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1.
Heart Rhythm ; 2024 Jul 15.
Article in English | MEDLINE | ID: mdl-39019386

ABSTRACT

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has emerged as an alternative to transvenous systems for preventing sudden cardiac death. However, concerns have been raised regarding its efficacy and safety in obese individuals. OBJECTIVE: This meta-analysis aims to evaluate the efficacy and safety of the S-ICD in patients with obesity by assessing the relationship between body mass index (BMI) and clinical outcomes. METHODS: A comprehensive search of multiple databases was conducted for English-language peer-reviewed studies reporting clinical outcomes in S-ICD recipients with (BMI ≥30 kg/m2) and without obesity (BMI <30 kg/m2). Data on pre-implantation screening failure, defibrillation testing, complications, appropriate and inappropriate shocks, and survival were analysed using standard random-effect meta-analytical techniques. RESULTS: Twenty-nine studies involving 20,486 patients were included. There was no statistically significant difference in the mean BMI values of patients with failed or successful preimplantation screening (mean difference -0.60 kg/m2, 95% CI -2.06 to 0.86). Obesity was associated with higher rates of failed defibrillation testing at ≤65J (OR 2.16, 95% CI 1.39-3.35), and mal-/suboptimal positioning occurred more frequently in obese compared to non-obese patients (OR 3.37, 95% CI 1.76-6.44). Increased BMI as a continuous variable (per increase in 1 kg/m2 BMI) was associated with elevated defibrillation thresholds (OR 1.05, 95% CI 1.03-1.08), a higher risk of complications (HR 1.04, 95% CI 1.02-1.05), a trend towards increased number of appropriate shocks (HR 1.02, 95% CI 1.00-1.04), and no significant increase in the risk for inappropriate shocks (HR 1.01, 95% CI 0.99-1.03). CONCLUSION: This meta-analysis underscores the importance of considering obesity in S-ICD implantation decisions. While S-ICD remains effective in obese patients, attention to potential technical challenges and higher complication rates is warranted.

2.
Int J Cardiol ; 412: 132321, 2024 Oct 01.
Article in English | MEDLINE | ID: mdl-38977225

ABSTRACT

BACKGROUND: Left ventricular lead positioning represents a key step in CRT optimization. However, evidence for its guidance based on specific topographical factors and related imaging techniques is sparse. OBJECTIVE: To analyze reverse remodeling (RR) and clinical events in CRT recipients based on LV cathode (LVC) position relative to latest mechanical activation (LMA) and scar as determined by cardiac magnetic resonance (CMR). METHODS: This is a retrospective single-center study of 68 consecutive Q-LV-guided CRT-D and CRT-P recipients. Through CMR-based 3D reconstructions overlayed on fluoroscopy images, LVCs were stratified as concordant, adjacent, or discordant to LMA (3 segments with latest and greatest radial strain) and scar (segments with >50% scar transmurality). The primary endpoint of RR (expressed as percentage ESV change) and secondary composite endpoint of HF hospitalizations, LVAD/heart transplant, or cardiovascular death were compared across categories. RESULTS: LVC proximity to LMA was associated with a progressive increase in RR (percentage ESV change: concordant -47.0 ± 5.9%, adjacent -31.4 ± 3.1%, discordant +0.4 ± 3.7%), while proximity to scar was associated with sharply decreasing RR (concordant +10.7 ± 12.9%, adjacent +0.3 ± 5.3%, discordant -31.3 ± 4.4%, no scar -35.4 ± 4.8%). 4 integrated classes of LVC position demonstrated a significant positive RR gradient the more optimal the category (class I -47.0 ± 5.9%, class II -34.9 ± 2.8%, class III -5.5 ± 4.3%, class IV + 3.4 ± 5.2%). Freedom from composite secondary endpoint of HF hospitalization, LVAD/heart transplant, or cardiovascular death confirmed these trends demonstrating significant differences across both integrated as well as individual LMA and scar categories. CONCLUSION: Integrated CMR-determined LVC position relative to LMA and scar stratifies response to CRT.


Subject(s)
Magnetic Resonance Imaging, Cine , Humans , Male , Female , Retrospective Studies , Middle Aged , Magnetic Resonance Imaging, Cine/methods , Aged , Cardiac Resynchronization Therapy/methods , Ventricular Remodeling/physiology , Heart Ventricles/diagnostic imaging , Heart Ventricles/physiopathology , Electrodes, Implanted , Heart Failure/diagnostic imaging , Heart Failure/therapy , Cardiac Resynchronization Therapy Devices , Follow-Up Studies
3.
Heart Rhythm ; 2024 Jul 17.
Article in English | MEDLINE | ID: mdl-39029882

ABSTRACT

BACKGROUND: Limited data are available on leadless pacemaker (LPM) outcomes according to different stages of chronic kidney disease (CKD). OBJECTIVE: To investigate differences regarding safety and efficacy in LPMs patients stratified per different stages of renal function. METHODS: Consecutive patients enrolled in the multicenter, international i-LEAPER registry were analyzed. Patients were divided into three groups according to CKD stage. The primary endpoint was the comparison of LPM-related major complication rate at implant and during follow-up. Differences in electrical performance were deemed secondary outcomes. RESULTS: Among 1748 patients enrolled, 33% were CKD stage G3a/G3b and 9.4% were CKD stage G4/G5. CKD patients presented cardiovascular comorbidities more frequently. During a median follow-up of 39 [interquartile range (IQR) 18-59] months, major complications rate did not differ between groups (normal kidney function, NKF=1.8% vs CKD stage-G3a/G3b 2.9% vs CKD stage-G4/G5 2.4%, p=0.418). All-cause mortality resulted higher in CKD stage-G4/G5 when compared with NKF group (19.5% vs 9.8%, aHR:1.9, 95%CI 1.25-2.89, p=0.003). LPM electrical performance was comparable between groups, except for CKD patients who showed a slightly higher pacing threshold during the 1-month follow-up (NKF group 0.50 [IQR 0.35-0.70]V vs G3a/G3b group 0.56 [IQR 0.38-0.81]V vs G4/G5 group, 0.51 [0.38-0.84]V @0.24 msec, p<.001). CONCLUSION: In a real-world setting, advanced CKD patients who underwent LPM implantation were underrepresented. Although all-cause mortality was higher in end-stage CKD, periprocedural complications and LPM performance were overall comparable between NKF and different stages of CKD, except for higher values of pacing threshold in CKD patients up to first-month follow-up.

4.
Europace ; 26(5)2024 May 02.
Article in English | MEDLINE | ID: mdl-38696701

ABSTRACT

AIMS: Women have been historically underrepresented in implantable cardioverter-defibrillator (ICD) trials. No data on sex differences regarding subcutaneous ICDs (S-ICD) carriers have been described. Aim of our study was to investigate sex-related differences among unselected S-ICD recipients. METHODS AND RESULTS: Consecutive patients enrolled in the multicentre, international i-SUSI registry were analysed. Comparisons between sexes were performed using a 1:1 propensity matching adjusted analysis for age, body mass index (BMI), left ventricular function, and substrate. The primary outcome was the rate of appropriate shocks during follow-up. Inappropriate shocks and other device-related complications were deemed secondary outcomes. A total of 1698 patients were extracted from the i-SUSI registry; 399 (23.5%) were females. After propensity matching, two cohorts of 374 patients presenting similar baseline characteristics were analysed. Despite similar periprocedural characteristics and a matched BMI, women resulted at lower risk of conversion failure as per PRAETORIAN score (73.4% vs. 81.3%, P = 0.049). Over a median follow-up time of 26.5 [12.7-42.5] months, appropriate shocks were more common in the male cohort (rate/year 3.4% vs. 1.7%; log-rank P = 0.049), while no significant differences in device-related complications (rate/year: 6.3% vs. 5.8%; log-rank P = 0.595) and inappropriate shocks (rate/year: 4.3% vs. 3.1%; log-rank P = 0.375) were observed. After controlling for confounders, sex remained significantly associated with the primary outcome (aHR 1.648; CI 0.999-2.655, P = 0.048), while not resulting predictor of inappropriate shocks and device-related complications. CONCLUSION: In a propensity-matched cohort of S-ICD recipients, women are less likely to experience appropriate ICD therapy, while not showing higher risk of device-related complications. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0473876.


Subject(s)
Defibrillators, Implantable , Electric Countershock , Propensity Score , Registries , Humans , Female , Male , Middle Aged , Aged , Sex Factors , Electric Countershock/instrumentation , Electric Countershock/adverse effects , Risk Factors , Treatment Outcome , Arrhythmias, Cardiac/therapy , Risk Assessment , Europe , Time Factors , Death, Sudden, Cardiac/prevention & control
5.
EMBO Mol Med ; 16(6): 1427-1450, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38684862

ABSTRACT

Lentiviral vectors (LV) are efficient vehicles for in vivo gene delivery to the liver. LV integration into the chromatin of target cells ensures their transmission upon proliferation, thus allowing potentially life-long gene therapy following a single administration, even to young individuals. The glycoprotein of the vesicular stomatitis virus (VSV.G) is widely used to pseudotype LV, as it confers broad tropism and high stability. The baculovirus-derived GP64 envelope protein has been proposed as an alternative for in vivo liver-directed gene therapy. Here, we perform a detailed comparison of VSV.G- and GP64-pseudotyped LV in vitro and in vivo. We report that VSV.G-LV transduced hepatocytes better than GP64-LV, however the latter showed improved transduction of liver sinusoidal endothelial cells (LSEC). Combining GP64-pseudotyping with the high surface content of the phagocytosis inhibitor CD47 further enhanced LSEC transduction. Coagulation factor VIII (FVIII), the gene mutated in hemophilia A, is naturally expressed by LSEC, thus we exploited GP64-LV to deliver a FVIII transgene under the control of the endogenous FVIII promoter and achieved therapeutic amounts of FVIII and correction of hemophilia A mice.


Subject(s)
Endothelial Cells , Factor VIII , Genetic Therapy , Genetic Vectors , Hemophilia A , Lentivirus , Liver , Animals , Hemophilia A/therapy , Hemophilia A/genetics , Genetic Vectors/genetics , Endothelial Cells/metabolism , Mice , Lentivirus/genetics , Genetic Therapy/methods , Liver/metabolism , Factor VIII/genetics , Factor VIII/metabolism , Humans , Viral Envelope Proteins/genetics , Viral Envelope Proteins/metabolism , Transduction, Genetic/methods , Hepatocytes/metabolism , Hepatocytes/virology , Membrane Glycoproteins/genetics , Membrane Glycoproteins/metabolism
6.
J Clin Med ; 13(8)2024 Apr 09.
Article in English | MEDLINE | ID: mdl-38673430

ABSTRACT

Objectives: Conduction system pacing (CSP) and atrioventricular junction ablation (AVJA) improve the outcomes in patients with symptomatic, refractory atrial fibrillation (AF). In this setting, AVJA can be performed simultaneously with implantation or in a second procedure a few weeks after implantation. Comparison data on these two alternative strategies are lacking. Methods: A prospective, multicentre, observational study enrolled consecutive patients with symptomatic, refractory AF undergoing CSP and AVJA performed in a single procedure or in two separate procedures. Data on the long-term outcomes and healthcare resource utilization were prospectively collected. Results: A total of 147 patients were enrolled: for 105 patients, CSP implantation and AVJA were performed simultaneously (concomitant AVJA); in 42, AVJA was performed in a second procedure, with a mean of 28.8 ± 19.3 days from implantation (delayed AVJA). After a mean follow-up of 12 months, the rate of procedure-related complications was similar in both groups (3.8% vs. 2.4%; p = 0.666). Concomitant AVJA was associated with a lower number of procedure-related hospitalizations per patient (1.0 ± 0.1 vs. 2.0 ± 0.3; p < 0.001) and with a lower number of hospital treatment days per patient (4.7 ± 1.8 vs. 7.4 ± 1.9; p < 0.001). Conclusions: Concomitant AVJA resulted as being as safe as delayed AVJA and was associated with a lower utilization of healthcare resources.

8.
Europace ; 26(4)2024 Mar 30.
Article in English | MEDLINE | ID: mdl-38584394

ABSTRACT

AIMS: Catheter ablation (CA) of ventricular tachycardia (VT) has become an important tool to improve clinical outcomes in patients with appropriate transvenous implantable cardioverter defibrillator (ICD) shocks. The aim of our analysis was to test whether VT ablation (VTA) impacts long-term clinical outcomes even in subcutaneous ICD (S-ICD) carriers. METHODS AND RESULTS: International Subcutaneous Implantable Cardioverter Defibrillator (iSUSI) registry patients who experienced either an ICD shock or a hospitalization for monomorphic VT were included in this analysis. Based on an eventual VTA after the index event, patients were divided into VTA+ vs. VTA- cohorts. Primary outcome of the study was the occurrence of a combination of device-related appropriate shocks, monomorphic VTs, and cardiovascular mortality. Secondary outcomes were addressed individually. Among n = 1661 iSUSI patients, n = 211 were included: n = 177 experiencing ICD shocks and n = 34 hospitalized for VT. No significant differences in baseline characteristics were observed. Both the crude and the yearly event rate of the primary outcome (5/59 and 3.8% yearly event rate VTA+ vs. 41/152 and 16.4% yearly event rate in the VTA-; log-rank: P value = 0.0013) and the cardiovascular mortality (1/59 and 0.7% yearly event rate VTA+ vs. 13/152 and 4.7% yearly event rate VTA-; log-rank P = 0.043) were significantly lower in the VTA + cohort. At multivariate analysis, VTA was the only variable remaining associated with a lower incidence of the primary outcome [adjusted hazard ratio 0.262 (0.100-0.681), P = 0.006]. CONCLUSION: In a real-world registry of S-ICD carriers, the combined study endpoint of arrhythmic events and cardiovascular mortality was lower in the patient cohort undergoing VTA at long-term follow-up. CLINICALTRIALS.GOV IDENTIFIER: NCT0473876.


Subject(s)
Catheter Ablation , Defibrillators, Implantable , Tachycardia, Ventricular , Humans , Arrhythmias, Cardiac/etiology , Catheter Ablation/adverse effects , Catheter Ablation/methods , Electric Countershock/adverse effects , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/surgery , Treatment Outcome
9.
Heart Rhythm ; 2024 Mar 16.
Article in English | MEDLINE | ID: mdl-38493989

ABSTRACT

BACKGROUND: Atrial high-rate episodes (AHREs) are frequent in patients with cardiac implantable electronic devices. A decrease in device-detected P-wave amplitude may be an indicator of periods of increased risk of AHRE. OBJECTIVE: The objective of this study was to assess the association between P-wave amplitude and AHRE incidence. METHODS: Remote monitoring data from 2579 patients with no history of atrial fibrillation (23% pacemakers and 77% implantable cardioverter-defibrillators, of which 40% provided cardiac resynchronization therapy) were used to calculate the mean P-wave amplitude during 1 month after implantation. The association with AHRE incidence according to 4 strata of daily burden duration (≥15 minutes, ≥6 hours, ≥24 hours, ≥7 days) was investigated by adjusting the hazard ratio with the CHA2DS2-VASc score. RESULTS: The adjusted hazard ratio for 1-mV lower mean P-wave amplitude during the first month increased from 1.10 (95% confidence interval [CI], 1.05-1.15; P < .001) to 1.18 (CI, 1.09-1.28; P < .001) with AHRE duration strata from ≥15 minutes to ≥7 days independent of the CHA2DS2-VASc score. Of 871 patients with AHREs, those with 1-month P-wave amplitude <2.45 mV had an adjusted hazard ratio of 1.51 (CI, 1.19-1.91; P = .001) for progression of AHREs from ≥15 minutes to ≥7 days compared with those with 1-month P-wave amplitude ≥2.45 mV. Device-detected P-wave amplitudes decreased linearly during the 1 year before the first AHRE by 7.3% (CI, 5.1%-9.5%; P < .001 vs patients without AHRE). CONCLUSION: Device-detected P-wave amplitudes <2.45 mV were associated with an increased risk of AHRE onset and progression to persistent forms of AHRE independent of the patient's risk profile.

10.
Acta Cardiol ; 79(3): 367-373, 2024 May.
Article in English | MEDLINE | ID: mdl-38441069

ABSTRACT

BACKGROUND: Conduction system disorders represent a frequent complication in patients undergoing surgical (surgical aortic valve replacement, SAVR) or percutaneous (transcatheter aortic valve implantation, TAVI) aortic valve replacement. The purpose of this survey was to evaluate experienced operators approach in this clinical condition. METHODS: This survey was independently conducted by the Italian Association of Arrhythmology and Cardiac Pacing (AIAC) and it consisted of 24 questions regarding the respondents' profile, the characteristics of participating centres, and conduction disease management in different scenarios. RESULTS: Fifty-five physicians from 55 Italian arrhythmia centres took part in the survey. Prophylactic pacemaker implantation is rare. In case of persistent complete atrioventricular block (AVB), 49% and 73% respondents wait less than one week before implanting a definitive pacemaker after SAVR and TAVI, respectively. In case of second degree AVB, the respondents wait some days more for definitive implantation. Respondents consider bundle branch blocks, in particular pre-existing left bundle branch block (LBBB), the worst prognostic factors for pacemaker implantation after TAVI. The implanted valve type is considered a relevant element to evaluate. In patients with new-onset LBBB and severe/moderate left ventricular systolic dysfunction, respondents would implant a biventricular pacemaker in 100/55% of cases, respectively. CONCLUSIONS: Waiting time before a definitive pacemaker implantation after aortic valve replacement has reduced compared to the past, and it is anticipated in TAVI vs. SAVR. Bundle branch blocks are considered the worse prognostic factor for pacemaker implantation after TAVI. The type of pacemaker implanted in new-onset LBBB patients without severe left ventricular systolic dysfunction is heterogeneous.


Subject(s)
Transcatheter Aortic Valve Replacement , Humans , Italy/epidemiology , Transcatheter Aortic Valve Replacement/adverse effects , Transcatheter Aortic Valve Replacement/methods , Cardiac Conduction System Disease/therapy , Cardiac Conduction System Disease/diagnosis , Cardiac Conduction System Disease/epidemiology , Aortic Valve Disease/surgery , Surveys and Questionnaires , Cardiac Pacing, Artificial/methods , Cardiac Pacing, Artificial/statistics & numerical data , Societies, Medical , Pacemaker, Artificial , Heart Valve Prosthesis Implantation/methods , Heart Valve Prosthesis Implantation/adverse effects , Female , Male , Aortic Valve/surgery , Disease Management , Heart Conduction System/physiopathology
11.
Heart Rhythm ; 2024 Mar 10.
Article in English | MEDLINE | ID: mdl-38467355

ABSTRACT

BACKGROUND: Cardiac conduction disorder (CCD) in patients <50 years old is a rare and mostly unknown condition. OBJECTIVE: We aimed to assess clinical characteristics and genetic background of patients <50 years old with CCD of unknown origin. METHODS: We retrospectively reviewed a consecutive series of patients with a diagnosis of CCD before the age of 50 years referred to our center between January 2019 and December 2021. Patients underwent complete clinical examination and genetic evaluation. RESULTS: We enrolled 39 patients with a median age of 40 years (28-47 years) at the onset of symptoms. A cardiac implantable electronic device was implanted in 69% of the patients. In 15 of 39 CCD index patients (38%), we found a total of 13 different gene variations (3 pathogenic, 6 likely pathogenic, and 4 variants of uncertain significance), mostly in 3 genes (SCN5A, TRPM4, and LMNA). In our cohort, genetic testing led to the decision to implant an implantable cardioverter-defibrillator in 2 patients for the increased risk of sudden cardiac death. CONCLUSION: Patients with the occurrence of CCD before the age of 50 years present with a high rate of pathologic gene variations, mostly in 3 genes (SCN5A, TRPM4, and LMNA). The presence of pathogenic variations may add information about the prognosis and lead to an individualized therapeutic approach.

12.
Heart Rhythm ; 21(6): 874-880, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38428448

ABSTRACT

BACKGROUND: Cardiac resynchronization therapy (CRT) with biventricular pacing (BVP) is a well-established therapy in patients with reduced left ventricular ejection fraction, heart failure, and left bundle branch block. Left bundle branch area pacing (LBBAP) has recently been shown to be a feasible and effective alternative to BVP. Comparative data on the risk of complications between LBBAP and BVP among patients undergoing CRT are lacking. OBJECTIVE: The aim of this study was to compare the long-term risk of procedure-related complications between LBBAP and BVP in a cohort of patients undergoing CRT. METHODS: This prospective, multicenter, observational study enrolled 668 consecutive patients (mean age 71.2 ± 10.0 years; 52.2% male; 59.4% with New York Heart Association class III-IV heart failure symptoms) with left ventricular ejection fraction 33.4% ± 4.3% who underwent BVP (n = 561) or LBBAP (n = 107) for a class I or II indication for CRT. Propensity score matching for baseline characteristics yielded 93 matched pairs. The rate and nature of intraprocedural and long-term post-procedural complications occurring during follow-up were prospectively collected and compared between the 2 groups. RESULTS: During a mean follow-up of 18 months, procedure-related complications were observed in 16 patients: 12 in BVP (12.9%) and 4 in LBBAP (4.3%) (P = .036). Compared with patients who underwent LBBAP, those who underwent BVP showed a lower complication-free survival (P = .032). In multivariate analysis, BVP resulted an independent predictive factor associated with a higher risk of complications (hazard ratio 3.234; P = .042). Complications related to the coronary sinus lead were most frequently observed in patients who underwent BVP (50.0% of all complications). CONCLUSION: LBBAP was associated with a lower long-term risk of device-related complications compared with BVP in patients with an indication for CRT.


Subject(s)
Bundle-Branch Block , Cardiac Resynchronization Therapy , Heart Failure , Propensity Score , Registries , Stroke Volume , Humans , Male , Female , Aged , Cardiac Resynchronization Therapy/methods , Cardiac Resynchronization Therapy/adverse effects , Heart Failure/therapy , Heart Failure/physiopathology , Prospective Studies , Bundle-Branch Block/therapy , Bundle-Branch Block/physiopathology , Stroke Volume/physiology , Treatment Outcome , Bundle of His/physiopathology , Follow-Up Studies , Ventricular Function, Left/physiology
14.
JACC Case Rep ; 29(4): 102211, 2024 Feb 21.
Article in English | MEDLINE | ID: mdl-38379650

ABSTRACT

Postpartum electrical storm due to torsade de pointes is a rare but life-threatening condition. The uniqueness of this case lies in the use of cabergoline to suppress postpartum ventricular arrhythmias in absence of heart disease. Timely multidisciplinary management is crucial to achieve final diagnosis, deliver proper treatment and improve prognosis.

15.
J Clin Med ; 13(2)2024 Jan 17.
Article in English | MEDLINE | ID: mdl-38256672

ABSTRACT

BACKGROUND: Bradyarrhythmia requiring pacemaker implantation among patients undergoing valve surgery may occur even after several years, with unclear predictors. Our aim was to investigate the incidence of pacemaker implantation at different follow-up times and identify associated predictors. METHODS: We conducted a retrospective study evaluating 1046 consecutive patients who underwent valve surgery at the Cardiac Surgery Division of Bologna University Hospital from 2005 to 2010. RESULTS: During 10 ± 4 years of follow-up, 11.4% of these patients required pacemaker implantation. Interventions on both atrioventricular valves independently predicted long-term pacemaker implantation (SHR 2.1, 95% CI 1.2-3.8, p = 0.014). Preoperative atrioventricular conduction disease strongly predicted long-term atrioventricular block, with right bundle branch block as the major predictor (SHR 7.0, 95% CI 3.9-12.4, p < 0.001), followed by left bundle branch block (SHR 4.9, 95% CI 2.4-10.1, p < 0.001), and left anterior fascicular block (SHR 3.9, 95% CI 1.8-8.3, p < 0.001). CONCLUSION: Patients undergoing valvular surgery have a continuing risk of atrioventricular block late after surgery until the 12-month follow-up, which was clearly superior to the rate of atrioventricular block observed at long-term. Pre-operative atrioventricular conduction disease and combined surgery on both atrioventricular valves are strong predictors of atrioventricular block requiring pacemaker implantation.

16.
Int J Cardiol ; 400: 131807, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38272130

ABSTRACT

BACKGROUND: Left ventricular assist devices (LVADs) are an increasingly used strategy for the management of patients with advanced heart failure (HF). Subcutaneous implantable cardioverter defibrillator (S-ICD) might be a viable alternative to conventional ICDs with a lower risk of short- and long-term of device-related complications and infections.The aim of this multicenter study was to evaluate the outcomes and management of S-ICD recipients who underwent LVAD implantation. METHODS: The study population included patients with a preexisting S-ICD who underwent LVAD implantation for advanced HF despite optimal medical therapy. RESULTS: The study population included 30 patients (25 male; median age 45 [38-52] years).The HeartMate III was the most common LVAD type. Median follow-up in the setting of concomitant use of S-ICDs and LVADs was 7 months (1-20).There were no reports of inability to interrogate S-ICD systems in this population. Electromagnetic interference (EMI) occurred in 21 (70%) patients. The primary sensing vector was the one most significantly involved in determining EMI. Twenty-seven patients (90%) remained eligible for S-ICD implantation with at least one optimal sensing vector. The remaining 3 patients (10%) were ineligible for S-ICD after attempts of reprogramming of sensing vectors. Six patients (20%) experienced inappropriate shocks (IS) due to EMI. Six patients (20%) experienced appropriate shocks. No S-ICD extraction because of need for antitachycardia pacing, ineffective therapy or infection was reported. CONCLUSIONS: Concomitant use of LVAD and S-ICD is feasible in most patients. However, the potential risk of EMI oversensing, IS and undersensing in the post-operative period following LVAD implantation should be considered. Careful screening for EMI should be performed in all sensing vectors after LVAD implantation.


Subject(s)
Defibrillators, Implantable , Heart Failure , Heart-Assist Devices , Pacemaker, Artificial , Adult , Female , Humans , Male , Middle Aged , Defibrillators, Implantable/adverse effects , Electric Countershock/adverse effects , Heart Failure/diagnosis , Heart Failure/therapy , Heart Failure/complications , Heart-Assist Devices/adverse effects , Pacemaker, Artificial/adverse effects , Treatment Outcome
17.
Heart Rhythm ; 21(4): 410-418, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38246594

ABSTRACT

BACKGROUND: Outcome comparisons among subcutaneous implantable cardioverter-defibrillator (S-ICD) recipients with nonischemic cardiomyopathies are scarce. OBJECTIVE: The aim of this study was to evaluate differences in device-related outcomes among S-ICD recipients with different structural substrates. METHODS: Patients enrolled in the i-SUSI (International SUbcutaneouS Implantable cardioverter defibrillator registry) project were grouped according to the underlying substrate (ischemic vs nonischemic) and subgrouped into dilated cardiomyopathy, hypertrophic cardiomyopathy, Brugada syndrome (BrS), arrhythmogenic right ventricular cardiomyopathy (ARVC). The main outcome of our study was to compare the rates of appropriate and inappropriate shocks and device-related complications. RESULTS: Among 1698 patients, the most common underlying substrate was ischemic (31.7%), followed by dilated cardiomyopathy (20.5%), BrS (10.8%), hypertrophic cardiomyopathy (8.5%), and ARVC (4.4%). S-ICD for primary prevention was more common in the nonischemic cohort (70.9% vs 65.4%; P = .037). Over a median (interquartile range) follow-up of 26.5 (12.6-42.8) months, no differences were observed in appropriate shocks between ischemic and nonischemic patients (4.8%/y vs 3.9%/y; log-rank, P = .282). ARVC (9.0%/y; hazard ratio [HR] 2.492; P = .001) and BrS (1.8%/y; HR 0.396; P = .008) constituted the groups with the highest and lowest rates of appropriate shocks, respectively. Device-related complications did not differ between groups (ischemic: 6.4%/y vs nonischemic: 6.1%/y; log-rank, P = .666), nor among underlying substrates (log-rank, P = .089). Nonischemic patients experienced higher rates of inappropriate shocks than did ischemic S-ICD recipients (4.4%/y vs 3.0%/y; log-rank, P = .043), with patients with ARVC (9.9%/y; P = .001) having the highest risk, even after controlling for confounders (adjusted HR 2.243; confidence interval 1.338-4.267; P = .002). CONCLUSION: Most S-ICD recipients were primary prevention nonischemic cardiomyopathy patients. Among those, patients with ARVC tend to receive the most frequent appropriate and inappropriate shocks and patients with BrS the least frequent appropriate shocks.


Subject(s)
Arrhythmogenic Right Ventricular Dysplasia , Cardiomyopathies , Cardiomyopathy, Dilated , Defibrillators, Implantable , Humans , Defibrillators, Implantable/adverse effects , Death, Sudden, Cardiac/epidemiology , Death, Sudden, Cardiac/etiology , Death, Sudden, Cardiac/prevention & control , Electric Countershock/adverse effects , Arrhythmogenic Right Ventricular Dysplasia/complications , Cardiomyopathy, Dilated/complications , Cardiomyopathy, Dilated/therapy , Registries , Treatment Outcome
18.
Int J Cardiol ; 400: 131687, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38151163

ABSTRACT

The use of subcutaneous ICDs (S-ICD) is growing over years despite increasing alerts on premature battery depletion (PBD) and lead fractures leading to unanticipated device replacements. In our single-centre study including 192 patients, per year analysis demonstrated that incidence of PBD is higher than previously reported with overall greatest battery replacement requirements around the fifth year of follow-up. The underlying issue appears to be limited to old series devices, but only a longer follow-up will clarify the real impact of this phenomenon on patient outcomes. PBD is an underestimated S-ICDs issue and if the hereby demonstrated trend were to be confirmed in latest device series, this would bring significant concerns to patient safety and huge economic expense to health system.


Subject(s)
Defibrillators, Implantable , Patient Safety , Humans , Defibrillators, Implantable/adverse effects , Death, Sudden, Cardiac/epidemiology , Treatment Outcome
19.
J Cardiovasc Med (Hagerstown) ; 24(12): 864-870, 2023 12 01.
Article in English | MEDLINE | ID: mdl-37942788

ABSTRACT

AIMS: Brugada syndrome (BrS) is an inherited arrhythmic disease characterized by a coved ST-segment elevation in the right precordial electrocardiogram leads (type 1 ECG pattern) and is associated with a risk of malignant ventricular arrhythmias and sudden cardiac death. In order to assess the predictive value of the Shanghai Score System for the presence of a SCN5A mutation in clinical practice, we studied a cohort of 125 patients with spontaneous or fever/drug-induced BrS type 1 ECG pattern, variably associated with symptoms and a positive family history. METHODS: The Shanghai Score System items were collected for each patient and PR and QRS complex intervals were measured. Patients were genotyped through a next-generation sequencing (NGS) custom panel for the presence of SCN5A mutations and the common SCN5A polymorphism (H558R). RESULTS: The total Shanghai Score was higher in SCN5A+ patients than in SCN5A- patients. The 81% of SCN5A+ patients and the 100% of patients with a SCN5A truncating variant exhibit a spontaneous type 1 ECG pattern. A significant increase in PR (P = 0.006) and QRS (P = 0.02) was detected in the SCN5A+ group. The presence of the common H558R polymorphism did not significantly correlate with any of the items of the Shanghai Score, nor with the total score of the system. CONCLUSION: Data from our study suggest the usefulness of Shanghai Score collection in clinical practice in order to maximize genetic test appropriateness. Our data further highlight SCN5A mutations as a cause of conduction impairment in BrS patients.


Subject(s)
Brugada Syndrome , Humans , Brugada Syndrome/diagnosis , Brugada Syndrome/genetics , China/epidemiology , NAV1.5 Voltage-Gated Sodium Channel/genetics , Arrhythmias, Cardiac , Mutation , Electrocardiography
20.
Eur Heart J Cardiovasc Imaging ; 25(1): e1-e32, 2023 Dec 21.
Article in English | MEDLINE | ID: mdl-37861372

ABSTRACT

More than 500 000 cardiovascular implantable electronic devices (CIEDs) are implanted in the European Society of Cardiology countries each year. The role of cardiovascular imaging in patients being considered for CIED is distinctly different from imaging in CIED recipients. In the former group, imaging can help identify specific or potentially reversible causes of heart block, the underlying tissue characteristics associated with malignant arrhythmias, and the mechanical consequences of conduction delays and can also aid challenging lead placements. On the other hand, cardiovascular imaging is required in CIED recipients for standard indications and to assess the response to device implantation, to diagnose immediate and delayed complications after implantation, and to guide device optimization. The present clinical consensus statement (Part 1) from the European Association of Cardiovascular Imaging, in collaboration with the European Heart Rhythm Association, provides comprehensive, up-to-date, and evidence-based guidance to cardiologists, cardiac imagers, and pacing specialists regarding the use of imaging in patients undergoing implantation of conventional pacemakers, cardioverter defibrillators, and resynchronization therapy devices. The document summarizes the existing evidence regarding the use of imaging in patient selection and during the implantation procedure and also underlines gaps in evidence in the field. The role of imaging after CIED implantation is discussed in the second document (Part 2).


Subject(s)
Cardiovascular System , Defibrillators, Implantable , Pacemaker, Artificial , Humans , Arrhythmias, Cardiac/diagnostic imaging , Arrhythmias, Cardiac/therapy , Electric Countershock , Heart
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