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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

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.

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.

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.

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.

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.

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.

The number of hemodialysis patients requiring aortic valve replacement (AVR) is increasing. Although bioprosthetic valves are increasingly popular, they are associated with a risk of structural valve deterioration (SVD). The aim of this study is to examine the outcomes of bioprosthetic valves in hemodialysis patients undergoing AVR and to identify treatment strategies that can decrease the risk of SVD. Between February 2010 and November 2019, 61 patients on hemodialysis underwent AVR using bioprosthetic valves at our hospital. Five patients died while still in the hospital. Kaplan–Meier estimates of overall survival and univariate Cox proportional hazards regression analyses were performed for the remaining 56 patients. During follow-up, there were six SVD events (10.7%) related to the bioprosthetic valves. The survival rate was 67.9% at 3 years and 39.5% at 5 years. In all SVD cases, SVD was caused by aortic stenosis. The mean interval between AVR and the discovery of SVD was 41.5 months. The SVD-free rate was 88.6% at 3 years and 65.3% at 5 years. Preoperative phosphorus levels are associated with SVD risk. High preoperative phosphorus concentration is associated with elevated SVD risk. In this study, we determined that the risk of SVD can be influenced by preoperative phosphorus level. Strict control of the phosphorus concentration of hemodialysis patients may decrease structural valve deterioration after aortic valve replacement.

OBJECTIVES Long-term durability of surgical bio-prostheses is a key factor, especially in the era of transcatheter aortic valve replacement. We compared the incidence of structural valve deterioration (SVD) between patients undergoing surgical aortic valve replacement (SAVR) with the Trifecta (Abbott Laboratories, Abbott Park, IL, USA) or the Intuity valve (Edwards Lifesciences, Irvine, CA, USA). METHODS Between April 2010 and May 2020, 1118 patients underwent SAVR with the Trifecta (n = 346) and the Intuity (n = 772) valve at a single centre. A total of 1070 patients (Trifecta n = 298, Intuity n = 772) were analysed after the exclusion of patients with pure regurgitation and endocarditis. Retro- and prospective echocardiographic and clinical follow-up was performed. Cox proportional hazards regression models were performed to identify prognostic factors for SVD, aortic re-interventions and mortality. RESULTS With 27 cases (Trifecta n = 23, Intuity n = 4) of SVD observed, cumulative incidence of SVD was significantly higher in the Trifecta cohort (P CONCLUSIONS SVD was significantly more frequent in patients receiving a Trifecta valve and its implantation was an independent risk factor for the occurrence of SVD and aortic valve re-interventions. This comparative analysis of 2 low-gradient bioprosthesis put the long-term durability of the Trifecta valve in question and need to be taken into consideration when performing bioprosthetic SAVR.

A cluster of aortic bioprosthetic valve failures, most of which were Trifecta bioprostheses, was observed in Southampton General Hospital, Southampton, United Kingdom. This study was performed to assess whether the cluster represents a significant failure of this valve model or whether there is a selection bias that can explain the failure of these valves.This retrospective study evaluated all bioprosthetic aortic valve replacement operations performed between 2011 and 2016 inclusive in our center. The study compared the performance of the Trifecta valve (Abbott, Abbott Park, IL) with that of Perimount (Edwards Lifesciences, Irvine, CA), Perimount Magna Ease, and Mitroflow (LivaNova, London, United Kingdom) bioprostheses. In addition, the study analyzed patient-related and valve-related risk factors for early failure in the failed valves.A total of 2807 bioprosthetic aortic valve replacements were performed. Of these, 836 were Trifecta valves, 1031 were Perimount, 449 were Perimount Magna Ease, and 351 were Mitroflow valves. A total of 24 Trifecta valves had premature structural failure, a number significantly higher than seen with Perimount or Perimount Magna Ease (no failure, P.001 and P.005, respectively) valves and the Mitroflow valve (1 failure, P .05). There was no difference in the incidence of endocarditis or death. At the time of valve failure, 17 (71%) of the failed Trifecta valves had moderate or severe regurgitation, and the average peak gradient was 61 ± 29 mm Hg. The median failed prosthetic size was 23 mm. One failed valve had severe patient-prosthesis mismatch. The mean time to failure was 4.5 ± 1.7 years.The Trifecta bioprosthesis has an increased incidence of early structural valve failure, which is significantly higher than that of Perimount, Perimount Magna Ease, or Mitroflow. No patient-related or valve-related cause for the failure could be identified.

Objectives The COMMENCE trial was conducted to evaluate the safety and effectiveness of an aortic bioprosthesis with novel RESILIA tissue (Edwards Lifesciences, Irvine, Calif). Reports of early noncalcific valve failure resulting from thrombosis or leaflet tears in other valves warrant careful evaluation of early valve performance. Methods Patients underwent clinically indicated surgical aortic valve replacement with the Edwards Pericardial Aortic Bioprosthesis, Model 11000A (Edwards Lifesciences) in a prospective, multinational, multicenter (n = 27), single-arm, Food and Drug Administration Investigational Device Exemption trial. Events were adjudicated by an independent clinical events committee; echocardiograms were analyzed by an independent core laboratory. Results Between January 2013 and March 2016, 689 patients received the study valve. Mean age was 67.0 ± 11.6 years. Mean Society of Thoracic Surgeons predicted risk of mortality was 2.0% ± 1.8%. Follow-up duration was 3.7 ± 1.2 years, with a total of 2533 patient years of follow-up and a median follow-up of 4 years. Early all-cause mortality was 1.2%, thromboembolism 2.3%, all bleeding 1.0%, and major paravalvular leak 0.1%. One- and 4-year actuarial freedom from all-cause mortality was 97.7% (95% confidence interval, 96.5%-98.8%) and 91.9% (95% confidence interval, 89.7%-94.1%), respectively. At 4 years, New York Heart Association functional class improved compared with baseline in 63.0%, effective orifice area was 1.5 ± 0.5 cm2, and mean gradient was 11.0 ± 5.6 mm Hg. Freedom from moderate or greater transvalvular insufficiency was 99.7%. There were no events of structural valve deterioration. Conclusions Safety and hemodynamic performance of this aortic bioprosthesis with RESILIA tissue at 4 years are favorable. This novel tissue does not appear to result in unexpected early thrombosis events or noncalcific structural valve deterioration.

Objective: To compare early and midterm outcomes of transcatheter valve-in-valve implantation (ViV-TAVI) and redo surgical aortic valve replacement (re-SAVR) for aortic bioprosthetic valve degeneration.Design: Patients who underwent ViV-TAVI and re-SAVR for aortic bioprosthetic valve degeneration between January 2010 and October 2018 were retrospectively analyzed. Mean follow-up was 3.0 years.Setting: In-hospital, early, and mid-term outcomes.Participants: Eighty-eight patients were included in the analysis.Interventions: Thirty-one patients (37.3%) had ViV-TAVI, and 57 patients (62.7%) had re-SAVR.Measurements and Main Results: In the ViV-TAVI group, patients were older (79.1 +/- 7.4 v 67.2 +/- 14.1, p < 0.01). The total operative time, intubation time, intensive care unit length of stay, total hospital length of stay, inotropes infusion, intubation >24 hours, total amount of chest tube losses, red blood cell transfusions, plasma transfusions, and reoperation for bleeding were significantly higher in the re-SAVR cohort (p < 0.01). There was no difference regarding in-hospital permanent pacemaker implantation (ViV-TAVI = 3.2% v re-SAVR = 8.8%, p = 0.27), patient-prosthesis mismatch (ViV-TAVI = 12 patients [mean 0.53 +/- 0.07] and re-SAVR = ten patients [mean 0.56 +/- 0.08], p = 0.4), stroke (ViV-TAVI = 3.2% v re-SAVR = 7%, p = 0.43), acute kidney injury (ViV-TAVI = 9.7% v re-SAVR = 15.8%, p = 0.1), and all-cause infections (ViV-TAVI = 0% v re-SAVR = 8.8%, p = 0.02), between the two groups. In-hospital mortality was 0% and 7% for ViV-TAVI and re-SAVR, respectively (p = 0.08). At three-years' follow-up, the incidence of pacemaker implantation was higher in the re-SAVR group (ViV-TAVI = 0 v re-SAVR = 13.4%, p < 0.01). There were no differences in reintervention (ViV-TAVI = 3.8% v re-SAVR = 0%, p = 0.32) and survival (ViV-TAVI = 83.9% v re-SAVR = 93%, p = 0.10) between the two cohorts.Conclusions: ViV-TAVI is a safe, feasible, and reliable procedure. (c) 2021 The Authors. Published by Elsevier Inc.

All bioprosthetic valves, both surgical and transcatheter, have a finite lifespan before their leaflets inevitably degenerate, leading to stenosis or regurgitation. As younger, low-risk patients receive a transcatheter aortic valve, it is expected that they will most likely outlive their bioprosthetic valve. The heterogeneity of studies regarding surgical valve durability makes the interpretation of the data challenging. Leaflet thickening is seen in transcatheter heart valves but currently there is no evidence that it leads to premature valve deterioration or clinical events. Standardized definitions of structural valve deterioration should allow for comparisons between future clinical trials to assess the durability of different transcatheter heart valves.

Perceval S is a self-expandable, stent-mounted bioprosthetic valve (BPV), with glutaraldehyde treated bovine pericardium, processed with homocysteic acid as an anti-calcification treatment. The stent is crimpable but the valve insertion is done surgically via a shorter procedure which does not require sutures. OBJECTIVES: MATERIAL AND METHODS: RESULTS: CONCLUSIONS: Collapsing and ballooning do not alter cusp collagen periodicity. Structural valve deterioration with stenosis, due to dystrophic calcification and fibrous tissue overgrowth, seldom occurred in the mid-term. Glutaraldehyde fixed pericardium has the potential to undergo structural valve deterioration with time, similar to well-known BPV failure. This supports the recommendation to pursue improvement of tissue valve treatment with enhanced durability.

Transcatheter aortic valve implantation (TAVI) within failed bioprosthetic surgical aortic valves (valve-in-valve TAVI) has become an established procedure, currently approved for patients deemed at high risk for repeat aortic valve intervention. Although less invasive than surgical reoperation, challenges of valve-in-valve treatment include higher rates of malposition, prosthesis-patient mismatch and coronary obstruction. Thus, optimal patient selection and preprocedural planning is of the utmost importance to minimise the risk of these complications. In this review article we provide a fully illustrated overview of the most significant periprocedural operative considerations for valve-in-valve TAVI.

Background Although transcatheter technology has achieved some success in the field of mitral valves, the feasibility of applying it to patients with degenerated mitral valve bioprostheses (valve-in-valve, ViV), failure of mitral valvuloplasty (valve-in-ring, ViR) and serious mitral annulus calcification (vale-in-MAC, ViMAC) has not been effectively evaluated. Methods By searching published literature before December 5, 2020 in four databases, we found all the literature related to the evaluation of feasibility assessment of TMViV, TMViR and TMViMAC. Outcomes focused on all-cause mortality within 30 days, bleeding and LVOT obstruction. Results A total of six studies were included, and all of them were followed up for at least 30 days. After analysis of the ViV–ViR group, we obtained the following results: the all-cause mortality within 30 days of the ViV group was lower than that of the ViR group. Life-threatening or fatal bleeding was more likely to occur in the ViR group after surgery. At the same time, the ViR group was more prone to left ventricular outflow tract obstruction. However, in the ViMAC–ViR group, only the all-cause mortality within 30 days and stroke were statistically significant. In the indirect comparison, we found that TMViV had the best applicability, followed by TMViR. There were few TMViMAC available for analysis, and it requires further studies to improve the accuracy of the results. Conclusion TMViV and TMViR had good applicability and could benefit patients who underwent repeat valve surgery. The feasibility of TMViMAC needs to be further explored and improved.

Acute coronary artery occlusion is a rare but devastating complication of transcatheter aortic valve replacement. Coronary obstruction is angiographic evidence of a new-partial or complete-obstruction of a coronary artery. Key factors identifying patients at risk are aortic root anatomy, type of aortic valve, and type of transcatheter heart valve. Techniques to prevent coronary obstruction include intentional leaflet laceration. If acute coronary obstruction does occur, bailout stenting can be challenging and conversion to emergent open heart surgery may be required, both of which are associated with high morbidity and mortality.

Objectives We sought to evaluate the early outcomes of patients undergoing a Bentall procedure after previous cardiac surgery. Methods From 1990 to 2014, 473 patients underwent a Bentall procedure after previous cardiac surgery with a composite valve graft at a single institution: composite valve graft with a mechanical prosthesis (n = 256) or composite valve graft with a bioprosthesis (n = 217). Patients were excluded if their index operation was less than 30 days before the reoperation. The primary outcome was 30-day mortality. The secondary outcome was a composite of major morbidity and operative mortality: stroke, renal failure, prolonged mechanical ventilation, deep sternal infection, or reoperation during the same admission. Multivariable logistic regression was used to identify risk factors associated with the primary and secondary outcomes of interest. Results Median age was 57 (interquartile range, 44-67) years, and 349 patients (74%) were male. Median time between index surgery and reoperation was 13 (interquartile range, 8-21) years. A total of 178 patients (38%) underwent urgent or emergency intervention, 61 patients (13%) had active endocarditis/abscess, 87 patients (19%) had left ventricular ejection fraction less than 40%, and 262 patients (55%) had undergone more than 1 previous operation. Previous operations (not mutually exclusive) included coronary artery bypass grafting (n = 58, 12%), aortic valve/root replacement (n = 376, 80%) or repair (n = 36, 8%), and other surgical interventions (n = 245, 52%). Ninety-six patients (20%) had undergone coronary reimplantation during the previous operation, which consisted of a Bentall procedure in 81 patients, a Ross operation in 8 patients, a valve-sparing root replacement in 4 patients, and an arterial switch in 3 patients. At the time of the reoperative Bentall, both coronary arteries were reimplanted directly in 357 patients (77%), whereas 79 patients (17%) received at least 1 interposition graft. In 26 patients (5%), at least 1 of the native coronary arteries was oversewn and a vein graft bypass was performed. Thirty-day mortality occurred in 37 patients (7.8%), and 152 patients (32%) had major morbidity and operative mortality. On multivariable analysis, risk factors associated with increased 30-day mortality included older age and coronary reimplantation by a technique other than direct anastomosis. Indirect coronary reimplantation was also associated with a higher incidence of major morbidity and operative mortality, as were more than 1 previous cardiac operation and preoperative New York Heart Association functional class III/IV or greater. Conclusions In the largest reported cohort of aortic root replacement after previous cardiac surgery, the reoperative Bentall procedure was associated with a significant operative risk. The need for complex coronary reimplantation techniques was an important factor associated with adverse perioperative events.

OBJECTIVE Recent studies suggested higher rates of early structural valve degeneration or reintervention for the Trifecta valve compared to other valves. Thus, we conducted a systematic review and meta-analysis comparing the outcomes of the Trifecta valve and the Perimount valves in patients who underwent a surgical aortic valve replacement (SAVR). METHODS All randomized control trials and observational studies which investigated the outcomes of the Trifecta valve and Perimount valves were identified with PubMed and EMBASE. The endpoints were the rates of reintervention and all-cause mortality. Hazard ratios (HRs) for reintervention and all-cause mortality were combined with the random-effects model. RESULTS Our search identified 6 eligible observational studies which enrolled a total of 11,135 patients who underwent SAVR with either the Trifecta valve (n = 4932) or Perimount (n = 6203). Pooled analyses demonstrated that the reintervention rates were significantly higher with the Trifecta valve compared with Perimount valves (HR [95% confidence interval {CI}] = 3.16 [1.83-5.46]; p

Background The implantation of rapid-deployment aortic valves may interfere with the conduction system of the heart. This study evaluates the occurrence and predictive factors of conduction anomalies in patients undergoing surgical aortic valve replacement (SAVR) with a rapid-deployment balloon-expandable bioprosthesis in a single-center, real-world experience. Methods Between May 2010 and April 2019, 700 consecutive patients were included in a prospective, ongoing database with a longitudinal follow-up preoperatively, at discharge, and at 3 months, 1 year, 3 years, and 5 years postoperatively. Thirty-seven patients (5.3%) had a permanent pacemaker at baseline and were excluded from further analysis, leaving 663 patients for analysis. Assessment of conduction anomalies was performed by electrocardiography (ECG) monitoring and repeated 12-lead ECG during the hospital stay and at postoperative follow-ups. Results Preoperatively, 126 patients (19.0%) presented with different conduction disturbances. New permanent pacemaker implantation (PPI) occurred in 61 patients during the first 14 days (cumulative incidence, 9.4%). The indication for PPI was complete atrioventricular block in 47 cases (77%). Preoperative conduction anomalies, such as right bundle branch block, as well as operative characteristics (concomitant procedures) were found to be independent predictors for new PPI. One-year survival was 98% in patients with new early PPI and 96% in those without new early PPI (P = .60). Conclusions The PPI rate was in the range of previous reports for rapid-deployment prostheses. PPI did not have a significant influence on short- to intermediate-term survival. Case selection with exclusion of patients presenting with baseline conduction disturbances may decrease the rate of new PPIs after SAVR with rapid-deployment balloon-expandable bioprostheses.

We report our experience with aortic valve replacement in a patient with severe aortic stenosis who had self-reported allergies to multiple metals. The patient was a 74-year-old man. He developed palmoplantar pustulosis after using a dental prosthesis, and a patch test revealed reactions to several metals; therefore, he was diagnosed with systemic metal allergy. His condition progressed to severe aortic stenosis, and bioprosthetic aortic valve replacement was planned. The Avalus valve (Medtronic, Minneapolis, MN, USA) was selected for aortic valve replacement, since the patient reported having allergies to several metals. While most devices used in cardiac surgery contain some amount of metal, the Avalus bioprosthetic valve does not contain metal in the stent and has been extremely useful for aortic valve replacement in patients with suspected metal allergies.

Stentless porcine bioprothesis is a surgical strategy to treat aortic root disease. Use has been limited due to the concern for long-term valve degeneration. This study evaluated the perioperative and late outcomes of patients with aortic root disease requiring root replacement.A total of 409 patients underwent aortic root replacement by a single surgeon using a stentless porcine bioroot between February 1996 and May 2020. The cohort was divided into two groups (age ≤65 and65 years). Descriptive statistics were used to analyze the data and Kaplan-Meier curves used to evaluate long-term outcomes.Patients age65 years were more likely to be female (p = .01), have hypertension (p = .01), require circulatory arrest (p = .01), and have concomitant coronary artery bypass grafting (CABG) (p = .04). Baseline creatinine1.8 (p = .20), diabetes (p = .06), and ejection fraction (p = .20) were similar between groups. The 1-, 5-, and 10-year survival for patients age ≤65 years were 92%, 87%, and 69%, respectively, significantly better than patients age65 (88%, 73%, and 43%, respectively) (p .01, Figure 1). The 1-, 5-, and 10-year freedom from reoperation for patients ≤65 years were 99%, 97%, and 93% versus 99%, 98%, and 96% in patients age65 years, respectively (p = .24).Patients with aortic root disease can be treated with acceptable perioperative outcomes, long-term survival, and low reoperation rates using a stentless porcine bioprothesis. It should be considered irrespective of age due to its excellent durability and freedom from anti-coagulation requirement.

Introduction In tracheal replacement transplantation, prelamination is a critical stage. Nowadays, the most widely used prelamination technique is the prethoracic fascia flap with lateral thoracic artery. We propose a flap based on the internal thoracic artery, which allows a relatively non-aggressive double organ implant, and we have tested its efficacy in decellularized tracheas. Material and methods Tracheas of albino New Zealand rabbits were decellularized following a protocol that uses detergents and cryogenization, sterilized with 1kGy gamma radiation and tutorized with a stent. Bilateral pedicled flaps made of pectoral fascia and a muscular component were harvested through a longitudinal 3-cm central thoracic incision, wrapping the tracheas with them in 16 rabbits, remaining them implanted for 2, 4, 8 and 12 weeks. The tracheas were then studied histologically using standard stainings plus immunohistochemistry (CD31). The models were adjusted with Bayesian statistics using ordinal regression; results as odds ratios and credibility intervals. All analysis were performed using R software. Results Acute inflammatory cell invasion was observed at 2 weeks, which almost disappeared in the week 8 after implant. Only macrophages and giant cells increased between weeks 8 and 12 (OR 10.487, IC [1.603-97.327]). The cartilage maintained its structure, with slight signs of ischemia in a few cases. New CD31-positive vessels were observed from week 2 and increasing thereafter, reaching a maximum peak at week 8. Conclusion We propose a bilateral implant technique that is viable and effective as a prelamination option for two concurrent tracheas, achieving perfect vascularization and integration of the organ with hardly any inflammatory response in the medium- or long-term.

Clinical outcomes of redo surgical aortic valve replacement (redo-SAVR) compared with valve-in-valve transcatheter aortic valve replacement (VIV-TAVR) are poorly understood. This study compared short- and midterm outcomes of patients undergoing isolated redo-SAVR vs VIV-TAVR after previous SAVR.A single-institutional review of the initial use of VIV-TAVR from 2012 to 2019 identified 273 patients undergoing VIV-TAVR (n = 187) or redo-SAVR (n = 86) after prior SAVR. Outcomes analysis included a univariate analysis and Kaplan-Meier survival analysis.The Society of Thoracic Surgeons predicted risk of mortality was higher for VIV-TAVR (6.3%; interquartile range [IQR], 3.6%-10.5%) vs redo-SAVR (4.2%; IQR, 2.4%-6.9%; P.01). VIV-TAVR patients (76 years; IQR, 67.5-82.5 years) were older than redo-SAVR patients (64 years; IQR, 54-72; P.01). Redo-SAVR and VIV-TAVR had similar early mortality (1.2% vs 1.6%, P = .92). Two redo-SAVR (2.3%) and 3 VIV-TAVR patients (1.6%) died 4.8 ± 0.5 years and 4.8 ± 1.5 months after discharge, respectively. Redo-SAVR had an increased stroke rate (7.0% vs 1.1%, P = .02). Postoperative mean valve gradients were similar between VIV-TAVR (14 mm Hg; IQR, 9-21 mm Hg) and redo-SAVR patients (12 mm Hg; IQR, 8-20 mm Hg; P = .08). Postprocedure transesophageal echocardiography showed at least mild aortic insufficiency for 24 VIV-TAVR patients (16%) and 2 redo-SAVR patients (2.9%) (P = .01). The cumulative incidence of aortic valve reintervention was 5.2% for the redo-SAVR patients and 28.5% for the VIV-TAVR patients (P = .07).After previous SAVR, redo-SAVR and VIV-TAVR can both be performed with acceptable operative results. Despite treating a high-risk patient population, we found redo-SAVR and VIV-TAVR both carry similar operative outcomes. Improved valve hemodynamics were observed in redo-SAVR patients compared with VIV-TAVR patients.

OBJECTIVE: The long-term durability of transcatheter aortic bioprosthetic valves continues to be a major concern. Standardized criteria of the structural valve deterioration (SVD) and bioprosthetic valve failure (BVF) have recently been defined. Limited studies have evaluated the long-term durability of transcatheter aortic valve implantation (TAVI) according to these new definitions. We aim to analyze the durability of TAVI beyond 5 years and to report the frequency of SVD and BVF. METHODS: A total of 89 patients who had undergone TAVI and had theoretically completed at least 5 years after the procedure were included. Either a Medtronic CoreValve or an Edwards SAPIEN XT valve were implanted in the patients. New standardized definitions were used to evaluate SVD and BVF. RESULTS: The mean age of the patients was 78.70±6.95 years. SVD occured in 4 (4.5%) patients during 6 years of follow-up. Severe SVD was observed in 2 patients (2.2%), and these patients had the New York Heart Association class II symptoms. Both patients with severe SVD also met the criteria of BVF. Moderate SVD was observed in 2 patients (2.2%), and these patients had no valve-related symptoms. Of the 4 SVD cases, 2 were associated with increased mean transaortic gradients, whereas the remaining 2 cases were associated with intraprosthetic aortic regurgitation. All patients with SVD are still alive, and none of them have required aortic valve reintervention. CONCLUSION: Although first-generation TAVI devices were used, we determined the low rate of SVD and BVF at the 6-year follow-up. It may be suggested that there is no major concern associated with TAVI even with first-generation devices regarding long-term durability.

OBJECTIVES Intima hyperplasia is a major issue of biological cardiovascular grafts resulting in progressive in vivo degeneration that particularly decreases the durability of coronary and peripheral vascular bypasses. Previously, dichloroacetate (DCA) has been reported to prevent the formation of hyperplastic intima in injured arteries. In this study, the effect of DCA on the neointima formation and degeneration of decellularized small-caliber implants was investigated in a rat model. METHODS Donor rat aortic grafts (n = 22) were decellularized by a detergent-based technique, surface-coated with fibronectin (50 µl ml−1, 24 h incubation) and implanted via anastomoses to the infrarenal aorta of the recipients. Rats in the DCA group (n = 12) received DCA via drinking water during the whole follow-up period (0.75 g l−1), while rats without DCA treatment served as controls (n = 10). At 2 (n = 6 + 5) and 8 (n = 6 + 5) weeks, the grafts were explanted and examined by histology and immunofluorescence. RESULTS Systemic DCA treatment inhibited neointima hyperplasia, resulting in a significantly reduced intima-to-media ratio (median 0.78 [interquartile range, 0.51–1.27] vs 1.49 [0.67–2.39] without DCA, P, Tissue-engineered vascular grafts represent an implant source that promises to overcome the limitations of clinical standard grafts.

In cases of aortic stenosis, bioprosthetic heart valves (BHVs), with glutaraldehyde-fixed bovine pericardium leaflets (GLBP), are often implanted to replace the native diseased valve. Widespread use of BHVs, however, is restricted due to inadequate long-term durability, owing specifically to premature leaflet failure. Mechanical fatigue damage and calcification remain the primary leaflet failure modes, where glutaraldehyde treatment is known to accelerate calcification. The literature in this area is limited, with some studies suggesting mechanical damage increases calcification and others that they are independent degenerative mechanisms. In this study, specimens which were non-destructively pre-sorted according to collagen fibre architecture and uniaxially cyclically loaded until failure or 1 million cycles, were placed in an in vitro calcification solution. The weakest specimen group (those with fibres aligned perpendicular to the load) had statistically significantly higher volumes of calcification when compared to those with a high fatigue life. Moreover, SEM imaging revealed that ruptured and damaged fibres presented calcium binding sites; resulting in 4 times more calcification in fractured samples in comparison to those which did not fail by fatigue. To the authors’ knowledge, this study quantifies for the first time, that mechanical damage drives calcification in commercial-grade GLBP and that calcification varies spatially according to localised damage levels. These findings illustrate that not only is calcification of GLBP exacerbated by fatigue damage, but that both failure phenomena are underpinned by the collagen fibre organisation. Consequently, controlling for GLBP collagen fibre architecture in leaflets could minimise the progression of these primary failure modes in patient BHVs. Statement of significance Mechanical damage and calcification are the primary premature failure modes of glutaraldehyde-fixed bovine pericardial (GLBP) leaflets in bioprosthetic heart valves. In this study, commercial-grade GLBP specimens which were uniaxially cyclically loaded to failure or 1 million cycles, were placed in an in vitro calcification solution. MicroCT and SEM analysis showed that localised calcification levels varied spatially according to damage, where ruptured fibres offered additional calcium binding sites. Furthermore, specimens with a statistically significant lower fatigue life were associated with statistically significant higher calcification. This study revealed that mechanical damage drives calcification of GLBP. Non-destructive pre-screening of collagen fibres demonstrated that both the fatigue life and calcification potential of commercial-grade GLBP, are underpinned by the collagen fibre architecture.

Background Chronic venous insufficiency (CVI) is a disease characterized by failure of the venous valves that allow blood from the lower limbs to return to the heart. The more severe types of CVI (C4b-C6 disease) significantly influence patients' quality of life (QOL). The treatment options for CVI of the deep system are limited. The present study is the first-in-human study using a prosthetic venous valve, VenoValve, to initially evaluate patient outcomes. We evaluated the feasibility, initial safety, and performance outcomes of the VenoValve. Methods Ten patients with C5-C6 CVI of the deep venous system secondary to postthrombotic syndrome had had a VenoValve surgically implanted into the femoral vein in Bogota, Colombia, under approval of the local ethics committee and Colombian National Food and Drug Surveillance Institute, national health care regulatory body, or the Colombian National Food and Drug Surveillance Agency. Follow-up examinations were conducted postoperatively at 2 and 14 days and then every 30 days for 6 months. The results of the assessments for adverse events, reflux time, disease severity (venous clinical severity scores), pain scores (visual analog scale), and QOL (VEINES-QOL/Sym [venous insufficiency epidemiological and economic study–QOL/symptoms] questionnaire) were documented. Results Ten patients underwent successful implantation of the VenoValve into the femoral vein as outpatients (100% technical success rate). Of the 10 patients, 9 had undergone VenoValve placement under regional anesthesia and 1 under local anesthesia. Six patients had required bovine patch angioplasty of the vein. Four adverse events occurred, including one case of hematoma at the incision site that was aspirated, 2 cases of superficial wound infection in C6 patients treated with antibiotics, and 1 case of a bleeding complication due to warfarin anticoagulation. One patient's VenoValve had thrombosed at 5 months due to nontherapeutic anticoagulation. Improvements in all 5 patients who had reached the 6-month follow-up mark with the VenoValve were demonstrated during the study period by decreases in the venous clinical severity scores (61% decrease from baseline), visual analog scale for pain scores (57% decrease), and reflux time (40% decrease) and a statistically significant improvement in the VEINES-QOL/Sym questionnaire. The patient with the occluded VenoValve had experienced improvements in all areas except for the reflux time. The latter patient had shown improvement because her ulcer had nearly healed before the occurrence of the thrombosis. Conclusions The early results of the first-in-human trial using the VenoValve appear promising, with improvements in clinical outcomes and QOL. The VenoValve is the first prosthetic valve that has shown success at 6 months of follow-up. These findings offer insight for creating better outcomes for these highly disabled patients.

Patients undergoing surgical aortic valve replacement (SAVR) are at high risk for atrial fibrillation (AF) and stroke after surgery. There is an unmet clinical need to improve stroke prevention in this patient population. The LAA-CLOSURE trial aims to assess the efficacy and safety of prophylactic surgical closure of the left atrial appendage for stroke and cardiovascular death prevention in patients undergoing bioprosthetic SAVR. This randomized, open-label, prospective multicenter trial will enroll 1,040 patients at 13 European sites. The primary endpoint is a composite of cardiovascular mortality, stroke and systemic embolism at 5 years. Secondary endpoints include cardiovascular mortality, stroke, systemic embolism, bleed fulfilling academic research consortium (BARC) criteria, hospitalization for decompensated heart failure and health economic evaluation. Sample size is based on 30% risk reduction in time to event analysis of primary endpoint. Prespecified reports include 30-day safety analysis focusing on AF occurrence and short-term outcomes and interim analyses at 1 and 3 years for primary and secondary outcomes. Additionally, substudies will be performed on the completeness of the closure using transesophageal echocardiography/cardiac computed tomography and long-term ECG recording at one year after the operation.

Background This study aimed to evaluate the early outcomes of Perceval sutureless valves in the Korean population and to introduce a modified technique of guiding suture placement during valve deployment.Methods and Results:From December 2014 to April 2019, 121 patients (mean age: 74.7±6.2 years; 53.7% female) received a Perceval sutureless aortic valve replacement. To prevent conduction system injury, the depth of guiding suture placement (1 mm below the nadir of the annulus) was modified. All patients underwent echocardiographic evaluation at discharge and 6-12 months postoperatively, with a mean follow up of 13.7±11.2 months. Concomitant surgeries, such as coronary artery bypass grafting, and other valvular surgeries, were performed in 45.5% of cases. The mean aortic cross-clamp times for isolated and minimal procedures were 32.8±7.9, and 41.2±8.0 min, respectively. The overall transvalvular mean gradients were 13.1±3.8 mmHg at discharge and 11.5±4.7 mmHg at the last follow up. After modifying the guiding suture placement, permanent pacemaker implantation risk decreased from 9.9% to 2.5%. Cardiac-related mortality was 0.8%, with no patient developing valvular or paravalvular aortic regurgitation, valve thrombosis, or endocarditis. Conclusions Perceval valve implantation provided a significant cardiac-related survival benefit with excellent early hemodynamic and clinical outcomes. Further research is needed to determine whether adjusting the implantation depth, such as modification of the guiding suture technique, can reduce the risk of permanent pacemaker implantation.

Aortic and mitral bioprosthesis are the gold standard treatment to replace a pathological native valve. However, bioprostheses are prone to structural valve degeneration, resulting in limited long-...

The increase of both arterial occlusive diseases and coronary heart diseases leads to a higher demand for small-diameter vascular grafts ( 6 mm), they are associated with thrombosis, intimal hyperplasia, calcification, and chronic inflammation when used as small-diameter vascular grafts. Therefore, natural materials have been studied for this application. In this study, a decellularized human chorion membrane (dHCM) vascular graft with a 3-4 mm diameter was created. Herein, the biocompatibility of dHCM with endothelial cells was demonstrated in vitro and ex ovo. Blood biocompatibility of dHCM was also shown by studying plasma protein adsorption, platelet adhesion and activation, and its hemolytic potential. Furthermore, dHCM antibacterial properties against Staphylococcus aureus were also studied. In summary, the dHCM reticular layer side presented all the needed characteristics to be used in the inner side of a vascular graft. Additionally, the mechanical properties of the dHCM tubular construct were studied, being similar to the ones of the saphenous vein, the gold standard for autologous small-diameter vessel replacement.

Sutureless/rapid-deployment (SRD) valves for aortic valve replacement (AVR) are new surgical bioprosthetic valves that allow for expedited implantation and facilitate minimally invasive approaches. Although clinical trial data are available for SRDs in the United States, how their clinical outcomes compare with traditional stented bioprosthetic (SBP) valves is unknown in a post-approval, commercial setting.The Society of Thoracic Surgery Adult Cardiac Surgery Database was queried for patients who underwent an AVR. Transcatheter AVR cases were excluded. Thirty-day outcomes were compared between SRD valves (Perceval S [LivaNova, Houston, TX] and Intuity Elite [Edwards Lifesciences, Irvine CA]) and SBP valve patients. The SRD and SBP patients were propensity score-matched in a 1:(up to) 3 ratio. Primary outcome was 30-day mortality and secondary outcomes were major comorbidities, paravalvular regurgitation, and predischarge pacemaker implant.Propensity score matching resulted in 4486 SRD patients and 13,215 SBP patients. The SRD recipients had more permanent pacemakers (11.4% vs 4.9%, P.001) shorter cross-clamp times (median: 68 vs 86 minutes, P.001), and fewer full sternotomies (75% vs 77% , P.024) than SBP but similar 30-day mortality (3.1% vs 3.1%, P = .98) and moderate or greater paravalvular regurgitation (0.2% vs 0.1%, P = .21).SRD implantation was associated with reduced operative times and smaller incisions. Rates of 30-day mortality, major comorbidities, and perivalvular regurgitation were similar between SRD and SBP patients. Longer follow-up is needed to determine the implications of increased permanent pacemaker implantation rates in SRD patients.

Background This study evaluated the early and intermediate-term clinical and hemodynamic results after implant of the Medtronic 3F (Minneapolis, MN) stentless aortic valve. Methods Between March 2007 and August 2015, 226 consecutive patients affected by aortic valve disease received a 3F valve at our unit by a single surgeon. The valve in 30 patients was included in a tubular prosthesis for a Bentall procedure. Size ranged between 21 and 29, age at operation was 74.17 ± 8.58 years, mean logistic European System for Cardiac Operative Risk Evaluation was 9.73 ± 6.00, and 51.3% of patients received a concomitant procedure. For isolated valve replacement, mean extracorporeal circulation time was 92 ± 17 minutes, and cross-clamp time was 73 ± 11 minutes. Follow-up was 100% complete and was a mean of 63 ± 2.4 months (range, 6-138 months). Primary end points were early and late mortality, freedom from endocarditis, freedom from structural valve deterioration, and freedom from valve-related reoperation. Results Early mortality after isolated aortic valve replacement was 1.7%. Of the 59 (25.3%) late overall deaths, 15 (6.6%) were cardiac-related, and survival rate was 93% at 10 years. At follow-up, 97% of patients were in New York Heart Association class I or II. Actuarial freedom from reoperation due to structural deterioration was 100% at 5 years and 96% at 10 years. Freedom from endocarditis at 10 years was 97%. Mean aortic pressure gradient measured by echocardiography was 11.5 mm Hg at hospital discharge and 10.4 mm Hg at the last follow-up. Conclusions The 3F valve is a user-friendly third-generation stentless aortic prosthesis with proven durability and remarkable hemodynamic performance preserved over time. The 3F is particularly useful in cases of expected patient/prosthesis mismatch

Background Previous reports of extracellular matrix (ECM) patch use after carotid endarterectomy (CEA) have noted an approximately 10% rate of pseudoaneurysm (PSA) formation. PSA-related rupture of ECM patches has also been described after femoral artery repair. In these studies, different thicknesses (4-ply versus 6-ply) and no standard length of soaking the patch in saline before implantation were used. Herein, we describe our experience with ECM CorMatrix patches in 291 CEAs with 6-ply patches. Methods The records of 275 consecutive patients undergoing 291 CEAs with CorMatrix 6-ply patches beginning in November of 2011 and extending until 2015 were reviewed. Only 6-ply patches and a 1 min hydration time in saline were used in all patients. No shunts were used. Results There were three deaths within the first 30 d secondary to subsequent cardiac surgical procedures. Nine patients experienced a perioperative stroke (3.1%), only one of which occurred secondary to an occluded internal carotid artery. One patient had a transient ischemic attack with a patent endarterectomy site. In follow-up, 11 patients (4.5%) developed severe recurrent stenoses requiring reintervention. Only one patient (0.34%) developed a PSA at 2 years possibly secondary to chronic infection. The median follow-up was 72 mo. Conclusions Our experience with 6-ply CorMatrix ECM patches and a brief period of soaking demonstrated that these patches performed well in patients requiring a CEA. Only one PSA was noted.

Background Transcatheter aortic valve implantation (TAVI) has become standard treatment for elderly patients with symptomatic severe aortic valve stenosis. The ACURATE neo AS study evaluates 30-day and 1-year clinical and hemodynamic outcomes in patients treated with the ACURATE neo2 valve. Methods The primary endpoint of this single-arm multicenter study is 30-day all-cause mortality. Other key endpoints include device performance, echocardiographic measures assessed by an independent core laboratory, and VARC-2 clinical efficacy and safety endpoints through 12 months. Results The study enrolled 120 patients (mean age 82.1 ± 4.0 years; 67.5% female, mean baseline STS score 4.8 ± 3.8%). The VARC-2 composite safety endpoint at 30 days occurred in 13.3% of patients. All-cause mortality was 3.3% at 30 days and 11.9% at 1 year. The 30-day stroke rate was 2.5% (disabling stroke 1.7%); there were no new strokes between 30 days and 12 months. The rate of permanent pacemaker implantation was 15.0% (18/120) at 30 days and 17.8% (21/120) at 1 year. No patients required re-intervention for valve-related dysfunction and there were no cases of valve thrombosis or endocarditis. Patients demonstrated significant improvement in mean aortic valve gradient (baseline 38.9 ± 13.1 mmHg, 1 year 7.8 ± 3.5 mmHg; P Conclusions One-year outcomes from the ACURATE neo AS study support the safety and performance of TAVI with the ACURATE neo2 valve. Graphic Abstract

Background The value of allografts for aortic root replacement is controversial, with recent concern about limited durability. Currently, we prefer allografts for invasive infective endocarditis. Purposes of this study were to assess allograft performance and durability in our cumulative experience with aortic allografts. Methods From January 1987 to January 2017, 2042 adults received 2110 aortic allograft root replacements at our institution: 986 (47%) for infective endocarditis (669 [68%] for prosthetic valve endocarditis) and 1124 (53%) for other indications. Mean recipient age was 54 ± 15 years, and mean allograft donor age was 35 ± 13 years. Follow-up was 85% complete and comprised 17,253 patient-years of data. Longitudinal allograft performance was extracted from 6339 available echocardiographic studies. Durability was assessed by explant for allograft structural failure. Results Allograft mean gradient at hospital discharge was 6 mm Hg and 9, 13, and 15 mm Hg at 5, 10, and 15 years post-implant, respectively. Severe aortic regurgitation was 0% at hospital discharge, but 14%, 25%, and 35% at 5, 10, and 15 years, respectively. A total of 405 allografts were explanted for structural failure, actuarially 2%, 14%, 34%, and 51% at 5, 10, 15, and 20 years, respectively. Risk factors for structural failure were younger recipient age, larger body surface area, hypertension, and thoracic aorta disease; donor factors were older age and larger allograft size. Implant for infective endocarditis was not associated with accelerated structural failure. Conclusions This study affirms allografts’ long-term acceptable hemodynamic performance and durability. Concern about structural failure should not limit allograft use. Recipient hypertension, allograft size, and donor age are modifiable risk factors.

Background This report presents 5-year outcomes of the rapid-deployment Edwards Intuity valve in a prospective, single-center study. Methods All patients who underwent an aortic valve replacement (AVR) with an Edwards Intuity bioprosthesis at La Timone Hospital, Marseille, France, from July 2012 to June 2015 were assessed over a 5-year follow-up period. The primary outcome was overall mortality at 5 years. Secondary outcomes were reoperation, overall mortality and stroke, cardiovascular mortality, composite endpoints defined by the updated Valve Academic Research Consortium-2 (VARC-2), periprosthetic regurgitation, prosthesis-patient mismatch, and the need for new pacemaker implantation. Results In total, 170 consecutive patients were assessed, of which 67.1% were males. The mean age was 76 years, mean EuroSCORE II was 3.5% and 5-year overall mortality was 12.4%. At 5 years, reoperation was 2.9%, overall mortality and stroke was 4.1% per patient-year, and cardiovascular mortality was 4.7%. VARC clinical efficacy and VARC time-related valve safety were achieved in 46.0% and 59.9% of patients, respectively. At one month VARC device success was 71.2% and VARC early safety was 87.1%. At one year, mild and moderate periprosthetic regurgitation were 2.4% and 0.6%, respectively, and moderate and severe prosthesis-patient mismatch were 18.8% and 4.8%, respectively. Conduction disturbances needing new PPI occurred in 3.5% patients. Conclusion The 5-year outcomes of AVR with the Edwards Intuity valve system demonstrate satisfactory midterm safety and excellent haemodynamic performance.

Background: Transcatheter aortic valve implantation (TAVI) has become a standard therapeutic option for patients with severe aortic stenosis (AS) at high cardiac surgical risk. The aim of the NAUTILUS study was to investigate the safety and performance of the New Valve Technology (NVT) Allegra bioprosthesis in high-risk patients undergoing TAVI. Methods: Twenty seven patients with severe, symptomatic AS at high surgical risk were prospectively enrolled, who underwent treatment using the novel self-expanding NVT Allegra bioprosthesis via transfemoral approach (TF-TAVI). The primary end-point was all-cause mortality at 30 days. Results: Patients were elderly (83 years, range 75–89 years), and predominantly female (70.4%, n = 19). All patients were deemed to be at high surgical risk, with a mean logistic EuroSCORE of 12.4% (range, 2.8–31.8%). The bioprosthesis was successfully implanted in 96% of the cases (n = 25). The echocardiographic assessment confirmed good hemodynamic profile after implantation of the NVT Allegra bioprosthesis. Complications included cardiac tamponade (4%, n = 1) and the need for permanent pacemaker implantation (8%, n = 2). The analysis of procedural aspects showed a short learning effect related to the precise placement of the valve. A significant improvement in clinical symptoms were observed, and no patients died in-hospital or within 30 days of post-discharge observation. Conclusions: This prospective observation shows that the NVT Allegra bioprosthesis was associated with a satisfactory safety profile and a remarkable hemodynamic performance after implantation.

The 25-mm Medtronic Mosaic porcine bioprosthesis (MB25) is the smallest bioprosthesis that has been approved for use in the mitral position in Japan. Various studies have reported satisfactory hemodynamic performance and good long-term outcomes of the Medtronic Mosaic porcine bioprosthesis. However, the hemodynamic and clinical performances of the MB25 in the mitral position remain unknown. This study aimed to evaluate the hemodynamic and clinical performance of the MB25 in mitral valve replacement (MVR). Twenty patients who underwent MVR using the MB25 between February 2013 and April 2018 were studied. We evaluated the hemodynamic performance of the MB25, cardiac chamber size, cardiac function, and systolic pulmonary artery pressure (PAP) using echocardiography during follow-up. The study outcomes were major adverse cardiac events (MACEs) and all-cause mortality. Sixteen patients (80%) had a patient prosthesis mismatch defined as an index effective orifice area of ≤ 1.2 cm2/m2. The left atrial dimension was significantly reduced after surgery (p = 0.0282). The mean pressure gradients (MPG) in the mitral position were 5.5 ± 1.7 mmHg at discharge and 4.2 ± 1.3 mmHg at 1 year postoperatively. The MPG in the mitral position significantly decreased during the follow-up period (p = 0.0489). Systolic PAP significantly improved postoperatively. The 1-, 3-, and 5-year survival rates were 87, 79, and 70%, respectively. No cardiac death occurred. There were no MACEs or reports of structural valve degeneration during the follow-up period. The hemodynamic and clinical performances of the MB25 in the mitral position were satisfactory as the smallest biological mitral valve. The MB25 is a reasonable option for MVR to reduce the surgical difficulty in high-risk patients with an advanced age, a small body size or MAC and when recurrent MVR or complex procedures are performed.

OBJECTIVES Sutureless aortic valve prostheses have been introduced to facilitate the implant process, speed up the operating time and improve haemodynamic performance. The goal of this study was to assess the potential advantages of using sutureless prostheses during minimally invasive aortic valve replacement in a large multicentre population. METHODS From 2011 to 2019, a total of 3402 patients in 11 hospitals underwent isolated aortic valve replacement with minimal access approaches using a bioprosthesis. A total of 475 patients received sutureless valves; 2927 received standard valves. The primary outcome was the incidence of 30-day deaths. Secondary outcomes were the occurrence of major complications following procedures performed with sutureless or standard bioprostheses. Propensity matched comparisons was performed based on a multivariable logistic regression model. RESULTS The annual number of sutureless valve implants increased over the years. The matching procedure paired 430 sutureless with 860 standard aortic valve replacements. A total of 0.7% and 2.1% patients with sutureless and standard prostheses, respectively, died within 30 days (P = 0.076). Cross-clamp times [48 (40–62) vs 63 min (48–74); P = 0.001] and need for blood transfusions (27.4% vs 33.5%; P = 0.022) were lower in patients with sutureless valves. No difference in permanent pacemaker insertions was observed in the overall population (3.3% vs 4.4% in the standard and sutureless groups; P = 0.221) and in the matched groups (3.6% vs 4.7% in the standard and sutureless groups; P = 0.364). CONCLUSIONS The use of sutureless prostheses is advantageous and facilitates the adoption of a minimally invasive approach, reducing cardiac arrest time and the number of blood transfusions. No increased risk of permanent pacemaker insertion was observed.

Background This study describes the long-term survival, risk of reoperation and clinical outcomes of patients undergoing solitary surgical aortic valve replacement (SAVR) with a Carpentier-Edwards Perimount (CE-P) bioprosthetic in Western Denmark. The renewed interest in SAVR is based on the questioning regarding the long-term survival since new aortic replacement technique such as transcatheter aortic-valve replacement (TAVR) probably have shorter durability, why assessment of long-term survival could be a key issue for patients. Methods From November 1999 to November 2013 a cohort of a total of 1604 patients with a median age of 73 years (IQR: 69–78) undergoing solitary SAVR with CE-P in Western Denmark was obtained November 2018 from the Western Danish Heart Registry (WDHR). The primary endpoint was long-term survival from all-cause mortality. Secondary endpoints were survival free from major adverse cardiovascular and cerebral events (MACCE), risk of reoperation, cause of late death, patient-prothesis mismatch, risk of AMI, stroke, pacemaker or ICD implantation and postoperative atrial fibrillation (POAF). Time-to-event analysis was performed with Kaplan-Meier curve, cumulative incidence function was performed with Nelson-Aalen cumulative hazard estimates. Cox regression was applied to detect risk factors for death and reoperation. Results In-hospital mortality was 2.7% and 30-day mortality at 3.4%. The 5-, 10- and 15-year survival from all-cause mortality was 77, 52 and 24%, respectively. Survival without MACCE was 80% after 10 years. Significant risk factors of mortality were small valves, smoking and EuroSCORE II ≥4%. The risk of reoperation was Conclusions Patients undergoing aortic valve replacement with a Carpentier-Edwards Perimount valve shows a very satisfying long-term survival. Future research should aim to investigate biological valves long-term durability for comparison of different SAVR to different TAVR in long perspective.

Objectives To report the implant experience and long-term outcomes from a large tertiary care referral center on surgical aortic valve replacement (SAVR) with a contemporary stented pericardial bioprosthesis with anticalcification treatment. Methods Patients underwent SAVR using the Trifecta valve at a single institution. Endpoints included procedural outcomes, adverse events, prosthesis–patient mismatch (PPM), long-term survival, and valve durability. Follow-up included 30-day, 6-month, and annual assessments. Treatment for structural valve deterioration (SVD) included surgical explant and valve-in-valve (V-in-V) transcatheter aortic valve implantation (TAVI). Results SAVR was performed in 1241 patients (median age, 73.5 ± 6.4 years; 54% male; median logistic EuroSCORE, 7.8) with concomitant procedures in 713 cases (57.5%). Intraprocedural mortality was 1.4%, and 30-day mortality was 6.0%. At hospital discharge, 68 patients (5.5%) had moderate PPM, and no patients had severe PPM. Adverse events included cardiac arrhythmias (44.7%, mostly atrial fibrillation), respiratory failure (22.9%), acute renal failure requiring temporary renal replacement therapy (12.9%), and low cardiac output syndrome (3.3%). Follow-up data were available over a total of 5469 patient-years (median duration of follow-up, 4.7 years). Freedom at 8 years from all-cause mortality, valve-related mortality, reoperation for SVD (redo SAVR or V-in-V TAVI), and endocarditis were 78.4%, 98.0%, 93.3%, and 96.5%, respectively. Of the 30 patients with SVD, 17 were treated by V-in-V TAVI and 13 underwent surgical explant. Conclusions Outcomes from this large single-center cohort at increased surgical risk demonstrate excellent long-term durability of the Trifecta valve for SAVR and feasibility of treating SVD by V-in-V TAVI.