Who benefits from percutaneous closure of patent foramen ovale vs medical therapy for stroke prevention? In-depth and updated meta-analysis of randomized trials.

BACKGROUND: A few randomized clinical trials (RCT) and their meta-analyses have found patent foramen ovale closure (PFOC) to be beneficial in prevention of stroke compared to medical therapy. Whether the benefit is extended across all groups of patients remains unclear. AIM: To evaluate the efficacy and safety of PFOC vs medical therapy in different groups of patients presenting with stroke, we performed this meta-analysis of RCTs. METHODS: Electronic search of PubMed, EMBASE, Cochrane Central, CINAHL and ProQuest Central and manual search were performed from inception through September 2018 for RCTs. Ischemic stroke (IS), transient ischemic attack (TIA), a composite of IS, TIA and systemic embolism (SE), mortality, major bleeding, atrial fibrillation (AF) and procedural complications were the major outcomes. Random-effects model was used to perform analyses. RESULTS: Meta-analysis of 6 RCTs including 3560 patients showed that the PFOC, compared to medical therapy reduced the risk of IS [odds ratio: 0.34; 95% confidence interval: 0.15-0.78; P = 0.01] and the composite of IS, TIA and SE [0.55 (0.32-0.93); P = 0.02] and increased the AF risk [4.79 (2.35-9.77); P < 0.0001]. No statistical difference was observed in the risk of TIA [0.86 (0.54-1.38); P = 0.54], mortality [0.74 (0.28-1.93); P = 0.53] and major bleeding [0.81 (0.42-1.56); P = 0.53] between two strategies. Subgroup analyses showed that compared to medical therapy, PFOC reduced the risk of stroke in persons who were males, ≤ 45 years of age and had large shunt or atrial septal aneurysm. CONCLUSION: In certain groups of patients presenting with stroke, PFOC is beneficial in preventing future stroke compared to medical therapy.

Optical coherence tomography guidance in percutaneous coronary intervention: a meta-analysis of randomized controlled trials.

The benefit of optical coherence tomography (OCT) guidance in percutaneous coronary intervention (PCI) is unclear. We aimed to assess the incremental value of adding OCT to coronary angiography in PCI by meta-analytic technique. We searched PubMed, EMBASE, Cochrane, Scopus and relevant references for randomized studies (inception through January 5, 2018 without language restrictions) and performed meta-analysis using random effects model. Major adverse cardiac events (MACE), all-cause mortality, myocardial infarction, target vessel revascularization, stent thrombosis, fluoroscopic time, contrast volume, and procedural side effects were the measured outcomes. Five randomized studies with a total population of 931 were analyzed. There was no difference in MACE between angiography plus OCT and angiography alone arms (2.5 vs. 2.0% OR 1.26; 95% CI 0.40-3.99; P = 0.69; I2 = 5%). Two groups were not different in terms of all-cause mortality (0.2 vs. 0% OR 3.03; 95% CI 0.12-75; P = 0.5; I2 = not applicable), myocardial infarction (1 vs. 0.2% OR 2.21; 95% CI 0.39-12.49; P = 0.3; I2 = 0%), target vessel revascularization (1.6 vs. 1.2% OR 1.36; 95% CI 0.4-4.4; P = 0.6; I2 = 0%), and stent thrombosis (0.2 vs. 0.5% OR 0.7; 95% CI 0.11-4.51; P = 0.7; I2 = 0%). OCT group had significantly higher fluoroscopic time and contrast volume. Our meta-analysis shows that the addition of OCT to angiography for PCI guidance is not associated with lower MACE, all-cause mortality, myocardial infarction, target vessel revascularization, or stent thrombosis. It is associated with longer fluoroscopic time and higher contrast volume.

Meta-Analysis Comparing Outcomes of Smokers Versus Nonsmokers With Acute Coronary Syndrome Underwent Percutaneous Coronary Intervention.

Several studies have found improved mortality in smokers after acute coronary syndrome (ACS) especially in the thrombolytic era. We aimed to assess the association of smoking status with mortality and cardiovascular outcomes in patients with ACS treated with percutaneous coronary intervention (PCI). We searched PubMed, EMBASE, CINAHL, and Cochrane CENTRAL for randomized controlled trials since inception through February 15, 2018 and used random effects model for analysis. The outcomes analyzed were all-cause mortality, major adverse cardiac events (MACE), myocardial infarction, and target vessel revascularization at 1 month and 1 year. We included 17 randomized and nonrandomized studies with a total of 55,491 patients with 21,989 smokers' and 33,502 nonsmokers. In ACS patients treated with PCI, smokers were found to have lower mortality than nonsmokers at 30-day ([2.3% vs 3.3%; Odds ratio; 0.54; 95% confidence interval: 0.39 to 0.76; p <0.001, I2 = 74%] and 1-year [2.3% vs 3.6%; Odds ratio 0.54 (0.3 to 0.7); p <0.001, I2 = 77%]. Meta-regression showed lower mortality in smokers was associated with younger age, man gender, and lower prevalence of diabetes mellitus. No significant differences were observed in myocardial infarction, MACE, and target-vessel revascularization between smokers and nonsmokers. In conclusion, smoking is associated with lower mortality but not MACE in ACS patients treated with PCI at 1-month and 1-year. This association with mortality was strongly associated with younger age, man gender, prevalence of diabetes mellitus, and extent of coronary artery disease.

Comparison of manual compression and vascular hemostasis devices after coronary angiography or percutaneous coronary intervention through femoral artery access: A meta-analysis of randomized controlled trials.

OBJECTIVES: To compare the efficacy and safety of manual compression (MC) with vascular hemostasis devices (VHD) in patients undergoing coronary angiography (CA) or percutaneous coronary intervention (PCI) through femoral artery access. INTRODUCTION: The use of femoral artery access for coronary procedures may result in access-related complications, prolonged immobility and discomfort for the patients. MC results in longer time-to-hemostasis (TTH) and time-to-ambulation (TTA) compared to VHDs but its role in access-related complications remains unclear in patients undergoing coronary procedures. METHODS: We searched MEDLINE, EMBASE, Cochrane CENTRAL and relevant references for English language randomized controlled trials (RCT) from inception through September 30, 2016. We performed the meta-analysis using random effects model. The outcomes were time-to-hemostasis, time-to-ambulation, major bleeding, large hematoma >5cm, pseudoaneurysm and other adverse events. RESULTS: The electronic database search resulted in a total of 44 RCTs with a total of 18,802 patients for analysis. MC, compared to VHD resulted in longer TTH [mean difference (MD): 11.21min; 95% confidence interval (CI) 8.13-14.29; P<0.00001] and TTA [standardized mean difference: 1.2 (0.79-1.62); P<0.00001] along with excess risk of hematoma >5cm formation [risk ratio (RR): 1.38 (1.15-1.67); P=0.0008]. MC resulted in similar risk of major bleeding [1.01 (0.64-1.60); P=0.95] pseudoaneurysm [0.99 (0.75-1.29); P=0.92], infections [0.52 (0.25-1.10); P=0.09], need of surgery [0.60 (0.29-1.22); P=0.16), AV fistula [0.93 (0.68-1.27); P=0.63] and ipsilateral leg ischemia [0.95 (0.57-1.60); P=0.86] compared to VHD. CONCLUSION: Manual compression increase time-to-hemostasis, time-to-ambulation and risk of hematoma formation compared vascular hemostasis devices.

Stroke, Major Bleeding, and Mortality Outcomes in Warfarin Users With Atrial Fibrillation and Chronic Kidney Disease: A Meta-Analysis of Observational Studies.

BACKGROUND: The use of warfarin in patients with atrial fibrillation (AF) and chronic kidney disease (CKD) can be problematic because of increased bleeding risk. We performed a systematic review and meta-analysis of observational studies that evaluated the use of warfarin in patients with AF and CKD to evaluate the risks of ischemic stroke/thromboembolism, major bleeding, and mortality. METHODS: PUBMED, EMBASE, CINAHL, ProQuest, and Google Scholar databases were electronically searched through January 12, 2015. Additionally, a manual search was performed for relevant references. Random-effects model was used to estimate the pooled hazard ratio (HR) with 95% CI. CKD was divided into non-end-stage CKD and end-stage CKD (on renal replacement therapy) and separate analyses were performed. RESULTS: Thirteen publications from 11 cohorts (six retrospective and five prospective) including >48,500 total patients with >11,600 warfarin users were included in the meta-analysis. In patients with AF and non-end-stage CKD, warfarin resulted in a lower risk of ischemic stroke/thromboembolism (HR, 0.70; 95% CI, 0.54-0.89; P = .004) and mortality (HR, 0.65; 95% CI, 0.59-0.72; P < .00001), but had no effect on major bleeding (HR, 1.15; 95% CI, 0.88-1.49; P = .31). In patients with AF and end-stage CKD, warfarin had no effect on the risks of stroke (HR, 1.12; 95% CI, 0.69-1.82; P = .65) and mortality (HR, 0.96; 95% CI, 0.81-1.13; P = .60), but increased the risks of major bleeding (HR, 1.30; 95% CI, 1.08-1.56; P = .005). CONCLUSIONS: Based on this meta-analysis, the use of warfarin for AF may have an unfavorable risk/benefit ratio in patients with end-stage CKD but not in those with non-end-stage CKD.

Transulnar versus transradial access for coronary angiography or percutaneous coronary intervention: A meta-analysis of randomized controlled trials.

BACKGROUND: Although transfemoral access (TFA) remains the standard of care for patients undergoing coronary angiography (CA) or percutaneous coronary intervention (PCI) in the USA, TRA is being increasingly used over TFA due to lower bleeding and mortality rates on the basis of meta-analyses and recently published MATRIX trial. In patients with unsuccessful ipsilateral radial access, TUA has been used as an alternative approach. The randomized controlled trials (RCTs) comparing TUA and TRA have reached mixed conclusions regarding the use of transulnar approach for coronary procedures. OBJECTIVES: To systematically review and perform a meta-analysis of published RCTs comparing the safety and efficacy of transulnar access (TUA) vs. transradial access (TRA) in patients undergoing CA or PCI. METHODS: PubMed, EMBASE, and CENTRAL databases were searched for RCTs since inception through December, 2014. Meta-analysis was performed using random-effects model. RESULTS: Five RCTs involving 2,744 total patients were included in the meta-analysis. TUA compared with TRA had similar risks of MACE [risk ratio (RR): 0.87; 95% confidence interval (CI): 0.56-1.36; P = 0.54] and access-related complications [RR: 0.92 (0.67-1.27); P = 0.62]. Higher rates of access cross-over [RR: 2.31 (1.07-4.98); P = 0.003] and number of punctures [1.57 vs. 1.4; mean difference (MD): 0.17; 95% CI: 0.08-0.26; P = 0.0002] were noted with TUA. There was no difference in arterial access time [12.8 vs. 10.9 min; MD: 1.86 (-1.35-5.7); P = 0.26], fluoroscopy time [7.6 vs. 7.2 min; MD: 0.37 (-0.39 - 1.13); P = 0.34] and contrast volume [151 vs. 153.7 ml; MD: -2.74 (-17.21 - 11.73); P = 0.71]. CONCLUSION: For patients requiring CA or PCI, TUA compared with TRA has similar efficacy and safety except for higher puncture rates and access cross-over.

A case of Brugada Syndrome unmasked by a postoperative febrile state.

BACKGROUND: Brugada Syndrome (BS) is an inherited ion channelopathy characterized by an electrocardiographic (ECG) pattern of a coved type ST segment elevation in right precordial leads with or without right bundle branch block. CASE PRESENTATION: A 23-year old male presented with right lower quadrant abdominal pain. Further evaluation revealed a diagnosis of acute appendicitis. The patient developed a febrile episode on second post-operative day of laparoscopic appendectomy. ECG revealed features consistent with BS. Prompt control of temperature in the patient resolved the ST-segment elevation and prevented potentially life-threatening arrhythmias. CONCLUSION: Febrile episodes in susceptible patients may unmask a concealed BS. Prompt control of temperature is advocated to reduce the risk of life-threatening arrythmias.

The Effects of Aldosterone Antagonists in Patients With Resistant Hypertension: A Meta-Analysis of Randomized and Nonrandomized Studies.

BACKGROUND: A few studies have shown aldosterone antagonists (AA) to be effective therapy in patients with resistant hypertension (RH). We performed a meta-analysis of randomized and nonrandomized studies of AA in patients with RH. METHODS: We searched PUBMED, EMBASE, and CENTRAL for studies on the use of AA in patients with RH. Meta-analysis was performed using random-effects model. The change in office and ambulatory blood pressures (BP), effects on biochemical profile, change in the number of antihypertensive agents, and adverse events were main outcomes. RESULTS: We included 15 studies (3 randomized controlled trials, 1 nonrandomized comparative study, and 11 single-arm studies) with 1,204 total patients in the meta-analysis. In comparative studies, AA reduced systolic BP (SBP) by 24.26 mm Hg (95% CI: 8.65-39.87, P = 0.002) and diastolic BP (DBP) by 7.79 mm Hg (3.79-11.79, P = 0.0001). Similarly, AA reduced SBP by 22.74 mm Hg (18.21-27.27, P < 0.00001) and DBP by 10.49 mm Hg (8.85-12.13, P < 0.00001) in single-arm studies. AA resulted in significant change in serum electrolytes in single-arm studies but not in comparative studies. Significantly more adverse events were noted in single-arm studies but not in comparative studies. CONCLUSIONS: On the basis of the current meta-analysis, we conclude that AA is safe and effective therapy in patients with RH.

Multi-vessel versus culprit-vessel and staged percutaneous coronary intervention in STEMI patients with multivessel disease: a meta-analysis of randomized controlled trials.

INTRODUCTION: Percutaneous coronary intervention (PCI) is preferred in patients with acute ST-elevation myocardial infarction (STEMI). In patients with acute STEMI with multivessel disease (MVD), the guidelines recommend culprit vessel PCI (CV-PCI) in the absence of hemodynamic instability. We performed a meta-analysis of all randomized controlled trials (RCTs) comparing multi-vessel PCI (MV-PCI) with CV-PCI or staged PCI (S-PCI) in patients with acute STEMI and MVD. METHODS: PubMed, EMBASE and CENTRAL were searched for publications since inception to December 2013. Random effects model was used to compute summary effects. RESULTS: Four RCTs (840 patients) were identified. MV-PCI compared to CV-PCI significantly reduced the risks of major adverse cardiac events (MACE)-a composite of MI, revascularization and all-cause mortality (RR: 0.46, 95% CI: 0.35-0.60, P<0.00001) by reducing the risks of MI (0.35, 0.17-0.71, P=0.004) and revascularization (0.35, 0.24-0.52, P<0.00001). The risk of all-cause mortality was not different (0.69, 0.39-1.21, P=0.19). S-PCI and MV-PCI had similar risks of MACE (0.96, 0.59-1.57, P=0.87), MI (0.60, 0.20-1.78, P=0.36), revascularization (0.86, 0.47-1.54, P=0.60) and all-cause mortality (1.50, 0.44-5.07, P=0.57). CONCLUSIONS: MV-PCI compared to CV-PCI resulted in lower risks of MACE driven by lower MI and revascularization in patients with STEMI and multi-vessel disease.

Tuberous sclerosis complex with autosomal dominant polycystic kidney disease: a rare duo.

Tuberous sclerosis complex (TSC) is an autosomal dominant condition characterised by the presence of multiple hamartomas in various organ systems in the body. The kidneys are affected in 80% of patients, usually in the form of renal angiomyolipomas, renal cysts or renal cell carcinoma. Although extremely rare, TSC and autosomal dominant polycystic kidney disease (ADPKD) can co-exist in the same patient as a result of concurrent deletion of both polycystic kidney disease (PKD) 1 and TSC2 genes present on the chromosome 16p13.3. These patients develop end-stage renal disease at an earlier age and have an increased risk of malignancy. We present a case of a 30-year-old man with a history of tuberous sclerosis, presenting with loin pain and subsequently diagnosed to have ADPKD.

Major complications of cryoballoon catheter ablation for atrial fibrillation and their management.

Atrial fibrillation (AF) is the most common symptomatic and sustained cardiac arrhythmia. It affects approximately 2-3 million people in the USA alone with an increased incidence and prevalence worldwide. It is associated, in addition to worsening quality of life, with increased morbidity and mortality especially in poorly controlled AF, affecting mostly those older than 65 years of age. Radiofrequency ablation was found to be a good strategy for focal isolation of pulmonary veins triggering from the vulnerable atrial substrate but is a time-consuming procedure and carries the risk of multiple complications like tamponade which could be fatal, atrioesophageal fistula and local thrombus formation at the site of ablation. Cryoballoon ablation with pulmonary vein isolation has emerged in the past few years as a breakthrough novel technology for the treatment of drug-refractory AF. It is a relatively simple alternative for point-by-point radiofrequency ablation of paroxysmal AF and is associated with fewer incidences of fatal complications such as cardiac perforation. As experience with this new tool accumulates, the field faces new challenges in the form of rare compilations including gastroparesis, phrenic nerve palsy, atrioesophageal fistula, pulmonary vein stenosis, thromboembolism pericardial effusion, and tamponade.

A case of toxic epidermal necrolysis caused by trimethoprim-sulfamethoxazole.

Toxic epidermal necrolysis (TEN) is a rare but serious dermatological emergency characterised by diffuse exfoliation of the skin and mucous membranes due to immune mediated destruction of the epidermis which can lead to sepsis and respiratory distress. Trimethoprim-sulfamethoxazole is a widely used antibiotic which can rarely lead to TEN. Early diagnosis and aggressive medical care is essential for the reduction of high morbidity and mortality associated with this disease. We present a case of successfully recovered TEN due to trimethoprim-sulfamethoxazole in a 62-year-old woman.

Acute mesenteric ischemia: a sequela of abdominal aortography.

The use of abdominal angiography and transcatheter embolization has increased rapidly in the last few decades. Although improvement in angiographic techniques has made the procedure safe, ischemic colitis is a rare but potentially dreadful complication. We report a case of a 51-year-old woman who developed ischemic colitis following aortography, demonstrating that such angiographic studies may produce substantial morbidity.

Posterior reversible encephalopathy syndrome (PRES) in a patient with late postpartum eclampsia.

Posterior reversible encephalopathy syndrome (PRES) is a reversible neurological entity characterised by seizure, headaches, visual symptoms, impaired consciousness and other focal neurological findings. It is caused by a wide variety of causes ultimately leading to a vasogenic cerebral oedema of occipital and parietal lobes of the brain. We present here a young woman with headache, generalised tonic-clonic seizures and cortical blindness in a late postpartum stage. Reversibility of the symptoms and characteristic imaging findings led us to a diagnosis of PRES in our patient.

The Rate Of Complications Associated With Concomitant Use Of Dabigatran With Cryoballoon Ablation For Atrial Fibrillation.

INTRODUCTION: Catheter ablation is an evolving therapeutic strategy for the management of atrial fibrillation (AF). It is associated with a risk of thromboembolic events. The peri-procedural anticoagulation management with warfarin has been successful in mitigating this risk. However, introduction of novel oral anticoagulants like dabigatran offers more flexibility in anticoagulation approaches. Previous studies had evaluated the safety and efficacy of dabigatran in the radiofrequency ablation, but data related to cryoballoon ablation is lacking. METHODS AND RESULTS: We performed a retrospective observational study involving patients who underwent cryoballoon ablation for drug-refractory, symptomatic AF while on dabigatran in periprocedural period. Thromboembolic, hemorrhagic or other complications occurring within the first 30 days after the ablation procedure were analyzed. Our study population comprised of 50 patients with mean age of 58.96 ± 3.54 years with 76% (n=38) being male. We found 3 (6%) minor complications in peri-procedural period including 2 groin hematomas and 1 trace asymptomatic pericardial effusion. There were no major intraprocedural or post procedural hemorrhagic or thromboembolic events. None of patients with the minor complications required significant additional workup or extended hospital stay. All the patients were able to continue dabigatran for 30 days without any additional side effects or complications. CONCLUSION: Dabigatran is a safe and efficacious agent in patients undergoing cryoballoon AF ablation.

Neutrophil to lymphocyte ratio and cardiovascular diseases: a review.

The role of inflammatory markers in cardiovascular diseases has been studied extensively and a consistent relationship between various inflammatory markers and cardiovascular diseases has been established in the past. Neutrophil to lymphocyte ratio (NLR) is a new addition to the long list of these inflammatory markers. NLR, which is calculated from complete blood count with differential, is an inexpensive, easy to obtain, widely available marker of inflammation, which can aid in the risk stratification of patients with various cardiovascular diseases in addition to the traditionally used markers. It has been associated with arterial stiffness and high coronary calcium score, which are themselves significant markers of cardiovascular disease. NLR is reported as an independent predictor of outcome in stable coronary artery disease, as well as a predictor of short- and long-term mortality in patients with acute coronary syndromes. It is linked with increased risk of ventricular arrhythmias during percutaneous coronary intervention (PCI) and higher long-term mortality in patients undergoing PCI irrespective of indications of PCI. In patients admitted with advanced heart failure, high NLR was reported with higher inpatient mortality. Recently, NLR has been reported as a prognostic marker for outcome from coronary artery bypass grafting and postcoronary artery bypass grafting atrial fibrillation.