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AIMS: In the light of an increasing prevalence of atrial fibrillation (AF) and growing evidence for the superiority of early invasive rhythm control, the demand for ablation therapy is rising. Accordingly, ablation centres will have to maximize their capacity by either adding electrophysiology laboratory resources or optimizing process management. In order to optimize process management, we applied "Lean Six Sigma" method to a single ablation center. We compared procedural parameters, acute efficacy and safety of cryoballoon pulmonary vein isolation (cryoPVI) before and after modifications. METHODS AND RESULTS: Patients (n = 713) undergoing cryoPVI (108 before and 605 after process optimization) were analysed. Within 3 years of process optimization, electrophysiology laboratory occupancy time (150.7 ± 44.4 vs. 94 ± 22.1â min, P < 0.001), procedure time (84.5 ± 21-47.4 ± 12â min, P < 0.001), left-atrial dwell time (53.9 ± 18.4-31.9 ± 9.9â min, P < 0.001), and fluoroscopy time (15.8 ± 5.1 vs. 6.2 ± 2.8â min, P < 0.001) decreased. Contrast dye use (116 ± 35 vs. 27 ± 15â mL, P < 0.001) and radiation dose (893 ± 1078 vs. 253 ± 249â cGyâ cm2, P < 0.001) were reduced by â¼77 and â¼72%, respectively. There was no difference in safety endpoint occurrence (3.7 vs. 1.5%, P = 0.11). CONCLUSION: The process optimization of cryoPVI for AF therapy using the 'Lean Six Sigma' method significantly increases efficiency without compromising patient safety.
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Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Veias Pulmonares , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Fibrilação Atrial/epidemiologia , Criocirurgia/métodos , Resultado do Tratamento , Ablação por Cateter/efeitos adversos , Ablação por Cateter/métodos , Veias Pulmonares/cirurgia , RecidivaRESUMO
BACKGROUND: Age is a relevant risk factor for the development of atrial fibrillation (AF) and is associated with increased recurrence rates in the setting of rhythm-control. Catheter ablation is increasingly advocated in elderly despite conflicting data regarding its efficacy and safety in this patient cohort. Therefore, we aimed to analyze currently available evidence regarding catheter ablation for AF in patients ≥75 years compared to younger patients. METHODS: We performed a systematic literature search and meta-analysis on efficacy and safety of catheter ablation in patients ≥75 years with AF. Primary efficacy and safety endpoints were: first recurrence of atrial arrhythmia following first-time ablation and occurrence of death, stroke, or any procedure-related complication. Secondary outcomes included procedure and fluoroscopy time. RESULTS: We identified 301 potentially relevant studies of which 39 underwent detailed analysis. A total of 19 studies (MINORS score ≥13) reporting on 108,419 patients (101,844 <75 years, 6,575 ≥75 years) undergoing first-time catheter ablation for AF were included. Risk of arrhythmia recurrence following catheter ablation (39% vs. 32%; RR [95% CI] 1.24 [1.09-1.41]; P=0.001) and occurrence of safety endpoints (10.8% vs. 8.5%; RR [95% CI] 1.64 [1.53-1.76], P<0.00001) were significantly higher in patients ≥ 75 years compared to younger patients. There was no difference concerning procedure (P=0.33) or fluoroscopy time (P=0.91) between younger and elderly patients. CONCLUSION: In patients ≥75 years of age catheter ablation for AF has higher risk of arrhythmia recurrence and is associated with an increased risk of procedure-related complications and safety endpoint occurrence compared to younger patients.
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Age is a major risk-factor for atrial fibrillation (AF) and associated hospitalisations. With increasing emphasis on rhythm control, pulmonary vein isolation (PVI) is often suggested, even to elderly patients (≥ 75 years of age). Efficacy of PVI aiming at rhythm control is limited in persistent AF. Pacemaker implantation with atrioventricular node (AVN) ablation may represent a reasonable alternative, with the aim of controlling symptoms and improving quality of life in elderly patients. In this investigator-initiated, randomised, multicentre trial, we test the hypothesis that pacemaker implantation and AVN ablation provides superior symptom control over PVI in elderly patients with symptomatic persistent AF, without any increase in adverse event profile. In the ABLATE Versus PACE (NCT04906668) prospective open-label superiority trial, 196 elderly patients with normal ejection fraction and symptomatic persistent AF despite guideline-indicated medical therapy will be randomised to either cryoballoon PVI (ABLATE) or dual-chamber pacemaker implantation with subsequent AVN ablation (PACE), and followed for a minimum of 12 months. The primary efficacy outcome is a composite end point of rehospitalisation for atrial arrhythmia or cardiac decompensation/heart failure, (outpatient) electrical cardioversion, or upgrade to cardiac resynchronisation therapy owing to worsening of left ventricular ejection fraction to ≤ 35%. Secondary end points include death from any cause, stroke, quality of life, and procedure-related complications. Sample size is designed to achieve 80% power for the primary end point (2-tailed alpha of 5%). ABLATE Versus PACE will determine whether pacemaker implantation and AVN ablation can improve symptom-control in elderly patients with persistent AF over PVI without increasing safety end points.
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BACKGROUND: Heart failure with reduced ejection fraction is associated with potentially deleterious imbalance of the cardiac autonomic nervous system. Sacubitril/valsartan (angiotensin receptor-neprilysin inhibitor [ARNI]) reduces cardiovascular mortality and hospitalization for heart failure with reduced ejection fraction. Whether ARNI affects the cardiac autonomic nervous system has not been studied. METHODS AND RESULTS: This investigator-initiated, prospective, single-center cohort study compared heart rate (HR) variability, HR, deceleration capacity, and periodic repolarization dynamics as noninvasive measures of the cardiac autonomic nervous system before and after initiation of ARNI therapy. Patients underwent standardized 12-lead Holter-ECG, echocardiography and laboratory testing before and 3 months after start of therapy. End points were changes in HR variability (SD of normal-to-normal intervals, mean square of differences between consecutive R-R intervals), HR, deceleration capacity, and periodic repolarization dynamics as well as ventricular function and NT-proBNP (N-terminal pro-B-type natriuretic peptide). Of 63 patients with heart failure with reduced ejection fraction enrolled, 48 (76.2%) patients were still on ARNI at follow-up. SD of normal-to-normal intervals increased from 25 to 36 milliseconds (P<0.001), mean square of differences between consecutive R-R intervals increased from 12 to 19 milliseconds (P<0.001), HR decreased from 73±9 bpm to 67±4 bpm, (P<0.001), and deceleration capacity increased from 2.1 to 4.4 milliseconds (P<0.001). A trend for periodic repolarization dynamics reduction was observed (5.6 deg2 versus 4.7 deg2, P=0.09). Autonomic changes were accompanied by increased left ventricular ejection fraction (29±6% versus 40±8%, P<0.001) and reduced NT-proBNP (3548 versus 685 ng/L, P<0.001). Correlation analysis showed a significant relationship between volume-unloading (as evidenced by NT-proBNP reduction) and autonomic improvement. CONCLUSIONS: Three months of ARNI therapy resulted in a significant increase in cardiac parasympathetic tone. The improvement in autonomic properties may be mediated by "volume unloading" and likely contributes to the beneficial effects of ARNI in heart failure with reduced ejection fraction. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique Identifier: NCT04587947.
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Aminobutiratos , Antagonistas de Receptores de Angiotensina , Sistema Nervoso Autônomo , Compostos de Bifenilo , Combinação de Medicamentos , Insuficiência Cardíaca , Frequência Cardíaca , Neprilisina , Volume Sistólico , Tetrazóis , Valsartana , Função Ventricular Esquerda , Humanos , Insuficiência Cardíaca/tratamento farmacológico , Insuficiência Cardíaca/fisiopatologia , Masculino , Feminino , Valsartana/uso terapêutico , Aminobutiratos/uso terapêutico , Aminobutiratos/farmacologia , Sistema Nervoso Autônomo/fisiopatologia , Sistema Nervoso Autônomo/efeitos dos fármacos , Idoso , Estudos Prospectivos , Antagonistas de Receptores de Angiotensina/uso terapêutico , Antagonistas de Receptores de Angiotensina/farmacologia , Volume Sistólico/efeitos dos fármacos , Volume Sistólico/fisiologia , Pessoa de Meia-Idade , Frequência Cardíaca/efeitos dos fármacos , Tetrazóis/uso terapêutico , Neprilisina/antagonistas & inibidores , Função Ventricular Esquerda/efeitos dos fármacos , Eletrocardiografia Ambulatorial , Fragmentos de Peptídeos/sangue , Resultado do Tratamento , Peptídeo Natriurético Encefálico/sangue , Coração/inervação , Coração/efeitos dos fármacosRESUMO
BACKGROUND: Age is a major risk factor for development of atrial fibrillation (AF) and associated with increased recurrence rates in the setting of rhythm control. Current data tend to support catheter ablation in elderly patients, but uncertainties exist regarding efficacy and safety of ablation in elderly patients. METHODS: This was a prospective single-centre observational study with propensity score matching (PSM) to investigate the influence of age on efficacy and safety of cryoballoon ablation (CBA) stratified by age (< 75 years vs ≥ 75 years) and AF phenotype (paroxysmal vs persistent). Primary efficacy endpoint was recurrence of atrial arrhythmia after a 90-day blanking period. Safety endpoints were death, stroke, or procedure-associated complications. RESULTS: Consecutive patients (n = 953) underwent CBA for first-time AF ablation. Median follow-up was 18 months. By means of PSM, 268 matches were formed. At 1 year, primary efficacy endpoint occurred in 22.4% of young vs 33.2% of elderly patients, including both AF phenotypes (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.47-0.90; P = 0.01). AF relapse occurred in 19.7% of young vs 28.5% of elderly patients with paroxysmal (HR, 0.63; 95% CI, 0.40-0.99; P = 0.046) compared with 25.9% (30 of 116, young) vs 38.8% (45 of 116, elderly) patients with persistent AF (HR, 0.62; 95% CI, 0.39-0.97; P = 0.038). No difference was observed regarding the incidence of safety endpoints between young and elderly patients (P = 0.38). CONCLUSIONS: CBA is associated with higher recurrence rates in elderly (≥ 75 years) than in younger patients, with highest recurrence rates in elderly patients with persistent AF.
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BACKGROUND: Atrioventricular-nodal reentrant tachycardia (AVNRT) is a common supraventricular tachycardia, particularly in younger patients. The treatment of choice is radiofrequency catheter ablation (RFCA), traditionally necessitating ionizing radiation for catheter guidance. OBJECTIVE: The authors aimed to demonstrate the feasibility and safety of zero-fluoroscopy RFCA of AVNRT using EnSite™ NavX™ as a three-dimensional (3D) electroanatomical mapping system (EAM). METHODS: The authors retrospectively analyzed 68 patients that underwent AVNRT-RFCA. One group was a priori allocated to conventional fluoroscopy mapping (convFluoro, nâ¯= 30). In 38 cases, the electrophysiologist chose to use 3D-EAM for ablation. Of these patients, 20 could be ablated without fluoroscopy use (zeroFluoro). In 18 cases that were initially intended as 3D-EAM, additional fluoroscopy use was necessary due to difficult anatomic conditions (convertedFluoro). Procedure duration, fluoroscopy duration and dose, as well as complications were analyzed. RESULTS: Procedure duration was similar for the convFluoro and zeroFluoro groups (74⯱ 24â¯min vs. 80⯱ 26â¯min, pâ¯= ns). The convertedFluoro group showed longer procedure duration compared to the convFluoro group (94⯱ 30â¯min vs. 74⯱ 24â¯min, pâ¯< 0.05). The use of 3D-EAM significantly reduced fluoroscopy duration comparing the convFluoro with the convertedFluoro group (12⯱ 9â¯min vs. 7⯱ 6â¯min, pâ¯< 0.05). The difference in fluoroscopy dose between convFluoro and convertedFluoro did not reach significance (169⯱ 166â¯cGycm2 vs. 134⯱ 137â¯cGycm2, pâ¯= ns). In zeroFluoro cases, no radiation was used at all. 3D-EAM-guided RFCA was primarily successful in all patients. Overall, there were only few minor complications in the different groups. No major complications occurred. CONCLUSION: Zero-fluoro RFCA in patients with AVNRT is feasible and safe. 3D-EAM can reduce radiation exposure in the majority of patients without prolonging procedure duration or increasing complications.
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Ablação por Cateter , Taquicardia por Reentrada no Nó Atrioventricular , Taquicardia Supraventricular , Humanos , Estudos Retrospectivos , Resultado do Tratamento , Taquicardia por Reentrada no Nó Atrioventricular/diagnóstico , Taquicardia por Reentrada no Nó Atrioventricular/cirurgia , Arritmias Cardíacas/cirurgia , Ablação por Cateter/métodos , Fluoroscopia/métodosRESUMO
Background: Radiation exposure to patient and surgeon during cardiac implantable electrical device (CIED) procedures remains a substantial health hazard to date. Advanced technical options for radiation dose reduction often pose considerable financial hurdles. We propose a near-zero cost, low-effort modification to a clinical x-ray system significantly reducing radiation dose during CIED implantation. Objective: We aim to evaluate a reduced frame rate protocol in CIED implantation for complication rates and reduction in radiation exposure. Methods: Starting May 2019, the frame rate during CIED implantations at our hospital was halved from 7.5 frames/s to 3.8 frames/s, and no further technical changes were made. During the following year, 264 patients were operated using this protocol and retrospectively compared with 231 cases implanted in the year before the protocol change, totaling 495 cases. Of these, 17%, 63%, and 19% were single-chamber, dual-chamber, or resynchronization devices, respectively. Incidence of complication prior to hospital discharge was considered the primary endpoint of the analysis. Radiation dose and procedural parameters were secondary endpoints. Results: There was no increase in complications with the reduced frame rate protocol. Regression analysis further supported that the reduced frame rate radiation protocol was not associated with complication rates. Radiation exposure measured as dose area product was significantly reduced by â¼62% (median 369 [interquartile range 154-1207] cGy·cm2 via the reduced frame rate protocol vs median 970 [interquartile range 400-1906] cGy·cm2 with the standard frame rate; P < 0.01). Conclusion: A reduction of frame rate during CIED implantation is safe in terms of complication incidence and effective in terms of reducing radiation exposure.
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Background: Patients with obesity are at higher risk of developing atrial fibrillation (AF) and benefit from radiofrequency ablation. Potentially, cryoballoon ablation (CBA) may be equally effective and safe in such patients. Methods: We conducted a prospective, single-center study to investigate whether CBA for pulmonary vein isolation is as effective and safe in obese patients as it is in non-obese controls. Primary efficacy endpoint was recurrence of AF, atrial flutter or atrial tachycardia after a 90-day blanking period. Safety endpoints were death, stroke or procedure-associated complications. Conduction of a subgroup analysis regarding the impact of additional diabetes was predefined in case the primary efficacy endpoint was met. The study was event driven and powered for noninferiority. Results: A total of 949 patients underwent CBA (251 obese with mean body-mass-index 33.5 ± 3 kg/m2 and 698 non-obese with mean body-mass-index 25.3 ± 3 kg/m2) during a 5-year recruitment period. Median follow-up was 15 months. The primary efficacy endpoint occurred in 78/251 obese and 247/698 non-obese patients (12-months Kaplan-Meier event-rate estimates, hazard ratio 0.79; 95% confidence interval [CI], 0.58 to 1.07; log-rank P = 0.0002 for noninferiority). No differences were observed in safety end point occurrence (P = 0.78). The occurrence of primary efficacy end point was found to be unaffected by the presence of diabetes in the prespecified subgroup analysis (log-rank P = 0.57). Conclusion: CBA is effective and safe in obese and DM patients. Weighing the high cardiovascular risk of obese patients against a reduction of cardiovascular events by early rhythm control, CBA should be offered to this patient population.
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BACKGROUND: Pacemaker implantations have been performed for >â¯50 years, reaching 1.25 million implants worldwide per year. Despite this, only few randomized studies exist regarding technical aspects of the implantation procedure-in particular, wound closure. Accordingly, the authors compared absorbable vs. non-absorbable suture regarding wound healing. METHODS: Consecutive patients scheduled for de novo pacemaker implantation without defibrillation therapy were prospectively randomized into two groups: non-absorbable (Prolene®, Ethicon Inc.) or absorbable suture (Monocryl®, Ethicon Inc.). The wound was systematically assessed for cosmetic outcome at 1 day, 6 weeks, and 1 year post implantation using the patient and observer scar assessment scale (POSAS). Adverse events noted included bleeding, pocket hematoma, infection, suture insufficiency, and revision surgery. RESULTS: A total of 114 patients (mean age: 79⯱ 10 years, nâ¯= 60 male) were randomized into the two groups. Of these, 105 completed follow-up (lost to follow-up: 7.9%). Groups were comparable for clinical characteristics or use of oral anticoagulants. There was no difference in cosmetic outcome and incidence of adverse events at any follow-up visit. POSAS scores were: 1 day: 1.4⯱ 0.4 vs. 1.3⯱ 0.4, Pâ¯= 0.44, 6 weeks: 1.4⯱ 0.6 vs. 1.4⯱ 0.7, Pâ¯= 0.57; 1 year: 1.4⯱ 1.4 vs. 2.1⯱ 3, Pâ¯= 0.60. No pocket hematoma or infection occurred in either group. No additional surgery was necessary for local findings. Retrospectively, scar development was straight in the Prolene® group and slightly wavy with Monocryl®. CONCLUSION: Suture material does not influence wound healing as represented by the cosmetic result and the occurrence of adverse events. The choice of suture material used should be left to the physician's discretion.
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Cicatriz , Marca-Passo Artificial , Idoso , Idoso de 80 Anos ou mais , Hematoma/etiologia , Humanos , Masculino , Polipropilenos , Estudos Prospectivos , Estudos Retrospectivos , Suturas/efeitos adversos , Resultado do TratamentoRESUMO
(1) Background: Cryoballoon pulmonary vein isolation (cryoPVI) is established for symptomatic paroxysmal atrial fibrillation (AF) treatment, but its value in persistent AF is less clear. In particular, limited data are available on its efficacy in elderly patients (≥75 years) with persistent AF. Age is an important modifier of AF progression and represents a risk-factor for AF recurrence. (2) Methods: Prospective, single-center observational study to evaluate the impact of age on efficacy and safety of cryoPVI in elderly patients. Primary efficacy endpoint was symptomatic AF recurrence after 90-day blanking period. Primary safety endpoints were death from any cause, procedure-associated complications or stroke/transient ischemic attack. Median follow-up was 17 months (range 3−24). (3) Results: We included 268 patients with persistent AF (94 ≥ 75 years of age). Multivariate Cox regression analysis identified age as the only independent factor influencing AF recurrence in the overall cohort (p = 0.006). To minimize confounding bias in efficacy and safety analysis of cryoPVI, we matched younger and elderly patients with respect to baseline characteristics. At 24 months, primary efficacy endpoint occurred in 13/69 patients <75 years and 31/69 patients ≥75 years of age (24 months Kaplan−Meier event-rate estimates, HR 0.34; 95% CI, 0.19 to 0.62; log-rank p = 0.0004). No differences were observed in the occurrence of safety end points. (4) Conclusions: Elderly (≥75 years) patients with persistent AF undergoing cryoPVI had an approximately threefold higher risk of symptomatic AF recurrence than matched younger patients. Accordingly, other treatment modalities may be evaluated in this population.
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Supraventricular tachycardia (SVT) is a very common cause of hospital admission and its diagnostic and treatment may be difficult sometimes. While vagal maneuvers or intravenous adenosis administration during 12-lead ECG recording should be performed in hemodynamically stable patients for diagnosis and treatment, hemodynamically unstable patients should be carioverted immediately. The new ESC guideline (2019) on diagnosis and clinical management of SVT significantly upgrades catheter ablation and gives it a new preferential status. For example, in patients with symptomatic recurrence, atrioventricular nodal re-entrant tachycardia should be ablated due to the very low risk of AV block. Furthermore, catheter ablation should also be offered as first-line therapy to patients with reentrant and focal arrhythmias. The diagnosis and therapy of tachycardiomyopathy is of particular importance and treatment should incorporate the ablation of the underlying supraventricular tachycardia. The therapy of supraventricular tachycardia during pregnancy should be free of antiarrhythmic medication, especially in the first trimester. If ablation is necessary during pregnancy, only fluoroscopy-free mapping systems should be used. This review covers aspects of ECG diagnosis and guideline-based treatment of SVT.
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Eletrocardiografia , Taquicardia Supraventricular , Adulto , Antiarrítmicos , Ablação por Cateter , Feminino , Humanos , Imageamento Tridimensional , Masculino , Pessoa de Meia-Idade , Gravidez , Complicações Cardiovasculares na Gravidez/diagnóstico , Complicações Cardiovasculares na Gravidez/terapia , Taquicardia Supraventricular/diagnóstico , Taquicardia Supraventricular/terapiaRESUMO
BACKGROUND: Recent animal and human studies have shown antiarrhythmic effects inhibiting inducibility of atrial fibrillation through low-level transcutaneous electrical stimulation at the auricular branch of the vagus nerve (ABVN). OBJECTIVE: The present study investigated effects of acupuncture at the ABVN on the autonomic cardiac nervous system in humans through analysis of heart rate and heart rate variability (HRV) parameters. METHODS: We enrolled 24 healthy male volunteers and compared acupuncture at the ABVN to placebo-acupuncture performed at the Ma-35 point (an acupuncture point used in traditional Chinese medicine to treat pain caused by gonarthrosis). An additional measurement without acupuncture served as control. We analyzed the following heart rate and HRV parameters: standard deviation of normal-to-normal intervals (SDNN), root mean square of successive R-R interval differences (RMSSD), high frequency (HF), low frequency (LF), LF/HF ratio. RESULTS: In comparison to placebo acupuncture, acupuncture at the ABVN led to a significant reduction in heart rate (approximately 4%-6%, P < .05) and an increase in overall HRV demonstrated by SDNN (approximately 19%, P < .05). RMSSD and power spectral density parameters (HF, LF, LF/HF) showed statistical trends (P < .1) induced by auricular acupuncture in favor of vagal tone. No relevant difference was shown between control and placebo group. CONCLUSION: Acupuncture of the region innervated by the ABVN may activate the parasympathetic nervous system, as suggested by reduction in heart rate and increase in SDNN. However, given the lack of clear significant changes in other HRV parameters, this effect seems modest and its evaluation requires further investigation.