Valve-shaped thrombus underneath an aortic bioprosthesis.
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SUBMITTER: Cibin G
PROVIDER: S-EPMC9290846 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundFailure of a small surgical aortic bioprosthesis represents a challenging clinical scenario with valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) often resulting in patient-prosthesis mismatch. Bioprosthetic valve fracture (BVF) performed as a part of the ViV TAVI has recently emerged as an alternative approach with certain types of surgical bioprostheses.Case summaryAn 81-year-old woman with a history of three surgical aortic valve procedures presented with heart failure. Aortic bioprosthesis degeneration with severe stenosis and moderate regurgitation was found. The patient was deemed a high-risk surgical candidate and the heart team decided that ViV TAVI was the preferred treatment option. Due to the very small 19 mm stented surgical aortic bioprosthesis Mitroflow 19 mm (Sorin Group, Italy) we decided to perform BVF as a part of ViV TAVI to prevent patient-prosthesis mismatch. Since this was the first BVF procedure in our centre, an ex vivo BVF of the same kind of bioprosthetic valve was performed first. Subsequently, successful BVF with implantation of Evolut R 23 mm (Medtronic, USA) self-expandable transcatheter valve was performed. Excellent haemodynamic result was achieved and no periprocedural complications were present. The patient had an immediate major improvement in clinical status and remains asymptomatic after 6 months.DiscussionBioprosthetic valve fracture together with ViV TAVI is a safe and effective emerging technique for treatment of small surgical aortic bioprosthesis failure. Bioprosthetic valve fracture allows marked oversizing of implanted self-expandable transcatheter aortic valves, leading to excellent haemodynamic and clinical results. An ex vivo BVF can serve as an important preparatory step when introducing the new method.
| S-EPMC7793178 | biostudies-literature
Project description:BackgroundRapid-deployment aortic valve replacement (RDAVR) is an alternative to conventional AVR (cAVR) for aortic stenosis. Benefits include a reduction in operative times, facilitation of minimal access surgery and superior haemodynamics compared to conventional valves. However, further evidence is required to inform guidelines, preferably in the form of propensity-matched studies that include mid-term follow-up data.MethodsThis was a single-centre, retrospective, propensity-matched cohort study comparing the Perceval and conventional Perimount Magna Ease valve for short- and mid-term clinical parameters and size-matched mid-term echocardiographic parameters (n = 102 in both groups) from 2014 to 2020. Data were extracted from a nationally managed dataset.ResultsThere were no demographic differences between the matched groups. The Perceval group had shorter cross-clamp time (Perceval 62 [49-81] minutes; Perimount 79 [63-102] minutes, P < 0.001), shorter bypass time (Perceval 89 [74-114] minutes; Perimount 104 [84-137] minutes, P < 0.001), and more frequent minimally-invasive approaches (Perceval 28%; Perimount 5%, P < 0.001). Size-matched haemodynamics showed initially higher gradients in the Perceval group, but haemodynamics equalised at 12 + months. The Perceval group had a more favourable % change in the left ventricular posterior wall dimension at 2 + years (Perceval - 4.8 ± 18; Perimount 17 ± 2).ConclusionsThe Perceval facilitated shorter operations, which may benefit intermediate-high-risk, elderly patients with comorbidities requiring concomitant procedures. It also facilitated minimally invasive surgery. Size-matched haemodynamic performance was similar at mid-term follow-up, with the Perceval possibly better facilitating regression of left ventricular hypertrophy.
| S-EPMC10865583 | biostudies-literature
Project description:BackgroundLimited data are available regarding outcomes for stentless aortic valve reoperation. The reported reoperative mortality has been unacceptably high.MethodsBetween 1997 and 2017, a retrospective analysis was performed on 143 patients who underwent open aortic valve reoperations for failed stentless aortic valve bioprostheses. We evaluated both short-term and long-term outcomes on this cohort of patients.ResultsBicuspid aortic valve was present in 107 of 143 patients (75%) at the time of the initial Freestyle (Medtronic, Minneapolis, MN) procedure, and 120 of 143 patients (84%) underwent a modified inclusion aortic root replacement procedure. The interval from first operation to reoperation was 9 years (range, 5.4 to 11.8), which was significantly shorter for patients with infectious endocarditis (4.1 years; range, 1.8 to 7.1) compared with patients with structural valvular deterioration (10.4 years; range, 8.1 to 12.4, p < 0.001). The median age at the time of reoperation was 59 years (range, 50 to 67). Aortic valve reoperation was performed for structural valve deterioration in 68% cases compared with 32% for infectious prosthetic valve endocarditis. Concomitant surgery included coronary artery bypass (13%), mitral valve surgery (4%), and ascending aorta and arch replacement (42%). The 30-day and inhospital mortality was 1% and 2%, respectively. The composite outcome including myocardial infarction, stroke, new-onset renal failure on hemodialysis, and operative mortality was 4%. The 5-year and 10-year Kaplan-Meier survival after reoperation for failed stentless valve was 83% (95% confidence interval: 73% to 89%) and 57% (95% confidence interval: 36% to 74%).ConclusionsAortic valve reoperation after stentless valve implantation can be performed with low operative mortality and favorable long-term survival.
| S-EPMC6669885 | biostudies-literature
Project description:We assessed the safety, effectiveness and haemodynamic performance of a new bovine stented aortic valve bioprosthesis (Avalus™).The PERIGON Pivotal Trial is a prospective, non-randomized, multicentre study. Subjects had symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. Death, valve-related adverse events (AEs), functional recovery and haemodynamic performance were assessed at discharge, 3-6 months and 1 year. The primary analysis compared 'late' (>30 days post-implant) linearized rates of valve-related thromboembolism, thrombosis, all and major haemorrhage, all and major paravalvular leak (PVL) and endocarditis after implantation with objective performance criteria (OPC) for AEs, in accordance with EN ISO 5840:2009. We hypothesized that the upper 95% confidence bounds of the true linearized AE rates would be ??2?×?OPC; rejection of the null hypothesis would demonstrate that these rates were below acceptable rates. The analysis was required to include at least 150 patients followed to 1 year and 400 valve-years. Kaplan-Meier survival analysis was also performed.Total number of valve-years was 459.5 (n?=?686). Linearized rates were <2?×?OPC for death and valve-related thromboembolism, valve thrombosis, all and major PVL, and endocarditis, but ?2?×?OPC for all and major haemorrhage. Survival at 1 year (n?=?270) was 96.4%. Patients showed good functional recovery, and haemodynamic performance was within expected range.This analysis demonstrated a good safety profile and clinical effectiveness of the Avalus valve except for bleeding rates. The linearized rates of all and major haemorrhage may be related to long-term anticoagulation for non-valvular indications and the length of follow-up of this cohort.NCT02088554 (www.clinicaltrials.gov).
| S-EPMC5848807 | biostudies-literature
Project description:Background: The valve-in-valve (VIV) procedure is being increasingly performed in high-risk patients with a degenerated bioprosthesis in an aortic position in Western countries. The early safety and efficacy of the VIV procedure, however, remain unclear in Japanese patients with a small aortic annulus. We present the protocol for a study designed to evaluate the early safety and efficacy of the VIV procedure in the aortic position in Japanese patients. Methods and Results: The prospective, single-center, non-comparative, clinical study of the VIV procedure for the aortic position (AORTIC VIV study) commenced in August 2016 and will end in March 2020. Patients will be monitored for ≥1 month after the VIV procedure. The targeted number of patients is 11. Eligible patients are those who have undergone transcatheter aortic valve replacement for a surgical valve (including stented or stentless bioprosthetic valves), or for a transcatheter heart valve. The VIV procedure is performed in high-operative-risk patients with substantial prosthetic valve stenosis, and regurgitation and heart failure resistant to medical treatment (unless the patient meets an exclusion criterion). The safety and efficacy of the VIV procedure will be evaluated in accordance with the Valve Academic Research Consortium-2 initiative. Conclusions: The AORTIC VIV study will clarify the early safety and efficacy of the VIV procedure in Japanese patients.
| S-EPMC7890281 | biostudies-literature
Project description:ObjectivesLong-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA™ tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue.MethodsThis was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 sites in Poland. Clinical outcomes and haemodynamic performance were assessed annually for 5?years post-implant. Safety events were adjudicated by a Clinical Events Committee and echocardiographic data were assessed by an independent core laboratory.ResultsMean patient age was 65.3?±?13.5?years, with 34 patients (25.6%) ?60. The mean follow-up was 4.2?±?1.5?years. Early (?30?days) and late (>30?days) all-cause mortality were 2.3% (N?=?3) and 3.2%/late patients-years (N?=?18) respectively. Early events included thromboembolism in 3 patients (2.3%). Late valve-related events included endocarditis in 1 patient, which led to explant, and valve thrombosis in another patient. There were no events of structural valve deterioration throughout the study. At 5?years, mean gradient was 14.8?±?7.6?mmHg and effective orifice area was 1.4?±?0.5 cm2, a marked improvement over baseline values. All New York Heart Association class III patients and most class II patients at baseline had improved classifications at 5?years.ConclusionsThe bioprosthesis with RESILIA tissue demonstrated a good safety profile with excellent haemodynamic performance over 5?years of follow-up. These encouraging outcomes warrant additional investigation of this novel tissue.Clinical trial registration numberNCT01651052.
| S-EPMC7850021 | biostudies-literature
Project description:Background We assessed the Ozaki procedure, aortic valve reconstruction using autologous pericardium, with respect to its learning curve, hemodynamic performance, and durability compared with a stented bioprosthesis. Methods and Results From January 2007 to January 2016, 776 patients underwent an Ozaki procedure at Toho University Ohashi Medical Center. Learning curves, aortic regurgitation (AR), and peak gradient, assessed by serial echocardiograms, valve rereplacement, and survival were investigated. Valve performance and durability were compared with 627 1:1 propensity-matched patients receiving stented bovine pericardial valves implanted from 1982 to 2011 at Cleveland Clinic. Learning curves were observed for aortic clamp and cardiopulmonary bypass times, AR prevalence, and early mortality. Decreased aortic clamp time was observed over the first 300 cases. New surgeons performing parts of the procedure after case 400 resulted in a slight increase in aortic clamp and cardiopulmonary bypass times. Among matched patients, the Ozaki cohort had more AR than the PERIMOUNT cohort (severe AR at 1 and 6 years, 0.58% and 3.6% versus 0.45% and 1.0%, respectively; P[trend]=0.006), although with a steep learning curve. Peak gradient showed the opposite trend: 14 and 17 mm Hg for Ozaki and 24 and 28 mm Hg for PERIMOUNT at these times (P[trend]<0.001). Freedom from rereplacement was similar (P=0.491). Survival of the Ozaki cohort was 85% at 6 years. Conclusions Patients undergoing the Ozaki procedure had lower gradients but more recurrent AR than those receiving PERIMOUNT bioprostheses. Although recurrent AR is concerning, results confirm low risk and good midterm performance of the Ozaki procedure, supporting its continued use.
| S-EPMC9939068 | biostudies-literature
Project description:BackgroundThe NAUTILUS study aimed to evaluate the safety and performance of the Allegra bioprosthesis in high-risk recipients undergoing transcatheter aortic valve implantation and previously reported 30-day outcomes. In the current investigation 1-year results of the trial are presented.MethodsTwenty-seven recipients with severe, symptomatic aortic valve stenosis at high surgical risk, who underwent treatment using the next-generation self-expanding Allegra via transfemoral approach were prospectively enrolled. Clinical endpoints assessed were: mortality, stroke, permanent pacemaker implantation, New York Heart Association class and re-hospitalizations. Prosthetic valve performance evaluation comprised of: mean gradient, effective orifice area and paravalvular leak.ResultsPatients were elderly (82.8 ± 4.2 years) and predominantly female (n = 19, 70.4%). All of them were deemed to be at high surgical risk with a mean logistic EuroSCORE of 12.5 ± 6.7. The bioprosthesis was successfully implanted in 92.6% of the cases (n = 25). At 1-year, all-cause mortality was 12.0% (n = 3) and stroke was 4.0% (n = 1). Three (12%) of patients developed complete atrioventricular block and received permanent pacemakers. 84% of patients were in New York Heart Association class II or lower. Need for subsequent hospitalization arose in 48% patients. The echocardiographic assessment confirmed an acceptable hemodynamic profile of the Allegra with low mean transprosthetic gradient (9.5 ± 3.4 mmHg), absence of severe paravalvular leak and a 20%-presence of moderate paravalvular leak.ConclusionsThe current follow-up observation study shows that the Allegra was associated with a satisfactory safety profile and hemodynamic performance at 1-year after implantation.
| S-EPMC8747808 | biostudies-literature
Project description:Transapical aortic valve implantation (TA-AVI) has been widely introduced for treatment of patients with severe aortic stenosis in the last decade. Here we report our first clinical experience with 10 patients using the second-generation transapical Symetis Acurate TA aortic valve designed for transapical implantation.To evaluate the results of transapical access in transcatheter aortic valve implantation (TAVI) among patients with unsuitable vascular access.All patients had been assessed by a local heart team and were disqualified from surgical aortic valve replacement (AVR) and the transfemoral TAVI approach. Mean age was 75.4 ±3.9 years (range: 68-80), with 20% being female. Logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) and STS (Society of Thoracic Surgeons) were 15.4 ±8.9% and 20.5 ±4.5%, respectively.All implantations were performed successfully in the intra-annular and subcoronary position. There were no conversions to surgical AVR. All patients survived 30-day follow-up. No strokes or transient ischemic attacks were reported. There was no need for pacemaker implantation and none of the patients demonstrated moderate or significant paravalvular leakage. The mean aortic gradients improved significantly from a baseline of 57.0 ±19.2 mm Hg to a 30-day value of 14.2 ±4.1 mm Hg.Our initial clinical results indicate satisfactory functionality in patients after trans-apical implantation of the Symetis Acurate aortic valve. The procedure of implantation seems to be straightforward and may be considered in patients in whom a transfemoral approach is not a good option.
| S-EPMC5502338 | biostudies-other
Project description:BackgroundThe durability of bioprosthetic heart valves is limited by structural valve deterioration (SVD) due to long-term calcification. A novel bioprosthetic tissue (RESILIATM) has been developed which, in preclinical studies, has shown reduced calcification. The purpose of this study was to evaluate the intermediate-term clinical outcomes and hemodynamic performance of this tissue.MethodsA prospective, single-arm, observational trial was conducted in patients who required surgical aortic valve replacement (AVR). Between July 2011 and February 2013, 133 patients were implanted at two sites in Poland. Hemodynamic performance and clinical outcomes were assessed annually through 4 years of follow-up. All safety events were adjudicated by an independent Clinical Events Committee, and echocardiographic data were evaluated by a core laboratory.ResultsPatients were 65.3±13.5 years old and 26% were ≤60 years old. The average follow-up was 3.8±1.1 (median: 4.1; IQR, 4.0-4.3) years. Early (≤30 day) and late (>30 day) all-cause mortality rates were 2.3% (n=3) and 3.2% late patient-years (n=16), respectively. There were no cases of early or late SVD. There was one early case of major paravalvular leak (0.8%), and no late cases. At 4 years, the mean gradient was 14.5±7.4 mmHg and the effective orifice area was 1.6±0.4 cm2, both markedly improved from baseline. At 4 years, the New York Heart Association functional class had improved from baseline in 54.5% of patients.ConclusionsThe aortic bioprosthesis with novel RESILIATM tissue demonstrated excellent hemodynamic performance and safety outcomes over 4 years. Longer follow-up will be important to confirm the durability of this bioprosthesis.
| S-EPMC6688015 | biostudies-literature