RESUMEN
MR-guided focused ultrasound (MRgFUS) has proven its efficacy and safety for the treatment of essential tremor (ET) and/or Parkinson's disease (PD). However, having a cardiac pacemaker has been considered an exclusion criterion for the use of MRgFUS. Only 2 patients with a cardiac pacemaker treated with MRgFUS have been previously reported, both treated using 1.5-T MRI. In this paper, the authors present their experience performing 3-T MRgFUS thalamotomy in 4 patients with an implanted cardiac pacemaker. Treatments were uneventful regarding complications or severe side effects. MRgFUS using 3-T MRI was found to be an efficient and safe treatment for ET and/or PD in patients with an MRI-compatible pacemaker.
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Temblor Esencial , Imagen por Resonancia Magnética , Marcapaso Artificial , Tálamo , Humanos , Tálamo/cirugía , Tálamo/diagnóstico por imagen , Masculino , Anciano , Femenino , Temblor Esencial/cirugía , Temblor Esencial/diagnóstico por imagen , Imagen por Resonancia Magnética/métodos , Persona de Mediana Edad , Temblor/cirugía , Temblor/etiología , Temblor/diagnóstico por imagen , Enfermedad de Parkinson/cirugía , Enfermedad de Parkinson/diagnóstico por imagen , Enfermedad de Parkinson/complicaciones , Anciano de 80 o más Años , Ultrasonido Enfocado de Alta Intensidad de Ablación/métodosRESUMEN
BACKGROUND: Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear. METHODS AND RESULTS: This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6% per patient-year]; no anticoagulation: 6 out of 131 [2.3% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients). CONCLUSIONS: Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.
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Anticoagulantes , Fibrilación Atrial , Ataque Isquémico Transitorio , Accidente Cerebrovascular , Humanos , Fibrilación Atrial/tratamiento farmacológico , Fibrilación Atrial/complicaciones , Fibrilación Atrial/diagnóstico , Ataque Isquémico Transitorio/prevención & control , Ataque Isquémico Transitorio/etiología , Femenino , Anciano , Masculino , Anticoagulantes/administración & dosificación , Anticoagulantes/efectos adversos , Anticoagulantes/uso terapéutico , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/etiología , Método Doble Ciego , Administración Oral , Anciano de 80 o más Años , Resultado del Tratamiento , Hemorragia/inducido químicamente , Factores de Tiempo , Marcapaso ArtificialRESUMEN
To guarantee the safety of medical devices, including embedded systems, it is essential to consider both electronic components and the natural environment during validation and verification. In contrast to prior research, we present a hardware-in-the-loop environment that connects a real medical system to a biological model in real time for validation, including the modeling of the mechanical component of the heart valves in addition to the modeling of the electrical conduction and electrical stimulation of the heart chambers. Our model accounts for the dynamic adaptation of the temporal processes in the heart chambers to the pacing frequency of the individual chambers as a function of the action potential. This study investigates two additional risk factors affecting the heart under different conditions: pacemaker syndrome and electrical stimulation during the vulnerable phase. Both can be life-threatening to the patient if left untreated. In implementing our concept on a physical pacemaker connected to our software-based model of the heart, we discovered that the test pacemaker was unable to generate the required heart rate in three of the scenarios we tested. Additionally, our tests revealed occurrences of pacemaker syndrome and stimulation in the vulnerable phase.
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Modelos Cardiovasculares , Marcapaso Artificial , Humanos , Corazón/fisiología , Corazón/fisiopatologíaRESUMEN
BACKGROUND: Left Bundle Branch Area Pacing (LBBaP) is a cardiac pacing technique designed to mimic the natural conduction system of the heart. Traditional right ventricular apical pacing has been associated with increased risks of heart failure and atrial fibrillation. This study investigates the stability and safety of LBBaP using the Selectra 3D sheath (Biotronik) with an inclined angle for implanting the Solia S lead (Biotronik, SE & Co, KG). METHODS: A single-center retrospective study was conducted on 25 patients who underwent LBBaP implantation using the Selectra 3D sheath at our hospital. The procedure involved inserting the Solia S lead into the interventricular septum at an inclined angle. Surgical and postoperative data were collected, including the success rate, depth and angle of electrode insertion, complications, and follow-up data. RESULTS: The success rate of LBBaP implantation was 92%. The length of electrode insertion into the interventricular septum ranged from 12 to 23.0 mm, with an average of 18.1 ± 3.08 mm. The angle formed between the electrode and the septum ranged from 0° to 57.3°, with an average of 35.14°±14.31°. During the 3-month follow-up period, pacing parameters remained stable, and no complications were reported. CONCLUSIONS: LBBaP implantation using the Selectra 3D sheath with an inclined angle for the Solia S implantation demonstrates stability and safety. The procedure boasts a high success rate and offers an effective option for LBBaP implantation.
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Estimulación Cardíaca Artificial , Humanos , Estudios Retrospectivos , Masculino , Anciano , Femenino , Resultado del Tratamiento , Persona de Mediana Edad , Factores de Tiempo , Marcapaso Artificial , Anciano de 80 o más Años , Fascículo Atrioventricular/fisiopatología , Bloqueo de Rama/fisiopatología , Bloqueo de Rama/terapia , Bloqueo de Rama/diagnóstico , Frecuencia Cardíaca , Diseño de Equipo , Potenciales de AcciónRESUMEN
OBJECTIVE: This study aimed to identify the incidence, risk factors, and outcomes of permanent pacemaker (PPM) implantation after transcatheter aortic valve implantation (TAVI) procedures. METHODS: A retrospective analysis was conducted on 70 patients who underwent TAVI at the Department of Cardiology, Fujian Provincial Hospital, from January 2018 to March 2022. Based on whether a new PPM was implanted after TAVI, all patients were divided into two groups: NEW PPM and NO PPM. Baseline characteristics and clinical data were compared between the two groups. Univariate analysis was used to analyze different variables between the two groups. A binary logistic regression analysis was used to evaluate independent correlates for PPM implantation after TAVI. RESULTS: The mean age of the 70 patients was 73.1 ± 8.8 years. The incidence of PPM implantation was 17.1%. Patients with diabetes and chronic kidney disease were more likely to require PPM (50% vs. 20.7%, p = 0.042, 25% vs. 5.2%, p = 0.042). Our study did not identify any significant differences in the incidence of electrocardiographic conduction disturbances except for the previous right bundle branch block (RBBB) (NO PPM 6.9% vs. NEW PPM 33.3%, p < 0.05). We found that prosthesis size, implantation depth, procedural duration, and length of hospital and intensive care unit (ICU) stays were comparable between the two groups. The leading independent predictors of PPM implantation were previous RBBB (odds ratio 10.129, p = 0.034). CONCLUSION: The previous RBBB was the leading independent predictor of PPM implantation. New PPM was not associated with significantly new-onset left BBB, extended post-procedure hospitalization, ICU stay, or procedural duration.
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Estenosis de la Válvula Aórtica , Estimulación Cardíaca Artificial , Marcapaso Artificial , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Masculino , Femenino , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Estudios Retrospectivos , Factores de Riesgo , Anciano , Resultado del Tratamiento , Estimulación Cardíaca Artificial/efectos adversos , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/fisiopatología , Anciano de 80 o más Años , Factores de Tiempo , Medición de Riesgo , China/epidemiología , Incidencia , Válvula Aórtica/cirugía , Válvula Aórtica/fisiopatología , Válvula Aórtica/diagnóstico por imagen , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/terapia , Arritmias Cardíacas/fisiopatología , Arritmias Cardíacas/etiología , Arritmias Cardíacas/epidemiologíaRESUMEN
BACKGROUND: Knowledge about impact of age and comorbidities on outcome in patients with leadless pacemakers (LPM) is limited. OBJECTIVES: To analyse outcome in LPM patients according to age and comorbidities. METHODS: This Swiss, multi-centre, retrospective analysis includes all patients with LPM implanted between 2015 and 2022. Charlson-Comorbidity-Index (CCI) was determined and patients were divided into a low- (CCI ≤ 5) and high-comorbidity (CCI > 5) group. Peri-procedural complications, in-hospital death, and all-cause mortalities were assessed. Finally, all-cause mortality according to three groups (CCI ≤ 3, 4-5, >5) was compared to age and sex-adjusted mortality in the general Swiss population. RESULTS: 863 patients (median age 81 years, 65% male, 42% with CCI > 5) were included. Peri-procedural/long-term complication rates did not differ between the low- vs. high-comorbidity groups (2.6% vs. 1.7%, p = 0.48 and 1.2% vs. 2.8%, p = 0.12, respectively). In-hospital (3.6% vs. 0.6%, p = 0.002) and all-cause mortality (HR 2.9, 95%CI 2.2-3.8, p < 0.001) were significantly higher in the high-comorbidity group resulting in a three-year mortality of 58% (95%CI 51-65%) vs. 22% (95%CI 17-27%) in the low-comorbidity group. In patients with a CCI ≤ 3, all-cause mortality was comparable to the age- and sex-adjusted mortality of the general Swiss population. CONCLUSIONS: In elderly patients with high comorbidity, LPM implantation was not associated with increased peri-procedural/long-term complications. All-cause mortality in LPM patients with a CCI ≤ 3 was comparable to age- and sex-adjusted mortality in the general Swiss population. Despite a relatively high three-year mortality due to competing risk factors, LPM implantation is safe, even in elderly patients with high comorbidity. CONDENSED ABSTRACT: In this Swiss, multi-centre, retrospective cohort analysis, 863 patients implanted with a leadless pacemaker were included and divided into a high-comorbidity (with a CCI > 5) and low-comorbidity (with a CCI ≤ 5) group. There was no between group difference in terms of implantation outcomes and peri-operative or long-term complications. Furthermore, all-cause mortality during follow-up in patients with a CCI ≤ 3 was comparable to age- and sex-adjusted mortality in the general Swiss population. These data indicate that LPM implantation is a safe procedure, even in elderly patients with high comorbidity.
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Comorbilidad , Esperanza de Vida , Marcapaso Artificial , Humanos , Masculino , Femenino , Marcapaso Artificial/efectos adversos , Marcapaso Artificial/tendencias , Anciano de 80 o más Años , Estudios Retrospectivos , Anciano , Suiza/epidemiología , Esperanza de Vida/tendencias , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/mortalidad , Mortalidad Hospitalaria/tendenciasRESUMEN
BACKGROUND AND AIMS: Cardiac Implantable Electronic Device (CIED) infections pose significant mortality and morbidity despite optimal treatment. This survey aimed to understand whether and how the risk of CIED infection is assessed and mitigated in clinical practice in Europe, and to detect gaps with respect to EHRA recommendations. METHODS: An Expert Group of 8 European cardiologists with specific expertise across CIED therapy designed and distributed electronically a survey to a number of European Cardiologists. RESULTS: 302 physicians from 18 European countries responded to the survey. 288/302 (95%) physicians agreed that CIED-related infections represent a burden on healthcare resources and are associated with significant morbidity and mortality. 285/302 respondents (94%) primarily assess the risk of CIED infections by only evaluating the patient's clinical profile (137/302, 46%) or with the support of a risk score (148/302, 49%). Intravenous antibiotic prophylaxis is used by 282/302 (93%), followed by the implantation of the lowest number of leads possible (182/302, 60%), and by the use of an antibacterial envelope (173/302, 57%). 230/302 respondents (76%) declared that there is need for clear and concise guidelines and more sensitive risk-scores for CIED infection, to maximize the chances of preventative strategies. CONCLUSIONS: This survey demonstrates a high level of awareness about the multifaceted issue of CIED infection, however, it also highlights an incomplete penetration of scoring systems for risk stratification owing to their perceived limitations, and detects a strong commitment to increase the effectiveness of preventative strategies.
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Desfibriladores Implantables , Infecciones Relacionadas con Prótesis , Humanos , Europa (Continente)/epidemiología , Desfibriladores Implantables/efectos adversos , Infecciones Relacionadas con Prótesis/epidemiología , Infecciones Relacionadas con Prótesis/prevención & control , Encuestas y Cuestionarios , Marcapaso Artificial/efectos adversos , Cardiólogos , Médicos , Femenino , Masculino , Concienciación , Conocimientos, Actitudes y Práctica en Salud , Pautas de la Práctica en MedicinaRESUMEN
BACKGROUND: Medical device expenditures have increased in the 21st century, with cardiac devices comprising an outsized portion of the market. Meanwhile, the disproportionate share of FDA recalls of cardiac devices is often overshadowed. Using the FDA 510(k) premarket notification pathway and FDA recalls issued from 2000 to 2020, this project seeks to engage our understanding of innovation and recalls in the cardiac device space. METHODS: 510(k) premarket notification submission dates, outcomes, and recalls from 1/1/2000 to 12/31/2019 were obtained from publicly available FDA data as a function of cardiac device innovation. We compared the annual number of 510(k) premarket clearances and FDA recalls from 1/1/2000 to 12/31/2009 to 1/1/2010 to 12/31/2019. RESULTS: We found 343 moderate risk cardiac medical devices cleared for sale between the years 2000 and 2020. Comparing the last 10 years of the study period to the first, the yearly number of cleared devices decreased 39.7 %, from 21.4 to just 12.9 (p = 0.0019), defying positive trends in U.S. GDP and healthcare expenditures. Meanwhile, the number of FDA recalls issued for these devices increased 94.5 % from 7.3 to 14.2 recalls per year (p = 0.031). 215 device recalls were issued; 78 % Class II and 16 % Class I which constitute serious, potentially fatal recalls. CONCLUSIONS: While United States healthcare spending continues to trend upward, there was a distinct decrease in the number of new and updated cardiac devices entering the market between 2000 and 2020. Meanwhile, recalls of these devices have uncomfortably increased. Together, these trends suggest cardiac device innovation has become risk averse.
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Aprobación de Recursos , Recall de Suministro Médico , United States Food and Drug Administration , Estados Unidos , Humanos , Desfibriladores Implantables/tendencias , Invenciones/tendencias , Marcapaso Artificial/tendenciasRESUMEN
AIMS: Physiological activation of the heart using algorithms to minimize right ventricular pacing (RVPm) may be an effective strategy to reduce adverse events in patients requiring anti-bradycardia therapies. This systematic review and meta-analysis aimed to evaluate current evidence on clinical outcomes for patients treated with RVPm algorithms compared to dual-chamber pacing (DDD). METHODS AND RESULTS: We conducted a systematic search of the PubMed database. The predefined endpoints were the occurrence of persistent/permanent atrial fibrillation (PerAF), cardiovascular (CV) hospitalization, all-cause death, and adverse symptoms. We also aimed to explore the differential effects of algorithms in studies enrolling a high percentage of atrioventricular block (AVB) patients. Eight studies (7229 patients) were included in the analysis. Compared to DDD pacing, patients using RVPm algorithms showed a lower risk of PerAF [odds ratio (OR) 0.74, 95% confidence interval (CI) 0.57-0.97] and CV hospitalization (OR 0.77, 95% CI 0.61-0.97). No significant difference was found for all-cause death (OR 1.01, 95% CI 0.78-1.30) or adverse symptoms (OR 1.03, 95% CI 0.81-1.29). No significant interaction was found between the use of the RVPm strategy and studies enrolling a high percentage of AVB patients. The pooled mean RVP percentage for RVPm algorithms was 7.96% (95% CI 3.13-20.25), as compared with 45.11% (95% CI 26.64-76.38) of DDD pacing. CONCLUSION: Algorithms for RVPm may be effective in reducing the risk of PerAF and CV hospitalization in patients requiring anti-bradycardia therapies, without an increased risk of adverse symptoms. These results are also consistent for studies enrolling a high percentage of AVB patients.
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Algoritmos , Fibrilación Atrial , Estimulación Cardíaca Artificial , Anciano , Femenino , Humanos , Masculino , Fibrilación Atrial/terapia , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/mortalidad , Bloqueo Atrioventricular/diagnóstico , Bloqueo Atrioventricular/mortalidad , Bloqueo Atrioventricular/fisiopatología , Bloqueo Atrioventricular/terapia , Bradicardia/terapia , Bradicardia/prevención & control , Bradicardia/mortalidad , Bradicardia/diagnóstico , Estimulación Cardíaca Artificial/efectos adversos , Estimulación Cardíaca Artificial/métodos , Frecuencia Cardíaca , Ventrículos Cardíacos/fisiopatología , Hospitalización/estadística & datos numéricos , Marcapaso Artificial/efectos adversos , Factores de Riesgo , Resultado del Tratamiento , Función Ventricular DerechaRESUMEN
Background and Objectives: The number of cardiac pacemakers being used has increased in recent decades, and this increase has led to a rise in device-related complications, requiring percutaneous device extraction. Our aim was to present our single-center clinical experience in percutaneous lead extractions. Materials and Methods: We analyzed an observational retrospective cohort study of 93 patients for the transvenous removal of a total of 163 endocardial leads. We evaluated the device details, indications, lead characteristics, extraction methods, complications, reimplantation procedure, follow-up data, effectiveness, and safety. Results: Patients' mean age was 68.6 ± 11.6 years. Lead extraction indications were pocket infection in 33 (35.5%), lead dysfunction in 33 (35.5%), and system upgrade in 21 (23%) cases, and lead endocarditis in 6 (6%) cases. The duration from implantation to extraction time was a detected median of 43 (24-87) months. The most common retracted lead type was the RV defibrillator lead (62%), and the lead fixation type was active for one hundred (61%) patients. A new device was inserted in 74 (80%) patients, and the device type was most commonly a CRT-D (61%). Patients were followed up at a median of 17 (8-36) months, and 18 patients (19%) died at follow-up. Complete procedural success was obtained in 78 (84%) patients, and clinical procedural success was obtained in 83 (89%) patients. Procedural failure was detected in 15 (16%) patients. Major and minor complications were detected in 10 (11%) and 6 (6.5%) patients, respectively. The most common minor complication was pocket hematoma. Conclusions: Our experience suggests that transvenous lead extraction has a high success rate with an acceptable risk of procedural complications. The simple manual traction method has a high rate of procedural success, despite a high dwell time of the lead.
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Desfibriladores Implantables , Remoción de Dispositivos , Marcapaso Artificial , Humanos , Anciano , Masculino , Femenino , Estudios Retrospectivos , Marcapaso Artificial/efectos adversos , Remoción de Dispositivos/métodos , Remoción de Dispositivos/estadística & datos numéricos , Persona de Mediana Edad , Desfibriladores Implantables/efectos adversos , Desfibriladores Implantables/estadística & datos numéricos , Anciano de 80 o más Años , Resultado del Tratamiento , Estudios de CohortesRESUMEN
AIMS: The application of conduction system pacing (CSP) in clinical practice is growing, and the need for lead extraction will also increase. The data on outcomes and safety of CSP lead extraction are limited. The aim of this study was to assess procedural outcomes and safety of CSP lead removal. METHODS AND RESULTS: Forty-seven patients from the EXTRACT Registry with the indication for CSP lead removal were enrolled in the study conducted at the Department of Electrocardiology in Katowice, Poland. Extraction technique, outcomes, safety, and complication were evaluated. Forty-three (91.5%) leads were successfully removed, and 41 (87.2%) were removed with traction only. The dwelling time of 28 extracted leads was longer than 1 year, and the oldest extracted lead was implanted for 89 months. Seven (14.9%) leads were removed from the left bundle branch (LBB) area and 36 from the His bundle (HB). Transient complete atrioventricular block occurred during the procedure in two patients. In 27 out of 31 attempts (87.1%), new CSP leads were implanted: nine (33.3%) HB pacing leads and 18 (66.7%) LBB area pacing leads. CONCLUSION: The CSP lead extraction is safe and feasible with a low complication rate and high rate of CSP lead reimplantation.
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Fascículo Atrioventricular , Estimulación Cardíaca Artificial , Remoción de Dispositivos , Marcapaso Artificial , Sistema de Registros , Humanos , Masculino , Femenino , Fascículo Atrioventricular/fisiopatología , Fascículo Atrioventricular/cirugía , Anciano , Resultado del Tratamiento , Estimulación Cardíaca Artificial/métodos , Persona de Mediana Edad , Remoción de Dispositivos/métodos , Remoción de Dispositivos/efectos adversos , Polonia , Hospitales de Alto Volumen , Anciano de 80 o más Años , Factores de TiempoRESUMEN
BACKGROUND: Pocket hematoma is the most prevalent complication with cardiac implantable electronic devices (CIEDs), especially in patients who are undergoing oral anticoagulation and/or antiplatelet therapy. OBJECTIVE: To evaluate the efficacy of hypothermic compression bandaging versus conventional compression bandaging for the prevention of surgical wound hematoma of CIEDs in patients who are undergoing chronic anticoagulant drug use and/or antiplatelet therapy. METHODS: This was a single-center randomized prospective study. The intervention group received a hypothermic compression bandage, and the control group received a conventional compression bandage. The primary endpoint was the appearance of hematoma 10 days after the intervention. RESULTS: A total of 310 patients participated in the study. The mean age of the participants was 73.77 ± 10.68 years, and 74.8% were men. In the intervention group, 5.88% (n = 18) of patients developed ecchymosis, and 1.3% (n = 4) developed mild hematoma. In the control group, 5.88% (n = 18) of patients developed ecchymosis, and 2.9% (n = 9) developed mild hematoma. No patient in either group had a severe hematoma. No significant differences were observed between the two types of dressing in any of the three degrees of hematoma. CONCLUSIONS: This study demonstrated that compression bandaging with or without hypothermic therapy effectively prevents pocket hematoma of CIEDs in patients at high risk of bleeding.
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Vendajes de Compresión , Humanos , Masculino , Femenino , Anciano , Estudios Prospectivos , Persona de Mediana Edad , Hematoma/prevención & control , Hematoma/etiología , Anciano de 80 o más Años , Herida Quirúrgica/terapia , Herida Quirúrgica/complicaciones , Hipotermia Inducida/métodos , Hipotermia Inducida/instrumentación , Hipotermia Inducida/efectos adversos , Desfibriladores Implantables/efectos adversos , Marcapaso Artificial/efectos adversos , Resultado del TratamientoRESUMEN
INTRODUCTION: Pacemakers (PMs) are used to treat patients with severe bradycardia symptoms. They do, however, pose several complications. Even with these risks, there are only a few studies assessing PM implantation outcomes in resource-limited settings like Ethiopia and other sub-Saharan countries in general. Therefore, this study aims to assess the mid-term outcome of PM implantation in patients who have undergone PM implantation in the Cardiac Center of Ethiopia by identifying the rate and predictors of complications and death. METHODOLOGY: This retrospective study was conducted at the Cardiac Center of Ethiopia from October 2023 to January 2024 on patients who had PM implantation from September 2012 to August 2023 to assess the midterm outcome of the patients. Complication rate and all-cause mortality rate were the outcomes of our study. Multivariable logistic regression was used to identify factors associated with complications and death. To analyze survival times, a Kaplan-Meier analysis was performed. RESULTS: This retrospective follow-up study included 182 patients who underwent PM implantation between September 2012 and August 2023 and were at least 18 years old. The patients' median follow-up duration was 72 months (Interquartile range (IQR): 36-96 months). At the end of the study, 26.4% of patients experienced complications. The three most frequent complications were lead dislodgement, which affected 6.6% of patients, PM-induced tachycardia, which affected 5.5% of patients, and early battery depletion, which affected 5.5% of patients. Older age (Adjusted Odds Ratio (AOR) 1.1, 95% CI 1.04-1.1, p value < 0.001), being female (AOR 4.5, 95%CI 2-9.9, p value < 0.001), having dual chamber PM (AOR 2.95, 95%CI 1.14-7.6, p value = 0.006) were predictors of complications. Thirty-one (17%) patients died during the follow-up period. The survival rates of our patients at 3, 5, and 10 years were 94.4%, 92.1%, and 65.5% respectively with a median survival time of 11 years. Patients with a higher Charlson comorbidity index before PM implantation (AOR 1.2, 95% CI 1.1-1.8, p = 0.04), presence of complications (AOR 3.5, 95% CI 1.2-10.6, p < 0.03), and New York Heart Association (NYHA) class III or IV (AOR 3.3, 95% CI 1.05-10.1, p = 0.04) were associated with mortality. CONCLUSION: Many complications were experienced by patients who had PMs implanted, and several factors affected their prognosis. Thus, it is essential to identify predictors of both complications and mortality to prioritize and address the manageable factors associated with both mortality and complications.
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Estimulación Cardíaca Artificial , Marcapaso Artificial , Humanos , Estudios Retrospectivos , Femenino , Masculino , Etiopía/epidemiología , Persona de Mediana Edad , Anciano , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Estimulación Cardíaca Artificial/mortalidad , Estimulación Cardíaca Artificial/efectos adversos , Estudios de Seguimiento , Medición de Riesgo , Bradicardia/mortalidad , Bradicardia/terapia , Bradicardia/diagnóstico , Adulto , Anciano de 80 o más Años , Países en Desarrollo , Configuración de Recursos LimitadosRESUMEN
The impact of age (≥ 85 vs < 85 years) on clinical outcomes and pacemaker performance of conduction system pacing (CSP) compared to right ventricular pacing (RVP) were examined. Consecutive patients from a prospective, observational, multicenter study with pacemakers implanted for bradycardia were studied. The primary endpoint was a composite of heart failure (HF)-hospitalizations, pacing-induced cardiomyopathy requiring cardiac resynchronization therapy or all-cause mortality. Secondary endpoints were acutely successful CSP, absence of pacing-complications, optimal pacemaker performance defined as pacing thresholds < 2.5 V, R-wave amplitude ≥ 5 V and absence of complications, threshold stability (no increases of > 1 V) and persistence of His-Purkinje capture on follow-up. Among 984 patients (age 74.1 ± 11.2 years, 41% CSP, 16% ≥ 85 years), CSP was independently associated with reduced hazard of the primary endpoint compared to RVP, regardless of age-group (< 85 years: adjusted hazard ratio [AHR] 0.63, 95% confidence interval [CI] 0.40-0.98; ≥ 85 years: AHR 0.40, 95% CI 0.17-0.94). Among patients with CSP, age did not significantly impact the secondary endpoints of acute CSP success (86% vs 88%), pacing complications (19% vs 11%), optimal pacemaker performance (64% vs 69%), threshold stability (96% vs 96%) and persistent His-Purkinje capture (86% vs 91%) on follow-up (all p > 0.05). CSP improves clinical outcomes in all age-groups, without compromising procedural safety or pacemaker performance in the very elderly.
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Bradicardia , Humanos , Anciano de 80 o más Años , Anciano , Masculino , Femenino , Bradicardia/terapia , Estudios Prospectivos , Resultado del Tratamiento , Estudios de Factibilidad , Estimulación Cardíaca Artificial/métodos , Estimulación Cardíaca Artificial/efectos adversos , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/fisiopatología , Marcapaso Artificial , Terapia de Resincronización Cardíaca/métodos , Terapia de Resincronización Cardíaca/efectos adversosRESUMEN
AIM: This study aimed to assess the feasibility and effectiveness of the pectoral nerves (PECS) II block in facilitating cardiac implantable electronic device (CIED) insertion in a sample of 120 patients, with a focus on the percentage of cases completed without additional intraoperative local anesthesia. METHODS: PECS II blocks were performed on the left side using ultrasound guidance in all 120 patients. Feasibility was assessed by the proportion of cases completed without the need for extra intraoperative local anesthetic. Secondary outcomes included the amount of additional local anesthetic used, intraoperative opioid requirements, postoperative pain scores, time to first postoperative analgesia, analgesic consumption, patient satisfaction, and block-related complications. RESULTS: Of the 120 patients, 78 (65%) required additional intraoperative local anesthetic, with a median volume of 8.2 mL (range 3-13 mL). Fifteen patients (12.5%) needed intraoperative opioid supplementation. Nine patients (7.5%) required postoperative tramadol for pain relief. In total, 98 patients (81.7%) reported high satisfaction levels with the procedure. CONCLUSIONS: The PECS II block, when combined with supplementary local anesthetic, provided effective postoperative analgesia for at least 24 h in 120 patients undergoing CIED insertion. While it did not completely replace surgical anesthesia in most cases, the PECS II block significantly contributed to a smoother intraoperative experience for patients.
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Desfibriladores Implantables , Bloqueo Nervioso , Nervios Torácicos , Humanos , Masculino , Femenino , Anciano , Bloqueo Nervioso/métodos , Persona de Mediana Edad , Dolor Postoperatorio/tratamiento farmacológico , Marcapaso Artificial , Estudios de Factibilidad , Resultado del Tratamiento , Anestésicos Locales/administración & dosificación , Anestésicos Locales/uso terapéutico , Satisfacción del Paciente/estadística & datos numéricos , Ultrasonografía Intervencional/métodos , Anciano de 80 o más AñosRESUMEN
AIMS: Leadless pacemaker therapy was introduced to overcome lead- and pocket-related complications in conventional transvenous pacemaker systems. Implantation via the femoral vein, however, may not always be feasible. The aim of this study was to evaluate leadless pacemaker implantation using a jugular vein approach and compare it to the standard implantation via the femoral vein. METHODS AND RESULTS: The records of the first consecutive 100 patients undergoing Micra™ leadless pacemaker implantation via the right internal jugular vein from two centres were included in this study. Peri-procedural safety and efficacy of the jugular approach were compared to the first 100 patients using a femoral implantation approach at the University Hospital Zurich. One hundred patients underwent successful implantation of a leadless pacemaker via the internal jugular vein (mean age, 81.18 ± 8.29, 60% males). Mean procedure time was 35.63 ± 10.29 min with a mean fluoroscopy time of 4.66 ± 5.16 min. The device was positioned at the inferior septum in 25 patients, at the high septum in 24 patients, and mid-septum in 51 patients. The mean pacing threshold was 0.56 ± 0.35 V at 0.24 ms pulse width with a sensed amplitude of 10.0 ± 4.4 mV. At follow-up, electrical parameters remained stable in all patients. Compared with femoral implantation, patients undergoing the jugular approach were of similar age and had similar comorbidities. Mean procedure (48.9 ± 21.0 min) and fluoroscopy times (7.7 ± 7.8 min, both P < 0.01) were shorter compared to the femoral approach. Electrical parameters were similar between the two approaches. There were only two complications during jugular veinous implantations (1 pericardial effusion and 1 dislocation), compared to 16 complications using the femoral approach (1 pericardial effusion, 2 femoral artery injuries, and 13 major groin haematomas). CONCLUSION: The jugular approach may represent a safe and efficient alternative to femoral implantation of the Micra leadless pacemaker.
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Estimulación Cardíaca Artificial , Vena Femoral , Venas Yugulares , Marcapaso Artificial , Humanos , Masculino , Femenino , Anciano de 80 o más Años , Anciano , Estimulación Cardíaca Artificial/métodos , Resultado del Tratamiento , Implantación de Prótesis/métodos , Diseño de Equipo , Estudios Retrospectivos , Arritmias Cardíacas/terapia , Arritmias Cardíacas/fisiopatología , Factores de TiempoRESUMEN
BACKGROUND: A dual-chamber leadless pacemaker system has been designed for atrioventricular synchronous pacing using wireless, beat-to-beat, implant-to-implant (i2i) communication between distinct atrial and ventricular leadless pacemakers. The atrioventricular synchrony achieved across various ambulatory scenarios has yet to be systematically evaluated. METHODS: A prospective, single-arm, unblinded, multicenter, international clinical trial of the leadless pacemaker system was conducted in patients with a conventional dual-chamber pacing indication enrolled from February 2022 to March 2023. Leadless pacemaker systems were implanted, and 12-lead Holter electrocardiographic recordings were collected 3 months after implantation over various postures/activities: sitting, supine, left lateral recumbent, right lateral recumbent, standing, normal walk, and fast walk. An independent Holter core laboratory performed a manual adjudication of the percent of atrioventricular synchronous beats using the standard 300-millisecond PR interval limit. Atrium-to-ventricle and ventricle-to-atrium i2i communication success rates were also assessed. Post hoc summary statistics describing the relationships between atrioventricular synchrony and i2i success, posture/activity, implantation indication, atrioventricular event, and heart rate were calculated. RESULTS: In the evaluable population (n=384 of 464 enrolled [83%]; 61% male; age, 70 years; weight, 82 kg; 60% ejection fraction; 95% of beats evaluable), the mean atrioventricular synchrony of 98% of beats observed across all postures using the standard 300-millisecond limit was greater than both atrial-to-ventricular i2i (94%) and ventricular-to-atrial i2i (94%; P<0.001), exceeding both i2i values in 95% of patients. Atrioventricular synchrony was achieved in >95% of evaluable beats across all postures/activities, implantation indications, atrioventricular paced/sensed event combinations, and heart rate ranges (including >100 bpm). CONCLUSIONS: This dual-chamber leadless pacemaker system demonstrated atrioventricular synchrony in 98% of evaluable beats at 3 months after implantation. Atrioventricular synchrony was maintained across postures/activities and remained robust for heart rates >100 bpm.
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Marcapaso Artificial , Humanos , Masculino , Femenino , Anciano , Estudios Prospectivos , Anciano de 80 o más Años , Frecuencia Cardíaca , Electrocardiografía Ambulatoria , Persona de Mediana Edad , Estimulación Cardíaca Artificial/métodosRESUMEN
BACKGROUND: Evidence is limited regarding the effectiveness of leadless pacemaker implantation for conduction disturbance following transcatheter aortic valve replacement (TAVR). OBJECTIVES: This study sought to examine the national trends in the use of leadless pacemaker implantation following TAVR and compare its performance with transvenous pacemakers. METHODS: Medicare fee-for-service beneficiaries aged ≥65 years who underwent leadless or transvenous pacemakers following TAVR between 2017 and 2020 were included. Outcomes included in-hospital overall complications as well as midterm (up to 2 years) all-cause death, heart failure hospitalization, infective endocarditis, and device-related complications. Propensity score overlap weighting analysis was used. RESULTS: A total of 10,338 patients (730 leadless vs 9,608 transvenous) were included. Between 2017 and 2020, there was a 3.5-fold increase in the proportion of leadless pacemakers implanted following TAVR. Leadless pacemaker recipients had more comorbidities, including atrial fibrillation and end-stage renal disease. After adjusting for potential confounders, patients with leadless pacemakers experienced a lower rate of in-hospital overall complications compared with patients who received transvenous pacemakers (7.2% vs 10.1%; P = 0.014). In the midterm, we found no significant differences in all-cause death (adjusted HR: 1.13; 95% CI: 0.96-1.32; P = 0.15), heart failure hospitalization (subdistribution HR: 0.89; 95% CI: 0.74-1.08; P = 0.24), or infective endocarditis (subdistribution HR: 0.98; 95% CI: 0.44-2.17; P = 0.95) between the 2 groups, but leadless pacemakers were associated with a lower risk of device-related complications (subdistribution HR: 0.37; 95% CI: 0.21-0.64; P < 0.001). CONCLUSIONS: Leadless pacemakers are increasingly being used for conduction disturbance following TAVR and were associated with a lower rate of in-hospital complications and midterm device-related complications compared to transvenous pacemakers without a difference in midterm mortality.