Abstract Background Transaortic septal myectomy is the gold standard for the treatment of symptomatic hypertrophic obstructive cardiomyopathy refractory to medical therapy. The aim of this study was ...to assess early outcomes of minimally invasive septal myectomy performed via a right anterior minithoracotomy. Methods Between 2011 and 2014, 24 consecutive patients underwent isolated septal myectomy via a 4-5cm right parasternal minithoracotomy. Perioperative clinical and echocardiographic outcomes of these patients were compared to those of a historical cohort of 26 consecutive patients who underwent isolated septal myectomy performed through a median sternotomy between 2002 and 2010. Results Age and gender distribution were similar between the groups. A higher proportion of patients in the sternotomy group had undergone failed percutaneous alcohol septal ablation prior to surgery (50% vs 17%, p =.009). Median aortic cross-clamp time was 57 minutes in the minithoracotomy group versus 43 minutes in the sternotomy group ( p =.149). There was no in-hospital mortality in either group. Intraoperative conversion to sternotomy was required in one patient. Postoperative permanent pacemaker implantation was required in 5 patients from each group ( p =.999). Both groups demonstrated similar reductions in left ventricular outflow tract gradient and septal thickness. Residual obstructive systolic anterior motion of the mitral valve was observed in two patients (8%) in the minithoracotomy group and one (4%) in the sternotomy group ( p =.602). Conclusions This study demonstrates the feasibility of transaortic septal myectomy through a right minithoracotomy. Our early results suggest that this technique yields clinical and echocardiographic outcomes similar to those obtained with standard sternotomy.
Abstract Bioresorbable vascular scaffold (BVS) is a novel technology designed to overcome the long-term limitations of permanent metallic stent implantation in percutaneous coronary intervention. ...However, little is known about the development of coronary aneurysms after the use of BVSs, and additional experience is needed to establish the entire spectrum of complications related to the use of these emerging materials. We hereby report an unusual case of early multiple coronary artery micro aneurysms formation after BVS implantation.
Background
Inflammation has a key role in the process of atherosclerosis. Production of leukotrienes by 5‐lipoxygenase has been linked to atherosclerotic plaques and cardiovascular events.
Hypothesis
...In this study, a selective 5‐LO inhibitor will slow plaque progression using serial cardiac computed tomographic angiography (CCTA).
Methods
Patients with recent acute coronary syndrome (ACS) were prospectively assigned to one of 3 VIA‐2291 doses (25 mg, 50 mg, 100 mg) or placebo by oral administration. All groups underwent CCTA at baseline and at 6 months’ follow‐up. Plaque types such as low‐attenuation plaque (LAP), fibro‐fatty tissue (FF), fibro‐calcified plaque (FC), and dense calcium plaque (DC) were measured based upon predefined density threshold, and changes from baseline CCTA were analyzed.
Results
The final analysis included 54 patients (age, 56 ± 9 years; 85.1% male) with CCTA at baseline and 24 weeks. Evaluating on treatment VIA‐2291 (all 3 doses, n = 37) demonstrated significant reductions in plaque progression compared with placebo (n = 17). VIA‐2291 significantly reduced LAP (5.9 ± 20.7 mm3 vs −9.7 ± 33.3 mm3), FF (11.1 mm3 ± 13.3 mm3 vs −0.9 ± 2.7 mm3), and FC (−0.1 ± 6.22 mm3 vs −14.3 ± 6.2 mm3; all P < 0.05) and retarded the progression of DC (3.9 ± 3.2 mm3 vs 0.2 ± 0.4 mm3) compared with placebo.
Conclusions
VIA‐2291 resulted in slowed plaque progression compared with placebo across different plaque subtypes in patients with recent ACS (http://ClinicalTrials.gov NCT00358826).
Production of leukotrienes by 5-lipoxygenase (5-LO) has been linked to unstable atherosclerotic plaques and cardiovascular events. VIA-2291 is a potent 5-LO inhibitor.
In a double-blinded study, 191 ...patients were randomly assigned 3 weeks after an acute coronary syndrome to receive 25, 50, or 100 mg VIA-2291 or placebo daily for 12 weeks. The primary study end point, whole blood stimulated leukotriene LTB4 at trough drug level, was reduced in all VIA-2291 groups (P<0.0001) in a dose-dependent fashion, with approximately 80% inhibition in >90% of patients in the 100-mg group. A significant reduction of urine leukotriene LTE4 was obtained in all dose groups. No serious adverse events were considered related to study drug. A subset of 93 patients who had undergone a 64-slice coronary CT examination at baseline continued on study medication for a total of 24 weeks and underwent a repeat scan. Five of these patients withdrew or were noncompliant and 28 had nonevaluable scans. Among the 60 remaining patients, new coronary plaques were observed in 5 of 18 (27.8%) placebo-treated patients and in 2 of 42 (4.8%) VIA-2291-treated patients (P=0.01). A reduction in noncalcified plaque volume at 24 weeks versus placebo was observed in VIA-2291-treated groups in the 34 of these 60 patients in whom this end point was analyzable (P<0.01).
VIA-2291 reduces leukotriene production at 12 weeks after an acute coronary syndrome. Preliminary data from the CT substudy suggest that such a reduction in leukotriene production may influence atherosclerosis; however, this requires confirmation in a larger study. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00358826.
No data exist on the acute effects of statin therapy on human coronary atherosclerotic plaques. The objective of our study was to evaluate the early (<2 months) effects of newly initiated statin ...therapy on coronary atherosclerosis as evaluated by intravascular ultrasonography. The study population consisted of 74 patients (mean age 58 ± 8 years) who had been included in the ERASE trial (evaluating the effects of reconstituted high-density lipoprotein infusions). All patients underwent serial intravascular ultrasonographic (IVUS) evaluation at baseline (3 ± 2 days after an acute coronary syndrome ACS) and after 6 ± 1 weeks of follow-up. Statin therapy was initiated after ACS in 36 patients who received ≤1 dose of statins before baseline IVUS examination (newly initiated statin therapy group), and 38 patients were already on a stable statin dose before the ACS (long-term statin therapy group). Atorvastatin at a dose of 40 mg/day was the most common regimen in the 2 groups. Percent changes in atheroma volume (prespecified primary efficacy parameter) were −4.71 ± 0.96% in the newly initiated statin therapy group (p <0.0001) and −0.54 ± 0.89% in the long-term statin therapy group (p = 0.546; p = 0.002 for comparison between groups). Median nominal changes in atheroma volume were −9.10 mm3 (interquartile range −12.56 to −3.73, p <0.0001 vs baseline) and 1.21 mm3 (interquartile range −6.41 to 3.76, p = 0.429 vs baseline) in the newly initiated and long-term statin therapy groups, respectively (p = 0.003 for comparison between groups). Greater decreases in total cholesterol (r = 0.25, p = 0.035), ratio of total to high-density lipoprotein cholesterol (r = 0.28, p = 0.018), and high-sensitivity C-reactive protein (r = 0.31, p = 0.046, for patients with high-sensitivity C-reactive protein measurements within 7 days after IVUS examination) were associated with larger percent changes in atheroma volume. In conclusion, newly initiated statin therapy is associated with rapid regression of coronary atherosclerosis within 2 months. This effect was in part associated with decreases in atherogenic lipid and inflammatory parameters. These results provide insight into the rapid clinical benefits of statin therapy after an ACS.
Abstract In the present report, we review the phenotypes of coronary artery disease (CAD) patients unsuitable for revascularization procedures. We then analyze these phenotypes and propose a simple ...angiographic-based classification for patients with CAD unsuitable for revascularization. Under this classification, the following four distinct angiographic phenotypes are proposed: (1) suspected cardiac syndrome X; (2) limited territory at risk; (3) diffuse thread-like coronary atherosclerosis; and (4) end-stage CAD. It is hoped that such a classification system, as well as the general principles described in this report, will help to standardize the collection of epidemiological data on patients with refractory angina (RFA) and advanced CAD. It is also hoped that this system will be useful to extend the principles of clinical equipoise to the development of clinical trials of innovative therapies or devices for the treatment of RFA. Finally, we anticipate that the elaboration of this system, the first of its type in the literature, will stimulate discussion of what we feel to be a subject that has received insufficient attention in the literature, and ultimately to improved management of a challenging patient population.
Vascular inflammation can lead to plaque instability and acute coronary syndromes (ACS). Viruses produce potent immunomodulating proteins that regulate key inflammatory pathways. A myxoma ...virus-derived serpin Serp-1 reduces inflammatory cell invasion and plaque growth in vascular injury models. Our objective was to evaluate the safety and efficacy of Serp-1 in patients with ACS undergoing percutaneous coronary intervention.
This double-blind pilot trial included 48 ACS patients undergoing percutaneous coronary intervention randomly assigned to Serp-1 at doses of 5 μg/kg (n=19) or 15 μg/kg (n=17) or to placebo (n=12). Serp-1 was given by intravenous bolus immediately before intervention and 24 and 48 hours later. Patients were assessed for safety (primary objective) and efficacy outcomes, including biomarker analysis. In-stent neointimal hyperplasia was evaluated by intravascular ultrasound at 6 months. Key safety outcomes including coagulation parameters and adverse events did not differ between Serp-1 and placebo groups. A dose-dependent reduction in troponin I levels was observed with Serp-1 at 8, 16, 24, and 54 hours (P<0.05) and in creatine kinase-MB levels at 8, 16, and 24 hours after dose (P<0.05). The composite of death, myocardial infarction, or coronary revascularization occurred in 2 of 12 patients with placebo, 5 of 19 in the low-dose group, and none of 17 patients with the high-dose (P=0.058). Intravascular ultrasound did not detect changes in neointimal hyperplasia among groups.
This is the first study of a viral serpin demonstrating its safety in ACS patients. The significant reduction in myocardial damage biomarkers supports further assessment of Serp-1 in ACS patients undergoing stent deployment.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00243308.
Objectives
This study aimed at comparing direct stenting (DS) versus stenting with pre‐dilation (SP) in patients with ST‐elevation myocardial infarction (STEMI), using a systematic review and ...meta‐analysis of published evidence.
Background
There is conflicting evidence whether stenting strategy impacts clinical outcomes in patients with STEMI.
Methods
We searched EMBASE, MEDLINE, and CENTRAL, from inception to December 2014. The primary endpoint was mortality. Secondary endpoints included major adverse cardiac events (MACEs), ST‐segment resolution, and angiographic outcomes.
Results
A total of 9,331 patients enrolled in 12 studies (3 randomized controlled trials, RCTs; 9 non‐randomized studies, NRSs) were included. DS was associated with lower mortality (OR 0.55; 95%CI: 0.33–0.94; P = 0.03) in NRSs, and overall (OR 0.56; 95%CI: 0.37–0.86; P = 0.008). Mortality was non‐significantly reduced in RCTs (OR 0.56; 95%CI: 0.26–1.23; P = 0.15). DS was also associated with lower MACE rate (OR 0.71; 95%CI 0.60–0.84; P < 0.0001) in NRSs, but not in RCTs (OR 0.99; 95%CI: 0.61–1.60; P = 0.96). ST‐segment resolution, no reflow, final thrombolysis in myocardial infarction (TIMI) flow and final TIMI myocardial perfusion or blush grade were significantly better with DS in NRSs, and non‐significantly better in RCTs.
Conclusions
The available evidence suggests that DS in STEMI might be associated with better clinical and procedural outcomes, as compared with SP. However, the fact that RCTs account for the minority of available data and that most of the available studies poorly reflect current clinical practice, as well as the existence of publication bias, preclude drawing definitive conclusions.
The objective of this study was to determine the effects of angiotensin-converting enzyme inhibition (ACEI) versus long-acting calcium-channel blockade (CCB) on atrial fibrillation (AF) in patients ...with hypertension.
Atrial fibrillation is the most common significant cardiac arrhythmia, and angiotensin II has been implicated in its pathophysiology.
This was a retrospective, longitudinal cohort study from a database of 8 million people in the U.S. Patients age ≥18 years with hypertension were eligible if they filled a prescription for either an ACEI or a CCB between January 1995 and June 1999. The use of all other antihypertensive medications was permitted. Patient chronic disease burden was assessed using a modified Charlson index. Patients were matched on a propensity score generated from a logistic regression model. A survival analysis approach was used to compare the incidence of AF between groups. The final cohorts were evaluated until June 2002, and the average follow-up was 4.5 years.
After cohort matching, 10,926 patients were included in the analysis and divided equally into the ACEI and CCB groups. Mean patient age was 65 years. The adjusted hazards ratio (95% confidence interval CI) in the ACEI versus CCB groups for the entire follow-up period was 0.85 (95% CI: 0.74 to 0.97) for new-onset AF, and the adjusted incidence ratio for AF-related hospitalizations was 0.74 (95% CI: 0.62 to 0.89).
Angiotensin-converting enzyme inhibition was associated with a reduced incidence of AF for patients with hypertension in a usual care setting. These results need to be confirmed in a large-scale randomized clinical trial.