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Vasileios F Panoulas,1 Ioannis Mastoris,2 Klio Konstantinou,1 Maurizio Tespili,3 Alfonso Ielasi3 1National Heart and Lung Institute, Imperial College London, London, UK; 2Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A Wiener Cardiovascular Institute, The Icahn School of Medicine at Mount Sinai, New York NY, USA; 3Cardiology Department, Bolognini Hospital Seriate, Seriate (BG), Italy Abstract: Despite the remarkable benefits obtained following the introduction of the first-generation drug-eluting stent (DES), concerns were raised over its long-term safety, particularly with regard to very late (beyond 1 year) stent thrombosis. Newer-generation DESs have been developed to overcome this limitation using novel stent platforms, new drugs, more biocompatible durable polymers, and bioabsorbable polymers or backbones. To date, new-generation DESs have virtually replaced the use of first-generation DESs worldwide. In this review article, we discuss in detail the design, pharmacology, and mechanism of action of the newer-generation permanent and bioresorbable everolimus-eluting platforms. Furthermore, we present and evaluate the current evidence on the performance and safety of these devices compared to those of other available stent platforms. Keywords: PCI, angioplasty, stent, outcome

Successful remote patient monitoring depends on bidirectional interaction between patients and multidisciplinary clinical teams. Invasive pulmonary artery pressure monitoring has been shown to reduce heart failure (HF) hospitalizations, facilitate guideline-directed medical therapy optimization, and improve quality of life. Cardiac implantable electronic device-based multiparameter monitoring has shown encouraging results in predicting future HF-related events. Potential expanded indications for remote monitoring include guideline-directed medical therapy optimization, application to specific populations, and subclinical detection of HF. Voice analysis, inferior vena cava diameter monitoring, and artificial intelligence-based remote electrocardiogram show potential to gain some merit in remote patient monitoring in HF., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Remote patient monitoring (RPM) in patients with heart failure (HF) involves transmitting physiological data from devices to a health-care provider via a wireless connection with targeted interventions when values exceed the preset threshold. Devices used in telemonitoring range from weighing scales, blood pressure cuffs, and pulse oximeters to devices used to measure cardiac filling pressure and intrathoracic impedance using cardiac implantable electronic devices and wearables. Accordingly, RPM devices can potentially engage patients in their cardiovascular care and reduce the burden of HF in society., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Successful remote patient monitoring depends on bidirectional interaction between patients and multidisciplinary clinical teams. Invasive pulmonary artery pressure monitoring has been shown to reduce heart failure (HF) hospitalizations, facilitate guideline-directed medical therapy optimization, and improve quality of life. Cardiac implantable electronic device-based multiparameter monitoring has shown encouraging results in predicting future HF-related events. Potential expanded indications for remote monitoring include guideline-directed medical therapy optimization, application to specific populations, and subclinical detection of HF. Voice analysis, inferior vena cava diameter monitoring, and artificial intelligence-based remote electrocardiogram show potential to gain some merit in remote patient monitoring in HF., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Iron deficiency is present in approximately 50% of patients with symptomatic heart failure and is independently associated with worse functional capacity, lower quality of, life and increased mortality. The purpose of this document is to summarize current knowledge of how iron deficiency is defined in heart failure and its epidemiology and pathophysiology, as well as pharmacological considerations for repletion strategies. This document also summarizes the rapidly expanding array of clinical trial evidence informing when, how, and in whom to consider iron repletion., Competing Interests: Declaration of Competing Interests None., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Remote patient monitoring (RPM), within the larger context of telehealth expansion, has been established as an effective and safe means of care for patients with heart failure (HF) during the recent pandemic. Of the demographic groups, female patients and black patients are underenrolled relative to disease distribution in clinical trials and are under-referred for RPM, including remote haemodynamic monitoring, cardiac implantable electronic devices (CIEDs), wearables and telehealth interventions. The sex- and race-based disparities are multifactorial: stringent clinical trial inclusion criteria, distrust of the medical establishment, poor access to healthcare, socioeconomic inequities, and lack of diversity in clinical trial leadership. Notwithstanding addressing the above factors, RPM has the unique potential to reduce disparities through a combination of implicit bias mitigation and earlier detection and intervention for HF disease progression in disadvantaged groups. This review describes the uptake of remote haemodynamic monitoring, CIEDs and telehealth in female patients and black patients with HF, and discusses aetiologies that may contribute to inequities and strategies to promote health equity., Competing Interests: Disclosure: EMDF is a section editor and HGCVS is an editorial board member of Cardiac Failure Review; this did not influence peer review. EMDF owns stock in Abbott Laboratories. TM receives research support from Ionis Therapeutics Inc and is an advisor to Recora Health. AAM receives research support from the American Heart Association and the Association of Black Cardiologists, and consulting fees from Abbott, Acorai, BI Lilly, Edwards Lifesciences, Ionis Therapeutics Inc and Merck. HGCVS is funded by the Canadian Institutes of Health Research and the Heart and Stroke Foundation of Canada. AJS receives research funding and consulting fees from Abbott, Biotronik, Boston Scientific, General Prognostics, Impulse Dynamics, Medtronic and Story Health. IM has no conflicts of interest to declare., (Copyright © 2023, Radcliffe Cardiology.)

Background: We sought to describe and compare outcomes among advanced patients with heart failure (not candidates for orthotopic heart transplant/left ventricular assist device) on long-term milrinone or dobutamine, which are not well-studied in the contemporary era., Methods and Results: We included adults with refractory stage D heart failure who were not candidates for orthotopic heart transplant or left ventricular assist device and discharged on palliative dobutamine or milrinone. The primary outcome was 1-year survival. A 6-month predictor of survival analysis was conducted. A total of 248 patients (133 on milrinone, 115 on dobutamine) were included. There were no differences in baseline comorbidities between milrinone and dobutamine cohorts, except for the prevalence of chronic kidney disease, which was higher in the dobutamine group. On discharge, the proportion of patients on beta-blockers and mineralocorticoid antagonists was higher in milrinone group. Overall, the 1-year mortality rate was 70%. The dobutamine cohort had a significantly higher 1-year mortality rate (84% vs 58%, P <0.001). The type of inotrope did not predict survival at 6 months when adjusted for discharge medications and comorbidities. Beta-blockers and angiotensin-converting enzyme/angiotensin receptor blocker/angiotensin receptor neprilysin inhibitor continued at discharge predicted survival at 6 months., Conclusions: The 1-year mortality from palliative inotropes remains high. Compared with dobutamine, use of milrinone was associated with improved survival owing to better optimization of guideline-directed medical therapy, primarily beta-blocker therapy., Competing Interests: Conflicts of Interest No authors have any conflicts of interest related to the manuscript., (Copyright © 2022. Published by Elsevier Inc.)

CardioMEMS, a remote pulmonary artery pressure monitoring system, provides waveform patterns for the ambulatory heart failure patient. These waveforms provide significant insights into patient volume and clinical management. We aim to provide a foundation for understanding the determinants of waveform characteristics and provide practical examples illustrating how to interpret and integrate common scenario waveforms into clinical decision-making. A total of three groups of relevant scenarios were included namely (a) location and activity at time of waveform transmission, (b) impact of contemporary interventions, and (c) arrhythmias. We illustrate that waveform analysis can be individualized to each patient's care strategy in the appropriate clinical context to help guide clinical decision-making., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: There is paucity of data regarding durable left ventricular assist device (LVAD) outcomes in patients with chronic kidney disease (CKD) stages 3-5 and CKD stage 5 on dialysis (end-stage renal disease [ESRD])., Methods and Results: We conducted a retrospective study of Medicare beneficiaries with ESRD and a 5% sample of patients with CKD with an LVAD (2006-2018) to determine 1-year outcomes using the United States Renal Data System database. The LVAD implantation, comorbidities, and outcomes were identified using appropriate International Classification of Diseases, 9th and 10th edition codes. We identified 496 patients with CKD and 95 patients with ESRD who underwent LVAD implantation. The patients with ESRD were younger (59 years vs 66 years; P < .001), had more Blacks (40% vs 24.6%, P = .009), compared with the CKD group. The 1-year mortality (49.5% vs 30.9%, P < .001) and index mortality (27.4% vs 16.7%, P = .014) rates were higher for patients with ESRD. A subgroup analysis showed significantly higher mortality in ESRD vs CKD 3 (49.5% vs 30.2%, adjusted P = .009), but no significant difference in mortality between stage 3 vs 4/5 (30.2% vs 30.8%, adjusted P = .941). There was no significant difference in secondary outcomes (bleeding, stroke, and sepsis/infection) during follow-up between the 2 groups., Conclusions: Patients with ESRD undergoing LVAD implantation had significantly higher index and 1-year mortality rates compared with patients with CKD., Competing Interests: Declaration of Competing Interest None of the authors have any direct conflicts of interest related to this article., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: To study the demographics, clinical presentations, and outcomes of emergency department (ED) visits of patients with heart transplantation (HT) in the United States., Methods: We performed a secondary analysis of the National Emergency Department Sample database from 2016 to 2018. All ED visits of patients with HT aged ≥ 18 years were identified using International Classification of Diseases, Tenth Revision codes., Results: Out of a total 308,182,495 national ED visits, 55,583 were HT-related visits. The median age was 61.07 years (interquartile range [IQR]: 46.91-69.38) and 69.44% were males. The hospital admission rate was 54.3% and median inpatient length of stay was 3.19 days (IQR: 1.63-5.92). The mortality rate during inpatient stay was 1.16%. Median inpatient and ED charges among admitted patients were $37,911 (IQR: $21,487-$71,262). The most common primary diagnosis of HT-related ED visits was sepsis (4.3%) followed by acute kidney injury (3.57%) and chest pain (3%)., Conclusion: More than half of total ED visits among HT patients resulted in hospital admission. The most common cause for ED visit in these patients was sepsis followed by acute kidney injury and chest pain., Competing Interests: The authors report no conflict of interest., (© 2022 The Authors. JACEP Open published by Wiley Periodicals LLC on behalf of American College of Emergency Physicians.)

Cardiac implantable electronic devices, including implantable cardioverter-defibrillators and therapy, are part of guideline-indicated treatment for a subset of patients with heart failure with reduced ejection fraction. Current technological advancements in cardiac implantable electronic devices have allowed the detection of specific physiological parameters that are used to forecast clinical decompensation through algorithmic, multiparameter remote monitoring. Other recent emerging technologies, including cardiac contractility modulation and baroreflex activation therapy, may provide symptomatic or physiological benefits in patients without indications for cardiac resynchronization. Our goal in this state-of-the-art review is to describe the new commercially available technologies, their purported mechanisms of action, and the evidence surrounding their clinical roles, limitations and future directions. Finally, we underline the need for standardized workflow and close interdisciplinary management of this population to ensure the delivery of high-quality care., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Although seen in ∼5% of sarcoidosis patients, cardiac sarcoidosis (CS) accounts for nearly 25% of disease-related deaths. This study aimed to describe characteristics and outcomes among CS patients. Patients diagnosed with CS in 2016-2017 in the US National Inpatient Sample Database were evaluated to study patient characteristics, reasons ascribed to admission, in-hospital outcomes, and complications. A total of 2420 patients (median age 56 years) were included in the analysis. Most admissions occurred due to ventricular tachycardia (12.8%), followed by myocarditis (9.9%) with a mean length of stay of 7 ± 7 days. The overall incidence of in-hospital mortality was 2.5%., Competing Interests: Declaration of competing interest The authors have no conflicts of interest to declare., (Copyright © 2022 Cardiological Society of India. Published by Elsevier, a division of RELX India, Pvt. Ltd. All rights reserved.)

Summary: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) induce osmotic diuresis by inhibiting the proximal renal tubular reabsorption of the filtered glucose load, which in turn can occasionally lead to severe dehydration and hypotension amidst other adverse effects. We present a case of a 49-year-old man with type 2 diabetes mellitus (T2D) on canagliflozin, a SGLT2i. The patient was brought to the emergency room following a motor vehicle accident. He was confused and had an altered mental status. His blood alcohol and urine toxicology screens were negative. Initial investigations revealed that he had severe hyponatremia with euglycemic ketoacidosis. The adverse condition was reversed with close monitoring and timely management, and the patient was eventually discharged. This is the first report to suggest hyponatremia as a potentially serious adverse effect following SGLT2i therapy. Its impact on the renal tubule handling of sodium and water is not yet well characterized. While further studies are warranted to understand better the pathophysiological mechanisms associated with SGLT2i-induced adverse effects, timely dose reduction or perhaps even its temporary discontinuation may be recommended to prevent complications., Learning Points: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are usually well-tolerated, but some serious adverse effects have been documented. Our case report suggests hyponatremia as a potential, rare side effect of SGLT2i and makes physicians aware of the occurrence of such life-threatening but preventable complications. Timely and close monitoring of the patient, with temporary discontinuation of this drug, may be recommended towards effective management. Studies demonstrating a comprehensive understanding of SGLT2i-related electrolyte derangements are warranted.

Background: There has been increasing use of extracorporeal membrane oxygenation (ECMO) as bridge to heart transplant (orthotopic heart transplant [OHT]) or left ventricular assist device (LVAD) over the last decade. We aimed to provide insights on the population, outcomes, and predictors for the selection of each therapy., Methods: Using the Extracorporeal Life Support Organization Registry between 2010 and 2019, we compared in-hospital mortality and length of stay, predictors of OHT versus LVAD, and predictors of in-hospital mortality for patients with cardiogenic shock that were bridged with ECMO to OHT or LVAD. One hundred sixty-seven patients underwent LVAD versus 234 patients who underwent OHT., Results: The overall use of ECMO has increased from 1.7% in 2010 to 22.2% in 2019. Mortality was similar between groups (LVAD: 28.7% versus OHT: 29.1%) while length of stay was longer for OHT (LVAD: 49.6 versus OHT: 59.5 days, P =0.05). Factors associated with OHT included prior transplant (odds ratio [OR]=31.26 [CI, 3.84-780.5]), use of a temporary pacemaker (OR=6.5 [CI, 1.39-50.15]), and increased use of inotropes on ECMO (OR=3.77 [CI, 1.39-11.07]), whereas LVAD use was associated with weight (OR=0.98 [CI, 0.97-0.99]), cardiogenic shock presentation (OR=0.40 [CI, 0.21-0.78]), previous LVAD (OR=0.01 [CI, 0.0001-0.22]), respiratory failure (OR=0.28 [CI, 0.11-0.70]), and milrinone infusion (OR=0.32 [CI, 0.15-0.67]). Older age (OR=1.07 [CI, 1.02-1.12]), cannulation bleeding (OR=26.1 [CI, 4.32-221.3]), and surgical bleeding (OR=6.7 [CI, 1.26-39.9]) in patients receiving LVAD and respiratory failure (OR=5 [CI, 1.17-23.1]) and continuous renal replacement therapy (OR=3.82 [CI, 1.28-11.9]) in patients receiving OHT were associated with increased mortality., Conclusions: ECMO use as a bridge to advanced therapies has increased over time, with more patients undergoing LVAD than OHT. Mortality was equal between the 2 groups while length of stay was longer for OHT.

Background: There is a paucity of data on readmission rates and predictors of readmissions in cardiogenic shock patients after contemporary Extracorporeal Membrane Oxygenation (ECMO) use., Methods: Using the Nationwide Readmission Database, we included adult patients (≥18 years old) hospitalized between January to November 2016-2018 for cardiogenic shock requiring ECMO support. Thirty-day readmission rates, associated variables, and predictors of readmission were assessed., Results: A total of 10,723 patients underwent ECMO for cardiogenic shock. After excluding patients who died ( n  = 5602; 52%) and who underwent LVAD or OHT during index admission ( n  = 892; 8%), 4229 patients discharged alive were included. Of those, 694 (16.4%) were readmitted within 30 days. The median time to readmission was 10 days. Diabetes mellitus (OR = 1.77; 95% CI 1.32-2.37), chronic liver disease (OR = 1.35; 95% CI 1.03-1.77), and prolonged LOS (≥30 days; OR = 1.38; 95% CI 1.05-1.81) were associated with increased risk of 30-day readmissions while heart failure diagnosis (OR = 0.69; 95% CI 0.50-0.95) and short-term hospital post-discharge care (OR = 0.53; 95% CI 0.28-0.99) conferred a lower risk. Sepsis, followed by congestive heart failure, was the most common readmission diagnoses., Conclusions: Patients with CS requiring ECMO support have high mortality and high 30-day readmission rates, with sepsis being the leading cause of readmissions followed by heart failure., Competing Interests: Joseph E. Tonna, MD reports a relationship with LivaNova and Philips Healthcare that includes: speaking and lecture fees and travel reimbursement. Joseph E. Tonna, MD reports a relationship with The National Institutes of Health, The National Heart, Lung, And Blood Institute that includes: funding grants., (© 2021 Published by Elsevier Inc.)

Background The usefulness of right heart catherization (RHC) has long been debated, and thus, we aimed to study the real-world impact of the use of RHC in cardiogenic shock. Methods and Results In the Nationwide Readmissions Database using International Classification of Diseases, Tenth Revision ( ICD-1 0 ), we identified 236 156 patient hospitalizations with cardiogenic shock between 2016 and 2017. We sought to evaluate the impact of RHC during index hospitalization on management strategies, complications, and outcomes as well as on 30-day readmission rate. A total 25 840 patients (9.6%) received RHC on index admission. The RHC group had significantly more comorbidities compared with the non-RHC group. During the index admission, the RHC group had lower death (25.8% versus 39.5%, P <0.001) and stroke rates (3.1% versus 3.4%, P <0.001). Thirty-day readmission rates (18.7% versus 19.7%, P =0.04) and death on readmission (7.9% versus 9.3%, P =0.03) were also lower in the RHC group. After adjustment, RHC was associated with lower index admission mortality (odds ratio, 0.69; 95% CI, 0.66-0.72), lower stroke rate (odds ratio, 0.81; 95% CI, 0.72-0.90), lower 30-day readmission (odds ratio, 0.83; 95% CI, 0.78-0.88), and higher left ventricular assist device implantations/orthotopic heart transplants (odds ratio, 6.05; 95% CI, 4.43-8.28) during rehospitalization. Results were not meaningfully different after excluding patients with cardiac arrest. Conclusions RHC use in cardiogenic shock is associated with improved outcomes and increased use of downstream advanced heart failure therapies. Further blinded randomized studies are required to confirm our findings.

Competing Interests: Disclosure: The authors have no conflicts of interest to report.

Background: Coronavirus disease 2019 (COVID-19) has been reported to cause worse outcomes in patients with underlying cardiovascular disease, especially in patients with acute cardiac injury, which is determined by elevated levels of high-sensitivity troponin. There is a paucity of data on the impact of congestive heart failure (CHF) on outcomes in COVID-19 patients., Methods: We conducted a literature search of PubMed/Medline, EMBASE, and Google Scholar databases from 11/1/2019 till 06/07/2020, and identified all relevant studies reporting cardiovascular comorbidities, cardiac biomarkers, disease severity, and survival. Pooled data from the selected studies was used for metanalysis to identify the impact of risk factors and cardiac biomarker elevation on disease severity and/or mortality., Results: We collected pooled data on 5967 COVID-19 patients from 20 individual studies. We found that both non-survivors and those with severe disease had an increased risk of acute cardiac injury and cardiac arrhythmias, our pooled relative risk (RR) was - 8.52 (95% CI 3.63-19.98) (p < 0.001); and 3.61 (95% CI 2.03-6.43) (p = 0.001), respectively. Mean difference in the levels of Troponin-I, CK-MB, and NT-proBNP was higher in deceased and severely infected patients. The RR of in-hospital mortality was 2.35 (95% CI 1.18-4.70) (p = 0.022) and 1.52 (95% CI 1.12-2.05) (p = 0.008) among patients who had pre-existing CHF and hypertension, respectively., Conclusion: Cardiac involvement in COVID-19 infection appears to significantly adversely impact patient prognosis and survival. Pre-existence of CHF, and high cardiac biomarkers like NT-pro BNP and CK-MB levels in COVID-19 patients correlates with worse outcomes., Competing Interests: Declaration of competing interest The author(s) report no relationships that could be construed as a conflict of interest., (Copyright © 2020 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.)

Background: Left ventricular assist devices (LVAD) have been increasingly used in the treatment of end-stage heart failure. While warfarin has been uniformly recommended in the long-term as anticoagulation strategy, no clear recommendation exists for the post-operative period. We sought to evaluate the feasibility of enoxaparin in the immediate and early postoperative period after LVAD implantation., Methods: This is a two-center, retrospective analysis of 250 consecutive patients undergoing LVAD implantation between January 2017 and December 2018. Patients were bridged postoperatively to therapeutic INR by either receiving unfractionated heparin (UFH) or low molecular weight heparin (LMWH). Patients were followed while inpatient and for 3 months after LVAD implantation. The efficacy outcome was occurrence of first and subsequent cerebrovascular accident while safety outcome was the occurrence of bleeding events. Length of stay (LOS) was also assessed., Results: Two hundred fifty and 246 patients were analyzed for index admission and 3-month follow up respectively. No statistically significant differences were found between the two groups in CVA (OR = 0.67; CI = 0.07-6.39, P = 0.73) or bleeding events (OR = 0.91; CI = 0.27-3.04, P = 0.88) during index admission. Similarly, there were no differences at 3 months in either CVAs or bleeding events (OR = 0.85; 0.31-2.34; p = 0.76). No fatal events occurred during the study follow-up period. Median LOS was significantly lower (4 days; p = 0.03) in the LMWH group., Conclusions: LMWH in the immediate and early postoperative period after LVAD implantation appears to be a concurrently safe and efficacious option allowing earlier postoperative discharge and avoidance of recurrent hospitalizations due to sub-therapeutic INR.

Left ventricular assist devices (LVADs) use in treatment of stage D heart failure (HF) has evolved and expanded in the past decade. There is paucity of data on LVAD utilization in patients with age ≥65 years with multiple co-morbidities. We aimed to investigate utilization trends, outcomes, and rates and predictors of readmissions in patients receiving LVADs with age ≥65 years (AO) and comparing them with patient age <65 years (AY). We analyzed hospitalization data from the Nationwide Inpatient Sample from 2007 to 2015 to evaluate LVAD utilization trends and outcomes between the 2 patient cohorts. We also queried the Nationwide Readmission Database from 2014 to third quarter of 2015 to identify trends and compare etiologies of readmissions. Implants in AO patients increased from 20% (154) of the total LVADs implanted in 2007 to 33.2% (1,215) in 2014 and 31.8% (910) through September 2015 (p < 0.01). Over the study period there was a steady and significant increase in the mean Elixhauser scores in elderly patients who underwent LVAD implantation from 15.4 in 2007 to 24.54 in 2015 (p < 0.01). Despite this finding, the mean LOS in the AO cohort decreased from 56.0 days in 2007 to 33.8 days in 2015 (p < 0.001). Furthermore, the in-hospital mortality associated with LVAD implantation among the AO group gradually decreased over the study time period (39% in 2007 to 12.2% in 2015, p < 0.001). The overall readmission rate was not significantly different between AO versus AY group (28% vs 33%, p = 0.2). The most common cause in both groups was gastrointestinal bleed but it was significantly higher in AO group (24.3% vs 11.3%, p = 0.01). In conclusion, patients age ≥65 years with multiple co-morbidities are receiving increasing number of LVADs with improved survival outcomes. Their 30-day readmissions are comparable to the younger patients., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Elderly patients may have increased platelet reactivity and adverse events after percutaneous coronary intervention. Whether age is an independent predictor of worse outcomes after accounting for platelet reactivity is unknown. We sought to determine the relation between age and platelet reactivity on 2-year outcomes after percutaneous coronary intervention with drug-eluting stents (DES). ADAPT-DES was a prospective observational registry comprising 8,582 DES-treated patients. Patients were categorized with an age cutoff of 75 years. On-clopidogrel platelet reactivity was evaluated with VerifyNow P2Y12 testing. Multivariable Cox proportional hazards regression models were used to describe the relation between increasing age and 2-year clinical outcomes. Patients ≥75 old were more likely to be women and had more cardiovascular risk factors and more extensive coronary artery disease than younger patients. Residual platelet reactivity on-clopidogrel increased slightly with age (adjusted r = 0.05, p <0.0001). Age ≥75 years was associated with greater all-cause mortality (adjusted HR 1.64, 95% CI 1.25 to 2.15, p <0.001), myocardial infarction (adjusted HR 1.33, 95% CI 1.01 to 1.74, p = 0.04) and clinically relevant bleeding (adjusted HR 1.33, 95% CI 1.10 to 1.61 p = 0.003). In contrast, the risk of stent thrombosis was independent of age (adjusted HR 0.83, 95% CI 0.46 to 1.52, and p = 0.55). Considered as a continuous variable, age was directly related to clinically relevant bleeding, cardiac and all-cause mortality, was inversely related to stent thrombosis, and was not related to myocardial infarction. There was no significant interaction between age and on-treatment platelet reactivity for the risk of 2-year clinical outcomes. In conclusion, increasing age had a stronger association with the risk of death and bleeding than of thrombotic events. Despite being associated with older age, higher residual platelet reactivity did not modify the adjusted relative risks of ischemic and bleeding events associated with age., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Data on geographical variations in dual antiplatelet therapy (DAPT) cessation and the impact on outcomes after percutaneous coronary intervention (PCI) are limited. We sought to evaluate geographical patterns of DAPT cessation and associated outcomes in patients undergoing PCI in the United States versus Europe., Methods: Analyzing data from the PARIS registry, we studied 3,660 U.S. patients (72.9%) and 1,358 European patients (27.1%) that underwent PCI with stent implantation. DAPT cessation was classified as physician-recommended discontinuation, interruption (< 14 days), or disruption due to bleeding or noncompliance. The primary endpoint was 2-year major adverse cardiovascular events (MACE) defined as a composite of cardiac death, stent thrombosis, myocardial infarction, or target lesion revascularization., Results: Cardiovascular risk factors were more common in the United States, whereas procedural complexity was greater in Europe. The incidence of 2-year DAPT discontinuation was significantly lower in U.S. versus European patients (30.7% vs. 65.6%; p  < 0.001); however, rates of interruption (13.7% vs. 1.5%, p  < 0.001) and disruption (17.7% vs. 5.1%, p  < 0.001) were higher. DAPT discontinuation was associated with lower adjusted risk, whereas DAPT disruption was associated with greater risk for 2-year MACE, without interaction by region. After adjustment for baseline characteristics and DAPT cessation, 2-year MACE risk was not statistically different between regions (10.3% for Europe vs. 11.9% for U.S., adjusted hazard ratio 0.81, 95% confidence interval 0.65-1.01, p  = 0.065)., Conclusion: DAPT cessation patterns, along with clinical and angiographic risk, vary substantially between PCI patients in the U.S. versus Europe. Despite such differences, cardiovascular risk associated with DAPT cessation remains uniform., Competing Interests: D.C. has received research grant support from Eli Lilly and Astra Zeneca, consulting fees from Eli Lilly, Astra Zeneca, and speaking honoraria from Astra Zeneca. T.H. has received research grant support from Eli Lilly & Company and Daiichi-Sankyo. G.D. has received consulting fees and honoraria from Johnson & Johnson, Sanofi, Covidien, The Medicines Company, Merck, CSL Behring, AstraZeneca, Medtronic, Abbott, Bayer, Boston Scientific, Osprey Medical, and GE Healthcare; and research grant support from Sanofi, Bristol-Myers Squibb, and Eli Lilly & Company/Daiichi-Sankyo. M.G. has received research grant support from Angel Medical Corporation, Atrium Medical Systems, Bayer Corporation, Ikaria, Janssen/Johnson & Johnson Corporation, Lantheus Medical Imaging, Merck & Company, Portola Pharmaceuticals, Roche Diagnostics, Sanofi, Stealth Peptides, St. Jude Medical, Volcano Corporation, and Walk Vascular; consulting fees from AstraZeneca, Baxter Healthcare, Bayer Corporation, CRF, Consensus Medical Communications, CSL Behring, Cytori Therapeutics, Eli Lilly & Company/Daiichi Sankyo, Exeter Group, Genentech, GlaxoSmithKline, Janssen/Johnson & Johnson Corporation, Ortho McNeil, St. Jude Medical, and The Medicines Company; and royalty fees from UpToDate in Cardiovascular Medicine. D.M. has received institutional research grant support from AstraZeneca. M.K. has received consulting fees from Abbott Vascular, Abbott Laboratories, OrbusNeich, Angelmed, Volcano, Biosensors, Svelte, OrbusNeich, Medtronic, and Terumo; and research grant support from Abbott, Terumo, Angelmed, Ikaria, OrbusNeich, Cardiovascular Systems, Inc. (CSI), Eli Lilly & Company, and Medtronic. A.C. has received consulting fees and honoraria from Carbostent and Implantable Devices (CID); and other fees from Direct Flow Medical. A.K. serves on the speaker's bureau of the American College of Cardiology; and has received consulting fees from WebMD. P.G.S. discloses the following relationship: research grant from Bayer, Merck, Sanofi, and Servier, speaking or consulting fees from Amarin, Amgen, AstraZeneca, Bayer/Janssen, Boehringer-Ingelheim, Bristol-Myers-Squibb, Lilly, Merck, Novartis, Novo-Nordisk, Pfizer, Regeneron, Sanofi, and Servier, received personal fees from Amarin, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Lilly, Merck Sharpe & Dohme, Novartis, Pfizer, Roche, Medtronic, Servier, Janssen, CSL Behring, and Regeneron; grants and personal fees from Sanofi; and personal fees and nonfinancial support from The Medicines Company, outside the submitted work. R.M. has received institutional research grant support from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers-Squibb, CSL Behring, Eli Lilly/Daiichi-Sankyo, Medtronic, Novartis Pharmaceuticals, and OrbusNeich; has served as a consultant for Abbott Vascular, American College of Cardiology, AstraZeneca, Boston Scientific, CardioKinetix, CSL Behring, Medscape, Shanghai Bracco Sine Pharmaceutical, and Spectranetics; has served on the advisory board for Bristol Myers-Squibb; has received institutional advisory board funding from Bristol-Myers Squibb; has received institutional funding from Claret Medical; owns equity in Claret Medical and Elixir Medical; has served on the executive committee for Janssen Pharmaceuticals and Osprey Medical; has served on the data safety monitoring board for Watermark Research Partners; and has a spouse who has served as a consultant for Abiomed and The Medicines Company., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: Patients with history of cryptogenic stroke are more likely to have a patent foramen ovale (PFO) and should be managed with antithrombotic agents, while the alternative option is percutaneous closure of PFOs. Our aim was to perform a meta-analysis of randomized controlled trials (RCTs) comparing percutaneous closure vs. medical treatment for patients with PFO and prior cryptogenic stroke., Methods: Medline, Scopus and Cochrane databases were reviewed. A random-effect model meta-analysis was used and I-square was utilized to assess the heterogeneity. New ischemic stroke was defined as the primary endpoint. A sensitivity analysis was performed for Amplatzer device. Subgroup analyses were performed for different patient and PFO characteristics for the composite endpoints as defined by the included RCTs., Results: In total of 3440 patients were included in this meta-analysis. Closure devices were superior to medical therapy for prevention of recurrent ischemic strokes (HR = 0.29; CI: 0.02-0.56), but were associated with increased risk of new onset of atrial fibrillation (AF) and atrial flutter (RR = 4.67; CI: 2.22-9.81). However, in the sensitivity analysis for Amplatzer device, there was no difference between the two groups in new onset of atrial arrhythmias. Closure devices were superior across all different subgroups when compared to medical treatment with the exception of patients with a small shunt., Conclusion: This meta-analysis shows that closure devices for patients with PFO and history of cryptogenic stroke can significantly decrease the risk of a new ischemic stroke. The use of Amplatzer device was not associated with increased risk of newly diagnosed atrial arrhythmias., (Copyright © 2018. Published by Elsevier Inc.)

Aims: Patients with human immunodeficiency virus (HIV) infection have an increased risk of acute myocardial infarction (MI), and 6.5-15% of mortality in this population is attributable to cardiovascular disease. However, the angiographic pattern of coronary artery disease (CAD) in patients with HIV undergoing percutaneous coronary intervention (PCI) remains unknown. We sought to assess and describe the angiographic features and burden of CAD in patients with HIV as compared to those without HIV infection., Methods and Results: This is a retrospective, single-centre study comparing 93 patients with HIV infection who underwent PCI between 2003 and 2011 with 93 control patients without HIV infection matched for age (±3 years), gender, diabetes, and year of PCI (±2 years). Quantitative coronary angiography (QCA) was performed for all treated lesions at baseline and following PCI in both groups. One-year clinical outcomes post PCI were also analysed and compared. The mean age for both study populations was 57 years; patients with HIV were more likely to present with ST-segment elevation myocardial infarction (STEMI). Patients had a similar extent of CAD as measured by the presence of multivessel disease as well as SYNTAX score; however, patients with HIV were more likely to have lesions in the proximal segment of the respective coronary artery. While both groups mostly displayed none/mild calcified lesions, HIV+ patients had longer and fewer stenotic lesions. Clinical outcomes at one year were similar., Conclusions: While HIV+ patients were more likely to present with STEMI, detailed coronary angiographic analysis revealed less complex lesions and favourable anatomy. This paradox may suggest alterations in genesis and progression of atherosclerosis in this clinical setting.

Objectives: The aim of this study was to investigate the clinical correlates and prognostic impact of coronary artery calcification (CAC) in women undergoing percutaneous coronary intervention with drug-eluting stents (DES)., Background: The clinical correlates and the prognostic significance of CAC in women undergoing percutaneous coronary intervention with DES remain unclear., Methods: Patient-level data from female participants in 26 randomized trials of DES were pooled. Study population was categorized according to the presence of moderate or severe versus mild or no target lesion CAC, assessed through coronary angiography. Co-primary endpoints of interest were the composite of death, myocardial infarction (MI), or target lesion revascularization and death, MI, or stent thrombosis at 3-year follow-up., Results: Among 11,557 women included in the pooled dataset, CAC status was available in 6,371 women. Of these, 1,622 (25.5%) had moderate or severe CAC. In fully adjusted models, independent correlates of CAC were age, hypertension, hypercholesterolemia, smoking, previous coronary artery bypass graft surgery, and worse left ventricular and renal function. At 3 years, women with CAC were at higher risk for death, MI, or target lesion revascularization (18.2% vs. 13.1%; adjusted hazard ratio: 1.56; 95% confidence interval: 1.33 to 1.84; p < 0.0001) and death, MI, or stent thrombosis (12.7% vs. 8.6%; adjusted hazard ratio: 1.48; 95% confidence interval: 1.21 to 1.80; p = 0.0001). The adverse effect of CAC on ischemic outcomes appeared to be consistent across clinical and angiographic subsets of women, including new-generation DES., Conclusions: Women undergoing PCI of calcified lesions tend to have worse clinical profile and remain at increased ischemic risk, irrespective of new-generation DES., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to compare the incidence and impact of cessation of dual-antiplatelet therapy (DAPT) in women and men treated with percutaneous coronary intervention., Background: Nonadherence to cardiovascular medications and female sex are associated with worse outcomes. However, the patterns and impact of DAPT cessation in women compared with men following percutaneous coronary intervention have not been studied., Methods: Baseline characteristics, patterns of DAPT cessation, and 2-year clinical outcomes were compared in 5,031 patients (1,279 women, 3,739 men) enrolled following successful percutaneous coronary intervention with stents in the PARIS (Patterns of Non-Adherence to Antiplatelet Regimens in Stented Patients) study. DAPT cessation was adjudicated as physician-guided discontinuation, interruption for surgery, or disruption due to bleeding or noncompliance. Clinical endpoints were major adverse cardiac events (a composite of cardiac death, definite or probable stent thrombosis, spontaneous myocardial infarction, or clinically indicated target lesion revascularization), a second restricted definition of major adverse cardiac events excluding target lesion revascularization, and bleeding., Results: DAPT cessation was more common in women than men (59.1% vs. 55.9%, p = 0.007) and comprised increased rates of discontinuation, disruption for bleeding, and disruption due to noncompliance. The impact of DAPT cessation was similar regardless of sex and varied according the mode; in particular, disruption was associated with increased risk for both ischemic and bleeding events. After adjusting for differences in baseline and treatment characteristics as well as DAPT cessation events, female sex remained an independent predictor of bleeding but not of ischemic events., Conclusions: DAPT cessation was more common in women, but its impact was similar in women and men. Female sex was an independent predictor of bleeding but not of ischemic events after adjustment for differences in DAPT cessation and baseline and treatment characteristics., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Purpose: Multiple regimens of antiplatelet and anticoagulation therapy have been used in the past in patients undergoing percutaneous coronary intervention (PCI). Later trials of PCI stenting demonstrated the efficacy of dual-antiplatelet therapy (DAPT) in reducing stent- and non-stent-related thrombotic events in this specific population. Nonetheless, the required duration of DAPT has not yet been elucidated. In this article we sought to identify various randomized clinical trials (RCTs), pooled analyses, meta-analyses, and data pertaining to the optimal duration of DAPT and attempt some recommendations based on patients' clinical and procedural profiles., Methods: We performed an extensive search using MEDLINE, Scopus, Cochrane Library, and Internet sources for abstracts, manuscripts, and conference reports without any language or date restrictions. In our review we included all available evidence from RCTs, meta-analyses, observational studies, and abstracts pertaining to our topic. Search results that were deemed irrelevant or that would not serve the goal or topic of our review were excluded., Results: Our search yielded 10 RCTs directly comparing different durations of DAPT, 3 meta-analyses amassing the evidence resulting from randomized data, and numerous observational studies that served the aim of our review. The observational studies included in the manuscript are directly related to instances in which RCTs could not be performed or introduce important concepts related to the duration of DAPT., Implications: There is no conclusive evidence that determines the mandatory DAPT duration after PCI. In addition, there are distinct patient populations that need specific treatment regimens, such as diabetic patients or those on long-term oral anticoagulation. Therefore, clinical judgement and meticulous examination of all pertaining risk factors are required for each individual. These factors include those related to a patient's characteristics, treatment procedures, lesion complexity, and stent type. Currently ongoing studies are anticipated to further elucidate and integrate our understanding with regard to DAPT., (Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.)

Background: Long-term clinical outcomes after exposure to non-ionic iso-osmolar contrast medium (IOCM) or ionic low-osmolar CM (LOCM) in patients with chronic kidney disease (CKD) undergoing coronary angiography are unclear., Methods: The ICON trial was a prospective, double-blinded, multicentre study that randomly assigned 146 patients with CKD undergoing coronary angiography with or without percutaneous coronary intervention to the non-ionic IOCM Iodixanol or the ionic LOCM Ioxaglate. We report the 1-year clinical outcomes., Results: After randomization, baseline and procedural characteristics were well-matched between the two groups. At 1 year, three deaths (4.1%) occurred in the ioxaglate and nine deaths in the iodixanol group (13.6%, P = 0.07). The cardiac death rate at 1 year was 2.7% in the ioxaglate group and 9.1% in the iodixanol group (P = 0.07). There were no significant differences in the rates of myocardial infarction (1.4% vs. 1.5%; P = 1.00) and repeated revascularization (6.8% vs. 9.1%; P = 0.75)., Conclusions: The use of ionic LOCM ioxaglate was associated with a numerically lower mortality at 1 year as compared to iodixanol in patients who underwent cardiac catheterization. Future studies evaluating long-term safety following exposure to different types of CM are warranted., (© 2015 Wiley Periodicals, Inc.)

Background: Randomized clinical trials evaluating the role of thrombus aspiration (TA) in patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) have yielded contrasting results. Therefore, the efficacy and safety of TA in STEMI is unclear., Objective: We sought to evaluate the efficacy and safety of TA during PPCI for STEMI compared with conventional PPCI alone., Methods: We included study-level data from 25 randomized, controlled trials, involving 21,733 patients with STEMI and PPCI. The primary efficacy endpoint was major adverse cardiac events (MACE) according to study definitions; the primary safety endpoint was stroke., Results: The mean weighted follow-up time across studies was 8.2 months. Compared with conventional PPCI, TA was associated with significant lower risk for MACE [relative risk (RR): 0.91; 95% confidence interval (CI): 0.83-1.00; P = 0.042). However, this benefit in MACE was counterbalanced by a significant increase in the risk for stroke (RR: 1.58; 95% CI: 1.11-2.25; P = 0.011). There were no differences in the risk of myocardial infarction (RR: 0.94; 95% CI: 0.78-1.12; P = 0.486), target vessel revascularization (RR: 0.93; 95% CI: 0.82-1.04; P = 0.2), and definite or probable stent thrombosis (RR: 0.84; 95% CI: 0.66-1.07; P = 0.148). TA was associated with an ostensible lower risk for all-cause mortality, which did not reach statistical significance (RR: 0.88; 95% CI: 0.78-1.00; P = 0.059)., Conclusions: Compared with conventional PPCI for STEMI, adjunctive TA reduces the risk of subsequent MACE. However, the benefit in MACE is counterbalanced by an increased risk in stroke. Considering the above potential risks and benefits, TA should be considered in selected patients lesions rather than routinely., (© 2015 Wiley Periodicals, Inc.)

Objectives: This study sought to evaluate: 1) the effect of impaired renal function on long-term clinical outcomes in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES); and 2) the safety and efficacy of new-generation compared with early-generation DES in women with chronic kidney disease (CKD)., Background: The prevalence and effect of CKD in women undergoing PCI with DES is unclear., Methods: We pooled patient-level data for women enrolled in 26 randomized trials. The study population was categorized by creatinine clearance (CrCl) <45 ml/min, 45 to 59 ml/min, and ≥60 ml/min. The primary endpoint was the 3-year rate of major adverse cardiovascular events (MACE). Participants for whom baseline creatinine was missing were excluded from the analysis., Results: Of 4,217 women included in the pooled cohort treated with DES and for whom serum creatinine was available, 603 (14%) had a CrCl <45 ml/min, 811 (19%) had a CrCl 45 to 59 ml/min, and 2,803 (66%) had a CrCl ≥60 ml/min. A significant stepwise gradient in risk for MACE was observed with worsening renal function (26.6% vs. 15.8% vs. 12.9%; p < 0.01). Following multivariable adjustment, CrCl <45 ml/min was independently associated with a higher risk of MACE (adjusted hazard ratio: 1.56; 95% confidence interval: 1.23 to 1.98) and all-cause mortality (adjusted hazard ratio: 2.67; 95% confidence interval: 1.85 to 3.85). Compared with older-generation DES, the use of newer-generation DES was associated with a reduction in the risk of cardiac death, myocardial infarction, or stent thrombosis in women with CKD. The effect of new-generation DES on outcomes was uniform, between women with or without CKD, without evidence of interaction., Conclusions: Among women undergoing PCI with DES, CKD is a common comorbidity associated with a strong and independent risk for MACE that is durable over 3 years. The benefits of newer-generation DES are uniform in women with or without CKD., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

While the main gist of research pertaining to TAVR procedure involves improvement of existing valve technologies, lower size delivery systems and post-procedure antithrombotic therapy, the optimal intra-procedure anticoagulation has not been sufficiently defined. Peri-procedural complications such as cerebrovascular events and bleeding are largely associated with the safety and efficacy of anticoagulation regimen. Current guidelines advocate the use of heparin for anticoagulation with a target activated clotting time ≥300 seconds and careful protamine infusion in patients with high estimated bleeding risk. In this setting bivalirudin, devoid of all undesirable properties of unfractionated heparin such as highly variable elimination time and heparin-induced thrombocytopenia, may represent an alternative option in the interventionist's armamentarium. Initial experience with bivalirudin has been encouraging as shown in two observational studies in the context of TAVR and balloon aortic valvuloplasty. The need for bleeding events reduction is particularly pronounced in this population that exhibits an inherent high bleeding risk due to platelet and von Willebrand factor dysfunction. Nevertheless, data from randomized studies are needed to establish bivalirudin role during TAVR procedure.