Promises and Perils of Consumer Mobile Technologies in Cardiovascular Care: JACC Scientific Statement.

Direct-to-consumer (D2C) wearables are becoming increasingly popular in cardiovascular health management because of their affordability and capability to capture diverse health data. Wearables may enable continuous health care provider-patient partnerships and reduce the volume of episodic clinic-based care (thereby reducing health care costs). However, challenges arise from the unregulated use of these devices, including questionable data reliability, potential misinterpretation of information, unintended psychological impacts, and an influx of clinically nonactionable data that may overburden the health care system. Further, these technologies could exacerbate, rather than mitigate, health disparities. Experience with wearables in atrial fibrillation underscores these challenges. The prevalent use of D2C wearables necessitates a collaborative approach among stakeholders to ensure effective integration into cardiovascular care. Wearables are heralding innovative disease screening, diagnosis, and management paradigms, expanding therapeutic avenues, and anchoring personalized medicine.

Mechanistic assessment and ablation of left ventricular assist device related ventricular tachycardia in patients with severe heart failure.

Aims: Left-ventricular-assist-devices (lvad) are an established treatment for patients with severe heart failure with reduced ejection fraction (HF) and reduce mortality. However, HF patients have significant substrate for ventricular tachycardia (VT) and the lvad itself might be pro-arrhythmogenic. We investigated the mechanism of VT in lvad-patients in relation to the underlying etiology and provide in silico and ex-vivo data for ablation in these HF patients. Methods and Results: We retrospectively analyzed invasive electrophysiological (EP) studies of 17 patients with VT and lvad. The mechanism of VT was determined using electroanatomical, entrainment and activation time mapping. Ischemic cardiomyopathy was present in 70% of patients. VT originated from the lvad region in >30%. 1/6 patients with VT originating from the lvad region had episodes before lvad implantation, while 7/11 patients with VT originating from other regions had episodes before implantation. Number and time of radiofrequency (RF)-ablation lesions were not different between VTs originating from the lvad or other regions. Long-term freedom from VT was 50% upon ablation in patients with VT originating from the lvad region and 64% if ablation was conducted in other regions. To potentially preemptively mitigate lvad related VT in patients undergoing lvad implantation, we obtained in silico derived data and performed ex-vivo experiments targeting ventricular myocardium. Of the tested settings, application of 25 W for 30 s was safe and associated with optimal lesion characteristics. Conclusion: A significant percentage of patients with lvad undergoing VT ablation exhibit arrhythmia originating in close vicinity to the device and recurrence rates are high. Based on in silico and ex-vivo data, we propose individualized RF-ablation in selected patients at risk for/with lvad related VT.

Influence of monitoring and atrial arrhythmia burden on quality of life and health care utilization in patients undergoing pulsed field ablation: A secondary analysis of the PULSED AF trial.

BACKGROUND: Freedom from atrial arrhythmia (AA) recurrence ≥30 seconds after pulsed field ablation (PFA) in patients with atrial fibrillation (AF) was reported in PULSED AF (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF; ClinialTrials.gov Identifier: NCT04198701). AA burden may be a more clinically meaningful endpoint. OBJECTIVE: The purpose of this study was to determine the influence of monitoring strategies on AA detection and AA burden association with quality of life (QoL) and health care utilization (HCU) after PFA. METHODS: Patients underwent 24-hour Holter monitoring at 6 and 12 months and weekly, and symptomatic transtelephonic monitoring (TTM). AA burden post-blanking was calculated as the greater of (1) percentage of AA on total Holter time; or (2) percentage of weeks with ≥1 TTM with AA out of all weeks with ≥1 TTM. RESULTS: Freedom from all AAs varied by >20% when differing monitoring strategies were used. PFA resulted in zero burden in 69.4% of paroxysmal atrial fibrillation (PAF) and 62.2% of persistent atrial fibrillation (PsAF) patients. Median burden was low (<9%). Most PAF and PsAF patients had ≤1 week of AA detection on TTM (82.6% and 75.4%) and <30 minutes of AA per day of Holter monitoring (96.5% and 89.6%), respectively. Only PAF patients with <10% AA burden averaged a clinically meaningful (>19 point) QoL improvement. PsAF patients experienced clinically meaningful QoL improvements irrespective of burden. Repeat ablations and cardioversions significantly increased with higher AA burden (P <.01). CONCLUSION: The ≥30-second AA endpoint is dependent on the monitoring protocol used. PFA resulted in low AA burden for most patients, which was associated with clinically relevant improvement in QoL and reduced AA-related HCU.

Cardiovascular magnetic resonance pulmonary perfusion for functional assessment of pulmonary vein stenosis.

BACKGROUND: Cardiovascular magnetic resonance (CMR) imaging allows to combine pulmonary perfusion measurements and pulmonary venous angiography during a single-session examination with both imaging modules representing the basis for accurate diagnosis and therapeutic stratification of pulmonary vein (PV) stenosis. The present study investigated the clinical utility of dynamic pulmonary perfusion imaging integrated into a comprehensive CMR protocol for the evaluation of patients with suspected PV stenosis. METHODS: 162 patients with clinically suspected PV stenosis after catheter ablation of atrial fibrillation underwent a combined single-session CMR examination (cardiac cine imaging, dynamic pulmonary perfusion, and three-dimensional PV angiography). CMR angiography was used for visual grading of PV stenoses; dynamic pulmonary perfusion imaging was evaluated per lung lobe visually and quantitatively. RESULTS: All PV stenosis ≥90% showed a visible perfusion deficit of the corresponding lung lobe (60/60, 100%) while all PVs with luminal narrowing <50% exhibited normal pulmonary perfusion (680/680, 100%). However, every third 70-89% stenosis showed a normal pulmonary perfusion (10/31, 32%) while every fourth 50-69% PV stenosis was associated with hypoperfusion of the corresponding lung lobe (9/39, 23%). For quantitative pulmonary perfusion measurements, ROC analysis demonstrated high discriminatory power regarding PV stenosis detection with the highest AUC values for time-to-peak enhancement (cut-off value, 8.5 s). CONCLUSIONS: The combination of CMR angiography and CMR pulmonary perfusion allowed for assessment of the anatomical degree of PV stenosis and its hemodynamic impact on the pulmonary parenchymal level. Thus, the proposed comprehensive CMR protocol provided an efficient diagnostic work-up of patients with suspected PV stenosis.

Cardiac tamponade complicating ventricular arrhythmia ablation: Real life data on incidence, management, and outcome.

BACKGROUND AND OBJECTIVE: Cardiac tamponade during ablation procedures is a life-threatening complication. While the incidence and management of tamponade in atrial fibrillation ablation have been extensively described, the data on tamponade during ventricular ablations are very limited. The purpose of this study is to shed light on the incidence, typical perforation sites, and optimal management as observed through real-life data in a tertiary referral center for ventricular ablation. METHODS AND RESULTS: Consecutive patients with structural heart disease undergoing ventricular tachycardia ablation from 2008-2020 were analyzed. Of the 1078 patients undergoing 1287 ventricular ablation procedures, 20 procedures (1.5%) were complicated by cardiac tamponade. In all but one patient, the tamponade was treated with emergent pericardial drainage, while nine patients eventually underwent surgical repair. The perforation occurred during transseptal or subxiphoid puncture in six patients, during ventricle mapping in two patients, and during ablation in five patients (predominantly basal left ventricle). Steam pop as definite perforation cause could only be established in two patients. Regardless of the management of the complication, all patients survived to discharge. CONCLUSION: Cardiac tamponade during ventricular ablation occurred in 1.5% of the procedures. In nine patients cardiac repair was necessary. Perforation was mostly associated with subxiphoid puncture or ablation of the basal left ventricle.

A long-term cost-effectiveness analysis of cardiac resynchronisation therapy with or without defibrillator based on health claims data.

BACKGROUND: In Germany, CRT devices with defibrillator capability (CRT-D) have become the predominant treatment strategy for patients with heart failure and cardiac dyssynchrony. However, according to current guidelines, most patients would also be eligible for the less expensive CRT pacemaker (CRT-P). We conducted a cost-effectiveness analysis for CRT-P devices compared to CRT-D devices from a German payer's perspective. METHODS: Longitudinal health claims data from 3569 patients with de novo CRT implantation from 2014 to 2019 were used to parametrise a cohort Markov model. Model outcomes were costs and effectiveness measured in terms of life years. Transition probabilities were derived from multivariable parametric survival regression that controlled for baseline differences of CRT-D and CRT-P patients. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: The Markov model predicted a median survival of 84 months for CRT-P patients and 92 months for CRT-D patients. In the base case, CRT-P devices incurred incremental costs of € - 13,093 per patient and 0.30 incremental life years were lost. The ICER was € 43,965 saved per life year lost. In the probabilistic sensitivity analysis, uncertainty regarding the effectiveness was observed but not regarding costs. CONCLUSION: This modelling study illustrates the uncertainty of the higher effectiveness of CRT-D devices compared to CRT-P devices. Given the difference in incremental costs between CRT-P and CRT-D treatment, there would be significant potential cost savings to the healthcare system if CRT-D devices were restricted to patients likely to benefit from the additional defibrillator.

Device runtime and costs of cardiac resynchronization therapy pacemakers - a health claims data analysis.

Introduction: This study investigates the runtime and costs of biventricular defibrillators (CRT-D) and biventricular pacemakers (CRT-P). Accurate estimates of cardiac resynchronization therapy (CRT) device runtime across all manufactures are rare, especially for CRT-P. Methods: Health claims data of a large nationwide German health insurance was used to analyze CRT device runtime. We defined device runtime as the time between the date of implantation and the date of generator change or removal. The median costs for implantation, change, and removal of a CRT device were calculated accordingly. Results: In total, the data set comprises 17,826 patients. A total of 4,296 complete runtimes for CRT-D devices and 429 complete runtimes for CRT-P devices were observed. Median device runtime was 6.04 years for CRT-D devices and 8.16 years for CRT-P devices (log-rank test p<0.0001). The median cost of implantation for a CRT-D device was 14,270 EUR, and for a CRT-P device 9,349 EUR. Conclusions: Compared to CRT-P devices, CRT-D devices had a significantly shorter device runtime of about two years. Moreover, CRT-D devices were associated with higher cost. The study provides important findings that can be utilized by cost-effectiveness analyses.

European Society of Cardiology guidance for the diagnosis and management of cardiovascular disease during the COVID-19 pandemic: part 1-epidemiology, pathophysiology, and diagnosis.

AIMS: Since its emergence in early 2020, the novel severe acute respiratory syndrome coronavirus 2 causing coronavirus disease 2019 (COVID-19) has reached pandemic levels, and there have been repeated outbreaks across the globe. The aim of this two-part series is to provide practical knowledge and guidance to aid clinicians in the diagnosis and management of cardiovascular disease (CVD) in association with COVID-19. METHODS AND RESULTS: A narrative literature review of the available evidence has been performed, and the resulting information has been organized into two parts. The first, reported here, focuses on the epidemiology, pathophysiology, and diagnosis of cardiovascular (CV) conditions that may be manifest in patients with COVID-19. The second part, which will follow in a later edition of the journal, addresses the topics of care pathways, treatment, and follow-up of CV conditions in patients with COVID-19. CONCLUSION: This comprehensive review is not a formal guideline but rather a document that provides a summary of current knowledge and guidance to practicing clinicians managing patients with CVD and COVID-19. The recommendations are mainly the result of observations and personal experience from healthcare providers. Therefore, the information provided here may be subject to change with increasing knowledge, evidence from prospective studies, and changes in the pandemic. Likewise, the guidance provided in the document should not interfere with recommendations provided by local and national healthcare authorities.

SARS-CoV-2 rapid antigen testing in the healthcare sector: A clinical prediction model for identifying false negative results.

OBJECTIVES: SARS-CoV-2 rapid antigen tests (RAT) provide fast identification of infectious patients when RT-PCR results are not immediately available. We aimed to develop a prediction model for identification of false negative (FN) RAT results. METHODS: In this multicenter trial, patients with documented paired results of RAT and RT-PCR between October 1st 2020 and January 31st 2021 were retrospectively analyzed regarding clinical findings. Variables included demographics, laboratory values and specific symptoms. Three different models were evaluated using Bayesian logistic regression. RESULTS: The initial dataset contained 4,076 patients. Overall sensitivity and specificity of RAT was 62.3% and 97.6%. 2,997 cases with negative RAT results (FN: 120; true negative: 2,877; reference: RT-PCR) underwent further evaluation after removal of cases with missing data. The best-performing model for predicting FN RAT results containing 10 variables yielded an area under the curve of 0.971. Sensitivity, specificity, PPV and NPV for 0.09 as cut-off value (probability for FN RAT) were 0.85, 0.99, 0.7 and 0.99. CONCLUSION: FN RAT results can be accurately identified through ten routinely available variables. Implementation of a prediction model in addition to RAT testing in clinical care can provide decision guidance for initiating appropriate hygiene measures and therefore helps avoiding nosocomial infections.

Hospitalisations for emergency-sensitive conditions in Germany during the COVID-19 pandemic: insights from the German-wide Helios hospital network.

BACKGROUND: While there are numerous reports that describe emergency care during the early COVID-19 pandemic, there is scarcity of data for later stages. This study analyses hospitalisation rates for 37 emergency-sensitive conditions in the largest German-wide hospital network during different pandemic phases. METHODS: Using claims data of 80 hospitals, consecutive cases between 1 January and 17 November 2020 were analysed and compared with a corresponding period in 2019. Incidence rate ratios (IRRs) comparing the two periods were calculated using Poisson regression to model the number of hospitalisations per day. RESULTS: There was a reduction in hospitalisations between 12 March and 13 June 2020 (coinciding with the first pandemic wave) with 32 807 hospitalisations (349.0/day) as opposed to 39 379 (419.0/day) in 2019 (IRR 0.83, 95% CI 0.82 to 0.85, p<0.01). During the following period (14 June-17 November 2020, including the start of second wave), hospitalisations were reduced from 63 799 (406.4/day) in 2019 to 59 910 (381.6/day) in 2020, but this reduction was not as pronounced (IRR 0.94, 95% CI 0.93 to 0.95, p<0.01). During the first wave hospitalisations for acute myocardial infarction, aortic aneurysm/dissection, pneumonitis, paralytic ileus/intestinal obstruction and pulmonary embolism declined but subsequently increased compared with the corresponding periods in 2019. In contrast, hospitalisations for sepsis, pneumonia, obstructive pulmonary disease and intracranial injuries were reduced during the entire observation period. CONCLUSIONS: There was an overall reduction of absolute hospitalisations for emergency-sensitive conditions in Germany during the first 10 months of the COVID-19 pandemic with heterogeneous effects on different disease categories. The increase in hospitalisations for acute myocardial infarction, aortic aneurysm/dissection and pulmonary embolism requires attention and further studies.

Cardiac Resynchronisation Therapy in Patients with Moderate to Severe Heart Failure in Germany: A Cost-Utility Analysis of the Additional Defibrillator.

BACKGROUND: Cardiac resynchronisation therapy (CRT) is a well-established form of treatment for patients with heart failure and cardiac dyssynchrony. There are two different types of CRT devices: the biventricular pacemaker (CRT-P) and the biventricular defibrillator (CRT-D). The latter is more complex but also more expensive. For the majority of patients who are eligible for CRT, both devices are appropriate according to current guidelines. The purpose of this study was to conduct a cost-utility analysis for CRT-D compared to CRT-P from a German payer's perspective. METHODS: A cohort Markov-model was developed to assess average costs and quality-adjusted life-years (QALY) for CRT-D and CRT-P. The model consisted of six stages: one for the device implementation, one for the absorbing state death, and two stages ("Stable" and "Hospital") for either a CRT device or medical therapy. The time horizon was 20 years. Deterministic and probabilistic sensitivity analyses and scenario analyses were conducted. RESULTS: The incremental cost-effectiveness ratio (ICER) of CRT-D compared with CRT-P was €24,659 per additional QALY gained. In deterministic sensitivity analysis, the survival advantage of CRT-D to CRT-P was the most influential input parameter. In the probabilistic sensitivity analysis 96% of the simulated cases were more effective but also more costly. CONCLUSIONS: Therapy with CRT-D compared to CRT-P resulted in an additional gain of QALYs, but was more expensive. In addition, the ICER was subject to uncertainty, especially due to the uncertainty in the survival benefit. A randomised controlled trial and subgroup analyses would be desirable to further inform decision making.

Educational needs among physicians treating patients with atrial fibrillation: lessons for Poland from the European Society of Cardiology international educational needs assessment study.

INTRODUCTION: A study by the European Society of Cardiology assessing international educational needs has identified educational and organizational barriers preventing the implementation of optimal therapy of atrial fibrillation (AF) across European countries. OBJECTIVES: Our aim was to investigate educational and organizational barriers in the implementation of guideline­recommended AF care that are specific to physicians and health-care system in Poland. PATIENTS AND METHODS: An internet­based survey was conducted to assess education, skills, and confidence in managing patients with AF among European cardiologists, neurologists, and family physicians (FPs) from 6 countries. RESULTS: Out of 571 respondents, the Polish sample included 90 physicians (16%): 44 cardiologists (15%), 21 neurologists (16%), and 25 FPs (18%). Polish physicians generally reported skills and confidence similar to those presented by their foreign colleagues, but there was high uncertainty concerning skills and confidence in the identification and pathophysiological classification of AF. Also, FPs reported low confidence in applying CHA2DS2­VASc and HAS­BLED scores to clinical practice. The need for access to long­term heart rhythm monitoring including implantable loop recorders was highlighted. There was a general dissatisfaction with the cooperation among Polish physicians, which was significantly higher than in other countries. CONCLUSIONS: The number of substantial educational gaps among physicians from Poland and other European countries is low. Nonetheless, educational programs tailored for different specialist groups separately to improve competence are warranted. There is a clear need for improvement of communication among different specialists treating patients with AF in Poland.

Inguinal vascular complications after ablation of atrial fibrillation: an economic impact assessment.

AIMS: Ablation of atrial fibrillation (AF) is recommended in the guidelines as a Class Ia/IIa indication. However, associated complications should not be dismissed; specifically, inguinal vascular complications (IVC). Although IVCs are generally considered trivial, they represent an economic burden for the procedure-performing hospital and the patient. Therefore, the ability to monitor and ultimately minimize potential complications is of considerable interest. METHODS AND RESULTS: An economic model was developed to calculate the economic impact for certain IVC-types from a large German single-centre perspective in 2015 and 2016. Twenty-nine of 1040 (2.79%) and 48 of 1152 (4.17%) AF-ablation patients had documented IVC in 2015 and 2016 (P = 0.08), respectively. Inguinal vascular complications that required invasive treatment (thrombin, intervention, surgery) occurred in 0.58% of the 2015 and in 0.87% of the 2016 AF-ablation cases. The expected excess costs (incorporating direct costs, benefit lost adjusted for reimbursement) per patient treated with AF-ablation were 139.54€ and 153.31€ in 2015 and 2016, respectively. This was mostly driven by opportunity costs, which could reach 15 544.71€ for certain IVC. Sensitivity analysis revealed the probability of occurrence, length of stay of certain IVC types, and the revenue per day influenced the expected costs per AF-ablation patient. CONCLUSION: Even relatively benign complications such as IVC can result in considerable cost increases. Therefore, measures to reduce them should be established and implemented.

Major knowledge gaps and system barriers to guideline implementation among European physicians treating patients with atrial fibrillation: a European Society of Cardiology international educational needs assessment.

Aims: Guideline-adherent treatment is associated with improved prognosis in atrial fibrillation (AF) patients but is insufficiently implemented in clinical practice. The European Society of Cardiology (ESC) performed a multinational educational needs assessment study among cardiologists, general practitioners/family physicians (GPs/FPs), and neurologists in order to evaluate knowledge and skills of physicians and system factors related to AF care delivery. Methods and results: A total of 561 physicians (294 cardiologists, 131 neurologists, and 136 GPs/FPs) from six European countries participated. This mixed-methods study included exploratory semi-structured qualitative interviews (n = 30) and a quantitative survey that included two clinical cases (n = 531). We identified eight key knowledge gaps and system barriers across all domains of AF care. A majority across all specialties reported skills needing improvement to classify AF pathophysiologically, rather than based on duration of episodes, and reported lack of availability of long-term electrocardiogram recording. Skills interpreting the CHA2DS2-VASc and the HAS-BLED scores were reported as needing improvement by the majority of neurologists (52% and 60%, respectively) and GPs/FPs (65% and 74%). Cardiologists calculated the CHA2DS2-VASc and HAS-BLED scores in 94%/70% in a presented case patient, but only 60%/49% of neurologists and 58%/42% of GPs/FPs did. There was much uncertainty on how to deal with anticoagulant therapy in complex patients. There was also a high disparity in using rate or rhythm control strategies, and indications for ablation. Information delivery to patients and communication between different specialties was often considered suboptimal, while national regulations and restrictions often hamper international guideline implementation. Conclusion: We identified major gaps in physicians' knowledge and skills across all domains of AF care, as well as system factors hampering guideline-compliant care implementation and communication. These gaps should be addressed by targeted educational and advocacy efforts.