Paravalvular Aortic Regurgitation Research Articles

Transcatheter aortic valve replacement with the VenusA-Pro and VenusA-Plus systems: preliminary experience in China.

The outcomes of transcatheter aortic valve replacement (TAVR) employing the second-generation retrievable VenusA-Pro and VenusA-Plus delivery systems with the self-expanding VenusA-Valve have not been described yet. This study aims to report the outcomes of these two second-generation delivery systems. From January 2022 to April 2023, we prospectively enrolled patients with severe aortic stenosis undergoing TAVR with VenusA-Pro from three centers across China in this first-in-man study and retrospectively identified those undergoing TAVR with VenusA-Plus. All outcomes were reported according to the Valve Academic Research Consortium 3 definition. The primary outcome was 30-day all-cause mortality. A total of 156 patients were included, of which 46 underwent TAVR with VenusA-Pro and 110 underwent TAVR with VenusA-Plus. The Society of Thoracic Surgeons median score was 2.1%, bicuspid anatomy prevalence rate was 55.1%, and the mean aortic root calcification volume was 693 mm3. The technical success rate was 91.7%, comparable between the VenusA-Pro and VenusA-Plus groups (87.0% vs. 93.6%, P = 0.169). The 30-day all-cause mortality was 2.6%, similar between the VenusA-Pro and VenusA-Plus groups (2.2% vs. 2.7%, P = 0.842). No myocardial infarction occurred. The incidences of stroke (0.6%), major bleeding (3.8%), major vascular complications (5.1%), acute kidney injury (9.0%), permanent pacemaker implantation (5.1%), new-onset atrial fibrillation (5.8%), and moderate-to-severe paravalvular aortic regurgitation (6.0%) were favorable and comparable between the two groups. The clinical outcomes were similar between the patients with bicuspid and tricuspid aortic valve, except that the incidence of permanent pacemaker implantation was lower in patients with bicuspid anatomy (1.2% vs. 10.6%, P = 0.010). The 30-day outcomes of TAVR with VenusA-Pro and VenusA-Plus were favorable and comparable.

TAV-in-TAV for paravalvular aortic regurgitation due to a deeply implanted Navitor transcatheter aortic valve.

TAV-in-TAV for paravalvular aortic regurgitation due to a deeply implanted Navitor transcatheter aortic valve.

Ultra-low radiation dose and contrast volume CT protocol and TAVI-CT score for TAVI planning and outcome.

To investigate the feasibility of an ultra-low radiation dose and contrast volume protocol using third-generation dual-source (DS) CT for transcatheter aortic valve implantation (TAVI) planning with coronary artery disease (CAD) assessment, coronary artery calcium score (CACS) and aortic valve calcium score (AVCS) quantification and to evaluate their relationship with TAVI outcome. In this retrospective study were selected 203 patients (131 males, 79.4 ± 5.4 years) underwent to TAVI and at 30- and 90-day follow-up. All patients had performed a third-generation 2 × 192-slices DSCT. The CT protocol included a non-contrast and a contrast high-pitch aortic acquisition for TAVI planning and CAD assessment. Semi-qualitative and quantitative image analysis were performed; the performance in CAD assessment was compared with ICA; the relationship between AVCS and CACS and paravalvular aortic regurgitation (PAR) and major cardiovascular events (MACEs) were evaluated. Mean radiation dose were calculated. Non-parametric tests were used. Semi-qualitative image analysis was good. Contrast enhancement >500 Hounsfield unit (HU) and contrast-to-noise ratio <20 were obtained in all segments. The diagnostic accuracy in CAD was 89.0%. AVCS was significantly higher in patients with 30-day severe PAR. AVCS and CACS were higher in patients with 90-day MACE complications, respectively, 1904.5 ± 621.3 HU (p < 0.0001) and 769.2 ± 365.5 HU (p < 0.0230). Mean radiation dose was 2.8 ± 0.3 mSv. A TAVI planning ultra-low radiation dose and contrast volume protocol using third-generation DSCT provides highly diagnostic images with CAD assessment, AVCS and CACS quantification and these latter were related with TAVI outcomes. The proposed protocol using third-generation 2 × 192-slices DSCT allows with an ultra-low radiation dose and contrast volume the TAVI planning and the coronary artery assessment.

Intraprocedural delayed reassessment of paravalvular regurgitation in TAVR significantly reduces the use of postdilatation.

We sought to investigate the effect of a 15-min delayed intraprocedural reassessment of paravalvular aortic regurgitation (PVR) after an immediate evaluation of posttranscatheter aortic valve replacement (TAVR) on the regurgitation grading and usage of postdilatation. PVR after TAVR is associated with poor prognosis, but postdilatation may increase the risk of other complications. In a prospective cohort of consecutive patients treated with balloon-expandable valve ES-3 ultra, the degree of PVR was assessed immediately and 15 min after that first evaluation (excluded severe cases), with the indication of postdilatation based on the delayed assessment. As a control group, the previous consecutive series of patients also treated with the same model of valve prosthesis was used. A total of 180 patients were included in the prospective study cohort and 152 in the retrospective control group. In the study group, the immediate PVR assessment showed none-trace 27.5%, mild 52%, moderate 19%, and severe 1.5%, and the delayed re-evaluation graded PVR as none-trace 83%, mild 15.6%, and moderate 1.2% (p < 0.001 as compared to immediate). In the control group, the immediate PVR assessment showed none-trace 33.5%, mild 52%, moderate 13%, and severe 1.5%. The rate of postdilatation was 2.8% in the study group versus 10.5% in the control group (p = 0.006). At discharge, no differences were observed between groups in PVR echocardiographic grading. A post-TAVR delayed intraprocedural reassessment of the PVR shows a clearly lower degree of regurgitation as compared to immediate evaluation, which significantly decreased the indication of postdilatation.

P151 UTILITY OF MULTIMODALITY IMAGING IN A CASE OF MULTIPLE AORTIC POST–ENDOCARDITIS PSEUDOANEURYSMS

Abstract Introduction First–line therapy for infective endocarditis is antibiotic treatment to avoid the occurrence of complications such as septic embolization, septic shock (1), pseudoaneurysm or abscess formation (1). A pseudoaneurysm is a cavity that communicates with the vascular lumen and develops as a result of necrosis of the infected tissue (1). Case report: An 81–year–old man with past medical history of aortic valve replacement with bioprosthesis for severe stenosis and re–intervention for infective Enterococcus faecalis endocarditis was admitted to hospital for hyperpyrexia. PET–CT scan was performed. An aortic bioprosthesis hypercaptation suggestive of endocarditis recurrence was found. Blood cultures were positive for Staphylococcus epidermidis. Transesophageal echocardiography was initially negative for vegetations. Therefore, it was decided for a conservative approach with antibiotic therapy. About 2 months later the patient presented in our emergency department with atypical chest pain. At a transthoracic echocardiogram was reported an eccentric paravalvular regurgitation jet on bioprosthesis in atypical position and thickening of the periaortic tissue (Fig 1A). A contrast enhanced cardio–synchronized CT scan was performed confirming the presence of three paravalvular aortic pseudoaneurysms, the largest of 16x8 mm and located on the posterolateral portion of the valvular ring near to the left atrial wall (Fig 1B). Finally, a transesophageal echocardiogram was repeated finding a fistula from the posterior pseudoaneurysm to the left ventricular outflow tract (Fig 1C). The patient underwent re–intervention of aortic valve and ascending aorta replacement. Conclusions In this case–report, the use of multimodality imaging allowed adequate diagnosis of fistulizing paravalvular aortic pseudoaneurysms and proper subsequent surgical planning. The results of this case report suggest that following infective endocarditis presence of paravalvular aortic regurgitation with eccentric jet should be investigated with second–level diagnostic examinations for better anatomic resolution, such as cardio–synchronized CT and transesophageal echocardiogram. Bibliography: 1. Okada K et al. doi: 10.1007/s11748–012–0152–x

Transcatheter Aortic Valve Implantation Outcomes and Challenges in Asia: A Systematic Review and Meta-Analysis

Background: Aortic stenosis (AS) is the world’s most prevalent heart valve disease. Transcatheter aortic valve replacement (TAVR) or Implantation (TAVI) is widely available yet adopting this procedure in Asia has been slow due to high device cost, the need for specific training programs, and the lack of specialized heart teams and dedicated infrastructures. The limited number of randomized controlled trials describing TAVI outcomes among the Asian population hampered the approval for medical reimbursements as well as acceptance among surgeons and operators in some Asian countries. Methods: A comprehensive medical literature search on TAVI and/or TAVR performed in Asian countries published between January 2015 and June 2022 was done through MEDLINE and manual searches of bibliographies. The full text of eligible articles was obtained and evaluated for final analysis. The event rates for key efficacy and safety outcomes were calculated using the data from the registries and randomized controlled trials. Results: A total of 15,297 patients were included from 20 eligible studies. The mean patient age was 82.88 ± 9.94 years, with over half being females (62.01%). All but one study reported Society of Thoracic Surgeons (STS) scores averaging an intermediate risk score of 6.28 ± 1.06%. The mean logistic European Systems for Cardiac Operations Risk Evaluation (EuroSCORE) was 14.85. The mean baseline transaortic gradient and mean aortic valve area were 50.93 ± 3.70 mmHg and 0.64 ± 0.07 cm2, respectively. The mean procedural success rate was 95.28 ± 1.51%. The weighted mean 30-day and 1-year all-cause mortality rate was 1.66 ± 1.21% and 8.79 ± 2.3%, respectively. The mean average for stroke was 1.98 ± 1.49%. The acute kidney injury (AKI) rate was 6.88 ± 5.71%. The overall major vascular complication rate was 2.58 ± 2.54%; the overall major bleeding rate was 3.88 ± 3.74%. Paravalvular aortic regurgitation rate was 15.07 ± 9.58%. The overall rate of pacemaker insertion was 7.76 ± 4.6%. Conclusions: Compared to Americans and Europeans, Asian patients who underwent TAVI had lower all-cause mortality, bleeding, and vascular complications, however, had a higher rate of postprocedural aortic regurgitation. More studies with greater sample sizes are needed among Asian patients for a more robust comparison.

Transcatheter Valve Implantation in Patients with Multivalvular Heart Disease

Free AccessTranscatheter Valve Implantation in Patients with Multivalvular Heart DiseaseTranskatheter-Klappenimplantation bei Personen mit multivalvulärer HerzerkrankungOjuola Boris Adjibodou, Miriam Brinkert, and Laurent HaegeliOjuola Boris AdjibodouDr. med. Ojuola Boris Adjibodou, Kantonsspital Aarau AG, Tellstrasse 25, 5001 Aarau, Switzerlandojuola.adjibodou@ksa.ch Department of Cardiology, Cantonal Hospital Aarau, Aarau, Switzerland Search for more papers by this author, Miriam Brinkert Department of Cardiology, Cantonal Hospital Aarau, Aarau, Switzerland Search for more papers by this author, and Laurent Haegeli Department of Cardiology, Cantonal Hospital Aarau, Aarau, Switzerland Search for more papers by this authorPublished Online:February 01, 2023https://doi.org/10.1024/1661-8157/a003983PDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinkedInReddit SectionsMoreTranscatheter aortic valve replacement (TAVR) has increased during the last two decades as an alternative to surgery across all risk profiles for patients with symptomatic aortic stenosis (AS), the most common valvular disease in western countries. Although the prevalence of degenerative multivalvular disease is growing with advancing age, little randomized data exist to guide therapy in this population. Mitral regurgitation (MR) is the most common valve impairment in patients undergoing TAVR (near to 20%), followed by tricuspid regurgitation (TR), mitral stenosis (MS) and aortic regurgitation (AR). The prognostic impact and the changes of severity of MR combined to AS in TAVR patients has been well studied, but there are several underlying limitations not allowing a definitive conclusion. In general, the impact of multivalvular disease on mortality after TAVR remains uncertain [1, 2].In this issue of the journal "Praxis", Fritschi et al. [3] review the evidence currently supporting a comprehensive pathophysiology, the clinical implications and treatment of multivalvular disease in patients undergoing TAVR. They highlight the challenge of quantifying and assessing the severity of these multivalvular disease, pointing out that it is essential not only to have a good knowledge of the pathophysiological interactions they induce, but also to use new imaging modalities (3D-echocardiography, multi-slice CT imaging) and right/left heart catheterisation in order to avoid underestimation of the disease and enhance the comprehension of the underlying mechanism before the heart team decision. Indeed, because the evolution of the combined valve disease is not always predictable after successful TAVR, the authors emphasise the central role of the multidisciplinary heart team bearing on the decision to propose the most appropriate and therefore individualised treatment for each patient, considering the plethora of clinical, hemodynamic, and imaging data as well as physiological and psychological considerations. The authors also provide three scenarios inspired by Khan et al. 2020 [4], covering the most frequent clinical situations occurring in our daily practise. They nicely illustrated the topic with a clinical case description.Siddiqi et al. recently published a meta-analysis and systematic review on the same topic with covariate-adjusted risk of mortality associated with concomitant valve disease. They demonstrated that moderate to severe MR was associated with increased mortality at 30 days and one year. An increased risk of 1-year mortality was observed in patients with severe MS compared with patients without MS. Moderate-to-severe TR was also at higher risk of all-cause mortality at one year compared with no or mild TR [5].Regarding the pathophysiological and prognostic considerations, a staging of aortic stenosis has been proposed by Généreux et al. [6] based on anatomical, haemodynamic, or echocardiographic criteria. The disease can therefore be divided into four stages: 1. signs of left ventricular overload, decreased left ventricular function; 2. mitral valve damage and left atrial deformation; 3. increased pulmonary pressure and tricuspid valve damage; 4. impairment of right ventricular function. Based on this staging, Okuno et al. were later able to document the impressive clinical correlate in a clinical survey: the 1-year mortality rate was five times higher in TAVI patients at stage-4 compared to stage-1 patients (25.8 vs 5.3%), highlighting how relevant it is to treat aortic stenosis at an early stage and not to miss the optimal time for intervention before an irreversible left or right ventricle damage occurs [7].That is the reason why the following principles were suggested by the European Society of Cardiology [8] to facilitate the heart team decision: – It is important to understand the pathophysiological interactions between the different valve diseases. – The indication for intervention should only be made after a thorough review of the haemodynamic and functional impact of the valve diseases (e.g., symptoms, dilatation or dysfunction of the left ventricle). – In case of multivalvular disease, treat the predominant disease. – The risk of intervention on multiple valves must be weighed against the risk of untreated disease. – For interventional treatment procedures, particularly in the association between aortic stenosis and functional mitral regurgitation, a staged approach should be evaluated.Future and perspectiveWith the aging population, the prevalence of patients with multivalvular disease will inexorably increase in the future. Although TAVR procedure is well standardised, several issues need to be addressed to propose more broadly this option across all risk profiles: specific anatomical characteristics (bicuspid aortic valve, aortic regurgitation), device durability, risk of permanent pacemaker implantation, paravalvular aortic regurgitation and coronary access). As transcatheter treatment option is rapidly increasing for both mitral and tricuspid valve impairment with substantial improvement of the transcatheter edge-to-edge repair (TEER) technology and the progressive expansion of transcatheter mitral valve replacement (TVMR), the role of the multidisciplinary heart team becomes more central in the complex decision-making process that must be patient-oriented, based on a lifetime approach and take into account patient preferences. More research is needed to evaluate the optimal use of mitral and tricuspid transcatheter procedures in TAVR patients with concomitant mitral and tricuspid valve disease and determine the resulting physiological and clinical implications.Bibliography Alkhouli M , Alqahtani F , Ziada KM , Aljohani S , Holmes DR , Mathew V . Contemporary trends in the management of aortic stenosis in the USA. Eur Heart J . 2020; 41 (8):921–928. First citation in articleCrossref Medline, Google Scholar Unger P , Pibarot P , Tribouilloy C , et al. European Society of Cardiology Council on Valvular Heart Disease. Multiple and mixed valvular heart diseases. Circ Cardiovasc Imaging . 2018; 11 (8): e007862. First citation in articleCrossref Medline, Google Scholar Fritschi D , Oechslin L , Biaggi L , Wenavesser P . Transkatheter-Aortenklappenimplantation (TAVI) bei multivalvulären Herzerkrankungen. Praxis (Bern 1994) . 2023; 112 :65–73. First citation in articleAbstract, Google Scholar Khan F , Okuno T , Malebranche D , et al. Transcatheter aortic valve replacement in patients with multivalvular heart disease. JACC Cardiovasc Interv . 2020; 13 (13):1503–1514. First citation in articleCrossref Medline, Google Scholar Siddiqi TJ , Usman MS , Ahmed J , Shahid I , Ahmed W , Alkhouli M . Evaluating the effect of multivalvular disease on mortality after transcatheter aortic valve replacement for aortic stenosis: a meta-analysis and systematic review. Future Cardiol . 2022; 18 (6):487–496. First citation in articleCrossref, Google Scholar Généreux P , Pibarot P , Redfors B , et al. Staging classification of aortic stenosis based on the extent of cardiac damage. Eur Heart J . 2017; 38 (45):3351–3358. First citation in articleCrossref Medline, Google Scholar Okuno T , Heg D , Lanz J , et al. Refined staging classification of cardiac damage associated with aortic stenosis and outcomes after transcatheter aortic valve implantation. Eur Heart J Qual Care Clin Outcomes . 2021; 7 (6):532–541. First citation in articleCrossref Medline, Google Scholar Vahanian A , Beyersdorf F , Praz F , et al. 2021 ESC/EATCS Guidelines for the management of valvular heart disease. Eur Heart J . 2022; 43 (7):561–632. First citation in articleCrossref Medline, Google ScholarFiguresReferencesRelatedDetails Volume 112Issue 2Februar 2023ISSN: 1661-8157eISSN: 1661-8165 InformationPraxis (2023), 112, pp. 53-54 https://doi.org/10.1024/1661-8157/a003983.© 2023Hogrefe AGPDF download

A Contrast Frugal Approach to Transcatheter Aortic Valve Replacement in Chronic Kidney Disease: A Pilot Study.

Transcatheter aortic valve replacement (TAVR) is now regarded as a viable treatment option for all cases of severe aortic stenosis (AS). Acute kidney injury (AKI) is common and lowers the survival of patients after TAVR and iodine-based contrast-induced nephropathy (CIN) plays a significant adverse role in AKI. Therefore, in chronic kidney disease (CKD) patients requiring pre-operative evaluation for TAVR, the risk of CIN is of particular concern. It was a single-center study including eight CKD patients who underwent pre-operative evaluation for TAVR with minimized contrast exposure by means of pre-operative contrast-sparing evaluation and intra-operative contrast minimization. All patients had glomerular filtration rate (eGFR) calculated before TAVR and on a follow-up about one month and one year post-operatively to document the impact of this TAVR protocol on prognosis of kidney function in patients with advanced CKD. New York Heart Association (NYHA) functional classification demonstrated significant improvement of symptomatology (p = 0.0001) by one-year post-TAVR. Patients' mean AS gradient was significantly improved (p = 0.00004) after the TAVR procedure. No significant post-operative paravalvular aortic regurgitation was noted on follow up echocardiogram. eGFR data showed mean eGFR for the group was slightly better (27.38 ml/min/per 1.73 m2 BSA vs. 30.38 ml/min/per 1.73 m2 BSA) after TAVR. "Contrast frugal" approach is feasible and safe for pre-TAVR evaluation and the procedure itself. Our pilot study showed no significant paravalvular leak of the prosthetic valve following this proposed protocol. No statistically significant decrease in eGFR was noted on a one-year follow-up.

Abstract 14229: Utilization of Calcium Scores to Predict TAVR Outcomes in Paradoxical Severe Aortic Stenosis

Introduction: In patients with severe symptomatic (Stage D) aortic stenosis (AS), the disease is subcategorized based on the gradient, flow and left ventricular ejection fraction (LVEF). Stage D3 reflects low-flow, low-gradient severe AS with normal LVEF (paradoxical low-flow severe AS [PLFLG AS]. Current guidelines suggest measurement of a Computed Tomography (CT) derived calcium score of the native valve is helpful for management. Furthermore, calcium score can provide prognostic information for transcatheter aortic valve replacement (TAVR) in the general AS population. However, whether CT-derived calcium scores can predict major adverse cardiovascular events (MACE) in PLFLG AS patients undergoing TAVR has not been examined. Methods: We retrospectively investigated post-TAVR outcomes at 1 year, in patients echocardiographically characterized as PLFLG AS at our center between Jan. 2017 and Dec. 2020. Continuous variables were assessed for normality using the Kolmogorov-Smirnov test, histogram, and Q-Q plot. Logistic regression models were used to assess if calcium scores were associated with outcomes, and statistical significance was assumed if p&lt;0.05. Results: : A total of 85 patients were included in the analysis. The baseline pre- and immediately post TAVR data are described in Table 1. In our cohort, 16 had MACE (18.8%) at 1 year. Calcium score as a predictor of MACE (odds ratio (OR): 0.99; p=0.93), death (OR: 0.99; p=0.79), stroke (OR 1.01; p=0.90), myocardial infarction (OR 0.97; p=0.63), and post-TAVR paravalvular aortic regurgitation (OR 1.02; p=0.47) did not reach statistical significance. Conclusions: In our cohort, CT-derived calcium scores did not predict MACE events or post-TAVR paravalvular aortic regurgitation in PLFLG AS. The study had several limitations: it is a single center retrospective study with a small sample size, potentially leading to recording bias.

Haemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2.

Transcatheter aortic valve replacement (TAVR) with the ACURATE neo device has been associated with a non-negligible incidence of paravalvular aortic regurgitation (AR). The new-generation ACURATE neo2 has been designed to mitigate this limitation. The aim of the study was to compare TAVR with the ACURATE neo and neo2 devices. The NEOPRO and NEOPRO-2 registries retrospectively included patients undergoing transfemoral TAVR with self-expanding valves at 24 and 20 centres, respectively. Patients receiving the ACURATE neo and neo2 devices (from January 2012 to December 2021) were included in this study. Predischarge and 30-day VARC-3 defined outcomes were evaluated. The primary endpoint was predischarge moderate or severe paravalvular AR. Subgroup analyses per degree of aortic valve calcification were performed. A total of 2,026 patients (neo: 1,263, neo2: 763) were included. Predischarge moderate or severe paravalvular AR was less frequent for the neo2 group (2% vs 5%; p<0.001), resulting in higher VARC-3 intended valve performance (96% vs 90%; p<0.001). Furthermore, more patients receiving the neo2 had none/trace paravalvular AR (59% vs 38%; p<0.001). The reduction in paravalvular AR with neo2 was mainly observed with heavy aortic valve calcification. New pacemaker implantation and VARC-3 technical and device success rates were similar between the 2 groups; there were more frequent vascular and bleeding complications for the neo device. Similar 1-year survival was detected after TAVR (neo2: 90% vs neo: 87%; p=0.14). TAVR with the ACURATE neo2 device was associated with a lower prevalence of moderate or severe paravalvular AR and more patients with none/trace paravalvular AR. This difference was particularly evident with heavy aortic valve calcification.

Left ventricular outflow tract pseudoaneurysms and severe paravalvular aortic regurgitation treated by percutaneous approach in a Marfan syndrome patient

A 66-year-old male with a history of Marfan syndrome and resolved infective endocarditis was found to have shortness of breath after a previous aortic valve replacement in 2010. Several severe paravalvular leaks were seen on imaging, and left ventricular outflow tract pseudoaneurysms were identified as the cause of his symptoms which warranted treatment. Due to this patient’s risk of surgical intervention, a retrograde transaortic approach was used.

Cost-effectiveness of transcatheter aortic valve implantation in patients with severe symptomatic aortic stenosis of intermediate surgical risk in Singapore

ObjectiveThe objective was to assess the cost-effectiveness of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis with intermediate surgical risk in Singapore.MethodsA de novo Markov model with three health states – stroke with long-term sequelae, no stroke, and death – was developed and simulated using Monte Carlo simulations with 10,000 iterations over a five-year time horizon from the Singapore healthcare system perspective. A 3% annual discount rate for costs and outcomes and monthly cycle lengths were used. By applying the longest available published clinical evidence, simulated patients received either TAVI or surgical aortic valve replacement (SAVR) and were at risk of adverse events (AEs) such as moderate-to-severe paravalvular aortic regurgitation (PAR).ResultsWhen five-year PARTNER 2A data was applied, base-case analyses showed that the incremental cost-effectiveness ratio (ICER) for TAVI compared to SAVR was US$315,760 per quality-adjusted life year (QALY) gained. The high ICER was due to high incremental implantation and procedure costs of TAVI compared to SAVR, and marginal improvement of 0.10 QALYs as simulated mortality of TAVI exceeded SAVR at 3.75 years post-implantation. One-way sensitivity analysis showed that the ICERs were most sensitive to cost of PAR, utility values of SAVR patients, and cost of TAVI and SAVR implants and procedures. When disutilities for AEs were additionally applied, the ICER decreased to US$300,070 per QALY gained. TAVI was dominated by SAVR when the time horizon increased to 20 years. Clinical outcomes projected from one-year PARTNER S3i data further reduced the ICER to US$86,337 per QALY gained for TAVI, assuming early all-cause mortality benefits from TAVI continued to persist. This assumption was undermined when longer term data showed that TAVI’s early mortality benefits diminished at five years.Limitations and conclusionTAVI is unlikely to be cost-effective in intermediate surgical-risk patients compared to SAVR in Singapore.

Effect of Aortic Angulation on Outcomes in Transcatheter Aortic Valve Implantation with the Self-Expanding Portico Valve

Introduction: Aortic angulation (AA), defined as the angle between the aortic annulus plane and the horizontal plane, may result in failed prosthesis positioning. The effect of AA on the procedural and short-term outcomes with the portico valves for transcatheter aortic valve implantation (TAVI) has not been fully investigated. The present study aimed to evaluate the impact of AA on device success and early outcomes of TAVI using a selfexpanding portico valve. Patients and Methods: Preoperative computed tomography scans of 121 consecutive patients treated with the portico valve were analyzed. TAVI device success and outcomes were determined according to VARC-3 definitions. Patients were divided into two groups based on mean AA. Results: The mean AA was 48.7 ± 8.9°. There were no differences in technical success (92.2 vs 89.5%, p= 0.604), device success (81.2% vs 77.2%, p= 0.582), and early safety endpoints (68.8% vs 61.4%, p= 0.397) between the AA≤ 48° and AA&gt;48° groups. The frequency and severity of paravalvular aortic regurgitation (PAR) was statistically higher in patients with AA&gt; 48° (p= 0.028). Moreover, an increased AA was also associated with valve malposition (12.3% vs. 1.6%, p= 0.018), prolonged procedure time (85 ± 26 vs. 75 ± 20 minutes, p= 0.028), and greater Δimplantation depth (2.2 ± 0.5 vs. 0.8 ± 0.1 mm; p&lt;0.001). Conclusion: Despite comparable device success and early outcomes rates, increased AA is associated with higher rates of PAR and valve malposition, with the self-expanding portico valve.

Epicardial fat thickness assessment by multi-slice computed tomography for predicting cardiac outcomes in patients undergoing transcatheter aortic valve implantation.

Chronic inflammation promotes aortic valve calcification. It is known that epicardial fat is a source of inflammation. The aim of this study was to investigate the relationship between epicardial fat thickness, cardiac conduction disorders and outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). During a three-year period, 45 patients with severe aortic stenosis who underwent TAVI were recruited to the study. Data were collected retrospectively. Epicardial fat was defined as the adipose tissue between the epicardium and the visceral pericardium. Mean epicardial fat thickness was determined by multi-slice computed tomography, which was performed before the procedure. The average thickness of epicardial fat was 13.06 ± 3.29 mm. This study failed to reveal a significant correlation between epicardial fat thickness and post-procedural left bundle branch block, right bundle branch block, paravalvular aortic regurgitation and pacemaker implantation rates (p > 0.05). The results of this study failed to show a significant relationship between epicardial fat thickness, cardiac conduction disorders and outcomes, however further studies with larger sample numbers are required to explore the relationship.

Transcatheter aortic valve-in-valve implantation to treat aortic para-valvular regurgitation after TAVI

BackgroundPara-valvular regurgitation (PVR) after transcatheter aortic valve (TAV) implantation is associated with increased mortality. Redo-TAVI may be applied to treat PVR, yet with unknown efficacy. We thought to assess redo-TAVI efficacy in reducing PVR using the Redo-TAVI registry (45 centers; 600 TAV-in-TAV cases). MethodsPatients were excluded if redo-TAVI was done urgently (N = 253), for isolated TAV stenosis (N = 107) or if regurgitation location at presentation remained undetermined (N = 123). The study group of patients with PVR (N = 70) were compared against patients with intra-valvular regurgitation (IVR) (N = 41). Echocardiographic examinations of 67 (60%) patients were reassessed in a core-lab for data accuracy validation. ResultsCore-lab examination validated the jet location in 66 (98.5%) patients. At 30 days, the rate of residual AR ≥ moderate was 7 (10%) in the PVR cohort vs. 1 (2.4%) in the IVR cohort, p = 0.137. The rate of procedural success was 53 (75.7%) vs. 33 (80.5%), p = 0.561; procedural safety 51 (72.8%) vs. 31 (75.6%), p = 0.727; and mortality 2 (2.9%) vs. 1 (2.4%), p = 0.896 at 30 days and 7 (18.6%) vs. 2 (11.5%), p = 0.671 at 1 year, respectively. Of patients with residual PVR ≥ moderate at 30 days, 5/7 occurred after implanting balloon-expandable in self-expanding TAV and 2/7 after balloon-expandable in balloon-expandable TAV. ConclusionsThis study puts in perspective redo-TAVI efficacy and limitations to treat PVR after TAVI. Patient selection for this and other therapies for PVR needs further investigation.

Transcatheter Aortic Valve Replacement With Self-Expanding ACURATE neo2: PostproceduralHemodynamic and Short-Term ClinicalOutcomes.

The first-generation ACURATE neo transcatheter heart valve (THV) (Boston Scientific) was associated with a non-negligible occurrence of moderate or greater paravalvular aortic regurgitation (AR) following transcatheter aortic valve replacement. To overcome this issue, the ACURATE neo2 iteration, which incorporates a taller outer skirt aimed at reducing the occurrence of paravalvular AR, has recently been developed. The aim of this study was to assess the efficacy and safety of the ACURATE neo2 (Boston Scientific) THV in patients with severe aortic valve stenosis. ITAL-neo was an observational, retrospective, multicenter registry enrolling consecutive patients with severe aortic valve stenosis, treated with first- and second-generation ACURATE neo THVs, via transfemoral and trans-subclavian access, in 13 Italian centers. One-to-one propensity score matching was applied to account for baseline characteristics unbalance. The primary endpoint was the occurrence of moderate or greater paravalvular AR on predischarge echocardiographic assessment. Secondary endpoints included postprocedural technical success and 90-day device success and safety. Among 900 patients included in the registry, 220 received the ACURATE neo2 THV, whereas 680 were treated with the first-generation device. A total of 410 patients were compared after 1:1 propensity score matching. The ACURATE neo2 THV was associated with a 3-fold lower frequency of postprocedural moderate or greater paravalvular AR (11.2% vs 3.5%; P< 0.001). No other hemodynamic differences were observed. Postprocedural technical success was similar between the 2 cohorts. Fewer adverse events were observed in patients treated with the ACURATE neo2 at 90days. Transfemoral transcatheter aortic valve replacement using the ACURATE neo2 was associated with a significant lower frequency of moderate or greater paravalvular AR compared with the earlier generation ACURATE neo device, with encouraging short-term safety and efficacy.

Comparative Quantitative Aortographic Assessment of Regurgitation in Patients Treated With VitaFlow Transcatheter Heart Valve vs. Other Self-Expanding Systems.

ObjectivesTo compare the quantitative angiographic aortic regurgitation (AR) of six self-expanding valves after transcatheter aortic valve replacement (TAVR).BackgroundQuantitative videodensitometric aortography (LVOT-AR) is an accurate and reproducible tool for assessment of AR following TAVR.MethodsThis is a retrospective central core-lab analysis of 1,257 consecutive cine aortograms performed post-TAVR. The study included 107 final aortograms of consecutive patients who underwent TAVR with first-generation VitaFlow in four Chinese centers and 1,150 aortograms with five other transcatheter aortic valves (Evolut Pro, Evolut R, CoreValve, Venus A-Valve, and Acurate Neo). LVOT-AR analyses of these five valves were retrieved from a previously published pooled database.ResultsAmong 172 aortograms of patients treated with VitaFlow, 107 final aortograms (62.2%) were analyzable by LVOT-AR. In this first in man eight cases necessitated a procedural valve in valve due to inappropriate TAVR positioning and severe aortic paravalvular regurgitation. In the VitaFlow group, the mean LVOT-AR of the intermediate aortograms was 7.3 ± 7.8% and the incidence of LVOT-AR >17% was 8.6%. The mean LVOT-AR of the final aortogram was 6.1 ± 6.4% in the VitaFlow group, followed by Evolut Pro (7.3 ± 6.5%), Evolut R (7.9 ± 7.4%), Venus A-valve (8.9 ± 10.0%), Acurate Neo (9.6 ± 9.2%), and lastly CoreValve (13.7 ± 10.7%) (analysis of variance p < 0.001). Post hoc 2-by-2 testing showed that CoreValve had significantly higher LVOT-AR compared with each of the other five THVs. No statistical difference in LVOT-AR was observed between VitaFlow, Evolut Pro, Evolut R, Acurate Neo, and Venus A-valves. The VitaFlow system had the lowest proportion of patients with LVOT-AR >17% (4.7%) (AR after the final aortograms), followed by Evolut Pro (5.3%), Evolut R (8.8%), Acurate Neo (11.3%), Venus A-valve (14.2%), and CoreValve (30.1%) (chi-square p < 0.001).ConclusionCompared to other commercially available self-expanding valves, VitaFlow seems to have a low degree of AR and a low proportion of patients with ≥moderate/severe AR as assessed by quantitative videodensitometric angiography. Once the learning phase is completed, comparisons of AR between different transcatheter heart valves should be attempted in a prospective randomized trial.

The effect of the learning curve on paravalvular aortic regurgitation and mid-term mortality in transfemoral transcatheter aortic valve implantation.

Paravalvular aortic regurgitation is an important independent mortality predictor in transcatheter aortic valve implantation (TAVI). Our study evaluated the association between paravalvular aortic regurgitation and mid-term mortality in relation with the learning curve, in patients with severe aortic stenosis who underwent transfemoral TAVI in the first 3years since the establishment of the program. Patients with severe aortic stenosis who underwent transfemoral TAVI between 2017 and 2020 were included in the analysis. Paravalvular aortic regurgitation was assessed by transthoracic echocardiography at 48hours after the procedure. All-cause mortality was evaluated after 30 days and at mid-term follow-up. Paravalvular aortic regurgitation ≥grade II was associated with mid-term all-cause mortality (OR 4.4; 95%CI 1.82-11.55; p<0.001), their prevalence declining after the first 60 cases. Baseline characteristics did not significantly differ in the first 60 patients from the rest of the cohort. Male sex (p=0.006), advanced age (p=0.04), coronary artery disease (p=0.003), or elevated STS Score (p=0.02) influenced mid-term survival. When adjusting for the presence of these factors, only age (OR 1.1; 95%CI 1.0-1.2), paravalvular aortic regurgitation ≥grade II (OR 3.9; 95%CI 1.3-12.9), and the number of days spent in the intensive care unit (OR 1.4; 95%CI 1.1-1.8) were independent predictors of mid-term all-cause mortality. In a group of patients with severe aortic stenosis who underwent transfemoral TAVI in the first 3years since the establishment of the program, paravalvular aortic regurgitation ≥grade II was associated with mid-term mortality, both declining after the first 60 cases.

Long-term outcomes in patients undergoing transcatheter aortic valve implantation: insights on clinical outcomes and prognostic markers from a large cohort of patients

Abstract   Transcatheter Aortic valve Replacement (TAVR) has emerged as paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Clinical and performance data on long-term TAVR are still limited. The aim of this study was to determine the survival and the factors predicting mortality after TAVR with the first and second generation of prostheses. Methods From April 2008 to December 2019, the auto-expandible prostheses were implanted in 765 patients with symptomatic severe aortic stenosis with deemed high risk. The first generation prostheses included CoreValve and Accutrak System and the second prostheses included Evolut R and Pro. Results The mean age was 79.4±6.6 years. The logistic EuroSCORE and STS score were 17.1±11% and 5.7±3.9%, respectively. The implantation success rate was 98.87%. In-hospital mortality was 3.7%, and the combined endpoint of death, vascular complications, myocardial infarction or stroke had a rate of 15.1%. The clinical outcomes in according to prosthesis generation were, for pacemaker requirement (CoreValve vs. Accutrak system vs. Evolut R vs. and Evolut pro) 35.3% vs. 26.1% vs. 14.3% vs. 14%, p=0.001; and the paravalvular aortic regurgitation, were: none 28% vs. 44.8% vs. 43.3% vs. 58; mild 40% vs. 32.3% vs. 30.8% vs. 35.2%; moderate 32% vs. 20.3 vs. 23.9% vs. 5.7%; severe 0% vs. 2.6% vs. 0% vs. 1.1, p 0.001 The late mortality (beyond 30 days) was 35.9%. Survival at 1, 3, 5, 7 and 9 years were 88.9%, 76.1%, 61.1%, 44% and 32.6% respectively, after a mean follow-up of 42.3±27 months. The NYHA functional class improved from 3.1±0.6 to 1.77±0.7 in the follow-up. At 5 years, 5 patients had severe prosthetic valve dysfunction (severe stenosis and moderate transvalvular regurgitation The predictors of cumulative mortality were: Charlson index [HR 1.25 (95% CI 1.077–1.461), p=0.004], Readmision Heart Failure [HR 3.02 (95% CI 1.554–5.879), p=0.001], stroke post-TAVR [HR 3.472 (95% CI 1.115–10.53), p=0.032], residual aortic regurgitation [HR 1.45 (95% CI 1.093–1.934), p=0,010], and severe pulmonary hypertension [HR −0.983 (95% CI 0.645–0.423) p=0.032]. Conclusions TAVR is associated with significant survival benefit throughout 3.09 years of follow-up. Survival during follow-up depends particularly among patients with associated comorbidities and cardiac markers such as aortic regurgitation or pulmonary hypertension Funding Acknowledgement Type of funding sources: None.

Paravalvular Aortic Regurgitation Severity Assessed by Quantitative Aortography: ACURATE neo2 versus ACURATE neo Transcatheter Aortic Valve Implantation.

The new-generation ACURATE neo2 system was commercially released in September 2020. In this study, we sought to compare the aortic regurgitation (AR) severity of the ACURATE neo2 versus the ACURATE neo transcatheter heart valve, using quantitative videodensitometric angiography (qAR). This is a retrospective, Corelab analysis of final post-transcatheter aortic valve implantation (TAVI) aortograms of patients treated with the ACURATE neo2 and ACURATE neo systems. The ACURATE neo2 cohort comprised consecutive patients treated between September 2020 and January 2021 at two centers. The ACURATE neo cohort included consecutive patients treated before September 2020. Our primary objective was to compare AR severity on qAR following TAVI with ACURATE neo2 and ACURATE neo. Out of 401 aortograms, 228 (56.9%) were analyzable, with 120 in the ACURATE neo2 cohort, and 108 in the ACURATE neo cohort. The mean AR fraction was 4.4 ± 4.8% in the neo2 cohort, and 9.9 ± 8.2% in the neo cohort (p < 0.001). Furthermore, moderate or severe AR (qAR > 17%) was detected in 2 aortograms (1.7%) in the neo2 cohort and 15 aortograms (13.9%) in the neo cohort (p < 0.001). Quantitative aortography shows a lower rate of moderate or severe paravalvular AR in what is the first European experience of the new-generation, self-expanding ACURATE neo2 when compared to the first-generation ACURATE neo. Moreover, aortographic data need to be correlated and compared to Core Laboratory-adjudicated 30-day echocardiographic data.