A frozen decade: Ten years outcome of atrial fibrillation ablation using a single shot device for pulmonary vein isolation.

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.

Long-term outcomes after cryoballoon pulmonary vein isolation: results from a prospective study in 605 patients.

OBJECTIVES: The purpose of this study was to investigate long-term outcomes of freedom from atrial fibrillation (AF) after pulmonary vein (PV) isolation using cryoballoon ablation with balloon-size selection based on individual PV diameters. BACKGROUND: Data are lacking on long-term outcomes from cryoablation and on the most effective balloon size. METHODS: This was a prospective observational study involving 605 consecutively enrolled patients with symptomatic paroxysmal AF (n = 579) or persistent AF. Cryoballoon size was based on magnetic resonance imaging and/or conventional angiograms. Patients were followed up every 3 months during the first year after discharge and every 6 months in the second year. After 24 months, follow-up was on an outpatient basis with documented AF episodes recorded. RESULTS: The PV isolation was achieved without touch-up in 91.1% of patients, using the smaller balloon in 26.7%, the larger balloon in 25.6%, and both balloons in 47.7% of patients. Follow-up data for >12 months (median 30 months; interquartile range 18 to 48 months) were available for 451 patients, 278 (61.6%) of whom were free of AF recurrence with no need for repeat procedures after the 3-month blanking period. Rates of freedom from AF after 1, 2, and 3 repeat procedures (using cryoballoon or radiofrequency ablation with similar success rates) were 74.9%, 76.2%, and 76.9%, respectively. Use of the smaller balloons or both balloons produced the highest rates of long-term freedom from AF. Phrenic nerve palsy occurred in 12 patients (2%), resolving within 3 to 9 months. CONCLUSIONS: Rates of long-term freedom from AF after cryoballoon ablation are similar to those reported for radiofrequency ablation. A choice between balloons may improve outcomes.

Magnetically guided irrigated gold-tip catheter ablation of persistent atrial fibrillation--techniques, procedural parameters and outcome.

PURPOSE: Magnetically guided irrigated ablation has been introduced for atrial fibrillation (AF) ablation. However, data on ablation of persistent AF is scarce, and first-generation platinum-iridium catheters were burdened by char formation at the catheter tip. Furthermore, energy transmission of these catheters may be suboptimal. Irrigated gold-tip catheters have been introduced to overcome these problems. METHODS: Antral pulmonary vein (PV) isolation (PVAI) was performed using a 5-mm irrigated gold-tip magnetic catheter (power setting, 48 °C maximum, 50 W, 15 s lesion duration; flow-rate, 30 mL/min). The catheter tip was guided by a uniform magnetic field and a motor drive. Left atrial maps were created using an impedance-based left atrial reconstruction and fused with a preprocedural CT or an intraprocedural rotational angiography-based scan. RESULTS: Fifty-seven patients (42 male, 61.9 ± 8.8 years) underwent PVAI for symptomatic, drug-refractory persistent AF. PVAI was performed successfully in all patients confirmed by entrance block. Procedure time (skin-to-skin) was 214 ± 47 min (104-354 min). Fluoroscopy time was 31 ± 21 min. Ablation time was 4,153 ± 1,350 s. No char or thrombus formation was found at the catheter tip. One pericardial tamponade was observed. Freedom from atrial tachyarrhythmias could be achieved in 57.9 % of the patients included in a follow-up of 11.6 ± 4.2 month. There was a trend to a better outcome in patients without previous attempts of AF ablation (n = 48; 60.4 % vs. 44.4 %, p = 0.47). CONCLUSIONS: Remote magnetic navigation for PVAI seems to be safe and feasible using an irrigated gold-tip catheter. Effectiveness of this novel technique can be confirmed by mid-term outcome.

Left atrial lesion formation and volume overload by open irrigation ablation technology during pulmonary vein antrum isolation: acute effects on cardiac hemodynamics.

PURPOSE: Our goal was to evaluate acute effects of left atrial lesion formation and volume overload on hemodynamics during pulmonary vein antrum isolation (PVAI) as it might be a potential cause of acute pulmonary edema. METHODS: In consecutive patients presenting for PVAI, open irrigation ablation was performed (50 W, 48°C, 15 s lesion duration, saline flow rate 30 mL/min). Blood samples were drawn from the left atrium and the pulmonary artery immediately before and 30 min after PVAI. The cardiac output (CO) and stroke volume (SV) were calculated by the method of Fick. RESULTS: We included 61 (27 female, 61 ± 11 years) patients suffering from paroxysmal (px; 33) or persistent (per; 28) atrial fibrillation (AF) in this study. A total of 2,917 ± 242 mL of volume was infused (2,651 ± 223 mL pxAF vs. 3,184 ± 255 mL perAF, (p < 0.01)). Total ablation time was 60 ± 7 min (52 ± 7 min in pxAF vs. 69 ± 8 min in perAF; (p < 0.001)). CO increased from 5.2 ± 1.3 to 6.2 ± 1.5 L/min (p < 0.001) during PVAI (5.7 ± 1.3 to 6.5 ± 1.7 L/min in pxAF; (p < 0.002) and 4.8 ± 1.1 to 5.9 ± 1.2 L/min in perAF; (p < 0.001)). SV increased from 74 ± 24 to 83 ± 21 mL (p < 0.005) during PVAI, and subgroups showed an increase of 82 ± 23 to 88 ± 22 mL in pxAF (p < 0.009) and 62 ± 21 to 76 ± 16 mL in perAF (p < 0.009). CONCLUSIONS: From our preliminary experience, left atrial scarring and volume overload during PVAI do not seem to impact negatively hemodynamics. On the contrary, an improvement in cardiac output was documented acutely independent of type of AF.

Intracardiac echocardiography for registration of rotational angiography-based left atrial reconstructions: a novel approach integrating two intraprocedural three-dimensional imaging techniques in atrial fibrillation ablation.

AIMS: Image integration of three-dimensional (3D) reconstructions of left atrial (LA) and pulmonary vein (PV) anatomy into electroanatomical mapping (EAM) plays a major role in atrial fibrillation (AF) ablation. Point-by-point EAM is commonly used for registration of imported LA and PV anatomy. We aimed to assess the accuracy of intraprocedural rotational angiography-based LA imaging registered by spatial reconstruction of intracardiac echocardiography (ICE) in patients undergoing AF ablation. METHODS AND RESULTS: Twenty-two patients (11 males, 66 ± 12 years) were studied. Reconstructions of LA and PVs based on rotational angiography were registered by a second 3D reconstruction based on ICE. In a second step, EAM points were added to ICE 3D reconstructions. A 3D image of the LA and PVs was reconstructed in all patients by both imaging modalities. Rotational angiography and ICE-based LA 3D reconstructions took 11.5 ± 5.2 and 20.4 ± 11.2 min, respectively. A total of 17 ± 6 two-dimensional ICE fans were used for spatial reconstruction of ICE. The deviation between the two 3D shells was 2.6 ± 0.5 mm. Integration of 78 ± 58 EAM points into ICE 3D reconstruction did not significantly reduce the deviation to rotational angiography-based reconstructions (2.7 ± 0.6 mm). All PVs were isolated successfully. CONCLUSIONS: Intraprocedural 3D reconstruction of LA and PVs for ablation of AF is feasible based on both rotational angiography and ICE. LA reconstructions based on rotational angiography can accurately be registered using 3D ICE shells. Additional EAM does not enhance accuracy. Therefore, registration of rotational angiography-based 3D reconstructions by 3D reconstructions from ICE seems to be an alternative technique to support AF ablation.

Cryoballoon pulmonary vein isolation supported by intracardiac echocardiography: integration of a nonfluoroscopic imaging technique in atrial fibrillation ablation.

INTRODUCTION: cryoballoon ablation has been adopted for pulmonary vein (PV) isolation (PVI) in many centers. Complete occlusion of PV by an adequately sized balloon is crucial for effectiveness of cryoenergy delivery. The aim of this study was to evaluate intracardiac echocardiography (ICE) as an alternative imaging technique compared to angiographic imaging in cryoballoon PVI. METHODS AND RESULTS: a total of 75 PVs were treated in 22 patients (61 ± 13 years, 17 male) undergoing PV cryoballoon ablation for drug refractory paroxysmal atrial fibrillation. Decision for an adequate balloon size was based on diameters of the PV antra assessed by ICE and PV angiography. Per PV 2.4 ± 0.4 cryoenergy pulses were applied. Decision for the balloon size was similar either based upon angiography or on ICE. A single 23 or 28 mm balloon was chosen in 10 and 3 patients, respectively. Two different sized balloons were used in 9 patients. PVI was evaluated after 2 cryoenergy applications. Total occlusion of the PV confirmed by ICE color flow Doppler (CFD) during ablation predicted successful PVI in 70 of 75 (93%) and unsuccessful PVI in 8 of 8 (100%). PV flow registered by pulsed wave Doppler at the PV ostium pre- and postablation was 0.48 ± 0.10 and 0.51 ± 0.12 m/s, respectively (n.s.). PVI was finally confirmed by entrance block in all PVs. No procedural complications occurred. CONCLUSIONS: ICE is a feasible novel imaging technique in cryoballoon ablation procedures. It allows decision for adequate balloon size, exact balloon placement, prediction of acute ablation success, and excludes acute narrowing of PV ostia.

Cardiac resynchronization therapy: long-term alternative to cardiac transplantation?

BACKGROUND: Cardiac transplantation remains the gold standard for treating end-stage heart failure. However, because of donor shortage and posttransplant complications alternative options are needed. METHODS: We investigated the impact of cardiac resynchronization therapy on clinical outcome in 545 patients with left bundle-branch block and interventricular asynchrony, who fulfilled the cardiac criteria for cardiac transplantation listing. Primary end point was heart failure death. Secondary end points were New York Heart Association class, functional (cardiopulmonary exercise tolerance, 6-minute hall walk distance), and morphologic (left ventricular end-diastolic diameter) factors. RESULTS: The average follow-up period was 39.6 months (standard deviation, 26.1 months). In total, 1,784 years of observation were accrued. The percentage of nonresponders (no functional and morphologic improvement during follow-up) was 21.2%. One-year and 3-year freedom from heart failure death was 92.3% and 77.3%, respectively. Functional variables improved, but the left ventricular end-diastolic diameter decreased during the first 6 months of cardiac resynchronization therapy only in patients who survived during follow-up. Under cardiac resynchronization therapy, 42.5% (n = 34) of the cardiac transplantation candidates with atrial fibrillation at baseline returned to sinus rhythm. CONCLUSIONS: Our data suggest that cardiac resynchronization therapy is a reliable long-term therapeutic option for the treatment of end-stage heart failure and intraventricular asynchrony.

Circumferential pulmonary vein isolation with the cryoballoon technique results from a prospective 3-center study.

OBJECTIVES: The purpose of this study was to investigate the efficacy safety of the novel cryoballoon device (Arctic Front, Cryocath, Quebec, Canada). BACKGROUND: Antral pulmonary vein (PV) ablation with radiofrequency energy is widely used as a strategy for catheter ablation of paroxysmal atrial fibrillation (PAF). A novel double lumen cryoballoon catheter was designed for circumferential pulmonary vein isolation (PVI) with the cryoablation technique. METHODS: We consecutively enrolled 346 patients with symptomatic, drug refractory paroxysmal (n = 293) or persistent (n = 53) atrial fibrillation (AF). In all patients, PVI of all targeted PVs was the therapeutic aim. The primary end points of this nonrandomized study were: 1) acute isolation rate of targeted PV; and 2) first electrocardiogram-documented recurrence of AF. The secondary end point was occurrence of PV stenosis or atrio-esophageal fistula. RESULTS: The 1,360 of 1,403 PVs (97%) were targeted with balloons or balloons in combination with the use of Freezor Max (Cryocath). We found that ablation with the cryoballoon resulted in maintenance of sinus rhythm in 74% of patients with PAF and 42% of patients with persistent AF. No PV narrowing occurred. The most frequent complication was right phrenic nerve palsy observed during cryoballoon ablation at the right superior PV. CONCLUSIONS: Pulmonary vein isolation with a new cryoballoon technique is feasible. Sinus rhythm can be maintained in the majority of patients with PAF by circumferential PVI using a cryoballoon ablation system. Cryoablation was less effective in patients with persistent AF than in patients with PAF.

Implantation of active fixation leads in coronary veins for left ventricular stimulation: report of five cases.

BACKGROUND: Securing transvenous left ventricular (LV) pacing leads without an active fixation mechanism in proximal coronary vein (CV) segments is usually challenging and frequently impossible. We investigated how active fixation leads can be safely implanted in this location, how to avoid perforating the free wall of the CV, and how to recognize and respond to perforations. MATERIALS AND METHODS: In five patients with no alternative to LV pacing from proximal CV segments, 4 Fr SelectSecure (Medtronic, Minneapolis, MN, USA) leads, which have a fixed helix, were implanted through a modified 6 Fr guide catheter with a pre-shaped tip (Launcher, Medtronic). RESULTS: Active fixation leads were successfully implanted in proximal CVs in five patients. There were no complications. Acute and chronic pacing thresholds were comparable to those of conventional CV leads. The pre-shaped guide catheter tip remains in close proximity to the myocardial aspect of the CV, directing the lead helix toward a safe implantation site. CONCLUSIONS: If only proximal CV pacing sites are available, 4 Fr SelectSecure leads can be safely implanted through a modified Launcher guide catheter, avoiding more invasive implantation techniques. Other than venous stenting or implantation of leads with retractable tines, SelectSecure leads are expected to remain extractable.

Coronary vein balloon angioplasty for left ventricular pacemaker lead implantation.

OBJECTIVES: Retrospective analysis of five cases of coronary vein balloon angioplasty performed to allow insertion of left ventricular pacing leads. BACKGROUND: Coronary vein stenoses or an insufficient vessel caliber can preclude transvenous placement of coronary vein leads. METHODS: We compared our total patient population (n = 218), in whom we implanted coronary vein leads, to those five patients who required coronary vein angioplasty to allow lead placement. Standard over-the-wire coronary artery balloon angioplasty catheters were used to dilate the vessel to 2.5 mm (n = 3) or 3.5 mm (n = 2). RESULTS: Transvenous lead placement succeeds in >99% of patients. Four cases of target vein stenoses and one case of a vein of insufficient caliber were successfully treated by balloon angioplasty. There were no complications. CONCLUSIONS: Coronary vein angioplasty is an effective and safe technique to permit transvenous left ventricular pacing lead insertion in cases of target vein stenoses or insufficient target vein caliber.

Left heart pacing--experience with several types of coronary vein leads.

Our experience with 121 coronary vein (CV) leads in 116 patients shows that CV leads are the leads of choice for pacing the left ventricle (LV). The information gained from pre-operative venous angiography permits individual selection of the most appropriate lead model for each case. The use of steerable electrophysiology catheters facilitates guide catheter cannulation of the coronary sinus (CS) when the anatomy is difficult and reduces the risk of complications. By selecting the CV lead model most suitable for each individual patient, we achieved successful implantation in 99.1% of patients. In this day and age, epicardial electrodes should be restricted to cases with CS anomalies which make CS cannulation impossible, and to LV lead implantation during heart surgery.