Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 98
Filter
1.
J Cardiovasc Electrophysiol ; 35(10): 2006-2016, 2024 Oct.
Article in English | MEDLINE | ID: mdl-39136311

ABSTRACT

BACKGROUND: The prevalence and impact of obesity on outcomes of atrial fibrillation (AF) ablation randomized controlled trials (RCTs) have not been well studied. OBJECTIVE: To examine the proportion of participants with obesity enrolled in RCTs of AF ablation and outcomes of ablation when subgroup analysis of participants with obesity were available. METHODS: We systematically searched PubMed and EMBASE for AF ablation RCTs published between January 1, 2015 to May 31, 2022. When body mass index (BMI) data were available, normal distribution was assumed and a z score was used to estimate the proportion of obesity. Results categorized by BMI or body weight status were reviewed. Authors were contacted for additional information. RESULTS: Of 148 eligible RCTs with 30174 participants, 144 (97.30%) RCTs did not report the proportion of participants with obesity, while published information regarding BMI was available in 63.51%. Three trials excluded patients based on BMI. Using reported BMI, we estimated the proportion of participants with obesity varied greatly across these trials, ranging from 5.82%-71.9% (median 38.02%, interquartile 29.64%, 49.10%). Patients with obesity were represented in a greater proportion among trials conducted in North America (50.23%) and Asia (44.72%), compared to others (32.16%), p < .001. Subgroup analysis or analysis adjusting for BMI was reported in only 13 (8.78%) RCTs; four (30.77%) of these suggested that BMI or body weight might negatively affect primary outcomes. CONCLUSION: Obesity is a common comorbidity among AF patients. However, most AF ablation RCTs underreported the proportion of participants with obesity and its impact on the primary outcomes.


Subject(s)
Atrial Fibrillation , Body Mass Index , Catheter Ablation , Obesity , Randomized Controlled Trials as Topic , Humans , Atrial Fibrillation/surgery , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Atrial Fibrillation/physiopathology , Obesity/epidemiology , Obesity/diagnosis , Catheter Ablation/adverse effects , Treatment Outcome , Male , Female , Prevalence , Middle Aged , Risk Factors , Aged , Risk Assessment , Heart Rate
2.
Heart Rhythm ; 2024 Aug 05.
Article in English | MEDLINE | ID: mdl-39111610

ABSTRACT

BACKGROUND: Despite their improved safety, by and large, cardiac electrophysiology procedures including catheter ablation (CA), are presently performed in hospital outpatient departments. OBJECTIVE: This large multicenter study investigated the safety and outcomes associated with various cardiac electrophysiology procedures performed at 6 ambulatory surgery centers (ASCs), primarily during the coronavirus disease 2019 pandemic under the Center for Medicare and Medicaid Services Hospitals Without Walls program. METHODS: We retrospectively analyzed the outcomes from consecutive electrophysiology procedures performed in ASCs with same-day discharge, including transesophageal echocardiography, cardioversion, cardiac implantable electronic device (CIED) implantation, electrophysiology studies, and CA for atrial fibrillation (AF), atrial flutter (AFL)/supraventricular tachycardia, ventricular premature complexes (VPCs), and atrioventricular node. RESULTS: Altogether, 4037 procedures were performed, including 779 transesophageal echocardiography/cardioversion procedures (19.3%), 1453 CIED implantation procedures (36.0%), 26 electrophysiology studies (0.6%), and 1779 CA procedures (44.1%) for AF (75.4%), AFL/supraventricular tachycardia (18.8%), VPC (4.7%), and atrioventricular node (1.1%). Overall, 80.2% of CA procedures were for left-sided atrial arrhythmias (AF/atypical AFL) requiring transseptal catheterization. Left-sided VPC ablation procedures (42.2%) were performed using a transseptal/retrograde approach. Adverse event rates were low, but comparable between CIED implantation and CA (0.76% vs 0.73%; P = .93), as were the incidences of urgent/unplanned postprocedure hospitalization (0.48% vs 0.45%; P = .89), respectively. Moreover, the adverse event rates in ASCs vs hospital outpatient departments did not differ for CIED (0.76% vs 0.65%; P = .71) or CA (0.73% vs 0.80%; P = .79). CONCLUSION: The results from this large multicenter study suggest that ASCs represent a safe and effective setting to perform a variety of cardiac electrophysiology procedures including CA. These findings bear important implications for healthcare delivery and policy.

4.
J Cardiovasc Electrophysiol ; 35(4): 832-842, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38448797

ABSTRACT

INTRODUCTION: Cryoablation therapy for pulmonary vein isolation (PVI) to treat paroxysmal atrial fibrillation (PAF) is well established. A novel 28 mm cryoballoon system designed to operate under low pressure to safely reach a lower nadir temperature and maintain constant balloon size during cooling has not been prospectively studied in a large patient population for safety and efficacy. The FROZEN AF (NCT04133168) trial was an international multicenter, open-label, prospective, single-arm study on the safety and performance of a novel cryoballoon system for treatment of PAF. METHODS AND RESULTS: The study enrolled patients at 44 sites in 10 countries across North America, Europe, and Asia. Subjects were indicated for PVI treatment of PAF and had failed or were intolerant of one or more antiarrhythmic drugs. Procedural outcomes were defined based on the 2017 HRS consensus statement. Follow-up was performed at 7 days, 3, 6, and 12 months. Data are reported as mean ± SD or median (IQR). PVI was performed with a 28 mm cryoballoon in 325 drug refractory PAF patients. Complete PVI was achieved in 95.7% of patients. In cryoablation lesions longer than 60 s, 60.1% of PV isolations required only a single cryoballoon application. Procedure related complications included: phrenic nerve palsy [temporary 4 (1.2%), persistent 0 (0.0%)], cardiac tamponade/perforation 2 (0.6%), and air embolism 1 (0.3%). Freedom from documented atrial arrhythmia recurrence at 12 months was 79.9% (AF 82.7%, AFL 96.5%, AT 98.1%), antiarrhythmic drugs (AAD) were continued or re-initiated in 26.8% of patients after the 3-month blanking period. Additionally, an extension arm enrolled 50 pts for treatment with 28/31 mm variable size cryoballoon. A single temporary PNP occurred in this group, which resolved before discharge. Freedom from documented recurrence at 12 months in these pts was 82.0%. CONCLUSIONS: This novel cryoballoon may facilitate PVI to treat PAF, providing more options to address the variety of anatomies present in patients with PAF. This cryoballoon system proved to be safe and effective for treatment of patients with drug refractory or drug intolerant PAF.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Heart Injuries , Pulmonary Veins , Humans , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Fibrillation/epidemiology , Catheter Ablation/adverse effects , Catheter Ablation/methods , Cryosurgery/adverse effects , Cryosurgery/methods , Heart Injuries/etiology , Prospective Studies , Pulmonary Veins/surgery , Recurrence , Treatment Outcome
6.
Article in English | MEDLINE | ID: mdl-38157151

ABSTRACT

BACKGROUND: We investigated the preclinical safety and efficacy of ventricular pulsed field ablation (PFA) using a family of novel, 6-/8-Fr, linear, and spiral PFA/mapping catheters (CRC EP, Inc). METHODS: QRS-gated, bipolar PFA (>2.0 kV) was performed in 10 healthy swine. Altogether, 20 endocardial and epicardial right and left ventricular applications were delivered. The catheters were inserted through an 8.5-Fr steerable introducer. The intensity of skeletal muscle activation was quantified using an accelerometer. Lesions were assessed by pre- versus post-PFA electrogram analysis, pacing threshold, 3D voltage mapping, necropsy, and histology. The swine rete mirabile, liver and kidneys were examined for embolic events. RESULTS: All applications were single-shot (56 ± 18 s) without catheter repositioning. Minimal microbubbling was observed without significant skeletal muscle stimulation (mean acceleration 0.05 m/s2) or ventricular tachyarrhythmias. There was significant reduction in post- versus pre-PFA electrogram amplitude (0.5 ± 0.2 mV versus 3.2 ± 0.9 mV, P < 0.001) with a marked increase in pacing threshold (>20 mA versus 7.5 ± 2.9 mA, P < 0.001). All lesions were large and durable up to 28 days, measuring 32 ± 5 mm (length), 27 ± 8 mm (width), and 8 ± 3 mm (depth) using the spiral catheters and 43 ± 1 mm (length), 7 ± 1 mm (width), and 8 ± 1 mm (depth) using the linear catheters. Despite higher waveform voltages and prolonged applications, no thermal effects were detected at necropsy/histology. Moreover, gross and microscopic examinations revealed no evidence of thromboembolism, vascular or collateral injury. CONCLUSIONS: A novel, QRS-gated PFA system using linear and spiral PFA catheters is capable of creating large and durable ventricular lesions in vivo without significant microbubbling, ventricular arrhythmias or thromboembolism.

7.
J Cardiovasc Electrophysiol ; 34(11): 2203-2212, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37464948

ABSTRACT

INTRODUCTION: Pulsed field ablation (PFA) is a nonthermal ablative strategy that achieves cell death via electroporation. Herein, we investigated the preclinical safety and efficacy of PFA using two novel 8-French, 16-electrode spiral PFA/mapping catheters (ElePulse; CRC EP, Inc.). METHODS: Bipolar PFA (>1.8 kV) was performed using 30 s, single-shot, QRS-gated applications. Altogether, 94 atrial structures were ablated in 23 swine, one canine, and one ovine, including right and left atria and atrial appendages, pulmonary veins, and superior and inferior (IVC) vena cavae. We also examined the impact of PFA on the phrenic nerve (14 swine) and on a deviated esophagus after delivery of PFA from inside the IVC (five swine). RESULTS: All applications were single-shot without catheter repositioning. Minimal microbubbling was observed without significant skeletal muscle twitching/activation (mean acceleration: 0.05 m/s2 ). There was a marked reduction in post-PFA versus pre-PFA atrial electrogram amplitude (0.17 ± 0.21 vs. 1.18 ± 1.08 mV; p < .0001). Lesion durability was demonstrated up to 3 months in all targeted tissues. Histologically, lesions were contiguous and transmural, except in the atrial appendage, and without any thermal effects. Magnetic resonance, gross, and histologic examinations of the brain, rete mirabile, and kidneys revealed no thromboembolism. No acute/long-term phrenic nerve dysfunction was encountered. Although within 2 h of ablation, histologic examinations of the esophagus revealed acute PFA-related changes in the muscular layer, these completely resolved by 21 ± 5 days. CONCLUSION: A novel, single-shot, spiral PFA system is capable of safely creating large, durable atrial lesions without significant adverse effects on the phrenic nerve or the esophagus.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pulmonary Veins , Animals , Dogs , Sheep , Swine , Pulmonary Veins/surgery , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Irreversible Electroporation Therapy , Catheter Ablation/adverse effects , Electroporation Therapies , Treatment Outcome
8.
Pacing Clin Electrophysiol ; 46(7): 563-573, 2023 07.
Article in English | MEDLINE | ID: mdl-37377391

ABSTRACT

BACKGROUND: Although pulmonary vein isolation (PVI) remains the cornerstone of catheter ablation of atrial fibrillation (AF), several studies have illustrated clinical benefits associated with PVI with posterior wall isolation (PWI). METHODS: This retrospective study investigated the outcomes of PVI alone versus PVI+PWI performed using the cryoballoon in patients with cardiac implantable electronic devices (CIEDs) and paroxysmal AF (PAF) or persistent AF (PersAF). RESULTS: Acute PVI was achieved in all patients using cryoballoon ablation. Compared to PVI alone, PVI+PWI was associated with longer cryoablation, fluoroscopy, and total procedure times. Adjunct radiofrequency was required to complete PWI in 29/77 patients (37.7%). Adverse events were similar with PVI alone versus PVI+PWI. But at 24 ± 7 months of follow-up, not only cryoballoon PVI+PWI was associated with improved freedom from recurrent AF (74.3% vs. 46.0%, P = .007) and all atrial tachyarrhythmias (71.4% vs. 38.1%, P = .001) in patients with PersAF, cryoballoon PVI+PWI also yielded greater freedom from AF (88.1% vs. 63.7%, P = .003) and all atrial tachyarrhythmias (83.3% vs. 60.8%, P = .008) in those with PAF. Additionally, PVI+PWI was associated with higher reductions in atrial tachyarrhythmia burden (97.9% vs. 91.6%, P < .001), need for cardioversion (5.2% vs. 23.6%, P < .001) and repeat catheter ablation (10.4% vs. 26.1%, P = .005), and a longer time-to-arrhythmia recurrence (16 ± 6 months vs. 8 ± 5 months, P < .001) in both PersAF and PAF patients. CONCLUSION: In CIED patients with PersAF or PAF, cryoballoon PVI+PWI is associated with a greater freedom from recurrent AF and atrial tachyarrhythmias, as compared to PVI alone during long-term follow-up.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Atrial Fibrillation/surgery , Retrospective Studies , Treatment Outcome , Heart Atria , Pulmonary Veins/surgery , Cryosurgery/methods , Catheter Ablation/methods , Recurrence
9.
JACC Clin Electrophysiol ; 9(5): 628-637, 2023 05.
Article in English | MEDLINE | ID: mdl-37225309

ABSTRACT

BACKGROUND: Prior studies have demonstrated clinical benefits associated with cryoballoon pulmonary vein isolation (PVI) and concomitant posterior wall isolation (PWI) in patients with persistent atrial fibrillation (AF). However, the role for this approach in patients with paroxysmal atrial fibrillation (PAF) remains unclear. OBJECTIVES: This study investigated the acute and long-term outcomes of PVI vs PVI+PWI using cryoballoon in patients with symptomatic PAF. METHODS: This retrospective study (NCT05296824) examined the outcomes of cryoballoon PVI (n = 1,342) vs cryoballoon PVI+PWI (n = 442) in patients with symptomatic PAF during long-term follow-up. Using the nearest-neighbor method, a 1:1 matched sample of patients receiving PVI alone and PVI+PWI was created. RESULTS: The matched cohort consisted of 320 patients (PVI: n = 160; PVI+PWI: n = 160). PVI+PWI was associated with longer cryoablation (23 ± 10 minutes vs 42 ± 11 minutes; P < 0.001) and procedure times (103 ± 24 minutes vs 127 ± 14 minutes; P < 0.001). In 39 (24.4%) of 160 patients, adjunct radiofrequency ablation was required for PVI+PWI. Adverse event rates were similar (PVI 3.8% vs PVI+PWI 1.9%; P = 0.31). Though there were no differences at 12 months, freedom from all atrial arrhythmias (67.5% vs 45.0%; P < 0.001) and AF (75.6% vs 55.0%; P < 0.001) were significantly greater with PVI+PWI vs PVI alone at 39 ± 9 months of follow-up. PVI+PWI was also associated with reduced long-term need for cardioversion (16.9% vs 27.5%; P = 0.02) and repeat catheter ablation (11.9% vs 26.3%; P = 0.001), and emerged as the only significant predictor of freedom from recurrent AF (HR: 2.79; 95% CI: 1.64-4.74; P < 0.001). CONCLUSIONS: Compared with cryoballoon PVI, cryoballoon PVI+PWI appears to be associated with greater freedom from recurrent atrial arrhythmias and AF in patients with PAF during long-term follow-up >3 years.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Pulmonary Veins/surgery , Atrial Fibrillation/surgery , Retrospective Studies , Catheter Ablation/adverse effects , Cryosurgery/adverse effects
11.
Europace ; 25(2): 374-381, 2023 02 16.
Article in English | MEDLINE | ID: mdl-36414239

ABSTRACT

AIMS: Cryoballoon (CB)-based pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). The most frequent complication during CB-based PVI is right-sided phrenic nerve injury (PNI) which is leading to premature abortion of the freeze cycle. Here, we analysed reconnection rates after CB-based PVI and PNI in a large-scale population during repeat procedures. METHODS AND RESULTS: In the YETI registry, a total of 17 356 patients underwent CB-based PVI in 33 centres, and 731 (4.2%) patients experienced PNI. A total of 111/731 (15.2%) patients received a repeat procedure for treatment of recurrent AF. In 94/111 (84.7%) patients data on repeat procedures were available. A total of 89/94 (94.7%) index pulmonary veins (PVs) have been isolated during the initial PVI. During repeat procedures, 22 (24.7%) of initially isolated index PVs showed reconnection. The use of a double stop technique did non influence the PV reconnection rate (P = 0.464). The time to PNI was 140.5 ± 45.1 s in patients with persistent PVI and 133.5 ± 53.8 s in patients with reconnection (P = 0.559). No differences were noted between the two populations in terms of CB temperature at the time of PNI (P = 0.362). The only parameter associated with isolation durability was CB temperature after 30 s of freezing. The PV reconnection did not influence the time to AF recurrence. CONCLUSION: In patients with cryoballon application abortion due to PNI, a high rate of persistent PVI rate was found at repeat procedures. Our data may help to identify the optimal dosing protocol in CB-based PVI procedures. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03645577?term=YETI&cntry=DE&draw=2&rank=1 ClinicalTrials.gov Identifier: NCT03645577.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Fibrillation/etiology , Catheter Ablation/adverse effects , Cryosurgery/adverse effects , Cryosurgery/methods , Phrenic Nerve , Pulmonary Veins/surgery , Recurrence , Time Factors , Treatment Outcome
12.
J Interv Card Electrophysiol ; 66(1): 99-107, 2023 Jan.
Article in English | MEDLINE | ID: mdl-34988846

ABSTRACT

PURPOSE: Due to their internal rotating magnets, conventional impeller-driven percutaneous ventricular assist devices (PVADs) yield high-frequency electrogram artifact and electromagnetic interference (EMI) when used with magnetic-based 3D electroanatomic mapping systems. The new percutaneous heart pump (PHP; Abbott, Chicago, IL) is a 14-French, 5-L/min, impeller axial-flow PVAD with a novel design that utilizes an external motor. METHODS: We evaluated the feasibility of 3D mapping and radiofrequency ablation (RFA) in vivo during PHP mechanical circulatory support (MCS) in simulated ventricular tachycardia (pacing at 300 ms) and ventricular flutter (VFL, pacing at 200 ms) and also during ventricular fibrillation (VF) in a porcine model. Anterograde (right ventricular), transseptal, retrograde, and epicardial right and left ventricular 3D mapping (EnSite/CARTO) and RFA were performed in 6 swine using high-density mapping and force-sensing RFA catheters (TactiCath/ThermoCool). Surface and intracardiac electrograms and 3D maps were analyzed for noise/interference with and without MCS using PHP in sinus rhythm and simulated VT/VFL and VF. RESULTS: Mapping and RFA proved feasible in the presence of MCS using PHP. The mean arterial pressure in sinus rhythm was 55 ± 2 mmHg (baseline) and 84 ± 4 mmHg during MCS with PHP and well-maintained during simulated VT (73 ± 8 mmHg) and VFL (65 ± 2 mmHg) and even in VF (65 ± 5 mmHg). No electrogram noise/artifact, EMI, or 3D map distortions were observed during mapping/RFA with either of two mapping systems. CONCLUSIONS: Endocardial and epicardial 3D mapping and RFA in the presence of PHP are feasible and offer significant MCS during simulated VT/VFL and VF. Furthermore, PHP yielded no electrogram noise/artifact, EMI, or 3D mapping distortions in conjunction with magnetic-based 3D mapping systems.


Subject(s)
Catheter Ablation , Tachycardia, Ventricular , Animals , Swine , Tachycardia, Ventricular/surgery , Ventricular Fibrillation , Arrhythmias, Cardiac/surgery , Heart Ventricles/surgery , Epicardial Mapping , Catheter Ablation/methods
14.
J Cardiovasc Electrophysiol ; 33(6): 1146-1156, 2022 06.
Article in English | MEDLINE | ID: mdl-35322477

ABSTRACT

INTRODUCTION: During radiofrequency ablation (RFA) using conventional RFA catheters (RFC), ~90% of the energy dissipates into the bloodstream/surrounding tissue. We hypothesized that a novel insulated-tip ablation catheter (SMT) capable of blocking the radiofrequency path may focus most of the energy into the targeted tissue while utilizing reduced power and irrigation. METHODS: This study evaluated the outcomes of RFA using SMT versus an RFC in silico, ex vivo, and in vivo. Radiofrequency applications were delivered over porcine myocardium (ex vivo) and porcine thigh muscle preparations superfused with heparinized blood (in vivo). Altogether, 274 radiofrequency applications were delivered using SMT (4-15 W, 2 or 20 ml/min) and 74 applications using RFC (30 W, 30 ml/min). RESULTS: RFA using SMT proved capable of directing 66.8% of the radiofrequency energy into the targeted tissue. Accordingly, low power-low irrigation RFA using SMT (8-12 W, 2 ml/min) yielded lesion sizes comparable with RFC, whereas high power-high irrigation (15 W, 20 ml/min) RFA with SMT yielded lesions larger than RFC (p < .05). Although SMT was associated with greater impedance drops ex vivo and in vivo, ablation using RFC was associated with increased charring/steam pop/tissue cavitation (p < .05). Lastly, lesions created with SMT were more homogeneous than RFC (p < .001). CONCLUSION: Low power-low irrigation (8-12 W, 2 ml/min) RFA using the novel SMT ablation catheter can create more uniform, but comparable-sized lesions as RFC with reduced charring/steam pop/tissue cavitation. High power-high irrigation (15 W, 20 ml/min) RFA with SMT yields lesions larger than RFC.


Subject(s)
Catheter Ablation , Radiofrequency Ablation , Animals , Catheter Ablation/adverse effects , Catheters , Equipment Design , Humans , Steam , Swine , Therapeutic Irrigation/adverse effects
15.
J Innov Card Rhythm Manag ; 13(1): 4863-4868, 2022 Jan.
Article in English | MEDLINE | ID: mdl-35127241

ABSTRACT

Here, we describe the first reported case of pulmonary vein, posterior wall, and left atrial appendage (LAA) isolation with concomitant ablation of a mitral isthmus flutter using the cryoballoon, guided by intracardiac echocardiography (ICE)-integrated 3-dimensional mapping in a patient with long-standing persistent atrial fibrillation and intolerance to long-term oral anticoagulation, followed by ICE-guided LAA closure using an endocardial occlusion device. This report illustrates the safety and feasibility of this combined approach. Additionally, it advocates for empiric LAA isolation prior to LAA occlusion, as LAA ablation/isolation can prove challenging in those with existing endocardial LAA occlusion devices should they require subsequent ablations to target arrhythmias or triggers arising from this structure.

16.
Circ Arrhythm Electrophysiol ; 15(1): e010516, 2022 01.
Article in English | MEDLINE | ID: mdl-34962134

ABSTRACT

BACKGROUND: Cryoballoon-based pulmonary vein isolation (PVI) has emerged as an effective treatment for atrial fibrillation. The most frequent complication during cryoballoon-based PVI is phrenic nerve injury (PNI). However, data on PNI are scarce. METHODS: The YETI registry is a retrospective, multicenter, and multinational registry evaluating the incidence, characteristics, prognostic factors for PNI recovery and follow-up data of patients with PNI during cryoballoon-based PVI. Experienced electrophysiological centers were invited to participate. All patients with PNI during CB2 or third (CB3) and fourth-generation cryoballoon (CB4)-based PVI were eligible. RESULTS: A total of 17 356 patients underwent cryoballoon-based PVI in 33 centers from 10 countries. A total of 731 (4.2%) patients experienced PNI. The mean time to PNI was 127.7±50.4 seconds, and the mean temperature at the time of PNI was -49±8°C. At the end of the procedure, PNI recovered in 394/731 patients (53.9%). Recovery of PNI at 12 months of follow-up was found in 97.0% of patients (682/703, with 28 patients lost to follow-up). A total of 16/703 (2.3%) reported symptomatic PNI. Only 0.06% of the overall population showed symptomatic and permanent PNI. Prognostic factors improving PNI recovery are immediate stop at PNI by double-stop technique and utilization of a bonus-freeze protocol. Age, cryoballoon temperature at PNI, and compound motor action potential amplitude loss >30% were identified as factors decreasing PNI recovery. Based on these parameters, a score was calculated. The YETI score has a numerical value that will directly represent the probability of a specific patient of recovering from PNI within 12 months. CONCLUSIONS: The incidence of PNI during cryoballoon-based PVI was 4.2%. Overall 97% of PNI recovered within 12 months. Symptomatic and permanent PNI is exceedingly rare in patients after cryoballoon-based PVI. The YETI score estimates the prognosis after iatrogenic cryoballoon-derived PNI. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03645577. Graphic Abstract: A graphic abstract is available for this article.


Subject(s)
Atrial Fibrillation/surgery , Cryosurgery/adverse effects , Iatrogenic Disease , Peripheral Nerve Injuries/epidemiology , Phrenic Nerve/injuries , Pulmonary Veins/surgery , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Female , Humans , Incidence , Male , Middle Aged , Peripheral Nerve Injuries/diagnosis , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
17.
J Innov Card Rhythm Manag ; 12(8): 4633-4646, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34476116

ABSTRACT

There is strong evidence in support of pulmonary vein isolation (PVI) with concomitant left atrial (LA) posterior wall (PW) isolation (PWI) for the treatment of patients with persistent atrial fibrillation (persAF). While this may be achieved using surgical and catheter-based strategies, there is growing interest in performing this approach using the cryoballoon. There are several potential advantages to this strategy. First, lesions created using the current-generation cryoballoons are typically large and durable. Second, cryoballoon ablation offers a simple technique to directly ablate and debulk the LAPW. Moreover, some consider cryoenergy a safer modality specifically with regard to collateral structures (ie, the esophagus). Based on the available data, cryoballoon PVI + PWI is associated with greater intraprocedural AF terminations and reductions in long-term AF recurrence (typically by ~20%), as compared to PVI alone in patients with persAF, but with similar rates of adverse events. As such, PVI + PWI has emerged as a significant predictor of freedom from recurrent AF (odds ratio: 3.67, 95% confidence interval: 1.44-9.34; p = 0.006) as well as all atrial arrhythmias (hazard ratio: 2.04, 95% confidence interval: 1.15-3.61; p = 0.015). Adjunct radiofrequency ablation to complete PWI is required in at least one-third of the patients, and this need is highly predicted by the LA size (significantly increased with an LA diameter > 48 mm). LAPW reconnection also seems to be associated with LA dimension, particularly an LA diameter greater than 48 mm (negative predictive value: 89.7%). Nevertheless, based on the analysis of patients who underwent repeat electrophysiology study for arrhythmia recurrences, cryoballoon PVI + PWI yields acceptable long-term durability (> 80%).

20.
Heart Rhythm ; 18(8): 1435-1444, 2021 08.
Article in English | MEDLINE | ID: mdl-33905811

ABSTRACT

Although cryoballoon ablation of atrial fibrillation (AF) traditionally has been guided by pulmonary vein (PV) occlusion, there is evidence and growing interest in performing segmental, nonocclusive cryoballoon ablation to target not only large/common PVs but extra-PV structures such as the left atrial (LA) roof and posterior wall in conjunction with PV isolation. A number of studies have demonstrated improved clinical efficacy associated with nonocclusive cryoballoon ablation of the LA roof and posterior wall in addition to PV isolation, particularly in patients with persistent AF. Not only can the cryoballoon be used for targeting extra-PV structures through segmental, nonocclusive ablation, but the large size and durability of cryolesions coupled with the enhanced stability afforded through cryoadhesion render the cryoballoon an effective tool for such an approach. This article reviews the rationale and practical approach to segmental, nonocclusive cryoballoon ablation of large/common PV antra and the LA roof and posterior wall.


Subject(s)
Atrial Fibrillation/surgery , Cryosurgery/methods , Pulmonary Veins/surgery , Atrial Fibrillation/physiopathology , Humans , Recurrence , Treatment Outcome
SELECTION OF CITATIONS
SEARCH DETAIL