RESUMO
BACKGROUND: Physiotherapy prior to open-heart surgery lowers the rate of pneumonia and length of the hospital stay. Pneumonia is a major contributor to short-term mortality following transcatheter aortic valve replacement (TAVR). Hence, we hypothesized that pre- and intensified postprocedural physiotherapy in patients undergoing TAVR might impact the net functional and clinical outcome. METHODS AND RESULTS: The 4P-TAVR study was a prospective, monocentric, randomized trial. The study was designed to compare the efficacy and safety of intensified periprocedural physiotherapy including inspiratory muscle training versus standard postprocedural physiotherapy. Patients were randomized in a 1 : 1 fashion. 108 patients were included and followed up for 90 days after TAVR. While patients in group A (control group: 50 patients, age: 81.7 ± 5.0 years, 52% male) did not receive physiotherapy prior to TAVR, group B (intervention group: 58 patients, age: 82.2 ± 5.82 years, 47% male) participated in intensive physiotherapy. Compared to the control group, patients in the interventional group showed a lower incidence of postinterventional pneumonia (10 [20.0%] vs. 3 [5.1%], p=0.016) and had a 3-day shorter mean hospital stay (13.5 ± 6.1 days vs. 10.1 ± 4.7 days, p=0.02). The primary composite endpoint of mortality and rehospitalization was not different between the groups. CONCLUSION: Intensified physiotherapy is safe and has positive effects on clinical outcomes up to 90 days after TAVR but has no impact on the primary combined endpoint of mortality and rehospitalization. Longer follow-up, a multicenter design, and a higher number of subjects are needed to confirm these preliminary results. This trial is registered with DRKS00017239.
Assuntos
Estenose da Valva Aórtica , Modalidades de Fisioterapia , Pneumonia/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Substituição da Valva Aórtica Transcateter , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/cirurgia , Feminino , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Pneumonia/etiologia , Pneumonia/mortalidade , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/mortalidade , Estudos Prospectivos , Fatores de Risco , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/reabilitação , Resultado do TratamentoRESUMO
After aortic valve stenosis, mitral regurgitation (MR) is the second most common valvular disease, particulary affecting older patients. Optimal medical treatment within the context of heart failure therapy is the favored first-line therapy for secondary MR. If symptoms persist despite optimal medical therapy, surgical or transcatheter mitral valve repair is indicated (recommendation class IIb). In contrast, surgical treatment is essential for patients with symptomatic primary MR and left-ventricular ejection fraction (LVEF) >30% and justifiable perioperative risk (repair preferred over replacement, recommendation class I); for high-risk patients, interventional transcatheter mitral valve repair (especially by "edge-to-edge-reconstruction") is a viable option (recommendation class IIb).Recently, transcatheter mitral valve replacement (TMVR) has come into focus as another attractive treatment option and is currently under intensive research. At first, the TMVR was used both for patients with symptomatic insufficiency or stenosis after biological mitral valve replacement (Bio-MKE) or after reconstruction as a "valve-in-valve" or "valve-in-ring" procedure. Therefore, transcatheter aortic valve prostheses were used.In the past few years several dedicated TMVR prostheses were developed for the treatment of native MR. So far, no TMVR prosthesis is CE-certified. All of the following TMVR methods are under clinical evaluation in the scope of pivotal trials. The interdisciplinary heart team, consisting of experienced cardiologists and heart surgeons develops a patient-specific, individual treatment concept considering the particular MR etiology, pre-existing comorbidities, age, clinical symptoms, and status.
Assuntos
Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Cateterismo Cardíaco , Humanos , Valva Mitral , Insuficiência da Valva Mitral/cirurgia , Resultado do TratamentoRESUMO
The heart team, consisting of conservative cardiologists, cardiac surgeons and interventional cardiologists, is important for a balanced, multidisciplinary decision-making process for patients suffering from coronary artery disease (CAD). Standard evidence-based, interdisciplinary, institutional protocols can be used for commonly encountered case scenarios to avoid the need for a systematic case by case review. Complex cases with a SYNTAX score of more than 32, diabetes mellitus and lesions of the left main stem or three-vessel disease should in general not be treated by an ad hoc percutaneous coronary intervention (PCI) but first discussed in the heart team. Culprit lesion PCI is usually the first choice in most patients with acute coronary syndrome. If complete percutaneous revascularization is not possible, coronary artery bypass grafting (CABG) should be considered by the heart team. In patients assigned for CABG, timing of the procedure should be decided on an individual basis, depending on the symptoms, hemodynamic stability, coronary anatomy and signs of ischemia. In stabilized patients with acute coronary syndrome, the choice of revascularization modality can be made in analogy to patients with stable CAD.
Assuntos
Cardiologia/normas , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Revascularização Miocárdica/normas , Equipe de Assistência ao Paciente/normas , Cuidados Pré-Operatórios/normas , Europa (Continente) , Humanos , Revascularização Miocárdica/instrumentação , Revascularização Miocárdica/métodos , Seleção de PacientesRESUMO
Transcatheter aortic valve implantation (TAVI) is the new standard-of-care for inoperable patients with superior outcome compared to conservative management including balloon valvuloplasty. In high-risk patients, TAVI has shown non-inferiority compared with surgical aortic valve replacement. Although data from national multi-centre registries are very encouraging and use of TAVI in intermediate risk patients has been discussed, it is of note that the commercially available and currently used transcatheter heart valves (THV) have not yet been assessed by randomized clinical trials in those patients. New technology advances promise to simplify TAVI and to improve outcome by reducing the rate of TAVI-specific issues such as paravalvular aortic regurgitation (PAR), annular rupture, and conduction disturbances. A reduction in the incidence and severity of PAR represents an obvious target for technical improvements in the design of upcoming "next generation" THVs and of implantation techniques including repositioning/recapturing features, paravalvular sealing techniques, and precise peri-interventional imaging modalities.
Assuntos
Valva Aórtica/cirurgia , Cateterismo Cardíaco , Procedimentos Endovasculares/métodos , Implante de Prótese de Valva Cardíaca/métodos , Próteses Valvulares Cardíacas , Terapias em Estudo , Idoso , Insuficiência da Valva Aórtica/prevenção & controle , Insuficiência da Valva Aórtica/cirurgia , Estenose da Valva Aórtica/cirurgia , Arritmias Cardíacas/prevenção & controle , Cateterismo Cardíaco/instrumentação , Cateterismo Cardíaco/métodos , Procedimentos Endovasculares/instrumentação , Ruptura Cardíaca/prevenção & controle , Implante de Prótese de Valva Cardíaca/instrumentação , Humanos , Estudos Multicêntricos como Assunto , Complicações Pós-Operatórias/prevenção & controle , Desenho de Prótese , Ensaios Clínicos Controlados Aleatórios como Assunto , Sistema de RegistrosRESUMO
The effect of respiratory infectious diseases on STEMI incidence, but also STEMI care is not well understood. The Influenza 2017/2018 epidemic and the COVID-19 pandemic were chosen as observational periods to investigate the effect of respiratory virus diseases on these outcomes in a metropolitan area with an established STEMI network. We analyzed data on incidence and care during the COVID-19 pandemic, Influenza 2017/2018 epidemic and corresponding seasonal control periods. Three comparisons were performed: (1) COVID-19 pandemic group versus pandemic control group, (2) COVID-19 pandemic group versus Influenza 2017/2018 epidemic group and (3) Influenza 2017/2018 epidemic group versus epidemic control group. We used Student's t-test, Fisher's exact test and Chi square test for statistical analysis. 1455 patients were eligible. The daily STEMI incidence was 1.49 during the COVID-19 pandemic, 1.40 for the pandemic season control period, 1.22 during the Influenza 2017/2018 epidemic and 1.28 during the epidemic season control group. Median symptom-to-contact time was 180 min during the COVID-19 pandemic. In the pandemic season control group it was 90 min (p = 0.183), and in the Influenza 2017/2018 cohort it was 90 min, too (p = 0.216). Interval in the epidemic control group was 79 min (p = 0.733). The COVID-19 group had a door-to-balloon time of 49 min, corresponding intervals were 39 min for the pandemic season group (p = 0.038), 37 min for the Influenza 2017/2018 group (p = 0.421), and 38 min for the epidemic season control group (p = 0.429). In-hospital mortality was 6.1% for the COVID-19 group, 5.9% for the Influenza 2017/2018 group (p = 1.0), 11% and 11.2% for the season control groups. The respiratory virus diseases neither resulted in an overall treatment delay, nor did they cause an increase in STEMI mortality or incidence. The registry analysis demonstrated a prolonged door-to-balloon time during the COVID-19 pandemic.
Assuntos
Pandemias , Infarto do Miocárdio com Supradesnível do Segmento ST , COVID-19 , Epidemias , Humanos , Incidência , Pessoa de Meia-IdadeRESUMO
This article provides information and commentaries on trials which were presented at the Hotline and Clinical Trial Update Sessions during the Late Breaking Clinical Trial Sessions at the 60th annual meeting of the American College of Cardiology in New Orleans, USA, from 2nd April to 5th April 2011. This article gives an overview on a number of novel clinical trials in the field of cardiovascular medicine, which were presented. The comprehensive summaries have been generated from the oral presentation and the webcasts of the American College of Cardiology, similar as previously reported (Gensch et al. Clin Res Cardiol 100:1-9, 2011; Lenski et al. Clin Res Cardiol 99:679-692, 2010) and should provide the readers with the most comprehensive information of relevant publications. The data were presented by leading experts in the field with relevant positions in the trials.
Assuntos
Cardiologia , Doenças Cardiovasculares/terapia , Ensaios Clínicos como Assunto , Sistema de Registros , Humanos , Sociedades Médicas , Estados UnidosRESUMO
This article provides information and commentaries on trials, which were presented during the Hotline Sessions at the 77th annual spring meeting of the German Society of Cardiology in Mannheim, Germany, from April 27 to 30, 2011. This article summarizes a number of important, novel clinical trials in the field of cardiovascular medicine. The comprehensive summaries have been generated from the oral presentation from the authors as previously reported [1] and should provide the readers with the most comprehensive information of relevant publications. The data were presented by leading experts in the field with relevant positions in the trials.
Assuntos
Doenças Cardiovasculares/terapia , Ensaios Clínicos como Assunto , Sistema de Registros , Cardiologia , Humanos , Sociedades MédicasRESUMO
This article provides information and commentaries on trials which were presented at the Hotline and Clinical Trial Update Sessions during the Late Breaking Clinical Trial Sessions European Society of Cardiology Congress, held in Paris, France, from 27th to 31st August 2011. This article gives an overview on a number of novel clinical trials in the field of cardiovascular medicine, which were presented. The data have been presented by leading experts in the accordant field with relevant positions in the trials. Unpublished reports should be considered as preliminary data as the analysis may change in the final publications. The comprehensive summaries have been generated from the oral presentation and the webcasts of the European Society of Cardiology, similar as previously reported (Lenski et al. in Clin Res Cardiol Off J Ger Card Soc 99: 679-692, 2010) and should provide the readers with the most comprehensive information of relevant publications. The data were presented by leading experts in the field with relevant positions in the trials.