Pulmonary artery pressure monitoring in chronic heart failure: effects across clinically relevant subgroups in the MONITOR-HF trial.

BACKGROUND AND AIMS: In patients with chronic heart failure (HF), the MONITOR-HF trial demonstrated the efficacy of pulmonary artery (PA)-guided HF therapy over standard of care in improving quality of life and reducing HF hospitalizations and mean PA pressure. This study aimed to evaluate the consistency of these benefits in relation to clinically relevant subgroups. METHODS: The effect of PA-guided HF therapy was evaluated in the MONITOR-HF trial among predefined subgroups based on age, sex, atrial fibrillation, diabetes mellitus, left ventricular ejection fraction, HF aetiology, cardiac resynchronization therapy, and implantable cardioverter defibrillator. Outcome measures were based upon significance in the main trial and included quality of life-, clinical-, and PA pressure endpoints, and were assessed for each subgroup. Differential effects in relation to the subgroups were assessed with interaction terms. Both unadjusted and multiple testing adjusted interaction terms were presented. RESULTS: The effects of PA monitoring on quality of life, clinical events, and PA pressure were consistent in the predefined subgroups, without any clinically relevant heterogeneity within or across all endpoint categories (all adjusted interaction P-values were non-significant). In the unadjusted analysis of the primary endpoint quality-of-life change, weak trends towards a less pronounced effect in older patients (Pinteraction = .03; adjusted Pinteraction = .33) and diabetics (Pinteraction = .01; adjusted Pinteraction = .06) were observed. However, these interaction effects did not persist after adjusting for multiple testing. CONCLUSIONS: This subgroup analysis confirmed the consistent benefits of PA-guided HF therapy observed in the MONITOR-HF trial across clinically relevant subgroups, highlighting its efficacy in improving quality of life, clinical, and PA pressure endpoints in chronic HF patients.

Efficacy of the Cardiac Implantable Electronic Device Multisensory Triage-HF Algorithm in Heart Failure Care: A Real-World Clinical Experience.

Heart failure (HF) admissions are burdensome, and the mainstay of prevention is the timely detection of impending fluid retention, creating a window for medical treatment intensification. This study evaluated the accuracy and performance of a Triage-HF-guided carepath in real-world ambulatory HF patients in daily clinical practice. In this prospective, observational study, 92 adult HF patients (71 males (78%), with a median age of 69 [IQR 59-75] years) with the Triage-HF algorithm activated in their cardiac implantable electronic devices (CIEDs), were monitored. Following high-risk alerts, an HF nurse contacted patients to identify signs and symptoms of fluid retention. The sensitivity and specificity were 83% and 97%, respectively. The positive predictive value was 89%, and negative predictive value was 94%. The unexplained alert rate was 0.05 alerts/patient year, and the false negative rate was 0.11 alerts/patient year. Ambulatory diuretics were initiated or escalated in 77% of high-risk alert episodes. In 23% (n = 6), admission was ultimately required. The median alert handling time was 2 days. Fifty-eight percent (n = 18) of high-risk alerts were classified as true positives in the first week, followed by 29% in the second-third weeks (n = 9), and 13% (n = 4) in the fourth-sixth weeks. Common sensory triggers included an elevated night ventricular rate (84%), OptiVol (71%), and reduced patient activity (71%). The CIED-based Triage-HF algorithm-driven carepath enables the timely detection of impending fluid retention in a contemporary ambulatory setting, providing an opportunity for clinical action.

Myocardial infarction care in low and high socioeconomic environments: claims data analysis.

BACKGROUND: To date, claims data have not been used to study outcome differences between low and high socioeconomic status (SES) patients surviving ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) in the Netherlands. AIM: To evaluate STEMI and NSTEMI care among patients with low and high SES in the referral area of three Dutch percutaneous coronary intervention (PCI) centres, using claims data as a source. METHODS: STEMI and NSTEMI patients treated in 2015-2017 were included. Patients' SES scores were collected based on their postal code via an open access government database. In patients with low (SES1) and high (SES4) status, revascularisation strategies and secondary prevention medication were compared. RESULTS: A total of 2065 SES1 patients (age 68 ± 13 years, 58% NSTEMI) and 1639 SES4 patients (age 68 ± 13 years, 63% NSTEMI) were included. PCI use was lower in SES1 compared to SES4 in both STEMI (80% vs 84%, p < 0.012) and NSTEMI (42% vs 48%, p < 0.002) patients. Coronary artery bypass grafting was performed more often in SES1 than in SES4 in both STEMI (7% vs 4%, p = NS) and NSTEMI (11% vs 7%, p < 0.001) patients. Optimal medical therapy use in STEMI patients was higher in SES1 compared to SES4 (52% vs 46%, p = 0.01) but comparable among NSTEMI patients (39% vs 40%, p = NS). One-year mortality was comparable in SES1 and SES4 patients following STEMI (14% vs 16%, p = NS) and NSTEMI (10% vs 11%, p = NS). CONCLUSION: Combined analysis of claims data and area-specific socioeconomic statistics can provide unique insight into how to improve myocardial infarction care for low and high SES patients.

Fewer Worsening Heart Failure Events With HeartLogic on top of Standard Care: a Propensity-Matched Cohort Analysis.

BACKGROUND: The implantable cardiac defibrillator-based HeartLogic algorithm aims to detect impending fluid retention in patients with heart failure (HF). Studies show that HeartLogic is safe to integrate into clinical practice. The current study investigates whether HeartLogic provides clinical benefit on top of standard care and device telemonitoring in patients with HF. METHODS: A multicenter, retrospective, propensity-matched cohort analysis was performed in patients with HF and implantable cardiac defibrillators, and it compared HeartLogic to conventional telemonitoring. The primary endpoint was the number of worsening HF events. Hospitalizations and ambulatory visits due to HF were also evaluated. RESULTS: Propensity score matching yielded 127 pairs (median age 68 years, 80% male). Worsening HF events occurred more frequently in the control group (2; IQR 0-4) compared to the HeartLogic group (1; IQR 0-3; P = 0.004). The number of HF hospitalization days was higher in controls than in the HeartLogic group (8; IQR 5-12 vs 5; IQR 2-7; P = 0.023), and ambulatory visits for diuretic escalation were more frequent in the control group than in the HeartLogic group (2; IQR 0-3 vs 1; IQR 0-2; P = 0.0001). CONCLUSION: Integrating the HeartLogic algorithm in a well-equipped HF care path on top of standard care is associated with fewer worsening HF events and shorter duration of fluid retention-related hospitalizations.

Improved prehospital triage for acute cardiac care: results from HART-c, a multicentre prospective study.

BACKGROUND: Cardiac symptoms are one of the most prevalent reasons for emergency department visits. However, over 80% of patients with such symptoms are sent home after acute cardiovascular disease has been ruled out. OBJECTIVE: The Hollands-Midden Acute Regional Triage-cardiology (HART-c) study aimed to investigate whether a novel prehospital triage method, combining prehospital and hospital data with expert consultation, could increase the number of patients who could safely stay at home after emergency medical service (EMS) consultation. METHODS: The triage method combined prehospital EMS data, such as electrocardiographic and vital parameters in real time, and data from regional hospitals (including previous medical records and admission capacity) with expert consultation. During the 6­month intervention and control periods 1536 and 1376 patients, respectively, were consulted by the EMS. The primary endpoint was the percentage change of patients who could stay at home after EMS consultation. RESULTS: The novel triage method led to a significant increase in patients who could safely stay at home, 11.8% in the intervention group versus 5.9% in the control group: odds ratio 2.31 (95% confidence interval (CI) 1.74-3.05). Of 181 patients staying at home, only 1 (< 1%) was later diagnosed with ACS; no patients died. Furthermore the number of interhospital transfers decreased: relative risk 0.81 (95% CI 0.67-0.97). CONCLUSION: The HART­c triage method led to a significant decrease in interhospital transfers and an increase in patients with cardiac symptoms who could safely stay at home. The presented method thereby reduced overcrowding and, if implemented throughout the country and for other medical specialties, could potentially reduce the number of cardiac and non-cardiac hospital visits even further.

The Box-eHealth in the Outpatient Clinic Follow-up of Patients With Acute Myocardial Infarction: Cost-Utility Analysis.

BACKGROUND: Smartphone compatible wearables have been released on the consumers market, enabling remote monitoring. Remote monitoring is often named as a tool to reduce the cost of care. OBJECTIVE: The primary purpose of this paper is to describe a cost-utility analysis of an eHealth intervention compared to regular follow-up in patients with acute myocardial infarction (AMI). METHODS: In this trial, of which clinical results have been published previously, patients with an AMI were randomized in a 1:1 fashion between an eHealth intervention and regular follow-up. The remote monitoring intervention consisted of a blood pressure monitor, weight scale, electrocardiogram device, and step counter. Furthermore, two in-office outpatient clinic visits were replaced by e-visits. The control group received regular care. The differences in mean costs and quality of life per patient between both groups during one-year follow-up were calculated. RESULTS: Mean costs per patient were €2417±2043 (US $2657±2246) for the intervention and €2888±2961 (US $3175±3255) for the control group. This yielded a cost reduction of €471 (US $518) per patient. This difference was not statistically significant (95% CI -€275 to €1217; P=.22, US $-302 to $1338). The average quality-adjusted life years in the first year of follow-up was 0.74 for the intervention group and 0.69 for the control (difference -0.05, 95% CI -0.09 to -0.01; P=.01). CONCLUSIONS: eHealth in the outpatient clinic setting for patients who suffered from AMI is likely to be cost-effective compared to regular follow-up. Further research should be done to corroborate these findings in other patient populations and different care settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT02976376; https://clinicaltrials.gov/ct2/show/NCT02976376. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.8038.

Early Detection of Fluid Retention in Patients with Advanced Heart Failure: A Review of a Novel Multisensory Algorithm, HeartLogicTM.

Heart failure (HF) hospitalisations due to decompensation are associated with shorter life expectancy and lower quality of life. These hospitalisations pose a significant burden on the patients, doctors and healthcare resources. Early detection of an upcoming episode of decompensation may facilitate timely optimisation of the ambulatory medical treatment and thereby prevent heart-failure-related hospitalisations. The HeartLogicTM algorithm combines data from five sensors of cardiac implantable electronic devices into a cumulative index value. It has been developed for early detection of fluid retention in heart failure patients. This review aims to provide an overview of the current literature and experience with the HeartLogicTM algorithm, illustrate how the index can be implemented in daily clinical practice and discuss ongoing studies and potential future developments of interest.

Vasoplegia After Restrictive Mitral Annuloplasty for Functional Mitral Regurgitation in Patients With Heart Failure.

OBJECTIVES: Patients undergoing heart failure surgery are at risk for developing postoperative vasoplegia. The aim of this study was to determine the incidence, survival, and predictors of vasoplegia in heart failure patients undergoing mitral valve repair for functional mitral regurgitation and to evaluate the effect of ischemic versus non-ischemic etiology. DESIGN: Retrospective. SETTING: University medical center, single institutional. PARTICIPANTS: Heart failure patients with functional mitral regurgitation who underwent restrictive mitral annuloplasty (2006-2015). MEASUREMENTS AND MAIN RESULTS: One hundred twenty-two patients were included (48% ischemic etiology). The incidence of vasoplegia was 19% and was not influenced by mitral regurgitation etiology. Ninety-day survival rate was decreased in vasoplegic compared with non-vasoplegic patients (65% v 93%, p < 0.001). After adjusting for age, gender, and heart failure etiology, prior hypertension (odds ratio [OR] 0.28; 95% confidence interval [CI] 0.08-0.91; p = 0.034), higher creatinine clearance (OR 0.97; 95% CI 0.95-0.99; p = 0.009), and beta-blocker use (OR 0.25; 95% CI 0.09-0.73; p = 0.011) decreased the risk of vasoplegia. Anemia (OR 3.00; 95% CI 1.10-8.20; p = 0.032) and longer cross clamp (OR 1.03; 95% CI 1.01-1.04; p = 0.001), cardiopulmonary bypass (OR 1.01; 95% CI 1.00-1.02; p = 0.003), and procedure times (OR 1.01; 95% CI 1.00-1.02, p = 0.002) increased the risk of vasoplegia. CONCLUSIONS: Vasoplegia occurs in 19% of heart failure patients undergoing mitral valve repair for functional mitral regurgitation. It is associated with a poor early outcome. Prior hypertension, a higher creatinine clearance, and beta-blocker use were associated with a decreased risk of vasoplegia, whereas anemia and longer procedure times were associated with an increased risk of vasoplegia, independent of heart failure etiology.

Safety and efficacy of percutaneous intramyocardial bone marrow cell injection for chronic myocardial ischemia: Long-term results.

BACKGROUND: Intramyocardial injection of bone marrow cells (BMC) in refractory angina patients with chronic myocardial ischemia has shown to be safe and improve clinical status during short-term follow-up. However, scarce data are available on long-term (>12 months) safety and efficacy. Therefore, the occurrence of clinical events and the long-term clinical effects of intramyocardial BMC injection were evaluated in patients with chronic myocardial ischemia up to 10 years after treatment. METHODS AND RESULTS: Patients (n = 100, age 64 ± 9 years, male 88%) with chronic myocardial ischemia who underwent intramyocardial BMC injection between 2004 and 2010 were evaluated. During yearly outpatient clinic visits, the occurrence of clinical events was documented. In addition, clinical status was assessed according to the Canadian Cardiovascular Society (CCS) score and quality of life was measured using the Seattle Angina Questionnaire. These parameters were evaluated at baseline and during the first year, followed by cross-sectional long-term follow-up which was performed in 2011 and 2014. No adverse events considered related to the procedure occurred during 10 years of follow-up. Observed annual mortality rate and annual myocardial infarction rate were 3.8% and 1.9% per year, respectively. When compared to baseline, CCS class and quality of life remained significantly better during 5-year follow-up after BMC treatment (both P < 0.05). CONCLUSIONS: The present long-term follow-up study shows that intramyocardial BMC injection in patients with chronic myocardial ischemia is safe and improves both angina complaints and quality of life up to 5 years after BMC treatment.

Chronic care for heart failure patients: Who to refer back to the general practitioner?-Experiences of the Dutch integrated heart failure care model.

OBJECTIVE: The number of patients with heart failure (HF) and corresponding burden of the healthcare system will increase significantly. The Dutch integrated model, 'Transmural care of HF Patients' was based on the European Society of Cardiology (ESC) guidelines and initiated to manage the increasing prevalence of HF patients in primary and secondary care and stimulate integrated care. It is unknown how many HF patients are eligible for back-referral to general practitioners (GPs), which is important information for the management of chronic HF care. This study aims to evaluate clinical practice of patients for whom chronic HF care can be referred from the cardiologist to the GP based on the aforementioned chronic HF care model. DESIGN AND METHODS: A retrospective case record-based study was conducted, which included all chronic HF patients registered in the cardiology information systems of two different hospitals. Subsequently, 200 patients were randomly selected for evaluation. The following patients were considered eligible for referral to the GP: 1/Stable HF patients with reduced left ventricular ejection fraction (LVEF), 2/Stable HF patients with a recovered LVEF and 3/Stable HF patients with a preserved LVEF, 4/HF, palliative setting. RESULTS: Of the 200 patients, 17% was considered eligible for referral to the GP. This group consisted of 5% patients with a reduced LVEF, 10.5% patients with recovered LVEF and 1.5% patients with a preserved LVEF. Main indicators for HF care by cardiologists were active cardiac disease other than HF (39.5%), recent admission for HF (29.5%) or a recent adjustment in HF medication (7.5%). CONCLUSION: Applying the chronic HF care model of the 'Transmural care of HF patients' and the ESC-guidelines, results in an important opportunity to further optimise HF integrated care and to deal with the increasing number of HF patients referred to the hospital.

The Potential of the HeartLogicTM Algorithm in Patients with a Left Ventricular Assist Device, an Initial Report.

BACKGROUND: Survival and quality-of-life of left ventricular assist device (LVAD) recipients improved significantly because of growing experience and technological advances. However, LVAD-related complication rates, including recurrent episodes of congestion, remain high. Early detection of fluid retention to provide a time-window for medical intervention is the pillar in preventing hospitalizations. The multisensory HeartLogicTM algorithm accurately detected impending congestion in ambulant heart failure patients. The aim of the current study is to investigate the feasibility of HeartLogicTM-driven care in LVAD patients. METHODS: Consecutive LVAD destination therapy patients were followed-up according the structured HeartLogicTM-based heart failure carepath. An alert triggered a device check-up, and the heart failure team contacted the patient to evaluate for signs and symptoms of impending congestion. An alert was adjudicated as true positive or unexplained. An episode of congestion not preceded by an alert was deemed as a false negative. RESULTS: Data from 7 patients were included: the median age was 67 years [IQR 61-71], 71% were male and 71% had a non-ischemic aetiology. Total follow-up entailed 12 patient-years. All patients experienced at least one alert. In total, 33 alerts were observed. Majority of alerts (70%, n = 23) were driven by congestion and one alerts (15%) were clinically meaningful but not primarily fluid-retention-related (e.g., altered hemodynamic triggered by a pump thrombosis). Of all the alerts, five (15%) were classified as an unexplained alert, and during follow-up, four false negative episodes were documented. CONCLUSIONS: HeartLogicTM-driven care with continuous monitoring to detect impending fluid retention in LVAD patients was feasible and deserves further prospective validation.

CIED-based remote monitoring in heart failure using the HeartLogic™ algorithm: Which patients benefit most?

BACKGROUND & AIMS: Early identification of worsening HF enables timely adjustments to prevent hospitalization. Recent studies show the HeartLogic™ algorithm detects congestion and reduces HF events. However, it is unclear which patients benefit most. Therefore, this study aims to identify and characterize HF patients who benefit most from CIED-based remote monitoring with HeartLogic™. METHODS: In this multicenter retrospective study, patients with a CIED and HeartLogic™ algorithm under structured follow-up were included. Patients were classified as having "substantial benefit" or "no benefit" from monitoring. RESULTS: In total, 242 patients were included (male n = 190, 79%, median age 61 years [IQR 61-77]). Median follow-up was 1.2 years [IQR 1.1-2.7]. Among 378 alerts, 266 were true positive (70%) and 112 false positive (30%). Of the 242 patients, 69 (29%) were classified as having "substantial benefit", while 173 (71%) had "no benefit" from HeartLogic™ monitoring. Univariate and multivariate analysis showed that patients with "substantial benefit" had higher NYHA functional class (OR 2.64, P = 0.004), higher NT-ProBNP (OR 1.02, P = 0.003), higher serum creatinine (OR 1.10, P < 0.001), lower LVEF (OR 1.19, P = 0.004), more severe mitral regurgitation (OR 2.16, P = 0.006), higher right ventricular end diastolic volume (OR 1.05, P = 0.040), higher pulmonary artery pressures (OR 1.19, P = 0.003), and were more likely to use loop diuretics (OR 2.79, P = 0.001). Among patients with "substantial benefit," the positive predictive value (PPV) of HeartLogic™ to detect congestion was 92%. CONCLUSION: The utilization of CIED-based HeartLogic™ driven HF care demonstrated pronounced efficacy, predominantly in patients exhibiting characteristics of HF at a more advanced disease stage.

Serial cardiac biomarkers, pulmonary artery pressures and traditional parameters of fluid status in relation to prognosis in patients with chronic heart failure: Design and rationale of the BioMEMS study.

AIMS: Heart failure (HF), a global pandemic affecting millions of individuals, calls for adequate predictive guidance for improved therapy. Congestion, a key factor in HF-related hospitalizations, further underscores the need for timely interventions. Proactive monitoring of intracardiac pressures, guided by pulmonary artery (PA) pressure, offers opportunities for efficient early-stage intervention, since haemodynamic congestion precedes clinical symptoms. METHODS: The BioMEMS study, a substudy of the MONITOR-HF trial, proposes a multifaceted approach integrating blood biobank data with traditional and novel HF parameters. Two additional blood samples from 340 active participants in the MONITOR-HF trial were collected at baseline, 3-, 6-, and 12-month visits and stored for the BioMEMS biobank. The main aims are to identify the relationship between temporal biomarker patterns and PA pressures derived from the CardioMEMS-HF system, and to identify the biomarker profile(s) associated with the risk of HF events and cardiovascular death. CONCLUSION: Since the prognostic value of single baseline measurements of biomarkers like N-terminal pro-B-type natriuretic peptide is limited, with the BioMEMS study we advocate a dynamic, serial approach to better capture HF progression. We will substantiate this by relating repeated biomarker measurements to PA pressures. This design rationale presents a comprehensive review on cardiac biomarkers in HF, and aims to contribute valuable insights into personalized HF therapy and patient risk assessment, advancing our ability to address the evolving nature of HF effectively.

Contemporary guideline-directed medical therapy in de novo, chronic, and worsening heart failure patients: First data from the TITRATE-HF study.

AIMS: Despite clear guideline recommendations for initiating four drug classes in all patients with heart failure (HF) with reduced ejection fraction (HFrEF) and the availability of rapid titration schemes, information on real-world implementation lags behind. Closely following the 2021 ESC HF guidelines and 2023 focused update, the TITRATE-HF study started to prospectively investigate the use, sequencing, and titration of guideline-directed medical therapy (GDMT) in HF patients, including the identification of implementation barriers. METHODS AND RESULTS: TITRATE-HF is an ongoing long-term HF registry conducted in the Netherlands. Overall, 4288 patients from 48 hospitals were included. Among these patients, 1732 presented with de novo, 2240 with chronic, and 316 with worsening HF. The median age was 71 years (interquartile range [IQR] 63-78), 29% were female, and median ejection fraction was 35% (IQR 25-40). In total, 44% of chronic and worsening HFrEF patients were prescribed quadruple therapy. However, only 1% of HFrEF patients achieved target dose for all drug classes. In addition, quadruple therapy was more often prescribed to patients treated in a dedicated HF outpatient clinic as compared to a general cardiology outpatient clinic. In each GDMT drug class, 19% to 36% of non-use in HFrEF patients was related to side-effects, intolerances, or contraindications. In the de novo HF cohort, 49% of patients already used one or more GDMT drug classes for other indications than HF. CONCLUSION: This first analysis of the TITRATE-HF study reports relatively high use of GDMT in a contemporary HF cohort, while still showing room for improvement regarding quadruple therapy. Importantly, the use and dose of GDMT were suboptimal, with the reasons often remaining unclear. This underscores the urgency for further optimization of GDMT and implementation strategies within HF management.

AI Algorithm to Predict Acute Coronary Syndrome in Prehospital Cardiac Care: Retrospective Cohort Study.

BACKGROUND: Overcrowding of hospitals and emergency departments (EDs) is a growing problem. However, not all ED consultations are necessary. For example, 80% of patients in the ED with chest pain do not have an acute coronary syndrome (ACS). Artificial intelligence (AI) is useful in analyzing (medical) data, and might aid health care workers in prehospital clinical decision-making before patients are presented to the hospital. OBJECTIVE: The aim of this study was to develop an AI model which would be able to predict ACS before patients visit the ED. The model retrospectively analyzed prehospital data acquired by emergency medical services' nurse paramedics. METHODS: Patients presenting to the emergency medical services with symptoms suggestive of ACS between September 2018 and September 2020 were included. An AI model using a supervised text classification algorithm was developed to analyze data. Data were analyzed for all 7458 patients (mean 68, SD 15 years, 54% men). Specificity, sensitivity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for control and intervention groups. At first, a machine learning (ML) algorithm (or model) was chosen; afterward, the features needed were selected and then the model was tested and improved using iterative evaluation and in a further step through hyperparameter tuning. Finally, a method was selected to explain the final AI model. RESULTS: The AI model had a specificity of 11% and a sensitivity of 99.5% whereas usual care had a specificity of 1% and a sensitivity of 99.5%. The PPV of the AI model was 15% and the NPV was 99%. The PPV of usual care was 13% and the NPV was 94%. CONCLUSIONS: The AI model was able to predict ACS based on retrospective data from the prehospital setting. It led to an increase in specificity (from 1% to 11%) and NPV (from 94% to 99%) when compared to usual care, with a similar sensitivity. Due to the retrospective nature of this study and the singular focus on ACS it should be seen as a proof-of-concept. Other (possibly life-threatening) diagnoses were not analyzed. Future prospective validation is necessary before implementation.

Intramyocardial injection of bone marrow mononuclear cells in chronic myocardial ischemia patients after previous placebo injection improves myocardial perfusion and anginal symptoms: an intra-patient comparison.

BACKGROUND: We recently demonstrated in a randomized, double-blind, placebo-controlled trial that intramyocardial bone marrow cell (BMC) injection is associated with improvements in myocardial perfusion and anginal symptoms in chronic myocardial ischemia patients. In the present study the results of the crossover phase of this trial, in which patients previously treated with placebo received autologous BMC injections are reported. This allows a unique intra-patient comparison on the effect of BMC versus placebo injection with elimination of patient-related confounding factors. METHODS: In 16 patients (14 male, 64 ± 10 years), who previously received intramyocardial placebo injections in the setting of a randomized trial, 100 × 10(6) BMC were injected using the NOGA-system. Canadian Cardiovascular Society angina score and quality of life were evaluated at baseline, 3 and 6 months. Tc-99m single photon emission computed tomography and magnetic resonance imaging were performed at baseline and 3 months to assess myocardial perfusion and left ventricular (LV) function. RESULTS: Canadian Cardiovascular Society score and quality of life improved significantly after BMC injection as compared to placebo (P = 0.01 and P = 0.02, respectively). Single photon emission computed tomography revealed a significant greater improvement (P = 0.03) in summed stress score after BMC injection as compared to placebo. LV end-systolic volume significantly decreased after BMC injection but not after placebo injection. LV end-diastolic volume and LV ejection fraction did not change. CONCLUSION: Intramyocardial BMC injection in patients with chronic myocardial ischemia who previously received intramyocardial placebo treatment resulted in significant improvement in angina symptoms and myocardial perfusion. These results confirm the outcome of our previously reported randomized trial.

Managing Hospital Capacity: Achievements and Lessons from the COVID-19 Pandemic.

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic challenged health care systems in an unprecedented way. Due to the enormous amount of hospital ward and intensive care unit (ICU) admissions, regular care came to a standstill, thereby overcrowding ICUs and endangering (regular and COVID-19-related) critical care. Acute care coordination centers were set up to safely manage the influx of COVID-19 patients. Furthermore, treatments requiring ICU surveillance were postponed leading to increased waiting lists. HYPOTHESIS: A coordination center organizing patient transfers and admissions could reduce overcrowding and optimize in-hospital capacity. METHODS: The acute lack of hospital capacity urged the region West-Netherlands to form a new regional system for patient triage and transfer: the Regional Capacity and Patient Transfer Service (RCPS). By combining hospital capacity data and a new method of triage and transfer, the RCPS was able to effectively select patients for transfer to other hospitals within the region or, in close collaboration with the National Capacity and Patient Transfer Service (LCPS), transfer patients to hospitals in other regions within the Netherlands. RESULTS: From March 2020 through December 2021 (22 months), the RCPS West-Netherlands was requested to transfer 2,434 COVID-19 patients. After adequate triage, 1,720 patients with a mean age of 62 (SD = 13) years were transferred with the help of the RCPS West-Netherlands. This concerned 1,166 ward patients (68%) and 554 ICU patients (32%). Overcrowded hospitals were relieved by transferring these patients to hospitals with higher capacity. CONCLUSION: The health care system in the region West-Netherlands benefitted from the RCPS for both ward and ICU occupation. Due to the coordination by the RCPS, regional ICU occupation never exceeded the maximal ICU capacity, and therefore patients in need for acute direct care could always be admitted at the ICU. The presented method can be useful in reducing the waiting lists caused by the delayed care and for coordination and transfer of patients with new variants or other infectious diseases in the future.

Left ventricular assist device and pump thrombosis: the importance of the inflow cannula position.

Pump thrombosis is a devastating complication after left ventricular assist device implantation. This study aims to elucidate the relation between left ventricular assist device implantation angle and risk of pump thrombosis. Between November 2010 and March 2020, 53 left ventricular assist device-patients underwent a computed tomography scan. Using a 3-dimensional multiplanar reformation the left ventricular axis was reconstructed to measure the implantation angle of the inflow cannula. All patients were retrospectively analyzed for the occurrence of pump thrombosis. In 10 (91%) patients with a pump thrombosis, the implantation angle was towards the lateral wall of the left ventricle. In only 20 patients (49%) of the patients without a pump thrombosis the inflow cannula pointed towards the lateral wall of the left ventricle. The mean angle in patients with a pump thrombosis was 10.1 ± 11.9 degrees towards the lateral wall of the left ventricle compared to 4.1 ± 19.9 degrees towards the septum in non-pump thrombosis patients (P = 0.005). There was a trend towards a significant difference in time to first pump thrombosis between patients with a lateral or septal deviated left ventricular assist device (hazard ratio of 0.15, P = 0.07). This study demonstrates that left ventricular assist device implantation angle is associated with pump thrombosis. Almost all patients in whom a pump thrombosis occurred during follow-up had a left ventricular assist device implanted with the inflow-cannula pointing towards the lateral wall of the left ventricle.

Systemic thrombolysis in the management of pump thrombosis in patients with left ventricular assist devices.

Left ventricular assist device (LVAD) implantation as destination therapy (DT) is a valuable treatment option in patients with end-stage heart failure ineligible for heart transplant. However, this therapy can be complicated by life-threatening pump thrombosis (PT). This case series reports our single-center experience with a structured systemic thrombolysis protocol in case of PT. Consecutive patients undergoing DT LVAD (HVAD, Medtronic, Framingham, MA) implantation between 2010 and April 2021 at our institution were reviewed and those with PT identified. Clinical, laboratory and LVAD specific data were collected and analyzed retrospectively. All patients with PT were treated with systemic thrombolysis according to a structured bedside protocol. Treatment was defined successful if a patient was alive at 30 days follow-up and free of recurrent PT, stroke or device exchange. Fourteen out of 94 patients experienced a PT after LVAD implantation (11%). Systemic thrombolysis was successful in 10 of 14 patients (71%) at 30 days. Two patients died within 30 days due to a hemothorax and multi-organ failure. In three patients treatment was complicated by a major bleeding; twice a hemothorax (one fatal) and one right calf bleeding. No intracerebral hemorrhage was observed. Three patients experienced a thrombotic complication within 30 days; all recurrent PT. Eleven of the 14 DT patients were discharged home after a limited hospital stay after thrombolysis (average of 11 days). In conclusion, systemic thrombolysis may be a reasonable option for life-threatening PT in this vulnerable DT group in whom device exchange is often impossible due to comorbidity.