Reliable Detection of Atrial Fibrillation with a Medical Wearable during Inpatient Conditions.

Atrial fibrillation (AF) is the most common arrhythmia and has a major impact on morbidity and mortality; however, detection of asymptomatic AF is challenging. This study sims to evaluate the sensitivity and specificity of non-invasive AF detection by a medical wearable. In this observational trial, patients with AF admitted to a hospital carried the wearable and an ECG Holter (control) in parallel over a period of 24 h, while not in a physically restricted condition. The wearable with a tight-fit upper armband employs a photoplethysmography technology to determine pulse rates and inter-beat intervals. Different algorithms (including a deep neural network) were applied to five-minute periods photoplethysmography datasets for the detection of AF. A total of 2306 h of parallel recording time could be obtained in 102 patients; 1781 h (77.2%) were automatically interpretable by an algorithm. Sensitivity to detect AF was 95.2% and specificity 92.5% (area under the receiver operating characteristics curve (AUC) 0.97). Usage of deep neural network improved the sensitivity of AF detection by 0.8% (96.0%) and specificity by 6.5% (99.0%) (AUC 0.98). Detection of AF by means of a wearable is feasible in hospitalized but physically active patients. Employing a deep neural network enables reliable and continuous monitoring of AF.

Safety and feasibility of percutaneous skin closure using purse-string suture compared with compression bandage after pulmonary vein isolation.

INTRODUCTION: This observational study was designed to analyze the safety and feasibility of percutaneous skin closure using a purse-string suture and compare it with the use of a compression bandage after pulmonary vein isolation. METHODS AND RESULTS: A total of 407 patients undergoing pulmonary vein isolation (217 with radiofrequency and 190 with cryoballoon ablation) were treated with either purse-string sutures or compression bandages. The purse-string suture was applied after ablation before withdrawal of the sheaths. Patients were on bed rest for 6 hours prior to suture removal, which was accomplished 18-24 h after ablation. The compression bandage was applied after sheath withdrawal and was removed after 12 hours of bed rest. We analyzed the occurrence of any vascular or thromboembolic complication as well as hospital costs and hospital stay length after ablation. The incidence of vascular complications after compression bandage was higher than after purse-string suture in the cryoballoon and radiofrequency group (P < 0.05, respectively). The hospital costs were lower and hospital stay was shorter in both radiofrequency (4.921 ± 3.145 vs. 5.802 ± 4.006 Euro; 2.34 ± 1.32 vs. 2.98 ± 1.57 days, P < 0.05) and cryoballoon groups (4.705 ± 3.091 vs. 5.661 ± 3.563 Euro; 2.14 ± 1.37 vs. 2.61 ± 1.55 days, P < 0.05) in patients treated with a purse-string suture. CONCLUSIONS: Percutaneous skin closure with a purse-string suture has the clinical impact to reduce vascular complications, hospital costs, and hospital stay length after pulmonary vein isolation.

The slope of the initial temperature drop predicts acute pulmonary vein isolation using the second-generation cryoballoon.

AIMS: There is no objective, early indicator of occlusion quality, and efficacy of cryoballoon pulmonary vein isolation. As previous experience suggests that the initial cooling rate correlates with these parameters, we investigated the slope of the initial temperature drop as an objective measure. METHODS AND RESULTS: A systematic evaluation of 523 cryoapplications in 105 patients using a serial ROC-AUC analysis was performed. We found the slope of a linear regression of the temperature-time function to be a good predictor (PPV 0.9, specificity 0.72, sensitivity 0.71, and ROC-AUC 0.75) of acute isolation. It also correlated with nadir temperatures (P< 0.001, adjusted R2= 0.43), predicted very low nadir temperatures, and varied according to visual occlusion grades (ANOVA P< 0.001). CONCLUSIONS: About 25 s after freeze initiation, the temperature-time slope predicts important key characteristics of a cryoablation, such as nadir temperature. The slope is the only reported predictor to actually precede acute isolation and thus to support decisions about pull-down manoeuvres or aborting a cryoablation early on. It is also predictive of very low nadir temperatures and phrenic nerve palsy and thus may add to patient safety.

Cryoballoon ablation of persistent atrial fibrillation: feasibility and safety of left atrial roof ablation with generation of conduction block in addition to antral pulmonary vein isolation.

AIMS: Although the generation of linear lesions by ablation improves success rates in patients with persistent atrial fibrillation (AF), the procedure has been considered unsuitable for cryoablation balloon catheter technologies. We developed a technique for linear ablations, using second-generation cryoballoon technology. METHODS AND RESULTS: This was a single-arm, prospective study in 76 patients with persistent AF treated consecutively at our centre. Cryoablation was performed using a 28 mm second-generation cryoballoon. The first cryoenergy application was performed in close proximity to the position during isolation of the left superior pulmonary vein (PV). Sequential overlapping freezes were applied along the left atrial (LA) roof by slight clockwise rotation of the sheath in combination with slight retraction of the sheath and incremental advancement of the cryoballoon, until reaching the original position for right superior PV isolation. The acute endpoint was the creation of a roofline, defined as complete conduction block across the LA roof >120 ms and ascending activation across the posterior LA wall. Acute success in roofline generation was achieved in 88% of patients, applying on average five (median 4-6) freezes with nadir temperature of -40°C (-36 to -44°C). In five patients, conduction block could not be achieved. No phrenic nerve injuries occurred during roofline generation. CONCLUSION: Generation of linear roofline lesions is possible with the second-generation cryoballoon. The technique can be used in combination with PV isolation to treat persistent AF with good acute success rates, short procedure times, and acceptable safety concerns. If validated by further studies, the method would be an appealing alternative to radiofrequency ablation techniques.

Prognostic value of aldosterone and cortisol in patients hospitalized for acutely decompensated chronic heart failure with and without mineralocorticoid receptor antagonism.

BACKGROUND: Serum aldosterone and cortisol independently predict an increased mortality risk in heart failure (HF), and mineralocorticoid receptor antagonism (MRA) improves survival. The prognostic relevance of aldosterone and cortisol with MRA is unclear. METHODS AND RESULTS: In this post hoc analysis of a prospective cohort, study serum levels of aldosterone and cortisol were measured at baseline in 842 patients with systolic HF. The mean age was 68 ± 12 years (27% female, 45% in New York Heart Association functional class III/IV, 43% with MRA; median follow-up 38 months [interquartile range 30-43 mo]). Crude mortality in the total cohort was 43% (patients with vs without MRA: 34% vs 41%; P = .052). In MRA-naïve patients, higher levels of both aldosterone and cortisol were predictive of increased mortality risk in multivariable Cox regression: hazard ratio (HR) with 95% confidence interval of highest vs lowest tertile for aldosterone: 1.51 [1.02-2.24] (P = .040); and for cortisol: 1.94 [1.28-2.93] (P = .002). In MRA-treated patients, aldosterone (highest vs lowest tertile: HR 1.65 [1.01-2.71]; P = .048) but not cortisol (HR 0.77 [0.44-1.27]; P = .33) was associated with all-cause mortality. Further subgroup analysis revealed that particularly patients with low cortisol and high aldosterone levels had the worst prognosis (HR 5.01 [2.22-11.3]; P < .001), compared with the reference of low cortisol and low aldosterone. Subjects with this profile had larger ventricles and more often coronary artery disease. CONCLUSIONS: In systolic HF, the prognostic value of aldosterone and cortisol levels differs in dependency of MRA intake. The pathophysiologic link between low cortisol, high aldosterone, and increased mortality risk in patients with MRA needs to be clarified.

The Impact of Left Atrial Surface Area and the Second Generation Cryoballoon on Clinical Outcome of Atrial Fibrillation Cryoablation.

AIMS: In this observational study, we examine the significance of the left atrial (LA) surface area and compare the clinical usage of the Arctic Front Advance (CBA) versus Arctic Front (CB) cryoballoon with the intent to investigate the impact of each in terms of long-term freedom from atrial fibrillation (AF) for patients with nonvalvular AF. METHODS: Pulmonary vein isolation (PVI) was performed while using a cryoballoon ablation catheter in conjunction with an intraluminal circular diagnostic mapping catheter, Achieve. The consecutive patients ablated with CBA were matched with patients previously ablated with CB, using propensity score matching. The primary endpoint of this observational single-center retrospective study was the first observation of electrocardiogram-documented recurrence of atrial arrhythmias lasting >30 seconds. RESULTS: The patient demographic data were similar in the CBA- and CB-group (N = 188 patients each group). In all patients in the CBA-group and in 95% of the patients in the CB group, acute procedural PVI of all veins was achieved with the single usage of a 28-mm cryoballoon. The one-year freedom from atrial arrhythmias was significantly better in the CBA- versus the CB-group of patients, 90% versus 64%, respectively. During 15-month clinical follow-up in CBA group, patients with LA area above 23 cm(2) were more likely to experience recurrence of AF (23%) than patients with LA area below 23 cm(2) (7%). CONCLUSIONS: Comparing one-year outcomes, the CBA is superior to the CB with regards to maintenance of normal sinus rhythm. When using the CBA catheter, an enlarged LA is associated with a higher recurrence of arrhythmia.

Safety and feasibility of a 1 frame-per-second X-ray framerate in cardiac electrophysiology.

BACKGROUND: We investigated the feasibility and safety of a framerate of 1 frame per second ("fps") for fluoroscopy and cine-angiography, to lower radiation exposure for patients and personnel in cardiac electrophysiology ("EP"). METHOD: Analysis of 2521 EP procedures, 899 (36%) with the lowest available conventional framerate (3.75 fps) and 1622 (64%) procedures performed with a framerate lowered further to 1.0 fps (by looping a 1 Hz square pulse to the ECG trigger) performed between 01/2016 and 01/2020. RESULTS: Procedures performed with 1.0 fps had the same acute procedural success rates (p = 0.20) and adverse event rates (p = 0.34) as the 3.75 fps group. There was no difference in total X-ray operation time (p = 0.40). The dose-area-product (DAP) was significantly reduced from 638 to 316 cGy*cm2 (p < < 0.0001) for all procedure types together, and for each subgroup. In a multivariable linear regression model, total X-ray operation time (estimate 38 cGy*cm2 /min) and body mass index (estimate 32 cGy*cm2 / index point) and a framerate of 1.0 fps (-314 cGy*cm2 against 3.75 fps) were independent predictors of a lower DAP (p-value of t-statistic for all << 0.0001). CONCLUSIONS: A framerate of 1.0 fps is safe and feasible in cardiac electrophysiology procedures. It was associated with a significant reduction of radiation exposure for patient and personnel.

The omega-3 index in patients with heart failure: A prospective cohort study.

BACKGROUND: Epidemiologic studies on the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in heart failure are scarce, while one large intervention trial demonstrated a modest benefit. METHODS: This is a secondary analysis from the Interdisciplinary Network Heart Failure (INH) program. Patients hospitalized for systolic heart failure were enrolled and followed for 36 months. At baseline, whole blood samples from 899 patients were analyzed for fatty acid composition using a standardized analytical procedure (HS-Omega-3 Index®, O3-I). Associations of the O3-I with markers of heart failure severity, clinical characteristics, biomarkers, and mortality were analyzed. RESULTS: The mean O3-I was 3.7 ±â€¯1.0%. Patient mean age was 68 ±â€¯12 years (72% male, 43% in New York Heart Association (NYHA) class III or IV, mean LVEF 30 ±â€¯8%). During follow-up 258 patients (28.7%) died. After adjustment for potential confounders, the O3-I showed weak associations with uncured malignancy, end-systolic diameter of the left atrium, left ventricular end-diastolic and end-systolic diameters, and blood lipids and other laboratory parameters (all p < 0.05), but not with NYHA class, left ventricular ejection fraction, and the underlying cause of heart failure. The O3-I did not predict the 3-year mortality risk. CONCLUSIONS: Our results show a marked depletion of omega-3 fatty acids in patients hospitalized for decompensated heart failure (suggested target range 8-11%). Although the O3-I was associated with a panel of established risk indicators in heart failure, it did not predict mortality risk. CLINICAL TRIAL REGISTRATION: www.controlled-trials.com; ISRCTN23325295.

Frequency and prognostic impact of mid-expiratory flow reduction in stable patients six months after hospitalisation for heart failure with reduced ejection fraction.

AIM: This study investigates the prevalence and prognostic impact of central and small airways obstruction (CAO and SAO) in patients with stable heart failure (HF). METHODS & RESULTS: Spirometry was performed in 585 outpatients (mean age 65±12years, 75% male) six months after hospitalisation for acute decompensation secondary to HF with ejection fraction <40%. We assessed forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and mid-expiratory flow (MEF) at 50% of FVC. CAO was defined by FEV1/FVC <0.7. SAO was defined by FEV1/FVC ≥0.7 plus MEF <60% of predicted value. CAO and SAO were excluded in 359 patients (61% of all). MEF <60% predicted was found in 226 patients (39% of all), among those 88 with CAO (15% of all) and 138 (24% of all) with SAO. During a twelve month follow-up, 42 patients (7.2%) died. Mortality rates of patients with CAO and SAO were comparable (12.5% and 10.9%, respectively, p=0.74), and both higher than in patients without airways obstruction (4.5%, both p<0.01). In univariable Cox regression analysis, both CAO and SAO were associated with 2-fold increased all-cause mortality risk (hazard ratios [95% confidence intervals]: 2.78 [1.33-6.19], p=0.007 and 2.51 [1.24-5.08], p=0.010, respectively). Adjustment for determinants of CAO and SAO, prognostic markers of heart failure and comorbidities attenuated the association of mortality with CAO but not with SAO. CONCLUSIONS: SAO is more common than CAO and indicates an increased mortality risk in HF. Thus, reduced MEF may be a feature of patients at risk and merits special attention in HF management.

How safe are NOACs compared with phenprocoumon after pulmonary vein isolation with the cryoballoon technique using purse-string suture closure?

INTRODUCTION: The aim of this observational study was to compare the postprocedural incidence of bleeding and thromboembolic complications associated with novel oral anticoagulants (NOACs) with that of interrupted and continuous phenprocoumon after pulmonary vein isolation (PVI) using a purse-string suture (PSS) closure of the puncture site. METHODS AND RESULTS: Consecutive patients who had undergone PVI via cryoballoon ablation were divided into the following groups: (1) interrupted phenprocoumon with heparin bridging (n=101), (2) continuous phenprocoumon targeting an internationally normalized ratio>2 (n=70), and (3) NOACs without bridging that were restarted 2-4h after the procedure (n=185). Protamine was not administered after venous closure with PSS at the end of the procedure. The total complication rate was significantly lower in group 3 than in groups 1 and 2 (1.62% vs. 6.93% vs. 7.14%, p=0.04). The hospital costs were lower and the hospital stay length was significantly shorter (4484±3742 vs. 6082±4044 Euro vs. 4908±2925, p=0.03; 1.94±1.67 vs. 2.70±1.80 vs. 2.19±1.30days, p<0.01). No thromboembolic event occurred. Vascular complications were the most common complications noted (80%). The occurrence of any complication led to a significantly longer hospital stay (5 vs. 2days, p<0.01) and higher costs (10,052±6241 Euro vs. 4747±3447, p<0.01). The vascular complication rate after PSS was independent of intraprocedural heparin dosage and activated clotting time. CONCLUSIONS: NOACs have a lower complication rate and appear to be safer in this setting than phenprocoumon. The hospital costs and hospital stay length after PVI was significantly reduced in patients treated with NOACs compared with phenprocoumon.

Nurse-coordinated collaborative disease management improves the quality of guideline-recommended heart failure therapy, patient-reported outcomes, and left ventricular remodelling.

BACKGROUND: Heart failure (HF) pharmacotherapy is often not prescribed according to guidelines. This longitudinal study investigated prescription rates and dosages of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACEi/ARB), beta-blockers, and mineralocorticoid receptor antagonists (MRA), and concomitant changes of symptoms, echocardiographic parameters of left ventricular (LV) function and morphology and results of the Short Form-36 (SF-36) Health Survey in participants of the Interdisciplinary Network Heart Failure (INH) programme. METHODS AND RESULTS: The INH study evaluated a nurse-coordinated management, HeartNetCare-HF(TM) (HNC), against Usual Care (UC) in patients hospitalized for decompensated HF [LV ejection fraction (LVEF) ≤40% before discharge). A total of 706 subjects surviving >18 months (363 UC, 343 HNC) were examined 6-monthly. At baseline, 92% received ACEi/ARB, (HNC/UC 91/93%, P = 0.28), 86% received beta-blockers (86/86%, P = 0.83), and 44% received MRA (42/47%, P = 0.07). After 18 months, beta-blocker use had increased only in HNC (+7.6%, P < 0.001). Guideline-recommended target doses were achieved more frequently in HNC for ACEi/ARB (HNC/UC: 50/25%, P < 0.001) and beta-blockers (39/15%, P < 0.001). The following variables were more improved and/or better in subjects undergoing HNC compared with UC: LVEF (47 ± 12 vs. 44 ± 12%, P = 0.004, change +17/+14%, P = 0.010), LV end-diastolic diameter (59 ± 9 vs. 61 ± 9.6 mm, P = 0.024, change -2.3/-1.4 mm, P = 0.13), New York Heart Association class (1.9 ± 0.7 vs. 2.1 ± 0.7, P = 0.001, change -0.44/-0.25, P = 0.002) and SF-36 physical component summary score (41.6 ± 11.2 vs. 38.5 ± 11.8, P = 0.004, change +3.3 vs. +1.1 score points, P < 0.02). CONCLUSIONS: Prescription rates and dosages of ACEi/ARB and beta-blockers improved more in HNC than UC patients. Concomitantly, participation in HNC was associated with significantly better clinical outcomes and more favourable echocardiographic changes after 18 months.

Impact of cardiac magnet resonance imaging on management of ventricular septal rupture after acute myocardial infarction.

A 74-year-old man was admitted to the cardiac catheterization laboratory with acute myocardial infarction. After successful angioplasty and stent implantation into the right coronary artery, he developed cardiogenic shock the following day. Echocardiography showed ventricular septal rupture. Cardiac magnet resonance imaging (MRI) was performed on the critically ill patient and provided detailed information on size and localization of the ruptured septum by the use of fast MRI sequences. Moreover, the MRI revealed that the ventricular septal rupture was within the myocardial infarction area, which was substantially larger than the rupture. As the patient's condition worsened, he was intubated and had intra-aortic balloon pump implanted, and extracorporeal membrane oxygenation was initiated. During the following days, the patient's situation improved, and surgical correction of the ventricular septal defect could successfully be performed. To the best of our knowledge, this case report is the first description of postinfarction ventricular septal rupture by the use of cardiac MRI in an intensive care patient with cardiogenic shock and subsequent successful surgical repair.

Airway obstruction in systolic heart failure--COPD or congestion?

BACKGROUND: The diagnosis of chronic obstructive pulmonary disease (COPD) in patients with systolic heart failure (SHF) is challenging because symptoms of both conditions overlap. We aimed to estimate the prevalence, correlates and prognostic impact of true COPD in patients with SHF. METHODS: To diagnose COPD under stable conditions according to the guidelines, pulmonary function testing (PFT) was performed in 619 patients six months after hospitalization for congestive SHF. In 272 patients, PFT had been also performed prior to discharge. RESULTS: In the total cohort, COPD was reported in 23% (144/619). PFT under stable conditions revealed that COPD was absent in 73% (449/619), unconfirmed in 18% (112/619), and proven in 9% (58/619). In 272 patients with serial PFT, initial airway obstruction was found in 19% (51/272) but had resolved in 47% of those (24/51) after six months. Initial hyperinflation detected by bodyplethysmography strongly predicted proven COPD six months later: odds ratio for elevated intrathoracic gas volume 12.8, 95% confidence interval (CI) 2.5-65.9; p=0.002. After a median follow-up of 34 months, 27% of the total cohort (165/619) had died. Only proven COPD was associated with an increased mortality risk after adjustment for age, sex, NYHA functional class, ejection fraction, atrial fibrillation, smoking, renal dysfunction and diabetes: hazard ratio 1.64, 95%CI 1.03-2.63; p=0.039. CONCLUSIONS: Airway obstruction is a dynamic phenomenon in SHF. Therefore, a valid diagnosis of COPD in SHF demands serial PFT under stable conditions with special attention to hyperinflation. COPD proven by PFT is associated with an increased all-cause mortality risk.

Dysnatraemia in heart failure.

AIMS: To investigate in detail the correlates of dysnatremia, and to estimate its differential prognostic relevance in patients with heart failure with reduced or preserved LVEF. Background Hyponatraemia has been shown to carry important prognostic information in patients with heart failure with reduced left ventricular ejection fraction (LVEF). However, exact serum sodium cut-off levels are not defined and the implications for heart failure with preserved ejection fraction (HF-pEF) are unclear. The prognostic value of hypernatraemia has not been investigated systematically. Therefore, the aim of this study was to investigate in detail the correlates of dysnatraemia, and to estimate its differential prognostic relevance in patients with heart failure with reduced or preserved LVEF. METHODS AND RESULTS: One thousand consecutive patients with heart failure of any cause and severity from the Würzburg Interdisciplinary Network for Heart Failure registry were included. Non-linear models for the association between serum sodium and mortality risk were calculated using restricted cubic splines and Cox proportional hazard regression. Median follow-up time for survivors was 5.1 years. Results Independent correlates of dysnatraemia included guideline-recommended medication for chronic heart failure, indicators of renal function, and reverse associations with established cardiac risk factors. Overall mortality was 56%. Both hyponatraemia (n = 72) and hypernatraemia (n = 98) were associated with a significantly increased mortality risk: hazard ratio (HR) 2.10, 95% confidence interval (CI) 1.60-2.77; and HR 1.91, 95% CI 1.49-2.45, respectively. A U-shaped association of serum sodium with mortality risk was found. Prognosis was best for patients with high normal sodium levels, i.e. 140-145 mmol/L. CONCLUSIONS: Both hypo- and hypernatraemia indicate a markedly compromised prognosis in heart failure regardless of LVEF. Sodium levels within the reference range carry differential information on survival, with serum levels of 135-139 mmol/L indicating an increased mortality risk.

Cardiac beta1-adrenoceptor autoantibodies in human heart disease: rationale and design of the Etiology, Titre-Course, and Survival (ETiCS) Study.

AIMS: Evidence for a pathophysiologic relevance of autoimmunity in human heart disease has substantially increased over the past years. Conformational autoantibodies stimulating the cardiac beta1-adrenoceptor (beta1-aabs) are considered of importance in heart failure development and clinical pilot studies have shown their prognostic significance in human 'idiopathic' cardiomyopathy. METHODS: We recently developed a novel highly sensitive fluorescence-based functional assay to detect stimulating beta1-aabs. We will use this method to assess Etiology, Titre-Course, and effect on Survival (ETiCS) of beta1-aabs in a prospective multicentre study with serial follow-up of patients after a first acute myocarditis or myocardial infarction. Several European core laboratories will jointly study the hypothesis that both disorders may trigger autoimmune reactions leading to the generation of beta1-aabs and/or other heart-directed aabs. Further, sera from healthy controls and well-characterized patient cohorts with dilated, ischaemic, or hypertensive cardiomyopathy will be analysed retrospectively for beta1-aab prevalence, incidence, persistence, and/or clearance. CONCLUSION: ETiCS is so far the largest clinical diagnostic study projected to address cardiac autoimmunity. It attempts to unravel the pathophysiology of cardiac autoantibody formation and persistence/clearance. ETiCS will enhance current knowledge on autoimmunity in human heart disease and promote endeavours to develop novel therapies targeting cardiac aabs.