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Background Cardiovascular procedural volumes can serve as metrics of hospital infrastructure and quality, and are the basis for thresholds for initiating transcatheter mitral valve repair (TMVr) programs. Whether hospital volumes of TMVr, surgical mitral valve replacement or repair (SMVRr), and percutaneous coronary intervention (PCI) are indicators of TMVr quality of care is not known. Methods We used the 2017 Nationwide Readmissions Database to identify hospitals that performed at least 5 TMVr procedures. Hospitals were divided into quartiles of TMVr volume. Associations of hospital TMVr, SMVRr, and PCI volumes, as well as SMVRr and PCI outcomes with TMVr outcomes were examined. Outcomes studied were risk-standardized in-hospital mortality rate (RSMR) and 30-day readmission rate (RSRR). Results The study included 3404 TMVr procedures performed across 150 hospitals in the US. The median hospital TMVr volume was 17 (IQR 10, 28). The mean hospital-level RSMR and RSRR for TMVr were 3.0% (95% CI 2.5%, 3.4%) and 14.8% (95% CI 14.5%, 15.0%), respectively. There was no significant association between hospital TMVr volume (as quartiles or as a continuous variable) and TMVr RSMR or RSRR (P > 0.05). Similarly, there was weak or no correlation between hospital SMVRr and PCI volumes and outcomes with TMVr RSMR or RSRR (Pearson correlation coefficients, r = −0.199 to 0.269). Conclusion In this study, we found no relationship between hospital TMVr, SMVRr, and PCI volume and TMVr outcomes. Further studies are needed to determine more appropriate structure and process measures to assess the performance of established and new TMVr centers.

Acute kidney injury after transcatheter aortic valve implantation (TAVI) has been associated with adverse outcomes; however, data are limited on the subacute changes in renal function that occur after discharge and their impact on clinical outcomes. This study investigates the relation between subacute changes in kidney function at 30 days after TAVI and survival. Patients from 2 centers who underwent TAVI and survived beyond 30 days with baseline, in-hospital, and 30-day measures of renal function were retrospectively analyzed. Patients were stratified based on change in estimated glomerular filtration rate (eGFR) from baseline to 30 days as follows: improved (≥15% higher than baseline), worsened (≤15% lower), or unchanged (values in between). Univariable and multivariable models were constructed to identify predictors of subacute changes in renal function and of 2-year mortality. Of the 492 patients who met inclusion criteria, eGFR worsened in 102 (22%), improved in 110 (22%), and was unchanged in 280 (56%). AKI occurred in 90 patients (18%) and in only 27% of patients with worsened eGFR at 30 days. After statistical adjustment, worsened eGFR at 30 days (hazard ratio vs unchanged eGFR 2.09, 95% CI 1.37 to 3.19, p0.001) was associated with worse survival, whereas improvement in renal function was not associated with survival (hazard ratio vs unchanged eGFR 1.30, 95% CI 0.79 to 2.11, p = 0.30). Worsened renal function at 30 days after TAVI is associated with increased mortality after TAVI. In conclusion, monitoring renal function after discharge may identify patients at high risk of adverse outcomes.

Introduction: This physician-initiated study provides 5-year (i.e., long-term) treatment durability data from 3 top recruitment sites that participated in the prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study (ClinicalTrials.gov identifier: NCT02080871). It evaluates the long-term treatment durability of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of subjects with de novo or restenotic aortoiliac lesions. Materials and Methods: A total of 59 subjects with 94 treated lesions were enrolled at the 3 participating sites from the original 140 intent-to-treat subjects in the VBX FLEX study. The primary durability endpoint was long-term primary patency. Secondary long-term outcomes included freedom from target lesion revascularization (TLR), freedom from target vessel revascularization (TVR), as well as resting ankle-brachial index (ABI), Rutherford category, EuroQol 5 Dimensions, and Walking Impairment status. Results: Fifty-nine subjects participated and twenty-eight (47.5%) were available through the end of the study at 5-year follow-up (the median follow-up time was 6.6 years due to complications resulting from COVID-19 precautions). At 3 and 5 years, the Kaplan-Meier estimates for freedom from all-cause mortality were 94.5% and 81.7%, respectively. The Kaplan-Meier estimates for primary patency at 3 and 5 years were 94.0% and 89.5% (by lesion) and 91.7% and 84.4% (by subject). Primary assisted patency at 3 and 5 years were 93.3% and 93.3%. Kaplan-Meier estimate for freedom from TLR at 5 years was 89.1%. The majority of subjects were asymptomatic (Rutherford category 0) at 3 years (29/59; 72%), and at 5-year follow-up (18/28; 64%). The 5-year mean resting ankle-brachial index was 0.95±0.18, an improvement of 0.15±0.26 from the baseline (pConclusion: The 5-year long-term follow-up data underscore the robustness and durability of the Viabahn Balloon-Expandable Endoprosthesis for treating aortoiliac occlusive disease. Clinical Impact Durable improvement after endovascular treatment of iliac occlusive disease is clinically important because many of these patients are claudicants with significant life expectancy. This study is the first to evaluate the long-term outcomes in patients with iliac occlusive disease treated with the Viabahn VBX balloon-expandable endopirostheses. The study reports excellent long-term patency outcomes with prolonged clinical benefit. These durable results are likely to be an important consideration for clinicians undertaking iliac artery revascularization procedures.

The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is highly infectious, carries significant morbidity and mortality, and has rapidly resulted in strained health care system and hospital resources. In addition to patient-related care concerns in infected individuals, focus must also relate to diminishing community spread, protection of staff, case selection, and concentration of resources. The current document based on available data and consensus opinion addresses appropriate catheterization laboratory preparedness for treating these patients, including procedure-room readiness to minimize external contamination, safe donning and doffing of personal protective equipment (PPE) to eliminate risk to staff, and staffing algorithms to minimize exposure and maximize team availability. Case selection and management of both emergent and urgent procedures are discussed in detail, including procedures that may be safely deferred or performed bedside.

Objectives This study sought to evaluate the long-term effect of transcatheter patent foramen ovale (PFO) closure on migraineurs with and without aura and examine the effect of residual right-to-left shunt. Background Many studies reported improvement in migraine symptoms after PFO closure, yet randomized trials failed to reach its clinical endpoints. Methods The study retrospectively analyzed data from 474 patients who underwent transcatheter PFO closure at Massachusetts General Hospital. Patients completed a migraine burden questionnaire at baseline and at follow-up. Migraine severity is reported as migraine frequency (days/month), average duration (min), and migraine burden (days × min/month). Improvement following closure was defined as complete abolishment of symptoms or >50% reduction in migraine burden. Results A total of 110 migraineurs who underwent PFO closure were included; 77.0% had aura and 23.0% were without aura, and 91.0% had a cryptogenic stroke. During long-term median follow-up of 3.2 (interquartile range: 2.1 to 4.9) years, there was a significant improvement in migraine symptoms in migraineurs with or without aura. Migraine burden was reduced by >50% in 87.0% of patients, and symptoms were completely abolished in 48%. Presence of aura was associated with abolishment of migraine (odds ratio: 4.30; 95% confidence interval: 1.50 to 12.30; p = 0.006). At 6 months after PFO closure, residual right-to-left shunt was present in 26% of patients. Absence of right-to-left shunt was associated with improvement in migraine burden by >50% (odds ratio: 4.60; 95% confidence interval: 1.30 to 16.10; p = 0.017). Conclusions Long-term follow-up after transcatheter PFO closure was associated with significant improvement in migraine burden. Aura was a predictor of abolishing symptoms. Absence of residual right-to-left shunt was a predictor of significant reduction in migraine burden.

Background Transcatheter closure of patent foramen ovale (PFO) in patients with cryptogenic stroke reduces the rate of recurrent events. Although presence of thrombophilia increases the risk for paradoxical emboli through a PFO, such patients were excluded from large randomized trials. Objectives We compared the safety and efficacy of percutaneous PFO closure in patients with and without a hypercoagulable state. Methods Data from 800 consecutive patients undergoing percutaneous PFO closure in our medical center were analyzed. All patients were independently evaluated by specialists in neurology, cardiology, hematology, and vascular medicine. A post-procedural treatment of at least 3 months of anticoagulation was utilized in patients with thrombophilia. Follow-up events included death, recurrent neurological events, and the need for reintervention for significant residual shunt. Results A hypercoagulable state was found in 239 patients (29.9%). At median follow-up of 41.9 months, there were no differences in the frequencies of stroke or transient ischemic attack between patients with or without thrombophilia (2.5% in non-hypercoagulable group vs. 3.4% in hypercoagulable group, log-rank test p = 0.35). There were no significant differences in baseline demographics, echocardiographic characteristics, procedural success, or complications between groups. Conclusion Percutaneous PFO closure is a safe and effective therapeutic approach for patients with cryptogenic stroke and an underlying hypercoagulable state.

Background Left atrial appendage closure (LAAC) is an alternative to long-term anticoagulation for thromboembolic protection in patients with atrial fibrillation (AF) and high bleeding risk. Short-term Warfarin use following LAAC is well-studied, while data pertaining to novel oral anticoagulant (NOAC) use in this setting is less robust. Specifically, data regarding the safety and efficacy of postprocedural NOAC use in high-risk patients is lacking. Objective To compare the safety and efficacy of Warfarin and NOAC use in a high-risk patient population undergoing LAAC with the WATCHMAN device. Methods From November 2015 to October 2017, 97 patients underwent LAAC with the WATCHMAN device. All patients were discussed at a multidisciplinary meeting prior to device implantation. Longitudinal data were collected and analyzed for a composite endpoint of stroke and death at 8 months, and major bleeding at 3 and 6 months. Results Among the 90 patients included in the safety and efficacy analysis, 43 were prescribed Warfarin and 47 were prescribed NOACs. Baseline characteristics were comparable between study groups. There were no procedural complications and no significant differences in the incidence of death and stroke at 8 months or major bleeding at 3 and 6 months. Conclusion For patients with AF at high risk of both thromboembolic and hemorrhagic events, NOACs as compared to Warfarin, seem to be safe and effective for short-term anticoagulation following LAAC with the WATCHMAN device. Further validation in large randomized controlled trials is required.

Background Transcatheter aortic valve replacement (TAVR) has emerged as a safe and effective therapeutic option for patients with severe aortic stenosis (AS) who are at prohibitive, high, or intermediate risk for surgical aortic valve replacement (SAVR). However, in low-risk patients, SAVR remains the standard therapy in current clinical practice. Objectives This study sought to perform a meta-analysis of randomized controlled trials (RCTs) comparing TAVR versus SAVR in low-risk patients. Methods Electronic databases were searched from inception to March 20, 2019. RCTs comparing TAVR versus SAVR in low-risk patients (Society of Thoracic Surgeons Predicted Risk of Mortality [STS-PROM] score Results The meta-analysis included 4 RCTs that randomized 2,887 patients (1,497 to TAVR and 1,390 to SAVR). The mean age of patients was 75.4 years, and the mean STS-PROM score was 2.3%. Compared with SAVR, TAVR was associated with significantly lower risk of all-cause death (2.1% vs. 3.5%; RR: 0.61; 95% CI: 0.39 to 0.96; p = 0.03; I2 = 0%) and cardiovascular death (1.6% vs. 2.9%; RR: 0.55; 95% CI: 0.33 to 0.90; p = 0.02; I2 = 0%) at 1 year. Rates of new/worsening atrial fibrillation, life-threatening/disabling bleeding, and acute kidney injury stage 2/3 were lower, whereas those of permanent pacemaker implantation and moderate/severe paravalvular leak were higher after TAVR versus SAVR. There were no significant differences between TAVR versus SAVR for major vascular complications, endocarditis, aortic valve re-intervention, and New York Heart Association functional class ≥II. Conclusions In this meta-analysis of RCTs comparing TAVR versus SAVR in low-risk patients, TAVR was associated with significantly lower risk of all-cause death and cardiovascular death at 1 year. These findings suggest that TAVR may be the preferred option over SAVR in low-risk patients with severe AS who are candidates for bioprosthetic AVR.

Background Mitral valve replacement in the setting of severe mitral annular calcification remains a surgical challenge. Transcatheter mitral valve replacement (TMVR) using an aortic balloon-expandable transcatheter heart valve is emerging as a potential treatment option for high surgical risk patients. Transseptal, transapical, or transatrial access is not always feasible, so an understanding of alternative implantation techniques is important. Objectives The authors sought to present a step-by-step description of a contemporary transatrial TMVR technique using balloon-expandable aortic transcatheter heart valves. This procedure has evolved over time to address valve migration, left ventricular outflow tract obstruction, and paravalvular leak. The authors present a refined technique that has been associated with the most reproducible outcomes. Methods A step-by-step description of the TMVR technique and outcomes of 8 patients treated using this technique are described. Baseline patient clinical and echocardiographic characteristics and 30-day post-TMVR outcomes are presented. Results Eight patients underwent transatrial TMVR at a single institution. Five had previous cardiac surgery. Mean STS score was 8%. Technical success by MVARC (Mitral Valve Academic Research Consortium) criteria was 100%. There was zero in-hospital and 30-day mortality. Procedural success by MVARC criteria at 30 days was 100%. Paravalvular leak immediately post-implant was none or trace in 6 and mild in 1. Conclusions The technique described is reproducible and was associated with favorable outcomes in this early experience. It represents a useful technique for the treatment of mitral valve disease in the setting of severe annular calcification. A structured and defined implantation technique is critical to investigators as this field evolves.

Heyde syndrome, the co-occurrence of aortic stenosis and bleeding gastrointestinal (GI) angiodysplasia, is managed with aortic valve replacement. However, severe bleeding and anemia can preclude safe use of the antiplatelet or anticoagulant therapy required for this intervention. We present a case of the novel and successful treatment of severe, refractory bleeding and transfusion dependence with antiangiogenic therapy in a patient with Heyde syndrome. After systemic bevacizumab was initiated, the patient achieved durable hemostasis with normalization of hemoglobin and liberation from red cell transfusion and dependence on iron infusion; aspirin therapy was successfully initiated where it had previously failed. This durable hemostasis facilitated her subsequent successful transcatheter aortic valve replacement. Plasma vascular endothelial growth factor levels, which were monitored during therapy, paradoxically rose after bevacizumab was initiated but normalized after it was discontinued. Given the angiogenic dysregulation of Heyde syndrome, systemic bevacizumab may be an effective and safe targeted therapy for managing refractory GI bleeding, which thereby facilitates antiplatelet therapy and aortic valve replacement in these challenging cases. Additional investigation into the therapeutic role of inhibiting angiogenesis as a hemostatic modality in Heyde syndrome is warranted.

Introduction: The most common complication of alcohol septal ablation (ASA) is periprocedural high grade AV block (HGAVB). No long-term follow-up of cardiovascular implantable electronic device (CIED) utilization after ASA has been reported. Hypothesis: Pacemaker dependence on long-term follow up can be predicted by ECG or procedural characteristics. Methods: We analyzed all patients with hypertrophic cardiomyopathy who underwent ASA from December 1998 to December 2019 at our institution and received their first CIED within 30 days after ASA for HGAVB. All available follow-up interrogations were reviewed. CIED dependence was defined as ventricular pacing of ≥5%. CIED programming was determined by the patients’ cardiologists' discretion. Results: A total of 103 patients with hypertrophic cardiomyopathy underwent ASA. The average follow up duration was 10.1 years. Within 30 days after ASA, a total 25 patients received a CIED for HGAVB. On long term follow-up 16 patients (64%) were found to be CIED-dependent. Baseline characteristics, including pre and post-ASA ECG, were not significantly different between dependent and non-dependent patients (Table). The only predictor for CIED dependence was >1 ml of alcohol injected during ASA (OR 6.0, p Conclusions: CIED implantation after ASA is common. Almost two thirds of patients who received CIED for postprocedural HGAVB were CIED-dependent on long term follow up. CIED dependence can be predicted by amount of injected alcohol >1 ml during ASA.

Cardiac catheterization is the gold standard diagnostic procedure for assessing cardiac function and coronary anatomy. It is also a platform for the treatment of coronary artery disease, peripheral vascular disease and, increasingly, structural heart disease and advanced heart failure.

Background: The optimal treatment strategy for treating ST-segment–elevation myocardial infarction (STEMI) in context of the coronavirus disease 2019 (COVID-19) pandemic is unclear given the potential risk of occupational exposure during primary percutaneous coronary intervention (PPCI). We quantified the impact of different STEMI treatment strategies on patient outcomes and provider risk in context of the COVID-19 pandemic. Methods: Using a decision-analytic framework, we evaluated the effect of PPCI versus the pharmaco-invasive strategy for managing STEMI on 30-day patient mortality and individual provider infection risk based on presence of cardiogenic shock, suspected coronary territory, and presence of known or presumptive COVID-19 infection. Results: For patients with low suspicion for COVID-19, PPCI had mortality benefit over the pharmaco-invasive strategy, and the risk of cardiac catheterization laboratory provider infection remained very low ( Conclusions: Usual care with PPCI remains the appropriate treatment strategy in the majority of cases presenting with STEMI in the setting of the COVID-19 pandemic. However, utilization of a pharmaco-invasive strategy in selected patients with STEMI with presumptive COVID-19 and low likelihood of mortality from STEMI and use of preventive strategies such as preprocedural intubation in high risk patients when PPCI is the preferred strategy may be reasonable to reduce provider risk of COVID-19 infection.

Background Transcatheter closure of patent foramen ovale (PFO) in patients with cryptogenic stroke reduce the rate of recurrent events. Although presence of thrombophilia increases the risk for paradoxical emboli through a PFO, such patients were excluded from the large randomized studies. Purpose To examine the effect of hypercoagulable state on clinical outcomes after PFO closure. Methods We retrospectively analyzed data of 800 consecutive patients undergoing percutaneous PFO closure at the Massachusetts general hospital. We compared the safety and efficacy of the procedure in patients with and without a hypercoagulable state. Periprocedural treatment included 3 months of anticoagulation followed by low dose aspirin. Results A hypercoagulable disorder was found in 239 patients (29.9%). There were no significant differences in baseline demographics, echocardiographic characteristics, procedural success rate, or complication rate between both groups. At median follow-up of 41.9 months there were no differences in the rate of stroke/transient ischemic attack (2.5% in non-hypercoagulable group vs. 3.4% in hypercoagulable group, log-rank test p=0.349). Survival analysis of composite outcome that included: ischemic neurologic event, reintervention and procedural or neurologic death did not show significant difference between groups (Log-rank p=0.122). Conclusion Percutaneous PFO closure is a safe and effective therapeutic approach for patients with cryptogenic stroke and an underlying hypercoagulable state Funding Acknowledgement Type of funding source: Public hospital(s). Main funding source(s): Research funds of the Massachusetts general hospital

A Man with Chronic Kidney Disease A 74-year-old man presented for evaluation of his chronic kidney disease before a planned transcatheter aortic-valve replacement. Pancreatitis had been diagnosed 2...

Reports on the role of hemodynamic support devices in patients with severe aortic stenosis (AS) and left ventricular (LV) dysfunction undergoing balloon aortic valvuloplasty (BAV) are limited.Patients were identified from the cVAD registry, an ongoing multicenter voluntary registry at selected sites in North America that have used Impella in10 patients.A total of 116 patients with AS who underwent BAV with Impella support were identified. Mean age was 80.41±9.03years and most patients were male. Mean STS score was 18.77%±18.32, LVEF was 27.14%±16.07, and 42% underwent concomitant PCI. In most cases Impella was placed electively prior to BAV, whereas 26.7% were placed as an emergency. The two groups had similar baseline characteristics except for higher prevalence of CAD and lower LVEF in the elective group, and higher STS score in the emergency group. Elective strategy was associated higher 1-year survival compared to emergency placement (56% vs. 29.2%, p=0.003). One-year survival was higher when BAV was used as a bridge to definitive therapy as opposed to palliative treatment (90% vs. 28%, p0.001). On multivariate analysis, STS score and aim of BAV (bridge to definitive therapy vs. palliative indication) were independent predictors of mortality.In this large cohort of patients with AS and severe LV dysfunction undergoing BAV, our results demonstrates feasibility and promising long-term outcomes using elective Impella support with the intention to bridge to a definitive therapy.

Transcatheter aortic valve replacement (TAVR) with percutaneous coronary intervention (PCI) has emerged as a less-invasive therapeutic option for high surgical risk patients with aortic stenosis and coronary artery disease. The aim of this study was to determine the outcomes of TAVR when performed with PCI during the same hospitalization. We identified patients using the International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes from the Nationwide Inpatient Sample between the years 2011 and 2013. A total of 22,344 TAVRs were performed between 2011 and 2013. Of these, 21,736 (97.3%) were performed without PCI (TAVR group) while 608 (2.7%) along with PCI (TAVR + PCI group). Among the TAVR + PCI group, 69.7% of the patients had single-vessel, 22.2% had 2-vessel, and 1.6% had 3-vessel PCI. Drug-eluting stents were more commonly used than bare-metal stents (72% vs 28%). TAVR + PCI group witnessed significantly higher rates of mortality (10.7% vs 4.6%) and complications: vascular injury requiring surgery (8.2% vs 4.2%), cardiac (25.4% vs 18.6%), respiratory (24.6% vs 16.1%), and infectious (10.7% vs 3.3%), p0.001% for all, compared with the TAVR group. The mean length of hospital stay and cost of hospitalization were also significantly higher in the TAVR + PCI group. The propensity score-matched analysis yielded similar results. In conclusion, performing PCI along with TAVR during the same hospital admission is associated with higher mortality, complications, and cost compared with TAVR alone. Patients would perhaps be better served by staged PCI before TAVR.

IMPORTANCE: Pulmonary hypertension (pHTN) is associated with increased risk of mortality after mitral valve surgery for mitral regurgitation. However, its association with clinical outcomes in patients undergoing transcatheter mitral valve repair (TMVr) with a commercially available system (MitraClip) is unknown. OBJECTIVE: To assess the association of pHTN with readmissions for heart failure and 1-year all-cause mortality after TMVr. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study analyzed 4071 patients who underwent TMVr with the MitraClip system from November 4, 2013, through March 31, 2017, across 232 US sites in the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy registry. Patients were stratified into the following 4 groups based on invasive mean pulmonary arterial pressure (mPAP): 1103 with no pHTN (mPAP

Peripheral arterial disease (PAD) is a global health problem. The risk factors for developing PAD have been clearly described in the literature, as have the medical therapies and preventative strategies for the prevention and treatment of PAD. Unfortunately, PAD patients remain undertreated with regard to guideline-directed medical therapy. During the last 2 decades, endovascular therapies for PAD have evolved such that randomized controlled trial level data are available for the treatment of lower extremity PAD at every major anatomic segment. Furthermore, endovascular therapy has evolved to the point that among experienced operators, an endovascular first strategy is reasonable for the treatment of most patients with intermittent claudication or critical limb ischemia.

With the advent of transcatheter aortic valve replacement (TAVR), appropriately selected intermediate-, high-, and extreme-risk patients with severe aortic stenosis (AS) are now offered a less invasive option compared to conventional surgery. In contemporary practice, TAVR is performed predominantly via a transfemoral arterial approach, whereby a transcatheter heart valve (THV) is delivered in a retrograde fashion through the iliofemoral arterial system and thoraco-abdominal aorta, into the native aortic valve annulus. While the majority of patients possess suitable anatomy for transfemoral arterial access, there is a subset of patients with extensive peripheral vascular disease that precludes this traditional approach to TAVR. Fortunately, innovation in the field of structural heart disease has led to the refinement of alternative access options for THV delivery. Selection of the most appropriate route of therapy mandates a careful consideration of multiple factors, including patient anatomy, technical feasibility, and equipment specifications. Furthermore, understanding the risks conferred by each access site for valve delivery-notably stroke, vascular injury, and major bleeding-is of paramount importance when selecting the approach that will best optimize the outcome for an individual. In this review, we provide a comprehensive summary of alternative approaches to transfemoral arterial TAVR as well as the available outcome data supporting each of these various techniques.

Background: Patent foramen ovale (PFO) is an independent risk factor for ischemic stroke, and recent clinical trials have shown long-term benefit of PFO closure. We previously found PFO may increase the risk of stroke due to right-to-left shunting, resulting in venous contamination of arterial circulation, with elevated neurovascular mediators such as homocysteine. However, in clinical practice, residual blood shunting can be observed in ~10% of patients post PFO closure, with unclear significance. Here we prospectively investigated the long-term influence of residual shunting on patient outcome. Method: 1018 PFO stroke patients s/p PFO closure from several medical centers were prospectively recruited in accordance with IRB protocol and followed up to 7 years. Result: While closure rate at our center is much lower ( Conclusion: Consistent with clinical trials, our prospective observational study suggests complete PFO closure results in lower risk of stroke recurrence. Patients with residual shunting (incomplete PFO closure) may face continued risk, though the overall risk of stroke recurrence is very low. PFO-related shunting appears to be critical in the pathophysiology of recurrent stroke.

Objectives To describe the first single center experience with a novel aspiration thrombectomy device. Background The appearance of inferior vena cava or right-sided intracardiac thrombus may prompt consideration of percutaneous thrombectomy as a method to prevent new or worsening pulmonary embolism (PE). The AngioVac is a novel thrombectomy device composed of a cannula and extracorporeal circuit with filter for pump-assisted removal of intravascular debris which is coupled with a reinfusion catheter for return of blood to the patient. The device has been approved by the United States Food and Drug Administration since 2009. This report represents the first significant case series describing its use, feasibility and outcomes in evacuating large caval thrombi or intracardiac masses in PE. Methods This is a retrospective analysis of patient and case characteristics and in-hospital clinical outcomes of AngioVac thrombectomy in 14 consecutive patients treated between April 2010 and July 2013 at our institution. Results Fourteen consecutive patients (mean age 50, 64% female) underwent 15 AngioVac procedures over 40 months. Indications included intracardiac mass (73%), acute PE (33%), and caval thrombus (73%). Four patients (27%) were in shock at the start of the procedure. Peri-procedure mortality was 0% and in-hospital mortality was 13% at a mean follow-up of 23 days. There were no pulmonary hemorrhages, strokes or myocardial infarctions. Though 73% had a post procedural drop in hematocrit, only two bleeding events were related to access site and required a transfusion. Conclusions AngioVac thrombectomy is feasible in critically ill patients with acute DVT or PE and large caval thrombi or intracardiac masses. © 2015 Wiley Periodicals, Inc.

Antiplatelet therapy is an essential component of ST elevation myocardial infarction (STEMI) management. Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel has previously been the standard of care for STEMI management, but the advent of newer, more potent P2Y12 inhibitors has expanded the options for the management of STEMI. As compared with clopidogrel, these newer P2Y12 agents-such as prasugrel and ticagrelor-allow for further reductions in ischemic end points, without the robust increases in bleeding seen in previous studies of antithrombotic therapies. Understanding the nuances of these newer agents allows optimization of therapy for the individual patient and circumstance. Ultimately, combining these newer therapies, in specific populations, and specific approaches-alternative access strategies (e.g., radial)-may allow us to maximize efficacy and reduce the risk of antiplatelet therapies in treating patients with STEMI.

Septic coronary embolization in a patient with endocarditis is a rare and can be a devastating complication. The management of this clinical problem in the current era may be best served with a multi-modality approach. We present an interesting case of a patient with septic coronary embolization managed with the combined use of aspiration thrombectomy followed by surgical management of the infected valve.

Symptomatic carotid artery stenosis is an important cause of stroke with significant morbidity and mortality. Revascularization with carotid endarterectomy reduces the recurrence of stroke and until recently was considered the gold standard of therapy. Carotid artery stenting has emerged as an alternative method of revascularization in both high-risk and standard-risk patients. This review appraises the role of surgery versus stenting for patients with symptomatic carotid stenosis.

The optimal strategy for acute mechanical circulatory support (MCS) in isolated right ventricular (RV) failure is unknown. Here we present a case of isolated acute RV failure with cardiogenic shock supported with an Impella RP to complete RV recovery. A thirty-five-year-old male with a past medical

Objectives: The aim of the present study was to compare the characteristics of nonculprit coronary plaques between diabetes mellitus (DM) and non-DM patients using 3-vessel optical coherence tomogr...

Background— Risk-standardized all-cause 30-day readmission rates (RSRRs) after percutaneous coronary intervention (PCI) have been endorsed as a national measure of hospital quality. Little is known about variation in the performance of hospitals on this measure, and whether high hospital rates of readmission after PCI are due to modifiable deficiencies in quality of care has not been assessed. Methods and Results— We estimated 30-day, all-cause RSRRs for all nonfederal PCI-performing hospitals in Massachusetts, adjusted for clinical and angiographic variables, between 2005 and 2008. We assessed if differences in race, insurance type, and PCI and post-PCI characteristics, including procedural complications and discharge characteristics, could explain variation between hospitals using nested hierarchical logistic regression models. Of 36 060 patients undergoing PCI at 24 hospitals and surviving to discharge, 4469 (12.4%) were readmitted within 30 days of discharge. Hospital RSRRs ranged from 9.5% to 17.9%, with 8 of 24 hospitals being identified as outliers (4 lower than expected and 4 higher than expected). Differences in race, insurance, PCI, and post-PCI factors accounted for 10.4% of the between-hospital variance in RSRRs. Conclusions— We observed wide variation in hospital 30-day all-cause RSRRs after PCI, most of which could not be explained by identifiable differences in procedural and postprocedural factors. A better understanding of etiologies of hospital variation is necessary to determine whether this measure is an actionable assessment of hospital quality, and, if so, how hospitals might improve their performance.

Tremendous advances have been made in the endovascular treatment of lower-extremity arterial occlusive disease. New technology has enabled operators to successfully revascularize patients with complex arterial occlusive disease. This article summarizes the latest advances in endovascular therapy of aortoiliac and femoral arteries and reviews the clinical outcomes and costs associated with the use of these treatments.

Background— To evaluate outcomes after carotid artery stenting in larger real-world populations, the Food and Drug Administration mandated that companies conduct postmarketing surveillance (PMS) studies of approved stent systems. Whether PMS studies are representative of carotid artery stenting in routine clinical practice has not been established. Methods and Results— Within the National Cardiovascular Database Registry–Carotid Artery Revascularization and Endarterectomy (NCDR CARE) Registry, we compared patient and procedural characteristics, in-hospital outcomes, and subsequent all-cause mortality after carotid artery stenting in PMS study participants and nonparticipants. We conducted both crude and propensity score–adjusted comparisons for all outcomes between groups. Compared with nonparticipants, participants in PMS studies had lower rates of symptomatic carotid artery disease within the preceding 6 months, prior stroke, and acute evolving stroke at baseline. The PMS study participants had lower unadjusted rates of combined in-hospital death, stroke, or myocardial infarction (2.3% versus 4.1%; P P =0.005) and death (0.3% versus 1.4%; P P =0.04 for in-hospital mortality; and hazard ratio, 0.80; 95% confidence interval, 0.66 to 0.97; P =0.02 for 2-year mortality). Baseline differences in neurological history explained the largest proportion of the difference in outcomes between groups. Conclusions— Participants in PMS studies for carotid artery stenting have different clinical and procedural characteristics and lower mortality compared with nonparticipants. Extrapolating results from PMS studies of carotid artery stenting to larger real-world settings should be done only with great caution.

The platelet plays an essential role in atherothrombosis. Clinically, platelet-rich thrombi underlie acute coronary syndromes (ACSs). Current therapies have improved outcomes, however, often at the expense of increased risk of bleeding. With the increase in our understanding of the underlying pathophysiology of ACSs, newer targets for antiplatelet therapies continue to emerge. Novel antiplatelet agents may provide even greater reductions in ischemic events with the potential for less bleeding. This article reviews the evidence for current antiplatelet agents in ACSs as well as for the newer agents in later phases of clinical testing.

Acute myocardial infarction is a common and life-threatening presentation of coronary artery disease in adults. In the settings of ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction, significant mortality benefit has been observed in randomized trials of coronary stent procedures compared with medical therapy alone. However, data regarding procedural choices, and particularly stent choices, are limited, and significant controversy exists. Drug-eluting stents were introduced in the United States in 2003 and have been widely adopted based on profound reduction in restenosis. Yet recent years have witnessed a decline in use of drug-eluting stents in the setting of myocardial infarction due to long-term safety concerns. We review the current data regarding drug-eluting stent performance relative to bare metal stents in the setting of acute myocardial infarction with regard to effectiveness, safety, and the need for adjunctive long-term pharmacologic therapy.

Patients with end-stage renal disease (ESRD) are at a high risk for sudden cardiac death (SCD). SCD is the most common cause of death in this population and, as in the general population, ventricular arrhythmias seem to be the most common cause of SCD. The increased risk of SCD in ESRD is likely due to factors that are unique to the metabolic derangements associated with this state, as well as the increased prevalence of traditional risk factors. Despite this, the evidence base for the assessment and management of SCD in these patients is limited. This article reviews the current data on underlying risk factors for SCD in patients with ESRD, the role of common medical and device-based therapies for the prevention and treatment of SCD, and the applicability of common methods of risk stratification to patients with ESRD.

Atrial fibrillation (AF) is common in patients who have implantable defibrillators and presents some unique challenges and opportunities. AF burden can be assessed more accurately, allowing for evaluation of therapy efficacy (drugs or ablation). It remains to be shown whether home monitoring of defibrillators to detect and treat AF more quickly can reduce cardiovascular and stroke end points. One major goal will be to reduce inappropriate shocks from atrial fibrillation. Otherwise, the goals of therapy remain the same-reduction of symptoms (including heart failure exacerbation and inappropriate implantable cardioverter defibrillator therapies) by controlling rate or rhythm and anticoagulation for stroke prophylaxis.

Risk stratification for patients with acute dyspnoea is a challenging task. No quantitative tool for mortality prediction among patients with acute dyspnoea is available.595 dyspnoeic subjects were enrolled in an emergency department. Clinical and biochemical factors independently predictive of death by 1 year were used to develop a mortality risk prediction tool.Seven factors comprised the final tool: age (x0.3), heart rate (x0.2), blood urea nitrogen (x0.3), New York Heart Association class (x5), amino-terminal pro-B-type natriuretic peptide (NT-proBNP)or=986 pg/ml (18 points), systolic blood pressure100 mm Hg (11 points) and presence of a murmur (11 points). A continuous rise in mortality was seen from 1.7% in the lowest score quintile (n = 118; scoreor=48.5) to 43.1% in the highest quintile (n = 116, scoreor=85.5; p0.001 for trend). Receiver operating characteristic curve analysis of the score's accuracy produced an area under the curve (AUC) of 0.82 (95% CI 0.78 to 0.85) with similar AUCs in subjects with acutely destabilised heart failure (AUC = 0.73, 95% CI 0.67 to 0.79) and those without (AUC = 0.83, 95% CI 0.77 to 0.85, p for the comparison = NS). The score was validated in a separate population of dyspnoeic patients (AUC = 0.73, 95% CI 0.64 to 0.82; p0.001) and was incorporated into a computer program suitable for near-patient calculation.A new risk stratification tool for acutely dyspnoeic patients has been derived and validated.

Objectives The aim of this study was to examine the value of measurement of the interleukin-1 receptor family member ST2 in patients with dyspnea. Background Concentrations of ST2 have been reported to be elevated in patients with heart failure (HF). Methods Five hundred ninety-three dyspneic patients with and without acute destabilized HF presenting to an urban emergency department were evaluated with measurements of ST2 concentrations. Independent predictors of death at 1 year were identified. Results Concentrations of ST2 were higher among those with acute HF compared with those without (0.50 vs. 0.15 ng/ml; p Conclusions Among dyspneic patients with and without acute HF, ST2 concentrations are strongly predictive of mortality at 1 year and might be useful for prognostication when used alone or together with NT-proBNP.

Diagnostic cardiac catheterization may include many different procedural components such as hemodynamic assessment, noncoronary angiography, and coronary angiography. This chapter provides an overview of diagnostic coronary angiography. Diagnostic coronary angiography is the gold standard for evaluating coronary artery disease. This chapter covers the anatomic and angiographic assessment of the coronary arteries, describes the rationale for invasive coronary angiography, identifies the steps necessary for invasively imaging the coronary arteries, and defines the risks associated with coronary angiography.

Background Ventricular septal defect is a lethal complication after an acute myocardial infarction, which has become infrequent with the advent of reperfusion strategies; however, it remains a major contributor to mortality. Methods We identified patients using the International Classification of Diseases, 9th Revision, Clinical Modification procedure codes from the Nationwide Inpatient Sample between the years 2001 and 2013. A multivariate hierarchical logistic regression model was used to identify significant predictors of in-hospital mortality. Results We identified 3,373,206 ST-elevation myocardial infarctions, out of which 10,012 (0.3%) were complicated with ventricular septal defects. Most of the patients (60%) were older than 65 years, male (55%), and white (63%). Inferior (49.7%) and anterior (41.1%) myocardial infarctions were more commonly implicated with the development of ventricular septal defects. The median (interquartile range) hospitalization length was 7 (3.0-13.5) days. Only 7.65% of patients underwent some intervention, with 7% surgical and 0.65% minimally invasive. Mechanical support devices were used in 36.5% of patients, with intra-aortic balloon pump (96%) being the most common. In-hospital mortality remained high at 30.5% (downward trending from 41.6% in 2001 to 23.3% in 2013). Age, cardiogenic shock, and in-hospital cardiac arrest were statistically significant predictors of in-hospital mortality. The utilization of corrective procedures significantly declined. The use of mechanical support devices and performing a corrective procedure were associated with higher mortality, length of stay, and cost. Conclusions Ventricular septal defects after acute myocardial infarctions remain associated with significantly high mortality rates. Highly specialized regional centers with individual expertise in the management of septal ruptures are required to improve outcomes of these patients.

To describe the first single center experience with a novel aspiration thrombectomy device.The appearance of inferior vena cava or right-sided intracardiac thrombus may prompt consideration of percutaneous thrombectomy as a method to prevent new or worsening pulmonary embolism (PE). The AngioVac is a novel thrombectomy device composed of a cannula and extracorporeal circuit with filter for pump-assisted removal of intravascular debris which is coupled with a reinfusion catheter for return of blood to the patient. The device has been approved by the United States Food and Drug Administration since 2009. This report represents the first significant case series describing its use, feasibility and outcomes in evacuating large caval thrombi or intracardiac masses in PE.This is a retrospective analysis of patient and case characteristics and in-hospital clinical outcomes of AngioVac thrombectomy in 14 consecutive patients treated between April 2010 and July 2013 at our institution.Fourteen consecutive patients (mean age 50, 64% female) underwent 15 AngioVac procedures over 40 months. Indications included intracardiac mass (73%), acute PE (33%), and caval thrombus (73%). Four patients (27%) were in shock at the start of the procedure. Peri-procedure mortality was 0% and in-hospital mortality was 13% at a mean follow-up of 23 days. There were no pulmonary hemorrhages, strokes or myocardial infarctions. Though 73% had a post procedural drop in hematocrit, only two bleeding events were related to access site and required a transfusion.AngioVac thrombectomy is feasible in critically ill patients with acute DVT or PE and large caval thrombi or intracardiac masses.