Bioprosthetic Aortic Valve Research Articles

Abstract 4138717: Infective Root Aortitis: Medical Therapy Alone or Medical Therapy and Surgery?

Clinical presentation: A 75-year-old male with previous 3 vessel CABG and bioprosthetic aortic valve (BAV) surgical replacement in 2013 was admitted with severe sepsis from diabetic foot ulcer complicated with Group A Streptococcus bacteremia and infective root aortitis. Imaging Findings: Initial technically limited transthoracic echocardiogram was followed by a transesophageal echocardiogram (TEE) that demonstrated a well seated BAV with mildly thickened leaflets but no vegetations, mild intra-valvular regurgitation, and 9 mm end-diastolic soft tissue echoreflectant thickening of the posterior aortic root (AoR) extending up 3 cm from the aortic annulus to the ascending aorta (Fig 1A,B). There were no signs of perivalvular abscess formation. Initial FDG PET-CT demonstrated heterogenous hypermetabolic activity at the annulus of the BAV (Fig 1C) and AoR (Fig 1D) consistent with aortitis. Decision-making: In the absence of guidelines for the management of these patients, a multidisciplinary team including cardiology, cardiothoracic surgery, and infectious disease opted for a conservative medical therapy instead of high-risk surgery. Patient then underwent left foot first digit amputation to achieve infectious source control. Upon completion of 4 out of 6 weeks of intravenous ceftriaxone 2 grams daily, repeat TEE showed improved AoR thickening to 6 mm (Fig 1E,F), no AoR abscess, and unchanged BAV structure and function. Repeat FDG PET-CT at the same time of TEE demonstrated persistent but improved hypermetabolic activity of the BAV annulus and AoR. After 10 weeks of IV antibiotics, repeat FDG PET-CT showed further decrease in metabolic activity on both areas. However, an Indium-111 labeled leukocyte scan showed no activity at the BAV annulus and root (Fig 1G) and therefore indicated healed AoR aortitis, which was further supported by significant decrease of ESR and CRP initial values of 126 mm/hr and 122.7 mg/L to 11 mm/hr and 3 mg/L, respectively. Patient is currently clinically stable 8 months later. Conclusion: This case illustrates that a conservative management of infective AoR aortitis with an extended course of intravenous antibiotics is a reasonable alternative to high-risk re-do valve and root surgery.

Abstract 4120140: Catastrophic Bioprosthetic Aortic Valve Thrombosis: An Unappreciated Complication of Veno-Arterial Extracorporeal Membrane Oxygenation Support in Cardiogenic Shock

Description of Case: A 56-year-old male with a history of cardiac sarcoidosis with biventricular systolic heart failure (HF) and a bioprosthetic aortic valve presented with acute decompensated HF. Progressive cardiogenic shock and hemodynamic instability ensued, requiring urgent bedside placement of an intra-aortic balloon pump (IABP) which provided only marginal hemodynamic support. After extensive multidisciplinary discussion, emergent cannulation for veno-arterial ECMO (VA-ECMO) was performed at the bedside as a bridge-to-decision for advanced HF therapies. The IABP was left in place for LV venting. Within 72 hours, extensive bilateral pulmonary opacities had developed. It was later realized that true LV ejection (as evidenced by aortic pulsatility on the arterial line) was not present and had been masked by pseudo-pulsatility provided by IABP inflations and deflations. Compared to an echocardiogram done 7 days prior to VA-ECMO cannulation, the bioprosthetic leaflets were no longer opening, thrombosis of the AV had occurred, and thrombus formation along the ECMO venous drainage cannula was noted. Failure to achieve LV venting culminated in complete thrombosis of the entire LV and LA and the patient ultimately expired. Discussion: Bioprosthetic valve thrombosis is a lesser-known complication of VA-ECMO support, with most reports involving bioprosthetic valves in the mitral position. Indeed, bioprosthetic valve thrombosis occurs at a higher rate than native valve thrombosis during VA-ECMO support. However, bioprosthetic AV thrombosis is an extremely rare complication of VA-ECMO support and arguably results in a more catastrophic scenario as most traditional approaches to LV unloading are contraindicated. The optimal LV unloading strategy for these patients (IABP, Impella, surgical apical unloading, etc) is unknown. Data from large retrospective analyses have demonstrated extremely poor outcomes when prosthetic valve thrombosis occurs, and it is thus critical to prevent this complication from developing. In contrast to IABP counter-pulsation, the benefit of upfront transvalvular LV venting with an Impella device safeguards the presence of a direct LV vent in the event of bioprosthetic AV thrombosis and eliminates the false reassurance of IABP pseudo-pulsatility. Further studies are needed to better elucidate the optimal LV unloading strategy in patients with bioprosthetic valves, particularly in the aortic position.

Prosthetic Valve Fate in Patients With Continuous-Flow Left Ventricular Assist Devices.

Prosthetic valve-related morbidity and mortality in patients with left ventricular assist devices (LVADs) remain unclear. We retrospectively reviewed patients who received a HeartMate II or 3 LVAD at our center between April 2004 and December 2022. Patients with a valve prosthesis in any position were included. Of the 726 LVAD recipients, 74 (10.2%) underwent valve replacement before (n = 37, 50.0%), concomitantly with (n = 32, 43.2%), or after (n = 6, 8.1%) LVAD insertion. Prosthetic valves were implanted in the aortic (n = 32), mitral (n = 23), and tricuspid (n = 26) positions. Mechanical valves were present in eight (three aortic, five mitral) patients. At a median follow-up of 1.97 years post-VAD (interquartile range [IQR]: 0.56-4.58 years), there was one valve-related death due to severe aortic bioprosthetic insufficiency. Five of 28 (17.9%) patients with an aortic bioprosthesis had evidence of dysfunction on follow-up echocardiography. Median time to first sign of aortic bioprosthetic valve dysfunction was 1 (IQR: 0.6-5.1) year from time of LVAD with the prosthesis in place and 10.8 (IQR: 9.5-12.6) years from date of initial valve insertion. Prosthetic valve-related mortality or reinterventions are uncommon in patients with LVADs; however, bioprosthetic aortic valve dysfunction can develop less than 1 year after LVAD implantation.

Subaortic Pannus Causing Complete Outlet Obstruction After Bioprosthetic Aortic Valve Replacement in a Patient with Left Ventricular Assist Device: A Case Report

Abstract Background Subaortic pannus formation complicates bioprosthetic aortic valve(AV) replacement. We report an extreme case in a continuous-flow left-ventricular-assist-device(LVAD) patient. Case Summary A 49-year-old Caucasian female with dilated cardiomyopathy was bridged-to-transplant with a HeartWare ventricular-assist-device(HVAD). Duration of support was prolonged, 6-years and 7-months, due to allosensitisation requiring desensitisation. Pump thrombosis occurred 2-years and 4-months post-LVAD requiring alteplase thrombolysis. The patient underwent bioprosthetic AV replacement 3-years and 10-months post-LVAD for symptomatic aortic incompetence. Transthoracic echocardiography(TTE) performed 1-year and 2-years post-bioprosthetic AV replacement repeatedly demonstrated an AV closed during all cardiac cycles without incompetence and nil flow through the left-ventricular-outflow-tract(LVOT). Following transplant, analysis of explanted heart revealed a fused AV. A pannus adherent to the underside of the AV had formed across the entire AV outlet, with complete obliteration of LVOT. This subaortic pannus was not visualised on previous TTE. Histologically, the pannus consisted of hypocellular fibrous tissue with chronic inflammatory cells, spindle histiocytes and myofibroblasts scattered throughout the loose fibromyxoid stroma, the latter highlighted on CD68 immunohistochemical stain(IHC). Partial endothelialisation on the pannus surface was highlighted on ERG & CD31 IHC. Neither calcification, nor signs of acute inflammation were noted. In contrast to previous cases, there was no evidence of associated thrombus macroscopically or microscopically. Discussion Prolonged LVAD support may facilitate subaortic pannus following bioprosthetic AV replacement due to AV closure and altered transvalvular flow. Due to the parallel LVAD circulation, subaortic pannus may develop asymptomatically, without haemodynamic compromise, allowing progression to total LVOT obstruction. This requires consideration prior to LVAD explantation in bridge-to-recovery patients.

Core laboratory versus center-reported echocardiographic assessment of the native and bioprosthetic aortic valve

Abstract Background The use of a central echocardiographic core laboratory (ECL) is advised to minimize measurement variation and heterogeneity in clinical trials. Insights into quantitative differences between ECL and center-reported echocardiographic assessment of the native and bioprosthetic aortic valve are lacking. We aimed to explore clinically relevant differences between these evaluations. Methods Data were used from the PERIcardial SurGical AOrtic Valve ReplacemeNt (PERIGON) Pivotal Trial for the Avalus valve. In this trial, patients with an indication for surgical aortic valve replacement (SAVR) due to aortic stenosis or regurgitation (AR) were enrolled. Serial echocardiographic examinations were performed at each center and reanalyzed by an independent ECL. For the bioprosthetic valve analysis, postoperative data throughout 5-year follow-up were pooled. Differences between the ECL and the centers in continuous parameters were quantified in mean differences and intraclass correlation coefficients (ICCs). Between-center differences were illustrated by plotting standardized mean differences (SMDs) between centers and the ECL for the 10 sites that implanted the most prostheses. Agreement on AR, paravalvular leak (PVL), and prosthesis-patient mismatch (PPM) classification was investigated using Cohen’s kappa coefficients. Results The analysis on the native aortic valve was performed on 1118 patients. The relative mean difference was largest for the left ventricular outflow tract (LVOT) area, followed by stroke volume and effective orifice area (index), with center-reported values being 11-7% higher (Table 1). High ICCs of around 0.90 were observed for peak aortic jet velocity, mean pressure gradient, and the velocity-time integral across the aortic valve. More than 5000 echocardiograms were available for the bioprosthetic valve analysis. Therein, comparable results were observed. In Figure 1, differences in assessment on center level are illustrated. The SMDs for peak velocity were between 0 and 0.5 for all centers, while there was more heterogeneity between centers for other parameters. The kappa coefficient was 0.59 (95% confidence interval [CI] 0.56, 0.63) for agreement on native AR, 0.28 (95% CI 0.18, 0.37) for PVL, and 0.42 (95% CI 0.40, 0.44) for PPM. Conclusions For echocardiographic assessment of the native and bioprosthetic aortic valve, agreement between the ECL and the clinical centers varies by parameter and by center. There is high agreement on continuous-wave Doppler-related measurements. On the contrary, agreement is low for parameters that involve measurement of the LVOT diameter. These results provide important context for the interpretation of aortic valve performance in studies that lack central ECL evaluation.

A sex-specific comparison of valve-in-valve transcatheter aortic valve implantation

Abstract Introduction Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable and less-invasive alternative to open heart surgery in selected patients with bioprosthetic valve dysfunction. Since patients receiving initially a new bioprosthetic aortic valve are predominantly male, data on a sex-specific comparison of ViV-TAVI is scarce. Thus, we compared patient characteristics, procedural outcomes, and 1-year outcomes of female (F) versus male (M) patients with failing bioprosthetic aortic valves undergoing ViV-TAVI. Methods A total of 375 Patients at 3 German centres were included in this analysis. The 1-year mortality was the primary outcome measure, secondary outcomes included VARC-3 defined technical and device success and early safety. Results Overall, 160 (42.6 %) women and 215 (57.4 %) men were included. Women were older (F 81 (77; 84), p < 0.001), had a greater surgical risk (STS PROM F: 9.1 (6.1; 13,9) %, p < 0.001) and a higher rate of previous coronary bypass surgery (F: 25.6 % vs M: 40 %, p = 0.004), while presenting mostly failed valve sizes < 20 mm (F: 59.4 % vs M: 33.4 %, p < 0.001) and therefore higher gradients (F: 40 (31; 50) mmHg vs M: 32 (25; 42) mmHg, p < 0.001). Aortic regurgitation was the mode of failure in 7.5 % of F vs. 14.4 % of M. The number of stentless valves was higher in men (F: 8,1 % vs M: 14 %, p = 0.08). Patients received a self-expanding TAVI prostheses in 79.4 % and 75.8 % respectively in F and M patients. The rates of technical success (F: 75.6 % vs M: 83.3 %, p =0.06), device success (F: 52.5 % vs M: 58.2 %, p = 0.27) and early safety (F: 67.5 % vs M: 67 %, p = 0.91) were comparable between genders. Residual mean gradients were higher in F (F: 15 (11;22) mmHg vs M: 15 (10; 20) mmHg, p = 0.03), while the rates of residual regurgitations were greater in M patients (F: 1 (0.6 %) vs M: 11 (5.1 %), p = 0.04). The Kaplan-Meier estimated 30-day mortality rate (F: 2.5% vs M: 3.3%, p = 0.66) and 1-year mortality rates (F: 10 % vs M: 92.6 %, p = 0.37) were comparable between genders. Conclusion: F and M patients treated by ViV-TAVI have comparable short-term outcomes according to VARC-3-defined endpoints and similar mortality rates after 30 days and 1 year. The residual gradients in F and residual regurgitations in M could be explained by structural features of their failed valves. Further large scale studies are needed to determine, if such procedural outcomes are truly sex-specific.

Major bleeding complications and antithrombotic treatment after isolated surgical bioprosthetic aortic valve replacement

Abstract Background Despite advancements in surgical techniques and perioperative care, post-operative bleeds and stroke remain significant concerns after bioprosthetic surgical aortic valve replacement (SAVR). Purpose We assessed the incidence of short-term (30d) and long-term major bleeds and strokes and their relations to antithrombotic treatment after isolated bioprosthetic SAVR. Methods The CAREAVR study included 721 patients who underwent isolated SAVR at four Finnish university hospitals between 2002 and 2014. The day-to-day information on short-term antithrombotic treatment was available from a subgroup including 227 patients, of whom 138 (60.7%) had preoperative aspirin. Preoperative aspirin was usually discontinued the day before the index surgery. Enoxaparin 1mg/kg twice daily and vitamin K antagonist (VKA) were routinely initiated on the first postoperative day, and enoxaparin continued until the INR remained at a therapeutic level ≥ 2.0 for two days. The routine duration of VKA treatment after surgery was 3 months. Results The median follow-up time was 4.9 (interquartile range 3.0–7.0) years. During the short-term 30-day period, 31 (4.3%) patients had a major bleed, and 13 (1.8%) patients experienced a major stroke. A vast majority of the bleeding (80.6%) occurred within two days after the surgery, and the tail effect of preoperative aspirin (5-7d) was present in 51.6% of episodes, indicating unintentional triple antithrombotic therapy. During the long-term follow-up (>30d after the index surgery), 40 (5.5%) major bleeding episodes occurred, and 47 (6.5%) patients experienced a major stroke. Overall, 23 (57.5%) of the patients with major bleeding were on OAC during the event. In addition, 13 (27.7%) of the patients experiencing major stroke during the long-term follow-up were on OAC during the event. Conclusions Compared to major strokes, the incidence of perioperative major bleeds was over twofold, the majority occurring during the tail effect of preoperative aspirin. During the long-term follow-up, the risks of stroke and bleeding were equal, and the majority of bleeding episodes appeared during anticoagulation treatment.

Bioprosthetic versus mechanical prostheses in patients aged 50 to 70 years undergoing aortic valve replacement surgery: outcomes analysis from propensity score matching

Abstract Introduction Despite increasing use of bioprosthetic surgical aortic valve replacement (bAVR) in patients ≤70 years [1, 2], the relative benefits compared to mechanical valve replacement (mAVR) remain uncertain [3, 4]. Purpose The current study aims to compare mortality and other important clinical endpoints by prosthesis type for patients aged 50-70 years who received an AVR in a well-characterised Australian cohort. Methods A retrospective cohort study was designed utilising the WAVES Patient Registry and incorporating linked administrative outcome data including all patients who had an AVR in Western Australian public hospitals between 2010-2020. The primary endpoint was all-cause mortality. Secondary endpoints included cardiovascular (CV) mortality, separately and combined with non-fatal myocardial infarction and non-fatal stroke (MACE), major bleeding, and days alive and out of hospital (DAOH). Outcomes were compared based on a propensity-matched analysis (including demographics, biometrics, and clinical characteristics). Results Within the initial cohort of 727 patients undergoing surgical AVR (mean age = 63 ± SD 6), a propensity-matched cohort identified 151 patients each with bAVR (mean age = 61 ± 4) and mAVR (mean age = 60 ± 5). Patients who received mAVR versus bAVR had improved all-cause survival (Hazard Ratio [HR] 0.50; 95% CI 0.25-0.99) but increased risk of major bleeding (HR 4.85; 95% CI 1.57-14.98). There were no significant differences in CV mortality (HR 0.58; 95% CI 0.19-1.74), MACE (HR 0.59; 95 % CI 0.32-1.07), or DAOH by prosthesis type (P = 0.452). Conclusions Patients aged 50-70 years who underwent mAVR had lower risk of all-cause mortality compared with bAVR, despite higher bleeding risk. Although risks of CV mortality and MACE were lower in mAVR, statistical significance was not reached, likely due to the small sample size. Larger studies are necessary to confirm these findings, which have important clinical implications.

Transcatheter aortic valve implantation in failed bioprosthetic or native valves: a systematic review and meta analysis

Abstract Background and purpose Currently, there is no comparative assessment of pooled clinical outcomes between valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) for either failed transcatheter or surgical bioprosthetic aortic valves (TAV or SAV) and native aortic valve TAVI (NV-TAVI) for aortic stenosis. Thus, this systematic review investigated the clinical outcomes of ViV-TAVI compared with NV-TAVI. Methods A meta-analysis was conducted according to Cochrane Handbook and the PRISMA statement. A systematic literature search was performed, using EMBASE and MEDLINE from inspection to December 25, 2023, to explore the comparative outcomes between ViV-TAVI and NV-TAVI. RStudio software was used to calculate pooled odds ratio (OR) with 95% confidence intervals (CI). Random-effects model was used to allow a more conservative assessment. Results Eighteen cohort studies (n=65,350) met eligibility criteria. Studies were categorized into 2 groups according to initially implanted bioprosthetic valve: TAV-in-TAV (5 studies, n=14490) and TAV-in-SAV implantation (13 studies, n=50860). Each ViV-TAVI group was compared with NV-TAVI. TAV-in-TAV implantation: There were no significant differences in all-cause mortality or stroke rates at ≥ 12 months between groups. The follow-up period was 12 months in all studies except in one (i.e., 24 months). Sensitivity analyses, by removing that study, did not show difference for both outcomes [(OR=1.25, 95%CI: 0.72-2.18) and (OR=1.14, 95%CI: 0.59-2.20), respectively]. TAV-in-TAV implantation was associated with higher rates of permanent pacemaker (PPM) insertion (OR=1.78, 95%CI: 1.10-2.88) within 30-day of follow-up. PPM insertion rate remained higher by 34% (OR=1.34, 95%CI: 1.02-1.76) even after removing the study that reported PPM insertion during index admission. Early conversion to open heart surgery and coronary occlusion (OR=3.75, 95%CI: 0.99-1417) did not differ between groups. TAV-in-SAV implantation: TAV-in-SAV implantation did not significantly reduce the risk of all-cause mortality, but stroke risk was reduced by 19% at ≥ 12 months follow-up. Sensitivity analyses by removing the studies with 24 months follow-up yielded comparable results [(OR=0.88, 95%CI: 0.64-1.21) and (OR=0.81, 95%CI: 0.70-0.94), respectively]. TAV-in-SAV implantation was associated with lower rates of PPM insertion compared with NV-TAVI (OR=0.33, 95%CI: 0.17-0.62) within 30-day of follow-up. The risk remained significantly lower by 69% (OR=0.31, 95%CI: 0.10-0.92) upon removing the studies that reported PPM insertion during the index admission. Early conversion to open heart surgery and coronary occlusion (OR=1.88, 95%CI: 0.82-4.32) did not differ between groups. Conclusion In comparison with NV-TAVI, TAV-in-TAV implantation was associated with higher PPM insertion rates, whereas, TAV-in-SAV implantation was associated with lower stroke and PPM insertion rates without an impact on mortality.

Adaptation of Aortic Bioprosthetic Valves for Pulmonary Position: Comparative Analysis of Transcatheter and Surgical Valves.

Pulmonary valve dysfunction is common in congenital heart disease, often leading to interventions like right ventricular outflow tract reconstruction. Transcatheter pulmonary valve replacement (TPVR) has emerged as a successful alternative to surgery, showcasing promising outcomes for managing postoperative RVOT complications. The study aimed to compare two bioprosthetic valves-Carpentier Edwards Perimount Magna Ease surgical valve and Edwards SAPIEN 3 transcatheter valve-originally designed for aortic use but adapted for pulmonary applications. The hemodynamic characteristics of a 26-mm SAPIEN 3 and a 25-mm Magna Ease were assessed in a pulse duplicator under both pulmonary and aortic conditions. Furthermore, detailed structural analyses of the leaflets were conducted using computational simulations under these conditions. The results highlighted significant differences in the hydrodynamic and structural characteristics of these two bioprosthetic valves when exposed to pulmonary versus aortic conditions. The study enhances our understanding of the biomechanics involved in surgical and transcatheter pulmonary valve replacement.

Evaluation of Anti-k Antibody in a Patient Undergoing Redo Sternotomy

Abstract Introduction/Objective Introduction: The Kell blood group system, discovered in 1946, holds paramount significance in transfusion medicine and hemolytic disease of the newborn (HDN). Named after Mrs. Kelleher, who exhibited anti-Kell antibodies resulting in HDN, this system comprises 25 antigens, with the original K antigen retaining primary importance. Additionally, Levine et al. identified anti-Cellano, now known as anti-k, presenting an antibody antithetical to anti-K. Methods/Case Report Case Presentation: A 60-year-old male with a history of bioprosthetic aortic valve insufficiency, pulmonary homograft stenosis, and recurrent aortic insufficiency presents for a fourth redo sternotomy for root and ascending aorta replacement. Preoperative assessment revealed a positive antibody screen for anti-k, a clinically significant antibody associated with decreased survival of transfused red blood cells (RBCs). Given limited compatible blood units available, efforts are underway to secure additional donations before the scheduled surgery on 2/22/24. The patient’s medical history indicates no recent blood transfusions or iron therapy, with the last transfusion in 1996. He is anticoagulated with warfarin for mechanical valve and atrial fibrillation, necessitating preoperative bridging with Lovenox injections. Methods The patient’s antibody screen and initial panel demonstrated pan-reactivity with 3+ reactivity, suggesting an antibody targeting a high-frequency antigen. Further testing using polyethylene glycol (PEG) confirmed the presence of anti-k, supported by negative reactions to additional K-negative cells. The absence of other clinically significant antibodies was verified using 0.2 M Dithiothreitol (DTT) modified cells. Results (if a Case Study enter NA) NA Conclusion Conclusion: The identification of anti-k antibody underscores the critical role of preoperative antibody screening in mitigating transfusion-related complications, particularly in patients requiring complex surgical interventions. Collaborative efforts between clinical teams and transfusion medicine specialists are imperative to ensure adequate blood product availability and optimize patient outcomes.To prevent further exposure, it is recommended that patients with rare antibodies carry an Antibody ID card indicating the rare antibody they possess.k antigen blood donors are underrepresented in the general donor pool. It is recommended to develop a systematic recruitment for k antigen donors.

Lipoprotein (a) as a Cardiovascular Risk Factor in Controversial Clinical Scenarios: A Narrative Review.

Lipoprotein (a) is a complex lipid molecule that has sparked immense interest in recent years, after studies demonstrated its significant association with several cardiovascular conditions. Lp(a) promotes cardiovascular disease through its combined proatherogenic, pro-inflammatory, and prothrombotic effects. While the measurement of Lp(a) has become widely available, effective methods to reduce its concentration are currently limited. However, emerging data from ongoing clinical trials involving antisense oligonucleotides have indicated promising outcomes in effectively reducing Lp(a) concentrations. This may serve as a potential therapeutic target in the management and prevention of myocardial infarction, calcific aortic stenosis, and cerebrovascular accidents. In contrast, the role of Lp(a) in atrial fibrillation, in-stent restenosis, cardiac allograft vasculopathy, and bioprosthetic aortic valve degeneration remains unclear. This review article aims to thoroughly review the existing literature and provide an updated overview of the evidence surrounding the association of Lp(a) and these cardiovascular diseases. We seek to highlight controversies in the existing literature and offer directions for future investigations to better understand Lp(a)'s precise role in these conditions, while providing a summary of its unique molecular characteristics.

Prospective study on the impact of different antithrombotic therapies on subclinical leaflet thickening and its temporal dynamics in transcatheter aortic valves—The NOTION-4 trial

Transcatheter aortic valve replacement (TAVR) has become the standard-of-care treatment for a majority of patients with severe, symptomatic aortic stenosis. The post-procedural anti-thrombotic therapeutic management is still a topic of debate and could affect the incidence of HALT, a phenomenon which can be assessed by four-dimensional computed tomography (4DCT). The NOTION-4 trial is a randomized controlled trial comprising TAVR patients with no indication for oral anticoagulant (OAC) therapy, comparing lifelong single anti-platelet therapy (standard arm) versus early 3-month direct oral anticoagulant (DOAC) therapy followed by single anti-plateletet therapy (experimental arm). The incidence of HALT and clinical endpoints will be evaluated in both groups at 3 months, 1 year and 5 years after randomization. The primary endpoint is the number of patients with at least one bioprosthetic aortic valve leaflet with HALT as assessed by cardiac 4DCT imaging at 1 year. The trial is powered for superiority testing and started enrollment in 2021. In total, 324 patients will be included. The last patient is expected to be enrolled by the end of 2024 and the primary endpoint is to be presented in 2026. The NOTION-4 trial aims to study whether an early 3-month DOAC therapy after TAVR can result in a sustained lower incidence of HALT in transcatheter aortic valves. This trial holds the potential to give valuable insights into whether early OAC therapy should be integrated in future guidelines for post-TAVR anti-thrombotic therapeutic management. NOTION-4, ClinicalTrials.gov ID NCT06449469, https://clinicaltrials.gov/study/NCT06449469.

TCT-870 Prediction Models for the Treatment of Bioprosthetic Aortic Valve Failure in the United States

TCT-870 Prediction Models for the Treatment of Bioprosthetic Aortic Valve Failure in the United States

Stroke Prevention With Prophylactic Left Atrial Appendage Occlusion in Cardiac Surgery Patients Without Atrial Fibrillation: A Meta-Analysis of Randomized and Propensity-Score Studies.

The role of left atrial appendage occlusion (LAAO) in patients without previous atrial fibrillation (AF) is not established. This meta-analysis was conducted on patients with normal sinus rhythm who underwent cardiac surgery, with and without concomitant LAAO, to evaluate its effect on the incidence of cerebrovascular accidents (CVAs). A systematic review was conducted from inception until December 2023 for randomized and propensity-score studies comparing CVA in patients without AF undergoing cardiac surgery with or without LAAO. Six studies met our inclusion criteria with a total of 4130 patients: 2146 in the LAAO group and 1984 in the no-LAAO group. The risk ratio of postoperative AF was 1.05 (95% CI, 0.86-1.28); P=0.628. The CVA rates at 5 years were 6.8±1.0% in the no-LAAO group and 4.3±0.8% in the LAAO group (log-rank P=0.021). The Cox regression analysis for CVA in patients undergoing LAAO reported a hazard ratio of 0.65 (95% CI, 0.45-0.94); P=0.022. Landmark analysis at 4 years highlighted a significant difference in overall survival between no-LAAO and LAAO groups, 86±12.2% versus 89.6±11.0%; P=0.041. In this meta-analysis of patients without previous AF undergoing cardiac surgery, LAAO was associated with a decreased risk of CVA, no difference in the incidence of postoperative atrial fibrillation, and a significant overall survival benefit at a 4-year landmark analysis. Although these findings support LAAO, the randomized LeAAPS trial (Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial), LAA-CLOSURE trial (A Randomized Prospective Multicenter Trial for Stroke Prevention by Prophylactic Surgical Closure of the Left Atrial Appendage in Patients Undergoing Bioprosthetic Aortic Valve Surgery), and LAACS-2 trial (Left Atrial Appendage Closure by Surgery-2) will help define the effectiveness of LAAO in patients undergoing cardiac surgery who have risk factors for AF and CVA. URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42024496366.

TCT-760 Valve in Valve Transcatheter Versus Redo Surgical Replacement of a Failing Bioprosthetic Aortic Valve: An Updated Meta-Analysis of Echocardiographic and Long-Term Outcomes

TCT-760 Valve in Valve Transcatheter Versus Redo Surgical Replacement of a Failing Bioprosthetic Aortic Valve: An Updated Meta-Analysis of Echocardiographic and Long-Term Outcomes

TCT-910 Valve-in-Valve Transcatheter Versus Redo Surgical Replacement of a Failing Bioprosthetic Aortic Valve: An Updated Systematic Review and Meta-Analysis

TCT-910 Valve-in-Valve Transcatheter Versus Redo Surgical Replacement of a Failing Bioprosthetic Aortic Valve: An Updated Systematic Review and Meta-Analysis

Redo surgical aortic valve replacement for bioprosthetic structural valve deterioration.

To compare isolated primary bioprosthetic surgical aortic valve replacement (SAVR) with isolated redo surgical aortic valve replacement (rSAVR) due to structural valve deterioration (SVD). Clinical data of consecutive patients who underwent primary isolated SAVR and isolated rSAVR due to SVD between January 1, 2011, and December 31, 2022, at Leipzig Heart Center were retrospectively compared with regard to the primary outcome of all-cause mortality or stroke during hospitalization. Secondary outcomes of interest included myocardial infarction, re-exploration for bleeding, and permanent pacemaker implantation. A total of 2620 patients, 39.5% females, with a median EuroSCORE II of 1.7 (interquartile Range [IQR] 1.1; 2.7] were identified, of which rSAVR was performed in 174 patients (6.6%). Patients undergoing primary SAVR were older (69 versus 67 years of age, p = 0.001) and were less likely to have a history of prior stroke (0.9% versus 4.0%, p = 0.003). Although both all-cause death and death or stroke occurred less often following primary SAVR (0.5% versus 5.8%, and 2.2% versus 6.9%, respectively; p < 0.001), prior surgery was not associated with adverse clinical outcome in multivariable analysis. In a matched comparison of 322 patients, rates of death or stroke did not differ between groups (4.8% for both rSAVR and SAVR, p = 1.0). Although redo surgery for SVD is associated with increased rates of early mortality and stroke by univariate analysis, much of this increased risk can be accounted for by comorbidities. Patients undergoing rSAVR on an elective basis can expect an outcome similar to that of primary SAVR.

Trends and Outcomes of Aortic Root Enlargement During Bioprosthetic Aortic Valve Replacement

BackgroundAortic root enlargement (ARE) during aortic valve replacement (AVR) mitigates prosthesis-patient mismatch, but its use has been low. Transcatheter aortic valve-in-valve (VIV) as a treatment for failing bioprosthetic valves is limited by small surgical valves, renewing interest in ARE during the index AVR. This study demonstrates trends and outcomes of ARE after commercial approval of VIV in 2015. MethodsThis retrospective cohort study analyzed 2182 patients undergoing nonemergent AVR between August 2007 and December 2022. Endocarditis, aortic dissection, and concomitant root replacement or ventricular assist device placement were excluded. Trends in ARE use, valve size, and types were compared. Outcome measures included 30-day mortality and gradients and were compared between patients with and without ARE. ResultsOverall, 74 patients (3.4%) underwent ARE, 14 (1.0%) before 2015 and 60 (7.6%, P < .0001) after 2015. Use of smaller valves (19-21 mm) decreased from 372 (26.8%) before 2015 to 85 (10.7%, P < .0001) after 2015. ARE group was younger than the AVR-alone group (64 vs 68 years, P = .001) but had similar predicted risk of mortality (median, 1.7%). Both groups had comparable postoperative mean gradients (ARE: 11 vs AVR-alone: 10 mm Hg, P = .42). ARE had higher 30-day mortality (5 [7%] vs 48 [2%], P = .014); however, no difference was found in elective patients (2 of 65 [3%] vs 39 of 1898 [2%], P = .57). ConclusionsARE use has increased since commercial approval of VIV. The addition of ARE to AVR did not affect early safety in elective cases, and postoperative gradients were similar to those in patients not requiring ARE. Further studies are required to determine long-term outcomes after ARE, including VIV candidacy.

Correlations between intraoperative and postoperative echocardiographic measurements in patients undergoing aortic bioprosthetic valve replacement: a prospective observational study.

Patient-prosthesis mismatch (PPM) should be avoided during surgical aortic valve replacement because PPM would worsen the mortality and morbidity. Diagnosis of PPM could be made using various parameters measured by intraoperative transesophageal echocardiography. However, few studies have examined which parameters correlate most accurately between intraoperative and postoperative values. This single-center prospective observational study analyzed 46 patients who underwent surgical aortic valve replacement (SAVR). Echocardiography was performed at the following 3-time points: preoperatively, intraoperatively, and 1month postoperatively. The correlation between intraoperative and postoperative measurement values, including peak velocity (PV), mean pressure gradient (MPG), effective orifice area (EOA), and effective orifice area index (EOAI), were assessed using Pearson's correlation coefficient. Moreover, to evaluate whether a multivariable linear regression model with intraoperative and postoperative stroke volume added as an explanatory variable improves the correlation, the multiple correlation coefficients were calculated. PV, MPG, EOA, and EOAI measured intraoperatively and 1month postoperatively were significantly correlated. The r values of each measurement were 0.35, 0.344, 0.411 and 0.323, respectively. The multivariable linear regression model showed that the multiple correlation coefficients for MG and EOA were 0.491 and 0.663, respectively. Intraoperative and postoperative PV, MPG, EOA, and EOAI were significantly correlated in patients undergoing SAVR with a bioprosthetic valve. The r value for EOA was 0.441, the largest among the measured values. Adjustment for stroke volume improved the strength of the correlation. Intraoperative evaluation of prosthetic valve function was considered most appropriate using EOA. University Hospital Medical Information Network Clinical Trials Registry, registration number UMIN000046164, https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052695 .