Aortic valve reconstruction surgery with Ozaki technique: initials results from a single center / Cirugía de reconstrucción de válvula aórtica con técnica de Ozaki: resultados iniciales en un centro de referencia

Abstract Background: Aortic valve (AV) replacement is the gold standard treatment for severe symptomatic AV disease. Recently, AV reconstruction surgery (Ozaki procedure) emerges as a surgical alternative with good results in the medium term. Methods: We retrospectively analyzed 37 patients who underwent AV reconstruction surgery between January 2018 and June 2020 in a national reference center in Lima, Peru. The median age was 62 years, interquartile range (IQR: 42-68). The main indication for surgery was AV stenosis (62.2%), in most cases due to bicuspid valve (19 patients, 51.4%). Twenty-two (59.4%) patients had another pathology with surgical indication associated to AV disease, 8 (21.6%) had dilatation of the ascending aorta with indication for replacement. Results: One in-hospital death occurred (1/38, 2.7%) due to perioperative myocardial infarction. There was a significant reduction in the medians of the peak (70 mmHg, CI 95% = 50.03-79.86 vs. 14 mmHg, CI 95% = 11.93-17.5, p < 0.0001) and mean (45.5 mmHg CI 95% = 30.6-49.68 vs. 7 mmHg, CI 95% = 5.93-9.6, p < 0.0001) AV gradients when we compared baseline characteristics with first 30-days results. In an average of 19 (± 8.9) months of follow-up, survival, reoperation-free survival for valve dysfunction, and survival free of AV insufficiency ≥ II were 97.3%, 100% and 91.9%, respectively. Significant reduction in the medians of the peak and mean AV gradients was maintained. Conclusions: AV reconstruction surgery showed optimal results in term of mortality, reoperation-free survival, and hemodynamic characteristics of the neo-AV.

Resumen Introducción: El reemplazo de la válvula aórtica es el tratamiento de elección para la valvulopatía aórtica severa sintomática. Recientemente, la cirugía de reconstrucción valvular aórtica (procedimiento de Ozaki) emerge como una alternativa quirúrgica con buenos resultados a mediano plazo. Métodos: Analizamos retrospectivamente 37 pacientes intervenidos de reconstrucción de válvula aórtica entre enero de 2018 y junio de 2020 en un centro de referencia nacional en Lima, Perú. La mediana de edad fue de 62 años (rango intercuartílico: 42-68). La estenosis de la válvula fue la principal indicación de cirugía (62.2%), en la mayoría de los casos por válvula bicúspide (19 pacientes, 51.4%). 22 (59.4%) pacientes presentaban otra patología con indicación de cirugía, 8 (21.6%) presentaban dilatación de la aorta ascendente con indicación de reemplazo. Resultados: La mortalidad intrahospitalaria fue de 1/38, 2.7%, por infarto de miocardio perioperatorio. Hubo una reducción significativa en las medianas del gradiente máximo (70 mmHg, IC 95% = 50.03-79.86 vs. 14 mmHg, IC 95% = 11.93-17.5, p < 0.0001) y gradiente medio (45.5 mmHg IC 95% = 30.6-49.68 vs. 7 mmHg, IC 95% = 5.93-9.6, p < 0.0001) de la válvula aórtica cuando comparamos las características basales con los resultados de los primeros 30 días. En una media de 19 (± 8.9) meses de seguimiento la sobrevida fue del 97.3%; la sobrevida libre de reoperación por disfunción valvular, 100% y la sobrevida libre de insuficiencia aórtica ≥ II, 91.9%, respectivamente. Se mantuvo una reducción significativa en las medianas de los gradientes máximo y medio de la válvula aórtica. Conclusiones: La cirugía de reconstrucción de válvula aórtica con pericardio autólogo mostró resultados óptimos en términos de mortalidad, supervivencia libre de reoperación y características hemodinámicas de la neo-válvula.

Alterações da Rigidez Arterial em Pacientes com Estenose Aórtica Grave Submetidos à Cirurgia de Troca Valvar / Arterial Stiffness Changes in Severe Aortic Stenosis Patients Submitted to Valve Replacement Surgery

Resumo Fundamento: Pouco se sabe sobre o impacto da estenose aórtica (EA) grave na rigidez aórtica e se ocorre alguma alteração após a remoção da barreira de EA com a cirurgia de substituição da válvula aórtica (SVA). Objetivo: Estimar as mudanças na velocidade de onda de pulso carotídeo-femoral (VOP) após a cirurgia de SVA e definir os preditores de VOP alta em pacientes com EA grave. Métodos: Estudo de coorte retrospectivo unicêntrico, incluindo pacientes com EA grave submetidos à cirurgia de SVA com bioprótese, entre fevereiro de 2017 e janeiro de 2019, e medições da VOP (Complior®) antes e depois do procedimento (2±1 meses). Antes e depois da SVA, os valores da VOP foram comparados por meio de testes pareados. foram analisadas as associações de VOP com dados clínicos, bem como aplicados modelos de regressão linear multivariada para estimar os preditores independentes da VOP pré- e pós-operatória. O nível de significância foi estabelecido em 5%. Resultados: Foram incluídos na amostra 150 pacientes, com média de idade de 72±8 anos, sendo 51% deles do sexo masculino. Identificamos um aumento estatisticamente significativo nos valores de VOP após a cirurgia (9,0 ± 2,1 m/s vs. 9,9 ± 2,2, p<0,001, antes e depois da SVA, respectivamente) e uma associação inversa com as variáveis de gravidade da EA. No modelo de regressão linear multivariada, idade e pressão arterial sistólica (PAS) foram estabelecidas como preditores independentes da VOP pré- e pós-operatória mais alta, enquanto o gradiente valvar médio mais alto foi considerado um determinante da VOP pré-SVA mais baixa. Conclusão: Identificamos uma correlação inversa da rigidez arterial com a gravidade da EA em pacientes acometidos, e um aumento significativo nos valores da VOP após a cirurgia de SVA. Idade avançada e PAS elevada foram associadas a valores mais altos da VOP, embora as medidas de função arterial estivessem dentro da normalidade. (Arq Bras Cardiol. 2021; 116(3):475-476)

Abstract Background: Little is known about the impact of severe aortic stenosis (AS) in aortic stiffness and if there is any change after removing AS barrier with aortic valve replacement (AVR) surgery. Objective: To estimate carotid-femoral pulse wave velocity (PWV) changes after AVR surgery and to define PWV predictors in severe AS patients. Methods: Single-center retrospective cohort, including patients with severe AS who underwent AVR surgery with bioprostheses, between February 2017 and January 2019 and performed PWV measurements (Complior®) before and after the procedure (2±1 months). Before and after AVR, PWV values were compared through paired tests. The associations of PWV with clinical data were studied and linear regression models were applied to estimate pre and postoperative PWV independent predictors. The significance level was set at 5%. Results: We included 150 patients in the sample, with mean age of 72±8 years, and 51% being males. We found a statistically significant increase in PWV values after surgery (9.0±2.1 m/s vs. 9.9±2.2, p<0.001, before and after AVR, respectively) and an inverse association with AS severity variables. In the linear regression model, age and systolic blood pressure (SBP) were established as independent predictors of higher pre- and postoperative PWV, while higher mean valvular gradient emerged as a determinant of lower pre-AVR PWV. Conclusion: We documented an inverse correlation of arterial stiffness with the severity of AS in patients with AS, and a significant increase in PWV values after AVR surgery. Advanced age and higher SBP were associated with higher PWV values, although arterial function measurements were within the normal range. (Arq Bras Cardiol. 2021; 116(3):475-482)

Correction of left ventricular outflow tract obstruction caused by anomalous papillary muscle and subaortic membrane

Abstract This paper presents a case study of a 30-year-old male patient with dyspnea on exertion had echocardiographic diagnosis of aortic subvalvar stenosis. Discrete mitral regurgitation and aortic valve dysplasia with mild to moderate insufficiency and hypertrophic cardiomyopathy were also noted. During surgery, a rare condition was identified: presence of papillary muscle anomaly associated with the subaortic membrane as a cause of obstruction of the left ventricular outflow tract. With the resection of these structures and a mitral valve annuloplasty, the patient evolved with a significant improvement of clinical condition and heart failure, with no residual mitral insufficiency.

Primeros implantes de la válvula sin sutura Perceval S® en Argentina / First Perceval S™ Sutureless Aortic Valve Prosthesis Implantations in Argentina

RESUMEN El reemplazo valvular aórtico con prótesis sin sutura es una alternativa innovadora para el tratamiento de la estenosis aórtica en los ancianos y en los pacientes de alto riesgo. Aunque la experiencia mundial con estas prótesis lleva ya varios años, solo recientemente comenzó a comercializarse en Argentina el modelo Perceval S®. Se trata de una prótesis autoexpandible sin sutura hecha de pericardio bovino y montada en un stent de nitinol. En este estudio se presentan los primeros tres casos de reemplazo valvular aórtico con la bioprótesis Perceval realizados en Argentina. La técnica sin sutura es una alternativa prometedora para el reemplazo valvular aórtico quirúrgico con una bioprótesis, y, posiblemente, pueda competir con la terapéutica intravascular en los pacientes de alto riesgo.

ABSTRACT Aortic valve replacement with sutureless prostheses is an innovative alternative for the treatment of aortic stenosis in the el-derly and in high-risk patients. Although the world experience with these prostheses has been going on for several years, only recently, the Perceval S™ model, consisting of a self-expanding sutureless prosthesis made of bovine pericardium and mounted on a nitinol stent, has begun to be commercialized in Argentina. In this study, we present the first three cases of aortic valve replacement with Perceval bioprostheses performed in Argentina. The sutureless technique is a promising alternative for surgi-cal aortic valve replacement with a bioprosthesis, and may possibly compete with intravascular therapy in high-risk patients.

Aortic valve replacement combined with ascending aortic aneurysmectomy in a patient with sickle cell disease: a case report

Abstract Sickle cell anemia is a haematological disorder characterized by multiple vaso-occlusive complications, resulting in a reduced life expectancy. These patients are exposed to several triggering factors for sickle cell crises when they are submitted to cardiovascular surgeries with extracorporeal circulation. Therefore, meticulous care and perioperative management are required. This paper reports a successful case of combined cardiovascular surgery - aortic valve replacement and ascending aortic aneurysmectomy - with no serious post-operative complications. In this report, we emphasize the peculiarities of perioperative care in patients with sickle cell anemia.

Thrombocytopenia after aortic valve replacement: comparison between sutureless perceval s valve and perimount magna ease bioprosthesis

Abstract Introduction: The incidence of postoperative thrombocytopenia after aortic valve replacement (AVR) with the Perceval S Sutureless bioprosthesis remains unclear. The aim of this study was to report thrombocytopenia associated with the use of sutureless AVR. Methods: The data was collected retrospectively for patients who had isolated AVR with sutureless Perceval S valve (Group A: 72 patients) and was compared with patients who underwent isolated sutured AVR with Perimount Magna Ease Bioprosthesis (Group B: 101 patients) in our institution between June 2014 and January 2017. Results: Cardiopulmonary bypass and cross-clamp time were significantly shorter in group A. Maximum drop in platelet count was 58% mean (day 2.3) in group A versus 44% mean (day 1.7) in group B (P=0.0001). Absolute platelet count on postoperative day 1-6 in group A was significantly less than in group B (P≤0.05). Platelet count recovered to preoperative value in 44% patients in group B versus only in 26% patients in group A at discharge (P=0.018). Moderate thrombocytopenia occurs more often in group A (41% vs. 26%) (P=0.008) while severe thrombocytopenia (<50 x 109) was observed in 6% in group A but never in group B. Platelets (P=0.007) and packed red blood cells (P=0.009) transfusion was significantly higher in the group A. Conclusion: The implantation of sutureless Perceval aortic valves was associated with a significant drop in platelet count postoperatively with slow recovery and higher platelets and packed red blood cells transfusion requirements. A prospective randomised trial is needed to confirm our findings.

Aortic valve replacement with a conventional stented bioprosthesis versus sutureless bioprosthesis: a study of 763 patients

Abstract Objective: The aim of this retrospective study was to compare early postoperative outcomes after aortic valve replacement (AVR) with sutureless bioprostheses and conventional stented bioprostheses implanted through median sternotomy. Methods: From January 2011 to December 2016, 763 patients underwent aortic valve replacement with bioprostheses; of these, 139 received a Perceval S sutureless valve (Group A) and 624 received a Perimount Magna Ease valve (Group B). These groups were further divided into A1 (isolated Perceval AVR), A2 (Perceval AVR with coronary artery bypass grafting [CABG]), B1 (isolated conventional stented bioprosthesis), and B2 (conventional stented bioprosthesis + CABG). Results: Patients in Group A were older (mean 74 years vs. 71 years; P<0.0001), predominantly women (53% vs. 32%; P<0.0001), had a higher logistic EuroSCORE (3.26 vs. 2.43; P<0.001), more preoperative atrial fibrillation (20% vs. 13%; P=0.03), and had a lower reopening rate for bleeding (2.1% vs. 6.7%; P=0.04). Compared to Group B1, Group A1 had shorter cross-clamp (mean 40 min vs. 57 min; P≤0.0001) and bypass times (mean 63 min vs. mean 80 min; P=0.02), and they bled less postoperatively (mean 295 ml vs. mean 393 ml; P=0.002). The mean gradient across Perceval valve was 12.5 mmHg while its effective orifice area was 1.5 cm2. Conclusion: In our retrospective study of 763 patients, sutureless valve group patients are older, mostly women, more symptomatic preoperatively, and have higher logistic EuroSCORE. They have shorter cross-clamp and bypass times, less postoperative bleeding, and reduced incidence of reopening. Further studies are needed to evaluate the clinical benefits in short, mid, and long-terms.

Early clinical results of perceval sutureless aortic valve in 139 patients: freeman experience

Abstract Objective: The aim of this retrospective study is to evaluate the safety and performance of the Perceval sutureless valve in patients undergoing aortic valve replacement. We report the 30-day clinical outcomes of 139 patients. Methods: From January 2014 to December 2016, 139 patients underwent sutureless aortic valve replacement. Their operation notes, National Adult Cardiac Surgery Database and perioperative transoesophageal echocardiography findings were studied retrospectively. Results: Ninety-two patients underwent isolated aortic valve replacement (group A) with Perceval valve and 47 patients had combined procedures of aortic valve replacement and coronary artery bypass grafting (group B). The patients received a size S (n=23), M (n=39), L (n=42) or XL (n=35) prosthesis. Perceval valve was successfully implanted in 135 (97.1%) patients. Mean cross-clamping time and bypass time were 40 and 63 minutes for isolated cases, while 68 and 107 minutes for combined cases. Three (2.1%) patients died within 30 days. Four patients suffered stroke and 5 patients went into acute renal failure. Median intensive care unit and hospital stay was 2 and 8.5, respectively. Four valves were explanted due to significant paravalvular leak after surgery. Five patients had permanent pacemaker as a result of complete heart block and mean postoperative drainage was 295 mL for isolated case and 457 mL for combined cases. The mean gradient across Perceval valve was 12.5 mmHg while its effective orifice area was 1.5 cm2. Conclusion: Early postoperative results showed that Perceval valve is safe. Further follow up is needed to evaluate the long-term outcome with this bioprosthesis.

Single-dose lignocaine-based blood cardioplegia in single valve replacement patients

Abstract OBJECTIVE: Myocardial protection is the most important in cardiac surgery. We compared our modified single-dose long-acting lignocaine-based blood cardioplegia with short-acting St Thomas 1 blood cardioplegia in patients undergoing single valve replacement. METHODS: A total of 110 patients who underwent single (aortic or mitral) valve replacement surgery were enrolled. Patients were divided in two groups based on the cardioplegia solution used. In group 1 (56 patients), long-acting lignocaine based-blood cardioplegia solution was administered as a single dose while in group 2 (54 patients), standard St Thomas IB (short-acting blood-based cardioplegia solution) was administered and repeated every 20 minutes. All the patients were compared for preoperative baseline parameters, intraoperative and all the postoperative parameters. RESULTS: We did not find any statistically significant difference in preoperative baseline parameters. Cardiopulmonary bypass time were 73.8±16.5 and 76.4±16.9 minutes (P=0.43) and cross clamp time were 58.9±10.3 and 66.3±11.2 minutes (P=0.23) in group 1 and group 2, respectively. Mean of maximum inotrope score was 6.3±2.52 and 6.1±2.13 (P=0.65) in group 1 and group 2, respectively. We also did not find any statistically significant difference in creatine-phosphokinase-MB (CPK-MB), Troponin-I levels, lactate level and cardiac functions postoperatively. CONCLUSION: This study proves the safety and efficacy of long-acting lignocaine-based single-dose blood cardioplegia compared to the standard short-acting multi-dose blood cardioplegia in patients requiring the single valve replacement. Further studies need to be undertaken to establish this non-inferiority in situations of complex cardiac procedures especially in compromised patients.

Bovine pericardial patch augmentation of one insufficient aortic valve cusp with twenty-three-year positive clinical follow-up independent of the patch degeneration

Abstract Scientific progress shall ultimately boost the current acceptance level for conservative aortic valve surgery. The present text aimed to report the 23-year long-term follow-up of one patient operated with bovine pericardium cusp extension. Growing confidence in the efficacy of the operation will allow a more expeditious indication for surgical treatment, as is already the case in mitral valve repair. This change of attitude will certainly make it possible for patients to be sent for operation in mild aortic valve regurgitation. The present report reinforces the concept and highlights the impression that the aortic valvoplasty, independent of the progressive bovine pericardium degeneration, may positively change the natural history of the aortic valve insufficiency.

Comparison of the Outcomes between Surgical Aortic Valve Replacement and Transcatheter Aortic Valve Replacement in Patients Aged above 80

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has been suggested as a less invasive treatment for high-risk patients with aortic valve disease. In this study, we compared the outcomes of conventional surgical aortic valve replacement (AVR) and TAVR in elderly patients aged over 80. METHODS: A total of 108 patients aged 80 years or older who underwent isolated AVR (n=35) or TAVR (n=73) from 2010 through 2015 at Asan Medical Center were identified. Early and late clinical outcomes, including echocardiographic findings, were evaluated in both groups. The mean follow-up duration was 766.4±528.7 days in the AVR group and 755.2±546.6 days in the TAVR group, and the average timing of the last follow-up echocardiography was at 492.6±512.5 days in the AVR group and 515.7±526.8 days in the TAVR group. RESULTS: The overall early mortality was 2.8% (0 of 35, 0% in the AVR group vs. 3 of 73, 4.1% in the TAVR group). Permanent pacemaker insertion was significantly more common in the TAVR group (p=0.010). Renal failure requiring dialysis and new-onset atrial fibrillation was more frequent and the length of hospital stay was longer in the AVR group; however, this difference did not reach statistical significance. In the TAVR group, 14 patients (19.2%) were rehospitalized due to cardiac problems, and 13 patients (17.8%) had developed significant paravalvular leakage by the time of the last follow-up echocardiography. CONCLUSION: TAVR could be a good alternative to conventional surgical AVR in elderly patients. However, TAVR has several shortcomings, such as frequent significant paravalvular leakage or readmission, which should be considered in decision-making.

Establishment of a minimally invasive cardiac surgery programme in Singapore

Although minimally invasive cardiac surgery is available in Singapore, it is not widely practised. Local surgeons have pioneered and introduced technologies in Singapore that were launched in the West to address various heart pathologies. However, in spite of the possibilities, the unique position and function of Singapore in the region, the structure and dynamics of cardiothoracic surgery practice in government centres and private practice, and the overall small volume of patients in the country may pose limitations in the thriving and sharing of such new technologies. Herein, we give an account of our progress and accomplishments with regard to minimally invasive cardiac surgery in Singapore and indicate areas of improvement that have further potential for synergy and growth.

Aortic valve replacement: treatment by sternotomy versus minimally invasive approach

Abstract Objective: To compare the results of aortic valve replacement with access by sternotomy or minimally invasive approach. Methods: Retrospective analysis of medical records of 37 patients undergoing aortic valve replacement by sternotomy or minimally invasive approach, with emphasis on the comparison of time of cardiopulmonary bypass and aortic clamping, volume of surgical bleeding, time of mechanical ventilation, need for blood transfusion, incidence of atrial fibrillation, length of stay in intensive care unit, time of hospital discharge, short-term mortality and presence of surgical wound infection. Results: Sternotomy was used in 22 patients and minimally invasive surgery in 15 patients. The minimally invasive approach had significantly higher time values of cardiopulmonary bypass (114.3±23.9 versus 86.7±19.8min.; P=0.003), aortic clamping (87.4±19.2 versus 61.4±12.9 min.; P<0.001) and mechanical ventilation (287.3±138.9 versus 153.9±118.6 min.; P=0.003). No difference was found in outcomes surgical bleeding volume, need for blood transfusion, incidence of atrial fibrillation, length of stay in intensive care unit and time of hospital discharge. No cases of short-term mortality or surgical wound infection were documented. Conclusion: The less invasive approach presented with longer times of cardiopulmonary bypass, aortic clamping and mechanical ventilation than sternotomy, however without prejudice to the length of stay in intensive care unit, time of hospital discharge and morbidity.

Comparison of Transcatheter Aortic Valve Implantationversus Surgical Aortic Valve Replacement to Improve Quality of Life in Patients >70 Years of Age with Severe Aortic Stenosis

Abstract Objective: Transcatheter aortic valve implantation has recently been used in the treatment of severe aortic valve stenosis, particularly in patients with high mortality and morbidity rates for open surgery. The purpose of this study was to compare quality of life in patients over 70 years of age undergoing surgical or transcatheter aortic valve implantation, before the procedure and in the early post-procedural period. Methods: Seventy-nine patients were included in the study, 38 (48.1%) male and 41 (51.9%) female. Mean age of patients was 74.3±5.2 (70-91) years. The surgical aortic valve replacement group consisted of 51 (64.6%) patients and the transcatheter aortic valve replacement group of 28 (35.4%). Quality of life data before the procedure and at the 3rd month postoperatively in patients aged 70 years and older undergoing surgical or transcatheter aortic valve implantation were assessed using the 36-item Short Form Health Survey form. Results: Positive increases in physical task difficulty (13.2±9.8vs. 5.1±7.3) (P=0.001), emotional task difficulty (14.4±11.9 vs.8.5±6.4) (P=0.035), and mental health (0.4±10.4 vs. 9.6±15.1) (P=0.001; P<0.01) scores in patients undergoing transcatheter aortic valve replacement were significantly higher compared to the surgical aortic valve replacement group. No statistically significant difference was determined between the groups in terms of pain, vitality, social function, physical function or general health scores in the preoperative and postoperative periods. Conclusion: The positive increase in quality of life parameters in the transcatheter aortic valve implantation group at the 3rd month postoperatively was significantly higher compared to the surgical aortic valve replacement group.

Perceval S aortic valve implantation in an achondroplastic Dwarf.

Despite cardiovascular disease in patients with dwarfism is not rare; there is a lack of reports referring to cardiac interventions in such patients. Dwarfism may be due to achondroplasia or hormonal growth disorders. We present a 58‑year‑old woman with episodes of dyspnea for several months. She underwent on transthoracic echocardiography, and she diagnosed with severe aortic valve stenosis. She referred to our department for surgical treatment of this finding. In accordance of her anthropometric characteristics and her very small aortic annulus, we had the dilemma of prosthesis selection. We decided to implant a stentless valve to optimize her effective orifice area. Our aim is to present the successful Perceval S valve implantation and the descriptions of the problems coming across in operating on these special patients. To our knowledge, this is the first case patient in which a Perceval S valve is implanted according to the international bibliography.

Valve-Sparing Root Replacement: Aortic Root Remodeling with External Subvalvular Ring Annuloplasty

The original valve-sparing procedures for aortic root aneurysms were remodeling and reimplantation of the aortic root. The remodeling technique provides more physiologic movement of the cusps within 3 reconstructed neo-sinuses, thus preserving root expansibility through the interleaflet triangles. However, the durability of remodeling has been a matter of concern due to the high rate of aortic insufficiency when annular dilation is not addressed. Therefore, a modified approach was developed, combining a physiologic remodeling of the root with a subvalvular annuloplasty. This case report highlights the first case of successful aortic root remodeling with external subvalvular ring annuloplasty in Korea.

Experimental Study and Early Clinical Application Of a Sutureless Aortic Bioprosthesis

ABSTRACT INTRODUCTION: The conventional aortic valve replacement is the treatment of choice for symptomatic severe aortic stenosis. Transcatheter technique is a viable alternative with promising results for inoperable patients. Sutureless bioprostheses have shown benefits in high-risk patients, such as reduction of aortic clamping and cardiopulmonary bypass, decreasing risks and adverse effects. OBJECTIVE: The objective of this study was to experimentally evaluate the implantation of a novel balloon-expandable aortic valve with sutureless bioprosthesis in sheep and report the early clinical application. METHODS: The bioprosthesis is made of a metal frame and bovine pericardium leaflets, encapsulated in a catheter. The animals underwent left thoracotomy and the cardiopulmonary bypass was established. The sutureless bioprosthesis was deployed to the aortic valve, with 1/3 of the structure on the left ventricular face. Cardiopulmonary bypass, aortic clamping and deployment times were recorded. Echocardiograms were performed before, during and after the surgery. The bioprosthesis was initially implanted in an 85 year-old patient with aortic stenosis and high risk for conventional surgery, EuroSCORE 40 and multiple comorbidities. RESULTS: The sutureless bioprosthesis was rapidly deployed (50-170 seconds; average=95 seconds). The aortic clamping time ranged from 6-10 minutes, average of 7 minutes; the mean cardiopulmonary bypass time was 71 minutes. Bioprostheses were properly positioned without perivalvar leak. In the first operated patient the aortic clamp time was 39 minutes and the patient had good postoperative course. CONCLUSION: The deployment of the sutureless bioprosthesis was safe and effective, thereby representing a new alternative to conventional surgery or transcatheter in moderate- to high-risk patients with severe aortic stenosis.