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2.
Neth Heart J ; 2024 Aug 19.
Article in English | MEDLINE | ID: mdl-39158682

ABSTRACT

INTRODUCTION: Conventional implantable cardioverter-defibrillators (ICDs) and pacemakers carry a risk of pocket- and lead-related complications in particular. To avoid these complications, extravascular devices (EVDs) have been developed, such as the subcutaneous ICD (S-ICD) and leadless pacemaker (LP). However, data on patient or centre characteristics related to the actual adoption of EVDs are lacking. OBJECTIVE: To assess real-world nationwide trends in EVD adoption in the Netherlands. METHODS: Using the Netherlands Heart Registration, all consecutive patients with a de novo S­ICD or conventional single-chamber ICD implantation between 2012-2020, or de novo LP or conventional single-chamber pacemaker implantation between 2014-2020 were included. Trends in adoption are described for various patient and centre characteristics. RESULT: From 2012-2020, 2190 S­ICDs and 10,683 conventional ICDs were implanted; from 2014-2020, 712 LPs and 11,103 conventional pacemakers were implanted. The general use has increased (S-ICDs 8 to 21%; LPs 1 to 8%), but this increase seems to have reached a plateau. S­ICD recipients were younger than conventional ICD recipients (p < 0.001) and more often female (p < 0.001); LP recipients were younger than conventional pacemaker recipients (p < 0.001) and more often male (p = 0.03). Both S­ICDs and LPs were mainly implanted in high-volume centres with cardiothoracic surgery on-site, although over time S­ICDs were increasingly implanted in centres without cardiothoracic surgery (p < 0.001). CONCLUSION: This nationwide study demonstrated a relatively quick adoption of innovative EVDs with a plateau after approximately 4 years. S­ICD use is especially high in younger patients. EVDs are mainly implanted in high-volume centres with cardiothoracic surgery back-up, but S­ICD use is expanding beyond those centres.

5.
Europace ; 2024 Aug 30.
Article in English | MEDLINE | ID: mdl-39210643

ABSTRACT

BACKGROUND AND AIMS: The extravascular implantable cardioverter-defibrillator (EV ICD) has been shown to be safe and effective for patients at risk of sudden cardiac death, but little is known about EV ICD lead removal in humans. This analysis aimed to characterize the EV ICD lead removal experience thus far. METHODS: This was a retrospective analysis of lead removals from the EV ICD Pilot, Pivotal, and Continued Access Studies. Patients with a successful EV ICD implant who underwent lead removal were included. The main objective was lead removal success. Ancillary objectives included characterizing technique used, procedure complications, and reimplantation status. RESULTS: An EV ICD system was successfully implanted in 347 patients across the 3 studies (25.9% female; 53.4±13.3 years; LVEF: 39.7±15.9). Of these patients, 29 (8.4%) underwent lead removal with a mean lead dwell time of 12.6±14.3 months (0.2-58.4). The main reason for lead removal was lead dislodgement (n=9, 31.0%). Lead removal was successful in 27/29 (93.1%) cases [100% (19/19) success rate <1 year and 80% (8/10) success rate >1-year post-implant]. Simple traction was used in 22/26 (84.6%) and extraction tools in 4/26 (15.4%) successful cases where technique was known. No complications were reported for any of the removal procedures. All 11 EV ICD reimplant attempts were successful. CONCLUSIONS: Complete removal of the EV ICD lead was successful in 93.1% of cases and simple traction was sufficient in most instances. Based on these results, lead removal from the substernal space was safe and achievable up to 3 years post-implant.

6.
Cardiology ; : 1-8, 2024 Jul 22.
Article in English | MEDLINE | ID: mdl-38986462

ABSTRACT

INTRODUCTION: Patients undergoing left atrial appendage occlusion (LAAO) are at increased risk for bleeding or thromboembolic events. Concurrently, biomarkers are of growing importance in risk stratification for atrial fibrillation patients. We aimed to evaluate the association of hematological markers and clinical characteristics with the occurrence of thromboembolic and bleeding events following LAAO. METHODS: Seven implanting centers retrospectively gathered data on hematological markers (i.e., platelet count [PC], mean platelet volume [MPV], and fibrinogen) prior to LAAO. Prespecified thromboembolic and major bleeding outcomes were collected and the association with pre-procedural hematological markers and clinical characteristics was evaluated using Cox regression analysis. RESULTS: In total, 1,315 patients were included (74 ± 9 years, 36% female, CHA2DS2-VASc 4.3 ± 1.5, HAS-BLED 3.3 ± 1.1). Over a total follow-up duration of 2,682 patient years, 77 thromboembolic events and 107 major bleeding events occurred after LAAO. Baseline PC was the only biomarker showing a signal for a relation to thromboembolic events (HR 1.18, 95% CI: 1.00-1.39) per 50*109 increment, p = 0.056). Thrombotic event rates, including device-related thrombus, increased within higher PC quartiles. Thromboembolism was associated with age (HR 1.05, 95% CI: 1.00-1.10, per year increase) and prior thromboembolism (HR 2.08, 95% CI: 1.07-4.03), but with none of the biomarkers in multivariate analysis. No association of any of the hematological markers with major bleeding was observed. Major bleeding following LAAO was associated with prior major bleeding (HR 5.27, 95% CI: 2.71-10.22), renal disease (HR 1.93, 95% CI: 1.17-3.18), and discharge on dual antiplatelet therapy (DAPT) (HR 1.71, 95% CI: 1.05-2.77). CONCLUSION: Most thrombotic events occurred in the highest PC quartile, but no association of any of the hematological markers with thromboembolism or major bleeding was observed in our analysis. In multivariate analysis, older age and prior thromboembolism were associated with thromboembolism. Prior major bleeding, renal disease and discharge on DAPT were multivariate predictors of major bleeding after LAAO.

7.
Europace ; 26(7)2024 Jul 02.
Article in English | MEDLINE | ID: mdl-39082730

ABSTRACT

AIMS: Sufficient survival time following left atrial appendage occlusion (LAAO) is essential for ensuring the efficacy and cost-effectiveness of this strategy for stroke prevention. Understanding prognostic factors for early mortality after LAAO could optimize patient selection. In the current study, we perform an in-depth analysis of 2-year mortality after LAAO, focusing particularly on potential predictors. METHODS AND RESULTS: The EWOLUTION registry is a real-world cohort comprising 1020 patients that underwent LAAO. Endpoint definitions were pre-specified, and death was categorized as cardiovascular, non-cardiovascular, or unknown origin. Mortality rates were calculated from Kaplan-Meier estimates. Baseline characteristics significantly associated with death in univariate Cox regression analysis were incorporated into the multivariate analysis. All multivariate predictors were included in a risk model. Two-year mortality rate was 16.4% [confidence interval (CI): 14.0-18.7%], with 50% of patients dying from a non-cardiovascular cause. Multivariate baseline predictors of 2-year mortality included age [hazard ratio (HR) 1.05, CI: 1.03-1.08, per year increase], heart failure (HR 1.73, CI: 1.24-2.41), vascular disease (HR 1.47, CI: 1.05-2.05), valvular disease (HR 1.63, CI: 1.15-2.33), abnormal liver function (HR 1.80, CI: 1.02-3.17), and abnormal renal function (HR 1.58, CI: 1.10-2.27). Mortality rate exhibited a gradual rise as the number of risk factors increased, reaching 46.1% in patients presenting with five or six risk factors. CONCLUSION: One in six patients died within 2 years after LAAO. We identified six independent predictors of mortality. When combined, this model showed a gradual increase in mortality rate with a growing number of risk factors, which may guide appropriate patient selection for LAAO. CLINICAL TRIAL REGISTRATION: The original EWOLUTION registry was registered at clinicaltrials.gov under identifier NCT01972282.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Registries , Stroke , Humans , Atrial Appendage/surgery , Male , Female , Atrial Fibrillation/mortality , Atrial Fibrillation/surgery , Aged , Incidence , Risk Factors , Stroke/prevention & control , Stroke/mortality , Stroke/etiology , Aged, 80 and over , Cardiac Catheterization , Risk Assessment , Time Factors , Treatment Outcome , Cause of Death , Middle Aged
8.
Heart Rhythm ; 2024 Jun 24.
Article in English | MEDLINE | ID: mdl-38925335

ABSTRACT

BACKGROUND: Early recurrence of atrial tachyarrhythmias (ERAT) within 3 months of thermal ablation for atrial fibrillation (AF) is common and often considered transient. Pulsed field ablation (PFA) is a nonthermal energy source in which ERAT is not well described. OBJECTIVE: The purpose of this study was to analyze ERAT in patients with AF undergoing PFA in the Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF (PULSED AF) trial. METHODS: This analysis included 154 (52.4%) paroxysmal AF and 140 (47.6%) persistent AF who had ≥10 rhythm assessments during the 90-day blanking period. ERAT was defined as any instance of ≥30 seconds of AF, atrial flutter, or atrial tachycardia on transtelephonic monitoring (weekly and symptomatic) or ≥10 seconds on electrocardiography (at 3 months), both within 90 days. Late recurrence of atrial tachyarrhythmias (LRAT) was defined as observed atrial tachyarrhythmias between 90 days and 12 months. RESULTS: The overall prevalence of ERAT was 27.1% in patients with paroxysmal AF and 31.6% in patients with persistent AF. In patients with ERAT, 73% had ERAT onset within the first month of the procedure. The presence of ERAT was associated with LRAT in patients with paroxysmal AF (hazard ratio 6.4; 95% confidence interval 3.6-11.3) and patients with persistent AF (hazard ratio 3.8; 95% confidence interval 2.2-6.6). Yet, in 29.4% of patients with paroxysmal AF and 34.3% of patients with persistent AF with ERAT, LRAT was not observed. LRAT was positively correlated with the number of ERAT observations. CONCLUSION: ERAT after PFA predicted LRAT in patients with paroxysmal and persistent AF. However, the concept of a blanking period after PFA is still valid, as approximately one-third of patients with ERAT did not continue to have LRAT during follow-up and may not need reablation.

9.
N Engl J Med ; 2024 May 18.
Article in English | MEDLINE | ID: mdl-38767244

ABSTRACT

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.).

10.
JACC Clin Electrophysiol ; 10(8): 1896-1912, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38752961

ABSTRACT

BACKGROUND: The extravascular (EV) implantable cardioverter-defibrillator (ICD) includes features to address sensing and arrhythmia detection challenges presented by its substernal lead location. OBJECTIVES: In this study, the authors sought to evaluate sensing and detection performance in 299 patients discharged with an EV-ICD in the global pivotal study. METHODS: We reviewed and adjudicated all induced ventricular fibrillation (VF) episodes and spontaneous device-stored episodes that satisfied rate and duration criteria in a programmed ventricular tachycardia (VT)/VF therapy zone. RESULTS: At implantation, all EV-ICDs detected induced VF at the programmed sensitivity; 95.9% detected VF with a 3× safety margin. In follow-up, EV-ICDs detected all 59 VT/VF episodes that sustained until therapy. Of 1,034 non-VT/VF episodes, oversensing caused 87.9% and supraventricular tachycardia caused 12.1%. Therapy was withheld in 80.9%, aborted in 10.6%, and delivered in 8.5%. The most common causes of oversensing were myopotentials (61.2%) and P-wave oversensing (PWOS) (19.9%). Inappropriate shocks occurred in only 3.2% of myopotential episodes, but in 21.8% of PWOS episodes. Myopotential oversensing was more common with Ring-Can sensing (P < 0.0001) and correlated with low R-wave amplitude (P < 0.0001). PWOS occurred almost exclusively with Ring1-Ring2 sensing (P = 0.0001) and began with transient decrease in R-wave or increase in P-wave amplitude (P < 0.0001). In software emulation, a new PWOS discriminator significantly reduced total inappropriate detections. CONCLUSIONS: In a global population, EV-ICD detected induced and spontaneous VT/VF accurately. Although discriminators withheld detection from most non-VT/VF episodes, inappropriate shocks were common. The most common cause was PWOS, which may be reduced by optimizing sensing at implantation and incorporation of the PWOS discriminator, which is now in the current device. (Extravascular ICD Pivotal Study [EV ICD]; NCT04060680).


Subject(s)
Defibrillators, Implantable , Tachycardia, Ventricular , Ventricular Fibrillation , Humans , Male , Female , Middle Aged , Aged , Ventricular Fibrillation/therapy , Ventricular Fibrillation/diagnosis , Tachycardia, Ventricular/therapy , Tachycardia, Ventricular/diagnosis , Tachycardia, Ventricular/physiopathology , Electrocardiography
11.
JACC Cardiovasc Interv ; 17(11): 1311-1321, 2024 Jun 10.
Article in English | MEDLINE | ID: mdl-38795093

ABSTRACT

BACKGROUND: Left atrial appendage occlusion (LAAO) provides mechanical cardioembolic protection for atrial fibrillation (AF) patients who cannot use oral anticoagulation therapy (OAT). Patients with a thrombotic event despite OAT are at high risk for recurrence and may also benefit from LAAO. OBJECTIVES: This study sought to investigate the efficacy of LAAO in AF patients with a thrombotic event on OAT compared to: 1) LAAO in AF patients with a contraindication for OAT; and 2) historical data. METHODS: The international LAAO after stroke despite oral anticoagulation (STR-OAC LAAO) collaboration included patients who underwent LAAO because of thrombotic events on OAT. This cohort underwent propensity score matching and was compared to the EWOLUTION (Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology) registry, which represents patients who underwent LAAO because of OAT contraindications. The primary outcome was ischemic stroke. Event rates were compared between cohorts and with historical data without OAT, yielding relative risk reductions based on risk scores. RESULTS: Analysis of 438 matched pairs revealed no significant difference in the ischemic stroke rate between the STR-OAC LAAO and EWOLUTION cohorts (2.5% vs 1.9%; HR: 1.37; 95% CI: 0.72-2.61). STR-OAC LAAO patients exhibited a higher thromboembolic risk (HR: 1.71; 95% CI: 1.04-2.83) but lower bleeding risk (HR: 0.39; 95% CI: 0.18-0.88) compared to EWOLUTION patients. The mortality rate was slightly higher in EWOLUTION (4.3% vs 6.9%; log-rank P = 0.028). Relative risk reductions for ischemic stroke were 70% and 78% in STR-OAC LAAO and EWOLUTION, respectively, compared to historical data without OAT. CONCLUSIONS: LAAO in patients with a thrombotic event on OAT demonstrated comparable stroke rates to the OAT contraindicated population in EWOLUTION. The thromboembolic event rate was higher and the bleeding rate lower, reflecting the intrinsically different risk profile of both populations. Until randomized trials are available, LAAO may be considered in patients with an ischemic event on OAT.


Subject(s)
Anticoagulants , Atrial Appendage , Atrial Fibrillation , Cardiac Catheterization , Contraindications, Drug , Ischemic Stroke , Registries , Humans , Atrial Appendage/physiopathology , Atrial Appendage/diagnostic imaging , Atrial Fibrillation/diagnosis , Atrial Fibrillation/complications , Atrial Fibrillation/mortality , Atrial Fibrillation/drug therapy , Atrial Fibrillation/therapy , Female , Male , Anticoagulants/adverse effects , Anticoagulants/administration & dosage , Aged , Risk Factors , Risk Assessment , Aged, 80 and over , Time Factors , Administration, Oral , Ischemic Stroke/prevention & control , Ischemic Stroke/mortality , Ischemic Stroke/diagnosis , Ischemic Stroke/etiology , Cardiac Catheterization/adverse effects , Cardiac Catheterization/instrumentation , Cardiac Catheterization/mortality , Treatment Failure , Hemorrhage/chemically induced , Recurrence , Middle Aged , Retrospective Studies , Europe
12.
J Am Heart Assoc ; 13(8): e032033, 2024 Apr 16.
Article in English | MEDLINE | ID: mdl-38591264

ABSTRACT

BACKGROUND: Chronic total coronary occlusions (CTO) substantially increase the risk for sudden cardiac death. Among patients with chronic ischemic heart disease at risk for sudden cardiac death, an implantable cardioverter defibrillator (ICD) is the favored therapy for primary prevention of sudden cardiac death. This study sought to investigate the impact of CTOs on the risk for appropriate ICD shocks and mortality within a nationwide prospective cohort. METHODS AND RESULTS: This is a subanalysis of the nationwide Dutch-Outcome in ICD Therapy (DO-IT) registry of primary prevention ICD recipients in The Netherlands between September 2014 and June 2016 (n=1442). We identified patients with chronic ischemic heart disease (n=663) and assessed available coronary angiograms for CTO presence (n=415). Patients with revascularized CTOs were excluded (n=79). The primary end point was the composite of all-cause mortality and appropriate ICD shocks. Clinical follow-up was conducted for at least 2 years. A total of 336 patients were included, with an average age of 67±9 years, and 20.5% was female (n=69). An unrevascularized CTO was identified in 110 patients (32.7%). During a median follow-up period of 27 months (interquartile range, 24-32), the primary end point occurred in 21.1% of patients with CTO (n=23) compared with 11.9% in patients without CTO (n=27; P=0.034). Corrected for baseline characteristics including left ventricular ejection fraction, and the presence of a CTO was an independent predictor for the primary end point (hazard ratio, 1.82 [95% CI, 1.03-3.22]; P=0.038). CONCLUSIONS: Within this nationwide prospective registry of primary prevention ICD recipients, the presence of an unrevascularized CTO was an independent predictor for the composite outcome of all-cause mortality and appropriate ICD shocks.


Subject(s)
Coronary Occlusion , Defibrillators, Implantable , Humans , Female , Middle Aged , Aged , Coronary Occlusion/complications , Coronary Occlusion/diagnostic imaging , Coronary Occlusion/therapy , Arrhythmias, Cardiac , Defibrillators, Implantable/adverse effects , Stroke Volume , Incidence , Ventricular Function, Left , Death, Sudden, Cardiac/epidemiology , Death, Sudden, Cardiac/etiology , Death, Sudden, Cardiac/prevention & control , Registries , Risk Factors
14.
Heart Rhythm ; 21(6): 836-844, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38336193

ABSTRACT

BACKGROUND: The PRAETORIAN score estimates the risk of failure of subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy by using generator and lead positioning on bidirectional chest radiographs. The PRospective randomized compArative trial of subcutanEous implanTable cardiOverter-defibrillatoR ImplANtation with and without DeFibrillation Testing (PRAETORIAN-DFT) investigates whether PRAETORIAN score calculation is noninferior to defibrillation testing (DFT) with regard to first shock efficacy in spontaneous events. OBJECTIVE: This prespecified subanalysis assessed the predictive value of the PRAETORIAN score for defibrillation success in induced ventricular arrhythmias. METHODS: This multicenter investigator-initiated trial randomized 965 patients between DFT and PRAETORIAN score calculation after de novo S-ICD implantation. Successful DFT was defined as conversion of induced ventricular arrhythmia in <5 seconds from shock delivery within 2 attempts. Bidirectional chest radiographs were obtained after implantation. The predictive value of the PRAETORIAN score for DFT success was calculated for patients in the DFT arm. RESULTS: In total, 482 patients were randomized to undergo DFT. Of these patients, 457 (95%) underwent DFT according to protocol, of whom 445 (97%) had successful DFT and 12 (3%) had failed DFT. A PRAETORIAN score of ≥90 had a positive predictive value of 25% for failed DFT, and a PRAETORIAN score of <90 had a negative predictive value of 99% for successful DFT. A PRAETORIAN score of ≥90 was the strongest independent predictor for failed DFT (odds ratio 33.77; confidence interval 6.13-279.95; P < .001). CONCLUSION: A PRAETORIAN score of <90 serves as a reliable indicator for DFT success in patients with S-ICD, and a PRAETORIAN score of ≥90 is a strong predictor for DFT failure.


Subject(s)
Defibrillators, Implantable , Electric Countershock , Predictive Value of Tests , Humans , Female , Male , Middle Aged , Electric Countershock/methods , Prospective Studies , Aged , Death, Sudden, Cardiac/prevention & control , Death, Sudden, Cardiac/etiology , Risk Assessment/methods , Tachycardia, Ventricular/therapy , Tachycardia, Ventricular/physiopathology , Ventricular Fibrillation/therapy
17.
Europace ; 26(4)2024 Mar 30.
Article in English | MEDLINE | ID: mdl-38291925

ABSTRACT

A significant proportion of patients who suffer from atrial fibrillation (AF) and are in need of thromboembolic protection are not treated with oral anticoagulation or discontinue this treatment shortly after its initiation. This undertreatment has not improved sufficiently despite the availability of direct oral anticoagulants which are associated with less major bleeding than vitamin K antagonists. Multiple reasons account for this, including bleeding events or ischaemic strokes whilst on anticoagulation, a serious risk of bleeding events, poor treatment compliance despite best educational attempts, or aversion to drug therapy. An alternative interventional therapy, which is not associated with long-term bleeding and is as effective as vitamin K anticoagulation, was introduced over 20 years ago. Because of significant improvements in procedural safety over the years, left atrial appendage closure, predominantly achieved using a catheter-based, device implantation approach, is increasingly favoured for the prevention of thromboembolic events in patients who cannot achieve effective anticoagulation. This management strategy is well known to the interventional cardiologist/electrophysiologist but is not more widely appreciated within cardiology or internal medicine. This article introduces the devices and briefly explains the implantation technique. The indications and device follow-up are more comprehensively described. Almost all physicians who care for adult patients will have many with AF. This practical guide, written within guideline/guidance boundaries, is aimed at those non-implanting physicians who may need to refer patients for consideration of this new therapy, which is becoming increasingly popular.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Physicians , Stroke , Thromboembolism , Adult , Humans , Stroke/prevention & control , Stroke/complications , Left Atrial Appendage Closure , Consensus , Hemorrhage/chemically induced , Hemorrhage/prevention & control , Anticoagulants/adverse effects , Thromboembolism/etiology , Thromboembolism/prevention & control , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/surgery , Vitamin K , Atrial Appendage/surgery , Treatment Outcome
18.
J Cardiovasc Electrophysiol ; 35(2): 240-246, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38047465

ABSTRACT

INTRODUCTION: The pivotal study of the extravascular implantable cardioverter-defibrillator (EV ICD) recently demonstrated primary efficacy and safety endpoints comparable to previous ICD systems. Patient experience with this novel device has not been reported. The current study examined the standardized patient-reported outcome (PRO) metrics of quality of life (QOL) and patient acceptance of the device. METHODS: The EV ICD Pivotal Study was a prospective, single-arm, nonrandomized, global, premarket approval trial. Patients completed the 12-Item Short Form Survey (SF-12) QOL surveys at baseline and at 6 months following implant. Additionally, patients completed the Florida Patient Acceptance Survey (FPAS) QOL survey at 6 months. RESULTS: From baseline to 6 months, patients within the EV ICD Pivotal Study (n = 247) reported statistically significant SF-12 improvements in physical QOL (45.4 ± 9.4 vs. 46.8 ± 9.1 respectively, p = .020) and no changes in mental QOL (49.3 ± 10.4 vs. 50.5 ± 9.7, p = .061). No differences were noted by sex, atrial fibrillation, or the experience of ICD shock. EV ICD patients reported better total FPAS patient acceptance of their ICD than TV-ICD or S-ICD patients using historical norms comparisons (80.4 ± 15.7 vs. 70.2 ± 17.8, p < .0001 for S-ICD and 73.0 ± 17.4, p = .004 for TV-ICD). CONCLUSION: The initial PROs for EV ICD patients indicated that patients had improvements in physical QOL from baseline to 6-month follow-up and markedly better overall acceptance of their ICD compared to a previous study with S-ICD and TV-ICD data. These initial results suggest that the EV ICD is evaluated positively by patients.


Subject(s)
Defibrillators, Implantable , Humans , Quality of Life , Prospective Studies , Surveys and Questionnaires , Patient Reported Outcome Measures
19.
J Arrhythm ; 39(5): 776-783, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37799786

ABSTRACT

Background: The tissue response viewer (TRV) is a novel marker for ablation lesion quality that aims to classify lesions into transmural or nontransmural lesions (high or low dielectric response, HDR or LDR) using dielectric-based tissue assessment. The objective of this study was to gain insight in the TRV by relating its outcomes to conventional ablation parameters. Methods: Patients that had repeat ablation for atrial fibrillation with a dielectric imaging-based mapping system were enrolled. All ablation data were downloaded from the mapping system and analyzed to explore associations between TRV outcomes and other ablation parameters. Results: The cohort included 24 patients, in which 58 pulmonary veins and 8 superior vena cavas were targeted. A total of 388 energy applications were applied, resulting in 639 ablation points. The system classified 36% of ablation points as HDR and 44% as LDR. The system did not provide a dielectric response in 20%. The system's ability to provide a dielectric response was related to longer ablation duration and absence of dragging ablation. HDR (versus LDR) was multivariably associated with longer energy applications, higher mean ablation power, and lower wall thickness. Greater impedance drop was univariably associated with HDR. Conclusion: Outcomes of the TRV are associated with conventional ablation parameters (e.g., duration and power) but also local wall thickness. Catheter stability seems important for successful lesion assessment with the TRV. Further reduction of missing outcomes and validation of the tool are warranted before widespread use.

20.
Pacing Clin Electrophysiol ; 46(11): 1403-1411, 2023 11.
Article in English | MEDLINE | ID: mdl-37724739

ABSTRACT

BACKGROUND: High-density (HD) mapping is increasingly used to characterize arrhythmic substrate for ablation of atypical atrial flutters (AAFl). However, results on clinical outcomes and factors that are associated with arrhythmia recurrence are scarce. METHODS: Single-center, prospective, observational cohort study that enrolled patients with catheter ablation for AAFl using a HD mapping system and a grid-shaped mapping catheter. Procedural characteristics, rates of atrial flutter recurrence, and factors that were associated with atrial flutter recurrence were evaluated. RESULTS: Sixty-one patients with a total of 94 AAFl were included in the cohort. HD mapping was used to successfully identify the flutter circuit of 80/94 AAFl. The circuit was not identified for 14/94 AAFl in 11 patients. Critical isthmuses were identified and ablated in 29 patients (48%). Acute procedural success was achieved in 52 patients (85%), and 37 patients (61%) remained free from atrial flutter recurrence during a follow up of 1.3 [1.0-2.1] years. Atrial flutter recurrence was univariably associated with presence of a non-identified flutter circuit (HR:2.6 95% CI [1.1-6.3], p = .04) and critical isthmus-targeted ablation (HR:0.4 [0.15-0.90], p = .03). In multivariable regression analyses, critical isthmus ablation remained significant (HR:0.4 [0.16-0.97], p = .04), whereas presence of a non-identified flutter did not (HR:2.4 [0.96-5.8], p = .06). CONCLUSION: HD mapping was successfully used to identify the majority of AAFl circuits. Ablation resulted in freedom from atrial flutter recurrence in 61% of the cohort. Successful identification of all flutter circuits and critical isthmuses appears to be beneficial for long-term outcomes.


Subject(s)
Atrial Flutter , Catheter Ablation , Humans , Prospective Studies , Cohort Studies , Catheter Ablation/methods
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