RESUMEN
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.
Asunto(s)
Apéndice Atrial , Fibrilación Atrial , Cardiopatías , Accidente Cerebrovascular , Trombosis , Humanos , Estudios Retrospectivos , Cardioversión Eléctrica/efectos adversos , Apéndice Atrial/diagnóstico por imagen , Trombosis/diagnóstico por imagen , Trombosis/etiología , Trombosis/prevención & control , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/terapia , Ecocardiografía Transesofágica , Resultado del Tratamiento , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Cateterismo Cardíaco/efectos adversosRESUMEN
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.
Asunto(s)
Apéndice Atrial , Fibrilación Atrial , Trombosis , Humanos , Apéndice Atrial/diagnóstico por imagen , Apéndice Atrial/cirugía , Fibrilación Atrial/diagnóstico por imagen , Fibrilación Atrial/cirugía , Estudios Retrospectivos , Ecocardiografía Transesofágica/métodos , Imagen por Resonancia Magnética , Trombosis/diagnóstico por imagen , Cateterismo Cardíaco , Resultado del TratamientoRESUMEN
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.
Asunto(s)
Desfibriladores Implantables , Adulto , Arritmias Cardíacas , Cardioversión Eléctrica , Impedancia Eléctrica , Humanos , Masculino , Persona de Mediana Edad , Ohio , Tejido SubcutáneoRESUMEN
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.
Asunto(s)
Cardiomiopatías , Marcapaso Artificial , Estimulación Cardíaca Artificial/efectos adversos , Cardiomiopatías/diagnóstico por imagen , Cardiomiopatías/epidemiología , Humanos , Incidencia , Marcapaso Artificial/efectos adversos , Estudios Retrospectivos , Volumen Sistólico , Función Ventricular IzquierdaRESUMEN
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.
Asunto(s)
Marcapaso Artificial , Filtros de Vena Cava , Remoción de Dispositivos , Fluoroscopía , Humanos , Estudios Retrospectivos , Resultado del Tratamiento , Filtros de Vena Cava/efectos adversos , Vena Cava Inferior/diagnóstico por imagen , Vena Cava Inferior/cirugíaRESUMEN
BACKGROUND: Insertable cardiac monitors are utilized for the diagnosis of arrhythmias and traditionally have been inserted within hospitals. Recent code updates allow for reimbursement of office-based insertions; however, there is limited information regarding the resources and processes required to support in-office insertions. We sought to determine the safety and feasibility of in-office insertion of the BioMonitor 2 and better understand in-office procedures, including patient selection, pre-insertion protocols, resource availability, and staff support. METHODS: Patients meeting an indication for a rhythm monitor were prospectively enrolled into this single-arm, non-randomized trial. All patients underwent insertion in an office setting. Two follow-up visits at days 7 and 90 were required. Information on adverse events, device performance, office site preparations, and resource utilization were collected. RESULTS: Eighty-two patients were enrolled at six sites. Insertion was successful in all 77 patients with an attempt. Oral anticoagulation was stopped in 20.8% of patients and continued through insertion in 23.4%, while prophylactic antibiotics were infrequently utilized (37.7% of study participants). On average, the procedure required a surgeon plus two support staff and 35 min in an office room to complete the 8.4 min insertion procedure. The mean R-wave amplitude was 0.77 mV at insertion and 0.67 mV at 90-days with low noise burden (2.7%). There were no procedure related complications. Two adverse events were reported (event rate 2.7% [95% CI 0.3, 9.5%]). CONCLUSIONS: In-office insertion of the BioMonitor 2 is safe and feasible. Devices performed well with high R-wave amplitudes and low noise burden. These results further support shifting cardiac monitor insertions to office-based locations. TRIAL REGISTRATION: clinicaltrials.gov, NCT02756338. Registered 29 April 2016.
Asunto(s)
Procedimientos Quirúrgicos Ambulatorios , Arritmias Cardíacas/diagnóstico , Electrocardiografía Ambulatoria/instrumentación , Frecuencia Cardíaca , Telemetría/instrumentación , Adulto , Procedimientos Quirúrgicos Ambulatorios/efectos adversos , Arritmias Cardíacas/fisiopatología , Diseño de Equipo , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Tempo Operativo , Seguridad del Paciente , Valor Predictivo de las Pruebas , Vigilancia de Productos Comercializados , Estudios Prospectivos , Factores de Riesgo , Factores de Tiempo , Estados UnidosRESUMEN
BACKGROUND: An internal risk stratification algorithm was developed to decrease the risk of major adverse cardiac events (MACEs) during lead extractions (LEs). OBJECTIVE: To report upon the impact of a risk stratification algorithm (RISE [RIsk Stratification prior to lead Extraction] protocol) on outcomes of LEs in a high-volume center. METHODS: A retrospective review of a prospectively maintained LEs database was performed to identify features associated with MACEs. On the basis of the retrospective data, the RISE protocol differentiated LEs procedures into "High" and "Low" risk for occurrence of MACEs. High-risk LEs included dual-coil defibrillator lead (≥3 years), pacemaker and single-coil lead (≥5 years), and any StarFix coronary sinus lead. During the prospective evaluation of the RISE protocol, "High-risk" LEs were performed in an operating room (OR) or hybrid laboratory with the cardiac anesthesiologist, OR nursing team, perfusionist in the room, and a cardiac surgeon on the premises. "Low-risk" LEs were performed in the electrophysiology (EP) laboratory with anesthesia provided by EP nursing team. The preintervention (pre-RISE) and postintervention (post-RISE) group spanned 19 and 40 months and consisted of 449 (632 leads) and 751 patients (1055 leads), respectively. The primary outcome of MACEs in the two groups was compared. RESULTS: Protocol compliance was 100%. The primary outcome of MACEs occurred in 15 patients (3.34%) before and 12 (1.6%) after implementation of the RISE protocol (P = .04). CONCLUSION: RISE identified a low-risk group where minimal resources are needed and allowed for rapid intervention in the high-risk group that reduced the consequences of MACEs.
Asunto(s)
Protocolos Clínicos , Desfibriladores Implantables , Remoción de Dispositivos/efectos adversos , Marcapaso Artificial , Complicaciones Posoperatorias/prevención & control , Anciano , Anciano de 80 o más Años , Bases de Datos Factuales , Remoción de Dispositivos/mortalidad , Femenino , Hospitales de Alto Volumen , Humanos , Masculino , Persona de Mediana Edad , Ohio , Complicaciones Posoperatorias/mortalidad , Estudios Prospectivos , Diseño de Prótesis , Mejoramiento de la Calidad , Indicadores de Calidad de la Atención de Salud , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: The perioperative management of anticoagulation with the use of subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is still evolving. OBJECTIVE: The purpose of this study was to assess whether it is safe to perform S-ICD implantation with uninterrupted warfarin. METHODS: This is a multi-center retrospective review of patients undergoing S-ICD implantation between October 1, 2012 and June 30, 2017. Forty-eight patients underwent successful S-ICD implantation during the study period. The most common indication for implantation was primary prevention of sudden cardiac death. In 23 (47.9%) patients, warfarin was continued without any interruption. In 25 (52.1%) patients, warfarin was interrupted prior to implantation. The incidence of clinically significant lateral pocket hematoma was compared in the two groups. RESULTS: The mean international normalized ratio was 2.0 ± 0.4 in the uninterrupted group and 1.4 ± 0.4 for the interrupted group. A total of seven patients developed a hematoma at the lateral pocket. No patient developed a hematoma at the parasternal pockets. Six patients in the uninterrupted group (26.1%) and one patient in the interrupted group (0.04%) developed a significant lateral pocket hematoma (P = .04). The concomitant use of dual antiplatelet therapy did not increase the risk of hematoma. There was no significant difference between HASBLED and CHA2 DS2 VASc scores between the groups. None of the patients with a hematoma developed infection or required hematoma evacuation. CONCLUSIONS: The uninterrupted use of warfarin in the perioperative period of S-ICD implantation is associated with an increased risk of lateral pocket hematoma.
Asunto(s)
Anticoagulantes/administración & dosificación , Desfibriladores Implantables , Hematoma/epidemiología , Complicaciones Posoperatorias/epidemiología , Warfarina/administración & dosificación , Adulto , Anciano , Anticoagulantes/efectos adversos , Femenino , Hematoma/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/inducido químicamente , Estudios Retrospectivos , Medición de Riesgo , Warfarina/efectos adversosRESUMEN
BACKGROUND: Lead dislodgement (LD) is a well-recognized complication during implantation of cardiac implantable electronic devices (CIEDs). An intraprocedural protocol, referred to as reduction of LD protocol, was developed to reduce the risk of LD. METHODS: The protocol involved (1) inserting a straight stylet down the right atrial lead and applying forward pressure while monitoring for fluoroscopic stability, (2) visualizing all leads during deep inspiration to determine if there is adequate lead redundancy, and (3) having the patient take a deep breath and cough while pacing just at capture threshold to assess for loss of capture in each lead. Any intraprocedural change in the parameters fulfilling the predefined criteria for inadequate lead implantation prompted lead repositioning. Data regarding demographic factors, clinical characteristics, and incidence of LD in the first 30 days after implant was obtained from intramural CIED database. The preintervention (control) group spanned 27 months and consisted of a total of 4,294 leads while the postintervention (intervention) group spanned 17 months and consisted of 2,361 leads implanted. RESULTS: There was no significant difference in the demographic factors and clinical characteristics in the two groups. Protocol compliance was > 90%. There were 44 occurrences of LD (1.02%) before and 10 (0.4%) after implementation of the protocol. The protocol significantly reduced the incidence of LD during the 30 days after implant (P = 0.014). No clinical characteristic predicted the risk of LD. CONCLUSION: Intraprocedural maneuvers performed to assess the adequacy of lead implantation results in reduced risk of LD.
Asunto(s)
Dispositivos de Terapia de Resincronización Cardíaca , Electrodos Implantados , Falla de Equipo , Complicaciones Posoperatorias/prevención & control , Anciano , Electrocardiografía , Femenino , Fluoroscopía , Humanos , Masculino , Estudios Prospectivos , Estudios Retrospectivos , Factores de RiesgoRESUMEN
BACKGROUND: The Micra clinical trials have enrolled more than 2500 patients without any reported device-related infections that required removal during follow-up. Leadless pacemakers might be more resistant to bacterial seeding due to smaller surface area and a greater tendency for encapsulation. OBJECTIVE: To analyze the incidence and outcomes of serious infectious events (SIEs: bacteremia or endocarditis) that developed during follow-up in patients with history of Micra leadless pacemaker implantation. METHODS: SIE and outcomes were characterized based upon adverse event reports. Among 720 patients implanted with Micra in the investigational device exemption trial, we identified 16 patients who had documented 21 SIEs during follow-up. RESULTS: Among patients with SIEs, mean age was 71.9 ± 11.7 years. SIEs occurred at a mean 4.8 ± 4.5 months after implant and patients were followed for 13.1 ± 9.1 months after documentation of SIE. All events were adjudicated as unrelated to the Micra device or procedure. Bacteremia was documented to be related to a gram-positive organism in 13 events (seven Staphylococcus, three Streptococcus, two Enterococcus, and one uncharacterized gram-positive bacteria), and gram-negative organisms in three events. In five events, the type of organism was not characterized (two patients with endocarditis). No persistent cases of bacteremia after antibiotic cessation were seen over the duration of follow-up CONCLUSION: In this small series of Micra patients who developed SIEs postimplant, the occurrence of bacteremia and/or endocarditis did not appear to lead to persistent bacteremia off antibiotics; most events resolved with antibiotic treatment.
Asunto(s)
Bacteriemia/epidemiología , Endocarditis/epidemiología , Marcapaso Artificial/efectos adversos , Infecciones Relacionadas con Prótesis/epidemiología , Anciano , Anciano de 80 o más Años , Bacteriemia/etiología , Estudios de Cohortes , Endocarditis/etiología , Diseño de Equipo , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Infecciones Relacionadas con Prótesis/etiología , Resultado del TratamientoRESUMEN
BACKGROUND: The perioperative anesthesia care during subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation is still evolving. OBJECTIVE: To assess the feasibility and safety of S-ICD implantation with monitored anesthesia care (MAC) versus general anesthesia (GA) in a tertiary care center. METHODS: This is a single-center retrospective study of patients undergoing S-ICD implantation between October 2012 and May 2019. Patients were categorized into MAC and GA group based on the mode of anesthesia. Procedural success without escalation to GA was the primary endpoint of the study, whereas intraprocedural hemodynamics, need of pharmacological support for hypotension and bradycardia, length of the procedure, stay in the post-anesthesia care unit, and postoperative pain were assessed as secondary endpoints. RESULTS: The study comprises 287 patients with MAC in 111 and GA in 176 patients. Compared to MAC, patients in GA group were younger and had a higher body mass index. All patients had successful S-ICD implantation. Only one patient (0.9%) in the MAC group was converted to GA. Despite a similar baseline heart rate (HR) and mean arterial blood pressure (MAP) in both groups, patients with GA had significantly lower HR and MAP during the procedure and more frequently required pharmacological hemodynamic support. Length of the procedure, stay in the postanesthesia care unit, and postoperative pain was similar in both groups. CONCLUSION: This retrospective experience suggests that implantation of S-ICD is feasible and safe with MAC. Use of GA is associated with more frequent administration of hemodynamic drugs during S-ICD implantation.
Asunto(s)
Anestesia/métodos , Desfibriladores Implantables , Implantación de Prótesis/métodos , Anestesia General , Anestesia Local , Bradicardia/tratamiento farmacológico , Estudios de Factibilidad , Femenino , Hemodinámica , Humanos , Hipotensión/tratamiento farmacológico , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Tempo Operativo , Dimensión del Dolor , Dolor Postoperatorio/prevención & control , Estudios RetrospectivosRESUMEN
BACKGROUND: Cardiac implantable electronic device (CIED) infections associated with large, mobile vegetation adds to the complexity of lead extraction and is associated with significant patient morbidity and mortality. OBJECTIVE: To show the feasibility of concomitant cardiovascular implantable electronic device extraction and vacuum-assisted removal of lead-related vegetations. METHODS: This is a single-center retrospective case series of consecutive patients with persistent bacteremia, sepsis, or endocarditis despite medical therapy who have vegetations >2 cm and subsequently underwent immediate CIED lead extraction after debulking with vacuum-assisted suction. RESULTS: Eight patients underwent successful removal of 17 leads immediately after debulking of vegetations with vacuum-assisted device suction. Debulking procedure was not successful in 1 patient due to inability to direct the vacuum suction device into proper position. There were no intraprocedure complications related to the vacuum-assisted debulking. One patient required open sternotomy for tear of the coronary sinus ostium related to extraction of a left ventricular pacing electrode. There was no mortality within 30 days of the procedure. CONCLUSIONS: Based upon these clinical results, it is feasible for patients with infected CIED systems that have large right-sided vegetations to undergo vacuum-assisted debulking then immediately followed by percutaneous CIED removal in whom surgical removal is considered high risk.
Asunto(s)
Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/instrumentación , Procedimientos Quirúrgicos de Citorreducción/métodos , Remoción de Dispositivos/métodos , Implantación de Prótesis/efectos adversos , Implantación de Prótesis/instrumentación , Infecciones Relacionadas con Prótesis/terapia , Adulto , Anciano , Procedimientos Quirúrgicos de Citorreducción/efectos adversos , Remoción de Dispositivos/efectos adversos , Ecocardiografía Transesofágica , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Infecciones Relacionadas con Prótesis/diagnóstico , Infecciones Relacionadas con Prótesis/microbiología , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Succión , Resultado del Tratamiento , Vacio , Adulto JovenRESUMEN
BACKGROUND: A wearable cardioverter defibrillator (WCD) is an alternative for patients who are not immediate candidates for an implantable cardioverter defibrillator (ICD). METHODS: Retrospective analysis of 242 patients prescribed a WCD from January 2014 through March 2015 with 1-year follow-up. RESULTS: A WCD was prescribed to 242 patients during the 15-month period. Forty-one patients were excluded due to lack of complete follow-up. The remaining 201 patients received a WCD for primary or secondary prevention of SCD. Seventy-nine percent of WCDs were prescribed by nonelectrophysiologists. Underlying etiologies for the WCD prescription included: 38% nonischemic cardiomyopathy, 25% recent myocardial infarction, 16% newly diagnosed ischemic cardiomyopathy, 12% documented ventricular arrhythmia, 6% ICD lead extraction, and 3% had high risk conditions for sudden cardiac death. During 1-year follow-up, 96 patients (48%) received an ICD and five patients (2.5%) received appropriate shocks and one patient (0.5 %) received an inappropriate shock. Other 105 (52%) patients subsequently did not require an ICD due to either improvement in ejection fraction, refusal of ICD therapy, or death. CONCLUSIONS: About half of patients prescribed a WCD subsequently receive an ICD and the rate of appropriate shock therapy from the WCD is 2.5%.
Asunto(s)
Muerte Súbita Cardíaca/prevención & control , Desfibriladores , Cardioversión Eléctrica/instrumentación , Diseño de Equipo , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Prevención Primaria , Estudios Retrospectivos , Factores de Riesgo , Prevención Secundaria , Resultado del TratamientoRESUMEN
BACKGROUND: Atrioventricular junctional (AVJ) ablation and pacemaker implantation are indicated when pharmacotherapy fails to achieve adequate rate control in atrial fibrillation (AF). The purpose of our study is to assess the feasibility and safety of concurrent Micra leadless transcatheter pacemaker implantation and AVJ ablation. METHODS: We retrospectively assessed patients who underwent Micra implantation and concurrent AVJ ablation at three institutions between August 2014 and March 2016. All patients and devices were followed at baseline and at 1, 3, 6, and 12 months postimplantion. RESULTS: Twenty-one patients with permanent AF (median age 77 [range: 62-88], female 15 [71.4%]) underwent successful Micra implantation followed by concurrent AVJ ablation. There was no device dislodgement or malfunction during the 12-month follow-up. Complete 12-month electrical performance data were available in 14 patients (67%). Among patients with the complete data set, median pacing thresholds at implant and at 1, 3, 6, and 12 months were 0.5 V (range: 0.25-0.88), 0.44 V (range: 0.25-2.0), 0.5 V (range: 0.25-1.63), 0.5 V (range: 0.25-1.13), and 0.5 V (range: 0.25-1.13) at a pulse width of 0.24 msec, respectively. Two patients died due to noncardiac causes during follow-up. There were no patients with major device-related complications. CONCLUSIONS: Concurrent Micra implantation and AVJ ablation is feasible and appears safe. There was no device dislodgement, malfunction, or significant pacing threshold rise requiring device reimplantation during the 12-month follow-up. This combined approach can be considered for patients with AF with suboptimal rate control who have failed AF catheter ablation and/or pharmacotherapy.
Asunto(s)
Fibrilación Atrial/cirugía , Nodo Atrioventricular/cirugía , Ablación por Catéter/métodos , Marcapaso Artificial , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/fisiopatología , Nodo Atrioventricular/fisiopatología , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Cardiac resynchronization defibrillator (CRT-D) devices improve survival for New York Heart Association classes II-IV systolic heart failure patients with QRS > 120 ms and left ventricular ejection fraction < 35%. A limitation of 100% CRT pacing is excess battery depletion and pulse generator (PG) replacement compared to VVI or dual-chamber systems. Ampere hour (Ah) measures PG battery capacity and may predict CRT-D device longevity. METHODS: We performed a multicenter retrospective study of all CRT-D devices implanted at our centers from August 1, 2008 to December 31, 2010. Analysis was performed for survival to elective replacement indicator (ERI) between 1.0 Ah, 1.4 Ah, and 2.0 Ah devices, per manufacturers' specifications. RESULTS: One thousand three hundred and two patients were studied through December 31, 2014. Patients were followed for an average of 3.0 ± 1.3 years (794 1.0 Ah, 322 2.0 Ah, and 186 1.4 Ah devices under study). CRT-D generator ERI occurred in 13.5% of 1.0 Ah systems (107 out of 794), versus 3.8% in 1.4 Ah (seven out of 186), and 0.3% in 2.0 Ah devices (one out of 322) over mean follow-up of 3.0 years. Odds ratio (OR) for reaching ERI with 1.0 Ah device versus 1.4 Ah or 2.0 Ah was 9.73, P < 0.0001. Univariate predictors for ERI included 1.0 Ah device and LV pacing output >3V @ 1 ms (OR: 3.74, P < 0.001). LV impedance >1,000 ohms predicted improved device survival (OR: 0.38, P = 0.0025). CONCLUSIONS: CRT-D battery capacity measured by Ah is a strong predictor of survival to ERI for modern systems. Further study on cost and morbidity associated with early PG change in 1.0 Ah systems is warranted.
Asunto(s)
Dispositivos de Terapia de Resincronización Cardíaca/estadística & datos numéricos , Desfibriladores Implantables/estadística & datos numéricos , Remoción de Dispositivos/estadística & datos numéricos , Suministros de Energía Eléctrica/estadística & datos numéricos , Análisis de Falla de Equipo/métodos , Insuficiencia Cardíaca/prevención & control , Anciano , Remoción de Dispositivos/métodos , Transferencia de Energía , Falla de Equipo/estadística & datos numéricos , Femenino , Insuficiencia Cardíaca/epidemiología , Humanos , Masculino , Prevalencia , Estudios Retrospectivos , Estados Unidos/epidemiologíaAsunto(s)
Arritmias Cardíacas/terapia , COVID-19/prevención & control , Estimulación Cardíaca Artificial , Corazón Auxiliar , Marcapaso Artificial , Implantación de Prótesis/instrumentación , Tecnología de Sensores Remotos , Telemedicina , Anciano , Anciano de 80 o más Años , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/fisiopatología , COVID-19/transmisión , Ablación por Catéter , Control de Enfermedades Transmisibles , Femenino , Humanos , Masculino , Persona de Mediana Edad , Salud Laboral , Estudios Retrospectivos , Resultado del TratamientoAsunto(s)
Fascículo Atrioventricular Accesorio/cirugía , Potenciales de Acción , Ablación por Catéter , Frecuencia Cardíaca , Síndrome de QT Prolongado/cirugía , Fascículo Atrioventricular Accesorio/fisiopatología , Canal de Potasio ERG1/genética , Electrocardiografía , Técnicas Electrofisiológicas Cardíacas , Predisposición Genética a la Enfermedad , Humanos , Síndrome de QT Prolongado/diagnóstico , Síndrome de QT Prolongado/genética , Síndrome de QT Prolongado/fisiopatología , Masculino , Mutación , Fenotipo , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
Importance: Approximately 40% of patients with heart failure (HF) who are eligible for cardiac resynchronization therapy (CRT) either fail to respond or are untreatable due to anatomical constraints. Objective: To assess the safety and efficacy of a novel, leadless, left ventricular (LV) endocardial pacing system for patients at high risk for a CRT upgrade or whose coronary sinus (CS) lead placement/pacing with a conventional CRT system failed. Design, Setting, and Participants: The SOLVE-CRT study was a prospective multicenter trial, enrolling January 2018 through September 2022, with follow-up in March 2023. Data were analyzed from DATE MONTH, YEAR, through DATE MONTH, YEAR. The trial combined data from an initial randomized, double-blind study (n = 108) and a subsequent single-arm part (n = 75). It took place at 36 centers across Australia, Europe, and the US. Participants were nonresponders, previously untreatable (PU), or high-risk upgrades (HRU). All participants contributed to the safety analysis. The primary efficacy analysis (n = 100) included 75 PU-HRU patients from the single-arm part and 25 PU-HRU patients from the randomized treatment arm. Interventions: Patients were implanted with the WiSE CRT System (EBR Systems) consisting of a leadless LV endocardial pacing electrode stimulated with ultrasound energy delivered by a subcutaneously implanted transmitter and battery. Main Outcomes and Measures: The primary safety end point was freedom from type I complications. The primary efficacy end point was a reduction in mean LV end systolic volume (LVESV). Results: The study included 183 participants; mean age was 68.1 (SD, 10.3) years and 141 were male (77%). The trial was terminated at an interim analysis for meeting prespecified stopping criteria. In the safety population, patients were either New York Heart Association Class II (34.6%) or III (65.4%). The primary efficacy end point was met with a 16.4% (95% CI, -21.0% to -11.7%) reduction in mean LVESV (P = .003). The primary safety end point was met with an 80.9% rate of freedom from type I complications (P < .001), which included 12 study device system events (6.6%), 5 vascular events (2.7%), 3 strokes (1.6%), and 7 cardiac perforations which mostly occurred early in the study (3.8%). Conclusions and Relevance: The SOLVE-CRT study has demonstrated that leadless LV endocardial pacing with the WiSE CRT system is associated with a reduction in LVESV in patients with HF. This novel system may represent an alternative to conventional CRT implants in some HF patient populations. Trial Registration: ClinicalTrials.gov Identifier: NCT0292203.