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1.
J Cardiovasc Electrophysiol ; 35(6): 1101-1111, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38519418

RESUMO

INTRODUCTION: Limited data exist on pulsed-field ablation (PFA) in patients with persistent atrial fibrillation (PeAF) undergoing left atrial posterior wall isolation (LAPWI). METHODS: The Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA) prospective registry included consecutive patients referred for PeAF catheter ablation at 9 Italian centers, treated with the FARAPULSETM-PFA system. The primary efficacy and safety study endpoints were the acute LAPWI rate, freedom from arrhythmic recurrences and the incidence of major periprocedural complications. Patients undergoing pulmonary vein isolation (PVI) alone, PWI + LAPWI and redo procedures were compared. RESULTS: Among 249 patients, 21.7% had long-standing PeAF, 79.5% were male; mean age was 63 ± 9 years. LAPWI was performed in 57.6% of cases, with 15.3% being redo procedures. Median skin-to-skin times (PVI-only 68 [60-90] vs. PVI + LAPWI 70 [59-88] mins) did not differ between groups. 45.8% LAPWI cases were approached with a 3D-mapping system, and 37.3% with intracardiac echocardiography. LAPWI was achieved in all patients by means of PFA alone, in 88.8% cases at first pass. LAPWI was validated either by an Ultrahigh-density mapping system or by recording electrical activity + pacing maneuvers. No major complications occurred, while 2.4% minor complications were detected. During a median follow-up of 273 [191-379] days, 41 patients (16.5%) experienced an arrhythmic recurrence after the 90-day blanking period, with a mean time to recurrence of 223 ± 100 days and no differences among ablation strategies. CONCLUSION: LAPWI with PFA demonstrates feasibility, rapidity, and safety in real-world practice, offering a viable alternative for PeAF patients. LAPWI is achievable even with a fluoroscopy-only method and does not significantly extend overall procedural times.


Assuntos
Potenciais de Ação , Fibrilação Atrial , Ablação por Cateter , Frequência Cardíaca , Veias Pulmonares , Recidiva , Sistema de Registros , Humanos , Fibrilação Atrial/cirurgia , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico , Masculino , Feminino , Veias Pulmonares/cirurgia , Veias Pulmonares/fisiopatologia , Pessoa de Meia-Idade , Ablação por Cateter/efeitos adversos , Idoso , Estudos Prospectivos , Fatores de Tempo , Itália , Fatores de Risco , Átrios do Coração/fisiopatologia , Átrios do Coração/cirurgia , Resultado do Tratamento , Intervalo Livre de Progressão
2.
Eur Heart J Suppl ; 25(Suppl C): C253-C257, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-37125309

RESUMO

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.

3.
J Cardiovasc Electrophysiol ; 33(7): 1587-1589, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35557022

RESUMO

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.


Assuntos
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/cirurgia
4.
J Cardiovasc Electrophysiol ; 33(7): 1414-1424, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35524404

RESUMO

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.


Assuntos
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 Tratamento
5.
Heart Vessels ; 37(1): 115-120, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34240266

RESUMO

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.


Assuntos
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 Tratamento
6.
Europace ; 23(2): 264-270, 2021 02 05.
Artigo em Inglês | MEDLINE | ID: mdl-33212484

RESUMO

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.


Assuntos
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/cirurgia
7.
Pacing Clin Electrophysiol ; 44(10): 1717-1723, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34498748

RESUMO

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.


Assuntos
Fibrilação Atrial/cirurgia , Veias Pulmonares/cirurgia , Ablação por Radiofrequência/métodos , Feminino , Temperatura Alta , Humanos , Masculino , Pessoa de Meia-Idade , Duração da Cirurgia , Irrigação Terapêutica
8.
Pacing Clin Electrophysiol ; 44(1): 63-70, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33210304

RESUMO

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.


Assuntos
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 Especificidade
9.
J Cardiovasc Electrophysiol ; 31(9): 2319-2327, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32613661

RESUMO

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.


Assuntos
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 Tratamento
10.
J Cardiovasc Electrophysiol ; 28(7): 762-767, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28422368

RESUMO

INTRODUCTION: Pulmonary vein (PV) isolation is the cornerstone of catheter ablation in patients with atrial fibrillation (AF). Surround flow and contact force (CF) measurement capabilities might enhance procedure efficacy and safety. We report on the safety and midterm efficacy of a novel ablation catheter for PV isolation in patients with AF. METHODS AND RESULTS: Two hundred thirty-three consecutive patients (57 ± 11 years, 76% males, 51% with structural heart disease), referred for paroxysmal (157) or persistent (76) AF, underwent PV isolation by a surround flow catheter with CF measurement capability in four centers. Ablation was guided by electroanatomic mapping allowing radiofrequency (RF) energy delivery in the antral region aiming at PV isolation. Mean overall procedure time was 100 ± 42 minutes with a mean fluoroscopy time of 6 ± 5 minutes. Mean ablation time was 31±15 minutes; 99% of the targeted veins were isolated. The mean CF value during ablation was 13 ± 4 g. Intraprocedural early (30 minutes) PV reconnection occurred in 12% PVs, and all PVs were effectively reisolated. One pericardial effusion and five groin hematomas were reported. During a mean follow-up of 12 ± 6 months, 30 (12.9%) (10% paroxysmal AF vs. 18% persistent AF, P = 0.07) patients had an atrial arrhythmias recurrence. CONCLUSIONS: In this multicenter registry, RF ablation using a new surround flow catheter, with CF sensor, resulted as feasible, achieving a high rate of isolated PVs. Procedural and fluoroscopy times and success rates were comparable with other techniques with a low complication rate.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/instrumentação , Ablação por Cateter/métodos , Veias Pulmonares/cirurgia , Sistema de Registros , Adulto , Idoso , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/epidemiologia , Ablação por Cateter/efeitos adversos , Feminino , Seguimentos , Humanos , Itália/epidemiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento , Adulto Jovem
14.
Heart Rhythm ; 2024 May 27.
Artigo em Inglês | MEDLINE | ID: mdl-38810922

RESUMO

BACKGROUND: Pulsed field ablation (PFA) and very high-power short-duration (vHPSD) radiofrequency ablation are the most recently introduced technologies for atrial fibrillation (AF) ablation. The procedural performance, safety, and effectiveness of PFA vs vHPSD are currently unknown. OBJECTIVE: The study aimed to compare PFA with vHPSD for the treatment of paroxysmal or persistent AF. METHODS: We conducted an observational, multicenter study enrolling 534 consecutive patients (63 ± 9 years; 36% female) with paroxysmal (n = 368 [69%]) or persistent (n = 166 [31%]) AF undergoing ablation by either PFA (Farapulse; n = 192) or vHPSD (90 W/4 seconds; QDOT Micro; n = 342) between 2020 and 2023. Atrial tachyarrhythmia recurrence after a 1-month blanking period was the primary efficacy end point and was assessed both overall and in propensity score-matched patients. The primary safety end point was a composite of procedure-related complications. RESULTS: Successful pulmonary vein isolation was achieved in all patients, with shorter procedure duration (PFA,70 minutes; vHPSD, 100 minutes; P < .001) but longer fluoroscopy time (PFA, 15 minutes; vHPSD, 7 minutes; P < .001) in the PFA group. PFA was associated with more frequent use of general anesthesia (P < .001). Primary safety outcome events occurred in 19 patients (3.5%), with similar prevalence in both groups (PFA, 4%; vHPSD, 3%; P = .745). After a median follow-up of 12 (9-12) months, survival free from recurrent atrial tachyarrhythmia was similar between the PFA and vHPSD groups, both overall (12-month estimate: PFA, 75%; vHPSD, 76%; log-rank P = .73) and in propensity score-matched patients (n = 342; 12-month estimate: PFA, 75%; vHPSD, 77%; log-rank P = .980). CONCLUSION: In a large, multicenter experience, PFA was associated with more common use of general anesthesia, shorter procedural times, and longer fluoroscopy exposure compared with vHPSD ablation, with both techniques displaying superimposable safety and efficacy.

15.
Artigo em Inglês | MEDLINE | ID: mdl-38814525

RESUMO

BACKGROUND: Recent data on pulsed field ablation (PFA) for atrial fibrillation (AF) ablation suggest a progressive reduction in procedural times. Real-world data regarding the relationship between the learning curve of PFA and clinical outcomes are scarce. The objective was to evaluate the PFA learning curve and its impact on acute outcomes. METHODS: Consecutive patients undergoing AF ablation with the FARAPULSE™ PFA system were included in a prospective, non-randomized multicenter study. Procedural times were stratified on the operators' learning curve. Comparative analysis of skin-to-skin time was conducted with radiofrequency (RF) and cryoablation (CB) pulmonary vein isolation (PVI) procedures performed by the same operators in the previous year. RESULTS: Among 752 patients, 35.1% were females, and 66.9% had paroxysmal AF; mean age was 62.2 ± 10 years. A total of 62.5% of procedures were performed by operators with > 20 PFA procedures. Both time to PVI (25.6 ± 10 min vs 16.5 ± 8, p < 0.0001) and fluoroscopy time (19.8 ± 8 min vs 15.9 ± 8 min, p = 0.0045) significantly improved after 10 associated with consistent linear trend towards procedural time reduction (R2 0.92-0.68 across various procedural metrics). Current PFA skin-to-skin time was lower than the historical skin-to-skin one in 217 (62.4%) procedures; it was similar in 112 (32.2%) cases and higher than the historical skin-to-skin one in 19 (5.5%). No major complications were reported. CONCLUSIONS: In this nationwide multicentric experience, the novel PFA system proved to be fast, safe, and acutely effective in both paroxysmal and persistent AF patients. The learning curve appears to be rapid, as improvements in procedural parameters were observed after only a few procedures. CLINICAL TRIAL REGISTRATION: Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/ Identifier: NCT05617456.

16.
Int J Cardiol ; 373: 57-63, 2023 02 15.
Artigo em Inglês | MEDLINE | ID: mdl-36460209

RESUMO

BACKGROUND: Reliable post-approval surveillance of implantable cardioverter-defibrillator (ICD) lead performance remains a challenge. In the past, two ICD leads were recalled due to a high frequency of failures. In this meta-analysis, we sought to provide a combined estimate of failure-free rate for ICD leads by reconstructing individual patient data from published Kaplan-Meier (KM) curves and to investigate whether estimates could be influenced by the characteristics of the study. METHODS: Observational studies assessing failure-free estimates of transvenous ICD leads with KM method, were identified through a systematic search up to November 2021. RESULTS: Forty-four studies were eligible that included 41,870 (63.1%) non-recalled leads and 24,493 (36.9%) recalled leads. The 8-year cumulative failure-free rate was 94.1% (CI, 93.6% - 94.6%) for contemporary non-recalled leads and 81.2% (80.3% - 82.0%) for recalled leads (hazard ratio [HR], 3.15 [2.85-3.47], p < 0.001). Failure-free rate was lower in single-center studies in both the non-recalled (HR, 0.28 [0.15-0.51], p < 0.001) and recalled (HR, 0.54 [0.33-0.88], p = 0.014) group compared with multicenter studies. Similarly, estimates were significantly lower in small (i.e. extracted KM curve with <312 leads) versus large studies (HR non-recalled group, 0.54 [CI, 0.33-0.89], p = 0.015; HR recalled group, 0.62 [CI, 0.43-0.89], p = 0.009). CONCLUSIONS: In this meta-analysis including >66,000 leads, we provide pooled survival curves that may play a role in generating evidence-based standards for assessing clinically acceptable failure rates for ICD leads. Lead performance was underestimated with single-center and small-sized studies; multicenter studies remain the main tool to reliably conduct post-market surveillance of ICD leads.


Assuntos
Desfibriladores Implantáveis , Humanos , Estudos Retrospectivos , Modelos de Riscos Proporcionais , Estudos Observacionais como Assunto
17.
J Interv Card Electrophysiol ; 66(9): 2011-2020, 2023 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36964415

RESUMO

BACKGROUND: Contact force (CF)-sensing catheters have not proved superior to standard catheters in the ablation of premature ventricular contractions (PVCs) from the right and left ventricular outflow tract (RVOT, LVOT). In this context, the utility of measuring local impedance (LI) is not known. We aimed to ascertain whether the use of a catheter combining LI and CF information was associated with superior outcomes in comparison with other catheter technologies. METHODS: We compared three groups of 40 propensity-matched patients with PVCs from the OTs, ablated by means of different catheter technologies: a CF-plus LI-featured catheter, an LI-featured catheter, and a standard irrigated catheter. RESULTS: The CF + LI group displayed a significantly lower risk of PVC recurrence than the standard ablation group (HR, 0.22; 95%CI, 0.07-0.71; p = 0.01). In the CF + LI group, LI drop and RF time were the only predictors of successful lesions (OR = 1.19, CI: 1.13-1.26, p < 0.001; OR = 1.06 CI: 1.01-1.07, p = 0.044, respectively). In the coronary cusps, unlike the RVOT/LVOT region, CF was not associated with LI drop (p = 0.48), and RF duration showed a linear relationship with LI drop (p < 0.001). CONCLUSIONS: The use of ablation catheters that combine CF and LI information is associated with increased success in the RF ablation of PVCs from the OTs. LI drop is the most important predictor of effective lesions, but its behavior depends on the ablation site: in the coronary cusps, unlike the RVOT/LVOT region, longer RF application times are needed in order to achieve LI drops associated with successful outcomes. REGISTRY AND REGISTRATION NO. OF THE STUDY/TRIAL: NCT03793998.


Assuntos
Ablação por Cateter , Complexos Ventriculares Prematuros , Humanos , Catéteres , Impedância Elétrica , Complexos Ventriculares Prematuros/cirurgia
18.
J Interv Card Electrophysiol ; 66(8): 1911-1917, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36897460

RESUMO

BACKGROUND: The very high-power short-duration (vHPSD) temperature-controlled ablation (vHPSD) improves the efficiency of pulmonary vein isolation (PVI) procedures. We evaluated the procedural and 12-months outcomes in atrial fibrillation (AF) patients undergoing PVI by means of vHPSD ablation. In patients with AF or atrial tachyarrythmia (AT) recurrence undergoing a redo procedure the durability of the PVI was investigated. METHODS: Consecutive paroxysmal/persistent AF patients undergoing PVI with the vHPSD ablation strategy (90 W, for 4 s) were enrolled. The rate of PVI, first-pass isolation, acute reconnection, and procedural complications were evaluated. Follow-up examinations and EKG were scheduled at 3,6, and 12 months. In case of AF/AT recurrence, patients underwent a redo procedure. RESULTS: Overall, 163 AF patients (29 persistent and 134 paroxysmal) were enrolled. The PVI was reached in 100% of patients (88% at the first pass). The rate of acute reconnection was 2%. The radiofrequency, fluoroscopy and procedural times were respectively 5.5 ± 1 min, 9 ± 1 min and 75 ± 20 min. No death, tamponade nor steam pops occurred; however, 5 patients had vascular complications. The 12-months freedom from AF/AT recurrence was 86% in both paroxysmal and persistent patients. Overall, 9 patients underwent a redo procedure, and in 4 all veins were still isolated, whereas in 5 pulmonary vein reconnections were found. The PVI durability was 78%. No overt clinical complications were observed in the follow-up. CONCLUSIONS: The vHPSD ablation represents an effective and safe ablation strategy to achieve PVI. The 12-months follow-up showed high freedom from AF/AT recurrence and a good safety profile.

19.
Artigo em Inglês | MEDLINE | ID: mdl-37775727

RESUMO

BACKGROUND: Criteria such as electrograms voltage or late potentials have been largely utilized in the past to help identify areas of substrate maps that are within the ventricular tachycardia (VT) isthmus; yet their specificity and positive predictive value are quite low. The Lumipoint fractionation tool of the Rhythmia system illuminates regions with fractionated electrograms irrespective of their timing and annotation. We aimed to ascertain whether the use of this tool can rapidly identify areas within VT isthmuses from substrate maps. METHODS: Thirty patients with structural cardiomyopathy in whom a complete right ventricular-paced substrate map and a full reconstruction of the diastolic isthmus during VT could be obtained were enrolled. The VT isthmus border was projected on each substrate map to verify whether the areas illuminated by Lumipoint fell within those borders. The behavior of the electrograms detected at the illuminated areas of the substrate maps was studied during a right ventricular drive train and extra stimulus protocol: if the near field potentials showed a delayed conduction after a single extra stimulus, defined as a minimum of 10 ms increase of the time interval between the far field and the near field activation measured during the drive train, the electrogram was said to have a "decremental" behavior. RESULTS: The logistic analysis showed that areas with fractionated electrograms illuminated by the Lumipoint software and showing the greatest decremental behavior fell within the VT isthmus borders (OR = 1.66, CI: 1.41-1.75, p<0.001; OR=1.57 CI: 1.32-1.72, p<0.001, respectively) with a sensitivity, specificity, and positive predictive value of 87%, 96%, and 97%, respectively. CONCLUSIONS: Fractionated electrograms illuminated by the automated Lumipoint software on right ventricular-paced substrate maps showing the greatest decremental behavior fall within the VT isthmus borders with a probability of 0.97, irrespective of their timing, annotation, or voltage, without any need for subjective assessment of their involvement in slow conduction areas.

20.
Artigo em Inglês | MEDLINE | ID: mdl-37985538

RESUMO

BACKGROUND: Intracardiac echocardiography (ICE) is increasingly employed in atrial fibrillation (AF) ablation procedures, with the potential to enhance procedural efficacy. Nevertheless, there is currently a lack of evidence assessing the impact of ICE on the efficiency, effectiveness, and safety outcomes in the context of novel pulsed-field ablation (PFA) for AF. PURPOSE: We aimed to assess whether the use of ICE could improve procedural parameters in a large population undergoing AF ablation with FARAPULSE™ catheter. METHODS: Consecutive patients who had undergone PFA of AF from nine Italian centers were included. In procedures where the ICE catheter was employed for guidance (ICE-guided group), it was used to maneuver the PFA catheter within the left atrium to achieve optimal contact with atrial structures. RESULTS: We analyzed 556 patients: 357 (66%) with paroxysmal AF, 499 (89.7%) de novo PVI. ICE-guided procedures (n = 138) were propensity matched with patients with a standard approach (n = 138), and their outcomes were compared. During ICE-guided procedures, no improvement in procedural metrics was recorded (ICE vs Standard, 23 ± 6 min vs 18.5 ± 9 min for time to PVI, p < 0.0001; 38.8 ± 7 vs 32.5 ± 5 number of PFA deliveries to achieve PVI, p < 0.0001; 68.8 ± 19 min vs 71.8 ± 29 min for primary operator time, p = 0.5301; 16.1 ± 8 min vs 18.2 ± 10 min for fluoroscopy time, p = 0.5476) except for support time (76.8 ± 26 min vs 91.4 ± 37 min, p = 0.0046). No major procedure-related adverse events were reported. CONCLUSION: Our findings confirmed that PFA could be consistently performed in a rapid, safe, and efficacious manner. The use of ICE to guide PFA was not associated with an improvement in procedural metrics.

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