Repeated procedures at the generator pocket are a determinant of implantable cardioverter-defibrillator infection.

BACKGROUND: Rates of cardiac-device infections have increased in recent years, but the current incidence and risk factors for infection in patients with implantable cardioverter-defibrillators (ICDs) are not well known. HYPOTHESIS: The increasing number of ICD infections is related to accumulated pocket manipulations over time. METHODS: This single-center, prospective study included patients that underwent ICD implantation from 2008 to 2015. The endpoint was time to infection. Multivariate analysis was performed to identify independent risk factors related to infection. RESULTS: The study included a total of 570 patients, of whom 419 (73.5%) underwent a first implantation. Mean age was 59 ± 14 years, and 80% were male. During a median follow-up of 36 months (interquartile range, 18-61 months; 1887 patient-years), infection was identified in 26 patients (4.56%), an incidence of 14.9 × 1000 patient-years. Median time to infection was 9.7 months (interquartile range, 1.35-23.4 months), and 38.5% were late infections (beyond 12 months of follow-up). In patients with replacement implants, the incidence was 3-fold higher than in first implantations (27.7 vs 9.1 × 1000 patient-years; P = 0.002). Cox regression identified 2 independent predictors of ICD infection: cumulative number of interventions at the generator pocket (hazard ratio: 1.92, 95% confidence interval: 1.42-2.6, P < 0.001) and pocket hematoma (hazard ratio: 7.0, 95% confidence interval: 2.7-17.9, P < 0.0001). CONCLUSIONS: The incidence of infection in ICD patients is greater than previously reported, largely due to late infections. Each new cumulative intervention at the same generator pocket nearly doubles the risk of infection.

Remote Magnetic Navigation for Catheter Ablation in Patients With Congenital Heart Disease: A Review.

In patients with congenital heart disease, challenges to catheter-based arrhythmia interventions are unique and numerous given the complexity of the underlying defects, anatomic and surgical intervention variants including baffles, conduits, patches, and/or shunts. Remote magnetic navigation offers significant advantages in these cases that may present with limited vascular access or difficult access to the target cardiac chambers implicated by the previous surgical interventions. We reviewed the data available on the safety, feasibility, and effectiveness of magnetic navigation for the treatment of arrhythmia in congenital heart disease and discussed the specific challenges related to various congenital defects and repair with the potential advantages offered by magnetic navigation in these circumstances.

Left Atrial Geometry Improves Risk Prediction of Thromboembolic Events in Patients With Atrial Fibrillation.

BACKGROUND: Left atrial (LA) sphericity (LASP) is a new remodeling parameter based on LA shape analysis, with independent predictive value for recurrence after atrial fibrillation (AF) ablation. OBJECTIVES: To evaluate the association between LASP and thromboembolic events (TE) in patients with AF. METHODS: Twenty-nine AF patients and prior TE and 29 age- and gender-matched controls were included. LASP was calculated using a 3D-LA reconstruction. The LA appendage (LAA) volume and morphology were assessed. ROC curve analysis was performed for LASP, LA volume, LAA volume, and CHAD/CHA2 D-VASc scores (Stroke2 -the grouping variable-was excluded). RESULTS: Mean age of the study population was 61 ± 11 years (79.3% males, 53.4% hypertension, 8.6% diabetes). Patients with prior TE had higher LASP than those without (82.5 ± 3.3% vs. 80.2 ± 3.1%, P = 0.008); there were no differences in CHAD or CHA2 D-VASc scores, LA volume, LAA volume, or LAA morphology. The C-statistic was higher for LASP (0.71) than for other tested variables (CHAD score = 0.58, CHA2 D-VASc score = 0.59, LA volume = 0.50, LAA volume = 0.46; P < 0.01 for all vs. LASP). The best cutoff value for LASP was 83.6% (sensitivity 0.52, specificity 0.90). Logistic regression analysis showed predictive value for LASP (OR 1.26 per each 1% increase [1.85-52.20], P = 0.013), but not for clinical risk scores. The addition of LASP to the CHAD and CHA2 D-VASc scores increased the predictive value over the risk scores alone (P = 0.004), and reclassified 45.5% of patients with CHAD = 0 (no anticoagulation indicated) to moderate-risk (anticoagulation indicated). CONCLUSION: LA sphericity is associated with prior TE in AF patients and improves the performance of the CHAD and CHA2 D-VASc scores alone.

Impact of Contact Force Monitoring in Acute Pulmonary Vein Isolation Using an Anatomic Approach. A Randomized Study.

BACKGROUND: The impact of contact force (CF) monitoring in pulmonary vein (PV) isolation after a circumferential anatomic ablation (CAA) is unknown. We analyze the usefulness of CF monitoring in acute PV isolation and procedure parameters using a CAA. METHODS: Fifty patients with paroxysmal atrial fibrillation were randomized into CF-on (CF >10 grams; n = 25) or CF-off (CF blinded; n = 25) groups. We performed a first round of CAA with a ThermoCool(®) SmartTouch(®) catheter blinded to the LASSO(®) catheter (Biosense Webster, Diamond Bar, CA, USA), with radiofrequency (RF) lesions tagged with the VisiTag(™) Module. After the CAA, each PV was reviewed with the LASSO(®) catheter recording the segments with gaps. RESULTS: All the PVs were isolated with a CAA in 20 patients of the CF-on versus eight of the CF-off (P = 0.001). Of the 45 segments with gaps in the left PVs, 38 were from the CF-off (P = 0.0001). Of the eight segments with gaps in the right PVs, seven were from the CF-off (P = 0.06). The CF in the left PVs was higher in the CF-on (16.3 ± 3.2 grams vs 10.5 ± 4.3 grams; P = 0.0001) and similar in the right PVs (17.6 ± 3.6 grams vs 15.2 ± 5.3 grams; P = 0.08). All of the gaps were closed with additional RF LASSO(®) -guided touch-up. Procedure and fluoroscopy times were shorter in the CF-on (139 ± 24 minutes vs 157 ± 32 minutes and 20 ± 6 minutes vs 24 ± 7 minutes; both P = 0.039). At 12 months the patients free of AF recurrence was 84% CF-on versus 75% CF-off (log-rank P = 0.4) [corrected]. CONCLUSIONS: In paroxysmal atrial fibrillation, a CAA guided by CF reduces PV gaps and shortens the procedure parameters at the expense of the left PVs.

Contact force threshold for permanent lesion formation in atrial fibrillation ablation: A cardiac magnetic resonance-based study to detect ablation gaps.

BACKGROUND: Catheter contact force (CF) has a strong correlation with lesion formation during radiofrequency ablation. Delayed-enhancement cardiac magnetic resonance (DE-CMR) provides lesion information in patients with prior atrial fibrillation (AF) ablation. OBJECTIVE: The aim of this study was to determine the CF threshold to create permanent lesions detected by DE-CMR. METHODS: A total of 36 patients referred for AF ablation were included. A CF catheter was used during the ablation procedure, and DE-CMR was performed 3 months after the ablation procedure. Eighteen pulmonary vein (PV) segments were defined, and 3-dimensional (3D) reconstructions of the left atrium (LA) derived from the DE-CMR images were obtained. One observer evaluated the presence of any discontinuity of previous ablation lesions (gap) in the 3D reconstructions of the LA, and another observer (blinded to the gap findings) determined the minimum CF value in each PV segment. RESULTS: The PV segments where a gap was observed had a lower maximal CF value than did the segments without gap in the 3D LA reconstructions (6.7 ± 4.4 g vs 12.2 ± 4.7 g; P < .001). In receiver operating characteristic analysis, a CF threshold of >8 g provided 73% sensitivity and 81% specificity in the prediction of a complete PV lesion (positive predictive value [PPV] 84%). A CF threshold of >12 g had a specificity of 94% and increased the PPV to 91% in creating a complete lesion in the LA wall (area under the curve 0.834). CONCLUSION: A CF threshold of >12 g H5H20 predicts a complete lesion with high specificity and PPV when a dragging ablation strategy is used in AF ablation.

Reverse atrial remodeling following pulmonary vein isolation: the importance of the body mass index.

BACKGROUND: Pulmonary vein isolation (PVI) causes a reduction in left atrium size that is attributable to reverse atrial remodeling (RAR). The objective of this study was to identify predictors of RAR and determine its association with other parameters of improvement in cardiac function. METHODS: It is a prospective study with 74 patients (52 ± 9 years old, 81% male), and 51% of patients had paroxysmal atrial fibrillation. Patients were serially assessed with transthoracic echocardiography; plasma N-terminal B-type natriuretic peptide (NT-proBNP); and high-sensitivity C-reactive protein levels at baseline and 3, 6, and 12 months following the PVI. RAR was defined as a reduction in the left atrial volume index (LAV-index) >10% from baseline at the end of follow-up. A multivariate analysis was conducted to identify predictors of RAR. RESULTS: The LAV-index decreased significantly during follow-up in the entire population (P = 0.0005). RAR (experienced by 63.5% of the patients) was more frequent (76% vs. 42%; P = 0.004) and pronounced (reduction 16.65 ± 14% vs. 8 ± 14%; P = 0.015) in patients with a successful ablation (46 of 74 patients, 62.2%). Only patients with RAR showed significant improvement in NT-proBNP levels (P = 0.0001), systolic function (P = 0.035), and diastolic function (P = 0.005). Multivariable analysis revealed that a successful ablation (odds ratio [OR] = 4.6; 95% confidence interval [CI] 1.46-14.68; P = 0.009), LAV-index (OR = 1.15; 95% CI 1.03-1.2; P = 0.021), and patient's body mass index (OR = 0.84; 95% CI 0.74-0.96; P = 0.012) were independent predictors of RAR. CONCLUSIONS: Successful PVI ablation is the main predictor of RAR that is associated with other parameters of improvement in cardiac function. The patient's body mass index may have a negative effect on RAR.

Paroxysmal atrial fibrillation burden before and after pulmonary veins isolation: an observational study through a subcutaneous leadless cardiac monitor.

AIMS: Data on the success rate of ablation in atrial fibrillation (AF) are controversial. Our hypothesis is that the efficacy must be evaluated considering the AF burden (AFB) before the procedure. Moreover, the clinical significance of early recurrence (ERAT) of AF or atrial tachyarrhythmias (AT) is debatable. The aim is to describe the outcome of pulmonary vein isolation in paroxysmal AF through a subcutaneous cardiac monitor (ICM) implanted before the procedure. METHODS: Using CARTO 3, circumferential lesions around the pulmonary veins were placed. The study endpoint was the first documented recurrence of AF/AT by ICM after the blanking period (3 months). AFB (percentage of time in AF/AT) was collected every month before and after the procedure during the 12-month follow-up. RESULTS: The ICM was implanted 94 ± 23 days before the procedure in 35 patients with paroxysmal AF (54 ± 11 years, refractory to 1.8 ± 0.6 antiarrhythmic drugs). Cumulative AFB before the procedure and after the blanking period was 2.5% (1-5%) versus 0% (0-0.25%), P < 0.001. Twenty patients (57.1%) were free of documented AF/AT recurrence, 5 patients (14.2%) reduced the AFB 90%, 6 patients (17.1%) continued the same, and 4 patients (11.4%) increased the AFB 90% for AT. The success rate with second procedure was 71.4%. All 13 patients with ERAT had recurrence after the blanking period. CONCLUSIONS: The outcome of pulmonary vein isolation in patients with paroxysmal AF is well documented by an ICM. The success rate is dependent of the previous AFB that can be randomly variable and lower than expected. ERATs predict late recurrence.

Doble fístula coronaria como causa de angina inestable / Dual coronary artery fistulas as a cause of unstable angina

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