 96% to 100%) vs 94% (95% CI 85% to 98%), 95% (95% CI 89% to 97%) vs 80% (95% CI 66% to 89%) and 82% (95% CI 69% to 89%) vs 72% (95% CI 55% to 84%) (log-rank test, p<0.01), respectively. In multivariable analysis adjusted for age at ASA, sex, baseline LVOTO and baseline septum thickness, the independent predictors of cardiovascular mortality events were early postdischarge LVOTO ≥30u2005mmu2005Hg (HR 2.95, 95% CI 1.26 to 6.91; p=0.01) and baseline septum thickness (HR 1.07, 95% CI 1.01 to 1.13; p=0.02). Conclusions After ASA for obstructive HCM, LVOTO ≥30u2005mmu2005Hg at the first postdischarge clinical check-up is associated with significantly higher occurrence of subsequent cardiovascular mortality events.