| 1. |
- Balabanski, Tosho, et al.
(författare)
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Impact of monitoring on detection of arrhythmia recurrences in the ESC-EHRA EORP atrial fibrillation ablation long-term registry
- 2019
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Ingår i: Europace. - : Oxford University Press. - 1099-5129 .- 1532-2092. ; 21:12, s. 1802-1808
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: Monitoring of patients after ablation had wide variations in the ESC-EHRA atrial fibrillation ablation long-term (AFA-LT) registry. We aimed to compare four different monitoring strategies after catheter AF ablation.METHODS AND RESULTS: The ESC-EHRA AFA-LT registry included 3593 patients who underwent ablation. Arrhythmia monitoring during follow-up was performed by 12-lead electrocardiogram (ECG), Holter ECG, trans-telephonic ECG monitoring (TTMON), or an implanted cardiac monitoring (ICM) system. Patients were selected to a given monitoring group according to the most extensive ECG tool used in each of them. Comparison of the probability of freedom from recurrences was performed by censored log-rank test and presented by Kaplan-Meier curves. The rhythm monitoring methods were used among 2658 patients: ECG (N = 578), Holter ECG (N = 1874), TTMON (N = 101), and ICM (N = 105). A total of 767 of 2658 patients (28.9%) had AF recurrences during follow-up. Censored log-rank test discovered a lower probability of freedom from relapses, which was detected with ICM compared to TTMON, ECG, and Holter ECG (P < 0.001). The rate of freedom from AF recurrences was 50.5% among patients using the ICM while it was 65.4%, 70.6%, and 72.8% using the TTMON, ECG, and Holter ECG, respectively.CONCLUSION: Comparing all main electrocardiographic monitoring methods in a large patient sample, our results suggest that post-ablation recurrences of AF are significantly underreported by TTMON, ECG, and Holter ECG. The ICM estimates AF ablation recurrences most reliably and should be a preferred mode of monitoring for trials evaluating novel AF ablation techniques.
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| 2. |
- Di Cori, Andrea, et al.
(författare)
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Clinical impact of antithrombotic therapy in transvenous lead extraction complications : a sub-analysis from the ESC-EORP EHRA ELECTRa (European Lead Extraction ConTRolled) Registry
- 2019
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Ingår i: Europace. - : Oxford University Press. - 1099-5129 .- 1532-2092. ; 21:7, s. 1096-1105
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: A sub-analysis of the ESC-EHRA European Lead Extraction ConTRolled (ELECTRa) Registry to evaluate the clinical impact of antithrombotic (AT) on transvenous lead extraction (TLE) safety and efficacy.METHODS AND RESULTS: ELECTRa outcomes were compared between patients without AT therapy (No AT Group) and with different pre-operative AT regimens, including antiplatelets (AP), anticoagulants (AC), or both (AP + AC). Out of 3510 pts, 2398 (68%) were under AT pre-operatively. AT patients were older with more comorbidities (P < 0.0001). AT subgroups, defined as AP, AC, or AP + AC, were 1096 (31.2%), 985 (28%), and 317 (9%), respectively. Regarding AP patients, 1413 (40%) were under AP, 1292 (91%) with a single AP, interrupted in 26% about 3.8 ± 3.7 days before TLE. In total, 1302 (37%) patients were under AC, 881 vitamin K antagonist (68%), 221 (17%) direct oral anticoagulants, 155 (12%) low weight molecular heparin, and 45 (3.5%) unfractionated heparin. AC was 'interrupted without bridging' in 696 (54%) and 'interrupted with bridging' in 504 (39%) about 3.3 ± 2.3 days before TLE, and 'continued' in 87 (7%). TLE success rate was high in all subgroups. Only overall in-hospital death (1.4%), but not the procedure-related one, was higher in the AT subgroups (P = 0.0500). Age >65 years and New York Heart Association Class III/IV, but not AT regimens, were independent predictors of death for any cause. Haematomas were more frequent in AT subgroups, especially in AC 'continued' (P = 0.025), whereas pulmonary embolism in the No-AT (P < 0.01).CONCLUSIONS: AT minimization is safe in patients undergoing TLE. AT does not seem to predict death but identifies a subset of fragile patients with a worse in-hospital TLE outcome.
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| 3. |
- Grecu, Mihaela, et al.
(författare)
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In-hospital and 12-month follow-up outcome from the ESC-EORP EHRA Atrial Fibrillation Ablation Long-Term registry : sex differences
- 2020
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 22:1, s. 66-73
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Tidskriftsartikel (refereegranskat)abstract
- AIM: The purpose of this study was to compare sex differences of atrial fibrillation (AF) catheter ablation (CA) and to analyse the opportunities for improved outcomes.METHODS AND RESULTS: All data were collected from the Atrial Fibrillation Ablation Long-Term registry, a prospective, multinational study conducted by the ESC-EORP European Heart Rhythm Association (EHRA) under the EURObservational Research Programme (ESC-EORP). A total of 104 centres in 27 European countries participated. Of 3593 included patients, 1146 (31.9%) were female. Female patients were older (61.0 vs. 56.4 years; P < 0.001), had more comorbidities (hypertension, diabetes, and obesity), more episodes of arrhythmias per month (6.9 vs. 6.2; P < 0.001), and a higher average EHRA score (2.6 vs. 2.4; P < 0.001). The duration of the procedure was shorter in females (160.1 min vs. 167.9 min; P < 0.001), irrespective of additional ablation lesions added to pulmonary vein isolation. Overall cardiovascular complications were more frequent in women than in men (5.7% vs. 3.4%; P < 0.001). Furthermore, cardiac perforations (3.8% vs. 1.3%; P = 0.011) and neurological complications (2.2% vs. 0.3%; P = 0.004) were found in females in less experienced centres than in experienced ones. On a final note, at 12 months, AF recurrence rate was similar in females and males (34.4% vs. 34.2%; P = 0.897), but more females were still on antiarrhythmic drugs (50.6% vs. 44.1%; P < 0.001) when compared with men.CONCLUSION: Females underwent CA procedures for AF less frequently than males throughout Europe, despite more recurrent symptoms. With the same success rate, severe acute complications remained considerable in females, especially in less experienced centres.
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| 4. |
- Mörtsell, David, et al.
(författare)
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Cryoballoon vs. radiofrequency ablation for atrial fibrillation : a study of outcome and safety based on the ESC-EHRA atrial fibrillation ablation long-term registry and the Swedish catheter ablation registry
- 2019
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 21:4, s. 581-589
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Tidskriftsartikel (refereegranskat)abstract
- Aims: Pulmonary vein isolation (PVI), the standard for atrial fibrillation (AF) ablation, is most commonly applied with radiofrequency (RF) energy, although cryoballoon technology (CRYO) has gained widespread use. The aim was to compare the second-generation cryoballoon and the irrigated RF energy regarding outcomes and safety.Methods and results: Of 4657 patients undergoing their first AF ablation, 982 with CRYO and 3675 with RF energy were included from the Swedish catheter ablation registry and the Atrial Fibrillation Ablation Long-Term registry of the European Heart Rhythm Association of the European Society of Cardiology. The primary endpoint was repeat AF ablation. The major secondary endpoints included procedural duration, tachyarrhythmia recurrence, and complication rate. The re-ablation rate after 12 months was significantly lower in the CRYO vs. the RF group, 7.8% vs. 11%, P=0.005, while freedom from arrhythmia recurrence (30 s duration) did not differ between the groups, 70.2 % vs. 68.2%, P=0.44. The result was not influenced by AF type and lesion sets applied. In the Cox regression analysis, paroxysmal AF had significantly lower risk for re-ablation with CRYO, hazard ratio 0.56 (P=0.041). Procedural duration was significantly shorter with CRYO than RF, (meanSD) 133.6 +/- 45.2 min vs. 174.6 +/- 58.2 min, P<0.001. Complication rates were similar; 53/982 (5.4%) vs. 191/3675 (5.2%), CRYO vs. RF, P=0.806.Conclusion: The lower re-ablation rates and shorter procedure times observed with the cryoballoon as compared to RF ablation may have important clinical implications when choosing AF ablation technique despite recognized limitations with registries.
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| 5. |
- Nof, Eyal, et al.
(författare)
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Comparison of outcomes in infected cardiovascular implantable electronic devices between complete, partial, and failed lead removal : an ESC-EHRA-EORP ELECTRa (European Lead Extraction ConTrolled) registry
- 2019
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Ingår i: Europace. - : Oxford University Press. - 1099-5129 .- 1532-2092. ; 21:12, s. 1876-1889
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: The present study sought to determine predictors for success and outcomes of patients who underwent cardiac implantable electronic devices (CIED) extraction indicated for systemic or local CIED related infection in particular where complete lead removal could not be achieved.METHODS AND RESULTS: ESC-EORP ELECTRa (European Lead Extraction ConTRolled Registry) is a European prospective lead extraction registry. Out of the total cohort, 1865/3510 (52.5%) patients underwent removal due to CIED related infection. Predictors and outcomes of failure were analysed. Complete removal was achieved in 1743 (93.5%) patients, partial (<4 cm of lead left) in 88 (4.7%), and failed (>4 cm of lead left) in 32 (1.8%) patients. Removal success was unrelated to type of CIED infection (pocket or systemic). Predictors for failure were older leads and older patients [odds ratio (OR) 1.14 (1.08-1.19), P < 0.0001 and OR 2.68 (1.22-5.91), P = 0.0146, respectively]. In analysis by lead, predictors for failure were: pacemaker vs. defibrillator removal and failure to engage the locking stylet all the way to the tip [OR 0.20 (0.04-0.95), P = 0.03 and OR 0.32 (0.13-0.74), P = 0.008, respectively]. Significantly higher complication rates were noted in the failure group (40.6% vs. 15.9 for partial and 8.7% for success groups, P < 0.0001). Failure to remove a lead was a strong predictor for in hospital mortality [hazard ratio of 2.05 (1.01-4.16), P = 0.046].CONCLUSION: A total of 6.5% of infected CIED patients failed attempted extraction. Only were >4 cm of lead remained resulted in higher procedural complications and mortality rates.
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| 6. |
- Polewczyk, Anna, et al.
(författare)
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Transvenous lead extraction procedures in women based on ESC-EHRA EORP European Lead Extraction ConTRolled ELECTRa registry : is female sex a predictor of complications?
- 2019
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 21:12
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: Female sex is considered an independent risk factor of transvenous leads extraction (TLE) procedure. The aim of the study was to evaluate the effectiveness of TLE in women compared with men.METHODS AND RESULTS: A post hoc analysis of risk factors and effectiveness of TLE in women and men included in the ESC-EHRA EORP ELECTRa registry was conducted. The rate of major complications was 1.96% in women vs. 0.71% in men; P = 0.0025. The number of leads was higher in men (mean 1.89 vs. 1.71; P < 0.0001) with higher number of abandoned leads in women (46.04% vs. 34.82%; P < 0.0001). Risk factors of TLE differed between the sexes, of which the major were: signs and symptoms of venous occlusion [odds ratio (OR) 3.730, confidence interval (CI) 1.401-9.934; P = 0.0084], cumulative leads dwell time (OR 1.044, CI 1.024-1.065; P < 0.001), number of generator replacements (OR 1.029, CI 1.005-1.054; P = 0.0184) in females and the number of leads (OR 6.053, CI 2.422-15.129; P = 0.0001), use of powered sheaths (OR 2.742, CI 1.404-5.355; P = 0.0031), and white blood cell count (OR 1.138, CI 1.069-1.212; P < 0.001) in males. Individual radiological and clinical success of TLE was 96.29% and 98.14% in women compared with 98.03% and 99.21% in men (P = 0.0046 and 0.0098).CONCLUSION: The efficacy of TLE was lower in females than males, with a higher rate of periprocedural major complications. The reasons for this difference are probably related to disparities in risk factors in women, including more pronounced leads adherence to the walls of the veins and myocardium. Lead management may be key to the effectiveness of TLE in females.
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| 7. |
- Segreti, Luca, et al.
(författare)
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Procedural outcomes associated with transvenous lead extraction in patients with abandoned leads : an ESC-EHRA ELECTRa (European Lead Extraction ConTRolled) Registry Sub-Analysis.
- 2019
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 21:4, s. 645-654
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Tidskriftsartikel (refereegranskat)abstract
- Aims: The decision to abandon or extract superfluous leads remains controversial. We sought to compare procedural outcome of patients with and without abandoned leads undergoing transvenous lead extraction (TLE).Methods and results: An analysis of the ESC-EHRA European Lead Extraction ConTRolled ELECTRa registry was conducted. Patients were stratified into two groups based on the presence (Group 1) or absence (Group 2) of abandoned leads at the time for extraction. Out of 3508 TLE procedures, 422 patients (12.0%) had abandoned leads (Group 1). Group 1 patients were older and more likely to have implantable cardioverter-defibrillator devices, infection indication (78.8% vs. 49.8%), and vegetations (24.6% vs. 15.3%). Oldest lead dwelling time was longer in Group 1 (10.9 vs. 6.3 years) as was the number of extracted leads per patient (3.2 vs. 1.7). Manual traction failure (94.5% vs. 78.8%), powered sheath use (50.7% vs. 28.4%), and femoral approach were higher in Group 1 (P < 0.0001). Procedural success rate and clinical success (89.8% vs. 96.6%, P < 0.0001) were lower in Group 1. Major complication including deaths (5.5% vs. 2.3%, P = 0.0007) and procedure related major complications (3.3% vs. 1.4%, P = 0.0123) were higher in Group 1. The presence of abandoned leads at the time of TLE was an independent predictor of clinical failure [odds ratio (OR) 2.31, confidence interval (CI) 1.57-3.40] and complications [OR 1.69, CI 1.22-2.35]. receiver-operating characteristic curve analysis showed a dwell time threshold of 9 years for radiological failure and major complications.Conclusions: Previously abandoned leads at the time of TLE were associated with increased procedural complexity, clinical failure, and major complication, which may have important implications for future studies regarding managing of lead failures.
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| 8. |
- Tilz, Roland Richard, et al.
(författare)
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Which patients with atrial fibrillation undergo an ablation procedure today in Europe? : A report from the ESC-EHRA-EORP Atrial Fibrillation Ablation Long-Term and Atrial Fibrillation General Pilot Registries
- 2020
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 22:2, s. 250-258
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Tidskriftsartikel (refereegranskat)abstract
- AimsRhythm control management in patients with atrial fibrillation (AF) may be unequal across Europe. The aim of this study was to investigate how selective the patient cohort referred for AF ablation is, as compared to the general AF population in Europe, and to describe the governing mechanisms for such selection.Methods and resultsDescriptive comparative statistical analyses of the baseline characteristics were performed between the cohorts of Atrial Fibrillation Ablation Long-Term (ESC EORP AFA-LT) registry, designed to provide a picture of contemporary real-world AF ablation, and the AF population from the AF-General (ESC EORP AF-Gen) pilot registry. Data collection was performed using a web-based system. In the AFA and in the Atrial Fibrillation General (AFG) pilot registries, 3593 and 3049 patients were enrolled, respectively. Patients who underwent AF ablation were younger, more commonly male, and had significantly less comorbidities. Atrial Fibrillation Ablation patients often presented without comorbidities, resulting in a lower risk of stroke (CHA2DS2-VASc ≥5: 2.9% vs. 24.5%, all P < 0.001) and bleeding (HAS-BLED ≥2: 8.5% vs. 40.5%, P < 0.001) but with European Heart Rhythm Association (EHRA) scores >1 and more prevalent AF-related symptoms such as palpitations, fatigue, and weakness (all P < 0.001) as compared to the general AF patients. Atrial Fibrillation Ablation patients were significantly more often male, had higher left ventricular ejection fraction (59.5% vs. 52.4%) and smaller left atrial size on echocardiogram (P < 0.001 each).ConclusionThe comparison of the patient cohorts in the AFA and AFG registries showed that AF ablation in European clinical practice is mostly performed in relatively young, symptomatic and relatively healthy patients.
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| 9. |
- Vassilikos, Vassilios P., et al.
(författare)
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Impact of centre volume on atrial fibrillation ablation outcomes in Europe : a report from the ESC EHRA EORP Atrial Fibrillation Ablation Long-Term (AFA LT) Registry
- 2021
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Ingår i: Europace. - : Oxford University Press. - 1099-5129 .- 1532-2092. ; 23:1, s. 49-58
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: The aim of the study was to investigate differences in clinical outcomes and complication rates among European atrial fibrillation (AF) ablation centres related to the volume of AF ablations performed.METHODS AND RESULTS: Data for this analysis were extracted from the ESC EHRA EORP European AF Ablation Long-Term Study Registry. Based on 33rd and 67th percentiles of number of AF ablations performed, the participating centres were classified into high volume (HV) (≥ 180 procedures/year), medium volume (MV) (<180 and ≥74/year), and low volume (LV) (<74/year). A total of 91 centres in 26 European countries enrolled in 3368 patients. There was a significantly higher reporting of cardiovascular complications and stroke incidence in LV centres compared with HV and MV (P = 0.039 and 0.008, respectively) and a lower success rate after AF ablation (55.3% in HV vs. 57.2% in LV vs. 67.4% in MV centres, P < 0.001), despite lower CHA2DS2-VASc score of patients, enrolled in LVs and less complex ablation techniques used. Adjustments of confounding factors (including type of AF ablation) led to elimination of these differences.CONCLUSION: Low-volume centres tended to present slightly higher cardiovascular complications' and stroke incidence and a lower unadjusted success rate after AF ablation, despite the fact that ablation procedures and patients were of lower risk compared with MV and HV centres. On the other hand, adjusted overall complication and recurrence rates were non-significantly different among different volume centres, a fact reflecting the heterogeneity of patient and procedural profiles, and a counterbalance between expertise and risk level among participating centres.
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| 10. |
- Zucchelli, Giulio, et al.
(författare)
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Major cardiac and vascular complications after transvenous lead extraction : acute outcome and predictive factors from the ESC-EHRA ELECTRa (European Lead Extraction ConTRolled) registry
- 2019
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Ingår i: Europace. - : Oxford University Press (OUP). - 1099-5129 .- 1532-2092. ; 21:5, s. 771-780
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Tidskriftsartikel (refereegranskat)abstract
- Aims: We aimed at describing outcomes and predictors of cardiac avulsion or tear (CA/T) with tamponade and vascular avulsion or tear (VA/T) after transvenous lead extraction (TLE) in the ESC-EHRA European Lead Extraction ConTRolled (ELECTRa) registry.Methods and results: A total of 3555 consecutive patients of whom 3510 underwent TLE at 73 centres in 19 European countries were enrolled. Among 58 patients (1.7%) with procedure-related major complications, 49 (84.5%) patients (30 CA/T and 19 VA/T) presented cardiovascular complications requiring pericardiocentesis, chest tube positioning and/or surgical repair. The mortality was 20% in patients with tamponade due to CA/T and 31.6% in patients with VA/T. Pericardiocentesis as first manoeuvre followed by rescue surgical repair was highly effective in case of CA/T (93.8%). At multivariate analysis, CA/T with tamponade was more common in RIATA lead extraction, female patients, leads with a mean dwelling time more than 10 years, and when ≥3 leads were extracted or multiple sheaths required. Occlusion or critical stenosis of superior venous access and the leads mean dwelling time more than 10 years were independent predictors for VA/T, while mechanical dilatation was an independent predictor of a lower incidence of this complication as compared to the use of powered sheaths.Conclusions: In the ELECTRa registry, RIATA lead extraction and superior venous access occlusion/thrombosis are two new independent predictors for cardiac tamponade and major vascular complications, respectively. The use of mechanical sheaths seems to be associated with a lower incidence of VA/T. A strategy of pericardiocentesis followed by a rescue surgical approach seems to be reasonable in order to treat a CA/T with tamponade.
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