Nimesh K. Patel

Transcatheter Patent Foramen Ovale Closure After Cryptogenic Stroke: An Updated Meta-Analysis of Randomized Trials

Paradoxical embolism from a patent foramen ovale (PFO) mediated right-to-left shunt is a well-described mechanism of ischemic stroke [(1)][1]. In a patient level meta-analysis of the earlier 3 randomized trials, percutaneous PFO closure was superior to medical therapy for secondary prevention of

Staged versus index procedure complete revascularization in ST‐elevation myocardial infarction: A meta‐analysis

BACKGROUND Complete revascularization of patients with ST-elevation myocardial infarction and multivessel coronary artery disease reduces adverse events compared to infarct-related artery only revascularization. Whether complete revascularization should be done as multivessel intervention during index procedure or as a staged procedure remains controversial. METHOD We performed a meta-analysis of randomized controlled trials comparing outcomes of multivessel intervention in patients with ST-elevation myocardial infarction and multivessel coronary artery disease as staged procedure versus at the time of index procedure. Composite of death or myocardial infarction was the primary outcome. Mantel-Haenszel risk ratios were calculated using random effect model. RESULTS Six randomized studies with a total of 1126 patients met our selection criteria. At a mean follow-up of 13 months, composite of myocardial infarction or death (7.2% vs 11.7%, RR: 1.66, 95%CI: 1.09-2.52, P = 0.02), all cause mortality (RR: 2.55, 95%CI: 1.42-4.58, P < 0.01), cardiovascular mortality (RR: 2.8, 95%CI: 1.33-5.86, P = 0.01), and short-term (<30 days) mortality (RR: 3.54, 95%CI: 1.51-8.29, P < 0.01) occurred less often in staged versus index procedure multivessel revascularization. There was no difference in major adverse cardiac events (RR: 1.14, 95%CI: 0.88-1.49, P = 0.33), repeat myocardial infarction (RR: 1.14, 95%CI: 0.68-1.92, P = 0.61), and repeat revascularization (RR: 0.92, 95%CI: 0.66-1.28, P = 0.62). CONCLUSION In patients with ST-elevation myocardial infarction and multivessel coronary artery disease, a strategy of complete revascularization as a staged procedure compared to index procedure revascularization results in reduced mortality without an increase in repeat myocardial infarction or need for repeat revascularization.

Meta-Analysis of Aspirin Versus Dual Antiplatelet Therapy Following Coronary Artery Bypass Grafting

Although aspirin monotherapy is considered the standard of care after coronary artery bypass grafting (CABG), more recent evidence has suggested a benefit with dual antiplatelet therapy (DAPT) after CABG. We performed a meta-analysis of observational studies and randomized controlled trials comparing outcomes of aspirin monotherapy with DAPT in patients after CABG. Subgroup analyses were conducted according to surgical technique (i.e., on vs off pump) and clinical presentation (acute coronary syndrome vs no acute coronary syndrome). Random effects overall risk ratios (RR) were calculated using the DerSimonian and Laird model. Eight randomized control trials and 9 observational studies with a total of 11,135 patients were included. At a mean follow-up of 23 months, major adverse cardiac events (10.3% vs 12.1%, RR 0.84, confidence interval [CI] 0.71 to 0.99), all-cause mortality (5.7% vs 7.0%, RR 0.67, CI 0.48 to 0.94), and graft occlusion (11.3% vs 14.2%, RR 0.79, CI 0.63 to 0.98) were less with DAPT than with aspirin monotherapy. There was no difference in myocardial infarction, stroke, or major bleeding between the 2 groups. In conclusion, DAPT appears to be associated with a reduction in graft occlusion, major adverse cardiac events, and all-cause mortality, without significantly increasing major bleeding compared with aspirin monotherapy in patients undergoing CABG.

Letter by Mojadidi et al Regarding Article, “Closure of Patent Foramen Ovale Versus Medical Therapy in Patients With Cryptogenic Stroke or Transient Ischemic Attack: Updated Systematic Review and Meta-Analysis”

We read with interest the recent article by Ntaios et al.1 In a meta-analysis of randomized trials, the authors reported the efficacy and safety of transcatheter patent foramen ovale (PFO) closure for prevention of recurrent stroke, in patients with an index cryptogenic stroke/transient ischemic attack. Among 3627 patients (5 trials), there was a significantly lower rate of recurrent stroke in patients randomized to a PFO-occluding device compared with medical therapy (0.53 versus 1.1 per 100 patient-years; odds ratio, 0.43; 95% confidence interval, 0.21–0.90) at a mean follow-up of 3.7 years. In the discussion, the authors mention the important role of non-vitamin K antagonists in the prevention of venous thromboembolism, given venous thromboembolism seems to be the main issue in PFO-mediated stroke. …

Electrocardiogram-based scoring system for predicting secondary pulmonary hypertension: A cross-sectional study.

Objectives In this study, we have developed an electrocardiogram-based scoring system to predict secondary pulmonary hypertension. Design A cross-sectional study. Setting Single tertiary-care hospital in Scranton, Pennsylvania, USA. Participants Five hundred and fifty-two consecutive patients undergoing right heart catheterization between 2006 and 2009. Main outcome measures Surface electrocardiogram was assessed for R-wave in lead V1 ≥ 6mm, R-wave in V6 ≤ 3mm, S-wave in V6 ≥ 3mm, right atrial enlargement, right axis deviation and left atrial enlargement. Pulmonary hypertension was defined as mean pulmonary artery pressure ≥25 mmHg, determined by right heart catheterization. Results A total of 297 (54%) patients in the study cohort had pulmonary hypertension. In total, 332 patients from the study cohort formed the development cohort and the remaining 220 patients formed the validation cohort. In the development cohort, based on log odds ratios of association, RAE, LAE, RAD, R-wave in V1 ≥ 6 mm were assigned scores of 5, 2, 2 and 1, respectively, to form a 10-point scoring system “Scranton PHT (SP) score”. SP scores of 5 points and 7 points in DC showed C-statistic of 0.83 and 0.89, respectively, for discriminating pulmonary hypertension. C-statistic for RAE alone was significantly lower compared to an SP score of 7 (0.83 vs. 0.89, P = 0.021). The reliability of SP score in the validation cohort was acceptable. Conclusion SP score provides a good point-of-care tool to predict pulmonary hypertension in patients with clinical suspicion of it.

Letter by Zaman et al Regarding Article, “Safety Outcomes After Percutaneous Transcatheter Closure of Patent Foramen Ovale”

We read with interest the recent article by Merkler et al.1 In a retrospective cohort study, the authors investigated the safety of transcatheter patent foramen ovale (PFO) closure in patients with ischemic stroke/transient ischemic attack who underwent PFO closure within 1 year. The study concluded that closure was associated with adverse events in 7% of patients; the rate of events was higher in patients >60 years old compared with those aged ≤60 years (10.9% versus 4.9%; P <0.001). We commend the authors for their work and describe lessons learned from 5 randomized trials, which add to our interpretation of these results. Contrary to prior observational studies, the CLOSURE I trial (Evaluation of the STARFlex Septal Closure System in Patients With a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism Through a PFO) failed to demonstrate superiority of PFO closure for secondary stroke prevention in patients with …

Patent foramen ovale closure for patients excluded from the randomized cryptogenic stroke trials

We read with interest the recent article by Alushi et al. [1]. In a meta-analysis of five cryptogenic stroke trials, the authors compared the efficacy and safety of percutaneous patent foramen ovale (PFO) closure versus medical therapy for prevention of recurrent stroke, in patients with an index ischemic stroke of unknown etiology. The authors reported that PFO closure reduced the risk of stroke [HR 0.39, (0.19–0.83); p < 0.01], and increased the risk of atrial fibrillation [OR 3.75, (2.44–5.78); p < 0.01] compared to medical therapy. We commend the authors for their work and discuss the challenge of determining PFO-mediated paradoxical embolism as the culprit of stroke, and the potential role of PFO closure in some patients who were not included in the randomized trials. When PFO closure is considered for a patient with ischemic stroke of undetermined source, the question arises whether the PFO was the conduit for a paradoxical embolus originating from the venous circulation, or if the PFO was an incidental finding [2]. In an attempt to help the clinician make this differentiation, the RoPE study separated identified PFOs in cryptogenic stroke patients into those likely to be the offender (and thus requiring device closure) from those more likely to be an incidental finding (and thus to be left untreated) [3]. Using the RoPE score, patients could be given a probability that their PFO was or was not the culprit of their stroke by accounting for their age, cerebral infarct pattern, smoking status, and other comorbidities. However, the RoPE score does not account for additional clinical factors, the presence of which may also increase the likelihood of stroke from paradoxical embolism. These factors include prior venous thromboembolism, occurrence of stroke after straining, and echocardiographic features of the atrial septal anatomy (i.e., atrial septal aneurysm or large PFO/shunt). Although Alushi et al. did not find the presence of an atrial septal aneurysm or shunt size to modify the treatment effect in their meta-analysis [1], the RESPECT, DEFENSE-PFO, and CLOSE trials showed that ischemic stroke patients who have these echocardiographic features benefit the most from PFO closure, having the lowest number needed to treat [4–6]. In fact, the DEFENSE-PFO and CLOSE trials (studies enrolling only patients with an atrial septal aneurysm or large PFO/shunt) observed a remarkable finding of zero recurrent strokes in 2 and 5 years, respectively, in those randomized to a device [5, 6]. Methods such as the RoPE score may lead to the conjecture that a PFO cannot be the culprit for the index stroke in the presence of another known cause of stroke; this assumption is counterintuitive. For instance, a 50-year-old ischemic stroke patient who is found to have a large PFO with an atrial septal aneurysm will likely benefit from PFO closure, even in the presence of a short duration of atrial fibrillation. There are also patients in their 60s or 70s who present with cryptogenic stroke associated with a PFO with no evidence of atherosclerosis, occult atrial fibrillation, or other stroke etiologies. Although these patients were not included in the randomized trials, neurologists often refer them for PFO closure. To help clinicians make the difficult determination of whether an ischemic stroke was or was not a result of PFOmediated paradoxical embolism, we recently published an evidence-based algorithm for patients that will have the highest clinical yield from device closure, based on the results of randomized trials [7]. However, there are scenarios where it is impossible to prove the exact cause of the stroke, or where paradoxical embolism is suspected as the culprit * Mohammad K. Mojadidi mkmojadidi@gmail.com

Hospital Complications and Causes of 90-Day Readmissions After Implantation of Left Ventricular Assist Devices

Left ventricular assist devices (LVADs) have emerged as an attractive option in patients with advance heart failure. Nationwide readmission database 2013 to 2014 was utilized to identify LVAD recipients using ICD-9 procedure code 37.66. The primary outcome was 90-day readmission. Readmission causes were identified using ICD-9 codes in primary diagnosis field. The secondary outcomes were LVAD associated with hospital complications. Hierarchic 2-level logistic models were used to evaluate study outcomes. We identified 4,693 LVAD recipients (mean age 57 years, 76.2% males). Of which 53.9% were readmitted in first 90 days of discharge. Cardiac causes (33.3%), bleeding (21.3%), and infections (12.4%) were leading etiologies of 90-day readmissions. Significant predictors (odds ratio, 95% confidence interval, p value) of readmission were disposition to nursing facilities (1.33, 1.09 to 1.63, p = 0.01) and longer length of stay (1.01, 1.00 to 1.01, p <0.01). Although private insurance (0.75, 0.66 to 0.86, p <0.01), and self-pay (0.58, 0.42 to 0.81, p <0.01) predicted lower readmissions. Cardiac complications (36.3%), major bleeding (29.8%), and postoperative infections (10.4%) were most common LVAD-related complications. In conclusion, high early readmission rate was observed among LVAD recipients with Cardiac complications, bleeding complications, and infections were driving force for major complications and most of readmissions.