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Annuloplasty should always accompany mitral valve repair in order to achieve proper annular remodeling and stabilization. Numerous types of annuloplasty rings-that differ from rigid to semi-rigid and flexible devices, from complete to partial, and from flat to saddle-shaped rings-are clinically available. A deeper understanding of mitral valve function, in conjunction with several recent studies, suggest it is advisable to prefer annuloplasty rings that mimic the physiological mitral annulus shape and three-dimensional (3D) dynamic changes in order to reduce haemodynamic stress on valve components and optimize leaflet coaptation, perhaps improving valve repair durability too. This paper aims to focus on 3D annuloplasty rings, with dynamic features: MEMO 3D™ and MEMO 4D™ (Sorin Medical, New York, New York), as well as Physio Flex (Edwards Lifesciences, Irvine, California).
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Aortic annuloplasty has been clearly demonstrated to have a protective influence in aortic valve repair. Over the past 20 years, different annuloplasty concepts have been proposed by different groups. However, the most appropriate approach to enable long-term annular stability remains highly controversial. The aim of this article is to give a general overview of all types of aortic annuloplasty, particularly focusing on the use of an external Teflon ring, as proposed by our group. In this technique, external root dissection is performed in the same fashion as for reimplantation; the only difference is that it is necessary to go below the coronary ostia take-off. A series of pledgeted sutures (usually between 6 and 9 sutures) are placed at the level of the virtual basal ring. The external ring is made using a Teflon strip with a length of 8 to 9 cm, to reduce the annulus to a diameter of between 21 and 23 mm. The sub-annular sutures are then passed at the appropriate level through the Teflon strip and the strip is parachuted outside the aortic root base, passing under the coronary ostia. The two ends of the Teflon strip are tied at the level of the non-coronary sinus. Aortic annuloplasty is a crucial step to improve valve competence and stabilization. While several techniques offer good mid- to long-term results, annuloplasty with an external Teflon ring appears to be a simple and effective alternative to guarantee stable root diameters. Longer follow-up studies are needed to confirm the mid- to long-term results.
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Coronary artery bypass grafting remains one of the most frequently performed cardiac operations, with well-established prognostic benefits in patients with multivessel coronary artery disease and left main disease. Despite an increasingly higher patients' risk profile, the results of this procedure have significantly improved over time, with an evident and striking decrease in operative mortality and peri-operative complications. A fair amount of technical and technological refinements has further improved the short- and long-term results of coronary artery bypass surgery. The improvements in the beating heart coronary surgery and aortic 'no-touch' technique, in the appropriate use of conduits (bilateral internal mammary artery, radial artery, and composite conduits configuration), and in the optimization of venous grafts' patency are reviewed.
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We report an unusual case of black discoloration of an aortic root aneurysm and aortic valve cusps due to homogentisic acid deposition in a patient suffering from alkaptonuria. The patient underwent a valve-sparing aortic root replacement after careful and objective evaluation of the valve cusps. Despite alkaptonuria is classically associated with aortic valve stenosis and replacement, in the present case, the affected valve cusps were suitable for repair. To our knowledge, this is the first reported case of aortic valve-sparing procedure performed in a patient with alkaptonuria.
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Alcaptonuria , Aneurisma de la Aorta Torácica , Estenosis de la Válvula Aórtica , Alcaptonuria/complicaciones , Aorta , Aneurisma de la Aorta Torácica/complicaciones , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/cirugía , HumanosRESUMEN
BACKGROUND: Deep hypothermic circulatory arrest (DHCA) at ≤20°C for aortic arch surgery has been widely used for decades, with or without cerebral perfusion (CP), antegrade (antegrade cerebral perfusion [ACP]), or retrograde. In recent years nadir temperature progressively increased to 26°C-28°C (moderately hypothermic circulatory arrest [MHCA]), adding ACP. Aim of this multicentric study is to evaluate early results of aortic arch surgery and if DHCA with 10 min of cold reperfusion at the same nadir temperature of the CA before rewarming (delayed rewarming [DR]) can provide a neuroprotection and a lower body protection similar to that provided by MHCA + ACP. METHODS: A total of 210 patients were included in the study. DHCA + DR was used in 59 patients and MHCA + ACP in 151. Primary endpoints were death, neurologic event (NE), temporary (TNE), or permanent (permanent neurologic deficit [PND]), and need of renal replacement therapy (RRT). RESULTS: Operative mortality occurred in 14 patients (6.7%), NEs in 17 (8.1%), and PNDs in 10 (4.8%). A total of 23 patients (10.9%) needed RRT. Death + PND occurred in 21 patients (10%) and composite endpoint in 35 (19.2%). Intergroup weighed logistic regression analysis showed similar prevalence of deaths, NDs, and death + PND, but need of RRT (odds ratio [OR]: 7.39, confidence interval [CI]: 1.37-79.1) and composite endpoint (OR: 8.97, CI: 1.95-35.3) were significantly lower in DHCA + DR group compared with MHCA + ACP group. CONCLUSIONS: The results of our study demonstrate that DHCA + DR has the same prevalence of operative mortality, NE and association of death+PND than MHCA + ACP. However, the data suggests that DHCA + DR when compared with MHCA + ACP provides better renal protection and reduced prevalence of composite endpoint.
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Aorta Torácica , Paro Circulatorio Inducido por Hipotermia Profunda , Humanos , Aorta Torácica/cirugía , Resultado del Tratamiento , Paro Circulatorio Inducido por Hipotermia Profunda/métodos , Encéfalo , Puente Cardiopulmonar/métodos , Perfusión/métodos , Circulación Cerebrovascular , Estudios RetrospectivosRESUMEN
An indefinitely lasting bioprosthesis that does not require anticoagulation treatment is the holy grail of substitutive heart surgery. However, this goal is not yet in sight with the present state of technology. Over the past few years, tremendous advances have been achieved regarding tissue anticalcification processes, hemodynamic performance and future-proofing by ensuring compatibility with transcatheter valve-in-valve procedures. The Inspiris Resilia valve (Edwards Lifesciences, Irvine, CA) was designed to incorporate all of these enhancements. It is now leaving the experimental phase and is being tested in the real world. We present here a comprehensive review of the evolution of biological prostheses, details of new anticalcification technologies, and early results of published studies as well as the experience at the European Hospital (Rome, Italy), the site of the first European implant and a leading center in various protocols. In our two years of experience with the Inspiris Resilia, there have been no cases of structural valve deterioration, endocarditis, detachment or periprocedural complication, and gradients seem to be superior to those with the previous generation of Edwards valves. While longer-term experience is clearly needed, the results thus far are encouraging.
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Bioprótesis , Calcinosis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Válvula Aórtica/cirugía , Calcinosis/cirugía , Humanos , Diseño de PrótesisRESUMEN
We present the case of a 73-year-old male patient undergoing a modified Bentall-DeBono procedure in 2015 due to aortic stenosis and aortic aneurism involving the root. A bioprosthetic stented conduit made with a stented Edwards Perimount 21-mm bioprosthesis and a Vascutek Valsalva 28-mm Dacron graft was implanted along with a mitral annuloplasty. Five years later, due to early degeneration of the bioprosthesis and a progression of the mitral disease, he underwent a second surgical procedure where a Medtronic Mosaic 27-mm valve prosthesis was implanted in mitral position and a sutureless Livanova Perceval 23-mm valve in aortic position. Because of the difficulty in removing the previously implanted aortic prosthesis, the Perceval valve was inserted inside the frame of the PeriMount as an open "valve-in-valve" procedure. In October 2020, the patient underwent a ViV TAVI with a 23-mm Edwards Sapien 3 (Edwards Lifescience). After induction of general anesthesia and heparin administration, the procedure was performed via right femoral artery approach with preimplantation of two Proglides. After transfemoral insertion of a 14-French sheath, the aortic valve was crossed with a 0.035-in. straight guide-wire, taking care to avoid crossing the crowns of Perceval frame. After exchange of the standard wire with an extra-stiff 0.035-in. Safari wire, the Sapien-3 valve was advanced across the two previously implanted surgical valves and deployed at the level of the Perceval ring. After bioprosthesis deployment, peak-to-peak left ventricular aortic gradient was reduced from 51 to 16 mmHg.
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Estenosis de la Válvula Aórtica , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Anciano , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Hemodinámica , Humanos , Masculino , Diseño de Prótesis , Resultado del TratamientoRESUMEN
In the original pre-formed Valsalva graft, the skirt is the defining feature. It is a self-expanding portion, obtained by 90° rotation of the Dacron fabric corrugation with respect to the rest of the graft. Due to this manufacturing feature, the skirt length is equal to the graft diameter and, once pressurized, it expands by 25-30% (up to 10 mm) from the nominal size. Proximal to this bulged portion, a small collar completes the prosthesis. By virtue of this anatomical design, the Valsalva graft is recommended for most aortic root surgeries including valve-sparing and Bentall procedures. The skirt, by recreating the pseudo-sinuses, represents the key feature of the graft when used for aortic valve-sparing procedures (remodeling and reimplantation). However, in the Bentall procedure, the graft collar is an important feature because it is useful to attach the Valsalva graft to the valve prosthesis sewing ring when making a valved conduit. Moreover, once the graft is pressurized, the whole volume of the skirt better accommodates the struts and the leaflets of biological and mechanical prostheses. Furthermore, the expanded skirt reduces the distance and the tension on the coronary button anastomosis, increasing safety and possibly reducing complication rates. This review demonstrates the versatility of the Valsalva graft in various scenarios of aortic root surgery, with special emphasis on different uses of the skirt and the collar.
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Implantación de Prótesis de Válvulas Cardíacas , Aorta/cirugía , Válvula Aórtica/cirugía , Humanos , Diseño de Prótesis , ReimplantaciónRESUMEN
PURPOSE OF REVIEW: Until the year 2000, the publications concerning aortic valve sparing (AVS) did not exceed 20 articles; in the following years almost 300 publications have appeared. Over 35 years from the introduction of valve sparing techniques and 500 years after the death of Leonardo da Vinci, this review highlights the significant steps in modern imaging techniques and the excellent clinical results in the field of reconstructive aortic root surgery. RECENT FINDINGS: AVS operations underwent significant modifications over the last few years making it reproducible with satisfactory outcomes. The extraordinary potential of imaging opens new boundless horizons in the perspective of an increasingly patient-tailored surgical planning. The basic surgical concepts include the preservation and resuspension of the aortic valve in a near-normal environment (with the creation of functionally suited neo-aortic sinuses) and the re-establishment of a normal relationship of the aortic root components. SUMMARY: Today is possible to perform a reimplantation procedure with the creation of neo-sinuses or a remodeling procedure with the addition of annular support. Both procedures can now guarantee an anatomical root reconstruction and an increased long-term durability. AVS operations have become established alternatives to Bentall procedures for patients with aortic root pathology, especially in young patients.
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Aneurisma de la Aorta , Insuficiencia de la Válvula Aórtica/cirugía , Válvula Aórtica/cirugía , Humanos , Reimplantación , Resultado del TratamientoRESUMEN
BACKGROUND: The aim of this multicenter prospective study was to evaluate the prognostic weight of preoperative right ventricular assessment on early mortality in cardiac surgery. METHODS: This is a multicenter prospective observational study performed by the Italian Group of Research for Outcome in Cardiac Surgery (GIROC) including 11 centers. From October 2017 to March 2019, out of 923 patients undergoing cardiac surgery, 28 patients with some missing data were excluded and 895 patients were enrolled in the study right ventricular dilatation was defined as a basal end-diastolic diameter >42 mm. The right ventricle (RV) function was assessed using the combination of three parameters: fractional area changing (FAC), tricuspid annular plane systolic excursion (TAPSE), and S'-wave using tissue Doppler imaging (TDI-S'); RV dysfunction was defined as the presence of at least two of the following cutoffs: FAC <35%, TAPSE <17 mm, and TDI S' <9.5 mm RESULTS: Among the entire cohort, 624 (70%) showed normal RV, 92 (10%) isolated RV dilatation, 154 (17%) isolated RV dysfunction, and 25 (3%) both RV dilatation and dysfunction. Non-surviving patients showed a significantly higher rate of RV alteration at multivariable analysis, RV status was found to be an independent predictor for higher in-hospital mortality beside Euroscore II. CONCLUSIONS: This prospective multicenter observation study shows the importance to assess RV preoperatively and to include both RV function and dimension in a risk score model such as Euroscore II to implement its predictivity, since PH cannot always mirror the status of the right ventricle.
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Procedimientos Quirúrgicos Cardíacos/mortalidad , Ventrículos Cardíacos/patología , Evaluación de Resultado en la Atención de Salud/métodos , Proyectos de Investigación , Función Ventricular Derecha , Adulto , Anciano , Anciano de 80 o más Años , Dilatación Patológica , Femenino , Humanos , Masculino , Persona de Mediana Edad , Periodo Preoperatorio , Pronóstico , Estudios Prospectivos , Riesgo , Disfunción Ventricular Derecha , Adulto JovenRESUMEN
INTRODUCTION: Progressive saphenous vein graft (SVG) failure remains a key limitation to the long-term success of coronary artery bypass grafting (CABG). SVG disease after the first year is dominated by intimal hyperplasia, which predisposes the SVG to thrombosis and accelerated atherosclerosis. The objective of this study was to review and summarize the latest experimental and clinical data on the use of mechanical external stents for vein grafts. METHODS: In January 2020, the PubMed database was searched using the terms "external stent", "CABG", "saphenous vein graft" and "intimal hyperplasia". The results were reviewed and only randomized experimental and clinical studies that analyzed the effect of external stenting on venous intimal hyperplasia were included in the analysis, together with studies that investigated the clinical benefit of external stenting. RESULTS: Eight experimental and four clinical trials met the search criteria. Controlled trials in different large animal models concluded that external stenting significantly reduced intimal hyperplasia 3-6 months post implantation, and reduced both thrombosis rates and the development of lumen irregularities. Data from randomized controlled trials with a follow-up period of 1-4.5 years supported the pre-clinical findings and demonstrated that external stents significantly reduced vein graft disease. CONCLUSION: Strong evidence indicates that supporting the vein with external stents is safe and leads to clear advantages at both the anatomical and cellular levels. With the further accumulation of consistent positive results, external stenting of SVG may become the standard of care in future CABG.
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Puente de Arteria Coronaria/métodos , Oclusión de Injerto Vascular/prevención & control , Vena Safena/trasplante , Stents , Túnica Íntima/patología , Animales , Aterosclerosis/etiología , Aterosclerosis/prevención & control , Implantación de Prótesis Vascular/métodos , Oclusión de Injerto Vascular/etiología , Humanos , Hiperplasia/cirugía , Ensayos Clínicos Controlados Aleatorios como Asunto , Vena Safena/cirugía , Trombosis/etiología , Trombosis/prevención & control , Túnica Íntima/cirugía , Grado de Desobstrucción VascularRESUMEN
This is the third and final part of our update on the latest advances in cardiac valvular replacement. Part 1 was dedicated to cardiac valvular replacement, and Part 2 focused on transcatheter cardiac valvular treatment. This part concerns annuloplasty prostheses for valvular reconstructive surgery. The number of patients undergoing surgical heart valve repair has been increasing, particularly in high-volume centers. Annuloplasty is now considered the gold standard in mitral valve regurgitation repair secondary to degenerative, ischemic and idiopathic dilated cardiomyopathy disease. The techniques of mitral valve reconstruction have been well established, but controversies remain regarding the type of annuloplasty ring to be used. The available annuloplasty rings include rigid, flexible, complete, partial, and semi-rigid/flexible. The choice of annuloplasty ring has been the focus of extensive investigation and debate, but to date it still largely remains a matter of "surgeon's preference" rather than an evidence-based selection. Functional tricuspid regurgitation was traditionally treated by the classic De Vega annuloplasty, but has since evolved after the development of prosthetic tricuspid annuloplasty. Head-to-head comparisons have demonstrated superior long-term outcomes with device-based annuloplasty compared to suture-based surgery, but the type of ring to be used (flexible versus rigid) has recently been questioned, without reaching definitive conclusions. In contrast to mitral and tricuspid valve repair, aortic repair is more difficult with respect to specific valve features. Annuloplasty is considered to play a key role in controlling aortic regurgitation and preventing recurrence after valve repair. Various modifications of annuloplasty have been advocated (internal/external, with/without ring (suture), rigid/flexible ring). but none of them has become a de facto standard. This paper describes the various rings that are available to help orient surgeons and to serve as a reference for students.
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Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Anuloplastia de la Válvula Mitral , Insuficiencia de la Válvula Tricúspide , Humanos , Válvula Mitral , Anuloplastia de la Válvula Mitral/métodos , Resultado del Tratamiento , Válvula Tricúspide , Insuficiencia de la Válvula Tricúspide/cirugíaRESUMEN
Biological systems ubiquitously and inevitably exhibit stochasticity in traits from the molecular level to the multicellular and morphological level. However, there are several examples of natural events that might be described in mathematical terms. Plants grow in a structured and geometric way to maximize their sun exposure for photosynthesis while reducing the stress. The 'Fibonacci sequence' and its 'golden ratio' are considered a mathematical regularity and model that is one of the corner-stone of the 'phyllotaxis', the part of the botany that studies how plants branch. Nevertheless, we currently do not know if such mathematical model can be applied to humans. Different authors have hypothesized that 'fractal' might be identified along with the 'golden-ratio' in the human body (coronary artery, heart valves etc.). The aortic valve and the aortic root might represent an interesting model of human fractal geometry, where the phyllotactic rules can be reasonably applied, and where deviation from normality might results in dysfunction. However, in the absence of scientific validations, such report represents only the authors' perceptions of a beautiful shape.
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Válvula Aórtica/anatomía & histología , Botánica/historia , Hojas de la Planta/anatomía & histología , Fractales/historia , Historia del Siglo XVI , Historia Antigua , HumanosRESUMEN
When the original monograph on valvular prostheses was published in Surgical Technology International, back in 1993, transcatheter technology had not yet been invented. These techniques have been gradually revealed in subsequent issues. When we first considered writing a paper that described both surgical and transcatheter prosthesis, we realized that such a combined paper would be impractically large. Therefore, we decided to split our survey into more than one paper. This paper seeks to address the paucity of information available regarding transcatheter aortic valve implantation (TAVI) and similar devices. This publication may serve as a reference point for critically organizing information on an evolving topic. The following article deals with the large number of transcatheter devices related to valvular and ventricular pathologies: TAVI for the aortic and mitral valves, with a focus on indications, techniques and complications, as well as specific aortic devices, and devices to treat mitral regurgitation with non-conventional access. Every effort has been made to make the content relevant and up-to-date, which proved to be particularly challenging due to the continuous technological evolution which characterizes this field.
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Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Enfermedades de las Válvulas Cardíacas/cirugía , Válvulas Cardíacas/cirugía , Humanos , Diseño de Prótesis , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Reemplazo de la Válvula Aórtica Transcatéter/tendenciasRESUMEN
The original monograph on valvular prostheses in Surgical Technology International was published in 1993. It represents a milestone and a reference point for critically organizing information on a complex and rapidly evolving topic. The last update was published in 2010. Since then, there have been significant developments regarding both "traditional" surgical prosthesis and valves for transcatheter implantation. Both bioprostheses and mechanical prostheses continue to evolve with respect to both their design and materials to further optimize hemodynamics and prevent a patient-prosthesis mismatch. Each type of prosthesis has its own Achilles's heel: limited durability leading to structural failure for bioprostheses, and the need for anticoagulation for mechanical prostheses. After a long period of only marginal improvements, new techniques for tissue preservation and manufacturing seem to have placed surgeons on the verge of a minor revolution regarding bioprostheses. In addition, in the realm of mechanical prostheses, the many promises of silicon-free pyrolitic carbon still need to be confirmed, while an extremely cautious approach with new anticoagulants has left patients out of the non-dose-adjusted revolution, which has radically improved the quality of life of other patients, such as those suffering from atrial fibrillation. On the other hand, transcatheter therapies are maturing, and the next few years will probably see an even stronger shift in the treatment of patients away from surgical theaters to cath labs, or perhaps to a new mixed theater (which could lead to a new mixed surgeon/catheter expert professional). This paper provides device descriptions and images of the technologies that are considered to be predominant, at least for the moment, to help orient surgeons and to serve as a reference for students. This report would not have been possible without the prior work of Profs. Denton Cooley and Eric Jamieson.
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Implantación de Prótesis de Válvulas Cardíacas , Prótesis Valvulares Cardíacas , Bioprótesis , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/tendencias , Humanos , Calidad de VidaRESUMEN
AIMS: The aim of this study was to evaluate the clinical and echocardiographic results and the predictors of outcomes in patients undergoing valve-sparing operation (VSO) at two aortic centers. In addition, we sought to evaluate the potential effect of recreation of the sinuses of Valsalva (SV) on the outcome of valve-sparing procedures. METHODS: During a 14-year period, 328 patients underwent aortic valve-sparing root replacement at two institutions. Clinical and echo evaluation was performed 6 months after surgery and every year thereafter or in case of clinical symptoms. Propensity weighting and propensity-weighted risk competing analysis were used. RESULTS: No operative mortality was reported; the most common complication was revision for bleeding, occurring in 15 patients (4.6%). At a mean follow-up of 30.0 ± 33.9 months, two patients died (0.6%). Recurrent aortic insufficiency (AI) >2+ was found in 11 patients (3.3%); five (1.5%) underwent reoperation. Recreation of the SV did not affect clinical outcome and aortic valve status. Need for aortic valve repair was the only independent predictor of recurrent AI, whereas a bicuspid aortic valve was a protective factor. CONCLUSIONS: Re-creation of the SV does not affect short-term outcomes following VSO.
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Aorta/cirugía , Insuficiencia de la Válvula Aórtica/cirugía , Válvula Aórtica , Implantación de Prótesis Vascular/métodos , Tratamientos Conservadores del Órgano/métodos , Procedimientos de Cirugía Plástica/métodos , Seno Aórtico/cirugía , Adulto , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Ecocardiografía , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Puntaje de Propensión , Estudios Retrospectivos , Medición de Riesgo/métodos , Resultado del TratamientoAsunto(s)
Infecciones por Coronavirus/patología , Neumonía Viral/patología , Betacoronavirus/aislamiento & purificación , COVID-19 , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/mortalidad , Infecciones por Coronavirus/virología , Oxigenación por Membrana Extracorpórea , Humanos , Pandemias , Neumonía Viral/epidemiología , Neumonía Viral/mortalidad , Neumonía Viral/virología , Riesgo , SARS-CoV-2 , Tasa de SupervivenciaRESUMEN
OBJECTIVE: Hemostasis is a critical component of all surgical procedures and especially cardiac surgery. In addition to traditional means, topical hemostatic agents have been reported to be extremely effective in terminating bleeding during cardiac procedures. We compared a hemostatic matrix sealant agent (HEMOPATCH Baxter Healthcare Corporation, Deerfield, IL) with alternative topical hemostatic treatment in patients undergoing ascending aorta surgery with moderate bleeding. MATERIALS AND METHODS: Following sample size calculation, in a prospective randomized study design, 85 patients were treated with HEMOPATCH matrix sealant and 85 patients received alternative treatment (dry or wet gauze compression or similar [control group]). The primary outcome measure was the percentage of patients with successful hemostasis within three minutes of HEMOPATCH or traditional treatment application. Other study outcome measures were postoperative blood loss and the rate of transfusion of blood products. RESULTS: A statistically higher rate of successful hemostasis within three minutes was observed in the HEMOPATCH group (97.6% [83/85] vs. 65.8% [56/85] in the control group; p< 0.001). The percentages of patients with postoperative bleeding and the rate of transfusion were lower in the HEMOPATCH group than in the control group. CONCLUSIONS: The use of HEMOPATCH is effective in terminating bleeding in patients undergoing ascending aorta cardiac procedures. Fewer patients treated with HEMOPATCH required blood transfusion. The cost-utility profile of HEMOPATCH should be addressed in dedicated trials.
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BACKGROUND: We conducted a prospective single-blind randomized study to assess whether a single 80,000 IU dose of human recombinant erythropoietin (HRE), given just 2 days before cardiac surgery, could be effective in reducing perioperative allogeneic red blood cell transfusion (aRBCt). STUDY DESIGN AND METHODS: Six-hundred patients presenting with preoperative hemoglobin (Hb) level of not more than 14.5 g/dL were randomly assigned to either HRE or control. The primary endpoint was the incidence of perioperative aRBCt. The secondary endpoints were mortality and the incidence of adverse events in the first 45 days after surgery, Hb level on Postoperative Day 4, and number of units of RBC transfusions in the first 4 days after surgery. RESULTS: A total of 17% (HRE) versus 39% (control) required transfusion (relative risk, 0.436; p<0.0005). After baseline Hb was controlled for, there was no difference in the incidence of aRBCt between HRE (0%) and control (3.5%) among the patients with baseline Hb of 13.0 g/dL or more, which included the nonanemic fraction of the study population. The mean (range) Hb level on Postoperative Day 4 was 10.2 (9.9-10.6) g/dL (HRE) versus 8.7 (8.5-9.2) g/dL (control; p<0.0005). The distribution of number of units transfused was shifted toward fewer units in HRE (p<0.0005). The all-cause mortality at 45 days was 3.00% (HRE) versus 3.33% (control). The 45-day adverse event rate was 4.33% (HRE) versus 5.67% (control; both p=NS). CONCLUSION: In anemic patients (Hb<13 g/dL), a single high dose of HRE administered 2 days before cardiac surgery is effective in reducing the incidence of aRBCt without increasing adverse events.