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.

Current generation balloon-expandable transcatheter valve positioning strategies during aortic valve-in-valve procedures and clinical outcomes

OBJECTIVES: This study sought to evaluate SAPIEN 3 (S3) (Edwards Lifesciences, Irvine, California) positioning using different strategies. BACKGROUND: Aortic valve-in-valve (ViV) is associated with high risk of elevated gradients. METHODS: S3 aortic ViV procedures in stented bioprostheses were studied. Transcatheter heart valve (THV) positioning was analyzed in a centralized core lab blinded to clinical outcomes. A combined endpoint of severely elevated mean gradient ($30 mm Hg) or pacemaker need was established. Two positioning strategies were compared: central marker method and top of S3 method. Optimal final depth was defined as S3 depth #20%. RESULTS: A total of 113 patients met inclusion criteria and were analyzed (76.5 _ 9.7 years of age, 65.8% male, STS score 8 _ 7.6%). THVs had incomplete shortening in comparison to fully expanded valves (92 _ 3.4%), and expansion was more complete in optimal positioning cases compared with others (93.2 _ 2.7% vs. 91.5 _ 3.5%; p » 0.027). The central marker method demonstrated greater correlation with final implantation depth than the top of S3 method (R2 of 0.48 and 0.14; p < 0.001 and p » 0.001, respectively). The combined endpoint rate was 4.3% in the optimal (higher than 3 mm) implantation group, 12% in the intermediate group, and 50% in the low group (p < 0.001). There were no cases of THV embolization. In cases with central marker higher than 3 mm, 72.4% had optimal final depth. In those with central marker higher than 6 mm, 90% had optimal final depth. CONCLUSIONS: Optimal S3 positioning in aortic ViV is associated with better outcomes. Central marker positioning is more reliable than top of S3 positioning. Central marker bottom position should be 3 mm to 6 mm above the ring. (AU)

Mitral implant of the Inovare transcatheter heart valve in failed surgical bioprostheses: a novel alternative for valve-in-valve procedures.

Objectives: Reoperative procedure for the treatment of a failed mitral bioprosthesis is associated with considerable risk. In some cases, mortality is high and might contraindicate the benefit of the procedure. The minimally invasive valve-in-valve (ViV) transcatheter mitral valve implant offers an alternative less-invasive approach, reducing morbidity and mortality. The objective of this paper was to evaluate the mitral ViV approach using the Braile Inovare prosthesis. Methods: The transcatheter balloon-expandable Braile Inovare prosthesis was used in 12 cases. Procedures were performed in a hybrid operating room, under fluoroscopic and echocardiographic control. Through left minithoracotomy, the prostheses were implanted through the cardiac apex. Serial echocardiographic and clinical examinations were performed. Follow-up varied from 1 to 30 months. Results: A total of 12 transapical mitral ViV procedures were performed. Patients had a mean age of 61.6 ± 9.9 years and 92% were women. Mean logistic EuroSCORE was 20.1%. Successful valve implantation was possible in all cases. In one case, a right lateral thoracotomy was performed for the removal of an embolized prosthesis. There was no operative mortality. Thirty-day mortality was 8.3%. Ejection fraction was preserved after the implant (66.7%; 64.8%; P = 0.3). The mitral gradient showed a significant reduction (11 mmHg; 6 mmHg; P < 0.001). Residual mitral regurgitation was not present. There was no left ventricular outflow tract obstruction. Conclusions: The mitral ViV implant in a failed bioprosthesis is an effective procedure. This possibility might alter prosthesis selection in the future initial surgical prosthesis selection, favouring bioprostheses. Further large trials should explore its safety.

New Braile Inovare transcatheter aortic prosthesis: clinical results and follow-up.

AIMS: Transcatheter aortic valve implantation has emerged as an alternative to conventional aortic valve replacement in high-risk patients. Diverse prostheses are currently under investigation. The aim of this study was the clinical, safety and efficacy assessment of Braile Inovare Transcatheter Aortic Prosthesis usage. METHODS AND RESULTS: Ninety high-risk or inoperable patients underwent transcatheter aortic valve implantation. The mean logistic EuroSCORE was 39.3%. All patients presented calcified aortic stenosis. The procedures were performed under fluoroscopic and echocardiographic guidance. Prostheses were implanted through the transapical approach under rapid ventricular pacing. Echocardiographic and angiographic controls were included. Implantation was feasible in 87 cases. There was only one case of operative mortality, and 30-day mortality was 13.3%. The median transvalvular aortic gradient was reduced from 44.8±15.3 to 14.1±8.0 mmHg. Left ventricular function improved in the first seven postoperative days. Paravalvular aortic regurgitation was present in 29.7% of cases, mostly trace. One case presented a major vascular complication, and there were two cases of permanent pacemaker implantation. Two cases of major stroke occurred. CONCLUSIONS: Transcatheter aortic valve replacement using the Braile Inovare prosthesis is able to provide encouraging results with significant functional and structural cardiac improvement. It is mandatory to continue follow-up to measure the benefits of this device as well as to improve selection criteria of patients.

Ventricular assist device implantation with CentriMag VAS® for biventricular mechanical support.

Despite recent advances in acute heart failure treatment, actual results remain limited in refractory cardiogenic shock. Temporary ventricular assist devices have emerged as an alternative in this serious and challenging medical. The purpose of this communication is to present a case of refractory cardiogenic shock, underwent temporary left ventricular assistance device implantation, progressing to right ventricular failure and conversion to biventricular support.

Off-pump transapical closure of a mitral periprosthetic leak: a new approach to a difficult problem.

A 60-year old male patient with multiple risk factors and two previous interventions over the mitral valve was admitted to the emergency unit with symptoms of cardiac failure. Initial examination revealed a competent mitral bioprosthesis with severe perivalvular mitral insufficiency. Based on previous experiences with transapical procedures, a transapical transcatheter closure of the perivalvular leak was performed. The apex was punctured with a 7 French introducer sheath, and a hydrophilic guidewire was advanced with the aid of a right Judkins catheter and positioned across the defect in the left atrium. Fluoroscopic and tridimensional transoesophageal echocardiography was used to guide the manoeuvre. Next, a long introducer sheath was advanced through the guidewire and positioned inside the left atrium. Two Amplatzer Vascular Plug II (St Jude Medical) were deployed, resulting in a significant reduction in the perivalvular leak. The procedure was considered to be successful. The patient regained consciousness, and the orotracheal tube was removed in the operating theatre. No neurological deficits were detected, and the patient was transferred to the intensive care unit. The patient recovered well and was transferred to the ward after 1 day. Discharge was accomplished after 4 days.

Pulsatile stent graft: a new alternative in chronic ventricular assistance.

OBJECTIVE: Heart failure is currently one of the most common hospitalization causes. Several chronic circulatory assist devices have been tested and are highly complex. The objective is the description of a pulsatile endoprosthesis capable of applying a chronic pulse within the descending aorta, similar to that produced by intra-aortic balloon. METHODS: Pulsatile stents composed of nickel-titanium were built and positioned to engage latex tubes simulating the aorta. Different electric currents were applied to units connected in series in order to cause structure contraction and displacement of a liquid column. There were two sequence tests: first composed of two metallic cages and the second composed of five cages. At first sequence tests was applied a voltage of 16.3 volts and a current of 5 amperes. In the second, voltage of 15 volts and current of 07 amperes. RESULTS: In the first sequence was obtained the pulsatile effect of stent, with contraction of the tube and displacement of the water column sufficient to validate the pulsating effect of the endoprosthesis. The two structures ejected a volume of 2.6 ml per cycle, with a range of 29 mm in height of the column of water equivalent to 8% shrinkage during the pulse. In the second sequence, it reachead a variation of 7.4 mL per cycle. CONCLUSION: The results obtained confirm the stent pulsatile contractility activated by electrical current. The continuity of the study and material improvement are necessary to obtain more efficient model from the point of view of energy and pulse, to allow ejection volumes comparable with the intra-aortic balloons.

Stent aórtico pulsátil: uma nova alternativa na assistência ventricular crônica / Pulsatile stent graft: a new alternative in chronic ventricular assistance

OBJETIVO: A insuficiência cardíaca é uma das causas mais comuns de internação. Dispositivos para assistência circulatória crônica foram testados e, em sua maioria, são de alta complexidade. O objetivo deste estudo é a descrição de uma endoprótese contrátil com capacidade de pulsação crônica no interior da aorta descendente, de maneira semelhante à produzida pelo balão intra-aórtico. MÉTODOS: Endopróteses pulsáteis compostas de níquel-titânio foram posicionadas de forma a envolver tubos de látex, simulando a aorta. Diferentes correntes elétricas foram aplicadas a unidades ligadas em série, de modo a causar contração da estrutura e deslocamento de uma coluna líquida. Foram realizadas duas sequências de testes: a primeira com duas gaiolas metálicas e a segunda com cinco gaiolas. Na primeira sequência de testes, aplicou-se tensão de 16,3 volts e corrente de 5 amperes e, na segunda sequência, tensão de 15 volts e corrente de 7 amperes. RESULTADOS: Na primeira sequência de testes, obteve-se o efeito pulsátil dos 2 stents, havendo contração do tubo e deslocamento da coluna d'água suficientes para validar o efeito pulsátil da endoprótese. As duas estruturas ejetaram um volume de 2,6 mL por ciclo, com uma variação de 29 mm na altura da coluna de água, equivalente a 8% de contração durante a pulsação. Na segunda sequência, conseguiu-se uma variação de 7,4 mL por ciclo. CONCLUSÃO: Os resultados obtidos comprovam a contratilidade da endoprótese pulsátil ativada pela aplicação de corrente elétrica. Continuidade do estudo e aperfeiçoamento do material se fazem necessários para obtenção de modelo mais eficiente do ponto de vista energético e com maior pulsação, para permitir volumes de ejeção comparáveis aos de balões intra-aórticos.

OBJECTIVE: Heart failure is currently one of the most common hospitalization causes. Several chronic circulatory assist devices have been tested and are highly complex. The objective is the description of a pulsatile endoprosthesis capable of applying a chronic pulse within the descending aorta, similar to that produced by intra-aortic balloon. METHODS: Pulsatile stents composed of nickel-titanium were built and positioned to engage latex tubes simulating the aorta. Different electric currents were applied to units connected in series in order to cause structure contraction and displacement of a liquid column. There were two sequence tests: first composed of two metallic cages and the second composed of five cages. At first sequence tests was applied a voltage of 16.3 volts and a current of 5 amperes. In the second, voltage of 15 volts and current of 07 amperes. RESULTS: In the first sequence was obtained the pulsatile effect of stent, with contraction of the tube and displacement of the water column sufficient to validate the pulsating effect of the endoprosthesis. The two structures ejected a volume of 2.6 ml per cycle, with a range of 29 mm in height of the column of water equivalent to 8% shrinkage during the pulse. In the second sequence, it reachead a variation of 7.4 mL per cycle. CONCLUSION: The results obtained confirm the stent pulsatile contractility activated by electrical current. The continuity of the study and material improvement are necessary to obtain more efficient model from the point of view of energy and pulse, to allow ejection volumes comparable with the intra-aortic balloons.

Implante valve-in-valve transcateter em posição aórtica: uma mudança de seleção? / Transcatheter aortic valve-in-valve implantation: a selection change?

INTRODUÇÃO: A reoperação para substituição de biopróteses aórticas com disfunção é procedimento que envolve considerável risco. Em alguns casos, a mortalidade é elevada e pode contraindicar o procedimento. O implante minimamente invasivo "valve-in-valve" transcateter de valva aórtica parece ser uma alternativa, reduzindo morbimortalidade. O objetivo deste estudo foi avaliar esses implantes utilizando a prótese Braile Inovare. MÉTODOS: A prótese Braile Inovare, transcateter, balão expansível foi utilizada em 14 casos. Euroscore médio foi de 42,9%. Todos os pacientes eram portadores de dupla disfunção de bioprótese aórtica. Os procedimentos foram realizados em ambiente cirúrgico híbrido, sob controle ecocardiográfico e fluoroscópico. Por meio de minitoracotomia esquerda, as próteses foram implantadas através do ápice ventricular, sob estimulação ventricular de alta frequência. Foram realizados controles clínicos e ecocardiográficos seriados. O seguimento variou de 1 a 30 meses. RESULTADOS: A correta liberação protética foi possível em todos os casos. Não ocorreu conversão. Não houve mortalidade operatória. A mortalidade em 30 dias foi de 14,3% (dois casos). A fração de ejeção apresentou aumento significativo após o 7º pós-operatório e o gradiente aórtico apresentou redução significativa. A insuficiência aórtica residual não esteve presente. Não ocorreu complicação vascular periférica ou bloqueio atrioventricular total. CONCLUSÕES: O implante "valve-in-valve" de valva aórtica transcateter em biopróteses com disfunção é um procedimento seguro e com morbimortalidade baixa. Essa possibilidade poderá alterar a indicação de seleção de prótese no procedimento inicial, favorecendo próteses biológicas.

OBJECTIVE: Aortic valve replacement for bioprosthesis dysfunction is a procedure involving considerable risk. In some cases, mortality is high and may contraindicate the procedure. Minimally invasive transcatheter aortic "valve-in-valve" implant appears to be an alternative, reducing morbidity and mortality. The objective is to evaluate aortic valve-in-valve procedure using Braile Inovare prosthesis. METHODS: The Braile Inovare prosthesis, transcatheter, expandable balloon, was used in 14 cases. Average EuroSCORE was 42.9%. All patients had double aortic bioprosthesis dysfunction. Procedures were performed in a surgical hybrid environment under echocardiographic and fluoroscopic guidance. Using left minithoracotomy prostheses were implanted through the ventricular apex under high-frequency ventricular pacing. Serial clinical and echocardiographic controls were performed. Follow-up ranged 1-30 months. RESULTS: Correct prosthetic deployment was obtained in all cases. There was no conversion. There was no operative mortality. The 30-day mortality was 14.3% (two cases). Ejection fraction increased significantly after the 7th postoperative day. Aortic gradient significantly reduced. The residual aortic regurgitation was not present. There were no vascular complications or complete atrioventricular block. CONCLUSION: The transcatheter "valve-in-valve" procedure for bioprosthesis dysfunction is safe with low morbidity. This possibility may change prosthesis choice during the first aortic valve replacement, favoring bioprostheses.

Substituição do tronco da artéria pulmonar em carneiros utilizando heteroenxerto tubular valvado com preservação não-aldeídica / Replacement of pulmonary artery trunk in sheep using tubular valved heterograft in non-aldehydic preservation

INTRODUÇÃO: As biopróteses valvares cardíacas estão relacionadas a eventos tromboembólicos, infecciosos e degenerativos. Seu desgaste é atribuído principalmente à desnaturação do colágeno. O glutaraldeído, método predominante de preservação de biopróteses, favorece o processo de calcificação e limita sua durabilidade. Diversas técnicas tentam conter o processo degenerativo das biopróteses. OBJETIVO: Avaliar o processo de calcificação, in vivo, de heteroenxertos pulmonares valvados, preservados em meio não-aldeídico (L-Hydro®). MÉTODOS: Dezessete carneiros foram submetidos à substituição do tronco da artéria pulmonar por enxerto tubular valvado de pericárdio bovino. Os animais foram distribuídos em dois grupos: Grupo L-Hydro® (teste / n=14) e Grupo Glutaraldeído (controle /n=3). Cerca de 150 dias pós-implante os animais foram sacrificados, necropsiados e as próteses submetidas a estudo anatomopatológico, avaliação radiológica e dosagem do cálcio por espectrofotometria de absorção atômica. A análise estatística foi obtida por meio dos testes exato de Fisher, T de Student ou Mann-Whitney (significância: 5%). RESULTADOS: A avaliação radiológica, macroscopia, microscopia e dosagem de cálcio por espectrofotometria de absorção atômica demonstraram maior calcificação nas próteses do Grupo Glutaraldeído, quando comparadas às próteses do Grupo L-Hydro® (P=0,001). Sete animais do Grupo L-Hydro® (50%) apresentaram aderência das cúspides à parede do tubo (P=0,228). CONCLUSÕES: As próteses preservadas em L-Hydro® demonstraram-se mais resistentes à calcificação, quando comparadas às preservadas em glutaraldeído.

INTRODUCTION: The cardiac bioprostheses are related to thromboembolic events, infectious and degenerative diseases. Wear is mainly attributed to the denaturation of collagen. Glutaraldehyde, the predominant method of preservation of bioprostheses, favors the calcification process and limits their durability. Several techniques try to contain the degenerative process of bioprostheses. OBJECTIVES: To evaluate the process of calcification in vivo pulmonary valve heterografts preserved in non-aldehydic (L-Hydro®). METHODS: Seventeen sheep underwent replacement of the pulmonary artery valved tubular grafts of bovine pericardium. The animals were divided into two groups: Group L-Hydro® (test / n = 14) and Group Glutaraldehyde (control / n = 3). About 150 days after implantation the animals were sacrificed, necropsied and implants subjected to a pathological study, radiological evaluation and measurement of calcium by atomic absorption spectrophotometry. Statistical analysis was obtained through the Fisher's exact test, Student's t or Mann-Whitney test (significance: 5%). RESULTS: The radiological evaluation, the macroscopic and microscopic measurement of serum calcium by atomic absorption spectrophotometry showed increased calcification of the prosthetic group Glutaraldehyde, when compared to denture-HydroR Group L (P = 0.001). Seven animals in Group L-Hydro® (50%) had adherence of the leaflets to the wall of the tube (P = 0.228). CONCLUSIONS: Prostheses preserved in L-Hydro® were more resistant to calcification when compared with glutaraldehyde preserved.

Tricuspid transcatheter valve-in-valve: an alternative for high-risk patients.

Tricuspid valve disease is not uncommon. Some patients with tricuspid valve disease require tricuspid replacement with bioprosthesis and, over time, may require re-interventions. Transcatheter tricuspid valve-in-valve approach has emerged as an alternative to treat dysfunctional bioprosthesis. In this article, we report a case of a patient with four previous cardiac interventions presenting with tricuspid bioprosthesis dysfunction. The patient was treated with the transcatheter transatrial tricuspid valve-in-valve procedure. The procedure was successful with no residual leakage and a non-significant mean gradient. The patient recovered well and was discharged in 1 week. The procedure is a feasible alternative for high-risk patients. Selection and postoperative care are crucial for the outcome.

Transcatheter aortic valve-in-valve implantation: a selection change?

OBJECTIVE: Aortic valve replacement for bioprosthesis dysfunction is a procedure involving considerable risk. In some cases, mortality is high and may contraindicate the procedure. Minimally invasive transcatheter aortic "valve-in-valve" implant appears to be an alternative, reducing morbidity and mortality. The objective is to evaluate aortic valve-in-valve procedure using Braile Inovare prosthesis. METHODS: The Braile Inovare prosthesis, transcatheter, expandable balloon, was used in 14 cases. Average EuroSCORE was 42.9%. All patients had double aortic bioprosthesis dysfunction. Procedures were performed in a surgical hybrid environment under echocardiographic and fluoroscopic guidance. Using left minithoracotomy prostheses were implanted through the ventricular apex under high-frequency ventricular pacing. Serial clinical and echocardiographic controls were performed. Follow-up ranged 1-30 months. RESULTS: Correct prosthetic deployment was obtained in all cases. There was no conversion. There was no operative mortality. The 30-day mortality was 14.3% (two cases). Ejection fraction increased significantly after the 7th postoperative day. Aortic gradient significantly reduced. The residual aortic regurgitation was not present. There were no vascular complications or complete atrioventricular block. CONCLUSION: The transcatheter "valve-in-valve" procedure for bioprosthesis dysfunction is safe with low morbidity. This possibility may change prosthesis choice during the first aortic valve replacement, favoring bioprostheses.

Replacement of pulmonary artery trunk in sheep using tubular valved heterograft in non-aldehydic preservation.

INTRODUCTION: The cardiac bioprostheses are related to thromboembolic events, infectious and degenerative diseases. Wear is mainly attributed to the denaturation of collagen. Glutaraldehyde, the predominant method of preservation of bioprostheses, favors the calcification process and limits their durability. Several techniques try to contain the degenerative process of bioprostheses. OBJECTIVES: To evaluate the process of calcification in vivo pulmonary valve heterografts preserved in non-aldehydic (L-Hydro®). METHODS: Seventeen sheep underwent replacement of the pulmonary artery valved tubular grafts of bovine pericardium. The animals were divided into two groups: Group L-Hydro® (test / n = 14) and Group Glutaraldehyde (control / n = 3). About 150 days after implantation the animals were sacrificed, necropsied and implants subjected to a pathological study, radiological evaluation and measurement of calcium by atomic absorption spectrophotometry. Statistical analysis was obtained through the Fisher's exact test, Student's t or Mann-Whitney test (significance: 5%). RESULTS: The radiological evaluation, the macroscopic and microscopic measurement of serum calcium by atomic absorption spectrophotometry showed increased calcification of the prosthetic group Glutaraldehyde, when compared to denture-HydroR Group L (P = 0.001). Seven animals in Group L-Hydro® (50%) had adherence of the leaflets to the wall of the tube (P = 0.228). CONCLUSIONS: Prostheses preserved in L-Hydro® were more resistant to calcification when compared with glutaraldehyde preserved.

Off-pump coronary artery bypass surgery in selected patients is superior to the conventional approach for patients with severely depressed left ventricular function.

OBJECTIVES: Patients with coronary artery disease and left ventricular dysfunction have high mortality when kept in clinical treatment. Coronary artery bypass grafting can improve survival and the quality of life. Recently, revascularization without cardiopulmonary bypass has been presented as a viable alternative. The aim of this study is to compare patients with left ventricular ejection fractions of less than 20% who underwent coronary artery bypass graft with or without cardiopulmonary bypass. METHODS: From January 2001 to December 2005, 217 nonrandomized, consecutive, and nonselected patients with an ejection fraction less than or equal to 20% underwent coronary artery bypass graft surgery with (112) or without (off-pump) (105) the use of cardiopulmonary bypass. We studied demographic, operative, and postoperative data. RESULTS: There were no demographic differences between groups. The outcome variables showed similar graft numbers in both groups. Mortality was 12.5% in the cardiopulmonary bypass group and 3.8% in the off-pump group. Postoperative complications were statistically different (cardiopulmonary bypass versus off-pump): total length of hospital stay (days)-11.3 vs. 7.2, length of ICU stay (days)-3.7 vs. 2.1, pulmonary complications-10.7% vs. 2.8%, intubation time (hours)-22 vs. 10, postoperative bleeding (mL)-654 vs. 440, acute renal failure-8.9% vs. 1.9% and left-ventricle ejection fraction before discharge-22% vs. 29%. CONCLUSION: Coronary artery bypass grafting without cardiopulmonary bypass in selected patients with severe left ventricular dysfunction is valid and safe and promotes less mortality and morbidity compared with conventional operations.

Transcatheter aortic valve implantation: results of the current development and implantation of a new Brazilian prosthesis.

OBJECTIVE: Aortic valve replacement is a routine procedure with acceptable risk, but in some cases, such risk can justify contraindication. Minimally invasive transcatheter aortic valve implantation has emerged as an alternative, with lower morbidity and mortality. The aim of this study was clinical, safety and efficacy assessment. METHODS: Thirty-three high risk patients underwent transcatheter balloon expandable aortic valve implantation. Mean Logistic EuroScore risk was 39.30% and STS score 30.28%. Eight patients presented with dysfunctional bioprosthesis, remaining ones presented calcified aortic stenosis. Procedures were performed in a hybrid OR under fluoroscopic and echocardiography guidance. Using a left minithoracotomy the prosthesis were implanted trough the ventricular apex under rapid ventricular pacing or hemorrhagic shock. Echocardiographic and angiographic controls were performed. RESULTS: Implant was feasible in 30 cases. Three conversions occured. There was only one case of operative death. Median transvalvular aortic gradient reduced from 43.58 mmHg to 10.54 mmHg. Left ventricular function improved in the first 7 postoperative days. Paravalvular aortic regurgitation was mild and present in 30.30%. One case presented major vascular complication and another one permanent pacemaker implant. One major stroke case occurred. Overall 30-day mortality was 18.18%. CONCLUSION: The transapical implantation of catheter mounted bioprosthesis is a safe procedure with acceptable midterm results. Long term follow-up with increased sample power is mandatory in order to access hemodynamic, life quality and survival.

Transcatheter implantation of self-expandable valved prosthesis in outlet right ventricle an experimental study in pigs.

INTRODUCTION: Patients with congenital heart disease who underwent pulmonary valvotomy or surgery to open the pulmonary valve ring are prone to develop residual pulmonary insufficiency or stenosis that may lead to right heart failure with clinical deterioration. These children require multiple interventions throughout their lives, which impose a high rate of morbidity and mortality. OBJECTIVE: To develop a less invasive technique for implantation of a valved prosthesis through the right ventricle. METHODS: The valved prosthesis consists of an auto expanding metal stent built with nitinol, surrounded with polyester, where the three leaflets of bovine pericardium were mounted. Twelve pigs were used to perform the implants. Echocardiographic control was performed immediately after implantation and one, four, eight and 12 weeks. RESULTS: One animal showed reflux of moderate to severe and three mild reflux. Transvalvular gradients measured before implantation ranged from 3 to 6 mmHg and that soon after the implant was increased, ranging from 7 to 45 mmHg. There was a decrease in these gradients during follow up and in only four of the twelve animals the gradients were above 20 mmHg. Thrombus formation occurred in the prosthesis of six animals, and this was the most frequent complication. CONCLUSION: These findings highlight the need for studies with the use of anticoagulants and antiplatelet, an attempt to reduce this event. The study aims to contribute for the start of the use of prosthetic heart valves that could be implanted through minimally invasive techniques without the use of cardiopulmonary bypass.