Long-term outcomes of percutaneous versus surgical revascularization in patients with diabetes and left main coronary artery disease: A meta-analysis of randomized controlled trials.

BACKGROUND: The efficacy and safety of percutaneous coronary interventions (PCI) relative to coronary artery bypass grafting (CABG) in patients with diabetes and unprotected left main coronary artery disease (LMCAD) are not well established. OBJECTIVES: To perform a meta-analysis evaluating the long-term outcomes after PCI with drug-eluting stents (DES), as compared with CABG, in patients with diabetes and unprotected LMCAD. METHODS: MEDLINE, Cochrane, and Embase were searched for randomized controlled trials (RCTs) that reported outcomes after PCI with DES versus CABG in unprotected LMCAD among patients with diabetes. To evaluate the long-term effects of these interventions, we restricted this analysis to studies with a minimum follow-up period of 3 years. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled with a random-effects model. Quality assessment and risk of bias were performed according to Cochrane recommendations. RESULTS: Four RCTs with a total of 1080 patients were included, 553 (51.2%) of whom underwent PCI. There was no difference for individual outcomes of all-cause mortality (RR: 1.21; 95% CI: 0.86-1.71; p = .27; I2 = 28%), cardiovascular death (RR 1.29; 95% CI: 0.76-2.18; p = .34; I2 = 0%), or myocardial infarction (MI) (RR: 0.94; 95% CI: 0.61-1.45; p = .79; I2 = 0%). However, the risk of stroke was reduced with PCI relative to CABG (RR: 0.41; 95% CI: 0.18-0.94; p = .04; I2 = 0%), whereas the risk of any repeat revascularization was higher in the PCI group (RR: 1.99; 95% CI: 1.44-2.75; p < .001; I2 = 0%). The risk of the composite outcome of all-cause mortality, MI, stroke, or repeat revascularization was higher after PCI compared with CABG (RR: 1.30; 95% CI: 1.09-1.56; p = .004; I2 = 0%). CONCLUSION: In this meta-analysis with more than 1000 patients with diabetes and unprotected LMCAD followed for a minimum of 3 years, the incidence of repeat revascularization was higher among those treated with PCI, whereas the risk of stroke was higher in patients treated with CABG.

A comprehensive review of coronary artery disease in patients with end-stage liver disease.

The prevalence of coronary artery disease has increased in patients with end stage liver disease. In the near future, non-alcoholic steatohepatitis is expected to be the leading cause of end stage liver disease and shares common risk factors with coronary artery disease such as hypertension, hyperlipidemia, obesity and diabetes mellitus. At present, liver transplantation is the only definitive treatment for end stage liver disease, with post-operative mortality associated with the presence of coronary artery disease. Given the high prevalence of cardiovascular disease and the unique balance of pro-thrombotic and antithrombotic factors in patients with end stage liver disease, we sought to discuss the non-invasive and invasive diagnosis, medical and procedural management considerations and pre-transplant evaluation of coronary artery disease in patients with end stage liver disease.

Comparison of In-Hospital Outcomes and Readmission Rates of Transcatheter Aortic Valve Implantation in Mixed Aortic Valve Disease Versus Pure Aortic Stenosis.

Recently, transcatheter aortic valve implantation (TAVI) has been performed in patients with combined aortic stenosis (AS) and aortic regurgitation. We sought to evaluate in-hospital outcomes and readmission rates after TAVI in patients with mixed aortic valve disease (MAVD). A total of 100,573 TAVI procedures were identified between 2011 and 2017 using International Classification of Diseases, Ninth Revision and International Classification of Diseases, Tenth Revision procedure codes the from Nationwide Readmissions Database. We separated patients into 2 cohorts, those with MAVD and those with pure AS. The primary outcome was all-cause inpatient mortality after TAVI, and secondary outcomes included rates of 30- and 90-day readmissions and postprocedural complications. A total of 3,260 patients had MAVD (median age 83 years, 43.5% women). In-hospital mortality (2.5% vs 2.6%, p = 0.531) and rates of paravalvular leak (1.0% vs 1.3%, p = 0.056) were similar between the MAVD and pure AS groups. Major bleeding (7.4% vs 9.6%, p <0.001), 30-day readmission (0.5% vs 8.8%, p <0.001) and 90-day readmission rates (0.8% vs 16.0%, p <0.001), acute kidney injury (12.9% vs 15.1%, p <0.001), postoperative ischemic stroke (2.0% vs 5.7%, p <0.001), and mechanic circulatory support use (1.9% vs 4.5%, p <0.001) were less prevalent in the MAVD cohort. Using a multivariate logistic regression model to adjust for confounding factors, MAVD was not predictive of mortality in patients who underwent TAVI (adjusted odds ratio [adjOR] 1.25, 95% confidence interval [CI] 0.99 to 1.57, p = 0.056); however, MAVD was associated with: decreased odds of 30-day readmission (adjOR 0.05, 95% CI 0.03 to 0.08, p <0.001), 90-day readmission rates (adjOR 0.04, 95% CI 0.03 to 0.06, p <0.001), and higher odds of pacemaker implantation (adjOR 1.46, 95% CI 1.29 to 1.65, p <0.001). In conclusion, despite differences in the aortic valve and left ventricular anatomy (pressure vs volume-related adaptive changes) in patients with MAVD and pure AS, TAVI appears safe and feasible. However, patients with MAVD were more likely to have permanent pacemakers implanted. The results of our study warrant further randomized controlled studies to confirm these findings.

Trends, Predictors and In-Hospital Outcomes of the Next Day Discharge Approach After Transcatheter Mitral Valve Repair.

Early discharge strategies are associated with lower cost and resource utilization during hospitalization, as such we sought to evaluate trends, predictors and outcomes of the next day discharge (NDD) approach after transcatheter mitral valve repair (TMVR) procedures with the MitraClip device. The National Inpatient Sample (NIS) was queried between 2013 and 2018 for patients undergoing TMVR using the International Classification of Diseases (ICD) 9 procedure code '3597' and ICD-10 procedure code '02UG3JZ'. Patients undergoing TMVR were stratified into two groups, determined by hospital length of stay (LOS) [≤1 day, NDD versus >1-day, non-NDD]. Overall, 22,035 patients underwent TMVR with 35.7% (n  = 7,870) belonging to the NDD group (mean age 78.1 ± 9.7 years, women 45%). From 2013 to 2018, the proportion of patients being discharged using the NDD approach trended upward from 18.3% to 46.0%. Amongst demographic and social factors, female sex, black race, and low median household income were predictive of non-NDD (p <0.05 for all). Amongst clinical factors, anemia, iron deficiency anemia, major depressive disorder, thrombocytopenia, obesity and end stage renal disease were some predictors of non-NDD (p <0.05 for all). In the non-NDD group there was a downward trend of pooled post-procedure complications, post procedure cardiogenic shock, vascular complications, acute kidney injury, mechanical circulatory support use, acute respiratory distress and postoperative ischemic stroke and (p for trend <0.001 for all). Despite the overall downward trend, complications began increasing in 2017-18. In conclusion, these trends may reflect improving operator experience, advancement in vascular access device closures and techniques, and prioritization of decreasing length of stay. Ideally, the feasibility and safety of this approach should be confirmed in larger-sized multicenter, randomized trials.

In-Hospital Outcomes in Patients With a History of Malignancy Undergoing Transcatheter Aortic Valve Implantation.

A history of malignancy is incorporated in the Society of Thoracic Surgeons score to assess presurgical risk in patients undergoing surgical aortic valve replacement, however data on the prognostic importance in those undergoing transcatheter aortic valve implantation (TAVI) remains limited. We sought to investigate the utilization and in-hospital outcomes of TAVI in patients with a history of malignancy. The National Inpatient Sample Database was queried from 2012 to 2017 to identify patients who underwent TAVI using International Classification of Diseases (ICD) 9 and ICD-10 procedure codes. Between 2012 and 2017, there were 123,070 patients who underwent TAVI, of these 23,670 patients (19.2%) had a previous history of malignancy. The proportion of patients undergoing TAVI with a history of malignancy trended upward between 2012 and 2017. Patients with a history of malignancy were similar in age to those without (81.1 ± 7.9 vs 80.1 ± 6.7 years old, p <0.001), with a higher prevalence of tobacco use and major depressive disorder (p <0.001 for both). Patients with a history of malignancy had higher rates of post-TAVI pacemaker implantation (p <0.001), otherwise periprocedural complication rates were similar to those without. Using a multivariate logistic regression model to adjust for confounding factors, a history of malignancy was predictive of decreased odds of death in patients underwent TAVI (OR: 0.67, 95% CI, 0.60 to 0.76, p <0.001) and higher odds of pacemaker implantation (OR: 1.14, 95% CI, 1.09 to 1.19, p <0.001). In conclusion, with time the proportion of TAVI patients with a history of malignancy trended upward. Despite a greater prevalence of previous tobacco use and major depressive disorder, patients with a history of malignancy had TAVI safely with a low in-hospital all-cause mortality, yet greater cost of hospitalization and more frequent implantation of pacemaker devices.

Coronary artery disease in lung transplant patients.

Coronary artery disease (CAD) is a pathology often found in patients with end-stage lung disease. Although in the past CAD might have been considered an absolute contraindication, modern revascularization techniques have helped increase the number of transplants performed in this population. However, discrepancies in the guidelines for perioperative evaluation and risk mitigation strategies for the ischemic cardiac burden are present in the current literature. This is a review of the available data regarding perioperative evaluation, revascularization tactics, postoperative management, and survival rate that patients with different grades of coronary artery disease present after lung transplantation.

Large-bore arterial access in the era of structural cardiovascular disease.

Over the last two decades, the medical community witnessed an outstanding and accelerated development on minimally invasive therapies. The definition of what constitutes large bore access is subject to discussion, however within the field it is generally accepted to reflect a catheter diameter exceeding 8-French. We sought in this review to explore the evolution, characteristics and vascular compatibility of the current commercially available devices, analyze the devices along with access site-specific complications rates and finally review the present methods for percutaneous vascular closure.

Transcatheter aortic valve replacement in low risk patients: a review of PARTNER 3 and Evolut low risk trials.

Transcatheter aortic valve replacement (TAVR) has become a mainstay in treatment for patients with severe aortic stenosis who are considered high-risk surgical candidates. The use of TAVR in low-risk patients with severe aortic stenosis is being explored as an alternative to surgical aortic valve replacement (SAVR). Recent results from the Medtronic Evolut Low Risk trial and the Placement of Aortic Transcatheter Valves (PARTNER) 3 trial shed light on the use of TAVR in low-risk surgical candidates. The Evolut Low Risk trial compared TAVR with a self-expanding supra-annular bioprosthesis to SAVR in 1468 patients with severe aortic stenosis who were low surgical risk. Patients with a mean age of 74 and a mean Society of Thoracic Surgeons (STS) risk score of 1.9% were randomized to either TAVR or SAVR groups. Using the composite end point of death or disabling stroke at 24 months, the study found an incidence of 5.3% in the TAVR arm and 6.7% in the surgical arm. The Evolut Low Risk trial thus concluded that TAVR was statistically noninferior but not superior to SAVR (difference, -1.4 percentage points; 95% Bayesian credible interval for the difference, -4.9 to 2.1; posterior probability of noninferiority, >0.999). The PARTNER 3 trial assigned 1,000 patients with severe aortic stenosis and low surgical risk to either TAVR with transfemoral placement of balloon expandable valve or SAVR. Patients with a mean age of 73 and a mean STS score of 1.9% were randomized to either TAVR or SAVR groups. With respect to the primary endpoint of composite death from any cause, stroke, or rehospitalization, the study found an occurrence of 8.5% in TAVR and 15.1% in SAVR, confirming both noninferiority and superiority in the TAVR group [absolute difference, -6.6 percentage points; 95% confidence interval (CI), -10.8 to -2.5; P<0.001 for noninferiority; hazard ratio, 0.54; 95% CI, 0.37 to 0.79; P=0.001 for superiority]. Both the Evolut low risk trial and the PARTNER 3 trial provide evidence that the use of TAVR extends beyond the scope of high and intermediate risk surgical patients and is at the very least equivalent to SAVR in the treatment low-risk surgical candidates when using a transfemoral approach in patients without bicuspid aortic valves. In this article we provide an extensive review on the Evolute low risk and PARTNER 3 trials, including a discussion on clinically relevant outcomes.

Balloon aortic valvuloplasty: Treatment of rapid deployment aortic valve replacement complicated by a paravalvular leak.

The Edwards Intuity Elite valve system was designed to facilitate minimally invasive surgery and streamline complex aortic valve replacements and has since gained more popularity. Despite the superior results shown with rapid deployment aortic valve replacement (RDAVR) utilizing this valve system, paravalvular leaks (PVL), as a complication, remains a concern. Currently, there is no universally agreed single treatment option. A 53-year-old male with a history of well-controlled diabetes mellitus and hypertension presented to the emergency room with a 1-month history of angina, syncope on exertion and dyspnea. On further workup, he was found to have severe aortic stenosis in the setting of a bicuspid aortic valve, with non-obstructive coronary artery disease. He proceeded to urgent RDAVR with a 23 mm Edwards Intuity Valve. Six months post-RDAVR he re-presented with dyspnea on exertion and near syncopal episodes. Postoperative transthoracic and transesophageal echocardiography revealed moderate to severe PVL posterior to the prosthetic aortic valve. Balloon valvuloplasty with a 25 mm True Balloon was performed. Resolution of the PVL was confirmed postprocedure both by angiography and echocardiography. The patient was followed for 1 year and remained symptom-free with evidence of mild PVL on surveillance echocardiography. In conclusion, multiple treatment options for RDAVR complicated by PVL exist; however mid to long-term outcome data are lacking. We presented one such case successfully treated with balloon aortic valvuloplasty.

Prehospital use of i.m. ketamine for sedation of violent and agitated patients.

INTRODUCTION: Violent and agitated patients pose a serious challenge for emergency medical services (EMS) personnel. Rapid control of these patients is paramount to successful prehospital evaluation and also for the safety of both the patient and crew. Sedation is often required for these patients, but the ideal choice of medication is not clear. The objective is to demonstrate that ketamine, given as a single intramuscular injection for violent and agitated patients, including those with suspected excited delirium syndrome (ExDS), is both safe and effective during the prehospital phase of care, and allows for the rapid sedation and control of this difficult patient population. METHODS: We reviewed paramedic run sheets from five different catchment areas in suburban Florida communities. We identified 52 patients as having been given intramuscular ketamine 4 mg/kg i.m., following a specific protocol devised by the EMS medical director of these jurisdictions, to treat agitated and violent patients, including a subset of which would be expected to suffer from ExDS. Twenty-six of 52 patients were also given parenteral midazolam after medical control was obtained to prevent emergence reactions associated with ketamine. RESULTS: Review of records demonstrated that almost all patients (50/52) were rapidly sedated and in all but three patients no negative side effects were noted during the prehospital care. All patients were subsequently transported to the hospital before ketamine effects wore off. CONCLUSION: Ketamine may be safely and effectively used by trained paramedics following a specific protocol. The drug provides excellent efficacy and few clinically significant side effects in the prehospital phase of care, making it an attractive choice in those situations requiring rapid and safe sedation especially without intravenous access.

Desfechos clínicos após investigação para Embolia Pulmonar utilizando TC de tórax/membros inferiores / Clinical outcomes after investigation for pulmonary embolism using CT angiography and venography

FUNDAMENTO: O diagnóstico de Embolia Pulmonar (EP) ainda requer longos períodos de trabalho e inúmeros testes. OBJETIVO: Nosso objetivo é avaliar os desfechos clínicos após uma investigação negativa usando um protocolo combinado de angio TC de tórax e venografia por TC (CTA/CTV) como único teste de diagnóstico em pacientes não selecionados com suspeita de EP. MÉTODOS: Estudo de coorte retrospectivo que incluiu pacientes consecutivos com suspeita de EP que foram investigados com um protocolo combinado de CTA/CTV. Os pacientes que apresentaram inicialmente uma investigação negativa e não receberam anticoagulantes foram acompanhados por seis meses para ocorrência de eventos tromboembólicos venosos recorrentes. RESULTADOS: De 425 pacientes com suspeita de EP, 62 (14,6%) tiveram diagnóstico de tromboembolismo venoso no CTA/CTV inicial. A média de idades foi de 56 ± 19 anos, e 61% da população se enquadravam na categoria de baixa probabilidade clínica. A trombose venosa profunda isolada representou 21% de todos os eventos tromboembólicos venosos, e quando se considerou toda a população, a CTV foi associada a um incremento no rendimento diagnóstico de 3,1%. Nosso grupo era composto de 320 pacientes com CTA/CTV inicialmente negativo e que não receberam anticoagulantes. Após seis meses de acompanhamento, apenas três pacientes apresentaram recorrência de eventos tromboembólicos (0,9%, IC 95% -0,1% - 2,0%) e nenhum foi fatal. Não houve mortes relacionadas com a EP. CONCLUSÕES: Nosso estudo sugere que uma estratégia de diagnóstico que utiliza CTA/CTV como único teste de diagnóstico pode descartar EP com segurança, em população com risco baixo a moderado, e está associada a resultados favoráveis, com um valor preditivo negativo de 99,1%. (Arq Bras Cardiol. 2012; [online].ahead print, PP.0-0).

BACKGROUND: The diagnosis of pulmonary embolism (PE) still requires long work-up periods and multiple tests. OBJECTIVE: We aim to assess clinical outcomes after a negative investigation using a combined protocol of CT pulmonary angiography and CT venography (CTA/CTV) as a sole diagnostic test in unselected patients with suspected PE. METHODS: This retrospective cohort study enrolled consecutive patients with suspected PE who were investigated with a combined CTA/CTV protocol. Patients who had an initially negative investigation and were not anticoagulated were followed for 6 months for the occurrence of recurrent venous thromboembolic events. RESULTS: Out of 425 patients with suspected PE, 62 (14.6%) had venous thromboembolism diagnosed on the initial CTA/CTV. The mean age was 56 ± 19 years and 61% of the population fell into the low clinical probability category. Isolated deep vein thrombosis represented 21% of all venous thromboembolic events, and when considering the whole population, CTV was associated with an increment in diagnostic yield of 3.1%. Our cohort was composed of 320 patients with initially negative CTA/CTVs and who were not anticoagulated. After 6 months of follow up, only three patients presented with recurrent thromboembolic events (0.9%; 95% CI -0.1% - 2.0%) and none was fatal. There were no PE-related deaths. CONCLUSION: Our study suggests that a diagnostic strategy that utilizes CTA/CTV as a sole diagnostic test can safely rule out PE in a low to moderate risk population and is associated with favorable outcomes with a negative predictive value of 99.1%. (Arq Bras Cardiol. 2012; [online].ahead print, PP.0-0).

Clinical outcomes after investigation for pulmonary embolism using CT angiography and venography.

BACKGROUND: The diagnosis of pulmonary embolism (PE) still requires long work-up periods and multiple tests. OBJECTIVE: We aim to assess clinical outcomes after a negative investigation using a combined protocol of CT pulmonary angiography and CT venography (CTA/CTV) as a sole diagnostic test in unselected patients with suspected PE. METHODS: This retrospective cohort study enrolled consecutive patients with suspected PE who were investigated with a combined CTA/CTV protocol. Patients who had an initially negative investigation and were not anticoagulated were followed for 6 months for the occurrence of recurrent venous thromboembolic events. RESULTS: Out of 425 patients with suspected PE, 62 (14.6%) had venous thromboembolism diagnosed on the initial CTA/CTV. The mean age was 56 ± 19 years and 61% of the population fell into the low clinical probability category. Isolated deep vein thrombosis represented 21% of all venous thromboembolic events, and when considering the whole population, CTV was associated with an increment in diagnostic yield of 3.1%. Our cohort was composed of 320 patients with initially negative CTA/CTVs and who were not anticoagulated. After 6 months of follow up, only three patients presented with recurrent thromboembolic events (0.9%; 95% CI -0.1% - 2.0%) and none was fatal. There were no PE-related deaths. CONCLUSION: Our study suggests that a diagnostic strategy that utilizes CTA/CTV as a sole diagnostic test can safely rule out PE in a low to moderate risk population and is associated with favorable outcomes with a negative predictive value of 99.1%.

Analysis of Schistosoma mansoni population structure using total fecal egg sampling.

Many parasite populations are difficult to sample because they are not uniformly distributed between several host species and are often not easily collected from the living host, thereby limiting sample size and possibly distorting the representation of the population. For the parasite Schistosoma mansoni, we investigated the use of eggs, in aggregate, from the stools of infected individuals as a simple and representative sample. Previously, we demonstrated that microsatellite allele frequencies can be accurately estimated from pooled DNA of cloned S. mansoni adults. Here, we show that genotyping of parasite populations from reproductively isolated laboratory strains can be used to identify these specific populations based on characteristic patterns of allele frequencies, as observed by polyacrylamide gel electrophoresis and automated sequencer analysis of fluorescently labeled PCR products. Microsatellites used to genotype aggregates of eggs collected from stools of infected individuals produced results consistent with the geographic distribution of the samples. Preferential amplification of smaller alleles, and stutter PCR products, had negligible effect on measurement of genetic differentiation. Direct analysis of total stool eggs can be an important approach to questions of population genetics for this parasite by increasing the sample size to thousands per infected individual and by reducing bias.