Amulet device implantation following incomplete left atrial appendage closure with Watchman legacy device.

Peri-device leak after left atrial appendage closure (LAAC) is often treated with endovascular coils, plugs, or second occluders. This is the first study reporting the Amulet device used for peri-device leak. An 80-year-old male with paroxysmal atrial fibrillation and recurrent falls with head trauma who underwent LAAC with a 24 mm Watchman 2.5 device 3 years ago at another institution was referred to our clinic for management of the peri-device leak. Transesophageal echocardiogram showed persistent residual peri-device leak with 5 mm width along the Coumadin ridge aspect of the device. Computed tomography (CT) also showed the peri-device leak with width of 6 mm and complete opacification of left atrial appendage (LAA). Importantly, CT demonstrated that the Watchman 2.5 device was deployed at distal LAA, leaving the proximal part of LAA with length of 10 mm from ostium. Under general anesthesia, a 22 mm Amulet device was deployed successfully with complete sealing of LAA. Procedure planning is the key to minimize the risk of peri-device leak or device-related thrombosis. Careful assessment of LAA anatomy using multimodality images for peri-device leak after LAAC helped optimal treatment strategy including second LAAC with different type of devices.

Uncertainties and Controversies in the Management of Ischemic Stroke and Transient Ischemic Attack Patients With Patent Foramen Ovale.

Multiple randomized clinical trials have demonstrated the benefit of patent foramen ovale closure over medical therapy alone for patients who have had a stroke that has been attributed to the patent foramen ovale. Nevertheless, there are many areas of uncertainty and controversy related to patient selection, pathophysiology, diagnosis, and treatment. We summarize the available data on these challenging topics and attempt to provide some clarity and future directions for clinicians and investigators.

Coronary artery calcium score and risk of cardiovascular events without established coronary artery disease: a systemic review and meta-analysis.

BACKGROUND: Coronary artery calcium (CAC) is an indicator of atherosclerosis, and the CAC score is a useful noninvasive assessment of coronary artery disease. OBJECTIVE: To compare the risk of cardiovascular outcomes in patients with CAC > 0 versus CAC = 0 in asymptomatic and symptomatic population in patients without an established diagnosis of coronary artery disease. METHODS: A systematic search of electronic databases was conducted until January 2018 for any cohort study reporting cardiovascular events in patients with CAC > 0 compared with absence of CAC. RESULTS: Forty-five studies were included with 192 080 asymptomatic 32 477 symptomatic patients. At mean follow-up of 11 years, CAC > 0 was associated with an increased risk of major adverse cardiovascular and cerebrovascular events (MACE) compared to a CAC = 0 in asymptomatic arm [pooled risk ratio (RR) 4.05, 95% confidence interval (CI) 2.91-5.63, P < 0.00001, I2 = 80%] and symptomatic arm (pooled RR 6.06, 95% CI 4.23-8.68, P < 0.00001, I2 = 69%). CAC > 0 was also associated with increased risk of all-cause mortality in symptomatic population (pooled RR 7.94, 95% CI 2.61-24.17, P < 0.00001, I2 = 85%) and in asymptomatic population CAC > 0 was associated with higher all-cause mortality (pooled RR 3.23, 95% CI 2.12-4.93, P < 0.00001, I2 = 94%). In symptomatic population, revascularization in CAC > 0 was higher (pooled RR 15, 95% CI 6.66-33.80, P < 0.00001, I2 = 72) compared with CAC = 0. Additionally, CAC > 0 was associated with more revascularization in asymptomatic population (pooled RR 5.34, 95% CI 2.06-13.85, P = 0.0006, I2 = 93). In subgroup analysis of asymptomatic population by gender, CAC > 0 was associated with higher MACE (RR 6.39, 95% CI 3.39-12.84, P < 0.00001). CONCLUSION: Absence of CAC is associated with low risk of cardiovascular events compared with any CAC > 0 in both asymptomatic and symptomatic population without coronary artery disease.

Severe COVID-19 After Recent Heart Transplantation Complicated by Allograft Dysfunction.

A 50-year-old male presented with atrial flutter 25 days after heart and kidney transplantation. Rejection was excluded, but he developed severe COVID-19 infection with cardiac allograft dysfunction. Despite continued corticosteroid and tacrolimus therapy, he remained aviremic. Respiratory and myocardial functions recovered after a week of mechanical ventilation. The cardiomyopathy was stress induced. (Level of Difficulty: Advanced.).

Clinical and Angiographic Outcomes With Drug-Coated Balloons for De Novo Coronary Lesions: A Meta-Analysis of Randomized Clinical Trials.

Background The role of drug-coated balloons (DCBs) in the treatment of de novo coronary lesions is not well established. Methods and Results Electronic databases and major conference proceedings were searched for randomized controlled trials that compared DCBs with stents or angioplasty for de novo coronary lesions. The primary outcome was target lesion revascularization. Summary estimates were conducted using random-effects analysis complemented by several subgroup and sensitivity analyses. A total of 14 randomized controlled trials with 2483 patients were included. At a mean follow up of 12 months, DCBs were associated with no difference in the incidence of target lesion revascularization as compared with alternative strategies (risk ratio [RR], 0.79; 95% CI, 0.35-1.76). There was no difference in treatment effect based on the indication (ie, small-vessel disease, myocardial infarction, bifurcation, or high bleeding risk) (Pinteraction=0.22). DCBs were associated with lower target lesion revascularization compared with bare metal stents and similar target lesion revascularization compared with drug-eluting stents (Pinteraction=0.03). There was no difference between DCBs and control in terms of major adverse cardiac events, vessel thrombosis, or cardiovascular mortality. However, DCBs were associated with a lower incidence of myocardial infarction (RR, 0.48; 95% CI, 0.25-0.90) and all-cause mortality (RR, 0.45; 95% CI, 0.22-0.94). Conclusions In patients with de novo coronary lesions, use of DCBs was associated with comparable clinical outcomes irrespective of the indication or comparator device. DCBs had a similar rate of target lesion revascularization compared with drug-eluting stents. A randomized trial powered for clinical outcomes and evaluating the role of DCBs for all-comers is warranted.

Systematic review and meta-analysis of valve-in-valve transcatheter aortic valve replacement in patients with failed bioprosthetic aortic valves.

AIMS: The aim of this meta-analysis was to evaluate the evidence regarding the rates of procedural success and the incidence of adverse outcomes following valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) in patients with failed bioprosthetic aortic valves. METHODS AND RESULTS: A systematic search of major electronic databases was conducted for studies relevant to patients with failed bioprosthetic aortic valves undergoing VIV-TAVR. The primary outcome was procedural success. A total of 5,553 patients from 24 studies were included. The mean Society of Thoracic Surgeons (STS) score was 7.84±5.14. The procedural success rate was high (97%, 95% confidence interval [CI]: 94-98%). At 30 days, all-cause mortality was 5% (95% CI: 3-6%), stroke 2% (95% CI: 1-2%), myocardial infarction 1% (95% CI: 1-2%), permanent pacemaker placement 6% (95% CI: 5-8%), and aortic regurgitation 7% (95% CI: 5-10%). At one year, the incidence of all-cause mortality was 12% (95% CI: 10-14%), stroke 3% (95% CI: 2-4%), myocardial infarction 1% (95% CI: 0-2%), and permanent pacemaker placement 7% (95% CI: 5-11%). At three years, the incidence of all-cause mortality was 29% (95% CI: 25-34%) and stroke 6% (95% CI: 5-9%). CONCLUSIONS: VIV-TAVR appears to be associated with high procedural success rates and low adverse outcomes during the short-term and midterm follow-up period.

Incidence, Clinical Presentation, and Causes of 30-Day Readmission Following Hospitalization With Spontaneous Coronary Artery Dissection.

OBJECTIVES: The aim of this study was to investigate the impact of spontaneous coronary artery dissection (SCAD) on 30-day readmission rates following hospitalization with acute myocardial infarction (AMI) using a national database. BACKGROUND: AMI in the setting of SCAD represents an uncommon type of myocardial infarction with limited data on short-term outcomes. METHODS: All hospitalizations with primary or index diagnoses of AMI from 2010 to 2015 in the Nationwide Readmissions Database were queried. The primary outcome was overall 30-day readmission rates in both SCAD and non-SCAD cohorts. Propensity score matching (1:2) was conducted. RESULTS: A total of 2,654,087 patients with AMI were included in the final analysis, of whom 1,386 (0.052%) were diagnosed with SCAD. SCAD was associated with a higher readmission rate in the SCAD cohort (12.3% vs. 9.9%; p = 0.022). The main causes of readmissions in the SCAD cohort were cardiac causes (80.6%), and AMI was the most common cardiac cause (44.8%), followed by chest pain (20.1%) and arrhythmia (12.7%). Among the SCAD readmissions, 50.6% patients were readmitted in the first week post-discharge, with 54.5% of AMI readmissions occurring in the first 2 days post-discharge. CONCLUSIONS: The incidence of 30-day readmission following AMI and SCAD is nontrivial and occurs early post-discharge. Most readmissions are due to cardiac causes, especially AMI. Targeted management approaches are needed to diminish the high rates of readmission and early recurrent AMI.

Proposal for Updated Nomenclature and Classification of Potential Causative Mechanism in Patent Foramen Ovale-Associated Stroke.

Importance: Recent epidemiologic and therapeutic advances have transformed understanding of the role of and therapeutic approach to patent foramen ovale (PFO) in ischemic stroke. Patent foramen ovale is likely responsible for approximately 5% of all ischemic strokes and 10% of those occurring in young and middle-aged adults. Observations: Randomized clinical trials have demonstrated that, to prevent recurrent ischemic stroke in patients with PFO and an otherwise-cryptogenic index ischemic stroke, PFO closure is superior to antiplatelet medical therapy alone; these trials have provided some evidence that, among medical therapy options, anticoagulants may be more effective than antiplatelet agents. Conclusions and Relevance: These new data indicate a need to update classification schemes of causative mechanisms in stroke, developed in an era in which an association between PFO and stroke was viewed as uncertain. We propose a revised general nomenclature and classification framework for PFO-associated stroke and detailed revisions for the 3 major stroke subtyping algorithms in wide use.

In-Hospital Outcomes After Transcatheter Aortic Valve Implantation in Patients With Versus Without Chronic Thrombocytopenia.

Patients with chronic thrombocytopenia (cTCP) were excluded from the pivotal transcatheter aortic valve implantation (TAVI) trials. The National Inpatient Sample was queried and propensity score matching was performed to evaluate the prevalence and impact of cTCP on in-hospital clinical outcomes after TAVI. The main outcome was in-hospital mortality in patients with versus without cTCP. Among 38,855 TAVI hospitalizations, 7,105 had a diagnosis of cTCP (18.3%). In-hospital mortality was similar in both groups (ORadjusted 0.79; 95% confidence interval [CI] 0.57 to 1.09); however, cTCP was associated with higher risk of acute kidney injury (ORadjusted 1.29; 95% CI 1.08 to 1.54), vascular complications (ORadjusted 1.99; 95% CI 1.22 to 3.25), perioperative blood product transfusion (ORadjusted 1.69; 95% CI 1.42 to 2.01), cardiac tamponade (ORadjusted 4.04; 95% CI 1.51 to 10.82), cardiogenic shock (ORadjusted 1.52; 95% CI 1.07 to 2.15), and use of extracorporeal membrane oxygenation (ORadjusted 2.32; 95% CI 1.1 to 4.9). In conclusion, cTCP is common in patients who underwent TAVI and is associated with worse postprocedure clinical outcomes, however, with similar in-hospital mortality.

Intravascular Ultrasound-Guidance Is Associated With Lower Cardiovascular Mortality and Myocardial Infarction for Drug-Eluting Stent Implantation　- Insights From an Updated Meta-Analysis of Randomized Trials.

BACKGROUND: Randomized trials have been underpowered to determine an effect of intravascular ultrasound (IVUS) guidance on hard outcomes for drug-eluting stent (DES) implantation.Methods and Results:Randomized trials that compared IVUS guidance vs. angiographic guidance for DES implantation were included; 10 trials with 5,060 patients. IVUS guidance was associated with a lower incidence of cardiovascular death (odds ratio [OR] 0.44, 95% CI 0.26-0.75), and myocardial infarction (OR 0.55, 95% CI 0.32-0.94). CONCLUSIONS: IVUS-guidance is associated with a lower incidence of cardiovascular death and myocardial infarction in the era of DES. These findings should encourage operators to use IVUS more often.

Patent Foramen Ovale and Hypoxemia.

Patent foramen ovale (PFO), an embryonic remnant of the fetal circulation, is present in 20-25% of adults. Although recent observational studies and clinical trials have established the link between PFO-mediated right-to-left shunting with cryptogenic stroke and migraine with aura, the role of a PFO in exacerbating hypoxemic medical conditions (ie, sleep apnea, chronic obstructive pulmonary disease, pulmonary hypertension, platypnea-orthodeoxia, pulmonary arteriovenous malformation, high-altitude pulmonary edema, and exercise desaturation) remains less understood. PFO-mediated hypoxemia occurs when deoxygenated venous blood from the right atrium enters and mixes with oxygenated arterial blood in the left atrium. Patients with an intracardiac right-to-left shunt may have profound hypoxemia out of proportion to underlying primary lung disease, even in the presence of normal right-sided pressures. The presence of right-to-left cardiac shunting can exacerbate the degree of hypoxemia in patients with underlying pulmonary disorders. In a subset of these patients, percutaneous PFO closure may result in marked improvement in dyspnea and hypoxemia. This review discusses the association between PFO-mediated right-to-left shunting with medical conditions associated with hypoxemia and explores the role of percutaneous PFO closure in alleviating the hypoxemia.

Drug-Eluting Balloons Versus Everolimus-Eluting Stents for In-Stent Restenosis: A Meta-Analysis of Randomized Trials.

OBJECTIVES: Individual randomized trials comparing drug-eluting balloons (DEB) versus everolimus-eluting stents (EES) for in-stent restenosis (ISR) were underpowered for clinical end-points. The objective of this study was to compare the clinical outcomes of DEB versus EES for any ISR. MATERIALS & METHODS: Electronic databases were searched for randomized trials which compared DEB versus EES for any ISR (i.e., drug eluting or bare metal stents). Summary estimate risk ratios (RRs) were constructed using a DerSimonian and Laird random effects model. RESULTS: Five trials with 962 patients were included. In-segment minimum lumen diameter (MLD) was lower with DEB (standardized mean difference -0.24, 95% confidence interval [CI] -0.46 - -0.01) on angiographic follow-up at a mean of 8.6 months. There was no statistically significant difference in the risk of target vessel revascularization (TVR) at 1 year (RR 1.15, 95% CI 0.60-2.19), but TVR was increased with DEB at 3 years (RR 1.87, 95% CI 1.15-3.03). The risk of target lesion revascularization (TLR) was statistically increased with DEB (RR 2.17, 95% CI 1.13-4.19) at a mean of 24.4 months. There was no difference in the risk of MI, stent thrombosis, cardiac mortality and all-cause mortality between both groups. CONCLUSION: In patients with any type of ISR, DEB was associated a similar risk of TVR at 1-year, but increased risk of TVR and TLR at longer follow-up, as compared with EES. The quality of evidence was moderate, suggesting the need for further randomized trials with longer follow-up to confirm the role of DEB in the management of ISR.

In-hospital outcomes of transcatheter versus surgical aortic valve replacement for nonagenarians.

OBJECTIVES: To compare the in-hospital outcomes of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in nonagenarians. BACKGROUND: Data comparing the outcomes of TAVR versus SAVR in nonagenarians are limited. METHODS: Using the National Inpatient Sample years 2012-2014, hospitalization data were retrieved for subjects aged ≥90 years who underwent TAVR or SAVR for severe aortic stenosis. The incidence of in-hospital mortality and peri-procedural outcomes were compared using unadjusted, multivariate logistic regression, and propensity score matched analyses. RESULTS: The final cohort included 6,680 records of nonagenarians undergoing aortic valve replacement, among which 5,840 (87.4%) underwent TAVR. There was no difference in the incidence of in-hospital mortality between both groups in the unadjusted (5.8% versus 6.0% P = 0.95), multivariate (odds ratio [OR] 0.78, 95% confidence interval [CI] 0.35-1.74), and propensity score matched (OR 1.07, 95% CI 0.75-1.51) analyses. In the propensity-matched analysis, TAVR was associated with a lower incidence of acute kidney injury (OR 0.58, 95% CI 0.47-0.72), post-operative blood transfusion (OR 0.51, 95% CI 0.43-0.61), a higher likelihood of discharge to home (OR 4.71, 95% 3.44-5.06), and a similar incidence of pacemaker placement (OR 1.16, 95% 0.89-1.53) and stroke (OR 1.34, 0.90-1.99). CONCLUSIONS: In this nationwide analysis, TAVR was associated with an overall similar incidence of in-hospital mortality and less morbidity compared with SAVR. These findings suggest that TAVR is effective and safe in nonagenarians.

Efficacy and safety of aspirin for primary prevention of cardiovascular events: a meta-analysis and trial sequential analysis of randomized controlled trials.

AIMS: The role of aspirin in the primary prevention setting is continuously evolving. Recent randomized trials have challenged the role of aspirin in the primary prevention setting. METHODS AND RESULTS: Electronic databases were searched for randomized trials that compared aspirin vs. placebo (or control) in subjects without established atherosclerotic disease. The primary efficacy outcome was all-cause mortality, while the primary safety outcome was major bleeding. Summary estimates were reported using a DerSimonian and Laird random effects model. A total of 11 trials with 157 248 subjects were included. At a mean follow-up of 6.6 years, aspirin was not associated with a lower incidence of all-cause mortality [risk ratio (RR) 0.98, 95% confidence interval (CI) 0.93-1.02; P = 0.30]; however, aspirin was associated with an increased incidence of major bleeding (RR 1.47, 95% CI 1.31-1.65; P < 0.0001) and intracranial haemorrhage (RR 1.33, 95% CI 1.13-1.58; P = 0.001). A similar effect on all-cause mortality and major bleeding was demonstrated in diabetic and high cardiovascular risk patients (i.e. 10-year risk >7.5%). Aspirin was associated with a lower incidence of myocardial infarction (RR 0.82, 95% CI 0.71-0.94; P = 0.006); however, this outcome was characterized by considerable heterogeneity (I2 = 67%), and this effect was no longer evident upon limiting the analysis to the more recent trials. Trial sequential analysis confirmed the lack of benefit of aspirin for all-cause mortality up to a relative risk reduction of 5%. CONCLUSION: Among adults without established cardiovascular disease, aspirin was not associated with a reduction in the incidence of all-cause mortality; however, it was associated with an increased incidence of major bleeding. The routine use of aspirin for primary prevention needs to be reconsidered.