Cost-Effectiveness of a Shock Team Approach in Refractory Cardiogenic Shock.

BACKGROUND: Multidisciplinary Shock Teams have improved clinical outcomes for cardiogenic shock, but their implementation costs have not been studied. This study's objective was to compare costs between patients treated with and without a Shock Team and determine if the team's implementation is cost-effective compared with standard of care. METHODS: We examined patients with refractory cardiogenic shock treated with or without a Shock Team at a tertiary academic hospital from 2009 to 2018. Real-world hospital data were used to compare costs and outcomes, including survival at discharge, 1-year survival, and quality-adjusted life years gained at 1 year. Incremental cost-effectiveness ratios were calculated over a 1-year time horizon, with parameter uncertainty evaluated through probabilistic sensitivity analysis using 1000 second-order Monte Carlo simulations. RESULTS: The study involved 244 patients, with 123 treated by the Shock Team and 121 receiving standard of care. Patients were predominantly male (77.5%), with a mean age of 58 (18-92) years. The Shock Team approach improved survival rates at hospital discharge and 1-year follow-up (61.0% versus 47.9%; P=0.04 and 55.0% versus 40.5%; P=0.03, respectively). The incremental cost-effectiveness ratio for increases in survival probability at discharge for the multidisciplinary Shock Team compared with standard of care was $102 088. The incremental cost-effectiveness ratio for increases in survival probability at 1-year was estimated at $96 152 and at $127 862 per 1 quality-adjusted life year gained. Probabilistic sensitivity analysis estimates showed that the Shock Team was cost-effective in the majority of simulations using a willingness-to-pay threshold of $150 000, while it was also dominant in almost one-third of the simulations. CONCLUSIONS: The Shock Team approach for treating refractory cardiogenic shock may be a cost-effective alternative to traditional standard of care. These findings can help prioritize the implementation of Shock Team initiatives to further improve cardiogenic shock outcomes.

Integration of Patient Reported Quality-of-life Data into Risk Assessment in Heart Failure.

BACKGROUND: Optimal management of outpatients with heart failure (HF) requires serially updating the estimates of their risk for adverse clinical outcomes to guide treatment. Patient-reported outcomes (PROs) are becoming increasingly used in clinical care. The purpose of this study was to determine whether the inclusion of PROs can improve the risk prediction for HF hospitalization and death in ambulatory patients with HF. METHODS AND RESULTS: We included consecutive patients with HF with reduced ejection fraction (HFrEF) and HF with preserved EF (HFpEF) seen in a HF clinic between 2015 and 2019 who completed PROs as part of routine care. Cox regression with a least absolute shrinkage and selection operator regularization and gradient boosting machine analyses were used to estimate risk for a combined outcome of HF hospitalization, heart transplant, left ventricular assist device implantation, or death. The performance of the prediction models was evaluated with the time-dependent concordance index (Cτ). Among 1165 patients with HFrEF (mean age 59.1 ± 16.1, 68% male), the median follow-up was 487 days. Among 456 patients with HFpEF (mean age 64.2 ± 16.0 years, 55% male) the median follow-up was 494 days. Gradient boosting regression that included PROs had the best prediction performance - Cτ 0.73 for patients with HFrEF and 0.74 in patients with HFpEF, and showed very good stratification of risk by time to event analysis by quintile of risk. The Kansas City Cardiomyopathy Questionnaire overall summary score, visual analogue scale and Patient Reported Outcomes Measurement Information System dimensions of satisfaction with social roles and physical function had high variable importance measure in the models. CONCLUSIONS: PROs improve risk prediction in both HFrEF and HFpEF, independent of traditional clinical factors. Routine assessment of PROs and leveraging the comprehensive data in the electronic health record in routine clinical care could help more accurately assess risk and support the intensification of treatment in patients with HF.

Learnings from the 2024 Utah Cardiac Recovery Symposium: A Roadmap for the Field of Myocardial Recovery.

The 12th annual Utah Cardiac Recovery Symposium (U-CARS) in 2024 continued its mission to advance cardiac recovery by uniting experts across various fields. The symposium featured key presentations on cutting-edge topics such as CRISPR gene editing for heart failure, guideline-directed medical therapy for heart failure (HF) with improved/recovered ejection fraction (HFimpEF), the role of extracorporeal cardiopulmonary resuscitation (ECPR) in treating cardiac arrest, and others. Discussions explored genetic and metabolic contributions to HF, emphasized the importance of maintaining pharmacotherapy in HFimpEF to prevent relapse, and identified future research directions including refining ECPR protocols, optimizing patient selection, and leveraging genetic insights to enhance therapeutic strategies.

Clinical Characteristics and Outcomes of Patients Suffering Acute Decompensated Heart Failure Complicated by Cardiogenic Shock.

BACKGROUND: Cardiogenic shock (CS) can stem from multiple causes and portends poor prognosis. Prior studies have focused on acute myocardial infarction-CS; however, acute decompensated heart failure (ADHF)-CS accounts for most cases. We studied patients suffering ADHF-CS to identify clinical factors, early in their trajectory, associated with a higher probability of successful outcomes. METHODS: Consecutive patients with CS were evaluated (N=1162). We studied patients who developed ADHF-CS at our hospital (N=562). Primary end point was native heart survival (NHS), defined as survival to discharge without receiving advanced HF therapies. Secondary end points were adverse events, survival, major cardiac interventions, and hospital readmissions within 1 year following index hospitalization discharge. Association of clinical data with NHS was analyzed using logistic regression. RESULTS: Overall, 357 (63.5%) patients achieved NHS, 165 (29.2%) died, and 41 (7.3%) were discharged post advanced HF therapies. Of 398 discharged patients (70.8%), 303 (53.9%) were alive at 1 year. Patients with NHS less commonly suffered cardiac arrest, underwent intubation or pulmonary artery catheter placement, or received temporary mechanical circulatory support, had better hemodynamic and echocardiographic profiles, and had a lower vasoactive-inotropic score at shock onset. Bleeding, hemorrhagic stroke, hemolysis in patients with mechanical circulatory support, and acute kidney injury requiring renal replacement therapy were less common compared with patients who died or received advanced HF therapies. After multivariable adjustments, clinical variables associated with NHS likelihood included younger age, history of systemic hypertension, absence of cardiac arrest or acute kidney injury requiring renal replacement therapy, lower pulmonary capillary wedge pressure and vasoactive-inotropic score, and higher tricuspid annular plane systolic excursion at shock onset (all P<0.05). CONCLUSIONS: By studying contemporary patients with ADHF-CS, we identified clinical factors that can inform clinical management and provide future research targets. Right ventricular function, renal function, pulmonary artery catheter placement, and type and timing of temporary mechanical circulatory support warrant further investigation to improve outcomes of this devastating condition.

Wild-Type Transthyretin Amyloidosis: A Prevalent and Underdiagnosed Cause of Heart Failure With Preserved Ejection Fraction.

Cardiac amyloidosis is an infiltrative disease characterized by the extracellular deposition of misfolded protein in the myocardium, leading to increased stiffness and an eventual restrictive cardiomyopathy. The slow onset of symptoms and overlap with other cardiomyopathies make prompt diagnosis a challenge. Clinicians should be alerted and include amyloidosis in their differential diagnosis, particularly in patients with heart failure with preserved ejection fraction, unexplained left ventricle hypertrophy, particularly in those shown intolerance to previous antihypertensive medication, and early orthopedic manifestations of the disease such as carpal tunnel syndrome and spinal stenosis. The workup requires the exclusion of monoclonal gammopathies and technetium-99m pyrophosphate nuclear scintigraphy (99mTc-PYP) studies with single-photon emission computerized tomography (SPECT) imaging. Several therapies are now available and can prolong life with significantly improved quality of life, particularly when the diagnosis of amyloidosis is made early. We present the case of a 77-year-old with a delayed diagnosis by five years to highlight the need for heightened clinical suspicion and an appropriate diagnostic algorithm for cardiac amyloidosis.

Impact of Diabetes and Glycemia on Cardiac Improvement and Adverse Events Following Mechanical Circulatory Support.

BACKGROUND: Type 2 diabetes is prevalent in cardiovascular disease and contributes to excess morbidity and mortality. We sought to investigate the effect of glycemia on functional cardiac improvement, morbidity, and mortality in durable left ventricular assist device (LVAD) recipients. METHODS AND RESULTS: Consecutive patients with an LVAD were prospectively evaluated (n=531). After excluding patients missing pre-LVAD glycated hemoglobin (HbA1c) measurements or having inadequate post-LVAD follow-up, 375 patients were studied. To assess functional cardiac improvement, we used absolute left ventricular ejection fraction change (ΔLVEF: LVEF post-LVAD-LVEF pre-LVAD). We quantified the association of pre-LVAD HbA1c with ΔLVEF as the primary outcome, and all-cause mortality and LVAD-related adverse event rates (ischemic stroke/transient ischemic attack, intracerebral hemorrhage, gastrointestinal bleeding, LVAD-related infection, device thrombosis) as secondary outcomes. Last, we assessed HbA1c differences pre- and post-LVAD. Patients with type 2 diabetes were older, more likely men suffering ischemic cardiomyopathy, and had longer heart failure duration. Pre-LVAD HbA1c was inversely associated with ΔLVEF in patients with nonischemic cardiomyopathy but not in those with ischemic cardiomyopathy, after adjusting for age, sex, heart failure duration, and left ventricular end-diastolic diameter. Pre-LVAD HbA1c was not associated with all-cause mortality, but higher pre-LVAD HbA1c was shown to increase the risk of intracerebral hemorrhage, LVAD-related infection, and device thrombosis by 3 years on LVAD support (P<0.05 for all). HbA1c decreased from 6.68±1.52% pre-LVAD to 6.11±1.33% post-LVAD (P<0.001). CONCLUSIONS: Type 2 diabetes and pre-LVAD glycemia modify the potential for functional cardiac improvement and the risk for adverse events on LVAD support. The degree and duration of pre-LVAD glycemic control optimization to favorably affect these outcomes warrants further investigation.

A More Targeted and Selective Use of Implantable Loop Recorders Improves the Effectiveness of Syncope Units: A Single-Center Experience.

PURPOSE: Syncope remains a common medical problem. Recently, the role of dedicated syncope units and implantable loop recorders has emerged in the investigation of unexplained syncope. This study aims to investigate the possibilities for a more rational and targeted use of various diagnostic tools. METHODS: In this retrospective single-center study, 196 patients with unexplained syncope were included between March 2019 and February 2023. Various diagnostic tools were utilized during the investigation, according to clinical judgement. Patients were retrospectively allocated into Group A (including those who, among other tests, underwent loop recorder insertion) and Group B (including patients investigated without loop recorder implantation). Data were compared with Group C, including patients assessed prior to syncope unit establishment. RESULTS: There was no difference between Group A (n = 133) and Group B (n = 63) in the diagnostic yield (74% vs. 76%, p = 0.22). There were significant differences between Groups A and B regarding age (67.3 ± 16.9 years vs. 48.3 ± 19.1 years, p < 0.001) and cause of syncope (cardiogenic in 69% of Group A, reflex syncope in 77% of Group B, p < 0.001). Electrocardiography-based diagnosis occurred in 55% and 19% of Groups A and B, respectively (p < 0.001). The time to diagnosis was 4.2 ± 2.7 months in Group A and 7.5 ± 5.6 months in Group B (p < 0.001). In Group C, the diagnostic yield was 57.9% and the electrocardiography-based diagnostic yield was 18.3%. CONCLUSIONS: A selective use of loop recorders according to clinical and electrocardiographic characteristics increases the effectiveness of the structured syncope unit approach and further preserves financial resources.

Functional Mitral Valve Regurgitation: Mitral Valve Repair or Replacement? Our "Road Map" for the Appropriate Strategy.

Objectives: The optimal surgical approach for the treatment of functional mitral regurgitation (FMR) remains controversial. Current guidelines suggest that the surgical approach has to be tailored to the individual patient. The aim of the present study was to clarify further aspects of this tailored treatment. Methods: From 01/2006 to 12/2015, 390 patients underwent mitral valve (MV) surgery for FMR (ischemic n = 241, non-ischemic n = 149) at our institution. A regression analysis was used to determine the effect of MV repair or replacement on survival. The patients were analyzed according to the etiology of the MR (ischemic or non-ischemic), different age groups (<65 years, 65-75 years, and >75 years), LV function, and LV dimensions, as well as the underlying heart rhythm. Results: The overall survival rates for the repair group at 1, 5, and 8 years were 86.1 ± 1.9%, 70.6 ± 2.6%, and 55.1 ± 3.1%, respectively. For the same intervals, the survival rates in patients who underwent MV replacement were 75.9 ± 4.5%, 58.6 ± 5.4%, and 40.9 ± 6.4%, respectively (p = 0.003). Patients younger than 65 years, with an ischemic etiology of FMR, poor ejection fraction (<30%), severe dilatation of left ventricle (LVEDD > 60mm), and presence of atrial fibrillation had significantly higher mortality rates after MV replacement (HR, 3.0; CI, 1.3-6.9; p = 0.007). Patients between 65 and 75 years of age had a higher risk of death when undergoing mitral valve replacement (HR, 1.7; CI, 1.0-2.8; p = 0.04). In patients older than 75 years, the surgical approach (MV repair or replacement) had no effect on postoperative survival (HR, 0.8; CI, 0.4-1.3; p = 0.003). Conclusions: Our data demonstrate that, in patients younger than 65 years, the treatment of choice for FMR should be MV repair. This advantage was even more evident in patients with an ischemic origin of MR, a poor ejection fraction, a severe LV dilatation, and atrial fibrillation.

Impact of Patient-Prosthesis Mismatch on Long-term Outcomes After Aortic Valve Replacement.

BACKGROUND: Patient-prosthesis mismatch (PPM) after aortic valve replacement potentially affects the outcome after the operation. This study sought to determine whether PPM has an impact on long-term mortality and reoperation rates. METHODS: We included 645 patients who underwent biologic aortic valve replacement between 2000 and 2007. Based on echocardiographic examinations at postoperative month 6, the incidence of PPM was determined according to an indexed effective orifice area <0.85 cm2/m2. Survival and reoperation status were analyzed during 15 years of follow-up. RESULTS: PPM was present in 256 patients (40%), of whom 175 had moderate PPM and 81 had severe PPM. In multivariable adjusted analysis, survival was not statistically significantly impaired in patients with moderate PPM compared with patients with no PPM, whereas patients with severe PPM showed a marginally significant impairment of survival (hazard ratio [HR], 1.40; 95% CI, 0.99-1.97; P = .054). Risk factors for survival were higher age (HR, 1.12; 95% CI, 1.10-1.14; P < .001), arterial hypertension (HR, 1.78; 95% CI, 1.38-2.31; P < .001), and diabetes mellitus (HR, 1.67; 95% CI, 1.31-2.14; P < .001). In patients with no, moderate, and severe PPM, there were 10.1, 8.5, and 14.8 events of reoperation/1000 patient-years, respectively. The corresponding 10-year cumulative incidence of reoperation was 8.3%, 6.7%, and 12.1%, respectively. In multivariable adjusted analysis, PPM category was not significantly associated with the risk of reoperation (P > .2). CONCLUSIONS: In our study with directly measured effective orifice area, PPM was only marginally related to long-term survival and was not statistically significantly associated with the risk of reintervention.

Bridge-to-transplant temporary mechanical circulatory support and risk of allosensitization.

INTRODUCTION: Since the 2018 change in the US adult heart allocation policy, more patients are bridged-to-transplant on temporary mechanical circulatory support (tMCS). Previous studies indicate that durable left ventricular assist devices (LVAD) may lead to allosensitization. The goal of this study was to assess whether tMCS implantation is associated with changes in sensitization. METHODS: We included patients evaluated for heart transplants between 2015 and 2022 who had alloantibody measured before and after MCS implantation. Allosensitization was defined as development of new alloantibodies after tMCS implant. RESULTS: A total of 41 patients received tMCS before transplant. Nine (22.0%) patients developed alloantibodies following tMCS implantation: 3 (12.0%) in the intra-aortic balloon pump group (n = 25), 2 (28.6%) in the microaxial percutaneous LVAD group (n = 7), and 4 (44.4%) in the veno-arterial extra-corporeal membrane oxygenation group (n = 9)-p = .039. Sensitized patients were younger (44.7 ± 11.6 years vs. 54.3 ± 12.5 years, p = .044), were more likely to be sensitized at baseline - 3 of 9 (33.3%) compared to 2 out of 32 (6.3%) (p = .028) and received more transfusions with red blood cells (6 (66.6%) vs. 8 (25%), p = .02) and platelets (6 (66.6%) vs. 5 (15.6%), p = .002). There was no significant difference in tMCS median duration of support (4 [3,15] days vs. 8.5 [5,14.5] days, p = .57). Importantly, out of the 11 patients who received a durable LVAD after tMCS, 5 (45.5%) became sensitized, compared to 4 out of 30 patients (13.3%) who only had tMCS-p = .028. CONCLUSIONS: Our findings suggest that patients bridged-to-transplant with tMCS, without significant blood product transfusions and a subsequent durable LVAD implant, have a low risk of allosensitization. Further studies are needed to confirm our findings and determine whether risk of sensitization varies by type of tMCS and duration of support.

Hospital Readmissions in Patients Supported with Durable Centrifugal-Flow Left Ventricular Assist Devices.

Background: Centrifugal-flow left ventricular assist devices (CF-LVADs) have improved morbidity and mortality for their recipients. Hospital readmissions remain common, negatively impacting quality of life and survival. We sought to identify risk factors associated with hospital readmissions among patients with CF-LVADs. Methods: Consecutive patients receiving a CF-LVAD between February 2011 and March 2021 were retrospectively evaluated using prospectively maintained institutional databases. Hospital readmissions within three years post-LVAD implantation were dichotomized into heart failure (HF)/LVAD-related or non-HF/LVAD-related readmissions. Multivariable Cox regression models augmented using a machine learning algorithm, the least absolute shrinkage and selection operator (LASSO) method, for variable selection were used to estimate associations between HF/LVAD-related readmissions and pre-, intra- and post-operative clinical variables. Results: A total of 204 CF-LVAD recipients were included, of which 138 (67.7%) had at least one HF/LVAD-related readmission. HF/LVAD-related readmissions accounted for 74.4% (436/586) of total readmissions. The main reasons for HF/LVAD-related readmissions were major bleeding, major infection, HF exacerbation, and neurological dysfunction. Using pre-LVAD variables, HF/LVAD-related readmissions were associated with substance use, previous cardiac surgery, HF duration, pre-LVAD inotrope dependence, percutaneous LVAD/VA-ECMO support, LVAD type, and the left ventricular ejection fraction in multivariable analysis (Harrell's concordance c-statistic; 0.629). After adding intra- and post-operative variables in the multivariable model, LVAD implant hospitalization length of stay was an additional predictor of readmission. Conclusions: Using machine learning-based techniques, we generated models identifying pre-, intra-, and post-operative variables associated with a higher likelihood of rehospitalizations among patients on CF-LVAD support. These models could provide guidance in identifying patients with increased readmission risk for whom clinical strategies to mitigate this risk may further improve LVAD recipient outcomes.

Artificial intelligence predictive analytics in heart failure: results of the pilot phase of a pragmatic randomized clinical trial.

OBJECTIVES: We conducted an implementation planning process during the pilot phase of a pragmatic trial, which tests an intervention guided by artificial intelligence (AI) analytics sourced from noninvasive monitoring data in heart failure patients (LINK-HF2). MATERIALS AND METHODS: A mixed-method analysis was conducted at 2 pilot sites. Interviews were conducted with 12 of 27 enrolled patients and with 13 participating clinicians. iPARIHS constructs were used for interview construction to identify workflow, communication patterns, and clinician's beliefs. Interviews were transcribed and analyzed using inductive coding protocols to identify key themes. Behavioral response data from the AI-generated notifications were collected. RESULTS: Clinicians responded to notifications within 24 hours in 95% of instances, with 26.7% resulting in clinical action. Four implementation themes emerged: (1) High anticipatory expectations for reliable patient communications, reduced patient burden, and less proactive provider monitoring. (2) The AI notifications required a differential and tailored balance of trust and action advice related to role. (3) Clinic experience with other home-based programs influenced utilization. (4) Responding to notifications involved significant effort, including electronic health record (EHR) review, patient contact, and consultation with other clinicians. DISCUSSION: Clinician's use of AI data is a function of beliefs regarding the trustworthiness and usefulness of the data, the degree of autonomy in professional roles, and the cognitive effort involved. CONCLUSION: The implementation planning analysis guided development of strategies that addressed communication technology, patient education, and EHR integration to reduce clinician and patient burden in the subsequent main randomized phase of the trial. Our results provide important insights into the unique implications of implementing AI analytics into clinical workflow.

Machine Learning Multicenter Risk Model to Predict Right Ventricular Failure After Mechanical Circulatory Support: The STOP-RVF Score.

Importance: The existing models predicting right ventricular failure (RVF) after durable left ventricular assist device (LVAD) support might be limited, partly due to lack of external validation, marginal predictive power, and absence of intraoperative characteristics. Objective: To derive and validate a risk model to predict RVF after LVAD implantation. Design, Setting, and Participants: This was a hybrid prospective-retrospective multicenter cohort study conducted from April 2008 to July 2019 of patients with advanced heart failure (HF) requiring continuous-flow LVAD. The derivation cohort included patients enrolled at 5 institutions. The external validation cohort included patients enrolled at a sixth institution within the same period. Study data were analyzed October 2022 to August 2023. Exposures: Study participants underwent chronic continuous-flow LVAD support. Main Outcome and Measures: The primary outcome was RVF incidence, defined as the need for RV assist device or intravenous inotropes for greater than 14 days. Bootstrap imputation and adaptive least absolute shrinkage and selection operator variable selection techniques were used to derive a predictive model. An RVF risk calculator (STOP-RVF) was then developed and subsequently externally validated, which can provide personalized quantification of the risk for LVAD candidates. Its predictive accuracy was compared with previously published RVF scores. Results: The derivation cohort included 798 patients (mean [SE] age, 56.1 [13.2] years; 668 male [83.7%]). The external validation cohort included 327 patients. RVF developed in 193 of 798 patients (24.2%) in the derivation cohort and 107 of 327 patients (32.7%) in the validation cohort. Preimplant variables associated with postoperative RVF included nonischemic cardiomyopathy, intra-aortic balloon pump, microaxial percutaneous left ventricular assist device/venoarterial extracorporeal membrane oxygenation, LVAD configuration, Interagency Registry for Mechanically Assisted Circulatory Support profiles 1 to 2, right atrial/pulmonary capillary wedge pressure ratio, use of angiotensin-converting enzyme inhibitors, platelet count, and serum sodium, albumin, and creatinine levels. Inclusion of intraoperative characteristics did not improve model performance. The calculator achieved a C statistic of 0.75 (95% CI, 0.71-0.79) in the derivation cohort and 0.73 (95% CI, 0.67-0.80) in the validation cohort. Cumulative survival was higher in patients composing the low-risk group (estimated <20% RVF risk) compared with those in the higher-risk groups. The STOP-RVF risk calculator exhibited a significantly better performance than commonly used risk scores proposed by Kormos et al (C statistic, 0.58; 95% CI, 0.53-0.63) and Drakos et al (C statistic, 0.62; 95% CI, 0.57-0.67). Conclusions and Relevance: Implementing routine clinical data, this multicenter cohort study derived and validated the STOP-RVF calculator as a personalized risk assessment tool for the prediction of RVF and RVF-associated all-cause mortality.

Left ventricular functional improvement appears to contribute to lower rates of device thrombosis in patients on durable mechanical circulatory support.

By unloading the failing heart, left ventricular (LV) assist devices (LVADs) provide a favorable environment for reversing adverse structural and functional cardiac changes. Prior reports have suggested that an improved native LV function might contribute to the development of LVAD thrombosis. We used the Interagency Registry for Mechanically Assisted Circulatory Support and found that LV functional improvement is associated with a lower risk for device thrombosis. The risk for cerebrovascular accident and transient ischemic attack was comparable across post-LVAD LV function subgroups, while the risk of hemolysis was lower in subgroups of patients with better LV function on LVAD support.

Safety of same-day discharge versus overnight stay strategy following cardiac device implantations: a high-volume single-centre experience.

BACKGROUND: The strategy of cardiac implantable electronic device (CIED) implantations performed as day-case admissions has gained a wider acceptance overtime; however, data on safety are still limited. This study aims to investigate the safety of a same-day discharge protocol introduced in our hospital for the postprocedural management of patients undergoing CIED implantation. METHODS: Α prospective, non-interventional, non-randomised study performed in a single high-volume implanting centre for a 16-month period (March 2020 to June 2021). At total of 821 of 965 (85.1%) patients scheduled for elective CIED implantation were considered to be eligible for inclusion in the Short-stay Device Management Protocol. These patients were compared with a historical group of 932 patients, meeting the same inclusion criteria. RESULTS: Procedure was successful in 812 patients (98.9%), committed to same-day discharge versus 921 of 932 patients (98.8%) admitted for overnight stay (p = 0.87). Overall, 90-day complication rate was comparable in both groups (4.14% vs 4.07%, p = 0.95), as was major (1.46% vs. 1.82%, p = 0.55) and minor (2.67% vs. 2.25%, p = 0.64) complication rates. The composite early post-procedural complication rates and late post-procedural complication rates were comparable among groups (0.97 vs 1.18%, p = 0.70 and 0.73% vs 0.64%, p = 0.83, respectively). Six hundred sixty-seven patients (84%) preferred the same-day discharge strategy. Finally, a reduction of 792 bed-days was recorded, resulting in possible financial Health System benefits. CONCLUSIONS: Same-day discharge is feasible and safe in the majority of patients referred for CIED implantation. Additionally, same-day discharge is preferred by patients and may reduce procedure-related costs due to significant bed-day reductions.

COVID-19 in Patients with Melanoma: A Single-Institution Study.

We conducted a single-center, non-interventional retrospective study of melanoma patients with COVID-19 (1 March 2020 until 17 March 2023). The cohort was further divided into three groups according to the periods of SARS-CoV-2 variant dominance in Greece. We recorded demographics, comorbidities, vaccination data, cancer diagnosis/stage, types of systemic melanoma treatments, date of COVID-19 diagnosis and survival. We identified 121 patients. The vast majority (87.6%) had advanced disease (stages III or IV). A total of 80.1% of the patients were receiving immune checkpoint inhibitor-based therapies, 92.5% had asymptomatic/mild COVID-19 and 7.4% had moderate/severe/critical disease, while 83.5% contracted COVID-19 during the third period of the pandemic. Sixteen patients (13.2%) were hospitalized for COVID-19 with a median length of stay of 12 days (range: 1-55 days). Advanced age, heart failure, number of comorbidities (≤1 vs. >1), vaccination status and the time period of the infection correlated with more severe COVID-19, whereas only heart failure and time period were independently correlated with severity. The 30-day mortality rate after COVID-19 was 4.2%. With a median follow-up of 340 days post-COVID-19, 17.4% of patients were deceased. In this cohort of melanoma patients with COVID-19, the 30-day mortality rate was low. There was no association between melanoma stage, treatment receipt and type of treatment with COVID-19 severity.

Blood pressure control measures and cardiovascular outcomes: a prospective hypertensive cohort.

PURPOSE: We investigated whether blood pressure (BP) control measures, visit-to-visit BP variability, and time in therapeutic range (TTR) are associated with future cardiovascular outcomes in hypertensive patients. MATERIALS AND METHODS: Among 1,408 hypertensive patients without cardiovascular disease, we prospectively evaluated the incident major cardiovascular events over 6 years. In newly diagnosed patients, antihypertensive drug treatment was initiated. We estimated two markers of on-treatment BP control, (1) visit-to-visit BPV as the coefficient of variation of office systolic BP (BP-CV), and (2) TTR calculated as the percentage of office systolic BP measurements within 120-140mmHg across visits. RESULTS: The hypertensive cohort (672 males, mean age 60 years, 31% newly diagnosed) had a mean systolic/diastolic BP of 142/87 mmHg. The mean number of visits was 4.9 ± 2.6, while the mean attained systolic/diastolic BP during follow-up was 137/79 mmHg using 2.7 ± 1.1 antihypertensive drugs. The BP-CV and TTR were 9.1 ± 4.1% and 45 ± 29%, respectively, and the incidence of the composite outcome was 8.3% (n = 117). After adjustment for relevant confounders and standardization to z-scores, BP-CV and TTR were associated with a 43% (95% CI, 27-62%) increase and a 33% (95% CI, 15-47%) reduction in the outcome. However, the joint evaluation of TTR and BP-CV in a common multivariable model indicated that a standardized change of TTR was associated with the outcome to a greater extent than BP-CV (mean hazard ratios of 30% vs. 24%, respectively). When combined with the higher BP standardized-CV quartile, the lower TTR quartile predicted the outcome by 2.3 times (95% CI, 1.1-5.4) compared to the inverse TTR and BP-CV quartile pattern. CONCLUSION: High BP-CV or low TTR was associated with future cardiovascular events in a cohort of treated hypertensive patients. As a determinant, the extent of TTR value appears greater than BP-CV when these measures are considered in the same multivariable model.

AVNeo improves early haemodynamics in regurgitant bicuspid aortic valves compared to aortic valve repair.

OBJECTIVES: Calcified or fibrotic cusps in patients with bicuspid aortic valves and aortic regurgitation complicate successful aortic valve (AV)-repair. Aortic valve neocuspidization (AVNeo) with autologous pericardium offers an alternative treatment to prosthetic valve replacement. We compared patients with regurgitant bicuspid valves undergoing AV-repair or AVNeo. METHODS: We retrospectively analysed patients with regurgitant bicuspid valves undergoing AV-repair or AVNeo. We focused on residual regurgitation, pressure gradients and effective orifice area, determined preoperatively and at discharge. RESULTS: AV-repair was performed in 61 patients (mean age: 43.2 ± 11.3 years) and AVNeo in 22 (45.7 ± 14.1). Prior to the operation patients of the AV-repair group showed severe regurgitation in 38 cases (62.3%) and moderate in 23 (37.6%); in the AVNeo group, all patients exhibited severe regurgitation. Postoperatively, 57 patients (93.4%) patients had no or mild regurgitation after AV-repair and 21 (95.4%) after AVNeo. In AVNeo-patients, peak (10.6 ± 3.1 mmHg vs 22.7 ± 11 mmHg, P< 0.001) and mean pressure gradients (5.9 ± 2 mmHg vs 13.8 ± 7.3 mmHg, P < 0.001) were significantly lower and the orifice area significantly larger (2.9 ± 0.8 cm2 vs 1.9 ± 0.7 cm2, P < 0.001) compared to repair. CONCLUSIONS: Compared to AV-repair, patients AVNeo showed lower mean pressure gradients and larger orifice areas at discharge. The functional result was not different.