A study to evaluate the clinical outcome of drug-eluting vs. bare-metal stents for acute coronary syndrome patients during commercial use in real setting

Background: This study compared clinical outcome of Drug Eluting Stents (DES) versus Bare Metal Stents (BMS) in coronary arteries in patients with Acute Coronary Syndromes.Methods: A retrospective, observational study was carried out in an inpatient setting of the private tertiary care hospital. Patients with >18 years, diagnosed for Acute Coronary Syndromes (ACS), required intervention in coronary artery with implantation of Drug Eluting Stents (DES) or Bare Metal Stents (BMS) were recruited in the study. The data had been collected from file or database of the hospital. All subjects were followed for major adverse cardiac event.Results: A total of 202 patients who underwent percutaneous coronary intervention (PCI) were enrolled into DES group (n=101) and BMS group (n=101). All patients were followed up at 1 month, 3 months, 6 months & 12 months for Major Adverse Cardiac Events (MACE). Clinical outcomes during 12 months were compared between DES group & BMS group. Overall MACE rates were reported non-significantly high in BMS group patients (14.85%) compare to DES group patients (8.91%) (p=0.458). However, DES group had lower rates of death (0.99% vs 1.98%, p=0.57), rate of MI (3.96% vs 4.95% p=0.73), rate of revascularization (1.98% vs 3.96% p=0.42) & rate of sub acute thrombosis (1.98% vs 3.96% p=0.42) and higher rate of bleeding (1.98% vs 0.99% p=0.57) compare to cohort-II.Conclusions: The use of DES in the setting of Acute Coronary Syndrome is associated with lower Major Adverse Cardiac Event (MACE) rate compared to BMS without compromising the overall safety over the course of one-year follow-up. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials

A Study to Compare Major Adverse Cardiac Event in Patient Undergoing PCI with Drug Eluting Stents Vs Bare Metal Stents

This study compared Major Adverse Cardiac Event in patient with Acute Coronary Syndromes undergoing PCI with Drug Eluting Stents Vs Bare Metal Stents. A retrospective, observational study was carried out in an inpatient setting of the private tertiary care hospital. Patients with >18 years, diagnosed for Acute Coronary Syndromes (ACS), required intervention in coronary artery with implantation of Drug Eluting Stents (DES) or Bare Metal Stents (BMS) were recruited in the study. The data had been collected from file or database of the hospital. All subjects were followed for major adverse cardiac event. Result. A total of 202 patients who underwent percutaneous coronary intervention (PCI) were enrolled into DES group (N=101) and BMS group (N=101).  All patients were followed up at 1 month, 3 months, 6 months & 12 months for Major Adverse Cardiac Events (MACE). Clinical outcomes during 12 months were compared between DES group & BMS group. There was no significant difference in baseline parameters including demographic, risk factors of ACS, diagnosis, angiographic parameters between both groups. Overall MACE rates were reported non-significantly high in BMS group patients (14.85%) compare to DES group patients (8.91%) (P=0.458). However, DES group had lower rates of death (0.99% vs 1.98%, P=0.57), rate of MI (3.96% vs 4.95% P=0.73), rate of revascularization (1.98% vs 3.96% p=0.42) & rate of sub acute thrombosis (1.98% vs 3.96% P=0.42) and higher rate of bleeding (1.98% vs 0.99% p=0.57) compare to cohort-II. Conclusion. The use of DES in the setting of Acute Coronary Syndrome is associated with lower Major Adverse Cardiac Event (MACE) rate compared to BMS without compromising the overall safety over the course of one-year follow-up. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials.DOI: http://dx.doi.org/10.11591/ijphs.v1i2.125

A Study to Compare Major Adverse Cardiac Event in Patient Undergoing PCI with Drug Eluting Stents Vs Bare Metal Stents

This study compared Major Adverse Cardiac Event in patient with Acute Coronary Syndromes undergoing PCI with Drug Eluting Stents Vs Bare Metal Stents. A retrospective, observational study was carried out in an inpatient setting of the private tertiary care hospital. Patients with >18 years, diagnosed for Acute Coronary Syndromes (ACS), required intervention in coronary artery with implantation of Drug Eluting Stents (DES) or Bare Metal Stents (BMS) were recruited in the study. The data had been collected from file or database of the hospital. All subjects were followed for major adverse cardiac event. Result. A total of 202 patients who underwent percutaneous coronary intervention (PCI) were enrolled into DES group (N=101) and BMS group (N=101). All patients were followed up at 1 month, 3 months, 6 months & 12 months for Major Adverse Cardiac Events (MACE). Clinical outcomes during 12 months were compared between DES group & BMS group. There was no significant difference in baseline parameters including demographic, risk factors of ACS, diagnosis, angiographic parameters between both groups. Overall MACE rates were reported non-significantly high in BMS group patients (14.85%) compare to DES group patients (8.91%) (P=0.458). However, DES group had lower rates of death (0.99% vs 1.98%, P=0.57), rate of MI (3.96% vs 4.95% P=0.73), rate of revascularization (1.98% vs 3.96% p=0.42) & rate of sub acute thrombosis (1.98% vs 3.96% P=0.42) and higher rate of bleeding (1.98% vs 0.99% p=0.57) compare to cohort-II. Conclusion. The use of DES in the setting of Acute Coronary Syndrome is associated with lower Major Adverse Cardiac Event (MACE) rate compared to BMS without compromising the overall safety over the course of one-year follow-up. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials

A drug utilization study in glaucoma patients in ophthalmology out patient department in a tertiary care hospital

Background: According to World Health Organization (WHO) studies Glaucoma is a chronic progressive symptomatic disease that damages retinal cells and is one of the leading cause of preventable blindness worldwide. Availability of newer topical agents has modernized the management of glaucoma.Methods: A prospective observational study was carried out from August 2016 to December 2016 at ophthalmology Out Patient Department of L.G General Hospital, Ahmedabad by authours after the approval of the Institutional Ethics Committee.Results: Out of total 101 patients, 71 were males and 30 were females. Average age of patient is 54 years. Common variant of Glaucoma was Primary Open Angle Glaucoma in 57.4% of patients. Average number of drugs per prescription was 2 (45%). Most commonly used Fixed Dose Combination was Brimonidine +Timolol Drops which was used in 87 (86.1%) patients. Most commonly used adjuvant drug was Tab. Acetazolamide (60% of patients).Conclusions: Common variant of Glaucoma was Primary Open Angle Glaucoma in 57.4% of patients. Most commonly used Fixed Dose Combination was Brimonidine+Timolol Drops which was used in 87 (86.1%) patients and commonly used Single drug therapy is Tab. Acetazolamide in (60% of patients)

Natural history and clinical effect of aortic valve regurgitation after left ventricular assist device implantation

ObjectivesAortic valve regurgitation reduces left ventricular assist device mechanical efficiency. Evidence has also suggested that left ventricular assist device implantation can induce or exacerbate aortic valve regurgitation. However, this has not been compared with aortic valve regurgitation progression in a nonsurgical end-stage heart failure population. Furthermore, its clinical effect is unclear. We sought to characterize the development and progression of aortic valve regurgitation in left ventricular assist device recipients and to identify its clinical effect.MethodsA review of all consecutive patients who received an intracorporeal left ventricular assist device at Duke University Medical Center from January 2004 to January 2011 was conducted. Cases of previous or concomitant aortic valve surgery were excluded. Data from the remaining implants (n = 184) and a control group of contemporaneous nonsurgical patients with end-stage heart failure (n = 132) were analyzed. Serial transthoracic echocardiography was used to characterize aortic valve regurgitation as a function of time.ResultsLeft ventricular assist device implantation was associated with worsening aortic valve regurgitation, defined as an increase in aortic valve regurgitation grade, relative to the nonsurgical patients with end-stage heart failure (P < .0001). The recipients of continuous flow left ventricular assist devices were more likely than recipients of pulsatile left ventricular assist devices to develop worsening aortic valve regurgitation (P = .0348). Moderate or severe aortic valve regurgitation developed in 21 left ventricular assist device recipients; this was unrelated to the type of device implanted (continuous vs pulsatile; P = .754) or aortic valve regurgitation grade before left ventricular assist device implantation (P = .42). Five patients developed severe aortic valve regurgitation; all of whom underwent aortic valve procedures.ConclusionsNative aortic valve regurgitation developed and/or progressed after left ventricular assist device implantation, with this effect being more pronounced in continuous flow left ventricular assist device recipients. However, the preoperative aortic valve regurgitation grade failed to correlate with the development of substantial aortic valve regurgitation after left ventricular assist device implantation. After left ventricular assist device implantation, aortic valve regurgitation had a small, but discernible, clinical effect, with some patients developing severe aortic valve regurgitation and requiring aortic valve procedures. These data have implications for the long-term management of left ventricular assist device recipients, in particular as the durability of implantable continuous flow left ventricular assist device therapy improves

Hemodynamic Predictors of Heart Failure Morbidity and Mortality: Fluid or Flow?

BACKGROUND: Patients with advanced heart failure may persist for prolonged times with persistent hemodynamic abnormalities; intermediate and long-term outcomes of these patients are unknown. METHODS AND RESULTS: We used ESCAPE trial data to examine characteristics and outcomes of patients with invasive hemodynamic monitoring during an acute heart failure hospitalization. Patients were stratified by final measurement of cardiac index (CI; L/min/m2) and pulmonary capillary wedge pressure (PCWP; mmHg) before catheter removal. The study groups were CI ≥ 2/PCWP <20 (n = 74), CI ≥ 2/PCWP ≥ 20 (n = 37), CI < 2/PCWP < 20 (n = 23), and CI < 2/PCWP ≥ 20 (n = 17). Final CI was not associated with the combined risk of death, cardiovascular hospitalization, and transplantation (HR:1.03, 95% CI:0.96–1.11 per 0.2 L/min/m(2) decrease, p=0.39), but final PCWP ≥ 20mmHg was associated with increased risk of these events (HR:2.03, 95% CI:1.31–3.15, p<0.01), as was higher final right atrial pressure (RAP; HR:1.09, 95% CI:1.06–1.12 per mmHg increase, p<0.01). CONCLUSION: Final PCWP and final RAP were stronger predictors of post-discharge outcomes than CI in patients with advanced heart failure. The ability to lower filling pressures appears to be more prognostically important than improving CI in the management of patients with advanced heart failure. CLINICALTRIALS.GOV IDENTIFIER: NCT0000061

The incidence, risk factors, and outcomes associated with late right-sided heart failure in patients supported with an axial-flow left ventricular assist device

BACKGROUND: Early right-sided heart failure (RHF) after left ventricular assist device (LVAD) implantation is associated with increased mortality, but little is known about patients who develop late RHF (LRHF). We evaluated the incidence, risk factors, and clinical impact of LRHF in patients supported by axial-flow LVADs. METHODS: Data were analyzed from 537 patients enrolled in the HeartMate II (HM II; Thoratec/St. Jude) destination therapy clinical trial. LRHF was defined as the development of clinical RHF accompanied by the need for inotropic support occurring more than 30 days after discharge from the index LVAD implant hospitalization. Clinical variables, quality of life, rehospitalizations, and survival were compared between patients with and without LRHF. RESULTS: LRHF developed in 41 patients (8%), with a median time to LRHF of 480 days. A higher preoperative blood urea nitrogen and increased central venous pressure-to-pulmonary capillary wedge pressure ratio were independent predictors of LRHF. The Michigan and HMII RHF risk scores were both associated with an increased likelihood of LRHF (p < 0.05). Patients with LRHF had worse quality of life according to the Kansas City Cardiomyopathy Questionnaire (61 ± 26 vs 70 ± 21; p < 0.05), poorer functional capacity by 6-minute walk distance (275 ± 189 m vs 312 ± 216 m; p < 0.05), and more rehospitalizations (6 vs 3; p < 0.001). LRHF was associated with decreased survival (p < 0.001). CONCLUSIONS: LRHF is an important complication in patients with LVADs and is associated with worse quality of life, reduced functional capacity, more frequent hospitalizations, and worse survival compared with those without LRHF

Inhaled Epoprostenol Compared with Nitric Oxide for Right Ventricular Support After Major Cardiac Surgery

Background: Right ventricular failure (RVF) is a leading driver of morbidity and death after major cardiac surgery for advanced heart failure, including orthotopic heart transplantation and left ventricular assist device implantation. Inhaled pulmonary-selective vasodilators, such as inhaled epoprostenol (iEPO) and nitric oxide (iNO), are essential therapeutics for the prevention and medical management of postoperative RVF. However, there is limited evidence from clinical trials to guide agent selection despite the significant cost considerations of iNO therapy. Methods: In this double-blind trial, participants were stratified by assigned surgery and key preoperative prognostic features, then randomized to continuously receive either iEPO or iNO beginning at the time of separation from cardiopulmonary bypass with the continuation of treatment into the intensive care unit stay. The primary outcome was the composite RVF rate after both operations, defined after transplantation by the initiation of mechanical circulatory support for isolated RVF, and defined after left ventricular assist device implantation by moderate or severe right heart failure according to criteria from the Interagency Registry for Mechanically Assisted Circulatory Support. An equivalence margin of 15 percentage points was prespecified for between-group RVF risk difference. Secondary postoperative outcomes were assessed for treatment differences and included: mechanical ventilation duration; hospital and intensive care unit length of stay during the index hospitalization; acute kidney injury development including renal replacement therapy initiation; and death at 30 days, 90 days, and 1 year after surgery. Results: Of 231 randomized participants who met eligibility at the time of surgery, 120 received iEPO, and 111 received iNO. Primary outcome occurred in 30 participants (25.0%) in the iEPO group and 25 participants (22.5%) in the iNO group, for a risk difference of 2.5 percentage points (two one-sided test 90% CI, –6.6% to 11.6%) in support of equivalence. There were no significant between-group differences for any of the measured postoperative secondary outcomes. Conclusions: Among patients undergoing major cardiac surgery for advanced heart failure, inhaled pulmonary-selective vasodilator treatment using iEPO was associated with similar risks for RVF development and development of other postoperative secondary outcomes compared with treatment using iNO. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03081052