Degenerative Mitral Stenosis: Unmet Need for Percutaneous Interventions.

Degenerative mitral stenosis (DMS) is an important cause of mitral stenosis, developing secondary to severe mitral annular calcification. With the increase in life expectancy and improved access to health care, more patients with DMS are likely to be encountered in developed nations. These patients are generally elderly with multiple comorbidities and often are high-risk candidates for surgery. The mainstay of therapy in DMS patients is medical management with heart rate control and diuretic therapy. Surgical intervention might be delayed until symptoms are severely limiting and cannot be managed by medical therapy. Mitral valve surgery is also challenging in these patients because of the presence of extensive calcification. Hence, there is a need to develop an alternative percutaneous treatment approach for patients with DMS who are otherwise inoperable or at high risk for surgery. In this review, we summarize the available data on the epidemiology of DMS and diagnostic considerations and current treatment strategies for these patients.

Bleeding complications of triple antithrombotic therapy after percutaneous coronary interventions.

BACKGROUND: 5% of patients undergoing coronary stenting have an indication for anticoagulation. The aim of our study was to determine the bleeding rates and complications in patients on triple oral antithrombotic therapy (TOAT) after coronary stenting. METHODS: We studied patients who underwent coronary stenting in our institution between 2003-2013 and were started on TOAT. Bleeding was the primary outcome. RESULTS: Totally, 999 patients were treated with TOAT with a median follow up of 127 days. All patients were treated with warfarin as an anticoagulant. 267 patients (26.7%) developed a total of 331 bleeding events. 100 patients had bleeding during the first 30 days of therapy. Major bleeding, minor bleeding, bleeding requiring medical attention, and minimal bleeding developed in 2.9%, 3.3%, 17.2%, and 3.3% of the patients respectively as their most significant bleeding event. Patients with anticoagulation initiated at time of stenting had a significantly higher bleeding rate compared to those already on chronic anticoagulation [adjusted HR (95% CI): 1.37 (1.03-1.79), P = 0.03]. The bleeding likelihood was significantly higher for patients with drug-eluted stents (DES) compared to bare-metal stents (BMS) [adjusted OR (95% CI): 1.52 (1.14 - 2.04), P < 0.05]. Patients with atrial fibrillation had an increased rate of bleeding after 6 month of initiation of TOAT with significantly worse outcomes. CONCLUSIONS: TOAT after coronary stenting is associated with high bleeding rates. Patients with AF had worse outcomes. Patients with newly initiated anticoagulation at time of stenting bleed significantly more than people already on chronic anticoagulation prior to stenting. © 2016 Wiley Periodicals, Inc.

Length of stay and long-term mortality following ST elevation myocardial infarction.

BACKGROUND: Over the last few decades, there has been a significant reduction in hospital length of stay (LOS) among patients undergoing percutaneous intervention (PCI) for ST elevation myocardial infarction (STEMI). Although studies have looked at predictors of long hospital stay after STEMI, the impact of LOS on long-term outcomes after PCI remains unknown. We aimed to evaluate the association between LOS at the time of index hospitalization for PCI and long-term mortality among patients presenting with STEMI. METHODS: We examined all patients undergoing PCI for STEMI at the Cleveland Clinic Catheterization Laboratory between 2002 and 2011. Long-term all-cause mortality was assessed using the Social Security Death Index and electronic medical record review. LOS was extracted from the discharge summary of the index hospitalization. RESULTS: A total of 1,963 patients were included in the study. Of these 1,963 patients undergoing PCI for STEMI, 126 (6.4%) died during the index hospitalization. Among survivors of this hospitalization, we observed a significant increase in long-term mortality with an increase in LOS during index hospitalization (P < 0.001). Adjustment for demographic and clinical characteristics yielded statistically significant increased mortality among patients with LOS of 6-10 days [HR (95% CI): 2.2 (1.3-3.5)] and LOS > 10 days [HR (95% CI): 2.6 (1.6-4.3)], in comparison with patients with LOS of 1-2 days. CONCLUSIONS: Long hospital stay after PCI among patients with STEMI was associated with an increased long-term mortality. A long hospital stay may be used as a marker to identify patients at higher risk for long-term mortality.

Comparison of acute elastic recoil between the SAPIEN-XT and SAPIEN valves in transfemoral-transcatheter aortic valve replacement.

BACKGROUND: The SAPIEN-XT is a newer generation balloon-expandable valve created of cobalt chromium frame, as opposed to the stainless steel frame used in the older generation SAPIEN valve. We sought to determine if there was difference in acute recoil between the two valves. METHODS: All patients who underwent transfemoral-transcatheter aortic valve replacement using the SAPIEN-XT valve at the Cleveland Clinic were included. Recoil was measured using biplane cine-angiographic image analysis of valve deployment. Acute recoil was defined as [(valve diameter at maximal balloon inflation) - (valve diameter after deflation)]/valve diameter at maximal balloon inflation (reported as percentage). Patients undergoing SAPIEN valve implantation were used as the comparison group. RESULTS: Among the 23 mm valves, the mean (standard deviation-SD) acute recoil was 2.77% (1.14) for the SAPIEN valve as compared to 3.75% (1.52) for the SAPIEN XT valve (P = 0.04). Among the 26 mm valves, the mean (SD) acute recoil was 2.85% (1.4) for the SAPIEN valve as compared to 4.32% (1.63) for the SAPIEN XT valve (P = 0.01). Multivariable linear regression analysis demonstrated significantly greater adjusted recoil in the SAPIEN XT valves as compared to the SAPIEN valves by 1.43% [(95% CI: 0.69-2.17), P < 0.001]. However, the residual peak gradient was less for SAPIEN XT compared to SAPIEN valves [18.86 mm Hg versus 23.53 mm Hg (P = 0.01)]. Additionally, no difference in paravalvular leak was noted between the two valve types (P = 0.78). CONCLUSIONS: The SAPIEN XT valves had significantly greater acute recoil after deployment compared to the SAPIEN valves. Implications of this difference in acute recoil on valve performance need to be investigated in future studies.

Single center TAVR experience with a focus on the prevention and management of catastrophic complications.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an important treatment option for patients with severe symptomatic aortic stenosis (AS) who are inoperable or at high risk for complications with surgical aortic valve replacement. We report here our single-center data on consecutive patients undergoing transfemoral (TF) TAVR since the inception of our program, with a special focus on minimizing and managing complications. METHODS: The patient population consists of all consecutive patients who underwent an attempted TF-TAVR at our institution, beginning with the first proctored case in May 2006, through December 2012. Clinical, procedural, and echocardiographic data were collected by chart review and echo database query. All events are reported according to Valve Academic Research Consortium-2. RESULTS: During the study period, 255 patients with AS had attempted TF-TAVR. The procedure was successful in 244 (95.7%) patients. Serious complications including aortic annular rupture (n = 2), coronary occlusion (n = 2), iliac artery rupture (n = 1), and ventricular embolization (n = 1) were successfully managed. Death and stroke rate at 30 days was 0.4% and 1.6%, respectively. One-year follow-up was complete in 171 (76%) patients. One-year mortality was 17.5% with a 3.5% stroke rate. Descending aortic rupture, while advancing the valve, was the only fatal procedural event. There were 24.4% patients with ≥2+ aortic regurgitation. CONCLUSIONS: TAVR can be accomplished with excellent safety in a tertiary center with a well-developed infrastructure for the management of serious complications. The data presented here provide support for TAVR as an important treatment option, and results from randomized trials of patients with lower surgical risk are eagerly awaited.

Predicting vascular complications during transfemoral transcatheter aortic valve replacement using computed tomography: a novel area-based index.

BACKGROUND: Computed tomography (CT) imaging has not been systematically studied for predicting vascular complications during transcatheter aortic valve replacement (TAVR). METHODS: Clinical data were obtained from the electronic medical record and analysis was performed for each individual patient's iliofemoral CT angiogram. Sheath : femoral artery diameter ratio (SFAR) and sheath : femoral artery area ratio (SFAAR) were defined as the ratio of the sheath outer diameter to the femoral minimal lumen diameter (MLD) and sheath area to the femoral minimal lumen area (MLA), respectively. RESULTS: A total of 255 patients underwent TF-TAVR with a 30-day mortality of 0.4% and 30-day stroke rate of 1.6%. Twenty-eight (11%) patients suffered a vascular complication, the majority of whom (82%) were managed percutaneously. Receiver operating characteristic (ROC) curve analysis demonstrated an SFAAR of 1.35 to predict the occurrence of vascular complications with a sensitivity of 78.6%. By comparison, similar analysis using SFAR provided a value of 1.45 with sensitivity of 64.2%. Multivariable modeling confirmed SFAR [OR (95% CI): 8.3(1.8-39.1)] and log-transformed SFAAR [OR (95% CI): 40.1 (2.4-650.0)] as significant predictors of vascular complication. CONCLUSIONS: Using CT analysis, an SFAR of 1.45 and an SFAAR of 1.35 are each significant predictors of vascular complications among patients undergoing TF-TAVR. Utilization of CT-based area may provide a more accurate screen for patients undergoing evaluation for TF-TAVR as it takes into consideration the elliptical nature of the vessel. © 2014 Wiley Periodicals, Inc.

Metabolic, renal, and nutritional consequences of bariatric surgery: implications for the clinician.

Management of obesity-associated comorbidities costs about $60 billion/year, about 5% of total US healthcare expenditure. Bariatric surgery is the only proven effective weight loss therapy for severely obese patients with a BMI > or =35 kg/m2. Bariatric surgery produces long-term weight loss, improves quality of life, and reduces the number of sick days and medication costs. Surgery has a profound effect on the metabolic milieu and nutritional status from the first few days after surgery, even before significant weight loss has been achieved. Metabolic effects of bariatric surgery reduce obesity-related comorbidities like type 2 diabetes, hypertension, metabolic syndrome, and cardiovascular disease risk. Improvement in renal function is seen, but adverse effects like oxalate nephropathy can lead to chronic kidney disease or end-stage renal disease (CKD/ESRD). Surgery can also lead to micronutrient deficiencies, making dietary supplementation necessary. Reduction in insulin resistance and hypertension after surgery makes medication adjustment imperative. Improvement in comorbidities and nutritional deficiencies after bariatric surgery has important clinical implications.

Readmissions in ST-Elevation Myocardial Infarction and Cardiogenic Shock (from Nationwide Readmission Database).

Management of ST-elevation myocardial infarction complicated by cardiogenic shock (STEMI-CS) has evolved in the last decade. There is paucity of data on readmissions in this study population. We aimed to assess the burden, major etiologies, and resource utilization for 30-day readmissions among patients with STEMI and CS. The Nationwide Readmission Database was queried from 2010 to 2014. All adult patients with an index admission for STEMI-CS were identified using International Classification of Diseases, ninth edition codes. Patient with mortality on index admission and transfers to other hospitals were excluded. A total of 18,659 admissions were identified with primary diagnosis of STEMI-CS for the study duration. Percutaneous coronary interventions was performed in 78.1% and mechanical circulatory devices were utilized in 53.9% with a mean length of stay of 10.6 (±0.2) days and mean cost of hospitalization of $47,744 (±327). Among these, 2,404 (12.9%) patients were readmitted within 30 days. Major etiologies for readmission include congestive heart failure (25.7%), acute myocardial infarction (9.4%), arrhythmias (4.5%), and sepsis (4.2%). The mean length of stay and cost of hospitalization for 30-day readmission were 5.9 (±0.3) days and $17,043 (±590), respectively. Older age, female gender, lower socioeconomic status, and discharge to home health care were significant predictors for readmission. In conclusion, there is a significant burden of 30-day readmission among patients with STEMI-CS. Percutaneous coronary interventions and mechanical circulatory devices were utilized in a majority of index admissions. Congestive heart failure was the single most common reason for 30-day readmission. Patients discharged to skilled nursing facility, patients with private insurance and higher socioeconomic status were less likely to be readmitted. Moreover, readmissions among STEMI-CS patients contribute to significant resource utilization.

Impact of Coronary Artery Disease on 30-Day and 1-Year Mortality in Patients Undergoing Transcatheter Aortic Valve Replacement: A Meta-Analysis.

BACKGROUND: The impact of coronary artery disease (CAD) on outcomes after transcatheter aortic valve replacement (TAVR) is understudied. Literature on the prognostic role of CAD in the survival of patients undergoing TAVR shows conflicting results. This meta-analysis aims to investigate how CAD impacts patient survival following TAVR. METHODS AND RESULTS: We completed a comprehensive literature search of Embase, MEDLINE, and the Cochrane Library, and included studies reporting outcome of TAVR based on CAD status of patients for the analysis. From the initial 1631 citations, 15 studies reporting on 8013 patients were analyzed using a random-effects model. Of the 8013 patients undergoing TAVR, with a median age of 81.3 years (79-85.1 years), 46.6% (40-55.7) were men and 3899 (48.7%) had CAD (ranging from 30.8% to 78.2% in various studies). Overall, 3121 SAPIEN/SAPIEN XT/SAPIEN 3 (39.6%) and 4763 CoreValve (60.4%) prostheses were implanted, with transfemoral access being the most frequently used approach for the implantation (76.1%). Our analysis showed no significant difference between patients with and without CAD for all-cause mortality at 30 days post TAVR, with a cumulative odds ratio of 1.07 (95% confidence interval, 0.82-1.40; P=0.62). However, there was a significant increase in all-cause mortality at 1 year in the CAD group compared with patients without CAD, with a cumulative odds ratio of 1.21 (95% confidence interval, 1.07-1.36; P=0.002). CONCLUSIONS: Even though coexisting CAD does not impact 30-day mortality, it does have an impact on 1-year mortality in patients undergoing TAVR. Our results highlight a need to revisit the revascularization strategies for concomitant CAD in patients with TAVR.

Safety and Efficacy of Exercise Training in Patients With an Implantable Cardioverter-Defibrillator: A Meta-Analysis.

OBJECTIVES: In this study, the authors performed a meta-analysis of currently available comparative prospective studies to assess the efficacy and safety of exercise training in heart failure (HF) patients with implantable cardioverter-defibrillators (ICD). BACKGROUND: ICDs have been shown to improve survival in patients with HF. However, many patients with ICDs experience fear of shocks and avoid physical activity. Few data exist for efficacy and safety of exercise training in HF patients with ICDs. METHODS: Prospective parallel arm trials with control and exercise training groups that evaluated the efficacy of exercise training in patients with ICDs were included in the meta-analysis. Outcomes of interest were difference in the change in cardiorespiratory fitness (CRF) (ml/kg/min) between exercise and control group and the likelihood of ICD shocks among exercise training compared with that among control participants on follow-up. RESULTS: We included study level data from 6 trials (5 randomized controlled trials and 1 nonrandomized controlled trial). In the pooled analysis, ICD patients undergoing exercise training had significant improvement in CRF (weighted mean difference: 1.98 ml/kg/min; 95% confidence interval [CI]: 0.58 to 3.38). The likelihood of ICD shocks on follow-up was also significantly lower among exercise training than among control participants (pooled odds ratio: 0.47; 95% CI: 0.24 to 0.91). CONCLUSIONS: Among patients with HF and ICD implantation, exercise training was associated with significant improvement in CRF and lower likelihood of ICD shocks.

Impact of lean six sigma process improvement methodology on cardiac catheterization laboratory efficiency.

BACKGROUND: Operational inefficiencies are ubiquitous in several healthcare processes. To improve the operational efficiency of our catheterization laboratory (Cath Lab), we implemented a lean six sigma process improvement initiative, starting in June 2010. We aimed to study the impact of lean six sigma implementation on improving the efficiency and the patient throughput in our Cath Lab. METHODS: All elective and urgent cardiac catheterization procedures including diagnostic coronary angiography, percutaneous coronary interventions, structural interventions and peripheral interventions performed between June 2009 and December 2012 were included in the study. Performance metrics utilized for analysis included turn-time, physician downtime, on-time patient arrival, on-time physician arrival, on-time start and manual sheath-pulls inside the Cath Lab. RESULTS: After implementation of lean six sigma in the Cath Lab, we observed a significant improvement in turn-time, physician downtime, on-time patient arrival, on-time physician arrival, on-time start as well as sheath-pulls inside the Cath Lab. The percentage of cases with optimal turn-time increased from 43.6% in 2009 to 56.6% in 2012 (p-trend<0.001). Similarly, the percentage of cases with an aggregate on-time start increased from 41.7% in 2009 to 62.8% in 2012 (p-trend<0.001). In addition, the percentage of manual sheath-pulls performed in the Cath Lab decreased from 60.7% in 2009 to 22.7% in 2012 (p-trend<0.001). CONCLUSIONS: The current longitudinal study illustrates the impact of successful implementation of a well-known process improvement initiative, lean six sigma, on improving and sustaining efficiency of our Cath Lab operation. After the successful implementation of this continuous quality improvement initiative, there was a significant improvement in the selected performance metrics namely turn-time, physician downtime, on-time patient arrival, on-time physician arrival, on-time start as well as sheath-pulls inside the Cath Lab.

Percutaneous Intervention for Myocardial Infarction After Noncardiac Surgery: Patient Characteristics and Outcomes.

BACKGROUND: Few studies have explored percutaneous coronary intervention (PCI) in perioperative myocardial infarction (PMI), even though PMI is a major cause of mortality in patients undergoing urgent/emergent noncardiac surgery. OBJECTIVES: This study sought to describe the angiographic characteristics and outcomes in patients presenting to the cardiac catheterization laboratory for myocardial infarction sustained after undergoing noncardiac surgery, with a detailed analysis of those undergoing PCI. METHODS: We included all patients presenting to the catheterization laboratory at our institution after PMI from 2003 to 2012, who had noncardiac surgery within the previous 7 days. Data from patients who underwent PCI were analyzed using both standard regression and time-to-event survival analysis. RESULTS: From 2003 to 2012, 1,093 patients with 3,832 person-years of follow-up underwent diagnostic coronary angiography, of whom 281 (40 ST-segment elevation myocardial infarction [STEMI] and 241 non-ST-segment elevation myocardial infarction [NSTEMI] cases) underwent PCI. Using Kaplan-Meier survival analysis, we found 30-day mortality was 5.2% and 1-year mortality was 15% in the overall population. In the PCI subpopulation, we estimated 30-day mortality to be 11.3%. The 30-day death rate in the STEMI cohort was 31.2% and 8.5% in the NSTEMI cohort of the PCI subpopulation. Stepwise logistic regression revealed the following factors as strong predictors of 30-day mortality after PCI: bleeding event after PCI (odds ratio [OR]: 4.33; 95% confidence limits (CL): 1.52 to 12.30), peak troponin T level (OR: 1.20; 95% CL: 1.08 to 1.34), and underlying peripheral vascular disease (OR: 4.86; 95% CL: 1.66 to 14.22). Cox proportional hazard analysis of survival data showed that increasing age (hazard ratio [HR]: 1.03; 95% CL: 1.01 to 1.04), bleeding after PCI (HR: 2.31; 95% CL: 1.61 to 3.32), renal insufficiency (HR: 2.26; 95% CL: 1.51 to 3.39]), and vascular surgery (HR: 1.48; 95% CL: 1.02 to 2.15]) were all significant predictors of long-term mortality after PCI. CONCLUSIONS: Perioperative MI has a markedly high mortality rate, despite PCI. Bleeding event, peak troponin T level, and peripheral vascular disease predict mortality within 30 days of PCI in this patient population. Similarly, older age, vascular surgery, bleeding event, and renal dysfunction strongly predict long-term mortality after PCI in the setting of PMI.

Two-Decade Trends in the Prevalence of Atherosclerotic Risk Factors, Coronary Plaque Morphology, and Outcomes in Adults Aged ≤45 Years Undergoing Percutaneous Coronary Intervention.

Data are limited about the prevalence trends of risk factors, lesion morphology, and clinical outcomes of coronary artery disease in patients, aged ≤45 years, undergoing percutaneous coronary intervention (PCI), between the bare-metal stent (BMS; 1994 to 2002) and drug-eluting stent (DES; 2003 to 2012) eras. From the PCI database at the Cleveland Clinic, we identified 1,640 patients aged ≤45 years and without a history of coronary artery bypass grafting who underwent PCI from 1994 to 2012. There were 883 patients in the BMS era cohort with a mean follow-up period of 13.15 years and 757 in the DES era cohort with a mean follow-up of 5.02 years. The DES era had more obese (51.8% vs 44.7%, p <0.001) and diabetes (23.0% vs 19.5%, p = 0.09) patients. DES era patients had more B2/C lesions (74.0% vs 32.5%, p <0.001), more severe preprocedural stenosis (86.1 ± 12.9 vs 72.2 ± 21.3, p <0.001), and longer lesions (15.5 ± 9.9 vs 9.6 ± 6.8, p <0.001). No difference was observed in the 30-day mortality between the DES and BMS eras. Irrespective of era, diabetics had worse long-term mortality (19.4% vs 9.3%, p <0.001) compared with nondiabetics. Obese patients had similar long-term outcomes compared with nonobese patients. In conclusion, patients aged ≤45 years, who underwent a PCI procedure in the DES era had worse risk factor profiles, including obesity, compared with patients in the BMS era. They also had more complex lesions. Procedural and long-term outcomes of these patients have not changed between the 2 eras. Young diabetic patients have worse long-term outcomes compared with nondiabetics.

Cardiac Plug I and Amulet Devices: Left Atrial Appendage Closure for Stroke Prophylaxis in Atrial Fibrillation.

Percutaneous left atrial appendage (LAA) occlusion has emerged as an exciting and effective modality for stroke prophylaxis in patients with non-valvular atrial fibrillation who are deemed too high risk for anticoagulation with warfarin or newer anticoagulants. The Amplatzer devices have been used in LAA occlusion for more than a decade, starting with off label use of an atrial septal occluder device for LAA occlusion. This was followed by introduction of a dedicated Amplatzer cardiac plug (ACP) 1 for LAA occlusion, and more recently, the second generation Amulet device, with reported better stability enhancing features, has been introduced. Both these devices are widely used outside the United States, however in the US only the WATCHMAN device has been FDA approved. Unlike the WATCHMAN device, where the evidence is continuously building as the data from two pivotal randomized controlled trials are emerging, most of the evidence for ACP devices is from pooled multicenter registry data. In this article, we review the device design, implantation techniques and the most recently published evidence for both the Amplatzer cardiac plug 1 and the newer Amulet device. Our goal is to summarize the most recent literature and discuss the current role of the Amplatzer devices in the exciting and rapidly growing field of percutaneous LAA occlusion.

In-hospital mortality and stroke after surgical aortic valve replacement: A nationwide perspective.

BACKGROUND: Stroke is a widely recognized complication after aortic valve replacement (AVR), especially among elderly patients. The literature contains substantial variability in reports of the actual incidence of stroke after AVR among high-risk patients. Our objective was to define risk of stroke in patients undergoing surgical AVR, using a large national database. METHODS: We used the 2002 to 2011 Nationwide Inpatient Sample database for this analysis. All patients undergoing isolated AVR, or AVR with coronary artery bypass grafting (AVR + CABG), were identified using standard International Classification of Diseases codes. In-hospital mortality and any adverse neurologic event were the primary outcomes of the study. RESULTS: The incidence of in-hospital mortality was 3.0% and 5.1%, respectively, among patients undergoing isolated AVR and AVR + CABG; it was significantly lower in high-volume centers. The incidence of any adverse neurologic event was 2.0% and 2.9%, respectively, among patients undergoing isolated AVR, and AVR + CABG. We demonstrated a progressive increase in the risk of in-hospital mortality and adverse neurologic events with increasing age. Neurologic events increased with age, from 1.3% for patients aged <70 years, to 3.2% for those aged >85 years, for isolated AVR; and from 2.3% to 3.6% for AVR + CABG. The incidence of in-hospital mortality was as high as 5.7% and 7.4%, respectively, among patients aged >85 years undergoing isolated AVR, and AVR + CABG. Similarly, the incidence of any adverse neurologic event was 3.2% and 3.6%, respectively, among patients aged >85 years undergoing isolated AVR, and AVR + CABG. In addition, the risk of adverse neurologic events was significantly higher in the high-risk surgical cohort, compared with the low-risk surgical cohort (odds ratio [95% confidence interval]; isolated AVR: 2.38 [1.99-2.86]; AVR + CABG: 1.88 [1.57-2.24]). CONCLUSIONS: The incidence of in-hospital mortality and adverse neurologic events was significantly higher among patients with advanced age and elevated surgical risk.

Renin-Angiotensin System Antagonists in Patients Without Left Ventricular Dysfunction After Percutaneous Intervention for ST-Segment Elevation Myocardial Infarction.

There is a paucity of evidence on the impact of angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) on long-term outcomes in patients with ejection fraction (EF) >40% after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). We compared long-term all-cause mortality between patients with left ventricular ejection fraction (LVEF) >40% discharged on ACEi/ARB with patients who were discharged on neither of these agents. Patients discharged after percutaneous intervention for STEMI from our catheterization laboratories from January 2002 to December 2011 were considered for inclusion. Patients were excluded if they had LVEF <40% or chronic kidney disease or hypotension (systolic blood pressure <90 mm Hg any time after the procedure). Long-term mortality and discharge medications were determined using the Social Security Death Index and electronic medical record review, respectively. A total of 988 patients were included. The median follow-up duration was 4.6 years. Kaplan-Meier analysis showed no significant difference in long-term all-cause mortality in patients discharged on ACEi/ARB compared with those who were not discharged on these medications. The number needed to treat to prevent 1 death at 1 year was 714. In addition, multivariable Cox proportional hazard modeling failed to demonstrate any beneficial effect of ACEi/ARB similar to Kaplan-Meir analysis (hazard ratio 0.88, 95% confidence interval 0.57 to 1.36). In conclusion, we found no significant benefit in long-term mortality using ACEi/ARB in patients with LVEF >40% after primary percutaneous coronary intervention for STEMI.

Comparative meta-analysis of balloon-expandable and self-expandable valves for transcatheter aortic valve replacement.

BACKGROUND: Balloon-expandable valves (BEVs) and self-expandable valves (SEVs) are two major types of valves utilized for transcatheter aortic valve replacement (TAVR). We conducted a meta-analysis of available studies to compare the safety and efficacy of these two valve types. METHODS: Medline search was conducted using standard search terms to determine eligible studies. Primary outcomes of the meta-analysis included death and stroke at 30days and 1year. Pooled estimates of procedural outcomes were also compared between the valve types. Analysis was performed for entire cohort and separately for patients undergoing transfemoral TAVR (TF-TAVR). RESULTS: Analysis of entire cohort revealed similar 30-day mortality in the SEV and BEV cohorts. There was no significant difference in the incidence of stroke at 30days between the two study groups. Both pooled comparisons demonstrated a significant heterogeneity with I(2)>50%, necessitating the use of random effect modeling. We observed a significantly higher incidence of new pacemaker implantation, aortic regurgitation≥2+ at 30days, valve embolization, and need for >1 valve following SEV implantation compared with BEV implantation. Analysis of TF-TAVR cohort showed higher 30day [IRR (95% CI): 1.34 (1.19-1.52)] but a similar 1-year mortality [IRR (95% CI): 1.07 (0.96-1.19)] for SEV compared to BEV implantation. CONCLUSION: Compared to BEV implantation, SEV implantation was associated with a similar risk of mortality and stroke at 30-day and 1-year follow-up duration. Analysis of the TF-TAVR cohort revealed a significantly higher mortality at 30days among patients undergoing SEV implantation, compared with BEV implantation. In addition, there was a significantly higher incidence of other adverse events noted above, following SEV implantation, compared with BEV implantation.

Exercise training in patients with heart failure and preserved ejection fraction: meta-analysis of randomized control trials.

BACKGROUND: Heart failure with preserved ejection fraction (HFPEF) is common and characterized by exercise intolerance and lack of proven effective therapies. Exercise training has been shown to be effective in improving cardiorespiratory fitness (CRF) in patients with systolic heart failure. In this meta-analysis, we aim to evaluate the effects of exercise training on CRF, quality of life, and diastolic function in patients with HFPEF. METHODS AND RESULTS: Randomized controlled clinical trials that evaluated the efficacy of exercise training in patients with HFPEF were included in this meta-analysis. Primary outcome of the study was change in CRF (measured as change in peak oxygen uptake). Effect of exercise training on quality of life (estimated using Minnesota living with heart failure score), and left ventricular systolic and diastolic function was also assessed. The study included 276 patients who were enrolled in 6 randomized controlled trials. In the pooled data analysis, patients with HFPEF undergoing exercise training had significantly improved CRF (mL/kg per min; weighted mean difference, 2.72; 95% confidence interval, 1.79-3.65) and quality of life (weighted mean difference, -3.97; 95% confidence interval, -7.21 to -0.72) when compared with the control group. However, no significant change was observed in the systolic function (EF-weighted mean difference, 1.26; 95% confidence interval, -0.13% to 2.66%) or diastolic function (E/A-weighted mean difference, 0.08; 95% confidence interval, -0.01 to 0.16) with exercise training in patients with HFPEF. CONCLUSIONS: Exercise training in patients with HFPEF is associated with an improvement in CRF and quality of life without significant changes in left ventricular systolic or diastolic function.

Meta-analysis of the cardiovascular outcomes with dipeptidyl peptidase 4 inhibitors: validation of the current FDA mandate.

BACKGROUND: Earlier meta-analyses have demonstrated a significant reduction in major adverse cardiovascular events (MACE) with dipeptidyl peptidase 4-inhibitor (DPPI) use, as compared with placebo or alternative anti-diabetic therapies. However, the large phase III/IV trials, namely SAVOR-TIMI 53 and the EXAMINE trials, failed to demonstrate any significant differences in MACE between DPPI and placebo. We aimed to perform an updated meta-analysis of randomized controlled trials (RCTs) to investigate the differences in cardiovascular death, myocardial infarction (MI), and stroke between DPPI and placebo/alternative agents. METHODS: We searched the MEDLINE, EMBASE, and Cochrane databases for relevant phase III/IV RCTs. Unpublished trials with results available on national clinical trials registers were also included. RCTs with follow-up duration ≥24 weeks were included if they compared DPPI with placebo or an alternative anti-diabetic agent. RESULTS: A total of 82 RCTs including 73,678 patients were included. We did not observe any significant difference in the pooled odds of cardiovascular death, MI, or stroke in the composite DPPI arm as compared with the control arm. Similarly, the pooled odds of all-cause death and MACE were statistically similar between the two groups. None of the clinical outcomes studied demonstrated evidence of statistical heterogeneity or publication bias. Due to a larger sample size and a longer duration of follow-up, both SAVOR-TIMI 53 and EXAMINE trials had a considerably larger contribution to the pooled estimates in our meta-analysis, driving the updated pooled estimates towards null for all clinical outcomes assessed. CONCLUSIONS: DPPI use was not associated with increased incidence of cardiovascular mortality, MI, stroke, or MACE compared with placebo or alternative anti-diabetic agents.