Ring Fracture of Brazilian Aortic Valve Bioprostheses Using Non-Compliant High-Pressure Transcatheter Balloon, an Ex Vivo Test

ABSTRACT Introduction: Aortic valve bioprostheses ring fracture in valve-in-valve procedures has shown low complication rates and presents as an option in the treatment of patients at high risk for conventional surgery, avoiding high transvalvular gradients, which are associated with increased mortality. Some prostheses available in the market cannot be fractured. In an ex vivo test, the possibility of ring fracture of aortic valve bioprostheses produced in Brazil when submitted to radial force application using a high-pressure non-compliant balloon was evaluated. Methods: One unit of each aortic valve bioprosthesis model, sizes 19 and 21 mm, produced by Brazilian companies (Braile Biomédica, Cardioprótese, and Labcor), was used. In the experiment, a non-compliant high-pressure balloon (Atlas®-Gold), 1 mm larger than the external diameter of the prosthesis, was positioned inside the valve annulus and inflated gradually aiming to fracture the prosthesis. Fracture pressures and photographic and radiological images of the prostheses before and after test were recorded. Results: All prostheses were fractured. In the models with metal ring, the fracture pressures were between 23 and 25 atm. In the other prostheses, the rupture occurred between 10 and 13 atm. No deformations in the structure were observed, which could potentially damage the aortic root. Conclusion: All the Brazilian prostheses evaluated were fractured, although the presence of a metal ring in the prosthesis framework increases the pressure required for fracture. The information obtained helps in the planning of valve-in-valve procedures in patients with aortic valve bioprostheses.

Ring Fracture of Brazilian Aortic Valve Bioprostheses Using Non-Compliant High-Pressure Transcatheter Balloon, an Ex Vivo Test.

INTRODUCTION: Aortic valve bioprostheses ring fracture in valve-in-valve procedures has shown low complication rates and presents as an option in the treatment of patients at high risk for conventional surgery, avoiding high transvalvular gradients, which are associated with increased mortality. Some prostheses available in the market cannot be fractured. In an ex vivo test, the possibility of ring fracture of aortic valve bioprostheses produced in Brazil when submitted to radial force application using a high-pressure non-compliant balloon was evaluated. METHODS: One unit of each aortic valve bioprosthesis model, sizes 19 and 21 mm, produced by Brazilian companies (Braile Biomédica, Cardioprótese, and Labcor), was used. In the experiment, a non-compliant high-pressure balloon (Atlas®-Gold), 1 mm larger than the external diameter of the prosthesis, was positioned inside the valve annulus and inflated gradually aiming to fracture the prosthesis. Fracture pressures and photographic and radiological images of the prostheses before and after test were recorded. RESULTS: All prostheses were fractured. In the models with metal ring, the fracture pressures were between 23 and 25 atm. In the other prostheses, the rupture occurred between 10 and 13 atm. No deformations in the structure were observed, which could potentially damage the aortic root. CONCLUSION: All the Brazilian prostheses evaluated were fractured, although the presence of a metal ring in the prosthesis framework increases the pressure required for fracture. The information obtained helps in the planning of valve-in-valve procedures in patients with aortic valve bioprostheses.

Hemodynamic and Imaging Assessment of Transcatheter Aortic Valve Replacement with the Inovare® Proseal using Multislice Computed Tomography.

OBJECTIVE: To evaluate the hemodynamic performance (i.e., gradients and paravalvular leakage [PVL]) of the new and experimental Braile Inovare® Proseal. Additionally, we aimed to assess pre and postoperatively the aortic annulus and the transcatheter prosthesis using multislice computed tomography (MSCT). METHODS: Patients were selected by a multidisciplinary heart team and referred for transcatheter aortic valve replacement (TAVR). MSCT was performed before and after surgery. Measurements of the aortic valve and prosthesis were conducted and correlated with the valve gradient and residual PVL. RESULTS: Twenty-one patients were selected for the protocol. Patients had a mean age of 79 years and 38% of them were of female sex. The mean EuroSCORE II value was 12.5%±10.8. Mean gradient was reduced from 45.8±11.04 mmHg to 5.59±2.61 mmHg and there were no instances of PVL worse than mild. There were no cases of coronary obstruction or procedural death. Circularity was present in all prostheses evaluated. Circularity indexes for the prostheses were: inflow 0.05±0.03, middle third 0.04±0.02, and outflow 0.04±0.02 (P=0.08). The mean distance between the prosthesis and the left and right coronary ostia were 14.8 mm±3.3 and 17.3 mm±3, respectively. Oversizing was appropriate with a mean of 22.14%±6%. CONCLUSION: Braile Inovare® Proseal transcatheter device has demonstrated low gradients with low rates of PVL. Oversizing by annular measurements was adequate. MSCT was adequate to evaluate device sizing and has demonstrated preserved expansibility and circularity in the evaluated cases.

Hemodynamic and imaging assessment of transcatheter aortic valve replacement with the inovare® proseal using multislice computed tomography

Abstract Objective: To evaluate the hemodynamic performance (i.e., gradients and paravalvular leakage [PVL]) of the new and experimental Braile Inovare® Proseal. Additionally, we aimed to assess pre and postoperatively the aortic annulus and the transcatheter prosthesis using multislice computed tomography (MSCT). Methods: Patients were selected by a multidisciplinary heart team and referred for transcatheter aortic valve replacement (TAVR). MSCT was performed before and after surgery. Measurements of the aortic valve and prosthesis were conducted and correlated with the valve gradient and residual PVL. Results: Twenty-one patients were selected for the protocol. Patients had a mean age of 79 years and 38% of them were of female sex. The mean EuroSCORE II value was 12.5%±10.8. Mean gradient was reduced from 45.8±11.04 mmHg to 5.59±2.61 mmHg and there were no instances of PVL worse than mild. There were no cases of coronary obstruction or procedural death. Circularity was present in all prostheses evaluated. Circularity indexes for the prostheses were: inflow 0.05±0.03, middle third 0.04±0.02, and outflow 0.04±0.02 (P=0.08). The mean distance between the prosthesis and the left and right coronary ostia were 14.8 mm±3.3 and 17.3 mm±3, respectively. Oversizing was appropriate with a mean of 22.14%±6%. Conclusion: Braile Inovare® Proseal transcatheter device has demonstrated low gradients with low rates of PVL. Oversizing by annular measurements was adequate. MSCT was adequate to evaluate device sizing and has demonstrated preserved expansibility and circularity in the evaluated cases.

A New Experimental Device for Transapical Access of the Aortic and Mitral Valves as well as the Aorta in its Various Segments.

OBJECTIVE:: To present the results of a new experimental device developed to facilitate the transapical access in endovascular treatment of structural heart diseases. It aims to reduce the risk of bleeding and complications in this type of access and demonstrate the device as a safe, fast and effective alternative. METHODS:: CorPoint is composed of three parts: introducer, base with coiled spring, and closing capsule. By rotating movements, the spring is introduced into the myocardium and progressively approaches the base to the surface of the heart. Guidewires and catheters are inserted through the hollow central part and, at the end of the procedure, the capsule is screwed over the base, therefore stopping any bleeding. RESULTS:: The device was implanted in 15 pigs, weighing 60 kg each, through an anterolateral thoracotomy, while catheters were introduced and guided by fluoroscopy. All animals had minimal bleeding; introducers with diameter up to 22 Fr were used and various catheters and guidewires were easily handled. After finishing the procedure, the closing capsule was attached and no bleeding was observed at the site. CONCLUSION:: This new device has proved effective, fast and secure for the transapical access. This shows great potential for use, especially by ensuring an easier and direct access to the mitral and aortic valves; the shortest distance to be traveled by catheters; access to the ascending and descending aorta; decreased bleeding complications; decreased surgical time; and the possibility of allowing the technique to evolve and become totally percutaneous.

A new experimental device for transapical access of the aortic and mitral valves as well as the aorta in its various segments

Abstract Objective: To present the results of a new experimental device developed to facilitate the transapical access in endovascular treatment of structural heart diseases. It aims to reduce the risk of bleeding and complications in this type of access and demonstrate the device as a safe, fast and effective alternative. Methods: CorPoint is composed of three parts: introducer, base with coiled spring, and closing capsule. By rotating movements, the spring is introduced into the myocardium and progressively approaches the base to the surface of the heart. Guidewires and catheters are inserted through the hollow central part and, at the end of the procedure, the capsule is screwed over the base, therefore stopping any bleeding. Results: The device was implanted in 15 pigs, weighing 60 kg each, through an anterolateral thoracotomy, while catheters were introduced and guided by fluoroscopy. All animals had minimal bleeding; introducers with diameter up to 22 Fr were used and various catheters and guidewires were easily handled. After finishing the procedure, the closing capsule was attached and no bleeding was observed at the site. Conclusion: This new device has proved effective, fast and secure for the transapical access. This shows great potential for use, especially by ensuring an easier and direct access to the mitral and aortic valves; the shortest distance to be traveled by catheters; access to the ascending and descending aorta; decreased bleeding complications; decreased surgical time; and the possibility of allowing the technique to evolve and become totally percutaneous.

Cardiovascular behavior during rehabilitation after coronary artery bypass grafting / Comportamento cardiovascular durante a reabilitação após cirurgia de revascularização do miocárdio

OBJECTIVE: The aim of the present study was to assess the behavior of cardiovascular variables during an in-hospital cardiovascular rehabilitation program in patients following myocardial revascularization surgery. METHODS: A total of 14 patients (mean age: 55.4 ± 6.4 years, 78.6 percent male) participated in the study, all of whom had a previous diagnosis of coronary insufficiency and indication for elective surgery. The protocol consisted of a group of low-impact (2-3 METs) upper/lower extremity and walking exercises performed both pre and post-operatively (3rd and 4th days). The following variables were evaluated at rest and following the exercise program: heart rate (HR, bpm); systolic arterial pressure (SAP, mmHg); diastolic arterial pressure (DAP, mmHg); mean arterial pressure (MAP, mmHg); double product (DPr, bpm/mmHg); and the Rating of Perceived Exertion (RPE) scale. RESULTS: There was a significant increase in HR and DPr in the individual analysis (P<0.001) as well as in between days (P<0.001 for HR and P<0.05 for DPr), but only attaining maximal values that were < 30 percent of predicted. Moreover, a negative correlation was found between the RPE scale and both SAP and MAP. CONCLUSION: The exercises proposed proved to be safe with the change in key physiologic variables throughout the experiment below recommended values for the hospitalization phase. Furthermore, the RPE scale appears to have a correlation with some hemodynamic variables and thus may be a useful tool for this group of patients.

OBJETIVO: O objetivo do presente estudo foi avaliar o comportamento das variáveis cardiovasculares durante um programa de reabilitação cardiovascular hospitalar em pacientes submetidos à cirurgia de revascularização do miocárdio. MÉTODOS: Um total de 14 pacientes (idade média: 55,4 ± 6,4 anos, 78,6 por cento do sexo masculino) participaram do estudo, todos apresentavam diagnóstico prévio de insuficiência coronariana e indicação de cirurgia eletiva. O protocolo consistiu de um grupo de exercícios de baixo impacto (2-3 METs) para extremidade superior e inferior e exercícios de caminhada realizados no pré e pós-operatório (3 e 4 dias). As seguintes variáveis foram avaliadas em repouso e após o programa de exercício: frequência cardíaca (FC, bpm), pressão arterial sistólica (PAS, mmHg), pressão arterial diastólica (PAD, mmHg), pressão arterial média (MAP,mmHg), duplo produto (DPr, bpm/mmHg) e escala de Índice de Percepção de Esforço (IPE). RESULTADOS: Houve aumento significativo da FC e DPr na análise individual (P <0,001), bem como na análise entre os dias de avaliação (P <0,001 para FC e P <0,05 para DPr), mas apenas atingindo valores máximos que foram < 30 por cento do previsto. Além disso, ocorreu correlação negativa entre a escala IPE e SAP e MAP. CONCLUSÃO: Os exercícios propostos mostraram-se seguros com a mudança de variáveis fisiológicas fundamentais em todo o experimento abaixo do valor recomendado para a fase de hospitalização. Além disso, a escala percepção de esforço parece ter correlação com algumas variáveis hemodinâmicas e, portanto, pode ser uma ferramenta útil para este grupo de pacientes.

Tratamento endovascular nos aneurismas verdadeiros e na dissecção aórtica do tipo B: fase intra-hospitalar, seguimento de médio prazo e uma reflexão sobre seleção de pacientes / Endovascular treatment of aortic aneurysms and type B dissections: in-hospital results, mid-term follow-up and a consideration of patient selection

Introdução: O tratamento endovascular das doenças da aorta é procedimento estabelecido, mas com resultados tardios e diferenças nos resultados entre diferentes grupos demográficos ainda desconhecidos. Método: No período de dezembro de 1996 a dezembro de 2004, 92 pacientes com aneurismas verdadeiros ou úlcera penetrante de aorta em posição torácica (G1) e 130 pacientes com dissecção aórtica do tipo B ou hematoma intramural (G2) foram submetidos a tratamento endovascular primário ou secundário. Na fase hospitalar, sucesso clínico foi considerado como exclusão da lesão, sem morte ou conversão cirúrgica. Falência tardia foi definida pela ocorrência de morte por qualquer causa, conversão cirúrgica ou reintervenção. Resultados: A média de idade do G1 foi de 65 ± 11 anos e de 56 ± 11 anos no G2 (P < 0,0001). Quanto aos dados demográficos, destacou-se a alta frequência de acidente vascular cerebral prévio no G1 (8,7% vs. 0; P = 0,0007). Sucesso clínico do procedimento foi obtido em 71% do G1 e em 84% dos pacientes do G2 (P = 0,02), com maior mortalidade intra-hospitalar no G1 (14% vs. 4,6%; P = 0,01). Complicações neurológicas foram semelhantes (6,5% vs. 3%; P = 0,32), com discreto predomínio de paraplegia no G1 (3,2% vs. 0,8%; P = 0,3). Em seguimento de 33 ± 27 meses, falência tardia foi atingida em 60% (28/47) dos pacientes do G1 e em 43% (31/74) do G2 (P = 0,09). Conclusão: Resultados em pacientes com aneurismas verdadeiros submetidos a tratamento endovascular são discretamente inferiores aos de pacientes com dissecção aórtica do tipo B. Isso pode ser explicado pelas diferenças demográficas entre os grupos e pelas dificuldades técnicas inerentes à anatomia. O conhecimento dessas peculiaridades permite a melhor seleção de pacientes nos quais o procedimento será eficaz em reduzir a mortalidade.

Background: Endovascular treatment of thoracic aortic diseases is a well established procedure although late results and differences among demographic groups are unknown. Method: From December/1996 to December/ 2004, 92 patients with true aneurysms or penetrating ulcers (G1) and 130 patients with type B dissection or intramural hematoma (G2) were submitted to primary or complementary endovascular treatment. Clinical success was defined as sustained technical success without death or surgical conversion. Late failure was defined as death of any cause, surgical conversion or re-intervention. Results: G1 mean age was 65 ± 11 years and 56 ± 11 years in G2 (P < 0.0001). A high frequency of previous stroke was observed in G1 (8.7% vs. 0; P = 0.0007). Clinical success was observed in 71% in G1 and 84% in G2 (P = 0.02) with higher in-hospital death rates in G1 (14% vs. 4.6%; P = 0.01). Neurologic complications were similar (6.5% vs. 3%, respectively; P = 0.32), with a mild prevalence of paraplegia in G1 (3.2% vs. 0.8%; P = 0.3). Late failure rates of 60% were observed in G1 and 43% in G2 (P = 0.09) at 33 ± 27 months of follow-up. Conclusions: Endovascular treatment in patients with true aneurysms may be slightly inferior to those achieved in patients with type B dissection. This might be due to demographic differences between groups and technical difficulties related to aortic anatomy. The knowledge and understanding of these peculiarities enables better patient selection for theprocedure resulting in decreased mortality rates.

Utilização de endoprótese auto-expansível (stent) introduzida através da artéria femoral para tratamento de dissecção da aorta descendente / Utilization of self-expandable prosthesis (stent) introduced through the femoral artery for treatment of dissection of the descending aorta

PURPOSE: We present four cases of dissection of the thoracic descending aorta that underwent treatment with an auto expandable dácron-covered stent. METHODS: The stent was deployed through the femoral artery in the hemodynamic laboratory after sedation, local anesthesia in both inguinal areas and systemic heparinization. The catheter with the stent was introduced through a cutdown in the left femoral artery until the area in the thoracic aorta with the previously diagnosed tear. RESULTS: The stent was expanded with immediate occlusion of the false lumen. The whole procedure took 90 minutes and the patients were discharged without complications. CONCLUSION: Stent utilization is an important step to improve treatment results in type B aortic dissection.