Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 16 de 16
Filtrar
1.
Lancet ; 402(10419): 2317-2325, 2023 12 16.
Artigo em Inglês | MEDLINE | ID: mdl-37972628

RESUMO

BACKGROUND: Calcific aortic stenosis is commonly treated using surgical or transcatheter aortic valve replacement; however, many patients are not considered suitable candidates for these interventions due to severe comorbidities and limited life expectancy. As such, non-invasive therapies might offer alternative therapeutic possibilities in these patients. This study aimed to assess the safety of non-invasive ultrasound therapy and its ability to improve valvular function by softening calcified valve tissue. METHODS: This prospective, multicentre, single-arm series enrolled 40 adult patients with severe symptomatic aortic valve stenosis at three hospitals in France, the Netherlands, and Serbia between March 13, 2019, and May 8, 2022. Patients were treated with transthoracically delivered non-invasive ultrasound therapy. Follow-ups were scheduled at 1, 3, 6, 12, and 24 months. The primary endpoints were procedure-related deaths within 30 days and improved valve function. We report the 6-month data. This study is registered at ClinicalTrials.gov, NCT03779620 and NCT04665596. FINDINGS: 40 high-risk patients with a mean Society of Thoracic Surgeons score of 5·6% (SD 4·4) and multiple severe comorbidities were included. The primary endpoint, procedure-related mortality, did not occur; furthermore, no life-threatening or cerebrovascular events were reported. Improved valve function was confirmed up to 6 months, reflected by a 10% increase in mean aortic valve area from 0·58 cm2 (SD 0·19) at baseline to 0·64 cm2 (0·21) at follow-up (p=0·0088), and a 7% decrease in mean pressure gradient from 41·9 mm Hg (20·1) to 38·8 mm Hg (17·8; p=0·024). At 6 months, the New York Heart Association score had improved or stabilised in 24 (96%) of 25 patients, and the mean Kansas City Cardiomyopathy Questionnaire score had improved by 33%, from 48·5 (SD 22·6) to 64·5 (21·0). One serious procedure-related adverse event occurred in a patient who presented with a transient decrease in peripheral oxygen saturation. Non-serious adverse events included pain, discomfort during treatment, and transient arrhythmias. INTERPRETATION: This novel, non-invasive ultrasound therapy for calcified aortic stenosis proved to be safe and feasible. FUNDING: Cardiawave.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Terapia por Ultrassom , Humanos , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Estudos de Coortes , Estudos Prospectivos , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento
2.
Rev. esp. cardiol. (Ed. impr.) ; 76(11): 872-880, Nov. 2023. tab, graf, ilus
Artigo em Espanhol | IBECS | ID: ibc-226971

RESUMO

Introducción y objetivos: La última generación de válvulas cardiacas expandibles con balón y autoexpandibles para implante percutáneo no se han comparado en valvulopatía aórtica bicúspide (VAB).Métodos: Registro multicéntrico de pacientes consecutivos con VAB y estenosis grave tratados con las válvulas cardiacas expandibles con balón (Myval y SAPIEN 3 Ultra [S3U]) o autoexpandible Evolut PRO+(EP+). Se realizó un análisis de tripletes mediante el software TriMatch para minimizar el impacto de las diferencias basales. El objetivo primario del estudio fue evaluar la tasa de éxito del dispositivo a 30 días y los objetivos secundarios, el objetivo combinado de seguridad y sus componentes individuales a 30 días.Resultados: Se incluyó a 360 pacientes (media de edad, 76,6±7,6 años; el 71,9% varones); 122 con Myval (33,9%), 129 con S3U (35,8%) y 109 con EP+(30,3%). La media de puntuación STS fue de 3,6±1,9%. No hubo ningún caso de oclusión coronaria, rotura de anillo, disección aórtica o mortalidad periprocedimiento. El evento primario de éxito del dispositivo a 30-días fue significativamente superior en el grupo que recibió Myval (Myval, 100%; S3U, 87,5%, y EP+, 81,3%), fundamentalmente a expensas de mayor gradiente residual con S3U y mayor tasa de insuficiencia aórtica al menos moderada con EP+. La tasa no ajustada de implante de marcapasos no presentó diferencias significativas.Conclusiones: En la VAB con estenosis grave y cirugía contraindicada, Myval, S3U y EP+tuvieron una seguridad comparable, aunque Myval presentó mejor gradiente residual que S3U y ambos dispositivos expandibles con balón resultaron en menos fuga perivalvular residual que EP+. Por lo tanto, ajustándose a los riesgos específicos de cada paciente, se puede seleccionar cualquiera de los 3 dispositivos con resultados óptimos.(AU)


Introduction and objectives: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis.Methods: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days.Results: A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation.Conclusions: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.(AU)


Assuntos
Humanos , Masculino , Feminino , Idoso , Idoso de 80 Anos ou mais , Próteses Valvulares Cardíacas/efeitos adversos , Estenose da Valva Aórtica , Valvas Cardíacas , Cardiologia , Doenças Cardiovasculares , Próteses Valvulares Cardíacas/estatística & dados numéricos , Próteses Valvulares Cardíacas/tendências
3.
Am Heart J ; 266: 168-175, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-37806333

RESUMO

The optimal treatment strategy for coronary bifurcation lesions by percutaneous coronary intervention (PCI) is complex and remains a subject of debate. Current guidelines advise a stepwise provisional approach with optional two-stent strategy. However, a two-stent strategy, both upfront and stepwise provisional, is technically demanding. Therefore, there is increasing interest in the use of drug-eluting balloons (DEB) in bifurcation lesions, mainly after a provisional approach with unsatisfactory result of the side branch. Some small pilot studies already showed that the use of DEB in bifurcation lesions is safe and feasible. However, a randomized comparison of this hybrid DEB strategy with a two-stent strategy is currently lacking. TRIAL DESIGN: The Hybrid DEB study is a prospective, multicenter, randomized controlled trial investigating noninferiority of a hybrid DEB approach, using a combination of a drug-eluting stent (DES) in the main vessel and DEB in the side branch, compared to stepwise provisional two-stent strategy in patients with true bifurcation lesions. A total of 500 patients with de novo true coronary bifurcation lesions, treated with a stepwise provisional approach and an unsatisfactory result of the side branch after main vessel stenting (≥ 70% stenosis and/or < thrombolysis in myocardial infarction III flow), will be randomized in a 1:1 ratio to receive either treatment with a DEB or with a DES in the side branch. The primary endpoint is a composite endpoint of the occurrence of all-cause death, periprocedural or spontaneous myocardial infarction and/or target vessel revascularization at the anticipated median 2-year follow-up. CONCLUSION: The Hybrid DEB study will compare in a multicenter, randomized fashion a hybrid DEB approach with a stepwise provisional two-stent strategy in patients with true bifurcation lesions. TRIAL REGISTRATION: ClinicalTrials.gov no. NCT05731687.


Assuntos
Angioplastia Coronária com Balão , Doença da Artéria Coronariana , Stents Farmacológicos , Infarto do Miocárdio , Intervenção Coronária Percutânea , Humanos , Intervenção Coronária Percutânea/efeitos adversos , Stents Farmacológicos/efeitos adversos , Angioplastia Coronária com Balão/efeitos adversos , Estudos Prospectivos , Angiografia Coronária/efeitos adversos , Stents/efeitos adversos , Infarto do Miocárdio/etiologia , Resultado do Tratamento , Doença da Artéria Coronariana/complicações
4.
EuroIntervention ; 19(9): 766-771, 2023 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-37605804

RESUMO

About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events. The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) is a multicentre, randomised clinical trial with open-label treatment and blinded endpoint assessment. Patients are randomised 1:1 to periprocedural continuation versus interruption of OAC and are stratified for vitamin K antagonist or direct oral anticoagulant use. The primary endpoint is a composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding within 30 days after TAVI, according to the Valve Academic Research Consortium-3 criteria. Secondary endpoints include separate individual and composite outcomes, quality of life and cost-effectiveness. Since continuation of OAC is associated with the ancillary benefit that it simplifies periprocedural management, the primary outcome is first analysed for non-inferiority; if non-inferiority is proven, superiority will be tested. Recruitment started in November 2020, and the trial will continue until a total of 858 patients have been included and followed for 90 days. In summary, POPular PAUSE TAVI is the first randomised clinical trial to assess the safety and efficacy of periprocedural continuation versus interruption of OAC in patients undergoing TAVI.


Assuntos
Estenose da Valva Aórtica , Substituição da Valva Aórtica Transcateter , Humanos , Qualidade de Vida , Anticoagulantes/uso terapêutico , Hemorragia , Resultado do Tratamento , Valva Aórtica/cirurgia , Fatores de Risco
5.
J Clin Med ; 12(13)2023 Jun 22.
Artigo em Inglês | MEDLINE | ID: mdl-37445248

RESUMO

BACKGROUND: The Myval balloon-expandable (BE) valve has shown encouraging early clinical data in terms of safety and efficacy. Comparative data with other well-established contemporary valves are nonetheless still scarce. This study aims to compare the performance of the Myval BE valve with the Evolut self-expanding (SE) valve. METHODS: In this retrospective single-center study, 223 patients with symptomatic severe aortic stenosis (AS) were included and treated with the Myval BE valve (n = 120) or with the Evolut SE valve (n = 103). Then, 91 pairs were compared after matching. Clinical outcomes were evaluated at 30 days and 1 year. Echocardiographic follow-up was performed at 30 days. RESULTS: Procedural complications were rare in both groups. At the 30-day follow-up, no significant difference in cardiac death (Myval: 1% vs. Evolut: 2%, p = 0.56), stroke (2% vs. 4%, p = 0.41) and myocardial infarction (1% vs. 3%, p = 0.31) was observed. A permanent pacemaker implantation (PPI) was significantly less needed in the Myval group (4% vs. 15%, p = 0.01). At 1 year, cardiac death (2% vs. 4%, p = 0.41) and the stroke rate (7% vs. 5%, p = 0.76) were similar. Moderate-severe paravalvular leakage (PVL) was also comparable in both groups (1% vs. 4%, p = 0.17). CONCLUSION: Safety and efficacy outcomes were comparable between the two valves, except for a higher PPI rate for the Evolut SE valve. Up to 1-year follow-up, clinical outcomes showed acceptable rates of stroke and cardiac death with both valves. Valve hemodynamics were excellent with a low rate of moderate-severe PVL in both groups.

6.
Rev Esp Cardiol (Engl Ed) ; 76(11): 872-880, 2023 Nov.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-36898524

RESUMO

INTRODUCTION AND OBJECTIVES: No comparisons have been published yet regarding the newest iteration of balloon- and self-expandable transcatheter heart valves for the treatment of bicuspid aortic valve (BAV) stenosis. METHODS: Multicenter registry of consecutive patients with severe BAV stenosis treated with balloon-expandable transcatheter heart valves (Myval and SAPIEN 3 Ultra, S3U) or self-expanding Evolut PRO+(EP+). TriMatch analysis was carried out to minimize the impact of baseline differences. The primary endpoint of the study was 30-day device success, and the secondary endpoints were the composite and individual components of early safety at 30 days. RESULTS: A total of 360 patients (age 76.6±7.6 years, 71.9% males) were included: 122 Myval (33.9%), 129 S3U (35.8%), and 109 EP+(30.3%). The mean STS score was 3.6±1.9%. There were no cases of coronary artery occlusion, annulus rupture, aortic dissection, or procedural death. The primary endpoint of device success at 30 days was significantly higher in the Myval group (Myval: 100%; S3U: 87.5%; and EP+: 81.3%), mainly due to higher residual aortic gradients with S3U and greater≥moderate aortic regurgitation (AR) with EP+. No significant differences were found in the unadjusted rate of pacemaker implantation. CONCLUSIONS: In patients with BAV stenosis deemed unsuitable for surgery, Myval, S3U and EP+showed similar safety but balloon-expandable Myval had better gradients than S3U, and both balloon-expandable devices had lower residual AR than EP+, suggesting that, taking into consideration the patient-specific risks, any of these devices can be selected with optimal outcomes.


Assuntos
Estenose da Valva Aórtica , Doença da Válvula Aórtica Bicúspide , Doenças das Valvas Cardíacas , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Masculino , Humanos , Idoso , Idoso de 80 Anos ou mais , Feminino , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Constrição Patológica , Resultado do Tratamento , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Doenças das Valvas Cardíacas/complicações , Doenças das Valvas Cardíacas/cirurgia , Doença da Válvula Aórtica Bicúspide/cirurgia , Desenho de Prótese
7.
Br J Neurosurg ; 37(1): 20-25, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-33241967

RESUMO

BACKGROUND: Endoscopic suturectomy with postoperative helmeting (ESCH) has emerged as a successful treatment for craniosynostosis, initially in North America. We report early outcomes from the first cohort of ESCH patients treated in the United Kingdom (UK). METHODS: Retrospective cohort study with electronic chart review. RESULTS: 18 consecutive patients from the first ESCH procedure in UK (May 2017) until January 2020 identified. 12 male and 6 female infantsd, with a mean age of 4.6 months (range 2.5-7.8 months) and weight of 6.8 kg (range 4.8-9.8 kg). Diagnoses were metopic (n = 8), unicoronal (n = 7), sagittal (n = 2) and multi-sutural (n = 1) synostoses. Median incision length was 3 cm (range 2-10 cm). 16/18 received no blood products, with 2 (both metopics) requiring transfusion (1 donor exposure). Mean operative time (including anaesthesia) was 96 min (range 40-127 min). Median length of hospital stay was 1 night. 1 surgical complication (superficial infection). All patients are currently undergoing helmet orthosis therapy. So far, no patients have required revisional or squint surgery. CONCLUSION: Early experience from the first UK cohort of ESCH suggests that this is a safe and well tolerated technique with low morbidity, transfusion and short hospital stay. Long-term results in terms of shape, cosmetic and developmental outcome are awaited.


Assuntos
Craniossinostoses , Humanos , Masculino , Feminino , Lactente , Estudos Retrospectivos , Resultado do Tratamento , Craniossinostoses/cirurgia , Endoscopia/métodos , Aparelhos Ortopédicos , Craniotomia
8.
J Interv Cardiol ; 2022: 3139476, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36320718

RESUMO

Objective: In TAVR, area sizing is used for balloon-expandable (BE) valves, whereas self-expanding valves are sized to annulus perimeter. For BE valves, this seems illogical: these frames force a circular shape even on an ellipsoid annulus. This can potentially lead to relative undersizing when area sizing is being applied. We developed a perimeter-based sizing algorithm to evaluate the safety and feasibility of perimeter sizing for the Myval BE valve. Methods: In this prospective single-center study, 60 patients with severe aortic stenosis treated with the Myval BE valve were included. Perimeter sizing was used with limited oversizing of 3.7% ± 1.3% compared to the annulus perimeter. After TAVR, clinical outcomes were evaluated at 30 days and 1 year. An echocardiographic follow-up took place at 30 days. Results: At 30 days, the need for PPI and stroke occurred in 2% and 3% of the patients, respectively. Moreover, cardiac death and moderate-severe PVL were absent. At 1-year, cardiac death and stroke were observed in 3% and 8% of the patients, respectively. In 33.3% of the patients, a larger valve size was implanted compared to the valve size calculated by area sizing. Conclusions: Perimeter sizing with the Myval BE valve leads to substantial use of larger valve sizes and favorable clinical outcomes, with low PPI and the absence of significant PVL. A randomized controlled trial is being planned to prove the superiority of this alternative sizing method.


Assuntos
Estenose da Valva Aórtica , Bioprótese , Próteses Valvulares Cardíacas , Acidente Vascular Cerebral , Substituição da Valva Aórtica Transcateter , Humanos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Projetos Piloto , Estudos Prospectivos , Tomografia Computadorizada Multidetectores/métodos , Acidente Vascular Cerebral/etiologia , Morte , Desenho de Prótese , Resultado do Tratamento
9.
Int J Cardiol ; 351: 25-31, 2022 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-34979152

RESUMO

BACKGROUND: Several studies have compared surface electrocardiographic changes following different self-expandable (SE) (Evolut (Medtronic, USA); Acurate (Boston Scientific, USA); Portico (Abbott, USA); and Allegra (NVT, Germany)) and balloon-expandable (BE) Sapien-3 (Edwards Lifesciences, USA) transcatheter heart valves. We aimed to compare these prosthesis with the novel Myval BE prosthesis (Meril Life, India). METHODS: Academic European registry of consecutive patients with severe aortic stenosis who received any of the 6 aforementioned valves. Baseline, post-procedural, and discharge 12­leads electrocardiograms (ECG) were centrally analyzed and compared. RESULTS: A total of 1131 patients were included: 135 Myval (11.9%), 290 Sapien-3 (25.6%), 298 Evolut (26.3%), 180 Acurate (15.9%), 125 Portico (11.1%), and 103 Allegra (9.1%). There were no baseline differences in intraventricular conduction disturbances rate. Compared to the novel BE Myval, there were similar procedural and in-hospital outcomes. Similar rates of early new permanent pacemaker implant (PPI) were observed amongst Myval (7.4%), Sapien-3 (13.4%), and Acurate (9.1%), but Evolut, Portico, and Allegra presented significantly higher rates (18.5%, p = 0.003; 29.5% p < 0.001 and 22%, p = 0.001, respectively). Central analysis of ECGs, unraveled significant prolongation of the PR segment with Evolut, Portico and Allegra whereas Evolut, Acurate, and Portico showed significant QRS widening compared to Myval. However, at discharge no differences in PR segment duration were observed while, Evolut, and Portico- but not Acurate, Allegra or Sapien-3 - still presented significant widening of QRS segment compared to Myval. CONCLUSIONS: After blinded central ECG analysis, the novel Myval balloon-expandable prosthesis was associated with a low rate of early conduction disturbances.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/cirurgia , Humanos , Desenho de Prótese , Resultado do Tratamento
10.
Catheter Cardiovasc Interv ; 99(3): 889-895, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34390296

RESUMO

OBJECTIVES: We aimed to describe hemodynamic performance and clinical outcomes at 30-day follow-up of the balloon-expandable (BE) Myval transcatheter heart valve (THV) in low-risk patients. BACKGROUND: The results of the next-generation BE Myval THV in low-risk aortic stenosis (AS) patients are still unknown. METHODS: Retrospective registry performed in nine European centers including patients with low predicted operative mortality risk according to Society of thoracic surgeons (STS) and European system for cardiac operative risk evaluation (EuroSCORE-II) scores. RESULTS: Between September 2019 and February 2021, a total of 100 patients (51% males, mean age 80 ± 6.5 years) were included. Mean STS score and EuroSCORE-II were 2.4 ± 0.8% and 2.2 ± 0.7%, respectively. Intermediate sizes were used in 39% (21.5 mm: 8%, 24.5 mm: 15%, 27.5 mm: 15%). There were no cases of valve embolization, coronary artery occlusion, annulus rupture, or procedural death. A definitive pacemaker implantation was needed in eight patients (8%). At 30-day follow-up aortic valve area (0.7 ± 0.2 vs. 2.1 ± 0.6 cm2 ) and mean aortic valve gradient (43.4 ± 11.1 vs. 9.0 ± 3.7 mmHg) improved significantly (p < 0.001). Moderate aortic regurgitation occurred in 4%. Endpoints of early safety and clinical efficacy were 3 and 1%, respectively. CONCLUSIONS: Hemodynamic performance and 30-day clinical outcomes of the BE Myval THV in low-risk AS patients were favorable. Longer-term follow-up is warranted.


Assuntos
Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/etiologia , Estenose da Valva Aórtica/cirurgia , Feminino , Humanos , Masculino , Desenho de Prótese , Estudos Retrospectivos , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
11.
Heart ; 108(9): 725-732, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-34285104

RESUMO

OBJECTIVES: The balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device. METHODS: Consecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index. RESULTS: A total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were included and 103 pairs compared after matching. Baseline characteristics were similar. Procedural success rate (Sapien-3: 94.2%; Myval: 93.2%, p=0.219), 30-day mortality (Sapien-3: 2.9%; Myval: 0.97%, p=0.625), clinical efficacy (12.6 vs 4.9%, p=0.057) and early safety (12.6 vs 4.9%, p=0.096) were comparable. There was a lower need for new permanent pacemaker (15.5 vs 5.8% p=0.020) with Myval. No significant differences were found in terms of ≥moderate aortic regurgitation (1% for Sapien-3, 0% for Myval, p=0.314), but mean gradients were higher following Sapien-3 than after Myval (p<0.001). CONCLUSIONS: The new Myval balloon-expandable THV was favourable in terms of safety, with low rate of permanent pacemaker and with favourable residual gradients and paravalvular leak rate according to blinded echocardiographic analysis.


Assuntos
Insuficiência da Valva Aórtica , Estenose da Valva Aórtica , Próteses Valvulares Cardíacas , Substituição da Valva Aórtica Transcateter , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Insuficiência da Valva Aórtica/diagnóstico por imagem , Insuficiência da Valva Aórtica/etiologia , Estenose da Valva Aórtica/diagnóstico por imagem , Estenose da Valva Aórtica/cirurgia , Hemodinâmica , Humanos , Desenho de Prótese , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento
12.
Eye (Lond) ; 36(1): 198-205, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-33674727

RESUMO

BACKGROUND/AIM: Post-operative uveitis is the most common complication after cataract surgery in the UK. The study aims to evaluate the risk of post-operative uveitis in cataract surgery patients of different ethnicity in the presence and absence of co-morbidities as well as operative complications using multivariate analysis. METHODS: A retrospective case-control study of patients undergoing phacoemulsification cataract surgery between January 2018 to December 2019 at two hospital sites. Differences in demographic and clinical characteristics were compared between two groups defined by the development of post-operative uveitis. Statistically significant factors in univariate analysis were further analysed using multivariate analysis to account for confounders. RESULTS: One thousand and five hundred eighty seven eyes had undergone phacoemulsification cataract operations with 104 (6.6%) developing post-operative uveitis. Compared to eyes of White/Mixed/Other ethnicity, Asian and Afro-Caribbean eyes were associated with a twofold (OR 2.02, 95% CI 1.16-3.52, P = 0.013) and fivefold (OR 5.15, 95% CI 2.85-9.29, P < 0.001) risk of post-operative uveitis, respectively. Complicated surgery involving eyes with small pupil/iris hooks/Malyugin ring (OR 2.70, 95% CI 1.16-6.30, P = 0.022) and posterior capsular rupture (OR 6.00, 95% CI 2.55-14.12, P < 0.001) were associated with an increased risk of post-operative uveitis. CONCLUSIONS: The factors significantly associated with a post-operative uveitis outcome were patients of Asian and Afro-Caribbean ethnicity, small intra-operative pupil size, use of iris hooks or Malyugin ring and PCR. The post-operative management plan should be tailored in these group of patients with a view of early assessment and prompt management of symptoms.


Assuntos
Opacificação da Cápsula , Catarata , Facoemulsificação , Uveíte , Opacificação da Cápsula/cirurgia , Estudos de Casos e Controles , Catarata/complicações , Humanos , Iris/cirurgia , Facoemulsificação/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Estudos Retrospectivos , Fatores de Risco , Uveíte/complicações , Uveíte/etiologia , Acuidade Visual
13.
Surg Endosc ; 35(7): 3787-3795, 2021 07.
Artigo em Inglês | MEDLINE | ID: mdl-32804266

RESUMO

BACKGROUND: Laparoscopic skill acquisition involves a steep learning curve and laparoscopic suturing is an exceptionally challenging task. By improving the way feedback is given, trainees can learn these skills more effectively. This study aims to establish the most effective form of structured feedback on laparoscopic suturing skill acquisition in novices, by comparing the effects of expert verbal feedback, video review with expert feedback (video feedback), and video review with self-assessment. METHODS: A prospective randomized blinded trial comparing verbal feedback, video feedback, and self-assessment. Novices in laparoscopic surgery were tasked with performing laparoscopic suturing with intracorporeal knot tying. Time was given for practice, and pre- and post-feedback assessments were undertaken. Suturing performance was measured using a task-specific checklist and global ratings. A post-study questionnaire was used to measure participant-perceived confidence, knowledge, and experience levels. RESULTS: Fifty-one participants were randomized and allocated equally into the three groups. Performance in all three groups improved significantly from baseline. Video feedback had the largest improvement margin with checklist and global score improvements of 17.1% (± 9.9%) and 14.7% (± 9.3%), respectively. Performance improvements between groups were statistically significant in the global components (p = 0.004) but not the checklist components (p = 0.186). Global score improvement was significantly better in the video feedback group but was statistically insignificant between the self-assessment and verbal feedback groups. Questionnaire responses demonstrated positive results in confidence, knowledge, and experience levels, across all three study groups, with no differences between the groups (p > 0.05). CONCLUSION: Structured video feedback facilitates reflection and self-directed learning, which improves the ability to develop proficiency in surgical skills. Combining both self-assessment and video feedback may be beneficial over verbal feedback alone due to the advantages of video review. These techniques should therefore be considered for implementation into surgical education curricula.


Assuntos
Laparoscopia , Autoavaliação (Psicologia) , Competência Clínica , Retroalimentação , Humanos , Curva de Aprendizado , Estudos Prospectivos , Técnicas de Sutura , Gravação em Vídeo
14.
Future Cardiol ; 16(3): 151-158, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32048879

RESUMO

Endovascular baroreflex amplification is an alternative treatment strategy for patients with resistant hypertension. In endovascular baroreflex, the carotid baroreflex is activated by a MobiusHD® device (MD) which has been implanted in the internal carotid artery. This review will discuss the MD technology and mechanism of action and promising results in the first-in-human prospective study involving the use of the MD in patients with resistant hypertension.


Assuntos
Anti-Hipertensivos/uso terapêutico , Barorreflexo/fisiologia , Pressão Sanguínea/efeitos dos fármacos , Hipertensão/fisiopatologia , Humanos , Hipertensão/tratamento farmacológico
15.
Eur Heart J Case Rep ; 4(4): 1-4, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33426430

RESUMO

BACKGROUND: Embolization of a Watchman device in patients undergoing percutaneous left atrial appendage (LAA) closure is a rare complication. Retrieval of the device can be achieved percutaneously with a snaring technique or a bioptome. CASE SUMMARY: We present an illustrative case of Watchman closure device embolization during an LAA closure attempt in a 77-year-old man. The complication was caused by anatomical restraints of the LAA, in particular limited depth resulting in poor stability of the closure device after implantation. By the use of a double snaring technique, however, we managed to retrieve the device percutaneously. By applying such strategy, a more invasive surgical approach can be prevented. DISCUSSION: Prompt response is needed when embolization of a Watchman device occurs. A snaring technique can be used in most cases to attempt device retrieval. A double snaring technique is in this case associated with higher retrieval success than a single snaring technique.

16.
Pathog Glob Health ; 110(3): 119-29, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-27215933

RESUMO

Dengue is hyperendemic in Indonesia. In 2015, reported cases of dengue fever doubled those of 2014 in the Jambi municipality of Sumatra. We examined viral aetiology and its relationship with disease outcome in Jambi. Dengue-suspected patients' sera were collected and NS1 detection and IgM/IgG serology were performed. Dengue virus (DENV) serotyping was performed using real-time RT-PCR. Envelope genes were sequenced to determine the genotypes of DENV. Clinical, haematologic, and demographic data were recorded. Of 210 dengue-suspected patients, 107 were confirmed. The disease manifested as Dengue Fever (62%), Dengue Haemorrhagic Fever (36%), and Dengue Shock Syndrome (2%). The serotypes of 94 DENV were determined. All DENV serotypes were detected with DENV-1 as the predominant serotype (66%). Genotypically, the DENV-1 viruses belong to Genotype I, DENV-2 was of Cosmopolitan genotype, DENV-3 as Genotype I, and DENV-4 belonged to Genotype II. Comparison with historical data revealed serotype predominance switched from DENV-3 to DENV-1, and the replacement of Genotype IV of DENV-1 with Genotype I. In summary, DENV-1 predominated during the 2015 dengue outbreak in Jambi. The full spectrum of dengue disease occurred and was characterized by a switch in predominant serotypes.


Assuntos
Vírus da Dengue/genética , Vírus da Dengue/isolamento & purificação , Dengue/epidemiologia , Dengue/virologia , Sequência de Aminoácidos , Dengue/fisiopatologia , Vírus da Dengue/química , Surtos de Doenças , Doenças Endêmicas , Monitoramento Epidemiológico , Evolução Molecular , Feminino , Genes Virais , Genótipo , Humanos , Indonésia/epidemiologia , Masculino , Reação em Cadeia da Polimerase em Tempo Real , Sorotipagem
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...