Abstract
Funding Acknowledgements
Type of funding sources: Private company. Main funding source(s): P. JACON consultant: Boston Scientific France
Introduction
The implantable cardioverter ...defibrillator (ICD) is the most effective therapy for prevention of sudden cardiac death in high-risk patients with heart failure and reduced ejection fraction (HFrEF). The subcutaneous implantable cardioverter defibrillator (S-ICD) has been considered as a comparable and relatively safer alternative to transvenous ICD in patients (pts) without pacing indication.
Purpose
Our aim was to assess the clinical "real-life" outcomes of S-ICD in patients with HFrEF and primary or secondary prevention, over a long-term follow-up (FU) period after S-ICD implantation.
Methods
All pts with HFrEF (left ventricular ejection fraction ≤35%) implanted with a S-ICD and a FU above 6 months were included in a cross-sectional monocentric study. Pts were followed by remote monitoring.
Results
88 pts were included (52 ± 12.8 years old, male 87.5%). Indications were: primary 92% and secondary 8% prevention (ischemic cardiopathy 46%; dilated 46%; hypertrophic 5%; congenital 2%; valvular 1%). The mean left ventricular ejection fraction was 27%. 9 pts had a previous transvenous ICD implanted, but required revision because of infection or lead defects. The mean FU period was 33 ± 18 months with a mortality rate of 10% (S-ICD-related death secondary to inappropriate (inap) shocks for one patient). 5 pts underwent S-ICD system extraction after a mean FU period of 30 ± 21 months. Reasons were infectious complication (1 pt), pacing indication (2 pts) and S-ICD lead dysfunction (2 pts). Extraction after heart transplant was performed in 4 pts. During FU, 18 pts (20.5%) experienced at least one therapy: 8 pts (9%) with appropriate (ap) (3.3% per year) and 11 pts (12%) with inap shocks (4.36% per year). A total number of 24 ap shocks have been observed (3 ± 4 ap shocks per patient, several shocks for 3 pts), the first shock occurred after a mean FU period of 24 ± 14 months. 2 pts were referred to VT ablation and no recurrence of events was observed after medical therapy modification for the other pts. For the 11 pts with inap shocks, time to the first event was 19 ± 20 months. Reasons were: supraventricular arrhythmias (18%), T wave (36%) and noise (54%) oversensing. There was 1.8 ± 1.6 shock per patient with several shocks for 4 pts. Among pts with inap shocks, 2 pts required S-ICD system extraction, 1 pt died, while reprogramming and medical therapy options were efficient in other pts.
Conclusion
In pts with HFrEF at high risk of sudden cardiac death, S-ICD has proven to be effective in treating ventricular arrhythmias. However, more investigations must be conducted to explain the real-life high rate of inappropriate therapies. Abstract Figure. Survival-free from therapies curve
Abstract
Funding Acknowledgements
Type of funding sources: None.
Introduction
Leadless transcatheter pacemakers are considered as a safe and effective option for cardiac pacing in patients (pts) at ...higher risk of complications with conventional transvenous cardiac pacing.
Purpose
Our aim was to assess the clinical "real-life" feasibility and outcomes of leadless pacing in elderly pts in a high-volume center over a mid-term follow-up (FU) period.
Methods
Elderly pts (aged ≥ 75 years) who underwent leadless MICRA® system pacemaker implantation with a FU period above 3 months were included in this retrospective monocentric study.
Results
130 pts were included (84 ± 5.6 years old, male 66.2%). Indications were: Atrioventricular block (permanent 15.4%; transient 27.7%), atrial fibrillation bradycardia 50% and sinus node dysfunction 6.9%. Leadless system pacing was preferred over conventional pacing in pts with: transvenous pacemaker extractions due to infectious 18.5% or vascular 1.5% complications; active systemic infection and urgent need for cardiac stimulation 20%; complex conventional vascular approach 21.6%; severe tricuspid valve disease 1.5%; deterioration of general condition and clinical frailty 22.3%; shortly after transvalvular aortic valve replacement 8.5%. Among the pts, 6.2% had previous leadless Nanostim® device implantation with dysfunction of the system. Pts had either local anesthesia 13.2% or deep sedation 86.8%. The average fluoroscopy time was 4.3±2.9 minutes and number of device deployments before the final position ranged from 1 to 7 with a mean value of 1.5±1 positions. Pacing threshold during implant was 0.5±0.4 V at 0.24ms, only 4 pts (3%) had an implant threshold of >1.0 V at 0.24 ms. Two postoperative deaths were observed: 1 cardiac arrest related to myocardial dysfunction and consequent pulmonary edema in a patient with advanced heart failure, and 1 death secondary to myocardial perforation with need for surgical repair that occurred among the first implantations with an apical device position and a patient with multiple comorbidities. The total rate of major complications was 2.3% with only 1 vascular complication at the femoral puncture site. The median time from the leadless pacemaker implant procedure to discharge was 5±6.5 days (minimum 1 and maximum 40 days): 55.6% pts were able to leave the cardiology department within the first 72 hours. The mean FU period was 17 months ± 15 months with a mortality rate of 12.3% (cardiovascular impairment 5.4%; non cardiovascular-related deaths 6.9%). Increase in pacing thresholds was noted in 4 pts with subsequent stabilization; 92.2% of pts presented with thresholds lower than 1V at 0.24 ms. All pts remained free of infections during FU with no cases of device dislodgement observed.
Conclusion
Elderly pts are at higher risk of complications; our experience confirms their clinical frailty and underlines the favorable safety profile of leadless system pacing with a low rate of complications and stable pacing thresholds.
A 45-year-old man was hospitalized for syncope due to fascicular ventricular tachycardia degenerating into ventricular fibrillation (VF). The electrocardiogram showed an early repolarization ...syndrome. The arrhythmia was repetitive and disappeared after oral hydroquinidine. An implantable cardioverter-defibrillator (ICD) was implanted; subsequently, the patient was arrhythmia free at 9 months follow-up.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Abstract
Funding Acknowledgements
Type of funding sources: None.
Introduction
Defibrillation testing (DFT) is still recommended in patients with subcutaneous implantable cardioverter-defibrillator ...(S-ICD) to ensure proper detection of ventricular fibrillation and confirm effective defibrillation. Given the significant risk of complications, recent studies, are reconsidering the interest of the DFT in S-ICD. The purpose of this study was to assess the clinical "real-life" outcomes of DFT over a mid-term follow-up period after third-generation S-ICD implantation.
Methods and Results
368 patients (pts) (47.9 ± 15.5 years old; male 72.8%) implanted with Generation 3 S-ICD system were included in this retrospective multicenter registry-based study. Mean left ventricular ejection fraction (LVEF) was 40.8% (primary prevention 56.1%). For 99.2% pts, S-ICD implantation was performed using the two-incision technique and intermuscular positioning of the generator was performed for all pts. 81% pts underwent ICD testing during implantation. Reasons for not performing DFT were: very low LVEF (3.5%), intracardiac thrombus (2.4%) and VF induction failure. In 2.2% (8 pts) DFT was unsuccessful, causes were: induction of ventricular tachycardias with rates falling below the shock zone for 3 pts while shocks were ineffective for 5 pts. One patient required revision for contralateral lead implantation, while sensing vector reprogramming and shock polarity modification were efficient for the others. The mean impedance was 68.4 (±14.7) Ω and time to shock therapy ranged from 10 to 33 s, with a mean of 16.7 (±4) s. A total of 36 appropriate shocks (10.1%) have been observed after a FU period of 11.02±8.8 months (1.8 shocks per patient, several shocks for 12pts, failure of the first shock for 5 patients). 17 patients (4.6%) underwent S-ICD system extraction. The reasons were pocket site complication (7 pts), pacing indication for cardiac resynchronization therapy or bradycardia (3 pts), and S-ICD lead dysfunction (4 pts). Extraction after heart transplant was needed in 3 pts. Among the 4 pts explanted for system dysfunction, only one patient had a DFT during implantation. After a mean follow-up of 19±12.1 months, the mortality rate was 3.8% (no S-ICD-related deaths were reported). There was no significant difference between the 2 groups of pts with and without DFT testing (p=0.629).
Conclusion
The DFT remains for the moment highly recommended during S-ICD implantations. Results from randomized studies are still needed to confirm the relevance of DFT during S-ICD implantation.
Abstract
Funding Acknowledgements
Type of funding sources: Private company. Main funding source(s): Scientific grant support from the Boston Scientific Investigator Sponsored Research (ISR) ...Committee, Boston Scientific, St. Paul, MN, USA.
Background/Introduction
Cardiac implantable electronic devices and their integrated thoracic impedance sensors, meant to detect sleep apnea, are available for over a decade now. Despite its usage in daily clinical practice, there is only limited data on its diagnostic accuracy.
Purpose
To further validate an apnea sensor by using polysomnography (PSG) and investigate subgroups with potential differences in diagnostic accuracy.
Methods
AIRLESS and UPGRADE were prospective investigator driven trials meant to validate an apnea sensor. Patients, who either fulfilled the criteria for implantation of an implantable cardioverter-defibrillator (ICD), cardiac resynchronization therapy (CRT) or upgrading to CRT according to current guidelines were eligible for enrolment. Sleep apnea and its severity, measured by apnea-hypopnea index (AHI), were exclusively assessed by PSG. PSG was conducted in a time interval of 1 to 3 months post implantation of the device. For direct comparison, the apnea sensor derived respiratory disturbance index (RDI) was used from the identical night. Bivariate correlations (spearman coefficient) as well as the Bland-Altmann method were applied to assess diagnostic accuracy of the apnea sensor.
Results
Overall, 80 patients were analysed, out of whom the majority (n = 35, 43.8%) were diagnosed with central sleep apnea. Sixteen (20.0%) patients received a conventional ICD system, whereas 21 (26.3%) were implanted a CRT-P and 43 (53.8%) a CRT-D. Atrial fibrillation was known in 50.0% (n=40) of patients, 45 patients suffered from periodic leg movement syndrome (PLMS, 56.3%). In the overall cohort, the sensor derived RDI correlated significantly with the AHI (r = 0.61, p < 0.001) with a mean difference (MD) of -12.6 (95% CI -38.2 – 13.0). The sensor did specifically perform well in patients without atrial fibrillation (r = 0.80, p < 0.001; MD -9.0, 95% CI -30.4 – 12.5), while the presence of PLMS did not affect the accuracy of measurements (PLMS: r = 0.60, p = 0.007, MD -16.1, 95% CI -43.9 – 11.8 vs. no PLMS: r = 0.62, p = 0.001, MD -9.9, 95% CI -32.8 – 12.9). Furthermore, the RDI was found to correlate well in patients with central sleep apnea (r = 0.61, p = 0.013), although similar overestimation was observed (MD -11.6, 95% CI -35.4 – 12.2) as in other subgroups.
Conclusion
In an exclusive heart failure cohort, the apnea sensor did correlate well with the PSG derived AHI. Although similar correlation is found in most subgroups, there remains to be a decent overestimation of events.
Correlation between AP Scan and AHI
Bland-Altmann AP Scan and AHI
Un sportif de 45ans a été hospitalisé pour syncope survenue alors qu’il regardait un match de football. À son admission, nous avons découvert une tachycardie ventriculaire fasciculaire gauche ayant ...dégénéré rapidement en fibrillation ventriculaire. Son électrocardiogramme postcritique révélait un aspect de syndrome de repolarisation précoce. L’arythmie qui était répétitive disparaissait complètement après administration d’hydroquinidine. Il a bénéficié d’un défibrillateur automatique implantable (DAI) et n’a plus présenté de récurrence d’arythmie depuis lors.
A 45-year-old man was hospitalized for syncope due to fascicular ventricular tachycardia degenerating into ventricular fibrillation (VF). The electrocardiogram showed an early repolarization syndrome. The arrhythmia was repetitive and disappeared after oral hydroquinidine. An implantable cardioverter-defibrillator (ICD) was implanted; subsequently, the patient was arrhythmia free at 9 months follow-up.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
We examined the efficacy and safety of pulmonary vein (PV) isolation, using a cryoballoon catheter.
We studied 117 consecutive patients presenting with paroxysmal (n = 92) or persistent (n = 25) ...atrial fibrillation (AF), who underwent attempts at isolation of 442 PV with a cryoballoon catheter. They were followed in our ambulatory department for every 3 months, or earlier if they reported symptoms. A 48 h ambulatory electrocardiogram was recorded at the 3-month visit. We analysed the immediate and long-term procedural and clinical outcomes. We isolated 385 of 442 PV (87%) with a single cryoballoon application. In 19 patients (16%), an irrigated-tip radiofrequency (RF) catheter was used to create a supplemental focal lesion. A median of nine applications per procedure (range 6-12) was delivered. The mean, overall procedural duration was 155 ± 43 min (range 75-275), and mean duration of fluoroscopic exposure was 35 ± 15 min (range 12-73). At the end of the procedure, 103 patients (88%) were in sinus rhythm. Over a median period of 9.6 months (range 3-12), 11 patients were lost to follow-up. At 3, 6, 9, and 12 months of follow-up, respectively, 79, 79, 79, and 69% of patients presenting with paroxysmal AF had remained recurrence free, vs. 83, 73, 59, and 45% of patients, respectively, with persistent AF. Phrenic nerve palsy was the most frequent, although reversible complication.
Pulmonary vein isolation, using a cryoballoon catheter, was completed with a high rate of procedural and long-term success and low rate of minor complications. Supplemented, when needed, by focal RF, cryoballoon ablation was a safe and an effective alternative to a circumferential RF procedure.
Abstract
Funding Acknowledgements
Type of funding sources: None.
Introduction
Despite the recent improvements, inappropriate shocks (IAS) in patients implanted with subcutaneous implantable ...cardioverter-defibrillator (S-ICD) remain a challenge in "real-life" practice. The purpose of this study was to assess the preoperative predictive factors of IAS with the latest generation of S-ICD, with a particular focus on data obtained during the screening procedure.
Methods
Between January 2017 and March 2020, 300 patients implanted with Generation 3 S-ICD system for primary and secondary prevention were included in this multicentric study. Follow-up (FU) of at least 6 months and preoperative screening procedure data were mandatory for all patients.
Results
After a mean follow-up of 22.8 (±11.4) months, appropriate therapies occurred in 12.3% patients; while 26 patients (8.7%) experienced inappropriate therapies (incidence 4.9 per 100 patient-years). The total number of inappropriate shock episodes was 48; 9 patients experienced multiple episodes. Causes of IAS were: supraventricular arrhythmias (34.6%), cardiac (30.7%) and extra-cardiac noise oversensing (38.4%). In univariate analysis, availability of all 3 sensing vectors during preoperative screening significantly reduced inappropriate therapies occurrence (hazard ratio HR, 0.32; 95% confidence interval CI, 0.12-0.89, P=0.028). Clinical preoperative S-ICD inappropriate shocks predictors were: history of Supraventricular Tachycardia (SVT)(HR, 4.42; 95% CI, 1.45-13.47; P=0.009); overweight (BMI>25: HR, 1.93; 95% CI, 0.83-0.4.48; P=0.13); QRS duration (HR, 1.01; 95% CI, 0.1-1.03; P=0.14) and lower QRS/T wave ratio in lead I (for a threshold < 3: HR, 4.44; 95% CI, 1.88-10.48; P=0.001). By multivariate analysis, independent factors associated with IAS were: the availability of less than 3 sensing vectors during preoperative screening (p<0.05), a low QRS/T wave ratio in lead I (for a threshold <3; p<0.001), history of SVT (p<0.001) and overweight (BMI> 25; p<0.05).
Conclusion
Automatic preoperative screening data is of high interest as a predictor of IAS with a quantitative value. ECG specificities in association with other clinical factors should be taken into consideration to identify patients at high risk for IAS.
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