Safety and feasibility of conduction system pacing in patients with congenital heart disease.

INTRODUCTION: Conduction system pacing (CSP) has emerged as an ideal physiologic pacing strategy for patients with permanent pacing indications. We sought to evaluate the safety and feasibility of CSP in a consecutive series of unselected patients with congenital heart disease (CHD). METHODS: Consecutive patients with CHD in which CSP was attempted were included. Safety and feasibility, implant tools and electrical parameters at implant and at follow-up were evaluated. RESULTS: A total of 20 patients were included (10 with a previous device). A total of 10 patients had complex forms of CHD, 9 moderate defects and 1 a simple defect. CSP was achieved in 75% of cases (10 His bundle pacing, 5 left bundle branch pacing) with left ventricular septal pacing in the remaining 5 patients. Procedure times and fluoroscopy times were prolongued (126 ± 82 min and 27 ± 30 min, respectively). Ventricular lead implant times widely varied ranging from 4 to 115 min, (mean 31 ± 28 min) and the use of multiple delivery sheaths was frequent (50%). The QRS width was reduced from 145 ± 36 ms at baseline to 116 ± 18 ms with CSP. Implant electrical parameters included: CSP pacing threshold 0.95 ± 0.65 V; R wave amplitude 9.2 ± 8.8 mV and pacing impedance 632 ± 183 Ohms, and remained stable at a median follow-up of 478 days (interquartile range: 225-567). Systemic ventricle systolic function and NYHA class (1.50 ± 0.51 vs. 1.10 ± 0.31; p = .008) significantly improved at follow-up. Lead revision was required in one patient at Day 4. CONCLUSIONS: Permanent CSP is safe and feasible in patients with CHD although implant technique is complex.

Influence of baseline inducibility and activation mapping on ablation outcomes in patients with structural heart disease and ventricular tachycardia.

INTRODUCTION: Stand-alone substrate ablation has become a standard ventricular tachycardia (VT) ablation strategy. We sought to evaluate the influence of baseline VT inducibility and activation mapping on ablation outcomes in patients with structural heart disease (SHD) undergoing VT ablation. METHODS: Single center, observational and retrospective study including consecutive patients with SHD and documented VT undergoing ablation. Baseline VT induction was attempted before ablation in all patients and VT activation mapping performed when possible. Ablation was guided by activation mapping for mappable VTs plus substrate ablation for all patients. Ablation outcomes and complications were evaluated. RESULTS: One hundred and sixty patients were included and were classified in three groups according to baseline VT inducibility:group 1 (non inducible, n = 18), group 2 (1 VT morphology induced, n = 53), and group 3 (>1 VT morphology induced, n = 89). VT activation mapping was possible in 35%. After a median follow-up of 38.5 months, baseline inducibility of greater than 1 VT morphology was associated with a significant incidence of VT recurrence (42% for group 3 vs. 15.1% for group 2% and 5.6% for group 1, Log-rank p < .0001) and activation mapping with a lower rate of VT recurrence (24% vs. 36.3%, Log-rank p = .035). Baseline inducibility of greater than 1 VT morphology (hazards ratio [HR]: 12.05, 95% confidence interval [CI]: 1.60-90.79, p = .016) was an independent predictor of VT recurrence while left ventricular ejection fraction less than 30% (HR: 1.93, 95% CI: 1.13-3.25, p = .014) and advanced heart failure (HR: 4.69, 95% CI: 2.75-8.01, p < .0001) were predictors of mortality or heart transplantation. Complications occurred in 11.2% (5.6% hemodynamic decompensation). CONCLUSION: Baseline VT inducibility and activation mapping may add significant prognostic information during VT ablation procedures.

Viabilidad del desfibrilador automático implantable subcutáneo en un paciente con pectum excavatum / Feasibility of a subcutaneous implantable cardioverter-defibrillator in a patient with pectus excavatum

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Utilidad del quirófano híbrido en la extracción de dispositivos implantables: experiencia inicial de un centro / Utility of the hybrid operating room for lead extraction: initial experience in a single center

No disponible

Evaluation of a near-zero fluoroscopic approach for catheter ablation in patients with congenital heart disease.

PURPOSE: Radiation exposure (RE) is a matter of concern for patients with congenital heart disease (CHD) who not infrequently need multiple interventional procedures under fluoroscopy guidance. We sought to evaluate the safety and feasibility of a minimally fluoroscopic approach in patients with CHD undergoing catheter ablation using a new image integration module (IIM). METHODS: Consecutive patients with CHD undergoing catheter ablation using the Carto Univu™ IIM were included. A near-zero fluoroscopy procedure was defined by an effective dose (ED) ≤ 1 mSv. RE parameters (total fluoroscopy time [TFT], total dose area product [tDAP], and ED), ablation outcomes, and complications were evaluated. RESULTS: Fifty-five patients with CHD underwent 63 ablation procedures (supraventricular tachycardia, n = 53; ventricular tachycardia, n = 10). The CHD was simple in 25%, moderate in 42%, and complex in 33%. The use of the IIM resulted in very low levels of RE (median TFT 0.13 min [IQR 0-1.04], median tDAP 54.5 cGy cm2 [IQR 9.5-176.4], median ED 0.136 mSv [IQR 0.02-0.49]). Patients with complex CHD had significantly higher RE when compared with patients with simple and moderate defects. A total of 56/63 ablation procedures (89%) were performed with an ED ≤ 1 mSv. One patient developed sinus node dysfunction requiring pacemaker implantation. CONCLUSIONS: The use of a minimally fluoroscopic approach was safe and feasible resulting in very low RE during catheter ablation of patients with CHD. A near-zero fluoroscopy ablation was possible in up to 89% of the procedures.

Usefulness of Sodium Bicarbonate for the Prevention of Contrast-Induced Nephropathy in Patients Undergoing Cardiac Resynchronization Therapy.

The use of contrast media during cardiac resynchronization therapy (CRT) devices implantation is associated with the risk of contrast-induced nephropathy (CIN). The aim of this study was to evaluate the possible beneficial role of periprocedural intravenous volume expansion with isotonic saline and sodium bicarbonate solution in patients who undergo CRT implantation. Eligible patients were randomly assigned in a 1:1 ratio to receive hydration plus one-sixth molar sodium bicarbonate (study group) or not (control group). Primary end point was CIN incidence. Secondary end points were (1) a combined end point of death, heart transplantation, or hospitalization for heart failure at 12 months, (2) incidence of death, and (3) the need for renal replacement therapy at 12 months. Final analysis was performed with 93 patients. In the hydration group CIN incidence was significantly reduced related to control group (0% vs 11%, p = 0.02). There was a trend to reduce the combined end point in hydration group (12.5% vs 22%, p = 0.14). Finally, CIN incidence was related to a higher 12 months mortality (25% vs 7%, p = 0.03). In conclusion, CIN incidence was 11% in a nonselected population of patients receiving a CRT device. CIN appearance could be reduced by using a hydration protocol based on sodium bicarbonate and isotonic saline.

Utility of high density multielectrode mapping during ablation of scar-related ventricular tachycardia.

INTRODUCTION: Multielectrode mapping catheters (MEMC) allow the performance of high resolution and density maps but the utility of these catheters in ventricular tachycardia (VT) ablation procedures has not been yet widely described. We sought to evaluate the utility of a MEMC during scar-related VT ablation procedures. METHODS: Eighty-five consecutive scar-related VT ablation procedures were performed in 81 patients. In the first 26 procedures, a standard 3.5-mm tip linear catheter was employed for endocardial/epicardial mapping (control group). In the following 59 procedures mapping was performed with a MEMC (study group). Procedural time, LV endocardial and epicardial mapping time, complications and ablation outcomes were compared. RESULTS: The use of the MEMC resulted in a significant shortening of the endocardial and epicardial mapping times (38 ± 15 minutes vs. 56 ± 24 minutes for endocardial LV mapping in the study and control group, respectively, P = 0.001; and 28 ± 9 minutes vs 41 ± 16 minutes, for epicardial mapping, P = 0.011) as well as the total procedural time (177 ± 53 minutes vs. 206 ± 50 minutes, respectively, P = 0.02). The mapping density was also significantly increased in the study group (mean endocardial LV points: 2,143 ± 1,419 vs. 485 ± 174, for the study and control group, respectively, P < 0.0001), specially within the scar area (49.6 ± 34 points/cm2 vs. 8.4 ± 4.6 points/cm2 , P < 0.001). No differences in acute and long-term follow-up outcomes were observed. CONCLUSIONS: High-density multielectrode mapping is associated with a significant reduction of procedural and mapping times and a significant increase of mapping density without affecting outcomes in patients with scar-related VT.

The Role of Conventional and Right-Sided ECG Screening for Subcutaneous ICD in a Tetralogy of Fallot Population.

BACKGROUND: Information regarding suitability for subcutaneous implantable cardioverter-defibrillator (S-ICD) implant in tetralogy of Fallot (ToF) population is scarce and needs to be further explored. THE AIMS OF OUR STUDY WERE: (1) to determine the proportion of patients with ToF eligible for S-ICD, (2) to identify the optimal sensing vector in ToF patients, (3) to test specifically the eligibility for S-ICD with right-sided screening, and (4) to compare with the proportion of eligible patients in a nonselected ICD population. METHODS: We recruited 60 consecutive patients with ToF and 40 consecutive nonselected patients. Conventional electrocardiographic screening was performed as usual. Right-sided alternative screening was studied by positioning the left arm and right arm electrodes 1 cm right lateral to the xiphoid midline. The Boston Scientific electrocardiogram (ECG) screening tool was utilized. RESULTS: We found a higher proportion of patients with right-sided positive screening in comparison with standard screening (77 ± 0.4% vs. 67 ± 0.4%; P < 0.0001) and a trend to higher number of appropriate leads in right-sided screening (1.3 ± 1 vs. 1.1 ± 1 ms; P = 0.07). Patients who failed the screening had a longer QRS duration and longer QT interval. Standard and right-sided screening showed a higher percent of positive patients in the control group compared to ToF patients (P < 0.001). CONCLUSION: Right-sided screening was associated with a significant 10% increase in S-ICD eligibility in ToF patients. When comparing with an acquired cardiomyopathies group, ToF showed a lower eligibility for S-ICD. The most appropriate ECG vector was the alternate vector in contrast to what is observed in the general population.

Incidence and predictors of clinically relevant cardiac perforation associated with systematic implantation of active-fixation pacing and defibrillation leads: a single-centre experience with over 3800 implanted leads.

AIMS: Active-fixation leads have been associated with higher incidence of cardiac perforation. Large series specifically evaluating this complication are lacking. We sought to evaluate the incidence and predictors of clinically relevant cardiac perforation in a consecutive series of patients implanted with active-fixation pacing and defibrillation leads. METHODS AND RESULTS: We conducted a retrospective observational study including all consecutive patients implanted with an active-fixation pacing/defibrillation lead at our institution from July 2008 to July 2015. The incidence of clinically relevant cardiac perforation and cardiac tamponade was evaluated. Univariate and multivariate analyses were used to identify predictors of cardiac perforation. Acute and long-term management of these patients was also investigated. A total of 3822 active-fixation pacing (n = 3035) and defibrillation (n = 787) leads were implanted in 2200 patients. Seventeen patients (0.8%) had clinically relevant cardiac perforation (13 acute and 4 subacute perforations), and 13 (0.5%) had cardiac tamponade resolved with pericardiocentesis. None of the patients with cardiac perforation required surgical treatment. In multivariate analysis, an age >80 years (OR 3.84, 95% CI 1.14-12.87, P = 0.029), female sex (OR 3.14, 95% CI 1.07-9.22, P = 0.037), and an apical position of the right ventricular lead (OR 3.37, 95% CI 1.17-9.67, P = 0.024) were independent predictors of cardiac perforation. CONCLUSIONS: Implantation of active-fixation leads is associated with a low incidence of clinically relevant cardiac perforation. Older and female patients have a higher risk of perforation as well as those patients receiving the ventricular lead in an apical position.

Essential ECG clues in patients with congenital heart disease and arrhythmias.

The prevalence of adults with congenital heart disease has dramatically increased during the last decades due to significant advances in the surgical correction of these conditions. As a result, patient's survival has been prolonged and arrhythmias have become one of the principal causes of morbidity and mortality for these patients. The surface 12-lead ECG may play a critical role in the identification of the underlying heart disease of the patient, the recognition of the arrhythmia mechanism and may also help in the planification of the ablation procedure in this setting. Finally, important prognostic information can be also obtained from the ECG in these patients. The present review will offer an overview of the principal utilities of the surface ECG in the diagnosis and management of patients with CHD and arrhythmias.

Aislamiento eléctrico venoso pulmonar con catéter láser en el tratamiento de la fibrilación auricular paroxística y persistente. Resultados a un año / Electrical isolation of pulmonary veins using laser catheter in the treatment of paroxysmal and persistent atrial fibrillation. One-year results

Introducción y objetivos: Recientemente se ha introducido un nuevo catéter-balón láser para el aislamiento eléctrico venoso pulmonar que permite la visualización del tejido auricular. El objetivo del presente trabajo es evaluar la seguridad y la eficacia a medio plazo de este catéter en el tratamiento de la fibrilación auricular. Métodos: Se realizó ablación con catéter-balón láser a 71 pacientes con fibrilación auricular paroxística (80%) y persistente (20%). Se consideró recurrencia arrítmica los episodios de duración > 30 s. Durante el seguimiento se realizaron visitas periódicas cada 3 meses con Holter 24-48 h. Resultados: Se logró aislar 275 de 278 (99%) de las venas pulmonares. Los tiempos medios de procedimiento y de fluoroscopia fueron 154 ± 25 y 34 ± 15 min respectivamente. Un 89% de las venas se aislaron en el primer intento. La complicación más frecuente fue la parálisis del nervio frénico (5,6%), que apareció solo en los primeros 18 casos. Se siguió a 59 pacientes durante una media de 420 ± 193 días, con una tasa de recurrencia arrítmica del 12 y el 30% respectivamente en fibrilación auricular paroxística y persistente (p = 0,155). Conclusiones: El catéter-balón láser es un sistema seguro y efectivo para lograr el aislamiento eléctrico de las venas pulmonares. Entre sus ventajas destaca la capacidad de adaptarse a la anatomía venosa pulmonar con un único catéter y la eficacia con que logra el aislamiento eléctrico de las venas pulmonares, con una evolución clínica favorable a medio plazo, incluso para los pacientes con fibrilación auricular persistente (AU)

Introduction and objectives: A new laser balloon that allows visualization of atrial tissue has recently been introduced for pulmonary vein electrical isolation. The aim of this study was to evaluate the mid-term safety and efficacy of this catheter in the treatment of atrial fibrillation. Methods: Laser balloon ablation was performed in 71 patients with paroxysmal (80%) or persistent (20%) atrial fibrillation. Arrhythmia recurrence was defined as any episode lasting longer than 30 seconds. During follow-up, regular visits were performed every 3 months with 24- to 48-hour Holter tests. Results: Isolation was possible in 275 of 278 (99%) of pulmonary veins. Mean procedure and fluoroscopy times were 154 ± 25 and 34 ± 15 minutes, respectively. A total of 89% of veins were isolated during the first attempt. The most common complication was phrenic nerve paralysis (5.6%), which appeared in only the first 18 cases. A total of 59 patients received follow-up for a mean of 420 ± 193 days, with a rate of arrhythmia recurrence of 12% and 30%, respectively, in paroxysmal and persistent atrial fibrillation (P = .155). Conclusions: The laser balloon is a safe and effective system for pulmonary vein electrical isolation. Its advantages include the capacity to adapt to pulmonary vein anatomy using a single catheter, the efficacy with which pulmonary vein electrical isolation is achieved, and the favorable mid-term clinical progress, even for patients with persistent atrial fibrillation (AU)

Safety and Feasibility of a Minimally Fluoroscopic Approach for Ventricular Tachycardia Ablation in Patients With Structural Heart Disease: Influence of the Ventricular Tachycardia Substrate.

BACKGROUND: We sought to evaluate the safety and feasibility of a minimally fluoroscopic approach using the CARTOUNIVU module during scar-related ventricular tachycardia (VT) ablation. METHODS AND RESULTS: Consecutive patients with structural heart disease undergoing VT ablation using the CARTOUNIVU module were prospectively included and classified depending on their VT substrate: (1) ischemic VT (IVT) and (2) nonischemic VT and depending on the presence of an epicardial access. Radiation exposure parameters and major and minor procedure-related complications were registered. A near-zero fluoroscopy exposure was defined as those procedures with an effective dose ≤1 mSv. A total of 44 VT ablation procedures were performed in 41 patients (22 IVT and 19 nonischemic VT). The use of the CARTOUNIVU module resulted in low levels of radiation exposure: median total fluoroscopy time and effective dose of 6.08 (1.51-12.36) minutes and 2.15 (0.58-8.22) mSv, respectively. Patients with IVT had lower radiation exposure than patients with nonischemic VT (total fluoroscopy time, 2.53 [1.22-11.22] versus 8.51 [5.55-17.34] minutes; P=0.016). Epicardial access was associated with significantly higher levels of radiation exposure. Complications occurred in 4.9% patients, none of them being related to the use of the image integration tool. A near-zero fluoroscopy ablation could be performed in 14 of 44 procedures (32%), 43% of IVT procedures, and 50% of procedures with endocardial access only. CONCLUSIONS: The use of the CARTOUNIVU module during scar-related VT ablation resulted in low levels of radiation exposure. A near-zero fluoroscopy approach can be achieved in up to half of the procedures, especially in IVT patients with endocardial ablation.

Electrical Isolation of Pulmonary Veins Using Laser Catheter in the Treatment of Paroxysmal and Persistent Atrial Fibrillation. One-year Results.

INTRODUCTION AND OBJECTIVES: A new laser balloon that allows visualization of atrial tissue has recently been introduced for pulmonary vein electrical isolation. The aim of this study was to evaluate the mid-term safety and efficacy of this catheter in the treatment of atrial fibrillation. METHODS: Laser balloon ablation was performed in 71 patients with paroxysmal (80%) or persistent (20%) atrial fibrillation. Arrhythmia recurrence was defined as any episode lasting longer than 30 seconds. During follow-up, regular visits were performed every 3 months with 24- to 48-hour Holter tests. RESULTS: Isolation was possible in 275 of 278 (99%) of pulmonary veins. Mean procedure and fluoroscopy times were 154 ± 25 and 34 ± 15minutes, respectively. A total of 89% of veins were isolated during the first attempt. The most common complication was phrenic nerve paralysis (5.6%), which appeared in only the first 18 cases. A total of 59 patients received follow-up for a mean of 420 ± 193 days, with a rate of arrhythmia recurrence of 12% and 30%, respectively, in paroxysmal and persistent atrial fibrillation (P = .155). CONCLUSIONS: The laser balloon is a safe and effective system for pulmonary vein electrical isolation. Its advantages include the capacity to adapt to pulmonary vein anatomy using a single catheter, the efficacy with which pulmonary vein electrical isolation is achieved, and the favorable mid-term clinical progress, even for patients with persistent atrial fibrillation.

Initial Experience with a New Image Integration Module Designed for Reducing Radiation Exposure During Electrophysiological Ablation Procedures.

INTRODUCTION: Reduction of radiation exposure during cardiac arrhythmia ablation procedures is desirable. We sought to evaluate the utility of a new image integration module (CARTOUNIVU(TM) ) in reducing fluoroscopy times and dosages during left atrial arrhythmia (LAA) and ventricular tachycardia (VT) ablation procedures. METHODS AND RESULTS: Consecutive patients undergoing LAA (n = 28)/VT (n = 13) ablation using the CARTOUNIVU(TM) module were included. Total fluoroscopy time, radiation dose (total dose area product [tDAP], effective dose [ED]), and procedure duration were evaluated. A retrospective cohort of patients who underwent LAA (n = 16)/VT(n = 8) ablation without the new image integration module served as a control group. The use of the new image integration module significantly reduced mean fluoroscopy time (5.2 minutes [IQR 1.9;6.8] in the LAA ablation UNIVU group vs. 28.2 minutes [IQR 15.3;37.8] in the control group, P<0.001; 9.8 minutes [IQR 4.5;13.1] vs. 25.5 minutes [IQR 14.1;30.9] for VT ablation, P = 0.013), tDAP (2,088 cGy*cm(2) [IQR 664;2911] vs. 5,893 cGy*cm(2) [IQR 3088;8483], P< 0.001 for LAA ablation; 3,917 cGy*cm(2) [IQR 948;4217] vs. 12,377 cGy*cm(2) (IQR 3385;23157) for VT ablation patients, P = 0.025) and ED (4.1 mSv [IQR 1;5.8] vs. 11.8 mSv [IQR 6.2;16.9] for LAA ablation patients, P< 0.001; 7.8 mSv [IQR 1.9;8.4] vs. 24.7 mSv [IQR 6.8;46.3] for VT ablation patients, P = 0.025). Procedure duration did not significantly change (174 ± 45 minutes vs. 197 ± 36 minutes for LAA ablation, P = 0.083; 201 ± 51 minutes vs. 201 ± 63 minutes for VT ablation, P = 0.860). No serious adverse events related to the use of the CARTOUNIVU(TM) module occurred. CONCLUSIONS: The new image integration module significantly reduced total fluoroscopy time and mean radiation dose without influence in procedure duration during ablation of complex atrial and ventricular arrhythmias.

Systematic Implantation of Pacemaker/ICDs under Active Oral Anticoagulation Irrespective of Patient's Individual Preoperative Thromboembolic Risk.

BACKGROUND: A wide variability in the perioperative management of oral anticoagulation (OAC) has been documented in patients receiving cardiac rhythm management devices (CRMDs). We sought to evaluate the safety and feasibility of a new perioperative strategy consisting in systematically continuing OAC in all patients irrespective of their individual thromboembolic (TE) risk. METHODS: A total of 278 consecutive patients on chronic OAC receiving CRMDs were prospectively included. Patients were classified in high and low TE risk according to current guidelines for the perioperative management of antithrombotic therapy, but underwent implantation under active OAC (international normalized ratio 2-4) irrespective of their preoperative TE risk. Bleeding and TE complications were evaluated as well as other procedure-related complications, hospital stays, and the feasibility of outpatient implantations. RESULTS: A total of 117 patients were considered at high TE risk and 161 at low TE risk. Overall, the incidence of pocket hematoma was 2.9% with only three patients requiring pocket revision. Low TE risk patients had a very low incidence of pocket hematoma (1.9%) without needing pocket revision. The mean hospital stay was 1.17 ± 1.8 days and 169 patients (61%) received their CRMD in an outpatient basis, including 77 patients who were implanted with an implantable cardioverter defibrillator. No TE events were detected during the 30-day postimplant observation period in any patient. No other significant complications related with the implant (pneumothorax, hemothorax, cardiac tamponade) were registered. CONCLUSIONS: Systematic continuation of OAC in all patients undergoing implantation of CRMDs is safe and feasible, thus simplifying and standardizing the perioperative management in this setting.

The use of quadripolar left ventricular leads improves the hemodynamic response to cardiac resynchronization therapy.

BACKGROUND: The objective of the present study was to evaluate the usefulness of a left ventricle (LV) quadripolar lead in improving the hemodynamic response to cardiac resynchronization therapy (CRT). METHODS AND RESULTS: We included 27 consecutive patients implanted with a CRT device with an LV quadripolar lead. Hemodynamic parameters were evaluated at 3-month follow-up by using impedance cardiography. We assessed the highest cardiac output and the highest stroke volume (SV) obtained after atrioventricular and interventricular optimization with pacing from each of the four electrodes of the LV lead. Each patient was evaluated according to three different pacing configurations: unipolar-simulated, bipolar, and quadripolar. Biventricular pacing improved hemodynamics in comparison to the nonpaced measurements: cardiac index (CI): 2.69 L/min/m(2) versus 2.17 L/min/m(2) (P = 0.001). The hemodynamic response was highest in the quadripolar in comparison to unipolar-simulated and bipolar configurations, with an increase of 29%, 23%, and 27%, respectively, in relation to the reference CI and with an increase of 22%, 11%, and 18%, respectively, in relation to the reference indexed SV (P < 0.05, for the comparison between unipolar-simulated and quadripolar configurations). Twelve patients (44%) showed the best hemodynamic response by pacing from any of the two distal electrodes and 15 patients (56%) by pacing from the two proximal electrodes. Finally, CRT responder rates were higher in quadripolar versus bipolar and unipolar-simulated configurations: 90%, 85%, and 75%, respectively. CONCLUSIONS: The quadripolar LV lead was associated with a better hemodynamic response and higher CRT responder rates when compared with unipolar-simulated and bipolar LV leads.