Multicenter experience with the Evolution RL mechanical sheath for lead extraction using a stepwise approach: Safety, effectiveness, and outcome.

BACKGROUND: In addition to the Evolution RL sheath, tools by Cook Medical (Bloomington, IN, USA), supporting lead extraction (LE), are available. Data on their use are not reported in detail in previous studies. Moreover, data regarding outcome are lacking. The aim was to evaluate the safety and effectiveness of the Evolution sheath (Evolution RL and Evolution Shortie, Cook Medical) by using a stepwise approach with the available extraction tools and the outcome. METHODS: A total of 393 leads in 198 consecutive patients were removed with the Evolution RL sheath and ancillary tools using a stepwise approach. RESULTS: The main indication for LE was infection in 125 (63.1%) cases. The mean implant duration was 95.4 ± 59.7 months. According to our stepwise approach, the Evolution Shortie RL sheath was used in all cases and complete LE was achieved in 24 (12.2%) cases. The Evolution RL was used in 174 (87.8%) cases and the SteadySheath Evolution tissue stabilization sheath (Cook Medical) in 87 (44%) because of tenacious fibrosis anchored targeted leads. Compression coil (OneTie, Cook Medical) was used in 141 (71%) cases. Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 97%, 99%, and 99.5%, respectively. One major complication (0.5%) and 10 (5%) minor complications were encountered. During a mean time follow-up of 12 ± 9 months, 14 (7%) patients died. Predictors of mortality included impaired renal function (HR 5.7; 95% CI 1.9-17.6; P = 0.002), extraction because of infection (hazard ratio [HR] 4.0; 95% confidence interval [CI] 1-18.1; P = 0.045), and diabetes (HR 3.2; 95% CI 1.1-9.8; P = 0.036). CONCLUSIONS: Lead extraction using the Evolution RL bidirectional rotational mechanical sheath and ancillary tools in a systematic stepwise approach was effective and safe.

Electrical storm in dilated cardiomyopathy treated using epicardial radiofrequency ablation as a first line therapy.

We report a patient with non-ischemic dilated cardiomyopathy and low left ventricular systolic function (28%) presenting with an electrical storm originated in epicardial scar and ablated by radiofrequency. This case report suggests that a strategy of epicardial catheter ablation is reasonable for the patient presenting with electrical storm related to structural disease with a low left ventricular ejection fraction.

Stepwise ablation approach versus pulmonary vein isolation in patients with paroxysmal atrial fibrillation: Randomized controlled trial.

BACKGROUND: Pulmonary vein isolation (PVI) is a central procedure for the treatment of paroxysmal atrial fibrillation (PAF). However, in patients with PAF and structural atrial disease, PVI may fail and cause progressive atrial remodeling, often leading to persistent/permanent atrial fibrillation. OBJECTIVE: We performed a prospective, single-blind, 2-center randomized controlled trial to compare the efficacy of PVI alone with that of PVI plus stepwise ablation in achieving sinus rhythm and nonatrial arrhythmia inducibility in patients with PAF refractory to antiarrhythmic therapy. METHODS: Patients were randomized to perform a first catheter ablation procedure either through PVI alone or through PVI plus substrate modification in stepwise ablation. Data were recorded at 3, 6, and 12 months after both ablation procedures. Patients who experienced atrial fibrillation/atrial tachycardia (AF/AT) recurrence were encouraged to undergo repeat ablation using the technique of the first ablation procedure. RESULTS: A total of 150 patients were enrolled (mean age 62.8 ± 8.7 years; 92 (61.3%) men; 104 (69.3%) hypertensive; AF mean duration 10.7 months), with 75 patients in each group. After 12 months of the first procedure, patients who were converted to sinus rhythm using stepwise ablation showed a significantly lower rate of AF/AT recurrence (26.7%) than did those who were treated using PVI alone (46.7%; P < .001). Similar results were observed in the 52 patients who underwent a second catheter ablation procedure. After adjusting for several potential confounders, the hazard ratio of 12-month AF/AT recurrence after the first ablation procedure was 0.53 (95% confidence interval 0.30-0.91) for those treated using stepwise ablation. CONCLUSION: In addition to PVI, stepwise ablation achieving sinus rhythm and nonatrial arrhythmia inducibility has relevantly improved the clinical outcome of the PAF control strategy.

Impact of atrial fibrillation termination mode during catheter ablation procedure on maintenance of sinus rhythm.

BACKGROUND: Catheter ablation is a common and effective procedure for addressing atrial fibrillation (AF) refractory to antiarrhythmic drugs. AF can be terminated in 3 modes: (1) directly into sinus rhythm (SR); (2) evolving into regular atrial tachycardia (AT) and subsequently into SR; and (3) after direct current (DC) cardioversion if AF persists. Scarce data are available on the relationship between clinical outcomes and termination mode after 1 catheter ablation. OBJECTIVE: The purpose of this study was to evaluate for the first time the association between 1-year ablation efficacy and termination mode after repeated catheter ablations in patients presenting with persistent or long-standing persistent AF. METHODS: This prospective study involved 400 consecutive patients (age 62.7 ± 7.2 years) who underwent catheter ablation for drug-refractory persistent AF (4.6 ± 2.4 months) using a stepwise ablation approach. RESULTS: AF was terminated by radiofrequency application directly into SR in 135 patients; passing through AT into SR in 195 patients; and through DC cardioversion in 70 patients. After 1-year follow-up with repeated Holter monitoring, the percentages of SR maintenance were 72.6%, 80.0%, and 28.6%, respectively (P < .001). Compared with the subjects who were converted directly into SR, the adjusted hazard ratios (HRs) of SR maintenance were significantly lower for those who required DC cardioversion (HR = 0.54; P < .001) and higher for those converted through AT (HR = 1.69; P = .027). The latter association was even stronger in the 104 subjects who required a second procedure (HR = 6.25; P = .001). CONCLUSION: Termination of AF through AT during catheter ablation was more effective than both DC shock and direct SR in maintaining stable SR 1 year after both the first and the second procedures.

A new approach for catheter ablation of atrial tachycardia following atrial fibrillation ablation.

OBJECTIVE: The origin and mechanisms of focal and macro-re-entrant atrial tachycardia occurring after ablation of paroxysmal or persistent atrial fibrillation are difficult to determine and are often the cause of distress for both patients and electrophysiologists. The purpose of this study was to describe a novel practical approach which would be helpful in planning the treatment of atrial tachycardia in patients who had received prior atrial fibrillation ablation. We used an algorithm which aims to facilitate mapping and ablation strategies, using both conventional electrophysiological tools and a three-dimensional electroanatomic approach. METHODS: We investigated a series of 40 patients with atrial tachycardia who had undergone a prior ablation procedure for paroxysmal or persistent atrial fibrillation with a step-wise approach. This approach consisted of four steps: the use of a decapolar catheter to assess the coronary sinus and an entrainment map to evaluate the cavotricuspid isthmus (CTI). If the CTI was not involved, we used a 20-pole dual-loop circular mapping catheter, AFocusII DL, to map the left atrium chamber rapidly during the rhythm of interest. We identified the target entrainment at the putative channels and performed catheter ablation at the critical isthmus of these macrocircuits until the restoration of sinus rhythm. RESULTS: Seventy-five atrial tachycardias were identified in 40 consecutive patients (1.9 ±â€Š1.6 per patient). In 48, the mechanism was macro-re-entry, and the remaining 27 were focal. During 18 months of follow-up, the treated arrhythmia recurred in only three patients, whereas in another four patients, a different atrial tachycardia was observed. The remaining 33 patients maintained sinus rhythm. CONCLUSION: The increased acquisition speed by AFocusII DL facilitated the reconstruction of the geometric chamber, and the generation of an isochronal activation map reduced processing time and fluoroscopy time per patient, together with the radiation exposure and patient radiation dose. A novel algorithm combining both conventional electrophysiology and a three-dimensional electroanatomic approach for rapid diagnosis, accurate mapping and ablation of iatrogenic atrial tachycardias showed high reproducibility and a satisfactory overall success rate.

Transcatheter patch occlusion of the left atrial appendage using surgical adhesives in high-risk patients with atrial fibrillation.

OBJECTIVES: The efficacy of left atrial appendage (LAA) occlusion using the Transcatheter Patch (TP) (Custom Medical Devices, Athens, Greece) in conjunction with surgical adhesives was assessed. BACKGROUND: The TP is a bioabsorbable device that can be adjusted for the shape and size of the LAA without the risk of perforation. It is attached by a surgical adhesive and is released in 45 min. METHODS: Occlusion of the LAA was performed in 20 high-risk patients, 59 to 89 years of age, with atrial fibrillation. A 2-stage polyethylene glycol surgical adhesive was applied to the distal half of the device. Activation of the adhesive was achieved by direct injection of alkaline solution. Fluoroscopy and transesophageal echocardiography only were used for device placement in 17 patients. In 3 patients, angiography was used as well. Follow-up transesophageal echocardiography was performed upon discharge. RESULTS: The procedure was successful in 17 cases. In the 3 patients in whom angiography was performed, the patch did not attach and was retrieved. In 1 case, the patch was placed beyond the mouth of the appendage, resulting in a residual opening. There was further improvement of the occlusion rate on the follow-up transesophageal echocardiography. There was 1 complication related to the procedure, namely, thrombus was released from the long sheath in the left atrium upon withdrawal and required treatment to be dissolved. No recurrent strokes were reported. CONCLUSIONS: Occlusion of the LAA by the TP is feasible and effective in most patients with atrial fibrillation at high risk for embolic stroke. Angiography before placement probably affects patch adhesion and is contraindicated.

Automatic adjustment of stimulation output in resynchronization therapy: impact and effectiveness in clinical practice.

BACKGROUND: Algorithms for automatic pacing output adjustment have been implemented in pacemakers and implantable defibrillators (ICD) and recently in cardiac resynchronization therapy defibrillators (CRT-D). We assessed the impact and effectiveness of these automatic features. METHOD AND RESULTS: We prospectively enrolled patients successfully implanted with the following Medtronic CRT-Ds: Concerto [with automatic left ventricular (LV) output management algorithm], Consulta [automatic management of atrial, right ventricular (RV) and LV voltage], and Sentry (only manual voltage adjustments). Patients with complete device data available for at least 12 months were included in the analysis. We analysed data from 739 patients (360 Sentry, 335 Concerto, 44 Consulta). During the first 6 months, the LV pacing amplitude underwent more frequent adjustments in Concerto (63%, P< 0.001) and Consulta (64%, P= 0.047) patients than in Sentry (48%). Similarly, RV and atrial amplitude at 6 months differed from the pre-discharge value more frequently in Consulta (61 and 50%, respectively) than in Sentry patients (33 and 28%, both P< 0.01). The LV pulse amplitude for Concerto and the voltages in the three chambers of Consulta were significantly lower than the corresponding values programmed in Sentry at 6 and 12 months. The proportion of CRT-D interrogations involving manual reprogramming was 97 ± 8% for Sentry, 79 ± 20% for Concerto, and 56 ± 16% for Consulta (all P< 0.001). CONCLUSIONS: Algorithms for the automatic management of the pacing output reduced pacing output in comparison with the standard manual management approach, with potential optimization of battery longevity. Moreover, they reduced the need to manually reprogram CRT-Ds, suggesting the possibility to simplify CRT-D management and facilitate remote monitoring.