ABSTRACT
INTRODUCTION: Three randomised controlled trials (RCTs) have demonstrated that first-line cryoballoon pulmonary vein isolation decreases atrial tachycardia in patients with symptomatic paroxysmal atrial fibrillation (PAF) compared with antiarrhythmic drugs (AADs). The aim of this study was to develop a cost-effectiveness model (CEM) for first-line cryoablation compared with first-line AADs for the treatment of PAF. The model used a Danish healthcare perspective. METHODS: Individual patient-level data from the Cryo-FIRST, STOP AF and EARLY-AF RCTs were used to parameterise the CEM. The model structure consisted of a hybrid decision tree (one-year time horizon) and a Markov model (40-year time horizon, with a three-month cycle length). Health-related quality of life was expressed in quality-adjusted life years (QALYs). Costs and benefits were discounted at 3% per year. Model outcomes were produced using probabilistic sensitivity analysis. RESULTS: First-line cryoablation is dominant, meaning it results in lower costs (-2,663) and more QALYs (0.18) when compared to first-line AADs. First-line cryoablation also has a 99.96% probability of being cost-effective, at a cost-effectiveness threshold of 23,200 per QALY gained. Regardless of initial treatment, patients were expected to receive â¼ 1.2 ablation procedures over a lifetime horizon. CONCLUSION: First-line cryoablation is both more effective and less costly (i.e. dominant), when compared with AADs for patients with symptomatic PAF in a Danish healthcare system.
Subject(s)
Anti-Arrhythmia Agents , Atrial Fibrillation , Cost-Benefit Analysis , Cryosurgery , Drug Costs , Markov Chains , Models, Economic , Quality of Life , Quality-Adjusted Life Years , Randomized Controlled Trials as Topic , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Atrial Fibrillation/economics , Atrial Fibrillation/therapy , Atrial Fibrillation/drug therapy , Atrial Fibrillation/physiopathology , Humans , Cryosurgery/economics , Cryosurgery/adverse effects , Denmark , Anti-Arrhythmia Agents/therapeutic use , Anti-Arrhythmia Agents/economics , Treatment Outcome , Time Factors , Male , Female , Middle Aged , Decision Support Techniques , Aged , Pulmonary Veins/surgery , Pulmonary Veins/physiopathology , Cost Savings , Decision TreesABSTRACT
AIMS: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. METHODS AND RESULTS: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. CONCLUSION: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.
Subject(s)
Atrial Fibrillation , Catheter Ablation , Esophageal Fistula , Humans , Atrial Fibrillation/epidemiology , Atrial Fibrillation/surgery , Atrial Fibrillation/diagnosis , Treatment Outcome , Incidence , Risk Factors , Esophageal Fistula/epidemiology , Esophageal Fistula/etiology , Esophageal Fistula/diagnosis , Prognosis , Catheter Ablation/adverse effects , Catheter Ablation/methodsABSTRACT
INTRODUCTION: Cryoballoon ablation (CBA) aiming at pulmonary vein isolation (PVI) became a standardized atrial fibrillation (AF) ablation procedure. Life-threatening complications like cardiac tamponade exist. Intracardiac echocardiography (ICE) usage is associated with superior safety in radiofrequency ablation. It is unclear if ICE has an impact on safety of CBA. METHODS: The FREEZE Cohort (NCT01360008) subanalysis included patients undergoing "PVI only" CBA. Patients with intraprocedural transesophageal echocardiography were excluded. Group A comprises conventional, group B ICE-guided CBA. Periprocedural results were compared. RESULTS: From 2011 to 2016, a total of 4189 patients were enrolled, and 1906 (45.5%) were included in this subanalysis, split up in two groups (A: 1066 [55.9%], B: 840 [44.1%]). Group A was younger (60.6 ± 10.8 vs. 62.4 ± 10.5 years, p < .001), with smaller left atria (41 vs. 43 mm, p < .001), and less persistent AF (23.1 vs. 38.1%, p < .001). Procedure, left atrial, and fluoroscopy times were shorter in group A as compared to group B. Dose area product was significantly higher in group A (2911 vs. 2072 cGyxcm2 , p < .001). In-hospital major adverse cerebrovascular and cardiac event rates including two deaths in group A were not different between groups (0.5% vs. 0.1%, p = .18). The rate of total procedural (10.4% vs. 5.1%, p < .001) and major complications (3.2% vs. 1.3%, p < .001) was significantly higher in group A. Cardiac tamponade occurred significantly more frequently in group A (8 [0.8%] vs. 1 [0.1%], p = .046). Independent predictors for major complications were female sex (odds ratio [OR] 2.03, p = .03) and non-ICE usage (OR 2.38, p = .02). No differences were observed for persistent phrenic nerve palsy, nor for groin complications. CONCLUSION: CBA was significantly safer and required less radiation if ICE was used, although the procedures were more complex. The risk of groin complications was not increased with ICE usage. Non-ICE usage was the only modifiable independent predictor of major complications.
Subject(s)
Atrial Fibrillation , Cardiac Tamponade , Catheter Ablation , Cryosurgery , Pulmonary Veins , Female , Humans , Male , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/surgery , Atrial Fibrillation/etiology , Cardiac Tamponade/etiology , Catheter Ablation/adverse effects , Catheter Ablation/methods , Cohort Studies , Cryosurgery/adverse effects , Cryosurgery/methods , Echocardiography , Pulmonary Veins/diagnostic imaging , Pulmonary Veins/surgery , Recurrence , Treatment Outcome , Prospective StudiesABSTRACT
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 OutcomeABSTRACT
BACKGROUND: Pulmonary vein isolation (PVI) is recommended to treat paroxysmal and persistent atrial fibrillation (AF). This analysis aimed to assess the hospital efficiency of single-shot cryoballoon ablation (CBA) and point-by-point radiofrequency ablation (RFA). METHODS: The discrete event simulation used PVI procedure times from the FREEZE Cohort study to establish the electrophysiology (EP) lab occupancy time. 1000 EP lab days were simulated according to an illustrative German hospital, including 3 PVI cases per day using CBA at one site and RFA at the other. RESULTS: The analysis included 1560 CBA patients and 1344 RFA patients from the FREEZE Cohort. Some baseline patients' characteristics were different between groups (age, AF type, and some concomitant diseases), without being statistically associated to ablation procedure time. Mean procedure time was 122.2 ± 39.4 min for CBA and 160.3 ± 53.5 min for RFA (p < 0.0001). RFA was associated with a more than five-fold increase of cumulative overtime compared to CBA over the simulated period (1285 h with RFA and 253 h with CBA). 70.7% of RFA lab days included overtime versus 25.7% for CBA. CBA was associated with more days with an additional hour at the end of the EP lab shift compared to RFA (47.8% vs 11.5% days with one hour left, respectively). CONCLUSION: CBA is faster and more predictable than point-by-point RFA, and enables improvements in EP lab efficiency, including: fewer cumulative overtime hours, more days where overtime is avoided and more days with remaining time for the staff or for any EP lab usage. Clinical trial registration NCT01360008 (first registration 25/05/2011).
Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Humans , Cohort Studies , Cryosurgery/adverse effects , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Catheter Ablation/methods , Pulmonary Veins/surgery , Electrophysiology , Treatment Outcome , RecurrenceABSTRACT
Atrial fibrillation (AF) is a commonly encountered chronic and progressive heart rhythm disorder, characterized by exacerbations and remissions. Contemporary clinical practice guidelines recommend a trial of antiarrhythmic drugs (AADs) as the initial therapy for sinus rhythm maintenance; however, these medications have modest efficacy and are associated with significant adverse effects. Recently, several trials have demonstrated that an initial treatment strategy of cryoballoon catheter ablation significantly improves arrhythmia outcomes (e.g. freedom atrial tachyarrhythmia and reduction in arrhythmia burden), produces clinically meaningful improvements in patient-reported outcomes (e.g. symptoms and quality of life), and significantly reduces subsequent healthcare resource utilization (e.g. hospitalization), without increasing the risk of serious or any adverse events. These findings are relevant to patients, providers, and healthcare systems, helping inform the decision regarding the initial choice of rhythm-control therapy in patients with treatment-naïve AF.
Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Anti-Arrhythmia Agents/adverse effects , Atrial Fibrillation/diagnosis , Atrial Fibrillation/drug therapy , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Cryosurgery/adverse effects , Humans , Quality of Life , Treatment OutcomeABSTRACT
BACKGROUND: Cryoballoon ablation (CBA) as a first-line rhythm control strategy is superior to antiarrhythmic drugs (AADs) for preventing atrial fibrillation (AF) recurrence; the impact of first-line CBA on quality of life (QoL) and symptoms has not been well characterized. METHODS: Patients aged 18 to 75 with symptomatic paroxysmal AF naïve to rhythm control therapy were randomized (1:1) to CBA (Arctic Front Advance, Medtronic) or AAD (Class I or III). Symptoms and QoL were assessed at baseline, 1, 3, 6, 9, and 12 months using the EHRA classification and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and SF-36v2 questionnaires. Symptomatic palpitations were evaluated via patient diary. RESULTS: Overall, 107 patients were randomized to CBA and 111 to AAD; crossovers occurred in 9%. Larger improvements in the AFEQT summary, subscale and treatment satisfaction scores were observed at 12 months with CBA vs AAD (all P <0.05). At 12 months, the mean adjusted difference in the AFEQT summary score was 9.9 points higher in the CBA group (95% CI: 5.5 -14.2, P <0.001). Clinically important improvements in the SF-36 physical and mental component scores were observed at 12 months in both groups, with no significant between group differences at this timepoint. In the CBA vs AAD group, larger improvements in EHRA class were observed at 6, 9 and 12 months (P <0.05) and the incidence rate of symptomatic palpitations was lower (4.6 vs 15.2 days/year post-blanking; IRR: 0.30, P <0.001). CONCLUSIONS: In patients with symptomatic AF, first-line CBA was superior to AAD for improving AF-specific QoL and symptoms. TRIAL REGISTRATION: ClinicalTrials.gov number: NCT01803438.
Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Adolescent , Adult , Aged , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/drug therapy , Atrial Fibrillation/surgery , Humans , Middle Aged , Quality of Life , Treatment Outcome , Young AdultABSTRACT
AIMS: Treatment guidelines for patients with atrial fibrillation (AF) suggest that patients should be managed with an antiarrhythmic drug (AAD) before undergoing catheter ablation (CA). This study evaluated whether pulmonary vein isolation employing cryoballoon CA is superior to AAD therapy for the prevention of atrial arrhythmia (AA) recurrence in rhythm control naive patients with paroxysmal AF (PAF). METHODS AND RESULTS: A total of 218 treatment naive patients with symptomatic PAF were randomized (1 : 1) to cryoballoon CA (Arctic Front Advance, Medtronic) or AAD (Class I or III) and followed for 12 months. The primary endpoint was ≥1 episode of recurrent AA (AF, atrial flutter, or atrial tachycardia) >30 s after a prespecified 90-day blanking period. Secondary endpoints included the rate of serious adverse events (SAEs) and recurrence of symptomatic palpitations (evaluated via patient diaries). Freedom from AA was achieved in 82.2% of subjects in the cryoballoon arm and 67.6% of subjects in the AAD arm (HR = 0.48, P = 0.01). There were no group differences in the time-to-first (HR = 0.76, P = 0.28) or overall incidence [incidence rate ratio (IRR)=0.79, P = 0.28] of SAEs. The incidence rate of symptomatic palpitations was lower in the cryoballoon (7.61 days/year) compared with the AAD arm (18.96 days/year; IRR = 0.40, P < 0.001). CONCLUSIONS: Cryoballoon CA was superior to AAD therapy, significantly reducing AA recurrence in treatment naive patients with PAF. Additionally, cryoballoon CA was associated with lower symptom recurrence and a similar rate of SAEs compared with AAD therapy.
Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Anti-Arrhythmia Agents/adverse effects , Atrial Fibrillation/diagnosis , Atrial Fibrillation/drug therapy , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Cryosurgery/adverse effects , Humans , Pulmonary Veins/surgery , Recurrence , Treatment OutcomeABSTRACT
BACKGROUND: Radiofrequency current (RFC) catheter ablation for patients with paroxysmal atrial fibrillation (AF) has been shown to be safe and effective in first-line therapy. Recent data demonstrates that RFC ablation provides better clinical outcomes compared to antiarrhythmic drug (AAD) in the treatment of early AF disease. Furthermore, studies comparing RFC and cryoballoon have established comparable efficacy and safety of pulmonary vein isolation (PVI) for patients with symptomatic paroxysmal AF. OBJECTIVES: The Cryo-FIRST trial was designed to compare AAD treatment against cryoballoon PVI as a first-line therapy in treatment naïve patients with AF. Efficacy and safety will be compared between the two cohorts and amongst subgroups. METHODS: The primary hypothesis is that cryoablation is superior to AAD therapy. To test this hypothesis, patients will be randomized in a 1:1 design. Using a 90-day blanking period, primary efficacy endpoint failure is defined as (at least) one episode of atrial arrhythmia with a duration >30 sec (documented by 7-day Holter or 12-lead ECG). Secondary endpoints (Quality-of-Life, rehospitalization, arrhythmia recurrence rate, healthcare utilization, and left atrial function) and adverse events will also be evaluated. Study enrollment will include 218 patients in up to 16 centers. CONCLUSIONS: This study will be a multi-national randomized controlled trial comparing cryoablation against AAD as a first-line treatment in patients with paroxysmal AF. The results may help guide the selection of patients for early AF disease therapy via cryoballoon ablation.
Subject(s)
Ablation Techniques/methods , Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/therapy , Cryosurgery/methods , Electrocardiography , Heart Conduction System/physiopathology , Atrial Fibrillation/physiopathology , Atrial Function, Right/physiology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Pulmonary Veins/surgery , Quality of Life , Recurrence , Single-Blind Method , Treatment OutcomeABSTRACT
INTRODUCTION: Stroke is one of the most feared complications during catheter ablation of atrial fibrillation (AF). While symptomatic thromboembolic events are rare, magnetic resonance imaging (MRI) may identify asymptomatic (ie, silent) cerebral lesions (SCLs) following pulmonary vein isolation (PVI) procedures. METHODS AND RESULTS: The REDUCE-TE Pilot was a prospective multicenter, single-arm observational study investigating the incidence of SCL in patients with symptomatic paroxysmal AF undergoing PVI with a novel gold-tip, externally irrigated ablation catheter. After ablation, cerebral diffusion-weighted MRI and a postablation follow-up were performed at 1 to 3 days after the ablation procedure. A neurocognitive test was done before and after ablation. The primary study endpoint was the occurrence of one or more new SCLs. Secondary study endpoints included neurocognitive status, procedural success rate, and periprocedural complications including symptomatic thromboembolic events. A total of 104 patients were enrolled (69% male, mean age: 61.5 ± 9.7 years, mean CHA2 DS 2 -VASc score: 1.7 ± 1.2). Postprocedural MRI examination was performed in 97 patients, and in nine of them (9.3%; 95% CI: 4.3-16.9%) a total of 11 SCLs were detected. Univariate analyses did not reveal any significant predictor for new SCLs. Nonsignificant trends were observed for low activated clotting time during ablation and for international normalized ratio value outside the range of 2 to 3 at ablation. There was no evidence of significant deterioration of neurocognitive function after PVI. In four patients, a pericardial tamponade was noted but all patients fully recovered during follow-up. CONCLUSIONS: Ablation of AF using a novel gold-tip, externally irrigated ablation catheter, resulted in SCLs in approximately one out of 10 patients without a measurable effect on neurocognitive function.
Subject(s)
Atrial Fibrillation/surgery , Cardiac Catheters , Catheter Ablation/adverse effects , Catheter Ablation/instrumentation , Cognition , Gold , Intracranial Embolism/epidemiology , Postoperative Cognitive Complications/epidemiology , Pulmonary Veins/surgery , Therapeutic Irrigation/adverse effects , Therapeutic Irrigation/instrumentation , Action Potentials , Aged , Asymptomatic Diseases , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Diffusion Magnetic Resonance Imaging , Equipment Design , Female , Germany/epidemiology , Heart Rate , Humans , Incidence , Intracranial Embolism/diagnostic imaging , Male , Mental Status and Dementia Tests , Middle Aged , Pilot Projects , Postoperative Cognitive Complications/diagnosis , Postoperative Cognitive Complications/psychology , Pulmonary Veins/physiopathology , Time Factors , Treatment OutcomeABSTRACT
AIMS: To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF). METHODS AND RESULTS: Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was 'atrial arrhythmia recurrence', secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P < 0.001). Follow-up duration was 441 (CBA) and 511 days (RFA) (P < 0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70-1.04; P = 0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64-0.99; P = 0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26-1.10; P = 0.088). Re-ablations (adjHR 0.46, 95% CI 0.34-0.61; P < 0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48-0.88; P = 0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations. CONCLUSIONS: The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.
Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation/methods , Cryosurgery/methods , Aged , Atrial Fibrillation/physiopathology , Cohort Studies , Female , Humans , Male , Middle Aged , Operative Time , Patient Readmission , Postoperative Complications/epidemiology , Proportional Hazards Models , Prospective Studies , Radiation Dosage , Recurrence , Reoperation , Treatment OutcomeABSTRACT
INTRODUCTION: We analyzed the procedural experience and clinical outcome after pulmonary vein isolation (PVI) in patients with persistent atrial fibrillation (AF) gained over 5 years using the second-generation cryoballoon (CB-Adv). METHODS AND RESULTS: For this retrospective study, we enrolled 281 patients undergoing PVI at our institution between 2012 and 2016. The analyzed period was divided into 5 calendar years. Follow-up data, including Holter electrocardiography recordings, were collected during outpatient clinic visits. The impact of several variables on outcome was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models. The median procedure and fluoroscopy times over the years were 90 (72 of 114) and 15 (11 of 21) minutes, respectively. A continuous decline in complication rates and fluoroscopy and procedure times was observed in each subsequent year. During mid-term follow-up (33 [25 of 48] months), 178 (63.3%) patients were AF, atrial flutter, or atrial tachycardia free. Multivariate analysis revealed left atrial area (hazard ratio [HR] = 1.05; P < 0.001), female sex (HR = 2.53; P < 0.001), and common ostium (HR = 1.93; P < 0.001) as significant predictors of outcome. The overall 1-year success rate was 76.2%. A gradual decrease in the 1-year success rate (from 90.5% in 2012 to 67.9% in 2016) was mainly related to a steady increase of left atrial area in the entire cohort with successive years of the study. CONCLUSIONS: PVI using CB-Adv in patients with persistent AF is accompanied by a learning curve and facilitates a satisfactory outcome, followed by the proper selection of patients.
Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation/methods , Cryosurgery/methods , Pulmonary Veins/surgery , Aged , Atrial Fibrillation/diagnostic imaging , Catheter Ablation/trends , Cryosurgery/trends , Female , Follow-Up Studies , Humans , Male , Middle Aged , Pulmonary Veins/diagnostic imaging , Retrospective Studies , Time Factors , Treatment OutcomeABSTRACT
INTRODUCTION: Data on long-term outcomes of cryoballoon (CB) ablation for treatment of persistent atrial fibrillation (AF) are sparse. Here, we report the first 3-year follow-up results and predictors of success for catheter ablation using the second-generation CB in patients with persistent AF. METHODS AND RESULTS: For this prospective observational study, we enrolled 101 patients ablated with the second-generation CB at our institution. The endpoint was the first documented recurrence (> 30 seconds) of AF, atrial flutter, or atrial tachycardia after a 3-month blanking period. Follow-up data were collected during outpatient clinic visits and included Holter-ECG recordings. The impact of several variables on recurrence was evaluated by means of univariate and multivariate analyses and Cox proportional hazards regression models. After a median follow-up of 37 (31 of 42) months, recurrence was documented in 30 patients (29.7%). The median procedure and fluoroscopy times were 120 (102 of 147) and 20 (16 of 27) minutes, respectively. Phrenic nerve palsy occurred in 2.0% of the patients. Among the 30 patients who experienced recurrence, 16 underwent repeat ablation in radiofrequency technique. Cox regression analysis showed that left atrial area > 21 cm2 and AF history duration > 2 years independently predicted recurrence. CONCLUSIONS: Sinus rhythm was maintained in a substantial proportion of patients even 3 years after CB ablation. Patients with a nonenlarged left atrium and short AF history had the best outcome.
Subject(s)
Atrial Fibrillation/surgery , Cryosurgery , Action Potentials , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Atrial Flutter/etiology , Atrial Flutter/physiopathology , Cryosurgery/adverse effects , Female , Heart Rate , Humans , Male , Middle Aged , Prospective Studies , Recurrence , Risk Factors , Tachycardia, Supraventricular/etiology , Tachycardia, Supraventricular/physiopathology , Time Factors , Treatment OutcomeABSTRACT
INTRODUCTION: We aimed to compare arrhythmia recurrence rates after second-generation cryoballoon (CB-Adv) ablation and radiofrequency (RF) ablation in patients with symptomatic persistent atrial fibrillation (AF) and left atrial (LA) enlargement. METHODS AND RESULTS: Persistent AF patients with LA enlargement were compared using a propensity-score-matching algorithm, and 111 patients treated with CB-Adv ablation and 111 patients treated with RF ablation were selected. The primary endpoint was the first documented >30-second arrhythmia recurrence after a 3-month blanking period. Median LA area was comparable between the RF and CB-Adv groups (24.2 vs. 24.0 cm2 , P = 0.49). In addition to pulmonary vein isolation, roof lines (RLs) with bidirectional conduction block were created in 48 patients in the CB-Adv group and 49 patients in the RF group. Midterm outcome after single procedure is characterized by arrhythmia recurrences in 47 patients in the RF group and 32 patients in the CB-Adv group (P = 0.20). There were no differences in the number of AF recurrences in the two groups (38 vs. 32, P = 0.66), but there were more instances of LA tachycardia (LAT) in the RF group than in the CB-Adv group (11 vs. 0, P < 0.01). LAT recurrence in RF patients was associated with RL creation (9 with vs. 2 without, P < 0.01). Among patients in whom a RL was created, arrhythmia-free survival was lower in the RF group than in the CB-Adv group (44.9% vs. 79.2%, P < 0.01). CONCLUSIONS: Arrhythmia recurrence rates in the two groups during midterm follow-up were comparable. RL creation during CB-Adv ablation resulted in acceptable outcomes.
Subject(s)
Atrial Fibrillation/surgery , Atrial Function, Left , Atrial Remodeling , Cardiomegaly/physiopathology , Catheter Ablation , Cryosurgery , Action Potentials , Aged , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Cardiomegaly/complications , Cardiomegaly/diagnosis , Catheter Ablation/adverse effects , Cryosurgery/adverse effects , Female , Heart Rate , Humans , Male , Middle Aged , Progression-Free Survival , Recurrence , Risk Assessment , Risk Factors , Time FactorsABSTRACT
Sequence variants in the ion channel genes KCNH2 and SCN5A may cause the cardiac disorder long QT syndrome (LQTS). This disorder is associated with incomplete penetrance and variable expression in KCNH2- or SCN5A-mutation carriers. Common genetic variants, if associated with a mutation, may affect the severity of this cardiac disorder. This study identified rare mutations in the cardiac ion channel genes KCNH2 and SCN5A in a SCD case, as well as in a LQTS-affected family with a history of SCD. Moreover, common variants were found to occur together within the same genes. These findings support the concept that common single-nucleotide polymorphisms (SNPs) in genes encoding cardiac ion channels can directly modulate the functional effect of mutations and therefore enhance or weaken the risk of cardiac events.
Subject(s)
Death, Sudden, Cardiac/etiology , ERG1 Potassium Channel/genetics , NAV1.5 Voltage-Gated Sodium Channel/genetics , Adolescent , Adult , Amino Acid Substitution , Exons , Female , Gene Frequency , Heterozygote , Humans , Long QT Syndrome/genetics , Mutation , Pedigree , Polymorphism, GeneticABSTRACT
Aims: Predictors of atrial arrhythmia recurrence have not been described in a long-term follow-up study of patients undergoing pulmonary vein isolation (PVI) using the cryoballoon technique. We aimed to evaluate the efficacy of a second-generation cryoballoon and identify pre-procedural predictors of 3-year outcome after PVI. Methods and results: For this observational cohort study, we enrolled 440 patients ablated at our institution with a second-generation cryoballoon. The endpoint was the first documented recurrence (>30 s) of atrial fibrillation (AF), atrial flutter, or atrial tachycardia after a 3-month blanking period. The impact of several pre-existing variables on clinical outcome was evaluated by univariate and multivariate analyses using the Cox proportional hazards regression model. The PLAAF (persistent AF, left atrial area, abnormal PV anatomy, AF history, female gender) score was defined to predict outcome. After a median follow-up of 36 months (interquartile range 25/75-27/42), the endpoint was achieved in 95 of 440 (21.6%) patients. Cox regression analysis showed that persistent AF, left atrial (LA) area, abnormal PV anatomy, AF history, and female gender independently predicted recurrence. The calculated optimal cut-offs for LA area and AF history were 21 cm2 and 3 years, respectively. Patients with a PLAAF score of 0 showed the best outcome, with an arrhythmia-free survival of 86.7%. Conclusion: PVI using the cryoballoon technique shows acceptable long-term results depending on predictors described by the new PLAAF score, which may facilitate patient selection for PVI.
Subject(s)
Atrial Fibrillation/surgery , Cryosurgery , Decision Support Techniques , Pulmonary Veins/surgery , Action Potentials , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Atrial Flutter/etiology , Cardiac Catheters , Cryosurgery/adverse effects , Cryosurgery/instrumentation , Equipment Design , Female , Heart Rate , Humans , Male , Middle Aged , Predictive Value of Tests , Progression-Free Survival , Pulmonary Veins/physiopathology , Recurrence , Reproducibility of Results , Risk Assessment , Risk Factors , Sex Factors , Tachycardia, Supraventricular/etiology , Time FactorsABSTRACT
BACKGROUND: The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) showed that early intervention with cardiac-resynchronization therapy with a defibrillator (CRT-D) in patients with an electrocardiographic pattern showing left bundle-branch block was associated with a significant reduction in heart-failure events over a median follow-up of 2.4 years, as compared with defibrillator therapy alone. METHODS: We evaluated the effect of CRT-D on long-term survival in the MADIT-CRT population. Post-trial follow-up over a median period of 5.6 years was assessed among all 1691 surviving patients (phase 1) and subsequently among 854 patients who were enrolled in post-trial registries (phase 2). All reported analyses were performed on an intention-to-treat basis. RESULTS: At 7 years of follow-up after initial enrollment, the cumulative rate of death from any cause among patients with left bundle-branch block was 18% among patients randomly assigned to CRT-D, as compared with 29% among those randomly assigned to defibrillator therapy alone (adjusted hazard ratio in the CRT-D group, 0.59; 95% confidence interval [CI], 0.43 to 0.80; P<0.001). The long-term survival benefit of CRT-D in patients with left bundle-branch block did not differ significantly according to sex, cause of cardiomyopathy, or QRS duration. In contrast, CRT-D was not associated with any clinical benefit and possibly with harm in patients without left bundle-branch block (adjusted hazard ratio for death from any cause, 1.57; 95% CI, 1.03 to 2.39; P=0.04; P<0.001 for interaction of treatment with QRS morphologic findings). CONCLUSIONS: Our findings indicate that in patients with mild heart-failure symptoms, left ventricular dysfunction, and left bundle-branch block, early intervention with CRT-D was associated with a significant long-term survival benefit. (Funded by Boston Scientific; ClinicalTrials.gov numbers, NCT00180271, NCT01294449, and NCT02060110.).
Subject(s)
Bundle-Branch Block/therapy , Cardiac Resynchronization Therapy , Heart Failure/therapy , Aged , Bundle-Branch Block/complications , Combined Modality Therapy , Defibrillators, Implantable , Female , Follow-Up Studies , Heart Failure/complications , Heart Failure/mortality , Heart Failure/prevention & control , Humans , Intention to Treat Analysis , Kaplan-Meier Estimate , Male , Middle Aged , Proportional Hazards Models , Severity of Illness Index , Stroke Volume , Ventricular Dysfunction, Left/complicationsABSTRACT
INTRODUCTION: This observational study was designed to analyze the safety and feasibility of percutaneous skin closure using a purse-string suture and compare it with the use of a compression bandage after pulmonary vein isolation. METHODS AND RESULTS: A total of 407 patients undergoing pulmonary vein isolation (217 with radiofrequency and 190 with cryoballoon ablation) were treated with either purse-string sutures or compression bandages. The purse-string suture was applied after ablation before withdrawal of the sheaths. Patients were on bed rest for 6 hours prior to suture removal, which was accomplished 18-24 h after ablation. The compression bandage was applied after sheath withdrawal and was removed after 12 hours of bed rest. We analyzed the occurrence of any vascular or thromboembolic complication as well as hospital costs and hospital stay length after ablation. The incidence of vascular complications after compression bandage was higher than after purse-string suture in the cryoballoon and radiofrequency group (P < 0.05, respectively). The hospital costs were lower and hospital stay was shorter in both radiofrequency (4.921 ± 3.145 vs. 5.802 ± 4.006 Euro; 2.34 ± 1.32 vs. 2.98 ± 1.57 days, P < 0.05) and cryoballoon groups (4.705 ± 3.091 vs. 5.661 ± 3.563 Euro; 2.14 ± 1.37 vs. 2.61 ± 1.55 days, P < 0.05) in patients treated with a purse-string suture. CONCLUSIONS: Percutaneous skin closure with a purse-string suture has the clinical impact to reduce vascular complications, hospital costs, and hospital stay length after pulmonary vein isolation.
Subject(s)
Catheter Ablation/methods , Cryosurgery , Postoperative Complications/prevention & control , Pulmonary Veins/surgery , Suture Techniques/instrumentation , Sutures , Vascular Diseases/prevention & control , Feasibility Studies , Female , Follow-Up Studies , Germany/epidemiology , Humans , Incidence , Male , Middle Aged , Postoperative Care/methods , Postoperative Complications/epidemiology , Time Factors , Vascular Diseases/epidemiologyABSTRACT
AIMS: There is no objective, early indicator of occlusion quality, and efficacy of cryoballoon pulmonary vein isolation. As previous experience suggests that the initial cooling rate correlates with these parameters, we investigated the slope of the initial temperature drop as an objective measure. METHODS AND RESULTS: A systematic evaluation of 523 cryoapplications in 105 patients using a serial ROC-AUC analysis was performed. We found the slope of a linear regression of the temperature-time function to be a good predictor (PPV 0.9, specificity 0.72, sensitivity 0.71, and ROC-AUC 0.75) of acute isolation. It also correlated with nadir temperatures (P< 0.001, adjusted R2= 0.43), predicted very low nadir temperatures, and varied according to visual occlusion grades (ANOVA P< 0.001). CONCLUSIONS: About 25 s after freeze initiation, the temperature-time slope predicts important key characteristics of a cryoablation, such as nadir temperature. The slope is the only reported predictor to actually precede acute isolation and thus to support decisions about pull-down manoeuvres or aborting a cryoablation early on. It is also predictive of very low nadir temperatures and phrenic nerve palsy and thus may add to patient safety.