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1.
Heart Rhythm ; 20(9): 1238-1245, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37211146

RESUMO

BACKGROUND: Freedom from atrial arrhythmia (AA) recurrence ≥30 seconds after pulsed field ablation (PFA) in patients with atrial fibrillation (AF) was reported in PULSED AF (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF; ClinialTrials.gov Identifier: NCT04198701). AA burden may be a more clinically meaningful endpoint. OBJECTIVE: The purpose of this study was to determine the influence of monitoring strategies on AA detection and AA burden association with quality of life (QoL) and health care utilization (HCU) after PFA. METHODS: Patients underwent 24-hour Holter monitoring at 6 and 12 months and weekly, and symptomatic transtelephonic monitoring (TTM). AA burden post-blanking was calculated as the greater of (1) percentage of AA on total Holter time; or (2) percentage of weeks with ≥1 TTM with AA out of all weeks with ≥1 TTM. RESULTS: Freedom from all AAs varied by >20% when differing monitoring strategies were used. PFA resulted in zero burden in 69.4% of paroxysmal atrial fibrillation (PAF) and 62.2% of persistent atrial fibrillation (PsAF) patients. Median burden was low (<9%). Most PAF and PsAF patients had ≤1 week of AA detection on TTM (82.6% and 75.4%) and <30 minutes of AA per day of Holter monitoring (96.5% and 89.6%), respectively. Only PAF patients with <10% AA burden averaged a clinically meaningful (>19 point) QoL improvement. PsAF patients experienced clinically meaningful QoL improvements irrespective of burden. Repeat ablations and cardioversions significantly increased with higher AA burden (P <.01). CONCLUSION: The ≥30-second AA endpoint is dependent on the monitoring protocol used. PFA resulted in low AA burden for most patients, which was associated with clinically relevant improvement in QoL and reduced AA-related HCU.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Veias Pulmonares , Humanos , Qualidade de Vida , Resultado do Tratamento , Ablação por Cateter/métodos , Aceitação pelo Paciente de Cuidados de Saúde , Recidiva , Veias Pulmonares/cirurgia
2.
Circ Arrhythm Electrophysiol ; 16(4): e011237, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-36891899

RESUMO

BACKGROUND: Radiofrequency catheter ablation (RFCA) is an established treatment for atrial fibrillation (AF) refractory to antiarrhythmic drugs. The economic value of RFCA in delaying disease progression has not been quantified. METHODS: An individual-level, state-transition health economic model estimated the impact of delayed AF progression using RFCA versus antiarrhythmic drug treatment for a hypothetical sample of patients with paroxysmal AF. The model incorporated the lifetime risk of progression from paroxysmal AF to persistent AF, informed by data from the ATTEST (Atrial Fibrillation Progression Trial). The incremental effect of RFCA on disease progression was modeled over a 5-year duration. Annual crossover rates were also included for patients in the antiarrhythmic drug group to mirror clinical practice. Estimates of discounted costs and quality-adjusted life years asssociated with health care utilization, clinical outcomes, and complications were projected over patients' lifetimes. RESULTS: From the payer's perspective, RFCA was superior to antiarrhythmic drug treatment with an estimated mean net monetary benefit per patient of $8516 ($148-$16 681), driven by reduced health care utilization, cost, and improved quality-adjusted life years. RFCA reduced mean (95% CI) per-patient costs by $73 (-$2700 to $2200), increased mean quality-adjusted life years by 0.084 (0.0-0.17) and decreased the mean number of cardiovascular-related health care encounters by 24%. CONCLUSIONS: RFCA is a dominant (less costly and more effective) treatment strategy for patients with AF, especially those with early AF for whom RFCA could delay progression to advanced AF. Increased utilization of RFCA-particularly among patients earlier in their disease progression-may provide clinical and economic benefits.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Fibrilação Atrial/tratamento farmacológico , Antiarrítmicos/uso terapêutico , Resultado do Tratamento , Ablação por Cateter/efeitos adversos , Progressão da Doença , Recidiva
3.
Europace ; 24(12): 1917-1925, 2022 Dec 09.
Artigo em Inglês | MEDLINE | ID: mdl-36026521

RESUMO

AIMS: Pulmonary vein isolation (PVI) either by balloon devices or radiofrequency forms the cornerstone of invasive atrial fibrillation (AF) treatment. Although equally effective cryoballoon (CB)-based PVI offers shorter procedure duration and a better safety profile. Beside the worldwide established Arctic Front Advance system, a novel CB device, POLARx, was recently introduced. This CB incorporates unique features, which may translate into improved efficacy and safety. However, multicentre assessment of periprocedural efficacy and safety is lacking up to date. METHODS AND RESULTS: A total of 317 patients with paroxysmal or persistent AF were included and underwent POLARx CB-based PVI in 6 centres from Germany and Italy. Acute efficacy and safety were assessed in this prospective multicenter observational study. In 317 patients [mean age: 64 ± 12 years, 209 of 317 (66%) paroxysmal AF], a total of 1256 pulmonary veins (PVs) were identified and 1252 (99,7%) PVs were successfully isolated utilizing mainly the short tip POLARx CB (82%). The mean minimal CB temperature was -57.9 ± 7°C. Real-time PVI was registered in 72% of PVs. The rate of serious adverse events was 6.0% which was significantly reduced after a learning curve of 25 cases (9.3% vs. 3.0%, P = 0.018). The rate of recurrence-free survival after mean follow-up of 226 ± 115 days including a 90-day blanking period was 86.1%. CONCLUSION: In this large multicentre assessment, the novel POLARx CB shows a promising efficacy and safety profile after a short learning curve.


Assuntos
Fibrilação Atrial , Ablação por Cateter , Criocirurgia , Veias Pulmonares , Humanos , Pessoa de Meia-Idade , Idoso , Veias Pulmonares/cirurgia , Ablação por Cateter/métodos , Estudos Prospectivos , Resultado do Tratamento , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/cirurgia , Fibrilação Atrial/etiologia
4.
Clin Res Cardiol ; 110(6): 810-821, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32719917

RESUMO

INTRODUCTION: Pericardial access for ablation of ventricular arrhythmias (VA) can be gained either by an anterior-oriented or inferior-oriented epicardial puncture under fluoroscopical guidance. We retrospectively sought to assess the safety of these two puncture techniques and the incidence of epicardial adhesions and introduce our algorithm for management of pericardial tamponade. METHODS AND RESULTS: In 211 patients (61.4 ± 15.6 years, 179 males; 84.8%) 271 epicardial ablation procedures of VA were performed using either an anterior- or inferior-oriented approach for epicardial access. Puncture-related complications were systematically analyzed. Furthermore, the incidence of adhesions was evaluated during first and repeated procedures. A total of 34/271 (12.5%) major complications occurred and 23/271 (8.5%) were directly related to epicardial puncture. The incidence of puncture-related major complications in the anterior and inferior group was 4/82 (4.9%) and 19/189 (10.1%), respectively. Pericardial tamponade was the most common major complication (15/271; 5.5%). Collateral damages of adjacent structures such as liver, colon, gastric vessels and coronary arteries occurred in 6/189 (3.2%) patients and only within the inferior epicardial access group. Adhesions were documented in 19/211 (9%) patients during the first procedure and in 47.1% if patients had 2 or more procedures involving epicardial access. CONCLUSION: Anterior-oriented epicardial puncture shows an observed association to a reduced incidence of pericardial tamponades and overall puncture-related complications in epicardial ablation of VA. In cases of repeated epicardial access adhesions increase significantly and may lead to ablation failure.


Assuntos
Ablação por Cateter/métodos , Gerenciamento Clínico , Pericárdio/cirurgia , Complicações Pós-Operatórias/epidemiologia , Punções/efeitos adversos , Taquicardia Ventricular/cirurgia , Aderências Teciduais/epidemiologia , Algoritmos , Ablação por Cateter/efeitos adversos , Feminino , Fluoroscopia/métodos , Seguimentos , Alemanha/epidemiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Pericárdio/diagnóstico por imagem , Complicações Pós-Operatórias/terapia , Punções/métodos , Estudos Retrospectivos , Cirurgia Assistida por Computador , Taquicardia Ventricular/diagnóstico , Aderências Teciduais/etiologia , Resultado do Tratamento
5.
JACC Cardiovasc Interv ; 13(10): 1251-1261, 2020 05 25.
Artigo em Inglês | MEDLINE | ID: mdl-32360260

RESUMO

OBJECTIVES: The aim of this study was to assess the value of echocardiographic right ventricular (RV) and systolic pulmonary artery pressure (sPAP) assessment in predicting transcatheter tricuspid edge-to-edge valve repair (TTVR) outcome. BACKGROUND: RV dysfunction and pulmonary hypertension are associated with poor prognosis and are systematically sought during tricuspid regurgitation evaluation. The value of echocardiographic assessment in predicting TTVR outcome is unknown. METHODS: Data were taken from the TriValve (Transcatheter Tricuspid Valve Therapies) registry, which includes patients undergoing TTVR at 14 European and North American centers. The primary outcome was 1-year survival free from hospitalization for heart failure, and secondary outcomes were 1-year survival and absence of hospital admission for heart failure at 1 year. RESULTS: Overall, 249 patients underwent TTVR between June 2015 and 2018 (mean tricuspid annular plane systolic excursion [TAPSE] 15.8 ± 15.3 mm, mean sPAP 43.6 ± 16.0 mm Hg). Tricuspid regurgitation grade ≥3+ was found in 96.8% of patients at baseline and 29.4% at final follow-up; 95.6% were in New York Heart Association functional class III or IV initially, compared with 34.3% at follow-up (p < 0.05). Final New York Heart Association functional class did not differ among TAPSE and sPAP quartiles, even when both low TAPSE and high sPAP were present. Rates of 1-year survival and survival free from hospitalization for heart failure were 83.9% and 78.7%, respectively, without significant differences according to baseline echocardiographic RV characteristics (TAPSE, fractional area change, and end-diastolic area) and sPAP (p > 0.05 for all). CONCLUSIONS: TTVR provides clinical improvement, with 1-year survival free from hospital readmission >75% in patients with severe tricuspid regurgitation. Conventional echocardiographic parameters used to assess RV function and sPAP did not predict clinical outcome after TTVR.


Assuntos
Pressão Arterial , Cateterismo Cardíaco , Ecocardiografia , Artéria Pulmonar/diagnóstico por imagem , Insuficiência da Valva Tricúspide/terapia , Função Ventricular Direita , Pressão Ventricular , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/efeitos adversos , Progressão da Doença , Europa (Continente) , Feminino , Insuficiência Cardíaca/etiologia , Insuficiência Cardíaca/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , América do Norte , Valor Preditivo dos Testes , Estudos Prospectivos , Artéria Pulmonar/fisiopatologia , Recuperação de Função Fisiológica , Sistema de Registros , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Insuficiência da Valva Tricúspide/complicações , Insuficiência da Valva Tricúspide/diagnóstico por imagem , Insuficiência da Valva Tricúspide/fisiopatologia
6.
Echocardiography ; 37(3): 380-387, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-32049400

RESUMO

OBJECTIVES: The aim of this study was to investigate reliability and accuracy of noninvasive measurement method by echocardiography compared to invasive measurement of systolic pulmonary artery pressure (SPAP) in a large cohort of aortic stenosis (AS) patients. BACKGROUND: Pulmonary hypertension (PH) is common in patients with cardiac disease, especially in left heart disease like severe AS. Invasive measurement by right heart catheterization (RHC) is the gold standard to assess pulmonary pressures. Nevertheless, echocardiography is widely used in everyday practice for estimation of pulmonary pressures and diagnosing PH. METHODS: A total of 1400 patients with AS and full invasive hemodynamic assessment by RHC and noninvasive measurements by Doppler echocardiography were included. RESULTS: Mean patient age was 81.5 ± 6.8 years, and 46.3% were males. SPAP was 44.7 ± 15.1 mm Hg by echocardiography and 45.3 ± 15.2 mm Hg by RHC. Pearson's correlation coefficient was r = .820 (P < .0001). Bland-Altman analysis showed a bias of -0.56 mm Hg (95% limits of agreement -18.38 to + 17.26 mm Hg) and 80.6% measurement accuracy. Pulmonary hypertension defined by RHC as a mean PAP ≥25 mm Hg was reliably diagnosed via an echocardiographically measured SPAP of >40 mm Hg (82.2% sensitivity, 80.2% specificity, 83.1% positive predictive value, 79.2% negative predictive value). CONCLUSIONS: In a large cohort of patients with severe aortic stenosis, we could demonstrate a very good correlation of SPAP between Doppler echocardiography and invasive RHC measurement. Pulmonary hypertension could be diagnosed by echocardiography with high sensitivity and specificity.


Assuntos
Estenose da Valva Aórtica , Cateterismo Cardíaco , Artéria Pulmonar , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/diagnóstico por imagem , Ecocardiografia Doppler , Feminino , Humanos , Masculino , Artéria Pulmonar/diagnóstico por imagem , Reprodutibilidade dos Testes
7.
Catheter Cardiovasc Interv ; 95(4): 819-829, 2020 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-31233278

RESUMO

OBJECTIVES: Information on gender-related differences in terms of baseline characteristics and clinical outcome of patients undergoing MitraClip® implantation in daily clinical practice have been studied in smaller populations previously. This study sought to additionally evaluate gender-related differences in a larger German real-world patient population. METHODS AND RESULTS: We analyzed data from the prospective and multicenter German TRAMI Registry. Between 08/2010 and 07/2013 327 women and 501 men underwent MitraClip® implantation for significant mitral valve regurgitation. Female patients were significantly older and showed higher rates of frailty compared to men. In contrast, men had significantly higher rates of comorbidities compared to women. The majority of patients underwent MitraClip® implantation for secondary mitral regurgitation, with no significant gender-related differences. MitraClip® treatment was equally effective in terms of procedural results and residual mitral regurgitation in women and men and complication rates were low. However, in this real-world analysis severe bleeding complications were significantly higher in women (p = .02) and re-intervention rates were significantly higher in men after MitraClip® treatment (p = .02). Women showed less improvement in functional NYHA class after MitraClip® treatment compared to men at 1-year follow-up (FU; p < .001). No significant differences between female and male patients were found in 1-year mortality and in re-hospitalization rates. CONCLUSION: In this analysis from a large prospective, multicenter real-world registry MitraClip® implantation is safe and effective for treatment of significant mitral regurgitation with equal postprocedural results and mortality rates during 1-year follow-up. Men and women showed a persisting and significant clinical benefit at 1-year FU after treatment. Complication and re-intervention rates were low. Additional studies are needed to further evaluate our findings on increased bleeding complications and decreased functional improvement in women at 1-year follow-up after MitraClip® therapy.


Assuntos
Cateterismo Cardíaco/tendências , Disparidades em Assistência à Saúde/tendências , Implante de Prótese de Valva Cardíaca/tendências , Insuficiência da Valva Mitral/cirurgia , Prolapso da Valva Mitral/cirurgia , Valva Mitral/cirurgia , Idoso , Idoso de 80 Anos ou mais , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/mortalidade , Feminino , Alemanha , Disparidades nos Níveis de Saúde , Próteses Valvulares Cardíacas/tendências , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Implante de Prótese de Valva Cardíaca/mortalidade , Humanos , Masculino , Valva Mitral/diagnóstico por imagem , Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Insuficiência da Valva Mitral/fisiopatologia , Prolapso da Valva Mitral/diagnóstico por imagem , Prolapso da Valva Mitral/mortalidade , Prolapso da Valva Mitral/fisiopatologia , Complicações Pós-Operatórias/mortalidade , Complicações Pós-Operatórias/terapia , Estudos Prospectivos , Sistema de Registros , Medição de Risco , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Resultado do Tratamento
8.
Pol Arch Intern Med ; 129(9): 586-591, 2019 09 30.
Artigo em Inglês | MEDLINE | ID: mdl-31389403

RESUMO

INTRODUCTION: A study by the European Society of Cardiology assessing international educational needs has identified educational and organizational barriers preventing the implementation of optimal therapy of atrial fibrillation (AF) across European countries. OBJECTIVES: Our aim was to investigate educational and organizational barriers in the implementation of guideline­recommended AF care that are specific to physicians and health-care system in Poland. PATIENTS AND METHODS: An internet­based survey was conducted to assess education, skills, and confidence in managing patients with AF among European cardiologists, neurologists, and family physicians (FPs) from 6 countries. RESULTS: Out of 571 respondents, the Polish sample included 90 physicians (16%): 44 cardiologists (15%), 21 neurologists (16%), and 25 FPs (18%). Polish physicians generally reported skills and confidence similar to those presented by their foreign colleagues, but there was high uncertainty concerning skills and confidence in the identification and pathophysiological classification of AF. Also, FPs reported low confidence in applying CHA2DS2­VASc and HAS­BLED scores to clinical practice. The need for access to long­term heart rhythm monitoring including implantable loop recorders was highlighted. There was a general dissatisfaction with the cooperation among Polish physicians, which was significantly higher than in other countries. CONCLUSIONS: The number of substantial educational gaps among physicians from Poland and other European countries is low. Nonetheless, educational programs tailored for different specialist groups separately to improve competence are warranted. There is a clear need for improvement of communication among different specialists treating patients with AF in Poland.


Assuntos
Fibrilação Atrial/terapia , Cardiologistas/normas , Competência Clínica/normas , Padrões de Prática Médica/normas , Adulto , Fibrilação Atrial/prevenção & controle , Cardiologia/normas , Gerenciamento Clínico , Europa (Continente) , Feminino , Fibrinolíticos/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Polônia , Guias de Prática Clínica como Assunto , Padrões de Prática Médica/estatística & dados numéricos , Sociedades Médicas/normas
9.
Circ Arrhythm Electrophysiol ; 11(5): e006204, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29700058

RESUMO

BACKGROUND: Data on predictors of long-term clinical outcomes after catheter ablation of atrial fibrillation (AF) are limited. We sought to assess the association of baseline covariates with clinical outcomes in the 750 patients with drug-refractory paroxysmal AF enrolled in FIRE AND ICE. METHODS: In a 2-part analysis, univariate and multivariable Cox regression models were first used to identify baseline patient characteristics predictive of catheter ablation efficacy determined by the clinical end points of (1) atrial arrhythmia recurrence (primary efficacy failure), (2) cardiovascular rehospitalization, and (3) repeat ablation. Propensity score stratification methods were then used to account for differences in baseline characteristics between sexes. RESULTS: Female sex (hazard ratio [HR], 1.37; 95% confidence interval [CI], 1.08-1.73; P=0.010) and prior direct current cardioversion (HR, 1.40; 95% CI, 1.07-1.82; P=0.013) were independently associated with atrial arrhythmia recurrence. Female sex (HR, 1.36; 95% CI, 1.02-1.80; P=0.035) and hypertension (HR, 1.48; 95% CI, 1.09-2.00; P=0.013) independently predicted cardiovascular rehospitalization. A longer history of AF (HR, 1.03; 95% CI, 1.00-1.06; P=0.039) increased the rate of repeat ablation. Women continued to have higher rates of primary efficacy failure and cardiovascular rehospitalization after propensity score adjustment, with adjusted HRs of 1.51 (95% CI, 1.16-2.18; P<0.05) and 1.40 (95% CI, 1.15-2.17; P<0.05), respectively. CONCLUSIONS: After catheter ablation of paroxysmal AF, female sex was associated with an almost 40% increase in the risks of primary efficacy failure and cardiovascular rehospitalization. Primary efficacy failure was also adversely impacted by a history of direct current cardioversion, whereas hypertension had a negative impact on cardiovascular rehospitalization. History of AF was the only predictor of repeat ablation. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01490814.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter , Frequência Cardíaca , Potenciais de Ação , Idoso , Antiarrítmicos/uso terapêutico , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Ablação por Cateter/efeitos adversos , Resistência a Medicamentos , Europa (Continente) , Feminino , Disparidades nos Níveis de Saúde , Frequência Cardíaca/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva , Reoperação , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Falha de Tratamento
10.
Europace ; 20(12): 1919-1928, 2018 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-29538637

RESUMO

Aims: Guideline-adherent treatment is associated with improved prognosis in atrial fibrillation (AF) patients but is insufficiently implemented in clinical practice. The European Society of Cardiology (ESC) performed a multinational educational needs assessment study among cardiologists, general practitioners/family physicians (GPs/FPs), and neurologists in order to evaluate knowledge and skills of physicians and system factors related to AF care delivery. Methods and results: A total of 561 physicians (294 cardiologists, 131 neurologists, and 136 GPs/FPs) from six European countries participated. This mixed-methods study included exploratory semi-structured qualitative interviews (n = 30) and a quantitative survey that included two clinical cases (n = 531). We identified eight key knowledge gaps and system barriers across all domains of AF care. A majority across all specialties reported skills needing improvement to classify AF pathophysiologically, rather than based on duration of episodes, and reported lack of availability of long-term electrocardiogram recording. Skills interpreting the CHA2DS2-VASc and the HAS-BLED scores were reported as needing improvement by the majority of neurologists (52% and 60%, respectively) and GPs/FPs (65% and 74%). Cardiologists calculated the CHA2DS2-VASc and HAS-BLED scores in 94%/70% in a presented case patient, but only 60%/49% of neurologists and 58%/42% of GPs/FPs did. There was much uncertainty on how to deal with anticoagulant therapy in complex patients. There was also a high disparity in using rate or rhythm control strategies, and indications for ablation. Information delivery to patients and communication between different specialties was often considered suboptimal, while national regulations and restrictions often hamper international guideline implementation. Conclusion: We identified major gaps in physicians' knowledge and skills across all domains of AF care, as well as system factors hampering guideline-compliant care implementation and communication. These gaps should be addressed by targeted educational and advocacy efforts.


Assuntos
Fibrilação Atrial/terapia , Cardiologistas/educação , Educação de Pós-Graduação em Medicina , Clínicos Gerais/educação , Fidelidade a Diretrizes , Necessidades e Demandas de Serviços de Saúde , Avaliação das Necessidades , Neurologistas/educação , Guias de Prática Clínica como Assunto , Padrões de Prática Médica , Lacunas da Prática Profissional , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/fisiopatologia , Cardiologistas/normas , Competência Clínica/normas , Educação de Pós-Graduação em Medicina/normas , Europa (Continente) , Feminino , Clínicos Gerais/normas , Fidelidade a Diretrizes/normas , Necessidades e Demandas de Serviços de Saúde/normas , Disparidades em Assistência à Saúde/normas , Humanos , Masculino , Avaliação das Necessidades/normas , Neurologistas/normas , Guias de Prática Clínica como Assunto/normas , Padrões de Prática Médica/normas , Lacunas da Prática Profissional/normas
11.
Europace ; 20(5): 733-738, 2018 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-28605436

RESUMO

The European Heart Rhythm Association (EHRA) held an Innovation Forum in February 2016, to consider issues around innovation. The objective of the forum was to extend the innovation debate outside of the narrow world of arrhythmia specialists and cardiology in general, and seek input from all stakeholders including regulators, strategists, technologists, industry, academia, health providers, medical societies, payers, and patients. Innovation is indispensable for a continuing improvement in health care, preferably at higher efficacy and lower costs. It requires people who have been trained in a good scientific environment, high-quality research for achieving ground breaking inventions and the certainty of return on innovation investments. In the context of cardiovascular disease, innovation can imply better risk assessment and stratification, device technology, drug development, and process design. Several areas of promising developments were identified as well as several roadblocks to innovation. To drive innovation forward all stakeholders need to play a significant role. In a globalized and extremely competitive world, the leading role of Europe in medical innovation can only be achieved through a combined and well-coordinated effort from all involved parties.


Assuntos
Arritmias Cardíacas , Tecnologia Biomédica , Terapias em Estudo/tendências , Arritmias Cardíacas/diagnóstico , Arritmias Cardíacas/terapia , Tecnologia Biomédica/métodos , Tecnologia Biomédica/organização & administração , Tecnologia Biomédica/tendências , Difusão de Inovações , Europa (Continente) , Humanos , Invenções , Informática Médica/tendências , Inovação Organizacional
12.
J Invasive Cardiol ; 29(7): 232-238, 2017 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-28667807

RESUMO

AIMS: Correct sizing of the ostium is a crucial step in left atrial appendage (LAA) occlusion procedures. However, unfavorable anatomy of the ostium often complicates the assessment of the true ostium diameter. We hypothesized that area-derived diameter (ADD) and perimeter-derived diameter (PDD) from three-dimensional transesophageal echocardiogram (3D-TEE) can facilitate this step of the procedure as compared with two-dimensional (2D) measurements. METHODS AND RESULTS: For 55 patients within the ALSTER-LAA registry, retrospective analysis of PDD and ADD was correlated with 2D measurements used during the procedure to ascertain correct size of the Watchman device (Boston Scientific). The observed data were put into relation to the calculated area of the device with 10%-30% compression and the clinical outcome after 30 days. 3D area and perimeter measurements of the LAA ostium matched the calculated range of the different device sizes. Recapture during implantation, gaps <5 mm, and device size changes were more often observed when ADDs would also have suggested the use of a larger device. CONCLUSION: 3D ADDs and PDDs are feasible to use in device size decisions. Employing these measurements may allow operators to further reduce intraprocedural recapture maneuvers, peridevice leakage, and device size changes.


Assuntos
Algoritmos , Apêndice Atrial/diagnóstico por imagem , Fibrilação Atrial/cirurgia , Procedimentos Cirúrgicos Cardíacos/instrumentação , Ecocardiografia Tridimensional/métodos , Ecocardiografia Transesofagiana/métodos , Acidente Vascular Cerebral/prevenção & controle , Idoso , Apêndice Atrial/cirurgia , Fibrilação Atrial/complicações , Fibrilação Atrial/diagnóstico , Cateterismo Cardíaco/métodos , Feminino , Humanos , Masculino , Tamanho do Órgão , Curva ROC , Estudos Retrospectivos , Acidente Vascular Cerebral/etiologia
13.
J Am Heart Assoc ; 6(8)2017 Jul 27.
Artigo em Inglês | MEDLINE | ID: mdl-28751544

RESUMO

BACKGROUND: This study sought to assess payer costs following cryoballoon or radiofrequency current (RFC) catheter ablation of paroxysmal atrial fibrillation in the randomized FIRE AND ICE trial. METHODS AND RESULTS: A trial period analysis of healthcare costs evaluated the impact of ablation modality (cryoballoon versus RFC) on differences in resource use and associated payer costs. Analyses were based on repeat interventions, rehospitalizations, and cardioversions during the trial, with unit costs based on 3 national healthcare systems (Germany [€], the United Kingdom [£], and the United States [$]). Total payer costs were calculated by applying standard unit costs to hospital stays, using International Classification of Diseases, 10th Revision diagnoses and procedure codes that were mapped to country-specific diagnosis-related groups. Patients (N=750) randomized 1:1 to cryoballoon (n=374) or RFC (n=376) ablation were followed for a mean of 1.5 years. Resource use was lower in the cryoballoon than the RFC group (205 hospitalizations and/or interventions in 122 patients versus 268 events in 154 patients). The cost differences per patient in mean total payer costs during follow-up were €640, £364, and $925 in favor of cryoballoon ablation (P=0.012, 0.013, and 0.016, respectively). This resulted in trial period total cost savings of €245 000, £140 000, and $355 000. CONCLUSIONS: When compared with RFC ablation, cryoballoon ablation was associated with a reduction in resource use and payer costs. In all 3 national healthcare systems analyzed, this reduction resulted in substantial trial period cost savings, primarily attributable to fewer repeat ablations and a reduction in cardiovascular rehospitalizations with cryoballoon ablation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Identifier: NCT01490814.


Assuntos
Fibrilação Atrial/economia , Fibrilação Atrial/cirurgia , Cateterismo Cardíaco/economia , Ablação por Cateter/economia , Criocirurgia/economia , Custos Hospitalares , Fibrilação Atrial/diagnóstico , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Cateteres Cardíacos/economia , Ablação por Cateter/efeitos adversos , Redução de Custos , Análise Custo-Benefício , Criocirurgia/efeitos adversos , Criocirurgia/instrumentação , Cardioversão Elétrica/economia , Europa (Continente) , Humanos , Tempo de Internação/economia , Readmissão do Paciente/economia , Retratamento/economia , Medicina Estatal/economia , Fatores de Tempo , Resultado do Tratamento , Estados Unidos
14.
Europace ; 18(5): 635-7, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-26467405

RESUMO

Across Europe, the role of the welfare state is constantly being questioned and even eroded. At the same time, funding sources for post-graduate medical education and training are under attack as regulators review the working relationships between physicians and industry. Both of these issues have profound consequences for cardiologists and their patients, and were, therefore, chosen as the themes of the European Heart Rhythm Association (EHRA) 2014 Spring Summit held at Heart House, Sophia Antipolis, 25-26 March 2014. The meeting noted that some of the changes are already affecting patient care standards and that this is exacerbated by a reduction in research and education programmes. The principle conclusion was that EHRA must find better means of engagement with the authorities across Europe to ensure that its views are considered and that ethical patient care is preserved. Participants were particularly alarmed by the example from Sweden in which future healthcare planning appears to exclude the views of physicians, although this is not yet the case in other countries. The demand for greater transparency in relationships between physicians and industry was also discussed. Although intended to eliminate corruption, concern was expressed that such moves would cause long-term damage to education and research, threatening the future of congresses, whose role in these areas appears underestimated by the authorities.


Assuntos
Atenção à Saúde/economia , Educação Médica/tendências , Congressos como Assunto , Europa (Continente) , Humanos , Seguro Saúde , Assistência ao Paciente/normas , Seguridade Social , Sociedades Médicas/economia
15.
Europace ; 17 Suppl 1: i1-75, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25616426

RESUMO

AIMS: There has been large variations in the use of invasive electrophysiological therapies in the member countries of the European Society of Cardiology (ESC). The aim of this analysis was to provide comprehensive information on cardiac implantable electronic device (CIED) and catheter ablation therapy trends in the ESC countries over the last five years. METHODS: The European Heart Rhythm Association (EHRA) has collected data on CIED and catheter ablation therapy since 2008. Last year 49 of the 56 ESC member countries provided data for the EHRA White Book. This analysis is based on the current and previous editions of the EHRA White Book. Data on procedure rates together with information on economic aspects, local reimbursement systems and training activities are presented for each ESC country and the five geographical ESC regions. RESULTS: In 2013, the electrophysiological procedure rates per million population were highest in Western Europe followed by the Southern and Northern European countries. The CIED implantation and catheter ablation rate was lowest in the Eastern European and in the non-European ESC countries, respectively. However, in some Eastern European countries with relative low gross domestic product procedure rates exceeded those of some wealthier Western countries, suggesting that economic resources are not the only driver for utilization of arrhythmia therapies. CONCLUSION: These statistics indicate that despite significant improvements, there still is considerable heterogeneity in the availability of arrhythmia therapies across the ESC area. Hopefully, these data will help identify areas for improvement and guide future activities in cardiac arrhythmia management.


Assuntos
Fibrilação Atrial/terapia , Terapia de Ressincronização Cardíaca/estatística & dados numéricos , Ablação por Cateter/estatística & dados numéricos , Desfibriladores Implantáveis/estatística & dados numéricos , Técnicas Eletrofisiológicas Cardíacas/estatística & dados numéricos , Marca-Passo Artificial/estatística & dados numéricos , Certificação , Coleta de Dados , Europa (Continente) , Europa Oriental , Produto Interno Bruto , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Fatores Socioeconômicos
17.
Europace ; 16(1): 109-28, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-24265466

RESUMO

Several new devices for the treatment of heart failure (HF) patients have been introduced and are increasingly used in clinical practice or are under clinical evaluation in either observational and/or randomized clinical trials. These devices include cardiac contractility modulation, spinal cord stimulation, carotid sinus nerve stimulation, cervical vagal stimulation, intracardiac atrioventricular nodal vagal stimulation, and implantable hemodynamic monitoring devices. This task force believes that an overview on these technologies is important. Special focus is given to patients with HF New York Heart Association Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex. An overview on potential device options in addition to optimal medical therapy will be helpful for all physicians treating HF patients.


Assuntos
Determinação da Pressão Arterial/instrumentação , Insuficiência Cardíaca/diagnóstico , Insuficiência Cardíaca/prevenção & controle , Marca-Passo Artificial , Estimulação da Medula Espinal/instrumentação , Terapia Assistida por Computador/instrumentação , Estimulação do Nervo Vago/instrumentação , Desenho de Equipamento/métodos , Europa (Continente) , Medicina Baseada em Evidências , Humanos , Avaliação da Tecnologia Biomédica
18.
Europace ; 15(7): 927-36, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23729412

RESUMO

Implantations of cardiac devices therapies and ablation procedures frequently depend on accurate and reliable imaging modalities for pre-procedural assessments, intra-procedural guidance, detection of complications, and the follow-up of patients. An understanding of echocardiography, cardiovascular magnetic resonance imaging, nuclear cardiology, X-ray computed tomography, positron emission tomography, and vascular ultrasound is indispensable for cardiologists, electrophysiologists as well as radiologists, and it is currently recommended that physicians should be trained in several imaging modalities. There are, however, no current guidelines or recommendations by electrophysiologists, cardiac imaging specialists, and radiologists, on the appropriate use of cardiovascular imaging for selected patient indications, which needs to be addressed. A Policy Conference on the use of imaging in electrophysiology and device management, with representatives from different expert areas of radiology and electrophysiology and commercial developers of imaging and device technologies, was therefore jointly organized by European Heart Rhythm Association (EHRA), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology (ESCR). The objectives were to assess the state of the level of evidence and a first step towards a consensus document for currently employed imaging techniques to guide future clinical use, to elucidate the issue of reimbursement structures and health economy, and finally to define the need for appropriate educational programmes to ensure clinical competence for electrophysiologists, imaging specialists, and radiologists.


Assuntos
Estimulação Cardíaca Artificial/normas , Cardiologia/normas , Ablação por Cateter/normas , Diagnóstico por Imagem/normas , Cardioversão Elétrica/normas , Técnicas Eletrofisiológicas Cardíacas/normas , Sociedades Médicas/normas , Estimulação Cardíaca Artificial/economia , Cardiologia/economia , Cardiologia/educação , Ablação por Cateter/economia , Consenso , Análise Custo-Benefício , Desfibriladores Implantáveis/normas , Diagnóstico por Imagem/economia , Diagnóstico por Imagem/métodos , Educação Médica , Cardioversão Elétrica/economia , Cardioversão Elétrica/instrumentação , Técnicas Eletrofisiológicas Cardíacas/economia , Europa (Continente) , Medicina Baseada em Evidências , Custos de Cuidados de Saúde , Humanos , Reembolso de Seguro de Saúde , Marca-Passo Artificial/normas
19.
Europace ; 13 Suppl 2: ii39-43, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21518748

RESUMO

In the last decade, catheter ablation (CA) became a viable therapeutic approach for symptomatic patients with atrial fibrillation (AF) non-responsive to antiarrhythmic drugs (AAD). The economic analysis of CA is complex due to the presence of several confounding factors, such as the pattern of AF (paroxysmal AF, persistent or long-term persistent AF), the patient population (age, presence/absence of underlying structural heart disease, comorbidities, etc.), the different techniques for ablation (with impact on complexity and cost of the procedure, as well as on efficacy and safety), and the learning curve and experience of an individual centre (with impact on efficacy and cost effectiveness). At present, CA appears to be cost effective mainly in patients with paroxysmal AF who are refractory to AADs, especially if the success of the procedure and, thus, the benefit in quality of life remains >5 years, with a low complication rate. More data are needed on cost effectiveness of CA of persistent and long-term persistent AF or of AF associated with heart failure. Atrial fibrillation ablation is unlikely to be cost effective for patients who have preserved quality of life despite their AF or for patients whose quality of life is not expected to improve substantially despite elimination of AF (e.g. patients with poor quality of life mainly due to other health problems). These observations may help in the selection of candidates for AF ablation.


Assuntos
Arritmias Cardíacas/economia , Arritmias Cardíacas/cirurgia , Ablação por Cateter/economia , Atenção à Saúde/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Hospitalização/economia , Arritmias Cardíacas/mortalidade , Ablação por Cateter/estatística & dados numéricos , Análise Custo-Benefício , Europa (Continente)/epidemiologia , Humanos , Investimentos em Saúde/estatística & dados numéricos , Prevalência , Análise de Sobrevida , Taxa de Sobrevida
20.
JACC Cardiovasc Imaging ; 3(6): 555-62, 2010 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-20541709

RESUMO

OBJECTIVES: The aim of this analysis was to assess the diagnostic importance of pressure recovery in evaluation of aortic stenosis (AS) severity. BACKGROUND: Although pressure recovery has previously been demonstrated to be particularly important in assessment of AS severity in groups of patients with moderate AS or small aortic roots, it has never been evaluated in a large clinical patient cohort. METHODS: Data from 1,563 patients in the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study was used. Inner aortic diameter was measured at annulus, sinus, sinotubular junction, and supracoronary level. Aortic valve area index (AVAI) was calculated by continuity equation and pressure recovery and pressure recovery adjusted AVAI (energy loss index [ELI]), by validated equations. Primarily, sinotubular junction diameter was used to calculate pressure recovery and ELI, but pressure recovery and ELI calculated at different aortic root levels were compared. Severe AS was identified as AVAI and ELI < or =0.6 cm(2)/m(2). Patients were grouped into tertiles of peak transaortic velocity. RESULTS: Pressure recovery increased with increasing peak transaortic velocity. Overestimation of AS severity by unadjusted AVAI was largest in the lowest tertile and if pressure recovery was assessed at the sinotubular junction. In multivariate analysis, a larger difference between AVAI and ELI was associated with lower peak transaortic velocity (beta = 0.35) independent of higher left ventricular ejection fraction (beta = -0.049), male sex (beta = -0.075), younger age (beta = 0.093), and smaller aortic sinus diameter (beta = 0.233) (multiple R(2) = 0.18, p < 0.001). Overall, 47.5% of patients classified as having severe AS by AVAI were reclassified to nonsevere AS when pressure recovery was taken into account. CONCLUSIONS: For accurate assessment of AS severity, pressure recovery adjustment of AVA must be routinely performed. Estimation of pressure recovery at the sinotubular junction is suggested.


Assuntos
Estenose da Valva Aórtica/diagnóstico por imagem , Valva Aórtica/diagnóstico por imagem , Ecocardiografia Doppler , Hemodinâmica , Idoso , Anticolesterolemiantes/uso terapêutico , Valva Aórtica/efeitos dos fármacos , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/tratamento farmacológico , Estenose da Valva Aórtica/fisiopatologia , Azetidinas/uso terapêutico , Quimioterapia Combinada , Europa (Continente) , Ezetimiba , Feminino , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Interpretação de Imagem Assistida por Computador , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Prospectivos , Recuperação de Função Fisiológica , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Sinvastatina/uso terapêutico , Resultado do Tratamento , Função Ventricular Esquerda
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