Project description:The rapid expansion of transcatheter aortic valve implantation (TAVI) has been based upon robust clinical evidence derived from randomized controlled trials and large-scale international and national registries. Over the past decade, TAVI has evolved into a safe and effective procedure with predictable and reproducible outcomes. As a consequence, the TAVI technology is increasingly used to treat patients with a lower risk profile and the volume of TAVI now exceeds surgical aortic valve replacement (SAVR) in some countries. It may be anticipated that, in the near future, the majority of patients with severe symptomatic aortic valve stenosis will undergo TAVI as first line therapy, regardless of their age and risk profile. This article identifies some of the specific challenges that lie ahead when considering expansion of TAVI to younger patients.
Project description:AimTranscatheter aortic valve implantation (TAVI) is a mainstay in the management of severe aortic valve stenosis in elderly patients, but there is uncertainty on their long-term effectiveness. We aimed to assess the long-term outcome of patients undergoing TAVI with the Portico valve.MethodsWe retrospectively collected the data on patients in whom TAVI with Portico was attempted from 7 high-volume centres. Only patients theoretically eligible for 3 or more years of follow-up were included. Clinical outcomes, including death, stroke, myocardial infarction, reintervention for valve degeneration and hemodynamic valve performance were systematically assessed.ResultsA total of 803 patients were included, with 504 (62.8%) women, mean age of 82 years, median EuroSCORE II of 3.1%, and 386 (48.1%) subjects at low/moderate risk. The median follow-up was 3.0 years (3.0; 4.0). The composite of death, stroke, myocardial infarction, and reintervention for valve degeneration occurred in 37.5% (95% confidence interval: 34.1-40.9%), with all-cause death in 35.1% (31.8-38.4%), stroke in 3.4% (1.3-3.4%), myocardial infarction in 1.0% (0.3-1.5%), and reintervention for valve degeneration in 1.1% (0.6-2.1%). The mean aortic valve gradient at follow-up was 8.1 ± 4.6 mmHg, and at least moderate aortic regurgitation was present in 9.1% (6.7-12.3%). Independent predictors of major adverse events or death were: peripheral artery disease, chronic obstructive pulmonary disease, estimated glomerular filtration rate, atrial fibrillation, prior pacemaker implantation, EuroSCORE II, and reduced left ventricular ejection fraction (all p < 0.05).ConclusionsPortico use is associated with favorable long-term clinical outcomes. Clinical outcomes were largely impacted by baseline risk factors and surgical risk.
Project description:BackgroundSurgical implantation rates of bioprosthetic valves, especially the use of sutureless or rapid deployment valves, as well as the advent of transcatheter valve implantation (TAVR) have increased during the last decades mainly due to their excellent haemodynamic and clinical results. One common characteristic of all bioprosthetic types of surgical aortic valve replacement (SAVR) and TAVR is the risk of early degeneration, which leads to valve-dysfunction and is associated with higher rates of valve reinterventions. Recent studies have demonstrated that cusp thrombosis may play a role in early valve dysfunction. This case report is, to our knowledge, the first documentation on a successful treatment of early aortic valve (AV) degeneration of a sutureless AV thrombosis with a valve-in-valve (ViV) TAVR implantation.Case summaryA 77 years old woman was re-evaluated from the heart-team, which considered the following characteristics: severe impairment of mobility and frailty with an STS-score of 10.01% and a EuroSCORE II of 6.9%. Due to the high surgical risk for SAVR, we decided to perform a ViV-TAVR using a balloonexpandable bioprosthesis. The procedure was performed via transfemoral access under general anaesthesia using a 23 mm Edwards-Sapien 3 bioprosthesis without balloon-valvuloplasty and with nominal-volume dilation under rapid-pacing.DiscussionThe differentiation of bioprosthesis valve thrombosis, and hypoattenuating leaflet thickening vs. structural valve degeneration can be difficult, and a multimodality imaging approach, comprising trans-thoracic echocardiogram, transoesophageal echocardiography and computed tomography, useful. These investigations are very important to decide the right strategy of surgical valve replacement vs. TAVR.
Project description:Background: The outcome of redo transcatheter aortic valve (TAV) implantation (TAVI) is unknown for TAV structural valve degeneration (SVD). This paper reports the initial results of redo TAVI for TAV-SVD in Japanese patients. Methods and Results: Of 630 consecutive patients, 6 (1.0%) underwent redo TAVI for TAV-SVD (689-1,932 days after the first TAVI). The first TAV were 23-mm balloon-expandable valves (BEV, n=5) and a 26-mm self-expandable valve (SEV, n=1). All patients underwent multidetector computed tomography (MDCT) before redo TAVI, which showed first-TAV under-expansion (range, 19.1-21.0 mm) compared with the label size. Two BEV and 4 SEV were successfully implanted as second TAV, without moderate/severe regurgitation or 30-day mortality. One of 2 patients with a BEV-inside-BEV implantation had a high transvalvular mean pressure gradient post-procedurally (34 mmHg) and required surgical valve replacement 248 days after the redo TAVI. This, however, was unnoted in patients with SEV implantation during redo TAVI. Planned coronary artery bypass grafting was concomitantly performed in 1 patient with a small sino-tubular junction and SEV-inside-SEV implantation because of the risk of coronary malperfusion caused by the first TAV leaflets. Five of the 6 patients survived during the follow-up period (range, 285-1,503 days). Conclusions: Redo TAVI for TAV-SVD appears safe and feasible, while specific strategies based on MDCT and device selection seem important for better outcomes.
Project description:Transcatheter aortic valve implantation (TAVI) has emerged as the gold standard technique for all patients with symptomatic severe aortic stenosis at elevated surgical risk. Much progress has been made to reduce procedural complications and improve patient outcomes. The impressive results of contemporary TAVI can be attributed to a variety of factors, including improving operator experience, pre-operative patient screening, and developments in transcatheter heart valve and delivery system technology. Despite these advances, serious procedural complications continue to occur and there remain some anatomical subsets and patient groups to whom TAVI technology has not been expanded. Herein we discuss these unmet needs in TAVI.
Project description:ObjectiveTranscatheter aortic valve implantation (TAVI) procedures are increasing rapidly, but the durability of tissue valve and periprocedural complications are not satisfactory. Immune reaction to the galactose-α-1,3 galactose β-1,4-N-acetylglucosamine (α-Gal) and conventional processing protocols of cardiac xenografts lead to calcification. Next-generation TAVI needs to be made with α-Gal-free xenografts by multiple anticalcification therapies to avoid immune rejection and enhance durability, and three-dimensional (3D) printing technology to improve the procedural safety.MethodsPorcine pericardia were decellularized and immunologically modified with α-galactosidase. The pericardia were treated by space filler, crosslinked with glutaraldehyde in organic solvent, and detoxified. The sheep-specific nitinol (nickel-titanium memory alloy) wire backbone was made from a 3D-printed model for ovine aortic root. After it passed the fitting test, we manufactured a self-expandable stented valve with the porcine pericardia mounted on the customized nitinol wire-based stent. After in vitro circulation using customized silicone aortic root, we performed TAVI in 9 sheep and obtained hemodynamic, radiological, immunohistopathological, and biochemical results.ResultsThe valve functioned well, with excellent stent fitting and good coronary flow under in vitro circulation. Sheep were sequentially scheduled to be humanely killed until 238 days after TAVI. Echocardiography and cardiac catheterization demonstrated good hemodynamic status and function of the aortic valve. The xenografts were well preserved without α-Gal immune reaction or calcification based on the immunological, radiographic, microscopic, and biochemical examinations.ConclusionsWe proved preclinical safety and efficacy for next-generation α-Gal-free TAVI with multiple anticalcification therapies and 3D-printing technology. A future clinical study is warranted based on these promising preclinical results.
Project description:The use of transcatheter aortic valve implantation (TAVI) to treat severe symptomatic aortic valve stenosis has increased exponentially in the last decade. This rapid expansion was seen predominantly in Western developed nations and has been fuelled by favorable results reported from a plethora of well-publicized randomized controlled trials, large retrospective series and national registries. Now, TAVI has become the standard of care for inoperable patients and an alternative to open surgery in patients who are at intermediate to high risk for open surgery. Notwithstanding these positive results, Asia has been relatively slow to adopt this technology despite a potentially large patient pool. Unique features of Asian medical environments and differences in Asian anatomy affecting TAVI uptake in Asia will be discussed. This article serves to outline the various challenging aspects of disseminating TAVI in Asian countries.
Project description:BackgroundValve-in-valve transcatheter aortic valve implantation (TAVI) has emerged as a competent alternative for the treatment of degenerated bioprosthetic valves after surgical aortic valve replacement, or during TAVI procedure as a bailout option. Herein, we report a rare case of a self-expandable Medtronic Evolut R valve into a failing Medtronic CoreValve, with the use of modern pre-TAVI imaging screening, suggesting the proper procedural design steps for so complicated implantations.Case summaryA frail 78-year-old woman with a degenerated Medtronic Core Valve 26 mm bioprosthesis, implanted in 2011 due to severe aortic stenosis, was referred to our hospital due to worsening dyspnoea New York Heart Association III. The screening echocardiography documented severe aortic stenosis, while the classical risk scores were in favour of repeated TAVI (EuroSCORE II 5.67%). Computed tomography measurements and three-dimensional (3D) printing model were of great help for the proper valve selection (Medtronic Evolut R 26 mm), while the use of cerebral protection device (Claret Sentinel) was considered as a necessary part of the procedure. The simultaneous use of fluoroscopy and transoesophageal echocardiogram led to optimal haemodynamic result, confirmed by the discharge echocardiogram, with a significant clinical improvement during the first month follow-up.DiscussionThe main periprocedural concerns remain valve malpositioning, coronary artery obstruction, and high remaining transvalvular gradients. The multimodality pre-TAVI imaging screening may be helpful for precise procedural design. Despite the limited use of 3D models, it is necessary to adopt such tissue-mimicking phantoms to increase the possibility of optimal procedural result.
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.