Economic analyses in cardiac electrophysiology: from clinical efficacy to cost utility.

Cardiac electrophysiology is an evolving field that relies heavily on costly device- and catheter-based technologies. An increasing number of patients with heart rhythm disorders are becoming eligible for cardiac interventions, not least due to the rising prevalence of atrial fibrillation and increased longevity in the population. Meanwhile, the expansive costs of healthcare face finite societal resources, and a cost-conscious approach to new technologies is critical. Cost-effectiveness analyses support rational decision-making in healthcare by evaluating the ratio of healthcare costs to health benefits for competing therapies. They may, however, be subject to significant uncertainty and bias. This paper aims to introduce the basic concepts, framework, and limitations of cost-effectiveness analyses to clinicians including recent examples from clinical electrophysiology and device therapy.

Atrial pacing minimization in sinus node dysfunction and risk of incident atrial fibrillation: a randomized trial.

BACKGROUND AND AIMS: High percentages of atrial pacing have been associated with an increased risk of atrial fibrillation. This study is aimed at evaluating whether atrial pacing minimization in patients with sinus node dysfunction reduces the incidence of atrial fibrillation. METHODS: In a nationwide, randomized controlled trial, 540 patients with sinus node dysfunction and an indication for first pacemaker implantation were assigned to pacing programmed to a base rate of 60 bpm and rate-adaptive pacing (DDDR-60) or pacing programmed to a base rate of 40 bpm without rate-adaptive pacing (DDD-40). Patients were followed on remote monitoring for 2 years. The primary endpoint was time to first episode of atrial fibrillation longer than 6 min. Secondary endpoints included longer episodes of atrial fibrillation, and the safety endpoint comprised a composite of syncope or presyncope. RESULTS: The median percentage of atrial pacing was 1% in patients assigned to DDD-40 and 49% in patients assigned to DDDR-60. The primary endpoint occurred in 124 patients (46%) in each treatment group (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.76-1.25, P = .83). There were no between-group differences in atrial fibrillation exceeding 6 or 24 h, persistent atrial fibrillation, or cardioversions for atrial fibrillation. The incidence of syncope or presyncope was higher in patients assigned to DDD-40 (HR 1.71, 95% CI 1.13-2.59, P = .01). CONCLUSIONS: Atrial pacing minimization in patients with sinus node dysfunction does not reduce the incidence of atrial fibrillation. Programming a base rate of 40 bpm without rate-adaptive pacing is associated with an increased risk of syncope or presyncope.

Cost-effectiveness of an antibacterial envelope for infection prevention in patients undergoing cardiac resynchronization therapy reoperations in Denmark.

AIMS: Use of an absorbable antibacterial envelope during implantation prevents cardiac implantable electronic device infections in patients with a moderate-to-high infection risk. Previous studies demonstrated that an envelope is cost-effective in high-risk patients within German, Italian, and English healthcare systems, but these analyses were based on limited data and may not be generalizable to other healthcare settings. METHODS AND RESULTS: A previously published decision-tree-based cost-effectiveness model was used to compare the costs per quality-adjusted life year (QALY) associated with adjunctive use of an antibacterial envelope for infection prevention compared to standard-of-care intravenous antibiotics. The model was adapted using data from a Danish observational two-centre cohort study that investigated infection-risk patients undergoing cardiac resynchronization therapy (CRT) reoperations with and without an antibacterial envelope (n = 1943). We assumed a cost-effectiveness threshold of €34 125/QALY gained, based on the upper threshold used by the National Institute for Health and Care Excellence (£30 000). An antibacterial envelope was associated with an incremental cost-effectiveness ratio (ICER) of €12 022 per QALY in patients undergoing CRT reoperations, thus indicating that the envelope is cost-effective when compared with standard of care. A separate analysis stratified by device type showed ICERS of €6227 (CRT defibrillator) and €29 177 (CRT pacemaker) per QALY gained. CONCLUSIONS: Cost-effectiveness ratios were favourable for patients undergoing CRT reoperations in the Danish healthcare system, and thus are in line with previous studies. Results from this study can contribute to making the technology available to Danish patients and align preventive efforts in the pacemaker and ICD area.

Nephroprotective Properties of Antidiabetic Drugs.

Chronic kidney disease (CKD) is associated with increased morbidity and mortality, especially from cardiovascular (CV) causes, and especially in people with diabetes mellitus (DM). Already the presence of DM increases CV risk and potentiates the risk of CKD. Therefore, besides glycemic control, prevention and treatment of CKD to slow its progression are of clinical importance. A significant nephroprotective effect of novel antidiabetic drugs, namely sodium-glucose cotransporter 2 inhibitors (SGLT2-I) and glucagon-like peptide 1 receptor agonists (GLP1-RA), has been shown on top of their glucose-lowering effects and was confirmed in cardiovascular outcome trials. GLP1-RA mainly reduced the risk of macroalbuminuria, whereas SGLT2-I were also associated with a lower risk of declining glomerular filtration rate (GFR) over time. The nephroprotective effects of SGLT2-I are also evident in people without DM. According to current guidelines, SGLT2-I and/or GLP1-RA are recommended for people with DM who have chronic kidney disease and/or increased cardiovascular risk. However, other antidiabetic drugs offer nephroprotective properties, which will also be discussed in this review.

Long-term follow-up of selective and non-selective His bundle pacing leads in patients with atrioventricular block.

BACKGROUND: His bundle pacing (HBP) is a novel treatment with limited knowledge on long-term outcome. We aimed to assess long-term safety and effectiveness of HBP in patients with atrioventricular block treated with HBP and a back-up right ventricular pacing (RVP) lead. METHODS: We included 38 patients from a completed single-center, randomized controlled cross-over trial designed to compare left ventricular (LV) function after 12 months of HBP vs. RVP conducted between September 2007 and August 2011. Lead performance beyond the 2-year study period was assessed based on a retrospective review of capture thresholds, sensing, impedance, energy consumption, and rate of HBP interruption. RESULTS: Patients were followed for a mean of 7 ± 4 years. Both at baseline and during follow-up, HBP leads displayed significantly higher capture thresholds than RVP leads (P < 0.001), multifold higher energy consumption (P < 0.001), and lower sensing amplitudes (P < 0.001). During follow-up, 17 (53%) HBP leads were deactivated or abandoned. The principal cause for HBP interruption was high pacing thresholds in patients with preserved LVEF during RVP. Device longevity was shorter than that of contemporary cohorts treated with dual-chamber pacing or CRT, and time to first device exchange was 6.8 ± 1.5 years. No lead dislodgements occurred, but four patients (10%) developed device-related infections requiring device extraction. CONCLUSION: HBP was interrupted in > 50% of patients during long-term follow-up. The principal cause was unacceptably high capture thresholds and no significant difference in LV function with HBP compared with RVP. Device longevity was shorter, and infection rates were higher than anticipated.

Cardiac surgery in patients with cardiac implantable electronic devices and risk of device infections: a nationwide nested case-control study.

PURPOSE: Cardiac surgery in patients with cardiac implantable electronic devices (CIEDs) has been associated with a higher risk of infective endocarditis, but how it influences risk of CIED-specific infections is not known. Our aim was to examine risk of systemic CIED infections after cardiac surgery in patients with CIEDs. METHODS: Based on data obtained from Danish administrative registries and the Danish Pacemaker and ICD Register, we conducted a case-control study nested within a nationwide cohort of patients who underwent a de novo CIED implantation in Denmark between 1998 and 2017. We defined cases as incident systemic CIED infections resulting in device system extraction. Controls were sampled 1:100 on time, age, sex and device type using risk set sampling. Exposure was defined as coronary artery bypass graft, or cardiac heart valve replacement or repair surgery. RESULTS: From a study cohort comprising 67,621 patients, we identified 170 cases and 16,788 controls. In the minimally adjusted model, the incidence rate ratio (IRR) for systemic CIED infection was 6.4 (95% confidence interval (CI) 3.8-10.7) with cardiac surgery, and after additional confounder adjustment, 5.4 (95% CI 3.2-9.2). IRRs were higher with restriction to heart valve replacement surgery (adjusted IRR 7.5, 95% CI 4.0-16.6), and when limiting our exposure time window to one year (adjusted IRR 10.1, 95% CI 4.5-22.3). CONCLUSION: Cardiac surgery in patients with de novo CIEDs was associated with a high risk of systemic CIED infections. Highest risk was observed after heart valve replacement surgery and within the first year of surgery.

Lead complications after cardiac surgery in patients with cardiac implantable electronic devices.

OBJECTIVES: Manipulation of the heart during cardiac surgery in patients with cardiac implantable electronic devices (CIEDs) may result in lead damage or displacement, but whether cardiac surgery truly infers an excess risk of lead failure is not known. The objective of this study was to examine the risk of lead complications after cardiac surgery in patients with CIEDs. METHODS: We conducted a nationwide nested case-control study. The source population comprised all Danish patients ≥18 of age who underwent a de novo CIED implantation during 1998-2017. For inclusion, patients had to be alive and event free 6 months after implantation. Cases were matched 1:30 to controls on time, age, sex, and device type using risk set sampling. We used conditional logistic regression to estimate incidence rate ratios (IRRs) for the association between cardiac surgery and lead-related reoperation. RESULTS: Our final population consisted of 67 621 patients. We identified 1437 (2.1%) incident cases of lead-related reoperations and 42 698 controls. Risk of lead complications was highest within 6 months of cardiac surgery [IRR 9.7, 95% confidence interval (CI) 6.3-14.8, adjusted IRR 9.6, 95% CI 6.2-14.7], and at 1 year, the relative risk of lead-related reoperation was close to unity (adjusted IRR 1.2, 95% CI 0.8-1.7). CONCLUSIONS: Cardiac surgery was associated with a considerable risk of lead complications in patients with de novo CIEDs.

Rate of permanent cardiac implantable electronic device infections after active fixation temporary transvenous pacing: A nationwide Danish cohort study.

BACKGROUND: Temporary transvenous pacing (TP) has been associated with an increased risk of cardiac implantable electronic device (CIED) infections, but there is little data to document this in contemporary populations. OBJECTIVE: To investigate the impact of active fixation TP on rate of CIED infections in a nationwide cohort of Danish patients. METHODS: We identified all patients who underwent a first-time CIED implantation between 2009 and 2017. Patients were categorized according to TP status at implantation and followed for 1 year. The primary outcome was local or systemic CIED infection resulting in device system removal. The secondary outcomes were systemic CIED infections and hospitalization for infective endocarditis (IE). RESULTS: We included a total of 40,601 CIED patients. A total of 2952 were treated with active fixation TP. The primary outcome was met in 246 patients. Risk of CIED infection at 1 year was 0.61% for patients not treated with TP and 0.65% for patients who were, HR of 1.28 (95% CI 0.80-2.05) and adjusted HR 0.85 (95% CI 0.51-1.42). More systemic CIED infections and IE hospitalizations occurred in TP patients; however, these differences did not persist after confounder adjustment. Cumulative mortality at 1 year was 16.8% in patients with TP vs 8.4% in patients without. CONCLUSION: Active fixation TP was not associated with a higher rate of CIED infections. Patients treated with TP had higher mortality, more systemic CIED infections, and more IE hospitalizations within first year of implantation. Most was attributable to an accumulation of risk factors for infection among TP patients.

Cardiac computed tomography-verified right ventricular lead position and outcomes in cardiac resynchronization therapy.

PURPOSE: To evaluate the association between different right ventricular (RV) lead positions as assessed by cardiac computed tomography (CT) and echocardiographic and clinical outcomes in patients receiving cardiac resynchronization therapy (CRT). METHODS: We reviewed patient records of all 278 patients included in two randomized controlled trials (ImagingCRT and ElectroCRT) for occurrence of heart failure (HF) hospitalization or all-cause death (primary endpoint) during long-term follow-up. Outcomes were compared between RV lead positions using adjusted Cox regression analysis. Six months after CRT implantation, we estimated left ventricular (LV) reverse remodeling by measuring LV end-systolic and end-diastolic volumes by echocardiography. Changes from baseline to 6 months follow-up were compared between RV lead positions. Device-related complications were recorded at 6-month follow-up. RESULTS: During median (interquartile range) follow-up of 4.7 (2.9-7.1) years, the risk of meeting the primary endpoint was similar for patients with non-apical vs. apical RV lead position (adjusted hazard ratio (HR) 0.78, 95% confidence interval (CI) 0.54-1.12, p = 0.17) and free wall vs. septal RV lead position (adjusted HR 1.03, 95% CI 0.72-1.47, p = 0.86). Changes in LV ejection fraction and dimensions were similar with the different RV lead positions. We observed no differences in device-related complications relative to the RV lead position. CONCLUSIONS: In patients receiving CRT, the risk of HF hospitalization or all-cause death during long-term follow-up, and LV remodeling and incidence of device-related complications after 6 months are not associated with different anatomical RV lead position as assessed by cardiac CT.

Microbiological diagnosis in cardiac implantable electronic device infections detected by sonication and next-generation sequencing.

BACKGROUND: Device-related infection (DRI) is a severe complication of treatment with cardiac implantable electronic devices. Identification of the causative pathogen is essential for optimal treatment, but conventional methods often are inadequate. OBJECTIVE: The purpose of this study was to improve microbiological diagnosis in DRI using sonication and next-generation sequencing analysis. The primary objective was identification of causative pathogens. The secondary objective was estimation of the sensitivity of different microbiological methods in detecting the causative pathogen. METHODS: Consecutive patients with clinical signs of DRI between October 2016 and January 2019 from 3 tertiary centers in Denmark were included in the study. Patients underwent a diagnostic approach, including blood cultures and perioperative collection of microbiological samples (pocket swab, pocket tissue biopsies, generator, and leads). Conventional culturing was performed, and device components were sonicated and examined with an amplicon-based metagenomic analysis using next-generation sequencing. The results were compared with a reference standard-identified causative pathogen. RESULTS: In 110 patients with clinical signs of pocket (n = 50) or systemic DRI (n = 60), we collected 109 pocket swabs, 220 pocket tissue biopsies, 106 generators, 235 leads, and a minimum 1 set of blood cultures from 102 patients. Combining all findings, we identified the causative pathogen in 95% of cases, irrespective of DRI type. The usability of each microbiological method differed between DRI types. In pocket DRI, next-generation sequencing analysis of generators achieved sensitivity of 90%. For systemic DRI, blood cultures reached sensitivity of 93%. CONCLUSION: Using a strategy including sonication and next-generation sequencing, we identified the causative pathogen in 95% of DRI. Sensitivity of microbiological methods differed according to the type of DRI.

Recurrent atrial arrhythmia in a randomised controlled trial comparing contact force-guided and contact force-blinded ablation for typical atrial flutter.

BACKGROUND: Contact force (CF)-guided catheter ablation (CA) is a novel technology developed to improve efficacy and reduce complications. In a randomised controlled trial (RCT), we previously documented that after 3 months, rate of persistent conduction block was similar with and without using CF while performing CA for typical atrial flutter (AFL). Clinical effect of CF on recurrent arrhythmia is unknown. Our objective is to study recurrent atrial arrhythmia during 12-month follow-up in a RCT investigating whether CF-guided CA for typical AFL is superior to CF-blinded CA. METHODS: Patients were randomised 1:1 to CA guided by CF (intervention group) or blinded to CF (control group). After 12 months, patients attended clinical check-up preceded by a 5-day ambulatory Holter monitor recording. Primary outcome was any recurrent atrial arrhythmia ≥ 30 s within 12 months and documented in 12-lead ECG or Holter monitor recording. RESULTS: We included 156 patients, four patients withdrew consent and two died during follow-up. Thus, 150 patients were included in final analysis. Recurrent arrhythmia was detected in 36 of 77 (47%) patients in the intervention group, and 32 of 73 patients (44%) in the control group (p = 0.51). Atrial fibrillation was detected in 23 (30%) and 29 (40%) patients in the intervention and control groups respectively. AFL was detected in 11 (14%) and 5 (7%) patients in the intervention and control groups respectively. CONCLUSIONS: Contact force-guided ablation for typical atrial flutter does not reduce recurrent atrial arrhythmia after 12-month follow-up as compared with ablation blinded for contact force.

Long-term outcomes in a randomized controlled trial of multimodality imaging-guided left ventricular lead placement in cardiac resynchronization therapy.

AIMS: This study aims to investigate the long-term occurrence of the composite endpoint of heart failure (HF) hospitalization or all-cause death (primary endpoint) in patients randomized to cardiac resynchronization therapy (CRT) using individualized multimodality imaging-guided left ventricular (LV) lead placement compared with a routine fluoroscopic approach. Furthermore, this study aims to evaluate whether inter-lead electrical delay (IED) is associated with improved response rate of this endpoint. METHODS AND RESULTS: We reviewed follow-up data until November 2020 for all 182 patients included in the ImagingCRT trial for the occurrence of HF hospitalization and all-cause death. During median (inter-quartile range) time to primary endpoint/censuring of 6.7 (3.3-7.9) years, the rate of the primary endpoint was 60% (n = 53) in the imaging group compared with 52% (n = 48) in the control group [hazard ratio (HR) 1.22, 95% confidence interval (CI) 0.83-1.81, P = 0.31]. Neither the risk of HF hospitalization (HR 1.11, 95% CI 0.62-1.99, P = 0.72) nor of all-cause death differed between treatment groups (HR 1.23, 95% CI 0.82-1.85, P = 0.32). The risk of the primary endpoint was significantly reduced among those with IED ≥100 ms when compared with those with IED <100 ms (HR 0.62, 95% CI 0.39-0.98, P = 0.04). CONCLUSIONS: In this study, an individualized multimodality imaging-guided strategy targeting LV lead placement towards the latest mechanically activated non-scarred myocardial segment during CRT implantation did not reduce HF hospitalization or all-cause death when compared with routine LV lead placement during long-term follow-up. Targeting the latest electrical activation should be studied as an alternative individualized strategy for optimizing LV lead placement in CRT recipients.

Progression of Diabetic Complications in Subgroups of People with Long Term Diabetes Type 1 According to Clinical Course.

AIMS: Prevention and prediction of microvascular complications are important aims of medical care in people with type 1 diabetes. Since the course of the disease is heterogenous, we tried to identify subgroups with specific risk profiles for microvascular complications. METHODS: Retrospective analysis of a cohort of 285 people (22637 consultations) with >10 years of type 1 diabetes. Persons were grouped into slow (<15 years), fast (>15 years) and non progressors according to the average onset of microvascular complications. Generalized estimating equations for binary outcomes were applied and pseudo coefficients of determination were calculated. RESULTS: Progression to microvascular disease was associated with age (OR: 1.034 [1.001-1.068]; p=0.04), diabetes duration (OR: 1.057 [1.021-1.094]; p=0.002), HbA1c (OR: 1.035 [1.011-1.060]; p=0.005), BMI (OR: 0.928 [0.866-0.994]; p=0.034) and the social strata index (OR: 0.910 [0.830-0.998]; p=0.046). Generalized estimating equations predicted 31.02% and exclusion of HbA1c marginally reduced the value to 28.88%. The proportion of patients with LADA was higher in fast than slow progressors [13 (26.5%) vs. 14 (11.9%); p=0.019]. A generalized estimating equation comparing slow to fast progressors revealed no significant markers. CONCLUSION: In our analysis, we were able to confirm known risk factors for microvascular disease in people with type 1 diabetes. Overall, prediction of individual risk was difficult, the effect of individual markers minor and we could not find differences regarding slow or fast progression. We therefore emphasis the need for additional markers to predict individual risk for microvascular disease.

Non-infective left ventricular lead complications requiring re-intervention following cardiac resynchronization therapy: prevalence, causes and outcomes.

PURPOSE: Left ventricular (LV) lead complications in cardiac resynchronization therapy are challenging and poorly reported. We aimed to establish prevalence, causes and outcomes of LV lead complications requiring re-intervention. METHODS: We analysed the rate of complications in 2551 consecutive patients who received a transvenous de novo LV lead as part of a cardiac resynchronization therapy device between 2000 and 2018. LV lead complications requiring re-intervention were identified; those due to infection were excluded. Patient, procedural and device characteristics, and outcomes were examined for non-infective LV lead complications requiring re-intervention. RESULTS: During a median of 4.7 years, 142 (5.6%) patients required re-intervention for non-infective LV lead complications with a decrease from 10.7% between 2000 and 2004, 8.7% between 2005 and 2009, 3.2% between 2010 and 2014 to 3.2% after 2014. The most common complications were LV lead displacement (50%), high pacing threshold (28%) and phrenic nerve stimulation (15%). Of the complications, 79 (56%) occurred within 90 days post-implant and 63 (44%) later. At the end of the study period, 132/142 patients (93%) had a functional LV lead. Lead re-intervention was associated with higher risk of complications (20%), but no increase in mortality (P = 0.19). Quadripolar leads had longer longevity and lower risk of complications compared with unipolar and bipolar LV leads. CONCLUSIONS: A small but significant proportion of patients required LV lead re-intervention for complications following de novo implant. Lead displacement accounted for half of the re-interventions. Re-intervention was associated with a higher complication rate, but 92% of these patients had functional LV leads at the end of follow-up.

Rate of device-related infections using an antibacterial envelope in patients undergoing cardiac resynchronization therapy reoperations.

AIMS: Cardiac resynchronization therapy (CRT) reoperations are associated with a particularly high risk of device-related infection (DRI). An antibacterial envelope reduces the occurrence of DRIs in a broad population of moderate-tohigh-risk patients. To investigate the efficacy of an antibacterial envelope in a very high-risk population of patients undergoing CRT reoperation. METHODS AND RESULTS: In this Danish two-centre, observational cohort study, we included consecutive patients who underwent a CRT pacemaker- or defibrillator reoperation procedure between January 2008 and November 2019. We obtained data from the Danish Pacemaker and ICD Register and through systematic medical chart review. Follow-up was restricted to 2 years. A total of 1943 patients were included in the study of which 736 (38%) received an envelope. Envelope patients had more independent risk factors for infection than non-envelope patients. Sixty-seven (3.4%) patients met the primary endpoint of DRI requiring device system extraction; 50 in the non-envelope group and 17 in the envelope group [4.1% vs. 2.3%, adjusted hazard ratio (HR) 0.52, 95% confidence interval (CI) 0.30-0.90; P = 0.021]. This difference persisted in propensity score analysis (HR 0.51, 95% CI 0.29-0.90; P = 0.019). CONCLUSION: Use of an antibacterial envelope was associated with a clinically and statistically significant reduction in DRIs in patients undergoing CRT reoperations. Our results were comparable to those recently reported from a large randomized controlled trial, which is suggestive of a proportional effect of the envelope even in very high-risk patients.

Discontinuation of oral anticoagulation and risk of stroke and death after ablation for typical atrial flutter: A nation-wide Danish cohort study.

INTRODUCTION: Oral anticoagulation (OAC) is indicated for patients with atrial fibrillation (AF) and atrial flutter (AFL) with a CHA2DS2-VASc score ≥ 2 for men and ≥3 for women. This is regardless of successful catheter ablation for their arrhythmia. Studies have mainly focused on AF, and little is known regarding use of OAC in AFL patients following catheter ablation. PURPOSE: To describe discontinuation of OAC in a national cohort of patients who have undergone first-time cavo-tricuspid isthmus ablation (CTIA) for AFL. METHODS: We identified patients undergoing first-time CTIA during the period 2010-2016 using the Danish National Ablation Registry. Information on comorbidities and OAC use were gathered using the Danish National Patient Registry and the Danish National Prescription Registry. Patients were followed until March 1st, 2018. RESULTS: We identified 2409 consecutive patients. Median age was 66 (IQR 58-72) years, and 1952 (81%) were men. During mean follow-up of 4 ± 1.7 years, 723 (30%) patients discontinued OAC. Patients discontinuing OAC were younger, had less comorbidity, and a lower CHA2DS2-VASc score. During follow-up, 252 (10%) patients died, and 112 (5%) patients had a stroke. Incidence of both these events increased with increasing age and CHA2DS2-VASc score. In adjusted analysis, we observed higher mortality (p < 0.0001) in patients discontinuing OAC, while stroke rate was not significantly higher (p = 0.21). CONCLUSION: In this national cohort of patients who have undergone first-time CTIA, patients discontinuing OAC treatment were younger and had less comorbidities. Patients remain at elevated risk of death and stroke/TIA, increasing with their age and CHA2DS2-VASc score.

Repeat pulmonary vein isolation in patients with atrial fibrillation: low ablation index is associated with increased risk of recurrent arrhythmia.

OBJECTIVES: We aimed to investigate the predictors of recurrent arrhythmia after repeated pulmonary vein isolation (PVI) performed in the era of contact force without additional substrate ablation. One of the predictors studied, ablation index (AI), incorporates power, contact force, and time in a weighted formula and is reported to predict lesion size in animals. Design. Consecutive patients (n = 108) undergoing repeat PVI without additional substrate modification using a contact force sensing catheter were included retrospectively at a tertiary center. All ablation points were analyzed offline. A new variable, normalized AI (AI corrected for the location of the lesion-anterior vs. posterior) was calculated. The patients were systematically followed with clinical visit and 12-lead ECG as well as review of the regional electronic patient files at 3 and 12 months after the procedure with 5-day Holter at 12 months. Results. Electrical reconnection to at least one pulmonary vein (PV) was seen in 97% of the patients. The recurrence rate was 35%. There was no recurrence in patients with nAI above 1.15 (n = 26). Patients with electrical reconnection of up to two PVs had a higher risk of recurrence compared with patients having electrical reconnection of three or four PVs (p = .003), and this risk was especially high in patients with persistent atrial fibrillation (69 [39-91]%). Conclusions. The risk of recurrence is higher in patients with ablations performed with low levels of AI and in patients with reconnection to up to two PVs. Our data may indicate the need for higher target levels of AI during repeat PVI than normally used during de-novo PVI.

Reproducibility and repeatability of identifying the latest electrical activation during mapping of coronary sinus branches in CRT recipients.

INTRODUCTION: Studies have shown an association between the outcome in cardiac resynchronization therapy (CRT) and longer interventricular delay at the site of the left ventricular (LV) lead. Targeted LV lead placement at the latest electrically activated segment increases LV function further as compared with standard treatment. We aimed to determine reproducibility and repeatability of identifying the latest electrically activated segment during mapping of all available coronary sinus (CS) branches in patients receiving CRT. METHODS: We included 35 patients who underwent CRT implantation with protocolled mapping guided LV lead implantation aiming for the site of the latest electrical activation. Three different doctors experienced in electrophysiology and implantation of CRT devices independently measured time interval from the local bipolar right ventricular (RV) electrogram (EGM) to the local unipolar LV EGM at all mapped sites (RV-LV). The segment with the latest electrical activation was defined as the target segment (TS) and the CS tributary containing TS was defined as the target vein (TV). Weighted κ statistics with 95% confidence intervals were computed to assess intra- and interobserver agreement for TS and TV. RESULTS: We mapped 258 segments within 131 veins. Weighted κ values for repeatability were 0.85 (0.81-0.89) for TS and 0.92 (0.89-0.93) for TV, and weighted κ values of interobserver agreement ranged from 0.70 (0.61-0.73) to 0.80 (0.76-0.83) for TS and 0.73 (0.64-0.78) to 0.86 (0.83-0.89) for TV among all three observers. CONCLUSION: The reproducibility and repeatability of identifying the latest electrically activated segment during mapping of all available CS branches in patients receiving CRT range from good to very good.