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1.
Heart Rhythm ; 2024 May 24.
Artigo em Inglês | MEDLINE | ID: mdl-38797310

RESUMO

BACKGROUND: Peridevice leak (PDL) after left atrial appendage closure (LAAC) portends adverse outcomes. OBJECTIVE: The purpose of this study was to assess the incidence, predictors, clinical implications, and temporal evolution of PDL after LAAC. METHODS: This single-center retrospective study included all patients who underwent LAAC with Watchman FLX and had no PDL detected at the time of implantation. The primary end point was the incidence of new PDL at initial imaging. The composite secondary end point included continued oral anticoagulation after initial imaging, device-related thrombus, stroke or transient ischemic attack, major bleeding, and need for PDL closure at longest follow-up. Temporal evolution of PDL was assessed in patients with available surveillance imaging. RESULTS: Of the 355 patients who completed imaging at 47 days (interquartile range [IQR] 6 days), 139 (39%) had new PDL with a mean leak size of 3.2 ± 1.4 mm (median 3.0 mm; IQR 2.0 mm; range 1.0-9.0 mm]. Multiple deployment attempts and larger device size were positive predictors of PDL, while increased contrast volume administration was a negative predictor of PDL. The composite secondary end point occurred in 42 (30%) and 33 (15%) patients with and without PDL, respectively (P < .001). Of the 139 patients with PDL, 43 (31%) had surveillance imaging where the leak size regressed from 3.7 ± 1.8 mm at 46 days (IQR 7 days) to 1.7 ± 2.0 mm at 189 days (IQR 127 days) (P < .001). The leak size regressed in 33 (77%), remained stable in 4 (9%), and progressed in 6 (14%) cases. CONCLUSION: Despite design improvements, LAAC with Watchman FLX demonstrates a significant incidence of PDL with meaningful clinical implications. Regardless of initial size, most leaks regressed over time.

3.
J Cardiovasc Electrophysiol ; 34(9): 1961-1968, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37449437

RESUMO

INTRODUCTION: Insertable cardiac monitors (ICMs) are commonly used to diagnose cardiac arrhythmias. False detections in the latest ICM systems remain an issue, primarily due to inaccurate R-wave sensing. New discrimination algorithms were developed and tested to reduce false detections of atrial fibrillation (AF), pause, and tachycardia episodes in ICMs. METHODS: Stored electrograms (EGMs) of AF, pause, and tachycardia episodes detected by Abbott Confirm Rx™ ICMs were extracted from the Merlin.net™ Patient Care Network, and manually adjudicated to establish independent training and testing datasets. New discrimination algorithms were developed to reject false episodes due to inaccurate R-wave sensing, P-wave identification, and R-R interval patterns. The performance of these new algorithms was quantified by false positive reduction (FPR) and true positive maintenance (TPM), relative to the existing algorithms. RESULTS: The new AF detection algorithm was trained on 5911 EGMs from 744 devices, resulting in 66.9% FPR and 97.8% TPM. In the testing data set of 1354 EGMs from 119 devices, this algorithm achieved 45.8% FPR and 97.0% TPM. The new pause algorithm was trained on 7178 EGMs from 1490 devices, resulting in 70.9% FPR and 98.7% TPM. In the testing data set of 1442 EGMs from 340 devices, this algorithm achieved 74.4% FPR and 99.3% TPM. The new tachycardia algorithm was trained on 520 EGMs from 204 devices, resulting in 57.0% FPR and 96.6% TPM. In the testing data set of 459 EGMs from 237 devices, this algorithm achieved 57.9% FPR and 96.5% TPM. CONCLUSION: The new algorithms substantially reduced false AF, pause, and tachycardia episodes while maintaining the majority of true arrhythmia episodes detected by the Abbott ICM algorithms that exist today. Implementing these algorithms in the next-generation ICM systems may lead to improved detection accuracy, in-clinic efficiency, and device battery longevity.


Assuntos
Fibrilação Atrial , Eletrocardiografia Ambulatorial , Humanos , Eletrocardiografia Ambulatorial/métodos , Fibrilação Atrial/diagnóstico , Algoritmos , Síncope/diagnóstico
4.
J Cardiovasc Electrophysiol ; 34(8): 1698-1705, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37493499

RESUMO

INTRODUCTION: Among patients with non-valvular atrial fibrillation (AF) and percutaneous left atrial appendage closure (LAAC) undergoing direct current cardioversion (DCCV), the need for and use of LAA imaging and oral anticoagulation (OAC) is unclear. OBJECTIVE: The purpose of this study is to evaluate the real-world use of transesophageal echocardiography (TEE) or cardiac computed tomography angiography (CCTA) before DCCV and use of OAC pre- and post-DCCV in patients with AF status post percutaneous LAAC. METHODS: This retrospective single center study included all patients who underwent DCCV after percutaneous LAAC from 2016 to 2022. Key measures were completion of TEE or CCTA pre-DCCV, OAC use pre- and post-DCCV, incidence of left atrial thrombus (LAT) or device-related thrombus (DRT), incidence of peri-device leak (PDL), and DCCV-related complications (stroke, systemic embolism, device embolization, major bleeding, or death) within 30 days. RESULTS: A total of 76 patients with AF and LAAC underwent 122 cases of DCCV. LAAC consisted of 47 (62%), 28 (37%), and 1 (1%) case of Watchman 2.5, Watchman FLX, and Lariat, respectively. Among the 122 DCCV cases, 31 (25%) cases were identified as "non-guideline based" due to: (1) no OAC for 3 weeks and no LAA imaging within 48 h before DCCV in 12 (10%) cases, (2) no OAC for 4 weeks following DCCV in 16 (13%) cases, or (3) both in 3 (2%) cases. Among the 70 (57%) cases that underwent TEE or CCTA before DCCV, 16 (23%) cases had a PDL with a mean size of 3.0 ± 1.1 mm, and 4 (6%) cases had a LAT/DRT on TEE resulting in cancellation. There were no DCCV-related complications within 30 days. DISCUSSION: There is a widely varied practice pattern of TEE, CCTA, and OAC use with DCCV after LAAC, with a 6% rate of LAT/DRT. LAA imaging before DCCV appears prudent in all cases, especially within 1 year of LAAC, to assess for device position, PDL, and LAT/DRT.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Cardiopatias , Acidente Vascular Cerebral , Trombose , Humanos , Estudos Retrospectivos , Cardioversão Elétrica/efeitos adversos , Apêndice Atrial/diagnóstico por imagem , Trombose/diagnóstico por imagem , Trombose/etiologia , Trombose/prevenção & controle , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/terapia , Ecocardiografia Transesofagiana , Resultado do Tratamento , Acidente Vascular Cerebral/diagnóstico por imagem , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Cateterismo Cardíaco/efeitos adversos
5.
J Innov Card Rhythm Manag ; 14(4): 5403-5409, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-37143575

RESUMO

Persistent left superior vena cava (PLSVC) is the most common congenital thoracic venous anomaly, with 0.47% of patients undergoing pacemaker or cardiac implantable device placement found to have PLSVC. This review article describes challenges and interventions to successfully insert cardiac implantable electronic device leads into patients with PLSVC by providing multiple unique case examples.

6.
Pacing Clin Electrophysiol ; 46(7): 745-751, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-37221927

RESUMO

BACKGROUND: Transesophageal echocardiography (TEE) and cardiac computed tomography angiography (CCTA) are currently utilized for left atrial appendage closure (LAAC) planning. During the recent global iodine contrast media shortage in 2022, cardiac magnetic resonance imaging (CMR) was utilized for the first time for LAAC planning. This study sought to assess the utility of CMR versus TEE for LAAC planning. METHODS: This single center retrospective study consisted of all patients who underwent preoperative CMR for LAAC with Watchman FLX or Amplatzer Amulet. Key measures were accuracy of LAA thrombus exclusion, ostial diameter, depth, lobe count, morphology, accuracy of predicted device size, and devices deployed per case. Bland-Altman Analysis was used to compare CMR versus TEE measurements of LAA ostial diameter and depth. RESULTS: 25 patients underwent preoperative CMR for LAAC planning. A total of 24 (96%) cases were successfully completed with 1.2 ± 0.5 devices deployed per case. Among the 18 patients who underwent intraoperative TEE, there was no significant difference between CMR versus TEE in LAA thrombus exclusion (CMR 83% vs. TEE 100% cases, p = .229), lobe count (CMR 1.7 ± 0.8 vs. TEE 1.4 ± 0.6, p = .177), morphology (p = .422), and accuracy of predicted device size (CMR 67% vs. TEE 72% cases, p = 1.000). When comparing the difference between CMR and TEE measurements, Bland-Altman analysis demonstrated no significant difference in LAA ostial diameter (CMR-TEE bias 0.7 mm, 95% CI [-1.1, 2.4], p = .420), but LAA depth was significantly larger with CMR versus TEE (CMR-TEE bias 7.4 mm, 95% CI [1.6, 13.2], p = .015). CONCLUSIONS: CMR is a promising alternative for LAAC planning in cases where TEE or CCTA are contraindicated or unavailable.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Trombose , Humanos , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Estudos Retrospectivos , Ecocardiografia Transesofagiana/métodos , Imageamento por Ressonância Magnética , Trombose/diagnóstico por imagem , Cateterismo Cardíaco , Resultado do Tratamento
7.
J Cardiovasc Electrophysiol ; 33(4): 741-750, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35118767

RESUMO

BACKGROUND: Insertable cardiac monitors (ICMs) are essential for ambulatory arrhythmia diagnosis. However, definitive diagnoses still require time-consuming, manual adjudication of electrograms (EGMs). OBJECTIVE: To evaluate the clinical impact of selecting only key EGMs for review. METHODS: Retrospective analyses of randomly selected Abbott Confirm Rx™ devices with ≥90 days of remote transmission history were performed, with each EGM adjudicated as true or false positive (TP, FP). For each device, up to 3 "key EGMs" per arrhythmia type per day were prioritized for review based on ventricular rate and episode duration. The reduction in EGMs and TP days (patient-days with at least one TP EGM), and any diagnostic delay (from the first TP), were calculated versus reviewing all EGMs. RESULTS: In 1000 ICMs over a median duration of 8.1 months, at least one atrial fibrillation (AF), tachycardia, bradycardia, or pause EGM was transmitted by 424, 343, 190, and 325 devices, respectively, with a total of 95 716 EGMs. Approximately 90% of episodes were contributed by 25% of patients. Key EGM selection reduced EGM review burden by 43%, 66%, 77%, and 50% (55% overall), while reducing TP days by 0.8%, 2.1%, 0.2%, and 0.0%, respectively. Despite reviewing fewer EGMs, 99% of devices with a TP EGM were ultimately diagnosed on the same day versus reviewing all EGMs. CONCLUSION: Key EGM selection reduced the EGM review substantially with no delay-to-diagnosis in 99% of patients exhibiting true arrhythmias. Implementing these rules in the Abbott patient care network may accelerate clinical workflow without compromising diagnostic timelines.


Assuntos
Fibrilação Atrial , Diagnóstico Tardio , Fibrilação Atrial/diagnóstico , Bradicardia/diagnóstico , Humanos , Estudos Retrospectivos , Taquicardia/diagnóstico
8.
J Interv Card Electrophysiol ; 63(3): 661-668, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-34855036

RESUMO

PURPOSE: SharpSense™ technology is an upgradable software enhancement introduced to the Abbott Confirm Rx™ insertable cardiac monitor (ICM). This study aims to characterize the real-world performance of SharpSense algorithms by comparing device detected pause and bradycardia episodes before and after the SharpSense upgrade. METHODS: Confirm Rx devices with at least 90 days monitoring each before and after SharpSense upgrade were included in the study. Bradycardia and pause detections and subcutaneous electrocardiograms (SECGs) within 90 days before and after the upgrade were extracted from Merlin.net™ patient care network for evaluation and adjudicated by expert adjudicators. RESULTS: A total of 197 devices were included in the analysis. Devices were implanted for syncope (35.0%), atrial fibrillation (32.5%), cryptogenic stroke (16.8%), and other indications including palpitations (15.7%). The SharpSense upgrade significantly reduced the number of bradycardia detections by 86.8% and pause detections by 93.1%. In adjudicated SECGs, the upgrade significantly reduced false positive (FP) bradycardia episodes by 91.5% and FP pause episodes by 82.8%. The percentage of devices with at least one FP episode was reduced from 39 to 20% for bradycardia and from 52 to 35% for pause. The number of devices with FP rate greater than 1 episode per week was reduced from 23 to 8% for bradycardia and from 39 to 20% for pause. CONCLUSIONS: In this real-world performance evaluation, the algorithms incorporated in SharpSense software upgrade in Confirm Rx ICMs substantially reduced false positive bradycardia and pause detections and the number of transmitted SECGs for clinic review.


Assuntos
Fibrilação Atrial , Eletrocardiografia Ambulatorial , Algoritmos , Bradicardia/diagnóstico , Humanos , Síncope
9.
JACC Clin Electrophysiol ; 8(1): 15-25, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34454881

RESUMO

OBJECTIVES: The aim of this study was to assess temporal changes and clinical implications of peridevice leak (PDL) after left atrial appendage closure. BACKGROUND: Endocardial left atrial appendage closure devices are alternatives to long-term oral anticoagulation (OAC) for patients with atrial fibrillation. PDL >5 mm may prohibit discontinuation of OAC. METHODS: Patients included in the study had: 1) successful Watchman device implantation without immediate PDL; 2) new PDL identified at 45 to 90 days using transesophageal echocardiography; 3) eligibility for OAC; and 4) 1 follow-up transesophageal echocardiographic study for PDL surveillance. Relevant clinical and imaging data were collected by chart review. The combined primary outcome included failure to stop OAC after 45 to 90 days, transient ischemic attack or stroke, device-related thrombi, and need for PDL closure. RESULTS: Relevant data were reviewed for 1,039 successful Watchman device implantations. One hundred eight patients (10.5%) met the inclusion criteria. The average PDL at 45 to 90 days was 3.2 ± 1.6 mm. On the basis of a median PDL of 3 mm, patients were separated into ≤3 mm (n = 73) and >3 mm (n = 35) groups. In the ≤3 mm group, PDL regressed significantly (2.2 ± 0.8 mm vs 1.6 ± 1.4 mm; P = 0.002) after 275 ± 125 days. In the >3 mm group, there was no significant change in PDL (4.9 ± 1.4 mm vs 4.0 ± 3.0 mm; P = 0.12) after 208 ± 137 days. The primary outcome occurred more frequently (69% vs 34%; P = 0.002) in the >3 mm group. The incidence of transient ischemic attack or stroke in patients with PDL was significantly higher compared with patients without PDL, irrespective of PDL size. CONCLUSIONS: New PDL detected by transesophageal echocardiography at 45 to 90 days occurred in a significant percentage of patients and was associated with worse clinical outcomes. PDL ≤3 mm tended to regress over time.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos , Acidente Vascular Cerebral , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fibrilação Atrial/cirurgia , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Humanos , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Resultado do Tratamento
10.
Clin Transl Radiat Oncol ; 31: 71-79, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34646951

RESUMO

Cardiac radioablation with SBRT is a very promising non-invasive modality for the treatment of refractory VT and potentially other cardiac arrhythmias. Initial reports indicate that it is relatively safe and associated with excellent responses, particularly in reduction of ICD-related events, need for anti-arrhythmic medications, and resulting in significantly improved quality of life for patients. Establishment of objective criteria for candidates for cardiac radioablation will accelerate the adoption of this important radiation therapy modality in the treatment of refractory VT and other cardiac arrhythmias in the coming years. In addition, in order to develop more prospective safety and efficacy data, treatment of patients should ideally be performed in the context of clinical trials or prospective registries at, or in collaboration with, experienced centers. Taken together, the future of cardiac radioablation is rich and worthy of further investigation to become a standard treatment in the armamentarium against refractory VT.

11.
Expert Rev Cardiovasc Ther ; 19(10): 881-889, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34702128

RESUMO

INTRODUCTION: COVID-19 infection is associated with many different systemic complications. Among these, cardiovascular system complications are particularly important as these are associated with significant mortality. There are many different subgroups of cardiovascular complications, with Arrhythmias being one of them. Arrhythmias are especially important as there are a substantial percentage of patients who have arrhythmia after a COVID-19 infection, and these patients are seen with an increased mortality rate. The main interest of this review is understanding some of the specific post-COVID-19 arrhythmic complications and their predisposing factors. AREAS COVERED: This paper will highlight the findings of studies on cardiovascular system disease after COVID-19 infection, different specific arrhythmic complications of COVID-19, and changes in electrophysiologic interventions post-COVID-19 outbreak in different centers around the world. An extensive literature search was made to find pertinent articles. EXPERT OPINION: Studies show us that a significant percentage of COVID-19 patients have arrhythmia. Many distinct types of arrhythmias are associated with COVID-19 infection, and specific risk factors of these arrhythmias are important as this information can be used to detect and prioritize certain at-risk patients for early treatment, which can mean life or death in some cases.


Assuntos
COVID-19 , Doenças Cardiovasculares , Arritmias Cardíacas/epidemiologia , Arritmias Cardíacas/etiologia , Humanos , Fatores de Risco , SARS-CoV-2
12.
J Cardiovasc Electrophysiol ; 32(11): 3027-3034, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34554620

RESUMO

INTRODUCTION: Defibrillation testing (DT) is recommended during the subcutaneous defibrillator (S-ICD) placement. We sought to compare 10 J shock impedance in sinus rhythm (SR) with 65 J defibrillation impedance and evaluate device position on a postimplant chest X-ray (CXR) using an intermuscular (IM) technique. METHODS: Consecutive S-ICD implantations between 12/2019 and 12/2020 at The Ohio State University were reviewed. All implantations were performed using a two-incision IM technique. Standard DT with 65 J shock and 10 J shock in SR were performed unless contraindicated. The PRAETORIAN score was calculated based on CXR. RESULTS: A total of 37 patients (age: 47.2 ± 15.8 years old, male: n = 26 [70.3%], body mass index: 30.1 ± 6.7 kg/m2 ) underwent IM S-ICD implantation, and of those, 27 (73%) underwent both 65 J shock and 10 J shock in SR. The coefficient of determination (R2 ) between 10 J shock impedance and 65 J shock impedance was 0.84. The mean of an impedance difference was 1.6 ± 4.8 Ω (minimum - 11 and maximum 8). Postimplant CXR was available for 33 out of 37 patients (89.2%). The PRAETORIAN score was less than 90 in all patients and the mean score was 32.7 ± 8.8. CONCLUSION: We demonstrated that 10 J shock impedance in SR correlated well with 65 J defibrillation impedance during IM S-ICD implantation. An IM implantation technique provides excellent generator location on postimplant CXR. The IM technique combined with 10 J shock in SR may be sufficient to predict and ensure the defibrillation efficacy of the S-ICD.


Assuntos
Desfibriladores Implantáveis , Adulto , Arritmias Cardíacas , Cardioversão Elétrica , Impedância Elétrica , Humanos , Masculino , Pessoa de Meia-Idade , Ohio , Tela Subcutânea
13.
J Innov Card Rhythm Manag ; 12(6): 4562-4568, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-34234991

RESUMO

As leadless pacing (LP) use is expected to increase, it becomes increasingly essential that operators become familiar with the tools and techniques needed to retrieve an LP successfully. The purpose of this review is to describe a stepwise approach for the successful retrieval of tine-based LP devices, including ways to minimize complications.

14.
J Cardiovasc Electrophysiol ; 32(8): 2189-2198, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34164881

RESUMO

INTRODUCTION: The LARIAT epicardial suture snaring device has been fraught with technical challenges and procedural complications. Over time, technique modification and improved operator experience have helped overcome many of these challenges. METHODS AND RESULTS: Studies reporting left atrial appendage epicardial closure over a 12-year period from 2009 to 2020 were evaluated. The primary efficacy outcome evaluated was left atrial appendage closure with residual flow ≤1 mm. Safety outcomes evaluated were periprocedural and long term complications after device placement. Nine studies consisting of 1430 patients were included in this analysis, of which 1386 (97%) underwent successful device placement. The mean age was 69.3 years, with a mean CHADS2 -VASC score of 3.78. Primary efficacy end point was achieved in 95.8% patients immediately after device placement, and in 92.8% patients on long term follow-up. Early procedural complications consisted of pericardial effusion 5.6%, cardiac perforation 2.7%, pericarditis 2.6%, and need for open heart surgery 1.5%. Long term complications consisted of all-cause mortality 2.3%, stroke 1.5%, and left atrial appendage thrombus 2.3%. Reduced complications were noted using micropuncture needles (2.20% vs. 10.14%; p < .0001), a longer duration pericardial drainage, and use of anti-inflammatory medications (1.58% vs. 8.4%). Oral anticoagulation use decreased from 44.7% to 22.9% post device implantation, and to 8.5% on last clinical follow up. CONCLUSIONS: The LARIAT device is effective in epicardial closure of the left atrial appendage. Improvement in device techniques such as use of micropuncture needle, prophylactic colchicine, and maintenance of a pericardial drain have helped improve safety over time.


Assuntos
Apêndice Atrial , Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos , Acidente Vascular Cerebral , Idoso , Apêndice Atrial/diagnóstico por imagem , Apêndice Atrial/cirurgia , Fibrilação Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Cateterismo Cardíaco/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Humanos , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Suturas , Resultado do Tratamento
15.
Expert Rev Med Devices ; 18(7): 587-596, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34057872

RESUMO

Introduction: Subcutaneous cardiac rhythm monitors (SCRMs) provide continuous ambulatory electrocardiographic monitoring for surveillance of known and identification of infrequent arrhythmias. SCRMs have proven to be helpful for the evaluation of unexplained symptoms and correlation with intermittent cardiac arrhythmias. Successful functioning of SCRM is dependent on accurate detection and successful transmission of the data to the device clinic. As the use of SCRM is steadily increasing, the amount of data that requires timely adjudication requires substantial resources. Newer algorithms for accurate detection and modified workflow systems have been proposed by physicians and the manufacturers to circumvent the issue of data deluge.Areas covered: This paper provides an overview of the various aspects of ambulatory rhythm monitoring with SCRMs including indications, implantation techniques, programming strategies, troubleshooting for issue of false positive and intermittent connectivity and strategies to circumvent data deluge.Expert opinion: SCRM is an invaluable technology for prolonged rhythm monitoring. The clinical benefits from SCRM hinge on accurate arrhythmia detection, reliable transmission of the data and timely adjudication for possible intervention. Further improvement in SCRM technology is needed to minimize false-positive detection, improve connectivity to the central web-based server, and devise strategies to minimize data deluge.


Assuntos
Fibrilação Atrial , Eletrocardiografia Ambulatorial , Algoritmos , Humanos
17.
JACC Clin Electrophysiol ; 7(6): 745-754, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33516715

RESUMO

OBJECTIVES: This study reports resource use and economic implications of rhythm monitoring with subcutaneous cardiac rhythm monitors (SCRMs). BACKGROUND: SCRMs generate a substantial amount of data that requires timely adjudication for appropriate clinical care. Resource use for SCRM monitoring is not known. METHODS: The study included consecutive transmissions during 4 weeks from 1,811 SCRMs. Resource use was quantified by assessment of time commitment of device clinic personnel and electrophysiologists for data adjudication. Incidence and characteristics of false positive (FP) episodes were assessed. Impact of custom programming for arrhythmia detection on incidence of FP episodes and resource use was analyzed. RESULTS: A total of 1,457 transmissions (alerts = 462; full downloads = 995) were received during study period. Average device clinic personnel time for adjudication of 1 transmission was 15 ± 6 min. This totaled to 364 h spent (2.3 full-time staff) over the 4-week period, which translated into a salary cost of $12,000 U.S. dollars (USD). Average time spent by an electrophysiologist for 1 transmission was 1.5 ± 1 min and totaled to 37 h for 4 weeks, which translated into an estimated cost of $9,600 USD. Of 1,457 total transmissions, 512 (35%) represented multiple transmissions from the same patients, which resulted in no additional reimbursement. Incidence of FP episodes in the entire cohort was 50% and was variable in alert (60%) and full download (49%) (p = 0.04) transmissions. When SCRMs with manufacturer suggested nominal programming and institutional custom programming were compared, there was a reduction in FP episodes (55% vs. 16%; p = 0.01), which translated to a 34% reduction in resource use for data adjudication. CONCLUSIONS: SCRM data adjudication requires significant resources. Custom programming for SCRMs may overcome the data deluge.


Assuntos
Desfibriladores Implantáveis , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/epidemiologia , Humanos , Incidência , Monitorização Fisiológica
18.
J Cardiovasc Electrophysiol ; 32(2): 477-483, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33205561

RESUMO

INTRODUCTION: Frequent right AQ4ventricular pacing (≥40%) with a transvenous pacemaker (TVP) is associated with the risk of pacing-induced cardiomyopathy (PICM). Leadless pacemakers (LPs) have distinct physical and mechanical differences from TVP. The risk of PICM with LP is not known. To identify incidence, predictors, and long-term outcomes of PICM in LP and TVP patients. METHODS: The study comprised all pacemaker-dependent patients with LP or TVP who had left ventricular ejection fraction (LVEF) of ≥50 from 2014 to 2019. The incidence of PICM (≥10% LVEF drop) was assessed with an echocardiogram. Predictors for PICM were identified using multivariate analysis. Long-term outcomes after cardiac resynchronization (CRT) were assessed in both groups. RESULTS: A total of 131 patients with TVP and 67 with LP comprised the study. All patients in the TVP group and the majority in the LP group underwent atrioventricular node ablation. The mean follow-up duration in TVP and LP groups was 592 ± 549 and 817 ± 600 days, respectively. A total of 18 (13.7%) patients in TVP and 2 (3%) in LP developed PICM after a median duration of 254 (interquartile range: 470) days. The incidence of PICM was significantly higher with TVP compared with LP (p = .02). TVP as pacing modality was a positive (odds ratio [OR]: 1.07) while age was negative (OR: 0.94) predictor for PICM on multivariable analysis. Both patients in LP and all except two in the TVP group responded to CRT. CONCLUSION: Incidence of PICM is significantly lower with LP compared with TVP in pacemaker-dependent patients. Age and TVP as pacing modality were predictors for PICM.


Assuntos
Cardiomiopatias , Marca-Passo Artificial , Estimulação Cardíaca Artificial/efeitos adversos , Cardiomiopatias/diagnóstico por imagem , Cardiomiopatias/epidemiologia , Humanos , Incidência , Marca-Passo Artificial/efeitos adversos , Estudos Retrospectivos , Volume Sistólico , Função Ventricular Esquerda
20.
J Cardiovasc Electrophysiol ; 31(12): 3277-3285, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33058275

RESUMO

BACKGROUND: The leadless Micra transcatheter-pacing system (Micra-TPS) is implanted via a femoral approach using a 27-French introducer sheath. The Micra Transcutaneous Pacing Study excluded patients with inferior vena cava (IVC) filters. OBJECTIVE: To examine the feasibility and safety of Micra-TPS implantation through an IVC filter. METHODS: This multicenter retrospective study included patients with an IVC filter who underwent a Micra-TPS implantation. Data for clinical and IVC filter characteristics, preprocedure imaging, and procedural interventions were collected. The primary outcome was a successful leadless pacemaker (LP) implantation via a femoral approach in the presence of an IVC filter. Periprocedural and delayed clinical complications were also evaluated. RESULTS: Of the 1528 Micra-TPS implants attempted, 23 patients (1.5%) had IVC filters. The majority (69.6%) of IVC filters were permanent. Six (26.1%) patients underwent preprocedural imaging to assess for filter patency. One patient's filter was retrieved before LP implantation. The primary outcome was achieved in 21 of 22 patients (95.5%) with an existing IVC filter. An occluded IVC precluded LP implantation in one patient. Difficulty advancing the stiff guidewire or the 27-Fr sheath was encountered in five patients. These cases required repositioning of the wire (n = 2), gradual sheath upsizing (n = 2), or balloon dilation of the filter (n = 1). Postprocedure fluoroscopy revealed intact filters in all cases. During a median 6-month follow-up, there were no clinical complications related to the filter or the Micra-TPS. CONCLUSION: This multicenter experience demonstrates the feasibility and safety of Micra-TPS implantation via an IVC filter without acute procedural or delayed clinical complications.


Assuntos
Marca-Passo Artificial , Filtros de Veia Cava , Remoção de Dispositivo , Fluoroscopia , Humanos , Estudos Retrospectivos , Resultado do Tratamento , Filtros de Veia Cava/efeitos adversos , Veia Cava Inferior/diagnóstico por imagem , Veia Cava Inferior/cirurgia
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