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1.
Artigo em Inglês | MEDLINE | ID: mdl-32602237

RESUMO

A 72-year-old woman with a history of paroxysmal atrial fibrillation (AF) and sinus node dysfunction is seen in clinic for routine follow-up. She had undergone radiofrequency ablation for AF and a dual chamber pacemaker implant (Medtronic Advisa DR MRI with 5076 active fixation leads; Medtronic, Minneapolis, MN, United States) five years prior. This article is protected by copyright. All rights reserved.

2.
Artigo em Inglês | MEDLINE | ID: mdl-32530306

RESUMO

Coronavirus disease 2019 (COVID-19) has presented substantial challenges to patient care and impacted health care delivery, including cardiac electrophysiology practice throughout the globe. Based upon the undetermined course and regional variability of the pandemic, there is uncertainty as to how and when to resume and deliver electrophysiology services for arrhythmia patients. This joint document from representatives of the Heart Rhythm Society, American Heart Association, and American College of Cardiology seeks to provide guidance for clinicians and institutions reestablishing safe electrophysiological care. To achieve this aim, we address regional and local COVID-19 disease status, the role of viral screening and serologic testing, return-to-work considerations for exposed or infected health care workers, risk stratification and management strategies based on COVID-19 disease burden, institutional preparedness for resumption of elective procedures, patient preparation and communication, prioritization of procedures, and development of outpatient and periprocedural care pathways.

3.
Artigo em Inglês | MEDLINE | ID: mdl-32496820

RESUMO

Background - Electrophysiological procedures such as epicardial ventricular tachycardia (VT) ablation and Lariat left atrial appendage ligation (LAA) that involve the epicardial space are typically associated with significant postoperative pain due to mechanical irritation and associated inflammation. There is an unmet need for an effective pain management strategy in this group of patients. We studied how this impacts patient comfort and duration of hospitalization and other associated comorbidities related to pericardial access. Methods - This is a multi-center retrospective study including 104 patients who underwent epicardial ventricular tachycardia ablation and Lariat left atrial appendage exclusion. We compared 53 patients who received post-procedural intrapericardial liposomal bupivacaine (LB) + oral colchicine ("LB group") and 51 patients who received colchicine alone ("non-LB group") between January 2015 and March 2018. Results - LB was associated with significant lowering of median pain scale at 6 hours [1.0(0-2.0) vs. 8.0(6.0-8.0), p<0.001], 12 hours [1.0(1.0-2.0) vs. 6.0 (5.0-6.0), p<0.001] and up to 48 hours post procedure. Incidence of acute severe pericarditis delayed pericardial effusion and gastrointestinal adverse effects were similar in both groups. Median length of stay was significantly lower in "LB group" (2.0 vs. 3.0; adjusted linear coefficient -1, CI -1.3 to -0.6, P<0.001). Subgroup analysis demonstrated similar favorable outcomes in both Lariat and epicardial VT ablation groups. Conclusions - Addition of intrapericardial post - procedural liposomal bupivacaine to oral colchicine in patients undergoing epicardial access during VT ablation or Lariat procedure is associated with significantly decreased numeric pain score up to 48 hours compared with colchicine alone. It is also associated with significantly shorter length of hospital stay without an increase in the risk of adverse events.

4.
Artigo em Inglês | MEDLINE | ID: mdl-32583488

RESUMO

Rhythm control of persistent atrial fibrillation (AF) patients represents a challenge for the modern interventional cardiac electrophysiologist; as a matter of fact, there is still divergence regarding the best ablative approach to adopt in this population. Different investigational endpoints, variability of techniques and tools, significant technological evolution, and the lack of universally accepted pathophysiological models engendered a considerable heterogeneity in terms of techniques and outcomes, so much that the treatment of persistent subtypes of AF commonly still relies mainly on pulmonary vein (PV) isolation. The purpose of the present review is to report the current experimental and clinical evidence supporting the importance of mapping and ablating non-PV triggers and describe our institutional approach for the ablation of nonparoxysmal AF.

5.
Future Cardiol ; 2020 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-32583678

RESUMO

Incorporation of technological advances in healthcare delivery has played a foundational role in development of modern healthcare. With the use of wireless transmission in conjunction with digitization of electrocardiography, continuous monitoring strategies have redefined our approach to dysrhythmia. These devices show promising results in evolving implantable loop recorder technology. In this review, we summarize the history of remote monitoring, indications for loop recorders, devices available, evidence for specific devices and anticipated studies.

6.
Artigo em Inglês | MEDLINE | ID: mdl-32530528

RESUMO

INTRODUCTION: Transseptal puncture (TSP) is challenging in patients with prior percutaneous atrial septal defect (ASD) occluder. We aimed to perform a systematic review and meta-analysis of the safety and efficacy of catheter ablation for atrial fibrillation (AF) in patients with percutaneous ASD occluder. METHODS: We searched PubMed, Medline, Embase, Ovid, and Cochrane for studies reporting results of AF ablation (freedom from AF, fluoroscopy/procedure time, and complications) in patients with percutaneous ASD occluders. RESULTS: Three studies with a total of 64 patients met inclusion criteria. The success rate of TSP was 100%. All patients (but one) underwent TSP under fluoroscopic and intracardiac echocardiography guidance. Freedom from AF was achieved in 77.7% (95% confidence interval [CI]: 65.7-86.3) patients. In the subgroup analysis, comparing septal versus device puncture, no significant difference in recurrence of AF was observed (23.07% vs. 16.66%; risk ratio: 1.18; 95% CI: 0.35-4.00; p = .79, respectively). The total fluoroscopy time was not significantly different in patients with TSP via native septum or device (43.50 vs. 70.67 min; p = .44), total procedural time was significantly longer with TSP via the closure device (237.3 vs. 180 min; p = .004) compared with the native septum. There were no device dislodgement or residual interatrial shunt during the follow-up period. CONCLUSION: Catheter ablation for AF in patients with prior percutaneous ASD closure device is feasible and safe with favorable long-term outcomes.

7.
Artigo em Inglês | MEDLINE | ID: mdl-32478430

RESUMO

BACKGROUND: The pathologic process of ARVC (arrhythmogenic right ventricular cardiomyopathy) typically originates in the epicardium or subepicardial layers with progression toward endocardium. However, in the most recent ARVC international task force consensus statement, epicardial ventricular tachycardia (VT) ablation is recommended as a Class I indication only in patients with at least one failed endocardial VT ablation attempt. OBJECTIVE: The aim of this meta-analysis is to assess the outcomes of ARVC patients undergoing combined endo-epicardial VT ablation, as compared to endocardial ablation alone. METHODS: A systematic review of PubMed, Embase, and Cochrane was performed for studies reporting clinical outcomes of endo-epicardial VT ablation vs endocardial-only VT ablation in patients with ARVC. Fixed-Effect model was used if I2 < 25 and the Random-Effects Model was used if I2 ≥ 25%. RESULTS: Nine studies consisting of 452 patients were included (mean age 42.3 ± 5.7 years; 70% male). After a mean follow-up of 48.1 ± 21.5 months, endo-epicardial ablation was associated with 42% relative risk reduction in VA recurrence as opposed to endocardial ablation alone (risk ratio [RR], 0.58; 95% confidence interval [CI], 0.45-0.75; P < .0001). No significant differences were noted between endo-epicardial and endocardial VT ablation groups in terms of all-cause mortality (RR, 1.19; 95% CI, 0.03-47.08; P = .93) and acute procedural complications (RR, 5.39; 95% CI, 0.60-48.74; P = .13). CONCLUSIONS: Our findings suggest that in patients with ARVC, endo-epicardial VT ablation is associated with a significant reduction in VA recurrence as opposed to endocardial ablation alone, without a significant difference in all-cause mortality or acute procedural complications.

8.
Artigo em Inglês | MEDLINE | ID: mdl-32494896

RESUMO

BACKGROUND: Cardiovascular and arrhythmic events have been reported in hospitalized COVID-19 patients. However, arrhythmia manifestations and treatment strategies used in these patients have not been well-described. We sought to better understand the cardiac arrhythmic manifestations and treatment strategies in hospitalized COVID-19 patients through a worldwide cross-sectional survey. METHODS: The Heart Rhythm Society (HRS) sent an online survey (via SurveyMonkey) to electrophysiology (EP) professionals (physicians, scientists, and allied professionals) across the globe. The survey was active from March 27 to April 13, 2020. RESULTS: A total of 1197 respondents completed the survey with 50% of respondents from outside the USA, representing 76 countries and 6 continents. Of respondents, 905 (76%) reported having COVID-19-positive patients in their hospital. Atrial fibrillation was the most commonly reported tachyarrhythmia whereas severe sinus bradycardia and complete heart block were the most common bradyarrhythmias. Ventricular tachycardia/ventricular fibrillation arrest and pulseless electrical activity were reported by 4.8% and 5.6% of respondents, respectively. There were 140 of 631 (22.2%) respondents who reported using anticoagulation therapy in all COVID-19-positive patients who did not otherwise have an indication. One hundred fifty-five of 498 (31%) reported regular use of hydroxychloroquine/chloroquine (HCQ) + azithromycin (AZM); concomitant use of AZM was more common in the USA. Sixty of 489 respondents (12.3%) reported having to discontinue therapy with HCQ + AZM due to significant QTc prolongation and 20 (4.1%) reported cases of Torsade de Pointes in patients on HCQ/chloroquine and AZM. Amiodarone was the most common antiarrhythmic drug used for ventricular arrhythmia management. CONCLUSIONS: In this global survey of > 1100 EP professionals regarding hospitalized COVID-19 patients, a variety of arrhythmic manifestations were observed, ranging from benign to potentially life-threatening. Observed adverse events related to use of HCQ + AZM included prolonged QTc requiring drug discontinuation as well as Torsade de Pointes. Large prospective studies to better define arrhythmic manifestations as well as the safety of treatment strategies in COVID-19 patients are warranted.

9.
Heart Rhythm ; 2020 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-32540298

RESUMO

Coronavirus disease 2019 (COVID-19) has presented substantial challenges to patient care and impacted health care delivery, including cardiac electrophysiology practice throughout the globe. Based upon the undetermined course and regional variability of the pandemic, there is uncertainty as to how and when to resume and deliver electrophysiology services for arrhythmia patients. This joint document from representatives of the Heart Rhythm Society, American Heart Association, and American College of Cardiology seeks to provide guidance for clinicians and institutions reestablishing safe electrophysiological care. To achieve this aim, we address regional and local COVID-19 disease status, the role of viral screening and serologic testing, return-to-work considerations for exposed or infected health care workers, risk stratification and management strategies based on COVID-19 disease burden, institutional preparedness for resumption of elective procedures, patient preparation and communication, prioritization of procedures, and development of outpatient and periprocedural care pathways.

10.
Artigo em Inglês | MEDLINE | ID: mdl-32530541

RESUMO

BACKGROUND: Pulmonary vein isolation (PVI) is the mainstay of catheter ablation (CA) for paroxysmal atrial fibrillation (AF). However, for persistent and long-standing persistent AF, there are no established strategies to improve the success rate of CA. Despite studies indicating that prophylactic cavotricuspid isthmus (CTI) ablation provides no or limited incremental benefit in patients with AF, it is still routinely performed worldwide. OBJECTIVE: We sought to examine whether CTI ablation for AF is associated with improvement in recurrence of all-atrial arrhythmias, compared with PVI alone in patients with and without typical atrial flutter (AFL). METHODS: A systematic review of PubMed, Cochrane, and Embase was performed for clinical studies including AF patients, reporting outcomes of CTI + PVI versus PVI alone. The primary efficacy endpoint was recurrence of all-atrial arrhythmias. RESULTS: Five studies comprising 1400 patients undergoing CTI + PVI versus PVI alone were included; 1110 patients had AF without AFL, and 290 patients had coexistent AF and AFL. After a mean follow-up of 14.4 ± 4.8 months, CTI + PVI was not associated with improvement in recurrence of all-atrial arrhythmias when compared with PVI alone (risk ratio [RR]: 1.29; 95% confidence interval [CI]: 0.93-1.79;p = .13). In the subgroup analysis, there were no differences between both groups in patients with AF without AFL (RR: 1.55; 95% CI: 0.96-2.48; p = .07), and in patients with AF and AFL (RR: 0.91; 95% CI: 0.6-1.39; p = .68). CONCLUSION: In AF patients, irrespective of the presence of typical AFL, additional CTI ablation is not associated with improvement in recurrence of all-atrial arrhythmias, compared with PVI alone.

11.
JACC Clin Electrophysiol ; 6(6): 623-635, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32553211

RESUMO

OBJECTIVES: This study was designed to evaluate lesion durability on invasive electrophysiologic remapping. BACKGROUND: The lattice-tip catheter generates a large thermal footprint during temperature-controlled irrigated radiofrequency ablation. In a first-in-human study, this catheter performed rapid point-by-point pulmonary vein isolation (PVI) and other linear atrial ablations. METHODS: In a prospective 3-center single-arm study, paroxysmal or persistent atrial fibrillation patients underwent PVI and, as needed, linear ablation at the cavotricuspid isthmus (CTI), mitral isthmus (MI), and/or left atrial roof; no other atrial substrate was ablated. Using the lattice catheter and a custom electroanatomic mapping system, temperature-controlled (Tmax 73° to 80°C; 2 to 7 s) point-by-point ablation was performed. Patients were followed for 12 months. RESULTS: A total of 65 patients (61.5% paroxysmal/38.5% persistent) underwent ablation: PVI in 65, MI in 22, left atrial roof in 24, and CTI in 48 patients. At a median of 108 days after the index procedure, protocol-mandated remapping was performed in 27 patients. The pulmonary veins (PVs) remained durably isolated in all but 1 reconnected PV-translating to durable isolation in 99.1% of PVs, or 96.3% of patients with all PVs isolated. Of 47 linear atrial lesions initially placed during the index procedure, durability was observed in 10 of 11 (90.9%) MI lines, all 11 (100%) roof lines, and all 25 (100%) CTI lines. After a median follow-up of 270 days, the 12-month Kaplan-Meier estimate for freedom from atrial arrhythmias was 94.4 ± 3.2%. CONCLUSIONS: Temperature-controlled lattice-tip point-by-point ablation showed not only highly durable PVI lesion sets, but also durable contiguity of linear atrial lesions.

12.
JACC Clin Electrophysiol ; 6(6): 661-671, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32553216

RESUMO

OBJECTIVES: This study sought to evaluate the efficacy and safety of venous access techniques for cardiac implantable electronic device (CIED) implantation. BACKGROUND: Minimally invasive transvenous access is a fundamental step during implantation of CIEDs. However, the preferred venous access is still subject to ongoing debate, and the decision depends on patient characteristics and operator experience. METHODS: A comprehensive search for studies comparing subclavian vein puncture (SVP) and axillary vein puncture (AVP) versus cephalic vein cutdown (CVC) for CIED implantation was performed in PubMed, Google Scholar, EMBASE, SCOPUS, ClinicalTrials.gov, and various scientific conferences from inception to July 1, 2019. A meta-analysis was performed by using a random effects model to calculate risk ratios (RRs) and mean differences with 95% confidence interval (CIs). RESULTS: Twenty-three studies were eligible that included 35,722 patients (SVP, n = 18,009; AVP, n = 409; and CVC, n = 17,304). Compared with CVC, SVP was associated with a higher risk of pneumothorax (RR: 4.88; 95% CI: 2.95 to 8.06) and device/lead failure (RR: 2.09; 95% CI: 1.07 to 4.09), whereas there was no significant difference in these outcomes compared with AVP. Acute procedural success was significantly higher with SVP compared with CVC (RR: 1.24; 95% CI: 1.00 to 1.53). There was no significant difference in other complications such as pocket hematoma/bleeding, device infection, or pericardial effusion between SVP or AVP compared with CVC. CONCLUSIONS: CVC was associated with a lower risk of pneumothorax and lead failure compared with SVP. AVP and CVC are both effective approaches for CIED lead implantation and offer the potential to avoid the complications usually observed with traditional SVP.

13.
Artigo em Inglês | MEDLINE | ID: mdl-32596864

RESUMO

BACKGROUND: We evaluated the efficacy of a new method in identifying peri-device leak (PDL) using morphology of the thrombus formed inside the left atrial appendage (LAA) as seen on follow-up transesophageal echo (TEE). METHOD: A total of 291 consecutive patients undergoing Watchman procedure were included in this analysis. TEE was performed at 45 days post-procedure. Based on the presence of the thrombus inside the LAA behind the device, patients were grouped as 1) White (W) group: LAA completely filled with thrombus (n=101), 2) Non-white (NW) group: LAA completely black or mixed (part black and part white) (n=190). Follow-up TEE was repeated at 6 and 12 months. RESULTS: Baseline characteristics were comparable between groups except the device size, number of patients with chicken-wing morphology and prevalence of left atrial 'smoke' that were significantly higher in the NW group. Detection of black appearance was comparable between the pre-coil closure image and the NW population (26/36 (72.2%) vs 99/154 (64.3%), p=0.37). After adjusting for clinically relevant covariates, NW appearance of the LAA was associated with the presence of significant leak (OR 47.96, 95% CI: 2.91-790.2, p-value < 0.001). Of the 11 patients with mixed appearance at the 6-month TEE remained unchanged (part black and part white) at the 12-month TEE. LAA appearance was white in all 36 patients following coil closure. CONCLUSION: Our findings demonstrated White and Non-White appearance of the appendage on TEE to be reliable markers of complete closure and leak respectively, following LAA occlusion with the Watchman device. This article is protected by copyright. All rights reserved.

14.
Artigo em Inglês | MEDLINE | ID: mdl-32400890

RESUMO

Atrioesophageal fistula (AEF) is a rare but deadly complication of radiofrequency ablation for atrial fibrillation. Given its rarity, the diagnosis of AEF is usually delayed with a wide variation in management strategies, which contribute to the high mortality associated with AEF. As such, the most important step of AEF management is prevention, whereas early diagnosis and treatment are crucial to reduce its associated high mortality.

15.
Artigo em Inglês | MEDLINE | ID: mdl-32390061

RESUMO

PURPOSE: Real-world data can help medical administrators, physicians, and payers make evidence-based decisions regarding treatment choices. The objective of this study was to compare real-world safety outcomes with the latest catheter technologies used for the treatment of atrial fibrillation (AF). METHODS: The Vizient Health Systems database, a large US hospital database, was used to compare acute complications in AF ablation with the contact force sensing THERMOCOOL SMARTTOUCH® Catheter or the THERMOCOOL SMARTTOUCH® SF Catheter (ST) versus the second-generation Arctic Front Advance™ Cryoablation Catheter (CB2) between September 2015 and June 2017. The primary outcome was a composite safety endpoint of acute ablation-related complications defined via ICD-10 diagnosis and procedure codes, including tamponade and other pericardial events, respiratory complications, stroke, cerebral or pre-cerebral occlusion/stenosis without infarction, vascular access complications, hemorrhage, phrenic nerve injury, myocardial infarction, and pulmonary embolism. RESULTS: In total, 1473 ablations met all inclusion criteria (407 ST, 1066 CB2). Ablations for paroxysmal AF (PAF) had a lower complication rate than ablations for persistent AF (PsAF) (6.1% vs. 7.3%), as did ablations with ST compared with CB2 within each AF type (PAF 6.0% vs. 6.1%, PsAF 6.3% vs. 7.8%). Neither ablation catheter nor AF type was statistically significant after controlling for site volume, patient age, and comorbid conditions (ST vs. CB2: OR 0.86, p = 0.5544; PsAF vs. PAF: OR 1.08, p = 0.7376). CONCLUSION: Acute ablation-related complication rates were low and were not significantly associated with catheter technology. Increased risk of complication was attributable to low-volume sites and baseline patient characteristics.

16.
Card Electrophysiol Clin ; 12(2): 209-217, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32451105

RESUMO

When patients have symptomatic recurrent atrial tachyarrhythmias after 2 months following pulmonary vein antral isolation, a repeat ablation should be considered. Patients might present with isolated pulmonary veins posterior wall. In these patients, posterior wall isolation is extended, and non-pulmonary vein triggers are actively sought and ablated. Moreover, in those with non-paroxysmal atrial fibrillation or a known higher prevalence of non-pulmonary vein triggers, empirical isolation of the superior vena cava, coronary sinus, and/or left atrial appendage might be performed. In this review, we will focus on ablation of non-pulmonary vein triggers, summarizing our current approach for their mapping and ablation.

17.
Artigo em Inglês | MEDLINE | ID: mdl-32451798

RESUMO

PURPOSE: Idiopathic junctional ectopic tachycardia (JET) is typically refractory to antiarrhythmic agents. Catheter ablation for JET is feasible but is associated with high risk of unintended atrioventricular (AV) block. There is limited data on the appropriate procedural technique and clinical outcomes with catheter ablation for idiopathic JET in adults. METHODS: This is a multicenter, retrospective study of all adult patients (age ≥ 18 years) who underwent catheter ablation for idiopathic JET. Patient, procedural characteristics, and long-term outcomes were evaluated. RESULTS: Fifteen patients [radiofrequency ablation (RF) = 14 and cryoablation = 1) were treated with catheter ablation. The median age was 58 years with 67% males. All patients underwent mapping of the right atrium and the aortic cusps prior to energy delivery. The location of earliest activation in relation to the atrioventricular (AV) node was postero-superior in 73% (11/15), posterior in 13% (2/15), and superior in 13% (2/15) respectively. Acute success was 100%. Arrhythmia recurrence occurred in 53% (8/15) all of whom underwent a repeat ablation. High-grade AV block requiring permanent pacemaker occurred in 20% (3/15). At 12-month follow-up in the redo-ablation group, 37.5% (3/8) had recurrence of the arrhythmia two of which underwent a third ablation procedure. CONCLUSION: Catheter ablation of idiopathic JET in adults is associated with a high rate of recurrence requiring multiple procedures and high risk of AV block requiring a permanent pacemaker. Mapping and ablation of the non-coronary cusp can be considered as the arrhythmia was controlled in 3 patients with no inadvertent AV block.

18.
JACC Clin Electrophysiol ; 6(5): 507-519, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32439034

RESUMO

OBJECTIVES: This study sought to evaluate the safety and acute performance of the lattice tip for the treatment of atrial flutter and fibrillation (AF). BACKGROUND: A novel catheter using an expandable lattice structure with a wide thermal footprint incorporating multiple surface thermocouples/mini-electrodes has been designed for high-resolution mapping and high-current, temperature-controlled radiofrequency ablation (RFA). METHODS: Patients with typical right atrial flutter or AF were prospectively enrolled in a single-arm study at 3 centers. Patients with atrial flutter underwent cavotricuspid isthmus (CTI) ablation. Patients with paroxysmal AF underwent pulmonary vein isolation (PVI) and CTI if desired, and for patients with persistent AF, mitral isthmus and left atrial roof lines were also permitted. Mapping was performed with the lattice (Sphere-9) catheter and a novel compatible electroanatomic mapping system (Prism-1). RFA was performed in a point-by-point fashion (Tmax, 73°C to 80°C; range 2 to 7 s). Patients were followed for 3 months. RESULTS: A total of 71 patients underwent ablation: 65 PVI (38% with persistent AF) and 22 mitral isthmus, 24 roof, and 48 CTI lines. PVI was achieved in 64 of 65 (98.5%) by using the lattice alone and required a mean of 2.7 ± 0.70 RFA min. Mitral block was achieved in 100% by using 11.5 ± 10.7 applications and 1.0 ± 0.92 RFA min; only 1 patient required adjunctive epicardial coronary sinus ablation. Roof line and CTI block were achieved in 95.8% and 100% of patients, using 4.9 ± 1.9 and 5.9 ± 3.1 applications for 0.4 ± 0.16 and 0.5 ± 0.24 RFA min, respectively. At 3 months, there were no deaths, strokes, tamponade, or atrioesophageal fistula. CONCLUSIONS: This first-in-human study demonstrated clinical feasibility and safety for rapid high-current, temperature-controlled point-by-point PVI and linear ablation.

19.
20.
Artigo em Inglês | MEDLINE | ID: mdl-32462550

RESUMO

PURPOSE: The prospective, multicenter SMART SF trial demonstrated the acute safety and effectiveness of the 56-hole porous tip irrigated contact force (CF) catheter for drug-refractory paroxysmal atrial fibrillation (PAF) ablation with a low primary adverse event rate (2.5%), leading to FDA approval of the catheter. Here, we are reporting the long-term effectiveness and safety results that have not yet been reported. METHODS: Ablations were performed using the 56-hole porous tip irrigated CF catheter guided by the 3D mapping system stability module. The primary effectiveness endpoint was freedom from atrial tachyarrhythmia (including atrial fibrillation, atrial tachycardia, and/or atrial flutter), based on electrocardiographic data at 12 months. Atrial tachyarrhythmia recurrence occurring 3 months post procedure, acute procedural failures such as lack of entrance block confirmation of all PVs, and undergoing repeat procedure for atrial fibrillation in the evaluation period (91 to 365 days post the initial ablation procedure) were considered to be effectiveness failures. RESULTS: Seventy-eight patients (age 64.8 ± 9.7 years; male 52.6%; Caucasian 96.2%) participated in the 12-month effectiveness evaluation. Mean follow-up time was 373.5 ± 45.4 days. The Kaplan-Meier estimate of freedom from 12-month atrial tachyarrhythmia was 74.9%. Two procedure-related pericardial effusion events were reported at 92 and 180 days post procedure. There were no pulmonary vein stenosis complications or deaths reported through the 12-month follow-up period. CONCLUSIONS: The SMART SF 12-month follow-up evaluation corroborates the early safety and effectiveness success previously reported for PAF ablation with STSF.

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