Implante Percutâneo Transeptal de Bioprótese em Disfunção de Prótese Valvar Cirúrgica Mitral - Experiência Multicêntrica Brasileira / Percutaneous Transseptal Bioprosthetic Implantation in Failed Prosthetic Surgical Mitral Valve - Brazilian Multicenter Experience

Resumo Fundamento A intervenção percutânea em pacientes com disfunção de prótese biológica mitral apresenta-se como uma alternativa ao tratamento cirúrgico convencional. Objetivo Relatar a primeira experiência brasileira de implante transcateter de bioprótese valve-in-valve mitral via transeptal (TMVIV-via transeptal). Métodos Foram incluídos pacientes portadores de disfunção de bioprótese cirúrgica submetidos ao TMVIV-transeptal em 12 hospitais brasileiros. Foram considerados estatisticamente significativos valores de p<0,05. Resultados Entre junho/2016 e fevereiro/2019, 17 pacientes foram submetidos ao TMVIV-via transeptal. A mediana de idade foi 77 anos (IIQ,70-82), a mediana do escore STS-PROM foi 8,7% (IIQ,7,2-17,8). Todos os pacientes tinham sintomas limitantes de insuficiência cardíaca (CF≥III), tendo 5 (29,4%) sido submetidos a mais de uma toracotomia prévia. Obteve-se sucesso do TMVIV-via transeptal em todos os pacientes. A avaliação ecocardiográfica demonstrou redução significativa do gradiente médio (pré-intervenção, 12±3,8 mmHg; pós-intervenção, 5,3±2,6 mmHg; p<0,001), assim como aumento da área valvar mitral (pré-intervenção, 1,06±0,59 cm2; pós-intervenção, 2,18±0,36 cm2; p<0,001) sustentados em 30 dias. Houve redução significativa e imediata da pressão sistólica de artéria pulmonar, com redução adicional em 30 dias (pré-intervenção, 68,9±16,4 mmHg; pós-intervenção, 57,7±16,5 mmHg; 30 dias, 50,9±18,7 mmHg; p<0,001). Durante o seguimento, com mediana de 162 dias (IIQ, 102-411), observou-se marcada melhora clínica (CF≤II) em 87,5%. Um paciente (5,9%) apresentou obstrução de via de saída de ventrículo esquerdo (VSVE), evoluindo para óbito logo após o procedimento, e outro morreu aos 161 dias de seguimento.Conclusão: A primeira experiência brasileira de TMVIV-transeptal demonstra a segurança e a efetividade dessa nova técnica. A obstrução da VSVE é uma complicação potencialmente fatal, reforçando a importância da seleção dos pacientes e do planejamento do procedimento. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Abstract Background Percutaneous intervention in patients with bioprosthetic mitral valve dysfunction is an alternative to conventional surgical treatment. Objectives To report the first Brazilian experience with transseptal transcatheter bioprosthetic mitral valve-in-valve implantation (transseptal-TMVIV). Methods Patients with surgical bioprosthetic dysfunction submitted to transseptal-TMVIV in 12 Brazilian hospitals were included. The significance level adopted was p<0.05. Results From June/2016 to February/2019, 17 patients underwent transseptal-TMVIV. Their median age was 77 years (IQR,70-82) and median Society of Thoracic Surgeons predicted risk of mortality (STS-PROM) score was 8.7% (IQR,7.2-17.8). All patients had limiting symptoms of heart failure (FC≥III) and 5 (29.4%) had undergone more than one previous thoracotomy. Transseptal-TMVIV was successful in all patients. Echocardiographic assessment showed a significant reduction in mean mitral valve gradient (pre-intervention, 12±3.8 mmHg; post-intervention, 5.3±2.6 mmHg; p<0.001), in addition to an increase in mitral valve area (pre-intervention, 1.06±0.59 cm2; post-intervention, 2.18±0.36 cm2; p<0.001) sustained for 30 days. There was a significant and immediate reduction in the pulmonary artery systolic pressure, with an additional reduction in 30 days (pre-intervention, 68.9±16.4 mmHg; post-intervention, 57.7±16.5 mmHg; 30 days, 50.9±18.7 mmHg; p<0.001). During follow-up (median, 162 days; IQR, 102-411), significant clinical improvement (FC≤II) was observed in 87.5% of the patients. One patient (5.9%) had left ventricular outflow tract (LVOT) obstruction and died right after the procedure, and another died at 161 days of follow-up. Conclusion The first Brazilian experience with transseptal-TMVIV shows the safety and effectivity of the new technique. The LVOT obstruction is a potentially fatal complication, reinforcing the importance of patients' selection and of procedural planning. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

The beneficial effect of anticoagulation in aortic bioprosthesis is associated with its size

Abstract Objective: To evaluate the clinical and echocardiographic outcomes in aortic valve replacement (AVR) patients with aortic bioprosthesis under oral anticoagulation (OA). Methods: Patients who underwent AVR with bioprosthesiswere prospectively enrolled. They were classified based on postoperative use of OA. Clinical and operative variables were collected. Echocardiographic and clinical follow-ups were performed two years after surgery. The primary outcome evaluated was change in transprosthetic gradient. Secondary outcomes analyzed were change in New York Heart Association (NYHA) class, major bleeding episodes, hospitalization, stroke, and transient ischemic attack. Results: We included 103 patients (61 without OA and 42 with OA). Clinical characteristics were similar among groups, except for younger age (76±6.3 vs. 72.4±8.1 years, P=0.016) and higher prevalence of atrial fibrillation (0% vs. 23.8%, P<0.001) in the OA group. Mean (21.4±10 mmHg vs. 16.8±7.7 mmHg, P=0.037) and maximum (33.4±13.7 mmHg vs. 28.4±10.2 mmHg, P=0.05) transprosthetic gradients were higher in patients without OA. Improvement in NYHA class was more frequent in patients with OA (73% vs. 45.3%, P=0.032). Major bleeding, stroke, and hospitalization were similar among groups. OA was the only independent predictor for improvement of NYHA class after multivariate logistic regression analysis (odds ratio [OR]: 5.9, 95% confidence interval [CI]: 1.2-29.4; P=0.028). Stratification by prosthesis size showed that patients with ≤ 21 mm prosthesis benefited from OA. Conclusion: Early anticoagulation after AVR with bioprosthesis was associated with significant decrease of transprosthesis gradient and improvement in NYHA class. These associations were seen mainly in patients with ≤ 21 mm prosthesis.

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.

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.

Evaluación de la estrategia de terapia antitrombótica posterior al cambio valvular aórtico con válvulas biológicas en pacientes de bajo riesgo trombótico / Evaluation of the antithrombotic strategy in low thrombotic risk patients who underwent aortic valve replacement with a bioprosthesis

Resumen De acuerdo a las guías actuales, aún es materia de debate el uso de anticoagulación en los primeros 3 meses en pacientes de bajo riesgo trombótico sometidos a cambio valvular aórtico con prótesis biológicas. En base a la evidencia actual, la aspirina a dosis bajas es razonable como alternativa a los antagonistas de la vitamina K (AVK) durante el posquirúrgico temprano en pacientes con prótesis biológicas en posición aórtica. Se comparó la incidencia de complicaciones trombóticas o hemorrágicas de acuerdo a la estrategia de terapia antitrombótica en los pacientes de bajo riesgo trombótico sometidos a cambio valvular aórtico con válvulas biológicas en el Instituto Nacional de Cardiología Ignacio Chávez. La hipótesis: la aspirina como monoterapia antitrombótica tiene un efecto benéfico comparado con los AVK. Se estudiaron los pacientes de bajo riesgo trombótico sometidos a cambio valvular aórtico con válvulas biológicas en el Instituto Nacional de Cardiología Ignacio Chávez. Se incluyeron los pacientes operados del año 2011 al 2015. Se identificó en el seguimiento a un año la presencia de complicaciones trombóticas o hemorrágicas y si se manejaron con cualquiera de las siguientes: aspirina únicamente, AVK solo y la combinación aspirina más AVK. Se analizaron 231 pacientes. Solo se presentó una complicación hemorrágica en un paciente tratado con AVK. No hubo complicaciones trombóticas. No se presentaron complicaciones trombóticas en pacientes que no recibieron anticoagulación oral formal durante los primeros 3 meses posquirúrgicos, lo que indica que es seguro el uso de aspirina como monoterapia en estos pacientes de bajo riesgo trombótico.

Abstract According to current guidelines, in patients without additional risk factors who have undergone aortic valve replacement with a bioprosthesis, anticoagulation in the first 3 months after surgery is still a matter of debate. According to current evidence, aspirin in low doses is a reasonable alternative to vitamin K antagonists (VKA). A comparison is made between the incidence of thrombotic and haemorrhagic complications in patients with low thrombotic risk who underwent aortic valve replacement with a bioprosthesis in the National Institute of Cardiology of Ignacio Chávez of Mexico. The hypothesis: aspirin as monotherapy has a beneficial effect compared to VKA. The studied patients were the low thrombotic risk patients who underwent aortic valve replacement with a bioprosthesis in the National Institute of Cardiology of Ignacio Chávez of Mexico from 2011 to 2015. The groups studied were: aspirin only, VKA only, and the combination of VKA plus aspirin. The patients were retrospectively followed-up for 12 months, and the thrombotic and haemorrhagic complications were documented. Of the 231 patients included in the study, only one patient in the VKA only group presented with a haemorrhagic complication. No thrombotic complications were observed. In the present study no thrombotic complications were observed in patients who did not receive anticoagulation in the first 3 months after an aortic valve replacement with a bioprosthesis after a follow up period of 12 months. This suggests that the use of aspirin only is safe during this period.

Long-term mortality predictors in patients with small aortic annulus undergoing aortic valve replacement with a 19- or 21-mm bioprosthesis

Abstract Introduction: Replacement of the aortic valve in patients with a small aortic annulus is associated with increased morbidity and mortality. A prosthesis-patient mismatch is one of the main problems associated with failed valves in this patient population. Objective: To evaluate the long-term mortality predictors in patients with a small aortic annulus undergoing aortic valve replacement with a bioprosthesis. Methods: In this retrospective observational study, a total of 101 patients undergoing aortic valve replacement from January 2000 to December 2010 were studied. There were 81 (80.19%) women with a mean age of 52.81±18.4 years. Severe aortic stenosis was the main indication for surgery in 54 (53.4%) patients. Posterior annulus enlargement was performed in 16 (15.8%) patients. Overall, 54 (53.41%) patients underwent concomitant surgery: 28 (27.5%) underwent mitral valve replacement, and 13 (12.7%) underwent coronary artery bypass graft surgery. Results: Mean valve index was 0.82±0.08 cm2/m2. Overall, 17 (16.83%) patients had a valve index lower than 0.75 cm2/m2, without statistical significance for mortality (P=0.12). The overall 10-year survival rate was 83.17%. The rate for patients who underwent isolated aortic valve replacement was 91.3% and 73.1% (P=0.02) for patients who underwent concomitant surgery. In the univariate analysis, the main predictors of mortality were preoperative ejection fraction (P=0.02; HR 0.01) and EuroSCORE II results (P=0.00000042; HR 1.13). In the multivariate analysis, the main predictors of mortality were age (P=0.01, HR 1.04) and concomitant surgery (P=0.01, HR 5.04). Those relationships were statistically significant. Conclusion: A valve index of < 0.75 cm2/m2 did not affect 10-year survival. However, concomitant surgery and age significantly affected mortality.

Implante transcateter valve-in-valve para disfunção de biopróteses cirúrgicas aórticas / Transcatheter valve-in-valve implantation for surgical aortic bioprosthesis dysfunction

Introdução: Estudos recentes têm demonstrado a eficácia do implante transcateter valve-in-valve para otratamento de disfunção de biopróteses em pacientes de alto risco cirúrgico. Apresentamos nossa experiênciainicial com o implante valve-in-valve.Métodos: Caracterizamos o perfil clínico, ecocardiográfico e do procedimento, e reportamos os resultados de médio prazo de pacientes com disfunção de bioprótese submetidos a implante valve-in-valve em posição aórtica. Resultados: Incluímos sete pacientes do sexo masculino, com idade de 72,6 ± 10,0 anos. O escore STS foi 9,6± 10,5%, e o EuroSCORE logístico foi 22,7 ± 14,7%. Três pacientes apresentavam dupla disfunção; dois tinham insuficiência; e dois exibiam estenose isolada. A via transfemoral foi utilizada em seis casos, e a transapical, em um caso. Os dispositivos implantados incluíram as próteses Sapien XT (n = 5) e CoreValve (n = 2). O sucesso do procedimento foi obtido em seis (85,7%) casos. Após o procedimento, o gradiente médio reduziu-se de 38,2 ± 9,6mmHg para 20,9 ± 5,9 mmHg, e a área valvar elevou-se de 1,2 ± 0,4 cm2 para 1,5 ± 0,5 cm2. Ao final de 1 ano, nãoocorreram óbitos e nem outros desfechos adversos significativos; 80% dos pacientes encontravam-se em classefuncional NYHA I/II. Os gradientes transvalvares e a área valvar permaneceram inalterados nesse período. Conclusões: O procedimento valve-in-valve foi eficaz na maioria dos pacientes de alto risco cirúrgico comdisfunção de bioprótese. Quando realizado em pacientes bem selecionados, resulta em desfechos clínicos e hemodinâmicos satisfatórios.

Background: Recent studies have demonstrated the efficacy of the transcatheter valve-in-valveimplantation for the treatment of bioprosthesis dysfunction in high-risk surgical patients. This study presents the initial experience with valve-in-valve implantation. Methods: Clinical, echocardiographic, and procedural profiles were characterized, and the mid-term results of patients with surgical bioprosthesis dysfunction submitted to valve-in-valve implantation in theaortic position were reported.Results: Seven male patients were included, aged 72.6 ± 10.0 years. The STS score was 9,6 ± 10,5%, andthe logistic EuroSCORE was 22.7 ± 14.7%. Three patients had combined aortic bioprosthesis failure; two had isolated regurgitation; and two had isolated stenosis. The transfemoral access was used in six cases, and the transapical access in one case. Implanted devices included Sapien XT (n = 5) and CoreValve (n = 2) prostheses. Procedural success was achieved in six (85.7%) cases. After the procedure, the mean gradient decreased from 38.2 ± 9.6 mmHg to 20.9 ± 5.9 mmHg, and the valve area increased from 1.2 ±0.4 cm2 to 1.5 ± 0.5 cm2. After 1 year, there were no deaths and no other significant adverse outcomes; 80% of patients were in NYHA functional class I/II. The transvalvular gradients and valve area remained unchanged in this period.

Impact of aspirin use in the incidence of thromboembolic events after bioprosthesis replacement in patients with rheumatic disease / Impacto da aspirina na incidência de eventos tromboembólicos após implante de bioprótese valvar cardíaca na doença reumática crônica

INTRODUCTION: There is still much debate regarding the kind of antithrombotic therapy in the immediate postoperative period of bioprosthesis replacement (first three months). Thus, the authors consider relevant to determine the contemporary incidence of thromboembolic events in rheumatic patients early after implantation of aortic and mitral bioprosthesis replacement (first 90 days in the post-operative period) and perform a comparison between isolated Aspirin uses versus no-antiplatelet therapy, in this same context. METHODS: Between the period of January 2010 to July 2012, all consecutive rheumatic patients, with basal sinus rhythm, who performed mitral and aortic valve replacement with bioprosthesis (pericardial bovine), were included in this prospective cohort study, 184 patients in total. The primary endpoint evaluated were the rate of embolic events. RESULTS: In the first 30 days, there were three cerebral ischemic events among patients treated in Aspirin group (5.2%) compared with two events in patients without Aspirin therapy (1.7%), HR = 3.18; 95% CI 0.5 to 19.6; P=0.33. Between 31 and 90 days postoperatively, no patient had a primary outcome. The embolism-free survival, bleeding events and the overall survival were not statistically significant between the aspirin and no-antiplatelet groups. CONCLUSION: In conclusion, in this prospective cohort of rheumatic patients, we found a low and very rare incidence rate of embolic events during the first 90 days postoperative period in mitral and isolated aortic position, respectively. The use of aspirin did not significantly reduce the rate of thromboembolism.

INTRODUÇÃO: Ainda existem controvérsias em relação à melhor estratégia de terapia antitrombótica nos três meses iniciais de pós-operatório de implante de bioprótese valvar cardíaca. Assim, os autores consideram relevante determinar a incidência contemporânea de episódios de isquemia cerebral nos meses iniciais (primeiros 90 dias de pós-operatório), e realizar uma comparação entre a aspirina isolada versus a não terapia antiplaquetária no mesmo contexto. MÉTODOS: Entre o período de janeiro de 2010 a julho de 2012, consecutivamente todos pacientes reumáticos com ritmo sinusal basal, que realizaram a substituição da valva mitral, e ou aórtica, por bioprótese (pericárdio bovino), foram incluídos neste estudo de coorte prospectivo, totalizando 184 pacientes. O desfecho primário avaliado foi a ocorrência de eventos embólicos. RESULTADOS: Nos primeiros 30 dias, três (5,2%) eventos isquêmicos cerebrais foram observados em pacientes do grupo aspirina, em comparação com dois (1,7%) eventos em pacientes sem terapia aspirina, RR = 3,18, 95% IC 0,5-19,6; P=0,33. Entre 31 e 90 dias do pós-operatório, nenhum paciente apresentou episódios de embolia cerebral ou periférica. A sobrevida livre de eventos embólicos, sangramentos e a sobrevida geral não foram estatisticamente significativas entre os grupos aspirina e não-aspirina. CONCLUSÃO: Constatou-se baixa incidência de eventos embólicos durante os primeiros 90 dias de pós-operatório de troca valvar por bioprótese envolvendo a posição mitral, e uma ainda menor para mesma situação para troca aórtica isolada. O uso da aspirina não influenciou de maneira significativa na redução de episódios tromboembólicos.

O conduto valvulado bovino contegra, um biomaterial para o tratamento cirúrgico de cardiopatias congênitas / The contegra valved bovine conduit: a biomaterial for the surgical treatment of congenital heart defects

O Contegra, um enxerto de veia jugular bovina, tem sido amplamente utilizado como biomaterial de preferência no tratamento cirúrgico das cardiopatias congênitas, especialmente como um conduto para a reconstrução da via de saída ventricular direita. Este artigo tem como objetivo fazer uma revisão abrangente sobre os desfechos clínicos do Contegra. Foram recuperados, coletados e analisados, relatos de Contegra publicados desde 2002. Havia 1.718 Contegra, aplicados em 1.705 pacientes. Os tamanhos dos condutos foram de 8-22 mm. As idades dos pacientes foram de recém-nascidos até 74,5 anos, com prevalência de pacientes pediátricos. O diagnóstico primário foi cardiopatia congênita em todos os casos, sendo os três diagnósticos principais: tetralogia de Fallot, tronco arterioso e atresia pulmonar, que representaram 25,6%, 16,7% e 13,1%, respectivamente. O Contegra foi utilizado como enxerto tubular na posição pulmonar em 1635 (95,9%) pacientes, como remendo monocúspide em 12 (0,7%), como enxerto na posição da valva pulmonar ou monocúspide em 40 (2,3%), e, como conduto artéria pulmonar-veia cava inferior na operação de Fontan, em 18 (1,1%) pacientes, respectivamente. O reimplante de conduto foi realizado em 141 (8,3%) pacientes, 33,8 ± 37 (8,6-106,8) meses após a inserção do conduto inicial. A plástica do conduto foi necessária em seis (0,4%) e a reintervenção em 83 (4,9%) dos pacientes. As indicações do reimplante do conduto incluíram estenose importante da anastomose distal, pseudoaneurisma da anastomose proximal e regurgitação importante do conduto. Quanto ao bom desempenho, disponibilidade e longevidade, o Contegra é um biomaterial adequado para a reconstrução da via de saída ventricular direita e como remendo para reparo de comunicação interventricular, mas não é apto para a operação de Fontan.

Contegra, a bovine jugular vein graft, has been widely used as a preferable biomaterial in the surgical treatment of congenital heart defects, especially as a conduit for the right ventricular outflow tract reconstruction. This article aims to make a comprehensive review on the clinical outcomes of Contegra. Reports of Contegra published since 2002 were comprehensively retrieved, collected and analyzed. There were 1718 Contegra, applied in 1705 patients. The sizes of the conduits were 8-22 mm. The patients aged from newborn to 74.5 years, prevailed by pediatrics. The primary diagnosis was congenital heart defects in all cases, with Tetralogy of Fallot, truncus arteriosus and pulmonary atresia being the first three diagnoses, representing 25.6%, 16.7%, and 13.1%, respectively. Contegra was used as a tube graft in the pulmonary position in 1635 (95.9%) patients, as a monocuspid patch in 12 (0.7%), as a graft in the position of the pulmonary valve or a monocusps in 40 (2.3%), and as an inferior vena cava-pulmonary artery conduit in the Fontan procedure in 18 (1.1%) patients, respectively. Conduit reimplantation was performed in 141 (8.3%) patients 33.8 ± 37 (8.6-106.8) months after the initial conduit insertion. Conduit plasty was necessary in 6 (0.4%), and reintervention in 83 (4.9%) patients. Indications for conduit reimplantation included severe stenosis of the distal anastomosis, pseudoaneurysm of the proximal anastomosis and severe conduit regurgitation. As for the good performance, availability and longevity, Contegra is a biomaterial suitable for the right ventricular outflow tract reconstruction and for patch repair for ventricular septal defect, but not apt for Fontan procedure.

Clinical predictors of prosthesis-patient mismatch after aortic valve replacement for aortic stenosis

OBJECTIVE: We sought to ascertain predictors of Patient Prosthesis Mismatch, an independent predictor of mortality, in patients with aortic stenosis using bioprosthetic valves. METHOD: We analyzed 2,107 sequential surgeries. Patient Prosthesis Mismatch was calculated using the effective orifice area of the prosthesis divided by the patient's body surface area. We defined nonsignificant, moderate, and severe Patient Prosthesis Mismatch as effective orifice area indexes of .0.85 cm²/m, 0.85-0.66 cm²/m², and <0.65 cm²/m², respectively. RESULTS: A total of 311 bioprosthetic patients were identified. The incidence of nonsignificant, moderate, and severe Patient Prosthesis Mismatch was 41 percent, 42, and 16 percent, respectively. Severe Patient Prosthesis Mismatch was significantly more prevalent in females (82 percent). In severe Patient Prosthesis Mismatch, the perfusion and the crossclamp times were considerably lower when compared with nonsignificant Patient Prosthesis Mismatch and moderate Patient Prosthesis Mismatch. Patients with severe Patient Prosthesis Mismatch had a significantly higher likelihood of spending time in the intensive care unit and a significantly longer length of stay in the hospital. Body surface area was not different in severe Patient Prosthesis Mismatch when compared with nonsignificant Patient Prosthesis Mismatch. In-hospital mortality in patients with nonsignificant, moderate, and severe Patient Prosthesis Mismatch was 2.3 percent, 6.1 percent, and 8 percent, respectively. Minimally invasive surgery was significantly associated with moderate Patient Prosthesis Mismatch in 49 percent of the patients, but not with severe Patient Prosthesis Mismatch. CONCLUSION: Severe Patient Prosthesis Mismatch is more common in females, but not in those with minimal available body surface area. Though operative times were shorter in these patients, intensive care unit and hospital lengths of stay were longer. Surgeons and cardiologists should be cognizant of these clinical predictors and complications prior to valve surgery.

Resultados de pacientes submetidos à cirurgia de substituição valvar aórtica usando próteses mecânicas ou biológicas / Outcomes of patients subjected to aortic valve replacement surgery using mechanical or biological prostheses

OBJETIVO: Esse estudo avalia resultados em pacientes submetidos à cirurgia para troca valvar aórtica utilizando substituto biológico ou mecânico, com poder de relevância na seleção do tipo da prótese. MÉTODOS: Foram selecionados, randomicamente, 301 pacientes submetidos à cirurgia para troca valvar aórtica entre 1990 e 2005, com seguimento máximo de 20 anos. RESULTADOS: Sobrevivência em 5, 10 e 15 anos após cirurgia utilizando substituto mecânico foi de 83,9%, 75,4% e 60,2% e, para substituto biológico, foi de 89,3%, 70,4% e 58,4%, respectivamente (P=0,939). Fatores associados com óbito foram: idade, obesidade, doença pulmonar, arritmias, eventos hemorrágicos e insuficiência valvar aórtica. Probabilidade livre de reoperação desses pacientes em 5, 10 e 15 anos após cirurgia utilizando substituto mecânico foi de 97,9%, 95,8% e 95,8% e, para bioprótese, foi de 94,6%, 91,0% e 83,3%, respectivamente (P=0,057). Fatores associados com reoperação foram: insuficiência renal, endocardite de prótese e idade. Probabilidade livre de eventos hemorrágicos em 5, 10 e 15 anos após cirurgia utilizando substituto mecânico foi de 94,5%, 91,7% e 91,7% e, para bioprótese, foi de 98,6%, 97,8% e 97,8%, respectivamente (P=0,047). Fatores associados com eventos hemorrágicos foram: insuficiência renal e prótese mecânica. CONCLUSÕES: Os autores concluíram que: 1) mortalidade foi estatisticamente semelhante entre os grupos; 2) características basais dos pacientes foram os maiores determinantes de mortalidade tardia após a cirurgia; 3) houve tendência à reoperação para o grupo com bioprótese; 4) pacientes com prótese mecânica tiveram mais eventos hemorrágicos ao longo do tempo; 5) dados encontrados no presente estudo são concordantes com a literatura atual.

OBJECTIVE: This paper evaluates outcomes in patients subjected to surgery for replacement of the aortic valve using biological or mechanical substitutes, where selection of the type of prosthesis is relevant. METHODS: Three hundred and one patients, randomly selected, who had been subjected to aortic valve replacement surgery between 1990 and 2005, with a maximum follow-up period of 20 years. RESULTS: Survival at 5, 10 and 15 years after surgery using mechanical substitute was 83.9%, 75.4% and 60.2% and, for biological substitute, was 89.3%, 70.4% and 58.4%, respectively (P=0.939). Factors associated with death were: age, obesity, pulmonary disease, arrhythmia, bleeding and aortic valve failure. Probability free of reoperation for these patients at 5, 10 and 15 years after surgery using mechanical substitute was 97.9%, 95.8% and 95.8% and, for those using bioprostheses, was 94.6%, 91.0% and 83.3%, respectively (P=0.057). Factors associated with reoperation were: renal failure, prosthesis endocarditis and age. Probability free of bleeding events at 5, 10 and 15 years after surgery using mechanical substitute was 94.5%, 91.7% and 91.7% and, for bioprostheses, was 98.6%, 97.8% and 97.8%, respectively (P=0.047). Factors associated with bleeding events were: renal failure and mechanical prostheses. CONCLUSIONS: The authors have concluded that: 1) mortality was statistically similar in the groups; 2) patient characteristics at baseline were a major determinant of late mortality after surgery; 3) there was a tendency toward reoperation in the bioprostheses group; 4) patients using mechanical prosthesis had more bleeding events as time passed; 5) data presented in this paper is in accordance with current literature.

Reemplazo valvular aórtico con prótesis biológica en pacientes mayores de 70 años con estenosis aórtica / Aortic valve replacement with bioprosthesis in patients 70 years old or older with aortic stenosis

Background: Aortic valve stenosis is the most prevalent valvulopathy in the elderly, but it is frequently undertreated. Aim: To assess early and long term results of valve replacement with bioprostheses in patients 70 years old or older with aortic stenosis. Patients and Methods: A review of the database of the Cardiovascular Surgery Service of our hospital, for the period 1990-2007, identified 156 patients with aortic valve stenosis, aged 76.7 ± 4.5 years (67 percent males), that were subjected to an aortic valve replacement with bioprosthesis. Seventy eight (50 percent) were in functional class III-IV. Six patients had emergency surgery. In 67 patients (43 percent) coronary artery bypass graft were performed. Long term mortality was ascertained obtaining death records from Chilean death registry. Results: Operative mortality was 3.2 percent (5 patients). Four patients (2.6 percent) required a reoperation due to bleeding. The mean follow up was 66 ± 41 months. The survival rate at 1, 3 and 5years was 94 percent, 88 percent and 80 percent, respectively. Forty two patients (27 percent) were 80years old or older. In this sub-group, 1 patient (2.3 percent) died during the peri operative period and the estimated survival rate at 1, 3 and 5years was 97 percent, 92 percent, and 80 percent, respectively. Multivariate risk analysis, for the whole group, identified low ejection fraction and concomitant coronary artery bypass graft surgery as predictors of late mortality. Conclusions: Aortic valve replacement for aortic stenosis with bioprostheses in patients 70 years old or older had low perioperative mortality and morbidity and a good long term survival.

Aplicabilidade do escore de risco de Ambler para pacientes com substituição valvar por bioprótese de pericárdio bovino / Applicability of Ambler's risk score to patients who have undergone valve replacement with bovine pericardial bioprosthesis

OBJETIVO: O estudo objetiva verificar aplicabilidade do escore de Ambler para pacientes que receberam implante bioprótese de pericárdio bovino no Instituto de Cardiologia do RGS/FUC e quantificar os fatores de risco. MÉTODOS: Estudo retrospectivo com 703 pacientes submetidos ao implante de bioprótese de pericárdio bovino entre 1991 e 2005, no Instituto de Cardiologia do RS. Em 392 pacientes, ocorreu implante aórtico, em 250, mitral e, em 61, combinado. Desfecho primário foi mortalidade hospitalar. As características estimativas do risco foram: idade, sexo, IMC, classe funcional (NYHA), fração de ejeção ventricular esquerda (FE), lesão valvar, hipertensão arterial sistêmica, diabete melito, função renal, ritmo cardíaco, cirurgia cardíaca prévia, revascularização miocárdica e/ou plastia tricúspide concomitante, caráter cirúrgico. Utilizada regressão logística uni e multivariada para quantificar fatores de risco preponderantes, pelo odds ratio (OR). RESULTADOS: A mortalidade observada foi de 14,3%, superior à prevista de valor 3% para escore médio 6 de Ambler, (p<0,01). Pacientes falecidos mostraram escore médio 8,26, superior ao dos sobreviventes, de 5,68. Características de maior risco foram cirurgia emergencial (OR=10,87), diálise (OR=6,10) e idade > 80 anos (OR=6,10). A área sob curva ROC para nossa amostra foi calculada em 72,9% (aceitável > 70%). CONCLUSÃO: A mortalidade prevista no escore de Ambler não é reproduzida no resultado observado, mas a curva ROC evidenciou que o modelo é aplicável. Fatores de risco preponderantes foram individualizados.

OBJETIVES: This study aims to verify the applicability of Ambler's risk score to patients who have undergone implantation of bovine pericardial bioprosthesis at the Instituto de Cardiologia do RGS/FCU. This study also aims to quantify the risk factors. METHODS: Retrospective study with 703 patients who had undergone implantation of bovine pericardial bioprosthesis between 1991 and 2005 at the Instituto de Cardiologia do RS. Aortic implant occurred in 392 patients, mitral in 250 and combined in 61. Primary outcome was hospital mortality. Characteristics used to estimate risk were: gender, age, body mass index (BMI), NYHA functional class, left ventricular ejection fraction, valvular lesions, systemic arterial hypertension, diabetes mellitus, renal function, cardiac rhythm, previous cardiac operations, and surgical priority. Univariate and multivariate logistic regression was used to quantify preponderant risk factors by the odds-ratio (OR). RESULTS: The mortality rate was 14.3%, which was higher than the estimated mortality rate (3%, according to Ambler's mean score of 6, (p<0.01)). Patients who died presented a mean score of 8.26, which was higher than the survivors' average score of 5.68. Characteristics of increased risk were emergency surgery (OR=10.87), dialysis (OR=6.10), and age higher than 80 years (OR=6.10). Our sample indicates an area under the ROC curve of 72.9% (accepted value > 70%). CONCLUSION: The mortality predicted in Ambler's score was not reproduced in the observed results. However, the ROC curve provides evidence that this model is applicable. Preponderant risk factors were individualizated.

Fatores de risco hospitalar para implante de bioprótese valvar de pericárdio bovino / Hospital risk factors for bovine pericardial bioprosthesis valve implantation

FUNDAMENTO: Identificação de fatores de risco pré-operatórios na cirurgia cardíaca valvar visa melhor resultado cirúrgico pela possível neutralização de condições relacionadas com morbi-mortalidade aumentada. OBJETIVO: Este estudo objetiva identificar fatores de risco hospitalar em pacientes submetidos a implante de bioprótese de pericárdio bovino. MÉTODOS: Estudo retrospectivo incluindo 703 pacientes consecutivos submetidos a implante de pelo menos uma bioprótese de pericárdio bovino St. Jude Medical-Biocor® de setembro de 1991 a dezembro de 2005 no Instituto de Cardiologia do RS, sendo 392 aórticos, 250 mitrais e 61 mitro-aórticos. Analisadas as características sexo, idade, índice de massa corporal, classe funcional (New York Heart Association - NYHA), fração de ejeção, lesão valvar, hipertensão arterial sistêmica, diabete melito, função renal, arritmias cardíacas, cirurgia cardíaca prévia, revascularização miocárdica, plastia tricúspide e caráter eletivo, de urgência ou de emergência da cirurgia. Desfecho primordial foi mortalidade hospitalar. Utilizou-se regressão logística para examinar relação entre fatores de risco e mortalidade hospitalar. RESULTADOS: Ocorreram 101 (14,3 por cento) óbitos hospitalares. Características significativamente relacionadas à mortalidade aumentada foram sexo feminino (p<0,001), idade superior a 70 anos (p=0,004), fibrilação atrial (p=0,006), diabete melito (p=0,043), creatinina > 2,4mg/dl (p=0,004), classe funcional IV (p<0,001), lesão valvar mitral (p<0,001), cirurgia cardíaca prévia (p=0,005), plastia tricúspide (p<0,001) e caráter cirúrgico emergencial (p<0,001). CONCLUSÃO: Observada mortalidade aceita pela literatura, justificável pela prevalência de alguns fatores de risco, tendo elevado nível de significância sexo feminino, idade superior a 70 anos, classe funcional IV, plastia tricúspide e caráter emergencial. A possível neutralização destes poderá contribuir para redução da mortalidade hospitalar...

BACKGROUND: Identification of preoperative heart valve surgery risk factors aim to improve surgical outcomes with the possibility to offset conditions related to increased morbidity and mortality. OBJECTIVE: Intent of this study is to identify hospital risk factors in patients undergoing bovine pericardial bioprosthesis implantation. METHODS: Retrospective study including 703 consecutive patients who underwent implantation of at least one St. Jude Medical-Biocor™ bovine pericardial bioprosthesis between September 1991 and December 2005 at the Rio Grande do Sul Cardiology Institute; 392 were aortic, 250 were mitral and 61 were mitroaortic. Characteristics analyzed were gender, age, body mass index, NYHA (New York Heart Association) functional class, ejection fraction, valve lesions, systemic hypertension, diabetes mellitus, kidney function, arrhythmias, prior heart surgery, coronary artery bypass graft, tricuspid valve surgery and elective, urgent or emergency surgery. Main outcome was in-hospital mortality. Relationship between risk factors and in-hospital mortality was analyzed using logistic regression. RESULTS: Were 101 (14.3 percent) in-hospital deaths. Characteristics with significant relationship to increased mortality were female gender (p<0.001), age over 70 years (p=0.004), atrial fibrillation (p=0.006), diabetes mellitus (p=0.043), creatinine > 2.4mg/dl (p=0.004), functional class IV (p<0.001), mitral valve lesion (p<0.001), previous heart surgery (p=0.005), tricuspid valve surgery (p<0.001) and emergency surgery (p<0.001). CONCLUSION: Mortality rate observed is accepted by literature and is justifiable due to the high prevalence of risk factors, showing an increased significance level for female gender, age above 70, functional class IV, tricuspid valve repairs and emergency surgery. Offsetting these factors could contribute to reduced in-hospital mortality for valve surgery.