Efficacy and safety of novel left ventricular pacing leads: 1-year analysis of the NAVIGATOR trial.

OBJECTIVES: Assess safety and performance of novel quadripolar preshaped left ventricular (LV) leads: NAVIGO 4LV 2D ('S shaped') and NAVIGO 4LV ARC ('U shaped'). METHODS: Patients indicated for cardiac resynchronisation therapy were enrolled in a multicentre, prospective, controlled study (NAVIGATOR, NCT03279484). Patients were implanted with either a NAVIGO 4LV 2D or ARC lead, and assessed at 10 weeks, 6, 12 and 24 months post-implant. Co-primary safety and performance endpoints were assessed at 10 weeks. Safety endpoint was the patients' rate free from lead-related complications. Performance endpoint was the rate of patients with successful lead performance, defined as LV pacing threshold ≤2.5 V at 0.5 ms on at least one pacing vector, and the absence of phrenic nerve stimulation at the final programmed configuration. Lead-related complications and electrical parameters were monitored throughout study. RESULTS: A NAVIGO 4LV lead was successfully implanted in 211 out of 217 patients (97.2%). The safety endpoint was met, with 100% and 96.1% of patients free from complications for NAVIGO 4LV 2D and ARC, respectively. The performance endpoint was met with 98.1% and 98.9% of patients with a successful lead performance for NAVIGO 4LV 2D and ARC, respectively. Over 12 months, the global complication-free rate for both leads was 97.1% (95% CI: 93.71% to 98.70%), with a mean pacing capture threshold of 1.23 V±0.73 V and a mean impedance of 951 Ω±300.1 Ω. CONCLUSION: A high implantation success rate and low complication rate was reported for the novel NAVIGO 4LV 2D and ARC leads, along with successful performance up to 12 months.

ATE Score Diagnostic Accuracy for Predicting the Absence of Intra-Atrial Thrombi Before AF Ablation.

BACKGROUND: In a preliminary study in patients hospitalized for catheter ablation of atrial fibrillation (AF), the atrial thrombus exclusion (ATE) score (stroke, hypertension, heart failure, and D-dimers >270 ng/mL) was developed to rule out the diagnosis of intra-atrial thrombus, with a negative predictive value (NPV) of 100%, and to avoid performing transesophageal echocardiography (TEE). OBJECTIVES: The present study was designed to prospectively confirm the NPV of the ATE score in an independent population. METHODS: Consecutive patients hospitalized for catheter ablation of AF or left atrial tachycardia (LAT) were prospectively enrolled in a multicenter study. D-dimer levels were measured within 48 hours before ablation. An ATE score of 0 was considered predictive of no thrombus. TEE was routinely performed at the beginning or just before the ablation procedure. The primary endpoint was the presence of atrial thrombus diagnosed by TEE. RESULTS: The analysis included 3,072 patients (53.3% paroxysmal AF, 36.7% persistent AF, and 10% LAT). A thrombus was detected in 29 patients (0.94%; 95% CI: 0.63%-1.35%), all on appropriate anticoagulant therapy. An ATE score of 0 was observed in 818 patients (26.6%), and the sensitivity, specificity, positive predictive value, and NPV were 93.1%, 26.8%, 1.2%, and 99.8%, respectively. Follow-up of the 2 false negative patients revealed the persistence of chronic organized thrombi. CONCLUSIONS: In patients hospitalized for catheter ablation of AF or LAT, the ATE score identifies a population at very low risk for atrial thrombus. In consultation with the patient, the cardiologist may consider not performing a preoperative TEE in case of an ATE score of 0.

Cardiac implantable electronic device dysfunctions in patients undergoing radiotherapy: A prospective cohort study.

BACKGROUND: Increasing numbers of patients with cardiac implantable electronic devices (CIEDs) are undergoing radiotherapy (RT) for cancer. The aim of the study was to prospectively evaluate the incidence, characteristics, and associated factors of CIED dysfunctions related to RT. METHODS: Between April 2013 and March 2020, all patients with a CIED who underwent ≥1 RT session were enrolled. Patients were monitored according to a systematic protocol, including device interrogation before the first and after each RT session. The primary endpoint was CIED dysfunction, defined as oversensing, total or partial deprogramming, and/or unrecoverable reset. RESULTS: We included a total of 92 CIED RT courses: 77 (83.7%) in patients with a pacemaker and 15 (16.3%) in those with an implantable cardioverter-defibrillator. Overall, 13 dysfunctions (14.1%) were observed during 92 courses (1509 sessions), giving an incidence of 0.9 per 100 sessions. These included nine deprogramming (three total resets to back-up pacing mode and six partial deprogramming that were all successfully reprogrammed), three transient oversensing, and one unrecoverable oversensing requiring CIED and leads replacement. There were no adverse clinical events related to device dysfunction. In multivariable analysis, neutron-producing irradiation (odds ratio [OR], 5.59; 95% confidence interval [CI], 1.09-28.65; p = .039) and cumulative tumor dose (OR, 1.05; 95% CI, 1.01-1.10; p = .007) remained significantly associated with CIED dysfunction. CONCLUSION: In this prospective study, transient or permanent subclinical CIED dysfunction occurred in 14.1% of RT courses. Our findings emphasize the importance of high-energy beams and neutron-producing irradiation in risk assessment.

FRAGILE: FRench Attitude reGistry in case of ICD LEad replacement.

AIMS: FRench Attitude reGistry in case of ICD LEad replacement (FRAGILE) registry was set-up to describe the attitude in different French institutions in case of implantable cardioverter-defibrillator (ICD) lead replacement, extraction, or abandonment and to compare outcomes in both groups. METHODS AND RESULTS: Prospective observational study comparing two attitudes in case of ICD lead replacement, extraction, or abandonment. Primary endpoint describes the attitude in different French centres, collect parameters that may influence the decision. Secondary endpoint compares early and mid-term (2 years) complications in both groups.Between April 2013 and April 2017, 552 patients were included in 32 centres. 434 (78.6%) were male, mean patient's age was 60.3 ± 14.4 years. In 56.9% of the cases, the decision was to explant the lead. Patients in the extraction group were younger than in the abandonment group (56.7 ± 14.5 vs. 65 ± 12.7 P < 0.0001) and less likely to have comorbidities (46.5% vs. 58.3% of the patients P = 0.022). The mean lead dwelling time was significantly longer in the abandonment group as compared with the extraction group (7.6 ± 3.9 vs. 5.2 ± 3.1 years, P < 0.0001). There was no statistical difference between both groups concerning early and 2 years complications. CONCLUSION: In this registry, the strategy in case of non-infected ICD lead replacement was mainly influenced by patient's age and comorbidities and lead dwelling time. No difference was observed in outcomes in both strategies.

Pyoderma gangrenosum complicating a permanent pacemaker implantation: a case report and literature review.

BACKGROUND: Pocket complications are common after cardiac implantable electronic device implantation. We report a rare case of pyoderma gangrenosum (PG) complicating a permanent pacemaker implantation, and the first literature review of 10 published cases. CASE SUMMARY: Five days after pacemaker implantation for heart failure and 2:1 atrioventricular block, a 93-year-old man had pain in the scar and bleeding on contact. Two days later, he had fever, inflammatory syndrome, and a necrotic 7-cm wound. The pacemaker was removed and he was started on antibiotics. Due to a lack of bacterial growth in samples, PG (a rare aseptic, destructive inflammatory cutaneous condition) was suspected, and histology was compatible with this diagnosis. High-dose corticosteroids vastly improved his condition within 1 week, and after 2 months of decreasing-dose corticosteroid therapy, complete healing and normalization of the inflammatory syndrome were observed. DISCUSSION: Pyoderma gangrenosum should be considered if there is aseptic skin ulceration that is not controlled by antibiotic treatment. The first-line treatment for PG is high-dose systemic corticosteroids.

Incidence of sleep apnea and association with atrial fibrillation in an unselected pacemaker population: Results of the observational RESPIRE study.

BACKGROUND: Patients with atrial fibrillation (AF) often have sleep apnea (SA), but diagnosis of SA with polysomnography is costly. SA monitoring is a pacemaker feature that measures respiratory disturbance index, the sum of abnormal respiratory events divided by sleep duration. OBJECTIVE: The purpose of this study was to evaluate the incidence and severity of SA and its association with AF in an unselected population fitted with pacemakers. METHODS: RESPIRE (REgistry of Sleep APnea monItoring and Atrial Fibrillation in pacemakeR patients) was a multicenter, international, observational, open-label study following adult subjects for 18 months after implantation with an SA monitoring-enabled dual-chamber pacemaker. Severe SA was defined as average respiratory disturbance index ≥20 from implantation to follow-up visit. The first co-primary end point was the difference in significant AF (cumulative AF episodes lasting ≥24 hours over 2 consecutive days) between subjects with severe and those nonsevere SA at 12 months in the full analysis set (N = 553). The second co-primary end point was the rate of major serious adverse events at 18 months in the modified intention-to-treat set (N = 1024). RESULTS: Severe SA was detected in 31.1% (172 of 553). A higher incidence of significant AF was reported in patients with severe SA than in patients with nonsevere SA (25.0% vs 13.9%; difference 11.1%; 95% confidence interval 3.7%-18.4%; P = .002). Significant AF increased with time in both groups, but at a faster rate in the severe SA group. No intergroup difference in the overall rate of major serious adverse events was observed (P = .065). CONCLUSION: SA screening over 12 months identified severe SA in almost one-third of unselected patients fitted with pacemakers. Severe SA was associated with a higher incidence of significant AF.

Radiation exposure during cardiac device implantation: Lessons learned from a multicenter registry.

BACKGROUND: Little data are available about radiation exposure during cardiac electrical device implantation, and no dose reference levels have been published. This multicenter, prospective, observational study assesses patient and staff radiation exposure during cardiac device implantations, and aims at defining dose reference levels. METHODS: Patient demographic, procedural, and radiation data were obtained for 657 procedures from nine institutions. Physician and staff exposure were measured using real-time dosimeters worn beneath and above lead apron. Statistical analysis included fluoroscopy time (FT), dose-area product (DAP), and DAP adjusted for FT and body mass index. RESULTS: Pacemakers and cardioverter defibrillators were implanted in 481 and 176 patients, respectively. Of these, 152 were treated with cardiac resynchronization therapy (CRT). Median FTs were 837s (interquartile range [IQR]: 480-1323), 117s (IQR: 69-209), and 101s (IQR: 58-162), and median DAPs were 1410 (IQR: 807-2601), 150 (IQR: 72-338), and 129 (IQR: 72-332) cGy.cm² for biventricular, dual chamber, and ventricular device implantation, respectively. Dose reference levels correspond to the third quartile values. During CRT, higher exposure was observed with four X-ray systems than with the two newer and customizable ones (adjusted DAP of 0.90 [IQR: 0.26-1.01] and 0.29 [IQR: 0.23-0.39], respectively; P < .001). CONCLUSION: Based on real-life measurements, this multicenter registry provides dose reference levels and may help centers assess radiation exposure. Although biventricular device implantation was responsible for the highest radiation exposure, FT was meaningfully shortened compared to previously reported values. For a same FT, the use of new generators and custom settings has significantly reduced DAP.

Algorithm-based reduction of inappropriate defibrillator shock: Results of the Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator Study.

BACKGROUND: Inappropriate shocks (IS) continue to have a major negative impact on patients implanted with defibrillators. OBJECTIVE: The purpose of this study was to assess IS reduction with the PARAD+ discrimination algorithm in a general population implanted for primary or secondary prevention. METHODS: ISIS-ICD (Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator) was a 2-year international, interventional study in patients implanted with a dual implantable cardioverter-defibrillator (ICD) or triple-chamber defibrillator (cardiac resynchronization therapy-defibrillator [CRT-D]) featuring PARAD+. IS (shocks not delivered for ventricular tachycardia or fibrillation) were independently adjudicated. The primary endpoint was percentage of IS-free patients at 24 months. Primary and worst-case analyses of annual incidence rates of patients with ≥1 IS, overall and per defibrillator type, were conducted. RESULTS: In total, 1013 patients (80.7% male; age 67.1 ± 11.4 years; 68%/30%/2% primary/secondary/other indication) were enrolled and followed for a median of 552 days (interquartile range 354; 725). Of 993 analyzed patients programmed with PARAD+, 14 had ≥1 IS, corresponding to a percentage free from IS of 98.1% (95% confidence interval [CI] 96.8%- 98.9%). Annual incidence rates (per 100 person-years) of patients with IS were 1.0 (95% CI 0.59-1.69) and 2.1 (95% CI 1.46-3.02) in the primary and worst-case analyses, respectively. In ICD patients, rates were 1.2 (95% CI 0.68-2.23) and 2.3 (95% CI 1.47-3.53), and in CRT-D patients 0.59 (95% CI 0.19-1.83) and 1.8 (95% CI 0.93-3.44) per 100 person-years. CONCLUSION: The annual rate of defibrillator patients with IS using the enhanced PARAD+ discrimination algorithm alone ranged from 1.0 to 2.1 per 100 person-years in a general population implanted for primary or secondary prevention.

Asymptomatic migration of an AMPLATZER™ Amulet™ left atrial appendage occluder through the mitral valve.

An 84-year-old woman with a history of hemorrhagic stroke was admitted for a new cerebral ischemic event. While in hospital, she was diagnosed with paroxysmal atrial fibrillation. Owing to her high thromboembolic risk (CHA2 DS2 -VASc score of 6) we performed left atrial appendage (LAA) closure using a 22-mm AMPLATZER™ Amulet™. The procedure was successful. Systematic follow-up with transthoracic echocardiography 8 hr later revealed that the LAA occluder had migrated and become entrapped in the mitral subvalvular apparatus. At this time, the patient was asymptomatic. The device was recovered percutaneously using a loop-snare catheter, with no further complications. © 2016 Wiley Periodicals, Inc.

Detection of paroxysmal atrial fibrillation by prolonged electrocardiographic recording after ischaemic stroke in patients aged<60years: a study with 21-day recording using the SpiderFlash(®) monitor.

BACKGROUND: Many studies have suggested that longer duration of cardiac monitoring is suitable for the detection of occult paroxysmal atrial fibrillation (AF) after stroke; however, most studies involved patients aged≥65years - a population with a high stroke rate. AIMS: To assess the incidence of paroxysmal AF in unselected young patients presenting with stroke. METHODS: We included consecutive patients aged<60years with a stroke diagnosis on magnetic resonance imaging. Aetiological screening included clinical history and examination, and biological and cardiac tests. Patients were included if they had no history of AF and if a 24-hour electrocardiogram recording detected no AF or atrial flutter. Patients wore the SpiderFlash(®) monitor for 21days after discharge from hospital. The primary outcome was detection of paroxysmal AF episodes lasting>30seconds during monitoring. The secondary outcome was detection of paroxysmal AF episodes lasting<30seconds and any arrhythmia during monitoring. RESULTS: Among the 56 patients included (mean age 48±9years), 39 had cryptogenic stroke (CS) and 17 had stroke of known cause (SKC). Cardiac monitoring was achieved in 54 patients (37 CS, 17 SKC); one CS patient had a paroxysmal AF episode lasting>30seconds and one CS patient had a paroxysmal AF episode lasting<30seconds (versus no patients in the SKC group). Two CS patients and one SKC patient presented numerous premature atrial complexes. Non-sustained ventricular tachycardia was detected in one CS patient. CONCLUSION: This prospective observational study showed a low rate of paroxysmal AF among young patients presenting with stroke, on the basis of 21-day cardiac monitoring. This result highlights the need to identify patients who would benefit from such long monitoring.

New oral anticoagulants in patients undergoing atrial flutter radiofrequency catheter ablation: an observational study.

AIM: Atrial flutter (AFL) ablation requires optimal periprocedural anticoagulation in order to minimize thromboembolic events/bleeding risk. This study describes the characteristics of patients receiving new oral anticoagulants before AFL ablation and assesses complications. METHODS: This multicenter, retrospective study reports ischemic and hemorrhagic predischarge, postprocedural complications. RESULTS: We evaluated 60 patients (62.3% male; mean age: 69.2 ± 9.7 years; CHA2DS2-VASc score: 2.44 ± 1.46, HAS-BLED score: 1.14 ± 0.7). Twenty-one (35.0%) and 23 patients (38.3%) received twice-daily dabigatran 110 or 150 mg; 16 patients (26.6%) received once-daily rivaroxaban (15 mg [n = 5] or 20 mg [n = 11]). Four cases of postprocedural minor bleeding were reported. CONCLUSION: This is the first study assessing new oral anticoagulants for periprocedural anticoagulation, specifically in patients undergoing AFL ablation. No major bleeding was reported. Further prospective investigation is warranted.

Emergency extracorporeal membrane oxygenation in a hospital without on-site cardiac surgical facilities.

AIMS: We report the feasibility and outcomes of emergency extracorporeal membrane oxygenation (ECMO) implantation by a cardiac catheterisation team in patients in severe cardiogenic shock or refractory cardiac arrest in a hospital without cardiac surgical facilities. METHODS AND RESULTS: This prospective cohort study involved 51 consecutive patients who had ECMO implantation (September 2006 - September 2010). Twenty-seven were in severe cardiogenic shock and 24 in refractory cardiac arrest (17 with out-of-hospital cardiac arrest; seven with in-hospital cardiac arrest). Implantations were done via a percutaneous femoral approach by a local interventional cardiologist team, and in collaboration with the nearest cardiac surgical institution. Patients' mean age was 51±15 years; 38 (74.5%) were men. Stable ECMO implantation was achieved in 26/27 (96.3%) patients in severe cardiogenic shock and in 18/24 (75.0%) patients in refractory cardiac arrest. In-hospital complications occurred in 23/27 cardiogenic shock patients; 13/27 were discharged alive. In patients with refractory cardiac arrest, complications occurred in 20/24; 21/24 were disconnected from ECMO because of brain death or multiorgan failure occurring ≤24 hours; one patient was discharged alive. CONCLUSIONS: Emergency ECMO implantation by an interventional cardiologist in a hospital without cardiac surgical facilities is feasible, with a failure rate concordant with the literature.