Paroxysmal and persistent atrial fibrillation ablation outcomes with the pulmonary vein ablation catheter GOLD duty-cycled phased radiofrequency ablation catheter: quality of life and 12-month efficacy results from the GOLD Atrial Fibrillation Registry.

AIMS: The GOLD AF Registry has been designed to prospectively assess the population, indications, and outcomes using second-generation phased radiofrequency (RF) ablation (pulmonary vein ablation catheter GOLD) in a global examination of standard-of-care use for the treatment of paroxysmal and persistent atrial fibrillation (AF). METHODS AND RESULTS: GOLD AF (NCT02433613) is a prospective, observational, multi-centre registry designed to characterize efficacy and safety of phased RF ablation in patients with AF. The primary endpoint was freedom from AF recurrence at 12-month follow-up after a 90-day blanking period. Ancillary objectives include safety, procedural efficiency, and quality of life (QoL). The QoL assessment using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) and the European Heart Rhythm Association (EHRA) Score of AF-related symptoms was collected at baseline and 12 months. In total, 1054 patients were included in this analysis (age 60.6, 67.6% male, 26.5% PersAF). Kaplan-Meier estimate of freedom from AF recurrence was 77.7% at 12 months. Peri-procedural device or procedure-related complications were observed in 26 (2.5%) patients, with a low stroke rate of 0.3%. One-year post-ablation, the EHRA AF Symptom score decreased in 68% of patients. The AFEQT score improvement was observed in 88.4% and 90.4% of patients who completed the questionnaire in-person or interviewed by phone at 12 month follow-up, respectively. CONCLUSION: Phased RF ablation for the treatment of paroxysmal and persistent AF demonstrated a 77.7% freedom from AF recurrence at 12 months in addition to a significant reduction in arrhythmia symptoms and clinically meaningful improved QoL. Low peri-procedural complication rate of <3% was reported.

Clinical outcomes of AF patients treated with the first and second-generation of circular mapping and ablation catheter: insights from a real world multicenter experience.

PURPOSE: Complete pulmonary vein isolation (PVI) is the best documented target for catheter ablation, and different technologies have shown comparable outcomes. The multielectrode phased-RF/duty cycled (PhRF/DC) pulmonary vein ablation catheter (PVAC) and its second generation (PVAC-GOLD) have shown promising clinical results in single and multicenter experiences. Our aim is to assess and compare the safety and efficacy in the real clinical practice among two generations of circular PhRF/DC catheters by performing PVI in patients suffering from recurrent atrial fibrillation (AF). METHODS: Eighty-four AF patients treated with PVAC and 64 with PVAC-GOLD were prospectively followed in five Italian cardiology centers in the mainframe of the 1STOP-ClinicalService project. RESULTS: Fluoroscopic and total procedure time were significantly different in the two groups. In particular, in the PVAC-GOLD group, the mean fluoroscopic time was 22.8 ± 12.7 min vs 31.6 ± 18.9 in the PVAC group (p = 0.002), and the mean total procedure duration was 117.6 ± 36.0 vs 147.4 ± 40.6, in the PVAC-GOLD group and the PVAC group, respectively (p = 0.001). Only two out of 148 patients reported a peri-procedural complication. Over 20.9 ± 12.0 months of follow-up, AF recurrence occurred in 58 patients. Kaplan-Meier freedom from AF recurrence did not differ between the two groups (64.1 ± 10% in the PVAC group vs 68.2 ± 9% in the PVAC-GOLD group at 1 year, p = ns). CONCLUSIONS: In our multicenter analysis, AF ablation using two generations of circular PhRF/DC catheters is safe and effective. No difference was observed in terms of safety and efficacy of the AF ablation between the two catheters, with the mean procedural time being shorter in the PVAC-GOLD group.

Influence of myocardial viability on responsiveness to cardiac resynchronization in ischemic dilated cardiomyopathy: a prospective observational cohort study.

OBJECTIVE: To understand whether patients with post-ischemic dilated cardiomyopathy and myocardial viability (MV) could benefit from cardiac resynchronization therapy (CRT) in terms of clinical, echocardiographic and neuro- hormonal parameters compared to patients without MV. METHODS: One hundred and four consecutive patients were enrolled in a prospective observational cohort study. Using dobutamine stress echocardiography, 2 groups were identified: group A of 51 patients with MV and group B of 53 patients without MV. All patients were implanted with biventricular pacing devices combined with an internal cardioverter-defibrillator. Clinical, echocardiographic and neuro-hormonal parameters were evaluated at baseline and at six month follow-up. Analysis of variance for repeated measures on each variable suggestive of remodeling was performed. We considered responder every patient with: decrease of > 15% in left ventricular volumes and/or improvement in left ventricular ejection fraction of > 5% in addition to NYHA class improvement. RESULTS: All the variables improved in both groups (time effect). Comparing the two groups (group effect), the following variables were significantly better in group A: N-terminal pro-B-type natriuretic peptide (p=0.02), NYHA class (p=0.003), reverse remodeling (RR) (p=0.007), dP/dt (p=0.005), left ventricular ejection fraction (p=0.009), 3rd sound (p=0.01), and left ventricular end-systolic volume after the first week (p=0.035). RR occurred at the first week after CRT only in Group A and was maintained for all the time of this study. The maximum difference of the decrease of left ventricular volumes between the two groups occurred after the first week (p<0.001). CONCLUSION: Patients with MV responded better than patients without MV with a significant improvement after the first week from CRT.

Catheter ablation of atrial fibrillation in patients with diabetes mellitus type 2: results from a randomized study comparing pulmonary vein isolation versus antiarrhythmic drug therapy.

INTRODUCTION: Atrial fibrillation (AF) and diabetes mellitus type 2 (DM2) often coexist; however, a small number of patients with DM2 undergoing catheter ablation (CA) of AF have been included in previous studies. The aim of this study was to evaluate safety and efficacy of ablation therapy in DM2 patients with drug refractory AF. METHODS AND RESULTS: From January 2005 to September 2006, 70 patients with a diagnosis of DM2 and paroxysmal (n = 29) or persistent (n = 41) AF were randomized to receive either pulmonary vein isolation or a new antiarrhythmic drug treatment (ADT) with a 1-year follow-up. The primary endpoint was the time to first AF recurrence. By Kaplan-Meier analysis, at the end of follow-up, 42.9% of patients in the ADT group and 80% of patients who received a single ablation procedure and were without medications were free of AF (P = 0.001). In the ablation group, a significant improvement in quality-of-life (QoL) scores as compared with ADT group was observed. Six patients in the ADT group (17.1%) developed significant adverse drug effects. Hospitalization rate during follow-up was higher in the ADT group (P = 0.01). The only complication attributable to ablation was one significant access-site hematoma. CONCLUSION: In patients with DM2, CA of AF provides significant clinical benefits over the ADT and appears to be a reasonable approach regarding feasibility, effectiveness, and low procedural risk.

Initial experience with the Mesh catheter for pulmonary vein isolation in patients with paroxysmal atrial fibrillation.

BACKGROUND: A novel catheter design (HD Mesh ablator, Bard) combining high-density circumferential mapping and direct radiofrequency (RF) energy delivery has been developed to map and isolate the pulmonary veins (PVs). OBJECTIVE: The purpose of this study was to assess the feasibility of the Mesh catheter for PV isolation in patients with paroxysmal atrial fibrillation (AF). METHODS: Twenty consecutive patients (mean age 56.4 +/- 12.2 years; 16 men) with paroxysmal drug-refractory AF were referred for ablation. The procedure was performed in a stepwise manner: PV isolation was initially attempted with the Mesh ablator, and if that was not successful, a conventional ablation approach was then used. RESULTS: A total of 73 PVs including seven veins with left common ostium were targeted. Successful deployment of the Mesh was achieved in all but four veins (94.5%). Using the Mesh catheter for ablation, PV isolation was achieved in 46 (63%) of the 73 PVs. The mean (RF) ablation time required to achieve complete isolation was 12.4 +/- 6.1 minutes per PV. The Mesh-only approach allowed isolation of all veins in eight (40%) patients. In combination with conventional ablation, successful PV isolation was achieved in 71 (97%) of 73 PVs. No complications attributable to the Mesh ablator occurred in this series. CONCLUSIONS: PV isolation using the Mesh catheter is feasible and may simplify the current PV isolation procedures. With the current catheter design, PV isolation could be achieved in 63% of PVs. A larger Mesh diameter with an over-the-wire design may help improve the acute success rate.

Diagnostic value of endomyocardial biopsy guided by electroanatomic voltage mapping in arrhythmogenic right ventricular cardiomyopathy/dysplasia.

UNLABELLED: Voltage Mapping-Guided Biopsy in ARVC/D. INTRODUCTION: To improve the endomyocardial biopsy (EMB) diagnostic sensitivity for arrhythmogenic right ventricular cardiomyopathy/dysplasia (ARVC/D), we hypothesized a biopsy sampling focused on selected right ventricle (RV) low-voltage areas identified by electroanatomic voltage mapping. METHODS AND RESULTS: The study population (22 patients, 10 men; mean age 34 +/- 10 years) included 11 patients with overt ARVC/D (group A) and 11 patients with suspected ARVC/D (group B), according to both arrhythmic profile and standardized noninvasive diagnostic criteria. In all 22 patients, an RV bipolar voltage mapping was performed with CARTO system sampling multiple endocardial sites (262 +/- 61), during sinus rhythm, with a 0.5-1.5 mV color range setting of voltage display. All 11 (100%) group A patients and 8 of the 11 (73%) group B patients (P = nonsignificant [NS]) presented RV low-voltage areas (<0.5 mV). In 8 group A patients and in all 8 group B patients with a pathological RV voltage map, an EMB focused on the low-voltage areas was performed. In 6 (75%) group A patients and in 7 (87%) group B patients (P = NS), voltage mapping-guided EMB was diagnostic for ARVC/D. In the remaining 3 patients, only nonspecific histological findings were observed. CONCLUSIONS: The results of our study (1) confirm the high diagnostic sensitivity of RV voltage mapping in patients with overt ARVC/D, (2) document a high prevalence of RV low-voltage areas even in patients with suspected ARVC/D, and (3) demonstrate that in patients with clinical evidence or suspicion for ARVC/D, presenting RV low-voltage areas, EMB guided by voltage mapping may provide ARVC/D diagnosis confirmation.

Results of the SCART study: selection of candidates for cardiac resynchronisation therapy.

OBJECTIVE: To prospectively determine whether prespecified electrocardiographic, echocardiographic and tissue Doppler imaging (TDI) selection criteria may predict a positive response to cardiac resynchronisation therapy (CRT). METHODS: In this multicentre, prospective, non-randomised study, 96 heart failure patients with New York Heart Association class III-IV symptoms, an ejection fraction of < or =35%, and at least one marker of ventricular dyssynchrony according to prespecified electrocardiographic, echocardiographic or TDI criteria were enrolled. The primary endpoint was an improvement in the clinical composite score at 6 months. RESULTS: At enrolment, 70 patients fulfilled the electrocardiographic criterion (QRS duration > or =150 ms), 77 patients showed echocardiographic signs of dyssynchrony, and 37 patients met the TDI dyssynchrony criteria. The overall responder rate was 78/96 (81%). In particular, the primary endpoint was reached in 68 patients who fulfilled the echocardiographic criteria as compared with 10 patients who did not (88 vs. 53%, P = 0.001). The patients who met the echocardiographic criteria showed a significant greater reduction in left ventricular end-systolic diameter (P = 0.029) and a higher improvement in quality of life (P = 0.017) than patients who did not. Neither electrocardiographic nor TDI criteria seemed to predict a positive response to CRT. CONCLUSIONS: In our patient population, mechanical indexes of dyssynchrony as assessed by echocardiography appeared to identify CRT responders. Although TDI is useful for evaluating ventricular dyssynchrony after CRT, the prespecified TDI inclusion criteria adopted in this investigation did not increase the number of CRT responders.

Comparison of the effects of cardiac resynchronization therapy in patients with class II versus class III and IV heart failure (from the InSync/InSync ICD Italian Registry).

Cardiac resynchronization therapy (CRT) is recommended for patients with New York Heart Association (NYHA) class III or IV heart failure and wide QRS complexes. The aim of this study was to compare the effects of CRT in patients in NYHA class II with those in NYHA class III or IV. Nine hundred fifty-two patients (188 in NYHA class II) consecutively implanted with biventricular devices and enrolled in a national observational registry were studied. Clinical outcomes were estimated after 12 months of CRT, and long-term survival was assessed. At a median follow-up of 16 months, significantly fewer major cardiovascular events were reported in patients in NYHA class II compared with NYHA class III or IV (rate 13 vs 23 per 100 patient-years of follow-up, p<0.001). The percentage of patients who improved in NYHA class status after 12 months of CRT was lower in those in class II than in those in class III or IV (34% vs 69%, p<0.001), whereas the absolute increase in the ejection fraction was similar (8+/-9% vs 9+/-11%, p=NS), as well as the reductions in end-diastolic diameter (-3+/-8 vs -3+/-8 mm, p=NS) and end-systolic diameter (-4+/-10 vs -6+/-10 mm, p=NS). The NYHA class II group experienced lower all-cause mortality (log-rank test p=0.018). In the 2 groups, patients with major cardiovascular events during follow-up exhibited less or no reverse remodeling compared with those with better long-term clinical outcomes. In conclusion, the results of this study indicate that CRT induced similar improvements in ventricular function in the 2 groups, whereas the improvement in functional status was significantly lower for patients in NYHA class II than for those in class III or IV. A positive effect of CRT on cardiac dimensions was associated with a long-term beneficial effect on disease progression in patients in NYHA class II.

Biventricular upgrading in patients with conventional pacing system and congestive heart failure: results and response predictors.

BACKGROUND: There are few studies on cardiac resynchronization therapy (CRT) in heart failure (HF) patients with preexisting right ventricular (RV) pacing. The purpose of this study was to determine the efficacy of CRT upgrading in RV-paced patients and the predictivity of electromechanical dyssynchrony parameters (EDP) evaluated by standard echocardiography (ECHO) and tissue Doppler imaging (TDI). METHODS: Thirty-eight consecutive patients with HF [New York Heart Association (NYHA) class III or IV, LVEF < 35%], prior continuous RV pacing, and absence of atrial fibrillation were enrolled in the presence of a paced QRS > or = 150 ms and evaluated by ECHO and TDI. A responder was defined as a patient with a favorable change in NYHA class and neither HF hospitalization nor death, plus an absolute increase of LVEF > or = 10 units. RESULTS: At six-months follow-up, the whole study population had significant improvement in symptoms, systolic function, and QRS duration (P < 0.001); 32 (84%) patients had a favorable clinical outcome, 25 (66%) were considered responders according to the previous definition. Postimplant QRS was similarly reduced in both responders and nonresponders, whereas EDP had a significant improvement only in responders (P < 0.05). Using EDP, 23 (79%) patients were responders compared with 2 (22%) patients without mechanical dyssynchrony (P = 0.002). CONCLUSIONS: In HF patients with previous RV pacing, CRT is effective to improve clinical, functional outcome, and LV performance and to reduce electromechanical dyssynchrony in a large proportion of patients. Dyssynchrony evaluated by standard and TDI ECHO can be useful for CRT selection of paced patients.

Endomyocardial biopsy guided by electroanatomic voltage mapping in arrhythmogenic right ventricular cardiomyopathy: a case report.

A positive endomyocardial biopsy (EMB) is a major diagnostic criterion for arrhythmogenic right ventricular cardiomyopathy (ARVC). Nevertheless, its sensitivity is low due to the focal nature of the disease. Moreover, myocardial samples are usually taken from the uncommonly involved interventricular septum to minimize the risk of perforation. In this report, we describe a novel bioptical approach for ARVC diagnosis guided by the identification of right ventricle (RV) affected regions by means of electroanatomical voltage mapping.

Prediction of response to cardiac resynchronization therapy: the selection of candidates for CRT (SCART) study.

BACKGROUND: The aim of this study was to evaluate the ability of baseline clinical and echocardiographic parameters to predict a positive response to CRT. METHODS: We analyzed 6-month data from the first 133 consecutive patients enrolled in a multicenter prospective study. These patients had symptomatic heart failure (HF) refractory to pharmacological therapy (NYHA class II-IV), left ventricular ejection fraction (LVEF) < or =35%, and prespecified electrocardiographic, echocardiographic or tissue Doppler imaging markers of left ventricular (LV) dyssynchrony. RESULTS: After a follow-up period of 6 months, 1 patient died and 13 were hospitalized for worsening HF. There were significant (P < 0.01) clinical, functional, and echocardiographic improvements that included: New York heart Association Class, Quality-of-Life Score, QRS duration, LVEF, LV end-diastolic and end-systolic diameter (LVESD), and severity of mitral regurgitation A positive response was documented in 90/133 (68%) patients who presented an improved clinical composite score associated to an increase in LVEF > or = 5 units. A multivariate analysis identified that a smaller LVESD (OR = 0.957, 95% CI 0.920-0.996; P = 0.030) and longer interventricular mechanical delay (IVMD) (OR = 1.017, 95% CI 1.005-1.029, P = 0.007) as independent predictors of a positive response. Receiver-operating curve analysis showed that a positive response to CRT may be predicted in patients with IVMD > 44 ms (with a sensitivity of 66% and a specificity of 55%) or with LVESD < 60 mm (with a sensitivity of 66% and a specificity of 61%). CONCLUSIONS: Our results confirm the limited value of QRS duration in the selection of patients for CRT. A less-advanced stage of disease and echocardiographic evidence of interventricular dyssynchrony demonstrated to predict response to CRT, while intraventricular dyssynchrony did not predict response.

Pulmonary vein vestibule ablation for the control of atrial fibrillation in patients with impaired left ventricular function.

INTRODUCTION: Congestive heart failure (CHF) and atrial fibrillation (AF) are frequently linked, and when associated produce additive deleterious effects. In this prospective study, the effects of catheter ablation for AF in patients with impaired left ventricular (LV) function are presented. METHODS: Baseline data and clinical outcome have been prospectively collected in 105 consecutive patients who underwent pulmonary vein ablation for the control of AF. We evaluated 40 patients affected by LV dysfunction with ejection fraction (EF)<40% and compared them to the remaining 65 patients with normal ventricular function in terms of changes in LV function, maintenance of sinus rhythm, and quality of life during follow-up. RESULTS: After a mean follow-up of 14+/-2 months, 87% of patients with impaired LV function and 92% of patients with normal ventricular function were in sinus rhythm, with or without antiarrhythmic therapy (P=NS). A significant improvement in LVEF and fractional shortening was documented in patients with CHF (33+/-2% vs 47+/-3%, and 19+/-4% vs 30+/-3%, P<0.01 for both comparisons). Evaluation of exercise capacity and quality of life documented better improvements in patients with CHF compared to patients without CHF. CONCLUSIONS: Catheter ablation in patients with LV dysfunction is feasible, not associated with higher procedural complications, and provides a significant improvement in LV performance, symptoms, and quality of life during follow-up.