Transcatheter leadless cardiac pacing: The new alternative solution.

INTRODUCTION: A lack of information about the feasibility and safety of leadless pacemaker (LPMs) exists in a fragile population of patients with limited venous anatomy access or conventional pacemaker (PM) contraindication. Accordingly, the goal of this prospective observational study was to report our experience with this new leadless technology in a subset of patients with contraindication or limited venous access. METHODS AND RESULTS: Between May 2015 and July 2016, 14 patients were consecutively included. The indications for initial PM implantation were atrioventricular (AV) block in 10/14 patients (71%), bradyarrhythmia in one (7%), and uncontrolled atrial fibrillation (AFib) requiring AV-node ablation in three (21.5%). AFib was observed in 9 of the 14 patients (64.3%) and 3 were completely dependent with no escape rhythm (21.5%). Normal access pathways via the right or left subclavian veins were occluded due to previous PM implantations and revisions in 4 patients (28.6%) and total vena cava occlusion in 3 (21.4%). End-stage renal disease with hemodialysis was present in 8 (57%) with either local-device infections or presence of long-term implanted dialysis catheters. Evidence of previous bilaterally-infected pectoral tissue was present in 3 patients (21.5%). All procedures were successful (100%) and electrical parameters remained stable over time. No direct pacemaker-related adverse events were reported, including mechanical complications, except for one ventricular fibrillation one day post-implantation under very specific conditions. CONCLUSION: This series demonstrated very stable performance and reassuring safety results during mid-term follow-up in a very fragile population requiring a PM. The Micra LPM constitutes an excellent alternative to the epicardial surgical approach in this very fragile population.

A single-centre experience concerning the safety of Sprint Fidelis defibrillator lead extraction at the time of pulse generator replacement or in case of evidence of lead failure.

BACKGROUND: The reported failure rate of the Sprint Fidelis defibrillator lead (SFDL) has increased more than initially expected, with emerging evidence of accelerating fracture rates. Current consensus guidelines continue to discourage prophylactic lead extraction, citing major complication rates of 1.4-7.3%. Therefore, data relating to the risks of systematic SFDL extraction are lacking, with no methodical extraction protocol reported to date. Moreover, few statistical analyses have identified predictors of SFDL failure. OBJECTIVES: The aims of this single-centre study were: to examine the safety and feasibility of systematic SFDL extraction at the time of pulse generator replacement or in case of lead failure; and to identify predictors of SFDL failure. METHODS: Between January 2005 and October 2007, 218 consecutive patients underwent transvenous SFDL implantation in our centre. RESULTS: During a mean follow-up of 43 ± 15 months, SFDL extraction was performed in 49 patients (22.5%) for the following reasons: inappropriate shocks (n = 21; 9.6%), systematic extraction at time of pulse generator extraction (n = 23; 10.5%), high impedance (n = 3; 1.4%), high SFDL threshold (n = 1; 0.4%) and cardiac device-related infection (n = 1; 0.4%). No severe complications occurred, although two minor complications were reported (lead dislodgments). SFDL fracture was observed in 25 patients (11.5%; 3.2%/year incidence). The only predictor associated with SFDL fracture was the number of leads (P = 0.01). CONCLUSION: In our series, SFDL extraction at the time of pulse generator extraction or in case of evidence of lead failure was feasible and safe. Number of leads was identified as a new predictive factor for SFDL fracture.

Results from the Loire-Ardèche-Drôme-Isère-Puy-de-Dôme (LADIP) trial on atrial flutter, a multicentric prospective randomized study comparing amiodarone and radiofrequency ablation after the first episode of symptomatic atrial flutter.

BACKGROUND: There is no published randomized study comparing amiodarone therapy and radiofrequency catheter ablation (RFA) after only 1 episode of symptomatic atrial flutter (AFL). The aim of the Loire-Ardèche-Drôme-Isère-Puy-de-Dôme (LADIP) Trial of Atrial Flutter was 2-fold: (1) to prospectively compare first-line RFA (group I) versus cardioversion and amiodarone therapy (group II) after only 1 AFL episode; and (2) to determine the impact of both treatments on the long-term risk of subsequent atrial fibrillation (AF). METHODS AND RESULTS: From October 2002 to February 2006, 104 patients (aged 78+/-5 years; 20 women) with AFL were included, with 52 patients in group I and 52 patients in group II. The cumulative risk of AFL or AF was interpreted with the use of Kaplan-Meier curves and compared by the log-rank test. Clinical presentation, echocardiographic data, and follow-up were as follows: age (78.5+/-5 versus 78+/-5 years), history of AF (27% versus 21.6%); structural heart disease (58% versus 65%), left ventricular ejection fraction (56+/-14% versus 54.5+/-14%), left atrial size (43+/-7 versus 43+/-6 mm), mean follow-up (13+/-6 versus 13+/-6 months; P=NS), recurrence of AFL (3.8% versus 29.5%; P<0.0001), and occurrence of significant AF beyond 10 minutes (25% versus 18%; P=0.3). Five complications (10%) were noted in group II (sick sinus syndrome in 2, hyperthyroidism in 1, and hypothyroidism in 2) and none in group I (0%) (P=0.03). CONCLUSIONS: RFA should be considered a first-line therapy even after the first episode of symptomatic AFL. There is a better long-term success rate, the same risk of subsequent AF, and fewer secondary effects.

Cavotricuspid isthmus angiography predicts atrial flutter ablation efficacy in 281 patients randomized between 8 mm- and externally irrigated-tip catheter.

AIMS: Radiofrequency ablation (RFA) of cavotricuspid isthmus (CTI)-dependent atrial flutter can be performed using various types of ablation catheters. Recent evaluations comparing externally cooled-tip RFA (ecRFA) catheters and large-tip (8 mm) catheters found that ecRFA catheter may have a higher efficacy for CTI ablation. The aim of this prospective study was to compare both catheters by stratifying on CTI morphology in order to explain, in part, the discrepancies between previous randomized studies, and to validate predictive factors of difficult CTI ablation on clinical, echocardiographic, and angiographic data. METHODS AND RESULTS: Over a period of 24 months, 281 patients were included and stratified on CTI morphology: 'straight', 'concave', and 'pouch-like recess'. In straight CTI (n=150), the duration of application time with a median of 6 min [interquartile range (IQR) 4-9] vs. a median of 12 min (IQR 16-19; P<0.0001) and the duration of X-ray exposure with a median of 6 min (IQR 4.4-9.7) vs. a median of 10.4 min (IQR 7-17; P<0.0001) were significantly lower with an 8 mm-tip when compared with ecRFA catheter. In contrast, in concave CTI (n=95), a trend towards both shorter application time with a median of 12.5 min (IQR 6-23) vs. a median of 19 min (IQR 7-28; P=0.08) and X-ray duration exposure with a median of 10.4 min (IQR 6-20) vs. a median of 13 min (IQR 8-24; P=0.08) with an ecRFA catheter when compared with 8 mm-tip catheter were evidenced. No significant difference was shown between 8 mm-tip and ecRFA catheters in the pouch-like recess group (n=36). Predictive factors of difficult ablation include right CTI length and morphology. CONCLUSION: This study demonstrates that the 8 mm-tip catheter is more effective for ablation in case of a straight angiographic isthmus morphology and that the ecRFA catheter tends to be more effective in case of concave angiographic isthmus morphology. Thus, angiographic isthmus evaluation may predict both the effectiveness of an RF catheter, and the risk of an expensive crossover. These data may explain, in part, the discrepancies of previous studies comparing both catheters.

Simplified cardiac resynchronization implantation technique involving right access and a triple-guide/single introducer approach.

BACKGROUND: Biventricular pacing is useful for patients with congestive heart failure but has the disadvantage of being a long, user-dependent, highly technical procedure. OBJECTIVES: The purpose of this study was to simplify the procedure. The simplified technique consists of sinus (CS) venography prior to implantation, direct coronary access for the left ventricular (LV) lead without use of a left-heart delivery system, and triple-guide/one introducer cephalic vein access as the first approach in patients presenting in sinus rhythm. METHODS: A cephalic cutdown was performed, and a steerable hydrophilic guidewire was introduced in the cephalic vein. A 9Fr introducer was advanced over the guidewire, and two other guides were inserted through the introducer. This technique allowed for insertion of a right ventricular lead, an LV lead, and an atrial lead. RESULTS: One hundred three patients were evaluated from January 2002 to September 2004. Four implants failed (3.9%). The 7Fr LV lead was successfully placed in 99 of 103 patients (96.1%) directly via the 9Fr introducer, without use of a dedicated left-heart delivery system. The final position was lateral in 59 patients, posterolateral in 33, posterior in 4, and anterolateral in 3. Sixty patients were in sinus rhythm, 13 were in atrial fibrillation, and 26 had a previous pacemaker (n = 21) or defibrillator (n = 5). Triple cephalic vein access was possible in 48 of the patients in sinus rhythm (80%). Procedure parameters were as follows: LV threshold 0.9 +/- 0.7 V, LV wave amplitude 15 +/- 8 mV, LV impedance 790 +/- 232 Omega, skin-to-skin procedure time 76 +/- 33 minutes, and fluoroscopy time 23 +/- 19 minutes. Ten complications (10.1%) occurred: 7 lead dislodgments (3 within 48 hours and 4 within 6 months) requiring repositioning (7.1%), 1 subacute local infection requiring explantation (1%), 1 phrenic nerve stimulation (1%), and 1 pneumothorax (1%). The long-term success of biventricular pacing was 93.1%. CONCLUSIONS: This study demonstrates that cardiac resynchronization therapy implantation can be simplified with the combined use of a steerable hydrophilic guidewire, three guides, and one introducer via a right cephalic vein, without use of a left-heart delivery system. The triple cephalic vein approach yields an 80% implant success rate for patients in sinus rhythm. The long-term success of biventricular pacing was 93.1%.