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2.
BMC Cardiovasc Disord ; 23(1): 8, 2023 01 09.
Article in English | MEDLINE | ID: mdl-36624380

ABSTRACT

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 , Recurrence
3.
J Cardiovasc Electrophysiol ; 33(7): 1383-1390, 2022 07.
Article in English | MEDLINE | ID: mdl-35502754

ABSTRACT

AIMS: Cryoballoon-guided pulmonary vein isolation (CB-PVI) for symptomatic atrial fibrillation (AF) has become an established treatment option with encouraging results in terms of safety and efficacy. Data reporting on long-term data beyond a follow-up (FU) period of 5 years is scarce. This prospective study aimed to evaluate very long-term outcome after CB-PVI for AF. METHODS: Data from consecutive patients treated with CB-PVI for symptomatic and drug refractory AF between 2005 and 2012 were analyzed. Patients with a FU of ≥9 years after index CB-PVI were included. All patients were continuously followed-up in our outpatient clinic. Arrhythmia recurrence was defined as AF or atrial tachycardia (AT) lasting >30 s beyond a 3-month blanking period. RESULTS: A total of 385 patients (71% male) were included. Mean age was 58 ± 10 years and paroxysmal AF was present in 93% of patients. Mean FU duration was 124 ± 24 months. At the end of the observational period, 73% of all patients were in stable sinus rhythm after a mean of 2 ± 0.8 ablation procedures. Patients with AF/AT recurrence were older (60 ± 8 vs. 57 ± 10 years; p = .019), had a higher CHA2 DS2 -Vasc Score (2.47 ± 1.46 vs. 1.98 ± 1.50; p = .01) and presented with a larger left atrium (LA)-diameter (43 ± 5.6 vs. 40 ± 5.1 mm; p = .002). The LA-diameter was also a significant predictor for AF/AT recurrence after CB-PVI (odds ratio: 0.939, 95% confidence interval: [0.886, 0.992], p = .03). CONCLUSIONS: CB-PVI as index procedure for AF ablation resulted in favorable long-term outcome in symptomatic AF. CB-PVI might be recommended as interventional therapy in patients with lower LA remodeling.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Cryosurgery , Pulmonary Veins , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/etiology , Atrial Fibrillation/surgery , Catheter Ablation/methods , Female , Humans , Male , Middle Aged , Prospective Studies , Pulmonary Veins/surgery , Recurrence , Treatment Outcome
4.
Heart ; 106(24): 1919-1926, 2020 12.
Article in English | MEDLINE | ID: mdl-33046527

ABSTRACT

OBJECTIVE: To investigate changes in quality of life (QoL), cognition and functional status according to arrhythmia recurrence after atrial fibrillation (AF) ablation. METHODS: We compared QoL, cognition and functional status in patients with recurrent atrial tachycardia (AT)/AF versus those without recurrent AT/AF in the AXAFA-AFNET 5 clinical trial. We also sought to identify factors associated with improvement in QoL and functional status following AF ablation by overall change scores with and without analysis of covariance (ANCOVA). RESULTS: Among 518 patients who underwent AF ablation, 154 (29.7%) experienced recurrent AT/AF at 3 months. Patients with recurrent AT/AF had higher mean CHA2DS2-VASc scores (2.8 vs 2.3, p<0.001) and more persistent forms of AF (51 vs 39%, p=0.012). Median changes in the SF-12 physical (3 (25th, 75th: -1, 8) vs 1 (-5, 8), p=0.026) and mental scores (2 (-3, 9) vs 0 (-4, 5), p=0.004), EQ-5D (0 (0,2) vs 0 (-0.1, 0.1), p=0.027) and Karnofsky functional status scores (10 (0, 10) vs 0 (0, 10), p=0.001) were more favourable in patients without recurrent AT/AF. In the overall cohort, the proportion with at least mild cognitive impairment (Montreal Cognitive Assessment <26) declined from 30.3% (n=157) at baseline to 21.8% (n=113) at follow-up. ANCOVA identified greater improvement in Karnofsky functional status (p<0.001) but not SF-12 physical (p=0.238) or mental scores (p=0.065) in those without recurrent AT/AF compared with patients with recurrent AT/AF. CONCLUSIONS: Patients without recurrent AT/AF appear to experience greater improvement in functional status but similar QoL as those with recurrent AT/AF after AF ablation.


Subject(s)
Atrial Fibrillation/physiopathology , Catheter Ablation/methods , Cognition/physiology , Functional Status , Quality of Life , Aged , Atrial Fibrillation/psychology , Atrial Fibrillation/surgery , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Recurrence , Risk Factors , Single-Blind Method , Treatment Outcome
5.
Europace ; 21(9): 1313-1324, 2019 Sep 01.
Article in English | MEDLINE | ID: mdl-31199860

ABSTRACT

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 Outcome
6.
JAMA ; 321(13): 1261-1274, 2019 04 02.
Article in English | MEDLINE | ID: mdl-30874766

ABSTRACT

Importance: Catheter ablation is effective in restoring sinus rhythm in atrial fibrillation (AF), but its effects on long-term mortality and stroke risk are uncertain. Objective: To determine whether catheter ablation is more effective than conventional medical therapy for improving outcomes in AF. Design, Setting, and Participants: The Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation trial is an investigator-initiated, open-label, multicenter, randomized trial involving 126 centers in 10 countries. A total of 2204 symptomatic patients with AF aged 65 years and older or younger than 65 years with 1 or more risk factors for stroke were enrolled from November 2009 to April 2016, with follow-up through December 31, 2017. Interventions: The catheter ablation group (n = 1108) underwent pulmonary vein isolation, with additional ablative procedures at the discretion of site investigators. The drug therapy group (n = 1096) received standard rhythm and/or rate control drugs guided by contemporaneous guidelines. Main Outcomes and Measures: The primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Among 13 prespecified secondary end points, 3 are included in this report: all-cause mortality; total mortality or cardiovascular hospitalization; and AF recurrence. Results: Of the 2204 patients randomized (median age, 68 years; 37.2% female; 42.9% had paroxysmal AF and 57.1% had persistent AF), 89.3% completed the trial. Of the patients assigned to catheter ablation, 1006 (90.8%) underwent the procedure. Of the patients assigned to drug therapy, 301 (27.5%) ultimately received catheter ablation. In the intention-to-treat analysis, over a median follow-up of 48.5 months, the primary end point occurred in 8.0% (n = 89) of patients in the ablation group vs 9.2% (n = 101) of patients in the drug therapy group (hazard ratio [HR], 0.86 [95% CI, 0.65-1.15]; P = .30). Among the secondary end points, outcomes in the ablation group vs the drug therapy group, respectively, were 5.2% vs 6.1% for all-cause mortality (HR, 0.85 [95% CI, 0.60-1.21]; P = .38), 51.7% vs 58.1% for death or cardiovascular hospitalization (HR, 0.83 [95% CI, 0.74-0.93]; P = .001), and 49.9% vs 69.5% for AF recurrence (HR, 0.52 [95% CI, 0.45-0.60]; P < .001). Conclusions and Relevance: Among patients with AF, the strategy of catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest. However, the estimated treatment effect of catheter ablation was affected by lower-than-expected event rates and treatment crossovers, which should be considered in interpreting the results of the trial. Trial Registration: ClinicalTrials.gov Identifier: NCT00911508.


Subject(s)
Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/drug therapy , Atrial Fibrillation/surgery , Catheter Ablation , Heart Arrest/prevention & control , Hemorrhage/prevention & control , Stroke/prevention & control , Aged , Anti-Arrhythmia Agents/adverse effects , Atrial Fibrillation/complications , Atrial Fibrillation/mortality , Catheter Ablation/adverse effects , Female , Heart Arrest/etiology , Hemorrhage/etiology , Hospitalization/statistics & numerical data , Humans , Intention to Treat Analysis , Kaplan-Meier Estimate , Male , Middle Aged , Recurrence , Registries , Risk Factors , Stroke/etiology
7.
JACC Clin Electrophysiol ; 4(11): 1440-1447, 2018 11.
Article in English | MEDLINE | ID: mdl-30466850

ABSTRACT

OBJECTIVES: The CRYO4PERSISTENT AF (Cryoballoon Ablation for Early Persistent Atrial Fibrillation) trial aims to report long-term outcomes after a single pulmonary vein isolation (PVI)-only ablation procedure using the second-generation cryoballoon in persistent atrial fibrillation (PerAF) patients. BACKGROUND: Pulmonary vein isolation is recognized as the cornerstone of atrial fibrillation (AF) ablation, including ablation of PerAF. METHODS: The CRYO4PERSISTENT AF trial (NCT02213731) is a prospective, multicenter, single-arm trial designed to assess single-procedure outcomes of PVI using the cryoballoon. The primary endpoint was freedom from AF, atrial flutter, or atrial tachycardia ≥30 s after a 90-day blanking period. After enrollment, but before ablation, patients without 100% AF burden (18-h Holter monitoring or 3 consecutive electrocardiograms in a time frame ≥14 days) were excluded. Patients were followed at 3, 6, and 12 months, with 48-h Holter monitoring at 6 and 12 months. Quality of life and symptoms were evaluated at baseline and 12 months. Arrhythmia recurrence and adverse events were adjudicated by an independent committee. RESULTS: A total of 101 patients (62 ± 11 years of age, 74% men, left ventricular ejection fraction 56 ± 8%, left atrial diameter 43 ± 5 mm) meeting criteria, undergoing cryoballoon-based PVI, with follow-up data, were included. Kaplan-Meier estimate of freedom from AF, atrial flutter, or atrial tachycardia recurrence was 60.7% at 12 months. Compared with baseline, there were significantly fewer patients with arrhythmia-related symptoms at 12 months (16% vs. 92%; p < 0.0001). The symptom reduction was supported by significant improvement in 36-Item Short Form Health Survey composite scores and European Heart Rhythm Association score at 12 months. The only device related event was transient phrenic nerve injury in 2 (2%) patients, with resolution pre-discharge. CONCLUSIONS: Cryoballoon ablation for treatment of PerAF demonstrated 61% single-procedure success at 12 months post-ablation in addition to significant reduction in arrhythmia-related symptoms and improved quality of life. (Cryoballoon Ablation for Early Persistent Atrial Fibrillation [Cryo4 Persistent AF]; NCT02213731).


Subject(s)
Atrial Fibrillation , Cryosurgery , Quality of Life , Aged , Atrial Fibrillation/epidemiology , Atrial Fibrillation/surgery , Cryosurgery/adverse effects , Cryosurgery/methods , Cryosurgery/statistics & numerical data , Female , Humans , Male , Middle Aged
8.
Eur Heart J ; 38(10): 730-738, 2017 Mar 07.
Article in English | MEDLINE | ID: mdl-27941020

ABSTRACT

AIMS: Although cardiac resynchronization therapy (CRT) is effective in patients with systolic heart failure (HF) and a wide QRS interval, a substantial proportion of patients remain non-responsive. The SonR contractility sensor embedded in the right atrial lead enables individualized automatic optimization of the atrioventricular (AV) and interventricular (VV) timings. The RESPOND-CRT study investigated the safety and efficacy of the contractility sensor system in HF patients undergoing CRT. METHODS AND RESULTS: RESPOND-CRT was a prospective, randomized, double-blinded, multicentre, non-inferiority trial. Patients were randomized (2:1, respectively) to receive weekly, automatic CRT optimization with SonR vs. an Echo-guided optimization of AV and VV timings. The primary efficacy endpoint was the rate of clinical responders (patients alive, without adjudicated HF-related events, with improvement in New York Heart Association class or quality of life), at 12 months. The study randomized 998 patients. Responder rates were 75.0% in the SonR arm and 70.4% in the Echo arm (mean difference, 4.6%; 95% CI, -1.4% to 10.6%; P < 0.001 for non-inferiority margin -10.0%) (Table 2). At an overall mean follow-up of 548 ± 190 days SonR was associated with a 35% risk reduction in HF hospitalization (hazard ratio, 0.65; 95% CI, 0.46-0.92; log-rank P = 0.01). CONCLUSION: Automatic AV and VV optimization using the contractility sensor was safe and as effective as Echo-guided AV and VV optimization in increasing response to CRT. CLINICALTRIALS.GOV NUMBER: NCT01534234.


Subject(s)
Cardiac Resynchronization Therapy Devices , Heart Failure, Systolic/therapy , Aged , Cardiac Resynchronization Therapy/methods , Double-Blind Method , Equipment Design , Female , Follow-Up Studies , Heart Failure, Systolic/physiopathology , Humans , Male , Myocardial Contraction/physiology , Prospective Studies , Stroke Volume/physiology , Treatment Outcome
9.
Europace ; 18(3): 368-75, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26504108

ABSTRACT

AIMS: First-line ablation prior to antiarrhythmic drug (AAD) therapy is an option for symptomatic paroxysmal atrial fibrillation (PAF); however, the optimal ablation technique, radiofrequency (RF), or cryoballoon (CB) has to be determined. METHODS AND RESULTS: The FREEZE Cohort Study compares RF and CB ablation. Treatment-naïve patients were documented in the FREEZEplus Registry. Periprocedural data and outcome were analysed. From 2011 to 2014, a total of 373/4184 (8.9%) patients with PAF naïve to AAD were identified. Pulmonary vein isolation (PVI) was performed with RF (n = 180) or CB (n = 193). In the RF group, patients were older (65 vs. 61 years, P < 0.01) compared with the CB group. The procedure time was significantly shorter and radiation exposure higher in the CB group. Major adverse events occurred in 1.6% (CB) and 3.7% (RF) of patients (P = 0.22). AF/atrial tachycardia (AT) recurrence until discharge was 4.5% (RF) and 8.5% (CB, P = 0.2). Follow-up (FU) ≥12 months was available in 99 (RF) and 107 (CB) patients. After 1.4 years of FU, freedom from AF/atrial tachycardia (AT) was 61% (RF) and 71% (CB, P = 0.11). In the RF group, more patients underwent cardioversion, and a trend for more repeat ablations was observed. Persistent phrenic nerve palsy was observed in one patient treated by CB. CONCLUSION: First-line ablation for PAF is safe and effective with either RF or CB. The procedure was faster with the CB, but the radiation exposure was higher. Although there was a trend for more recurrences and complications in the RF group, a more favourable risk profile in patients undergoing CB ablation might have biased the results. CLINICALTRIALSGOV IDENTIFIER: NCT01360008.


Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation , Cryosurgery , Heart Rate , Pulmonary Veins/surgery , Action Potentials , Aged , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Catheter Ablation/adverse effects , Cryosurgery/adverse effects , Europe , Female , Humans , Male , Middle Aged , Operative Time , Prospective Studies , Pulmonary Veins/physiopathology , Radiation Dosage , Radiation Exposure , Recurrence , Registries , Reoperation , Risk Factors , South Africa , Time Factors , Treatment Outcome , United States
10.
Europace ; 17(10): 1518-25, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26498716

ABSTRACT

AIMS: Diabetes mellitus (DM) and atrial fibrillation (AF) share pathophysiological links, as supported by the high prevalence of AF within DM patients. Catheter ablation of AF (AFCA) is an established therapeutic option for rhythm control in drug resistant symptomatic patients. Its efficacy and safety among patients with DM is based on small populations, and long-term outcome is unknown. The present systematic review and meta-analysis aims to assess safety and long-term outcome of AFCA in DM patients, focusing on predictors of recurrence. METHODS AND RESULTS: A systematic review was conducted in MEDLINE/PubMed and Cochrane Library. Randomized controlled trials, clinical trials, and observational studies including patients with DM undergoing AFCA were screened and included if matching inclusion and exclusion criteria. Fifteen studies were included, adding up to 1464 patients. Mean follow-up was 27 (20-33) months. Overall complication rate was 3.5 (1.5-5.0)%. Efficacy in maintaining sinus rhythm at follow-up end was 66 (58-73)%. Meta-regression analysis revealed that advanced age (P < 0.001), higher body mass index (P < 0.001), and higher basal glycated haemoglobin level (P < 0.001) related to higher incidence of arrhythmic recurrences. Performing AFCA lead to a reduction of patients requiring treatment with antiarrhythmic drugs (AADs) from 55 (46-74)% at baseline to 29 (17-41)% (P < 0.001) at follow-up end. CONCLUSIONS: Catheter ablation of AF safety and efficacy in DM patients is similar to general population, especially when performed in younger patients with satisfactory glycemic control. Catheter ablation of AF reduces the amount of patients requiring AADs, an additional benefit in this population commonly exposed to adverse effects of AF pharmacological treatments.


Subject(s)
Anti-Arrhythmia Agents/therapeutic use , Atrial Fibrillation/therapy , Catheter Ablation/methods , Diabetes Complications , Catheter Ablation/adverse effects , Humans , Recurrence , Treatment Outcome
12.
Circ Arrhythm Electrophysiol ; 7(6): 1011-8, 2014 Dec.
Article in English | MEDLINE | ID: mdl-25262686

ABSTRACT

BACKGROUND: Catheter ablation of atrial fibrillation (AFCA) is an established therapeutic option for rhythm control in symptomatic patients. Its efficacy and safety among patients with left ventricular systolic dysfunction is based on small populations, and data concerning long-term outcome are limited. We performed this meta-analysis to assess safety and long-term outcome of AFCA in patients with left ventricular systolic dysfunction, to evaluate predictors of recurrence and impact on left ventricular function. METHODS AND RESULTS: A systematic review was conducted in MEDLINE/PubMed and Cochrane Library. Randomized controlled trials, clinical trials, and observational studies including patients with left ventricular systolic dysfunction undergoing AFCA were included. Twenty-six studies were selected, including 1838 patients. Mean follow-up was 23 (95% confidence interval, 18-40) months. Overall complication rate was 4.2% (3.6%-4.8%). Efficacy in maintaining sinus rhythm at follow-up end was 60% (54%-67%). Meta-regression analysis revealed that time since first atrial fibrillation (P=0.030) and heart failure (P=0.045) diagnosis related to higher, whereas absence of known structural heart disease (P=0.003) to lower incidence of atrial fibrillation recurrences. Left ventricular ejection fraction improved significantly during follow-up by 13% (P<0.001), with a significant reduction of patients presenting an ejection fraction <35% (P<0.001). N-terminal pro-brain natriuretic peptide blood levels decreased by 620 pg/mL (P<0.001). CONCLUSIONS: AFCA efficacy in patients with impaired left ventricular systolic function improves when performed early in the natural history of atrial fibrillation and heart failure. AFCA provides long-term benefits on left ventricular function, significantly reducing the number of patients with severely impaired systolic function.


Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation , Systole , Ventricular Dysfunction, Left/physiopathology , Ventricular Function, Left , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/physiopathology , Biomarkers/blood , Catheter Ablation/adverse effects , Chi-Square Distribution , Female , Humans , Male , Middle Aged , Natriuretic Peptide, Brain/blood , Odds Ratio , Peptide Fragments/blood , Recovery of Function , Recurrence , Risk Factors , Stroke Volume , Time Factors , Treatment Outcome , Ventricular Dysfunction, Left/complications , Ventricular Dysfunction, Left/diagnosis
13.
Pacing Clin Electrophysiol ; 32 Suppl 1: S219-22, 2009 Mar.
Article in English | MEDLINE | ID: mdl-19250100

ABSTRACT

INTRODUCTION: Sleep-related breathing disorders occur in 20-30% of Europeans and North Americans, including 10% of sleep apnea syndrome (SAS). A preliminary study suggested that atrial overdrive pacing with a fixed heart rate might alleviate SAS. However, it is not known whether dynamic atrial overdrive pacing alleviates SAS. METHODS: Patients with indications for a dual chamber pacemaker or implantable cardioverter-defibrillator (ICD) were screened for SAS using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. If PSQI was >5, cardio-respiratory polygraphy was performed before and 4 and 7 months after device implantation. Patients were randomized to algorithm ON-OFF (group A) or OFF-ON (group B) and the apnea-hypopnea index (AHI) was measured. RESULTS: Out of 105 consecutive patients, 46 (44%) had a positive PSQI. This analysis included 12 patients (mean age = 61 +/- 10 years, body mass index 28.9 +/- 6.5 kg/m(2), left ventricular ejection fraction = 38.3 +/- 13.6%; 10 men). All patients suffered from obstructive or mixed SAS. There were no significant differences in PSQI or AHI between baseline and follow-up or between the two study groups. Therefore, the study was terminated ahead of schedule. CONCLUSIONS: The prevalence of obstructive or mixed SAS was high in pacemaker or ICD recipients and reduced left ventricular ejection fraction. In these patients, long-term dynamic atrial overdrive pacing using did not improve PSQI or SAS. Therefore, patients with relevant obstructive or mixed SAS should not be offered atrial pacing therapy.


Subject(s)
Defibrillators, Implantable/statistics & numerical data , Pacemaker, Artificial/statistics & numerical data , Risk Assessment/methods , Sleep Apnea Syndromes/epidemiology , Therapy, Computer-Assisted/statistics & numerical data , Female , Humans , Incidence , Longitudinal Studies , Male , Middle Aged , Risk Factors
14.
J Am Coll Cardiol ; 51(25): 2407-11, 2008 Jun 24.
Article in English | MEDLINE | ID: mdl-18565397

ABSTRACT

OBJECTIVES: We present the initial clinical human experience with the use of a robotic remote navigation system (Hansen Medical, Mountain View, California), to perform left and right atrial mapping and radiofrequency ablation of atrial fibrillation (AF) and atrial flutter (AFL). BACKGROUND: Catheter ablation is an established curative modality for various arrhythmias. A robotic steerable sheath system (SSS) (Hansen Medical) allows better catheter stability and greater degrees of freedom of catheter movement. METHODS: A total of 40 patients (mean age 57 years) with antiarrhythmic drug (AAD)-refractory AF (23 had also concomitant documented typical AFL) were studied. Three-dimensional reconstruction of the corresponding atrial chamber anatomy was performed with the CARTO electroanatomic mapping system (Biosense Webster, Diamond Bar, California or the EnSite NavX system (St. Jude Medical, Minneapolis, Minnesota) in combination with the Artisan catheter (Hansen Medical). In patients undergoing AF ablation, 2 transseptal punctures were performed under intracardiac ultrasound (ICE) guidance, with one of the punctures being performed using SSS. Pulmonary vein antrum isolation was performed with a 3.5-mm thermocool catheter manipulated with the use of the SSS and was verified by circular mapping. Patients were followed clinically for recurrence of arrhythmia with an event transmitter and ambulatory holter monitoring. Clinical recurrence of AF/AFL was defined as AF/AFL episodes >1 min in duration. RESULTS: Pulmonary vein antrum isolation was performed in 40 patients, including 23 with concomitant typical AFL ablation. All pulmonary veins, including the superior vena cava, were successfully isolated. In 23 of 40 patients, cavotricuspid ablation was also performed with bidirectional block obtained. At 1-year follow-up, 34 patients (86%) and 5 patients were free from atrial arrhythmia off AADs and on AADs, respectively. CONCLUSIONS: This preliminary human experience suggests that mapping and ablation of AFL and AF using this novel robotic catheter with remote control system is feasible with similar results to conventional approach.


Subject(s)
Atrial Fibrillation/surgery , Atrial Flutter/surgery , Catheter Ablation/instrumentation , Robotics/instrumentation , Atrial Fibrillation/therapy , Atrial Flutter/therapy , Catheter Ablation/adverse effects , Feasibility Studies , Female , Humans , Imaging, Three-Dimensional/instrumentation , Imaging, Three-Dimensional/methods , Male , Middle Aged , Prospective Studies , Pulmonary Veins/pathology , Pulmonary Veins/surgery , Robotics/methods , Time Factors , Vena Cava, Superior/pathology , Vena Cava, Superior/surgery
16.
J Cardiovasc Electrophysiol ; 18(6): 583-8, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17490437

ABSTRACT

INTRODUCTION: We performed a prospective study to compare efficacy and safety of both open irrigation tip (OIT) technology with intracardiac echo (ICE)-guided energy delivery in patients presenting for PVAI. METHODS AND RESULTS: Fifty-three patients presenting for PVAI were randomized to ablation using an OIT catheter (Group 1, 26 patients; temperature and power were set at 50 degrees and 50 W, respectively, with a saline pump flow rate of 30 mL/min) or radiofrequency (RF) energy delivery under ICE guidance (Group 2, 27 patients; energy was titrated based on microbubbles formation). The mean procedure time and fluoroscopy exposure were lower in Group 1 (164 +/- 42 min and 7,560 +/- 2,298 microGray m2 vs 204 +/- 47 min and 12,240 +/- 4,356 microGray m2; P = 0.005 and 0.008, respectively). Moreover, the durations of RF lesions applied per PV antrum was lower in Group 1 compared with Group 2 (5.1 +/- 2.2 min vs 9.2 +/- 3.2 min, P = 0.03, respectively). Within 24 hours after PVAI in 35.7% (all erythema) of Group 1 and 57.1% (21.4% erythema and 35.7% necrosis) of Group 2, patients' esophageal wall changes were documented. After 14 +/- 2 months of follow up, recurrences were documented in 19.2% of Group 1 and 22.2% of Group 2 patients. CONCLUSION: Although both OIT and ICE-guided energy delivery possess a similar effect in treating AF, OIT seems to be superior in terms of achieving isolation and shortening fluoroscopy exposure. Moreover, a lower incidence of esophageal wall injury was observed utilizing OIT for PVAI.


Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation/instrumentation , Catheter Ablation/methods , Pulmonary Veins/surgery , Catheter Ablation/adverse effects , Echocardiography/methods , Esophageal Diseases/diagnosis , Esophageal Diseases/etiology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Prospective Studies , Recurrence , Therapeutic Irrigation/instrumentation , Therapeutic Irrigation/methods , Treatment Outcome
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