Josef Veselka

Long-term health outcome and mortality evaluation after invasive coronary treatment using drug eluting stents with or without the IVUS guidance. Randomized control trial. HOME DES IVUS.

Objective: To assess the role of the intravascular ultrasound (IVUS) during implantation of Drug‐eluting stents (DES) on long‐term outcome in patients with complex coronary artery disease and high clinical risk profile with special attention to the development of late stent thrombosis (LST). Methods: Two hunderd and ten patients were randomly assigned to receive DES either with (N = 105) or without (N = 105) the IVUS guidance. Dual antiplatelet treatment was administered for 6 months in all patients. At 18‐month follow‐up, the rates of Major adverse cardiac events (MACEs) (death, myocardial infarction, and reintervention) were assessed in both groups with special attention to possible LST. Stent thrombosis was classified according to Academic Research Consortium (ARC). Results: At the 18‐month follow‐up, there was no significant difference between both groups regarding MACE (11% vs. 12%; P = NS). Stent thrombosis has occurred in four patients (3.8%) in the group with and in 6 patients (5.7%; P = NS) in the group without the IVUS guidance. Conclusions: In our randomized trial we failed to demonstrate the superiority of the IVUS guidance during DES implantation over standard high‐pressure postdilatation. However we confirmed worrisome results concerning DES thrombosis after discontinuation of dual antiplatelet‐treatment with documented stent thrombosis related events in almost 5% of patients with 50% of mortality in this high‐risk clinical scenario.

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

AIMS The 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. METHODS AND RESULTS We 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). CONCLUSIONS The 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.

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.

Relationship of C-reactive protein to presence and severity of coronary atherosclerosis in patients with stable angina pectoris or a pathological exercise test.

BackgroundC-reactive protein (CRP) level is a sensitive marker of inflammation and a probable predictor of cardiovascular risk. The aim of this study was to assess the relationship between the presence and the extent of coronary atherosclerosis and CRP level in patients referred for coronary angiography for stable angina pectoris or a pathological exercise test. Patients and methodsA group of 200 patients were prospectively analyzed for the relationship between the presence and extent of coronary atherosclerosis and high-sensitivity CRP. Patients with stable angina pectoris or a pathological exercise test were included. ResultsFor the whole group the CRP geometric mean was 2.92 mg/l and the median 3.0 mg/l. There was no difference between groups of patients with different extents of coronary lesions (P  = 0.320, one-way analysis of variance). In patients without significant coronary disease the CRP geometric mean was 3.1 (2.28–4.21) mg/l with a variation coefficient of 118.4%; in patients with coronary artery disease the geometric mean was 2.83 (2.34–3.43) mg/l with a variation coefficient of 104.0%. The difference in CRP between both groups was not significant (P  = 0.601). There was also no significant difference in CRP levels between groups of patients with and without a history of myocardial infarction (2.65 (2.08–3.36) mg/l and 3.18 (2.54–3.98) mg/l, P  = 0.266) respectively. There was no correlation between the classification of angina pectoris and the logarithm of CRP level (P  = 0.331). This relationship was not confirmed even in the group of patients with significant coronary artery disease (P  = 0.693). ConclusionsCRP level is not related to the extent or the presence of coronary atherosclerosis assessed by coronary angiography, history of myocardial infarction or class of stable angina pectoris in patients referred for coronary angiography for stable angina pectoris or a pathological exercise test.

Alcohol septal ablation for hypertrophic obstructive cardiomyopathy: Lower alcohol dose reduces size of infarction and has comparable hemodynamic and clinical outcome

Patients with highly symptomatic hypertrophic obstructive cardiomyopathy (HOCM) are considered to be good candidates for percutaneous transluminal septal myocardial ablation (PTSMA). However, there is ongoing discussion regarding the optimal dose of alcohol injected into target septal artery and the impact of infarct sizes on the clinical and hemodynamic outcome. Thirty‐four patients with symptomatic HOCM receiving maximum medical therapy were consecutively enrolled. Patients were randomized in a 1:1 ratio into one of the two arms according to dose of injected alcohol during echocardiography‐guided PTSMA procedure. Clinical, electrocardiographic, and echocardiographic evaluation were performed 6 months after the procedure in all the patients. Both groups of patients matched in all clinical and echocardiographic data. The dose of alcohol injected was 1.6 ± 0.4 and 3.4 ± 0.9 (P < 0.001) with subsequent peak of CK‐MB 1.9 and 3.2 μkat/L (P < 0.05) in group A and B, respectively. There was a correlation between amount of injected alcohol and the peak of CK‐MB (r = 0.58; P < 0.01), whereas no significant relationship (r = 0.16; P = NS) was documented between the peak of CK‐MB and left ventricular outflow gradient at follow‐up. At 6‐month follow‐up, both groups of patients were not significantly different with regard to symptoms or electrocardiographic and echocardiographic findings. In conclusion, this study suggests that the low dose (1– 2 ml) of alcohol injected into target septal branch reduces size of necrosis. Moreover, the low dose is probably as safe and efficacious as usually used doses (2–4 ml). Catheter Cardiovasc Interv 2004;63:231–235.

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.

“Head‐to‐head comparison between sirolimus‐eluting and paclitaxel‐eluting stents in patients with complex coronary artery disease: An intravascular ultrasound study”

The aim of this study was to assess neointimal hyperplasia following sirolimus‐eluting (SES) and paclitaxel‐eluting stents (PES) implantation in a patients with complex coronary disease.

A FTO variant and risk of acute coronary syndrome.

BACKGROUND The FTO gene plays an important role in the determination of body weight and BMI and it has been suspected of being associated with all-case mortality. METHODS We have analyzed the FTO rs17817449 variant in consecutive 1092 male patients with acute coronary syndrome (ACS) and in 1191 randomly selected Caucasian individuals (population controls). RESULTS The FTO variant was significantly associated with BMI both in controls (P<0.02) and ACS patients (P<0.01). In both groups, BMI was highest in GG homozygotes and lowest in TT homozygotes. There was a significant difference between the ACS patients and controls in the frequency of the FTO genotype GG (21.4% vs. 15.9%, P<0.005). FTO GG homozygotes had a significantly increased risk of ACS, compared with TT homozygotes which was independent of age and BMI (odds ratio 1.49, 95% confidence interval 1.16-1.93). The odds ratio of ACS patients for the GG genotype remained significant even after the exclusion of diabetics (100 controls and 339 ACS patients), with OR 1.32 (95% CI 1.01-1.72). CONCLUSIONS This study provides an evidence of an association between the FTO variant and risk of ACS in Caucasian males.