Catheter ablation of ventricular arrhythmias and in-hospital mortality: insights from the German-wide Helios hospital network of 5052 cases.

AIMS: Catheter ablation (CA) of ventricular arrhythmias is one of the most challenging electrophysiological interventions with an increasing use over the last years. Several benefits must be weighed against the risk of potentially life-threatening complications which necessitates a steady reevaluation of safety endpoints. Therefore, the aims of this study were (i) to investigate overall in-hospital mortality in patients undergoing such procedures and (ii) to identify variables associated with in-hospital mortality in a German-wide hospital network. METHODS AND RESULTS: Between January 2010 and September 2018, administrative data provided by 85 Helios hospitals were screened for patients with main or secondary discharge diagnosis of ventricular tachycardia (VT) or premature ventricular contractions (PVCs) in combination with an arrhythmia-related CA using ICD- and OPS codes. In 5052 cases (mean age 60.9 ± 14.3 years, 30.1% female) of 30 different hospitals, in-hospital mortality was 1.27% with a higher mortality in patients ablated for VT (1.99%, n = 2, 955) compared to PVC (0.24%, n = 2, 097, P < 0.01). Mortality rates were 2.06% in patients with ischaemic heart disease (IHD, n = 2, 137), 1.47% in patients with non-ischaemic structural heart disease (NIHD, n = 1, 224), and 0.12% in patients without structural heart disease (NSHD, n = 1, 691). Considering different types of hospital admission, mortality rates were 0.35% after elective (n = 2, 825), 1.60% after emergency admission/hospital transfer <24 h (n = 1, 314) and 3.72% following delayed hospital transfer >24 h after initial admission (n = 861, P < 0.01 vs. elective admission and emergency admission/hospital transfer <24 h). In multivariable analysis, a delayed hospital transfer >24 h [odds ratio (OR) 2.28, 95% confidence interval (CI) 1.59-3.28, P < 0.01], the occurrence of procedure-related major adverse events (OR 6.81, 95% CI 2.90-16.0, P < 0.01), Charlson Comorbidity Index (CCI, OR 2.39, 95% CI 1.56-3.66, P < 0.01) and its components congestive heart failure (OR 8.04, 95% CI 1.71-37.8, P < 0.01), and diabetes mellitus (OR 1.59, 95% CI 1.13-2.22, P < 0.01) were significantly associated with in-hospital death. CONCLUSIONS: We reported in-hospital mortality rates after CA of ventricular arrhythmias in the largest multicentre, administrative dataset in Germany which can be implemented in quality management programs. Aside from comorbidities, a delayed hospital transfer to a CA performing centre is associated with an increased in-hospital mortality. This deserves further studies to determine the optimal management strategy.

In-hospital mortality of patients with atrial arrhythmias: insights from the German-wide Helios hospital network of 161 502 patients and 34 025 arrhythmia-related procedures.

Aims: Atrial fibrillation (AFib) and atrial flutter (AFlut) are common arrhythmias with increased use of invasive procedures. A steady re-evaluation of relevant safety endpoints is recommended and both quality management and pay-for-performance programs are evolving. Therefore, the aims of this study were (i) to investigate and report overall in-hospital mortality and mortality of invasive arrhythmia-related procedures and (ii) to identify mortality predictors in a German-wide hospital network. Methods and results: Administrative data provided by 78 Helios hospitals between 2010 and 2017 were examined using International Statistical Classification of Diseases and Related Health Problems- and Operations and Procedures-codes to identify patients with AFib or AFlut as main discharge diagnosis or secondary diagnosis combined with invasive arrhythmia-related interventions. In 161 502 patients, in-hospital mortality was 0.6% with a significant decrease from 0.75% to 0.5% (P < 0.01) during the observational period. In multivariable analysis, age [odds ratio (OR) 2.69, 95% confidence interval (CI) 2.36-3.05; P < 0.01], high centre volume (OR 0.57, 95% CI 0.50-0.65; P < 0.01), emergency hospital admission (OR 1.57, 95% CI 1.38-1.79; P < 0.01), and Charlson Comorbidity Index (CCI, OR 4.95, 95% CI 4.50-5.44; P < 0.01) were found as independent predictors of in-hospital mortality. Mortality rates were 0.05% for left atrial catheter ablation (CA, n = 21 744), 0.3% for right atrial CA (n = 9972), and 0.56% for implantation of a left atrial appendage occluder (n = 2309), respectively. Conclusion: We analysed for the first time in-hospital mortality rates of patients with atrial arrhythmias in a German-wide, multi-centre administrative dataset. This allows feasible, comparable, and up-to-date performance measurement of clinically important endpoints in a real-world setting which may contribute to quality management programs and towards value-based healthcare.

Cardiac tamponade in catheter ablation of atrial fibrillation: German-wide analysis of 21 141 procedures in the Helios atrial fibrillation ablation registry (SAFER).

Aims: Catheter ablation is an established therapy in patients with symptomatic atrial fibrillation (AF) with increasing popularity. Pericardial effusion requiring intervention (PE) is one of the most threatening adverse outcomes. The aim of this study was to examine rates of PE after catheter ablation in a large 'real-world' data set in a German-wide hospital network. Methods and results: Using ICD and OPS codes, administrative data of 85 Helios hospitals from 2010 to 2017 was used to identify AF catheter ablation cases [Helios atrial fibrillation ablation registry (SAFER)]. PE occurred in 0.9% of 21 141 catheter ablation procedures. Patients with PE were significantly older, to a higher percentage female, had more frequently hypertension, mild liver disease, diabetes with chronic complications, and renal disease. Low hospital volume (<50 procedures per year) and radiofrequency ablation (vs. cryoablation) were significantly associated with PE. Using two logistic regression models, age, female gender, hypertension, mild liver disease, diabetes with chronic complications, renal disease, low hospital volume, and radiofrequency ablation remained independent predictors for PE. Conclusion: Overall PE rate was 0.9%. Predictors for PE occurrence involved factors ascribed to the patient (age, gender, comorbidities), the type of catheter ablation (radiofrequency), and the institution (low-volume centres).

Prevention of cerebral thromboembolism by oral anticoagulation with dabigatran after pulmonary vein isolation for atrial fibrillation: the ODIn-AF trial.

BACKGROUND AND OBJECTIVES: Long-term oral anticoagulation (OAC) following successful catheter ablation of atrial fibrillation (AF) remains controversial. Prospective data are missing. The ODIn-AF study aimed to evaluate the effect of OAC on the incidence of silent cerebral embolic events and clinically relevant cardioembolic events in patients at intermediate to high risk for embolic events, free from AF after pulmonary vein isolation (PVI). METHODS: This prospective, randomized, multicenter, open-label, blinded endpoint interventional trial enrolled patients who were scheduled for PVI to treat paroxysmal or persistent AF. Six months after PVI, AF-free patients were randomized to receive either continued OAC with dabigatran or no OAC. The primary endpoint was the incidence of new silent micro- and macro-embolic lesions detected on brain MRI at 12 months of follow-up compared to baseline. Safety analysis included bleedings, clinically evident cardioembolic, and serious adverse events (SAE). RESULTS: Between 2015 and 2021, 200 patients were randomized into 2 study arms (on OAC: n = 99, off OAC: n = 101). There was no significant difference in the occurrence of new cerebral microlesions between the on OAC and off OAC arm [2 (2%) versus 0 (0%); P = 0.1517] after 12 months. MRI showed no new macro-embolic lesion, no clinical apparent strokes were present in both groups. SAE were more frequent in the OAC arm [on OAC n = 34 (31.8%), off OAC n = 18 (19.4%); P = 0.0460]; bleedings did not differ. CONCLUSION: Discontinuation of OAC after successful PVI was not found to be associated with an elevated risk of cerebral embolic events compared with continued OAC after a follow-up of 12 months.

Metabolic syndrome with or without diabetes contributes to left ventricular diastolic dysfunction.

OBJECTIVE: Left ventricular diastolic dysfunction (LVDD) is considered a precursor of diabetic cardiomyopathy, while the metabolic syndrome (MetS) is associated with an increased risk of cardiovascular morbidity and mortality. This study aimed to evaluate the association between LVDD, MetS and glucose metabolism disturbances classified by oral glucose tolerance testing (oGTT). METHODS AND RESULTS: The presence of LVDD was evaluated in 166 subjects with normal ejection fraction, 43 (26%) of whom had type 2 diabetes at inclusion. In subjects without diabetes, an oGTT was performed. The MetS was diagnosed as indentified by the NCEPIII-criteria, while LVDD was verified and graded according to the current guidelines. MetS was diagnosed in 97 (59%) patients, 44% of whom had known diabetes. The prevalence of LVDD was 68% in subjects with MetS vs. 19% in patients without MetS, respectively (P < 0.001). A severe form of LVDD was observed in 34% and 15% of patients with and without MetS, respectively (P = 0.001), whereupon the prevalence of mild and severe diastolic dysfunction increased with the number of MetS criteria (P= 0.001). In the MetS group, early diastolic tissue relaxation velocity (E') was significantly reduced (6.9 +/- 1.8 cm/s vs. 7.7 +/- 2.1 cm/s; P= 0.009) and the E/E' ratio was significantly higher (10.5 +/- 3.9 vs. 9.1 +/- 3.0 cm/s, P = 0.015) as compared to the group without MetS (n = 69). CONCLUSION: MetS was associated with a higher prevalence and severity of LVDD, whereupon coexisting diabetes aggravates these inding.Patients displaying MetS with concomitant LVDD might represent a target population in which appropriate medical care for early heart failure prevention should be initiated.

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.

Limiting esophageal temperature in radiofrequency ablation of left atrial tachyarrhythmias results in low incidence of thermal esophageal lesions.

BACKGROUND: Atrio-esophageal fistula formation following radiofrequency ablation of left atrial tachyarrhythmias is a rare but devastating complication. Esophageal injuries are believed to be precursors of fistula formation and reported to occur in up to 47% of patients. This study investigates the incidence of esophageal lesions when real time esophageal temperature monitoring and temperature limitation is used. METHODS: 184 consecutive patients underwent open irrigated radiofrequency ablation of left atrial tachyarrhythmias. An esophageal temperature probe consisting of three independent thermocouples was used for temperature monitoring. A temperature limit of 40°C was defined to interrupt energy delivery. All patients underwent esophageal endoscopy the next day. RESULTS: Endoscopy revealed ulcer formation in 3/184 patients (1.6%). No patient developed atrio-esophageal fistula. Patient and disease characteristics had no influence on ulcer formation. The temperature threshold of 40°C was reached in 157/184 patients. A temperature overshoot after cessation of energy delivery was observed frequently. The mean maximal temperature was 40.8°C. Using a multiple regression analysis creating a box lesion that implies superior- and inferior lines at the posterior wall connecting the right and left encircling was an independent predictor of temperature. Six month follow-up showed an overall success rate of 78% documented as sinus rhythm in seven-day holter ECG. CONCLUSION: Limitation of esophageal temperature to 40°C is associated with the lowest incidence of esophageal lesion formation published so far. This approach may contribute to increase the safety profile of radiofrequency ablation in the left atrium.

Sex differences of resource utilisation and outcomes in patients with atrial arrhythmias and heart failure.

OBJECTIVE: Atrial fibrillation or atrial flutter (AF) and heart failure (HF) often go hand in hand and, in combination, lead to an increased risk of death compared with patients with just one of both entities. Sex-specific differences in patients with AF and HF are under-reported. Therefore, the aim of this study was to investigate sex-specific catheter ablation (CA) use and acute in-hospital outcomes in patients with AF and concomitant HF in a retrospective cohort study. METHODS: Using International Statistical Classification of Diseases and Related Health Problems and Operations and Procedures codes, administrative data of 75 hospitals from 2010 to 2018 were analysed to identify cases with AF and HF. Sex differences were compared for baseline characteristics, right and left atrial CA use, procedure-related adverse outcomes and in-hospital mortality. RESULTS: Of 54 645 analysed cases with AF and HF, 46.2% were women. Women were significantly older (75.4±9.5 vs 68.7±11.1 years, p<0.001), had different comorbidities (more frequently: cerebrovascular disease (2.4% vs 1.8%, p<0.001), dementia (5.3% vs 2.2%, p<0.001), rheumatic disease (2.1% vs 0.8%, p<0.001), diabetes with chronic complications (9.7% vs 9.1%, p=0.033), hemiplegia or paraplegia (1.7% vs 1.2%, p<0.001) and chronic kidney disease (43.7% vs 33.5%, p<0.001); less frequently: myocardial infarction (5.4% vs 10.5%, p<0.001), peripheral vascular disease (6.9% vs 11.3%, p<0.001), mild liver disease (2.0% vs 2.3%, p=0.003) or any malignancy (1.0% vs 1.3%, p<0.001), underwent less often CA (12.0% vs 20.7%, p<0.001), had longer hospitalisations (6.6±5.8 vs 5.2±5.2 days, p<0.001) and higher in-hospital mortality (1.6% vs 0.9%, p<0.001). However, in the multivariable generalised linear mixed model for in-hospital mortality, sex did not remain an independent predictor (OR 0.96, 95% CI 0.82 to 1.12, p=0.579) when adjusted for age and comorbidities. Vascular access complications requiring interventions (4.8% vs 4.2%, p=0.001) and cardiac tamponade (0.3% vs 0.1%, p<0.001) occurred more frequently in women, whereas stroke (0.6% vs 0.5%, p=0.179) and death (0.3% vs 0.1%, p=0.101) showed no sex difference in patients undergoing CA. CONCLUSIONS: There are sex differences in patients with AF and HF with respect to demographics, resource utilisation and in-hospital outcomes. This needs to be considered when treating women with AF and HF, especially for a sufficient patient informed decision making in clinical practice.

[Catheter ablation of ventricular outflow tract arrhythmias using an electroanatomic mapping system]. / Katheterablation von ventrikulären Ausflusstrakt-Arrhythmien unter Einsatz eines elektroanatomischen Mapping-Systems.

BACKGROUND: In some patients with arrhythmias originating from the ventricular outflow tract, catheter ablation may be considered for curative treatment. The conventional ablation procedure may be limited particularly in cases with nonsustained arrhythmias. Only little information is available about three-dimensional electroanatomic mapping combined with the cooled radiofrequency (RF) catheter ablation technique in the treatment of such arrhythmias. PATIENTS AND METHODS: 17 symptomatic and drug-refractory patients were included into this study. Using an electroanatomic mapping system (CARTO), activation mapping was obtained in twelve patients during ventricular tachycardia (VT) or ventricular ectopic beats. In five cases with nonsustained arrhythmias pace mapping during sinus rhythm was performed. The aim was to identify the precise localization of the arrhythmia origin and to abolish its activity by cooled ablation. RESULTS: Procedure time was 117 +/- 35 min, fluoroscopy time totaled 17 +/- 13 min. Ablation was performed with a mean of 7 +/- 5 ablation pulses. In 15 patients (88%) ablation of the clinical VT was acutely successful. During a follow-up of 9 +/- 9 months, two patients had a recurrence of the clinical VT. In one of these cases a successful reablation was performed. No major complications were observed. CONCLUSION: Electroanatomic mapping combined with focal cooled ablation strategy is a safe method to treat ventricular outflow tract arrhythmias effectively.

Intraprocedural reduction of the veno-arterial norepinephrine gradient correlates with blood pressure response after renal denervation.

AIMS: No intraprocedural assessment is currently available to evaluate the extent of nerve ablation by renal denervation (RDN). We prospectively evaluated the association of intraprocedural reduction of renal veno-arterial norepinephrine gradient with blood pressure (BP) response after RDN. METHODS AND RESULTS: In 46 consecutive RDN patients, the periprocedural norepinephrine veno-arterial difference was defined as veno-arterial norepinephrine gradient. We observed a reduction of the office systolic BP from 176±19 mmHg to 165±24 mmHg (p=0.02) at three months and 163±22 mmHg (p=0.02) at six months. The mean and maximum systolic ABP decreased by 5 mmHg (p=0.03) and 9 mmHg (p=0.02), respectively. There was a decrease of the norepinephrine RV-RA difference from pre- to post-procedural levels (median 186 pg/ml [54;466] vs. 81 pg/ml [0;182], p=0.02). OBP responders (office systolic BP reduction ≥10 mmHg) showed a greater reduction of the norepinephrine gradient compared to non-responders (-290±450 pg/ml vs. -4±106 pg/ml, p=0.01). Patients with a reduction of norepinephrine gradient in both kidneys showed the most pronounced decrease of the systolic OBP (-24±14 mmHg) compared to patients with a reduction of norepinephrine gradient in only one kidney (-7±15 mmHg) or patients without a norepinephrine reduction (-3±19 mmHg, p=0.03 vs. bilateral reduction). CONCLUSIONS: Measuring renal norepinephrine gradient during RDN may be a method to gauge the extent of renal nerve ablation.

Circumferential pulmonary vein ablation for treatment of atrial fibrillation using an irrigated-tip catheter.

In this study, a series of 52 consecutive patients with atrial fibrillation from 1 institution underwent circumferential pulmonary vein ablation using an irrigated-tip catheter. The technique was safe, and 81% of the patients maintained sinus rhythm at 6 months. However, 1/3 of them required additional antiarrhythmic drug therapy.

Soluble P-selectin and matrix metalloproteinase 2 levels are elevated in patients with diastolic dysfunction independent of glucose metabolism disorder or coronary artery disease.

OBJECTIVE: The development of diastolic dysfunction (DDF) is multifactorial. Possible mechanisms include metabolic disturbances, myocardial fibrosis, chronic inflammation and endothelial dysfunction. Recognizing early stages of DDF may help to identify patients at risk of developing symptomatic DDF. Therefore, biomarkers reflecting pathophysiological changes within the myocardium were investigated in patients with DDF. METHODS: Seventy-seven patients submitted for coronary angiography with stable or suspected coronary artery disease (CAD) were consecutively enrolled. Those without known diabetes mellitus (DM) underwent a standardized oral glucose tolerance test. Echocardiography for the diagnosis of DDF was performed according to the European Society of Cardiology. Matrix metalloproteinase 2 (MMP-2) and soluble P-selectin (sP-selectin) serum concentrations were analyzed using the ELISA technique. RESULTS: A total of 36% of patients had DM and 74% had CAD. The prevalence of DDF was higher in patients with DM (89% versus 74%) and CAD (84% versus 53%) (P<0.05). DDF in patients with DM was more severe with a significantly lower mitral annulus velocity of 6.5 cm/s versus 7.8 cm/s (P<0.01). Patients with DDF showed significantly higher sP-selectin (140.3 mug/L versus 107.6 mug/L, P<0.05) and MMP-2 (270.5 mug/L versus 224.7 mug/L, P<0.05) levels compared with those without DDF. There was a significant correlation between sP-selectin and MMP-2 (P=0.01), independent of the diagnosis of DM or CAD. CONCLUSION: sP-selectin as a marker for platelet hyperactivity, inflammation and endothelial dysfunction, and MMP-2 as a marker for extracellular matrix turnover were significantly elevated in patients with DDF. This elevation was independent of coexisting DM or CAD. This observation may help to identify and monitor patients with DDF.