David Zemánek

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).

Effect of two-day atorvastatin pretreatment on the incidence of periprocedural myocardial infarction following elective percutaneous coronary intervention: a single-center, prospective, and randomized study.

Both randomized and observational studies have suggested that pretreatment with statins may reduce the incidence of periprocedural myocardial infarction (PMI) in patients with stable angina during elective percutaneous coronary intervention (PCI). The purpose of this randomized study (Clinical Trial Registration No. NCT00469326) was to investigate the effect of 2-day atorvastatin therapy on the incidence of PMI in patients with stable angina pectoris undergoing elective PCI. A total of 200 patients with stable angina pectoris who were not taking statins and who had been referred for PCI were enrolled and randomized (ratio 1:1) to a 2-day pretreatment regimen with atorvastatin 80 mg/day and subsequent PCI or immediate PCI. The serum concentration of creatine kinase-MB mass and troponin I were measured before and 16 to 24 hours after PCI. The incidence of PMI was assessed using established criteria. Of the patients, 10% in the atorvastatin group and 12% in the control group had a postprocedural creatine kinase-MB mass elevation > or =3 times the upper limit of normal (p = 0.65). The incidence of PMI as determined by the postinterventional release of troponin I > or =3 times the upper limit of normal was 17% in the atorvastatin group and 16% in the control group (p = 0.85). The median creatine kinase-MB mass peak after PCI was 1.46 ng/ml (interquartile range 0.83 to 2.52) in the atorvastatin group and 1.40 ng/ml (interquartile range 0.90 to 2.54) in the control group (p = 0.70). The median peak troponin I level after PCI was 0.100 ng/ml (0.096 to 0.385) in the atorvastatin group and 0.100 ng/ml (0.60 to 0.262) in the control group (p = 0.54). On multivariate analysis, the only independent predictor of PMI was patient age (odds ratio 1.09, 95% confidence interval 1.025 to 1.159, p = 0.006). In conclusion, in the present study 2-day pre-PCI therapy with atorvastatin did not reduce the occurrence of PMI in patients with stable angina pectoris undergoing elective PCI.

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

AIMS We 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. METHODS AND RESULTS A 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). CONCLUSIONS This 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

BACKGROUND Highly 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. METHODS Seventy-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). RESULTS Both 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. CONCLUSIONS This 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.

Early outcomes of alcohol septal ablation for hypertrophic obstructive cardiomyopathy: a European multicenter and multinational study.

Background: This study was designed to evaluate the outcomes of alcohol septal ablation (ASA) under multicenter and multinational conditions. Methods: Data for 459 patients (age 57 ± 13 years) from nine European centers were prospectively collected and retrospectively analyzed. Results: ASA led to a significant reduction in outflow gradient (PG) and dyspnea [median of PG from 88 (58–123) mm Hg to 21 (11–41) mm Hg; median of NYHA class from 3 (2–3) to 1 (1–2); P < 0.01]. The incidence of 3‐month major adverse events (death, electrical cardioversion for tachyarrhythmias, resuscitation) and mortality was 2.8% and 0.7%, respectively. Permanent pacemakers for post‐ASA complete heart block were implanted in 43 patients (9%). Multivariate analysis identified higher amount of alcohol (however, in generally low‐dose procedures), higher baseline left ventricular ejection fraction and higher age as independent predictors of PG decrease ≥50%. Conclusions: The results of the first European multicenter and multinational study demonstrate that real‐world early outcomes of ASA patients are better than was reported in observations from the first decade after ASA introduction.

Low Incidence of Procedure-Related Major Adverse Cardiac Events After Alcohol Septal Ablation for Symptomatic Hypertrophic Obstructive Cardiomyopathy

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). However, clinically relevant complications can result, including death and complete heart block (CHB) associated with syncope or resuscitation. This study was designed to evaluate the incidence of major ASA-related adverse cardiac events. METHODS This international multicentre retrospective study included 421 patients in 8 European centres who were treated using ASA from April 1998 to January 2011. Clinical and echocardiographic follow-up (3-6 months) was completed in 394 patients (94%). RESULTS ASA led to a significant reduction in symptoms and outflow gradients, with 0.7% mortality. A total of 70 patients (17%) experienced mostly transient CHB during and after the procedure; in 30% of them, CHB occurred or recurred later than 24 hours after ASA. Ninety-seven percent of CHB occurred up to the fifth day after ASA. Permanent pacemakers for CHB were implanted in 35 patients (8%). Multivariate analysis identified intraprocedural bundle branch block and age as independent predictors of CHB. CONCLUSIONS The results of the multicentre study demonstrate that ASA appears safe and efficacious, with low early mortality. The most frequent major complication after ASA was CHB (17%), which occurred late or was recurrent in almost one-third of these patients; 8% of patients required permanent pacemaker implantation. Independent predictors of CHB development were intraprocedural bundle branch block and age. Difficulty in predicting CHB should lead to close postprocedural monitoring and hospital stays lasting at least 5 days.

Feasibility, safety, and early outcomes of direct carotid artery stent implantation with use of the FilterWire EZ™ Embolic Protection System†

To report on early outcomes of prospective single‐center registry, which evaluated feasibility, safety, and effectiveness of direct carotid stenting using FilterWire EZ™ Embolic Protection System in high‐risk patients.

The anomalous origin of the left coronary artery from the right aortic sinus: is the coronary angiography still a 'gold standard'?

Coronary artery anomalies remain a poorly understood topic in modern cardiology. The most important issue is the origin of the left coronary artery or the left anterior descending artery from the opposite aortic sinus, frequently associated with sudden cardiac death. We report our experience concerning the evaluation of these anomalies. From 15 April 1997 to 1 December 2004, we performed 13.407 coronary angiographies and found eight patients with these anomalies. In seven patients the coronary angiography was sufficient for the ultimate decision. However, in one case was the angiographic signs contradictory and the optimal imaging of the coronary tree was received by the multi-slice spiral computer tomography. We consider the coronary angiography a sufficient method of evaluation in most of the patients with the coronary artery anomalies, but the ‘gold standard’ is 3-dimensional examination by the multi-slice computer tomography or the magnetic resonance. The computer tomography is the method of the choice to distinguish interarterial, intraseptal and prepulmonary course of the left coronary artery originating from the right aortic sinus.

Fluvastatin in the first-line therapy of acute coronary syndrome: results of the multicenter, randomized, double-blind, placebo-controlled trial (the FACS-trial)

BackgroundStatins have been proved to be effective in reduction of mortality and morbidity when started in the early secondary prevention in stabilized patients after acute coronary syndrome (ACS). The safety and efficacy of statin administration directly in the first-line therapy in unstable ACS patients is not clear. The aim of our study was, therefore, to assess the effect of statin treatment initiated immediately at hospital admission of patients with ACS.MethodsThe trial was stopped prematurely after enrollment of one hundred and fifty-six patients with ACS that were randomized at admission to fluvastatin 80 mg (N = 78) or placebo (N = 78). Study medication was administered immediately after randomization and then once daily for 30 days; all patients were then encouraged to continue in open-label statin therapy and at the end of one-year follow-up 75% in the fluvastatin group and 78% in the placebo group were on statin therapy.ResultsWe did not demonstrate any difference between groups in the level of C-reactive protein, interleukin 6, and pregnancy-associated plasma protein A on Day 2 and Day 30 (primary endpoint). Fluvastatin-therapy, however, significantly reduced one-year occurrence of major adverse cardiovascular events (11.5% vs. 24.4%, odds ratio (OR) 0.40, 95% CI 0.17-0.95, P = 0.038). This difference was caused mainly by reduction of recurrent symptomatic ischemia (7.7% vs. 20.5%, OR 0.32, 95% CI 0.12-0.88, P = 0.037).ConclusionsThis study failed to prove the effect of fluvastatin given as first-line therapy of ACS on serum markers of inflammation and plaque instability. Fluvastatin therapy was, however, safe and it may reduce cardiovascular event rate that supports immediate use of a statin in patients admitted for ACS.Trial registrationNCT00171275