Jay Shah

Effects of Phosphodiesterase Type 5 Inhibition on Systemic and Pulmonary Hemodynamics and Ventricular Function in Patients With Severe Symptomatic Aortic Stenosis

Background— Pressure overload resulting from aortic stenosis causes maladaptive ventricular and vascular remodeling that can lead to pulmonary hypertension, heart failure symptoms, and adverse outcomes. Retarding or reversing this maladaptive remodeling and its unfavorable hemodynamic consequences has the potential to improve morbidity and mortality. Preclinical models of pressure overload have shown that phosphodiesterase type 5 inhibition is beneficial; however, the use of phosphodiesterase type 5 inhibitors in patients with aortic stenosis is controversial because of concerns about vasodilation and hypotension. Methods and Results— We evaluated the safety and hemodynamic response of 20 subjects with severe symptomatic aortic stenosis (mean aortic valve area, 0.7±0.2 cm2; ejection fraction, 60±14%) who received a single oral dose of sildenafil (40 or 80 mg). Compared with baseline, after 60 minutes, sildenafil reduced systemic (−12%; P<0.001) and pulmonary (−29%; P=0.002) vascular resistance, mean pulmonary artery (−25%; P<0.001) and wedge (−17%; P<0.001) pressures, and increased systemic (13%; P<0.001) and pulmonary (45%; P<0.001) vascular compliance and stroke volume index (8%; P=0.01). These changes were not dose dependent. Sildenafil caused a modest decrease in mean systemic arterial pressure (−11%; P<0.001) but was well tolerated with no episodes of symptomatic hypotension. Conclusions— This study shows for the first time that a single dose of a phosphodiesterase type 5 inhibitor is safe and well tolerated in patients with severe aortic stenosis and is associated with improvements in pulmonary and systemic hemodynamics resulting in biventricular unloading. These findings support the need for longer-term studies to evaluate the role of phosphodiesterase type 5 inhibition as adjunctive medical therapy in patients with aortic stenosis. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT01060020.

First-in-human evaluation of the novel BioMime sirolimus-eluting coronary stent with bioabsorbable polymer for the treatment of single de novo lesions located in native coronary vessels - results from the meriT-1 trial

AIMS We report the initial human evaluation of the novel BioMimeTM sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer for the treatment of de novo coronary lesions. METHODS AND RESULTS The meriT-1 trial was a prospective, non-randomised, single-arm, single-centre, first-in-human evaluation of the safety, feasibility and performance of the BioMime SES. Lesion criteria included non-occlusive stenosis ≤ 19 mm in length located in native coronary vessels. Clinical follow-up (FU) was performed at 1, 8 and 12 months; all patients were assigned for angiographic FU at eight months. A total of 30 patients (30 lesions) were enrolled between March 2009 and February 2010. Mean age was 49.9 years, 30% were diabetics, and 36.7% had previous myocardial infarction (MI). Baseline median [25%, 75% interquartile range] lesion length, reference diameter and % diameter stenosis were 15.51 mm [12.74, 20.27], 2.94 mm [2.71, 3.34], and 80.5% [67.0%, 90.7%], respectively. Overall, there was one stent implanted per lesion and procedural success was 100%. At eight-month angiographic FU (26/30), median in-stent late lumen loss was 0.15 mm [0.09, 0.33]; also, there were no cases of binary restenosis within the treated segment. Clinical FU at 12 months (100%) demonstrated absence of MACE (cardiac death, MI and target lesion revascularisation) and stent thrombosis (ST). CONCLUSIONS The novel BioMime SES demonstrated excellent performance in single coronary lesions including high procedural success and efficacy, as demonstrated by the relatively low late lumen loss (a surrogate of neointimal hyperplasia) at eight-month angiographic FU. Overall, there were no safety concerns in this preliminary evaluation including absence of MACE or ST up to 12 months.

Effects of age, sex, race, diagnosis-related group, and hospital setting on lipid management in patients with coronary artery disease ☆

Among 1,211 patients hospitalized with documented CAD at either a university hospital or a large suburban community hospital, 36% failed to receive appropriate evaluation and treatment for dyslipidemia. Younger patients, those admitted to a university hospital, and those undergoing percutaneous coronary intervention were substantially more likely to receive appropriate lipid management than other subgroups.

Comparison of Outcomes and Cost of Endovascular Management Versus Surgical Bypass for the Management of Lower Extremities PeripheralArterial Disease

The management of lower extremities peripheral arterial disease (LE-PAD) has always been debatable. We sought to explore in-hospital outcomes in hospitalizations that underwent endovascular or bypass surgery for LE-PAD from nations largest, publicly available database. The National Inpatient Sample from 2012 to 2014 was queried to identify adult hospitalizations underwent endovascular management and bypass surgery for LE-PAD. Appropriate International Classification of Diseases, Ninth Revision, Clinical Modification diagnostic and procedural codes were utilized to identify hospitalizations. A total of 89,256 hospitalizations were identified having endovascular management or bypass surgery for LE-PAD. More hospitalizations underwent endovascular intervention as compared with bypass surgery. Overall, hospitalizations for endovascular management had higher baseline co-morbidities and older age. A propensity score matched analysis was performed to compare in-hospital outcomes. After matching, 28,791 hospitalizations were included in each group. In-hospital mortality was significantly lower with endovascular intervention procedure as compared with surgical bypass group (1.5% vs 2.5%, p ≤0.001). All other secondary outcomes were noted lower with endovascular management except stroke and postprocedural infection. Taken together, these may account for higher discharges to home, lower length of stay, and less cost of hospitalizations associated with endovascular management. In conclusion, endovascular management is associated with lower in-hospital morbidity, mortality, length of stay, and cost when compared with bypass surgery in this study.

Comparison of Transcatheter Mitral Valve Repair Versus Surgical Mitral Valve Repair in Patients With Advanced Kidney Disease (from the National Inpatient Sample)

Transcatheter mitral valve repair (TMVR) is an emerging treatment modality that has been reserved for high-risk patients with multiple co-morbidities. We hypothesize that TMVR is a safe and effective procedure for patients with moderate to severe mitral regurgitation who are not surgical candidates. The National Inpatient Sample (2012 to 2014) using the International Classification of Diseases, 9th Revision, Clinical Modification procedure codes 35.97 for TMVR and 35.12 for surgical mitral valve repair (SMVR) were used. Patients with chronic kidney disease stage IV, Stage V, and end-stage renal disease (ESRD) were considered as patients with advanced kidney disease. A total of 2,123 patients were treated with SMVR and 74 patients were treated with TMVR. There were notably fewer patients treated with TMVR compared with patients treated with SMVR. The mean age was higher with the TMVR group (72.4 vs 61.7 years, p = <0.001). After performing multivariate regression analysis, the primary outcome of in-hospital mortality (13.8% vs 1.3%, adjusted p = 0.003) and all secondary outcomes, excluding dialysis requirement, cardiogenic shock, and cardiac arrest, were significantly lower with the TMVR approach. The average length of stay was lower with TMVR compared with SMVR (22.8 vs 12.6 days, adjusted p = <0.001), with reduced in-hospital costs (

AS-209: Risk Factor Profile for Coronary Artery Disease in Very Young Gujarati Population

98,165 vs

AS-218: Echocardiographic Study of Truncus Arteriosus

52,646, adjusted p = <0.001). This large, national study suggests TMVR is associated with significantly lower in-patient morbidity and mortality, with significant cost savings in patients with advanced kidney disease compared with SMVR. Hence, TMVR could be a safe and effective alternative for patients with advanced kidney disease who are not surgical candidates.