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Background: Surgical aortic root enlargement (ARE) during aortic valve replacement (AVR) allows for larger prosthesis implantation and may be an important adjunct to surgical AVR in the transcatheter valve-in-valve era. The incremental operative risk of adding ARE to AVR has not been established. We aimed to evaluate the early outcomes of patients undergoing AVR with or without ARE. Methods: From January 1990 to August 2014, 7039 patients underwent AVR (AVR+ARE, n=1854; AVR, n=5185) at a single institution. Patients with aortic dissection and active endocarditis were excluded. Mean age was 65±14 years and 63% were male. Logistic regression and propensity score matching were used to adjust for unbalanced variables in group comparisons. Results: Patients undergoing AVR+ARE were more likely to be female (46% versus 34%, P P P =0.004), urgent/emergent status (6% versus 4%, P =0.01), and worse New York Heart Association status ( P P =0.98) and also underwent concomitant cardiac procedures (AVR+ARE: 68% versus AVR: 67%, P =0.31). Mean prosthesis size implanted was slightly smaller in patients requiring AVR+ARE versus AVR (23.4±2.1 versus 24.1±2.3, P P =0.008), although when the cohort was restricted to patients undergoing isolated aortic valve replacement with or without root enlargement, mortality was not statistically different (AVR+ARE: 1.7% versus AVR: 1.1%, P =0.29). After adjustment for baseline characteristics, AVR+ARE was not associated with an increased risk of in-hospital mortality when compared with AVR (odds ratio, 1.03; 95% confidence interval, 0.75–1.41; P =0.85). Furthermore, AVR+ARE was not associated with an increased risk of postoperative adverse events. Results were similar if propensity matching was used instead of multivariable adjustments for baseline characteristics. Conclusions: In the largest analysis to date, ARE was not associated with increased risk of mortality or adverse events. Surgical ARE is a safe adjunct to AVR in the modern era.

Bioprostheses are prone to structural valve degeneration, resulting in limited long-term durability. A significant challenge when comparing the durability of different types of bioprostheses is the lack of a standardized terminology for the definition of a degenerated valve. This issue becomes especially important when we try to compare the degeneration rate of surgically inserted and transcatheter bioprosthetic valves. This document, by the VIVID (Valve-in-Valve International Data), proposes practical and standardized definitions of valve degeneration and provides recommendations for the timing of clinical and imaging follow-up assessments accordingly. Its goal is to improve the quality of research and clinical care for patients with deteriorated bioprostheses by providing objective and strict criteria that can be utilized in future clinical trials. We hope that the adoption of these criteria by both the cardiological and surgical communities will lead to improved comparability and interpretation of durability analyses.

Background: The SOURCE 3 Registry (SAPIEN Aortic Bioprosthesis European Outcome) is a European multicenter, observational registry of the latest generation of transcatheter heart valve, the SAPIEN 3 (Edwards Lifesciences, Irvine, CA). Its purpose is to document outcomes of clinical safety and performance after European approval was given. Methods: Here, we present the 30-day outcome of the SOURCE 3 Registry. All data are self-reported, and all participating centers have committed to support their consecutive experience with the SAPIEN 3 transcatheter heart valve, dependent on patient consent, before the start of the study. Adverse events are defined with Valve Academic Research Consortium 2 criteria and adjudicated by an independent clinical events committee. Results: A total of 1950 patients from 80 centers in 10 countries were enrolled between July 2014 and October 2015. Of those, 1947 patients underwent transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 (mean age, 81.6±6.6 years; 48.1% female). Main comorbidities included coronary artery disease (51.5%), renal insufficiency (27.4%), diabetes mellitus (29.5%), chronic obstructive pulmonary disease (16.0%), and a mean logistic EuroSCORE of 18.3±13.2. Transfemoral access was used in 87.1% (n=1695); nontransfemoral, in 252 patients. Conscious sedation was used in 59.9% of transfemoral procedures, and in 50% of patients, TAVI was performed without aortic balloon valvuloplasty. Implantation success (1 valve in the intended location) was 98.3%. Conversion to conventional surgery (0.6%) and use of cardiopulmonary bypass (0.7%) were rare. Adverse events were low, with site-reported 30-day all-cause mortality of 2.2%, cardiovascular mortality of 1.1%, stroke of 1.4%, major vascular complications of 4.1%, life-threatening bleeding of 5%, and post-TAVI pacemaker implantation of 12%. Moderate or greater paravalvular regurgitation was observed in 3.1% of reporting patients. Conclusions: Results from the SOURCE 3 Registry demonstrate contemporary European trends and good outcomes of TAVI in daily practice when this third-generation TAVI device is used.

The presence of a small aortic annulus poses a considerable challenge in the management of patients with severe aortic stenosis, especially in elderly women, where it is a very frequent finding. The optimal approach for treating these patients remains controversial, and several surgical strategies such as aortic root enlargement, supra-annular stented prosthetic valves, stentless bioprosthesis, and sutureless bioprostheses have been proposed to improve valve hemodynamics and clinical outcomes. More recently, transcatheter aortic valve replacement has emerged as a valid alternative for the treatment of aortic stenosis and excellent valve hemodynamic results have been observed among patients with a small aortic annulus. The purpose of this review is to provide an overview of the current definition, prevalence, and clinical impact of small aortic annulus in patients with aortic stenosis, and evaluate the different therapeutic strategies currently available to improve valve hemodynamics and outcomes in this population.

Atrial fibrillation (AF) and valvular heart disease (VHD) frequently coexist and independently increase mortality1. Bioprosthetic valve implantation (surgical or transcatheter), is a common, increasingly utilized treatment for VHD2. Patients with AF and bioprosthetic valves require anticoagulation to prevent thromboembolic events. Non-vitamin K oral anticoagulants (NOACs) are safe and efficacious alternatives to vitamin K antagonists for anticoagulation in AF. However, guidelines recommend against NOACs in patients with bioprosthetic valves, citing a lack of supporting data. Only one of the first three warfarin-controlled pivotal NOAC trials in AF included patients with bioprosthetic valves (n>80)3. The Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial, which compared edoxaban (a direct oral factor Xa inhibitor) to warfarin in AF patients4, did not exclude patients with bioprosthetic valves, thus providing an opportunity to analyze this high-risk subgroup.

Background: Cardiovascular bypass grafting is an essential treatment for complex cases of atherosclerotic disease. Because the availability of autologous arterial and venous conduits is patient-limited, self-assembled cell-only grafts have been developed to serve as functional conduits with off-the-shelf availability. The unacceptably long production time required to generate these conduits, however, currently limits their clinical utility. Here, we introduce a novel technique to significantly accelerate the production process of self-assembled engineered vascular conduits. Methods: Human aortic smooth muscle cells and skin fibroblasts were used to construct bilevel cell sheets. Cell sheets were wrapped around a 22.5-gauge Angiocath needle to form tubular vessel constructs. A thin, flexible membrane of clinically approved biodegradable tissue glue (Dermabond Advanced) served as a temporary, external scaffold, allowing immediate perfusion and endothelialization of the vessel construct in a bioreactor. Subsequently, the matured vascular conduits were used as femoral artery interposition grafts in rats (n=20). Burst pressure, vasoreactivity, flow dynamics, perfusion, graft patency, and histological structure were assessed. Results: Compared with engineered vascular conduits formed without external stabilization, glue membrane–stabilized conduits reached maturity in the bioreactor in one-fifth the time. After only 2 weeks of perfusion, the matured conduits exhibited flow dynamics similar to that of control arteries, as well as physiological responses to vasoconstricting and vasodilating drugs. The matured conduits had burst pressures exceeding 500 mm Hg and had sufficient mechanical stability for surgical anastomoses. The patency rate of implanted conduits at 8 weeks was 100%, with flow rate and hind-limb perfusion similar to those of sham controls. Grafts explanted after 8 weeks showed a histological structure resembling that of typical arteries, including intima, media, adventitia, and internal and external elastic membrane layers. Conclusions: Our technique reduces the production time of self-assembled, cell sheet–derived engineered vascular conduits to 2 weeks, thereby permitting their use as bypass grafts within the clinical time window for elective cardiovascular surgery. Furthermore, our method uses only clinically approved materials and can be adapted to various cell sources, simplifying the path toward future clinical translation.

The estimated prevalence of mitral or aortic valvular heart disease is ≈2.5% in the general population of Western countries, and is expected to rise with population aging. A substantial proportion of patients with valvular heart disease undergoes surgical valve replacement. Mechanical heart valves are much more durable than bioprostheses, and are thus preferentially implanted in patients with a longer life expectancy, but have the major drawback of requiring lifelong anticoagulation to prevent valve thrombosis because of their higher thrombogenicity. The non–vitamin K antagonist oral anticoagulants (NOACs) are replacing vitamin K antagonists in many settings, including bioprostheses, because of their favorable safety and efficacy profiles. However, mechanical heart valves currently pose an absolute contraindication to NOACs based on the results of a single phase II study comparing dabigatran and warfarin (RE-ALIGN [Randomized, Phase II Study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate in Patients after Heart Valve Replacement]). That trial was stopped prematurely because of an excess of both stroke and bleeding with the dabigatran doses tested. Because of such negative findings, research in this area has been halted. We believe that several aspects of both the preclinical studies and the RE-ALIGN trial should be critically reevaluated. In our opinion, 1 single trial with a single NOAC does not represent sufficient evidence for dismissing a therapeutic strategy, anticoagulation with NOACs, that has shown better safety and at least similar efficacy as warfarin in the setting of atrial fibrillation and venous thromboembolism,. Herein, we reevaluate this topic to identify the patient profile that has the greatest likelihood of benefit from some of the NOACs, with a focus on factor Xa inhibitors, thus providing some perspectives for basic and translational research.

Background— Structural valve deterioration (SVD) is a major flaw of bioprostheses. Early SVD has been suspected in the last models of Mitroflow bioprosthesis. We sought to assess the incidence, mode, and impact of SVD on outcome in a large series of Mitroflow aortic valve replacement. Methods and Results— Six hundred seventeen consecutive patients (aged 76.1±6.3 years) underwent aortic valve replacement with a Mitroflow prosthesis (models 12A/LX) between 2002 and 2007. By echocardiography, 39 patients developed early SVD (1.66% per patient-year), with stenosis as the main mode (n=36). Mean delay to SVD was only 3.8±1.4 years, and 5-year SVD-free survival was 91.6% (95% confidence interval [CI], 88.7–94.7) for the whole cohort and 79.8% (95% CI, 71.2–89.4) and 94.0% (95% CI, 90.3–97.8) for 19- and 21-mm sizes, respectively. Among the 39 patients with SVD, 13 patients (33%) had an accelerated SVD once the mean gradient exceeded 30 mm Hg. Valve-related death was 46.2% in this SVD subgroup. Five-year overall survival was 69.6% (95% CI, 65.7–73.9). In multivariable analysis, SVD was the strongest correlate of overall mortality (hazard ratio=7.7; 95% CI, 4.4–13.6). Conclusions— Early SVD is frequent in Mitroflow bioprosthesis (models 12A/LX), especially for small sizes (19 and 21 mm), and reduces overall survival. An unpredictable accelerated pattern of SVD constitutes a life-threatening condition. In view of the large number of Mitroflow valves implanted worldwide, one can expect an epidemic of SVD and valve-related deaths, which represents a major public health issue, especially in the elderly. Hence, a close follow-up with yearly echocardiography after Mitroflow implantation is advisable. An urgent reoperation should be discussed in patients with severe SVD even though they are still asymptomatic.

Over the past decade, transcatheter aortic valve replacement (TAVR) has established itself as an important alternative to surgical aortic valve replacement for patients with symptomatic severe aortic stenosis who have a high or prohibitive surgical risk. The success of this breakthrough technology was propelled by data from several randomized, controlled trials and large registries.1,2 During this period, the technology has been serially refined to overcome many key limitations. Procedural planning and execution have been largely standardized, making TAVR a mature method with reproducible outcomes across a growing spectrum of patients. The general simplicity of the TAVR procedure, in comparison with traditional surgery, combined with excellent outcomes of this minimally invasive treatment option, even in highest-risk patients with native aortic stenosis, has initiated a tidal wave of new technologies using catheter-based devices for treating other valvular heart problems. Article, see p 1582 This phenomenon has coincided with increasing use of bioprosthetic valves as opposed to mechanical aortic valve replacements in cardiac surgery.3 This has presented an opportunity for existing TAVR systems to be harnessed for the treatment of failed bioprosthetic surgical valves. On March 30, 2015, the US Food and Drug Administration approved the expanded use of the CoreValve System for high-risk patients with failed surgical bioprosthetic aortic valves. This approval was based on a small prospective registry of 143 participants conducted in the United States. In the trial, the 30-day and 6-month survival rates without major stroke were 95.8% and 89.3%, respectively. On October 15, 2015, the US Food and Drug Administration approved the expanded use of the SAPIEN XT valve based on the results of the independently adjudicated data from the 197-patient Partner II Trials: Placement of Aortic Transcatheter Valves (PARTNER II) valve-in-valve (VIV) study. The VIV procedure was associated with a high overall 1-year …

Aortic stenosis is becoming more prevalent as populations age, and surgically implanting a replacement valve can restore a patient’s expected life span. There is much discussion about the relative merits of a mechanical or biological valve design. A mechanical valve is expected to outlast the patient but requires anticoagulation with a vitamin K antagonist, whereas a biological valve does not require anticoagulation but is subject to structural valve degeneration after 10 years. After taking patient preferences into consideration, the 2014 American Heart Association/American College of Cardiology guidelines1 recommend that a mechanical valve should be implanted in patients 65 years of age. However, biological valves are increasingly being used in patients

Information about a real patient is presented in stages (boldface type) to expert clinicians (Drs Murthy and Yang), who respond to the information and share their reasoning with the reader (regular type). A discussion by the authors follows. Patient presentation: Mr H is a 50-year-old male admitted in 2013 with methicillin-sensitive Staphylococcus aureus bacteremia and aortic valve endocarditis. Other medical history includes hypertension, paroxysmal atrial fibrillation, end stage renal disease, undergoing hemodialysis through a left upper extremity arteriovenous fistula, and stroke. He underwent intraoperative pulmonary vein isolation, epicardial left atrial appendage closure using a 50-mm AtriClip device, and bioprosthetic aortic valve replacement at an outside hospital. Dr Yang: Because 90% of thrombi in nonvalvular atrial fibrillation originate in the left atrial appendage (LAA), this structure has emerged as a therapeutic target to reduce the risk of cardioembolic stroke. Mr H has a history of labile international normalized ratios, a HAS-BLED (Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition [anemia], Labile INR, Elderly [age>65], Drugs/Alcohol concomitantly) score of 4, and prior stroke while on anticoagulation, thereby warranting consideration of alternative therapies to warfarin for stroke protection, if feasible. The 2014 American College of Cardiology/American Heart Association guideline statement on atrial fibrillation makes a class IIb recommendation for surgical occlusion of the LAA during other cardiac surgeries. Despite this guideline, surgical occlusion with a prosthetic device is not advisable in this patient because of active endocarditis and the risk for recurrent infection in the future. Moreover, patients with valvular heart surgery and those with active systemic infection were excluded in the pivotal EXCLUDE trial, which studied the safety and efficacy of the AtriClip placement.1 A suture-based LAA occlusion strategy to minimize implanted prosthetic material would have been preferred. The underlying rationale that exclusion of the thrombogenic LAA may reduce short- …

Background— Experience with aortic valve replacement (AVR) with current-generation pericardial bioprostheses in young patients is limited. The death of a child with accelerated bioprosthetic aortic stenosis prompted enhanced surveillance of all such patients at our institution. Methods and Results— We reviewed records of 27 patients who had undergone AVR (median follow-up, 13.7 months) with a bovine pericardial bioprosthesis at ≤30 years of age. In the Mitroflow LXA valve group (n=15), freedom from valve failure was 100% at 1 year, 53% (95% confidence interval, 12–82) at 2 years, and 18% (95% confidence interval, 1–53) at 3 years. No Magna/Magna Ease valves (n=12) failed by 3 years. Among valve failure patients, median age at AVR was 12 years (range, 10–21 years). Life-threatening prosthetic aortic stenosis was detected at a median of 6 months after prior echocardiograms showing mild or less gradients. Patients with Mitroflow LXA compared with Magna/Magna Ease valves were smaller (median body surface area, 1.42 versus 1.93 m 2 ; P =0.002) and younger (median age, 13.0 versus 20.9 years; P =0.02) at AVR. Pathology demonstrated diffuse intrinsic leaflet calcification, not associated with inflammation or infection, and virtually immobile leaflets in closed position. Conclusions— Young patients undergoing AVR with Mitroflow LXA pericardial valves are at high risk for rapid progression from mild or less to severe aortic stenosis over months, highlighting their need for heightened echocardiographic surveillance and suggesting that this aortic bioprosthesis should not be implanted in the young. Current data are insufficient to assess the safety of AVR with other pericardial bioprostheses in children and the youngest adults.

Bioprosthetic valves are increasingly used in patients with aortic stenosis. Compared with mechanical valves, bioprosthetic valves are associated with a lower risk of thromboembolic events and do not require long-term anticoagulation.1,2 However, bioprosthetic valves have limited durability; the best current valves can be expected to degenerate within 10 to 20 years, resulting in stenosis or regurgitation. Surgical valve replacement is the current standard of care for these patients. However, reoperative morbidity and mortality risk is significant, not only because of the complexity of reoperation but also because many of these patients have comorbidities, particularly advanced age.1–5 Transcatheter heart valve (THV) implantation for native valve aortic stenosis has evolved as a viable, less invasive alternative to open heart surgery in selected patients.6 Recently, THV implantation within failed surgically implanted bioprostheses has proven feasible.7–10 Here, we review what is known of the potential and challenges of valve-in-valve (VinV) implantation in patients with failing surgical aortic bioprostheses. Bioprosthetic valves incorporate leaflets made from animal tissue. Xenografts are fashioned from porcine aortic valves, from more durable bovine pericardium, or rarely from porcine pericardium. Homografts are fashioned from human aortic valves. Tissue is generally preserved in glutaraldehyde, which cross-links collagen fibers, reducing antigenicity and in vivo enzymatic degradation.11 Various proprietary anticalcification treatments are commonly used. Surgical bioprostheses are commonly stratified into stented and stentless valves (Figure 1). Figure 1. Common bioprosthetic surgical valves. The Mosaic (Medtronic) valve could be implanted either intra-annularly or supra-annularly. ### Stented Bioprostheses Stented valves are usually constructed with bovine pericardium or whole porcine aortic valves attached to a support structure such as a stent or frame. Current bioprosthetic frames are composed of alloy or polymer materials that absorb some of the forces acting on the leaflets. The frame of the bioprosthesis is responsible …

Background— The prognosis and treatment of patients with low-flow (LF) severe aortic stenosis are controversial. Methods and Results— The Placement of Aortic Transcatheter Valves (PARTNER) trial randomized patients with severe aortic stenosis to medical management versus transcatheter aortic valve replacement (TAVR; inoperable cohort) and surgical aortic valve replacement versus TAVR (high-risk cohort). Among 971 patients with evaluable echocardiograms (92%), LF (stroke volume index ≤35 mL/m 2 ) was observed in 530 (55%); LF and low ejection fraction (P =0.006). In the inoperable cohort, patients with LF had higher mortality than those with normal flow, but both groups improved with TAVR (46% versus 76% with LF and 38% versus 53% with normal flow; P P =0.02). LF was an independent predictor of mortality in all patient cohorts (hazard ratio, ≈1.5), whereas ejection fraction and gradient were not. Conclusions— LF is common in severe aortic stenosis and independently predicts mortality. Survival is improved with TAVR compared with medical management and similar with TAVR and surgical aortic valve replacement. A measure of flow (stroke volume index) should be included in the evaluation and therapeutic decision making of patients with severe aortic stenosis. Clinical Trial Registration— URL: http://www.clinicaltrial.gov . Unique identifier: NCT0053089.4.

Background— There is a paucity of long-term data comparing biological versus mechanical aortic valve prostheses in older individuals. Methods and Results— We performed follow-up of patients aged 65 to 80 years undergoing aortic valve replacement with a biological (n=24 410) or mechanical (n=14 789) prosthesis from 1991 to 1999 at 605 centers within the Society of Thoracic Surgeons Adult Cardiac Surgery Database using Medicare inpatient claims (mean, 12.6 years; maximum, 17 years; minimum, 8 years), and outcomes were compared by propensity methods. Among Medicare-linked patients undergoing aortic valve replacement (mean age, 73 years), both reoperation (4.0%) and endocarditis (1.9%) were uncommon to 12 years; however, the risk for other adverse outcomes was high, including death (66.5%), stroke (14.1%), and bleeding (17.9%). Compared with those receiving a mechanical valve, patients given a bioprosthesis had a similar adjusted risk for death (hazard ratio, 1.04; 95% confidence interval, 1.01–1.07), higher risks for reoperation (hazard ratio, 2.55; 95% confidence interval, 2.14–3.03) and endocarditis (hazard ratio, 1.60; 95% confidence interval, 1.31–1.94), and lower risks for stroke (hazard ratio, 0.87; 95% confidence interval, 0.82–0.93) and bleeding (hazard ratio, 0.66; 95% confidence interval, 0.62–0.70). Although these results were generally consistent among patient subgroups, bioprosthesis patients aged 65 to 69 years had a substantially elevated 12-year absolute risk of reoperation (10.5%). Conclusions— Among patients undergoing aortic valve replacement, long-term mortality rates were similar for those who received bioprosthetic versus mechanical valves. Bioprostheses were associated with a higher long-term risk of reoperation and endocarditis but a lower risk of stroke and hemorrhage. These risks varied as a function of a patient’s age and comorbidities.

A 32-year-old woman with a history of fibrosing mediastinitis attributable to histoplasmosis presented to Mayo Clinic with occlusion of her right pulmonary artery. She underwent bypass of the occluded pulmonary artery with a 26-mm CryoLife homograft conduit from the right ventricle to the right pulmonary artery. Her postoperative course was uncomplicated, and postoperative cardiac MRI showed a patent right ventricle (RV) to right pulmonary artery homograft conduit, normal perfusion of the lobar branches of the right pulmonary artery, and normal pulmonary venous return (Figure 1). The patient did well after surgery and had an uncomplicated pregnancy 2 years later. Figure 1. A , Computed tomography angiogram performed before the first surgical intervention, showing severe calcification (arrow) in …

Background— Patients with severe aortic stenosis and reduced left ventricular ejection fraction (LVEF) have a poor prognosis with conservative therapy but a high operative mortality when treated surgically. Recently, transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement (SAVR) for patients considered at high or prohibitive operative risk. The objective of this study was to compare TAVI and SAVR with respect to postoperative recovery of LVEF in patients with severe aortic stenosis and reduced LV systolic function. Methods and Results— Echocardiographic data were prospectively collected before and after the procedure in 200 patients undergoing SAVR and 83 patients undergoing TAVI for severe aortic stenosis (aortic valve area ≤1 cm 2 ) with reduced LV systolic function (LVEF ≤50%). TAVI patients were significantly older (81±8 versus 70±10 years; P P =0.005). At the 1-year follow-up, 58% of TAVI patients had a normalization of LVEF (>50%) as opposed to 20% in the SAVR group. On multivariable analysis, female gender ( P =0.004), lower LVEF at baseline ( P =0.005), absence of atrial fibrillation ( P =0.01), TAVI ( P =0.007), and larger increase in aortic valve area after the procedure ( P =0.01) were independently associated with better recovery of LVEF. Conclusion— In patients with severe aortic stenosis and depressed LV systolic function, TAVI is associated with better LVEF recovery compared with SAVR. TAVI may provide an interesting alternative to SAVR in patients with depressed LV systolic function considered at high surgical risk.

Background— Management of severe ischemic mitral regurgitation remains difficult with disappointing early and intermediate-term surgical results of valve repair. Methods and Results— Forty-four patients with severe (4+) Carpentier type IIIb ischemic mitral regurgitation underwent mitral valve repair, with or without surgical revascularization, by posterior leaflet extension with a patch of bovine pericardium and a remodeling annuloplasty. Serial echocardiography was performed preoperatively, intraoperatively, and postoperatively to assess mitral valve competence. The postoperative functional status of patients was assessed. The average Parsonnet score was 38±13. Thirty-day mortality was 11%, and late mortality was 14%. Mean follow-up was 38 months. The actuarial freedom from moderate or severe recurrent mitral regurgitation was 90% at 2 years, whereas 90% of patients were in New York Heart Association class I at 2 years. Conclusion— Posterior leaflet extension with annuloplasty of the mitral valve for severe type IIIb ischemic regurgitation is a safe, effective method that provides good early and intermediate-term competence of the mitral valve and therefore good functional status.

Background— Endothelial cell seeding of glutardialdehyde-fixed biological heart valves is hypothesized to improve biocompatibility and durability; however, the toxicity of glutardialdehyde prevents its use as a biological coating. Therefore, different detoxification strategies are applied, including surface coating with titanium, before in vitro endothelialization of glutaraldehyde-fixed bovine pericardium as the base material for prosthetic heart valves. Methods and Results— Bovine pericardium was fixed with 0.25% glutardialdehyde. Detoxification was performed with citric acid, aldehyde dehydrogenase, and plasma deposition with titanium at low temperatures of 30°C to 35°C. Toxic glutaraldehyde ligands were quantified photometrically, and the vitality of seeded cells was tested to validate detoxification methods. Detoxification agents and titanium coating were applied before seeding with human endothelial cells. Endothelial cells were visualized by electron microscopic surface scanning. To evaluate cell adhesion, shear stress was applied by a flow of 5 L/min over 24 hours. Compared with untreated glutaraldehyde-fixed samples, treatment with the different agents reduced free aldehyde groups gradually (citric acid 5% < citric acid 10% < titanium < aldehyde dehydrogenase). A combination of citric acid 10%, aldehyde dehydrogenase, and titanium coating resulted in a reduction of free aldehyde ligands to 17.3±4.6% ( P ≤0.05) and demonstrated a vitality of seeded cells of 94±6.7% ( P ≤0.05). This procedure yielded a completely confluent layer of regular human endothelial cells (n=5). After application of shear stress for 24 hours on these endothelial layers, cell vitality was 81%. Conclusions— Titanium coating combined with chemical procedures yielded significant detoxification and complete endothelialization of conventional glutaraldehyde-fixed pericardium. This new technique might improve glutardialdehyde-fixed cardiovascular bioimplants for better biocompatibility and longer durability.

In this update, current guidelines addressing prosthesis selection published by the American College of Cardiology/American Heart Association (ACC/AHA) and the European Society of Cardiology (ESC) are discussed, along with additional data that affect choices in valve prostheses. The case of a 50-year-old man undergoing aortic valve replacement is used to address anticipated operative mortality, risk of reoperation, and valve-related morbidity and mortality. The apparent advantages associated with the use of a bioprosthesis even in a relatively young patient help to explain current clinical trends toward the increasing use of tissue valves. We also provide a simplified algorithm that may be used to facilitate the choice of valve procedure in patients with heart valve disease. The outcomes after surgery for valvular heart disease in terms of survival, functional status, and quality of life are determined primarily by patient-related factors such as age, ventricular function, and other comorbidities.1 However, outcomes also are influenced by surgical factors; the best clinical outcomes often are associated with valve repair, although mitral repair is not always possible and aortic valve repair in adults remains the exception rather than the rule. For patients who require valve replacement, the valve prosthesis can significantly influence outcome. The ideal prosthetic valve that combines excellent hemodynamic performance and long-term durability without increased thromboembolic risk or the need for long-term anticoagulation does not exist. Hence, patients and their physicians need to choose between a mechanical and a tissue (bioprosthetic) valve. In general, the advantageous durability of mechanical valves is offset by the risk of thromboembolism and the need for long-term anticoagulation and its associated risk of bleeding. In contrast, bioprosthetic valves do not require long-term anticoagulation yet carry the risk of structural failure and reoperation.2,3 Two historic randomized clinical trials compared outcomes after valve replacement with a first-generation porcine heterograft …

We have with interest and thoroughness read the article by Senage et al1 reporting a high incidence of structural valve disease (SVD) in the small Mitroflow generation 11, 12, and LX. The article, to our understanding, leaves several unanswered questions, and conclusions cannot be left uncommented. Senage et al report a cohort 2109 patients, of whom 617 patients (29%) received Mitroflow implants. In the same time period, 1173 Carpentier-Edwards Perimount (56%), 206 Medtronic Mosaic (10%), and 113 miscellaneous (5%) bioprostheses were implanted. What was the authors’ rationale for choosing 1 implant over another? As Mitroflow users, we know its advantages very well, especially now that the …

Background— With improved event-free survival of patients undergoing primary bioprosthetic aortic valve replacement (AVR), reoperation to relieve severe prosthetic aortic stenosis (PAS) is increasing. We sought to (1) identify of the characteristics of patients with severe bioprosthetic PAS undergoing redo AVR, and (2) assess the outcomes of these patients, along with factors associated with adverse outcomes. Methods and Results— We studied 276 patients with severe bioprosthetic PAS (64±16 years, 58% men) who underwent redo-AVR between 2000 and 2012 (excluding mechanical PAS, severe other valve disease, and transcatheter AVR). Society of Thoracic Surgeons score was calculated. Severe PAS was defined as AV area 2 , mean AV gradient ≥40 mm Hg, or dimensionless index II+ aortic regurgitation. Only 39% had an isolated redo AVR, the rest were combination surgeries (coronary bypass and/or aortic surgeries). At 4.2±3 years, 64 (23%) patients met the composite end point (48 deaths and 19 congestive heart failure admissions, 2.5% 30-day deaths). On multivariable Cox survival analysis, higher Society of Thoracic Surgeons score (hazard ratio, 1.35), higher grades of aortic regurgitation (hazard ratio, 1.29), and higher right ventricular systolic pressure (hazard ratio, 1.3) were associated with worse longer-term outcomes (all P Conclusions— At an experienced center, in patients with severe bioprosthetic PAS undergoing redo AVR, the majority undergo combination surgeries but have excellent outcomes.

Background— The morbidity and mortality of surgical aortic valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic valve bioprosthesis (CoreValve). Methods and Results— Symptomatic high-risk patients with an aortic valve area 2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic valve stenosis (mean gradient before implantation, 44.2±10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic valve gradients (mean gradient after implantation, 12.4±3.0 mm Hg; P Conclusions— Percutaneous implantation of the self-expanding CoreValve aortic valve prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.

Background— Heart valve tissue engineering is a promising strategy to overcome the lack of autologous growing replacements, particularly for the repair of congenital malformations. Here, we present a novel concept using human prenatal progenitor cells as new and exclusive cell source to generate autologous implants ready for use at birth. Methods and Results— Human fetal mesenchymal progenitors were isolated from routinely sampled prenatal chorionic villus specimens and expanded in vitro. A portion was cryopreserved. After phenotyping and genotyping, cells were seeded onto synthetic biodegradable leaflet scaffolds (n=12) and conditioned in a bioreactor. After 21 days, leaflets were endothelialized with umbilical cord blood-derived endothelial progenitor cells and conditioned for additional 7 days. Resulting tissues were analyzed by histology, immunohistochemistry, biochemistry (amounts of extracellular matrix, DNA), mechanical testing, and scanning electron microscopy (SEM) and were compared with native neonatal heart valve leaflets. Fresh and cryopreserved cells showed comparable myofibroblast-like phenotypes. Genotyping confirmed their fetal origin. Neo-tissues exhibited organization, cell phenotypes, extracellular matrix production, and DNA content comparable to their native counterparts. Leaflet surfaces were covered with functional endothelia. SEM showed cellular distribution throughout the polymer and smooth surfaces. Mechanical profiles approximated those of native heart valves. Conclusions— Prenatal fetal progenitors obtained from routine chorionic villus sampling were successfully used as an exclusive, new cell source for the engineering of living heart valve leaflets. This concept may enable autologous replacements with growth potential ready for use at birth. Combined with the use of cell banking technology, this approach may be applied also for postnatal applications.