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1.
Europace ; 23(3): 456-463, 2021 03 08.
Artigo em Inglês | MEDLINE | ID: mdl-33595062

RESUMO

AIMS: During the COVID-19 pandemic, concern regarding its effect on the management of non-communicable diseases has been raised. However, there are no data on the impact on cardiac implantable electronic devices (CIED) implantation rates. We aimed to determine the impact of SARS-CoV2 on the monthly incidence rates and type of pacemaker (PM) and implantable cardiac defibrillator (ICD) implantations in Catalonia before and after the declaration of the state of alarm in Spain on 14 March 2020. METHODS AND RESULTS: Data on new CIED implantations for 2017-20 were prospectively collected by nine hospitals in Catalonia. A mixed model with random intercepts corrected for time was used to estimate the change in monthly CIED implantations. Compared to the pre-COVID-19 period, an absolute decrease of 56.5% was observed (54.7% in PM and 63.7% in ICD) in CIED implantation rates. Total CIED implantations for 2017-19 and January and February 2020 was 250/month (>195 PM and >55 ICD), decreasing to 207 (161 PM and 46 ICD) in March and 131 (108 PM and 23 ICD) in April 2020. In April 2020, there was a significant fall of 185.25 CIED implantations compared to 2018 [95% confidence interval (CI) 129.6-240.9; P < 0.001] and of 188 CIED compared to 2019 (95% CI 132.3-243.7; P < 0.001). No significant differences in the type of PM or ICD were observed, nor in the indication for primary or secondary prevention. CONCLUSIONS: During the first wave of the COVID-19 pandemic, a substantial decrease in CIED implantations was observed in Catalonia. Our findings call for measures to avoid long-term social impact.


Assuntos
Desfibriladores Implantáveis/tendências , Marca-Passo Artificial/tendências , Padrões de Prática Médica/tendências , Implantação de Prótese/tendências , Humanos , Segurança do Paciente , Estudos Prospectivos , Implantação de Prótese/instrumentação , Espanha , Fatores de Tempo
4.
J Cardiovasc Med (Hagerstown) ; 21(4): 305-314, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32073430

RESUMO

AIMS: The aim of this study was to evaluate the use of remote monitoring in Italian clinical practice and its trend over the last 5 years. METHODS: In 2012 and 2017, two surveys were conducted. Both were open to all Italian implanting centres and consisted of 25 questions on the characteristics of the centre, their actual use of remote monitoring, applied organizational models and administrative and legal aspects. RESULTS: The questionnaires were completed by 132 and 108 centres in 2012 and 2017, respectively (30.6 and 24.7% of all Italian implanting centres). In 2017, significantly fewer centres followed up fewer than 200 patients by remote monitoring than in 2012, while more followed up more than 500 patients (all P < 0.005). In most of the centres (77.6%) that responded to both surveys, the number of patients remotely monitored significantly increased from 2012 to 2017.In both surveys, remote monitoring was usually managed by physicians and nurses. Over the period, primary review of transmissions by physicians declined, while it was increasingly performed by nurses; the involvement of technicians rose, while that of manufacturers' technical personnel decreased. The percentage of centres in which transmissions were submitted to the physician only in critical cases rose (from 28.3 to 64.3%; P < 0.001). In 86.7% of centres, the lack of a reimbursement system was deemed the main barrier to implementing remote monitoring. CONCLUSION: In the last 5 years, the number of patients followed up by remote monitoring has increased markedly. In most Italian centres, remote monitoring has increasingly been managed through a primary nursing model. The lack of a specific reimbursement system is perceived as the main barrier to implementing remote monitoring .


Assuntos
Desfibriladores Implantáveis/tendências , Marca-Passo Artificial/tendências , Padrões de Prática em Enfermagem/tendências , Padrões de Prática Médica/tendências , Tecnologia de Sensoriamento Remoto/tendências , Telemedicina/tendências , Dispositivos de Terapia de Ressincronização Cardíaca/tendências , Pesquisas sobre Serviços de Saúde , Humanos , Consentimento Livre e Esclarecido , Reembolso de Seguro de Saúde/tendências , Itália , Padrões de Prática em Enfermagem/economia , Padrões de Prática Médica/economia , Falha de Prótese , Tecnologia de Sensoriamento Remoto/economia , Tecnologia de Sensoriamento Remoto/instrumentação , Telemedicina/instrumentação , Fatores de Tempo
6.
Int J Cardiol ; 300: 154-160, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-31402163

RESUMO

BACKGROUND: While major complications associated with CIED lead extractions are uncommon, they carry a significant risk of morbidity and mortality in the absence of surgical intervention. However, there is limited data on the differences in outcomes of these procedures between centers with and without on-site CS support. The present study examined outcomes of transvenous cardiac implantable electronic device (CIED) lead extractions according to admitting hospitals' cardiac surgery (CS) facilities. METHODS: We analyzed the National Inpatient Sample for CIED lead extraction procedures, stratified by hospitals' CS facilities into two groups; on-site and off-site CS. Logistic regression analyses were performed to estimate the adjusted odds (aOR) of procedure-related complications in off-site CS centers. RESULTS: In 221,606 procedures over an 11-year-period, CIED lead extractions were increasingly undertaken in on-site as opposed to off-site CS centers (Onsite CS 2004 vs. 2014: 78.2% vs. 90.4%, p < 0.001) during the study period. In comparison to on-site CS group, patients admitted to off-site CS group were older, less comorbid, and experienced lower adjusted odds of major adverse cardiovascular events (0.72 [0.67, 0.77]), mortality (0.60 [0.52, 0.69]), procedure-related bleeding (0.48 [0.44, 0.54]) and complications (thoracic: 0.81 [0.75, 0.88]; cardiac: 0.45 [0.38, 0.54]) (p < 0.001 for all). CONCLUSIONS: Our national analysis demonstrates that transvenous CIED lead extractions are being increasingly undertaken in centers with on-site CS surgery, in compliance with international guideline recommendations. Patients managed with lead extractions in on-site CS centers are more comorbid and critically ill compared to those admitted to off-site CS centers, and remain at a higher risk of procedure-related complications.


Assuntos
Procedimentos Cirúrgicos Cardíacos/tendências , Serviço Hospitalar de Cardiologia/tendências , Desfibriladores Implantáveis/tendências , Remoção de Dispositivo/tendências , Eletrodos Implantados/tendências , Marca-Passo Artificial/tendências , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Bases de Dados Factuais/tendências , Desfibriladores Implantáveis/efeitos adversos , Eletrodos Implantados/efeitos adversos , Feminino , Hospitalização/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Marca-Passo Artificial/efeitos adversos , Fatores de Risco , Resultado do Tratamento , Estados Unidos/epidemiologia
7.
Circulation ; 140(25): e944-e963, 2019 12 17.
Artigo em Inglês | MEDLINE | ID: mdl-31694402

RESUMO

The widespread use of cardiac implantable electronic devices and wearable monitors has led to the detection of subclinical atrial fibrillation in a substantial proportion of patients. There is evidence that these asymptomatic arrhythmias are associated with increased risk of stroke. Thus, detection of subclinical atrial fibrillation may offer an opportunity to reduce stroke risk by initiating anticoagulation. However, it is unknown whether long-term anticoagulation is warranted and in what populations. This scientific statement explores the existing data on the prevalence, clinical significance, and management of subclinical atrial fibrillation and identifies current gaps in knowledge and areas of controversy and consensus.


Assuntos
American Heart Association , Fibrilação Atrial/diagnóstico , Desfibriladores Implantáveis/normas , Conhecimentos, Atitudes e Prática em Saúde , Marca-Passo Artificial/normas , Dispositivos Eletrônicos Vestíveis/normas , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/terapia , Desfibriladores Implantáveis/tendências , Humanos , Marca-Passo Artificial/tendências , Fatores de Risco , Estados Unidos/epidemiologia , Dispositivos Eletrônicos Vestíveis/tendências
8.
Eur Heart J ; 40(44): 3641-3648, 2019 11 21.
Artigo em Inglês | MEDLINE | ID: mdl-31504437

RESUMO

AIMS: The objective of the current study is to investigate the risk of heart failure (HF) after implantation of a pacemaker (PM) with a right ventricular pacing (RVP) lead in comparison to a matched cohort without a PM and factors associated with this risk. METHODS AND RESULTS: All patients without a known history of HF who had a PM implanted with an RVP lead between 2000 and 2014 (n = 27 704) were identified using Danish nationwide registries. An age- and gender-matched control cohort (matched 1:5, n = 138 520) without PM and HF was identified to compare the risk. Outcome was the cumulative incidence of HF including fatal HF within the first 2 years of PM implantation, with all-cause mortality and myocardial infarction (MI) as competing risks. Due to violation of proportional hazards, the follow-up period was divided into three time-intervals: <30 days, 30-180 days, and >180 days-2 years. The cumulative incidence of HF including fatal HF was observed in 2937 (10.6%) PM patients. Risks for the three time-intervals were <30 days [hazard ratio (HR) 5.98, 95% CI 5.19-6.90], 30-180 days (HR 1.84, 95% CI 1.71-1.98), and >180 days (HR 1.11, 95% CI 1.04-1.17). Among patients with a PM device, factors associated with increased risk of HF were male sex (HR 1.33, 95% CI 1.24-1.43), presence of chronic kidney disease (CKD) (HR 1.64, 95% CI 1.29-2.09), and prior MI (1.77, 95% 1.50-2.09). CONCLUSIONS: Pacemaker with an RVP lead is strongly associated with risk of HF specifically within the first 6 months. Patients with antecedent history of MI and CKD had substantially increased risk.


Assuntos
Estimulação Cardíaca Artificial/métodos , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/terapia , Ventrículos do Coração/fisiopatologia , Marca-Passo Artificial/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Estudos de Casos e Controles , Dinamarca/epidemiologia , Feminino , Seguimentos , Insuficiência Cardíaca/mortalidade , Insuficiência Cardíaca/fisiopatologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/epidemiologia , Marca-Passo Artificial/tendências , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/epidemiologia , Medição de Risco
9.
PLoS One ; 14(8): e0219533, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31393871

RESUMO

BACKGROUND: Antitachycardia pacing (ATP) is an effective treatment for ventricular tachycardia (VT). We evaluated the efficacy of different ATP programs based on a large remote monitoring data set from patients with implantable cardioverter-defibrillators (ICDs). METHODS: A dataset from 18,679 ICD patients was used to evaluate the first delivered ATP treatment. We considered all device programs that were used for at least 50 patients, leaving us with 7 different programs and a total of 32,045 episodes. We used the two-proportions z-test (α = 0.01) to compare the probability of success and the probability for acceleration in each group with the corresponding values of the default setting. RESULTS: Overall, the first ATP treatment terminated in 78.4%-97.5% of episodes with slow VT and 81.5%-91.1% of episodes with fast VT. The default setting of the ATP programs with the number of sequences S = 3 was applied to treat 30.1% of the slow and 36.6% of the fast episodes. Reducing the maximum number of sequences to S = 2 decreased the success rate for slow VT (P < 0.0001, h = 0.38), while the setting S = 4 resulted in the highest success rate of 97.5% (P < 0.0001, h = 0.27). CONCLUSION: While the default programs performed well, we found that increasing the number of sequences from 3 to 4 was a promising option to improve the overall ATP performance.


Assuntos
Estimulação Cardíaca Artificial/métodos , Taquicardia Ventricular/terapia , Desfibriladores Implantáveis/tendências , Cardioversão Elétrica/métodos , Eletrocardiografia , Humanos , Marca-Passo Artificial/tendências , Taquicardia Ventricular/fisiopatologia , Resultado do Tratamento
10.
BMC Cardiovasc Disord ; 19(1): 197, 2019 08 14.
Artigo em Inglês | MEDLINE | ID: mdl-31412773

RESUMO

BACKGROUND: Cardiac pacing is a growing activity in Sub-Saharan Africa. There is little data on the characteristics of this interventional treatment in our regions. The goal was to evaluate the results of cardiac pacing in a referral service in sub-Saharan Africa. METHODS: We carried out a twelve-year retrospective study (from January 1st, 2004 to December 31st, 2015) in the Cardiology Department of Aristide Le Dantec University Hospital. This work included all patients who received definitive cardiac pacing during the study period and followed up in the service. RESULTS: In total we included 606 patients. There was a growing trend in activity with a peak in 2015 (17%). The average age was 70.6 ± 12.03 years. Some patients (15.4%) came from the subregion. The patients were mostly of medium socio-economic level (53%); 14% were of low socio-economic level. Patients were symptomatic in 85% of cases (37.4% syncope). The indications were dominated by complete atrioventricular block (81.5%); sinus dysfunction accounted for 1.9% of them. A temporary pacemaker was used in 60% of cases for an average duration of 5.1 ± 6.3 days. Antibiotics, local anesthesia and analgesics were used in all cases. Implanted pacemakers were single chamber in 56% of cases and double chamber in 44% of cases. In 39 patients (6.4%), the pacemaker was a « re-used ¼ one. The atrial leads were most often placed in a lateral position (94.5%). The ventricular ones were predominantly tined (95.7%) and more often located at the apical level. Complications were noted in 24 patients (3.9%), dominated by devices externalizations and infections, which together accounted for 2.7% of cases. The number of people in the cathlab was significantly higher and the duration of the temporary pacemaker was longer for patients who had a complication. There was no significant difference depending on the type of pacemaker used (new or reused). Seven (7) in hospital death cases were reported. CONCLUSION: Cardiac pacing is a growing activity in Dakar.


Assuntos
Arritmias Cardíacas/terapia , Estimulação Cardíaca Artificial/tendências , Serviço Hospitalar de Cardiologia/tendências , Hospitais de Ensino/tendências , Padrões de Prática Médica/tendências , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/mortalidade , Arritmias Cardíacas/fisiopatologia , Estimulação Cardíaca Artificial/efeitos adversos , Estimulação Cardíaca Artificial/mortalidade , Feminino , Mortalidade Hospitalar/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Marca-Passo Artificial/tendências , Encaminhamento e Consulta/tendências , Estudos Retrospectivos , Fatores de Risco , Senegal , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
11.
Zhongguo Yi Liao Qi Xie Za Zhi ; 43(4): 235-237, 2019 Jul 30.
Artigo em Chinês | MEDLINE | ID: mdl-31460710

RESUMO

In order to improve the accuracy of the pacemaker's parameter adjustment and to avoid the surgical replacement of the pacemaker when the battery is exhausted, this paper designs a novel single-chamber pacemaker circuit based on low-power single-chip microcomputer. The circuit uses digital control to accurately control the amplitude, pulse width and frequency of the pacing pulse. The circuit is also designed with wireless charging function, and wireless communication with the programmer can wirelessly charge the pacemaker and know the charging information in real time. Wireless charging function can reduce the number of times the patient replaces the pacemaker or even completely avoid it.


Assuntos
Desenho de Equipamento , Marca-Passo Artificial , Fontes de Energia Elétrica , Humanos , Marca-Passo Artificial/normas , Marca-Passo Artificial/tendências
12.
J Cardiovasc Med (Hagerstown) ; 20(8): 531-541, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31259858

RESUMO

AIMS: The aim of this survey was to assess the management and organization of cardiac implantable electronic device (CIED) replacement in Italy. METHODS: A questionnaire consisting of 24 questions on organizational aspects and on the peri-procedural management of anticoagulant therapies and antibiotic prophylaxis was sent via the Internet to 154 Italian arrhythmia centers. RESULTS: A total of 103 out of 154 centers completed the questionnaire (67% response rate). In 43% of the centers, the procedures were performed under day-case admission, in 40% under ordinary admission, and in 17% under either day-case or ordinary admission. The most frequent reason (66%) for choosing ordinary admission rather than day-case admission was to obtain full reimbursement. Although warfarin therapy was continued in 73% of the centers, nonvitamin K oral anticoagulants were discontinued, without bridging, 24 h or less prior to replacement procedures in 88%. Prophylactic antibiotic therapy was systematically administered in all centers; in 97%, the first antibiotic dose was administered 1-2 h prior to procedures. Local antibacterial envelopes were also used in 43% of the centers in patients with a higher risk of device infection. CONCLUSION: This survey provides a representative picture of how CIED replacements are organized and managed in current Italian clinical practice. The choice of the type of hospitalization (short versus ordinary) was more often motivated by economic reasons (reimbursement of the procedure) than by clinical and organizational factors. Peri-procedural management of anticoagulation and prophylactic antibiotic therapy was consistent with current scientific evidence.


Assuntos
Antibioticoprofilaxia/tendências , Anticoagulantes/administração & dosagem , Estimulação Cardíaca Artificial/tendências , Desfibriladores Implantáveis/tendências , Remoção de Dispositivo/tendências , Cardioversão Elétrica/tendências , Marca-Passo Artificial/tendências , Padrões de Prática Médica/tendências , Procedimentos Cirúrgicos Ambulatórios , Estimulação Cardíaca Artificial/economia , Desfibriladores Implantáveis/economia , Remoção de Dispositivo/efeitos adversos , Remoção de Dispositivo/economia , Esquema de Medicação , Cardioversão Elétrica/economia , Cardioversão Elétrica/instrumentação , Custos de Cuidados de Saúde , Pesquisas sobre Serviços de Saúde , Humanos , Itália , Tempo de Internação , Marca-Passo Artificial/economia , Admissão do Paciente , Padrões de Prática Médica/economia , Falha de Prótese , Fatores de Tempo , Resultado do Tratamento
14.
Int J Cardiol ; 282: 33-37, 2019 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-30755335

RESUMO

BACKGROUND: The need for permanent pacing has been identified as a predictor of poor outcomes in the late survivors of Fontan surgery. However, it is not clear if the need for a pacemaker is a surrogate marker of a declining Fontan state, or if pacing is deleterious to the Fontan circulation. OBJECTIVES: We sought to compare the long-term outcomes of propensity-matched Fontan patients with and without a permanent pacemaker. METHODS: Patients who have survived Fontan completion with a documented history of cardiac arrhythmia were identified from the Australia and New Zealand Fontan Registry. Pacemaker insertion details, cardiac function and electrophysiological data were obtained for the patients with a permanent pacemaker. Survival analysis was performed with propensity score matching to compare late survival and outcomes in patients with versus without a pacemaker. RESULTS: There was a total of 310 patients with a history of cardiac arrhythmia, of which 126 (41%) had a permanent pacemaker. After propensity-score matching, 99 pairs were generated (n = 198). Patients with a permanent pacemaker had a higher risk of death (HR 3.32 95% CI 1.60-6.90, p = 0.001) and death or transplantation (HR 3.55 95% CI 1.87-6.73, p < 0.001). Patients who were only paced atrially were not at a significantly increased risk of death or transplantation. However, patients who were ventricular paced >50% of the time were much more likely to encounter late death or transplantation (HR 3.82 95% CI 1.64-8.95, p = 0.002). CONCLUSIONS: Having a permanent pacemaker and needing ventricular pacing is likely associated with an increased risk of death and transplantation in patients with a Fontan circulation.


Assuntos
Arritmias Cardíacas/mortalidade , Arritmias Cardíacas/cirurgia , Técnica de Fontan/mortalidade , Transplante de Coração/mortalidade , Marca-Passo Artificial/efeitos adversos , Adolescente , Austrália/epidemiologia , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Seguimentos , Técnica de Fontan/tendências , Transplante de Coração/tendências , Humanos , Masculino , Mortalidade/tendências , Nova Zelândia/epidemiologia , Marca-Passo Artificial/tendências , Sistema de Registros , Fatores de Risco
15.
Int J Cardiol ; 279: 72-78, 2019 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-30642645

RESUMO

BACKGROUND: Myocardial scar assessment using late gadolinium enhancement Cardiovascular Magnetic Resonance (LGE CMR) is commonly indicated for patients with cardiac implantable electronic devices (CIEDs), however metal artifact can degrade images. We evaluated the clinical impact of LGE CMR incorporating a device-dependent metal artifact reduction strategy in patients with CIEDs. METHODS: 136 CMR studies were performed in 133 consecutive patients (age 56 ±â€¯19 years, 69% male) with CIEDs (22% implantable loop recorders [ILRs], 40% permanent pacemakers [PPMs], 38% implantable cardioverter defibrillators [ICDs]; 42% non-MRI conditional) over 2 years, without complication. LGE imaging was tailored to the CIED, using a wideband sequence for left-sided PPMs and ICDs and conventional sequences for ILRs and right-sided PPMs, scoring segmental artifact. Diagnostic utility and impact on clinical management were scored by consensus of experts. RESULTS: CMR provided unexpected diagnoses in 22 (16%) and changed management in 113 (83%) patients. Myocardial scar was present in 92 (68%), with other abnormalities detected in another 13%. Using conventional LGE, 43 (32%) studies were non-diagnostic (79% of defibrillators) compared to 0% using wideband LGE imaging. Wideband LGE results changed clinical management in an additional 39 (75%) defibrillator patients and 10 (19%) pacemaker patients when compared to imaging with conventional LGE sequences. CONCLUSION: The clinical yield from CMR using optimized LGE sequences in patients with CIEDs is high with no demonstrated clinical risk. A device-dependent LGE imaging strategy using wideband LGE is needed to achieve clinical utility especially in ICD recipients.


Assuntos
Cicatriz/diagnóstico por imagem , Desfibriladores Implantáveis/tendências , Imagem Cinética por Ressonância Magnética/tendências , Miocárdio/patologia , Marca-Passo Artificial/tendências , Adulto , Idoso , Cicatriz/etiologia , Desfibriladores Implantáveis/efeitos adversos , Feminino , Humanos , Imagem Cinética por Ressonância Magnética/métodos , Masculino , Pessoa de Meia-Idade , Marca-Passo Artificial/efeitos adversos , Distribuição Aleatória
16.
Int J Cardiol ; 280: 89-94, 2019 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-30658926

RESUMO

AIM: Post-mortem interrogation of the cardiac implantable electronic devices (CIEDs) in combination with autopsy findings can provide additional information regarding device functioning after implantation or the mechanism of death. The aim of the study is to review the available data on the post-mortem interrogation of CIEDs and its possible clinical implications. METHODS AND RESULTS: A systematic review of the published studies has been performed. Out of 762 unique citations 14 have been retained for final analysis. Post-mortem CIED interrogation reliably detects both serious device malfunctions and lead disorders but also improper device programming. As the need for CIED implantation is growing in the low-income countries, currently available data on battery longevity of devices explanted and destined for re-use have been reviewed. CONCLUSIONS: Post-mortem CIED interrogation provides a unique opportunity to explore different mechanisms of death, often unavailable for distinction during regular in-hospital observation or in autopsy analysis.


Assuntos
Autopsia/métodos , Causas de Morte , Desfibriladores Implantáveis , Remoção de Dispositivo/métodos , Autopsia/tendências , Causas de Morte/tendências , Desfibriladores Implantáveis/tendências , Remoção de Dispositivo/tendências , Humanos , Marca-Passo Artificial/tendências
17.
Minerva Cardioangiol ; 66(6): 762-769, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30468062

RESUMO

A very fast-paced improvement of technology in the field of cardiac implantable devices has been observed in the last ten years. The aim of this review is to highlight the most important innovations which have been recently introduced in this field, such as the leadless pacemaker (a heart stimulator without intracardiac leads), the subcutaneous defibrillator (a completely extracardiac defibrillator device), the injectable loop recorder (a miniaturized subcutaneous continuous echocardiographic monitor provided by alarms and telephonic transmission) and many other new devices which will completely change the clinical practice in this field over the next decade.


Assuntos
Arritmias Cardíacas/terapia , Desfibriladores Implantáveis/tendências , Marca-Passo Artificial/tendências , Arritmias Cardíacas/fisiopatologia , Eletrocardiografia , Desenho de Equipamento , Humanos
18.
BMC Geriatr ; 18(1): 223, 2018 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-30241511

RESUMO

BACKGROUND: With an ageing population and widening indications for pacemakers implantation, the number of persons carrying an implant is steadily increasing. The routine follow-up is thus a heavy burden for the respective NHS as well as for the patients and their relatives. Most of them of the studies have been performed in densely populated areas and nearby to the hospital. It is thus unknown whether these results could be applied also in rural areas such as Northern Norway with a more scattered population. The aim of this study was to assess the effectiveness of tele-monitoring (TM) in patients with pacemakers regarding reliability, safety and health-related quality of life, compared to traditional follow-up in outpatient clinic in a setting where geographical effects could possible influence the results. METHODS: The NORDLAND study is a controlled, randomized, non-masked clinical trial in pacemaker patients, with data collection carried out during the pre-implant stage and after 6 months. Between August of 2014 and November of 2015, 50 patients were assigned to either a tele-monitoring group (n = 25) or a conventional hospital monitoring (HM) group (n = 25). The EuroQol-5D (EQ-5D) utilities and visual analogue scale (VAS) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) were used to measure Health-Related Quality of Life. Baseline characteristics and number of hospital visits were also analyzed. RESULTS: The baseline characteristics of the two study groups were similar for EQ-5D utilities (TM:0.81; HM:0.76; p = 0.47), EQ-5D VAS (TM: 64.00; HM:64.88; p = 0.86) and the MLHFQ (TM:20.20; HM:28.96; p = 0.07). At the 6 month follow-up, there were no significant differences between the groups in EQ-5D utilities (TM: 0.81; HM: 0.76; p = 0.54) and EQ-5D VAS scores (TM: 72.71; HM: 59.79; p = 0.08). The MLHFQ score was improved in both groups (TM: -4.40; HM: -15.13; p <  0.001). The number of in-office visits was similar in both groups (TM: 1.24 vs HM: 1.12; P = 0.30). CONCLUSIONS: The NORDLAND trial shows that HRQoL is improved after implant in both groups. Without significant differences with regards to effectiveness and safety. In addition, provides a scientifically rigorous method to the field of HRQoL evaluations in patients with pacemakers. TRIAL REGISTRATION: ClinicalTrials.gov NCT02237404 , September 11, 2014.


Assuntos
Marca-Passo Artificial/psicologia , Marca-Passo Artificial/tendências , Qualidade de Vida/psicologia , Telemedicina/tendências , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Noruega/epidemiologia , Reprodutibilidade dos Testes , Inquéritos e Questionários , Fatores de Tempo , Escala Visual Analógica
19.
J Cardiovasc Electrophysiol ; 29(12): 1697-1704, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30168233

RESUMO

BACKGROUND: Transcatheter pacing systems (TPS) provide a novel, minimally invasive approach in which a miniaturized, leadless pacemaker (PM) is transfemorally implanted in the right ventricle. We evaluated the health-related quality of life (HRQoL) impact, patient satisfaction, and activity restrictions following TPS in a large prospective multicenter clinical trial. METHODS AND RESULTS: Patients who underwent a Micra TPS implantation between December 2013 and May 2015 were included. HRQoL impact was evaluated using the Short-Form-36 (SF-36) questionnaire at baseline, 3, and 12 months. Patient satisfaction was assessed using a three-item questionnaire determining recovery, activity level, and esthetic appearance at 3 months. Implanting physicians compared the patient activity restrictions for TPS to traditional PM therapy. A total of 720 patients were implanted with a TPS (76 ± 11 years; 59% male). Of these patients, 702 (98%), 681 (95%), and 635 (88%) completed the SF-36 at baseline, 3 and 12 months, respectively. Improvements were observed at 3 and 12 months in all SF-36 domains and all attained statistical significance. Of 693 patients who completed the patient satisfaction questionnaire, 96%, 91%, 74% were (very) satisfied with their esthetic appearance, recovery, and level of activity, respectively. TPS discharge instructions were rated less restrictive in 49%, equally restrictive in 47%, and more restrictive in 4% of cases compared with traditional PM systems. CONCLUSIONS: TPS resulted in postimplant HRQoL improvements at 3 and 12 months, and high levels of patient satisfaction at 3 months. Further, TPS was associated with less activity restrictions compared with traditional PM systems.


Assuntos
Estimulação Cardíaca Artificial/tendências , Doenças Cardiovasculares/cirurgia , Marca-Passo Artificial/tendências , Qualidade de Vida , Idoso , Idoso de 80 Anos ou mais , Doenças Cardiovasculares/diagnóstico , Doenças Cardiovasculares/fisiopatologia , Estudos de Coortes , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
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