Biological Prostheses Research Articles

A Comparison of Component Separation With Porcine Acellular Dermal Reinforcement to Bovine Acellular Dermal Matrix in the Repair of Significant Midline Ventral Hernia Defects.

The optimal material for reinforcement of complex abdominal ventral hernia repair (VHR) remains controversial. Biologic prostheses such as porcine and bovine acellular dermal matrix (PADM/BADM) have shown favorable results, but few head-to-head comparisons between the two types exist. We sought to provide such a comparison. We performed a retrospective cohort study comparing 40 consecutive patients who underwent open component separation (CS/VHR) with PADM reinforcement to 39 consecutive patients who underwent open CS/VHR with BADM reinforcement at our institution. Patient characteristics, outcomes, complications, reoperations, and hernia recurrences were obtained by chart review. Fisher's exact and t-test analyses compared patient characteristics and outcomes between the 2 cohorts. Statistical significance was set as P < .05. Patient groups did not differ significantly in race (P=.36), age (P=.8), BMI (P=.34), sex (P=.09), steroid usage (p-1.00), COPD (P=.43), number of previous abdominal operations (P=.66), and duration of follow-up (P=.65). There were significantly more smokers in the PADM group (37.5% vs 12.8%, P=.01). Mean defect size was significantly greater in the PADM group (372.5cm2 vs 292. cm2 in the BADM group, P=.001) as was the number of Ventral Hernia Working Group (VHWG) grade III/IV hernias (65.0% vs 38.4%, P=.02). Recurrence rates were lower in the BADM group, (12.5% vs 5.1%, P=.26), as was recurrence or complications requiring reoperation (17.5% vs 5.1%, P=.15). Postoperative wound events were also significantly lower in the BADM group (30.0% vs 2.6%, P=.001). In our series, CS/BADM was associated with significantly fewer wound complications. Recurrences and complications requiring reoperation were also fewer, which trended toward but did not reach statistical significance, presumably due to the small sample size. These findings indicating superiority of BADM over PADM are potentially confounded by the higher percentage of smokers, the larger mean defect size, and the higher number of VHWG III/IV patients in the PADM group. Further prospective study of these findings is warranted.

Guías ESC/EACTS 2021 sobre el tratamiento de valvulopatías

The 2021 ESC (European Society of Cardiology) and EACTS (European Association for Cardio-Thoracic Surgery) guidelines for the management of valvular heart disease are an update of the 2017 guidelines. The most notable new features include placing the patient at the centre of the assessment and diagnosis, and the importance and relevance of decisions made by the heart team. They stress that certain valve interventions should only be performed in specialist heart valve centres, and that these should have permanent cardiac surgery services and dedicated outpatient teams in heart valve clinics. There are new recommendations on the management of the left atrial appendage in patients with atrial fibrillation, on the indication for the treatment of aortic, mitral, and tricuspid valve disease, on the type of treatment for aortic stenosis and secondary mitral regurgitation, and on the anticoagulation treatment in patients with biological prostheses.

Comparison of total hip arthroplasty with conventional instrument OCM approach and posterolateral approach in supine position

To compare the clinical efficacy of total hip arthroplasty with conventional instrument OCM approach and posterolateral approach in supine position. From February 2017 to January 2019, 67 patients underwent hip arthroplasty due to hip diseases, including 21 patients in the minimally invasive group, 12 males and 9 females;there were 10 cases of femoral neck fracture, 5 cases of aseptic necrosis of femoral head and 6 cases of hip osteoarthritis. In the traditional group, 46 cases were treated by traditional posterolateral approach, including 28 males and 18 females;there were 24 cases of femoral neck fracture, 12 cases of aseptic necrosis of femoral head and 10 cases of hip osteoarthritis. All patientsused biological ceramic artificial joint prosthesis. The operation time, intraoperative bleeding, incision length, preoperative and postoperative creatine kinase (CK-NAC), underground activity time, hospital stay, abduction angle and anteversion angle of prosthesis were observed and compared between two groups. Harris scores before operation and 12 months after operation were compared between two groups. All cases were followed up for 14 to 26(18.4±3.6) months. There was no significant difference in intraoperative bleeding, postoperative anteversion and abduction angle between two groups (P>0.05). There were significant differences in operation time, incision length, postoperative creatine kinase, underground time and hospital stay between two groups (P<0.05). There was no significant difference in Harris function score between two groups before operation and 12 months after operation(P>0.05). The two approaches of total hip arthroplasty can obtain satisfactory results.OCM approach has less damage and rapid postoperative recovery. It is a reliable surgical approach and can be popularized and used.

Thrombotic and hemorrhagic complications during pregnancy, delivery and the postpartum period in females with prosthetic heart valves

Abstract Background/Introduction Women with mechanical prosthetic heart valves are at greatest risk of developing complications.The main reason is that mechanical prosthetic heart valves require lifelong anticoagulation to reduce the high risk of associated thrombotic and hemorrhagic complications. Purpose The main goal of this study was to estimated risk factors and frequency of thrombotic and hemorrhagic complications during pregnancy, delivery and the postpartum period in women with prosthetic heart valves Methods According to retrospective cohort analyses in this study were included 70 patients with prosthetic heart valves who delivered in a specialized perinatal center from October 2010 to February 2020. All the patients were divided into two groups depending on prosthesis type: mechanical prostheses (44 deliveries in 44 patients), biological prostheses (22 deliveries in 19 patients). All patients were performed ECHO (Vivid 7, GE, USA). The average age were 30.7±5.2 years. The N-terminal brain natriuretic propeptide (NT-proBNP) concentration was determined by the quantitative electrochemiluminescence method using a Cobas E 411 analyzer (Roche, Switzerland). The activity of the anti –Xa factor was measured by chromogenic assays. Results In 9 (21.4%) pregnants with a mechanical valve prosthesis (MVP), prosthetic thrombosis was recorded until 2016. In 1 patient with mechanical valve prosthesis (2%) during pregnancy was complicated by an acute cerebral circulation disorder. Since 2016 there were monitored the activity of the anti –Xa factor. In 7 patients on the background of a change in anticoagulant therapy, pregnancy stopped in the early stages. Before pregnancy, 31.4% of the patients didn't have heart failure clinical manifestations, but in 12 (17.1%) patients during pregnancy had increase in NYHA Class maximum to NYHA Class III. The average NT-proBNP concentration was 912.3±1586.6 pg / ml. The frequency of the cesarean section in both groups was high: in patients with mechanical valve prosthesis in 78.5% and in the group of patients with biological valve prostheses in 68.1% of cases. There were not registered any new cases of prosthetic thrombosis after delivery, however, 9 patients had hemorrhagic complications in the early postpartum period, which required relaparotomy and blood transfusions. Regardless of frequent complications during pregnancy and in the postpartum period, no fatal outcomes have been reported. Conclusion The absence of mortality over the 9-years old observation and delivery in patients with valvular prostheses demonstrates the feasibility of monitoring and delivery of this category of patients in a specialized multidisciplinary medical center with experience in managing patients during pregnancy with valvular prostheses on anticoagulant therapy. Funding Acknowledgement Type of funding sources: None.

Single centre experience in 1202 biological prosthesis: a comparison between sutured, sutureless and surgical transcatheter aortic valve

Abstract Background/Introduction Different types of bio-prosthesis are now available for the treatment of aortic valve disease. In absence of the “ideal” heart valve prosthesis, the best choice may be customized on the basis of the patient's profile. Purpose The aim of this study was to compare results in different subgroups of bio-prosthesis in elderly patients (&amp;gt;75 years old) undergoing conventional or surgical trans-catheter aortic valve replacement (AVR). Primary outcome was all cause mortality, secondary outcomes were: early post-operative complications (stroke, AV-block, acute kidney injury requiring temporary dialysis), freedom from structural vascular disease (SVD) and from re-operation. Methods In this retrospective study we analysed 1202 patients over 75 years old, underwent AVR from 2002 to 2018. Inclusion criteria were: age &amp;gt;75 years underwent AVR; we divided our population in 3 groups according to different strategy: primary aortic valve replacement with sutured (group 1, n=1005), sutureless (group 2, n=103) or surgical trans-catheter aortic valve replacement (group 3, n=94). Exclusion criteria: concomitant cardiac procedure other than coronary artery by-pass graft (CABG) or endocarditis. Patient and disease characteristics are described as numbers and percentages, continuous data were expressed using mean and standard deviation. Differences between groups were evaluated using either Student t-test or Mann-Whitney U test or ANOVA test. Survival curves of the primary outcome and freedom from secondary outcomes were built with the Kaplan-Meier method. Results The mean age of the overall population was 80.5±3.6 years with a mean STS score of assessed at 2.79±2.2% (2.27±1.0 for standard AVR, 3.3±2.2% for sutureless and 6.4±4.5 for S-TAVR, p-value&amp;lt;0.001). Early outcomes are depicted in figure 1. The overall 30-day mortality was 2.9%; among the different groups we observed 2.3%, 4.9% and 7.2% for sutured, sutureless and surgical-TAVR, respectively (p-value=0.01). The groups statistically differed also for permanent pacemaker implantation (sutured AVR 2.2%, sutureless AVR 4.9%, TAVR 9.6% (p-value&amp;lt;0.001) and acute renal failure requiring temporary dialysis sutured AVR 3%, Sutureless AVR 1.9% and Surgical TAVR 9.6% (p-value=0.004). The survival rate at follow-up was significantly different among group (log-rank &amp;lt;0.001, figure 2). Instead, freedom from reoperation was similar between cohorts (figure 2.) Conclusion(s) The outcomes of surgical AVR in a elderly population could be safely guaranteed with different biological prosthesis and operative techniques. A patient tailored approach should be always advised to improve current available transcatheter options. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2

Hadrontherapy for intra- or para-cardiac tumors: evaluation of cardiac radiation dose distribution and acute cardiac effects

Abstract Background There is growing interest in the possibility of using X-rays and hadrons (protons and carbon ions) for antiarrhythmic purposes both at the ventricular and the atrial level, but knowledge about the effects on cardiac tissue outside the target is still limited. Hadron therapy has the dosimetric advantage over photons of a greater ability to concentrate high doses on the target while minimizing the off-target dose. Oncological studies have shown a linear relationship between the mean total heart dose (Dm-heart) of X-rays and the long-term risk of heart damage, particularly when the Dm-heart is&amp;gt;5 Gray (Gy). Objectives We designed a prospective study aimed at investigating the effect of heavy particles on cardiac structure and function and on cardiac rhythm in patients undergoing hadrontherapy for intra or para-cardiac tumors. Methods Patients candidates to hadrontherapy with a mean predicted cardiac dose grather than zero underwent close cardiological monitoring including blood pressure detection, 12-lead ECG, 12-lead Holter ECG (including time-domain indices of heart rate variability in all cases and Brugada leads in selected cases), cardiac US and cardiac (troponin and natriuretic peptides) and inflammatory biomarkers. These assessments were obtained at baseline, during (ECG and biomarkers only) and at the end of the hadrontherapy cycle, and then every 3–6 months as appropriate. Physicists and radiotherapists collaborated to implement a robust optimization of the treatment plan aimed at minimizing cardiac dose. We present the results of the monitoring up to the end of the hadrontherapy. Results 17 consecutive patients (56±18 years, range 20–77 years, 59% male) have been enrolled to date, including 3 cases (18%) of intra-cardiac tumors (2 primary and 1 metastatic), who have undergone to 16±6 sessions of radiotherapy each, in 71% of cases with respiratory gating during delivery. Most patients (76%) were treated with carbon ions, the remaining with protons (mean total dose on the neoplastic target 51.8±10.7 Gy, from 2 to 4.2 Gy per fraction). Sixty-one percent of patients had ≥1 cardiovascular risk factor, 6% had a known heart disease (valvular cardiomyopathy despite aortic valve replacement with biological prosthesis and post-surgical pericarditis). The mean dose on the whole heart was 3.58±2.05 Gy, the maximum dose was 33.78±23.99 Gy, with a very variable dose distribution on cardiac substructures depending on the tumor site (table). At the end of the scheduled radiotherapy sessions (24±9 days), no significant changes were observed in cardiac function, cardiac rhythm, ventricular repolarization, biomarkers and autonomic indices. Conclusions Hadrontherapy with protons and carbon ions aimed at the treatment of para-cardiac or intra-cardiac tumors allowed to maintain a low heart Dm and showed no signs of acute cardiac toxicity. The collection of potential cardiac effects in the medium and long term is ongoing. Funding Acknowledgement Type of funding sources: None.

Predictors for dementia during long-term follow-up after aortic valve replacement in an elderly population

Abstract Introduction Patients undergoing surgical aortic valve replacement (SAVR) with a biological prosthesis usually receive this type of valve because higher age and comorbid conditions. This is the type of patient for whom transcatheter valve implantation (TAVI) has been developed and applied as a mean for less invasive treatment. However, this is also the age group at risk for dementia, a condition which severely reduces the quality of life. Purpose The predictors for the development of dementia during long-term follow-up after SAVR need identification. Methods From January 2008 to June 2017, 1305 patients underwent SAVR with a biological valve. Of these patients, 1221 left the hospital alive (93.6%). In a retrospective file study, the effect of age, gender, preoperative comorbid condition (chronic renal or pulmonary disease, diabetes, treated or treatable cancer, hypertension, stroke) and cardiac status (left ventricular function, coronary artery disease, myocardial infarction, prior CABG or PCI, severity of symptoms, atrial fibrillation, ventricular arrhythmias, conduction defects with or without a need for permanent pacemaker), operative data (bypass time&amp;gt;120 minutes, concomitant CABG, mitral valve repair, maze procedure, procedure on the ascending aorta) and in-hospital postoperative complications (endocarditis, thromboembolism, bleeding, atrial fibrillation, heart failure, pulmonary and renal complications) on the development of dementia was studied. Factors with an effect in a univariate Kaplan-Meier survival analysis were entered in a Cox' proportional hazard analysis. Results There was a follow-up of 7726 patient-years (mean 5.9y). Five-year survival was 78.8±1.3%. At 10 year, this was 50.7±2.1%. Dementia during long-term follow-up was diagnosed in 162/1080 patients (15%). Predictors for the development of dementia are grouped as 1) preoperative, 2) operative and 3) postoperative, and ranked according the p-value. 1) Preoperative predictors – Age &amp;gt;75 years: Odds ratio: 2.89, with 95% Confidence interval between 2.02–4.14 and p&amp;lt;0.001 – Need for emergent surgery: OR=2.84 (1.56–5.19), p=0.001 – Coronary artery disease: OR=1.57 (1.12–2.21), p=0.009 – Diabetes mellitus: OR=1.56 (1.08–2.24), p=0.017 – Atrial fibrillation: OR=1.51 (1.07–2.15), p=0.020 2) Operative predictors – Bypass time &amp;gt;120 minutes: OR=1.40 (1.01–1.94), p=0.043 3) Postoperative predictors – Delirium: OR=3.35 (2.26–4.97), p&amp;lt;0.001 – Acute renal injury: OR=1.98 (1.39–2.81),p&amp;lt;0.001 – Thromboembolism: OR=2.10 (1.02–4.30), p=0.043 Conclusions Development of dementia during long-term follow-up after SAVR in elderly is not uncommon. High age and need for emergent surgery are the dominant preoperative predictors. Long cardiopulmonary bypass, which is usually a marker for more complex procedures is the only operative predictor. Postoperative delirium during hospital stay is a warning sign. The only modifiable factor is need for emergent surgery. Funding Acknowledgement Type of funding sources: None.

1292 Aortic Valve Neocuspidization Using Glutaraldehyde-Treated Autologous Pericardium: A Literature Review

Abstract Background Aortic Valve Neocuspidization using glutaraldehyde-treated autologous pericardium was first performed by Ozaki et al. in 2007. This technique has become an alternative to tissue and mechanical valve as long-term anticoagulation is not required and shows promising midterm results and durability. Method A comprehensive search was performed on the major database using search terms “Ozaki technique” AND “Aortic Valve Neocuspidization” AND “AV Neocuspidization” AND “Autologous pericardium” AND “glutaraldehyde-treated autologous pericardium”. Articles up to 1st of August 2020 were included in this study. Results A total of 9 studies with a total of 1342 patients were included. The mean age was 67.36 and 54.23% were male. 66.32% and 23.92% of patients had aortic stenosis and aortic regurgitation, respectively. 66% of patients had a native tricuspid aortic valve and 31.37 % patients’ native aortic valve was bicuspid. Three studies reported their experience performing Aortic Valve Neocuspidization via mini sternotomy. Conclusions Aortic Valve Neocuspidization is an alternative to biological and mechanical prostheses for surgical aortic valve replacement. The short and mid-term outcome are comparable without the need for long term oral anticoagulation. Long term follow-up data is required for this novel approach to be widely adopted.

Aortic and mitral bioprosthetic valve dysfunction: surgical or percutaneous solutions?

In the last years, there has been a trend to prefer biological prostheses, especially among young patients, with the aim to avoid anticoagulant treatment. Surgical tissue valves have so far demonstrated their solid long-term durability. However, younger age has been identified as one of the main risk factors for developing structural valve deterioration (SVD). As a consequence, the proportion of subjects at risk for valve dysfunction will constantly rise in the near future. However, while surgical reintervention has always been considered the gold standard for treatment of prosthesis deterioration, the introduction of transcatheter heart valves could offer new therapeutical options, particularly among high-risk patients, aiming a second less invasive chance. The recent standardization of valve durability definitions will soon allow a more comprehensive understanding of the mechanism underlying SVD and guide the choice of prosthesis for patients needing valve replacement.

Оценка биосовместимости очищенного говяжьего сухожилия на модели гетеротопической имплантации

Damage to the tendon-ligamentous apparatus places serious limitations on a personʼs physical activity. Injuries are especially common in physically healthy people leading an active lifestyle, such as athletes. To treat such injuries in orthopaedics and traumatology, autoplastic operations are performed or prostheses made of synthetic or biological materials are installed. The known treatment methods, in spite of their effectiveness, have a number of serious drawbacks, which often limit their use. Therefore, the search for new approaches and materials for plastic ligaments is an urgent task. Today, biotissue prostheses are accumulating advantages over their synthetic counterparts. The most promising raw material for biological ligament prostheses, due to its availability in the required quantity and optimal size, is the flexor and extensor calf tendons. This paper aimed to develop a method for treating xenogenic tendon to manufacture ligament prostheses and assessing its biocompatibility in a heterotopic implantation model. To manufacture a ligament prosthesis, the raw material was subjected to mechanical cleaning and chemical-physical treatment, as well as treatment with supercritical carbon dioxide fluid with the addition of the nonionic surfactant Tween 80, which together contributed to effective decellularization and removal of other biologically active components, while maintaining the physical and mechanical parameters and natural fiberarchitectonics of native raw materials. The biocompatible properties of ligament prosthesis specimens made from the flexor and extensor calf tendons using this method were evaluated in a model of heterotopic implantation into the subcutaneous adipose tissue of rats. The results obtained confirm the promising use of this material, treated according to the proposed method, in clinical practice.

A Role for Peroxisome Proliferator-Activated Receptor Gamma Agonists in Counteracting the Degeneration of Cardiovascular Grafts.

Aortic valve replacement for severe stenosis is a standard procedure in cardiovascular medicine. However, the use of biological prostheses has limitations especially in young patients because of calcifying degeneration, resulting in implant failure. Pioglitazone, a peroxisome proliferator-activated receptor gamma (PPAR-gamma) agonist, was shown to decrease the degeneration of native aortic valves. In this study, we aim to examine the impact of pioglitazone on inflammation and calcification of aortic valve conduits (AoC) in a rat model. Cryopreserved AoC (n = 40) were infrarenally implanted into Wistar rats treated with pioglitazone (75 mg/kg chow; n = 20, PIO) or untreated (n = 20, controls). After 4 or 12 weeks, AoC were explanted and analyzed by histology, immunohistology, and polymerase chain reaction. Pioglitazone significantly decreased the expression of inflammatory markers and reduced the macrophage-mediated inflammation in PIO compared with controls after 4 (P = 0.03) and 12 weeks (P = 0.012). Chondrogenic transformation was significantly decreased in PIO after 12 weeks (P = 0.001). Calcification of the intima and media was significantly reduced after 12 weeks in PIO versus controls (intima: P = 0.008; media: P = 0.025). Moreover, echocardiography revealed significantly better functional outcome of the AoC in PIO after 12 weeks compared with control. Interestingly, significantly increased intima hyperplasia could be observed in PIO compared with controls after 12 weeks (P = 0.017). Systemic PPAR-gamma activation prevents inflammation as well as intima and media calcification in AoC and seems to inhibit functional impairment of the implanted aortic valve. To further elucidate the therapeutic role of PPAR-gamma regulation for graft durability, translational studies and long-term follow-up data should be striven for.

Valve sparing root replacement with the reimplantation technique in patients presenting with acute type A aortic dissections

: Patients presenting with acute type A aortic dissections (ATAAD) comprise an extremely heterogenous population. While a majority are older and suffer from chronic disease states, a non-insignificant minority are relatively healthy without long standing aneurysmal or aortic valve pathology. Selection of an appropriate proximal and distal operation can affect short- and long-term morbidity and mortality as well as the need for valve reintervention. In regard to management of the root, surgeons must be aggressive when indications for replacement—such as a sinus tear, aneurysmal degeneration, or friable tissue—are evident. In experienced centers, it is reasonable to proceed with a valve-sparing procedure in well selected patients. The risks and benefits of this decision must be considered carefully as a root replacement with either a biologic or mechanical prosthesis is preferred over a poorly executed valve sparing procedure. However, if the latter is approached in a standardized fashion with attention to the patient’s overall acuity, cardiac function, and aortic valve leaflet mobility, reproducible outcomes can and should be expected. Accordingly, we present our approach to valve sparing root replacement with the reimplantation technique in ATAAD. The following review includes a case-based discussion and video depiction of our technique, including safe and reliable cannulation methods for bypass, cerebral protection strategies, and a structured approach to critically appraise the valve prior to repair.

Long-Term Outcome of Mechanical and Biological Prostheses in Patients with Left-Side Infective Endocarditis: A Systematic Review and Meta-Analysis.

Background. Long-term outcomes of patients with infective endocarditis (IE) who received either a mechanical (MP) or biological prosthesis (BP) are conflicting. A meta-analysis of observational studies comparing the long-term outcomes of left-side IE with the use of MP versus BP was performed. Methods. Electronic databases from January 2000 to June 2021 were screened. Studies reporting long-term mortality were analyzed. The primary endpoint was long-term overall mortality. Secondary endpoints were in-hospital/.30-day mortality and freedom from both prosthesis reinfection and reintervention. The pooled hazard ratio (HR) with 95% confidence interval (CI) was calculated for survival according to the random effect model. Results. Thirteen retrospective observational studies reporting on 8645 patients (MP: 4688; BP: 4137) were included for comparison. Twelve studies reported data of long-term survival for a total of 8285 patients (MP: 4517; BP: 3768). The pooled analysis revealed that the use of MP was statistically associated with longer benefits compared to BP (HR 0.74; 95% CI 0.63–0.86; p < 0.0001). The median follow-up time ranged from 1 to 15.3 years. The pooled analysis of five studies reporting data on prosthesis reinfection in 4491 patients (MP: 2433; BP: 2058) did not reveal significant differences (HR 0.60; 95% CI 0.30–1.21; p = 0.15). Five studies reported data on prosthesis reintervention in 4401 patients (MP: 2307; BP: 2094). The meta-analysis revealed a significant difference in favor of MP (HR 0.40; 95% CI 0.29–0.55; p < 0.0001). Meta-regression reported no effect of male gender (p = 0.09) and age (p = 0.77) on long-term survival. Conclusions. In a meta-analysis of retrospective observational studies comparing the long-term outcome of patients who underwent surgery for left-sided IE, the use of MP compared to BP is associated with a significant longer-term survival and with a reduced incidence of late reoperation. The incidence of late reinfection is comparable between the two prostheses.

Comparative analysis of hemodynamic characteristics of the biological xenogenic pericardial prosthesis MEDINGE-BIO with “easy change” system and the xenogenic aortic prosthesis Hancock II after aortic valve replacement

Aim. To compare the outcomes of aortic valve replacement using the xenogenic aortic prosthesis Hancock II and the novel Russian xenogenic pericardial prosthesis MEDINGE-BIO.Material and methods. The study included patients operated on for aortic stenosis in the cardiac surgery department № 1 of the Cardiology Research Institute (Tomsk National Research Medical Center). All patients were divided into two groups. The first group included 54 patients with Hancock II prostheses, the second — 91 patients with MEDINGE-BIO prostheses. Hemodynamic characteristics of heart valves were assessed by echocardiography before surgery and before discharge (on average 10 days after surgery).Results. When comparing hemodynamic parameters before and after surgery, significant differences between the groups were not obtained. The average pressure gradient after surgery using Hancock II and MEDINGE-BIO prosthesis was 21,6±7,9 and 17,9±5,6 mm Hg, respectively (p=0,05).Conclusion. The comparative analysis showed that the novel biological prosthesis MEDINGE-BIO has comparable hemodynamic characteristics with the well-known aortic prosthesis Hancock II.

Tissue Engineering Heart Valves – a Review of More than Two Decades into Preclinical and Clinical Testing for Obtaining the Next Generation of Heart Valve Substitutes

Abstract Well documented shortcomings of current heart valve substitutes – biological and mechanical prostheses make them imperfect choices for patients diagnosed with heart valve disease, in need for a cardiac valve replacement. Regenerative Medicine and Tissue Engineering represent the research grounds of the next generation of valvular prostheses – Tissue Engineering Heart Valves (TEHV). Mimicking the structure and function of the native valves, TEHVs are three dimensional structures obtained in laboratories encompassing scaffolds (natural and synthetic), cells (stem cells and differentiated cells) and bioreactors. The literature stipulates two major heart valve regeneration paradigms, differing in the manner of autologous cells repopulation of the scaffolds; in vitro, or in vivo, respectively. During the past two decades, multidisciplinary both in vitro and in vitro research work was performed and published. In vivo experience comprises preclinical tests in experimental animal model and cautious limited clinical translation in patients. Despite initial encouraging results, translation of their usage in large clinical scenarios represents the most important challenge that needs to be overcome. This review purpose is to outline the most remarkable preclinical and clinical results of TEHV evaluation along with the lessons learnt from all this experience.

Developing the Tissue Engineered Heart Valve – a Descriptive Hemodynamic and Ultrasound in Vitro Characterization Study of Heart Valves in a Bioreactor

Abstract The inherent limitations of current heart valve substitutes create the premise for the Tissue Engineered Heart Valve (TEHV), considered the perfect substitute. We aimed to compare in vitro hemodynamic performances of our TEHV, the conventional prosthetic valve and similar porcine valves, by ultrasonography and geometry resulting in six valve models analysis. In a bioreactor, pulmonary and aortic physiology were replicated thus hemodynamic characteristics were tested. Using ultrasound, transvalvular pressure gradients and flow were measured and used to calculate their valvular functional area (VFA) and using a high-speed camera, the geometric peak opening area (GOA) was assessed. The obtained results were normalized to the diameter of the biological prosthesis in order to increase the measurement's accuracy. The ultrasound revealed normal function of all valves and physiologic transvalvular pressure gradients. The TEHV scaffold revealed absence of laceration or dehiscence, and performances in accordance with the control prostheses. The GOA was facile to obtain and the normalized values proved to be greater than the calculated functional area in all analyzed cases and the peak opening areas resulted lesser for the aortic conditions for all six used valves prototypes. To our knowledge, this is the first study to use bioreactors, for in vitro evaluation of heart valves.

What Can We Learn from the Past by Means of Very Long-Term Follow-Up after Aortic Valve Replacement?

Background: Studies on very long-term outcomes after aortic valve replacement are sparse. Methods: In this retrospective cohort study, long-term outcomes during 25.1 ± 2.8 years of follow-up were determined in 673 patients who underwent aortic valve replacement with or without concomitant coronary artery bypass surgery for severe aortic stenosis and/or regurgitation. Independent predictors of decreased long-term survival were determined. Cumulative incidence rates of major adverse events in patients with a mechanical versus those with a biologic prosthesis were assessed, as well as of major bleeding events in patients with a mechanical prosthesis under the age of 60 versus those above the age of 60. Results: Impaired left ventricular function, severe prosthesis–patient mismatch, and increased aortic cross-clamp time were independent predictors of decreased long-term survival. Left ventricular hypertrophy, a mechanical or biologic prosthesis, increased cardiopulmonary bypass time, new-onset postoperative atrial fibrillation, and the presence of symptoms did not independently predict decreased long-term survival. The risk of major bleeding events was higher in patients with a mechanical in comparison with those with a biologic prosthesis. Younger age (under 60 years) did not protect patients with a mechanical prosthesis against major bleeding events. Conclusions: Very long-term outcome data are invaluable for careful decision-making on aortic valve replacement.

Mitral surgical redo versus transapical transcatheter mitral valve implantation.

Transcatheter methods have been rapidly evolving to provide an alternative less invasive therapeutic option, mainly because redo patients often present with multiple comorbidities and high operative risk. We sought to evaluate and compare our experience with transapical transcatheter mitral valve replacement (TA-TMVR) to conventional redo mitral valve replacement in patients presenting with degenerated biological mitral valve prostheses or failed valve annuloplasty. Between March 2012 and November 2020, 74 consecutive high-risk patients underwent surgical redo mitral valve replacement (n = 33) or TA-TMVR (n = 41) at our institution. All patients presented with a history of a surgical mitral valve procedure. All transcatheter procedures were performed using the SAPIEN XT/3™ prostheses. Data collection was prospectively according to MVARC criteria. The mean logistic EuroSCORE-II of the whole cohort was 19.9±16.7%, and the median STS-score was 11.1±12.5%. The mean age in the SMVR group was 63.7±12.8 years and in the TMVR group 73.6±9.7 years. Patients undergoing TA-TMVR presented with significantly higher risk scores. Echocardiography at follow up showed no obstruction of the left ventricular outflow tract, no paravalvular leakage and excellent transvalvular gradients in both groups (3.9±1.2 mmHg and 4.2±0.8 mmHg in the surgical and transcatheter arm respectively). There was no difference in postoperative major adverse events between the groups with no strokes in the whole cohort. Both methods showed similar survival rates at one year and a 30-day mortality of 15.2% and 9.8% in SAVR and TMVR group, respectively. Despite using contrast dye in the transcatheter group, the rate of postoperative acute kidney failure was similar between the groups. Despite several contraindications for surgery, we showed the non-inferiority of TA-TMVR compared to conventional surgical redo procedures in high-risk patients. With its excellent hemodynamic and similar survival rate, TA-TMVR offers a feasible alternative to the conventional surgical redo procedure in selected patients.

Report on outcomes of valve-in-valve transcatheter aortic valve implantation and redo surgical aortic valve replacement in the Netherlands.

ObjectiveWe sought to investigate real-world outcomes of patients with degenerated biological aortic valve prostheses who had undergone valve-in-valve transcatheter aortic valve implantation (ViV-TAVI) or reoperative surgical aortic valve replacement (redo-SAVR) in the Netherlands.MethodsPatients who had undergone ViV-TAVI or redo-SAVR for a degenerated biological aortic valve prosthesis in the Netherlands between January 2014 and December 2018 were eligible for this retrospective study. Patients with a prior homograft, active endocarditis or mechanical aortic valve prosthesis were excluded. Patients were matched using the propensity score. The primary endpoint was a composite of 30-day all-cause mortality and in-hospital postoperative stroke. Secondary endpoints were all-cause mortality at different time points, in-hospital postoperative stroke, pacemaker implantation and redo procedures within one year. Baseline characteristics and outcome data were collected from the Netherlands Heart Registration.ResultsFrom 16 cardiac centres, 653 patients were included in the study (374 ViV-TAVI and 279 redo-SAVR). European System for Cardiac Operative Risk Evaluation I (EuroSCORE I) was higher in ViV-TAVI patients (19.4, interquartile range (IQR) 13.3–27.9 vs 13.8, IQR 8.3–21.9, p < 0.01). After propensity score matching, 165 patients were matched with acceptable covariate balance. In the matched cohorts, the primary endpoint was not significantly different for ViV-TAVI and redo-SAVR patients (odds ratio 1.30, 95% confidence interval 0.57–3.02). Procedural, 30-day and 1‑year all-cause mortality rates, incidence of in-hospital postoperative stroke, pacemaker implantation and redo procedures within one year were also similar between cohorts.ConclusionPatients with degenerated aortic bioprostheses treated with ViV-TAVI or redo-SAVR have similar mortality and morbidity.Supplementary InformationThe online version of this article (10.1007/s12471-021-01608-0) contains supplementary material, which is available to authorized users.

Valve-sparing aortic root replacement in adult patients with congenital heart disease.

Aortic root dilatation is frequently observed in patients with congenital heart defects (CHD), but has received little attention in terms of developing a best practice approach for treatment. In this study, we analysed our experience with aortic valve-sparing root replacement in patients following previous operations to repair CHD. In this study, we included 7 patients with a history of previous surgery for CHD who underwent aortic valve-sparing operations. The underlying initial defects were tetralogy of Fallot (n = 3), transposition of great arteries (n = 2), coarctation of the aorta (n = 1), and pulmonary atresia with ventricle septum defect (n = 1). The patients' age ranged from 20 to 40 years (mean age 31 ± 6 years). David reimplantation was performed in 6 patients and a Yacoub remodelling procedure was performed in 1 patient. Four patients underwent simultaneous pulmonary valve replacement. The mean interval between the corrective procedure for CHD and the aortic valve-sparing surgery was 26 ± 3 years. There was no operative or late mortality. The patient with transposition of great arteries following an arterial switch operation was re-operated 25 months after the valve-sparing procedure due to severe aortic regurgitation. In all other patients, the aortic valve regurgitation was mild or negligible at the latest follow-up (mean 8.7 years, range 2.1-15.1 years). Valve-sparing aortic root replacement resulted in good aortic valve function during the first decade of observation in 6 of 7 patients. This approach can offer a viable alternative to root replacement with mechanical or biological prostheses in selected patients following CHD repair.