A Modular Communicative Leadless Pacing-Defibrillator System.

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) is associated with fewer lead-related complications than a transvenous ICD; however, the subcutaneous ICD cannot provide bradycardia and antitachycardia pacing. Whether a modular pacing-defibrillator system comprising a leadless pacemaker in wireless communication with a subcutaneous ICD to provide antitachycardia and bradycardia pacing is safe remains unknown. METHODS: We conducted a multinational, single-group study that enrolled patients at risk for sudden death from ventricular arrhythmias and followed them for 6 months after implantation of a modular pacemaker-defibrillator system. The safety end point was freedom from leadless pacemaker-related major complications, evaluated against a performance goal of 86%. The two primary performance end points were successful communication between the pacemaker and the ICD (performance goal, 88%) and a pacing threshold of up to 2.0 V at a 0.4-msec pulse width (performance goal, 80%). RESULTS: We enrolled 293 patients, 162 of whom were in the 6-month end-point cohort and 151 of whom completed the 6-month follow-up period. The mean age of the patients was 60 years, 16.7% were women, and the mean (±SD) left ventricular ejection fraction was 33.1±12.6%. The percentage of patients who were free from leadless pacemaker-related major complications was 97.5%, which exceeded the prespecified performance goal. Wireless-device communication was successful in 98.8% of communication tests, which exceeded the prespecified goal. Of 151 patients, 147 (97.4%) had pacing thresholds of 2.0 V or less, which exceeded the prespecified goal. The percentage of episodes of arrhythmia that were successfully terminated by antitachycardia pacing was 61.3%, and there were no episodes for which antitachycardia pacing was not delivered owing to communication failure. Of 162 patients, 8 died (4.9%); none of the deaths were deemed to be related to arrhythmias or the implantation procedure. CONCLUSIONS: The leadless pacemaker in wireless communication with a subcutaneous ICD exceeded performance goals for freedom from major complications related to the leadless pacemaker, for communication between the leadless pacemaker and subcutaneous ICD, and for the percentage of patients with a pacing threshold up to 2.0 V at a 0.4-msec pulse width at 6 months. (Funded by Boston Scientific; MODULAR ATP ClinicalTrials.gov NCT04798768.).

Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator.

BACKGROUND: The extravascular implantable cardioverter-defibrillator (ICD) has a single lead implanted substernally to enable pause-prevention pacing, antitachycardia pacing, and defibrillation energy similar to that of transvenous ICDs. The safety and efficacy of extravascular ICDs are not yet known. METHODS: We conducted a prospective, single-group, nonrandomized, premarket global clinical study involving patients with a class I or IIa indication for an ICD, all of whom received an extravascular ICD system. The primary efficacy end point was successful defibrillation at implantation. The efficacy objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients with successful defibrillation was greater than 88%. The primary safety end point was freedom from major system- or procedure-related complications at 6 months. The safety objective would be met if the lower boundary of the one-sided 97.5% confidence interval for the percentage of patients free from such complications was greater than 79%. RESULTS: A total of 356 patients were enrolled, 316 of whom had an implantation attempt. Among the 302 patients in whom ventricular arrhythmia could be induced and who completed the defibrillation testing protocol, the percentage of patients with successful defibrillation was 98.7% (lower boundary of the one-sided 97.5% confidence interval [CI], 96.6%; P<0.001 for the comparison with the performance goal of 88%); 299 of 316 patients (94.6%) were discharged with a working ICD system. The Kaplan-Meier estimate of the percentage of patients free from major system- or procedure-related complications at 6 months was 92.6% (lower boundary of the one-sided 97.5% CI, 89.0%; P<0.001 for the comparison with the performance goal of 79%). No major intraprocedural complications were reported. At 6 months, 25 major complications were observed, in 23 of 316 patients (7.3%). The success rate of antitachycardia pacing, as assessed with generalized estimating equations, was 50.8% (95% CI, 23.3 to 77.8). A total of 29 patients received 118 inappropriate shocks for 81 arrhythmic episodes. Eight systems were explanted without extravascular ICD replacement over the 10.6-month mean follow-up period. CONCLUSIONS: In this prospective global study, we found that extravascular ICDs were implanted safely and were able to detect and terminate induced ventricular arrhythmias at the time of implantation. (Funded by Medtronic; ClinicalTrials.gov number, NCT04060680.).

Correlation between AV synchrony and device collected AM-VP sequence counter in atrioventricular synchronous leadless pacemakers: A real-world assessment.

INTRODUCTION: Micra atrioventricular (AV) provides leadless atrioventricular synchronous pacing by sensing atrial contraction (A4 signal). Real-world operation and reliability of AV synchrony (AVS) assessment using device data have not been described. The purposes of this study were to (1) assess the correlation between AVS and atrial mechanical sensed-ventricular pacing (AM-VP) percentages in patients with permanent high-degree AV block and (2) report on the real-world effectiveness of Micra AV. METHODS: The correlation between ECG-determined AVS in-clinic and device-collected %AM-VP was assessed using data from 40 patients with high-degree AV block enrolled in the Micra Atrial tRacking using a Ventricular AccELerometer (MARVEL) 2 study. A retrospective analysis to assess continuously-sampled %AM-VP since last session, device programming, and electrical parameters was performed using Micra AV transmissions from the Medtronic CareLink database. Patients with transmissions ≥180 days postimplant were included. RESULTS: Among the 40 MARVEL 2 AV block patients with a median %VP of 99.7%, AVS was highly correlated with AM-VP (median AVS 87.1%, median AM-VP 79.1%; R2 = 0.764, p < .001). The CareLink cohort included 4384 patients programmed to VDD mode. The mean A4 amplitude was 2.3 ± 1.8 m/s2 at implant and 2.3 ± 1.6 m/s2 at 28 weeks. In patients with %VP >90% (n = 1662), the median %AM-VP was 74.7%. For the full cohort, median %VP was 65.6% and median projected battery longevity was 10.5 years. CONCLUSION: In patients with a high pacing burden, %AM-VP provides a reasonable estimation of AVS. The first large real-world analysis of Micra AV patients with >90% VP showed stable atrial sensing over time with a median %AM-VP, a correlate of AVS, of 74.7%.

Lead management in patients undergoing percutaneous tricuspid valve replacement or repair: a 'heart team' approach.

Clinically significant tricuspid regurgitation (TR) has historically been managed with either medical therapy or surgical interventions. More recently, percutaneous trans-catheter tricuspid valve (TV) replacement and tricuspid trans-catheter edge-to-edge repair have emerged as alternative treatment modalities. Patients with cardiac implantable electronic devices (CIEDs) have an increased incidence of TR. Severe TR in this population can occur for multiple reasons but most often results from the interactions between the CIED lead and the TV apparatus. Management decisions in patients with CIED leads and clinically significant TR, who are undergoing evaluation for a percutaneous TV intervention, need careful consideration as a trans-venous lead extraction (TLE) may both worsen and improve TR severity. Furthermore, given the potential risks of 'jailing' a CIED lead at the time of a percutaneous TV intervention (lead fracture and risk of subsequent infections), consideration should be given to performing a TLE prior to a percutaneous TV intervention. The purpose of this 'state-of-the-art' review is to provide an overview of the causes of TR in patients with CIEDs, discuss the available therapeutic options for patients with TR and CIED leads, and advocate for including a lead management specialist as a member of the 'heart team' when making treatment decisions in patients TR and CIED leads.

Safety and success of transvenous lead extraction using excimer laser sheaths: a meta-analysis of over 1700 patients.

AIMS: While numerous studies have demonstrated favourable safety and efficacy of the excimer laser sheath for transvenous lead extraction (TLE) in smaller cohorts, comprehensive large-scale investigations with contemporary data remain scarce. This study aims to evaluate the safety and performance of laser-assisted TLE through a meta-analysis of contemporary data. METHODS AND RESULTS: A systematic literature search was conducted to identify articles that assessed the safety and performance of the spectranetics laser sheath (SLS) II and GlideLight Excimer laser sheaths in TLE procedures between 1 April 2016 and 31 March 2021. Safety outcomes included procedure-related death and major/minor complications. Performance outcomes included procedural and clinical success rates. A random-effects, inverse-variance-weighting meta-analysis was performed to obtain the weighted average of the evaluated outcomes. In total, 17 articles were identified and evaluated, including 1729 patients with 2887 leads. Each patient, on average, had 2.3 ± 0.3 leads with a dwell time of 7.9 ± 3.0 years. The TLE procedural successes rate was 96.8% [1440/1505; 95% CI: (94.9-98.2%)] per patient and 96.3% [1447/1501; 95% CI: (94.8-97.4%)] per lead, and the clinical success rate per patient was 98.3% [989/1010, 95% CI: (97.4-99.0%)]. The procedure-related death rate was 0.08% [7/1729, 95% CI: (0.00%, 0.34%)], with major and minor complication rates of 1.9% [41/1729; 95% CI: (1.2-2.8%)] and 1.9% [58/1729; 95% CI: (0.8-3.6%)], respectively. CONCLUSION: This meta-analysis demonstrated that excimer laser sheath-assisted TLE has high success and low procedural mortality rates. It provides clinicians with a reliable and valuable resource for extracting indwelling cardiac leads which require advanced extraction techniques.

Same-day discharge after transvenous lead extraction: feasibility and outcomes.

AIMS: Same-day discharge (SDD) is safe for patients undergoing electrophysiology procedures. There is no existing data regarding SDD for patients undergoing transvenous lead extraction (TLE). We report our experience with SDD for patients undergoing TLE. METHODS AND RESULTS: The study group included patients undergoing TLE between February 2020 and July 2021 without an infectious indication. A modified SDD protocol for device implants/ablations was applied to TLE patients. Patient characteristics, extraction details, outcomes, and complications were reviewed. Of 239 patients undergoing TLE, 210 were excluded (94 infections and 116 did not meet SDD criteria). Of the remaining 29 patients, seven stayed due to patient preference and 22 were discharged home the same day. The SDD group had an average age of 65.9 ± 12 (47-84), 41% female, and LVEF of 52.2 ± 18% (10-80). The indication for TLE was malfunction (20), upgrade (4), advisory lead (2), and magnetic resonance imaging compatibility (1). Extractions included four implantable cardioverter-defibrillators (ICDs), 17 pacemakers (PPM), and one cardiac resynchronization therapy (CRT)-P system. The leads were 9.6 years (1.5-21.7) old, and 1.8 leads were removed per patient (1-3); the lead extraction difficulty (LED) score was 11.6 ± 7. Twenty underwent cardiovascular implantable electronic device (CIED) re-implantation (2 ICD, 3 CRT-D, 13 PPM, and 2 CRT-P). For CIED re-implants, patients sent a remote transmission the next day, and all patients received a next-day call. There were no procedure or device-related issues, morbidities, or mortalities in the 30 days after discharge. CONCLUSION: Same-day discharge after TLE for non-infectious aetiologies is safe and feasible in a select group of patients with early procedure completion who meet strict SDD criteria.

Same-day discharge after cryoballoon ablation of atrial fibrillation: A multicenter experience.

BACKGROUND: It is common practice to observe patients during an overnight stay (ONS) following a catheter ablation procedure for the treatment of atrial fibrillation (AF). OBJECTIVES: To investigate the safety and economic impact of a same-day discharge (SDD) protocol after cryoballoon ablation for treatment of AF in high-volume, geographically diverse US hospitals. METHODS: We retrospectively reviewed 2374 consecutive patients (1119 SDD and 1180 ONS) who underwent cryoballoon ablation for AF at three US centers. Baseline characteristics, acute procedure-related complications, and longer-term evaluations of safety were recorded during routine clinical follow-up. The mean cost of an ONS was used in a one-way sensitivity analysis to evaluate yearly cost savings as a function of the percentage of SDD cases per year. RESULTS: The SDD and ONS cohorts were predominately male (69% vs. 67%; p = .3), but SDD patients were younger (64 ± 11 vs. 66 ± 10; p < .0001) with lower body mass index (30 ± 6 vs. 31 ± 61; p < .0001) and CHA2 DS2 -VASc scores (1.4 ± 1.0 vs. 2.2 ± 1.4; p < .0002). There was no difference between SDD and ONS in the 30-day total complication rate (n = 15 [1.26%] versus n = 24 [2.03%]; p = .136, respectively). The most common complication was hematoma in both the SDD (n = 8; 0.67%) and ONS (n = 11; 0.93%) cohorts. Sensitivity analysis demonstrated that when 50% of every 100 patients treated were discharged the same day, hospital cost savings ranged from $45 825 to $83 813 per year across US hospitals. CONCLUSIONS: SDD following cryoballoon ablation for AF appears to be safe and is associated with cost savings across different US hospitals.

Behavior of AV synchrony pacing mode in a leadless pacemaker during variable AV conduction and arrhythmias.

INTRODUCTION: MARVEL 2 assessed the efficacy of mechanical atrial sensing by a ventricular leadless pacemaker, enabling a VDD pacing mode. The behavior of the enhanced MARVEL 2 algorithm during variable atrio-ventricular conduction (AVC) and/or arrhythmias has not been characterized and is the focus of this study. METHODS: Of the 75 patients enrolled in the MARVEL 2 study, 73 had a rhythm assessment and were included in the analysis. The enhanced MARVEL 2 algorithm included a mode-switching algorithm that automatically switches between VDD and ventricular only antibradycardia pacing (VVI)-40 depending upon AVC status. RESULTS: Forty-two patients (58%) had persistent third degree AV block (AVB), 18 (25%) had 1:1 AVC, 5 (7%) had variable AVC status, and 8 (11%) had atrial arrhythmias. Among the 42 patients with persistent third degree AVB, the median ventricular pacing (VP) percentage was 99.9% compared to 0.2% among those with 1:1 AVC. As AVC status changed, the algorithm switched to VDD when the ventricular rate dropped less than 40 bpm. During atrial fibrillation (AF) with ventricular response greater than 40 bpm, VVI-40 mode was maintained. No pauses longer than 1500 ms were observed. Frequent ventricular premature beats reduced the percentage of AV synchrony. During AF, the atrial signal was of low amplitude and there was infrequent sensing. CONCLUSION: The mode switching algorithm reduced VP in patients with 1:1 AVC and appropriately switched to VDD during AV block. No pacing safety issues were observed during arrhythmias.

Limitation of standard ECG criteria to localize an outflow tract PVC.

Multiple ECG algorithms exist to localize outflow tract PVCs. They can be invaluable in pre-procedure planning and patient counseling. We describe a case where the published algorithm for PVC localization did not predict the site of origin and successful ablation site. This case highlights the strengths and limitations of established ECG PVC localization algorithms.

European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID), and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially lifesaving treatments for a number of cardiac conditions but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased health care costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well-recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, antibacterial envelopes, prolonged antibiotics post-implantation, and others. When compared with previous guidelines or consensus statements, the present consensus document gives guidance on the use of novel device alternatives, novel oral anticoagulants, antibacterial envelopes, prolonged antibiotics post-implantation, as well as definitions on minimum quality requirements for centres and operators and volumes. The recognition that an international consensus document focused on management of CIED infections is lacking, the dissemination of results from new important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a Novel 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.

Concomitant leadless pacemaker implantation and lead extraction during an active infection.

INTRODUCTION: The need for transvenous lead extractions due to cardiac implantable electronic device (CIED)-related infections continues to rise. Current guidelines recommend complete device removal in the setting of an active infection, which can be challenging in pacemaker-dependent patients. METHODS: We retrospectively reviewed all leadless pacemaker implants between January 2018 and November 2019 and identified a subset of patients who had undergone a concomitant CIED extraction in the setting of an active infection. Baseline characteristics, procedural details, and clinical follow-ups were recorded. RESULTS: Seventeen patients received a leadless pacemaker during the same procedure as the CIED extraction. There were no procedural complications. All patients were being treated for an active CIED infection at the time of the procedure. Fourteen patients (82.4%) were completely pacemaker-dependent and four patients (23.5%) had positive blood cultures at the time of the leadless pacemaker implantation. During a median follow-up of 143 days (interquartile range: 57, 181 days), there were no recurrent infections. CONCLUSION: Simultaneous leadless pacemaker implantation and CIED extraction are safe and feasible in the setting of an active infection. This strategy may be particularly useful in patients that are pacemaker-dependent.

Electrocardiographic localization of ventricular arrhythmias successfully ablated from the distal great cardiac vein.

BACKGROUND: Idiopathic ventricular arrhythmias (IVAs) from the left ventricular (LV) summit may be successfully ablated from the distal great cardiac vein (dGCV). Using a 12-lead electrocardiogram (ECG) to localize IVAs that can be ablated from the dGCV is valuable for ablation planning. OBJECTIVE: To determine if a "w" wave, a notch in the Q wave in lead I, and other ECG features can identify IVAs that can be successfully ablated from the dGCV. METHODS: We reviewed outflow tract premature ventricular contraction (PVC) ablations performed at two centers between September 2010 and June 2018. Successful PVC ablations, in which the PVCs were mapped from the right ventricular outflow tract, coronary cusps, commissures, endocardial LV, and the coronary venous system including the dGCV were included. ECG characteristics were compared between patients with successful ablations in the dGCV and non-dGCV sites. RESULTS: Of the 120 patients (age 56.8 ± 13.8 years, 45% female) that met the inclusion criteria, the dGCV was the successful ablation site in 18 patients (15%). Multivariate analysis with binary logistic regression showed that a "w" in lead I in combination with an early precordial pattern break and a maximum deflection index (MDI) ≥ 0.5 had sensitivity and specificity for a successful ablation in the dGCV of 94.4% and 96.1%, respectively. CONCLUSION: Combining a "w" wave in lead I with an early precordial pattern break and an MDI ≥ 0.5 is highly sensitive and specific for identifying the dGCV as a successful ablation site for PVCs.

Implantation of leadless pacemakers via inferior vena cava filters is feasible and safe: Insights from a multicenter experience.

BACKGROUND: The leadless Micra transcatheter-pacing system (Micra-TPS) is implanted via a femoral approach using a 27-French introducer sheath. The Micra Transcutaneous Pacing Study excluded patients with inferior vena cava (IVC) filters. OBJECTIVE: To examine the feasibility and safety of Micra-TPS implantation through an IVC filter. METHODS: This multicenter retrospective study included patients with an IVC filter who underwent a Micra-TPS implantation. Data for clinical and IVC filter characteristics, preprocedure imaging, and procedural interventions were collected. The primary outcome was a successful leadless pacemaker (LP) implantation via a femoral approach in the presence of an IVC filter. Periprocedural and delayed clinical complications were also evaluated. RESULTS: Of the 1528 Micra-TPS implants attempted, 23 patients (1.5%) had IVC filters. The majority (69.6%) of IVC filters were permanent. Six (26.1%) patients underwent preprocedural imaging to assess for filter patency. One patient's filter was retrieved before LP implantation. The primary outcome was achieved in 21 of 22 patients (95.5%) with an existing IVC filter. An occluded IVC precluded LP implantation in one patient. Difficulty advancing the stiff guidewire or the 27-Fr sheath was encountered in five patients. These cases required repositioning of the wire (n = 2), gradual sheath upsizing (n = 2), or balloon dilation of the filter (n = 1). Postprocedure fluoroscopy revealed intact filters in all cases. During a median 6-month follow-up, there were no clinical complications related to the filter or the Micra-TPS. CONCLUSION: This multicenter experience demonstrates the feasibility and safety of Micra-TPS implantation via an IVC filter without acute procedural or delayed clinical complications.

European Heart Rhythm Association (EHRA) international consensus document on how to prevent, diagnose, and treat cardiac implantable electronic device infections-endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), the Latin American Heart Rhythm Society (LAHRS), International Society for Cardiovascular Infectious Diseases (ISCVID) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS).

Pacemakers, implantable cardiac defibrillators, and cardiac resynchronization therapy devices are potentially life-saving treatments for a number of cardiac conditions, but are not without risk. Most concerning is the risk of a cardiac implantable electronic device (CIED) infection, which is associated with significant morbidity, increased hospitalizations, reduced survival, and increased healthcare costs. Recommended preventive strategies such as administration of intravenous antibiotics before implantation are well recognized. Uncertainties have remained about the role of various preventive, diagnostic, and treatment measures such as skin antiseptics, pocket antibiotic solutions, anti-bacterial envelopes, prolonged antibiotics post-implantation, and others. Guidance on whether to use novel device alternatives expected to be less prone to infections and novel oral anticoagulants is also limited, as are definitions on minimum quality requirements for centres and operators and volumes. Moreover, an international consensus document on management of CIED infections is lacking. The recognition of these issues, the dissemination of results from important randomized trials focusing on prevention of CIED infections, and observed divergences in managing device-related infections as found in an European Heart Rhythm Association worldwide survey, provided a strong incentive for a 2019 International State-of-the-art Consensus document on risk assessment, prevention, diagnosis, and treatment of CIED infections.

Bradyarrhythmias in patients with COVID-19: Marker of poor prognosis?

BACKGROUND: Despite descriptions of various cardiovascular manifestations in patients with coronavirus disease 2019 (COVID-19), there is a paucity of reports of new onset bradyarrhythmias, and the clinical implications of these events are unknown. METHODS: Seven patients presented with or developed severe bradyarrhythmias requiring pacing support during the course of their COVID-19 illness over a 6-week period of peak COVID-19 incidence. A retrospective review of their presentations and clinical course was performed. RESULTS: Symptomatic high-degree heart block was present on initial presentation in three of seven patients (43%), and four patients developed sinus arrest or paroxysmal high-degree atrioventricular block. No patients in this series demonstrated left ventricular systolic dysfunction or acute cardiac injury, whereas all patients had elevated inflammatory markers. In some patients, bradyarrhythmias occurred prior to the onset of respiratory symptoms. Death from complications of COVID-19 infection occurred in 57% (4/7) patients during the initial hospitalization and in 71% (5/7) patients within 3 months of presentation. CONCLUSIONS: Despite management of bradycardia with temporary (3/7) or permanent leadless pacemakers (4/7), there was a high rate of short-term morbidity and death due to complications of COVID-19. The association between new-onset bradyarrhythmias and poor outcomes may influence management strategies for acutely ill patients with COVID-19.

Clinical practice and implementation of guidelines for the prevention, diagnosis and management of cardiac implantable electronic device infections: results of a worldwide survey under the auspices of the European Heart Rhythm Association.

AIMS: Cardiac implantable electronic device (CIED) infection rates are increasing. Worldwide compliance and disparities to published guidelines for the prevention, diagnosis and management of these conditions are not well elucidated. The purpose of this survey, therefore, was to clarify these issues through an inquiry to arrhythmia-related associations and societies worldwide. METHODS AND RESULTS: A questionnaire comprising 15 questions related to CIED infections was distributed among members of seven arrhythmia societies worldwide. A total of 234 centres in 62 countries reported implantation rates of which 159 (68.0%) performed more than 200 device implantations per year and 14 (6.0%) performed fewer than 50 implantations per year. The reported rates of CIED infections for 2017 were ≤2% in 78.7% of the centres, while the infection rates exceeded 5% in 7.8% of the centres. Preventive measures for CIED infection differed from published recommendations and varied among different regions mainly in terms of pocket irrigation and administering post-operative antimicrobial therapy the use of which was reported by 39.9% and 44% of the respondents, respectively. Antibacterial envelopes were used by 37.7% of the respondents in selected circumstances. In terms of pocket infection management, 62% of the respondents applied complete system removal as an initial step. Diagnostic pocket needle aspiration and pocket surgical debridement were reported by 15.8% and 11.8% of centres, respectively. CONCLUSION: Clinical practices for prevention and management of CIED do not fully comply with current recommendations and demonstrate considerable regional disparities. Further education and programmes for improved implementation of guidelines are mandatory.

Escape mapping to achieve bidirectional block: A case series.

Escape mapping is a novel technique that can be used to locate sites of persistent conduction and achieve exit block during an atrial fibrillation ablation. This method allows for mapping solely with the ablation catheter in the left atrium by annotating to a catheter in the coronary sinus. We illustrate the utility escape mapping during an atrial fibrillation ablation where entrance block is achieved without exit block. We further expand upon this technique by describing the first reported case of escape mapping being used to achieve bidirectional block during an atrial flutter ablation.

Outcomes Associated With Extraction Versus Capping and Abandoning Pacing and Defibrillator Leads.

BACKGROUND: Lead management is an increasingly important aspect of care in patients with cardiac implantable electronic devices; however, relatively little is known about long-term outcomes after capping and abandoning leads. METHODS: Using the 5% Medicare sample, we identified patients with de novo cardiac implantable electronic device implantations between January 1, 2000, and December 31, 2013, and with a subsequent lead addition or extraction ≥12 months after the de novo implantation. Patients who underwent extraction for infection were excluded. Using multivariable Cox proportional hazards models, we compared cumulative incidence of all-cause mortality, device-related infection, device revision, and lead extraction at 1 and 5 years for the extraction versus the cap and abandon group. RESULTS: Among 6859 patients, 1113 (16.2%) underwent extraction, whereas 5746 (83.8%) underwent capping and abandonment. Extraction patients tended to be younger (median, 78 versus 79 years; P<0.0001), were less likely to be male (65% versus 68%; P=0.05), and had shorter lead dwell time (median, 3.0 versus 4.0 years; P<0.0001) and fewer comorbidities. Over a median follow-up of 2.4 years (25th, 75th percentiles, 1.0, 4.3 years), the overall 1-year and 5-year cumulative incidence of mortality was 13.5% (95% confidence interval [CI], 12.7-14.4) and 54.3% (95% CI, 52.8-55.8), respectively. Extraction was associated with a lower risk of device infection at 5 years relative to capping (adjusted hazard ratio, 0.78; 95% CI, 0.62-0.97; P=0.027). There was no association between extraction and mortality, lead revision, or lead extraction at 5 years. CONCLUSIONS: Elective lead extraction for noninfectious indications had similar long-term survival to that for capping and abandoning leads in a Medicare population. However, extraction was associated with lower risk of device infections at 5 years.

Temporal trends in safety and complication rates of catheter ablation for atrial fibrillation.

INTRODUCTION: Atrial fibrillation (AF) ablation is increasingly common, but is associated with potential major complications. Technology, experience, and protocols have evolved significantly in recent times, and may have impacted procedural safety. We sought to compare AF ablation safety profiles, including complication rates and fluoroscopy times in a "modern" versus "historical" cohort. METHODS AND RESULTS: We evaluated consecutive patients undergoing AF ablation from a modern cohort (MC) from 2014 to 2015 and a historic cohort (HC) from 2009 to 2011 for complications. Major complications were categorized according to Heart Rhythm Society guidelines. We included 1,425 patients, 726 in the HC and 699 in the MC. The MC was older, had more OSA and less valvular AF. Fifty-two (3.5%) procedures suffered major complications across the cohorts, with significantly fewer in the MC (5.0% vs. 2.3%, P  =  0.007). The largest reductions were seen in vascular, hemorrhagic, ischemic stroke, and perforation/tamponade related complications. Periprocedural antiplatelets drugs (aHR 2.1 [95 CI 1.1-3.9], P  =  0.02) and force-sensing catheters (aHR 0.4 [95 CI 0.2-0.9], P  =  0.03) were independently related to major complication rates. Direct oral anticoagulants and uninterrupted anticoagulation were not associated with complications. There was a decrease in both fluoroscopy (-17.4 minutes [95 CI 19.2-15.6], P < 0.0001) and radiofrequency ablation times (-561 seconds [95CI -750 to -371], P < 0.0001). CONCLUSIONS: The safety profile of AF ablation has improved significantly in less than a decade.