Clinical characteristics and outcomes of aortic prosthetic valve endocarditis: comparison between transcatheter and surgical bioprostheses.

PURPOSE: Most data regarding infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) comes from TAVI registries, rather than IE dedicated cohorts. The objective of our study was to compare the clinical and microbiological profile, imaging features and outcomes of patients with IE after SAVR with a biological prosthetic valve (IE-SAVR) and IE after TAVI (IE-TAVI) from 6 centres with an Endocarditis Team (ET) and broad experience in IE. METHODS: Retrospective analysis of prospectively collected data. From the time of first TAVI implantation in each centre to March 2021, all consecutive patients admitted for IE-SAVR or IE-TAVI were prospectively enrolled. Follow-up was monitored during admission and at 12 months after discharge. RESULTS: 169 patients with IE-SAVR and 41 with IE-TAVI were analysed. Early episodes were more frequent among IE-TAVI. Clinical course during hospitalization was similar in both groups, except for a higher incidence of atrioventricular block in IE-SAVR. The most frequently causative microorganisms were S. epidermidis, Enterococcus spp. and S. aureus in both groups. Periannular complications were more frequent in IE-SAVR. Cardiac surgery was performed in 53.6% of IE-SAVR and 7.3% of IE-TAVI (p=0.001), despite up to 54.8% of IE-TAVI patients had an indication. No differences were observed about death during hospitalization (32.7% vs 35.0%), and at 1-year follow-up (41.8% vs 37.5%), regardless of whether the patient underwent surgery or not. CONCLUSION: Patients with IE-TAVI had a higher incidence of early prosthetic valve IE. Compared to IE-SAVR, IE-TAVI patients underwent cardiac surgery much less frequently, despite having surgical indications. However, in-hospital and 1-year mortality rate was similar between both groups.

Mitral bioprosthesis early dysfunction treated with transapical valvuloplasty during V-A ECMO.

We report the case of a 61-year-old male who had complications with a mitral valve (MV) bioprosthesis replacement by post-cardiotomy shock leading to VA ECMO implantation. The patient suffered early bioprosthetic valve failure owing to early thrombosis. The complication was successfully treated with a MV bioprosthesis transapical balloon valvuloplasty that restored normal leaflet mobility.

Clinical Outcomes Following Transcatheter Mitral Valve-in-Valve Replacement Using a Meril Myval Transcatheter Heart Valve.

AIM: Transcatheter mitral valve-in-valve (TMViV) replacement for degenerated surgically implanted bioprosthetic valves has been described by both transseptal and transapical approaches. The balloon-expandable Myval transcatheter valve (Meril Life Sciences, Vapi, India) is commonly used for transcatheter valve-in-valve procedures in India. This study aimed to report in-hospital, 30-day, and 1-year outcomes of Myval patients who underwent TMViV in a single tertiary care centre in India. METHODS: Symptomatic patients with surgical bioprosthetic mitral valve failure with New York Heart Association (NYHA) class III-IV symptoms, despite optimal medical therapy and high or very high risk for redo surgery, were assigned to TMViV following heart team discussions. Data were retrospectively collected and outcomes assessed. RESULTS: Twenty patients were treated, with mean age 64.4 years, 60% were female, and mean Society of Thoracic Surgeons (STS) predicted risk of operative mortality score was 8.1. The failure mechanism was combined stenosis and regurgitation in 60% of patients. Technical success was achieved in 100% of patients. The mean postprocedure and 30-day gradients were 4.6±2.7 and 6.3±2.1, respectively. None of them had significant valvular or paravalvular leaks or left ventricular outflow tract obstruction. All-cause mortality at 1 year was 10%, and all survivors were in New York Heart Association (NYHA) class I or II. CONCLUSION: TMViV replacement with a Meril Myval can be safely performed with high technical success, and low 30-day and 1-year mortality.

Acellular Bovine Pericardial Patch for Difficult Abdominal Closure in the Pediatric Population: Our Experience with Review of Literature.

Aims: Closure of congenital body wall defects in children can be a challenging task for the pediatric Surgeon. Biological prosthesis has been increasingly used for high-risk wound closure in adult patients with excellent outcomes and use in the pediatric population has also been reported. Here, we aim to study the outcome of abdominal wound repair with a tissue-engineered acellular bovine pericardial patch. Methods: Over a period of 21 months, a total of 15 children had undergone abdominal wound repair with bioprostheses, i.e., bovine pericardial patch at our institute. Patient demographics, cause of defect, an indication of patch use, rate of infection, postoperative recovery, recurrence, and outcome were studied. Results: A total of 15 patients underwent abdominal wall closure with acellular bovine pericardial patch. Nine out of 15 patients were neonates, of whom five had gastroschisis, two had a congenital diaphragmatic hernia, and two had ruptured omphalocele major. Of the rest 6 patients, 2 were patients of bladder exstrophy, 2 were older children of congenital diaphragmatic hernia with incisional hernias, and 2 were older children with omphalocele major. Out of the five patients with gastroschisis, two died during the early postoperative period due to sepsis. The wound healed in the rest 13 patients with mild skin dehiscence in two patients. Only one child had a recurrence. Conclusion: Reconstruction with acellular bovine pericardial patch is a viable option in children with high-risk abdominal wounds as it allows tensionless repair with excellent healing and minimal complications. Recurrence, if any, may disappear with time as remodeling of the prosthesis occurs along with the growth of the body wall of the child.

Transcatheter Mitral Valve-in-Valve Implantation Applying a Long Pre-Curved Sheath for Patients with Degenerated Bioprosthetic Mitral Valve.

Backgrounds: Percutaneous transseptal transcatheter mitral valve-in-valve implantation (TMViV) has become an alternative minimally invasive treatment choice for patients with degenerated mitral bioprosthesis and high surgical risk. However, transseptal approach is more technically challenging than transapical approach in TMViV procedures. Objective: The objective of this study was to introduce the experience of applying long pre-curved sheaths in transseptal TMViV procedures and to evaluate the effect of long pre-curved sheath techniques in TMViV procedures. Methods: Between January 2020 and December 2021, 27 patients with degenerated bioprosthetic mitral valve underwent TMViV procedures using a balloon-expandable valve via the transseptal approach. The regular 14/16F expandable sheath were used for low-profile delivery in first 10 cases, and 22F long pre-curved sheath were used in the next 17 cases during procedures. We retrospectively reviewed the catheter techniques, perioperative characteristics, and prognosis. The median follow-up time was 12 (1-21) months. To further scrutinize our data, we divided the group into the early 10 patients using 14/16F expandable sheath and the subsequent 17 patients with long pre-curved sheath in order to assess the impact of different sheaths and procedural details on outcomes. Results: Procedural success was obtained in all patients with no in-hospital mortality. Seventeen patients received 26 mm prostheses; the remaining ten patients received 29 mm prostheses. Post balloon dilatation was performed in one case. Total procedure time was (96.1 ± 28.2) min, the fluoroscopic time was (27.4 ± 6.5) min, and total contrast volume was (50.7 ± 10.1) mL. One patient received blood transfusion because of hemorrhage at the femoral puncture site. One patient received a permanent pacemaker implantation due to high-degree atrioventricular block at postoperative day 3. There were no other major post-procedure complications and the median length of hospital stay was 4 days. Twenty-five (92.6%) patients improved by ≥ 1 New York Heart Association (NYHA) functional class at 30 days. In subsequent sub analysis, there were shorter procedural time [(85.2 ± 24.3) vs. (115.2 ± 25.6) min, p = 0.0048] and shorter fluoroscopic time [(24.3 ± 5.2) vs. (31.3 ± 5.1) min, p = 0.0073] in cases with the long pre-curved sheath than ones with regular expandable sheath. The iatrogenic atrial septal defect (ASD) closure was performed because of the transeptal large right to left shunt in 2 cases with regular expandable sheath, but no patient needed intraoperative ASD closure in cases with the long pre-curved sheath. Conclusions: Transseptal TMViV using long pre-curved sheath could simplify transseptal approach with reliable outcomes for patients of degenerated mitral bioprosthesis.

Transcatheter Aortic Valve Replacement in Special Populations.

Since its food and drug administration (FDA) approval in 2011, transcatheter aortic valve replacement (TAVR) has revolutionized the highly prevalent disease of aortic stenosis. In this review, we present a comprehensive overview of the data and considerations for utilization of TAVR in special populations who were either excluded from or not adequately represented in the seminal TAVR trials, due to high-risk valvular and/or systemic factors. These include nonagenarians, patients with renal dysfunction, chronic thrombocytopenia, bicuspid aortic valve, rheumatic valve disease, patients with failed aortic valve bioprosthesis requiring valve-in-valve intervention and patients with mixed aortic valve disease. In short, TAVR is a feasible therapeutic strategy in high-risk and special populations with mortality benefit and improvement in quality of life. Randomized controlled trials in high-risk populations are recommended to confirm results from observational studies.

Transcatheter tricuspid valve-in-valve implantation for degenerated surgical bioprosthesis.

BACKGROUND: Isolated redo surgery for degenerated tricuspid bioprosthesis is of very high risk. We aimed to evaluate the safety and efficacy of transcatheter valve-in-valve (TVIV) implantation using a novel balloon expandable Renato valve. METHODS: A prospective multicenter study was conducted to enroll patients with degenerated tricuspid bioprostheses. A total of 12 patients underwent TVIV implantation using the Renato valve system via transfemoral, transjugular, or transatrial approaches at three institutions from May 2021 to October 2021. All-cause mortality and hemodynamic performance were evaluated up to 6 months after procedure. RESULTS: The median age was 68.2 years, and 75.0% were female. Six patients had a history of rheumatic left-sided valve surgery and late tricuspid valve replacement. The median preoperative Society of Thoracic Surgeons score was 9.9%. The procedures were successful in all cases. Tricuspid regurgitation and paravalvular leak were none or mild in all patients. The median transvalvular gradient decreased from 7.8 mmHg preoperatively to 4.5 mmHg at 6 months after TVIV, respectively. No death occurred and all patients recovered to New York Heart Association functional class I or II during a 6-month follow-up. CONCLUSIONS: TVIV implantation with the Renato valve was a safe and effective treatment for degenerated bioprostheses in high-risk patients.

Developing Hemodynamic Valve Deterioration and Mortality in Aortic Valve Replacement.

BACKGROUND: As life span increases, in patients having a bioprosthetic valve, the development of hemodynamic valve deterioration (HVD) is an important concern. We evaluated the association of developing HVD to survival in patients undergoing surgical aortic valve replacement (SAVR). METHODS: The individuals undergoing isolated SAVR and serial echocardiography exams (interval >30 d) were included in this study. HVD was defined as mean pressure gradient ≥ 20 mmHg, mean pressure gradient ≥10 mmHg higher than in the baseline exam, or more than moderate regurgitation on Doppler echocardiography (moderate and severe grade). A time-dependent Cox proportional hazard model was used for this study. RESULTS: A total of 631 patients were included. The mean age was 71.8 ± 6.1 y old (female: 53.6%). HVD was found in 259 patients (41%) during echocardiographic follow-up (mean 3.3 ± 3.0 y). Patient-prosthetic mismatch was found in 174 patients. One hundred and twenty-six patients died during follow-up (median 62.1 mo, interquartile range 31.1-96.8). The development of HVD was an independent risk factor for death during follow-up (P = 0.038, hazard ratio 1.46, 95% confidential interval: 1.02-2.08). CONCLUSIONS: HVD was common after bioprosthetic SAVR during mid-term follow-up. Developing HVD, including moderate and severe grades, was associated with a poor survival rate compared with patients without HVD.

An Analysis of Early Results after Valve Replacement in Isolated Aortic Valve Stenosis by Using Sutureless vs. Stented Bioprostheses: A Single-Center Middle-Income Country Experience.

Background and Objectives: There is a lack of data about the survival of patients after the implantation of sutureless relative to stented bioprostheses in middle-income settings. The objective of this study was to compare the survival of people with isolated severe aortic stenosis after the implantation of sutureless and stented bioprostheses in a tertiary referral center in Serbia. Materials and Methods: This retrospective cohort study included all people treated for isolated severe aortic stenosis with sutureless and stented bioprostheses from 1 January 2018 to 1 July 2021 at the Institute for Cardiovascular Diseases "Dedinje". Demographic, clinical, perioperative and postoperative data were extracted from the medical records. The follow-up lasted for a median of 2 years. Results: The study sample comprised a total of 238 people with a stented (conventional) bioprosthesis and 101 people with a sutureless bioprosthesis (Perceval). Over the follow-up, 13.9% of people who received the conventional and 10.9% of people who received the Perceval valve died (p = 0.400). No difference in the overall survival was observed (p = 0.797). The multivariate Cox proportional hazard model suggested that being older, having a higher preoperative EuroScore II, having a stroke over the follow-up period and having valve-related complications were independently associated with all-cause mortality over a median of 2 years after the bioprosthesis implantation. Conclusions: This research conducted in a middle-income country supports previous findings in high-income countries regarding the survival of people with sutureless and stented valves. Survival after bioprosthesis implantation should be monitored long-term to ensure optimum postoperative outcomes.

Long-Term Outcomes of the Mosaic Mitral Porcine Bioprosthesis in Japan　- Results From the Japan Mosaic Valve Long-Term Multicenter Study.

BACKGROUND: This study retrospectively evaluated the long-term patient outcomes and durability of the Mosaic mitral porcine bioprosthesis in the Japan Mosaic valve long-term multicenter study.Methods and Results:The medical records of 390 patients who underwent mitral valve replacement with the Mosaic bioprosthesis at 10 centers in Japan (1999-2014) were reviewed. Patient data were collected using the Research Electronic Data Capture software. Patient survival was determined using the Kaplan-Meier method. Freedom from structural valve deterioration (SVD) and valve-related reoperation and death were determined using actuarial methods. The median (interquartile range [IQR]) age of the cohort was 73 (69-77) years. The median (IQR) follow-up period was 4.83 (1.84-8.26) years. The longest follow-up period was 15.8 years. The 30-day mortality rate was 5.4%. The 12-year actuarial survival rate was 54.1±4.5%, and the freedom from valve-related death was 85.3±3.4%. The freedom from reoperation at 12 years was 74.3±5.7%. The freedom from SVD at 12 years was 81.4±6.6% for patients aged ≥65 years and 71.6±11.1% for those aged <65 years. The median (IQR) mean pressure gradient was 4.1 (3.0-6.0) and 5.6 (4.0-6.7) mmHg at 1 and 10 years, respectively. The median (IQR) effective orifice area was 1.7 (1.4-2.0) and 1.4 (1.2-1.6) cm2at 1 and 10 years, respectively. CONCLUSIONS: The Mosaic porcine bioprosthesis offered satisfactory long-term outcomes for up to 12 years.

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

BACKGROUND: 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. CONCLUSIONS: 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.

Long-term outcomes of mechanical versus biological valve prosthesis in native mitral valve infective endocarditis.

Objectives. To study the long-term outcomes of mitral valve replacement with mechanical or biological valve prostheses in native mitral valve infective endocarditis patients. Desing. We conducted a retrospective, nationwide, multicenter cohort study with patients aged ≤70 years who were treated with mitral valve replacement for native mitral valve infective endocarditis in Finland between 2004 and 2017. Results. The endpoints were all-cause mortality, ischemic stroke, major bleeding, and mitral valve reoperations. The results were adjusted for baseline features (age, gender, comorbidities, history of drug abuse, concomitant surgeries, operational urgency, and surgical center). The median follow-up time was 6.1 years. The 12-year cumulative mortality rates were 36% for mechanical prostheses and 74% for biological prostheses (adj. HR 0.40; CI: 0.17-0.91; p = 0.03). At follow-up, the ischemic stroke had occurred in 19% of patients with mechanical prosthesis and 33% of those with a biological prosthesis (adj. p = 0.52). The major bleeding rates within the 12-year follow-up period were 30% for mechanical prosthesis and 13% for a biological prosthesis (adj. p = 0.29). The mitral valve reoperation rates were 13% for mechanical prosthesis and 12% for a biological prosthesis (adj. p = 0.50). Drug abuse history did not have a significant modifying impact on the results (interaction p = 0.51 for mortality and ≥0.13 for secondary outcomes). Conclusion. The use of mechanical mitral valve prosthesis is associated with lower long-term mortality compared to the biological prosthesis in non-elder native mitral valve infective endocarditis patients. The routine choice of biological mitral valve prostheses for this patient group is not supported by the results.

Effect of ethanol washing on porcine pulmonary artery wall decellularization using sodium dodecyl sulfate.

BACKGROUND: To determine the effectiveness of ethanol (EtOH) washing on porcine pulmonary artery (PA) wall decellularization using sodium dodecyl sulfate (SDS), we compared three different washing methods (phosphate-buffered saline [PBS], pH 9 alkali, and EtOH washing). METHODS: Fresh porcine PA walls were decellularized using 0.5% SDS and 0.5% sodium deoxycholate (SDC). The decellularized tissues were rinsed using three different washing techniques. Histological, biochemical, and mechanical analyses were conducted. Implantation into the subcutaneous tissue of rats and patch implantation into the carotid artery of dogs were performed as preliminary in vivo studies. RESULTS: The decellularization protocol based on SDS and SDC effectively removed the cells. The major extracellular matrix (ECM) structures (collagen, elastic fiber, and glycosaminoglycan) were properly preserved with the 75% EtOH-washing method. Significantly reduced residual SDS content was identified in EtOH-washed tissues compared to that in the other methods. No significant difference in the mechanical strength test was observed between the washing methods, and the EtOH-washing method showed better results in the metabolic activity test compared to the PBS-washing method. In the rat study model, no acute rejection or massive calcification was observed. The in vivo preliminary canine study showed better cell repopulation in the EtOH-washed group. CONCLUSION: EtOH washing of SDS-based decellularized porcine PA wall can reduce the residual SDS content and preserve ECM structures, especially the elastin content, and could also enhance cell repopulation after re-implantation.

Bacterial endocarditis with AACEK (HACEK) organisms.

INTRODUCTION: Gram-negative organisms of the AACEK group, formerly known as HACEK, rarely cause endocarditis. CASE SERIES: We present three cases of bacterial endocarditis, involving native and prosthetic valves, caused by AACEK organisms. In two patients, Cardiobacterium hominis was the responsible organism, and in a third, Aggregatibacter aphrophilus was implicated. A dental source of infection was identified in two patients, and in all three patients, the presentation of endocarditis was subacute. DISCUSSION: This case series highlights the indolent nature of infection with the AACEK organisms. It also demonstrates the crucial role of multimodality imaging, especially transesophageal echocardiography, in the diagnosis of AACEk endocarditis of both native and prosthetic valves, and in delineating the extent of abscess in those with prosthetic valve infection.

Hemodynamic performance of INSPIRIS RESILIA aortic bioprosthesis for severe aortic stenosis: 2-year follow-up in Japanese cohort.

The INSPIRIS RESILIA aortic bioprosthesis (Edwards Lifesciences LLC, Irvine, USA) was fixed in novel tissue preservation technology to ensure long-term durability. Hemodynamic performance after aortic valve replacement (AVR) for severe aortic stenosis (AS) has not been published in the Japanese cohort. Twenty-nine patients underwent AVR with INSPIRIS RESILIA bioprosthesis for severe AS between November 1, 2018 and December 31, 2020. The mean age was 75.1 ± 4.5 years with 19 female patients. Body surface area was 1.58 ± 0.19 m2 and New York Heart Association functional class was 2.2 ± 0.5. Hemodynamic performance was assessed using follow-up transthoracic echocardiographic data collected at 3-6 months, 1 year and 2 years. The mean follow-up time was 19.2 ± 7.2 months, with a 100% follow-up rate. One patient died of postoperative heart failure. The preoperative mean and peak transvalvular pressure gradients (PGs) were 51.9 ± 18.4 mmHg and 89.3 ± 34.9 mmHg, respectively, and effective orifice area 0.72 ± 0.26 cm2. They improved at 10.2 ± 3.5 mmHg (p < 0.0001), 19.3 ± 6.6 mmHg (p < 0.0001) and 1.73 ± 0.47cm2 (p < 0.0001) at discharge. The mean transvalvular PG at 3-6 months (n = 24), 1 year (n = 25) and 2 years (n = 15) was 11.2 ± 3.8 mmHg (p < 0.0001), 11.1 ± 3.2 mmHg (p < 0.0001) and 11.2 ± 3.3 mmHg (p < 0.0001), respectively. Left ventricular mass index decreased from 123.0 ± 35.0 g/m2 before surgery to 113.4 ± 35.0 g/m2 (p = 0.0133) at discharge. It has dropped to 88.0 ± 25.0 g/m2 (p = 0.0007) at 2 years. Constrictive pericarditis caused heart failure in one patient. INSPIRIS RESILIA bioprosthesis showed improved hemodynamic performance in the early postoperative phase. There were fewer valve-related events observed.

In patients with AF and a bioprosthetic mitral valve, rivaroxaban was noninferior to warfarin for time to clinical events.

SOURCE CITATION: Guimarães HP, Lopes RD, de Barros E Silva PG, et al. Rivaroxaban in patients with atrial fibrillation and a bioprosthetic mitral valve. N Engl J Med. 2020;383:2117-26. 33196155.

Hemodynamic and clinical performance of the 25-mm Medtronic Mosaic porcine bioprosthesis in the mitral position.

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

Eight-year outcomes of aortic valve replacement with the Carpentier-Edwards PERIMOUNT Magna Ease valve.

INTRODUCTION: The Carpentier-Edwards PERIMOUNT Magna Ease valve is a third-generation bioprosthesis for aortic valve replacement (AVR). This is a postapproval study reporting on its 8-year outcomes. METHODS: Adults undergoing AVR with the Magna Ease valve between October 2007 and December 2012 were enrolled for this prospective, nonrandomized, single-arm, and multicenter study. Assessments occurred preoperatively, at hospital discharge, 6 months, 1 year, and annually thereafter for up to 8 years. Outcomes included safety endpoints, hemodynamic performance, and New York Heart Association (NYHA) functional class. RESULTS: Of the 258 study patients, 67.5% were in NYHA Class I or II, and 32.5% were in NYHA Class III or IV at baseline. Concomitant procedures were performed in 44.2%. Total follow-up was 1597.6 patient-years, and median follow-up was 7 years (interquartile range: 5.5-8.0 years). Eight years following AVR, the functional class remained improved from baseline with 93.9% in NYHA Class I/II and 6.1% in NYHA Class III; 38 deaths had occurred, 8 of which were valve related; freedom from all-cause mortality was 80.7% (95% confidence intervals: 74.9, 86.4); freedom from valve-related mortality was 95.8% (92.8, 98.8); freedom from reintervention, explant, major bleeding events, and structural valve deterioration was 89.8% (85.1, 94.6), 94.8% (91.7, 97.9), 85.1% (80.0, 90.1), and 90.1% (84.7, 95.4), respectively; effective orifice area was 1.5 ± 0.5 cm2 , the mean gradient was 14.8 ± 8.3 mmHg, and 88.6% of patients had no or trivial aortic regurgitation. CONCLUSIONS: This study demonstrated satisfactory safety and sustained hemodynamic and functional improvements at 8 years following AVR with the Magna Ease valve.

Trans-cuff leakage in bio-Bentall operation.

We have reported a case of trans-cuff leakage that occurred in a composite graft of bio-Bentall operation. The leakage resolved several months after surgery, similar to the trans-cuff leakage seen in simple aortic valve replacement. We have proposed hypotheses on the mechanism of trans-cuff leakage during a bio-Bentall operation and suggested ways to prevent it from occurring.

Use of a self-expanding transcatheter valve for a degenerated INTUITY valve.

Valve-in-valve transcatheter aortic valve replacement for degenerated surgical bioprosthesis is becoming a more common therapeutic option. Rapid-deployment valves are novel, have distinct structural differences from standard surgical valves, and are increasingly used in minimal-access surgery. We report the case of a 61-year-old man who developed severe stenosis of an Edwards INTUITY Elite rapid-deployment valve and who subsequently underwent successful valve-in-valve placement of a self-expanding transcatheter valve. To our knowledge, this is the first description of the technical aspects of and considerations for using the self-expanding transcatheter platform in the Edwards INTUITY Elite valve.