Ability to remotely monitor atrial high-rate episodes using a single-chamber implantable cardioverter-defibrillator with a floating atrial sensing dipole

Aims To allow timely initiation of anticoagulation therapy for the prevention of stroke, the European guidelines on atrial fibrillation (AF) recommend remote monitoring (RM) of device-detected atrial high-rate episodes (AHREs) and progression of arrhythmia duration along pre-specified strata (6 min…&lt;1 h, 1 h…&lt;24 h, ≥ 24 h). We used the MATRIX registry data to assess the capability of a single-lead implantable cardioverter-defibrillator (ICD) with atrial sensing dipole (DX ICD system) to follow this recommendation in patients with standard indication for single-chamber ICD. Methods In 1841 DX ICD patients with daily automatic RM transmissions, electrograms of first device-detected AHREs per patient in and results each duration stratum were adjudicated, and the corresponding positive predictive values (PPVs) for the detections to be true atrial arrhythmia were calculated. Moreover, the incidence and progression of new-onset AF was assessed in 1451 patients with no AF history. A total of 610 AHREs ≥6 min were adjudicated. The PPV was 95.1% (271 of 285) for episodes 6min…&lt;1 h, 99.6% (253/254) for episodes 1 h…&lt;24 h, 100% (71/71) for episodes ≥24 h, or 97.5% for all episodes (595/ 610). The incidence of new-onset AF was 8.2% (119/1451), and in 31.1% of them (37/119), new-onset AF progressed to a higher duration stratum. Nearly 80% of new-onset AF patients had high CHA 2DS 2-VASc stroke risk, and 70% were not on anticoagulation therapy. Age was the only significant predictor of new-onset AF. Conclusion A 99.7% detection accuracy for AHRE ≥1 h in patients with DX ICD systems in combination with daily RM allows a reliable guideline-recommended screening for subclinical AF and monitoring of AF-duration progression.</p

A retrospective cohort study comparing differences in 30-day mortality among critically ill patients aged ≥ 70 years treated in European tax-based healthcare systems (THS) versus social health insurance systems.

In Europe, tax-based healthcare systems (THS) and social health insurance systems (SHI) coexist. We examined differences in 30-day mortality among critically ill patients aged ≥ 70 years treated in intensive care units in a THS or SHI. Retrospective cohort study. 2406 (THS n = 886; SHI n = 1520) critically ill ≥ 70 years patients in 129 ICUs. Generalized estimation equations with robust standard errors were chosen to create population average adjusted odds ratios (aOR). Data were adjusted for patient-specific variables, organ support and health economic data. The primary outcome was 30-day-mortality. Numerical differences between SHI and THS in SOFA scores (6 ± 3 vs. 5 ± 3; p = 0.002) were observed, but clinical frailty scores were similar (> 4; 17% vs. 14%; p = 0.09). Higher rates of renal replacement therapy (18% vs. 11%; p < 0.001) were found in SHI (aOR 0.61 95%CI 0.40-0.92; p = 0.02). No differences regarding intubation rates (68% vs. 70%; p = 0.33), vasopressor use (67% vs. 67%; p = 0.90) and 30-day-mortality rates (47% vs. 50%; p = 0.16) were found. Mortality remained similar between both systems after multivariable adjustment and sensitivity analyses. The retrospective character of this study. Baseline risk and mortality rates were similar between SHI and THS. The type of health care system does not appear to have played a role in the intensive care treatment of critically ill patients ≥ 70 years with COVID-19 in Europe

Pulmonary Hypertension in Adults with Congenital Heart Disease: Real-World Data from the International COMPERA-CHD Registry

Introduction: Pulmonary hypertension (PH) is a common complication in patients with congenital heart disease (CHD), aggravating the natural, post-operative, or post-interventional course of the underlying anomaly. The various CHDs differ substantially in characteristics, functionality, and clinical outcomes among each other and compared with other diseases with pulmonary hypertension. Objective: To describe current management strategies and outcomes for adults with PH in relation to different types of CHD based on real-world data. Methods and results: COMPERA (Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension) is a prospective, international PH registry comprising, at the time of data analysis, >8200 patients with various forms of PH. Here, we analyzed a subgroup of 680 patients with PH due to CHD, who were included between 2007 and 2018 in 49 specialized centers for PH and/or CHD located in 11 European countries. At enrollment, the patients’ median age was 44 years (67% female), and patients had either pre-tricuspid shunts, post-tricuspid shunts, complex CHD, congenital left heart or aortic disease, or miscellaneous other types of CHD. Upon inclusion, targeted therapies for pulmonary arterial hypertension (PAH) included endothelin receptor antagonists, PDE-5 inhibitors, prostacyclin analogues, and soluble guanylate cyclase stimulators. Eighty patients with Eisenmenger syndrome were treatment-naïve. While at inclusion the primary PAH treatment for the cohort was monotherapy (70% of patients), with 30% of the patients on combination therapy, after a median observation time of 45.3 months, the number of patients on combination therapy had increased significantly, to 50%. The use of oral anticoagulants or antiplatelets was dependent on the underlying diagnosis or comorbidities. In the entire COMPERA-CHD cohort, after follow-up and receiving targeted PAH therapy (n = 511), 91 patients died over the course of a 5-year follow up. The 5-year Kaplan–Meier survival estimate for CHD associated PH was significantly better than that for idiopathic PAH (76% vs. 54%; p < 0.001). Within the CHD associated PH group, survival estimates differed particularly depending on the underlying diagnosis and treatment status. Conclusions: In COMPERA-CHD, the overall survival of patients with CHD associated PH was dependent on the underlying diagnosis and treatment status, but was significantly better as than that for idiopathic PAH. Nevertheless, overall survival of patients with PAH due to CHD was still markedly reduced compared with survival of patients with other types of CHD, despite an increasing number of patients on PAH-targeted combination therapy

Versorgungsanalyse der Transkatheter-Aortenklappen-Implantation in Deutschland

Schächinger V, Elmhorst D, Zahn R, Perings C, Stellbrink C, Bestehorn K. Healthcare provision of transcatheter aortic valve implantation in Germany. Herz : Cardiovascular Diseases . 2023.BackgroundTranscatheter aortic valve implantation (TAVI) for aortic stenosis in older patients is the standard of care with a well-established supply density in Germany. In the near future, healthcare reform is planned that may affect TAVI capacities. Therefore, it is important to know how political regulations may interfere with access to services and what the need for TAVI will be in the future, based on demographic trends.MethodsThe number of TAVI procedures (DRG F98A +F98) and the in-hospital main diagnoses of aortic stenosis (ICD I35) in 2021 were analyzed at the level of county or federal state based on anonymized data from hospital reports, according to 21 of the German hospital reimbursement law. The number of TAVI and aortic stenosis cases was projected for 2035 based on data from the German Federal Statistical Office on demographic developments. With quality assurance data from hospitals in 2019 and a route planner, the travel time to the next hospital performing TAVI (OPS 5-35a.0) was calculated, and the consequence of a politically suggested minimum volume cut-off was analyzed.ResultsIn 2021, a total of 26,506 TAVI procedures were reported with a mean number of TAVI per 100,000 inhabitants of 32 (range between federal states from 25 to 42). Among the 66,045 diagnoses of aortic stenosis, there was a variation per 100,000 inhabitants from 64 to 108 (mean 79) between federal states. Compared to 2021, an additional 8748 (+13%) diagnoses of aortic stenosis and an increase of 4673 (+18%) TAVI procedures is to be expected in 2035. In 2019, 57% of German citizens could reach a TAVI hospital within 30 min and 91% within 60 min of driving time by car (mean time to hospital 31 min). Applying a minimum number of 150 TAVI/hospital per year would increase the driving time to hospital from 33 to 52 min in Saxony-Anhalt and instantly remove six out of eight hospitals from service in Hesse.ConclusionRegulation of TAVI services by minimum volume numbers would arbitrarily interfere with access to services, in contradiction to the medical service assurance tasks of federal state governments. These issues should be considered in the upcoming healthcare system reform. HintergrundDie Transkatheter-Aortenklappen-Implantation (TAVI) zur Behandlung der Aortenklappenstenose bei alteren Patienten ist zur Standardbehandlung gereift mit einem hohen Versorgungsgrad in Deutschland. Die avisierte Strukturreform des Gesundheitswesens konnte Einfluss auf die Versorgung mit TAVI haben. Deshalb ist es notwendig zu analysieren, welche Auswirkungen politische Vorgaben auf die TAVI-Versorgung haben konnen und wie der Bedarf an TAVI-Prozeduren entsprechend der demografischen Entwicklung zukunftig sein wird.MethodikDie Anzahl an TAVI-Prozeduren (DRG F98A + F98B) und Krankenhaus-Hauptdiagnosen der Aortenstenose (ICD I35) wurden fur 2021 fur die Landkreise und foderalen Bundeslander auf der Basis anonymisierter -21-Datensatze analysiert. Basierend auf der Prognose der demografischen Entwicklung von Landkreisen und Bundeslandern des Statistischen Bundesamtes wurden die Anzahl von Aortenklappenstenosen-Diagnosen und TAVI fur das Jahr 2035 hochgerechnet. Anhand der Krankenhaus-Qualitatsberichte von 2019 und eines Routenplaners wurde die Zeit zum Erreichen des nachsten TAVI (OPS 5-35a.0) durchfuhrenden Krankenhauses kalkuliert sowie Konsequenzen einer politisch vorgeschlagenen Mindestmenge analysiert.ErgebnisseIm Jahr 2021 wurde uber 26.506 TAVI-Prozeduren berichtet mit einer mittleren Anzahl TAVI pro 100.000 Einwohner von 32 (Unterschiede zwischen Bundeslandern von 25 bis 42). Bei den 66.045 Hauptdiagnosen Aortenstenose variierte die Anzahl Diagnosen pro 100.000 Einwohner von 64 bis 108 (im Mittel 79) zwischen den Bundeslandern. Verglichen mit 2021 werden zusatzliche 8748 (+13 %) Diagnosen Aortenstenose und 4673 (+18 %) TAVI-Prozeduren fur das Jahr 2035 erwartet. Im Jahr 2019 konnten 57 % der deutschen Bevolkerung ein TAVI-Krankenhaus in 30 min erreichen und 91 % innerhalb von 60 min Fahrzeit mit dem Auto (im Mittel 31 min Fahrzeit). Bei einer Mindestmenge von 150 TAVI/Krankenhaus im Jahr 2019 ware in Sachsen-Anhalt die Fahrzeit von im Mittel 33 auf 52 min angestiegen, und in Hessen hatten auf einen Schlag 6 von 8 TAVI-Krankenhausern die Versorgung mit TAVI einstellen mussen.SchlussfolgerungenMindestmengenregelungen verandern in willkurlicher Weise den Zugang zu TAVI fur die Bevolkerung und stehen im Gegensatz zu den Verpflichtungen der Bundeslander, die Versorgung sicherzustellen. Diese Aspekte sollten bei der kommenden Krankenhaus-Strukturreform berucksichtigt werden.Hintergrund Die Transkatheter-Aortenklappen-Implantation (TAVI) zur Behandlung der Aortenklappenstenose bei älteren Patienten ist zur Standardbehandlung gereift mit einem hohen Versorgungsgrad in Deutschland. Die avisierte Strukturreform des Gesundheitswesens könnte Einfluss auf die Versorgung mit TAVI haben. Deshalb ist es notwendig zu analysieren, welche Auswirkungen politische Vorgaben auf die TAVI-Versorgung haben können und wie der Bedarf an TAVI-Prozeduren entsprechend der demografischen Entwicklung zukünftig sein wird. Methodik Die Anzahl an TAVI-Prozeduren (DRG F98A + F98B) und Krankenhaus-Hauptdiagnosen der Aortenstenose (ICD I35) wurden für 2021 für die Landkreise und föderalen Bundesländer auf der Basis anonymisierter §‑21-Datensätze analysiert. Basierend auf der Prognose der demografischen Entwicklung von Landkreisen und Bundesländern des Statistischen Bundesamtes wurden die Anzahl von Aortenklappenstenosen-Diagnosen und TAVI für das Jahr 2035 hochgerechnet. Anhand der Krankenhaus-Qualitätsberichte von 2019 und eines Routenplaners wurde die Zeit zum Erreichen des nächsten TAVI (OPS 5‑35a.0) durchführenden Krankenhauses kalkuliert sowie Konsequenzen einer politisch vorgeschlagenen Mindestmenge analysiert. Ergebnisse Im Jahr 2021 wurde über 26.506 TAVI-Prozeduren berichtet mit einer mittleren Anzahl TAVI pro 100.000 Einwohner von 32 (Unterschiede zwischen Bundesländern von 25 bis 42). Bei den 66.045 Hauptdiagnosen Aortenstenose variierte die Anzahl Diagnosen pro 100.000 Einwohner von 64 bis 108 (im Mittel 79) zwischen den Bundesländern. Verglichen mit 2021 werden zusätzliche 8748 (+13 %) Diagnosen Aortenstenose und 4673 (+18 %) TAVI-Prozeduren für das Jahr 2035 erwartet. Im Jahr 2019 konnten 57 % der deutschen Bevölkerung ein TAVI-Krankenhaus in 30 min erreichen und 91 % innerhalb von 60 min Fahrzeit mit dem Auto (im Mittel 31 min Fahrzeit). Bei einer Mindestmenge von 150 TAVI/Krankenhaus im Jahr 2019 wäre in Sachsen-Anhalt die Fahrzeit von im Mittel 33 auf 52 min angestiegen, und in Hessen hätten auf einen Schlag 6 von 8 TAVI-Krankenhäusern die Versorgung mit TAVI einstellen müssen. Schlussfolgerungen Mindestmengenregelungen verändern in willkürlicher Weise den Zugang zu TAVI für die Bevölkerung und stehen im Gegensatz zu den Verpflichtungen der Bundesländer, die Versorgung sicherzustellen. Diese Aspekte sollten bei der kommenden Krankenhaus-Strukturreform berücksichtigt werden

Structured syncope care pathways based on lean six sigma methodology optimises resource use with shorter time to diagnosis and increased diagnostic yield.

To conduct a pilot study on the potential to optimise care pathways in syncope/Transient Loss of Consciousness management by using Lean Six Sigma methodology while maintaining compliance with ESC and/or NICE guidelines.Five hospitals in four European countries took part. The Lean Six Sigma methodology consisted of 3 phases: 1) Assessment phase, in which baseline performance was mapped in each centre, processes were evaluated and a new operational model was developed with an improvement plan that included best practices and change management; 2) Improvement phase, in which optimisation pathways and standardised best practice tools and forms were developed and implemented. Staff were trained on new processes and change-management support provided; 3) Sustaining phase, which included support, refinement of tools and metrics. The impact of the implementation of new pathways was evaluated on number of tests performed, diagnostic yield, time to diagnosis and compliance with guidelines. One hospital with focus on geriatric populations was analysed separately from the other four.With the new pathways, there was a 59% reduction in the average time to diagnosis (p = 0.048) and a 75% increase in diagnostic yield (p = 0.007). There was a marked reduction in repetitions of diagnostic tests and improved prioritisation of indicated tests.Applying a structured Lean Six Sigma based methodology to pathways for syncope management has the potential to improve time to diagnosis and diagnostic yield

Improvement of left ventricular function under cardiac resynchronization therapy goes along with a reduced incidence of ventricular arrhythmia

OBJECTIVES: The beneficial effects of cardiac resynchronization therapy (CRT) are thought to result from favorable left ventricular (LV) reverse remodeling, however CRT is only successful in about 70% of patients. Whether response to CRT is associated with a decrease in ventricular arrhythmias (VA) is still discussed controversially. Therefore, we investigated the incidence of VA in CRT responders in comparison with non-responders. METHODS: In this nonrandomized, two-center, observational study patients with moderate-to-severe heart failure, LV ejection fraction (LVEF) ≤35%, and QRS duration >120 ms undergoing CRT were included. After 6 months patients were classified as CRT responders or non-responders. Incidence of VA was compared between both groups by Kaplan-Meier analysis and Cox regression analysis. ROC analysis was performed to determine the aptitude of LVEF cut-off values to predict VA. RESULTS: In total 126 consecutive patients (64±11 years; 67%male) were included, 74 were classified as responders and 52 as non-responders. While the mean LVEF at baseline was comparable in both groups (25±7% vs. 24±8%; P = 0.4583) only the responder group showed an improvement of LVEF (36±6% vs. 24±7; p<0.0001) under CRT. In total in 56 patients VA were observed during a mean follow-up of 28±14 months, with CRT responders experiencing fewer VA than non-responders (35% vs. 58%, p<0.0061). Secondary preventive CRT implantation was associated with a higher likelihood of VA. As determined by ROC analysis an increase of LVEF by >7% was found to be a predictor of a significantly lower incidence of VA (AUC = 0.606). CONCLUSIONS: Improvement of left ventricular function under cardiac resynchronization therapy goes along with a reduced incidence of ventricular arrhythmia

Protected risk stratification with the wearable cardioverter-defibrillator: results from the WEARIT-II-EUROPE registry

Background!#!The prospective WEARIT-II-EUROPE registry aimed to assess the value of the wearable cardioverter-defibrillator (WCD) prior to potential ICD implantation in patients with heart failure and reduced ejection fraction considered at risk of sudden arrhythmic death.!##!Methods and results!#!781 patients (77% men; mean age 59.3 ± 13.4 years) with heart failure and reduced left ventricular ejection fraction (LVEF) were consecutively enrolled. All patients received a WCD. Follow-up time for all patients was 12 months. Mean baseline LVEF was 26.9%. Mean WCD wearing time was 75 ± 47.7 days, mean daily WCD use 20.3 ± 4.6 h. WCD shocks terminated 13 VT/VF events in ten patients (1.3%). Two patients died during WCD prescription of non-arrhythmic cause. Mean LVEF increased from 26.9 to 36.3% at the end of WCD prescription (p &amp;lt; 0.01). After WCD use, ICDs were implanted in only 289 patients (37%). Forty patients (5.1%) died during follow-up. Five patients (1.7%) died with ICDs implanted, 33 patients (7%) had no ICD (no information on ICD in two patients). The majority of patients (75%) with the follow-up of 12 months after WCD prescription died from heart failure (15 patients) and non-cardiac death (15 patients). Only three patients (7%) died suddenly. In seven patients, the cause of death remained unknown.!##!Conclusions!#!Mortality after WCD prescription was mainly driven by heart failure and non-cardiovascular death. In patients with HFrEF and a potential risk of sudden arrhythmic death, WCD protected observation of LVEF progression and appraisal of competing risks of potential non-arrhythmic death may enable improved selection for beneficial ICD implantation