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1.
Europace ; 23(6): 868-877, 2021 06 07.
Article in English | MEDLINE | ID: mdl-33458770

ABSTRACT

AIMS: Cryoballoon (CB) pulmonary vein isolation (PVI) is an accepted ablation strategy for rhythm control in atrial fibrillation (AF). We describe efficacy and safety in a high volume centre with a long experience in the use of the second-generation CB (CB2). METHODS AND RESULTS: Consecutive paroxysmal AF (PAF) or persistent AF (persAF) patients undergoing CB2-PVI were enrolled. Procedural data, efficacy, and safety issues were systematically collected. The 28 mm CB2 was used in combination with an inner lumen spiral catheter, a luminal oesophageal temperature (LET) probe was used with a cut-off of 15°C, the phrenic nerve (PN) monitored during septal PVs ablation. Freeze duration was mainly set at 240 s with a bonus application in case of delayed time-to-isolation (TTI > 75 s). A total of 1017 CB2 procedures were analysed (58% male, 66 ± 12 years old, 70% with PAF). 3964 PVs were identified, 99.8% PVs isolated using solely the 28 mm CB. Mean procedure time was 69 ± 25 min, TTI during the first application was recorded in 77% of PVs after a mean of 48 ± 31 s. We recorded 0.2% cardiac tamponade, 4.8% PN injury (1.6% of PN palsy), and 19% of LET < 15°C. Among 725 patients with follow-up data, 84% with PAF and 75% with persAF were in stable SR at 1 year. Shorter freezing duration and longer TTI were procedural predictors for recurrence. CONCLUSION: Cryoballoon procedures are fast and associated with a benign safety profile. Shorter TTI and longer freeze durations are associated with sinus rhythm during follow-up.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Cryosurgery/adverse effects , Female , Humans , Male , Middle Aged , Pulmonary Veins/surgery , Recurrence , Treatment Outcome
2.
JACC Clin Electrophysiol ; 6(10): 1253-1261, 2020 10.
Article in English | MEDLINE | ID: mdl-33092751

ABSTRACT

OBJECTIVES: This study sought to investigate the safety profile of a novel ablation index-guided high-power short-duration (AI-HP) pulmonary vein isolation (PVI) in terms of endoscopic esophageal lesions. BACKGROUND: The risk of esophageal injury during PVI is a major concern while ablating the posterior wall for patients with atrial fibrillation. Luminal esophageal temperature (LET) rise during ablation is a surrogate for esophageal lesion development. METHODS: A total of 122 consecutive symptomatic atrial fibrillation patients underwent AI-HP PVI (50 W throughout the ablation, AI anterior wall/posterior wall: 550/400). All patients were under LET monitoring (cutoff LET 39°C) during the ablation procedure, and patients with LET rise received esophageal endoscopy examination 1 to 3 days after the ablation. Ablation lesion data of the sites with LET rise were analyzed. RESULTS: Procedural PVI success rate was 100%. Per procedure, the mean radiofrequency ablation time, procedural time, and fluoroscopic time were 11.9 ± 2.7 min, 54.8 ± 9 min, and 5.5 ± 1.6 min. The incidence of LET >39°C was 47%, and the mean peak LET was 41.2 ± 1.8°C. The rate of endoscopic detected lesion was 2 of 57 (3.5%). No perforation or atrial-esophageal fistula was found. The mean contact force, application duration, impedance drop, and AI values at the sites with LET rise were 22.1 ± 8.9 g, 7 ± 2.4 s, 9.4 ± 4.6 Ω, and 419 ± 44.6. CONCLUSIONS: AI-HP (50 W) ablation appears to be a highly efficient ablation technique for PVI. The incidence of esophageal injury during AI-HP PVI seems markedly low. AI-HP ablation targeting AI 400 in combination with multisensor esophageal temperature monitoring for the left atrial posterior wall appears safe and efficient.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Atrial Fibrillation/surgery , Endoscopy , Humans , Pulmonary Veins/surgery
3.
J Cardiovasc Electrophysiol ; 31(8): 1923-1931, 2020 08.
Article in English | MEDLINE | ID: mdl-32495488

ABSTRACT

BACKGROUND: Time-to-isolation (TTI) guided second-generation cryoballoon (CB2) ablation has been shown to be effective for pulmonary vein isolation (PVI). OBJECTIVE: The objective of this paper is to compare the safety and clinical outcome of CB2 PVI using the TTI guided 4 minutes vs 3 minutes freeze protocol. METHODS: This was a propensity-matched study based on an institutional database. Symptomatic atrial fibrillation (AF) patients who underwent CB2 PVI and systematic follow-up were consecutively included. RESULTS: A total of 573 patients were identified, of them 214 (107 matched-pairs) symptomatic AF (paroxysmal AF: 61%, persistent AF: 39%) patients (age: 67.7 ± 11.2 years) were analyzed. The baseline characteristics were comparable between the two groups. Procedural time was significantly longer in the 4 minutes group compared to 3 minutes group (67.2 ± 21.8 vs 55.9 ± 16.9 minutes, P < .0001). During a mean follow-up of 2 years, the 4 minutes group was associated with a significantly higher rate of freedom from arrhythmia recurrence compared with the 3 minutes group (66.4% vs 56.1%, P = .009), which was mainly driven by patients with persistent AF. The multivariate regression showed that the 4 minutes freeze was the independent predictor of freedom from arrhythmia recurrence. During the repeat procedure, the 4 minutes group was associated with a significantly higher rate of durable PVI. There was no difference regarding procedural adverse events between the two groups. CONCLUSION: As compared with the 3 minutes freeze, the TTI guided 4 minutes freeze is associated with a significantly higher rate of arrhythmia-free and durable PVI without compromising the safety profile, patients with persistent AF may benefit from the TTI guided 4 minutes freeze more pronouncedly.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Cryosurgery/adverse effects , Humans , Pulmonary Veins/surgery , Recurrence , Time Factors , Treatment Outcome
4.
Heart Rhythm ; 17(11): 1833-1840, 2020 11.
Article in English | MEDLINE | ID: mdl-32470628

ABSTRACT

BACKGROUND: High-power, short-duration ablation for pulmonary vein isolation (PVI) in the treatment of atrial fibrillation (AF) facilitates the procedure and improve effectiveness; however, esophageal injury remains a safety concern. OBJECTIVE: The purpose of this study was to investigate the role of luminal esophageal temperature (LET) monitoring during high-power ablation for PVI in terms of endoscopic esophageal lesion. METHODS: Patients with symptomatic AF underwent ablation index-guided high-power (AI-HP) PVI (50 W; AI anterior wall/posterior wall: 550/400). In the first consecutive set of patients, an insulated esophageal temperature probe was used for LET monitoring (cutoff LET >39°C) (group A). In the second consecutive set of patients, the probe was not used (group B). All patients were scheduled to undergo esophageal endoscopy 1-3 days after ablation. RESULTS: A total of 120 patients (60 group A; 60 group B) were included in the study (mean age 67.8 years; 64% male). Baseline characteristics and procedural outcomes were similar between the 2 groups. Procedural PVI was achieved in all patients. First-pass PVI rate was 96.6%. Mean procedural radiofrequency (RF) time was 11.5 minutes, mean procedural time was 55.5 minutes, and fluoroscopic time was 5.6 minutes. Mean contact force at the LA posterior wall was 23 g, and mean RF ablation time at the LA posterior wall was 3.2 minutes. Two patients in group A and 1 patient in group B had endoscopic small esophageal lesions (P = .99). No serious procedural adverse events were observed. CONCLUSION: Among patients undergoing AI-HP (50 W) PVI, the incidences of ablation-related endoscopic esophageal lesion in patients with and those without use of a temperature probe for LET monitoring (cutoff 39°C) were comparably low.


Subject(s)
Atrial Fibrillation/surgery , Body Temperature/physiology , Catheter Ablation/methods , Esophagus/physiopathology , Pulmonary Veins/surgery , Aged , Atrial Fibrillation/physiopathology , Esophagoscopy , Female , Humans , Male , Recurrence , Time Factors , Treatment Outcome
5.
J Cardiovasc Electrophysiol ; 30(12): 2858-2863, 2019 12.
Article in English | MEDLINE | ID: mdl-31638713

ABSTRACT

BACKGROUND: Patients with a left atrial appendage thrombus (LAAT) despite oral anticoagulation (OAC) are at high risk of thromboembolism (TE) and a relevant proportion of LAAT do not resolve under continued OAC. Left atrial appendage closure (LAAC) in the presence of LAAT was anecdotally described as a therapeutic option to prevent TE in the patients. OBJECTIVE: To describe the feasibility of LAAC despite LAAT in consecutive patients. METHODS: We searched the LAAC database of our center to identify patients in whom a LAAC was performed despite evidence of a thrombus in the LAA. All procedures were performed under transesophageal echocardiography guidance, no angiographies were performed to avoid LAAT dislocation. An Amulet Occluder device was preferred to allow proximal implantation and sealing of the LAA. RESULTS: Nine patients were identified. The mean age was 68.1 ± 10.7 years, four were female, mean CHADSVASC and HASBLED were 3.6 ± 1.7 and 3.0 ± 1.0. Eight of nine patients were on OAC, one patient was under lone aspirin therapy because of bleeding. The mean distance between the LAAT and the estimated landing zone was 18 ± 6 mm, the minimal distance was 11 mm. The mean landing zone was 21 ± 3 mm, devices with a mean size of 25 ± 4 mm were chosen for implantation. All implantation succeeded, only two patients required an intraprocedural replacement. No procedural complication nor short term thromboembolic complication during a follow up of 138 ± 149 days were recorded. CONCLUSION: In the presented series a percutaneous LAAC despite a LAAT resulted to be feasible and safe.


Subject(s)
Atrial Appendage/physiopathology , Atrial Fibrillation/therapy , Cardiac Catheterization , Thromboembolism/prevention & control , Thrombosis/therapy , Action Potentials , Aged , Atrial Appendage/diagnostic imaging , Atrial Fibrillation/complications , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/physiopathology , Atrial Function, Left , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Databases, Factual , Echocardiography, Transesophageal , Feasibility Studies , Female , Heart Rate , Humans , Male , Middle Aged , Retrospective Studies , Risk Factors , Thromboembolism/diagnostic imaging , Thromboembolism/etiology , Thrombosis/diagnostic imaging , Thrombosis/etiology , Time Factors , Treatment Outcome
6.
J Cardiovasc Electrophysiol ; 30(12): 2724-2731, 2019 12.
Article in English | MEDLINE | ID: mdl-31588620

ABSTRACT

BACKGROUND: Radiofrequency high-power ablation appears to be a novel concept for atrial fibrillation (AF). The ablation index (AI) value has been associated with durability of pulmonary vein isolation (PVI). OBJECTIVES: This study aimed to report the procedural data and initial results of a combined ablation technique using AI-guided high-power (AI-HP; 50 W) ablation for PVI. METHODS: Symptomatic AF patients were consecutively enrolled and underwent wide-area contiguous circumferential PVI. Contact-force catheters were used, ablation power was set to 50 W targeting AI values (550 anterior and 400 posterior). Esophageal temperature was monitored during procedure, all patients underwent postablation esophageal endoscopy. RESULTS: PVI was achieved in all (n = 50, mean age: 68 ± 9 years, female: 60%) patients, rate of first-round PVI was 92%. A total of N = 2105 AI-guided ablation lesions were analyzed. Comparing left anterior wall vs left posterior wall and right anterior wall vs right posterior wall, mean ablation time (s) per lesion was 20.5 ± 8 vs 8.6 ± 3 and 12.2 ± 4 vs 9.3 ± 3; mean contact force (g): 17.1 ± 12 vs 25.4 ± 14 and 33.7 ± 13 vs 21.0 ± 11; mean AI: 547 ± 48 vs 445 ± 55 and 555 ± 56 vs 440 ± 47 (all P < .0001). Procedure and fluoroscopy time (minute) were 55.6 ± 6.6 and 6 ± 1.7, respectively. Only one (2%) patient had a minimal esophageal lesion. During In-hospital and 1-month follow-up no major complications such as death, stroke, tamponade, or atriaesophageal fistula (AE) occurred. Preliminary 6-month follow-up showed 48 of 50 (96%) patients were free from clinical AF/atrial tachycardia recurrence. CONCLUSION: AI-HP (50 W) ablation appears to be a feasible, safe, fast, and effective ablation technique for PVI.


Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation , Pulmonary Veins/surgery , Action Potentials , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Catheter Ablation/adverse effects , Feasibility Studies , Female , Heart Rate , Humans , Male , Middle Aged , Postoperative Complications/etiology , Pulmonary Veins/physiopathology , Recurrence , Time Factors , Treatment Outcome
7.
Europace ; 21(10): 1502-1508, 2019 Oct 01.
Article in English | MEDLINE | ID: mdl-31230078

ABSTRACT

AIMS: Left atrial appendage electrical isolation (LAAI) may improve the rhythm outcome in selected patients with atrial fibrillation (AF). Controversy exists if LAAI is associated with an increased rate of thromboembolic complications. We sought to assess the feasibility, efficacy, and safety of interventional left atrial appendage closure (LAAC) in comparison to oral anticoagulation (OAC) after electrical LAAI. METHODS AND RESULTS: Weeks after index LAAI using the cryoballoon or a linear maze like ablation strategy patients' left atrial appendage was invasively remapped. In case of persistent LAAI, LAAC was performed. Patients who refused invasive remapping continued OAC. The primary endpoint was composed of any stroke or systemic embolism (SE) and the occurrence of intracardiac thrombus. Secondary endpoints included stroke/SE, major bleeding, and all-cause death. Of 166 patients (51% female; mean age 70 ± 8 years; mean CHAD2S2VASc score 3.4 ± 1.8) after LAAI, 94 patients received LAAC (LAAC group) and 72 continued OAC (no LAAC). After LAAC, 83% of patients received dual antiplatelet therapy for 6 weeks and aspirin thereafter. During a mean follow-up of 778 ± 630 days, 5 and 11 primary endpoint events were observed in the LAAC and no LAAC group, respectively [hazard ratio (HR) 0.27, 95% confidence interval (CI) 0.10-0.75; P = 0.010]. The calculated annual thromboembolic event rates were 6.9% (no LAAC) and 2.3% (LAAC), respectively. Left atrial appendage closure significantly reduced the incidence of stroke and SE (HR 0.31, CI 0.1-0.98; P = 0.04). CONCLUSION: After electrical LAAI for rhythm control in AF patients, interventional LAAC was associated with fewer thromboembolic complications when compared with OAC.


Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/surgery , Cardiac Surgical Procedures/methods , Heart Conduction System/physiopathology , Thromboembolism/etiology , Aged , Atrial Fibrillation/complications , Feasibility Studies , Female , Follow-Up Studies , Germany/epidemiology , Humans , Incidence , Male , Prognosis , Retrospective Studies , Thromboembolism/epidemiology , Thromboembolism/prevention & control
8.
Pacing Clin Electrophysiol ; 42(6): 646-654, 2019 06.
Article in English | MEDLINE | ID: mdl-30963613

ABSTRACT

BACKGROUND: The left atrial appendage (LAA) has been identified as a potential source of atrial fibrillation (AF) and has been described as the "fifth" pulmonary vein (PV). We report our initial experience in LAA isolation (LAAI) using the cryoballoon (CB) and data on durability of CB-LAAI. METHODS: Patients treated with a CB-LAAI were retrospectively identified. Six weeks after electrical LAAI, patients were scheduled for staged percutaneous LAA closure. During the second procedure, a subset of patients underwent invasive remapping of the LAA. RESULTS: A total of 32 patients (21 males, 68 ± 10 years old) were treated with CB-LAAI. Acute LAAI was achieved in 29 of 32 (91%) patients: single-shot LAAI was observed in 18 of 32 (56%) patients. Acute procedural sustained LAAI was related with a significantly shorter time to LAAI (sustained LAAI: 84 ± 50 s vs nonsustained LAAI: 166 ± 76 s, P = 0.004). Mean procedure and fluoroscopy time were 61 ± 29 and 8 ± 6 min, respectively. One left-sided phrenic nerve palsy occurred. In 25 of 32 (78%) patients, a second procedure for percutaneous LAA closure device implantation was performed. In 22 patients, persistency of LAAI was tested: durable LAAI was documented in 16/22 patients (73%). CONCLUSION: In the present report, CB LAA isolation followed by staged LAA closure appeared to be safe and feasible but more data are required. Time to LAAI played a role in predicting acute sustained LAAI rate. CB LAA ablation leads to 73% of durable LAA isolation.


Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/surgery , Cryosurgery/methods , Aged , Epicardial Mapping , Female , Humans , Male , Retrospective Studies
9.
Pacing Clin Electrophysiol ; 42(7): 837-845, 2019 07.
Article in English | MEDLINE | ID: mdl-30969431

ABSTRACT

BACKGROUND: The procedural data of pulmonary vein (PV) isolation (PVI) for patients with atrial fibrillation using the second-generation laser balloon (LB2), which became available recently, remains unclear and were evaluated. METHODS: Thirty consecutive patients (116 PVs) underwent PVI using LB2 (LB2 group) and were matched to 30 patients (116 PVs) treated with the first-generation laser balloon (LB1 group). The left atrial isolated surface area (ISA) (ratio of the total isolated antral surface area excluding PV to the total isolated antral surface area including the posterior wall) was also measured after LB2 PVI. RESULTS: PVI was achieved in 103/116 (89%) PVs and 108/116 (93%) PVs in the LB2 and LB1 groups, respectively, after the initial circular ablation (P = 0.360) and in 115/116 (99%) PVs and 116/116 (100%) PVs in the LB2 and LB1 groups, respectively, at the end of the procedure (P = 1.000). PV occlusion grade, categorized by the degree of PV occlusion, was significantly better in the LB2 group than in the LB1 group (P < 0.001). Zero rotational maneuver was applicable in 23/116 (20%) PVs and 8/116 (7%) in the LB2 and LB1 groups, respectively (P = 0.007). There was no significant difference in the procedural time, fluoroscopic time, or complications. The mean ISA after LB2 PVI was 53 ± 14%. The application number was the only independent predictor of successful PVI after initial circular LB2 ablation (adjusted odds ratio 0.860; 95% confidence interval 0.764-0.968; P = 0.013). CONCLUSION: LB2 displays favorable PV occlusion characteristics and enables more zero rotational maneuvers.


Subject(s)
Atrial Fibrillation/surgery , Balloon Occlusion/methods , Laser Therapy/methods , Pulmonary Veins/surgery , Aged , Electrocardiography , Female , Humans , Male
10.
Pacing Clin Electrophysiol ; 42(1): 22-30, 2019 01.
Article in English | MEDLINE | ID: mdl-30461034

ABSTRACT

BACKGROUND: It remains unclear whether left atrial low-voltage area (LALVA) affects atrial tachyarrhythmia recurrence after laser balloon pulmonary vein isolation (PVI) for atrial fibrillation (AF). We prospectively evaluated the outcome of laser balloon PVI in patients with and without LALVA (≤ 0.5 mV) together with surface/intracardiac electrophysiological criteria. METHODS: One hundred consecutive paroxysmal/persistent AF patients underwent laser balloon PVI. The relative extent of LALVA (extent of LALVA/left atrial surface area × 100 [%]: rLALVA), total p-wave duration in lead II (PWD), and time interval from the beginning of p-wave to the local activation in left atrial appendage (TTLAA) were assessed. Patients were divided into patients with LALVA (group A: 23 patients) and those without LALVA (group B: 77 patients). The primary endpoint was freedom from atrial tachyarrhythmia after the blanking periods. RESULTS: Complete PVI was achieved in 99/100 (99%) patients. PWD and TTLAA were longer in group A (both, P < 0.001). During 12 months' follow-up, survival free from atrial tachyarrhythmia recurrence was lower in group A (12/23 [52%] patients vs 67/77 [87%] patients, P < 0.001). Multivariate analysis identified rLALVA as the only independent predictor of atrial tachyarrhythmia recurrence. rLALVA correlated with PWD and TTLAA (r = 0.41, P < 0.001 and r = 0.60, P < 0.001, respectively). Receiver operating characteristic curve for rLALVA revealed PWD of 122 ms and TTLAA of 92 ms as the optimal cut-off value. CONCLUSION: LALVA was associated with poorer outcome after laser balloon PVI. Patients may be identified by longer PWD and TTLAA.


Subject(s)
Atrial Fibrillation/surgery , Laser Therapy/methods , Pulmonary Veins/surgery , Aged , Atrial Fibrillation/physiopathology , Electrocardiography , Female , Heart Atria , Heart Conduction System/physiopathology , Humans , Male , Middle Aged , Prospective Studies , Recurrence , Treatment Outcome
11.
Circ J ; 82(6): 1558-1565, 2018 05 25.
Article in English | MEDLINE | ID: mdl-29618679

ABSTRACT

BACKGROUND: The incidence of pulmonary vein stenosis (PVS) after AF ablation following contemporary procedures remains unclear. We compared the incidence of PVS/narrowing (PVS/N) after PV isolation (PVI) for (1) 3-D mapping-guided wide-area encircling irrigated radiofrequency current (RFC) ablation; (2) first-third-generation big cryoballoon (CB1-3) ablation; and (3) laser balloon (LB) ablation.Methods and Results:All patients undergoing a second procedure between January 2012 and November 2016 were subgrouped according to index ablation (PVI): RFC; CB; or LB. PVS/N was classified using PV diameter ratio (second/index procedure) on selective PV angiogram performed before ablation: mild, 25-49%; moderate, 50-74%; or severe, ≥75%. A total of 344 patients (1,362 PV) were analyzed (RFC, n=211; 840 PV; CB1, n=21; 82 PV; CB2,3, n=64; 250 PV; LB, n=48; 190 PV). In the LB group, 45 patients (94%) were treated with dose ≥8.5 W. Second procedures were performed on average 14.9±14.1 months after the index procedure. Mild PVS/N was observed in 18.4%, 9.5% and 3.6% of PV in the LB, RFC and CB groups, respectively (P<0.01). Moderate PVS was recognized in 2 PV (0.1%; RFC, LB). Severe PVS was never observed, and no PV intervention/surgery was required. CONCLUSIONS: The risk for significant PVS is low after RFC/CB. The incidence of mild PVS/N was highest after standard-dose LB ablation and lowest after high-dose CB ablation.


Subject(s)
Ablation Techniques/standards , Atrial Fibrillation/therapy , Catheter Ablation/methods , Stenosis, Pulmonary Vein/etiology , Ablation Techniques/adverse effects , Aged , Angioplasty, Balloon , Angioplasty, Balloon, Laser-Assisted , Atrial Fibrillation/complications , Balloon Embolectomy , Catheter Ablation/adverse effects , Female , Humans , Incidence , Male , Middle Aged , Pulmonary Veins/surgery , Radiofrequency Ablation , Risk , Treatment Outcome
12.
EuroIntervention ; 13(18): e2138-e2146, 2018 04 06.
Article in English | MEDLINE | ID: mdl-29400653

ABSTRACT

AIMS: We aimed to assess the feasibility, efficacy and safety of short-term dual antiplatelet therapy (DAPT) for six weeks after left atrial appendage closure (LAAC). METHODS AND RESULTS: Data of the Cardioangiologisches Centrum Bethanien-LAAC registry were analysed. DAPT (aspirin 100 mg plus clopidogrel 75 mg) was administered until transoesophageal echocardiography (TEE) evaluation six weeks after LAAC. In the absence of significant peri-device flow or device-related thrombus (DRT), the medication was decreased to single antiplatelet therapy (SAPT). Outpatient visits were timed at six-month intervals. The incidences of major bleeding (BARC ≥3) and of thromboembolic events were investigated. A total of 298 patients (76±8 years; 62% male; CHA2DS2-VASc 4.3±1.5; HAS-BLED 3.5±1.0; 61% with history of bleeding) with successful LAAC were included. TEE revealed DRT in 7/298 (2.3%) patients (five at six-week follow-up [FU] 45±10 days after implant, two during a median long-term FU of 731 days). Non-procedure-related bleeding events occurred in 25/298 (8.4%) patients and non-procedure-related thromboembolic events in 11/298 (3.7%) patients. This translated into 3.9 bleeding events/100 patient-years and 1.7 thromboembolic events/100 patient-years, respectively. Procedure-related events consisted of major bleeding in 7/298 (2.3%) patients and stroke in 2/298 (0.7%) patients. Age ≥75 years (OR 3.2; CI: 1.2-8.0; p=0.015) and renal impairment (OR 2.5; CI: 1.1-5.7; p=0.027) were identified as independent predictors for major bleeding after LAAC. CONCLUSIONS: Short-term DAPT for six weeks appears to be a viable alternative for patients after LAAC. Age ≥75 years and renal impairment increase major bleeding events threefold.


Subject(s)
Aspirin/administration & dosage , Atrial Appendage , Atrial Fibrillation/therapy , Cardiac Catheterization/instrumentation , Clopidogrel/administration & dosage , Platelet Aggregation Inhibitors/administration & dosage , Stroke/prevention & control , Age Factors , Aged , Aged, 80 and over , Aspirin/adverse effects , Atrial Appendage/diagnostic imaging , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Cardiac Catheterization/adverse effects , Clopidogrel/adverse effects , Drug Administration Schedule , Drug Therapy, Combination , Echocardiography, Transesophageal , Feasibility Studies , Female , Germany/epidemiology , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Humans , Incidence , Kidney/physiopathology , Kidney Diseases/epidemiology , Kidney Diseases/physiopathology , Male , Platelet Aggregation Inhibitors/adverse effects , Registries , Risk Factors , Stroke/diagnosis , Stroke/epidemiology , Time Factors , Treatment Outcome
13.
JACC Clin Electrophysiol ; 3(2): 154-161, 2017 02.
Article in English | MEDLINE | ID: mdl-29759388

ABSTRACT

OBJECTIVES: The aim of this study was to identify predictors of cardiac tamponade (CT) during atrial fibrillation (AF) ablation using different technologies and strategies. BACKGROUND: The major cause of death during catheter ablation of AF is related to CT. The risk for CT may be linked to different procedural steps (transseptal puncture, catheter manipulation during left atrial and pulmonary vein mapping and ablation). METHODS: All AF ablation procedures undertaken from May 2010 to July 2015 at a single center were included. Two ablation groups were defined: group A, radiofrequency current, and group B, balloon. Group A was divided into groups A1 (pulmonary vein isolation [PVI] only) and A2 (PVI plus additional ablation). In group A, 2 transseptal punctures were performed, followed by wide-area circumferential point-by-point PVI (group A1) within a 3-dimensional left atrial map and complex fractionated atrial electrograms and/or linear lesions (group A2). In group B, 1 transseptal puncture by balloon-based PVI (cryoballoon, laser balloon). All episodes of CT were analyzed. RESULTS: In total, 3,000 AF ablation procedures were performed, 2,125 in group A (group A1, n = 1,559; group A2, n = 566) and 875 in group B (cryoballoon, n = 589; laser balloon, n = 286). The rate of CT was 1.1% (32 of 3,000) and was significantly lower in group B than in group A: 0.1% (1 of 875) versus 1.5% (31 of 2,125) (p = 0.001). The reduced CT risk remained if PVI only (group B vs. group A1) was compared: 0.8% (13 of 1,559) versus 0.1% (1 of 875) (p = 0.024). The greatest CT risk was seen in group A2: 3.2% (18 of 566). Radiofrequency current ablation beyond PVI was a predictor of CT. CONCLUSIONS: The risk for CT in patients undergoing AF ablation at a single high-volume center was decreased with the use of balloon catheters. Extensive radiofrequency current ablation beyond PVI leads to an increased perforation risk.


Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Aged , Catheter Ablation/methods , Female , Humans , Laser Therapy/adverse effects , Laser Therapy/methods , Male , Middle Aged , Operative Time , Postoperative Care , Recurrence , Reoperation/statistics & numerical data , Retrospective Studies , Risk Factors , Treatment Outcome
14.
Circ J ; 81(2): 172-179, 2017 Jan 25.
Article in English | MEDLINE | ID: mdl-27980294

ABSTRACT

BACKGROUND: Clinical outcome after pulmonary vein isolation (PVI) may be linked to both durability of PVI and the antral lesion size. Data on balloon-guided technologies are scarce. We investigated the size of the isolated surface area (ISA) acutely after PVI achieved by cryoballoon (CB) or laser balloon (LB), both using voltage mapping.Methods and Results:In 40 patients (73% male, mean age 66±9 years), a bipolar voltage map before and after PVI in sinus rhythm was acquired to delineate the isolated antral surface area (IASA, contiguous area of low voltage <0.5 mV) and the ISA (relative size of the low-voltage area in relation to the whole antral surface area including the posterior wall). IASA (CB: 57±14 cm2vs. LB: 42±15 cm2; P=0.002) as well as ISA (65±8% vs. 54±10%; P=0.001) were significantly larger in the CB than in the LB group. No periprocedural complications occurred. During a mean follow-up of 326±142 days, 4/20 and 5/20 patients experienced an AF/AT recurrence in the CB and LB groups, respectively. No differences in clinical outcome were observed between patients with a large (≥55%) or small (<55%) ISA. CONCLUSIONS: Balloon-guided PVI is associated with antral lesion formation. CB-guided PVI is associated with the largest ISA as compared with LB procedures. ISA size did not correlate with clinical outcome after a single procedure in the present study population.


Subject(s)
Angioplasty, Balloon/methods , Cryosurgery/methods , Pulmonary Veins/surgery , Aged , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/standards , Atrial Fibrillation , Cryosurgery/adverse effects , Female , Follow-Up Studies , Humans , Male , Middle Aged , Postoperative Complications , Pulmonary Veins/pathology
16.
Europace ; 17(5): 725-31, 2015 May.
Article in English | MEDLINE | ID: mdl-25618741

ABSTRACT

AIMS: Pulmonary vein isolation (PVI) using the first-generation cryoballoon (CB1) was characterized by a high rate of recovered pulmonary vein (PV) conduction along with a typical conduction gap pattern in patients with recurrent atrial tachyarrhythmia (ATa). Second generation (CB2) enables more uniform freezing. However, the rate of chronic PVI and PV conduction gap pattern is unknown. METHODS AND RESULTS: All patients with ATa recurrence undergoing a second procedure after CB2 or (historical) CB1 PVI (28 mm) were enrolled. In all patients, a left atrial three-dimensional electronatomic reconstruction was performed. The rates of chronic PVI and localization of PV conduction gaps were determined and compared between CB1 and CB2. Antral PV re-isolation was performed using irrigated-tip radiofrequency current energy ablation. Of 206 patients (CB2), 18 patients underwent the repeat procedure after 192 (75:245) days. In 6 of 18 (33%) patients, all PVs were electrically isolated whereas in the remaining 12 patients (66%) at least one PV demonstrated PV reconduction. Of 71 PVs [1 left common PV (LCPV)], 55 PVs (77%) were chronically isolated. The right superior PV (RSPV) was characterized by the lowest rate of chronic PVI (RSPV: 56%, LSPV: 76%, RIPV: 83%, LIPV: 94%, LCPV: 100%). Compared with CB1, CB2 ablation resulted in a significantly higher rate of chronic PVI (CB2: 77% vs. CB1: 32%; P < 0.0001) with the greatest improvement along both inferior PVs. CONCLUSION: Second-generation cryoballoon atrial fibrillation ablation is associated with a high rate of durable PVI in patients with ATa recurrence. The RSPV represents the PV with the greatest risk for left atrium-pulmonary vein reconnection.


Subject(s)
Atrial Fibrillation/surgery , Cryosurgery , Pulmonary Veins/surgery , Tachycardia, Supraventricular/surgery , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Cryosurgery/adverse effects , Cryosurgery/instrumentation , Databases, Factual , Electrophysiologic Techniques, Cardiac , Equipment Design , Female , Humans , Male , Middle Aged , Pulmonary Veins/physiopathology , Recurrence , Reoperation , Tachycardia, Supraventricular/diagnosis , Tachycardia, Supraventricular/physiopathology , Time Factors , Treatment Outcome
17.
Heart Rhythm ; 12(2): 268-74, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25446159

ABSTRACT

BACKGROUND: An increased incidence of esophageal lesions (EL) after pulmonary vein isolation (PVI) using the second-generation cryoballoon (CB2) has been described. We hypothesized that luminal esophageal temperature (LET)-guided PVI reduces the incidence of EL. OBJECTIVE: The aim of this study was to investigate the incidence of EL after LET-guided PVI using the CB2. METHODS: Ninety-four consecutive patients underwent CB2-PVI for paroxysmal or persistent atrial fibrillation. Target freezing time was 2 × 240 seconds. LET was continuously measured by a probe with 3 thermocouples. Early freezing interruption was performed when LET reached a prespecified cutoff temperature. A group of 32 patients who underwent CB2-PVI with observational LET measurement served as the control group. Postprocedural esophagoscopy was performed in all patients. RESULTS: Compared with observational LET measurement, a strategy of LET-guided CB-PVI significantly reduced the incidence of EL from 18.8% to 3.2% (P = .008). A progressive decline in the incidence of EL was observed with an increasing LET cutoff: 7.1% (2/28 patients, 12°C cutoff) and 1.5% (1/66 patients, 15°C cutoff, P = .005 vs control). Despite early freezing interruption at a single pulmonary vein in 27% (25/94) of patients, complete PVI was achieved in all patients using the 28 mm balloon. Repeat esophagoscopy confirmed healing of EL after 1 week. After a mean of 268 ± 119 days, 87% (76/87) of patients were free of recurrent atrial fibrillation or atrial tachycardia following a 90-days blanking period. CONCLUSION: LET-guided CB2-PVI significantly reduced the incidence of thermal EL. Interrupting cryoablation at 15°C LET was associated with the lowest incidence of esophageal injury.


Subject(s)
Atrial Fibrillation/surgery , Body Temperature/physiology , Cryosurgery/methods , Esophageal Diseases/epidemiology , Esophagus/physiopathology , Postoperative Complications/epidemiology , Tachycardia, Paroxysmal/surgery , Atrial Fibrillation/physiopathology , Cold Temperature/adverse effects , Electrocardiography , Esophageal Diseases/etiology , Esophageal Diseases/prevention & control , Esophagoscopy , Esophagus/injuries , Female , Fluoroscopy , Follow-Up Studies , Germany/epidemiology , Humans , Incidence , Male , Middle Aged , Postoperative Complications/etiology , Postoperative Complications/prevention & control , Prospective Studies , Tachycardia, Paroxysmal/physiopathology
18.
J Atr Fibrillation ; 7(1): 1034, 2014.
Article in English | MEDLINE | ID: mdl-27957078

ABSTRACT

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia and has been identified as an independent risk factor for stroke. Prevention of thromboembolic events has been based on oral anticoagulation (OAC) using Vitamin K antagonists (VKA). However, long-term OAC medication is limited by an increased bleeding risk and a low patient compliance. Relying on the observation that the majority of cardiac thrombi originate from the left atrial appendage (LAA) different devices aiming for LAA closure have been proposed. This review will discuss contemporary LAA closure devices with special emphasis on procedure related complications.

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