Safety, efficacy, and reproducibility of cavotricuspid isthmus ablation guided by the ablation index: acute results of the FLAI study.

AIMS: Ablation index (AI) is a marker of lesion quality during catheter ablation that incorporates contact force, time, and power in a weighted formula. This index was originally developed for pulmonary vein isolation as well as other left atrial procedures. The aim of our study is to evaluate the feasibility and efficacy of the AI for the ablation of the cavotricuspid isthmus (CTI) in patients presenting with typical atrial flutter (AFL). METHODS AND RESULTS: This prospective multicentre non-randomized study enrolled 412 consecutive patients with typical AFL undergoing AI-guided cavotricuspid isthmus ablation. The procedure was performed targeting an AI of 500 and an inter-lesion distance measurement of ≤6 mm. The primary endpoints were CTI 'first-pass' block and persistent block after a 20-min waiting time. Secondary endpoints included procedural and radiofrequency duration and fluoroscopic time. A total of 412 consecutive patients were enrolled in 31 centres (mean age 64.9 ± 9.8; 72.1% males and 27.7% with structural heart disease). The CTI bidirectional 'first-pass' block was reached in 355 patients (88.3%), whereas CTI block at the end of the waiting time was achieved in 405 patients (98.3%). Mean procedural, radiofrequency, and fluoroscopic time were 56.5 ± 28.1, 7.8 ± 4.8, and 1.9 ± 4.8 min, respectively. There were no major procedural complications. There was no significant inter-operator variability in the ability to achieve any of the primary endpoints. CONCLUSION: AI-guided ablation with an inter-lesion distance ≤6 mm represents an effective, safe, and highly reproducible strategy to achieve bidirectional block in the treatment of typical AFL.

Conservative Management of Uncomplicated Acute Type B Intramural Hematoma of the Aorta Not Always Is the Right Solution.

The natural course of intramural hematoma (IMH) of the aorta remains unpredictable and despite an increasing amount of literature reports its treatment is still debatable. IMH typically is diagnosed by computed tomography that has permitted to identify specific images whose onset, in uncomplicated cases, appears to be associated to a dismal prognosis. We report on a case series of acute uncomplicated type B IMH in which early detection of such findings, given the expected poor prognosis associated to the aorta-related mortality, suggests the need to shift toward an aggressive endovascular aortic repair in this subset of patients.

Contiguity Between Ablation Lesions and Strict Catheter Stability Settings Assessed by VISITAGTM Module Improve Clinical Outcomes of Paroxysmal Atrial Fibrillation Ablation　- Results From the VISITALY Study.

BACKGROUND: Our aim was to evaluate the clinical outcome of paroxysmal atrial fibrillation (AF) ablation with contact force technology, using an automated lesion tagging system (VISITAGTM module) with strict criteria of catheter stability.Methods and Results:We enrolled 200 consecutive patients who underwent pulmonary vein isolation (PVI) in 11 centers and were followed up for 12 months. The stability setting was within 3 mm for ≥10 s and for ≥15 s in 47% and 53% of patients, respectively. A mean of 67.2±21.9 VISITAGs was acquired. Freedom from atrial tachyarrhythmias at follow-up was 77.5% (155/200), and the contiguity between lesions was associated with a higher chronic success rate (96% vs. 77.1%; log-rank P=0.036). Radiofrequency (RF), fluoroscopy times, and recurrence rates at the 12-month follow-up were significantly lower than in a comparison group of 80 patients without VISITAGTM module (42.7±14.5 vs. 50.9±23.6 min; P=0.032; 11.6±7.8 vs. 18.4±12.8 min; P=0.003 and 22.5% vs. 41.2%; P=0.02). Two major complications (1 cardiac tamponade and 1 minor stroke) were observed only in the control group. CONCLUSIONS: Paroxysmal AF ablation with contact force technology and strict criteria of stability using the VISITAG module was a safe procedure, associated with an improvement in efficiency and a reduction of atrial tachyarrhythmia recurrence at the 12-month follow-up compared with manual annotation. Contiguity between lesions seemed to enhance effectiveness outcomes.

Transcatheter retrieval of Amplatzer Septal Occluder device embolized into the abdominal aorta.

The use of Amplatzer Septal Occluder device has become an alternative to surgical procedure in selected group of patients affected by atrial septal defect. Percutaneous closure of atrial septal defect has emerged as a low morbidity procedure but, at the same time, showed various complications associated to the device itself. Although embolization to the abdominal aorta is only sporadic reported, it could represent a potential vascular disaster and usually is treated by surgery. Herein, we report on the fourth, in English literature, successfully total transcatheter retrieval of an Amplatzer Septal Occluder device complicated by acute embolization into the abdominal aorta and propose a practical endovascular manoeuvre to address disc removal.

Predictors of Zero X-Ray Ablation for Supraventricular Tachycardias in a Nationwide Multicenter Experience.

BACKGROUND: This multicenter, prospective study evaluated the determinants of zero-fluoroscopy (ZFL) ablation of supraventricular tachycardias. METHODS AND RESULTS: Four hundred thirty patients (215 male, 55.4±22.1 years) with indication to electrophysiological study or ablation of supraventricular tachycardias were enrolled. All participating physicians agreed to follow the as low as reasonably achievable policy. A procedure was defined as ZFL when no fluoroscopy was used. The total fluoroscopy time inversely correlated to the number of procedures previously performed by each operator since study start (r=-0.112; P=0.02). Two hundred eighty-nine procedures (67.2%) were ZFL; multivariable analysis identified as predictors of ZFL: procedure after the 30th for each operator, compared with procedures up to the ninth (P=0.011; hazard ratio, 3.49; 95% confidence interval [CI], 1.79-6.80); the type of arrhythmia (P=0.031; electrophysiological study and atrioventricular nodal reentry tachycardia ablation having the highest probability of ZFL; hazard ratio, 6.87; 95% CI, 2.08-22.7 and hazard ratio, 2.02; 95% CI, 1.04-3.91, respectively); the operator's (P=0.002) and patient's age (P=0.009). Among operators, achievement of ZFL varied from 0% to 100%; 8 (22.8%) operators achieved ZFL in <25% of their procedures; 17 (48.6%) operators achieved ZFL in >75% of their procedures. The probability of ZFL increased by 2.8% (hazard ratio, 0.98; 95% CI, 0.97-0.99) as patient's age decreased by 1 year. Acute procedural success was obtained in all cases. CONCLUSIONS: The use of 3-dimensional mapping system completely avoided the use of fluoroscopy in most cases, with very low fluoroscopy time in the remaining and high safety and effectiveness profiles. Achievement of ZFL was predicted by the type of arrhythmia, operator's experience, and patient's age.

Pulsatile ECMO and VAD: a dual use of a new device in pediatric cardiac patients.

The purpose of this investigation was to present the first European clinical experience with the new MEDOS DELTASTREAM DP1 used in pulsatile extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD) options in the pediatric population. Between January 2002 and April 2006, 11 patients required ECMO and 5 patients received a left VAD (LVAD) in the San Vincenzo Hospital. Indications were postcardiotomy heart failure in 15 patients and fulminant myocarditis in one patient. ECMO was established in all patients by cannulation of the right atrium and ascending aorta. LVAD was instituted by cannulation of the left atrium and ascending aorta. The DP1, an extracorporeal rotary blood pump, was used as an ECMO and an LVAD device. The pump features a diagonal-flow impeller and can be used for both continuous and pulsatile modes of perfusion. Priming volume of the pump was approximately 30 ml, with a flow rate of up to 8 l/min. Ten patients were discharged from ECMO and four from VAD. In the ECMO group, one patient died of peritonitis while on ECMO and two patients died on days 3 and 4 after weaning because of persistent pulmonary hypertension and major neurologic complications. In the VAD group, one patient died of low output syndrome 9 days after weaning. A 12-year-old patient was successfully given transplantation on day 8 of ECMO support and discharged on day 30 after heart transplant. All other patients were discharged. Three pumps were changed for pump failure and one pump was electively replaced because of improper anticoagulation management. No other thromboembolic adverse events occurred. Our results suggest that the MEDOS DELTASTREAM DP1 pulsatile pump system can be used as an ECMO or a VAD support. The opportunity to utilize pulsatile flow in postcardiotomy cardiogenic shock significantly improved the outcomes by producing more physiologic hemodynamics and superior end organ function. Easy implantation and simple management of this device represents the major advantage.

Impact of transseptal puncture site on acute and mid-term outcomes during cryoballoon ablation: a comparison between anterior, medial and posterior transatrial access.

BACKGROUND: Cryoballoon ablation (CBA) (Arctic Front, Medtronic, USA) has proven very effective in achieving pulmonary vein isolation (PVI). Different transseptal (TS) puncture sites might influence CBA procedure. The aim of the present study was to analyze the influence of different TS puncture sites (anterior, medial and posterior) on the acute and midterm outcomes of CBA in a series of patients undergoing PVI for drug resistant AF. METHODS AND RESULTS: A total 103 patients (78 males, mean age: 57 ± 13 years) formed the study group. Transseptal punctures were performed in the anterior, medial and posterior portion of the FO in 41 (39.8%), 35 (34%) and 27 (26.2%) patients respectively. We found no statistical significant difference between the various sites of TS puncture in 1) the grade of PV occlusion (p = ns), the rate of PV isolation (p = ns), freedom from AF at a mean 12 month follow-up (p = ns) and complication rates (p = ns). Mean grade of occlusion was slightly lower in the RIPV when puncturing in the posterior FO but did not reach statistical significance. Mean procedural and fluoroscopy times were significantly lower when using the inner lumen mapping catheter (ILMC) (Achieve, Medtronic, USA) than the circular mapping catheter (CMC) (Lasso, Biosense Webster, California, USA) (107.24 mn vs 97.74 (p ≤ 0.001) and 25.7 mn vs 19.2 mn (p ≤ 0.001)). CONCLUSION: Different sites of TS puncture on the horizontal axis of the FO (anterior, medial and posterior) did not influence grades of PV occlusion, rates of isolation, mid-term outcome and rates of complications during CB ablation.

An observational study of CoSeal for the prevention of adhesions in pediatric cardiac surgery.

We sought to evaluate the utility and safety of CoSeal Surgical Sealant (Baxter) for the prevention of cardiac adhesions in children. Seven cardiac surgery centers in Europe recruited consecutive pediatric patients requiring primary sternotomy for staged repair of congenital heart defects. Exclusion criteria included immune system disorder, unplanned reoperation, or reoperation within three months of primary repair. CoSeal was sprayed onto the surface of the heart at the end of surgery. Evaluation of adhesions took place at first reoperation. Data on safety, duration of surgery, and ease of CoSeal use were also collected. Seventy-nine pediatric patients were recruited between February 2005 and September 2007. Of these, 76 underwent major surgery to repair a wide range of congenital heart defects. Thirty-six patients underwent reoperation >3 months after primary repair, and were included in the efficacy analysis. Mean adhesions score was 8.3 (standard deviation [S.D.] 2.4; range 7-16). Six adverse events (5 serious) were possibly/definitely attributed to CoSeal. CoSeal's ease of use at primary operation was graded by surgeons as 12.1 mm (S.D. 9.8) on a visual analog scale of 0 ('very easy') to 100 mm ('very difficult'). Results of this prospective uncontrolled trial justify further investigation in a randomized, controlled trial.

Bidirectional Glenn and antegrade pulmonary blood flow: temporary or definitive palliation?

BACKGROUND: We sought to investigate the role of the bidirectional Glenn with antegrade pulmonary blood flow in the surgical history of children with univentricular hearts. METHODS: A series of 246 patients, from three joint institutions, having univentricular heart with restricted but not critical pulmonary blood flow received a bidirectional cavopulmonary shunt with additional forward pulmonary blood flow. All patients have been studied according to their progression, or not, to Fontan operation. Two hundred and eight (84.5%) patients underwent bidirectional cavopulmonary anastomosis as primary palliation. Twenty patients (8.1%) with previous pulmonary artery banding were also enrolled in the study. Patients who had received additional pulmonary blood flow through a previous systemic to pulmonary artery shunt for the critical pulmonary blood flow were excluded. RESULTS: No in-hospital death occurred. Follow-up was complete at 100%. Mean follow-up was 4.2 +/- 2.8 years (range, 6 months to 7 years). During the observational period 73 (29.7%) patients, considered optimal candidates, underwent Fontan completion for increasing cyanosis and (or) hematocrit and (or) fatigue with exertion. Three patients expired after total cavopulmonary connection (3 of 73; 4.1% mortality rate). The remaining 173 (70.3%) patients are alive with initial palliation. All patients were still well palliated with an arterial oxygen saturation at rest about 90%. CONCLUSIONS: According to our experience and results, bidirectional Glenn with antegrade pulmonary blood flow may be an excellent temporary palliation prior to a Fontan operation, which can be performed at the onset of symptoms. Bidirectional Glenn may also be the best possible palliation for a suboptimal candidate for Fontan.

Implantation of a Berlin Heart as single ventricle by-pass on Fontan circulation in univentricular heart failure.

The clinical management of ventricular failure after the Fontan operation presents a formidable challenge to surgeons. We report our experience with successful implantation of a Berlin Heart EXCOR ventricular assist device as a bridge to transplantation in a child with Fontan circulation.