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OBJECTIVE: To analyze Italian Cardiac Surgery experience during the pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) identifying risk factors for overall mortality according to coronavirus disease 2019 (COVID-19) status. METHODS: From February 20 to May 31, 2020, 1354 consecutive adult patients underwent cardiac surgery at 22 Italian Centers; 589 (43.5%), patients came from the red zone. Based on COVID-19 status, 1306 (96.5%) were negative to SARS-CoV-2 (COVID-N), and 48 (3.5%) were positive to SARS-CoV-2 (COVID-P); among the COVID-P 11 (22.9%) and 37 (77.1%) become positive, before and after surgery, respectively. Surgical procedures were as follows: 396 (29.2%) isolated coronary artery bypass grafting (CABG), 714 (52.7%) isolated non-CABG procedures, 207 (15.3%) two associate procedures, and three or more procedures in 37 (2.7%). Heart failure was significantly predominant in group COVID-N (10.4% vs. 2.5%, p = .01). RESULTS: Overall in-hospital mortality was 1.6% (22 cases), being significantly higher in COVID-P group (10 cases, 20.8% vs. 12, 0.9%, p < .001). Multivariable analysis identified COVID-P condition as a predictor of in-hospital mortality together with emergency status. In the COVID-P subgroup, the multivariable analysis identified increasing age and low oxygen saturation at admission as risk factors for in-hospital mortality. CONCLUSION: As expected, SARS-CoV-2 infection, either before or soon after cardiac surgery significantly increases in-hospital mortality. Moreover, among COVID-19-positive patients, older age and poor oxygenation upon admission seem to be associated with worse outcomes.
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COVID-19 , SARS-CoV-2 , Adulto , Anciano , Puente de Arteria Coronaria , Humanos , PronósticoRESUMEN
BACKGROUND: The relationship between retrograde arterial perfusion and stroke in patients with peripheral vascular disease has been widely documented. Antegrade arterial perfusion has been favoured as an alternative approach in less invasive mitral valve (MV) operations. We aimed to analyse our experience in patients with peripheral arterial disease undergoing MV surgery through a right mini-thoracotomy adopting antegrade arterial perfusion. METHOD: A single-institution retrospective study on prospectively collected data was performed on patients undergoing right mini-thoracotomy MV surgery with antegrade arterial perfusion. Since 2009, indication for the latter was dictated by the severity of atherosclerotic burden. Preoperative screening included computed tomography, angiography, or both for the evaluation of the aorta and ileo-femoral arteries. RESULTS: Consecutive patients (n=117) underwent MV surgery through a right mini-thoracotomy with antegrade arterial perfusion, established either by transthoracic central aortic cannulation in 65 (55.6%) cases or by axillary arterial cannulation in 52 (44.4%). Mean logistic EuroSCORE was 11%±2.3%. Twenty-five (25) (21.4%) patients had undergone one or more previous cardiac operations. Operative mortality was 4.3% (n=5). Nonfatal iatrogenic aortic dissection occurred in one case (0.8%). The incidence of stroke was zero. CONCLUSIONS: Axillary or central aortic cannulation is a promising alternative route to provide excellent arterial perfusion in right mini-thoracotomy MV surgery, with a very low incidence of stroke and other major perioperative complications in patients with severe aortic or peripheral arterial disease.
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Procedimientos Quirúrgicos Cardíacos , Toracotomía , Procedimientos Quirúrgicos Cardíacos/métodos , Humanos , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Perfusión/métodos , Estudios Retrospectivos , Toracotomía/métodosRESUMEN
BACKGROUND: Right mini-thoracotomy cardiac surgery has been recognized as a safe and effective procedure, with remarkable early and long-terms outcomes. However, most of the literature is focused on mitral valve surgery and few studies report on the minimally invasive approach applied to congenital disease. Aim of this study was to review our experience on patients with grown-up congenital heart (GUCH) undergoing right mini-thoracotomy cardiac surgery. METHODS: Data of patients with GUCH undergoing right mini-thoracotomy cardiac surgery from 2006 to 2019 were retrospectively analyzed. Inclusion criteria were atrial septal defect, partial anomalous pulmonary venous return, partial atrioventricular septal defect, and mitral or tricuspid valve dysfunction in congenital heart diseases. RESULTS: During the study period 127 patients with GUCH underwent right mini-thoracotomy cardiac surgery. Mean age was 43.6 years and more than 60% were females; diagnosis was atrial septal defect in 57 cases (44.9%); 24 patients were redo (18.9%). No cases of stroke and major vascular complications were reported. Conversion to sternotomy was required in one case (0.8%). No residual shunts or valves dysfunction were recorded at the postoperative echocardiographic evaluation. Perioperative mortality was 1.6%. CONCLUSIONS: Right mini-thoracotomy cardiac surgery in selected patients with GUCH allows to avoid the big scar of the sternotomy approach and to accelerate the recovery in a young population. Moreover, in redo cases, it allows the surgeon to reach the heart and the aorta avoiding the well-known risks of a re-sternotomy procedure.
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Cardiopatías Congénitas , Toracotomía , Adulto , Femenino , Cardiopatías Congénitas/cirugía , Humanos , Masculino , Procedimientos Quirúrgicos Mínimamente Invasivos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Estudios Retrospectivos , Esternotomía , Resultado del TratamientoRESUMEN
OBJECTIVE: Custodiol® and St. Thomas cardioplegia are widely employed in mini-thoracotomy mitral valve (MV) operations. One-dose of the former provides 3 h of myocardial protection. Conversely, St. Thomas solution is usually reinfused every 30 min and safety of single delivery is unknown. We aimed to compare single-shot St. Thomas versus Custodiol® cardioplegia. METHODS: Primary endpoint of the prospective observational study was cardiac troponin T level at different post-operative time-points. Propensity-weighted treatment served to adjust for confounding factors. RESULTS: Thirty-nine patients receiving St. Thomas were compared with 25 patients receiving Custodiol® cardioplegia; cross-clamping always exceeded 45 min. No differences were found in postoperative markers of myocardial injury. Ventricular fibrillation at the resumption of electric activity was more frequent following Custodiol® cardioplegia (P = .01). CONCLUSION: Effective myocardial protection exceeding 1 h of ischemic arrest can be achieved with a single-dose St. Thomas cardioplegia in selected patients undergoing right mini-thoracotomy MV surgery.
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Válvula Mitral , Toracotomía , Humanos , Válvula Mitral/cirugía , Soluciones Cardiopléjicas/efectos adversos , Cloruro de Potasio/efectos adversos , Paro Cardíaco Inducido/efectos adversosRESUMEN
OBJECTIVE: Transventricular beating-heart mitral valve repair (TBMVR) with artificial chordae implantation is a technique to treat mitral valve prolapse. Two-dimensional (2D) echocardiography completed with simultaneous biplane view during surgeon finger pushing on the left ventricular (LV) wall (finger test [FT]) is currently used to localize the desired LV access, on the inferior-lateral wall, between the papillary muscles (PMs). We aimed to compare a new three-dimensional (3D) method with conventional FT in terms of safety and better localization of LV access. METHODS: During TBMVR, conventional FT was completed using 3D transesophageal echocardiography by placing the sample box in the bicommissural view of the LV, including the PMs and the apex. The 3D volume was subsequently edited to visualize the LV from above (surgical view) to localize the bulge of the operator's finger pushing on the LV. We asked the first operator, the second operator, and the cardiac surgery fellow, separately, to evaluate the location of their finger pushing, both with the 2D method and the 3D method, to estimate the interoperator concordance. RESULTS: From 2019 to 2021, 42 TBMVRs were performed without complications related to access using FT completed with the 3D method. Regarding the choice of the right and safe entry site, the operator's agreement was higher using 3D rendering compared with conventional FT (mean agreement 0.59 ± 0.29 for 2D vs 0.83 ± 0.20 for 3D), while full operator agreement was 10 of 42 for 2D and 23 of 42 for 3D (P = 0.004). CONCLUSIONS: Three-dimensional FT is easy to perform and facilitates surgeons choosing the best access for TBMVR in term of anatomical localization and safety.
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Ecocardiografía Tridimensional , Insuficiencia de la Válvula Mitral , Prolapso de la Válvula Mitral , Humanos , Insuficiencia de la Válvula Mitral/cirugía , Ecocardiografía , Prolapso de la Válvula Mitral/cirugía , Ecocardiografía Transesofágica/métodos , Ecocardiografía Tridimensional/métodosRESUMEN
BACKGROUND: Infective endocarditis (IE) is a serious disease, and in many cases, surgery is necessary. Whether the type of prosthesis implanted for aortic valve replacement (AVR) for IE impacts patient survival is a matter of debate. The aim of the present study is to quantify differences in long-term survival and recurrence of endocarditis AVR for IE according to prosthesis type among patients aged 40 to 65 years. METHODS: This was an analysis of the INFECT-REGISTRY. Trends in proportion to the use of mechanical prostheses versus biological ones over time were tested by applying the sieve bootstrapped t-test. Confounders were adjusted using the optimal full-matching propensity score. The difference in overall survival was compared using the Cox model, whereas the differences in recurrence of endocarditis were evaluated using the Gray test. RESULTS: Overall, 4365 patients were diagnosed and operated on for IE from 2000 to 2021. Of these, 549, aged between 40 and 65 years, underwent AVR. A total of 268 (48.8%) received mechanical prostheses, and 281 (51.2%) received biological ones. A significant trend in the reduction of implantation of mechanical vs. biological prostheses was observed during the study period (p < 0.0001). Long-term survival was significantly higher among patients receiving a mechanical prosthesis than those receiving a biological prosthesis (hazard ratio [HR] 0.546, 95% CI: 0.322-0.926, p = 0.025). Mechanical prostheses were associated with significantly less recurrent endocarditis after AVR than biological prostheses (HR 0.268, 95%CI: 0.077-0.933, p = 0.039). CONCLUSIONS: The present analysis of the INFECT-REGISTRY shows increased survival and reduced recurrence of endocarditis after a mechanical aortic valve prosthesis implant for IE in middle-aged patients.
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The role of aortic clamping techniques on the occurrence of neurological complications after right mini-thoracotomy mitral valve surgery is still debated. Brain injuries can occur also as silent cerebral micro-embolizations (SCM), which have been linked to significant deficits in physical and cognitive functions. Aims of this study are to evaluate the overall rate of SCM and to compare endoaortic clamp (EAC) with trans-thoracic clamp (TTC). Patients enrolled underwent a pre-operative, a post-operative, and a follow-up MRI. Forty-three patients were enrolled; EAC was adopted in 21 patients, TTC in 22 patients. Post-operative SCM were reported in 12 cases (27.9%). No differences between the 2 groups were highlighted (23.8% SCM in the EAC group versus 31.8% in the TTC). MRI analysis showed post-operative SCM in nearly 30% of selected patients after right mini-thoracotomy mitral valve surgery. Subgroup analysis on different types of aortic clamping showed comparable results. CLINICAL RELEVANCE: The rate of SCM reported in the present study on patients undergoing minimally invasive MVS and RAP is consistent with data in the literature on patients undergoing cardiac surgery through median sternotomy and antegrade arterial perfusion. Moreover, no differences were reported between EAC and TTC: both the aortic clamping techniques are safe, and the choice of the surgical setting to adopt can be really done according to the patient's characteristics.
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Procedimientos Quirúrgicos Cardíacos , Implantación de Prótesis de Válvulas Cardíacas , Humanos , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Procedimientos Quirúrgicos Cardíacos/métodos , Procedimientos Quirúrgicos Mínimamente Invasivos/efectos adversos , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Toracotomía/efectos adversos , Toracotomía/métodos , Imagen por Resonancia Magnética , Resultado del Tratamiento , Estudios Retrospectivos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversosRESUMEN
OBJECTIVE: Up to 28% of patients may need mitral valve (MV) surgery after transcatheter edge-to-edge repair (TEER). This study evaluates the outcomes of minimally invasive MV surgery after TEER. Methods: International multicenter registry of minimally invasive MV surgery after TEER between 2013 and 2020. Subgroups were stratified by the number of devices implanted (≤1 vs >1), as well as time interval from TEER to surgery (≤1 year vs >1 year). Results: A total of 56 patients across 13 centers were included with a mean age of 73 ± 11 years, and 50% were female. The median Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) score for MV replacement was 8% (Q1-Q3 = 5% to 11%) and the ratio of observed to expected mortality was 0.9. The etiology of mitral regurgitation (MR) prior to TEER was primary MR in 75% of patients and secondary MR in 25%. There were 30 patients (54%) who had >1 device implanted. The median time between TEER and surgery was 252 days (33 to 636 days). Hemodynamics, including MR severity, MV area, and mean gradient, significantly improved after minimally invasive surgery and sustained to 1-year follow-up. In-hospital and 30-day mortality was 7.1%, and 1-year actuarial survival was 85.6% ± 6%. Conclusions: Minimally invasive MV surgery after TEER may be achieved as predicted by the STS PROM. Most patients underwent MV replacement instead of repair. As TEER is applied more widely, patients should be informed about the potential need for surgical intervention over time after TEER. These discussions will allow better informed consent and post-procedure planning.
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Procedimientos Quirúrgicos Cardíacos , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Anciano , Anciano de 80 o más Años , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Femenino , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Masculino , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos/efectos adversos , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/etiología , Sistema de Registros , Resultado del TratamientoRESUMEN
Since the beginning of the COVID-19 emergency, the referral Intensive Care Unit for the Extracorporeal Membrane Oxygenation (ECMO) support of Piedmont Region (Italy), in cooperation with infectious disease specialists, perfusionists and cardiac surgeons, developed a protocol to guarantee operator safety during invasive procedures, among which the ECMO positioning or inter-hospital transport. The use of powered air-purifying respirators, filtering facepiece particles (FFP) 2-3 masks, protective suits, disposable sterile surgical gowns, and two pairs of sterile gloves as a part of a protocol seemed effective and feasible for trained healthcare workers and allow all the complex activities connected with the positioning of the ECMO support to be completed effectively. The simulation training on donning and doffing procedures and the presence of a dedicated team member to verify the compliance with the safety procedure effectively reassured operators and likely reduced the risk of self-contamination. From 1 March to 31 December 2020, we used the procedure in 35 severe acute respiratory distress syndrome (ARDS) patients and one acute respiratory failure caused by neoplastic total tracheal obstruction, all positive to COVID-19, to be connected to veno-venous ECMO in peripheral hospitals and centralized for ECMO management. This preliminary experience seems to confirm that the use of ECMO during COVID-19 outbreaks is feasible and the risks associated with its positioning and management are sustainable for the health-care workers and safe for patients.
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Background: Perfusion strategies and aortic clamping techniques for right mini-thoracotomy mitral valve (MV) surgery have evolved over time and remarkable short- and long-term results have been reported. However, some concerns have raised about the adequacy of myocardial protection during the minimally invasive approach, particularly with the endo-aortic clamp (EAC). Aim of this study was to compare the efficacy, in terms of myocardial preservation, of the EAC with the trans-thoracic aortic clamp (TTC) in patients undergoing right mini-thoracotomy MV surgery. Methods: A single center, prospective observational study was performed on patients undergoing right mini-thoracotomy MV surgery with retrograde arterial perfusion and EAC or TTC. A propensity matched analysis was performed to compare the two groups. Primary outcome was the comparison between cardiac troponin T levels measured at different time-points after surgery. Results: Eighty EAC patients were compared with 37 TTC patients. No cases of myocardial infarction or low cardiac-output syndrome were overall reported. No differences were recorded in terms of stroke, peri-operative mortality, and in the release of myocardial markers, lactates levels and need for inotropic support at different time-points after surgery. CK-MB peak levels were significantly lower in the EAC group. Conclusion: Despite concerns arising about the EAC, this prospective study shows equivalence in terms of myocardial preservation of the EAC compared with the TTC in patients undergoing right mini-thoracotomy MV surgery.
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An increased need of extracorporeal membrane oxygenation (ECMO) support is going to become evident as treatment of SARS-CoV-2 respiratory distress syndrome. This is the first report of the Italian Society for Cardiac Surgery (SICCH) on preliminary experience with COVID-19 patients receiving ECMO support. Data from 12 Italian hospitals participating in SICCH were retrospectively analyzed. Between March 1 and September 15, 2020, a veno-venous (VV) ECMO system was installed in 67 patients (94%) and a veno-arterio-venous ECMO in four (6%). Five patients required VA ECMO after initial weaning from VV ECMO. Thirty (42.2%) patients were weaned from ECMO, while 39 (54.9%) died on ECMO, and six (8.5%) died after ECMO removal. Overall hospital survival was 36.6% (n = 26). Main causes of death were multiple organ failure (n = 14, 31.1%) and sepsis (n = 11, 24.4%). On multivariable analysis, predictors of death while on ECMO support were older age (p = 0.048), elevated pre-ECMO C-reactive protein level (p = 0.048), higher positive end-expiratory pressure on ventilator (p = 0.036) and lower lung compliance (p = 0.032). If the conservative treatment is not effective, ECMO support might be considered as life-saving rescue therapy for COVID-19 refractory respiratory failure. However warm caution and thoughtful approaches for timely detection and treatment should be taken for such a delicate patients population.
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COVID-19/mortalidad , COVID-19/terapia , Oxigenación por Membrana Extracorpórea/efectos adversos , Oxigenación por Membrana Extracorpórea/métodos , Síndrome de Dificultad Respiratoria/terapia , Insuficiencia Respiratoria/etiología , Lesión Renal Aguda/etiología , Adulto , Anciano , Procedimientos Quirúrgicos Cardíacos , Femenino , Humanos , Unidades de Cuidados Intensivos , Italia/epidemiología , Enfermedades Pulmonares/etiología , Masculino , Persona de Mediana Edad , Respiración con Presión Positiva , Embolia Pulmonar/etiología , Terapia de Reemplazo Renal , Estudios Retrospectivos , Sepsis/etiología , Accidente Cerebrovascular/etiologíaRESUMEN
To evaluate the accuracy of 3D models of the aortic-root generated from non-contrast cardiac magnetic resonance (CMR). Data were retrospectively collected from 30 consecutive patients who underwent surgical aortic valve replacement and had available records of both intra-operative assessment and pre-surgery annulus assessment by cardiovascular computed tomography (CCT) and CMR. The 3D models were independently segmented, modelled and printed by two blinded "manufacturers". The measurements on the models were carried out by two cardiac surgeons with Hegar dilator. Data were analyzed with non-parametric tests. There was no significant intra- or inter-observer variability (p ≥ 0.13). The agreement between the diameter of the 3D model derived from CMR images and either the anatomical reference of the intraoperative measurement (p = 0.10, r = 0.97) or the radiological reference of the 3D model generated from CCT (p = 0.71, r = 0.92) was very good. The process of segmentation plus the post-processing was about 17 ± 2 min for a model created by CMR, significantly higher than a model created from CCT (7 ± 2 min; p < 0.001). The printing time for a single model did not differ between the two modalities (p = 0.61) and was less than 60 min. The cost for a single model was approximately 0.5 . 3D models generated from non-contrast CMR performed well when compared to the anatomical reference standard and are comparable to the pair CCT derived models.
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Estenosis de la Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/diagnóstico por imagen , Imagen por Resonancia Magnética , Modelos Cardiovasculares , Tomografía Computarizada Multidetector , Impresión Tridimensional , Anciano , Anciano de 80 o más Años , Válvula Aórtica/fisiopatología , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/cirugía , Femenino , Humanos , Masculino , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Estudios Retrospectivos , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter , Flujo de TrabajoRESUMEN
Minimally invasive approach has become key in cardiac surgery over the last decade and nowadays involves all areas of expertise, as it was initially developed for mitral valve surgery and has quickly expanded also to surgery for the treatment of aortic valve disease and to myocardial revascularization. Compared to standard sternotomy, the most evident difference is minimalization of surgical incision, which reduces chest trauma with several benefits for patients. Minimally invasive cardiac surgery requires dedicated instrumentation/devices as well as an additive learning curve. Different perfusion strategies and aortic clamping techniques are available that facilitate this approach, although their well known advantages are also accompanied by several disadvantages, including an increased rate of stroke or vascular complications, that can be minimized in high-volume centers and by adopting a tailored approach based on the patient's features.
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Procedimientos Quirúrgicos Cardíacos/métodos , Humanos , Procedimientos Quirúrgicos Mínimamente InvasivosRESUMEN
BACKGROUND: Minimally invasive cardiac surgery (MICS) has constantly evolved over the past years, and new technologies have been introduced. The aims of this study were to analyze the evolution of our 10-year experience in MICS and to highlight outcomes in different spans of time. METHODS: Patients undergoing MICS for mitral valve, tricuspid valve, and/or atrial septal defect or atrial masses from November 2005 to November 2015 were retrospectively analyzed. A comparative analysis was performed by identifying 2 groups: the control group (in the first time span of our experience) and the tailored group (patients who underwent surgery after a full preoperative anatomic evaluation with allocation to the proper setting). RESULTS: During the study period 971 patients underwent MICS. MICS procedures increased from 44% in 2006 to 96% in 2015. Subgroup analysis revealed a significant decrease in the rate of procedures performed with retrograde arterial perfusion (99.1% vs 91.7%, P < .0001), a significant increase in the rate of complex mitral valve procedures (22.4% vs 7.9%, P < .0001), and a significant decrease in the rate of stroke (from 5.2% to 1%, P < .001) in the tailored group. The logistic regression analysis showed that the tailored approach was a protective factor against neurologic complications. CONCLUSIONS: The present study shows the considerable and attractive results of our decision-making process based on the tailored approach. The 10-year outcome analysis demonstrated a trend toward a progressive decrease in the overall rate of postoperative complications and a significant protective effect of the tailored approach on the occurrence of stroke.
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Procedimientos Quirúrgicos Cardíacos/tendencias , Toma de Decisiones , Predicción , Cardiopatías/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos/tendencias , Complicaciones Posoperatorias/prevención & control , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Italia/epidemiología , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/epidemiología , Estudios RetrospectivosRESUMEN
BACKGROUND: to determine reliability and reproducibility of measurements of aortic annulus in 3D models printed from cardiovascular computed tomography (CCT) images. METHODS: Retrospective study on the records of 20 patients who underwent aortic valve replacement (AVR) with pre-surgery annulus assessment by CCT and intra-operative sizing by Hegar dilators (IOS). 3D models were fabricated by fused deposition modelling of thermoplastic polyurethane filaments. For each patient, two 3D models were independently segmented, modelled and printed by two blinded "manufacturers": a radiologist and a radiology technician. Two blinded cardiac surgeons performed the annulus diameter measurements by Hegar dilators on the two sets of models. Matched data from different measurements were analyzed with Wilcoxon test, Bland-Altmann plot and within-subject ANOVA. RESULTS: No significant differences were found among the measurements made by each cardiac surgeon on the same 3D model (pâ¯=â¯0.48) or on the 3D models printed by different manufacturers (pâ¯=â¯0.25); also, no intraobserver variability (pâ¯=â¯0.46). The annulus diameter measured on 3D models showed good agreement with the reference CCT measurement (pâ¯=â¯0.68) and IOH sizing (pâ¯=â¯0.11). Time and cost per model were: model creation â¼10-15â¯min; printing time â¼60â¯min; post-processing â¼5min; material cost â¼1. CONCLUSION: 3D printing of aortic annulus can offer reliable, not expensive patient-specific information to be used in the pre-operative planning of AVR or transcatheter aortic valve implantation (TAVI).
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Estenosis de la Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/diagnóstico por imagen , Prótesis Valvulares Cardíacas , Modelos Cardiovasculares , Modelación Específica para el Paciente , Impresión Tridimensional , Tomografía Computarizada por Rayos X , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Anciano , Anciano de 80 o más Años , Válvula Aórtica/fisiopatología , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/fisiopatología , Estenosis de la Válvula Aórtica/cirugía , Femenino , Humanos , Masculino , Valor Predictivo de las Pruebas , Datos Preliminares , Diseño de Prótesis , Estudios RetrospectivosRESUMEN
BACKGROUND: Recent data have highlighted a higher rate of neurological injuries in minimal invasive mitral valve surgery (MIMVS) compared with the standard sternotomy approach; therefore, the role of specific clamping techniques and perfusion strategies on the occurrence of this complication is a matter of discussion in the medical literature. The purpose of this trial is to prospectively evaluate major, minor and silent neurological events in patients undergoing right mini-thoracotomy mitral valve surgery using retrograde perfusion and an endoaortic clamp or a transthoracic clamp. METHODS/DESIGN: A prospective, blinded, randomized controlled study on the rate of neurological embolizations during MIMVS started at the University of Turin in June 2014. Major, minor and silent neurological events are being investigated through standard neurological evaluation and magnetic resonance imaging assessment. The magnetic resonance imaging protocol includes conventional sequences for the morphological and quantitative assessment and nonconventional sequences for the white matter microstructural evaluation. Imaging studies are performed before surgery as baseline assessment and on the third postoperative day and, in patients who develop postoperative ischemic lesions, after 6 months. DISCUSSION: Despite recent concerns raised about the endoaortic setting with retrograde perfusion, we expect to show equivalence in terms of neurological events of this technique compared with the transthoracic clamp in a selected cohort of patients. With the first results expected in December 2016 the findings would be of help in confirming the efficacy and safety of MIMVS. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT02818166 . Registered on 8 February 2016 - trial retrospectively registered.