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AIMS: The aim of this study was to evaluate the impact of rheumatic heart disease (RHD) on the long-term outcomes of the Ross operation when compared to patients with bicuspid aortic valves (BAV). METHODS AND RESULTS: We analysed patients with rheumatic disease and BAV who underwent a Ross operation between 1995 and 2020. The primary outcomes were late survival and reoperations on the pulmonary autograft and the right ventricular allograft. We also performed a propensity score analysis to adjust for differences in baseline characteristics. The cumulative incidence of the events in the matched cohorts was compared using the Fine-Gray model. There were 147 patients with rheumatic disease and 314 with bicuspid valves. In the unmatched population, patients with rheumatic disease were younger, more symptomatic, had worse left ventricular function and were more likely to present a preoperative diagnosis of aortic insufficiency. Propensity matching resulted in 86 pairs with similar baseline characteristics. Compared with those with bicuspid valves, rheumatic patients had similar 20-year survival both in the unmatched (RHD = 67.8% vs BAV = 79.7%, P = 0.27] and matched cohorts (RHD = 72.5% vs BAV = 82.9%, P = 0.46). Cumulative incidence of reoperations on the pulmonary autograft after 20 years was also comparable between them in the unmatched (RHD 13.4% vs BAV 14.4%, P = 0.67) and matched patients (RHD 11.6% vs BAV 21.1%, P = 0.47). Pulmonary autograft dysfunction due to rheumatic involvement was detected in only three occasions. Cumulative incidence of reoperations on the right-sided allograft was higher in the unmatched cohort (RHD = 5.5% vs BAV = 16.7%, P = 0.035) but became nonsignificant after propensity score matching (RHD = 9.9% vs BAV = 32.3%, P = 0.051). The cumulative incidence of all Ross-related reoperations was similar in both groups. CONCLUSIONS: Among patients undergoing Ross operation, patients with RHD had similar long-term survival and rates of reoperations, when compared to patients with BAV.

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ANTECEDENTES: En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias, aprobada mediante Resolución de Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021, se ha elaborado el presente dictamen, el cual expone la evaluación de la eficacia y seguridad de la prótesis valvular pulmonar percutánea (PVPP) para el tratamiento pacientes pediátricos con antecedente de malformación congénita e historia de cirugía reconstructiva del tracto de salida del ventrículo derecho (TSVD) que presentan regurgitación valvular pulmonar. De este modo, el Dr. Miguel Arboleda Torres, siguiendo la Directiva N° 001-IETSI-ESSALUD-2018, envió al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la solicitud de aprobación del dispositivo médico PVPP. ASPECTOS GENERALES: Aproximadamente un 10 % de pacientes con malformaciones cardiacas congénitas poseen alteraciones anatómicas que obstruyen el tracto de salida del ventrículo derecho (TSVD), el cual conecta el ventrículo derecho del corazón y la arteria pulmonar. La malformación congénita más común que afecta al TSVD es la tetralogía de Fallot y se estima que el 90 % de los pacientes con esta patología son sometidos a una cirugía a corazón abierto durante la infancia temprana para reconstruir el TSVD (que se encuentra obstruido o estrecho [estenótice. Por lo general, la reconstrucción se realiza mediante la colocación de un parche, una prótesis o un conducto entre el ventrículo derecho y la arteria pulmonar. No obstante, con el transcurrir de los años, estos pacientes desarrollan anormalidades de la válvula pulmonar, lo que requiere que se sometan a nuevas intervenciones quirúrgicas para reemplazarla por una prótesis valvular (Alkashkari et al., 2018; Gutiérrez-Larraya et al., 2021, p.). METODOLOGÍA: Se llevó a cabo una búsqueda bibliográfica exhaustiva con el objetivo de identificar la mejor evidencia sobre la eficacia y seguridad del reemplazo valvular pulmonar percutáneo empleando el dispositivo PVPP. La búsqueda bibliográfica se realizó en las bases de datos PubMed, The Cochrane Library y LILACS. Asimismo, se realizó una búsqueda manual dentro de las páginas web pertenecientes a grupos que realizan evaluación de tecnologías sanitarias (ETS) y guías de práctica clínica (GPC) incluyendo el National Institute for Health and Care Excellence (NICE), Canadian Agency for Drugs and Technologies in Health (CADTH), Scottish Medicines Consortium (SMC), Scottish Intercollegiate Guidelines Network (SIGN), Institute for Clinical and Economic Review (ICER), El Instituto de Calidad y Eficiencia en la Atención de la Salud (IQWiG, por sus siglas en alemán), la Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), la OMS, el Ministerio de Salud del Perú (MINSA) y el Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI). Además, se realizó una búsqueda de GPC de las principales sociedades o instituciones especializadas en cardiología y cirugía torácica, tales como: American Heart Association (AHA), American College of Cardiology (ACC), European Society of Cardiology (ESC), European Association for Cardio-Thoracic Surgery (EACTS), y la Sociedad Española de Cardiología. Finalmente, se realizó una búsqueda en ClinicalTrials.govpara identificar ensayos clínicos aleatorizados (ECA) en curso o que no hayan sido publicados aún. RESULTADOS: Luego de la búsqueda bibliográfica hasta noviembre del 2021, no se identificaron ECA que compararan las tecnologías de interés. Además, tampoco se encontraron guías de práctica clínica (GPC), evaluaciones de tecnología sanitaria (ETS), revisiones sistemáticas (RS), ni estudios realizados en población pediátrica exclusivamente. En consecuencia, se consideró la inclusión de evidencia científica con una población mixta (adultos y niños) que respondiera a la pregunta PICO. Así, se incluyeron dos GPC (Baumgartner et al., 2021; National Institute for Health and Care Excellence, 2013), dos revisiones sistemáticas (Ribeiro et al., 2020; Zhou et al., 2019), y dos estudios observacionales comparativos que no se encontraban incluidos en ninguna de las dos RS previas (Hribernik et al., 2021; OuYang et al., 2020). CONCLUSIÓN: Por lo expuesto, el IETSI aprueba el uso de prótesis de válvula pulmonar de inserción percutánea en pacientes pediátricos con antecedente de malformación cardiaca congénita e historia de cirugía reconstructiva del tracto de salida del ventrículo derecho que presenten una regurgitación valvular pulmonar moderada a severa, según lo establecido en el Anexo N° 1. La vigencia del presente dictamen preliminar es de un año a partir de la fecha de publicación y la continuación de dicha aprobación estará sujeta a la evaluación de los resultados obtenidos y de mayor evidencia que pueda surgir en el tiempo.

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BACKGROUND: It is hypothesized that decellularization of allografts used for right ventricular outflow tract reconstruction may result in decreased valve deterioration. This study compared the durability of fresh decellularized pulmonary allografts with standard cryopreserved pulmonary allografts in patients undergoing the Ross procedure. METHODS: The Ross procedure was performed in 144 patients with decellularized allografts (DA) from 2005 to 2014 and in 619 with standard cryopreserved allografts (SCA) from 1990 to 2014. Propensity score matching was used to compare early and midterm clinical outcome and echocardiographic allograft function over time between the two groups. RESULTS: We matched 94 DA patients (79.3% male; median age, 34.0 years; mean follow-up, 2.4 ± 1.9 years) to 94 SCA patients (78.3% male; median age, 35.0 years; mean follow-up, 9.4 ± 4.2 years). There were no significant differences in baseline characteristics after matching. The matched DA vs SCA groups, respectively, were comparable in actuarial 5-year freedom from allograft dysfunction (85.6% [95% confidence interval {CI}, 53.9% to 96.2%] vs 93.3% [95% CI, 85.7% to 96.9%], p = 0.892), freedom from allograft reintervention (98.8% [95% CI, 91.7% to 99.8%] vs 95.5% [95% CI, 88.5% to 98.3%], p = 0.383), survival (95.3% [95% CI, 87.8% to 98.2%] vs 97.7% [95% CI, 91.3% to 99.4%], p = 0.323), and event-free survival (83.5% [95% CI, 70.6% to 91.1%] vs 84.5% [95% CI, 75.2% to 90.5%], p = 0.515). Longitudinal echocardiographic analyses showed a similarly modest increase in allograft gradient and regurgitation grades over time in both groups, although direct statistical comparison was not possible. CONCLUSIONS: Up to 5 years of follow-up, DA and SCA used for right ventricular outflow tract reconstruction in the Ross procedure are associated with comparably excellent clinical and hemodynamic outcome. Longer follow-up and dedicated echocardiographic studies will shed light on the long-term performance of DAs.

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OBJECTIVE: Determine the midterm outcomes of decellularized allografts for right ventricular outflow tract (RVOT) reconstruction in children less than 12 years of age. METHODS: The study included all consecutive patients submitted to RVOT reconstruction with decellularized allografts between June 2006 and June 2016. Besides clinical and echocardiographic control, 20 patients with more than five years of follow-up were evaluated with computed tomography (CT) scans to determine allograft diameters and calcium scores. Structural valve deterioration was defined as any peak gradient above 40 mm Hg and/or insufficiency of moderate or severe degree. Conduit failure was defined as the need for allograft reintervention. RESULTS: There were 59 patients with a median age of six years (range = 0.01-12 years). The most common operation was the Ross procedure (34%). Mean clinical follow-up was 5.4 (2.8) years and was 94% complete. At eight years, only two patients needed a reintervention, with a 90.9% freedom from this event. Structural valve deterioration occurred in 13 patients, 5 due to stenosis and 8 due to insufficiency, with a freedom from structural valve deterioration due to any cause of 64.9% at eight years. Late CT scans demonstrated the absence or minimal calcification of the conduits. CONCLUSIONS: Decellularized allografts for RVOT reconstruction in children were associated with a low incidence of structural valve deterioration and conduit failure. Although these results still need to be confirmed in larger series and with longer follow-up, our data suggest favorable outcomes, at least in the first decade after the operation.

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Objectives: Review our long-term results with the Ross operation in middle-aged patients. Methods: Between 1995 and 2016, 129 consecutive patients (106 males); mean age (47.2 ± 5.2 years) underwent a Ross operation. Right ventricular outflow tract (RVOT) reconstruction was performed with cryopreserved (n = 45) or decellularized allografts (n = 84). Mean follow-up was 8.4 ± 5.3 years (0.1 20.5 years). We analyzed early and late mortality, as well as valve related events and the need for reoperations. Results: Early mortality was 1.6% and late survival was 87.6% at 16 years. There were 4 reoperations on the pulmonary autograft (96% freedom at 16 years) and 2 on the pulmonary allografts (99% freedom at 16 years). The 16-year freedom from more than mild aortic insufficiency (AI) and a late root diameter >45 mm was 64% and 71%, respectively. Patients with the preoperative diagnosis of AI are at greater risk for these complications. Among the allografts, decellularized allografts showed superior freedom from structural valve dysfunction. Conclusions: The Ross operation in this cohort was associated with long-term survival similar to the general population and low incidence of reoperations. Patients with the preoperative diagnosis of AI are at increased risk for late autograft insufficiency and root dilatation. Decellularized allografts presented the best results for reconstruction of the RVOT. These results support the conclusion that the Ross operation has an important role in the treatment of middle-aged patients with aortic valve disease, especially those with pure aortic stenosis.

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OBJECTIVES: The purpose of the study was to assess the 18-year outcome of the Ross operation (RO), with emphasis on survival, reoperations, and late function of the pulmonary autografts (PAs) and the right-sided pulmonary allografts. METHODS: Between May 1995 to July 2013, 414 patients with a mean age (mean ± standard deviation) of 30.8 ± 13.1 years were submitted to an RO with the root replacement (n = 356) or the inclusion (n = 58) technique. The most prevalent aetiology was bicuspid valve (n = 206, 49.8%). Patients were divided in four groups depending on the type of allograft used on the right side. The mean follow-up was 8.2 ± 5.2 years and was 97.7% complete. In addition to longitudinal outcomes determined by means of the Kaplan-Meier analysis, log-rank test and Cox regression analysis were used to identify predictors of valve failure. RESULTS: The early mortality rate was 2.7% and the late survival rate was 89.3% at 15 years, similar to an age- and sex-matched population. There were 22 reoperations on the PA (90.7% freedom at 15 years) and 15 on the pulmonary allografts (92.5% freedom at 15 years). The freedom rate from more than mild aortic insufficiency (AI) was 73.1% at 15 years. Thirty-three patients presented with a late root diameter >45 mm, corresponding to a freedom rate of 72.4% at 15 years. Patients with AI and a dilated annulus, especially males, are at greater risk for these complications. Among the right-sided allografts, fresh decellularized allografts showed significantly superior freedom from structural valve dysfunction. CONCLUSIONS: The RO was associated with excellent long-term survival and low incidence of reoperations up to 15 years. Male patients with AI and dilated annulus are at increased risk for late insufficiency and root dilatation. Fresh decellularized allografts presented the best results for reconstruction of the right ventricular outflow tract.

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We have evaluated the development of antibodies in response to donor allograft valve implant in patients who received cellularized and decellularized allografts and determined possible immunogenic epitopes considered responsible for antibodies reactivity. Serum samples from all recipients who received cellularized allografts or decellularized allografts were collected before valve replacement and at 5, 10, 30 and 90 days post-operatively and frozen until required. Tests were performed using the Luminex-based single human leukocyte antigen (HLA)-A, -B, -C and HLA-DR, -DQ antigen microsphere assay. To determine possible immunogenic epitopes, we used the HLAMatchmaker (HLAMM) software if applicable. Decellularized grafts elicited lower levels of anti-HLA class I and II antibody formation after implantation than cellularized allografts. All patients from cellularized group presented donor-specific antibodies class I and II within 3 months of observation period. In HLAMM analysis, the cellularized group had significantly higher numbers of immunogenic epitopes than decellularized group for both class I and II (p: 0.002 - cl I / p: 0.009 - cl II / p: 0.004 - cl I and II). Our findings demonstrate that the anti-HLA antibodies detected in the cellularized group were against donor HLA possible immunogenic epitopes and that in the decellularized group the anti-HLA antibodies were not against donor HLA possible immunogenic epitopes. These findings lead us to suggest that choosing sodium dodecyl sulfate decellularization process is the best alternative to decrease the immunogenicity of allograft valve transplant.

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OBJECTIVE: In an effort to make available homografts preserved in a simpler and less costly way, we evaluated the polyethyleneglycol, L-Hydro (LH) method, that consists in the controlled extraction of antigenic substances and the incorporation of anti-inflammatory and anti-thrombotic agent. METHODS: We substituted the pulmonary trunk in ten ovines, seven received LH treated pulmonary homografts and three, fresh pulmonary homografts, orthotopically implanted and followed-up for 320 days. Ovines where evaluated by means of laboratory tests, echocardiographic exams. At the 320 days, were euthanized, hemodynamic, radiology, macroscopic, optic/electronic microscopic, scanning/transmission evaluations were performed. Results were analyzed by Student t test of independent samples for continuous data, by variance analysis of repeated measures, and by Fisher exact test for categorical data. RESULTS: We couldn't establish relevant differences in clinical evolution and laboratory tests between groups. Echocardiogram revealed difference in pulmonary medium gradient, which was significant 10 months follow-up, higher in the control group. Radiologic and macroscopic evaluations didn't established differences. In the optic/electronic microscopic evaluation, liner and interstitial cells were equally found in both groups. The cell liner percent calculated in both groups was similar. Cellularity nodules were observed only infresh homograft group. CONCLUSIONS: These data indicate that both groups presented similar clinical/hemodynamic performances. The LH group's echocardiogram presented a better performance. It also presented histological evidences of interstitial and endothelial cell repopulation. In the macro/optic and electronic microscopic analysis, group L-H presented macroscopy/histological structure and ultra-structural similar to the fresh group, with the exception of nodules with higher interstitial cellularity, present only in the fresh homograft group.

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