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1.
Eur Heart J ; 39(15): 1308-1313, 2018 04 14.
Artigo em Inglês | MEDLINE | ID: mdl-29029058

RESUMO

Background: Transcatheter aortic valve replacement (TAVR) has been shown safe and feasible in patients with bicuspid aortic valve (BAV) morphology. Evaluation of inter-ethnic differences in valve morphology and function and aortic root dimensions in patients with BAV is important for the worldwide spread of this therapy in this subgroup of patients. Comparisons between large European and Asian cohorts of patients with BAV have not been performed, and potential differences between populations may have important implications for TAVR. Aim: The present study evaluated the differences in valve morphology and function and aortic root dimensions between two large cohorts of European and Asian patients with BAV. Methods and results: Aortic valve morphology was defined on transthoracic echocardiography according to the number of commissures and raphe: type 0 = no raphe and two commissures, type 1 = one raphe and two commissures, type 2 = two raphes and one commissure. Aortic stenosis and regurgitation were graded according to current recommendations. For this study, aortic root dimensions were manually measured on transthoracic echocardiograms at the level of the aortic annulus, sinus of Valsalva (SOV), sinotubular junction (STJ), and ascending aorta (AA). Of 1427 patients with BAV (45.2 ± 18.1 years, 71.9% men), 794 (55.6%) were Europeans and 633 (44.4%) were Asians. The groups were comparable in age and proportion of male sex. Asians had higher prevalence of type 1 BAV with raphe between right and non-coronary cusps than Europeans (19.7% vs. 13.6%, respectively; P < 0.001), whereas the Europeans had higher prevalence of type 0 BAV (two commissures, no raphe) than Asians (14.5% vs. 6.8%, respectively; P < 0.001). The prevalence of moderate and severe aortic regurgitation was higher in Europeans than Asians (44.2% vs. 26.8%, respectively; P < 0.001) whereas there were no differences in BAV with normal function or aortic stenosis. After adjusting for demographics, comorbidities, and valve function, the dimensions of the aortic annulus [mean difference 1.17 mm/m2, 95% confidence interval (CI) 0.96-1.39], SOV (mean difference 1.86 mm/m2, 95% CI 1.47-2.24), STJ (mean difference 0.52 mm/m2, 95% CI 0.14-0.90) and AA (mean difference 1.05 mm/m2, 95% CI 0.57-1.52) were significantly larger among Asians compared with Europeans. Conclusions: This large multicentre registry reports for the first time that Asians with BAV showed more frequently type 1 BAV (with fusion between right and non-coronary cusp) and have larger aortic dimensions than Europeans. These findings have important implications for prosthesis type and size selection for TAVR.


Assuntos
Valva Aórtica/anormalidades , Valva Aórtica/anatomia & histologia , Valva Aórtica/patologia , Doenças das Valvas Cardíacas/etnologia , Doenças das Valvas Cardíacas/cirurgia , Adulto , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/epidemiologia , Insuficiência da Valva Aórtica/etnologia , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/etnologia , Estenose da Valva Aórtica/cirurgia , Povo Asiático/etnologia , Doença da Válvula Aórtica Bicúspide , Ecocardiografia/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Estudos Retrospectivos , Seio Aórtico/anatomia & histologia , Seio Aórtico/diagnóstico por imagem , Substituição da Valva Aórtica Transcateter/métodos , População Branca/etnologia
2.
Pacing Clin Electrophysiol ; 37(1): 25-34, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23998638

RESUMO

BACKGROUND: Although randomized trials have shown the beneficial effect on survival of an implantable cardioverter defibrillator (ICD) as primary prevention therapy in selected patients, data concerning the cost-effectiveness in routine clinical practice remain scarce. Accordingly, the purpose of this study was to assess the cost-effectiveness of primary prevention ICD implantation in the real world. METHODS: Patients receiving primary prevention single-chamber or dual-chamber ICD implantation at the Leiden University Medical Center were included in the study. Using a Markov model, lifetime cost, life years (LYs), and gained quality-adjusted life years (QALYs) were estimated for device recipients and control patients. Data on mortality, complication rates, and device longevity were retrieved from our center and entered into the Markov model. To account for model assumptions, one-way deterministic and probabilistic sensitivity analyses were performed. Importantly, calculations for the estimated incremental cost-effectiveness rate (ICER) per QALY gained are based on several numbers of assumptions, and accordingly findings may have over- or underestimated the cost-effectiveness of ICD therapy. RESULTS: Primary prevention ICD implantation adds an estimated mean of 2.07 LYs and 1.73 QALYs. Increased lifetime cost for single-chamber and dual-chamber ICD recipients were estimated at €60,788 and €64,216, respectively. This resulted for single-chamber ICD recipients, in an estimated ICER of €35,154 per QALY gained. In dual-chamber ICD recipients, an estimated ICER of €37,111 per QALY gained was calculated. According to the probabilistic sensitivity analysis, estimated cost per QALY gained are €35,837 (95% confidence interval [CI]: €28,368-€44,460) for single-chamber and €37,756 (95% CI: €29,055-€46,050) for dual-chamber ICDs. CONCLUSIONS: On the basis of data and detailed costs, derived from routine clinical practice, ICD therapy in selected patients with a reduced left ventricular ejection fraction appears to be cost-effective.


Assuntos
Desfibriladores Implantáveis/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Insuficiência Cardíaca/economia , Insuficiência Cardíaca/prevenção & controle , Prevenção Primária/economia , Análise Custo-Benefício/economia , Feminino , Insuficiência Cardíaca/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Prevalência , Sistema de Registros , Fatores de Risco , Taxa de Sobrevida , Resultado do Tratamento
3.
Pacing Clin Electrophysiol ; 35(6): 652-8, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22352338

RESUMO

BACKGROUND: The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long-term follow-up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronic's Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and St. Jude Medical's Riata ICD lead (St. Jude Medical Inc., St. Paul, MN, USA). METHODS: Since 1996, all ICD system implantations at the Leiden University Medical Center, the Netherlands, are registered. For this study, data up to February 2011 on 396 Sprint Fidelis leads (follow-up 3.4 ± 1.5 years), 165 8-French (F) Riata leads (follow-up 4.6 ± 2.6 years), and 30 7-F Riata leads (follow-up 2.9 ± 1.3 years) were compared with a benchmark cohort of 1,602 ICD leads (follow-up 3.4 ± 2.7 years) and assessed for the occurrence of lead failure and cardiac perforation. RESULTS: During follow-up, the yearly lead failure rate of the Sprint Fidelis lead, 7-F Riata lead, 8-F Riata lead, and the benchmark cohort was 3.54%, 2.28%, 0.78%, and 1.14%, respectively. In comparison to the benchmark cohort, the adjusted hazard ratio of lead failure was 3.7 (95% confidence interval [CI] 2.4-5.7, P < 0.001) for the Sprint Fidelis lead and 4.2 (95% CI 1.0-18.0, P < 0.05) for the 7-F Riata lead. One cardiac perforation was observed (3.3%) in the 7-F Riata group versus none in the 8-F Riata and Sprint Fidelis lead population. CONCLUSION: The current update demonstrates that the risk of lead failure during long-term follow-up is significantly increased for both the Sprint Fidelis and the 7-F Riata lead in comparison to the benchmark cohort. Only one cardiac perforation occurred.


Assuntos
Desfibriladores Implantáveis/estatística & dados numéricos , Eletrodos Implantados/estatística & dados numéricos , Falha de Equipamento/estatística & dados numéricos , Traumatismos Cardíacos/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Prevalência , Fatores de Risco
4.
Eur Heart J ; 32(21): 2678-87, 2011 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-21646229

RESUMO

AIMS: Little evidence is available regarding restrictions from driving following implantable cardioverter defibrillator (ICD) implantation or following first appropriate or inappropriate shock. The purpose of the current analysis was to provide evidence for driving restrictions based on real-world incidences of shocks (appropriate and inappropriate). METHODS AND RESULTS: A total of 2786 primary and secondary prevention ICD patients were included. The occurrence of shocks was noted during a median follow-up of 996 days (inter-quartile range, 428-1833 days). With the risk of harm (RH) formula, using the incidence of sudden cardiac incapacitation, the annual RH to others posed by a driver with an ICD was calculated. Based on Canadian data, the annual RH to others of 5 in 100 000 (0.005%) was used as a cut-off value. In both primary and secondary prevention ICD patients with private driving habits, no restrictions to drive directly following implantation, or an inappropriate shock are warranted. However, following an appropriate shock, these patients are at an increased risk to cause harm to other road users and therefore should be restricted to drive for a period of 2 and 4 months, respectively. In addition, all ICD patients with professional driving habits have a substantial elevated risk to cause harm to other road users during the complete follow-up after both implantation and shock and should therefore be restricted to drive permanently. CONCLUSION: The current analysis provides a clinically applicable tool for guideline committees to establish evidence-based driving restrictions.


Assuntos
Arritmias Cardíacas/prevenção & controle , Condução de Veículo/legislação & jurisprudência , Desfibriladores Implantáveis/efeitos adversos , Acidentes de Trânsito/estatística & dados numéricos , Idoso , Medicina Baseada em Evidências , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Países Baixos , Doenças Profissionais/prevenção & controle , Prevenção Primária/estatística & dados numéricos , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Prevenção Secundária/estatística & dados numéricos , Fatores de Tempo
5.
Eur Heart J ; 32(15): 1926-34, 2011 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21217144

RESUMO

AIMS: The risk of infective endocarditis (IE) in adults with congenital heart disease is known to be increased, yet empirical risk estimates are lacking. We sought to predict the occurrence of IE in patients with congenital heart disease at the transition from childhood into adulthood. METHODS AND RESULTS: We identified patients from the CONCOR national registry for adults with congenital heart disease. Potential predictors included patient characteristics, and complications and interventions in childhood. The outcome measure was the occurrence of IE up to the age of 40 and 60. A prediction model was derived using the Cox proportional hazards model and bootstrapping techniques. The model was transformed into a clinically applicable risk score. Of 10 210 patients, 233 (2.3%) developed adult-onset IE during 220 688 patient-years. Predictors of IE were gender, main congenital heart defect, multiple heart defects, and three types of complications in childhood. Up to the age of 40, patients with a low predicted risk (<3%) had an observed incidence of less than 1%; those with a high predicted risk (≥3%) had an observed incidence of 6%. The model also yielded accurate predictions up to the age of 60. CONCLUSION: Among young adult patients with congenital heart disease, the use of six simple clinical parameters can accurately predict patients at relatively low or high risk of IE. After confirmation in other cohorts, application of the prediction model may lead to individually tailored medical surveillance and educational counselling, thus averting IE or enabling timely detection in adult patients with congenital heart disease.


Assuntos
Endocardite/etiologia , Cardiopatias Congênitas/complicações , Adulto , Idoso , Idoso de 80 Anos ou mais , Endocardite/epidemiologia , Métodos Epidemiológicos , Feminino , Transição Epidemiológica , Cardiopatias Congênitas/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Adulto Jovem
6.
J Am Soc Echocardiogr ; 35(7): 703-711.e3, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35091069

RESUMO

BACKGROUND: Left ventricular (LV) global longitudinal strain (GLS) has been proposed as a sensitive marker of myocardial damage in patients with chronic severe aortic regurgitation (AR) and preserved LV ejection fraction (LVEF). However, LV GLS does not take into account the afterload. Noninvasive LV myocardial work is a novel parameter of LV myocardial performance, which integrates measurements of myocardial deformation and noninvasive blood pressure (afterload). The aims of this study were (1) to assess noninvasive LV myocardial work in patients with chronic AR and preserved LVEF and its correlation with other echocardiographic parameters, (2) to evaluate changes of LV myocardial work after aortic valve replacement or repair (AVR), and (3) to assess the relationship between LV myocardial work and postoperative LV reverse remodeling. METHODS: Fifty-seven patients (53 ± 16 years; 67% men) with moderate or severe chronic AR and preserved LVEF treated by AVR were included. Noninvasive LV myocardial work indices were measured at baseline and postoperatively (between 2 and 12 months after surgery) and compared with previously reported normal reference ranges. RESULTS: Based on normal reference values, patients with chronic AR and preserved LVEF had preserved or increased values of LV global work index (GWI; 82% and 18%, respectively) and LV global constructive work (GCW; 74% and 25%, respectively) and preserved LV global work efficiency (GWE). Left ventricular GWI and GCW showed a positive correlation with markers of AR severity and parameters of LV systolic function. Left ventricular GWI, GCW, and GWE decreased after AVR (P < .001), without changes in LV global wasted work (P = .28). The postoperative impairment of LV GWI, observed in 28% of patients, was closely associated with reduced LV reverse remodeling. CONCLUSIONS: Noninvasive myocardial work may allow better understanding of myocardial function and energetics than afterload-dependent echocardiographic parameters in chronic AR with preserved LVEF.


Assuntos
Insuficiência da Valva Aórtica , Disfunção Ventricular Esquerda , Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/diagnóstico , Insuficiência da Valva Aórtica/diagnóstico por imagem , Ecocardiografia , Feminino , Humanos , Masculino , Volume Sistólico/fisiologia , Disfunção Ventricular Esquerda/diagnóstico por imagem , Disfunção Ventricular Esquerda/etiologia , Função Ventricular Esquerda/fisiologia , Remodelação Ventricular
7.
Am J Med Genet A ; 155A(7): 1661-7, 2011 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-21671389

RESUMO

With recent advances in medical and surgical management, most patients with congenital heart disease (CHD) survive to reproductive age. Current guidelines recommend counseling about inheritance and transmission of CHD to offspring. We evaluated whether adult CHD patients recalled having received information about the inheritance of their CHD, patients' knowledge about inheritance and their concerns in this regard. A questionnaire was sent to 486 non-syndromic CHD patients aged 20-45 years. We received 332 useful questionnaires (response rate 68%). One-third (33%) of patients recalled receiving information about inheritance of CHD from their cardiologist, and 13% had consulted a clinical geneticist. Eight percent of patients who were considering having children estimated the recurrence risk for their own offspring to be 1% or lower, whereas one-fourth (25%) estimated it to be higher than 10%. According to our classification, 44% estimated the recurrence risk in a correct range of magnitude. Additional information about inheritance of CHD was desired by 41% of patients. Forty-two percent of patients considering having children reported concerns about transmitting CHD to offspring. We conclude that a substantial proportion of adult CHD patients lacks knowledge and desires more information about inheritance, indicating a need for better patient education. Current guidelines and/or their implementation do not seem to meet the needs of these patients. A dedicated program of counseling for adults with CHD has to be developed to optimize knowledge and satisfaction with information provision and to reduce or manage concerns regarding inheritance of CHD.


Assuntos
Conhecimentos, Atitudes e Prática em Saúde , Cardiopatias Congênitas/genética , Cardiopatias Congênitas/psicologia , Hereditariedade , Adulto , Estudos Transversais , Feminino , Aconselhamento Genético , Humanos , Masculino , Sistema de Registros , Inquéritos e Questionários , Adulto Jovem
9.
Eur Heart J ; 31(10): 1220-9, 2010 May.
Artigo em Inglês | MEDLINE | ID: mdl-20207625

RESUMO

AIMS: Mortality in adults with congenital heart disease is known to be increased, yet its extent and the major mortality risks are unclear. METHODS AND RESULTS: The Dutch CONCOR national registry for adult congenital heart disease was linked to the national mortality registry. Cox's regression was used to assess mortality predictors. Of 6933 patients, 197 (2.8%) died during a follow-up of 24 865 patient-years. Compared with the general national population, there was excess mortality, particularly in the young. Median age at death was 48.8 years. Of all deaths, 77% had a cardiovascular origin; 45% were due to chronic heart failure (26%, age 51.0 years) or sudden death (19%, age 39.1 years). Age predicted mortality, as did gender, severity of defect, number of interventions, and number of complications [hazard ratio (HR) range 1.1-5.9, P < 0.05]. Several complications predicted all-cause mortality beyond the effects of age, gender, and congenital heart disease severity, i.e. endocarditis, supraventricular arrhythmias, ventricular arrhythmias, conduction disturbances, myocardial infarction, and pulmonary hypertension (HR range 1.4-3.1, P < 0.05). These risks were similar in patients above and below 40 years of age. Almost all complications predicted death due to heart failure (HR range 2.0-5.1, P < 0.05); conduction disturbances and pulmonary hypertension predicted sudden death (HR range 2.0-4.7, P < 0.05). CONCLUSION: Mortality is increased in adults with congenital heart disease, particularly in the young. The vast majority die from cardiovascular causes. Mortality risk, particularly by heart failure, is increased by virtually all complications. Complications are equally hazardous in younger as in older patients.


Assuntos
Cardiopatias Congênitas/mortalidade , Adolescente , Adulto , Distribuição por Idade , Idoso , Métodos Epidemiológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Distribuição por Sexo , Adulto Jovem
10.
Eur Heart J ; 31(6): 712-8, 2010 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19933693

RESUMO

AIMS: To assess survival and to construct a baseline mortality risk score in primary prevention implantable cardioverter defibrillator (ICD) patients with non-ischaemic or ischaemic heart disease. METHODS AND RESULTS: Since 1996, data of all consecutive patients who received an ICD system in the Leiden University Medical Center were collected and assessed at implantation. For the current study, all 1036 patients [age 63 (SD 11) years, 81% male] with a primary indication for defibrillator implantation were evaluated and followed for 873 (SD 677) days. During follow-up, 138 patients (13%) died. Non-ischaemic and ischaemic patients demonstrated similar survival but exhibited different factors that influence risk for mortality. A risk score, consisting of simple baseline variables could stratify patients in low, intermediate, and high risk for mortality. In non-ischaemic patients, annual mortality was 0.4% (95% CI 0.0-2.2%) in low risk and 9.4% (95% CI 6.6-13.1%) in high risk patients. In ischaemic patients, mortality was 1.0% (95% CI 0.2-3.0%) in low risk and 17.8% (95% CI 13.6-22.9%) in high risk patients. CONCLUSION: Utilization of an easily applicable baseline risk score can create an individual patient-tailored estimation on mortality risk to aid clinicians in daily practice.


Assuntos
Desfibriladores Implantáveis , Cardiopatias/mortalidade , Taquicardia Ventricular/prevenção & controle , Idoso , Causas de Morte , Ecocardiografia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Isquemia Miocárdica/mortalidade , Prevenção Primária , Estudos Prospectivos , Medição de Risco , Fatores de Risco , Taquicardia Ventricular/etiologia , Taquicardia Ventricular/mortalidade
11.
Eur Heart J Cardiovasc Imaging ; 22(2): 142-152, 2021 01 22.
Artigo em Inglês | MEDLINE | ID: mdl-33184656

RESUMO

AIMS: Right ventricular myocardial work (RVMW) is a novel method for non-invasive assessment of right ventricular (RV) function utilizing RV pressure-strain loops. This study aimed to explore the relationship between RVMW and invasive indices of right heart catheterization (RHC) in a cohort of patients with heart failure with reduced left ventricular ejection fraction (HFrEF), and to compare values of RVMW with those of a group of patients without cardiovascular disease. METHODS AND RESULTS: Non-invasive analysis of RVMW was performed in 22 HFrEF patients [median age 63 (59-67) years] who underwent echocardiography and invasive RHC within 48 h. Conventional RV functional measurements, RV global constructive work (RVGCW), RV global work index (RVGWI), RV global wasted work (RVGWW), and RV global work efficiency (RVGWE) were analysed and compared with invasively measured stroke volume and stroke volume index. Non-invasive analysis of RVMW was also performed in 22 patients without cardiovascular disease to allow for comparison between groups. None of the conventional echocardiographic parameters of RV systolic function were significantly correlated with stroke volume or stroke volume index. In contrast, one of the novel indices derived non-invasively by pressure-strain loops, RVGCW, demonstrated a moderate correlation with invasively measured stroke volume and stroke volume index (r = 0.63, P = 0.002 and r = 0.59, P = 0.004, respectively). RVGWI, RVGCW, and RVGWE were significantly lower in patients with HFrEF compared to a healthy cohort, while values of RVGWW were significantly higher. CONCLUSION: RVGCW is a novel parameter that provides an integrative analysis of RV systolic function and correlates more closely with invasively measured stroke volume and stroke volume index than other standard echocardiographic parameters.


Assuntos
Insuficiência Cardíaca , Disfunção Ventricular Direita , Ecocardiografia , Humanos , Pessoa de Meia-Idade , Volume Sistólico , Disfunção Ventricular Direita/diagnóstico por imagem , Função Ventricular Esquerda , Função Ventricular Direita
12.
Pacing Clin Electrophysiol ; 33(4): 431-6, 2010 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-19954503

RESUMO

BACKGROUND: The Medtronic Sprint Fidelis (SF) implantable cardioverter defibrillator (ICD; Medtronic Inc., Minneapolis, MN, USA) lead has a higher than expected failure rate. Because of patient safety, Medtronic announced two advisories consisting of (1) adjustments in device settings (October 2007) and (2) installation of a lead integrity algorithm (May 2008). The objective of this study was to evaluate the effect of Medtronic's announcements on patient safety. METHODS: To comply with the advisories, two clinical evaluations were conducted. The effect of the advisories was assessed by the lead failure rate and the occurrence of inappropriate shocks due to lead failure. Three periods were distinguished in the comparison of event rates: lead implantation to advisory 1 (period A), in-between both advisories (period B), and advisory 2 to follow-up (period C). RESULTS: Since 2004, 372 patients received a Medtronic ICD and SF lead and were followed from first implant (December 2004) to April 2009. Cumulative incidence rate of lead failure was 3.6%[95% confidence interval (CI) 1.6-5.6] at 21 months and increased to 11.0% (95% CI 6.1-15.9) at 42 months. After implementation of both advisories, the occurrence of inappropriate shocks due to lead failure decreased from 1.5 (95% CI 0.59, 3.00) per 100 lead-years in period A to 0.8 (95% CI 0.02, 4.25) per 100 lead-years in period C. CONCLUSION: The current study demonstrates that despite an increasing risk for SF lead failure, implementation of the advisories decreased the occurrence of inappropriate shocks due to lead failure. (PACE 2010; 431-436).


Assuntos
Desfibriladores Implantáveis/efeitos adversos , Desfibriladores Implantáveis/normas , Eletrodos Implantados/efeitos adversos , Guias de Prática Clínica como Assunto/normas , Falha de Prótese , Idoso , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade
13.
JAMA Netw Open ; 3(4): e202165, 2020 04 01.
Artigo em Inglês | MEDLINE | ID: mdl-32297946

RESUMO

Importance: Smart technology via smartphone-compatible devices might improve blood pressure (BP) regulation in patients after myocardial infarction. Objectives: To investigate whether smart technology in clinical practice can improve BP regulation and to evaluate the feasibility of such an intervention. Design, Setting, and Participants: This study was an investigator-initiated, single-center, nonblinded, feasibility, randomized clinical trial conducted at the Department of Cardiology of the Leiden University Medical Center between May 2016 and December 2018. Two hundred patients, who were admitted with either ST-segment elevation myocardial infarction or non-ST-segment acute coronary syndrome, were randomized in a 1:1 fashion between follow-up groups using smart technology and regular care. Statistical analysis was performed from January 2019 to March 2019. Interventions: For patients randomized to regular care, 4 physical outpatient clinic visits were scheduled in the year following the initial event. In the intervention group, patients were given 4 smartphone-compatible devices (weight scale, BP monitor, rhythm monitor, and step counter). In addition, 2 in-person outpatient clinic visits were replaced by electronic visits. Main Outcomes and Measures: The primary outcome was BP control. Secondary outcomes, as a parameter of feasibility, included patient satisfaction (general questionnaire and smart technology-specific questionnaire), measurement adherence, all-cause mortality, and hospitalizations for nonfatal adverse cardiac events. Results: In total, 200 patients (median age, 59.7 years [interquartile range, 52.9-65.6 years]; 156 men [78%]) were included, of whom 100 were randomized to the intervention group and 100 to the control group. After 1 year, 79% of patients in the intervention group had controlled BP vs 76% of patients in the control group (P = .64). General satisfaction with care was the same between groups (mean [SD] scores, 82.6 [14.1] vs 82.0 [15.1]; P = .88). The all-cause mortality rate was 2% in both groups (P > .99). A total of 20 hospitalizations for nonfatal adverse cardiac events occurred (8 in the intervention group and 12 in the control group). Of all patients, 32% sent in measurements each week, with 63% sending data for more than 80% of the weeks they participated in the trial. In the intervention group only, 90.3% of patients were satisfied with the smart technology intervention. Conclusions and Relevance: These findings suggest that smart technology yields similar percentages of patients with regulated BP compared with the standard of care. Such an intervention is feasible in clinical practice and is accepted by patients. More research is mandatory to improve patient selection of such an intervention. Trial Registration: ClinicalTrials.gov Identifier: NCT02976376.


Assuntos
Determinação da Pressão Arterial/métodos , Pressão Sanguínea/fisiologia , Infarto do Miocárdio , Smartphone , Telemedicina/métodos , Idoso , Estudos de Viabilidade , Feminino , Cardiopatias/mortalidade , Humanos , Hipertensão/diagnóstico , Masculino , Pessoa de Meia-Idade , Aplicativos Móveis , Satisfação do Paciente/estatística & dados numéricos
14.
Circulation ; 118(1): 26-32, 2008 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-18559697

RESUMO

BACKGROUND: Gender differences in prognosis have frequently been reported in cardiovascular disease but less so in congenital heart disease. We investigated whether gender is associated with outcome in adult patients with congenital heart disease. METHODS AND RESULTS: From the CONgenital CORvitia (CONCOR) national registry for adults with congenital heart disease, 7414 patients were identified. All outcomes before entry into the registry and during subsequent follow-up were recorded, and differences between men and women were analyzed with the underlying congenital heart defect taken into account. Median age at the end of follow-up was 35 years (range, 17 to 91 years); 49.8% were female. No gender difference in mortality was found. Women had a 33% higher risk of pulmonary hypertension (odds ratio [OR]=1.33; 95% CI, 1.07 to 1.65; P=0.01), a 33% lower risk of aortic outcomes (OR=0.67; 95% CI, 0.50 to 0.90; P=0.007), a 47% lower risk of endocarditis (OR=0.53; 95% CI, 0.40 to 0.70; P<0.001), and a 55% lower risk of an implantable cardioverter-defibrillator (OR=0.45; 95% CI, 0.26 to 0.80; P=0.006). Furthermore, the risk of arrhythmias appeared to be lower in women (OR=0.88; 95% CI, 0.77 to 1.02; P=0.08). CONCLUSIONS: The risk of several major cardiac outcomes in adult patients with congenital heart disease appears to vary by gender.


Assuntos
Cardiopatias Congênitas/epidemiologia , Caracteres Sexuais , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Aorta/cirurgia , Desfibriladores Implantáveis/efeitos adversos , Endocardite/diagnóstico , Feminino , Seguimentos , Cardiopatias Congênitas/diagnóstico , Humanos , Hipertensão Pulmonar/diagnóstico , Hipertensão Pulmonar/epidemiologia , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Razão de Chances , Prognóstico , Sistema de Registros/estatística & dados numéricos , Fatores de Risco , Taxa de Sobrevida , Resultado do Tratamento
15.
Am J Cardiol ; 124(6): 892-898, 2019 09 15.
Artigo em Inglês | MEDLINE | ID: mdl-31375242

RESUMO

Left ventricular (LV) global longitudinal strain (GLS) can detect subclinical myocardial systolic dysfunction in individuals with diabetes. The present study investigates the clinical usefulness and incremental net benefit of identifying subclinical myocardial systolic dysfunction in individuals with diabetes. A cohort of 397 type 2 diabetic individuals was followed up for the occurrence of all-cause mortality. Clinical and echocardiographic data of diabetic patients were assessed retrospectively. LV GLS was evaluated on transthoracic echocardiography using speckle tracking imaging. Subclinical LV systolic dysfunction was defined as LV GLS > -17.0% from 104 healthy volunteers recruited from the community. A total of 178 (44.8%) diabetic individuals had evidence of subclinical LV systolic dysfunction and 46 (11.6%) died during follow-up. The presence of subclinical LV systolic dysfunction was independently associated with all-cause mortality on follow-up (hazard ratio [HR] 2.83, 95% confidence interval [CI] 1.40 to 5.71, p = 0.004). Diabetic individuals without subclinical LV systolic dysfunction had similar survival as the general population (standardized mortality ratio 0.94, 95% CI 0.52 to 1.58). Decision curve analysis showed identification of subclinical LV systolic dysfunction and quantification of LV GLS provided an incremental net clinical benefit at risk stratifying patients for risk of death at 5 years. In conclusion, subclinical LV systolic dysfunction is independently associated with all-cause mortality in diabetic patients. Decision curve analyses suggest use of LV GLS and identification of subclinical LV systolic dysfunction is clinically useful, and provided incremental net clinical benefit for diabetic individuals.


Assuntos
Diabetes Mellitus Tipo 2/fisiopatologia , Ecocardiografia/métodos , Ventrículos do Coração/fisiopatologia , Medição de Risco/métodos , Volume Sistólico/fisiologia , Disfunção Ventricular Esquerda/fisiopatologia , Austrália/epidemiologia , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/mortalidade , Feminino , Seguimentos , Voluntários Saudáveis , Ventrículos do Coração/diagnóstico por imagem , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Sístole , Disfunção Ventricular Esquerda/epidemiologia , Disfunção Ventricular Esquerda/etiologia , Função Ventricular Esquerda
16.
Expert Rev Med Devices ; 15(2): 119-126, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-29271661

RESUMO

INTRODUCTION: Medication adherence is of key importance in the treatment of cardiovascular disease. Studies consistently show that a substantial proportion of patients is non-adherent. AREAS COVERED: For this review, telemedicine solutions that can potentially improve medication adherence in patients with cardiovascular disease were reviewed. A total of 475 PubMed papers were reviewed, of which 74 were assessed. EXPERT COMMENTARY: Papers showed that evidence regarding telemedicine solutions is mostly conflictive. Simple SMS reminders might work for patients who do not take their medication because of forgetfulness. Educational interventions and coaching interventions, primarily delivered by telephone or via a web-based platform can be effective tools to enhance medication adherence. Finally, it should be noted that current developments in software engineering may dramatically change the way non-adherence is addressed in the nearby future.


Assuntos
Doenças Cardiovasculares/tratamento farmacológico , Adesão à Medicação , Telemedicina , Humanos , Internet , Aplicativos Móveis
17.
J Telemed Telecare ; 24(6): 404-409, 2018 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28457182

RESUMO

Introduction Smartphone-compatible blood pressure devices may be a good alternative to enable self-measurement of blood pressure by patients. Furthermore, automatic transferral of data to the hospital allows for remote monitoring. To our knowledge, no study has compared four of these smartphone-compatible blood pressure devices. Methods Patients who were followed up for acute myocardial infarction were asked to participate during their outpatient clinic visit. After five minutes of rest, six blood pressure devices were applied. The order was randomised. Four devices were smartphone-compatible. One device was an automated oscillometric device. One device was a handheld aneroid sphygmomanometer (reference device). All measurements were compared using a linear mixed model. Results A total of 43 patients (62.7 ± 11.3 years, 79% male) were included. Compared to the reference device, four blood pressure monitors yielded a significant higher mean systolic blood pressure and four monitors yielded a significant higher diastolic BP. One device yielded a non-significant lower mean systolic blood pressure and one device yielded a non-significant higher mean diastolic blood pressure. Except for one blood pressure device, all mean differences were smaller than 5 mmHg. Conclusion In this study, average inter-device variability was shown to be statistically significant, however four devices remained within the predefined range of 5 mmHg for both systolic and diastolic blood pressures.


Assuntos
Assistência ao Convalescente , Determinação da Pressão Arterial/métodos , Monitores de Pressão Arterial/normas , Infarto do Miocárdio , Smartphone , Adulto , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial , Feminino , Humanos , Hipertensão/fisiopatologia , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/diagnóstico , Oscilometria
18.
Am Heart J ; 153(1): 14.e1-11, 2007 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-17174628

RESUMO

BACKGROUND: Guideline implementation programs for patients with acute myocardial infarction (AMI) enhance adherence to evidence-based medicine (EBM) and improve clinical outcome. Although undertreatment of patients with AMI is well recognized in both acute and chronic phases of care, most implementation programs focus on acute and secondary prevention strategies during the index hospitalization phase only. HYPOTHESIS: Implementation of an all-phase integrated AMI care program maximizes EBM in daily practice and improves the care for patients with AMI. AIM: The objective of this study is to assess the effects of the MISSION! program on adherence to EBM for patients with AMI by the use of performance indicators. DESIGN: The MISSION! protocol is based on the most recent American College of Cardiology/American Heart Association and European Society of Cardiology guidelines for patients with AMI. It contains a prehospital, inhospital, and outpatient clinical framework for decision making and treatment, up to 1 year after the index event. MISSION! concentrates on rapid AMI diagnosis and early reperfusion, followed by active lifestyle improvement and structured medical therapy. Because MISSION! covers both acute and chronic AMI phase, this design implies an intensive multidisciplinary collaboration among all regional health care providers. CONCLUSION: Continuum of care for patients with AMI is warranted to take full advantage of EBM in day-to-day practice. This manuscript describes the rationale, design, and preliminary results of MISSION!, an all-phase integrated AMI care program.


Assuntos
Protocolos Clínicos , Assistência Integral à Saúde/normas , Continuidade da Assistência ao Paciente , Fidelidade a Diretrizes/organização & administração , Infarto do Miocárdio/terapia , Doença Aguda , Adulto , Idoso , Idoso de 80 Anos ou mais , Doença Crônica , Comportamento Cooperativo , Medicina Baseada em Evidências , Feminino , Comportamentos Relacionados com a Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/reabilitação , Países Baixos , Equipe de Assistência ao Paciente/normas , Guias de Prática Clínica como Assunto , Indicadores de Qualidade em Assistência à Saúde , Terapia Trombolítica , Triagem
19.
Eur J Prev Cardiol ; 24(12): 1319-1327, 2017 08.
Artigo em Inglês | MEDLINE | ID: mdl-28541122

RESUMO

Background Young patients with congenital heart disease reaching adulthood face mandatory transition to adult cardiology. Their new cardiologist needs to assess the chances of major future events such as surgery. Using a large national registry, we assessed if patient characteristics at the age of 18 years could predict the chance of congenital heart surgery in adulthood. Design and methods Of 10,300 patients from the CONCOR national registry, we used general patient characteristics at age 18 years, underlying congenital heart defect, history of complications, and interventions in childhood as potential predictors of congenital heart surgery occurring from age 18 years up to age 40 and 60 years. Cox regression was used to calculate hazard ratios with 95% confidence intervals. Analyses were performed separately for all congenital heart surgery and for valvular surgery alone. Results Altogether 2427 patients underwent congenital heart surgery after age 18 years, 1389 of whom underwent valvular surgery. Underlying heart defect, male sex, multiple defects, childhood endocarditis, supraventricular arrhythmia, aortic complications and paediatric cardiovascular surgery, independently predicted adult congenital heart surgery. The mean chance of congenital heart surgery was 22% up to age 40 and 43% up to age 60 years; individual chances spanned from 9-68% up to age 40 and from 19-93% up to age 60 years. Conclusion At the time of transition from paediatric to adult cardiology, an easily obtainable set of characteristics of patients with congenital heart disease can meaningfully inform cardiologists about the patient's individual chance of surgery in adulthood. Our findings warrant validation in other cohorts.


Assuntos
Procedimentos Cirúrgicos Cardíacos/normas , Previsões , Transição Epidemiológica , Cardiopatias Congênitas/cirurgia , Sistema de Registros , Medição de Risco , Adolescente , Adulto , Distribuição por Idade , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Progressão da Doença , Feminino , Seguimentos , Cardiopatias Congênitas/epidemiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Fatores de Risco , Adulto Jovem
20.
Trials ; 18(1): 402, 2017 08 29.
Artigo em Inglês | MEDLINE | ID: mdl-28851409

RESUMO

BACKGROUND: Recently published randomised clinical trials indicate that prolonged electrocardiom (ECG) monitoring might enhance the detection of paroxysmal atrial fibrillation (AF) in cryptogenic stroke or transient ischaemic attack (TIA) patients. A device that might be suitable for prolonged ECG monitoring is a smartphone-compatible ECG device (Kardia Mobile, Alivecor, San Francisco, CA, USA) that allows the patient to record a single-lead ECG without the presence of trained health care staff. The MOBILE-AF trial will investigate the effectiveness of the ECG device for AF detection in patients with cryptogenic stroke or TIA. In this paper, the rationale and design of the MOBILE-AF trial is presented. METHODS: For this international, multicentre trial, 200 patients with cryptogenic stroke or TIA will be randomised. One hundred patients will receive the ECG device and will be asked to record their ECG twice daily during a period of 1 year. One hundred patients will receive a 7-day Holter monitor. DISCUSSION: The primary outcome of this study is the percentage of patients in which AF is detected in the first year after the index ischaemic stroke or TIA. Secondary outcomes include markers for AF prediction, orally administered anticoagulation therapy changes, as well as the incidence of recurrent stroke and major bleeds. First results can be expected in mid-2019. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02507986 . Registered on 15 July 2015.


Assuntos
Fibrilação Atrial/diagnóstico , Telefone Celular , Eletrocardiografia/instrumentação , Ataque Isquêmico Transitório/etiologia , Aplicativos Móveis , Acidente Vascular Cerebral/etiologia , Potenciais de Ação , Administração Oral , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/fisiopatologia , Protocolos Clínicos , Dinamarca , Frequência Cardíaca , Hemorragia/induzido quimicamente , Humanos , Ataque Isquêmico Transitório/diagnóstico , Ataque Isquêmico Transitório/terapia , Países Baixos , Valor Preditivo dos Testes , Recidiva , Reprodutibilidade dos Testes , Projetos de Pesquisa , Fatores de Risco , Processamento de Sinais Assistido por Computador , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/terapia , Fatores de Tempo , Resultado do Tratamento
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