Transvenous lead extraction of lumenless 3830 pacing lead in conduction system pacing: a single-center experience.

BACKGROUND: The Medtronic SelectSecure Model 3830 lumenless lead (Medtronic, Inc., Minneapolis, MN) is commonly used for conduction system pacing (CSP). However, with this increased use, the potential need for transvenous lead extraction (TLE) also will increase. While extraction of endocardial 3830 leads is rather well described especially in pediatric and adult congenital heart disease population, there is very limited data on extraction of CSP leads. In the present study, we reported our preliminary experience on TLE of CSP leads and provided technical considerations. METHODS: The study population comprised 6 consecutive patients (67% male; mean age 70 ± 22 years) with CSP leads (3830 leads), including left bundle branch pacing (LBBP) lead (n = 3) and His pacing lead (n = 3) undergoing TLE. Overall target leads were 17. The mean implant duration time of CSP leads was 97 ± 90 months [range 8-193). RESULTS: Manual traction was successful in 2 cases and mechanical extraction tools were required in the remaining cases. Sixteen leads (94%) were completely extracted, whereas incomplete removal was observed in one lead (6%) among 1 patient. Of note, in the only lead incompletely removed, we observed retention of < 1-cm remnant of lead material consisting of the screw of 3830 LBBP lead into the interventricular septum. No failure of lead extraction was reported and no major complications occurred. CONCLUSIONS: Our findings demonstrated that at an experienced center the success of TLE of chronically implanted CSP leads is high in the absence of major complications also when mechanical extraction tools are needed.

Heart Team for Left Appendage Occlusion without the Use of Antithrombotic Therapy: The Epicardial Perspective.

BACKGROUND: Left atrial appendage occlusion is an increasingly proposed treatment for patients with atrial fibrillation and poor tolerance to anticoagulants. All endovascular devices require antithrombotic therapy. Anatomical and clinical variables predisposing to device-related thrombosis, as well as post-procedural peri-device leaks, could mandate the continuation or reintroduction of aggressive antithrombotic treatment. Because of the absence of foreign material inside the heart, epicardial appendage closure possibly does not necessitate antithrombotic therapy, but data of large series are missing. METHODS: Multidisciplinary team evaluation for standalone totally thoracoscopic epicardial appendage closure was done in 180 consecutive patients with atrial fibrillation and poor tolerance to antithrombotic therapy. One hundred and fifty-two patients consented (male 66.1%, mean age 76.1 ± 7.4, CHA2DS2VASc mean 5.3 ± 1.6, HASBLED mean 3.8 ± 1.1). Indications were cerebral hemorrhage (48%), gastro-intestinal bleeding (33.3%), and other bleeding (20.7%). No antithrombotic therapy was prescribed from the day of surgery to the latest follow up. RESULTS: Procedural success was 98.7%. At a mean follow up of 38.2 ± 18.8 months, cardioembolic and bleeding events were 1.3% and 0.6%, respectively. Among patients with a history of blood transfusions (41.1%), none needed further transfusions or treatment post procedure. CONCLUSION: Epicardial appendage occlusion without any antithrombotic therapy appears to be safe and effective. This strategy could be advised when minimization of bleeding risk concomitant to stroke prevention is needed.

Computational electrophysiology of the coronary sinus branches based on electro-anatomical mapping for the prediction of the latest activated region.

This work dealt with the assessment of a computational tool to estimate the electrical activation in the left ventricle focusing on the latest electrically activated segment (LEAS) in patients with left bundle branch block and possible myocardial fibrosis. We considered the Eikonal-diffusion equation and to recover the electrical activation maps in the myocardium. The model was calibrated by using activation times acquired in the coronary sinus (CS) branches or in the CS solely with an electroanatomic mapping system (EAMS) during cardiac resynchronization therapy (CRT). We applied our computational tool to ten patients founding an excellent accordance with EAMS measures; in particular, the error for LEAS location was less than 4 mm. We also calibrated our model using only information in the CS, still obtaining an excellent agreement with the measured LEAS. The proposed tool was able to accurately reproduce the electrical activation maps and in particular LEAS location in the CS branches, with an almost real-time computational effort, regardless of the presence of myocardial fibrosis, even when information only at CS was used to calibrate the model. This could be useful in the clinical practice since LEAS is often used as a target site for the left lead placement during CRT. Overall picture of the computational pipeline for the estimation of LEAS.

Endocavitary electrophysiological study by percutaneous antecubital vein and without X-ray for risk stratification of asymptomatic ventricular pre-excitation in young athletes.

Athletes with asymptomatic ventricular pre-excitation (VP) should undergo electrophysiological study for risk stratification. We aimed to evaluate the feasibility, efficacy, safety and tolerability of an electrophysiological study using a percutaneous antecubital vein access and without the use of X-ray (ESnoXr). Methods: We collected data from all young athletes < 18 year-old with AVP, who underwent ESnoXr from January 2000 to September 2020 for evaluation of accessory pathway refractoriness and arrhythmia inducibility using an antecubital percutaneous venous access. Endocavitary signals were used to advance the catheter in the right atrium and ventricle. Results: We included 63 consecutive young athletes (mean age 14.6 ± 1.9 years, 46% male). Feasibility of the ESnoXr technique was 87% while in 13% fluoroscopy and/or a femoral approach were needed. Specifically, fluoroscopy was used in 7 cases to position the catheter inside the heart cavities with an average exposure of 43 ± 38 s while in 2 femoral venous access was needed. The mean procedural time was 35 ± 11 min. The exam was diagnostic in all patients, there were no procedural complications and tolerability was excellent. 53% of the patients had an accessory pathway with high refractoriness and no inducible atrio-ventricular reentry tachycardia: this subgroup was considered eligible to competitive sports and no event was observed during long-term follow-up (13.6 ± 5.2 years) without drug use. The others underwent catheter ablation. Conclusion. ESnoXr has been shown to be a feasible, effective, safe and well-tolerated procedure for the assessment of arrhythmic risk in a population of young athletes with asymptomatic VP.

First-line therapy: insights from a real-world analysis of cryoablation in patients with atrial fibrillation.

AIMS: Pulmonary vein isolation (PVI) using cryoballoon ablation (CBA) is mainly reserved for patients with drug-refractory or drug-intolerant symptomatic atrial fibrillation. We evaluated a large cohort of patients treated in a real-world setting and examined the safety and efficacy profile of CBA when applied as a first-line treatment for atrial fibrillation. METHODS: In total, 249 patients (23% women; 56 ±â€Š13 years; mean left atrial diameter 41 ±â€Š7 mm; 73.5% paroxysmal atrial fibrillation; and 26.5% persistent atrial fibrillation) underwent an index PVI by CBA. Data were collected prospectively in the framework of the 1STOP ClinicalService project, involving 26 Italian cardiology centers. RESULTS: Median procedure and fluoroscopy times were 90.0 and 21.0 min, respectively. Acute procedural success was 99.8%. Acute/periprocedural complications were observed in seven patients (2.8%), including: four transient diaphragmatic paralyses, one pericardial effusion (not requiring any intervention), one transient ischemic attack, and one minor vascular complication. The Kaplan--Meier freedom from atrial fibrillation recurrence was 86.3% at 12 months and 76% at 24 months. Seventeen patients (6.8%) had a repeat catheter ablation procedure during the follow-up period. At last follow-up, 10% of patients were on an anticoagulation therapy, whereas 6.8% were on an antiarrhythmic drug. CONCLUSION: In our multicenter real-world experience, PVI by CBA in a first-line atrial fibrillation patient population was well tolerated, effective, and promising. CBA with a PVI strategy can be used to treat patients with paroxysmal and persistent atrial fibrillation with good acute procedural success, short procedure times, and acceptable safety. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT01007474).

Scheduled versus alert transmissions for remote follow-up of cardiac implantable electronic devices: Clinical relevance and resource consumption.

BACKGROUND: The remote follow-up of pacemakers and implantable cardiac defibrillators (ICDs) usually includes scheduled checks and alert transmissions. However, this results in a high volume of remote data reviews to be managed. We measured the relative contribution of scheduled and alert transmissions to the detection of relevant conditions, and the workload generated by their management. METHODS: At our center, the frequency of remote scheduled transmissions is 4/year. Moreover, all system-integrity and clinical alerts are turned on for wireless notification. We calculated the number of transmissions received from January to December 2020, and identified transmissions that necessitated in-hospital access for further assessment and transmissions that required clinical discussion with the physician. For all alert transmissions, we identified whether the alert was clinically meaningful (i.e. center was not previously aware of the condition and no action had yet been taken to treat it). RESULTS: Of 8545 transmissions received from 1697 pacemakers and ICDs, 5766 (67%) were scheduled and 2779 (33%) were alert transmissions received from 764 patients (45%); 499 (9%) scheduled transmissions required clinical discussion with the physician, but only 2 of these necessitated in-hospital visits for further assessment. Of the alert transmissions, 664 (24%) required clinical discussion, and 75 (3%) necessitated in-hospital visits. The proportion of alerts judged clinically meaningful was 7%. CONCLUSION: Scheduled transmissions generate 67% of remote data reviews for pacemakers and ICDs, but their ability to detect clinically relevant events is very low. A strategy that relies exclusively on alert transmissions could ensure continuity of patient monitoring while reducing the workload at the center.

Integration of activation maps of epicardial veins in computational cardiac electrophysiology.

In this work we address the issue of validating the monodomain equation used in combination with the Bueno-Orovio ionic model for the prediction of the activation times in cardiac electro-physiology of the left ventricle. To this aim, we consider four patients who suffered from Left Bundle Branch Block (LBBB). We use activation maps performed at the septum as input data for the model and maps at the epicardial veins for the validation. In particular, a first set (half) of the latter are used to estimate the conductivities of the patient and a second set (the remaining half) to compute the errors of the numerical simulations. We find an excellent agreement between measures and numerical results. Our validated computational tool could be used to accurately predict activation times at the epicardial veins with a short mapping, i.e. by using only a part (the most proximal) of the standard acquisition points, thus reducing the invasive procedure and exposure to radiation.

Implementation of remote follow-up of cardiac implantable electronic devices in clinical practice: organizational implications and resource consumption.

AIMS: Current guidelines recommend remote follow-up for all patients with cardiac implantable electronic devices. However, the introduction of a remote follow-up service requires specifically dedicated organization. We evaluated the impact of adopting remote follow-up on the organization of a clinic and we measured healthcare resource utilization. METHODS: In 2016, we started the implementation of the remote follow-up service. Each patient was assigned to an experienced nurse and a doctor in charge with preestablished tasks and responsibilities. During 2016 and 2017, all patients on active follow-up at our center were included in the service; since 2018, the service has been fully operational for all patients following postimplantation hospital discharge. RESULTS: As of December 2018, 2024 patients were on active follow-up at the center. Of these, 93% of patients were remotely monitored according to the established protocol. The transmission rates were: 5.3/patient-year for pacemakers, 6.0/patient-year for defibrillators, and 14.1/patient-year for loop recorders. Only 21% of transmissions were submitted to the physician for further clinical evaluation, and 3% of transmissions necessitated an unplanned in-hospital visit for further assessment. Clinical events of any type were detected in 39% of transmissions. Overall, the nurses' total workload was 3596 h per year, that is, 1.95 full-time equivalent, which resulted in 1038 patients/nurse. The total workload for physicians was 526 h per year, that is, 0.29 full-time equivalent. After 1 year on follow-up, most patients judged the service positively and expressed their preference for the new follow-up approach. CONCLUSION: A remote follow-up service can be implemented and efficiently managed by nursing staff with minimal physician support. Patients are followed up with greater continuity and seem to appreciate the service.

Cryoballoon or radiofrequency ablation? Alternating technique for repeat procedures in patients with atrial fibrillation.

BACKGROUND: Which technique is better for repeat ablation in patients with atrial fibrillation (AF) remains unclear. The aim of the study was to compare long-term efficacy of repeat ablation using the alternative technique for the first redo ablation procedure: (a) cryoballoon (CB) re-ablation after a failed index pulmonary vein isolation (PVI) with radiofrequency (RF) ablation, RF-then-CB group or (b) RF repeat ablation following a failed CB ablation, CB-then-RF group. METHODS: Within the 1STOP Italian Project, consecutive patients undergoing repeat ablation with a different technique from the index procedure were included. RESULTS: We studied 474 patients, 349 in RF-then-CB and 125 in CB-then-RF group. Less women (21% vs 30%; P = .041), more persistent AF (33% vs 22%; P = .015), longer duration of AF (60 vs 31 months; P < .001), and more hypertension (50% vs 36%; P = .007) were observed in the RF-then-CB cohort as compared with the CB-then-RF group. The number of reconnected PVs was 3.7 ± 0.7 and 1.4 + 1.3 in RF-then-CB and CB-then-RF group, respectively (P < .001). During the follow-up, significantly less AF recurrence occurred in the CB-then-RF group (22% vs 8%, HR = 0.46; 95% CI: 0.24-0.92; P = .025). Cohort designation was the only independent predictor of AF recurrence. CONCLUSION: Alternation of energy source for repeat ablation was safe and effective, regardless the energy used first. However, patients initially treated with CB PVI undergoing repeat ablation with RF current had less AF recurrence at long-term follow-up as compared with those originally treated by RF ablation receiving a CB repeat ablation.

Coronary sinus and great cardiac vein electroanatomic mapping predicts the activation delay of the coronary sinus branches.

BACKGROUND: Implantation of left ventricular (LV) lead in segments with delayed electrical activation may improve response to cardiac resynchronization therapy (CRT). The search for the latest LV electrical delay (LVED) site can be time-consuming. OBJECTIVE: To assess if electrical mapping of coronary sinus (CS) and magna cardiac vein can help to identify the latest activated CS branch. METHODS: We retrospectively evaluated 48 consecutive patients who underwent electroanatomic mapping system-guided (EAMS)-CRT device implantation with ≥2 mapped CS branches. The activation mapping of the CS and relative branches were performed using an insulated guide wire. LVED was defined as the interval between the beginning of the QRS complex on the surface electrocardiogram and the local electrogram and expressed in milliseconds (ms). RESULTS: Thirty-two (67%) patients showed left bundle branch block (LBBB) and 16 (33%) non-LBBB electrocardiographic patterns. A total of 116 CS branches (mean, 2.4/patient; range, 2-5) were mapped. In the left oblique view, most patients (N = 39, 81%) showed the latest CS-LVED in lateral segments while nine (19%) showed the latest CS-LVED in anterior or posterior segments. Specifically, 94% of patients with LBBB showed the latest CS-LVED in lateral segments while CS activation among non-LBBB patients was heterogeneous. In all patients, the CS branch that demonstrated the highest LVED originated from the latest activated segment of the CS. CONCLUSION: Electrical mapping of CS allows identifying the latest activated branches. This finding may contribute to simplify CRT device implantation compared to activation mapping of all the branches.

Cryoablation for paroxysmal and persistent AF in patients with structural heart disease and preserved ejection fraction: Clinical outcomes from 1STOP, a multicenter observational project.

BACKGROUND: Pulmonary vein isolation (PVI) is an accepted strategy for paroxysmal atrial fibrillation (PAF) and persistent AF (PerAF) ablation. Limited data are available on outcomes of cryoballoon (CB) PVI in patients with structural heart disease (SHD). The purpose is to assess the clinical efficacy of a single CB-PVI procedure in patients with PAF or PerAF who also have SHD. METHODS: From April 2012, 460 AF patients with concomitant SHD underwent CB-PVI and were followed prospectively in the framework of the 1STOP ClinicalService® project. Data on procedural outcomes and long-term freedom from AF recurrence were evaluated. Out of 460 subjects, 282 patients (61%) had PAF and 178 (39%) PerAF. RESULTS: SHD patients were predominantly male (80.9%), old (62.8±8.9 years), with preserved functional capacity (New York Heart Association class >1: 39.4%), high cardioembolic risk (CHA2DS2VASc score ≥2: 69.3%), and conserved left ventricular ejection fraction (56.5±8% LVEF). Both subjects with PAF and PerAF had similar baseline clinical characteristics except for left atrial diameter (43.8±7 vs. 45.7±7mm) and area (22.9±5.2 vs. 25.1±4.4cm2), respectively. Procedure time and fluoroscopic time as well as the rate of procedural complications were not different between subjects with PAF and PerAF. After a mean follow-up of 12 months, antiarrhythmic drug therapy had dropped from 71.7% before ablation to 33.6% post-ablation (p<0.001) and the freedom from symptomatic AF recurrence was 78% for PAF and 77% for PerAF (p=0.793). Furthermore, atrial arrhythmia recurrence rate was not related to SHD. CONCLUSIONS: In a large multicenter, real-world cohort, CB-PVI was used to treat patients with PAF and PerAF who also had SHD. The arrhythmia recurrence after a single procedure was not related to either the degree of cardiac structural remodeling or the type of AF, and the rate of AF recurrence was lower than previously reported in patients with SHD in other cohort series using focal radiofrequency catheter ablation. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT01007474).

Use of impedance-based catheter tip-to-tissue contact assessment (electroanatomic coupling index, ECI) in typical right atrial flutter ablation.

PURPOSE: The electrical coupling index (ECI) (Abbott, USA) is a marker of tissue contact and ablation depth developed particularly for atrial fibrillation treatment. We sought to evaluate if these measures can be also a marker of lesion efficacy during cavotricuspid isthmus (CTI) ablation for typical right atrial flutter. METHODS: We assessed the ECI values in patients undergoing typical right atrial flutter point-by-point ablation guided by the Ensite Velocity Contact™ (St. Jude Medical, now Abbott St. Paul, MN, USA) electroanatomic mapping system. ECI values were collected before, during (at the plateau), and after radiofrequency (RF) delivery. The physician was blinded to ECI and judged ablation efficacy according to standard parameters (impedance drop, local potential reduction, and/or split in two separate potentials). Patients were followed up at 3 and 12 months. RESULTS: Fifteen consecutive patients (11 males, mean age 69.2 ± 10.6 years) with a history of typical right atrial flutter were included in this study. A total of 158 RF applications were assessed (mean 10.5 ± 6.6 per patient, range 6-28). The absolute and percentage ECI variations (pre-/post-ablation) were significantly greater when applications were effective (p < 0.001). A 12% drop in the ECI after ablation was identified by the ROC curve as the best cutoff value to discriminate between effective and ineffective ablation (sensitivity 94%, specificity 100%). Acute success was achieved in all patients with no complications and no recurrences during follow-up. CONCLUSION: The ECI appeared a reliable index to guide CTI ablation. A 12% drop of ECI during radiofrequency energy delivery was highly accurate in identifying effective lesion.

Management of patients with cardiac implantable electronic devices (CIED) undergoing radiotherapy: A consensus document from Associazione Italiana Aritmologia e Cardiostimolazione (AIAC), Associazione Italiana Radioterapia Oncologica (AIRO), Associazione Italiana Fisica Medica (AIFM).

The management of patients with a cardiac implanted electronic device (CIED) receiving radiotherapy (RT) is challenging and requires a structured multidisciplinary approach. A consensus document is presented as a result of a multidisciplinary working group involving cardiac electrophysiologists, radiation oncologists and physicists in order to stratify the risk of patients with CIED requiring RT and approaching RT sessions appropriately. When high radiation doses and beam energy higher than 6MV are used, CIED malfunctions can occur during treatment. In our document, we reviewed the different types of RT and CIED behavior in the presence of ionizing radiations and electromagnetic interferences, from the cardiologist's, radiation oncologist's and medical physicist's point of view. We also reviewed in vitro and in vivo literature data and other national published guidelines on this issue so far. On the basis of literature data and consensus of experts, a detailed approach based on risk stratification and appropriate management of RT patients with CIEDs is suggested, with important implications for clinical practice.

Clinical impact, safety, and accuracy of the remotely monitored implantable loop recorder Medtronic Reveal LINQTM.

Aims: Implantable loop recorders (ILR) are indicated in a variety of clinical situations when extended cardiac rhythm monitoring is needed. We aimed to assess the clinical impact, safety, and accuracy of the new Medtronic Reveal LINQTM ILR that can be inserted outside the electrophysiology (EP) laboratory and remotely monitored. Methods and results: All 154 consecutive patients (100 males, 63 ± 15 year-old) who received the Reveal LINQTM ILR during the period July 2014-June 2016 were enrolled. The device was implanted in a procedure room and all patients where provided with the MyCareLinkTM remote monitoring system. Data were reviewed every working day via the Carelink® web system by a specialist nurse who, in case of significant events, consulted an electrophysiologist. During a mean follow-up of 12.1 (6.7-18.4) months (range 2-24 months), a diagnosis was made in 99 (64%) patients and in 60 (39%) ≥1 therapeutic interventions were established following recording of arrhythmias. In 26 of these 60 patients, remote monitoring prompted therapeutic interventions following asymptomatic arrhythmic events 3.8 months before the next theoretical scheduled in-office data download. False bradycardia detection for undersensing occurred in 44 (29%) patients and false tachycardia detection for oversensing in 4 (3%). One patient experienced skin erosion requiring explantation and none suffered from infection. Conclusion: The remote monitoring feature of the Reveal LINQTM allowed earlier diagnosis of asymptomatic but serious arrhythmias in a significant proportion of patients. Implantation of the device outside the EP laboratory appeared safe. However, R-wave undersensing and consequent false recognition of bradyarrhythmias remains a clinically important technical issue.

Coronary sinus activation patterns in patients with and without left bundle branch block undergoing electroanatomic mapping system-guided cardiac resynchronization therapy device implantation.

BACKGROUND: Implantation of the left ventricular (LV) lead in segments with delayed electrical activation may improve response to cardiac resynchronization therapy (CRT). OBJECTIVE: The purpose of this study was to evaluate the amount and regional distribution of LV electrical delay (LVED) in patients with or without left bundle branch block (LBBB). METHODS: We enrolled 60 patients who underwent electroanatomic mapping system-guided CRT device implantation. Activation mapping of the coronary sinus (CS) branches was performed using an insulated guidewire. LVED was defined as the interval between the beginning of the QRS complex on the surface electrocardiogram (ECG) and the local electrogram and expressed in milliseconds or as percentage of the total QRS duration (LVED%). RESULTS: Forty-three patients showed a LBBB and 17 a non-LBBB electrocardiographic pattern. A total of 148 CS branches (mean 2.5 per patient; range 2-4 per patient) were mapped. Patients with LBBB showed higher maximum LVED (135 ms [108-150 ms] vs 100 ms [103-110 ms]; P < .001) and LVED% (86% [79%-89%] vs 72% [54%-80%]; P < .001) than did patients without LBBB. The maximum LVED was recorded in mid-basal anterolateral or inferolateral LV segments (traditional CRT targets), significantly more often in patients with LBBB than in patients without LBBB (85% vs 59%; P = .02). The number of CS branches showing LVED >50% of the total QRS duration, >75% of the total QRS duration, and >85 ms was significantly higher in patients with LBBB than in patients without LBBB. CONCLUSION: Patients without LBBB showed lower LVED and more heterogeneous electrical activation of the CS than did patients with LBBB. This finding may contribute to a lower rate of response to CRT of patients without LBBB and suggests the use of activation mapping to guide LV lead placement.

Pulmonary Vein Isolation with the Cryoballoon Technique: Feasibility, Procedural Outcomes, and Adoption in the Real World: Data from One Shot Technologies TO Pulmonary Vein Isolation (1STOP) Project.

BACKGROUND: Catheter ablation (CA) is recommended for patients with drug refractory symptomatic atrial fibrillation (AF). "One Shot" catheters have been introduced to simplify CA and cryoballoon ablation (CBA) is spreading rapidly. Few real-world data are available on standard clinical practice, mainly from single-center experience. We aimed to evaluate clinical settings, demographics, and acute procedural outcomes in a large cohort of patients treated with CBA. METHODS: A total of 903 patients (73% male, mean age 59 ± 11) underwent pulmonary vein CBA. Correlations between the patient's inclusion time and clinical characteristics, procedure duration, acute success rate, and intraprocedural complications were evaluated. RESULTS: Seventy-seven percent of patients were affected by paroxysmal AF and 23% by persistent AF. Overall, acute success rate was 97.9% and periprocedural complications were observed in 35 (3.9%) patients, 13 (1.4%) of which were classified as major complications. With respect to the patient's inclusion time analysis, an increase in treatment of persistent AF was observed, a significant decrease in CBA times (procedure, ablation, and fluoroscopy: 136.0 ± 46.5 minutes, 28.8 ± 19.6 minutes, and 34.3 ± 15.4 minutes, respectively) was observed, with comparable acute success rate and intraprocedural complications over time. The rate of major complications was extremely low (1.4%); no death, atrioesophageal fistula, stroke, or other major periinterventional or late complications occurred. CONCLUSION: This series represents the largest experience of CBA in the treatment of AF that also describes the adoption curve of this relatively recent technology. CBA showed an excellent safety profile when performed in a large real-world clinical setting, with satisfactory acute success rate and, on average, short procedural times. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT01007474).