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1.
Article in English | MEDLINE | ID: mdl-38878012

ABSTRACT

BACKGROUND: Purkinje fibers play an important role in initiation and maintenance of ventricular fibrillation (VF) and polymorphic ventricular tachycardia (PMVT). Fascicular substrate modification (FSM) approaches have been suggested to treat recurrent VF in case reports and small case series. OBJECTIVES: The aim of this study was to investigate outcomes of catheter-based FSM to treat VF and PMVT. METHODS: Of 2,212 consecutive patients with ventricular arrhythmia undergoing catheter ablation, 18 (0.81%) underwent FSM of the Purkinje fibers as identified with high-density mapping during sinus rhythm. Fascicular substrate and VF initiation were mapped using a multipolar catheter. The endpoint of the ablation was noninducibility of VF and PMVT. In select patients, remapping revealed elimination of the targeted Purkinje potentials. Demographic, clinical, and follow-up characteristics were prospectively collected in our institutional database. RESULTS: A total of 18 patients (mean age 56 ± 3.8 years, 22% women) were included in the study. Of those, 11 (61.1%) had idiopathic VF, 3 (16.7%) had nonischemic cardiomyopathy, and 4 (22.2%) had mixed cardiomyopathy. The average left ventricular ejection fraction was 42.5%. At least 2 antiarrhythmic drugs had failed preablation. At baseline, all patients had inducible VF or PMVT. At the end of the procedure, no patient demonstrated new evidence of fascicular block or bundle branch block. There were no procedure-related complications. After a median follow-up period of 24 months, 16 patients (88.9%) were arrhythmia free on or off drugs: 11 of 11 patients (100%) with idiopathic VF vs 5 of 7 patients (71.4%) with underlying cardiomyopathy (P = 0.06). CONCLUSIONS: Catheter ablation of human VF and PMVT with FSM is feasible and safe and appears highly effective, with high rates of acute VF noninducibility and long-term freedom from recurrent VF.

3.
J Cardiovasc Electrophysiol ; 35(7): 1422-1428, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38751010

ABSTRACT

INTRODUCTION: Both atrial fibrillation (AF) and amyloidosis increase stroke risk. We evaluated the best anticoagulation strategy in AF patients with coexistent amyloidosis. METHODS: Consecutive AF patients with concomitant amyloidosis were divided into two groups based on the postablation stroke-prophylaxis approach; group 1: left atrial appendage occlusion (LAAO) in eligible patients and group 2: oral anticoagulation (OAC). Group 1 patients were further divided into Gr. 1A: LAAO + half-does NOAC (HD-NOAC) for 6 months followed by aspirin 81 mg/day and Gr. 1B: LAAO + HD-NOAC. In group 1 patients, with complete occlusion at the 45-day transesophageal echocardiogram, patients were switched to aspirin, 81 mg/day at 6 months. In case of leak, or dense "smoke" in the left atrium (LA) or enlarged LA, they were placed on long-term half-dose (HD) NOAC. Group 2 patients remained on full-dose NOAC during the whole study period. RESULTS: A total of 92 patients were included in the analysis; group 1: 56 and group 2: 36. After the 45-day TEE, 31 patients from group 1 remained on baby-aspirin and 25 on HD NOAC. At 1-year follow-up, four stroke, one TIA and six device-thrombus were reported in group 1A, compared to none in patients in group 1B (5/31 vs. 0/25, p = .03). No bleeding events were reported in group 1, whereas group 2 had five bleeding events (one subdural hematoma, one retinal hemorrhage, and four GI bleedings). Additionally, one stroke was reported in group 2 that happened during brief discontinuation of OAC. CONCLUSION: In patients with coexistent AF and amyloidosis, half-dose NOAC following LAAO was observed to be the safest stroke-prophylaxis strategy.


Subject(s)
Amyloidosis , Anticoagulants , Atrial Appendage , Atrial Fibrillation , Catheter Ablation , Stroke , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/complications , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/surgery , Male , Female , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Atrial Appendage/surgery , Aged , Middle Aged , Treatment Outcome , Stroke/prevention & control , Stroke/etiology , Stroke/diagnosis , Catheter Ablation/adverse effects , Anticoagulants/administration & dosage , Anticoagulants/adverse effects , Risk Factors , Time Factors , Amyloidosis/complications , Amyloidosis/diagnosis , Amyloidosis/diagnostic imaging , Hemorrhage/chemically induced , Administration, Oral , Retrospective Studies , Risk Assessment , Aspirin/administration & dosage , Aspirin/adverse effects , Drug Administration Schedule , Cardiomyopathies/diagnostic imaging , Cardiomyopathies/complications , Cardiomyopathies/diagnosis
5.
JACC Case Rep ; 29(5): 102227, 2024 Mar 06.
Article in English | MEDLINE | ID: mdl-38464799

ABSTRACT

We present a case of persistent complete atrioventricular block that occurred during the diagnostic portion of a premature ventricular contractions' radiofrequency ablation in a complex heart failure patient. The case was managed by bailout deep left ventricular septal pacing after bipolar radiofrequency elimination of premature ventricular contractions.

6.
JACC Clin Electrophysiol ; 10(4): 709-715, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38310489

ABSTRACT

BACKGROUND: High-voltage pulses can cause hemolysis. OBJECTIVES: The authors evaluated the occurrence of hemoglobinuria after pulsed-field ablation (PFA) and its impact on renal function in patients with atrial fibrillation (AF). METHODS: A consecutive series of patients with AF undergoing PFA were included in this analysis. The initial patients who did not receive postablation hydration immediately after the procedure were classified as group 1 (n = 28), and the rest of the study patients who received planned fluid infusion (0.9% sodium chloride ≥2 L) after the procedure were categorized as group 2 (n = 75). RESULTS: Of the 28 patients in group 1, 21 (75%) experienced hemoglobinuria during the 24 hours after catheter ablation. The mean postablation serum creatinine (S-Cr) was significantly higher than the baseline value in those 21 patients (1.46 ± 0.28 mg/dL vs 0.86 ± 0.24 mg/dL, P < 0.001). Of those 21 patients, 4 (19%) had S-Cr. >2.5 mg/dL (mean: 2.95 ± 0.21 mg/dL). The mean number of PF applications was significantly higher in those 4 patients than in the other 17 patients experiencing hemoglobinuria (94.63 ± 3.20 vs 46.75 ± 9.10, P < 0.001). In group 2 patients, no significant changes in S-Cr were noted. The group 2 patients received significantly higher amounts of fluid infusion after catheter ablation than did those in group 1 (2,082.50 ± 258.08 mL vs 494.01 ± 71.65 mL, P < 0.001). In multivariable analysis, both hydration (R2 = 0.63, P < 0.01) and number of PFA applications (R2 = 0.33, P < 0.01) were independent predictors of postprocedure acute kidney injury. CONCLUSIONS: On the basis of our findings, both the number of PFA applications and postablation hydration were independent predictors of renal insult that could be prevented using planned fluid infusion immediately after the procedure.


Subject(s)
Acute Kidney Injury , Atrial Fibrillation , Catheter Ablation , Hemoglobinuria , Humans , Atrial Fibrillation/surgery , Male , Female , Catheter Ablation/adverse effects , Catheter Ablation/methods , Middle Aged , Acute Kidney Injury/prevention & control , Acute Kidney Injury/etiology , Aged , Hemoglobinuria/etiology , Hemoglobinuria/prevention & control , Creatinine/blood , Retrospective Studies , Postoperative Complications/prevention & control , Postoperative Complications/etiology , Fluid Therapy/methods
7.
JACC Clin Electrophysiol ; 10(3): 477-486, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38069973

ABSTRACT

BACKGROUND: Studies have reported development of pulmonary hypertension (PH) secondary to reduced LA compliance following AF ablation. OBJECTIVES: This study aimed to compare the risk of worsening of baseline PH between non-paroxysmal AF patients undergoing pulsed-field ablation (PFA) and standard radiofrequency ablation (RFA). METHODS: This multicenter study included 28 nonparoxysmal AF patients with PH undergoing a PFA-based ablation procedure after >1 failed RFA. A cohort of 28 AF patients with PH, scheduled for repeat RFA, 1:1 propensity-score matched using a multivariable logistic model, were used as the comparator group. Right heart catheterization and echocardiography were performed before and after the procedure to assess the pulmonary artery pressure (PAP). PH was defined as resting mean PAP of >20 mm Hg. RESULTS: The baseline characteristics of the PFA and propensity-matched RFA groups were comparable. The mean PAP assessments at baseline, follow-up, and change from baseline were analyzed. The groups had comparable baseline mean pulmonary artery pressures (mPAP) (P = 0.177). After adjustment for baseline mPAP in an analysis of covariance model, the least-squares means change at 3 months after ablation was -1.71 ± 1.03 mm Hg and 19.67 ± 1.03 mm Hg in PFA and RFA, respectively (P <0.001). CONCLUSIONS: In this propensity-matched population, no worsening of mPAP was detected following pulsed-field ablation in patients with pre-existing PH undergoing a repeat procedure for recurrence.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Hypertension, Pulmonary , Radiofrequency Ablation , Humans , Atrial Fibrillation/surgery , Hypertension, Pulmonary/etiology , Catheter Ablation/adverse effects , Catheter Ablation/methods , Radiofrequency Ablation/adverse effects , Cardiac Catheterization
8.
JACC Clin Electrophysiol ; 9(7 Pt 2): 1051-1059, 2023 07.
Article in English | MEDLINE | ID: mdl-37086226

ABSTRACT

BACKGROUND: Acute pericarditis is a known complication of ablation procedures for atrial fibrillation (AF). OBJECTIVES: This study aimed to evaluate the benefits of colchicine monotherapy in terms of reducing the risk of pericarditis and related hospitalization rate in AF patients undergoing catheter ablation. METHODS: Consecutive AF patients undergoing first catheter ablation were classified into 3 groups based on their colchicine use: Group 1: no colchicine; group 2: colchicine from 7 days before to 1 month after ablation; and group 3: colchicine from the day of the procedure to 1 month after. Standard institutional protocol was used to follow all patients for 1 year. RESULTS: A total of 1,075 patients were classified into groups 1 (n = 607), 2 (n = 213), and 3 (n = 255). Symptoms of acute pericarditis were reported in 129 patients (12%): group 1: n = 106 (17.5%); group 2: n = 4 (1.9%); and group 3: n = 19 (7.5%); P < 0.001. Rate of mild-moderate as well as severe pericarditis were significantly lower in group 2. In the multivariable regression analysis, pre- and post-ablation colchicine use was seen to be associated with significantly lower risk of acute pericarditis and related hospitalization compared with the other 2 groups. In addition, at 1-year follow-up, arrhythmia-free survival rate was significantly higher in paroxysmal AF patients receiving colchicine compared with the no-colchicine population. CONCLUSIONS: Colchicine therapy starting 7 days before to 1 month after the ablation procedure was associated with significantly lower risk of acute pericarditis and related hospitalization. In addition, paroxysmal AF patients receiving colchicine had a higher arrhythmia-free survival rate compared with those not receiving colchicine.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Pericarditis , Humans , Atrial Fibrillation/drug therapy , Atrial Fibrillation/surgery , Atrial Fibrillation/diagnosis , Treatment Outcome , Colchicine/therapeutic use , Catheter Ablation/adverse effects , Catheter Ablation/methods , Pericarditis/epidemiology , Pericarditis/etiology , Pericarditis/surgery
10.
J Cardiovasc Electrophysiol ; 34(1): 147-152, 2023 01.
Article in English | MEDLINE | ID: mdl-36378783

ABSTRACT

INTRODUCTION: Atrial fibrillation (AF) and premature ventricular complexes (PVC) are common arrhythmias. We aimed to investigate AF prevalence in patients with PVC and its impact on PVC ablation outcomes. METHODS: Consecutive patients undergoing PVC ablation at a single institution between 2016 and 2019 were included and prospectively followed for 2 years. Patients with severe valvular heart disease, hyperthyroidism, malignancy, alcohol use disorder and advanced renal/hepatic diseases were excluded. Twelve-lead electrocardiograms were used to diagnose AF and assess PVC morphology. All PVCs were targeted for ablation using 4-mm irrigated-tip catheters at standardized radiofrequency power guided by 3-D mapping and intracardiac echocardiography. Patients were followed with remote monitoring, device interrogations and office visits every 6 months for 2 years. Detection of any PVCs in follow-up was considered as recurrence. RESULTS: A total of 394 patients underwent PVC ablation and 96 (24%) had concurrent AF. Patients with PVC and AF were significantly older (68.2 ± 10.8 vs. 58.3 ± 15.8 years, p < .001), had lower LV ejection fraction (43.3 ± 13.3% vs. 49.6 ± 12.4%, p < .001), higher CHA2 DS2 -VASc (2.8 ± 1.3 vs. 2.0 ± 1.3, p < .001) than those without. PVCs with ≥2 morphologies were detected in 60.4% and 13.7% patients with vs without AF (p < .001). At 2-year follow-up, PVC recurrence rate was significantly higher in patients with vs without AF (17.7% vs. 9.4%, p = .02). CONCLUSION: AF was documented in 1/4 of patients undergoing PVC ablation and was associated with lower procedural success at long-term follow-up. This was likely attributed to older age, worse LV function and higher prevalence of multiple PVC morphologies in patients with concurrent AF.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Ventricular Premature Complexes , Humans , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Atrial Fibrillation/surgery , Treatment Outcome , Prevalence , Stroke Volume , Ventricular Premature Complexes/diagnosis , Ventricular Premature Complexes/epidemiology , Ventricular Premature Complexes/surgery , Catheter Ablation/adverse effects
11.
Circ Arrhythm Electrophysiol ; 15(6): e010975, 2022 06.
Article in English | MEDLINE | ID: mdl-35617267

ABSTRACT

BACKGROUND: Following left atrial appendage (LAA) electrical isolation, the decision on whether to continue oral anticoagulation after successful atrial fibrillation ablation is based on the study of its mechanical function on transesophageal echocardiography (TEE). In this cohort, LAA contraction is absent and the incorrect interpretation of emptying flow velocities can lead to unwanted clinical sequelae. METHODS: One hundred and sixty consecutive TEE exams performed to evaluate the LAA mechanical function following its electrical isolation were reviewed by an experienced operator blinded to the original diagnosis of LAA dysfunction. The rate of diagnostic discrepancy in the assessment LAA dysfunction and its clinical implications were evaluated. RESULTS: Diagnostic discrepancy with misclassification of the LAA mechanical function occurred 36% (58/160) of TEE exams. In most cases (57/58), such discrepancy was observed in the setting of an incorrect original diagnosis of a normal LAA mechanical function despite absent/reduced or inconsistent LAA contraction. This main source of this wrong diagnosis was the wrong interpretation of passive LAA flows (34/57; 60%), followed by failure to identify dissociated firing (15/57; 26%). In rare cases (8/57; 14%), velocities of surrounding structures were interpreted as LAA flow due to misplacement of the pulsed-wave Doppler sample volume. Following LAA isolation, the proportion of patients who experienced a cerebrovascular event while off oral anticoagulation due to the misclassification of their LAA mechanical function was 70% (7/10 [95% CI, 40%-89%]). CONCLUSIONS: Underdiagnosis of LAA mechanical dysfunction is common in TEEs performed following LAA electrical isolation, and it is associated with an increased risk of cerebrovascular events owing to oral anticoagulation discontinuation despite absent/reduced LAA contraction. Careful review of the TEE exam by an operator with specific expertise in LAA imaging and familiar with the functional implications of LAA isolation is necessary before interrupting oral anticoagulation in this cohort.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Catheter Ablation , Anticoagulants/therapeutic use , Atrial Appendage/diagnostic imaging , Atrial Appendage/surgery , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Echocardiography, Transesophageal/methods , Humans
12.
Cardiovasc Digit Health J ; 3(2): 75-79, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35493269

ABSTRACT

Introduction: Obesity, a known risk factor for atrial fibrillation (AF), is potentially reversible through lifestyle changes, including diet and physical activity. However, lack of compliance is a major obstacle in attaining sustained weight loss. We investigated the impact of patient engagement using a digital monitoring system on compliance for lifestyle-change measures and subsequent outcome. Methods: A total of 105 consecutive patients with coexistent AF and obesity (body mass index ≥28) were classified into 2 groups based on the monitoring method: group 1, use of digital platform (n = 20); group 2, conventional method (n = 85). Group 1 used the RFMx digital monitoring platform (smartphone app) that sets weekly goals for exercise and weight loss, tracks patient compliance data continuously, and sends regular text reminders. Conventional method included monitoring patients' adherence to diet and change in weight during in-person clinic visits or monthly phone calls from staff. Results: Baseline characteristics of groups 1 and 2 were comparable. At 6 months of follow-up, 12 (60%) and 28 (33%) from group 1 and 2, respectively, were compliant with the physician instructions regarding diet and exercise (P = .025). Weight loss was observed in 9 of 12 (75%) from group 1 and 11 of 28 (39%) from group 2 (P = .038) and mean reduction in weight was 9.9 ± 8.9 lb and 4.0 ± 2.1 lb (P = .042). Conclusion: In this series, continuous digital monitoring was seen to be associated with significant improvement in compliance through better patient engagement, resulting in more weight loss compared to the conventional method.

13.
JACC Clin Electrophysiol ; 8(4): 453-461, 2022 04.
Article in English | MEDLINE | ID: mdl-35246406

ABSTRACT

OBJECTIVES: In this study, the authors investigated the ablation success of scar homogenization with combined (epicardial + endocardial) vs endocardial-only approach for ventricular tachycardia (VT) in patients with ischemic cardiomyopathy (ICM) at 5 years of follow-up. BACKGROUND: Best ablation approach to achieve long-term success rate in VT patients with ICM is not known yet. METHODS: Consecutive ICM patients undergoing VT ablation at our center were classified into group 1: endocardial + epicardial scar homogenization and group 2: endocardial scar homogenization. Patients with previous open heart surgery were excluded. Epicardial ablation was performed despite being noninducible after endocardial ablation in all group 1 patients. All patients underwent bipolar substrate mapping with standard scar settings defined as normal tissue >1.5 mV and severe scar <0.5 mV. Noninducibility of monomorphic VT was the procedural endpoint in both groups. Patients were followed up every 4 months for 5 years with implantable device interrogations. RESULTS: A total of 361 patients (group 1: n = 70 and group 2: n = 291) were included in the study. At 5 years, 81.4% (n = 57/70) patients from group 1 and 66.3% (n = 193/291) from group 2 were arrhythmia-free (P = 0.01) Of those patients, 26 of 57 (45.6%) and 172 of 193 (89.1%) from group 1 and group 2 respectively were on anti-arrhythmic drugs (AAD) (log-rank P < 0.001). After adjusting for age, sex, and obstructive sleep apnea, endo-epicardial scar homogenization was associated with a significant reduction in arrhythmia-recurrence (HR: 0.48; 95% CI: 0.27-0.86; P = 0.02). CONCLUSIONS: In this series of patients with ICM and VT, epicardial substrate was detected in all group 1 patients despite being noninducible after endocardial ablation. Moreover, combined endo-epicardial scar homogenization was associated with a significantly higher success rate at 5 years of follow-up and a substantially lower need for antiarrhythmic drugs after the procedure compared with the endocardial ablation alone.


Subject(s)
Cardiomyopathies , Catheter Ablation , Myocardial Ischemia , Tachycardia, Ventricular , Catheter Ablation/adverse effects , Catheter Ablation/methods , Cicatrix/etiology , Endocardium/surgery , Humans , Myocardial Ischemia/complications , Myocardial Ischemia/surgery , Tachycardia, Ventricular/complications , Tachycardia, Ventricular/surgery , Treatment Outcome
14.
Card Electrophysiol Clin ; 14(1): 1-9, 2022 03.
Article in English | MEDLINE | ID: mdl-35221076

ABSTRACT

COVID-19 mainly affects the respiratory system but has been correlated with cardiovascular manifestations such as myocarditis, heart failure, acute coronary syndromes, and arrhythmias. Cardiac arrhythmias are the second most frequent complication affecting about 30% of patients. Several mechanisms may lead to an increased risk of cardiac arrhythmias during COVID-19 infection, ranging from direct myocardial damage to extracardiac involvement. The aim of this review is to describe the role of COVID-19 in the pathogenesis of cardiac arrhythmias and provide a comprehensive guidance for their monitoring and management.


Subject(s)
Atrial Fibrillation , Atrial Flutter , COVID-19 , Catheter Ablation , Tachycardia, Supraventricular , Atrial Fibrillation/surgery , COVID-19/complications , Catheter Ablation/adverse effects , Humans , Prevalence , SARS-CoV-2
15.
Heart Rhythm ; 18(8S): S318, 2021 08.
Article in English | MEDLINE | ID: mdl-34736718

ABSTRACT

This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal). This article has been retracted at the request of the authors. The authors inadvertently specified some ablation settings in the methods section that should not have been reported because they can be potentially linked to a specific pulsed field ablation technology that is currently under investigation for FDA approval. The Authors apologize for the inconvenience caused by this oversight, http://dx.doi.org/.

16.
JACC Cardiovasc Interv ; 14(21): 2353-2364, 2021 11 08.
Article in English | MEDLINE | ID: mdl-34656496

ABSTRACT

OBJECTIVES: This study evaluated the long-term efficacy of a standard antithrombotic strategy versus half-dose direct oral anticoagulation (DOAC) after Watchman implantation. BACKGROUND: No consensus currently exists on the selection of the most effective antithrombotic strategy to prevent device-related thrombosis (DRT) in patients undergoing endocardial left atrial appendage closure. METHODS: After successful left atrial appendage closure, consecutive patients were prescribed a standard antithrombotic strategy (SAT) or long-term half-dose DOAC (hdDOAC). The primary composite endpoint was DRT and thromboembolic (TE) and bleeding events. RESULTS: Overall, 555 patients (mean age 75 ± 8 years, 63% male; median CHA2DS2-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category] score 4 [interquartile range (IQR): 3-6]; median HAS-BLED [hypertension, abnormal renal or liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol] score 3 [IQR: 2-4]) were included. Patients were categorized into 2 groups (SAT: n = 357 vs hdDOAC: n = 198). Baseline clinical characteristics were similar between groups. The median follow-up duration was 13 months (IQR: 12-15 months). DRT occurred in 12 (2.1%) patients, all in the SAT group (3.4% vs 0.0%; log-rank P = 0.009). The risk of nonprocedural major bleeding was significantly more favorable in the hdDOAC group (0.5% vs. 3.9%; log-rank P = 0.018). The rate of the primary composite endpoint of DRT and TE and major bleeding events was 9.5% in SAT patients and 1.0% in hdDOAC patients (HR: 9.8; 95% CI: 2.3-40.7; P = 0.002). CONCLUSIONS: After successful Watchman implantation, long-term half-dose DOAC significantly reduced the risk of the composite endpoint of DRT and TE and major bleeding events compared with a standard, antiplatelet-based, antithrombotic therapy.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Stroke , Aged , Aged, 80 and over , Anticoagulants/adverse effects , Atrial Appendage/diagnostic imaging , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/drug therapy , Female , Fibrinolytic Agents/adverse effects , Humans , Male , Stroke/diagnosis , Stroke/etiology , Stroke/prevention & control , Treatment Outcome
18.
J Cardiovasc Electrophysiol ; 32(11): 2915-2922, 2021 11.
Article in English | MEDLINE | ID: mdl-34554634

ABSTRACT

BACKGROUND: Intracardiac electrogram data remain one of the primary diagnostic inputs guiding complex ablation procedures. However, the technology to collect, process, and display intracardiac signals has known shortcomings and has not advanced in several decades. OBJECTIVE: The purpose of this study was to evaluate a new signal processing platform, the PURE EP™ system (PURE), in a multi-center, prospective study. METHODS: Intracardiac signal data of clinical interest were collected from 51 patients undergoing ablation procedures with PURE, the signal recording system, and the 3D mapping system at the same time stamps. The samples were randomized and subjected to blinded, controlled evaluation by three independent electrophysiologists to determine the overall quality and clinical utility of PURE signals when compared to conventional sources. Each reviewer assessed the same (92) signal sample sets and responded to (235) questions using a 10-point rating scale. If two or more reviewers rated the PURE signal higher than the control, it was deemed superior. RESULTS: A total of 93% of question responses showed consensus amongst the blinded reviewers. Based on the ratings for each pair of signals, a cumulative total of 164 PURE signals out of 218 (75.2%) were statistically rated as Superior for this data set (p < .001). Only 14 PURE signals out of 218 were rated as Inferior (6.4%). CONCLUSION: The PURE intracardiac signals were statistically rated as superior when compared to conventional systems.


Subject(s)
Cardiac Electrophysiology , Catheter Ablation , Electrophysiologic Techniques, Cardiac , Heart , Humans , Prospective Studies , Signal Processing, Computer-Assisted
19.
J Cardiovasc Electrophysiol ; 32(10): 2781-2784, 2021 10.
Article in English | MEDLINE | ID: mdl-34411376

ABSTRACT

INTRODUCTION: Watchman FLX has been recently approved for left atrial appendage occlusion (LAAO) in the US. Intracardiac echocardiography (ICE) - which is already commonly used to guide trans-septal access - can serve as an alternative to TEE, simplifying the procedure and reducing associated costs. Herein, we report our experience with ICE-guided LAAO with Watchman FLX. METHODS AND RESULTS: This cohort study included the first 190 consecutive patients who underwent LAAO with Watchman FLX in our center. LAAO was successful in all patients without significant peri-procedural, device-related complications in either group. Compared to TEE, we observed a significant reduction in procedural times when using ICE. In addition, there was a potentially clinically relevant reduction in fluoroscopy dose, mainly secondary to fewer cine acquisition runs. At follow-up, no cases of device embolism were noted, whereas the rate of device-related thrombosis and peri-device leaks were comparable between groups. CONCLUSION: ICE-guided LAAO with Watchman FLX is safe and feasible, with a significant reduction in procedural time and potential reduction in fluoroscopy dose when compared to TEE.


Subject(s)
Atrial Appendage , Atrial Fibrillation , Atrial Appendage/diagnostic imaging , Atrial Appendage/surgery , Atrial Fibrillation/diagnostic imaging , Atrial Fibrillation/surgery , Cardiac Catheterization/adverse effects , Cohort Studies , Echocardiography, Transesophageal , Humans , Treatment Outcome , Ultrasonography, Interventional
20.
JACC Clin Electrophysiol ; 7(12): 1533-1543, 2021 12.
Article in English | MEDLINE | ID: mdl-34217665

ABSTRACT

OBJECTIVES: This study sought to report the incidence of device-related thrombosis (DRT) and thromboembolic (TE) events when an alternative to clopidogrel is prescribed in loss-of-function (LOF) allele carriers of the cytochrome P450 2C19 (CYP2C19) gene. BACKGROUND: LOF polymorphisms of the CYP2C19 gene are associated with reduced hepatic bioactivation of clopidogrel. METHODS: A total of 1,002 Watchman patients were included. Six hundred forty-five patients underwent CYP2C19 genetic testing; among patients with clopidogrel resistance, clopidogrel was replaced by either prasugrel (pilot cohort) or half dose direct oral anticoagulant ([DOAC]/Group 1), both in combination with aspirin. We compared the incidence of DRT/TE events among genotyped patients and a control group which received standard dual antiplatelet therapy (DAPT) (Group 2; n = 357). All reported events occurred during a timeframe between 45- and 180-day follow-up transesophageal echocardiograms, when the 2 different antithrombotic strategies (genotype-guided vs standard DAPT) were adopted. RESULTS: In the pilot cohort (n = 244), bleeding events occurred in 10.2% of patients who received aspirin plus prasugrel, leading to early discontinuation of the prasugrel-based protocol. DOAC Group 1 patients (n = 401), 25.7% were reduced metabolizers, and clopidogrel was replaced by half dose direct oral anticoagulant. DRT was documented in 1 (0.2%) patient of Group 1 and 7 (1.96%) patients of Group 2 (log-rank P = 0.021). The composite endpoint of DRT/TE events was significantly lower among patients receiving a genotype-guided antithrombotic strategy (0.75% vs 3.10%; log-rank P = 0.017). CONCLUSIONS: In Watchman patients, a genotype-based antithrombotic strategy with aspirin plus half dose DOAC in reduced clopidogrel metabolizers was superior to standard DAPT with respect to DRT/TE events.


Subject(s)
Fibrinolytic Agents , Thrombosis , Clopidogrel/adverse effects , Genotype , Humans , Incidence , Thrombosis/drug therapy , Thrombosis/epidemiology , Thrombosis/genetics
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