Short-Term Antiplatelet Versus Anticoagulant Therapy After Left Atrial Appendage Occlusion: A Systematic Review and Meta-Analysis.

OBJECTIVES: The aim of this study was to compare bleeding, thromboembolic, device-related thrombus (DRT), and all-cause mortality events between patients treated with short-term oral anticoagulation (OAC) and those treated with short-term antiplatelet therapy (APT) following left atrial appendage occlusion (LAAO). BACKGROUND: Short-term OAC is recommended for patients following LAAO. However, in practice many patients receive APT rather than OAC because of excessive bleeding risk. However, the safety and efficacy of APT compared with OAC have been debated. METHODS: A search was conducted of databases for studies comparing OAC with APT following LAAO. The outcomes of interest were all-cause stroke, major bleeding, DRT, and all-cause mortality. Noncomparative studies were pooled into a single study to generate comparisons of the studies' outcomes. Effects measure were pooled using the random-effect model. RESULTS: A total of 83 studies with 12,326 patients (APT, n = 7,900; OAC, n = 4,151) were included. Mean CHA2DS2-VASc and HAS-BLED scores were 4.1 ± 1.6 and 3.0 ± 1.3, respectively. There were no significance differences between the APT and OAC groups with regard to stroke (risk ratio [RR]: 1.04; 95% confidence interval [CI]: 0.54 to 1.98; p = 0.91; I2 = 31%), major bleeding (RR: 1.12; 95% CI: 0.68 to 1.84; p = 0.65; I2 = 53%), DRT (RR: 1.33; 95% CI: 0.74 to 2.39; p = 0.33; I2 = 36%), and all-cause mortality (RR: 1.29; 95% CI: 0.40 to 4.09; p = 0.18; I2 = 36%). These findings persisted in multiple secondary analyses: 1) excluding studies that reported no events; 2) including comparative studies only; 3) excluding patients who were treated with single APT; and 4) removing one study at a time to assess the effect of each study on the overall effect size. There was also no difference in the studies' endpoints among patients who received different LAAO devices. CONCLUSIONS: In a meta-analysis of observational data, there were no differences in the occurrence of stroke, major bleeding DRT, and all-cause mortality in patients treated with short-term OAC or APT following LAAO.

Observed versus Expected Ischemic and Bleeding Events Following Left Atrial Appendage Occlusion.

Data on the efficacy of left atrial appendage occlusion (LAAO) in clinical practice are limited. We performed a systematic review and meta-analysis of observational studies that reported observed versus expected rates of ischemic strokes and/or major bleeding following LAAO. Our primary end points were the pooled relative risk reduction (RRR) in ischemic stroke and major bleeding with corresponding 95% confidence intervals compared with what was expected by the CHA2DS2-VASc and HASBLED scores, respectively. Twenty-nine studies including 11,071 patients (age 74.0 ± 8.7 years, 60% males) met the inclusion criteria. The mean CHA2DS2-VASc score was 4.22 ± 1.48, and the mean HASBLED score was 3.04 ± 1.16. During 19,567 patient-year follow-up, 290 of 11,071 patients (2.62%) suffered an acute ischemic stroke. This represented a 73.6% (95% confidence interval 68.9-78.2%) RRR in ischemic strokes compared with what was expected based on the CHA2DS2-VASc score. A total of 26 studies reported observed versus expected major bleeding (10,056 patients; age 74.0 ± 8.7, 60% males). During 16,967 patient-year follow-up, 404 of 10,056 patients (4.0%) suffered a major bleeding event. This represented a 55% (95% confidence interval 44.2% to -65.9%) RRR in major bleeding compared with what was expected based on the HASBLED score. These estimates were consistent across subgroups stratified according to age, CHADS2VASc, HASBLED scores and type of LAAO device used. In conclusion, LAAO is associated with a favorable observed/expected ratio with regards to ischemic stroke and major bleeding in clinical practice. Future clinical trials remain essential to further assess the efficacy of LAAO via a direct comparison with oral anticoagulation.

Aorto-cardiac fistula etiology, presentation, and management: A systematic review.

BACKGROUND: Aorto-cardiac fistulae are a rare but increasingly reported entity, and data are scarce. METHOD: The authors performed a systematic review of ACFs to characterize the underlying etiology, clinical presentation, and compare outcomes of treatment strategies. RESULTS: 3,733 publications were identified in the search. Of those, 292 studies including 300 patients were included. Etiology of ACFs was 38% iatrogenic, 25% infectious, 14% traumatic, and 15% due to other causes. Most patients (74%) presented with heart failure. Common locations were aortic-right atrium (37%), and aortic-pulmonary artery (25%). The majority of patients (71%) were treated surgically, while 13% were treated percutaneously, and 16% were treated conservatively. Patients who were managed conservatively had a higher mortality than those treated with invasive closure (53% vs. 12% vs. 3%, p = <0.00001). CONCLUSIONS: This systematic review sheds light on this highly morbid condition. Once recognized, fistula closure appears to be superior to conservative management.

Meta-Analysis Comparing Renal Outcomes after Transcatheter versus Surgical Aortic Valve Replacement.

BACKGROUND: Acute kidney injury (AKI) is a common complication of aortic valve replacement. However, comparative on the incidence of (AKI) following transcatheter (TAVR) versus surgical valve replacement (SAVR) is sparse. METHODS: We performed a meta-analysis of the randomized controlled trials (RCT) and propensity-matched observational studies comparing (A) incidence of AKI and (B) incidence of dialysis-requiring AKI at 30 days after TAVR and SAVR. RESULTS: Twenty-six studies (20 propensity-matched studies; 6 RCTs) including 19,954 patients were analyzed. The incidence of AKI was lower after TAVR than after SAVR (7.1% vs. 12.1%, OR 0.52; 95%CI, 0.39-0.68; p<0.001, I2=57%), but the incidence of dialysis-requiring AKI was similar (2.8% vs. 4.1%, OR 0.78; 95%CI, 0.49-1.25; p=0.31, I2=70%). Similar results were observed in a sensitivity analysis including RCTs only for both AKI ([5 RCTs; 5,418 patients], 2.0% vs. 5.0%, OR 0.39; 95%CI, 0.28-0.53; p<0.001, I2=0%), and dialysis-requiring AKI ([2 RCTs; 769 patients]; 2.9% vs. 2.6%, OR 1.1; 95%CI, 0.47-2.58; p=0.83, I2=0%). However, in studies including low-intermediate risk patients only, TAVR was associated with lower incidence of AKI ([10 studies; 6,510 patients], 7.6% vs. 12.4%, OR 0.55, 95%CI 0.39-0.77, p<0.001, I2=57%), and dialysis-requiring AKI, ([10 studies; 12,034 patients], 2.0% vs. 3.6%, OR 0.57, 95%CI 0.38-0.85, p=0.005, I2=23%). CONCLUSIONS: TAVR is associated with better renal outcomes at 30 days in comparison with SAVR, especially in patients at low-intermediate surgical risk. Further studies are needed to assess the impact of AKI on long-term outcomes of patients undergoing TAVR and SAVR.

Incidence and Clinical Impact of Device-Related Thrombus Following Percutaneous Left Atrial Appendage Occlusion: A Meta-Analysis.

OBJECTIVES: This study sought to assess the incidence and clinical impact of device related thrombus (DRT) following precautions left atrial appendage occlusion (LAAO). BACKGROUND: Device-related thrombus is a known complication of LAAO. However, data on the incidence of DRT and its impact on outcomes are limited. METHODS: The authors performed a meta-analysis of randomized and observational studies to calculate the pooled incidence of DRT and the pooled odds ratio (OR) of ischemic events in patients with DRT and those without DRT. RESULTS: In the 66 included studies; the incidence of DRT was 351/10, 153 (3.8%, range 0% to 17%, I2 = 56.8). The diagnosis was made in <90, 90 to 365, and >365 days in 42%, 57%, and 1% of patients, respectively. There was no difference in DRT rates between the AMPLATZER (AMPLATZER, AGA Medical Corporation, Golden Valley, Minnesota) and WATCHMAN (WATCHMAN, Boston Scientific Corporation, Marlborough, Massachusetts) devices (3.6% vs. 3.1%, p = 0.24). In a meta-regression, age, gender, heart failure, diabetes, CHA2DS2-VASc score, previous stroke, and post-LAAO antithrombotic regimen did not explain the heterogeneity in the incidence of DRT. The pooled incidence of ischemic events in studies that compared outcomes of patients with and without DRT (32 studies; n = 7,689) was 13.2% (37 of 280) in patients with DRT and 3.8% (285 of 7,399) in those without DRT (OR: 5.27, 95% confidence interval [CI]: 3.66 to 7.59; p < 0.001, I2 = 0). In a sensitivity analysis including randomized trials and prospective multicenter registries, the incidence of DRT was 3.7%, and DRT remained associated with higher rates of ischemic events (13.5% vs. 4.4%, OR: 4.15, 95% CI: 2.77 to 6.22; p < 0.001, I2 = 0). CONCLUSIONS: DRT after LAAO is uncommon (3.8%) but is associated with a 4- to 5-fold increase in ischemic events. Further studies are needed to understand the underlying mechanisms and the optimal surveillance and management of DRT.

Meta-Analysis Comparing the Frequency of Stroke After Transcatheter Versus Surgical Aortic Valve Replacement.

Stroke is one of the most feared complications of aortic valve replacement. Although the outcomes of transcatheter aortic valve implantation (TAVI) improved substantially over time, concerns remained about a potentially higher incidence of stroke with TAVI compared with surgical replacement (SAVR). However, comparative data are sparse. We performed a meta-analysis comparing the incidence of stroke among patients undergoing TAVI versus SAVR. Of the 5067 studies screened, 28 eligible studies (22 propensity-score matched studies and 6 randomized trials) were analyzed. Primary endpoints were 30-day stroke and disabling stroke. Secondary endpoints were 1-year stroke and disabling stroke. A total of 23,587 patients were included, of whom 47.27% underwent TAVI and 52.72% underwent SAVR. For each endpoint, pooled estimates of odds ratio (OR) with 95% confidence interval (CI) were calculated. The pooled estimates for stroke (2.7% vs 3.1%, OR 0.86; 95% CI 0.72 to 1.02; p=0.08) and disabling stroke (2.5% vs 2.9%, OR 0.96; 95% CI 0.57 to 1.62; p=0.89) were comparable following TAVI versus SAVR at 30 days. Similarly, the pooled estimates for stroke (5.0% vs 4.6%, OR 1.01; 95% CI 0.79 to 1.28; p=0.96) and disabling stroke (4.1% vs 4.5%, OR 0.92; 95% CI 0.92 to 1.39; p=0.71) were similar at 1 year. A sensitivity analysis including only RCTs yielded similar results. Our meta-analysis documents comparable rates of strokes and disabling strokes following TAVI or SAVR both at 30 days and 1 year.

Impact of acute diabetes decompensation on outcomes of diabetic patients admitted with ST-elevation myocardial infarction.

BACKGROUND: Acute hyperglycemia is associated with worse outcomes in diabetic patients admitted with ST-elevation myocardial infarction (STEMI). However, the impact of full-scale decompensated diabetes on STEMI outcomes has not been investigated. METHODS: We utilized the national inpatient sample (2003-2014) to identify adult diabetic patients admitted with STEMI. We defined decompensated diabetes as the presence of diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar state (HHS). We compared in-hospital morbidity and mortality and cost between patients with and without diabetes decompensation before and after propensity-score matching. RESULTS: A total of 73,722 diabetic patients admitted with STEMI were included in the study. Of those, 1131 (1.5%) suffered DKA or HSS during the hospitalization. After propensity-score matching, DKA/HHS remained associated with a significant 32% increase in in-hospital mortality (25.6% vs. 19.4%, p = 0.001). The DKA/HHS group also had higher incidences of acute kidney injury (39.4% vs. 18.9%, p < 0.001), sepsis (7.3% vs. 4.9%, p = 0.022), blood transfusion (11.3% vs. 8.2%) and a non-significant trend towards higher incidence of stroke (3.8% vs. 2.4%, p = 0.087). Also, DKA/HHS diagnosis was associated with lower rates of referral to coronary angiography (51.5% vs. 55.5%, p = 0.023), coronary stenting (26.1% vs. 34.8%, p < 0.001), or bypass grafting (6.2% vs. 8.7%, p = 0.033). Referral for invasive angiography was associated with lower odds of death during the hospitalization (adjusted OR 0.66, 95%CI 0.44-0.98, p = 0.039). CONCLUSIONS: Decompensated diabetes complicates ~ 1.5% of STEMI admissions in diabetic patients. It is associated with lower rates of referral for angiography and revascularization, and a negative differential impact on in-hospital morbidity and mortality and cost.

Meta-analysis Comparing Transcatheter and Surgical Treatments of Paravalvular Leaks.

Percutaneous paravalvular leak (PVL) closure has emerged as a feasible alternative to redo valve surgery. However, comparative data on percutaneous and surgical treatment of PVL are scarce. We performed a systematic review and a meta-analysis of studies on percutaneous and surgical treatments of PVL. Of the 2,267 studies screened, 22 eligible studies were analyzed. Primary end points were technical success, 30-day mortality, stroke, and length of stay. Secondary end points were 1-year mortality, readmission for heart failure, reoperation, and symptomatic improvement at follow-up. A total of 2,373 patients were included, of whom 1,511 (63.7%) underwent percutaneous closure. Technical success was higher with surgery (96.7% vs 72.1%, odds ratio [OR] 9.7, p <0.001) but at the cost of higher 30-day mortality (8.6% vs 6.8%, OR 1.90, p <0.001), a trend toward higher stroke (3.3% vs 1.4%, OR 1.94, p = 0.069), and longer hospitalizations. However, surgery was associated with similar 1-year mortality (17.3% vs 17.2%, OR 1.07, p = 0.67), reoperation (9.1% vs 9.9%, OR 0.72, p = 0.1), readmission for heart failure (13.3% vs 26.4%, OR 0.51, p = 0.29), and improvement in New York Heart Association classification (67.4% vs 56%, OR 1.37, p = 0.74), compared with percutaneous closure. A sensitivity analysis including comparative studies only yielded similar results. Surgical treatment of PVL achieves higher technical success rates but is associated with higher early morbidity and mortality compared with percutaneous closure. Nevertheless, mortality rates and clinical efficacy parameters were similar at midterm with both procedures. Further studies are warranted to identify the ideal management approach to patients with symptomatic PVL.

Iatrogenic Circumflex Artery Stenosis Following Mitral Valve Repair.

Injury of the left circumflex coronary artery is a potentially serious complication of mitral valve surgery due to the proximity of the vessel to the posterior segment of the mitral annulus. Suture-related distortion of the artery with partial or subtotal occlusion is the most commonly implicated mechanism. Herein, we present a case of symptomatic iatrogenic circumflex coronary artery stenosis following mitral valve annuloplasty for degenerative mitral valve regurgitation.

Incidence and Outcomes of Myocardial Infarction in Patients Admitted With Acute Ischemic Stroke.

BACKGROUND AND PURPOSE: Data on the incidence and outcomes of acute myocardial infarction (AMI) complicating acute ischemic stroke (AIS) are limited. We aim to evaluate the incidence, treatment patterns, and outcomes of AMI in patients with AIS using a nationwide database. METHODS: The National Inpatient Sample was used to identify patient with AIS between 2003 and 2014. Trends of incidence of AMI and its associated in-hospital mortality were evaluated. Univariate and multivariate logistic regressions were used to evaluate predictors of AMI. The impact of AMI on in-hospital outcomes was assessed in a comparative analysis of propensity-matched groups of patients with and without AMI. RESULTS: Patients with AIS (n=864 043) were identified in the national inpatient sample, of whom 13 573 patients (1.6%) had an AMI (79.5% non-ST-segment-elevation myocardial infarction and 20.5% ST-segment-elevation myocardial infarction). In-hospital mortality was 21.4% and 7.1% in propensity-matched cohorts of patients with and without AMI, P<0.001. In-hospital length of stay and cost of care were 50% higher in the AMI group. In a multivariate logistical regression analysis, the strongest predictors of having AMI after AIS were older age, history of coronary artery disease, chronic renal insufficiency, undergoing mechanical thrombectomy, and rhythm and conduction abnormalities. In the AMI group, undergoing coronary angiography and undergoing percutaneous coronary intervention both strongly correlated with lower in-hospital mortality (odds ratio, 0.34 [confidence interval, 0.23-0.51] and 0.26 [confidence interval, 0.20-0.34], respectively, P<0.001). However, these were only performed in 7.5% and 2% of patients, respectively. CONCLUSIONS: AMI complicating stroke carries a substantial in-hospital mortality and cost of care. Patients who underwent coronary angiography with or without intervention may have improved survival although it was only utilized in a minority of patients. Further studies needed to discern the ideal approach in AMI in patients with AIS.