In vivo Lesion Index (LSI) validation in percutaneous radiofrequency catheter ablation.

INTRODUCTION: Lesion Index (LSI) has been developed to predict lesion efficacy during radiofrequency (RF) catheter ablation. However, its value in predicting lesions size has still to be established. The aim of our study was to assess the lesions size reproducibility for prespecified values of LSI reached during RF delivery in an in vivo beating heart. METHODS: Ablation lesions were created with different values of LSI in seven domestic pigs by means of a contact force-sensing catheter (TactiCathTM , Abbott). Lesions were identified during RF delivery by means of a three-dimensional mapping system (EnSiteTM Precision, Abbott) and measured after heart explantation. Histology was carried out after gross examination on the first three lesions to confirm the accuracy of the macroscopic evaluation. RESULTS: A total of 64 myocardial lesions were created. Thirty-nine lesions were excluded from the analysis for the following reasons: histological confirmation of macroscopic lesion measurement (n = 3), transmurality (n = 24), unfavorable anatomic position (n = 10), not macroscopically identifiable (n = 2). In a final set of 25 nontransmural lesions, injury width and depth were, respectively, 4.6 ± 0.6 and 2.6 ± 0.8 mm for LSI = 4, 7.3 ± 0.8 and 4.7 ± 0.6 mm for LSI = 5, and 8.6 ± 1.2 and 7.2 ± 1.1 mm for LSI = 6. A strong linear correlation was observed between LSI and lesion width (r = .87, p < .00001) and depth (r = .89, p < .00001). Multiple linear regression analysis identified LSI as the only ablation parameter that significantly predicted lesion width (p < .001) and depth (p < .001). CONCLUSION: In our in vivo study, LSI proved highly predictive of lesion size and depth.

Prospective Evaluation of Lesion Index-Guided Pulmonary Vein Isolation Technique in Patients with Paroxysmal Atrial Fibrillation: 1-year Follow-Up.

INTRODUCTION: Pulmonary vein isolation (PVI) using contact force (CF) sensing ablation catheters currently relies on CF and force-time integral (FTI) guidelines. Such measurement of lesion effectiveness still lacks information on current delivery to the tissue, influenced by system impedance and power. Lesion Index (LSI) is a multi-parametric index incorporating CF and radiofrequency current data across time. We aimed to prospectively assess the efficacy of an LSI-guided approach to PVI in patients with paroxysmal atrial fibrillation (PAF). METHODS AND RESULTS: The study prospectively enrolled 28 consecutive patients with PAF undergoing PVI with a CF sensing catheter (TactiCathTM, Abbott). LSI-guided ablation target was adapted according to the mean regional thickness of pulmonary vein antra (PVA): LSI range 5.5-6 was pursued in the anterior and septal portions of PVA, 5-5.5 elsewhere. Data from 32 consecutive PAF patients who underwent PVI ablation with a non-CF guided approach (NCF-group) were retrospectively collected for comparison of procedural and clinical outcome.AF-free survival rate at follow-up (17±6 months) was higher for LSI-guided group than NCF-group (89.3% vs 65.6%, p=0.037), with no increase in periprocedural complication rate (no tamponades or other major adverse events reported). Among 1126 lesions with LSI within target range (5-6), average CF was >10g and <30g for 976 lesions (86.7%). Moreover, 1015 lesions (90.1%) had FTI>400gs, but with wide distribution: 30.2% within 400-500gs, 30.0% within 501-600gs, 29.9% over 600gs. CONCLUSION: In this first prospective study, LSI-guided PVI improved clinical outcome without any increase in complication rate when compared with standard, non-LSI-guided approach.

In Vitro Validation of the Lesion Size Index to Predict Lesion Width and Depth After Irrigated Radiofrequency Ablation in a Porcine Model.

OBJECTIVES: In an in vitro model, the authors tested the hypotheses that: 1) lesion dimensions correlate with lesion size index (LSI); and 2) LSI could predict lesion dimensions better than power, contact force (CF), and force-time integral (FTI). BACKGROUND: When performing radiofrequency (RF) catheter ablation for cardiac arrhythmias, reliable predictors of lesion quality are lacking. The LSI is a multiparametric index incorporating time, power, CF, and impedance recorded during ablation. METHODS: RF lesions were created on porcine myocardial slabs by using an open-tip irrigated catheter capable of real-time monitoring of catheter-tissue CF. Initially, 3 power settings of 20, 25, and 30 W were used with a fixed CF of 10 g. A fixed power of 20 W was then set with a CF of 20 and 30 g, thereby yielding a total of 5 ablation groups. In each group, LSI values of 5, 6, 7, and 8 were targeted. Sixty RF lesions were created by using 20 ablation protocols (3 lesions for each protocol). RESULTS: Lesion width and depth were not correlated with power or CF, but the results significantly correlated with FTI (p < 0.01) and LSI (p < 0.0001). Four steam pops occurred with power set at 30 W; no pops were noted with 20 or 25 W even when high LSI values were targeted. CONCLUSIONS: In this in vitro model, FTI and LSI predicted RF lesion dimensions, whereas power and CF did not. The LSI predictive value was higher than that of FTI. Steam pops occurred only using high ablation power levels, regardless of the targeted LSI.

A Nonfluoroscopic Technique for Coronary Arteries Three-Dimensional Mapping during Epicardial Ventricular Tachycardia Ablation.

When performing epicardial ablation of ventricular tachycardia (VT), caution must be taken not to damage the coronary arteries. We report a case in which a new, nonfluoroscopic technique for incorporating an accurate, real-time reconstruction of the main coronary vessels into a three-dimensional electroanatomic map was used for epicardial VT ablation.

Left atrial model reconstruction in atrial fibrillation ablation: reliability of new mapping and complex impedance systems.

AIMS: The effectiveness of atrial fibrillation (AF) ablation relies on detailed knowledge of the anatomy of the left atrium (LA) and pulmonary veins (PVs). It is common to combine computed tomography/magnetic resonance (CT/MR) with imaging by electroanatomical (EA) mapping systems. The aim of this study was to evaluate the accuracy of LA anatomical reconstruction by 'One Model' and 'VeriSense' tools (Ensite Velocity 3.0, St Jude Medical), compared with CT/MR imaging. METHODS AND RESULTS: Seventy-two patients with AF underwent pre-procedural imaging (97% CT-scan, 3% MR imaging) and transcatheter ablation of PVs. Operators were blinded to CT/MR imaging. Electrical Coupling Index (ECI) was used to recognize venous structures when the circular catheter could not. The LA 'One Model' map was obtained without complications; all 124 main left PVs and 144 main right PVs were detected. Nine of 9 intermediate right PVs and 30 of 30 early branches were detected, whereas 1 of the 27 early branches on the right inferior PVs was missed. Comparison between LA intervein distances measured on the roof (RO) and the posterior wall (PW) showed a high correspondence between the EA model and CT/MR imaging (RO CT/MR imaging vs. EA: 32 ± 7 vs. 32 ± 7 mm; PW CT/MR imaging vs. EA: 36 ± 6 vs. 36 ± 7 mm). The EA model yielded slightly larger PV ostia diameters, owing to the distortion caused by catheter pressure. CONCLUSIONS: Recent 3D mapping tools allow outstanding anatomical rendering and are key in complex ablation procedure set-up. This study shows that 3D anatomical reconstruction of LA, PVs, and their variable branches is not only safe and fast but also accurate and reliable.

Three-Dimensional Electroanatomic Mapping System-Enhanced Cardiac Resynchronization Therapy Device Implantation: Results From a Multicenter Registry.

INTRODUCTION: Cardiac resynchronization therapy (CRT) device implantation guided by an electroanatomic mapping system (EAMS) is an emerging technique that may reduce fluoroscopy and angiography use and provide information on coronary sinus (CS) electrical activation. We evaluated the outcome of the EAMS-guided CRT implantation technique in a multicenter registry. METHODS: During the period 2011-2014 we enrolled 125 patients (80% males, age 74 [71-77] years) who underwent CRT implantation by using the EnSite system to create geometric models of the patient's cardiac chambers, build activation mapping of the CS, and guide leads positioning. Two hundred and fifty patients undergoing traditional CRT implantation served as controls. Success and complication rates, fluoroscopy and total procedure times in the overall study population and according to center experience were collected. Centers that performed ≥10 were defined as highly experienced. RESULTS: Left ventricular lead implantation was successful in 122 (98%) cases and 242 (97%) controls (P = 0.76). Median fluoroscopy time was 4.1 (0.3-10.4) minutes in cases versus 16 (11-26) minutes in controls (P < 0.001). Coronary sinus angiography was performed in 33 (26%) cases and 208 (83%) controls (P < 0.001). Complications occurred in 5 (4%) cases and 17 (7%) controls (P = 0.28). Median fluoroscopy time (median 11 minutes vs. 3 minutes, P < 0.001) and CS angiography rate (55% vs. 21%, P < 0.001) were significantly higher in low experienced centers, while success rate and complications rate were similar. CONCLUSIONS: EAMS-guided CRT implantation proved safe and effective in both high- and low-experienced centers and allowed to reduce fluoroscopy use by ≈75% and angiography rate by ≈70%.

Spontaneous fractures in custom-made porous hydroxyapatite cranioplasty implants: is fragility the only culprit?

BACKGROUND: Although the porous hydroxyapatite (PHA) used in custom-made cranioplasty implants is a material appreciated for its biomimetic properties, before osteointegration it is initially very fragile. Nevertheless, we wondered whether this primary fragility is entirely due to brittleness or whether the surgeon's actions may influence the behavior of the material. METHODS: To study the influence of the surgeon's behavior, we made a virtual model of a custom-made PHA cranioplasty implant and submitted it to three implant procedural variables using finite element methods. In the first test, a scenario in which the surgeon's design, validation, and positioning techniques are impeccable, the edges of the implant adhered well to the craniectomy margins. In the second test, a discrepancy between a portion of the perimeter of the craniectomy and the profile of the prosthesis was modeled, and in the third test, several gaps were simulated between the implant and the craniectomy margins. RESULTS: Our mathematical model showed that when local and general discontinuities were included in the test scenarios, there was an increase in the load coming to bear on the cranioplasty implant, which amounted to 80 and 50 %, respectively. CONCLUSIONS: The fragility of custom-made PHA cranioplasty implants increases if the surgeon fails to achieve a precise design and validation, and/or an accurate surgical procedure. Nevertheless, careful attention during these phases helps to maintain the strength of the implant, given the more favorable mechanical conditions, without interfering with its biomimetic capacity.

Novel ICE-guided registration strategy for integration of electroanatomical mapping with three-dimensional CT/MR images to guide catheter ablation of atrial fibrillation.

INTRODUCTION: Image integration is used in AF ablation procedures. To maximize the efficacy of image integration, it is essential to obtain good alignment between the electroanatomical map and the 3D image of the heart. In the present study, we compared an ICE-guided landmark registration with an ICE-guided focused endocardial surface registration. METHODS AND RESULTS: In 20 patients, registration was based on posterior landmarks acquired under ICE guidance (group A); in another 20 matched patients, a new ICE-guided focused endocardial surface registration technique was used (group B). In these latter patients, a single landmark was acquired in the inferior part of the LIPV, and several surface points were recorded in the posterior area of the left PV antrum and around the antra of the right PVs. The mean ablation point-to-CT image distance was calculated in both groups. In group A, the mean landmark point-to-CT image distance was also calculated after adding the surface registration. The mean landmark point-to-CT image distance was 4.62 +/- 1.65 mm and increased to 7.66 +/- 2.44 mm when surface registration was added. The ablation point-to-CT image distance was significantly shorter in group B (1.73 +/- 0.29 mm vs 3 +/- 0.99 mm; P < 0.001). CONCLUSIONS: This ICE-guided focused endocardial surface registration seems to be superior to landmark registration in achieving a better alignment between the CT/MR image and the electroanatomical map. The concurrent use of standard surface registration may result in rotation of the atrial chamber.