Use Of Bioprostheses Research Articles

Case Series of First Microinvasive Fully Endoscopic Use of a New Mitral Prosthesis.

The use of bioprostheses is increasing in younger patients, but it is associated with the risk of later valve deterioration, especially in the mitral position. A new bioprosthesis for mitral valve replacement offers possible longer-term durability and improved hemodynamics. Objectives: Here, we report the implantation of the novel Edwards MITRIS RESILIA mitral valve (Edwards Lifesciences Inc., Irvine, CA, USA) through microinvasive fully endoscopic access as an innovative surgical approach based on a series of twelve patients. Methods: Contrast-based ECG gated CT was preoperatively performed in all patients to determine the intravascular calcifications and vascular parameters, as well as to assess noticeable problems during the operation. CT software for cardiac interventions (3Mensio Medical Imaging BV) was used to simulate surgical prostheses digitally inside the native annulus. With this, a digital LVOT and neo LVOT was created, and the difference between the valve prostheses was measured. Implantation of the MITRIS RESILIA valve was performed in 12 patients according to the instructions for use through microinvasive access in a fully endoscopic fashion using 3D visualization. Results: The mean patient age was 56.50 years, and 7/12 (58.33%) were redo procedures. All patients survived the first 30 days after the procedure, the mean aortic cross-clamp time was 40.17 ± 13.72 min. and mean postoperative transvalvular gradient was 4.45 ± 1.74 mmHg. The neo LVOT in the CT-based simulation was measured with an average area of 414.98 ± 88.69 mm2. The average difference between the LVOT and neo LVOT area was 65.35 ± 34.99 mm2. There was no case of paravalvular leakage or obstruction of the left ventricular outflow tract. Conclusions: The novel MITRIS RESILIA valve is a promising new bioprosthesis for mitral valve replacement that offers improved features as compared to other prostheses. The ease of implantation is increased by this prosthesis by the improved pliability of the sewing cuff and the inward folding of the struts, which was confirmed by short operative times in our series.

Challenges and Opportunities in Developing Tracheal Substitutes for the Recovery of Long-Segment Defects.

Tracheal resection and reconstruction procedures are necessary when stenosis, tracheomalacia, tumors, vascular lesions, or tracheal injury cause a tracheal blockage. Replacement with a tracheal substitute is often recommended when the trauma exceeds 50% of the total length of the trachea in adults and 30% in children. Recently, tissue engineering and other advanced techniques have shown promise in fabricating biocompatible tracheal substitutes with physical, morphological, biomechanical, and biological characteristics similar to native trachea. Different polymers and biometals are explored. Even with limited success with tissue-engineered grafts in clinical settings, complete healing of tracheal defects remains a substantial challenge due to low mechanical strength and durability of the graft materials, inadequate re-epithelialization and vascularization, and restenosis. This review has covered a range of reconstructive and regenerative techniques, design criteria, the use of bioprostheses and synthetic grafts for the recovery of tracheal defects, as well as the traditional and cutting-edge methods of their fabrication, surface modification for increased immuno- or biocompatibility, and associated challenges.

BIOLOGICAL PROSTHESES FOR CARDIOVASCULAR SURGERY – A HALF-CENTURY HISTORY AND DEVELOPMENT PROSPECTS

HighlightsSurgical correction of cardiovascular deformities is inextricably linked with the use of prostheses. The development and clinical testing of biological prostheses has been conducted under the guidance of the Member of Russian Academy of Sciences Leonid Barbarash at the Kuzbass Cardiology Center for more than 50 years. The uniqueness of the developed products lies in the use of a new biological tissue preservative – ethylene glycol diglycidyl ether, and an integrated approach involving the development and manufacture of products, study of long-term replacement outcome, causes of prosthetic dysfunction and genetic aspects of the use of bioprostheses in patients. AbstractThis article highlights the main achievements in the development of biological prostheses for cardiovascular surgery under the leadership of the Member of Russian Academy of Sciences L.S. Barbarash since the 1980s. Throughout this period, Leonid Barbarash and his team have developed and mass-produced various designs of bioprosthetic heart valves and tissue preservation methods, arterial grafts, and patches. The article presents the results of developing next-generation vascular biodegradable grafts capable of complete remodeling and stimulating endothelialization after the implantation into the vascular bed. Moreover, we conducted a series of genetic studies evaluating the significance of gene polymorphisms of various pathogenetic pathways involved in the pathological calcification of native heart valves and their prostheses.

Prevalence and predictors of pacemaker implantation in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation: TAVI-NOR study

Abstract Background The transcatheter aortic valve implantation (TAVI) in patients with aortic stenosis (AS) asserts mechanical forces during valve expansion both on the aortic root and conduction system. TAVI is therefore frequently associated with the development of conduction abnormalities requiring a permanent pacemaker implantation (PMI). Purpose To identify predictors of new PMI in unselected patients with severe AS undergoing TAVI. Methods Among the 600 patients consecutively enrolled in TAVI-NOR study, 52 had PMI prior to TAVI and were excluded, remaining 548 patients eligible for this analysis. Predictors of PMI were identified in binary logistic regression analyses. Results A total of 189 patients (31.5%) required a new PMI post TAVI, evenly distributed between females and males (30.1% vs 32.9%, p=0.456). Higher age, comorbidities such as hypertension, chronic kidney disease, coronary artery disease, diabetes, and left ventricular hypertrophy on ECG or echocardiography, and the severity of AS had no association with the risk of PMI after TAVI (Table 1). In univariate logistic regression analyses, larger aortic root diameter was associated with a higher risk of new PMI (OR 1.66; 95% 1.07-2.58, p=0.024), but was no longer significant in multivariate model, and bioprosthesis size had no association with the need for a PMI following TAVI. Bundle branch block (BBB) (OR 1.52; 95% 1.00-2.31, p= 0.051), and especially right BBB (RBBB) (OR 2.05; 95% 1.14-3.70, p= 0.017) showed increased risk of a new PMI, also in a multivariable-adjusted analysis (OR 2.67; 95% 1.39-5.11, p=0.003). Lotus bioprosthesis with mechanical expansion was associated with an increased risk of PMI (OR 2.92; 95% CI 1.92-4.45, p<0.001), while balloon expandable Sapiens had a lower risk for PMI (OR 0.15; 95% CI 0.06-0.37, p<0.001). In a multivariable-adjusted analysis, the use of Lotus valve (OR 2.23; 95% CI 1.44-3.46, p<0.001) was still associated with a higher risk, and use of Sapien with a lower risk of PMI (OR 0.15; 95% CI 0.06-0.40, p<0.001) independent of non-significant association with atrial fibrillation (p=0.067), lower heart rate (0.077), aortic root (p=0.225) and stroke volume index (p=0.097). Adding age and gender to the same primary multivariable-adjusted model did not change our conclusions: Lotus (OR 2.28; 95% CI 1.46-3.57, p<0.001) and RBBB (OR 2.63; 95% CI 1.37-5.04, p=0.004) and Edward Sapien (OR 0.15; 95% 0.06-0.39, p<0.001) of post-procedural PMI. Conclusion Our data from less selected patients with severe AS patients show that pre-intervention RBBB and the use of bioprosthesis with mechanic expansion (Lotus) were associated with a higher risk, and the use of balloon expandable bioprothesis (Sapiens) with a lower risk of PMI after TAVI. We found no gender differences in risk of PMI.

Long-term outcomes of aortic valve replacement in dialysis patients - a nationwide retrospective cohort study.

Improved durability of modern biologic prostheses and growing experience with the transcatheter valve-in-valve technique have contributed to a substantial increase in the use of bioprostheses in younger patients. However, discussion of prosthetic valve selection in dialysis patients remains scarce as the guidelines are updated. This study aims to compare long-term outcomes between propensity score-matched cohorts of dialysis patients who underwent primary aortic valve replacement with a mechanical prosthesis or a bioprosthesis. Longitudinal data of dialysis patients who underwent primary aortic valve replacement between 1 January 2001 and 31 December 2018, were retrieved from the National Health Insurance Research Database. A total of 891 eligible patients were identified, of whom 243 ideally matched pairs of patients were analyzed. There was no significant difference in all-cause mortality (hazard ratio 1.11, 95% CI: 0.88-1.40) or the incidence of major adverse prosthesis-related events between the two groups (hazard ratio 1.03, 95% CI: 0.84-1.25). In patients younger than 50 years of age, using a mechanical prosthesis was associated with a significantly longer survival time across 10 years of follow-up than using a bioprosthesis (restricted mean survival time) at 10 years: 7.24 (95% CI: 6.33-8.14) years for mechanical prosthesis versus 5.25 (95% CI: 4.25-6.25) years for bioprosthesis, restricted mean survival time difference 1.99 years, 95% CI: -3.34 to -0.64). A 2-year survival gain in favor of mechanical prostheses was identified in dialysis patients younger than 50 years. The authors suggest mechanical prostheses for aortic valve replacement in these younger patients.

Aortic Valve Replacement With Mechanical Valves vs Perimount Bioprostheses in 50- to 69-Year-Old Patients

BackgroundEvidence is mixed regarding the most appropriate type of valve prosthesis for surgical aortic valve replacement (AVR) in patients 50 to 69 years. American and European guidelines differ. ObjectivesThe purpose of this study was to determine the long-term all-cause mortality and complication rates after AVR in patients aged 50 to 69 years according to implantation of a Perimount bioprosthetic valve or a mechanical valve. MethodsIn this nationwide observational cohort study, all patients aged 50 to 69 years who underwent primary surgical AVR in Sweden 2003 to 2018 using a Perimount bioprosthesis or mechanical valve were identified from the SWEDEHEART register. Primary outcome; all-cause mortality, secondary outcomes; major bleeding, aortic valve reintervention, heart failure hospitalization, and stroke. National health-data registers were used to ascertain outcomes. Regression standardization addressed confounding. ResultsA total of 6,907 patients aged 50 to 69 years were included (Perimount group, n = 3,831 and mechanical valve group, n = 3,076) and 74% were men. The use of bioprostheses increased during the study period. At 15 years of follow-up, the estimated cumulative incidence of all-cause mortality was 37% (95% CI: 35%-40%) vs 45% (95% CI: 42%-48%) in the mechanical and Perimount groups, respectively (survival difference −7.9% [95% CI: −11% to −4.6%]). Patients with mechanical valves had a lower risk of aortic valve reintervention but a higher risk for bleeding. Survival difference at 15 years in ages 50 to 59 years was −15% (95% CI: −8.4% to −21%). ConclusionsIn patients aged 50 to 69 years who underwent surgical AVR, survival was better in those who received mechanical compared to Perimount bioprosthetic valves. While valve choice should be guided by individual patient factors and patient preference rather than by chronological age, the substantial survival advantage observed in patients with mechanical valves in ages 50 to 59 years must be recognized.

Comparative Evaluation of Biomechanical Characteristics of Acellular Dermal Matrix for Hernioplasty

Background. With the introduction of synthetic mesh implants into clinical practice, the recurrence rate of postoperative ventral hernias was signifi cantly reduced. The extensive use of synthetic implants led to the development of specifi c complications. The development of biological implants, based on extensively purifi ed decellularized collagen matrix of xenogeneic origin is highly relevant due to the fact that, unlike synthetic analogues, they have a biological origin and biodegrade in a natural way, gradually being replaced with newly formed connective tissue. The use of bioprostheses reduces the risk of complications.Objectives. To conduct a comparative evaluation of the biomechanical characteristics of acellular dermal matrix, obtained by detergent-enzymatic decellularization, and commercially distributed Permacol™ matrix.Methods. Acellular dermal matrix (ADM) was created by using samples of native skin of pig of Landras breed aged 4 months. The dermis was processed by means of detergent-enzymatic method. In order to evaluate and compare the mechanical properties of acellular dermal matrix, the biological samples were divided into 2 groups of 15 samples each. The fi rst group included acellular dermal matrix samples, the second group — native samples of pigs unprocessed dermis. The control group consisted of samples of PermacolTM Surgical Implant, xenotransplant for hernioplasty approved for use in the Russian Federation (Covidien, France). All samples were tested wet using universal testing instrument Instron 1122. MedCalc Statistical Software (Belgium) was used for statistical processing of the study results.Results. In the present study, pig dermis was processed using a detergent-enzymatic method to produce ADM. Routine histological examination confi rmed the removal of all cellular elements, and at the same time it was proven that the native structure of the dermis remained intact during its processing. The mechanical characteristics of xenogenic ADM were further determined. Its tensile strength was 9.1 ± 0.6 MPa (910 N/cm2 ), elongation to break was 21.1 ± 2.3%, and elastic modulus was 50.0 ± 1.6 MPa. These characteristics largely corresponded to the strength characteristics of native pig dermis and far exceeded the necessary physiological parameters. PermacolTM control was tested in two directions (longitudinal and transverse). In the longitudinal direction, the sample had higher mechanical characteristics: strength — 12.0 ± 1.7 MPa, elongation to break — 29.7 ± 2.4%, stiffness modulus — 47.2 ± 6.5 MPa. In the transverse direction, all indicators were 1.5–2 times lower.Conclusion. The developed xenogeneic biological implant in the form of ADM demonstrates rather good characteristics of plasticity, tensile strength and elasticity, to be used as a biological endoprosthesis for plasty of hernia defects of the abdominal wall of any size and shape.

The decreasing risk of reoperative aortic valve replacement: Implications for valve choice and transcatheter therapy

ObjectiveIncreasing use of bioprostheses for surgical aortic valve replacement (SAVR) in younger patients, together with wider use of transcatheter aortic valve replacement, necessitates understanding risks associated with surgical valve reintervention. Therefore, we sought to identify risks of reoperative SAVR compared with those of primary isolated SAVR. MethodsFrom January 1980 to July 2017, 7037 patients underwent nonemergency isolated SAVR, with 753 reoperations and 6284 primary isolated operations. These 2 groups were propensity score-matched on 46 preoperative variables, yielding 581 patient pairs for comparing outcomes. ResultsAmong propensity score-matched patients, aortic clamp time (median 63 vs 52 minutes; P < .0001), cardiopulmonary bypass time (median 88 vs 67 minutes; P < .0001), and postoperative stay (median 7.1 vs 6.9 days; P = .003) were longer for reoperative SAVR than primary isolated SAVR. Hospital mortality after reoperative SAVR decreased from 3.4% in 1985 to 1.3% in 2011, similar to that of primary isolated SAVR. Occurrence of stroke, deep sternal wound infection, and new renal dialysis was similar. Blood transfusion (67% vs 36%; P < .0001) and reoperations for bleeding/tamponade (6.4% vs 3.1%; P = .009) were more common after reoperative SAVR. Survival at 1, 5, 10, and 20 years was 94%, 82%, 64%, and 33% after reoperative SAVR and 95%, 86%, 72%, and 46% after elective primary isolated SAVR. ConclusionsRisk of mortality and morbidity after reoperative SAVR has declined and is now similar to that of primary isolated SAVR. Decisions regarding prosthesis choice and SAVR versus transcatheter aortic valve replacement should be made in the context of lifelong disease management rather than avoidance of reoperation.

Different Rates of Bioprosthetic Aortic Valve Failure With Perimount™ and Trifecta™ Bioprostheses

ObjectivesThe use of bioprostheses in surgical aortic valve replacement (SAVR) has increased in younger patients. Comparative analysis of different types of bioprostheses is lacking. We aimed to compare two proprietary bioprostheses with different designs, i.e., internally and externally mounted leaflets, focusing on the long-term durability and survival.MethodsWe conducted a large single-center retrospective analysis of all consecutive patients who underwent SAVR with either Perimount™ or Trifecta™ bioprostheses between 2001 and 2019. The patient groups were further subdivided by age <65 and >65. Endpoints of the study were all-cause mortality and reoperation due to bioprosthetic valve failure (BVF).ResultsSelection criteria resulted in a total sample of 5,053 patients; 2,630 received a Perimount prosthesis (internally mounted leaflets) and 2,423 received a Trifecta prosthesis (externally mounted leaflets). The mean age at surgery was similar (69 ± 11 y, PM, and 68 ± 10 y, TF, p = 0.9), as was estimated survival at 8 years (76.1 ± 1.3%, PM, and 63.7 ± 1.9% TF; p=0.133). Patients in the Trifecta group had a significantly higher cumulative reoperation rate at 8 years compared to those in the Perimount group (16.9 ± 1.9% vs. 3.8 ± 0.4%; p < 0.01). This difference persisted across age groups (<65 y, 13.3% TF vs. 8.6% PM; >65 y, 12% TF vs. 7% PM).ConclusionBioprostheses for SAVR with externally mounted leaflets (Trifecta) showed significantly higher long-term reoperation rates compared to those with internally mounted leaflets (Perimount), regardless of the patient's age at SAVR. Survival was similar with both bioprostheses.

Immobilized Bisphosphonates as Potential Inhibitors of Bioprosthetic Calcification: Effects on Various Xenogeneic Cardiovascular Tissues.

Calcification is the major factor limiting the clinical use of bioprostheses. It may be prevented by the immobilization of bisphosphonic compounds (BPs) on the biomaterial. In this study, we assessed the accumulation and structure of calcium phosphate deposits in collagen-rich bovine pericardium (Pe) and elastin-rich porcine aortic wall (Ao) and bovine jugular vein wall (Ve) cross-linked with glutaraldehyde (GA) or diepoxy compound (DE). These tissues were then modified with pamidronic (PAM) acid or 2-(2′-carboxyethylamino)ethylidene-1,1-bisphosphonic (CEABA) acid. Tissue transformations were studied using Fourier-transform infrared spectroscopy. After subcutaneous implantation of the biomaterials in 220 rats, calcification dynamics were examined using atomic absorption spectrophotometry, light microscopy after von Kossa staining, and scanning electron microscopy coupled with energy-dispersive X-ray spectroscopy The calcium content in all GA-cross-linked tissues and DE-cross-linked Ao increased to 100–160 mg/g on day 60 after implantation. BPs prevented the accumulation of phosphates on the surface of all materials and most effectively inhibited calcification in GA-cross-linked Ao and DE-cross-linked Pe. PAM containing -OH in the R1 group was more effective than CEABA containing -H in R1. The calcification-inhibitory effect of BPs may be realized through their ability to block nucleation and prevent the growth of hydroxyapatite crystals.

Stentless valves for bicuspid and tricuspid aortic valve disease

ObjectiveTo determine long-term survival and reoperation rate in patients with a bicuspid aortic valve (BAV) and patients with a tricuspid aortic valve (TAV) after stentless aortic valve replacement (AVR)/aortic root replacement (ARR). MethodsBetween 1992 and 2014, 1293 patients underwent first AVR/ARR with a stentless aortic valve using the modified inclusion operating technique, including 741 patients with a TAV and 552 with a BAV. Using propensity scoring with 26 variables, 330 matched pairs were identified with AVR with or without ascending aorta/arch replacement. Data were obtained through chart review, surveys, and the National Death Index. ResultsPatient demographics were similar in the propensity score–matched groups. Both groups had similar cardiopulmonary bypass, cross-clamp, and hypothermia circulatory arrest times, cerebral protection strategies, and rate of aortic arch replacement. The median size of implanted valves was similar (BAV: 27 mm [range, 25-29 mm] vs TAV: 27 mm [range, 25-27 mm]). Compared with the TAV group, the BAV group had a shorter hospital stay (6 days vs 7 days; P = .001) but similar 30-day mortality (1.8% vs 1.2%). The BAV group had better long-term (15-year) survival (46% vs 33%; P = .002) but a higher cumulative incidence of reoperation for structural valve deterioration (15-year: 15% vs 11%; P = .048). Cox proportional hazard analysis identified a BAV as a protective factor for long-term mortality (hazard ratio [HR], 0.71; 95% CI, 0.56-0.91; P = .006), but a risk factor for reoperation due to structural valve deterioration (HR, 1.4 [95% CI, 0.8-2.6; P = .27] in the matched cohort and 2.2 [95% CI, 1.3-3.7; P = .004] in the unmatched cohort). ConclusionsThe BAV patients had better long-term survival but a higher reoperation rate compared with TAV patients after stentless AVR. Our findings suggest caution in the use of bioprostheses for BAV patients.

Long-Term Stability and Biocompatibility of Pericardial Bioprosthetic Heart Valves.

The use of bioprostheses for heart valve therapy has gradually evolved over several decades and both surgical and transcatheter devices are now highly successful. The rapid expansion of the transcatheter concept has clearly placed a significant onus on the need for improved production methods, particularly the pre-treatment of bovine pericardium. Two of the difficulties associated with the biocompatibility of bioprosthetic valves are the possibilities of immune responses and calcification, which have led to either catastrophic failure or slow dystrophic changes. These have been addressed by evolutionary trends in cross-linking and decellularization techniques and, over the last two decades, the improvements have resulted in somewhat greater durability. However, as the need to consider the use of bioprosthetic valves in younger patients has become an important clinical and sociological issue, the requirement for even greater longevity and safety is now paramount. This is especially true with respect to potential therapies for young people who are afflicted by rheumatic heart disease, mostly in low- to middle-income countries, for whom no clinically acceptable and cost-effective treatments currently exist. To extend longevity to this new level, it has been necessary to evaluate the mechanisms of pericardium biocompatibility, with special emphasis on the interplay between cross-linking, decellularization and anti-immunogenicity processes. These mechanisms are reviewed in this paper. On the basis of a better understanding of these mechanisms, a few alternative treatment protocols have been developed in the last few years. The most promising protocol here is based on a carefully designed combination of phases of tissue-protective decellularization with a finely-titrated cross-linking sequence. Such refined protocols offer considerable potential in the progress toward superior longevity of pericardial heart valves and introduce a scientific dimension beyond the largely disappointing ‘anti-calcification’ treatments of past decades.

Variablity of Mechanical or Tissue Valve Implantation in Patients Undergoing Surgical Aortic Valve Replacement in Spain: National Retrospective Analysis from 2007 to 2018.

Background: There is no robust evidence regarding the types of valves implanted among patients undergoing surgical aortic valve replacement (SAVR) in Spain. Methods: All cases of patients undergoing SAVR ± coronary artery bypass grafting from January 2007 to December 2018 in the public Spanish National Health System were included. We analyzed the trends of SAVR volume, risk profile and type of implanted valve across time and place. Using multivariable logistic regression, we identified factors associated with biological SAVR. Results: In total, 62,870 episodes of SAVR in 15 Spanish territories were included. In 35,693 (56.8%), a tissue valve was implanted. The annual volume of procedures increased from 107.3/million (2007) to 128.6 (2017). In 2018, it fell to 108.5. Age increased and Charlson’s comorbity index worsened throughout the study period. Tissue valve implantation increased in most regions. After adjusting for other covariates, we observed a high variability in aortic valve implantation across different regions, with differences of as much as 20-fold in the use of tissue valves. Conclusions: Between 2007 and 2018, we detected a significant increase in the use of bioprostheses in patients undergoing SAVR in Spain, and a great variability in the types of valve between the Spanish territories, which was not explained by the different risk profiles of patients.

Is redo mitral mortality getting better or getting worse?

Zubarevich et al. present the 30 day and 1-year outcomes of redo mitral valve replacement in 58 high-risk patients. The authors conclude that careful patient selection and risk stratification provides acceptable surgical results in this cohort. This series reminds us that increased use of bioprostheses, increased use of mitral replacement instead of repair, and an aging population drive the volume of high-risk redo mitral replacement. It remains to be seen whether redo mitral mortality is getting better or worse, but the risk and the patients will be with us for some time.

Similar long-term survival after isolated bioprosthetic versus mechanical aortic valve replacement: A propensity-matched analysis

ObjectivesImproved durability and preference to avoid anticoagulation have led to increasing use of bioprostheses in younger patients despite the need for eventual reoperation. Therefore, we compared in-hospital complications, reoperation, and survival after bioprosthetic and mechanical aortic valve replacement. MethodsFrom January 1990 to January 2020, 6143 patients underwent isolated aortic valve replacement at Cleveland Clinic; 637 patients received a mechanical prosthesis and 5506 a bioprosthesis. Propensity matching identified 527 well-matched pairs (83% of possible matches) for comparison of perioperative outcomes. The average age of patients was 54 years in the bioprosthesis group and 55 years in the mechanical prosthesis group. Random Forest machine-learning analysis was performed to compare survival using the entire cohort of 6143 patients. ResultsAmong matched patients, major in-hospital complications, including stroke, deep sternal wound infection, and reoperation for bleeding, were similar, as was in-hospital mortality (2 in the bioprosthesis group [0.38%] vs 3 in the mechanical prosthesis group [0.57%]; P > .9). Patients receiving a bioprosthesis had shorter hospital stays (median 6 vs 7 days, P < .0001). Fifty-one patients (32% at 14 years) in the bioprosthesis group and 17 patients in the mechanical prosthesis group (8% at 14 years) underwent reoperation (P [log-rank] < .0001); 5-year survival after reoperation was 85% versus 82% (P = .6). Risk-adjusted Random Forest prediction of 18-year survival was 60% in the bioprosthetic group and 58% in the mechanical prosthesis group. ConclusionsAortic valve bioprostheses are associated with excellent short-term outcomes and 18-year survival similar to that of patients receiving mechanical valves. Reoperation does not adversely affect survival. These results suggest that risk for reoperation alone should not deter the use of bioprostheses in younger patients.

Prosthesis-patient mismatch after mitral valve replacement: A pooled meta-analysis of Kaplan-Meier-derived individual patient data.

ObjectiveThe hemodynamic effect and early and late survival impact of prosthesis–patient mismatch (PPM) after mitral valve replacement remains insufficiently explored.MethodsPubmed, Embase, Web of Science, and Cochrane Library databases were searched for English language original publications. The search yielded 791 potentially relevant studies. The final review and analysis included 19 studies compromising 11,675 patients.ResultsProsthetic effective orifice area was calculated with the continuity equation method in 7 (37%), pressure half‐time method in 2 (10%), and partially or fully obtained from referenced values in 10 (53%) studies. Risk factors for PPM included gender (male), diabetes mellitus, chronic renal disease, and the use of bioprostheses. When pooling unadjusted data, PPM was associated with higher perioperative (odds ratio [OR]: 1.66; 95% confidence interval [CI]: 1.32–2.10; p < .001) and late mortality (hazard ratio [HR]: 1.46; 95% CI: 1.21–1.77; p < .001). Moreover, PPM was associated with higher late mortality when Cox proportional‐hazards regression (HR: 1.97; 95% CI: 1.57–2.47; p < .001) and propensity score (HR: 1.99; 95% CI: 1.34–2.95; p < .001) adjusted data were pooled. Contrarily, moderate (HR: 1.01; 95% CI: 0.84–1.22; p = .88) or severe (HR: 1.19; 95% CI: 0.89–1.58; p = .24) PPM were not related to higher late mortality when adjusted data were pooled individually. PPM was associated with higher systolic pulmonary pressures (mean difference: 7.88 mmHg; 95% CI: 4.72–11.05; p < .001) and less pulmonary hypertension regression (OR: 5.78; 95% CI: 3.33–10.05; p < .001) late after surgery.ConclusionsMitral valve PPM is associated with higher postoperative pulmonary artery pressure and might impair perioperative and overall survival. The relation should be further assessed in properly designed studies.

Trombosis de válvulas protésicas biológicas

Bioprosthetic valve thrombosis was considered a relatively rare entity. However, due to the increased use of bioprostheses in cardiac surgery and the advent of transcatheter biological prostheses, it has acquired more attention as a cause of prosthetic dysfunction. The long-term relevance of subclinical thrombosis has not yet been elucidated, nor are the optimal therapeutic strategies to prevent bioprosthetic valve thrombosis or thromboembolic complications. This review aims to provide a summary of the pathophysiology, diagnosis and treatment of bioprosthetic valve thrombosis to contribute to the knowledge of this pathology.

Use of Cutis Graft as Biologic Prosthesis in Complicated Abdominal Closures: A Case Report

Background: Loss of domain, fascial separation, and wound contamination are all recognized challenges of complex abdominal wall reconstruction. Often, traditional therapies, such as fascial advancement, mesh reinforcement, and the use of bio-prostheses for infection are insufficient. Recently, we have investigated using cutis as an alternative therapy. We present the case of a 61-year old male treated in such a manner. Methods: Our patient presented to our facility with a fascial defect of 30 by 40 cm, and an infected skin graft after undergoing an exploratory laparotomy for a gunshot wound at an outside hospital. During his course, he failed multiple traditional therapies, leaving him with a large open wound, four paired enterocutaneous fistulae, and a cholecystocutaneous fistula. We repaired his fistulae, performed a staged fascial closure, and reinforced it by placing an autograft of de-epithelialized dermis over it, bridging some areas of fascia. Results: The patient had rapid incorporation of his cutis graft, with granulation over the graft within 72 hours. Within three months, all wounds had healed, and the patient had fully recovered. Conclusions: Cutis autograft as a means for reinforcing abdominal wall closure is a versatile tool in the armamentarium of the surgeon to treat complex abdominal wall reconstruction. In the setting of failure of traditional therapies for fascial closure, it can potentially help with simultaneous bridging and reinforcement, demonstrating the strength of this type of repair

Effect of oral anticoagulation on clinical outcomes and haemodynamic variables after successful transcatheter aortic valve implantation

The effect of oral anticoagulation on clinical and haemodynamic outcomes following successful transcatheter aortic valve implantation is unclear. To evaluate the effect of oral anticoagulation within the first year after transcatheter aortic valve implantation. All patients undergoing transcatheter aortic valve implantation in two French tertiary centres from 2010 to 2016 were included prospectively. The composite outcome of death, stroke, readmission for heart failure or major/life-threatening bleeding according to Valve Academic Research Consortium 2 criteria within 1year was evaluated. Valvular haemodynamic deterioration was defined as mean transprosthetic gradient ≥20mmHg or an increase of ≥10mmHg during echocardiographic follow-up. Of the 1139 patients included, 400 (35.1%) were discharged on oral anticoagulation. The primary endpoint was more frequent in the group with versus without oral anticoagulation (29.4% vs. 17.3% 21.5%; hazard ratio 1.83, 95% confidence interval 1.42-2.35). Composite endpoint risk factors were chronic pulmonary and kidney diseases, previous atrial fibrillation, left ventricular ejection fraction ≤30% at discharge and no femoral vascular approach, but not oral anticoagulation prescription at discharge. Conversely, 58patients were identified with valvular haemodynamic deterioration, including 11 (19%) in the group with oral anticoagulation and 47 (81%) in the group without oral anticoagulation. Valvular haemodynamic deterioration risk factors were absence of oral anticoagulation exposure, increased body mass index, use of a balloon-expandable bioprosthesis and use of a bioprosthesis with diameter ≤23mm. Antithrombotic treatment crossover (i.e. oral anticoagulation interruption or introduction during follow-up) occurred in 9.6% of patients, and was a risk factor for death (adjusted hazard ratio 3.39, 95% confidence interval 1.63-7.07). Baseline characteristics, rather than oral anticoagulation prescription at discharge, were associated with adverse outcomes following successful transcatheter aortic valve implantation. Conversely, oral anticoagulation was associated with reduced valvular haemodynamic deterioration.

Contemporary Outcomes of Surgical Aortic Valve Replacement in Japan.

Given the rapid expansion in the use of transcatheter aortic valve implantation (TAVI), recent outcomes of surgical aortic valve replacement (SAVR) should be re-evaluated.Methods and Results:Using the data from the Japan Cardiovascular Surgery Database of 160 enrolled hospitals, trends in elective isolated SAVR were evaluated until the introduction of TAVI in Japan. Trend analyses were performed over 4 periods: period 1, 2008-2009 (4,415 cases); period 2, 2010-2011 (4,861 cases); period 3, 2012-2013 (5,674 cases); and period 4, 2014-2015 (5,563 cases). Baseline risk, evaluated on JapanSCORE, increased significantly over the 4 periods, from a median of 1.56 (IQR, 0.99-2.61) in period 1 to 2.08 (IQR, 1.33-3.96) in period 4 (P<0.001, trend test). Despite the increased risk, the composite major complication and operative mortality rate decreased significantly (10.7% in period 1 to 9.2% in period 4, P=0.01). Using a risk-adjusted model, the OR of operative mortality was 1.61 (95% CI: 1.29-2.02) in period 1 (P<0.0001) compared with period 4. An increase in the use of bioprostheses was also observed, from 60.4% to 76.8% (P<0.001) over the 4 periods. Even in a short 8-year period, SAVR outcomes improved in Japan. This should be taken into account when discussing the indications for aortic valve intervention.