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Vascular transplantation has become an ideal substitute for heart and peripheral vascular bypass therapy and tissue-engineered vascular grafts (TEVGs) present an attractive potential solution for vascular surgery. However, small diameter (Ф6 mm) vascular do not have ideal TEVGs for clinical use. Platelet-rich plasma (PRP), a key source of bioactive molecules, has been confirmed to promote tissue repair and regeneration. In this study, we prepared PRP-loaded TEVGs (PRP-TEVGs) by electrospinning, investigated the characterization of TEVGs, and verified the effect of PRP-TEVGs in vivo and in vitro experiments. The results suggested that PRP-TEVGs had good biocompatibility, released growth factors stably, promoted cell proliferation and migration significantly, up-regulated the expression of endothelial NO synthase (eNOS) in functional vascular endothelial cells (VECs), and maintained the stability of the endothelial structure. In vivo experiments suggest that PRP can promote rapid endothelialization and reconstruction of TEVGs. Overall, this finding indicated that PRP could promote the rapid vascular endothelialization of small-diameter TEVGs by improving contractile vascular smooth muscle cells (VSMCs) regeneration, and maintaining the integrity and functionality of VECs.

The MITRAL (Mitral Implantation of Transcatheter Valves) trial is the first prospective study for valve-in-mitral annular calcification (ViMAC), mitral valve-in-ring (MViR), and mitral valve-in-valve (MViV) using balloon-expandable aortic transcatheter heart valves. Procedural outcomes beyond 1 year are not well described.This study evaluated 2-year outcomes in ViMAC, MViR, and MViV in the MITRAL trial.This multicenter prospective study enrolled patients with severe MAC, prior failed mitral annuloplasty ring repair, or prior failed bioprosthetic MV replacement who were at high surgical risk at 13 U.S. sites.Between February 1, 2015, and December 31, 2017, 91 patients were enrolled (31 with ViMAC, 30 with MViR, and 30 with MViV). In the ViMAC group, 2-year all-cause mortality was 39.3%, 66.7% were New York Heart Association (NYHA) functional class I-II, and mean MV gradient was 5.6 ± 2.0 mm Hg. In the MViR group, 2-year all-cause mortality was 50%, 65% were NYHA functional class I-II, and mean MV gradient was 6.5 ± 2.7 mm Hg. In the MViV group, 2-year all-cause mortality was 6.7%, 85% were NYHA functional class I-II, and mean MV gradient was 6.9 ± 2.4 mm Hg. At 2 years, all patients had ≤mild mitral regurgitation and survivors in all 3 arms showed sustained improvement in Kansas City Cardiomyopathy Questionnaire scores compared to baseline.Use of balloon-expandable aortic transcatheter heart valves in selected patients with severe MAC, failed annuloplasty ring, and bioprosthetic MV dysfunction is associated with improvements in symptoms, quality of life, and stable prosthesis function at 2-year follow-up. Between 1 and 2 years, the MViR group experienced higher mortality rates than the MViV and ViMAC groups.

The Carpentier-Edwards PERIMOUNT Magna Ease valve is a third-generation bioprosthesis for aortic valve replacement (AVR). This is a postapproval study reporting on its 8-year outcomes.Adults undergoing AVR with the Magna Ease valve between October 2007 and December 2012 were enrolled for this prospective, nonrandomized, single-arm, and multicenter study. Assessments occurred preoperatively, at hospital discharge, 6 months, 1 year, and annually thereafter for up to 8 years. Outcomes included safety endpoints, hemodynamic performance, and New York Heart Association (NYHA) functional class.Of the 258 study patients, 67.5% were in NYHA Class I or II, and 32.5% were in NYHA Class III or IV at baseline. Concomitant procedures were performed in 44.2%. Total follow-up was 1597.6 patient-years, and median follow-up was 7 years (interquartile range: 5.5-8.0 years). Eight years following AVR, the functional class remained improved from baseline with 93.9% in NYHA Class I/II and 6.1% in NYHA Class III; 38 deaths had occurred, 8 of which were valve related; freedom from all-cause mortality was 80.7% (95% confidence intervals: 74.9, 86.4); freedom from valve-related mortality was 95.8% (92.8, 98.8); freedom from reintervention, explant, major bleeding events, and structural valve deterioration was 89.8% (85.1, 94.6), 94.8% (91.7, 97.9), 85.1% (80.0, 90.1), and 90.1% (84.7, 95.4), respectively; effective orifice area was 1.5 ± 0.5 cmThis study demonstrated satisfactory safety and sustained hemodynamic and functional improvements at 8 years following AVR with the Magna Ease valve.

© 2022 The Authors. Journal of Cardiac Surgery published by Wiley Periodicals LLC. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made., Background: Aortic valve stenosis is the most common adult valve disease in industrialized countries. The aging population and the increase in comorbidities urge the development of safer alternatives to the current surgical treatment. Sutureless bioprosthesis has shown promising results, especially in complex procedures and in patients requiring concomitant surgeries. Objectives: Assess the clinical and hemodynamic performance, safety, and durability of the Perceval® prosthetic valve. Methods: This single-center retrospective longitudinal cohort study collected data from all adult patients with aortic valve disease who underwent aortic valve replacement with a Perceval® prosthetic valve between February 2015 and October 2020. Of the 196 patients included (mean age 77.20 ± 5.08 years; 45.4% female; mean EuroSCORE II 2.91 ± 2.20%), the majority had aortic stenosis. Results: Overall mean cross-clamp and cardiopulmonary bypass times were 33.31 ± 14.09 min and 45.55 ± 19.04 min, respectively. Mean intensive care unit and hospital stay were 3.32 ± 3.24 days and 7.70 ± 5.82 days, respectively. Procedural success was 98.99%, as two explants occurred. Four valves were reimplanted due to intraoperative misplacement. Mean transvalvular gradients were 7.82 ± 3.62 mmHg. Pacemaker implantation occurred in 12.8% of patients, new-onset atrial fibrillation in 21.9% and renal replacement support was necessary for 3.1%. Early mortality was 2.0%. We report no structural valve deterioration, strokes, or endocarditis, and one successfully treated valve thrombosis. Conclusions: Our study confirms the excellent clinical and hemodynamic performance and safety of a truly sutureless aortic valve, up to a 5-year follow-up. These results were consistent in isolated and concomitant interventions, solidifying this device as a viable option for the treatment of isolated aortic valve disease.

A budget impact analysis (BIA) comparing bioprosthetic valves with RESILIA tissue and mechanical valves in aortic stenosis (AS) patients65 years in the public and private sectors of Saudi Arabia.A decision-tree with a partitioned survival model was adapted to estimate the financial consequences of either a RESILIA tissue valve or a mechanical valve in aortic valve replacement (AVR) procedures up to 5 years. The budget impact of resource consumption for both valve types was compared and included disabling strokes, reoperations, minor thromboembolic events, major bleeding, endocarditis, anticoagulation treatment and monitoring, and echocardiogram assessments. One-way sensitivity analyses (OWSA) were performed on cost and probability inputs.RESILIA tissue valves versus mechanical valves are overall budget saving commencing in Year 1 and savings gradually increase year-on-year. The higher costs of the initial procedure, reoperation, and additional monitoring (echocardiogram tests and visits) associated with RESILIA tissue valves are offset by savings in warfarin use, disabling strokes, major bleeding, and anticoagulation complications. The cost per initial procedure per patient is SAR795 higher for a RESILIA tissue valve reflecting the higher valve acquisition cost, which is partially offset by a shorter hospital stay. The OWSA suggests that total procedure costs of each valve, including the hospital stay, are the main cost drivers in the model.The variability of cost inputs and the presence of multiple payers with multiple costing data is a key challenge in Saudi Arabia. Budget impact results may, therefore, change if repeated per AVR center and may also be impacted by the long-term durability of RESILIA tissue valves.An AVR in patients65 years with a RESILIA tissue valve is budget-saving from the first year in Saudi Arabia. Patients, payers, providers and policymakers may benefit economically from increased implantation of RESILIA tissue valves.

Transcatheter aortic valve implant (TAVI) is gaining momentum in the treatment of severe, symptomatic aortic valve stenosis, and its indication is expanding to lower surgical risk individuals, who are generally younger and have a long life expectancy. Therefore, transcatheter bioprostheses durability appears of critical importance. Aim of the present study is to evaluate mid-term outcomes of TAVI in a high-volume single center cohort.We analyzed all consecutive patients (n = 408) who underwent transfemoral TAVI at a single, high-volume center, between 2007 and 2014. Study objectives were all-cause death and bioprosthetic valve failure (BVF) at long term follow-up. Structural valve deterioration (SVD), BVF and valve-related death were defined according to current international standards. Follow-up was performed by in person visit and transthoracic echocardiography, which was obtained only in a minority of patients, or phone call as per patient preference.At a median follow-up of 1821 days, overall mortality was 64.5%, with cardiovascular disease accounting for roughly half of total deaths. Valve-related deaths occurred in 10 patients. Seventeen patients were diagnosed with BVF, and 15 required repeat intervention. Moderate and severe SVD were observed in 10 and 7 patients, respectively. In the subgroup of patients with echocardiographic mid-term follow-up (n = 76), no significant increase of transprosthetic gradients nor increase of significant regurgitation was detected.In the present unselected, all-comers cohort, TAVI bioprostheses appeared to have excellent durability at long-term follow-up.

Transcatheter aortic valve-in-valve implantation (ViV-TAVI) has emerged in recent years as a safe alternative to redo surgery in high-risk patients. Although early results are encouraging, data beyond short-term outcomes are lacking. Herein, we aimed to assess the 2-year outcomes after ViV-TAVI.Patients undergoing ViV-TAVI for degenerated surgical valves between 2013 and 2019 at the Cleveland Clinic were reviewed. The coprimary endpoints were all-cause mortality and congestive heart failure (CHF) hospitalizations. We used time-to-event analyses to assess the primary outcomes. Further, we measured the changes in transvalvular gradients and the incidence of structural valve deterioration (SVD).One hundred and eighty-eight patients were studied (mean age = 76 years; 65% males). At 2 years of follow-up, all-cause mortality and CHF hospitalizations occurred in 15 (8%) and 28 (14.9%) patients, respectively. On multivariable analysis, the postprocedural length of stay was a significant predictor for both all-cause mortality (hazard ratio [HR] = 1.1; 95% confidence interval [CI]: 1.01, 1.19) and CHF hospitalization (HR = 1.16; 95% CI: 1.07, 1.27). However, the internal diameter of the surgical valve was not associated with significant differences in both primary endpoints. For hemodynamic outcomes, nine patients (4.8%) developed SVD. The mean and peak transvalvular pressure gradients remained stable over the follow-up period.ViV-TAVI for degenerated surgical valves was associated with favorable 2-year clinical and hemodynamic outcomes. Further studies are needed to better understand the role of ViV-TAVI as a treatment option in the life management of aortic valve disease.

The differences in long-term outcomes of aortic valve replacement for aortic stenosis between stentless and stented bioprostheses are controversial.Between 2007 and 2018, 1173 patients underwent aortic valve replacement for aortic stenosis, including 559 treated with a stentless valve and 614 with a stented valve. A propensity score matched cohort with 348 pairs was generated by matching for age, sex, body surface area, bicuspid aortic valve, chronic lung disease, previous cardiac surgery, coronary artery disease, renal failure on dialysis, valve size, concomitant procedures, and surgeon. The primary endpoints of the study were long-term survival and incidence of reoperation.Immediate postoperative outcomes were similar between the stentless and stented groups with an overall operative mortality of 2.9% (P = .19). Kaplan-Meier estimation for long-term survival was comparable between the stentless and stented valves in both the whole cohort and the propensity score matched cohort (10-year survival 59% vs 55%, P = .20). The hazard ratio of stentless vs stented valve for risk of long-term mortality was 1.12 (P = .33). The 10-year cumulative incidence of reoperation due to valve degeneration was 5.5% in the stentless group and 4.7% in the stented group (P = .25). The transvalvular pressure gradient at 5-year follow-up was significantly lower in the stentless group (7 vs 11 mm Hg, P.001).Both stented and stentless valves could be used in aortic valve replacement for aortic stenosis. We recommend stented valves for aortic valve replacement in patients with aortic stenosis for their simplicity of implantation.

BACKGROUND: This study compared clinical and hemodynamic in-hospital outcomes of patients undergoing sutureless vs rapid deployment aortic valve replacement (SURD-AVR) in the large population of the Sutureless and Rapid Deployment International Registry (SURD-IR). METHODS: We examined 4695 patients who underwent isolated or combined SURD-AVR. The "sutureless" Perceval valve (LivaNova PLC, London, United Kingdom) was used in 3133 patients and the "rapid deployment" Intuity (Edwards Lifesciences, Irvine, CA) in 1562. Potential confounding factors were addressed by the use of propensity score matching. After matching, 2 well-balanced cohorts of 823 pairs (isolated SURD-AVR) and 467 pairs (combined SURD-AVR) were created. RESULTS: Patients who received Perceval and Intuity valves showed similar in-hospital mortality and rate of major postoperative complications. Perceval was associated shorter cross-clamp and cardiopulmonary bypass times. In the isolated SURD-AVR group, patients receiving Perceval were more likely to undergo anterior right thoracotomy incision. Postoperative transvalvular gradients were significantly lower for the Intuity valve compared with those of the Perceval valve, either in isolated and combined SURD-AVR. The Intuity valve was associated with a lower rate of postoperative mild aortic regurgitation. CONCLUSIONS: Our results confirm the safety and efficacy of SURD-AVR regardless of the valve type. The Perceval valve was associated with reduced operative times and increased anterior right thoracotomy incision. The Intuity valve showed superior hemodynamic outcomes and a lower incidence of postoperative mild aortic regurgitation. ispartof: ANNALS OF THORACIC SURGERY vol:114 issue:3 pages:758-+ ispartof: location:Netherlands status: published

Transcatheter aortic valve replacement (TAVR) is increasingly being performed in younger and lower surgical risk patients. Given the longer life expectancy of these patients, the bioprosthetic valve will eventually fail, and aortic valve reintervention may be necessary. Although currently rare, redo-TAVR will likely increase in the future as younger patients are expected to outlive their transcatheter bioprosthesis. This review provides a contemporary overview of the indications, procedural planning, implantation technique, and outcomes of TAVR in failed transcatheter bioprosthetic aortic valves.

We reviewed the clinical outcomes of a novel method of aortic root replacement using a self-constructed tissue valve conduit composed of a Freestyle subcoronary valve sewn into a Valsalva graft.From 2005 to 2020, 523 patients had aortic root replacement operations using a self-constructed Freestyle subcoronary-Valsalva graft tissue valve conduit. Median patient age was 62 years (interquartile range [IQR] 54-70), and 430 (82%) were men. Primary outcomes were mortality and the need for reoperation. Multivariable regression analyses were performed to identify risk factors for mortality and reoperation.Urgent procedures comprised 48.37% of cases, and 29.26% were reoperative procedures. Concomitant ascending aorta replacement, hemiarch replacement, and total arch replacement were required in 348 (67%), 227 (44%), and 40 (8%) patients, respectively. Cardiopulmonary bypass and cross-clamp times were 189 minutes (IQR, 164-218) and 166 minutes (IQR, 145-191), respectively. Early mortality was 7.7% (40), and 5- and 10-year survival rates were 83% and 71%, respectively. At the last echocardiogram follow-up left ventricular ejection fraction, left ventricular end-diastolic diameter, degree of aortic insufficiency, and mean aortic valve gradient were significantly improved from baseline (P.001). Increasing age, peripheral artery disease, tobacco use, increased preoperative creatinine, and prior aortic valve surgery were risk factors for both mortality and the composite outcome (P.02).In a complex patient population aortic root replacement using a self-constructed composite tissue valve conduit comprising a Freestyle subcoronary valve-Valsalva graft can be performed with excellent operative and 10-year outcomes. Midterm survival was acceptable, and valve durability was outstanding with an exceedingly low incidence for valve reintervention.

Over the last two decades there has been a significant shift towards the use of bioprostheses in the context of surgical aortic valve replacement, despite the well-known process of structural valve deterioration (SVD). This process has been extensively evaluated even though with many different definitions and methods, thus, the true long-term durability of surgical bioprostheses is not yet fully elucidated. Following the increasing implementation of the transcatheter aortic valve implantation (TAVI) technology, a better understanding of the long-term durability of transcatheter bioprostheses has become increasingly important as well, despite the limited availability of such data compared to the surgical experience. This lack of knowledge is a major barrier to the use of TAVI platforms to treat relatively younger patients. We thus aimed at providing an overview on long-term actual data concerning the durability of bioprostheses focusing on definition, incidence, and subsequent management of SVD of both surgical and transcatheter bioprosthetic aortic valves.

Redo mitral valve replacement surgery due to bioprosthetic valve failure can carry serious surgical challenges. In addition to the usual redo sternotomy risk, there is risk of circumflex coronary artery injury or atrioventricular disruption from explanting the prosthesis. Alternatives to prosthesis explantation may be needed in some cases.We report a case of mitral bioprosthetic valve failure in a young patient who had a history of atrioventricular disruption during the first surgery and had pericardial patch repair of the defect. The risk of explanting the bioprosthesis during redo surgery was very high. Therefore, we performed valve replacement using valve-on-valve technique in which the new valve is implanted within the sewing ring of the previous bioprosthesis without explanting the valve. This technique converted a very highly futile surgery to a conventional redo surgery risk. The patient had a successful surgery with no intraoperative or postoperative complications.

A very small aortic root and annulus (≤17 mm) needs extensive aortic annular enlargement in adult patients. This report describes a technique that enlarged the aortic annulus by 5 valve sizes from 16 to 17 mm to size 27 bovine pericardial valve, as well as a modification of the aortotomy with the roof technique to make the aortotomy closure easier and more hemostatic while enlarging the sinotubular junction and proximal ascending aorta effectively for future valve-in-valve transcatheter aortic valve replacement.

The debate about the optimal mitral valve prosthesis continues. We aimed to compare the early and late outcomes, including stroke, bleeding, survival, and reoperation after isolated mitral valve replacement (MVR) using tissue versus mechanical valves.This retrospective cohort study included 291 patients who had isolated MVR from 2005 to 2015. Patients were grouped into the tissue valve group (n = 140) and the mechanical valve group (n = 151).There were no differences in duration of mechanical ventilation, hospital stay, and hospital mortality between groups. Fifteen patients required cardiac rehospitalization, nine in the tissue valve group, and six in the mechanical valve group (p = .44). Stroke occurred in nine patients, five with tissue valves, and four with mechanical valves (p = .66). Bleeding occurred in 22 patients, seven patients with tissue valves, and 15 patients with mechanical valves (p = .09). Freedom from reoperation was 95%, 93%, 84%, 67% at 3, 5, 7, and 10 years for tissue valve and 97%, 96%, 96%, and 93% for mechanical valves, respectively (p˂ .001). The median follow-up was 84 months (Q1: Q3: 38-139). Survival at 3, 5, 7, and 10 years was 94%, 91%, 89%, 86% in tissue valves and 96%, 93%, 91%, 91% in mechanical valves, respectively (p = .49).Tissue valve degeneration is still an issue even in the new generations of mitral tissue valves. The significant risk of reoperation in patients with mitral tissue valves should be considered when using those valves in younger patients. Mechanical valves remain a valid option for all age groups.

Described herein are certain clinical and morphologic findings in 33 patients who had their dysfunctioning native aortic valves replaced with a mechanical prosthesis and 4 to 302 months (mean 127) later had the mechanical prosthesis explanted because of developing prosthetic stenosis or regurgitation because of thrombus forming on a metallic disc, pannus on the cloth ring with overhanging the prosthetic orifice, or because of parabasilar regurgitation. Of the 33 patients, 25 were not infected and 8 were infected. At follow-up at least 23 of the 25 patients without infection and 7 of the 8 patients with prosthetic infection survived1 year after the prosthetic valve explantation.

Data comparing valve systems in the valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) field have been obtained from retrospective studies.The purpose of this study was to compare the hemodynamic results between the balloon-expandable valve (BEV) SAPIEN (3/ULTRA, Edwards Lifesciences) and self-expanding valve (SEV) Evolut (R/PRO/PRO+, Medtronic) in ViV-TAVR.Patients with a failed small (≤23 mm) surgical valve were randomized to receive a BEV or an SEV. The primary endpoint was valve hemodynamics (maximal/mean residual gradients, severe prosthesis patient mismatch [PPM], or moderate-severe aortic regurgitation) at 30 days as evaluated by Doppler echocardiography.A total of 102 patients were randomized, and of these, 98 patients finally underwent a ViV-TAVR procedure (BEV: n = 46, SEV: n = 52). The procedure was successful in all cases, with no differences in clinical outcomes at 30 days between groups (no death or stroke events). Patients in the SEV group exhibited lower mean and maximal transvalvular gradient values (15 ± 8 mm Hg vs 23 ± 8 mm Hg; P ˂ 0.001; 28 ± 16 mm Hg vs 40 ± 13 mm Hg, P ˂ 0.001), and a tendency toward a lower rate of severe PPM (44% vs 64%; P = 0.07). There were no cases of moderate-severe aortic regurgitation. In total, 55 consecutive patients (SEV: n = 27; BEV: n = 28) underwent invasive valve hemodynamic evaluation during the procedure, with no differences in mean and peak transvalvular gradients between both groups (P = 0.41 and P = 0.70, respectively).In patients with small failed aortic bioprostheses, ViV-TAVR with an SEV was associated with improved valve hemodynamics as evaluated by echocardiography. There were no differences between groups in intraprocedural invasive valve hemodynamics and 30-day clinical outcomes (Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprostheses. The 'LYTEN' Trial; NCT03520101).

Aim Endothelial progenitor cells (EPCs) play important roles in heart valve replacement surgery. Up-regulation of Grb2‑associated binder 1 (Gab1) promotes hepatocyte growth factor (HGF) – induced endothelial progenitor cell proliferation and migration. This study aimed to investigate the effects of up-regulation of Gab1 in hepatocyte growth factor-induced EPCs in tissue-engineered heart valves (TEHV).Material and methods Fresh porcine aortic valves were placed in 1 % Triton X-100 and trypsin buffer for decellularization. EPCs in the control group were cultured normally, whereas those in the experimental group were both HGF stimulated and transfected with adenovirus containing the Gab1 gene. Cells in the two groups were seeded onto the decellularized valve scaffolds and cultured for 3 or 7 days. TEHV were analyzed by HE and AB-PAS staining.Results By day 3, the experimental group had formed confluent endothelial monolayers on top of the decellularized valves, on the basis of by HE staining and AB-PAS staining. One week later, the control group showed a imperfect endothelial layer.Conclusion HGF-induced EPCs overexpressing Gab1 can endothelialize the decellularized matrix and create functional TEHV, which may then be preconditioned in a bioreactor before clinical implantation.

Given the recent surge in transcatheter heart valve replacement (THVR), cardiac surgeons will surely face the challenge of eventual explantation. The aim of this study was to determine indications for reoperation, while exploring pertinent technical aspects and survival after THV explantation in a cohort originally deemed high risk or even inoperable. Between February 2008 and March 2019, 31 patients with failed transcatheter aortic valve replacement (TAVR) underwent surgical explantations at our facility. Data were prospectively collected for retrospective analysis of procedural indications, technical issues, and postoperative survival. The major reason for TAVR removal was bioprosthetic valve failure (BVF) due to infective endocarditis (IE: 16/31 [51.6%]), non-structural (NSVD: 14/31 [45.2%]) and structural (SVD: 1/31 [3.2%]) valve deterioration accounting for the rest. Mean age at THV explantation was 76.3 ± 8.3 years, and median time from TAVR to explantation was 153 days (0 days–56.6 months). Median ICU and hospital stay were 6 days (1–44 days) and 23 days (8–62 days), respectively. Thirty-day and 1-year survival rates were 74.2% and 67.2%, respectively. Median follow-up interval after explantation was 364 days (3 days–80 months). Mean cardiopulmonary bypass time was 124.6 ± 46.8 min, and mean aortic cross-clamp time was 84.3 ± 32.9 min. There was no need for unplanned aortic root repair owing to tissue damage during dissection of the TAVR from surrounding tissue. The most common reason for THV explantation was (a) BVF for IE and (b) BVF secondary to NSVD. Although 30-day and 1-year mortality rates in this multimorbid cohort were predictably high, no procedural mortalities occurred.

Described herein are findings in 15 infected bioprostheses that had been in place from 5 to 120 months (mean 42). The major purpose was to show multiple photographs of the operatively-excised bioprostheses to illustrate the variable causes prompting excision of the bioprostheses. Eleven patients survived ≥ 30 days following the bioprosthetic excision and 9 patients lived longer than 1 year postoperatively. The techniques to explant the infected bioprosthesis appears to vary a bit among the operating surgeons.

Objectives Rapid deployment valves have been developed as a means to adjust for limitations in transcatheter aortic valve replacement and surgical aortic valve replacement for the management of aortic valve disease. To date, many studies have shown that although rapid deployment valves facilitate a shorter surgical aortic valve replacement, they offer no clinical benefit. The purpose of this study was to compare the outcomes of rapid deployment valves with conventional surgical aortic valve replacement. Methods This study was a retrospective review of all patients undergoing tissue aortic valve replacement at a single center. The majority of patients were men and aged more than 60 years. Patients were categorized into 2 groups: (1) rapid deployment valves and (2) conventional sutured valve. Inverse probability treatment weighting method was used to create a cohort of patients with similar baseline characteristics. Kaplan–Meier curves and log-rank tests were used to determine if there were statistically significant differences in outcomes. Primary outcome was all-cause mortality at 30 days, 1 year, and 5 years. Results A total of 2237 patients made up the study population from 2013 to 2019. After inverse probability treatment weighting, there were 295 patients in each group. Shorter cardiopulmonary bypass and crossclamp times were found with the rapid deployment valves. No statistically significant difference was found in the primary and secondary outcomes. There was a significant difference in the rate of permanent pacemaker insertion with a 7% pacemaker rate in the rapid deployment valve group (P Conclusions The data suggest that rapid deployment valves offer no benefit in straightforward aortic valve replacement, and further study will help identify which patient population the valve is suited for.

Background Guidelines for choice of prosthetic heart valve in people of reproductive age are not well established. Although biologic heart valves (BHVs) have risk of deterioration, mechanical heart valves (MHVs) require lifelong anticoagulation. This study aimed to characterize the association of prosthetic valve type with maternal and fetal outcomes in pregnant patients. Methods and Results Using the 2008 to 2019 National Inpatient Sample, we identified all adult patients hospitalized for delivery with prior heart valve implantation. Multivariable regressions were used to analyze the primary outcome, major adverse cardiovascular events, and secondary outcomes, including maternal and fetal complications, length of stay, and costs. Among 39 871 862 birth hospitalizations, 4152 had MHVs and 874 had BHVs. Age, comorbidities, and cesarean birth rates were similar between patients with MHVs and BHVs. The presence of a prosthetic valve was associated with over 22‐fold increase in likelihood of major adverse cardiovascular events (MHV: adjusted odds ratio, 22.1 [95% CI, 17.3–28.2]; BHV: adjusted odds ratio, 22.5 [95% CI, 13.9–36.5]) as well as increased duration of stay and hospitalization costs. However, patients with MHVs and BHVs had no significant difference in the odds of any maternal outcome, including major adverse cardiovascular events, hypertensive disease of pregnancy, and ante/postpartum hemorrhage. Similarly, fetal complications were more likely in patients with valve prostheses, including a 4‐fold increase in odds of stillbirth, but remained comparable between MHVs and BHVs. Conclusions Patients hospitalized for delivery with prior valve replacement carry substantial risk of adverse maternal and fetal events, regardless of valve type. Our findings reveal comparable outcomes between MHVs and BHVs.

Patients who need a prosthetic aortic heart valve may decide, working with their cardiologist and cardiac surgeon, among a variety of options: surgical or transcatheter approach, bioprosthetic or mechanical valve, or a Ross procedure if suitable to their age and anatomy. This review article examines the evidence for survival benefit with mechanical aortic valves, discusses bioprosthetic structural valve degeneration and its consequences, and considers the risks of redo aortic valve surgery or subsequent valve-in-valve (ViV) transcatheter intervention. It highlights the unique characteristics of the On-X aortic valve, including the US Food and Drug Administration approved and American College of Cardiology/American Heart Association guideline supported reduced anticoagulation target INR of 1.5 to 2.0, and discusses the PROACT Xa trial comparing apixaban vs warfarin anticoagulation. The choice of prosthetic valve should be individualized, carefully considering each patient's unique circumstances. In that context, the On-X aortic valve offers a potential lifetime solution without need for a repeat operation, while minimizing the risks of long-term anticoagulation. In an era of enthusiasm for bioprosthetic and transcatheter-based approaches, the option of a second-generation bileaflet mechanical valve with optimized hemodynamics-the On-X aortic valve-may well align with patient expectations.

The use of bioprosthetic valves for treating patients with severe valve disease has increased over the last 2 decades, and, as a consequence, a growing number of patients with failing surgical bioprosthesis is expected in the near future. In this setting, valve-in-valve (ViV) transcatheter aortic/mitral valve replacement (TAVR and TMVR) has emerged as an alternative to redo surgery. Despite the increasing experience in ViV procedures, the development of these techniques faces several specific challenges, mainly related to the unique anatomical and physiological characteristics presented in ViV-TAVR/TMVR. Subsequently, various approaches have been proposed to overcome ViV-related complications and pitfalls. A growing body of evidence is currently available concerning early- and long-term clinical outcomes of patients undergoing ViV-TAVR/TMVR. These data should be comprehensively evaluated by the Heart Team in the decision-making process involving patients with failing surgical bioprostheses. In this review, we aimed to delineate the technical challenges and risks associated with ViV-TAVR and ViV-TMVR, provide an updated overview of the main clinical results, and summarize the future perspectives of this evolving field.

The aim of this study was to report the outcomes of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) at 5 years.TAVR for degenerated surgical bioprostheses in patients at high risk for reoperative surgery is an important treatment option that may delay or obviate the need for surgical intervention; however, long-term outcomes of this procedure are unknown.The PARTNER (Placement of Aortic Transcatheter Valves) 2 ViV and continued access registries prospectively enrolled patients with failed surgical bioprostheses at high risk for reoperation. Five-year clinical and echocardiographic follow-up data were obtained in 95.9% of patients.In 365 (96 registry and 269 continued access) patients, the mean age was 78.9 ± 10.2 years, the mean Society of Thoracic Surgeons predicted risk of surgical mortality score was 9.1 ± 4.7%, and New York Heart Association functional class was III or IV in 90.4%. At 5 years, the Kaplan-Meier rates of all-cause mortality and any stroke were 50.6% and 10.5%, respectively. Using Valve Academic Research Consortium 3 definitions, the incidence of structural valve deterioration, related hemodynamic valve deterioration, or bioprosthetic valve failure at 5 years was 6.6%. Aortic valve re-replacement was performed in 6.3% (n = 14), the majority of which was due to stenosis (n = 6) and combined aortic insufficiency/paravalvular regurgitation (n = 3). The mean gradient, Doppler velocity index, paravalvular regurgitation, and quality of life measured by Kansas City Cardiomyopathy Questionnaire scores in survivors remained stable from 30 days postprocedure through 5 years.At the 5-year follow-up, TAVR for bioprosthetic aortic valve failure in high surgical risk patients was associated with sustained improvement in clinical and echocardiographic outcomes.

Background Our aim was to evaluate the durability of a third-generation porcine bioprosthesis (Epic porcine xenograft; Abbott Cardiovascular Inc, St Paul, MN) in the mitral position, according to patients’ age at surgery. Methods Four hundred eighty-two mitral valve replacements using the Epic valve at a single center were included (2009-2018). Perioperative and early postoperative data were prospectively collected. A systematic follow-up was performed (99% complete, 1609.5 patient-years; average, 3.8 ± 2.5). Standardized definitions of valve-related events were adopted. Mean patient age at mitral valve replacement was 68.1 ± 10.4 years. Results Operative mortality was 9.3%. There were 5 early valve-related reoperations, mainly due to recurrent infectious endocarditis. Global survival at 8.8 years was 69.5% ± 5%. Nine structural valve deterioration (SVD) events occurred during follow-up (3 receiving reoperations, 4 transcatheter mitral valve replacement valve-in-valve, and 2 medical treatment only). The freedom from SVD at 5 and 10 years was 97.4% ± 1.2% and 89.6% ± 4.4% (actuarial) and 97.8% ± 1% and 91.9% ± 3.3%, respectively (competing risks). After stratification into subgroups by age at surgery (≤59 years, 50.8%; 60-69, 32.8%; ≥70, 16.4%) there was no significant intergroup difference in freedom from SVD (log-rank P = .24). The overall freedom from any reintervention for SVD at 10 years was 90.5% ± 4.4% (actuarial) and 92.7% ± 3.3% (competing risks), with no intergroup difference (log-rank P = .14). The freedom from any valve-related complication at 8.4 years was 83.2% ± 4.5% (actuarial). Conclusions The Epic bioprosthesis shows good durability at 5 to 10 years in the mitral position.

The Edwards Intuity valve is a rapid deployment prosthesis designed for the aortic position. There is a paucity of literature on the use of the Intuity valve in combined aortic and mitral double valvular surgery. We present a case that highlights our novel surgical technique for implanting the Intuity valve in the aortic position following insertion of a conventional sutured bioprosthetic valve in the mitral position.

Despite the benefits of rapid deployment aortic valve prostheses (RDAVR), conventional sutured valves (cAVR) are more commonly used in the treatment for aortic stenosis. Given the paucity of randomized studies, this study aimed to synthesize available data to compare both treatment options.A systematic search of Pubmed, OVID, and MEDLINE was conducted to retrieve comparative studies for RDAVR versus cAVR in the treatment of aortic stenosis. Out of 1773 returned titles, 35 papers were used in the final analysis, including 1 randomized study, 1 registry study, 6 propensity-matched studies, and 28 observational studies, incorporating a total of 10,381 participants (RDAVR n = 3686; cAVR n = 6310).Random-effects meta-analysis found no difference between the two treatment groups in terms of operative mortality, stroke, or bleeding (p .05). The RDAVR group had reduced cardiopulmonary bypass (standardized mean difference [SMD]: -1.28, 95% confidence interval [CI]: [-1.35, -1.20], p .001) and cross-clamp times (SMD: -1.05, 95% CI: [-1.12, -0.98], p .001). Length of stay in the intensive care unit was also shorter in the RDAVR group (SMD: -0.385, 95% CI: [-0.679, -0.092], p = .010). The risk of pacemaker insertion was higher for RDAVR (odds ratio [OR]: 2.41, 95% CI: [1.92, 3.01], p .001) as was the risk of paravalvular leak (PVL) at midterm follow-up (OR: 2.52, 95% CI: [1.32, 4.79], p = .005). Effective orifice area and transvalvular gradient were more favorable in RDAVR patients (p .05).Despite the benefits of RDAVR in terms of reduced operative time and enhanced recovery, the risk of pacemaker insertion and midterm PVL remains a significant cause for concern.

Despite unusual high rates of patient-prosthesis mismatch (PPM), excellent midterm clinical outcomes have been reported after surgical aortic valve replacement (SAVR) with the Avalus™ bioprosthetic valve (Medtronic). To elucidate this "PPM conundrum," the Avalus valve haemodynamics were assessed during exercise testing.Of the 148 patients who had undergone SAVR with the Avalus valve at our institution, 30 were randomly selected among those in whom stress test was deemed feasible and underwent a resting transthoracic echocardiography immediately followed by exercise echocardiography. Severe PPM was defined as indexed effective orifice area (iEOA)Measured EOA significantly increased from rest to peak exercise in all PPM groups (p .05) and the rates of moderate and severe measured PPM decreased from 40% and 20% to 27% and 0%, respectively. The patients with low-flow state (flow 250 ml/s) had significantly lower measured rest EOA (p = .03). On the basis of the estimated iEOA, there was no severe PPM and 19 patients had moderate PPM (63.3%), with a significantly lower opening reserve than the patients without estimated PPM (p = .04). The estimated iEOA was more reliably correlated to the measured iEOA at maximal stress than the measured iEOA at rest, especially in patients with a low-flow state.This study supports the concept of an opening reserve of the Avalus valve to explain the PPM conundrum and promotes the use of exercise Doppler-echocardiography to complete the assessment of mismatch, especially in patients with a low-flow state. Published estimated EOA seems reliable to predict the haemodynamic performance of the Avalus valve, whether the flow conditions at rest.

This review aims to outline the current evidence base and guidance for care of patients post-valve intervention. Careful follow-up, optimisation of medical therapy, antithrombotics, reduction of cardiovascular risk factors and patient education can help improve patient outcomes and quality of life. Those with mechanical valves should receive lifelong anticoagulation with a vitamin K antagonist but in certain circumstances may benefit from additional antiplatelet therapy. Patients with surgical bioprosthetic valves, valve repairs and transcatheter aortic valve implantation also benefit from antithrombotic therapy. Additionally, guideline-directed medical therapy for coexistent heart failure should be optimised. Cardiovascular risk factors such as hyperlipidaemia, hypertension and diabetes should be treated in the same way as those without valve intervention. Patients should also be encouraged to exercise regularly, eat healthily and maintain a healthy weight. Currently, there is not enough evidence to support routine cardiac rehabilitation in individuals post-valve surgery or intervention but this may be considered on a case-by-case basis. Women of childbearing age should be counselled regarding future pregnancy and the optimal management of their valve disease in this context. Patients should be educated regarding meticulous oral health, be encouraged to see their dentist regularly and antibiotics should be considered for high-risk dental procedures. Evidence shows that patients post-valve intervention or surgery are best treated in a dedicated valve clinic where they can undergo clinical review and surveillance echocardiography, be provided with heart valve education and have access to the multidisciplinary valve team if needed.

Summary A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was: ‘Are NOACs as safe and efficient as vitamin K antagonist regarding thromboembolic prophylaxis and major bleeding in patients with surgical bioprosthesis and atrial fibrillation within 3 months of surgery?’ Altogether more than 324 papers were found using the reported search, of which 6 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. The RIVER and ENAVLE trials showed non-inferiority of rivaroxaban (regarding mean time free from composite of death, major cardiovascular events or major bleeding at 12 months) and edoxaban (composite of death, clinical thromboembolic events or asymptomatic intracardiac thrombosis; and major bleeding) when compared with vitamin K antagonist. These studies include a low number of patients within 3 months of index surgery and overall low statistical power regarding this particular subgroup of patients. Data derived from lower evidence studies are compatible with the aforementioned findings. The available evidence suggests that non-vitamin K antagonist anticoagulants are as safe and as efficient as vitamin K antagonist regarding thromboembolic prophylaxis and bleeding event rates in patients with surgical bioprosthesis and atrial fibrillation within 3 months of bioprosthesis implantation. However, this evidence is derived from a limited number of studies with important methodological limitations. Expanding non-vitamin K antagonist anticoagulant recommendation to the early postoperative period warrants more confirmatory research.

Aim of this retrospective, multicenter study was to evaluate early and mid-term clinical and hemodynamic results of patients who underwent surgical aortic valve replacement (SAVR) with Intuity rapid-deployment bioprostheses (RDB) (Edwards Lifesciences, Irvine, CA). We analyzed data from the Italian Registry of Intuity Valve (INTU-ITA registry) that is a national, real-world and independent from the industry registry. Preoperative variables were defined according to EuroSCORE and postoperative outcomes according to Valve Academic Research Consortium (VARC). Survival distribution was evaluated using the Kaplan-Meier approach. A Cox-Proportional Hazard Model was employed to assess the effect of the covariates on patients’ survival. The registry included 1687 patients from 23 centers (June 2012-September 2019). Aortic cross clamp time for isolated SAVR was 55 minutes (IQR: 45–70 minute). Postoperative pace-maker rate was 6.3%. At discharge transaortic peak and mean gradients were: 18 mm Hg (IQR: 14–23 mm Hg) and 10 mmHg (IQR: 8–13 mm Hg), respectively. Indexed effective orifice area was 1.10 cm2/m2 (IQR: 0.91–1.31 cm2/m2) and the incidence of severe patient-prosthesis mismatch was 0.6%. Hemodynamic data for all valve sizes remained stable during follow-up. Thirty-day overall mortality was 1.8% (30 patients), and at follow-up it was 5.3% (89 patients). Kaplan-Meier overall survival was 95.5% (94.3–96.7%); 90.7% (88.3–93.1%); 86.4% (82.6–90.4%) at 1, 3, and 5 years, respectively. Serum creatinine (HR: 1.36; 95%CI: 1.04–1.81; p = 0.0397) and cross-clamp time (HR: 1.01; 95%CI: 1.002–1.017; p = 0.0077) were identified as independent predictors of mortality. According to our data from the INTU-ITA registry, SAVR with RDB provides good early clinical and hemodynamic results that are confirmed at follow-up.

We examined the hemodynamic profile of bioprosthetic aortic valves in patients on hemodialysis (HD), longitudinally, and assess the incidence of adverse changes detected by echocardiography. Of 1,146 consecutive patients with severe aortic stenosis who underwent bioprosthetic aortic valve replacement (AVR), 148 patients had end-stage renal disease requiring HD. Each patient on HD was matched one-to-one with a non-HD patient on the basis of propensity scores. The mean follow-up period was 3.3 years for the HD group and 5.9 years for the non-HD group. Follow-up information was available for 95.2%. Postoperative trends of valve hemodynamics derived from linear mixed-effect models showed significant group vs time interactions between the two groups. Stable hemodynamics was consistently observed in the non-HD group, whereas the HD group showed a decrease of -0.06 cm2/y (95% confidence interval (CI), -0.10 to -0.02) in effective orifice area, an increase of 0.8 mm Hg/year (95% CI, 0.4–1.1) in mean pressure gradient, and an increase of 0.08 m/s/year (95%CI, 0.02–0.13) in peak velocity. Cumulative incidence function of SVD more than stage 2 was significantly higher in the HD group (13.1% vs 3.1% at 5 years, Gray test p = 0.01). In a multivariable Fine-Gray analysis, diabetes was independently associated with SVD more than stage 2 in the HD group (subhazard ratio, 1.91; 95% CI, 1.25–2.89; p = 0.02). Survival free-from stenotic-type SVD was significantly lower in HD patients undergoing bioprosthetic AVR. Diabetes was independently associated with postoperative stenotic-type SVD in HD patients.

To determine the impact of aortic root replacement (ARR) with a stentless bioprosthetic valve on midterm outcomes compared to a stented bioprosthetic valve-graft conduit. This was an observational study of aortic root operations from 2010 to 2018. All patients with a complete ARR for nonendocarditis reasons were included, while patients undergoing valve-sparing root replacements or primary aortic valve replacement or repair were excluded. Of the patients with a complete ARR, bioprosthetic valve implants were included, while mechanical valve implants were excluded. Patients were dichotomized into the stented ARR group and the stentless ARR group. A total of 1:1 nearest neighbor propensity matching was employed to assess the association of stentless valves with short-term and midterm outcomes. A total of 455 patients underwent a complete ARR with a bioprosthetic valve implant for nonendocarditis reasons, of which 212 (46.6%) received a stented valve, while 243 (53.4%) received a stentless valve. After matching, postoperative outcomes were similar across each group (P > 0.05), including operative mortality and adverse neurologic events. Median follow-up for the entire cohort was 4.41 years (95% CI: 4.01, 4.95). At 1 year follow-up, aortic regurgitation ≥ 2+ and ejection fraction were similar across each group (P > 0.05); however, the stentless valve group had lower aortic valve velocity and transvalvular pressure gradient. Finally, reoperations and survival were similar for each group over the study's follow-up (P > 0.05). Stentless valves may provide hemodynamic benefits after ARR; however, the clinical impact of those benefits for survival and reoperation may not yet be evident in the midterm.

Clinically frequently-used glutaraldehyde (GA)-crosslinked bioprosthetic valve leaflets (BVLs) are still curbed by acute thrombosis, malignant immunoreaction, calcification, and poor durability. In this study, an anticoagulant heparin-like biomacromolecule, sulfonated, oxidized pectin (SAP) with a dialdehyde structure was first obtained by modifying citrus pectin with sulfonation of 3-amino-1-propane sulfonic acid and then oxidating with periodate. Notably, a novel crosslinking approach was established by doubly crosslinking BVLs with SAP and the nature-derived crosslinking agent quercetin (Que), which play a synergistic role in both crosslinking and bioactivity. The double crosslinked BVLs also presented enhanced mechanical properties and enzymatic degradation resistance owing to the double crosslinking networks formed

Bioprosthetic heart valves (BHVs) are known for their lower thrombogenicity rates and excellent hemodynamic parameters similar to native valves. However, the lifespan of these medical devices is limited to 15 years due to the structural valve degeneration. One of the mechanisms underlying functional impairment and calcification of BHVs includes proteolytic degradation of biomaterials. However, proteases found in xenogeneic BHVs tissue remain poorly studied. In this study using the dot blot assay, we have performed a screening analysis of proteolytic enzymes and their inhibitors in the leaflets of five BHVs explanted due to their dysfunction. Five aortic valves (AVs) explanted due to calcific aortic valve disease were studied as a comparison group. The results of the study have demonstrated that at least 17 proteases and 19 of their inhibitors can be found in BHVs. In the AVs 20 proteases and 21 their inhibitors were identified. Small quantitative differences were noted between proteomic profiles of the BHVs and AVs. Matrix metalloproteinases (MMPs) were expressed in BHVs and AVs at comparable levels, but the level of tissue inhibitors of metalloproteinases-1/-2 and RECK protein in implant tissues was lower than in natural valves. Probably, excessive activity of MMPs cannot be counterbalanced by their inhibitors in BHVs and therefore MMPs can degrade prosthetic biomaterial. Moreover, the detection of a wide range of proteolytic enzymes and their inhibitors in the degenerated BHVs suggests the existence of several pathophysiological pathways that can lead to structural valve degeneration.Bioproteznye klapany serdtsa (BKS) kharakterizuiutsia nizkoĭ trombogennost'iu i prevoskhodnymi gemodinamicheskimi parametrami, priblizhennymi k takovym estestvennykh klapanov. Odnako sroki funktsionirovaniia étikh meditsinskikh izdeliĭ ogranicheny v srednem 15 godami, poskol'ku ikh biologicheskaia sostavliaiushchaia podverzhena strukturnoĭ degeneratsii. Odnim iz mekhanizmov, otvetstvennykh za razrushenie i kal'tsifikatsiiu BKS, iavliaetsia proteoliticheskaia degradatsiia biomateriala. V nastoiashchee vremia spektr proteaz, vstrechaiushchikhsia v ksenotkaniakh implantatov, ostaetsia slaboizuchennym. Posredstvom dot-blottinga nami proizveden skriningovyĭ analiz proteoliticheskikh fermentov i ikh ingibitorov v stvorkakh piati BKS, éksplantirovannykh po prichine disfunktsiĭ. V kachestve gruppy sravneniia ispol'zovali piat' aortal'nykh klapanov (AK), udalennykh iz-za kal'tsiniruiushchego aortal'nogo stenoza. Rezul'taty issledovaniia pokazyvaiut, chto v BKS prisutstvuet po men'sheĭ mere 17 proteaz i 19 ikh ingibitorov, togda kak v AK vyiavleno 20 i 21 soedinenie sootvetstvenno. Proteomnye profili nativnykh i proteznykh stvorok imeli nebol'shie kolichestvennye razlichiia. V chastnosti, matriksnye metalloproteinazy (MMP) byli ékspressirovany v BKS i AK na sopostavimykh urovniakh, togda kak produktsiia tkanevykh ingibitorov metalloproteinaz-1/-2 i RESK-belka v proteznykh stvorkakh okazalas' nizhe, chem v estestvennykh. Éto ukazyvaet na to, chto aktivnost' MMP v BKS, veroiatno, ne reguliruetsia ingibitorami, spetsifichnymi dlia étogo semeĭstva fermentov, vsledstvie chego oni mogut rasshchepliat' skleroproteiny ksenotkani, vyzyvaia postepennoe razrushenie proteznogo biomateriala. Obnaruzhenie v éksplantirovannykh BKS shirokogo spektra proteoliticheskikh fermentov i ikh ingibitorov predpolagaet sushchestvovanie mnogikh patofiziologicheskikh puteĭ, kotorye sposobny privodit' k strukturnoĭ degeneratsii implantatov.

The benefit of avoiding lifelong anticoagulation therapy in patients with bioprosthetic heart valve implantation may potentially be offset by atrial fibrillation (AF); however, clinical impact of surgical AF ablation in such patients remains controversial. We enrolled 426 patients (aged 72.0 ± 7.8 years) with AF who underwent left-side valve replacement with bioprostheses between 2001 and 2018. Of these, 297 underwent concomitant surgical ablation (ablation group) and 129 underwent valve replacement alone (non-ablation group). Clinical outcomes were compared, and mortality was considered as a competing risk factor against valve-related complications. Inverse-probability weighting (IPTW) was adopted to reduce selection bias. The ablation group had lower baseline risk profiles than the non-ablation group. In crude analysis, early mortality rates were 3.4% and 7.0% in the ablation and non-ablation groups, respectively (P = 0.104). During follow-up (1521.9 patient-years), the ablation group showed lower AF-recurrence (P0.001) and anticoagulant medication rate (P = 0.021), and lower overall mortality risk (subdistribution hazard ratio [SHR], 0.63; 95% confidence interval [CI], 0.42-0.94), but higher risk of permanent pacemaker implantation (SHR, 4.67; 95% CI, 1.36-16.05). No significant difference in the risk of stroke (SHR, 1.27; 95% CI, 0.55-2.95) was observed between the groups. After baseline IPTW-adjustment, findings of the clinical outcomes were analogous to those from crude analyses. In patients undergoing bioprosthetic valve replacement, the addition of surgical ablation was associated with improved rhythm outcomes and survival but at the expense of a higher risk of pacemaker implantation. The underlying mechanism of improved survival by AF ablation needs further investigation.

Despite the rapid adoption of transcatheter aortic replacement (TAVR), surgical TAVR valve explantation (TAVR-explant) and the clinical impact of explanted TAVR device type are not well described.TAVR-explant from 2016 to 2019 was queried using the Society of Thoracic Surgeons (STS) National Database. A total of 483 patients with documented explanted valve type, consisting of 330 (68%) patients with balloon-expandable and 153 (32%) patients with self-expandable devices, were identified. The primary outcome was 30-day mortality. The secondary outcome was the need for any simultaneous procedures with TAVR-explant.The mean age was 72.8 years, 38% of the patients were female, and 51% demonstrated New York Heart Association functional class III to IV symptoms. During TAVR-explant, 63% of patients required other simultaneous procedures, including aortic repair (27%), mitral procedures (22%), coronary artery bypass grafting (15%), and tricuspid procedures (7%). Patients with a self-expandable device underwent more frequent ascending aortic replacement (22% vs 9%; P.001) than those with a balloon-expandable device, whereas the aortic root replacement rate was similar (19% vs 24%; P = .22). The overall 30-day mortality was 18% without differences in the mortality or other major complications between the groups. Of the 157 patients with isolated surgical aortic valve replacement and available STS predicted risk of mortality score, the observed-to-expected (O/E) mortality ratio was 2.2.The TAVR-explant outcomes were comparable between patients with balloon-expandable devices and patients with self-expandable devices, whereas ascending aortic replacement was observed more frequently in patients with self-expandable devices. Younger patients undergoing TAVR should be informed of the future TAVR-explant risk that may accompany a higher O/E ratio and frequent morbid concurrent procedures.

Aortic root replacement is a complex procedure. Recently, the KONECT RESILIA aortic valved conduit (Edwards Lifesciences, Irvine, CA), the first prefabricated biologic valved conduit available in the United States, was approved for use. Here, we report a series of 3 patients representing implantation of the novel Konect AVC. The conduit was implanted in both supraannular and intraannular positions, and the unique design of the sewing ring offers several advantages. The Konect AVC streamlines the process of root replacement and may represent an improvement in terms of ease of implantation and durability.

Background The NAUTILUS study aimed to evaluate the safety and performance of the Allegra bioprosthesis in high-risk recipients undergoing transcatheter aortic valve implantation and previously reported 30-day outcomes. In the current investigation 1-year results of the trial are presented. Methods Twenty-seven recipients with severe, symptomatic aortic valve stenosis at high surgical risk, who underwent treatment using the next-generation self-expanding Allegra via transfemoral approach were prospectively enrolled. Clinical endpoints assessed were: mortality, stroke, permanent pacemaker implantation, New York Heart Association class and re-hospitalizations. Prosthetic valve performance evaluation comprised of: mean gradient, effective orifice area and paravalvular leak. Results Patients were elderly (82.8 ± 4.2 years) and predominantly female (n = 19, 70.4%). All of them were deemed to be at high surgical risk with a mean logistic EuroSCORE of 12.5 ± 6.7. The bioprosthesis was successfully implanted in 92.6% of the cases (n = 25). At 1-year, all-cause mortality was 12.0% (n = 3) and stroke was 4.0% (n = 1). Three (12%) of patients developed complete atrioventricular block and received permanent pacemakers. 84% of patients were in New York Heart Association class II or lower. Need for subsequent hospitalization arose in 48% patients. The echocardiographic assessment confirmed an acceptable hemodynamic profile of the Allegra with low mean transprosthetic gradient (9.5 ± 3.4 mmHg), absence of severe paravalvular leak and a 20%-presence of moderate paravalvular leak. Conclusions The current follow-up observation study shows that the Allegra was associated with a satisfactory safety profile and hemodynamic performance at 1-year after implantation.

Objective: The objective of this prospective study was to evaluate the characteristics (positive and negative) of Perceval S valve in patients undergoing aortic valve replacement with a biological prosthesis. The study included 67 patients operated on at our institution and a mean follow-up period of 18 months. Methods: From June 2016 to November 2019, 209 patients underwent aortic valve replacement with a biological prosthesis. Of these, 67 patients were included in the study based on the exclusion and inclusion criteria set before the study began. Their data were recorded during their hospital stay (preoperative, intraoperative, and early and late postoperative time). Results: Fifty-four patients underwent isolated aortic valve replacement (group I) with a Perceval S prosthesis, and 13 patients had combined aortic valve replacement procedures and CABG procedures (group II). Patients were implanted with the following prosthesis sizes: S (N = 12), M (N = 18), L (N = 28), or XL (N = 9). The Perceval S valve successfully was implanted in 67 (91.8%) patients (in 6 patients, the preoperative transthoracic echocardiographic data did not coincide with intraoperative TEE and surgical measurement of the size of the annulus in the suture). Surgical approaches in patients were medial sternotomy (N = 48), mini sternotomy (N = 15), and thoracotomy through the second intercostal space to the right (N = 4). The mean clamping time of the aorta and CPB length for isolated cases was 54 and 82 minutes, respectively, and 96 and 120 minutes for combined procedures. Four (5.9%) patients died within 30 days. Conclusion: Early postoperative results showed that the Perceval S valve was safe. Further follow up is required to evaluate the long-term duration of patients with this bioprosthesis.

Thrombosis is an important factor that causes the failure of artificial biological valves in addition to calcification and immune rejection. A hydrophobic antifouling surface can improve blood compatibility by reducing the absorption of protein. In this study, porcine pericardium was cross-linked with glycidyl methacrylate, and carbon-carbon double bonds were introduced. Then, fluoride monomer was added so that the pericardial surface would become hydrophobic and antifouling. Fluoride modification changed the hydrophilicity of the pericardium surface, and the surface water contact angle increased from 84° to 143°. Compared with unmodified pericardium, the adsorption of bovine serum albumin and fibrinogen decreased by 93.1% and 85%, respectively, and the anti-thrombogenicity was greatly enhanced.

Bioprosthetic heart valves (BHV), made from glutaraldehyde-fixed xenografts, are widely used for surgical and transcatheter valve interventions but suffer from limited durability due to structural valve degeneration (SVD). We focused on metabolic syndrome (MetS), a risk factor for SVD and a highly prevalent phenotype in patients affected by valvular heart disease with a well-recognized cluster of comorbidities. Multicenter patient data (N = 251) revealed that patients with MetS were at significantly higher risk of accelerated SVD and required BHV replacement sooner. Using a next-generation proteomics approach, we identified significantly differential proteomes from leaflets of explanted BHV from MetS and non-MetS patients (N = 24). Given the significance of protein infiltration in MetS-induced SVD, we then demonstrated the protective effects of polyoxazoline modification of BHV leaflets to mitigate MetS-induced BHV biomaterial degeneration (calcification, tissue cross-linking, and microstructural changes) in an ex vivo serum model and an in vivo with MetS rat subcutaneous implants.

Introduction: Few data are available about the newest generation surgical bioprosthesis. We aimed to evaluate early clinical and hemodynamic outcomes after using the INSPIRIS RESILIA aortic valve (Edwards Lifesciences, Irvine, California, USA). Methods: Between July 2018 and April 2021, 80 patients underwent aortic valve replacement receiving the INSPIRIS RESILIA aortic valve at our institution. Primary outcomes were the composite of early mortality, stroke, and myocardial infarction. Secondary outcomes were hemodynamic performances of the valve, paravalvular leakage, and new pacemaker implantation. Results: The mean age of the study population was 60.6 ± 8.3 years. The mean Society of Thoracic Surgery-Predicted Risk of Mortality score was 2.9 ± 1.7%. In 43.7% of the patients, concomitant surgery was performed. The in-hospital mortality, all-stroke, and myocardial infarction rates were 2.5%, 1.2%, and 1.2%, respectively. No valve was explanted and no redo was performed. The mean postoperative trans-prosthetic gradient at discharge was 10.2 ± 4.1 mm Hg. There was no need for new pacemaker implantation. We registered only two cases with minimal (trace) paravalvular leakage. Conclusion: The use of the INSPIRIS RESILIA aortic valve in a young, low-risk population is safe and associated with very good early clinical and hemodynamic outcomes.