Asymmetrical Expansion of Balloon-Expandable Transcatheter Aortic Valve Prostheses: Implications for Valve Hemodynamic and Clinical Outcomes.

BACKGROUND: Asymmetrical expansion of transcatheter heart valves (THVs), manifesting as stent frame deformation, is an occasional fluoroscopic finding in transcatheter aortic valve replacement (TAVR). OBJECTIVES: The aim of this study was to investigate the impact of asymmetrical expansion of balloon-expandable THVs on hemodynamic valve performance and clinical outcomes. METHODS: In a prospective registry, TAVR asymmetry index was measured using freeze-frame fluoroscopic images and was defined as the ratio of THV heights: [(longer height/shorter height) - 1] × 100. THV hemodynamic performance was measured using echocardiography before hospital discharge. Impaired hemodynamic valve performance was defined as a mean residual THV gradient ≥20 mm Hg and/or moderate or greater paravalvular regurgitation. RESULTS: Among 1,216 patients undergoing transfemoral TAVR for native severe aortic valve stenosis with contemporary balloon-expandable THVs between February 2014 and June 2022, asymmetry index was an excellent predictor of impaired hemodynamic valve performance (area under the receiver-operating characteristic curve: 0.88; 95% CI: 0.84-0.92; P < 0.001). The optimal asymmetry index threshold for predicting impaired THV performance was >5.5% (sensitivity 77%, specificity 86%) and occurred in 17% of patients. Higher asymmetry index, as a continuous variable, was associated with impaired hemodynamic valve performance independent of total aortic valve calcium, bicuspid anatomy, balloon-expandable valve prosthesis type or size, and Society of Thoracic Surgeons Predicted Risk of Mortality score (OR: 1.37; 95% CI: 1.29-1.46; P < 0.001). High TAVR asymmetry index was not associated with all-cause mortality during a median of 376 days of follow-up (HR: 1.00; 95% CI: 0.71-1.41; P = 0.989). CONCLUSIONS: Asymmetrical expansion of balloon-expandable THVs was associated with impaired hemodynamic valve performance but not with clinical outcomes.

Late-onset left atrial appendage occlusion device-related thrombus attributed to mitral bioprosthetic stenosis: a case report.

Background: Left atrial appendage occlusion (LAAO) is an alternative to anticoagulation for stroke prevention in select patients with atrial fibrillation (AF). In this study, we describe the case of a patient with delayed device-related thrombus (DRT) at 13 months post-LAAO in a setting of atrial stasis due to a worsening mitral bioprosthetic stenosis. Case summary: A 69-year-old woman with a history of rheumatic mitral stenosis and regurgitation post-bioprosthetic mitral valve replacement (6 years prior) and paroxysmal AF was referred for percutaneous LAAO due to recurrent severe gastrointestinal bleeding while on anticoagulation. She underwent an uncomplicated LAAO, for which a 35 mm Watchman Flx device was used. Peri-procedural transoesophageal echocardiogram (TEE) at the time of implant showed thickened and calcified mitral bioprosthetic leaflets and a mild mitral stenosis. Her 45-day post-LAAO TEE showed a mild mitral stenosis and no peri-device leak or DRT. At 12 months, the patient had worsening exertional dyspnoea and pedal oedema. Her 12-month transthoracic echocardiogram (TTE) showed a moderate mitral stenosis and LAAO remained free of DRT. Her symptoms were deemed secondary from a worsening mitral valve stenosis. Mitral valve-in-valve (MViV) replacement was planned because the patient was deemed a prohibitive risk for a redo surgical replacement. Transthoracic echocardiogram on the day of MViV showed a large thrombus on the LAAO device. MViV was postponed. After the patient completed 45 days of anticoagulation with warfarin, a repeat TTE was performed, which showed a resolution of DRT. Transcatheter MViV was performed successfully. Discussion: This case demonstrates that increased stasis and left atrial dysfunction from prosthetic mitral stenosis can be a risk factor for late DRT after successful LAAO. The use of a LAAO occlusion device in the presence of a mitral bioprosthesis requires more frequent echocardiographic monitoring to assess both the function of the prosthesis and a delayed formation of thrombus. More studies need to be conducted to assess the safety of percutaneous LAAO devices in those with mitral bioprosthesis.

Alpha-Gal Syndrome and Cardiac Surgery.

Galactose-alpha-1,3-galactose (alpha-gal) is a carbohydrate expressed by all mammals except for humans and certain old-world primates. It can be found in a plethora of products derived from mammals, including milk, organs, skeletal muscle and gelatin, in addition to products prepared with mammalian cells or constituents. In the late 2000s, an association between tick bites and the development of immunoglobulin E antibodies to the alpha-gal carbohydrate was discovered. The term "alpha-gal syndrome" (AGS) was then coined to describe allergic reactions to mammalian meat or other alpha-gal-containing products derived from mammals. Symptoms are often delayed several hours from consumption and can be urticarial and/or gastrointestinal. Medications and bioprosthetic inserts derived from mammals were also noted to cause allergic reactions in affected patients. Cardiac surgery, in particular, is considered high risk, given that unfractionated heparin has a bovine or porcine origin and is administered in large doses for cardiopulmonary bypass. Bioprosthetic valves have similar origins and risks. Awareness of AGS in cardiac surgery patients can lead to decreased risk preoperatively and inform management perioperatively and postoperatively. In this narrative review, we have reviewed the published literature relevant to AGS in patients undergoing cardiac surgery and shared our treatment approach.

Comparison of Two Generations of Self-Expandable Transcatheter Heart Valves in Nine Surgical Valves: An In Vitro Study.

(1) Background: This study aimed to analyse the hydrodynamic performance of two generations of self-expanding transcatheter heart valves (THV) as a valve-in-valve (ViV) in different surgical aortic valve (SAV) models under standardised conditions. The nitinol-based Evolut R valve is frequently used in ViV procedures. It is unclear whether its successor, the Evolut PRO, is superior in ViV procedures, particularly considering the previously implanted SAV model. (2) Methods: EvolutTM R 26 mm and EvolutTM PRO 26 mm prostheses were implanted in nine 21 mm labelled size SAV models (Hancock® II, Mosaic® UltraTM, EpicTM Supra, TrifectaTM GT, Perimount®, Perimount® Magna Ease, AvalusTM, IntuityTM, Freestyle®) to analyse their hydrodynamic performance under defined circulatory conditions in a pulse duplicator. (3) Results: Both THVs presented with the lowest effective orifice area (EOA) and highest mean pressure gradient (MPG) inside Hancock® II, whereas THVs in Intuity showed the highest EOA and lowest MPG. Evolut R and Evolut PRO showed significant hydrodynamic differences depending on the SAV. Both THVs performed similarly in porcine valves. Although the Evolut R performed better than Evolut PRO in stented bovine SAVs, the Evolut PRO was superior inside the Intuity. Further, the SAV model design markedly influenced the TAV's geometric orifice area and pin-wheeling index. (4) Conclusions: These findings show that the Evolut R and Evolut PRO perform differently depending on the previously implanted SAV model. THV selection for treatment of a specific SAV model should consider these results.

Coronary Access and PCI after Transcatheter Aortic Valve Replacement with Different Self-Expanding Platforms in Failed Surgical Valves.

BACKGROUND: Coronary access (CA) and percutaneous coronary intervention (PCI) might be challenging after valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) with supra-annular self-expanding valves (SS-TAVs) in surgical aortic valves (SAVs). Our study aim was to compare feasibility, predictors and techniques of CA and PCI following ViV-TAVR with ACURATE neo2 (Boston Scientific, Marlborough) and Evolut PRO+ (Medtronic, Minneapolis, Minnesota). METHODS: Fifteen computed tomography (CT)-based patient-specific aortic models were 3D-printed and implanted with specific SAVs and with the two SS-TAVs with commissural alignment. Two operators attempted CA (n=120) and PCI (n=120) of each coronary artery in a pulsatile-flow-simulator, under real catheterization laboratory conditions. The primary endpoints were the rate of successful CA and PCI. Outcomes with different SS-TAVs were directly compared. An internally mounted borescope camera was utilized to assess procedures. CT of the models was obtained. RESULTS: ACURATE neo2 showed significantly higher rates of successful CA (96.7%vs.75%, p=0.001) and PCI (98.3%vs.85%, p=0.008), and was associated with a shorter procedural time as compared to Evolut PRO+. Independent predictors of unsuccessful CA and PCI were smaller SAV size and Evolut PRO+. The advantage of ACURATE neo2 was mediated by a larger valve-to-anatomy distance at the top of the leaflet plane (11.3vs.4.8 mm), facilitating more often an external cannulation approach for both CA (36.7%vs.15%, p<0.001) and PCI (36.7%vs.21.7%, p=0.013). CONCLUSIONS: The rate of successful CA and PCI following ViV-TAVR was higher with ACURATE neo2 as compared to Evolut PRO+. The differences in SS-TAVs design impacted the cannulation approach and subsequent procedural outcomes.

Pioglitazone treatment mitigates cardiovascular bioprosthetic degeneration in a chronic kidney disease model.

Aims: Chronic kidney disease (CKD) is a risk factor for the development of cardiovascular diseases, e.g., atherosclerosis and calcific aortic valve disease, leading inevitably to valve replacement surgery. CKD patients with bioprosthetic cardiovascular grafts, in turn, have a higher risk of premature graft degeneration. Peroxisome proliferator-activated receptor gamma (PPARγ) activation by pioglitazone has cardio-renal protective properties, and research using a heterotopic valve implantation model has shown anti-degenerative effects of PPARγ activation on bioprosthetic valved grafts (BVG) in rats. The present work aims to analyze a potential protective effect of pioglitazone treatment on BVG in an adenine-induced rat model of CKD. Methods and Results: BVG of Sprague Dawley rats were heterotopically implanted in Wistar rats in an infrarenal position for 4 and 8 weeks. Animals were distributed into three groups for each time point: 1) control group receiving standard chow, 2) CKD group receiving 0.25% adenine and 3) CKD + pioglitazone group (300 mg per kg of 0.25% adenine chow). BVG function was analyzed by echocardiography. Plasma analytes were determined and explanted grafts were analyzed by semi-quantitative real-time PCR, Western blot analysis, histology and immunohistology.PPARγ activation significantly reduced CKD-induced calcification of aortic and valvular segments of BVG by 44% and 53%, respectively. Pioglitazone treatment significantly also reduced CKD-induced intima hyperplasia by 60%. Plasma analysis revealed significantly attenuated potassium and phosphate levels after pioglitazone treatment. Moreover, PPARγ activation led to significantly decreased interleukin-6 gene expression (by 57%) in BVG compared to CKD animals. Pioglitazone treatment leads to functional improvement of BVG. Conclusion: This study broadens the understanding of the potential value of PPARγ activation in cardio-renal diseases and delineates pioglitazone treatment as a valuable option to prevent bioprosthetic graft failure in CKD. Further mechanistic studies, e.g., using small molecules activating PPARγ signaling pathways, are necessary for the evaluation of involved mechanisms. Additionally, the translation into pre-clinical studies using large animals is intended as the next research project.

Redo-TAVR for bioprosthetic valve degeneration with obvious neoplasm in a left cerebral infarction patient.

Key Clinical Message: In recent years, it is necessary to Redo-TAVR for the patients with bioprosthetic valve degeneration. This case report described a unique instance to successfully Redo-TAVR a patient with bioprosthetic valve degeneration, in addition, with left cerebral infarction and renal insufficiency. Abstract: Over time, more and more patients have bioprosthetic valve degeneration either used in SAVR or TAVR. In order to solve the produced problems due to the degenerated bioprosthetic valve, Redo-TAVR was increasingly popular due to its safe and efficiency especially for the high risk and complicated symptoms patients. In this case, the patient with left cerebral infarction and renal insufficiency has exhibited severe regurgitation and obvious neoplasm around the previous replaced aortic valve. For the patient with complicated symptoms, we did not image for this patient and only used CT to determine the position and angle for the Redo-TAVR on the base of metal stent for the previous replaced aortic valve. During the Redo-TAVR process, for fear of the obvious neoplasm slipping from the previous replaced aortic valve to embolism of important organs, before carrying out the Redo-TAVR, cerebral protection device, temporary pacemaker, and coronary artery protection device were utilized in order to avoid the damage for the important organs from the obvious neoplasm slipping from the previous replaced aortic valve. The surgery was successful and the patient recovered well. The patient's symptoms of chest tightness and suffocation have been greatly reduced.

Emergent Surgical Replacement of a Tendyne Prosthesis for Bioprosthetic Valve Thrombosis.

A 66-year-old woman with a complex medical history underwent transcatheter mitral valve replacement (TMVI) owing to mitral insufficiency. Risk factors and noncompliance led to bioprosthetic valve thrombosis (BPVT) within 3 years. Emergent surgery indicated by an ad hoc heart team successfully managed the situation, showcasing challenges in BPVT management after TMVI.

Pushing the hybrid approach to the edges, three stories in one: a case report.

Background: Mitral annular calcification (MAC) is common in the elderly. Extensive calcification has been historically challenging for the cardiac surgeons, with traditional surgical approaches carrying significant risks. Less invasive approaches have recently been explored in an attempt to reduce this risk. Case summary: We report the case of a 75-year-old woman who presented with recurrent pulmonary oedema, due to severe MAC and mitral regurgitation. Her past medical history included bioprosthetic aortic valve replacement 5 years ago. Given the extensive MAC and the patient's frailty, a minimally invasive hybrid approach with direct implantation of a transcatheter balloon expandable Sapien 3 valve was selected to manage her. Although the post-surgical result was initially excellent with elimination of the mitral regurgitation, the patient's post-operative course was marked by two serious complications, namely, acute severe aortic regurgitation, due to rupture of the bioprosthetic valve's right cusp, and severe paravalvular leak of the Sapien valve, due to posterior migration towards the left atrium. These were managed successfully with emergency valve-in-valve implantation using the 'double chimney' technique for the bioprosthetic aortic valve, as well as transeptal valve-in-valve implantation of a 2nd Sapien valve in the mitral valve, which sealed the gap between the 1st Sapien and the calcified mitral annulus. Discussion: This case illustrates a less invasive approach for the management of severe MAC. Complications can still occur in this high-risk group of patients, and therefore, such cases should be managed with close collaboration between cardiac surgeons and cardiologists, in centres with high expertise.

Feasibility of intentional bioprosthetic valve fracture in the tricuspid position.

BACKGROUND: Transcatheter tricuspid valve-in-valve (ViV) replacement has yielded good hemodynamic outcomes in the treatment of dysfunctional bioprosthetic valves (BPVs). Intentional fracture of certain rigid BPV frames, if feasible, allows a larger implanted valve when compared with implant into an unfractured BPV. There remains limited data on the feasibility of tricuspid valve frame fracture. AIMS: Evaluate the feasibility of transcatheter tricuspid ViV replatement with fracture of the underlying BPV ring. METHODS: An international multicenter registry of tricuspid ViV replacement with intentional tricuspid valve frame fracture was created. Demographic data along with procedural characteristics, outcomes, and follow-up data were collected. Comparison was made to the pre- and post-ViV replacement with fracture of the tricuspid valve frame conditions. RESULTS: Ten patients from six centers were included with a median age and weight of 29 years and 67.3 kg respectively. Tricuspid valve frame fracture was performed using a median balloon diameter 3 mm (IQR 3-5) larger than the true inner diameter (ID). The final ID was a mean of 1.5 mm (95% CI: 0.35, 2.64: p < 0.05), and median 1.1 mm (0.5, 2.1) larger than the reported true ID of the surgical BPV after ViV replacement. The mean tricuspid inflow gradient by echocardiogram decreased by 6.65 mmHg (95% CI: 4.14, 9.15: p < 0.001). All procedures were without complication, specifically there was no heart block, pericardial effusion, or right coronary disruption. CONCLUSION: Intentional tricuspid valve frame fracture with tricuspid ViV replacement is feasible and can increase the valve orifice potentially reducing the risk of ViV patient prosthesis mismatch and is not associated with significant complications.

Computational Study on the Effects of Valve Orientation on the Hemodynamics and Leaflet Dynamics of Bioprosthetic Pulmonary Valves.

Pulmonary valves do not display a fibrous annulus as do other valves in the heart; thus, pulmonary valves can be implanted at multiple orientations and locations within the right ventricular outflow tract (RVOT). This gives surgeons more freedom when implanting the valve but it also results in uncertainties regarding placement, particularly with respect to valve orientation. We investigate the pulmonary artery hemodynamics and valve leaflet dynamics of pulmonary valve replacements (PVRs) with various orientations via fluid-structure interaction (FSI) models. A canonical model of the branching pulmonary artery is coupled with a dynamic model of a pulmonary valve, and from this we quantify the effect of valve implant orientation on the postvalvular hemodynamics and leaflet dynamics. Metrics such as turbulent kinetic energy (TKE), branch pulmonary artery flow distributions, projected valve opening area (PVOA), and pressure differentials across the valve leaflets are analyzed. Our results indicate that off-axis orientation results in higher pressure forces and flow and energy asymmetry, which potentially have implications for long-term durability of implanted bioprosthetic valves.

R2-CHA2DS2-VASc Score for Cardiovascular Event Prediction After Bioprosthetic Valve Replacement　- Subanalysis From the BPV-AF Registry.

Background: There are few studies evaluating the prognostic prediction method in atrial fibrillation (AF) patients after bioprosthetic valve (BPV) replacement. The R2-CHA2DS2-VASc score is increasingly used for the prediction of cardiovascular (CV) events in patients with AF, device implantation, and acute coronary syndrome. We aimed to evaluate the predictive value of the R2-CHA2DS2-VASc score for future CV events in AF patients after BPV replacement. Methods and Results: The BPV-AF, an observational, multicenter, prospective registry, enrolled AF patients who underwent BPV replacement. The primary outcome measure was a composite of stroke, systemic embolism, CV events including heart failure requiring hospitalization, and cardiac death. A total of 766 patients was included in the analysis. The mean R2-CHA2DS2-VASc score was 5.7±1.8. Low (scores 0-1), moderate (scores 2-4), and high (scores 5-11) R2-CHA2DS2-VASc score groups consisted of 12 (1.6%), 178 (23.2%), and 576 (75.2%) patients, respectively. The median follow-up period was 491 (interquartile range 393-561) days. Kaplan-Meier analysis showed a higher incidence of the composite CV events in the high R2-CHA2DS2-VASc score group (log rank test; P<0.001). Multivariate Cox proportional hazards regression analysis revealed that the R2-CHA2DS2-VASc score as a continuous variable was an independent predictor of composite CV outcomes (hazard ratio 1.36; 95% confidence interval 1.18-1.55; P<0.001). Conclusions: The R2-CHA2DS2-VASc score is useful for CV risk stratification in AF patients after BPV replacement.

Melody Valve Implantation in the Tricuspid Position After Pediatric Heart Transplantation-A Case Report.

Tricuspid regurgitation (TR) is common after a heart transplant and is associated with worse clinical outcomes. The incidence ranges from 34% immediately after transplant to 20% by 10 years. Most patients can be managed medically; however, severe TR and symptomatic right heart failure warrant tricuspid valve replacement. The use of Melody transcatheter pulmonary valve in the tricuspid position is previously described. We report a unique case of posttransplant severe TR treated with surgical bioprosthetic tricuspid valve replacement who subsequently underwent successful transcatheter Melody valve placement in tricuspid position for progressive bioprosthetic valve stenosis with 11 years of follow-up.

Clinical effects of direct oral anticoagulants in elderly patients with a bioprosthetic valve and atrial fibrillation.

BACKGROUND: Current guidelines recommend direct oral anticoagulants (DOACs) and warfarin for patients with atrial fibrillation (AF) who have a bioprosthetic valve (BPV). However, the data related to elderly patients (aged ≥80 years) with BPV replacement and AF are limited. METHODS: This post-hoc subgroup analysis of a BPV-AF Registry enrolled 752 patients with BPV replacement and AF. The primary net outcome was a composite of cardiac death, stroke, systemic embolism, major bleeding, and cardiovascular events. RESULTS: Among 752 patients, 429 (57%) patients were ≥ 80 and 323 (43%) were < 80 years old. The higher risk in patients aged ≥80 than <80 years was significant for the net outcome (hazard ratio [HR], 2.04; 95% confidence interval [CI], 1.31-3.17; P = 0.001). After adjustment for confounders, there was no statistically significant difference between warfarin (reference) and DOAC users in the risk of net outcomes (adjusted HR, 1.26; 95% CI, 0.71-2.24; P = 0.44), stroke and systemic embolism (adjusted HR, 2.01; 95% CI, 0.48-8.38; P = 0.34), and major bleeding (adjusted HR, 0.73; 95% CI, 0.11-4.98; P = 0.75) in patients aged ≥80 years old as well as those aged <80 years. Among 489 warfarin users, the cumulative incidence of net outcomes tended to be higher in patients aged ≥80 than <80 years (12.2% vs. 5.7% at 1 year, log-rank P = 0.002). Among 263 DOAC users, however, it was similar between patients aged ≥80 and < 80 years. CONCLUSIONS: The present study demonstrated that DOAC showed similar efficacy and safety compared with warfarin even in elderly patients aged ≥80 years with BPV replacement and AF.

Warfarin use is associated with higher aortic bioprosthetic 18F-fluoride PET uptake.

BACKGROUND: Prevalence of bioprosthetic valve degeneration (BVD) is rising as the use of bioprosthetic aortic valves increases. Detecting early signs of BVD remains a challenge, with conventional imaging methods often failing to identify early deterioration stages. 18F-fuoride positron emission tomography (PET-CT) is an emerging technique that offers promising prospects to detect subclinical BVD. This study aimed to compare early PET parameters of fluoride uptake with echocardiographic hemodynamic parameters and compare outcomes according to anticoagulation in patients who received bioprosthetic valves. METHODS: This is a sub-study of the ANTIPRO clinical trial, which involved patients undergoing surgical aortic valve replacement (SAVR) with a porcine bioprosthesis and randomized them into anticoagulated and non-anticoagulated groups. Hemodynamic changes were assessed by transthoracic echocardiography (TTE), while 18F-fluoride PET-CT quantified fluoride uptake and divided the patients in two groups: high-uptake and low-uptake. Mean and maximum gradients by TTE at three years were compared between the two uptake groups. Fluoride uptake was also compared between the anticoagulated and control groups. RESULTS: We found no significant differences in transprosthetic gradients between high-uptake(21.4 ± 8.6 mmHg) and low-uptake(17.3 ± 11.2 mmHg.p = 0.244) PET-defined groups in this specific timeframe. Notably, anticoagulated patients exhibited significantly risk of higher fluoride uptake(OR = 4.34;95%CI:1.04-18.21.p = 0.045). CONCLUSIONS: No association was found between fluoride uptake and hemodynamic evaluation. Anticoagulation was associated with higher fluoride uptake. These findings highlight the emerging role of PET-CT in studying bioprosthetic aortic valves and emphasize the need for extended follow-up to evaluate the impact of anticoagulation on valve degeneration.

Valve-in-Valve Transcatheter Mitral Valve Replacement in a Very High-Risk Octagenerian Patient: A Case Report.

Degeneration of the surgical bioprosthetic valves remains one of the most common complications of surgical valve replacement. Redo surgery is the gold standard, but unfortunately, most of these patients are deemed inoperable because of the high perioperative mortality. Transcatheter implantation of a new valve inside the degenerated bioprosthesis (valve-in-valve (ViV)) has emerged as an alternative solution. A 79-year-old patient with a medical history of surgical replacement of the mitral valve with a bioprosthetic valve, coronary artery bypass graft surgery (CABG) with implantation of the left internal mammary artery (LIMA) to the left anterior descending artery (LAD), paroxysmal atrial fibrillation, and chronic kidney disease was referred to our hospital for ViV transcatheter mitral valve replacement (TMVR). He had recent hospitalizations with pulmonary edema caused by severe stenosis of the bioprosthetic valve and his perioperative mortality for a redo surgery was very high (EuroSCORE II: 13.72%). The ViV TMVR was performed with a transseptal approach and after the implantation of the new valve, the mean pressure gradient was dropped from 19.39 to 2.33 mmHg. The procedure was technically successful and the patient was discharged asymptomatic.

Mechanical Valves: Past, Present, and Future-A Review.

The mechanical valve was first invented in the 1950s, and since then, a wide variety of prostheses have been developed. Although mechanical valves have outstanding durability, their use necessitates life-long treatment with anticoagulants, which increases the risk of bleeding and thromboembolic events. The current guidelines recommend a mechanical prosthetic valve in patients under 50-60 years; however, for patients aged 50-70 years, the data are conflicting and there is not a clear-cut recommendation. In recent decades, progress has been made in several areas. First, the On-X mechanical valve was introduced; this valve has a lower anticoagulant requirement in the aortic position. Second, a potential alternative to vitamin K-antagonist treatment, rivaroxaban, has shown encouraging results in small-scale trials and is currently being tested in a large randomized clinical trial. Lastly, an innovative mechanical valve that eliminates the need for anticoagulant therapy is under development. We attempted to review the current literature on the subject with special emphasis on the role of mechanical valves in the current era and discuss alternatives and future innovations.

Long-term outcomes of the BalMedic bovine pericardial bioprosthetic valve in female patients ≤50 years: a multicenter retrospective study.

Background: A bioprosthetic valve is recommended for women of childbearing age who require cardiac valve replacement in order to minimize the risk of blood clot formation. However, it should be noted that compared to mechanical valves, bioprosthetic valves have a shorter lifespan and a higher likelihood of requiring reoperation during follow-up. To assess the long-term postoperative results, including the incidence of structural valve deterioration (SVD) and other clinical outcomes, in female patients aged 50 years and younger who underwent BalMedic bovine pericardial bioprosthetic valve replacement, a multicenter retrospective study was implemented in China. Methods: Between 2004 and 2015, a cohort of 86 female patients across three medical centers underwent the implantation of 97 bioprosthetic valves. The primary outcome measure was overall survival (OS), while the secondary outcome measures were preliminary evidence of reoperation, SVD incidence, and bioprosthetic valve-related complications. Results: In this cohort study, 21 patients (24.4%, 21/86) died, while 37 patients (43.0%, 37/86) underwent a second valve replacement. The OS rates at 5 and 10 years were 97.56% and 71.93%, respectively. Additionally, the reoperation-free rates at 5 and 10 years were 92.83% and 80.68%, respectively. Similarly, the rates of freedom from SVD at 5 and 10 years were 95.65% and 51.82%, respectively, and the average duration of bioprosthetic valve replacement in our study was 9.34±3.31 years. Conclusions: Despite the recruitment of younger female patients of child-bearing age in our cohort, the OS, reoperation-free survival, and SVD-free rates of the BalMedic bovine pericardial bioprosthetic valve were not inferior to those of the other age groups in the study or those reported in the literature.