Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis-A Multicenter Real-World Experience.

Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is apparent in nearly 50% of candidates for AV replacement. While transcatheter aortic valve implantation (TAVI) is a recommended treatment for patients with symptomatic severe aortic stenosis (AS) at all surgical risk levels, experience with TAVI in severe bicuspid AS is limited. TAVI in BAV is still a challenge due to its association with multiple and complex anatomical considerations. A retrospective study has been conducted to investigate TAVI's procedural and 30-day outcomes using the Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd. Vapi, Gujarat, India) in patients with severe bicuspid AS. Data were collected on 68 patients with severe bicuspid AS who underwent TAVI with the Myval THV. Baseline characteristics, procedural, 30-day echocardiographic and clinical outcomes were collected. The mean age and STS PROM score were 72.6 ± 9.4 and 3.54 ± 2.1. Procedures were performed via the transfemoral route in 98.5%. Major vascular complications (1.5%) and life-threatening bleeding (1.5%) occurred infrequently. No patient had coronary obstruction, second valve implantation or conversion to surgery. On 30-day echocardiography, the mean transvalvular gradient and effective orifice area were 9.8 ± 4.5 mmHg and 1.8 ± 0.4 cm2, respectively. None/trace aortic regurgitation occurred in 76.5%, mild AR in 20.5% and moderate AR in 3%. The permanent pacemaker implantation rate was 8.5% and 30-day all-cause death occurred in 3.0% of cases. TAVI with the Myval THV in selected BAV anatomy is associated with favorable short-term hemodynamic and clinical outcomes.

Alpha-fetoprotein-producing esophageal adenocarcinoma: a mimicker of hepatocellular carcinoma.

Alpha-fetoprotein (AFP)-producing esophageal adenocarcinoma (EAC) is a rare occurrence. Elevation of serum AFP is commonly associated with hepatocellular carcinoma and yolk sac tumors, but rarely with esophageal carcinoma. Here, we report a rare case of AFP-producing EAC. A 51-year-old man presented with two weeks of acid reflux and a 35-lb weight loss. Laboratory data were notable for transaminitis and AFP was 2524 ng/mL. Computed tomography of the abdomen revealed abnormal thickening of the esophagus and multiple metastatic masses throughout the liver. Biopsy of one of the masses revealed adenocarcinoma of gastrointestinal origin. Subsequent upper endoscopy revealed an esophageal mass with biopsy notable for ulcerated dysplastic glandular mucosa with likely underlying malignancy. The patient underwent palliative esophageal stent placement but died two months later. Elevated AFP levels are an unusual occurrence in EAC. Prognosis is poor given its advanced presenting stage and high metastatic potential. Most cases are unsuccessfully treated with surgery and chemotherapy. Serial measurement of serum AFP may be useful for monitoring clinical status and treatment response. Clinicians should consider AFP-producing EAC in their differential diagnosis in the work-up of a liver mass in the setting of elevated AFP or liver function impairment, especially in the absence of chronic liver disease.

Radiofrequency ablation coupled with Roux-en-Y gastric bypass: a treatment option for morbidly obese patients with Barrett's esophagus.

Barrett's esophagus (BE) is a premalignant condition that is associated with the development of esophageal adenocarcinoma. Risk factors that have been associated with the development of BE include male gender, Caucasian race, chronic gastroesophageal reflux disease, smoking, age >50 and obesity. The current management of BE is dependent on underlying pathological changes and treatment can range from surveillance endoscopy with daily proton pump inhibitor (PPI) therapy in the setting of intestinal metaplasia or low-grade dysplasia (LGD) to radiofrequency ablation (RFA), endoscopic mucosal resection or surgical resection in the setting of high-grade dysplasia. We report the case of a morbidly obese patient who was found to have long-segment BE with LGD during preoperative work-up for weight loss surgery with Roux-en-Y gastric bypass (RYGBP). The patient underwent successful RFA for the treatment of her BE before and after her RYGBP procedure. At 5-year follow-up, there was minimal progression of BE after treatment.

Unusual Causes of Upper Gastrointestinal Bleeding.

Upper gastrointestinal (GI) bleeding is an important clinical condition managed routinely by endoscopists. Diagnostic and therapeutic options vary immensely based on the source of bleeding and it is important for the gastroenterologist to be cognizant of both common and uncommon etiologies. The focus of this article is to highlight and discuss unusual sources of upper GI bleeding, with a particular emphasis on both the clinical and endoscopic features to help diagnose and treat these atypical causes of bleeding.

Unique Aspects of Coronary Artery Disease in Indian Women.

PURPOSE: Epidemiologic and clinical research suggests important gender-related differences in the prevalence, presentation, associated conventional and non-conventional risk factors, management and outcomes of coronary heart disease (CHD) patients. Adequate data is not available for Indian population where prevalence of CHD and depression is high. METHOD: We conducted an observational, single-center, study from January 2010 to December 2011 on 10450 consecutive patients visiting a tertiary care center, Ahmedabad, Gujarat, India who presented with complaints related to CHD. RESULTS: Of these, 6867 patients had coronary artery disease (CAD) as confirmed by angiographic investigation; 5678 were males, and 1189 were females with similar mean age. As compared to males, females had higher prevalence of hypertension, diabetes and obesity while males had higher prevalence of smoking. Invasive treatment options like Coronary Artery Bypass Grafting (p < 0.001) and Percutaneous Coronary Intervention (p = 0.001) were used less often to treat females, and medical therapy (p < 0.001) was the preferred treatment option irrespective of the contributing risk factors/extent of CAD. Depression was observed in 39.8% of acute coronary syndrome patients (n = 1648) as assessed by MARDS scale. It was higher in female patients and in low socioeconomic strata (p < 0.001).At 12 and 36 months, rates of revascularization (p < 0.001) and mortality (p < 0.005) were higher with poor quality of life (QoL) (P < 0.001) in depressed CAD patients. CONCLUSION: In India, women appear to have a higher prevalence of hypertension, diabetes, obesity, and family history of CHD. Yet women get invasive treatments less often than men. Depression is also more common in women and is associated with poor QoL and early mortality than men.

Hysterectomy for uterine adenocarcinoma in the elderly: tumor characteristics, and long-term outcome.

OBJECTIVES: To evaluate the tumor recurrences and survival in elderly patients ≥75 years of age with uterine endometrioid carcinoma treated with surgical staging with/without adjuvant radiation therapy (RT). METHODS: We identified 675 surgically staged patients with FIGO stage I-II uterine endometrioid carcinoma who were treated between 1985 and 2009. Their medical records were retrospectively reviewed in this IRB-approved study. Patients were classified as ≥75 years vs. <75 years and compared regarding tumor recurrence and survival. Following a univariate analysis, multivariable modeling was done using Cox regression analysis. RESULTS: 121 patients (18%) were ≥75 years old at the time of hysterectomy. For this group of elderly patients, median age was 79. All patients were surgically staged and some received adjuvant RT. Older patients were found to have higher FIGO stages (p<0.001), higher grade tumors (p<0.001), more frequent deep myometrial involvement (p<0.001), and more frequent lower uterine segment involvement (p<0.001). There was no significant difference found between older and younger patients with respect to lymphovascular space involvement (LVSI) (p=0.415), number of lymph nodes dissected (p=0.440), or adjuvant RT received (p=0.089). Older patients had more tumor recurrence (15% vs 7%) (p=0.005) and lower five year relapse-free survival of 80% compared to 90% in younger patients (p=0.0016). Multivariate analysis confirmed the significance of LVSI, grade 3 tumors, and deep myometrial invasion as prognostic factors for recurrence. After adjusting for other poor prognostic factors, age was not found to be an independent prognostic factor for recurrence. CONCLUSION: Despite similar surgical staging and adjuvant radiation treatment, patients ≥75 years old diagnosed with FIGO stage I-II uterine endometrioid carcinoma were found to have more adverse pathologic features and worse relapse-free, disease-specific and overall survival than younger patients. Age ≥75 years alone may not be an independent significant prognostic factor affecting tumor recurrence.

Ticagrelor versus clopidogrel in acute coronary syndromes in relation to renal function: results from the Platelet Inhibition and Patient Outcomes (PLATO) trial.

BACKGROUND: Reduced renal function is associated with a poorer prognosis and increased bleeding risk in patients with acute coronary syndromes and may therefore alter the risk-benefit ratio with antiplatelet therapies. In the Platelet Inhibition and Patient Outcomes (PLATO) trial, ticagrelor compared with clopidogrel reduced the primary composite end point of cardiovascular death, myocardial infarction, and stroke at 12 months but with similar major bleeding rates. METHODS AND RESULTS: Central laboratory serum creatinine levels were available in 15 202 (81.9%) acute coronary syndrome patients at baseline, and creatinine clearance, estimated by the Cockcroft Gault equation, was calculated. In patients with chronic kidney disease (creatinine clearance <60 mL/min; n=3237), ticagrelor versus clopidogrel significantly reduced the primary end point to 17.3% from 22.0% (hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.65 to 0.90) with an absolute risk reduction greater than that of patients with normal renal function (n=11 965): 7.9% versus 8.9% (HR, 0.90; 95% CI, 0.79 to 1.02). In patients with chronic kidney disease, ticagrelor reduced total mortality (10.0% versus 14.0%; HR, 0.72; 95% CI, 0.58 to 0.89). Major bleeding rates, fatal bleedings, and non-coronary bypass-related major bleedings were not significantly different between the 2 randomized groups (15.1% versus 14.3%; HR, 1.07; 95% CI, 0.88 to 1.30; 0.34% versus 0.77%; HR, 0.48; 95% CI, 0.15 to 1.54; and 8.5% versus 7.3%; HR, 1.28; 95% CI, 0.97 to 1.68). The interactions between creatinine clearance and randomized treatment on any of the outcome variables were nonsignificant. CONCLUSIONS: In acute coronary syndrome patients with chronic kidney disease, ticagrelor compared with clopidogrel significantly reduces ischemic end points and mortality without a significant increase in major bleeding but with numerically more non-procedure-related bleeding. CLINICAL TRIAL REGISTRATION: URL:http://www.clinicatrials.gov. Unique identifier: NCT00391872.

Transitional cell carcinoma in urachal cyst.

A 33-year-old male patient with abdominal mass for a year was referred to our institute. CT scan with intravenous contrast was performed, which showed a cystic lesion at the infraumbilical region, beneath the anterior abdominal wall with the presence of solid enhancing mass apposed to the anterior wall of the cyst. We suggested a diagnosis of urachal cyst with possibility of malignancy. On surgical exploration, the cystic mass was found superior to and separate from the urinary bladder dome. Histopathology revealed transitional cell carcinoma in a urachal cyst.

Platelet inhibition with cangrelor in patients undergoing PCI.

BACKGROUND: Cangrelor, a nonthienopyridine adenosine triphosphate analogue, is an intravenous blocker of the adenosine diphosphate receptor P2Y(12). This agent might have a role in the treatment of patients who require rapid, predictable, and profound but reversible platelet inhibition. METHODS: We performed a large-scale international trial comparing cangrelor with 600 mg of oral clopidogrel administered before percutaneous coronary intervention (PCI) in patients with acute coronary syndromes. The primary efficacy end point was a composite of death from any cause, myocardial infarction, or ischemia-driven revascularization at 48 hours. RESULTS: We enrolled 8877 patients, and 8716 underwent PCI. At 48 hours, cangrelor was not superior to clopidogrel with respect to the primary composite end point, which occurred in 7.5% of patients in the cangrelor group and 7.1% of patients in the clopidogrel group (odds ratio, 1.05; 95% confidence interval [CI], 0.88 to 1.24; P=0.59). Likewise, cangrelor was not superior at 30 days. The rate of major bleeding (according to Acute Catheterization and Urgent Intervention Triage Strategy criteria) was higher with cangrelor, a difference that approached statistical significance (3.6% vs. 2.9%; odds ratio, 1.26; 95% CI, 0.99 to 1.60; P=0.06), but this was not the case with major bleeding (according to the Thrombolysis in Myocardial Infarction criteria) or severe or life-threatening bleeding (according to Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries criteria). A secondary exploratory end point of death from any cause, Q-wave myocardial infarction, or ischemia-driven revascularization showed a trend toward a reduction with cangrelor, but it was not significant (0.6% vs. 0.9%; odds ratio, 0.67; 95% CI, 0.39 to 1.14; P=0.14). CONCLUSIONS: Cangrelor, when administered intravenously 30 minutes before PCI and continued for 2 hours after PCI, was not superior to an oral loading dose of 600 mg of clopidogrel, administered 30 minutes before PCI, in reducing the composite end point of death from any cause, myocardial infarction, or ischemia-driven revascularization at 48 hours. (ClinicalTrials.gov number, NCT00305162.)

Effect of Metoprolol CR/XL on pulmonary artery pressure in chronic heart failure patients assessed by an implanted ultrasonic device with special emphasis on diurnal variation and exercise capacity.

OBJECTIVE: We evaluated the impact of Metoprolol CR/XL on the diurnal and exercise induced variation on Pulmonary Artery Pressure (PAP) in patients with Chronic Heart Failure (CHF) by implanted ultrasonic device. BACKGROUND: Metoprolol produces haemodynamic and clinical benefits in patients with chronic heart failure and improves survival rate. There is limited information about their effect on PAP, its diurnal and exercise induced variation in heart failure. This study evaluates the diurnal variation and effects of exercise capacity on PAP and impact of Metoprolol CR/XL (XL) on these variations on PAP in CHF patients. METHODS: In this first-in-man study, ten NYHA class III/IV patients were implanted with an ultrasonic pressure-monitoring device, followed a month later by loading with MXL 25 mg/day and uptitrated every two weeks to 200 mg/day. PAP was measured at each follow up. Diurnal variation was evaluated at baseline (no MXL), 100, and 200 mg/day MXL. Treadmill Test (TMT) was performed before and at each uptitration. Echocardiography was performed at one year. RESULTS: Uptitrating MXL caused a slight initial rise in PAP, followed by a subsequent decrease on reaching 200 mg/day dose. One patient showed repeated symptomatic rise in PAP indicating MXL intolerance and was discontinued from the uptitration. The nocturnal rise in PAP at baseline was reduced on reaching 200 mg/day MXL dose. Uptitrating MXL to 200mg7divide;day improved exercise time and metabolic equivalent tasks (METS) with no significant change in post TMT PAP. Ejection fraction also improved at one-year follow-up. CONCLUSIONS: PAP increases post exercise and diurnally in CHF patients. Slow and careful uptitration of MXL with simultaneous non-invasive monitoring of PAP may benefit in nocturnal rise and exercise capacity in CHF patients.

Intracoronary boluses of adenosine and sodium nitroprusside in combination reverses slow/no-reflow during angioplasty: a clinical scenario of ischemic preconditioning.

No or slow reflow following percutaneous coronary intervention (PCI), despite the presence of a patent epicardial vessel, is a serious complication resulting in increased morbidity and mortality. In the present study, we have evaluated the combination therapy of adenosine and sodium nitroprusside administered as sequential intracoronary (IC) boluses on no-reflow during PCI. Seventy-five high risk acute coronary syndrome patients who underwent PCI with evidence of initial less than TIMI (thrombolysis in myocardial infarction) III flow or developed deterioration in TIMI flow during the procedure were randomized to prophylactic administration of multiple boluses of IC saline solution, adenosine (12 microg/bolus) or the combination of adenosine (12 microg/bolus) and sodium nitroprusside (50 microg/bolus), sequentially. Assessment of TIMI and the TMP (tissue myocardial perfusion) grade was done and major adverse cardiac events (MACE) were assessed at the end of 6 months. Slow or no-reflow was persistent in 70% patients receiving saline solution, 31% patients receiving adenosine, and 4% patient receiving the combination. IC injection with saline solution did not produce improvement in TIMI flow or TMP grade. IC injection with combination resulted in greater improvement of TIMI flow and TMP grade. The crossover of patients with no-reflow in saline solution group or adenosine with combination treatment was associated with reestablishment of TIMI II in 4 and TIMI III in 20 patients. Our data suggest that combination therapy of adenosine and nitroprusside is safe and provides better improvement in coronary flow and MACE as compared with IC adenosine alone in cases of impaired flow during coronary interventions.