Comparison of Cryoballoon vs. Pulsed Field Ablation in Patients with Symptomatic Paroxysmal Atrial Fibrillation (SINGLE SHOT CHAMPION): Study protocol for a randomized controlled trial.

Background: Single-shot devices are increasingly used for pulmonary vein isolation (PVI) in atrial fibrillation (AF). The Arctic Front cryoballoon is the most frequently used single-shot technology. A recently developed novel pulsed field ablation (PFA) device (FARAPULSE) has been introduced with the aim to improve procedural safety and efficacy. Objective: This study will compare the novel FARAPULSE PFA device and the Arctic Front cryoballoon for first PVI in patients with symptomatic paroxysmal AF. Methods: SINGLE SHOT CHAMPION is a multicenter, randomized controlled trial with blinded endpoint adjudication by an independent clinical events committee. Overall, 210 patients with paroxysmal AF undergoing their PVI are randomized 1:1 between PFA and cryoballoon ablation. Continuous rhythm monitoring with an implantable cardiac monitor is performed in all patients. Results: The primary endpoint is time to first recurrence of any atrial tachyarrhythmia (AF and/or organized atrial tachyarrhythmia) lasting ≥120 seconds and identified by the implantable cardiac monitor within 91 and 365 days postablation. The composite procedural safety endpoint includes cardiac tamponade requiring drainage, persistent phrenic nerve palsy, vascular complications requiring intervention, stroke/transient ischemic attack, atrioesophageal fistula, and death occurring during or up to 30 days after the procedure. Key secondary endpoints include (1) increase in high-sensitivity troponin on day 1 postablation, (2) analysis of postablation 3-dimensional electroanatomic mapping (first 25 patients per study group), (3) AF burden, and (4) quality-of-life changes. Conclusion: SINGLE SHOT CHAMPION will evaluate the efficacy and safety of PVI using the novel FARAPULSE PFA for patients with symptomatic paroxysmal AF.

Long-term outcomes of catheter ablation for atrial fibrillation in octogenarians.

BACKGROUND AND AIMS: Catheter ablation is superior to pharmacological therapy in controlling atrial fibrillation (AF). There are few data on the long-term outcome of AF ablation in octogenarian patients. This analysis aims to evaluate the outcome of AF ablation in octogenarians vs. younger patients. METHODS: In this retrospective study in 13 centres in the UK, France, and Switzerland, the long-term outcomes of 473 consecutive octogenarian patients undergoing ablation for AF were compared to 473 matched younger controls (median age 81.3 [80.0, 83.0] vs. 64.4 [56.5, 70.7] years, 54.3% vs. 35.1% females; p-value for both < 0.001). The primary endpoint was the recurrence of atrial arrhythmia after a blanking period of 90 days within 365 days of follow-up. RESULTS: Acute ablation success as defined as isolation of all pulmonary veins was achieved in 97% of octogenarians. Octogenarians experienced more procedural complications (11.4% vs 7.0%, p = 0.018). The median follow-up time was 281 [106, 365] days vs. 354 [220, 365] days for octogenarians vs. non-octogenarians (p < 0.001). Among octogenarians, 27.7% (131 patients) experienced a recurrence of atrial arrhythmia, in contrast to 23.5% (111 patients) in the younger group (odds ratio 1.49; 95% confidence interval 1.16-1.92; p = 0.002). In a multivariable regression model including gender, previous AF ablation, vascular disease, chronic kidney disease, CHA2DS2-VASc score, left atrial dilatation, and indwelling cardiac implantable electronic device, age above 80 remained an independent predictor of recurrence of arrhythmia. CONCLUSION: Ablation for AF is effective in octogenarians, but is associated with slightly higher procedural complication rate and recurrence of atrial arrhythmia than in younger patients.

Impact of comorbidity on complication rates and life expectancy in patients with a leadless pacemaker.

BACKGROUND: Knowledge about impact of age and comorbidities on outcome in patients with leadless pacemakers (LPM) is limited. OBJECTIVES: To analyse outcome in LPM patients according to age and comorbidities. METHODS: This Swiss, multi-centre, retrospective analysis includes all patients with LPM implanted between 2015 and 2022. Charlson-Comorbidity-Index (CCI) was determined and patients were divided into a low- (CCI ≤ 5) and high-comorbidity (CCI > 5) group. Peri-procedural complications, in-hospital death, and all-cause mortalities were assessed. Finally, all-cause mortality according to three groups (CCI ≤ 3, 4-5, >5) was compared to age and sex-adjusted mortality in the general Swiss population. RESULTS: 863 patients (median age 81 years, 65% male, 42% with CCI > 5) were included. Peri-procedural/long-term complication rates did not differ between the low- vs. high-comorbidity groups (2.6% vs. 1.7%, p = 0.48 and 1.2% vs. 2.8%, p = 0.12, respectively). In-hospital (3.6% vs. 0.6%, p = 0.002) and all-cause mortality (HR 2.9, 95%CI 2.2-3.8, p < 0.001) were significantly higher in the high-comorbidity group resulting in a three-year mortality of 58% (95%CI 51-65%) vs. 22% (95%CI 17-27%) in the low-comorbidity group. In patients with a CCI ≤ 3, all-cause mortality was comparable to the age- and sex-adjusted mortality of the general Swiss population. CONCLUSIONS: In elderly patients with high comorbidity, LPM implantation was not associated with increased peri-procedural/long-term complications. All-cause mortality in LPM patients with a CCI ≤ 3 was comparable to age- and sex-adjusted mortality in the general Swiss population. Despite a relatively high three-year mortality due to competing risk factors, LPM implantation is safe, even in elderly patients with high comorbidity. CONDENSED ABSTRACT: In this Swiss, multi-centre, retrospective cohort analysis, 863 patients implanted with a leadless pacemaker were included and divided into a high-comorbidity (with a CCI > 5) and low-comorbidity (with a CCI ≤ 5) group. There was no between group difference in terms of implantation outcomes and peri-operative or long-term complications. Furthermore, all-cause mortality during follow-up in patients with a CCI ≤ 3 was comparable to age- and sex-adjusted mortality in the general Swiss population. These data indicate that LPM implantation is a safe procedure, even in elderly patients with high comorbidity.

Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study.

Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

Apixaban vs Aspirin According to CHA2DS2-VASc Score in Subclinical Atrial Fibrillation: Insights From ARTESiA.

BACKGROUND: ARTESiA (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation) demonstrated that apixaban, compared with aspirin, significantly reduced stroke and systemic embolism (SE) but increased major bleeding in patients with subclinical atrial fibrillation. OBJECTIVES: To help inform decision making, the authors evaluated the efficacy and safety of apixaban according to baseline CHA2DS2-VASc score. METHODS: We performed a subgroup analysis according to baseline CHA2DS2-VASc score and assessed both the relative and absolute differences in stroke/SE and major bleeding. RESULTS: Baseline CHA2DS2-VASc scores were <4 in 1,578 (39.4%) patients, 4 in 1,349 (33.6%), and >4 in 1,085 (27.0%). For patients with CHA2DS2-VASc >4, the rate of stroke was 0.98%/year with apixaban and 2.25%/year with aspirin; compared with aspirin, apixaban prevented 1.28 (95% CI: 0.43-2.12) strokes/SE per 100 patient-years and caused 0.68 (95% CI: -0.23 to 1.57) major bleeds. For CHA2DS2-VASc <4, the stroke/SE rate was 0.85%/year with apixaban and 0.97%/year with aspirin. Apixaban prevented 0.12 (95% CI: -0.38 to 0.62) strokes/SE per 100 patient-years and caused 0.33 (95% CI: -0.27 to 0.92) major bleeds. For patients with CHA2DS2-VASc =4, apixaban prevented 0.32 (95% CI: -0.16 to 0.79) strokes/SE per 100 patient-years and caused 0.28 (95% CI: -0.30 to 0.86) major bleeds. CONCLUSIONS: One in 4 patients in ARTESiA with subclinical atrial fibrillation had a CHA2DS2-VASc score >4 and a stroke/SE risk of 2.2% per year. For these patients, the benefits of treatment with apixaban in preventing stroke/SE are greater than the risks. The opposite is true for patients with CHA2DS2-VASc score <4. A substantial intermediate group (CHA2DS2-VASc =4) exists in which patient preferences will inform treatment decisions. (Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation; NCT01938248).

Sex-Based Differences in Clinical Characteristics of Patients with Acute Myocarditis: A Cohort Study.

BACKGROUND: This study investigated sex differences in acute myocarditis patients during index hospitalization. METHODS: We included 365 patients with acute myocarditis, hospitalized with continuous monitoring at the intensive care unit from 2000-2023 into the Basel Myocarditis Cohort study. We compared sex differences in clinical presentation, the presenting electrocardiogram, prior medical history, inflammatory and cardiac biomarkers, cardiac imaging, arrhythmia occurrence, and short- to midterm outcomes. RESULTS: Mean age was 41.3 years, and 26.3% were female. Compared with men, women were older (median 49.7 vs 38.3 years, P < .001) at the time of diagnosis and presented more frequently with dyspnea (41 vs 26%, P = .013) and a higher Killip class (P = .011). In the presenting electrocardiogram, men had a higher occurrence of diffuse ST-elevation (38 vs 9%, P < .001) and PQ-depression (31 vs 20%, P = .042), compared with women. Women had higher N-terminal pro B-type natriuretic peptide levels (1180 vs 387 ng/L, P = .015), lower cardiac troponin T levels (389 vs 726 ng/L, P = .006), and fewer segments with nonischemic late gadolinium enhancement on cardiac magnetic resonance imaging (1 vs 3, P = .005), but similar left ventricular ejection fraction (55 vs 55%, P = .629), compared with men. Overall, hospital stay was longer in women compared with men (7 vs 5 days, P = .018), with a similar length of intensive care unit stay (2.6 vs 2.7 days, P = .922). Women more often developed severe arrhythmia (8.3 vs 2.2%, P = .015) and heart failure during the hospitalization (31.3 vs 16.4%, P = .003). CONCLUSION: Compared with men, women with acute myocarditis were older at the time of diagnosis, presented more often with heart failure, and had an increased frequency of severe arrhythmia.

PolarX vs Arctic Front for Cryoballoon Ablation of Paroxysmal AF: The Randomized COMPARE CRYO Study.

BACKGROUND: Pulmonary vein isolation is an effective treatment for atrial fibrillation (AF). Cryoballoon ablation using the Arctic Front cryoballoon (Medtronic) was found to be superior to antiarrhythmic drug treatment. Recently, a novel cryoballoon system was introduced (PolarX, Boston Scientific). OBJECTIVES: The purpose of this study was to compare the efficacy and safety of the 2 cryoballoons in a randomized controlled trial. METHODS: Patients with symptomatic paroxysmal AF were enrolled in 2 centers and randomized 1:1 to pulmonary vein isolation using the PolarX or the Arctic Front cryoballoon. All patients received an implantable cardiac monitor. The primary endpoint was first recurrence of atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia [AT]) between days 91 and 365. Procedural safety was assessed by a composite of tamponade, phrenic nerve palsy lasting >24 hours, vascular complications, stroke/transient ischemic attack, atrioesophageal fistula or death up to 30 days. RESULTS: A total of 201 patients were enrolled. At 1 year, recurrence of atrial tachyarrhythmia had occurred in 41 of 99 patients (41.6%) assigned to the PolarX group and in 48 of 102 patients (47.1%) assigned to the Arctic Front group (HR: 0.85 [95% CI: 0.56-1.30]; P = 0.03 for noninferiority; P = 0.46 for superiority). The safety endpoint occurred in 5 patients (5%) in the PolarX group (n = 5 phrenic nerve palsies lasting >24 hours), whereas no safety endpoints occurred in the Arctic Front group (P = 0.03). CONCLUSIONS: In this randomized controlled trial using implantable cardiac monitors for continuous rhythm monitoring, the novel PolarX cryoballoon was noninferior compared with the Arctic Front cryoballoon regarding efficacy. However, the PolarX balloon resulted in significantly more phrenic nerve palsies. (Comparison of PolarX and the Arctic Front Cryoballoons for PVI in Patients With Symptomatic Paroxysmal AF [COMPARE-CRYO]; NCT04704986).

Severe Periprocedural Complications After Ablation for Atrial Fibrillation: An International Collaborative Individual Patient Data Registry.

BACKGROUND: Catheter ablation for atrial fibrillation (AF) including pulmonary vein isolation and possibly further substrate ablation is the most common electrophysiological procedure. Severe complications are uncommon, but their detailed assessment in a large worldwide cohort is lacking. OBJECTIVES: The aim of this study was to determine the incidence of periprocedural severe complications and to provide a detailed characterization of the diagnostic evaluation and management of these complications in patients undergoing AF ablation. METHODS: Individual patient data were collected from 23 centers worldwide. Limited data were collected for all patients who underwent catheter ablation, and an expanded series of data points were collected for patients who experienced severe complications during periprocedural follow-up. Incidence, predictors, patient characteristics, management details, and overall outcomes of patients who experienced ablation-related complications were investigated. RESULTS: Data were collected from 23 participating centers at which 33,879 procedures were performed (median age 63 years, 30% women, 71% radiofrequency ablations). The incidence of severe complications (n = 271) was low (tamponade 6.8‰, stroke 0.97‰, cardiac arrest 0.41‰, esophageal fistula 0.21‰, and death 0.21‰). Age, female sex, a dilated left atrium, procedure duration, and the use of radiofrequency energy were independently associated with the composite endpoint of all severe complications. Among patients experiencing tamponade, 13% required cardiac surgery. Ninety-three percent of patients with complications were discharged directly home after a median length of stay of 5 days (Q1-Q3: 3-7 days). CONCLUSIONS: This large worldwide collaborative study highlighted that tamponade, stroke, cardiac arrest, esophageal fistula, and death are rare after AF ablation. Older age, female sex, procedure duration, a dilated left atrium, and the use of radiofrequency energy were associated with severe complications in this multinational cohort. One in 8 patients with tamponade required cardiac surgery.

Lack of Prognostic Value of T-Wave Alternans for Implantable Cardioverter-Defibrillator Benefit in Primary Prevention.

BACKGROUND: New methods to identify patients who benefit from a primary prophylactic implantable cardioverter-defibrillator (ICD) are needed. T-wave alternans (TWA) has been shown to associate with arrhythmogenesis of the heart and sudden cardiac death. We hypothesized that TWA might be associated with benefit from ICD implantation in primary prevention. METHODS AND RESULTS: In the EU-CERT-ICD (European Comparative Effectiveness Research to Assess the Use of Primary Prophylactic Implantable Cardioverter-Defibrillators) study, we prospectively enrolled 2327 candidates for primary prophylactic ICD. A 24-hour Holter monitor reading was taken from all recruited patients at enrollment. TWA was assessed from Holter monitoring using the modified moving average method. Study outcomes were all-cause death, appropriate shock, and survival benefit. TWA was assessed both as a contiguous variable and as a dichotomized variable with cutoff points <47 µV and <60 µV. The final cohort included 1734 valid T-wave alternans samples, 1211 patients with ICD, and 523 control patients with conservative treatment, with a mean follow-up time of 2.3 years. TWA ≥60 µV was a predicter for a higher all-cause death in patients with an ICD on the basis of a univariate Cox regression model (hazard ratio, 1.484 [95% CI, 1.024-2.151]; P=0.0374; concordance statistic, 0.51). In multivariable models, TWA was not prognostic of death or appropriate shocks in patients with an ICD. In addition, TWA was not prognostic of death in control patients. In a propensity score-adjusted Cox regression model, TWA was not a predictor of ICD benefit. CONCLUSIONS: T-wave alternans is poorly prognostic in patients with a primary prophylactic ICD. Although it may be prognostic of life-threatening arrhythmias and sudden cardiac death in several patient populations, it does not seem to be useful in assessing benefit from ICD therapy in primary prevention among patients with an ejection fraction of ≤35%.

Definition and management of arrhythmia-induced cardiomyopathy: findings from the European Heart Rhythm Association survey.

AIMS: Arrhythmia-induced cardiomyopathy (AiCM) represents a subtype of acute heart failure (HF) in the context of sustained arrhythmia. Clear definitions and management recommendations for AiCM are lacking. The European Heart Rhythm Association Scientific Initiatives Committee (EHRA SIC) conducted a survey to explore the current definitions and management of patients with AiCM among European and non-European electrophysiologists. METHODS AND RESULTS: A 25-item online questionnaire was developed and distributed among EP specialists on the EHRA SIC website and on social media between 4 September and 5 October 2023. Of the 206 respondents, 16% were female and 61% were between 30 and 49 years old. Most of the respondents were EP specialists (81%) working at university hospitals (47%). While most participants (67%) agreed that AiCM should be defined as a left ventricular ejection fraction (LVEF) impairment after new onset of an arrhythmia, only 35% identified a specific LVEF drop to diagnose AiCM with a wide range of values (5-20% LVEF drop). Most respondents considered all available therapies: catheter ablation (93%), electrical cardioversion (83%), antiarrhythmic drugs (76%), and adjuvant HF treatment (76%). A total of 83% of respondents indicated that adjuvant HF treatment should be started at first HF diagnosis prior to antiarrhythmic treatment, and 84% agreed it should be stopped within six months after LVEF normalization. Responses for the optimal time point for the first LVEF reassessment during follow-up varied markedly (1 day-6 months after antiarrhythmic treatment). CONCLUSION: This EHRA Survey reveals varying practices regarding AiCM among physicians, highlighting a lack of consensus and heterogenous care of these patients.

Biomarkers to predict improvement of left ventricular ejection fraction after atrial fibrillation ablation.

BACKGROUND: Atrial fibrillation (AF) and heart failure frequently coexist. Prediction of left ventricular ejection fraction (LVEF) recovery after catheter ablation (CA) for AF remains difficult. OBJECTIVE: The purpose of this study was to evaluate the value of biomarkers, alone and in combination with the Antwerp score, to predict LVEF recovery after CA for AF. METHODS: Patients undergoing CA for AF with depressed LVEF (<50%) were included. Plasma levels of 13 biomarkers were measured immediately before CA. Patients were categorized into "responders" and "nonresponders" in a similar fashion to the Antwerp score performance derivation and validation cohorts. The predictive power of the biomarkers alone and combined in outcome prediction was evaluated. RESULTS: A total of 208 patients with depressed LVEF were included (median age 63 years; 39-19% female; median indexed left atrial volume 42 (33-52) mL/m2; median LVEF 43 (38-46)%). At a median follow-up time of 30 (20-34) months, 161 (77%) were responders and 47 (23%) were nonresponders. Of 13 biomarkers, -4-angiopoietin 2 (ANG2), growth differentiation factor 15 (GDF15), fibroblast growth factor 23, and myosin binding protein C3-were significantly different between responders and nonresponders (P ≤ .001) and their combination could predict the end point with an area under the curve of 0.72 (95% confidence interval [CI] 0.64-0.81) overall, 0.69 (95% CI 0.59-0.78) in heart failure with mildly reduced ejection fraction, and 0.88 (95% CI 0.77-0.98) in heart failure with reduced ejection fraction. Only ANG2 and GDF15 remained significantly associated with LVEF recovery after adjustment for age, sex, and Antwerp score and significantly improved the accuracy of the Antwerp score predictions (P < .001). The area under the curve of the Antwerp score in the outcome prediction improved from 0.75 (95% CI 0.67-0.83) to 0.78 (95% CI 0.70-0.86). CONCLUSION: A biomarker panel (ANG2 and GDF15) significantly improved the accuracy of the Antwerp score.

Repeat catheter ablation after very late recurrence of atrial fibrillation after pulmonary vein isolation.

AIMS: Atrial fibrillation (AF) recurs in about one-third of patients after catheter ablation (CA), mostly in the first year. Little is known about the electrophysiological findings and the effect of re-ablation in very late AF recurrences (VLR) after more than 1 year. The aim of this study was to determine the characteristics and outcomes of the first repeat CA after VLR of AF after index CA. METHODS AND RESULTS: We analysed patients from a prospective Swiss registry that underwent a first repeat ablation procedure. Patients were stratified depending on the time to recurrence after index procedure: early recurrence (ER) for recurrences within the first year and late recurrence (LR) if the recurrence was later. The primary endpoint was freedom from AF in the first year after repeat ablation. Out of 1864 patients included in the registry, 426 patients undergoing a repeat ablation were included in the analysis (28% female, age 63 ± 9.8 years, 46% persistent AF). Two hundred and ninety-one patients (68%) were stratified in the ER group and 135 patients (32%) in the LR group. Pulmonary vein reconnections were a common finding in both groups, with 93% in the ER group compared to 86% in the LR group (P = 0.052). In the LR group, 40 of 135 patients (30%) had a recurrence of AF compared to 90 of 291 patients (31%) in the ER group (log-rank P = 0.72). CONCLUSION: There was no association between the time to recurrence of AF after initial CA and the characteristics and outcomes of the repeat procedure.

Cryoballoon pulmonary vein isolation as first-line treatment of typical atrial flutter: long-term outcomes of the CRAFT trial.

BACKGROUND: CRAFT was an international, multicentre, randomised controlled trial across 11 sites in the United UK and Switzerland. Given the evidence that pulmonary vein triggers may be responsible for atrial flutter (AFL) as well as atrial fibrillation (AF), we hypothesised that cryoballoon pulmonary vein isolation (PVI) would provide greater symptomatic arrhythmia reduction than cavotricuspid isthmus (CTI) ablation, whilst also reducing the subsequent burden of AF. Twelve-month outcomes were previously reported. In this study, we report the extended outcomes of the CRAFT study to 36 months. METHODS: Patients with typical AFL and no evidence of AF were randomised 1:1 to cryoballoon PVI or radiofrequency CTI. All patients received an implantable loop recorder (ILR) for continuous cardiac rhythm monitoring. The primary outcome was time-to-symptomatic arrhythmia recurrence > 30 s. Secondary outcomes included time-to-first-AF episode ≥ 2 min. The composite safety outcome included death, stroke and procedural complications. RESULTS: A total of 113 patients were randomised to cryoballoon PVI (n = 54) or radiofrequency CTI ablation (n = 59). Ninety-one patients reconsented for extended follow-up beyond 12 months. There was no difference in the primary outcome between arms, with the primary outcome occurring in 12 PVI vs 11 CTI patients (HR 0.97; 95% CI 0.43-2.20; p = 0.994). AF ≥ 2 min was significantly less frequent in the PVI arm, affecting 26 PVI vs 36 CTI patients (HR 0.48; 95% CI 0.29-0.79; p = 0.004). The composite safety outcome occurred in 5 PVI and 6 CTI patients (p = 0.755). CONCLUSION: Cryoballoon PVI shows similar efficacy to radiofrequency CTI ablation in reducing symptomatic arrhythmia recurrence in patients presenting with isolated typical AFL but significantly reduces the occurrence of subsequent AF.

Impact of implantation depth and calcium burden on infranodal conduction delay after transcatheter aortic valve replacement.

Background: Infranodal conduction disorders are common after transcatheter aortic valve replacement (TAVR). Risk factors are incompletely understood. Objective: The purpose of this study was to assess the impact of valve implantation depth and calcium burden of the device landing zone on infranodal conduction intraprocedure pre- and post-TAVR. Methods: In all patients undergoing TAVR between June 2020 and June 2021, the His-ventricle (HV) interval was measured pre- and post-valve deployment. The difference between the 2 measurements defined delta HV, whereas infranodal conduction delay was defined as HV interval >55 ms. Valve implantation depth was measured as the distance between the aortic annular plane and the ventricular prosthesis end. Calcium burden was quantified as the volume of calcium in 6 regions of interest: the non-, right, and left coronary cusps (NCC, RCC, and LCC, respectively) and the corresponding regions of the left ventricular outflow tract (LVOT) underlying each cusp (LVOTNCC, LVOTRCC, LVOTLCC, respectively). Results: Of 101 patients (mean age 81 ± 5.7 years; 47% women), 37 demonstrated infranodal conduction delay intraprocedure post-TAVR. Overall, mean implantation depth was 5 ± 3.1 mm, median calcium volume was 2080 mm3 [interquartile range 632-2400]. Delta HV showed no correlation with implantation depth or calcium burden (r = -0.08 and r = 0.12, respectively). However, LVOTNCC calcification was a significant predictor for infranodal conduction delay post-valve deployment in a multivariable logistic regression model (odds ratio 1.62 per 100-mm3 increase (95% confidence interval 1.06-2.69; P = .04). Conclusion: Assessment of LVOTNCC calcification may identify patients at risk for infranodal conduction delay after TAVR, whereas implantation depth did not predict infranodal conduction delay.

Stepping back for good reasons: a reappraisal of the DF-1 connector for defibrillator leads.

The DF-4 defibrillator standard has been rapidly adopted due to its convenience at implantation. There are however trade-offs compared to the traditional DF-1 standard that are underappreciated. This viewpoint outlines the advantages and limitations of current defibrillator lead standards that should be kept in mind, as they impact the options that are available to deal with issues that may arise.

Patients on vitamin K treatment: is switching to direct-acting oral anticoagulation cost-effective? A target trial on a prospective cohort.

AIMS: Direct-acting oral anticoagulants (DOACs) have, to a substantial degree, replaced vitamin K antagonists (VKA) as treatments for stroke prevention in atrial fibrillation (AF) patients. However, evidence on the real-world causal effects of switching patients from VKA to DOAC is lacking. We aimed to assess the empirical incremental cost-effectiveness of switching patients to DOAC compared with maintaining VKA treatment. METHODS: The target trial approach was applied to the prospective observational Swiss-AF cohort, which enrolled 2415 AF patients from 2014 to 2017. Clinical data, healthcare resource utilisation and EQ-5D-based utilities representing quality of life were collected in yearly follow-ups. Health insurance claims were available for 1024 patients (42.4%). Overall survival, quality-of-life, costs from the Swiss statutory health insurance perspective and cost-effectiveness were estimated by emulating a target trial in which patients were randomly assigned to switch to DOAC or maintain VKA treatment. RESULTS: 228 patients switching from VKA to DOAC compared with 563 patients maintaining VKA treatment had no overall survival advantage over a 5-year observation period (HR 0.99, 95% CI 0.45, 1.55). The estimated gain in quality-adjusted life years (QALYs) was 0.003 over the 5-year period at an incremental costs of CHF 23 033 (€ 20 940). The estimated incremental cost-effectiveness ratio was CHF 425 852 (€ 387 138) per QALY gained. CONCLUSIONS: Applying a causal inference method to real-world data, we could not demonstrate switching to DOACs to be cost-effective for AF patients with at least 1 year of VKA treatment. Our estimates align with results from a previous randomised trial.