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

OBJECTIVES: 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. BACKGROUND: Little is known about the use of direct carotid stenting with FilterWire EZ Embolic Protection System and different carotid stents. METHODS: Between September 2005 and August 2008, 176 consecutive patients (70 +/- 9 years, 36% symptomatic, 89% at high risk) underwent 214 direct carotid artery stenting procedures with FilterWire EZ Embolic Protection System and different carotid stents. This study included both symptomatic (>or=50% carotid artery stenosis) as well as asymptomatic (>or=70% carotid artery stenosis) patients. The primary endpoint was the rate of 30-day adverse events, defined as neurological death, stroke, or myocardial infarction. RESULTS: We implanted 218 stents (55% with closed cell design) in 214 procedures. The technical success rate of direct stenting was 96%. Carotid artery stenosis before and after direct carotid artery stenting were 82% +/- 10% and 10% +/- 13%, respectively. The median of fluoroscopic time was 6 min (range 2.5-31.5 min). There were two (0.9%) minor strokes and one (0.5%) myocardial infarction within 30 post-procedural days; the primary endpoint occurred in three patients (1.4%). Two patients expired from nonneurological causes unrelated to carotid stenting. CONCLUSION: Direct carotid stenting with FilterWire EZ Embolic Protection System is feasible and safe. Short-term results with respect to neurological events are acceptable.

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).

Thirty-day outcomes of direct carotid artery stenting with cerebral protection in high-risk patients.

BACKGROUND: Implantation of a carotid artery stent after predilation is a standard approach in the endovascular treatment of carotid artery stenoses. Stenting without predilation may be an alternative approach in a certain subset of patients. The present prospective, single-center registry was designed to evaluate the feasibility and safety of direct carotid artery stenting (DCAS) in high-risk patients. METHODS AND RESULTS: Symptomatic patients with stenosis >50% and asymptomatic patients with stenosis >70% were eligible for enrolment. Criteria for high-risk patients included: need or history of open heart surgery, history of myocardial infarction, multivessel coronary artery disease, left ventricular dysfunction (ejection fraction < or =40%), severe pulmonary or renal disease, significant contralateral carotid disease, previous endarterectomy, and age > or =80 years. All procedures were performed using a filter protection device. Patients underwent complete clinical examination before and after DCAS and at 30-day follow-up. A total of 83 consecutive patients (45 males, 68+/-9 years, 33% symptomatic) underwent 100 procedures and 103 stents were deployed successfully. The technical success rate of stenting was 100%. Predilation of carotid stenosis was necessary in 1 (1%) procedure. Carotid-artery stenoses before and after DCAS were 80+/-9% and 7+/-9%, respectively. The median fluoroscopic time for DCAS was 7 min. The overall rate of in-hospital major adverse cerebrovascular events (death, stroke, myocardial infarction) was 5% (2 minor strokes, 3 transient attacks). There was 1 (1%) minor stroke within the 30-day follow-up. CONCLUSION: DCAS is feasible and can be performed with an acceptable risk in high-risk patients.

Impact of ethanol dosing on the long-term outcome of alcohol septal ablation for obstructive hypertrophic cardiomyopathy: a single-center prospective, and randomized study.

BACKGROUND: The impact of ethanol dose on the long-term outcome of alcohol septal ablation (ASA) for obstructive hypertrophic cardiomyopathy was investigated. METHODS AND RESULTS: Fifty-four patients (age 24-82 years; 65% women) undergoing ASA were randomized into 2 groups according to the dose of injected ethanol: Group A 1-2 ml, Group B >2 ml. Clinical and echocardiographic data were obtained at baseline and during follow-up. The volume of ethanol injected was 1.50+/-0.4 and 2.60+/-0.6 ml (p<0.001) with a subsequent peak of creatine kinase-MB of 2.25+/-1.00 and 2.62+/-1.57 microkat/L (p=0.02) in Groups A and B, respectively. The median follow-up was 39 (range 6-72) months after ASA, during which 1 patient died and 1 repeat procedure was necessary in both groups of patients. Both groups had a significant and similar improvement in outflow pressure gradient, dyspnea (New York Heart Association functional class) and angina pectoris (Canadian Cardiovascular Society class) (p<0.001). There was a significant decrease in the left ventricular ejection fraction (LVEF) in Group B (81+/-7 vs 75+/-7%; p=0.002), but not in Group A (80+/-7 vs 79+/-7%; p=0.67). Thinning of the basal septum was more pronounced in Group B than in Group A (9.3+/-5.7 vs 6.6+/-3.4 mm; p=0.04). CONCLUSIONS: A lower dose of ethanol injected into the target septal branch reduces both the size of necrosis and subsequent thinning of the basal septum, and preserves LVEF during long-term follow-up. Moreover, the low dose (1-2 ml) is as safe and as hemodynamically efficacious as higher doses.

Age-related hemodynamic and morphologic differences in patients undergoing alcohol septal ablation for hypertrophic obstructive cardiomyopathy.

BACKGROUND: Alcohol septal ablation (ASA) decreases the left ventricular (LV) outflow gradient and relieves symptoms in patients with highly symptomatic hypertrophic obstructive cardiomyopathy (HOCM). The aim of this study was to evaluate the early course of hemodynamic, morphologic and clinical changes in younger and elderly patients. METHODS AND RESULTS: Forty-four consecutive patients (age, 24-81 years) underwent the ASA procedure for HOCM. Clinical and echocardiographic data were obtained at baseline and periodically up to 12 months after ASA. There was a significant correlation between septum thickness and age at baseline and in the early post procedural period (p = 0.004 at baseline, p = 0.0033 days postoperative, p = 0.0193 weeks pos operative). The dependence of septal thickness on the duration of follow-up (p < 0.001) was significantly influenced by age (p = 0.026), which retained statistical significance after multivariate adjustment (p = 0.031). A decrease in the gradient of the LV outflow was identified in all age-related groups of patients (p < 0.001). After multivariate adjustment, there was a significant influence of age (p = 0.003) and creatine kinase-MB peak (p = 0.016) on the course of outflow gradient reduction. CONCLUSIONS: ASA is an effective treatment option for patients with HOCM, irrespective of their age. Younger patients are characterized by a thicker basal septum at baseline and a slower hemodynamic improvement within the early post procedural period.

Preprocedural statin therapy reduces the risk and extent of cardiac biomarker release following percutaneous coronary intervention.

This study evaluates the association between statin therapy in patients treated by percutaneous coronary intervention (PCI) for stable angina pectoris and postinterventional myocardial injury with subsequent long-term clinical outcome. Prospectively collected data on 400 consecutive patients with stable angina pectoris or evidence of inducible myocardial ischemia were analyzed. The incidence of myocardial infarction based on postinterventional release of troponin I>1.5 ng/ml was 12% in the statin pretreated patients and 20% in those not pretreated with statin therapy (P=0.04, odds ratio 1.84, 95% confidence interval 1.06-3.21). Of the patients experiencing a post-PCI troponin elevation>1.5 ng/ml, those pretreated with a statin pre-PCI had a lesser troponin elevation compared with those not receiving a statin pre-PCI (median: 2.9 ng/ml [1.9-11.5] vs 5.0 ng/ml [3.1-8.8]; P<0.001). In the multivariate model, preprocedural statin therapy was identified as the only independent negative predictor of procedure-related myocardial necrosis based on postprocedural troponin elevation. In the 21-month follow-up period, statin pretreated patients were observed to have fewer deaths, revascularizations, or myocardial infarction; however, this difference was not statistically significant. These results suggest that pretreatment with statins in patients undergoing PCI for stable angina pectoris reduces the risk and extent of procedure-related myocardial injury measured by troponin release.

Relationship of C-reactive protein to adverse cardiovascular events in patients treated by percutaneous coronary intervention for stable angina pectoris.

Low-grade inflammation as detected by increased C-reactive protein (CRP) levels predicts the risk of cardiovascular events. However, there is still controversy over the mid-term predictive value of CRP in patients referred for elective percutaneous coronary revascularization (PCI) for stable angina pectoris. The aim of this study was to assess the relationship between baseline CRP level and mid-term outcome of patients undergoing PCI. Two groups of patients with stable angina pectoris were prospectively studied. Group A consisted of 150 consecutive patients with a CRP level < or = 3 mg/L, and group B consisted of 150 consecutive patients with a CRP level > 3 mg/L undergoing PCI at our institution. Comparing both groups of patients, the analysis confirmed a significant difference between medians of the CRP levels (0.5 versus 8 mg/mL; P < 0.001). A higher level of CRP in group B was associated with a lower presence of male gender (P < 0.05) and history of myocardial infarction (P < 0.05). On the other hand, in group B there was higher occurrence of smoking (P < 0.001), hypertension (P < 0.05), hypertriglyceridemia (P < 0.001), and diabetes mellitus (P < 0.01). The incidence of myocardial infarction based on post-interventional release of TnI > 1.5 ng/mL reached 12% in group A and 14% in group B (P = 0.73). Analyses were repeated with adjustment for significant baseline variables, which did not change our findings. The incidence of adverse cardiovascular events during a six month follow-up was 13% in both groups (NS). Increased CRP serum prior to PCI was not associated with the risk and extent of procedure-related myocardial injury measured by TnI release and does not portend heightened cardiovascular risk at six months after percutaneous revascularization. On the other hand, a CRP level > 3 mg/L was associated with a higher occurrence of cardiovascular risk factors (smoking, hypertension, hypertriglyceridemia, and diabetes mellitus).

Effects of alcohol septal ablation for hypertrophic obstructive cardiomyopathy on Doppler Tei index: a midterm follow-up.

Alcohol septal ablation (PTSMA) improves outflow gradient, left ventricular (LV) diastolic function, and symptoms in patients with hypertrophic obstructive cardiomyopathy (HOCM). Tei index (TI) is a Doppler parameter reflecting both systolic and diastolic LV function. Midterm changes of TI after PTSMA have not been determined up to now. Twenty-seven consecutive patients (mean age 53 +/- 13 years) with symptomatic HOCM underwent PTSMA procedure. Clinical and echocardiographic data were collected at baseline, 6 and 12 months after PTSMA. TI decreased from 0.67 +/- 0.11 to 0.55 +/- 0.06, isovolumic contractile time (ICT) decreased from 74 +/- 20 to 48 +/- 11 ms, isovolumic relaxation time decreased from 146 +/- 25 to 117 +/- 9 ms, and LV ejection time decreased from 330 +/- 42 to 298 +/- 13 ms. LV remodeling was determined by LV dimension increase from 46 +/- 6 to 48 +/- 6 mm and basal septum thickness reduction from 22 +/- 4 to 15 +/- 3 mm. LV ejection fraction decreased from 78 +/- 7 to 73 +/- 6% and maximal outflow gradient decreased from 69 +/- 44 to 15 +/- 11 mmHg. All changes were statistically significant (P <0.01). Symptomatic improvement was characterized by relief of dyspnea (2.5 +/- 0.7 versus 1.4 +/- 0.6 NYHA class; P <0.01) and angina pectoris (2.6 +/- 0.9 versus 0.7 +/- 0.7 CCS class; P <0.01). PTSMA is an effective method of therapy for HOCM. Shortening of TI suggests the improvement of LV myocardial performance in the midterm follow-up.

Effects of varying ethanol dosing in percutaneous septal ablation for obstructive hypertrophic cardiomyopathy on early hemodynamic changes.

This prospective, randomized study evaluates the association between ethanol dose and postprocedural hemodynamic changes in 42 patients treated by alcohol septal ablation for obstructive hypertrophic cardiomyopathy. These results suggest that the early course of hemodynamic changes is not related to the use of a small (1 to 2 ml) or standard (>2 ml) dose of ethanol.

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 microkat/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).

The biphasic course of changes of left ventricular outflow gradient after alcohol septal ablation for hypertrophic obstructive cardiomyopathy.

BACKGROUND AND AIM: Alcohol septal ablation (PTSMA) decreases left ventricular outflow gradient (LVOG) and relieves symptoms in patients with hypertrophic obstructive cardiomyopathy (HOCM). The time course of early changes of LVOG has not been clearly determined up to now. METHODS: Doppler echocardiography was used to determine the maximal LVOG. Thirty-nine consecutive patients (24 women; age 55+/-14) were examined at baseline, immediately after the procedure, and 3-5 days, 3 weeks and 3 months thereafter. RESULTS: The baseline LVOG decreased immediately after PTSMA from 73+/-49 mmHg to 13+/-16 mmHg (p<0.01). During the hospital stay (postprocedural period) LVOG increased from 13+/-16 to 37+/-35 mmHg (p<0.01). All the patients were discharged 5-10 days after the procedure. At three-week examination LVOG decreased from 37+/-35 to 25+/-12 mmHg (p<0.01). Three-month survival was 97%. One patient died suddenly one month after PTSMA. At three-month examination LVOG decreased from 25+/-12 to 17+/-14 mmHg (NS). All the patients reported an improvement in symptoms at follow-up. CONCLUSIONS: The immediate decrease of LVOG after PTSMA procedure caused by myocardial necrosis and stunning, was followed by a significant LVOG increase during the early postprocedural period and continuous LVOG decrease at the short-term follow-up.

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

BACKGROUND: C-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 METHODS: A 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. RESULTS: For 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). CONCLUSIONS: CRP 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.