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INTRODUCTION: Recently, a new cryoballoon (CB) technology (POLARx; Boston Scientific) has come onto the market. Preliminary data have shown that its acute safety and efficacy are similar to those of the first-generation CB. The aim of this study was to assess the medium-term outcome of pulmonary vein isolation (PVI) with the POLARxTM CB in a large multicenter registry. METHODS: We prospectively collected data on 125 consecutive patients with paroxysmal atrial fibrillation (AF) who underwent PVI by means of a novel CB system. Two cases of transient phrenic nerve palsy occurred, with full recovery in the 48h post procedure; no major procedure-related adverse events were reported. During the 90-day blanking period, 4 (3.2%) patients experienced an early recurrence. After the blanking period, over a mean follow-up of 411 ± 62 days, 19 patients (15.2%) suffered an AF/atrial tachycardia (AT) recurrence. The 1-year freedom from AF/AT recurrence was 86.4% (n = 17): 10 (8%) patients had an AF recurrence, 6 (4.8%) had an AT occurrence and 1 (0.8%) suffered both events. Patients with AF/AT recurrences had both a shorter deflation time and total deflation time. Moreover, CB ablations with measured TTI < 90 s and TTI < 60 s were more frequent in patients without AF/AT recurrence (88.5% and 77.4%, respectively) than in those who experienced at least one AF/AT recurrence (67.5% and 55.0%, p = .001 and p = .005, respectively). CONCLUSION: The novel POLARx cryo-balloon system is safe and effective for PV isolation, displaying a 1-year freedom from atrial arrhythmia recurrence of 86.4%, which is in line to that reported with AFA-Pro CB or RF ablation. CLINICAL TRIAL REGISTRATION: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998. Registration date: January 4, 2019.
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Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Veias Pulmonares , Humanos , Veias Pulmonares/cirurgia , Resultado do Tratamento , Criocirurgia/métodos , Itália/epidemiologia , Sistema de Registros , Ablação por Cateter/métodos , RecidivaRESUMO
Radiofrequency catheter ablation of the cavotricuspid isthmus is the standard treatment for patients suffering from typical atrial flutter. The aim of this study was to test the feasibility of tissue thickness and lesion transmurality measurement by a novel dielectric system. This was a retrospective multicentric non-randomized open-label, single-arm study. The atrial wall thickness was significantly higher close to the tricuspid annulus than close to the inferior vena cava and a trend towards a progressive decrease of atrial wall thickness was observed moving the mapping catheter from the tricuspid valve to the inferior vena cava. The possibility to visualize the tissue thickness could modify the way to deliver radiofrequency energy, allowing a tailored approach in cardiac ablation procedures.
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INTRODUCTION: A new dielectric-based method (KODEX-EPD mapping system, EPD Solutions, a Philips company) for measuring tissue thickness at the catheter-tissue interface has recently been developed. We reported preliminarydata on real-time catheter-based measuring myocardial wall thickness in vivo, during typical atrial flutter radio frequency ablation. METHODS AND RESULTS: The study population consisted of 12 consecutive patients, suffering from symptomatic paroxysmal or persistent cavo-tricuspid isthmus dependent, counter clockwise and clockwise AFL, under going a first catheter ablation between April 2021 and November 2021. The new KODEX-EPD function, Wall Viever, was used to calculate atrialwall thickness. The atrial wall thickness was significantly higher closeto the tricuspid annulus than close to the inferior vena cava (3.6 ± 0.5 mm vs 2.4 ± 0.3 mm, p < .001) and a trend towards a progressive decrease of atrial wall thickness was observed moving the mapping catheter from the tricuspidvalve to the inferior vena cava. CONCLUSIONS: Thenew KODEX-EPD function, Wall Viever, allowed us to assess atrial wall thickness during atrial flutter radio frequency ablation.
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Flutter Atrial , Ablação por Cateter , Flutter Atrial/diagnóstico por imagem , Flutter Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Átrios do Coração , Humanos , Veia Cava Inferior/diagnóstico por imagem , Veia Cava Inferior/cirurgiaRESUMO
INTRODUCTION: Low-voltage activity beyond pulmonary veins (PVs) may contribute to the failure of ablation of atrial fibrillation (AF) in the long term. We aimed to assess the presence of gaps (PVG) and residual potential (residual antral potential [RAP]) within the antral scar by means of an ultra-high-density mapping (UHDM) system. METHODS: We studied consecutive patients from the CHARISMA registry who were undergoing AF ablation and had complete characterization of residual PV antral activity. The Lumipoint™ (Boston Scientific) map-analysis tool was used sequentially on each PV component. The ablation endpoint was PV isolation (PVI) and electrical quiescence in the antral region. RESULTS: Fifty-eight cases of AF ablation were analyzed. A total of 86 PVGs in 34 (58.6%) patients and 44 RAPs in 34 patients (58.6%) were found. In 16 (27.6%) cases, we found at least one RAP in patients with complete absence of PV conduction. RAPs showed a lower mean voltage than PVG (0.3 ± 0.2 mV vs. 0.7 ± 0.5 mV, p < .0001), whereas the mean number of electrogram peaks was higher (8.4 ± 1.4 vs. 3.2 ± 1.5, p < .0001). The percentage of patients in whom RAPs were detected through Lumipoint™ was higher than through propagation map analysis (58.6% vs. 36.2%, p = .025). Acute procedural success was 100%, with all PVs successfully isolated and RAPs completely abolished in all study patients. During a mean follow-up of 453 ± 133 days, 6 patients (10.3%) suffered an AF/AT recurrence. CONCLUSION: Local vulnerabilities in antral lesion sets were easily discernible by means of the UHDM system in both de novo and redo patients when no PV conduction was present.
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Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Humanos , Veias Pulmonares/cirurgia , Recidiva , Sistema de Registros , Resultado do TratamentoRESUMO
Pulmonary vein (PV) isolation using cryoballoon (CB) catheter is generally characterized by a high radiation and contrast media exposure. A new dielectric imaging system (KODEX-EPD imaging system) allows pulmonary vein (PV) occlusion assessment without dye use. The purpose of this study was to verify the feasibility of reducing the radiation and dye use during CB ablation in patients with atrial fibrillation (AF) using the new dielectric imaging system. In a retrospective, single center study, we enrolled 34 consecutive patients with paroxysmal AF divided in two groups: 17 patients in Conventional Group underwent the procedure under fluoroscopy guidance before the new system introduction, while 17 patient in KODEX-EPD Group underwent the procedure under fluoroscopy and KODEX-EPD imaging system guidance. There were no differences in any clinical and anatomical characteristics between the two study groups. Overall procedure time was comparable between the two groups (69 [IQR 63-98] min in Conventional Group vs. 65 [IQR 58-74] min in KODEX-EPD Group, p = 0.16), while fluoroscopy time (8 [IQR 5-9] min vs. 11 [IQR 9-12] min, p = 0.014) and dye use (35 [IQR 28-45] ml vs. 70 [IQR 57-83] ml, p < 0.001) were significantly lower in the KODEX-EPD Group. No 30-day complications were observed. At 12-month follow-up 7/37 (19%) patients had an atrial arrhythmias recurrence, without any difference between the two study groups (17.6% vs. 23.5%, p = 0.68). The use of a new dielectric imaging system allowed a significantly reduction in radiation exposure and dye use during CB ablation in patients with AF.
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Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Meios de Contraste , Fluoroscopia , Humanos , Veias Pulmonares/diagnóstico por imagem , Veias Pulmonares/cirurgia , Recidiva , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Highly localized impedance (LI) measurements during atrial fibrillation (AF) ablation have recently emerged as a viable real-time indicator of tissue characteristics and durability of the lesions created. We report the outcomes of acute and long-term clinical evaluation of the new DirectSense algorithm in AF ablation. METHODS: Consecutive patients undergoing AF ablation were included in the CHARISMA registry. RF delivery was guided by the DirectSense algorithm, which records the magnitude and time-course of the impedance drop. The ablation endpoint was pulmonary vein isolation (PVI), as assessed by the entrance and exit block. RESULTS: 3556 point-by-point first-pass RF applications of >10 s duration were analyzed in 153 patients (mean age=59 ± 10 years, 70% men, 61% paroxysmal AF, 39% persistent AF). The mean baseline LI was 105 ± 15 Ω before ablation and 92 ± 12 Ω after ablation (p < .0001). Both absolute drops in LI and the time to LI drop (LI drop/τ) were greater at successful ablation sites (n = 3122, 88%) than at ineffective ablation sites (n = 434, 12%) (14 ± 8 Ω vs 6 ± 4 Ω, p < .0001 for LI; 0.73 [0.41-1.25] Ω/s vs. 0.35[0.22-0.59 Ω/s, p < .0001 for LI drop/τ). No major complications occurred during or after the procedures. All PVs had been successfully isolated. During a mean follow-up of 366 ± 130 days, 18 patients (11.8%) suffered an AF/atrial tachycardia recurrence after the 90-day blanking period. CONCLUSION: The magnitude and time-course of the LI drop during RF delivery were associated with effective lesion formation. This ablation strategy for PVI guided by LI technology proved safe and effective and resulted in a very low rate of AF recurrence over 1-year follow-up.
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Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Idoso , Algoritmos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Impedância Elétrica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Veias Pulmonares/cirurgia , Recidiva , Resultado do TratamentoRESUMO
AIMS: Ablation index (AI) is a marker of lesion quality during catheter ablation that incorporates contact force, time, and power in a weighted formula. This index was originally developed for pulmonary vein isolation as well as other left atrial procedures. The aim of our study is to evaluate the feasibility and efficacy of the AI for the ablation of the cavotricuspid isthmus (CTI) in patients presenting with typical atrial flutter (AFL). METHODS AND RESULTS: This prospective multicentre non-randomized study enrolled 412 consecutive patients with typical AFL undergoing AI-guided cavotricuspid isthmus ablation. The procedure was performed targeting an AI of 500 and an inter-lesion distance measurement of ≤6 mm. The primary endpoints were CTI 'first-pass' block and persistent block after a 20-min waiting time. Secondary endpoints included procedural and radiofrequency duration and fluoroscopic time. A total of 412 consecutive patients were enrolled in 31 centres (mean age 64.9 ± 9.8; 72.1% males and 27.7% with structural heart disease). The CTI bidirectional 'first-pass' block was reached in 355 patients (88.3%), whereas CTI block at the end of the waiting time was achieved in 405 patients (98.3%). Mean procedural, radiofrequency, and fluoroscopic time were 56.5 ± 28.1, 7.8 ± 4.8, and 1.9 ± 4.8 min, respectively. There were no major procedural complications. There was no significant inter-operator variability in the ability to achieve any of the primary endpoints. CONCLUSION: AI-guided ablation with an inter-lesion distance ≤6 mm represents an effective, safe, and highly reproducible strategy to achieve bidirectional block in the treatment of typical AFL.
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Flutter Atrial , Ablação por Cateter , Idoso , Flutter Atrial/diagnóstico , Flutter Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Reprodutibilidade dos Testes , Resultado do Tratamento , Valva Tricúspide/diagnóstico por imagem , Valva Tricúspide/cirurgiaRESUMO
INTRODUCTION: A very high-power short-duration (vHPSD) strategy of radiofrequency (RF) ablation aims to minimize conductive heating and increase resistive heating. This study aimed to clarify the contribution of contact force (CF) and temperature and their interrelationship in making an adequate lesion with the vHPSD catheter. METHODS: We enrolled 46 consecutive patients undergoing first catheter ablation for atrial fibrillation (AF). The vHPSD ablation was performed applying 90 W, for 4 s, with an irrigation of 8 ml/min. During an application, an impedance drop (ID) ≥10 Ω was regarded as an adequate lesion formation. RESULTS: The mean procedural time was 95 ± 15 min. First-pass isolation was reached in 89% of patients and at the end of the procedure all pulmonary veins were isolated. No steam pop nor procedural complication occurred. A total of 3829 qualified RF points were analyzed and the median values of ID, CF and maximum temperature were respectively 10.6 (IQR 8.6-13.1) Ohm, 9 (5.8-13.8) g, 46.8 (44.1-49.8) °C. The mean ID significantly increased in parallel with the increasing CF as well as with the increasing maximum temperature. In the multivariable analysis only the CF and the maximum temperature were independent predictors of ID. From receiver operating characteristic curve analysis, a CF of 8 g and a maximum temperature of 47°C are the optimal cutoff discriminatory value for adequate lesion formation. CONCLUSIONS: The vHPSD ablation is highly effective and safe. The CF and the maximum temperature are independent predictors of adequate lesion formation assessed by means of ID.
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Fibrilação Atrial/cirurgia , Veias Pulmonares/cirurgia , Ablação por Radiofrequência/métodos , Feminino , Temperatura Alta , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Irrigação TerapêuticaRESUMO
BACKGROUND: Optimal pulmonary vein (PV) occlusion, usually verified with selective contrast injection, is mandatory to obtain an effective PV isolation during cryoballoon (CB) ablation. AIM OF THE STUDY: The purpose of this study was to verify the feasibility and the accuracy of a new dielectric sensing system in assessing PV occlusion during CB ablation in patients with atrial fibrillation (AF). METHODS: We enrolled 28 consecutive patients with paroxysmal or persistent AF. After transseptal access, a detailed image reconstruction of left atrium and PVs was achieved with an octapolar or decapolar mapping catheter (Achieve catheter, Medtronic Inc.) and KODEX-EPD system (EPD Solutions, a Philips company). The degree of PV occlusion with the inflated Arctic Front Advance Cryoballoon (Medtronic Inc.) was verified using the new "occlusion tool" software module (EPD Solutions, a Philips company) and compared to an angiogram obtained with contrast medium injection in each PV. RESULTS: A total of 105 PV CB occlusion were tested. The new occlusion tool software module showed a 91% sensitivity and 76% specificity in assessing a complete PV occlusion verified with contrast medium injection. The positive predictive value was 80%, and the negative predictive value was 88.6%. Mean procedure time was 81 ± 17 minutes. Mean fluoroscopy time was 6 ± 2 minutes. No 30-day complications were observed. CONCLUSION: The new dielectric imaging system was able to assess the degree of PV occlusion during a CB ablation with good sensitivity and specificity.
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Fibrilação Atrial/cirurgia , Criocirurgia/métodos , Veias Pulmonares/cirurgia , Software , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/fisiopatologia , Cateterismo Cardíaco , Angiografia Coronária , Criocirurgia/instrumentação , Mapeamento Epicárdico , Estudos de Viabilidade , Feminino , Humanos , Processamento de Imagem Assistida por Computador , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Veias Pulmonares/diagnóstico por imagem , Sensibilidade e EspecificidadeRESUMO
BACKGROUND: An early, comprehensive rhythm-control therapy is needed in order to treat atrial fibrillation (AF) effectively and to improve ablation outcomes. METHODS: A total of 153 consecutive patients from the CHARISMA registry undergoing AF ablation at eight centers were included. Patients with de novo PVI were classified as having undergone early treatment (ET) if the procedure was performed within 6 months after the first AF episode, and as having undergone delayed treatment (DT) if ablation was performed over 6 months after the first AF episode. RESULTS: One-hundred fifty-three patients were enrolled (69.9% male, 59 ± 10 years, 61.4% paroxysmal AF, 38.6% persistent AF). The time from the first AF episode to the ablation procedure was 1034 ± 1483 days. The ET group comprised 36 patients (25.3%), the DT group 60 (39.2%) and Redo cases were 57 (37.3%). During a mean follow-up of 366 ± 130 days, 18 patients (11.8%) suffered an AF/AT recurrence. More DT patients than ET patients suffered recurrences (15.7% vs. 2.2%, p = 0.0452) and the time to AT/AF recurrence was shorter in the group of patients who received an ablation treatment after 6 months (HR = 6.19, 95% CI: 1.7 to 21.9; p = 0.0474). On multivariate Cox analysis, only hypertension (HR = 4.86, 95% CI: 1.6 to 14.98, p = 0.0062) was independently associated with recurrences. Beyond the hypertension risk factor, ET was associated with a low risk of recurrence; recurrence rate ranged from 0% (ET patients without hypertension) to 25.0% (DT patients with hypertension). CONCLUSIONS: An early rhythm-control ablation therapy in the absence of common risk factors was associated with the lowest rate of recurrences.
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Fibrilação Atrial/prevenção & controle , Fibrilação Atrial/cirurgia , Ablação por Cateter , Eletrocardiografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Sistema de RegistrosRESUMO
INTRODUCTION: Recently, a novel technology able to measure local impedance (LI) and tissue characteristics has been made available for clinical use. This analysis explores the relationships among LI and generator impedance (GI) parameters in atrial fibrillation (AF) patients. Characterization of LI among different ablation spots and procedural success were also evaluated. METHODS AND RESULTS: Consecutive patients undergoing AF ablation from the CHARISMA registry at five Italian centers were included. A novel radiofrequency (RF) ablation catheter with a dedicated algorithm (DIRECTSENSE™) was used to measure LI and to guide ablation. The ablation endpoint was pulmonary vein (PV) isolation. We analyzed 2219 ablation spots created around PVs in 46 patients for AF ablation. The mean baseline tissue impedance was 105.8 ± 14 Ω for LI versus 91.8 ± 10 Ω for GI (p < .0001). Baseline impedance was homogenous across the PV sites and proved higher in high-voltage areas than in intermediate- and low-voltage areas and the blood pool (p < .001). Both LI and GI displayed a significant drop after RF delivery, and absolute LI drop values were significantly larger than GI drop values (14 ± 8 vs. 3.7 ± 5 Ω, p < .0001). Every 5-point increment in LI drop was associated with successful ablation (odds ratio = 3.05, 95% confidence interval: 2.3-4.1, p < .0001). Conversely, GI drops were not significantly different comparing successful versus unsuccessful sites (3.7 ± 5 vs. 2.8 ± 4 Ω, p = .1099). No steam pops or major complications occurred during or after the procedures. By the end of the procedures, all PVs had been successfully isolated in all patients. CONCLUSIONS: The magnitude of the LI drop was more closely associated with effective lesion formation than the GI drop.
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Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Algoritmos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Impedância Elétrica , Humanos , Projetos Piloto , Veias Pulmonares/diagnóstico por imagem , Veias Pulmonares/cirurgia , Resultado do TratamentoRESUMO
BACKGROUND: Ablation index (AI) is a new lesion quality marker that has been demonstrated to allow a high single-procedure arrhythmia-free survival in single-center studies. This prospective, multi-center study was designed to evaluate the reproducibility of pulmonary vein (PV) isolation guided by the AI. METHODS: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV isolation and were divided in four study groups according to operator's preference in choosing the ablation catheter (a contact force (ST) or contact force surround flow (STSF) catheter) and the AI setting (330-450 or 380-500 at anterior wall or posterior wall, respectively). RESULTS: At 12 months a high rate of freedom from AF recurrences was observed in patients with both paroxysmal and persistent AF (91% vs 83.3%; P = .039). There was no difference in the rate of AF recurrence among the four study groups (4.5% in group ST330-450, 12.2% in group ST 380-500, 14.9% in group STSF330-450, 9.4% in group STSF380-500; P = .083). Recurrence was also similar between patients treated with a ST (8%) or STSF catheter (12.1%; P = .2), and within patients targeting an AI settings of 330 to 450 (10.9%) or 380 to 500 (10.3%; P = .64). In patients with paroxysmal AF, there was no difference (P = .12) in the 1-year freedom from AF recurrence among 14 operators that performed ≥10 ablation procedure. CONCLUSIONS: An ablation protocol respecting strict criteria for contiguity and quality lesion resulted in high rate of 1-year freedom from AF recurrence, irrespective of the ablation catheters, AI settings, and operator.
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Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Humanos , Estudos Prospectivos , Veias Pulmonares/diagnóstico por imagem , Veias Pulmonares/cirurgia , Recidiva , Sistema de Registros , Reprodutibilidade dos Testes , Resultado do TratamentoRESUMO
AIMS: A prolonged PR interval is known to be associated with increased mortality and a higher risk of developing atrial fibrillation (AF). We tested the hypothesis that cardiac resynchronization therapy (CRT) is superior to conventional dual-chamber pacing with algorithms for right ventricular pacing avoidance (DDD-VPA) in preserving systolic and diastolic function and in preventing new-onset AF in patients with normal systolic function, indication for pacing and prolonged atrioventricular conduction (PR interval ≥220 ms). METHODS AND RESULTS: We randomly assigned 82 patients with ejection fraction >35%, indication for pacing and PR interval ≥220 ms to CRT or to DDD-VPA. On 12-month follow-up examination, the study and control arms did not differ in terms of left ventricular end-systolic volume (44 ± 17 mL vs. 47 ± 16 mL, P = 0.511) or ejection fraction (55 ± 6% vs. 57 ± 8%, P = 0.291). The E to A mitral wave amplitude ratio was higher in the CRT arm (1.3 ± 1.3 vs. 0.8 ± 0.4, P = 0.046) and the E wave deceleration time was longer (262 ± 83 ms vs. 205 ± 51 ms, P = 0.027). Left atrial volume was smaller in the CRT arm (64 ± 17 mL vs. 84 ± 25 mL, P = 0.035). Moreover, the functional class was lower in CRT patients (1.4 ± 0.6 vs. 1.8 ± 0.5, P = 0.010). During follow-up, CRT was associated with a lower risk of new-onset AF [hazard ratio = 0.37 (0.13-0.98), P = 0.046]. CONCLUSION: Cardiac resynchronization therapy proved superior to DDD-VPA in terms of better diastolic function, less left atrial enlargement and lower risk of new-onset AF, at 12 months. These data need to be confirmed in a larger trial with longer follow-up. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/ Identifier: NCT02150538.
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Fibrilação Atrial , Bloqueio Atrioventricular , Terapia de Ressincronização Cardíaca , Insuficiência Cardíaca , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Átrios do Coração , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/terapia , Humanos , Projetos Piloto , Resultado do TratamentoRESUMO
AIMS: The aims of this study were to determine the rate and the predictors of early recurrences of atrial fibrillation (ERAF) after cryoballoon (CB) ablation and to evaluate whether ERAF correlate with the long-term outcome. METHODS AND RESULTS: Three thousand, six hundred, and eighty-one consecutive patients (59.9 ± 10.5 years, female 26.5%, and 74.3% paroxysmal AF) were included in the analysis. Atrial fibrillation recurrence, lasting at least 30 s, was collected during and after the 3-month blanking period. Three-hundred and sixteen patients (8.6%) (Group A) had ERAF during the blanking period, and 3365 patients (Group B) had no ERAF. Persistent AF and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of ERAF. After a mean follow-up of 16.8 ± 16.4 months, 923/3681 (25%) patients had at least one AF recurrence. The observed freedom from AF recurrence, at 24-month follow-up from procedure, was 25.7% and 64.8% in Groups A and B, respectively (P < 0.001). ERAF, persistent AF, and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of AF. In a propensity score matching, the logistic model showed that ERAF 1 month after ablation are the best predictor of long-term AF recurrence (P = 0.042). CONCLUSION: In patients undergoing CB ablation for AF, ERAF are rare and are a strong predictor of AF recurrence in the follow-up, above all when occur >30 days after the ablation.
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Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Veias Pulmonares , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/cirurgia , Ablação por Cateter/efeitos adversos , Criocirurgia/efeitos adversos , Feminino , Humanos , Veias Pulmonares/cirurgia , Recidiva , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Which technique is better for repeat ablation in patients with atrial fibrillation (AF) remains unclear. The aim of the study was to compare long-term efficacy of repeat ablation using the alternative technique for the first redo ablation procedure: (a) cryoballoon (CB) re-ablation after a failed index pulmonary vein isolation (PVI) with radiofrequency (RF) ablation, RF-then-CB group or (b) RF repeat ablation following a failed CB ablation, CB-then-RF group. METHODS: Within the 1STOP Italian Project, consecutive patients undergoing repeat ablation with a different technique from the index procedure were included. RESULTS: We studied 474 patients, 349 in RF-then-CB and 125 in CB-then-RF group. Less women (21% vs 30%; P = .041), more persistent AF (33% vs 22%; P = .015), longer duration of AF (60 vs 31 months; P < .001), and more hypertension (50% vs 36%; P = .007) were observed in the RF-then-CB cohort as compared with the CB-then-RF group. The number of reconnected PVs was 3.7 ± 0.7 and 1.4 + 1.3 in RF-then-CB and CB-then-RF group, respectively (P < .001). During the follow-up, significantly less AF recurrence occurred in the CB-then-RF group (22% vs 8%, HR = 0.46; 95% CI: 0.24-0.92; P = .025). Cohort designation was the only independent predictor of AF recurrence. CONCLUSION: Alternation of energy source for repeat ablation was safe and effective, regardless the energy used first. However, patients initially treated with CB PVI undergoing repeat ablation with RF current had less AF recurrence at long-term follow-up as compared with those originally treated by RF ablation receiving a CB repeat ablation.
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Fibrilação Atrial/cirurgia , Criocirurgia/métodos , Ablação por Radiofrequência/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Veias Pulmonares/cirurgia , Recidiva , ReoperaçãoRESUMO
BACKGROUND: Pulmonary vein isolation (PVI) is the most widely adopted strategy for paroxysmal atrial fibrillation (PAF) ablation. Limited evidence on acute results and late outcomes of cryoballoon (CB)-PVI in patients with structural heart disease (SHD) exist. The aim of this analysis was to compare acute procedural results and the 1-year recurrence rate of a single CB-PVI procedure in a PAF population with and without SHD. METHOD: From April 2012 to May 2017, a total of 2,031 patients with AF underwent CB-PVI and were followed prospectively in the framework of the One Shot TO Pulmonary vein isolation (1STOP) ClinicalService project, involving 36 Italian cardiology centres. We identified patients with SHD according to criteria proposed by current ESC guidelines: left ventricular (LV) systolic or diastolic dysfunction, long-standing hypertension with LV hypertrophy, and/or other structural heart disease. Data on procedural outcomes and long-term freedom from AF recurrence were evaluated. RESULTS: Our population consisted of 1,452 patients, of whom 282 (19.4%) were classified as having SHD. Compared to non-SHD patients, the SHD cohort was older (mean ± standard deviation, 62.9 ± 9.0 vs 58.2 ± 11.4 years; p < 0.001), was more frequently male (79.1% vs 69.8%; p < 0.002), had a higher thrombo-embolic risk (CHA2DS2VASc ≥2: 63.4% vs 40.2%; p < 0.001), had a higher body mass index (27.7 ± 3.9 vs 26.4 ± 3.9 kg/m2; p < 0.001), had a larger atrial diameter (43.8 ± 7.0 vs 40.2 ± 5.8 mm; p < 0.001), and had a lower LV ejection fraction (57.2 ± 7.7% vs 60.7 ± 6.0%; p < 0.001). At the time of ablation, 73% of patients were on class Ic or III anti-arrhythmic drugs. Procedure time (106.9 ± 41.5 vs 112.1 ± 46.8 min; p = 0.248), fluoroscopic time (28.7 ± 14.7 vs 28.6 ± 15.2 min; p = 0.819), and complication rate (3.9% vs 4.8%; p = 0.525) were not different between the SHD and non-SHD cohorts. However, the acute success rate (98.9% vs 97.7%; p = 0.016) was higher in patients with SHD. After a follow-up of 13.4 ± 12.8 months, freedom from symptomatic recurrence was 78.0% for SHD and 78.4% for non-SHD (p = 0.895). Recurrence rate was not related to either left atrial size or LVEF. In the SHD cohort, Class Ic or III anti-arrhythmic drugs treatment decreased from 70.7% of patients before ablation to 28.7% of patients after CB-PVI (p = 0.001). CONCLUSIONS: CB-PVI was extensively applied to treat patients with PAF. Unlike previous PVI experiences, the acute success and recurrence rate after a single procedure was not related to the presence of SHD or to the degree of cardiac remodelling. Further studies are required to define whether CB-PVI has a useful role in patients with a significantly reduced ejection fraction as those patients were under-represented in the current population.
Assuntos
Técnicas de Ablação/métodos , Fibrilação Atrial/cirurgia , Criocirurgia/métodos , Sistema de Condução Cardíaco/fisiopatologia , Taquicardia Paroxística/cirurgia , Função Ventricular Esquerda/fisiologia , Fibrilação Atrial/fisiopatologia , Feminino , Seguimentos , Sistema de Condução Cardíaco/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Taquicardia Paroxística/fisiopatologia , Resultado do TratamentoRESUMO
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, (mean ± SD) 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.
Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Criocirurgia/métodos , Complicações Pós-Operatórias/epidemiologia , Veias Pulmonares/cirurgia , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Modelos de Riscos Proporcionais , Recidiva , Sistema de Registros , Reoperação , Suécia/epidemiologiaRESUMO
AIMS: The benefit of prolonged implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) therapy following device replacement is hindered by clinical and procedure-related adverse events (AEs). Adverse events rate is highest in more complex devices and at upgrades, as per the REPLACE registry experience, but is changing owing to the improvement in device technology and medical care. We aimed at understanding the extent and type of AEs in a contemporary Italian population. METHODS AND RESULTS: Detect long-term complications after ICD replacement (DECODE) was a prospective, single-arm, multicentre cohort study aimed at estimating medium- to long-term AEs in a large population of patients undergoing ICD/cardiac resynchronization defibrillator replacement/upgrade from 2013 to 2015. We prospectively analysed all clinical and device-related AEs at 12-month follow-up (FU) of 983 consecutive patients (median age 71 years, 76% male, 55% ischaemic, 47% CRT-D) followed for 353 ± 49 days. Seven percent of the patients died (60.6% for cardiovascular reasons), whereas 104 AEs occurred; 43 (4.4%) patients needed at least one surgical action to treat the AE. Adverse events rates were 3.3/100 years lead-related, 3.4/100 years bleedings, and 1.6/100 years infective. The primary endpoint was predicted by hospitalization in the month prior to the procedure [hazard ratio (HR) = 2.23, 1.16-4.29; 0.0169] and by upgrade (HR = 1.75, 1.02-2.99, 0.0441). One hundred and twelve (11.4%) patients met the combined endpoint of death from any cause, cardiac implantable electronic device (CIED)-related infection, and surgical action/hospitalization required to treat the AE. Hospitalization within 30 days prior to the procedure (HR = 2.07, 1.13-3.81; 0.0199), anticoagulation (HR = 1.97, 1.26-3.07; 0.003), and ischaemic cardiomyopathy (HR = 1.67, 95% confidence interval 1.06-2.63; P = 0.0276) were associated with the combined endpoint during FU. CONCLUSIONS: Adverse events following CIED replacement/upgrade are lower than previously reported, possibly owing to improved patients care. Hospitalization in the month prior to the procedure, upgrade, and clinical profile (anticoagulation, ischaemic cardiomyopathy) hint to increased risk, suggesting an individualized planning of the procedure to minimize overall AEs. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov/ Identifier: NCT02076789.
Assuntos
Terapia de Ressincronização Cardíaca/métodos , Morte Súbita Cardíaca/prevenção & controle , Desfibriladores Implantáveis , Insuficiência Cardíaca/terapia , Sistema de Registros , Idoso , Morte Súbita Cardíaca/epidemiologia , Remoção de Dispositivo , Feminino , Seguimentos , Humanos , Incidência , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Resultado do TratamentoRESUMO
BACKGROUND: The influence of risk factors on atrial fibrillation (AF) ablation recurrence is increasingly recognized. We present a sub-analysis of the European Society of Cardiology-European Heart Rhythm Association-European Society of Cardiology AF ablation long-term registry on the effect of traditional risk factors for AF on postablation recurrence, reablation, and complications using real-world data. METHODS: Risk factors for AF were defined as body mass index ≥27 kg/m², hypertension, chronic obstructive pulmonary disease, diabetes, alcohol ≥2 units/day, sleep apnea, smoking, no/occasional sports activity, moderate/severe mitral or aortic valve disease, any cardiomyopathy, peripheral vascular disease, chronic kidney disease, heart failure, coronary artery disease/infarction, and previous pacemaker/defibrillator implant. Patients were divided in two groups with ≥1 or without risk factors. Primary outcomes were arrhythmia recurrence after blanking period, reablation, and adverse events or death. Differences between the groups and the influence of individual risk factors were analyzed using multivariate Cox regression. RESULTS: Three thousand sixty nine patients were included; 217 patients were without risk factors. Risk factor patients were older (58.4 vs 54.1 years), more often female (32% vs 19.8%) and had more often persistent AF (27.2% vs 23.5%). In a multivariate analysis, patients without risk factors had a hazard ratio of 0.70 (95% CI 0.49-0.99) for recurrence compared to risk factor patients. The multivariate hazard ratios for reablation or adverse events/death were not different between the two groups. Hypertension and body mass index were univariate predictors of recurrence. CONCLUSIONS: Patients with ≥1 risk factor had a 30% higher risk for arrhythmia recurrence after ablation, but no differences in risk for repeat ablations and adverse events or death.
Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/métodos , Idoso , Comorbidade , Europa (Continente) , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Sistema de Registros , Fatores de RiscoRESUMO
BACKGROUND: Atrial fibrillation (AF) promotes atrial remodeling that in turn promotes AF perpetuation. The aim of our study is to investigate the impact of AF history length on 1-year outcome of AF catheter ablation in a cohort of patients enrolled in the Atrial Fibrillation Ablation Registry. METHODS: We described the real-life clinical epidemiology, therapeutic strategies, and the short- and mid-term outcomes of 1948 patients (71.9% with paroxysmal AF) undergoing AF ablation procedures, stratified according to AF history duration (<2 years or ≥2 years). RESULTS: The mean AF history duration was 46.2 ± 57.4 months, 592 patients had an AF history duration <2 years (mean 10.2 ± 5.9 months), and 1356 patients ≥2 years (mean 75.5 ± 63.5 months) (P < 0.001). Patients with AF history duration <2 years were younger; had a lower incidence of hypertension, coronary artery disease, and hypertrophic cardiomyopathy; and had a lower CHA2 DS2 -VaSc Score. At 1 year, the logrank test showed a lower incidence of AF recurrence in patients with AF history duration <2 years (28.9%) than in patients with AF history duration ≥2 years (34.0%) (P = 0.037). AF history duration ≥2 years, overall ablation procedure duration, hypertension, and chronic kidney disease were all predictors of recurrences after the blanking period. CONCLUSIONS: In this multicenter registry, performing catheter ablation in patients with an AF history ≥2 years was associated with higher rates of AF recurrences at 1 year. Since cumulative time in AF in not necessarily equivalent to AF history, its role remains to be clarified.