RESUMO
BACKGROUND AND AIMS: Pulsed-field ablation (PFA) is an emerging technology to perform pulmonary vein isolation (PVI). Initial data demonstrated high safety and efficacy. Data on long-term PVI durability and reconduction patterns in comparison to established energy sources for PVI are scarce. We compare findings in repeat ablation procedures after a first pulsed-field ablation (PFA) to findings in repeat ablation procedures after a first cryoballoon ablation (CBA) based PVI. METHODS: 550 consecutively enrolled patients underwent PFA or CBA index PVI. Repeat ablations in patients with symptomatic atrial arrhythmia recurrences were analyzed. RESULTS: A total of 22/191 (12%) patients after index PFA-PVI and 44/359 (12%) after CBA-PVI underwent repeat ablation. Reconduction of any pulmonary vein (PV) was detected by multipolar spiral mapping catheter at each PV with careful evaluation of PV potentials and by 3D-mapping in 16/22 patients (73%) after PFA-PVI and in 33/44 (75%) after CBA-PVI (p=1.000). Of 82 initially isolated PVs after PFA-PVI, 31 (38%) were reconducting; of 169 isolated PVs after CBA-PVI, 63 (37%) were reconducting (p=0.936). Clinical atrial tachycardia occurred similarly in patients after PFA (5/22; 23%) and CBA (7/44; 16%; p=0.515). Roof lines were set more often after PFA- (8/22; 36%) compared to CBA-PVI (5/44 ; 11%; p=0.023). Repeat procedure duration (PFA: 87 [76,123] min; CBA: 93 [75,128] min; p=0.446) was similar and fluoroscopy time (PFA: 11 [9,14] min; CBA: 11 [8,14] min; p=0.739) equal between groups at repeat ablation. CONCLUSION: During repeat ablation after previous PFA- or CBA-based PVI, electrical PV-reconduction rates and patterns were similar.
RESUMO
AIMS: Clinical concerns exist about the potential proarrhythmic effects of the sodium channel blockers (SCBs) flecainide and propafenone in patients with cardiovascular disease. Sodium channel blockers were used to deliver early rhythm control (ERC) therapy in EAST-AFNET 4. METHODS AND RESULTS: We analysed the primary safety outcome (death, stroke, or serious adverse events related to rhythm control therapy) and primary efficacy outcome (cardiovascular death, stroke, and hospitalization for worsening of heart failure (HF) or acute coronary syndrome) during SCB intake for patients with ERC (n = 1395) in EAST-AFNET 4. The protocol discouraged flecainide and propafenone in patients with reduced left ventricular ejection fraction and suggested stopping therapy upon QRS prolongation >25% on therapy. Flecainide or propafenone was given to 689 patients [age 69 (8) years; CHA2DS2-VASc 3.2 (1); 177 with HF; 41 with prior myocardial infarction, coronary artery bypass graft, or percutaneous coronary intervention; 26 with left ventricular hypertrophy >15â mm; median therapy duration 1153 [237, 1828] days]. The primary efficacy outcome occurred less often in patients treated with SCB [3/100 (99/3316) patient-years] than in patients who never received SCB [SCBnever 4.9/100 (150/3083) patient-years, P < 0.001]. There were numerically fewer primary safety outcomes in patients receiving SCB [2.9/100 (96/3359) patient-years] than in SCBnever patients [4.2/100 (135/3220) patient-years, adjusted P = 0.015]. Sinus rhythm at 2 years was similar between groups [SCB 537/610 (88); SCBnever 472/579 (82)]. CONCLUSION: Long-term therapy with flecainide or propafenone appeared to be safe in the EAST-AFNET 4 trial to deliver effective ERC therapy, including in selected patients with stable cardiovascular disease such as coronary artery disease and stable HF. Clinical Trial Registration ISRCTN04708680, NCT01288352, EudraCT2010-021258-20, www.easttrial.org.
Assuntos
Antiarrítmicos , Flecainida , Bloqueadores dos Canais de Sódio , Humanos , Idoso , Masculino , Feminino , Resultado do Tratamento , Pessoa de Meia-Idade , Flecainida/uso terapêutico , Flecainida/efeitos adversos , Antiarrítmicos/uso terapêutico , Antiarrítmicos/efeitos adversos , Bloqueadores dos Canais de Sódio/uso terapêutico , Bloqueadores dos Canais de Sódio/efeitos adversos , Fibrilação Atrial/tratamento farmacológico , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/fisiopatologia , Fatores de Tempo , Frequência Cardíaca/efeitos dos fármacos , Acidente Vascular CerebralRESUMO
BACKGROUND: Achieving early rhythm control and maintaining sinus rhythm are associated with improved outcomes in patients with atrial fibrillation (AF). Pulmonary vein isolation (PVI) is a validated alternative to medical rhythm control. This study determined associations between left atrial strain reservoir (LASR) and AF recurrence after PVI.MethodsâandâResults: In all, 132 patients (88 with paroxysmal AF [PAF], 44 with persisting AF [PersAF]) who presented in sinus rhythm for de novo PVI of AF between December 2017 and January 2019 were included in the study. All patients underwent preprocedural echocardiography. After 12 months, all patients underwent 24-h Holter electrocardiogram monitoring to screen for AF recurrence. Kaplan-Meier curve analysis revealed an association between decreasing LASRand increased AF recurrence, with a cut-off at 31.4%. In univariable Cox regression analysis, LASRdemonstrated an association with AF recurrence, with hazard ratios (HR) of 0.83 (95% confidence interval [CI] 073-0.93; P=0.001) per 5% increase in univariable models and 0.83 (95% CI 073-0.95; P=0.005) in multivariable analysis. When clinical variables with age, sex and type of AF (PAF/PersAF) were included in the multivariable analysis, LASRremained relevant in a model with age (HR 0.86; 95% CI 073-1.00; P=0.046). CONCLUSIONS: In patients undergoing de novo PVI for AF, LASRcould be of use in risk stratification regarding AF recurrence.
RESUMO
BACKGROUND: The randomized EAST-AFNET4 (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial-Atrial Fibrillation Network) demonstrated that early rhythm control (ERC) reduces adverse cardiovascular outcomes in patients with recently diagnosed atrial fibrillation and stroke risk factors. The effectiveness and safety of ERC in patients with multiple cardiovascular comorbidities is not known. METHODS: These prespecified subanalyses of EAST-AFNET4 compared the effectiveness and safety of ERC with usual care (UC) stratified into patients with higher (CHA2DS2-VASc score ≥4) and lower comorbidity burden. Sensitivity analyses ignored sex (CHA2DS2-VA score). RESULTS: EAST-AFNET4 randomized 1093 patients with CHA2DS2-VASc score ≥4 (74.8±6.8 years, 61% female) and 1696 with CHA2DS2-VASc score <4 (67.4±8.0 years, 37% female). ERC reduced the composite primary efficacy outcome of cardiovascular death, stroke, or hospitalization for worsening of heart failure or for acute coronary syndrome in patients with CHA2DS2-VASc score ≥4 (ERC, 127/549 patients with events; UC, 183/544 patients with events; hazard ratio [HR], 0.64 [0.51-0.81]; P < 0.001) but not in patients with CHA2DS2-VASc score <4 (ERC, 122/846 patients with events; UC, 133/850 patients with events; HR, 0.93 [0.73-1.19]; P=0.56, Pinteraction=0.037). The primary safety outcome (death, stroke, or serious adverse events of rhythm control therapy) was not different between study groups in patients with CHA2DS2-VASc score ≥4 (ERC, 112/549 patients with events; UC, 132/544 patients with events; HR, 0.84 [0.65, 1.08]; P=0.175), but occurred more often in patients with CHA2DS2-VASc scores <4 randomized to ERC (ERC, 119/846 patients with events; UC, 91/850 patients with events; HR, 1.39 [1.05-1.82]; P=0.019, Pinteraction=0.008). Life-threatening events or death were not different between groups (CHA2DS2-VASc score ≥4, ERC, 84/549 patients with event, UC, 96/544 patients with event; CHA2DS2-VASc scores <4, ERC, 75/846 patients with event, UC, 73/850 patients with event). When female sex was ignored for the creation of higher and lower risk groups (CHA2DS2-VA score), the Pinteraction was not significant for the primary efficacy outcome (P=0.25), but remained significant (P=0.044) for the primary safety outcome. CONCLUSIONS: Patients with recently diagnosed atrial fibrillation and CHA2DS2-VASc score ≥4 should be considered for ERC to reduce cardiovascular outcomes, whereas those with fewer comorbidities may have less favorable outcomes with ERC. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT01288352. URL: https://www.clinicaltrialsregister.eu; Unique identifier: 2010-021258-20. URL: https://www.isrctn.com/; Unique identifier: ISRCTN04708680.
Assuntos
Fibrilação Atrial , Acidente Vascular Cerebral , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Comorbidade , Feminino , Humanos , Masculino , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controleRESUMO
INTRODUCTION: Pulsed-field ablation (PFA) and the multielectrode radiofrequency balloon (RFB) are two novel ablation technologies to perform pulmonary vein isolation (PVI). It is currently unknown whether these technologies differ in lesion formation and lesion extent. We compared the acute lesion extent after PVI induced by PFA and RFB by measuring low-voltage area in high-density maps and the release of biomolecules reflecting cardiac injury. METHODS: PVI was performed with a pentaspline catheter (FARAPULSE) applying PFA or with the compliant multielectrode RFB (HELIOSTAR). Before and after PVI high-density mapping with CARTO 3 was performed. In addition, blood samples were taken before transseptal puncture and after post-PVI remapping and serum concentrations of high-sensitive Troponin I were quantified by immunoassay. RESULTS: Sixty patients undergoing PVI by PFA (n = 28, age 69 ± 12 year, 60% males, 39.3% persistent atrial fibrillation [AF]) or RFB (n = 32, age 65 ± 13 year, 53% males, 21.9% persistent AF) were evaluated. Acute PVI was achieved in all patients in both groups. Mean number of PFA pulses was 34.2 ± 4.5 and mean number RFB applications was 8.5 ± 3 per patient. Total posterior ablation area was significantly larger in PFA (20.7 ± 7.7 cm²) than in RFB (7.1 ± 2.09 cm²; p < .001). Accordingly, posterior ablation area for each PV resulted in larger lesions after PFA versus RFB (LSPV 5.2 ± 2.7 vs. 1.9 ± 0.8 cm², LIPV 5.5 ± 2.3 vs. 1.9 ± 0.8 cm², RSPV 4.7 ± 1.9 vs. 1.6 ± 0.5 cm², RIPV 5.3 ± 2.1 vs. 1.6 ± 0.7 cm,² respectively; p < .001). In a subset of 38 patients, increase of hsTropI was higher after PFA (625 ± 138 pg/mL, n = 28) versus RFB (148 ± 36 pg/mL, n = 10; p = .049) supporting the evidence of larger lesion extent by PFA. CONCLUSION: PFA delivers larger acute lesion areas and higher troponin release upon successful PVI than multielectrode RFB-based PVI in this single-center series.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Masculino , Humanos , Pessoa de Meia-Idade , Idoso , Idoso de 80 Anos ou mais , Feminino , Veias Pulmonares/cirurgia , Resultado do Tratamento , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , CatéteresRESUMO
AIMS: The randomized, controlled EAST-AFNET 4 trial showed that early rhythm control (ERC) reduces the rate of a composite primary outcome (cardiovascular death, stroke, or hospitalization for worsening heart failure or acute coronary syndrome) by â¼20%. The current study examined the cost-effectiveness of ERC compared to usual care. METHODS AND RESULTS: This within-trial cost-effectiveness analysis was based on data from the German subsample of the EAST-AFNET 4 trial (n = 1664/2789 patients). Over a 6-year time horizon and from a healthcare payer's perspective, ERC was compared to usual care regarding costs (hospitalization and medication) and effects (time to primary outcome; years survived). Incremental cost-effectiveness ratios (ICERs) were calculated. Cost-effectiveness acceptability curves were constructed to visualize uncertainty. Early rhythm control was associated with higher costs [+1924, 95% CI (-399, 4246)], resulting in ICERs of 10 638 per additional year without a primary outcome and 22 536 per life year gained. The probability of ERC being cost-effective compared to usual care was ≥95% or ≥80% at a willingness-to-pay value of ≥55 000 per additional year without a primary outcome or life year gained, respectively. CONCLUSION: From a German healthcare payer's perspective, health benefits of ERC may come at reasonable costs as indicated by the ICER point estimates. Taking statistical uncertainty into account, cost-effectiveness of ERC is highly probable at a willingness-to-pay value of ≥55 000 per additional life year or year without a primary outcome. Future studies examining the cost-effectiveness of ERC in other countries, subgroups with higher benefit from rhythm control therapy, or cost-effectiveness of different modes of ERC are warranted.
Assuntos
Fibrilação Atrial , Insuficiência Cardíaca , Acidente Vascular Cerebral , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Fibrilação Atrial/complicações , Análise Custo-Benefício , Análise de Custo-Efetividade , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Insuficiência Cardíaca/complicações , Acidente Vascular Cerebral/complicações , Anos de Vida Ajustados por Qualidade de VidaRESUMO
AIMS: A novel irrigated radiofrequency (RF) balloon (RFB) for pulmonary vein (PV) isolation (PVI) was released in selected centres. We pooled the procedural data on efficacy and safety of RFB-PVI from two high volume German centres. METHODS AND RESULTS: Consecutive patients with RFB procedures were enrolled. A 3D electroanatomical left atrial map guided the RFB navigation. Every RF delivery lasted 60â s, and duration was automatically reduced to 20â s for electrodes facing the posterior wall. Procedural data and post-procedural endoscopy data (<48â h) were analysed. Data from 140 patients were collected (57% male, 67 ± 11 years, 57% paroxysmal atrial fibrillation). There were 547 PVs identified, and 99.1% could be isolated using solely the RFB. Single-shot PVI was recorded in 330/547 (60%) PVs. Median time to isolation during the first application was 10â s (IQR 8-13). A total of 2.1 ± 1.8 applications per PV were delivered, with the left superior PV requiring more application compared to other PVs. Median procedure and fluoroscopy time were 77 min (61-99) and 13 min (10-17), respectively. Major safety events were recorded only in the first 25 cases at each centre and included 1/140(0.7%) cardiac tamponade, 1/140(0.7%) phrenic nerve palsy, and 2/140 strokes (1.4%). An oesophageal temperature rise was recorded in 81/547 (15%) PVs, and endoscopy detected oesophageal lesions in 7/85 (8%) patients undergoing endoscopy. CONCLUSION: The RFB showed a high efficacy allowing for fast PVI procedures, and 60% of PVs could be isolated at the first application. Most safety events were recorded during the learning phase. An oesophageal temperature monitoring is suggested: oesophageal lesions were detected in 8% of patients.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Masculino , Feminino , Resultado do Tratamento , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Fibrilação Atrial/etiologia , Átrios do Coração , Veias Pulmonares/cirurgiaRESUMO
BACKGROUND: A novel multielectrode radiofrequency balloon (RFB) catheter has been released for pulmonary vein isolation (PVI).MethodsâandâResults: In this observational study consecutive patients with drug-refractory paroxysmal or persistent atrial fibrillation (AF) undergoing first-time PVI were enrolled in 2 high-volume ablation centers. All procedures were conducted in conjunction with a 3D-mapping system. Clinical, procedural and ablation parameters were systematically analyzed. 105 patients (58% male; 52% paroxysmal AF, 68±11.3 years mean age, left atrial volume index 38.6±14.8 mL/m2) were included. 241/412 (58.5%) PVs were successfully isolated with a single shot (SS), with a time-to-isolation of 11.6±8 s. Total number of radiofrequency applications was 892 (mean 2.2/PV), resulting in successful isolation of 408/412 (99%) PVs at the end of the procedure. Mean electrodes' impedance drop was significantly higher in the SS-PVI compared with non-SS applications (21.5±6.6 vs. 18.6±6.5 Ohm). Concordantly, higher temperature rise was observed in the SS vs. non-SS applications (10.9±4.9â vs. 9.6±4.7â). CONCLUSIONS: In this multicenter real-world study, mean impedance drop and temperature rise were associated with successful SS-PVI applying the novel RFB catheter. These parameters may help to guide efficient usage of the new RF balloon.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Masculino , Feminino , Resultado do Tratamento , Ablação por Cateter/métodos , Fibrilação Atrial/cirurgia , Átrios do Coração , Veias Pulmonares/cirurgia , Catéteres , RecidivaRESUMO
BACKGROUND: Catheter ablation has been evolved to a cornerstone in the therapy of atrial fibrillation (AF); however, atrial tachycardias (AT) after AF ablation are still an important issue. Besides the electrical recurrence of atrial tachyarrhythmia after ablation, left atrial (LA) remodeling has received attention as a consequence of AF. OBJECTIVE: The aim of this study is to evaluate predictors for AT recurrence and LA remodeling in patients with repeat AF ablation procedures. METHODS AND RESULTS: One hundred thirteen patients who underwent repeat AF ablation with 3D electro-anatomical mapping system were evaluated. Mean age was 63.1 ± 9.3 years, and 2.3 ± 0.5 ablation procedures were performed during a time period of 22 [IQR 7;48] months. Reverse structural LA remodeling (LA volume decreased more than 15%) was observed in 25 (22.1%) patients. LA volume index (LAVI) during first procedure was the only predictor for positive reverse structural LA remodeling (hazard ratio (HR): 1.03, 95% CI: 1.00-1.07, p = .036) in multivariate analysis. Fifty-nine (52.2%) patients experienced only AF and 54 (47.8%) patients AT after first procedure. Female gender (HR: 5.21, 95% CI: 1.66-18.08, p = .006), LAVI (HR: 1.06, 95% CI: 1.02-1.11, p = .008) and LA scar percentage (HR: 1.08, 95% CI: 1.02-1.17, p = .019) were independent significant predictors for AT recurrence in multivariate analysis. CONCLUSIONS: Reverse structural LA remodeling occurred in a quarter of patients with repeat ablation procedures for AF. Only larger LAVI during first procedure predicted reverse structural LA remodeling. Half of the patients experienced AT between first and last ablation procedure. Female gender, larger LAVI and larger scar area were significant predictors for AT after catheter ablation for AF.
Assuntos
Fibrilação Atrial , Remodelamento Atrial , Ablação por Cateter , Taquicardia Supraventricular , Humanos , Feminino , Pessoa de Meia-Idade , Idoso , Cicatriz , Átrios do Coração/cirurgia , Ablação por Cateter/métodos , Resultado do Tratamento , RecidivaRESUMO
BACKGROUND: Catheter ablation is an effective treatment for atrial fibrillation (AF,) but arrhythmia recurrence occurs in a relevant number of patients. Mechanisms of late occurring arrhythmias after ablation procedures are not fully understood. We analyzed electrophysiological mechanisms of early and late arrhythmia recurrences in patients who underwent radiofrequency-based catheter ablation of AF. METHODS AND RESULTS: Consecutive patients who underwent repeat ablation procedures after initial pulmonary vein isolation (PVI) for symptomatic arrhythmia recurrence were analyzed. A total of 110 consecutive patients who underwent catheter ablation for paroxysmal (79%) or persistent AF (21%) were included. Forty-seven patients suffered from early arrhythmia recurrence (group #1: 3-24 months), 29 patients from mid-term arrhythmia recurrences (group #2: 2-5 years), and 34 patients from late arrhythmia recurrences (group #3: > 5 years). Electrical PV reconnection was found in 98% in group #1, 72% in group #2 and 56% in group #3 (p < .001). Mode of arrhythmia recurrence was organized tachycardia in 25%, 28%, and 65% of patients in groups #1, #2, and #3 (p = .001), respectively. Patients with late arrhythmia recurrence had more pronounced left atrial low voltage as compared to patients with early arrhythmia recurrence based on two published scoring system. CONCLUSION: Electrical PV reconnection was found in the majority of patients with early AF recurrence after PVI. In patients with late arrhythmia recurrences this mechanism may play an inferior role, with many patients presenting without PV reconnection, but with LA structural alterations. Thus, early and late occurring arrhythmia recurrence after catheter ablation may be the same symptom of different diseases.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Veias Pulmonares/cirurgia , Recidiva , Átrios do Coração , Resultado do Tratamento , Ablação por Cateter/métodosRESUMO
BACKGROUND: Even on optimal therapy, many patients with heart failure and atrial fibrillation experience cardiovascular complications. Additional treatments are needed to reduce these events, especially in patients with heart failure and preserved left ventricular ejection fraction. METHODS: This prespecified subanalysis of the randomized EAST-AFNET4 trial (Early Treatment of Atrial Fibrillation for Stroke Prevention Trial) assessed the effect of systematic, early rhythm control therapy (ERC; using antiarrhythmic drugs or catheter ablation) compared with usual care (allowing rhythm control therapy to improve symptoms) on the 2 primary outcomes of the trial and on selected secondary outcomes in patients with heart failure, defined as heart failure symptoms New York Heart Association II to III or left ventricular ejection fraction [LVEF] <50%. RESULTS: This analysis included 798 patients (300 [37.6%] female, median age 71.0 [64.0, 76.0] years, 785 with known LVEF). The majority of patients (n=442) had heart failure and preserved LVEF (LVEF≥50%; mean LVEF 61±6.3%), the others had heart failure with midrange ejection fraction (n=211; LVEF 40%-49%; mean LVEF 44 ± 2.9%) or heart failure with reduced ejection fraction (n=132; LVEF<40%; mean LVEF 31±5.5%). Over the 5.1-year median follow-up, the composite primary outcome of cardiovascular death, stroke, or hospitalization for worsening of heart failure or for acute coronary syndrome occurred less often in patients randomly assigned to ERC (94/396; 5.7 per 100 patient-years) compared with patients randomly assigned to usual care (130/402; 7.9 per 100 patient-years; hazard ratio, 0.74 [0.56-0.97]; P=0.03), not altered by heart failure status (interaction P value=0.63). The primary safety outcome (death, stroke, or serious adverse events related to rhythm control therapy) occurred in 71 of 396 (17.9%) patients with heart failure randomly assigned to ERC and in 87 of 402 (21.6%) patients with heart failure randomly assigned to usual care (hazard ratio, 0.85 [0.62-1.17]; P=0.33). LVEF improved in both groups (LVEF change at 2 years: ERC 5.3±11.6%, usual care 4.9±11.6%, P=0.43). ERC also improved the composite outcome of death or hospitalization for worsening of heart failure. CONCLUSIONS: Rhythm control therapy conveys clinical benefit when initiated within 1 year of diagnosing atrial fibrillation in patients with signs or symptoms of heart failure. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01288352. URL: http://www.controlled-trials.com; Unique identifier: ISRCTN04708680. URL: https://www.clinicaltrialsregister.eu; Unique identifier: 2010-021258-20.
Assuntos
Fibrilação Atrial/terapia , Insuficiência Cardíaca/terapia , Prevenção Secundária , Disfunção Ventricular Esquerda/terapia , Adulto , Idoso , Idoso de 80 Anos ou mais , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/fisiopatologia , Feminino , Humanos , Masculino , Acidente Vascular Cerebral/terapia , Volume Sistólico/fisiologia , Disfunção Ventricular Esquerda/fisiopatologia , Função Ventricular Esquerda/fisiologiaRESUMO
INTRODUCTION: Cryoballoon (CB) ablation for pulmonary vein isolation (PVI) is an effective treatment of atrial fibrillation (AF). Recently, a novel cryoablation system was introduced. The aim of the study was to compare the safety, efficacy and biophysical characteristics of a novel cryoablation system (POLARx™; Boston Scientific) to a commonly used and clinically well characterized system (Arctic Front Advance Pro™, AFA; Medtronic). METHODS AND RESULTS: Fifty consecutive patients with symptomatic AF, who underwent CB-based ablation with the POLARx were compared to 50 consecutive patients treated with the AFA. Acute PVI was achieved in 99.8% (POLARx 99.5%, AFA 100%, p = 1.00). Time to isolation (TTI) was comparable in both groups (POLARx 35 [27, 48] s, AFA 30 [21, 43] s, p = 0.165). The POLARx showed a lower balloon temperature at TTI (POLARx -44 [-50, -36] °C, AFA -31 [-38, -21] °C, p < 0.001) and lower nadir temperature (POLARx -60 [-65, -55] °C, AFA -48 [-54, -45] °C, p < 0.001). Procedure time (POLARx 80 [60, 105] min, AFA 62 [42, 80] min, p < 0.001), fluoroscopy time (POLARx 17 [13, 22] min, AFA 11 [7, 16] min, p < 0.001) and freeze cycles per patient (POLARx 5 [4, 6], AFA 4.5 [4, 5], p = 0.002) were higher in the POLARx group. Two cerebral ischemic events occurred in the POLARx group, two patients in each group had phrenic nerve injury. CONCLUSION: Both systems enable effective isolation of pulmonary veins. The POLARx required longer procedure and fluoroscopy times. Larger, prospective and randomized studies are needed to assess long-term efficacy and safety of this technology.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Veias Pulmonares , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Criocirurgia/efeitos adversos , Criocirurgia/métodos , Humanos , Estudos Prospectivos , Veias Pulmonares/diagnóstico por imagem , Veias Pulmonares/cirurgia , Tecnologia , Resultado do TratamentoRESUMO
BACKGROUND: Cryoballoon (CB)-based pulmonary vein isolation (PVI) has proven to be as effective as radiofrequency-based ablation. Different ablation protocols took the individual time-to-isolation (TTI) into account aiming at shorter but equally or even more effective freeze cycles. The current study sought to assess the impact of the TTI on PVI durability in patients undergoing a repeat procedure for recurrence of atrial tachyarrhythmia (ATA). METHODS AND RESULTS: In 205 patients with ATA recurrence after previous CB-based PVI, a total of 806 pulmonary veins (PVs) were identified. A total of 126 out of 806 PVs (16%) were previously treated with a TTI-guided ablation (Protocol #1; TTI + 120 s), in 92/806 (11%) PVs TTI was only monitored (m) but fixed freeze cycles were applied (Protocol #2; mTTI) and in 588/806 (73%) a fixed freeze cycle was applied without mTTI. There was no difference in the PV-reconduction rate between the groups (p = .23). The right inferior pulmonary vein (RIPV) showed overall significantly higher reconduction rates compared to the other PVs (RIPV-left inferior PV p < .003, -left superior PV p < .001, -right superior PV p < .013). Twenty-one patients (10%) were demonstrated to have only electrical reconduction of the RIPV, while all other PVs were still electrically isolated. CONCLUSIONS: The TTI-based CB ablation protocol did not show significant differences regarding PV-reconduction rates compared to the other ablation protocols.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Veias Pulmonares , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Criocirurgia/efeitos adversos , Criocirurgia/métodos , Humanos , Veias Pulmonares/cirurgia , Recidiva , Resultado do TratamentoRESUMO
INTRODUCTION: The prevalence of obesity is increasing. However, data on the periprocedural complication rate of catheter ablation for arrhythmia in patients stratified by body mass index (BMI) are scarce. METHODS: This study included 1000 consecutive patients (age 62.0 ± 14.4 years) undergoing catheter ablation for cardiac arrhythmia. The primary study endpoint was any periprocedural major complication (cardiac tamponade, pseudoaneurysm, arteriovenous fistula, transient ischemic attack, stroke, valve damage, myocardial infarction, or death). RESULTS: The mean BMI was 27.6 ± 5.1 kg/m2 and the majority of patients were overweight (BMI 25.0-29.9 kg/m2 , 43.4%). A BMI of 30.0-34.9 kg/m2 (Class I obesity) was present in 177 (17.7%) of patients, a BMI of 35.0-39.9 kg/m2 (Class II obesity) in 67 (6.7%), and a BMI ≥ 40 kg/m2 (Class III obesity) in 16 (1.6%). There were 31 major complications (3.1%) and one fatality (0.1%) due to terminal heart failure in a patient undergoing palliative ventricular tachycardia ablation. There was no significant impact of the BMI on the rate of major complications (p = .495). Compared to normal weight patients, odds ratios for complications in overweight patients, as well as Class I, II, and III obesity were 1.1 (95% confidence interval (CI): 0.8, 1.7), 1.3 (CI: 0.6, 2.6), 1.4 (CI: 0.5, 4.1), and 1.6 (CI: 0.4, 6.3), respectively. Radiation exposure and procedure duration were significantly increased in obese patients (p < .001 and p = .001, respectively). CONCLUSION: In this study, obesity did not have a significant impact on the incidence of periprocedural complications after CA for cardiac arrhythmia.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Idoso , Índice de Massa Corporal , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Humanos , Pessoa de Meia-Idade , Obesidade/complicações , Obesidade/diagnóstico , Obesidade/epidemiologia , Sobrepeso/complicações , Fatores de RiscoRESUMO
AIMS: Bipolar radiofrequency ablation (B-RFA) has been reported as a bail-out strategy for the treatment of therapy refractory ventricular arrhythmias (VA). Currently, existing setups have not been standardized for B-RFA, while the impact of conventional B-RFA approaches on lesion formation remains unclear. METHODS AND RESULTS: (i) In a multicentre observational study, patients undergoing B-RFA for previously therapy-refractory VA using a dedicated B-RFA setup were retrospectively analysed. (ii) Additionally, in an ex vivo model lesion formation during B-RFA was evaluated using porcine hearts. In a total of 26 procedures (24 patients), acute success was achieved in all 14 ventricular tachycardia (VT) procedures and 7/12 procedures with premature ventricular contractions (PVC), with major complications occurring in 1 procedure (atrioventricular block). During a median follow-up of 211 days in 21 patients, 6/11 patients (VT) and 5/10 patients (PVC) remained arrhythmia-free. Lesion formation in the ex vivo model during energy titration from 30 to 50 W led to similar lesion volumes compared with initial high-power 50 W B-RFA. Lesion size significantly increased when combining sequential unipolar and B-RFA (1429 mm3 vs. titration 501 mm3 vs. B-RFA 50 W 423 mm3, P < 0.001), an approach used in overall 58% of procedures and more frequently applied in procedures without VA recurrence (92% vs. 36%, P = 0.009). Adipose tissue severely limited lesion formation during B-RFA. CONCLUSION: Using a dedicated device for B-RFA for therapy-refractory VA appears feasible and safe. While some patients need repeat ablation, success rates were encouraging. Sequential unipolar and B-RFA may be favourable for lesion formation.
Assuntos
Ablação por Cateter , Taquicardia Ventricular , Complexos Ventriculares Prematuros , Animais , Ablação por Cateter/métodos , Estudos Retrospectivos , Suínos , Taquicardia Ventricular/diagnóstico , Taquicardia Ventricular/cirurgia , Resultado do Tratamento , Complexos Ventriculares Prematuros/diagnóstico , Complexos Ventriculares Prematuros/cirurgiaRESUMO
AIMS: Pulmonary vein isolation (PVI) either by balloon devices or radiofrequency forms the cornerstone of invasive atrial fibrillation (AF) treatment. Although equally effective cryoballoon (CB)-based PVI offers shorter procedure duration and a better safety profile. Beside the worldwide established Arctic Front Advance system, a novel CB device, POLARx, was recently introduced. This CB incorporates unique features, which may translate into improved efficacy and safety. However, multicentre assessment of periprocedural efficacy and safety is lacking up to date. METHODS AND RESULTS: A total of 317 patients with paroxysmal or persistent AF were included and underwent POLARx CB-based PVI in 6 centres from Germany and Italy. Acute efficacy and safety were assessed in this prospective multicenter observational study. In 317 patients [mean age: 64 ± 12 years, 209 of 317 (66%) paroxysmal AF], a total of 1256 pulmonary veins (PVs) were identified and 1252 (99,7%) PVs were successfully isolated utilizing mainly the short tip POLARx CB (82%). The mean minimal CB temperature was -57.9 ± 7°C. Real-time PVI was registered in 72% of PVs. The rate of serious adverse events was 6.0% which was significantly reduced after a learning curve of 25 cases (9.3% vs. 3.0%, P = 0.018). The rate of recurrence-free survival after mean follow-up of 226 ± 115 days including a 90-day blanking period was 86.1%. CONCLUSION: In this large multicentre assessment, the novel POLARx CB shows a promising efficacy and safety profile after a short learning curve.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Veias Pulmonares , Humanos , Pessoa de Meia-Idade , Idoso , Veias Pulmonares/cirurgia , Ablação por Cateter/métodos , Estudos Prospectivos , Resultado do Tratamento , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Fibrilação Atrial/etiologiaRESUMO
AIMS: Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications. METHODS AND RESULTS: This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65â min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). CONCLUSION: In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Acidente Vascular Cerebral , Adulto , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/etiologia , Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Feminino , Humanos , Pessoa de Meia-Idade , Veias Pulmonares/cirurgia , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia , Resultado do Tratamento , Adulto JovemRESUMO
Pulmonary vein (PV) isolation (PVI) by continuous, transmural and durable lesions is decisive for ensuring long-term freedom from atrial fibrillation (AF). AF ablation requires irrigated tip catheters to reduce thromboembolic complications. This precluded temperature-controlled delivery of radiofrequency (RF) energy.The aim of this study was to evaluate feasibility, acute efficacy, and safety of an irrigated, temperature-controlled ablation catheter [DiamondTemp™ (DT) Medtronic®] for PVI.Consecutive patients with AF underwent PVI using the DT catheter combined with high-power short-duration RF applications. Ablation settings were (1) a catheter tip temperature limit of 60°C, (2) a temperature-controlled power of 50 W, and (3) application duration of 10 seconds. The primary endpoint was acute isolation of PVs, reassessed after a 30-minute waiting period. Secondary endpoints included procedural parameters (defined as a catheter tip temperature of 50°C > 3 seconds, an impedance drop of 5-10 Ω) and the occurrence of serious adverse events.Fifty consecutive patients [mean age 66 ± 12 years, 38 (76%) women, 24 patients with paroxysmal AF (48%)] were included. Median procedure and left atrial dwell time was 89 [68; 107] and 63 [52; 79] minutes, respectively. Mean number of RF applications was 59 ± 20, and mean total RF duration was 14 ± 6 minutes. Acute PVI was achieved in all patients solely using DT ablation. Acute PV reconnection within the waiting period occurred in five patients; all reconnected PVs were successfully reisolated. One major complication occurred.In this study, the DT ablation system demonstrated high acute efficacy for PVI. Temperature-controlled ablation in conjunction with high-power short-duration applications might be effectively supported.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Idoso , Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Desenho de Equipamento , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Veias Pulmonares/cirurgia , Resultado do TratamentoRESUMO
BACKGROUND: The impact of basic atrial rhythm (sinus rhythm [SR] vs. atrial fibrillation [AF]) during AF ablation on efficacy and safety is unknown. METHODS: About 3375 patients from the German Ablation Registry undergoing first-time AF ablation were divided according to the type of AF and the basic atrial rhythm during the ablation procedure: paroxysmal AF (PAF) and SR [group Ia], PAF and AF [group Ib]), persistent AF and SR (IIa), and persistent AF and AF (IIb). RESULTS: Patients in SR (n = 2312 [67%]) underwent cryoballoon ablation more often (Ia vs. Ib p = .002 and IIa vs. IIb p = .010, whereas in patients in AF (n = 1063 [33%]) radiofrequency (RF)-based ablation (Ia vs. Ib p = .006 and IIa vs. IIb p = .014) including left and/or right atrial substrate modification was more frequently performed. Depending on the basic rhythm there was no difference regarding arrhythmia recurrence during long-term follow-up. For patients suffering from persistent AF acute procedure-related complications were more often documented when ablated in AF (9.1% vs. 4.6%, p = .012). which was mainly driven by the higher occurrence of pericardial effusion/tamponade. For patients suffering from persistent AF, favorable results were found regarding 366-day Kaplan-Meier estimates of the incidence of MACCE (death, myocardial infarction, and stroke; p = .011) and the composite endpoint of death, myocardial infarction, stroke, and major bleeding (p = .006), when ablated in SR. CONCLUSION: Basic atrial rhythm at the time of AF ablation did not affect long-term rhythm outcome. For patients suffering from persistent AF a more favorable acute and long-term safety profile was observed when ablated in SR.
Assuntos
Fibrilação Atrial , Ablação por Cateter , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Átrios do Coração , Humanos , Recidiva , Sistema de Registros , Resultado do TratamentoRESUMO
PURPOSE: Recently, a novel cardiac imaging system based on a wide-band dielectric technology (KODEX-EPD) was introduced to guide catheter ablation. The aim of the study was to evaluate this 3D wide-band dielectric imaging system (WDIS) during cryoballoon (CB)-based atrial fibrillation (AF) ablation focusing on accuracy of pulmonary vein (PV)-anatomy. METHODS: In consecutive patients with symptomatic AF, CB-based ablation was performed in conjunction with the 3D WDIS. Selective PV-angiographies were performed, and 3D anatomy of the left atrium (LA) and PVs using the 3D WDIS was created. The ostial diameters of the ipsilateral right-sided and left-sided PVs and ostial diameters of the right-/left-sided upper/lower PVs demonstrated by selective angiographies were analyzed and compared to 3D WDIS-based PV visualization. RESULTS: In 65 patients (42/65 (65%) male, age 65 ± 9 years, 29/65 (45%) paroxysmal AF) a total of 260 PVs were identified. Median ostial PV-diameters for the ipsilateral left- and right-sided PVs were 38 [34; 43] and 37 [34; 40.3] mm when assessed fluoroscopically and 40 [35.7; 43] and 39 [35.0; 43] mm as demonstrated by 3D WDIS. There was no statistically significant difference between both methods regarding PV-diameter measurements. KODEX-EPD overestimated fluoroscopy measurements by 1.08 mm (95% limits of agreement of -1.93 mm and 4.1 mm). CONCLUSION: The novel wide-band dielectric 3D-imaging system is feasible to create high-resolution images of cardiac structures during CB ablation procedures and accurately visualizes PV-anatomy.