Bioprosthetic Valve Replacement Research Articles

Recellularized bovine pericardium with autologous mesenchymal stem cells reduces immune activation.

Current bioprosthetic heart valve replacement options are limited by structural valvular deterioration (SVD) due to an immune response to the xenogenic scaffold. Autologous mesenchymal stem cell (MSC) recellularization is a method of concealing xenogenic scaffolds, preventing recipient immune recognition of xenogenic tissue heart valves, and potentially leading to reduction in SVD incidence. The purpose of this study is to examine the effects of autologous MSC recellularized tissue on the immune response of human whole blood to bovine pericardium (BP). We hypothesized that autologous MSC recellularization of BP will result in reduced pro-inflammatory cytokine production equivalent to autologous human pericardium. Bone marrow, human pericardium, and whole blood were collected from adult patients undergoing elective cardiac surgery. Decellularized BP underwent recellularization with autologous MSCs, followed by co-incubation with autologous whole blood. Immunohistochemical, microscopic, and quantitative immune analysis approaches were used. We demonstrated that native BP, exposed to human whole blood, results in significant TNF-α and IL1β production. When decellularized BP is recellularized with autologous MSCs and exposed to whole blood, there is a significant reduction in TNF-α and IL1β production. Importantly, recellularized BP exposed to whole blood had similar production of TNF-α and IL1β when compared to autologous human pericardium exposed to human whole blood. Our results suggest that preventing initial immune activation with autologous MSC recellularization may be an effective approach to decrease the recipient immune response, preventing recipient immune recognition of xenogeneic tissue engineered heart valves, and potentially leading to reduction in SVD incidence.

Feasibility of Low-Seated Composite Aortic Conduit for Surgical Treatment of Prosthetic Valve Endocarditis: A Case Report

Background: A 49-year-old male presented with a delayed diagnosis of infective endocarditis leading to extensive intracardiac destruction. Such cases present technical challenges to operative debridement as crucial anchoring points for replacement conduits are compromised. Case Presentation: Our patient presented at age 49 with nausea, lethargy, and diarrhea 2 weeks after recent travel. His prior history included bioprosthetic valve replacement for a bicuspid aortic valve. The patient was first given a trial of antimicrobials for a suspected UTI. Subsequently, he was admitted briefly to an outside hospital for a “cardiac work-up,” which returned negative. The patient sought care for the third time, during which he developed unstable supraventricular tachycardia, prompting echocardiography 16 days following the onset of symptoms. Echocardiography demonstrated a 6 cm abscess cavity invading the interventricular septum with a fistula into the left ventricular outflow tract, multiple ventricular septal defects (VSD), and suspected fistulae into the right ventricular outflow tract. The patient was treated with valve explant and extensive debridement. A valved-conduit for the aorta could not be sewn to the aortic annulus in the usual fashion due to destruction and debridement of the annulus, so a neo-annulus was created using the anterior leaflet of the mitral valve and the left ventricular outflow tract of the heart below the level of the VSDs. A mechanical-valved conduit was implanted onto the neo-annulus. A pacemaker was subsequently implanted. Conclusion: In patients with extensive intracardiac destruction with the compromise of the aortic annulus due to infective endocarditis, a low-seated, mechanical-valved conduit implanted directly to the aorto-mitral curtain and left ventricular outflow tract should be considered a novel, durable reconstructive option that allows complete debridement of infected tissues.

Safety and efficacy of non-vitamin K antagonist oral anticoagulants in adults with bioprosthetic pulmonary valve replacement for prevention of thromboembolic events: Mid-term results from the Note registry

We aimed to evaluate the safety and efficacy of non-vitamin K antagonist oral anticoagulants (NOACs) in adults with congenital heart disease (CHD) who underwent a pulmonary valve replacement (PVR). This is an international, multicenter, prospective study using data from the NOTE registry. All adults with a history of PVR taking NOACs constituted our study population. Follow-up took place at 6 months and yearly thereafter. The primary endpoint were thromboembolic (TE) events and major bleeding (MB). The secondary endpoint was minor bleeding. From January 2013 to June 2021, 29 patients (median age 52 years, interquartile range [43–58], 58% male) with a history of PVR (59% moderately and 31% severely complex CHD) on NOACs were included in the NOTE registry and constituted our study population. Atrial arrhythmia was the exclusive indication for anticoagulant therapy. During a median follow-up of 2 years (IQR 0.8–3.2), no patient experienced TE event. One MB (3.5%) which led to death and 6 minor bleedings (20.7%) occurred on NOACs alone ( Fig. 1 ). The annual incidence rate was 1.6% (95% CI 0.04 to 9.2%) for MB and 8.4% (96% CI 2.7 to 19.6%) for minor bleeding. The overall survival free from TE and MB was 100% and 87.5% respectively at 2.5 years of follow-up. Three invasive cardiac procedures, including 2 percutaneous PVR, were safely performed during the follow-up. On univariate analysis, increase in BLED score (HR 3.5; 95% CI 1.2–10.2, P = 0.02) and female gender (HR (male) 0.08; 95% CI 0.01–0.7; P = 0.02) were predictive factors of bleeding. This prospective study demonstrated excellent efficacy of NOACs at mid-term in patients with CHD and PVR, but suggested an increased risk of bleeding, particularly in women and patients with high BLED score.

Direct Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation and Valve Replacement or Repair.

BackgroundWe sought to examine outcomes of direct oral anticoagulants (DOACs) versus warfarin in atrial fibrillation with valve repair/replacement.Methods and ResultsTwo atrial fibrillation cohorts from Medicare were identified from 2015 to 2019. They comprised patients who underwent surgical or transcatheter mitral valve repair (MV repair cohort) and surgical aortic or mitral bioprosthetic or transcatheter aortic valve replacement (bioprosthetic cohort). Each cohort was divided into warfarin and DOACs (apixaban, rivaroxaban, and dabigatran) groups. Study outcomes included mortality, stroke, and major bleeding. Inverse probability weighting was used for adjustment between the 2 groups in each cohort. The MV repair cohort included 1178 patients. After a median of 468 days, DOACs were associated with lower risk of mortality (hazard ratio [HR], 0.67 [95% CI, 0.55–0.82], P<0.001), ischemic stroke (HR, 0.72 [95% CI, 0.52–1.00], P=0.05) and bleeding (HR, 0.79 [95% CI, 0.63–0.99], P=0.04) compared with warfarin. The bioprosthetic cohort included 8089 patients. After a median follow‐up of 413 days, DOACs were associated with similar risk of mortality (adjusted HR, 0.93 [95% CI, 0.86–1.01], P=0.08), higher risk of ischemic stroke (adjusted HR, 1.27 [95% CI, 1.13–1.43], P<0.001), and lower risk of bleeding (adjusted HR, 0.86 [95% CI, 0.80–0.93], P<0.001) compared with warfarin.ConclusionsIn patients with atrial fibrillation, DOACs are associated with similar mortality, lower bleeding, but higher stroke with bioprosthetic valve replacement and lower risk of all 3 outcomes with MV repair compared with warfarin.

Acute mitral valve regurgitation secondary to papillary muscle rupture due to infective endocarditis

BackgroundPapillary muscle rupture due to infective endocarditis is a rare event and proper management of this condition has not been described in the literature. Our case aims to shed light on treatment strategies for these patients using the current guidelines.Case presentationThis case presents a 58-year-old male with acute heart failure secondary to papillary muscle rupture. He underwent an en bloc resection of his mitral valve with a bioprosthetic valve replacement. Specimen pathology later showed necrotic papillary muscle due to infective endocarditis. The patient was further treated with antibiotic therapy. He recovered well post-operatively and continued to do well after discharge.ConclusionIn patients who present with papillary muscle rupture secondary to infective endocarditis, clinical symptoms should drive the treatment strategy. Despite the etiology, early mitral valve surgery remains treatment of choice for patients who have papillary muscle rupture leading to acute heart failure. Culture-guided prolonged antibiotic treatment is vital in this category of patients, especially those who have a prosthetic valve implanted.

Readmission After Bioprosthetic vs Mechanical Mitral Valve Replacement in the United States

BackgroundChoosing between a bioprosthetic and a mechanical mitral valve is an important decision for both patients and surgeons. We compared patient outcomes and readmission rates after bioprosthetic mitral valve replacement (Bio-MVR) vs mechanical mitral valve replacement (Mech-MVR). MethodsThe Nationwide Readmissions Database was queried to identify 31 474 patients who underwent isolated MVR (22 998 Bio-MVR, 8476 Mech-MVR) between January 1, 2016, and December 31, 2018. Propensity score matching by age, sex, elective status, and comorbidities was used to compare outcomes between matched cohorts by prosthesis type. Freedom from readmission within the first calendar year was estimated by Kaplan-Meier analysis and compared between matched cohorts. ResultsBio-MVR patients were older (median age, 69 vs 57 years; P < .001) and had more comorbidities (median Elixhauser score, 14 vs 11; P < .001) compared with Mech-MVR patients. After propensity score matching (n = 15 549), Bio-MVR patients had similar operative mortality (3.5% vs 3.4%; P = .97) and costs ($50 958 vs $49 782; P = .16) but shorter lengths of stay (8 vs 9 days; P < .001) and fewer 30-day (16.0% vs 18.1%; P = .04) and 90-day (23.8% vs 26.8%; P = .01) readmissions compared with Mech-MVR patients. The difference in readmissions persisted at 1 year (P = .045). Readmission for bleeding or coagulopathy complications was less common with Bio-MVR (5.7% vs 10.1%; P < .001). ConclusionsReadmission was more common after Mech-MVR than after Bio-MVR. Identifying and closely observing patients at high risk for bleeding complications may bridge the readmissions gap between Bio-MVR and Mech-MVR.

Mechanical or biologic prostheses for mitral valve replacement: A systematic review and meta-analysis.

Either a mechanical or bioprosthetic valve is used in patients undergoing mitral valve replacement (MVR). However, the optimal mitral prosthesis remains controversial. The aim of this meta‐analysis was thus to compare outcomes between mechanical mitral valve replacement (MVRm) and bioprosthetic mitral valve replacement (MVRb) for MVR patients. We searched Embase, PubMed, Web of Science, and Cochrane Library databases from January 1, 2000 to October 31, 2021 for studies that directly compared surgical outcomes of MVRm and MVRb. A total of 22 studies with 35 903 patients were included in the meta‐analysis (n = 23 868 MVRm and n = 12 035 MVRb). The MVRm group displayed lower long‐term all causes mortality (HR, 0.84; 95% confidence interval [CI]: 0.77−0.91; p < .0001; I² = 51%), and fewer mitral reoperation (hazard ratio [HR]: 0.34; 95% CI: 0.23−0.50; p < .00001; I² = 74%) than MVRb group. However, the MVRm group was associated with a greater risk of major bleeding events (HR: 1.21; 95% CI: 1.14−1.29; p < .00001; I² = 0%), stroke and systemic embolism (HR: 1.20; 95% CI: 1.10−1.32; p < .0001; I² = 0%) in matched or adjusted data. No significant difference was observed between MVRm and MVRb on operative mortality in matched/adjusted group (risk ratios: 0.83; 95% CI: 0.66−1.05; p = .12; I² = 0%). The results were consistent with patients aged under 70 years old. Patients who received a MVRm is associated with 16% lower risk of long‐term mortality and 66% lower risk of mitral reoperation, but 20% greater risk of stroke or systemic embolism, 21% greater risk of major bleeding compared with MVRb in matched/adjusted studies group, which were consistent to patients younger than the age of 70 years who underwent MVR.

Bioprosthetic vs. Mechanical Mitral Valve Replacement for Rheumatic Heart Disease in Patients Aged 50–70 Years

BackgroundRheumatic heart disease (RHD) is a critical problem in developing countries and is the cause of most of the cardiovascular adverse events in young people. In patients aged 50–70 years with RHD requiring mitral valve replacement (MVR), deciding between bioprosthetic and mechanical prosthetic valves remains controversial because few studies have defined the long-term outcomes.Methods1,691 Patients aged 50–70 years with RHD who received mechanical mitral valve replacement (MVRm) or bioprosthetic mitral valve replacement (MVRb) were retrospectively reviewed in Fuwai hospital from 2010 to 2014. Follow-up ended 31/12/2021; median duration was 8.0 years [interquartile range (IQR), 7.7–8.3 years]. Propensity score matching at a 1:1 ratio for 24 baseline features between MVRm and MVRb yielded 300 patient pairs. The primary late outcome was postoperative mid- to long-term all-cause mortality.ResultsTen-year survival after MVR was 63.4% in the MVRm group and 63.7% in the MVRb group (HR, 0.91; 95% CI, 0.69–1.21; P = 0.528). The cumulative incidence of mitral valve reoperation was 0.0% in the MVRm group and 1.2% in the MVRb group (HR, 0.92; 95% CI, 0.69–1.21; P = 0.530). The cumulative incidence of stroke was 5.5% in the MVRm group and 6.1% in the MVRb group (HR, 0.89; 95% CI, 0.67–1.18; P = 0.430). The cumulative incidence of major bleeding events was 3.3% in the MVRm group and 3.4% in the MVRb group (HR, 0.92; 95% CI, 0.70–1.22; P = 0.560).ConclusionsIn patients aged 50–70 years with RHD who underwent mitral valve replacement, there was no significant difference on survival, stroke, mitral valve reoperation and major bleeding events at 10 years. These findings suggest mechanical mitral valve replacement may be a more reasonable alternative in patients aged 50–70 years with rheumatic heart disease.

European Neuroendocrine Tumor Society (ENETS) 2022 Guidance Paper for Carcinoid Syndrome and Carcinoid Heart Disease

European Neuroendocrine Tumor Society (<scp>ENETS</scp>) 2022 Guidance Paper for Carcinoid Syndrome and Carcinoid Heart Disease

Valve-sparing root replacement after the Ross procedure

ObjectivesThe Ross procedure is a preferred treatment for infants and children with aortic valve disease. Progressive neoaortic root dilation and neoaortic insufficiency can occur after the Ross procedure, and because of the young age of these patients, valve-sparing aortic root replacement procedures have advantages compared with the Bentall procedure. The aim of this study is to describe our experience with different techniques of aortic valve-sparing root replacement in this unique cohort of patients. MethodsPatients undergoing valve-sparing aortic root replacement with a history of the Ross procedure between January 2001 and March 2021 were identified. A retrospective chart review was performed, and clinical characteristics of these patients were analyzed. The results of different types of valve-sparing aortic root replacement were also compared. ResultsForty-two patients who had previously undergone a Ross procedure in childhood presented for reintervention for neoaortic root or valve pathology. Seventeen of these patients were considered for valve-sparing aortic root replacement but underwent bioprosthetic or mechanical valve replacement, and 25 patients underwent successful valve-sparing aortic root replacement. Patients who underwent valve-sparing aortic root replacement received a traditional aortic root remodeling procedure with or without suture annuloplasty (Yacoub technique, group 1, n = 7), an aortic root reimplantation procedure (David technique, group 2, n = 11), or a modified root remodeling procedure that also used a geometric annuloplasty ring (group 3, n = 7). Patient demographics and comorbidities were similar between groups. Mean follow-up for these 3 cohorts was 14 years, 4 years, and 1 year, respectively. Overall survival was good, with 1 early death due to hemorrhage in group 2 and 1 death due to malignancy in group 1. Eight patients (7 in group 1; 1 in group 2) required subsequent aortic valve replacements due to neoaortic insufficiency, whereas none in group 3 have required any reintervention. Overall, patients requiring valve replacement after valve-sparing aortic root replacement had lower grades of preoperative neoaortic insufficiency and higher grades of postoperative neoaortic insufficiency. Greater than mild postoperative neoaortic insufficiency was associated with the need for subsequent neoaortic valve replacement. ConclusionsValve-sparing aortic root replacement is safe in patients with a prior Ross procedure. Reimplantation offers superior durability compared with the traditional remodeling procedure. Greater than mild neoaortic insufficiency on postoperative echocardiogram should prompt additional attempts at valve repair. A modified remodeling procedure with geometric ring annuloplasty that is personalized to the patient's individual anatomy is safe with good short-term results, but longer follow-up is needed.

Thoracoscopic Trans-mitral Septal Myectomy for Hypertrophic Obstructive Cardiomyopathy in the Elderly

BackgroundThe thoracoscopic trans-mitral approach can not only facilitate exposure of the ventricular septum, mitral valve, and subvalvular apparatus, it also enables the surgeons to perform concomitant mitral valve intervention. This study aimed to determine the safety and efficacy of thoracoscopic trans-mitral septal myectomy in elderly patients with hypertrophic obstructive cardiomyopathy (HOCM).MethodsWe reviewed the demographic to clinical characteristics and outcomes of patients who underwent thoracoscopic trans-mitral septal myectomy in our center between April 2019 and April 2021. The population was divided into a younger group (<60 years) and an elderly group (≥60 years).ResultsThere were 46 and 20 patients in the younger and elderly groups, respectively. The majority of patients in the elderly group were female (39.1 vs. 80.0%, P < 0.01). Patients in the elderly group were more likely to be in New York Heart Association Class IV (2.2 vs. 80.0%, P < 0.01). The European System for Cardiac Operation Risk Evaluation II predicted mortality rates were significantly higher (3.97 ± 1.81 vs. 1.62 ± 0.86%, P < 0.01) in the elderly group. In the elderly group, a patient converted to median sternotomy due to left ventricular posterior free wall rupture following septal myectomy and mitral bioprosthetic valve replacement. The patient then underwent double-patch sandwich repair for rupture and mitral mechanical valve replacement and was eventually discharged. All patients in the elderly group were discharged, while one in the younger group died. No patient in the elderly group required permanent pacemaker implantation vs. one in the younger group. Patients in the elderly group were more likely to spend more time in the intensive care unit than those in the younger group (5.44 ± 5.80 days vs. 3.07 ± 2.72, P < 0.05). However, there was no significant intergroup difference in in-hospital mortality or complications. Importantly, the left ventricular outflow tract pressure gradient was significantly decreased from 96.15 ± 32.89 mmHg to 8.2 ± 3.42 mmHg with no residual obstruction in the elderly group. The interventricular septal thickness was significantly decreased from 19.73 ± 3.14 mm to 11.30 ± 2.23 mm. Postoperative mitral regurgitation severity was significantly improved in the elderly group.ConclusionThis study demonstrated that thoracoscopic trans-mitral septal myectomy is a feasible option for selected elderly patients with satisfactory outcomes similar to those of young patients.

Antithrombotic Therapy for Patients With Atrial Fibrillation and Bioprosthetic Valves - Real-World Data From the Multicenter, Prospective, Observational BPV-AF Registry.

Although bioprosthetic valve (BPV) replacements are becoming more common within our aging society, there are limited prospective data on the appropriate antithrombotic therapy for East Asian patients with atrial fibrillation (AF) and BPV replacement. Antithrombotic therapy and thrombotic and hemorrhagic event rates in Japanese patients with AF and BPV replacement are investigated.Methods and Results:This multicenter, prospective, observational study enrolled patients with BPV replacement and AF. The primary efficacy outcome was stroke or systemic embolism, and the primary safety outcome was major bleeding. Of the 894 patients analyzed, 54.7%, 29.4%, and 9.6%, were treated with warfarin-based therapy, direct oral anticoagulant (DOAC)-based therapy, or antiplatelet therapy without anticoagulants, respectively; 6.3% did not receive any antithrombotic drugs. The mean observation period was 15.3±4.0 months. The event rates for stroke or systemic embolism and major bleeding were 1.95%/year and 1.86%/year, respectively. The multivariate adjusted hazard ratios for DOAC vs. warfarin were 1.02 (95% confidence intervals [CI], 0.30-3.41 [P=0.979]) for systemic embolic events and 0.96 (95% CI, 0.29-3.16 [P=0.945]) for major bleeding. Approximately 30% of patients with AF and BPV replacement were treated with DOAC. The risks of major bleeding and stroke or systemic embolism were similar between warfarin- and DOAC-treated patients with AF who had BPV replacement. Treatment with DOACs could be an alternative to warfarin in this population.

Direct oral anticoagulation in atrial fibrillation and heart valve surgery-a meta-analysis and systematic review.

Aims:Oral anticoagulation with direct oral anticoagulants (DOAC) could provide an alternative to vitamin K antagonists (VKA) for patients with atrial fibrillation (AF) undergoing bioprosthetic heart valve replacement or valve repair.Methods and results:The aim of this meta-analysis was to review the safety and efficacy of DOAC in patients with surgical implanted bioprosthetic heart valves or valve repairs and AF including data from six clinical trials with a total of 1,857 patients. The efficacy and safety data of DOAC and VKA were pooled to perform random-effects meta-analyses using the Mantel–Haenszel method with pooled risk ratios (RR) and 95% confidence interval (CI). A trial sequential analysis (TSA) was performed to assess statistical robustness. Death caused by cardiovascular cause or thromboembolic events were comparable (RR 0.67, 95% CI: 0.42–1.08; p = 0.10) as DOAC significantly reduced the risk for major bleeding (RR 0.55, 95% CI: 0.35–0.88; p = 0.01) and thromboembolic stroke or systemic embolism rates (RR 0.54, 95% CI: 0.32–0.90; p = 0.02). Rates for intracranial bleeding and hemorrhagic stroke (RR 0.27, 95% CI: 0.07–0.99; p = 0.05) show a trend toward fewer events in the DOAC group. Outcomes for major or minor bleeding events and all-cause mortality were comparable for DOAC and VKA.Conclusion:Cumulative data analysis reveals that DOAC may provide an effective and safe alternative to VKA in patients with AF after surgically implanted bioprosthetic heart valves or repair with AF. Within a relatively heterogeneous study population, this meta-analysis shows a risk reduction of major bleedings and thromboembolic stroke or systemic embolisms for DOAC.

Long-Term Outcomes of Bioprosthetic or Mechanical Valve Replacement in End-Stage Renal Disease: A Nationwide Population-Based Retrospective Study.

Background: Valve replacement is associated with worse outcomes in individuals who have end-stage renal disease (ESRD) and require a long-term renal replacement therapy. Prosthetic valve selection in patients with ESRD has remained controversial.Objective: We aimed to investigate long-term outcomes of mechanical and bioprosthetic valve replacement in individuals with ESRD.Methods: We conducted a population-based retrospective cohort study using data obtained from the Taiwan National Health Insurance Research Database. In total, 10,202 patients, including 912 ESRD and 9,290 non-ESRD patients, were selected after a 1:1 propensity-score matching based on the type of prosthetic valve used. The long-term mortality outcomes were then analyzed.Results: During a median follow-up period of 59.6 months, the Kaplan–Meier survival analysis revealed that ESRD patients who underwent mechanical valve replacement had higher rates of all-cause mortality and CV deaths than those who underwent bioprosthetic valve replacement (Log-rank test, p = 0.03 and 0.02, respectively). Multivariable regression analyses demonstrated that ESRD patients who underwent bioprosthetic valve replacement had lower rates of all-cause mortality (p < 0.001, hazard ratio: 0.88, 95% confidence interval: 0.82–0.93) and cardiovascular (CV) death (p < 0.001, hazard ratio: 0.83, 95% confidence interval: 0.76–0.90) than those who had mechanical valve replacement.Conclusion: Bioprosthetic valve replacement is significantly associated with lower rates of all-cause mortality and CV death in the ESRD population.

An Unusual Finding During a Diagnostic Heart Catheterization

A 73 year old man with a history of bradycardia with prior pacemaker implantation, mitral regurgitation with prior bioprosthetic mitral valve replacement, tricuspid valve repair, non-ischemic cardiomyopathy and recurrent pleural effusions was admitted from clinic due to worsening fatigue, abdominal distension, and leg swelling. Upon arrival, he was fluid overloaded on exam with markedly elevated B-type natriuretic peptide (3317 ng/dL). Acute decompensated heart failure was suspected and the patient was given intravenous furosemide. An echocardiogram was performed which revealed a newly declined ejection fraction of 20-24%, decreased from 30-35% previously. Given his decline in systolic function, a left heart catheterization was pursued to evaluate for new coronary ischemia. The left heart catheterization revealed obstructive distal vessel disease which was not significant enough to explain his cardiomyopathy. During the heart catheterization, the patient was incidentally noted to have a heavily calcified spleen (Figure 1A). To further evaluate this, a CT of the abdomen &amp; pelvis were performed which revealed diffuse, stippled calcifications throughout the spleen (Figure 1B).

Abstract 9868: Novel Oral Anticoagulants versus Vitamin K Antagonists in Patients with Atrial Fibrillation and Bioprosthetic Valve Replacement: A Systematic Review and Meta-Analysis

Background: Vitamin K antagonists (VKAs) such as warfarin are traditionally prescribed in patients with atrial fibrillation (AF) and bioprosthetic valves (BPVs) to prevent thromboembolic events. However, various studies have proposed novel oral anticoagulants (NOACs) as an effective and safer option to use. Therefore, we conducted a systematic review and meta-analysis to compare their relative efficacy and safety profiles. Methods: Pubmed, Cochrane Central, and Embase were searched up until May 15, 2021 for randomized clinical trials (RCTs) and observational studies determining efficacy and safety of NOACs or VKAs in AF patients who had undergone BPV replacement. Outcomes of interest were: stroke or systemic embolism (SSE), major bleeding, all-cause mortality, and intracranial hemorrhage (ICH). Subgroup analysis by study design (RCT and observational) was performed. Summary estimates were reported as random effects risk ratios (RRs) with 95% confidence intervals (CIs). Results: A total of 12 studies (4 RCTs and 8 observational) with 6436 patients (mean age 72.1 years; 51.4% males) were included in the analysis. In comparison to VKAs, NOACs demonstrated a significant reduction in ICH (RR 0.41 [95% CI 0.25,0.67]; p=0.0003; I 2 = 0%) and major bleeding (RR 0.63 [95% CI 0.53,0.74]; p&lt;0.00001; I 2 = 0%) at a mean duration follow up of 23.8 months. However, no difference was observed in risk of SSE (RR 0.77 [95% CI 0.50,1.19]; p=0.23; I 2 = 53%) and all-cause mortality (RR 0.98 [95% CI 0.78,1.22]; p=0.84; I 2 = 15%). Observational studies and RCTs did not significantly differ across all outcomes in the subgroup analysis. Conclusions: This meta-analysis suggests that NOACs are effective at reducing risk of ICH and major bleeding in AF patients with BPVs in contrast to VKAs. Future large-scale RCTs can aid in corroborating the legitimacy of these results.

Abstract 9414: Utilization of Antithrombotic Therapies in Patients With Atrial Fibrillation Across the Spectrum of Stroke Risk

Introduction: OAC are recommended for AF patients with CHA 2 DS 2 -VASc ≥2 in men or ≥3 in women (high-risk group), may be considered in patients with CHA 2 DS 2 -VASc 1 in men or 2 in women (medium-risk group), and are reasonable to omit in patients with CHA 2 DS 2 -VASc 0 in men or 1 in women (low-risk group). Furthermore, NOACs are recommended over warfarin in most AF patients. This study aimed to investigate AF stroke prevention treatment patterns in patients managed in routine practice, in particular, the under-use of OAC in the high-risk group and over-use in the low-risk group. Methods: Adult patients with AF were identified using de-identified claims for commercial and Medicare Advantage enrollees in the OptumLabs Data Warehouse. Prescription fills were assessed within 90 days of a patient’s AF encounter between 1/1/2016-12/31/2020. Patients with other indications for OAC, such as VTE, recent joint replacement, prior mechanical or bioprosthetic valve replacement, rheumatic mitral stenosis, and patients who underwent LAAO were excluded. Results: Among the 339,197 AF patients, 4.4%, 8.0%, and 87.6% were in the low-, medium-, and high-risk groups, respectively. The mean age was 51.2 ±10.5 yr, 59.9 ±9.4 yr, and 75.1 ±8.8 yr. In the low-risk group, 29.6% were treated with OAC, whereas in the high-risk group, 40.3% were not treated with any antithrombotic therapy and 7.5% used thienopyridine only. Although 71% of patients on OAC were on a NOAC, the proportion of patients on NOAC decreased from 91% in the low-risk group to 69% in the high-risk group. Conclusions: There are potentially both under-use of guideline-recommended stroke prevention therapies in the high-risk patients and over-use in the low-risk group. Because patients at a high risk of stroke are also at a high risk of major and intracranial bleeding who might benefit from NOACs, the decreased use of NOAC in high-risk patients might highlight the need for future quality improvement efforts.

Direct Oral Anticoagulants for Stroke Prevention in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves

Direct Oral Anticoagulants for Stroke Prevention in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves

Pulmonary Artery Intimal Sarcoma with Prolonged Survival: A Case Report and Review

Pulmonary artery intimal sarcoma (PAIS) is an extremly rare and agressive tumor. The prognosis is very poor, with median overall survival between 11 and 18 months. We report a case of a 38 year old man who presented to our oncology department with diagnosis of PAIS confirmed by histological examination after surgical resection and bioprosthetic pulmonary valve replacement. Six months after adjuvant chemotherapy, the patient presented a recurrence of his disease that requires other lines of chemotherapy with prolonged survival.

Impact of prosthesis-patient mismatch on late outcomes after bioprosthetic mitral valve replacement for mitral regurgitation.

Negative impact of prosthesis-patient mismatch on long-term survival after valve replacement has been reported. However, the effect of prosthesis-patient mismatch after bioprosthetic mitral valve replacement has not yet been well examined. The purpose of this study was to investigate the effect of prosthesis-patient mismatch on late outcomes after bioprosthetic mitral valve replacement for mitral regurgitation. A total of 181 patients underwent bioprosthetic mitral valve replacement between April 2008 and December 2016. After excluding patients with mitral stenosis and those with incomplete data, 128 patients were included in the study. Postoperative transthoracic echocardiography was performed before discharge for all patients and the effective orifice area of bioprosthetic mitral valve was calculated using the formula: 220/pressure half-time, and the effective orifice area index was calculated by the formula: effective orifice area/body surface area. Prosthesis-patient mismatch was defined as a postoperative effective orifice area index ≤ 1.2 cm2/m2. The characteristics and outcomes were compared between the groups. There were 34 patients (26.6%) with prosthesis-patient mismatch and 94 patients (73.4%) without prosthesis-patient mismatch. There were no significant differences in the in-hospital mortality and morbidities. Multivariable analysis showed that prosthesis-patient mismatch was an independent predictor of late mortality (hazard ratio 3.38; 95% confidence interval 1.69-6.75; p = 0.001) and death from heart failure (hazard ratio 31.03, 95% confidence interval 4.49-214.40, p < 0.001). Prosthesis-patient mismatch at discharge after mitral valve replacement for mitral regurgitation was associated with long-term mortality and death from heart failure.