Treatment Of Severe Aortic Stenosis Research Articles

What matters most to patients with severe aortic stenosis when choosing treatment? Framing the conversation for shared decision making.

Guidelines recommend including the patient's values and preferences when choosing treatment for severe aortic stenosis (sAS). However, little is known about what matters most to patients as they develop treatment preferences. Our objective was to identify, prioritize, and organize patient-reported goals and features of treatment for sAS. This multi-center mixed-methods study conducted structured focus groups using the nominal group technique to identify patients' most important treatment goals and features. Patients separately rated and grouped those items using card sorting techniques. Multidimensional scaling and hierarchical cluster analyses generated a cognitive map and clusters. 51 adults with sAS and 3 caregivers with experience choosing treatment (age 36-92 years) were included. Participants were referred from multiple health centers across the U.S. and online. Eight nominal group meetings generated 32 unique treatment goals and 46 treatment features, which were grouped into 10 clusters of goals and 11 clusters of features. The most important clusters were: 1) trust in the healthcare team, 2) having good information about options, and 3) long-term outlook. Other clusters addressed the need for and urgency of treatment, being independent and active, overall health, quality of life, family and friends, recovery, homecare, and the process of decision-making. These patient-reported items addressed the impact of the treatment decision on the lives of patients and their families from the time of decision-making through recovery, homecare, and beyond. Many attributes had not been previously reported for sAS. The goals and features that patients' value, and the relative importance that they attach to them, differ from those reported in clinical trials and vary substantially from one individual to another. These findings are being used to design a shared decision-making tool to help patients and their clinicians choose a treatment that aligns with the patients' priorities. ClinicalTrials.gov, Trial ID: NCT04755426, Trial URL https://clinicaltrials.gov/ct2/show/NCT04755426.

Sex Differences in the Impact of Aortic Valve Calcium Score on Mortality After Transcatheter Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) is now an approved alternative to surgical aortic valve replacement for the treatment of severe aortic stenosis. As the clinical adoption of TAVR expands, it remains important to identify predictors of mortality after TAVR. We aimed to evaluate the impact of sex differences in aortic valve calcium score (AVCS) on long-term mortality following TAVR in a large patient sample. We included consecutive patients who successfully underwent TAVR for treatment of severe native aortic valve stenosis from June 2010 to May 2021 across all US Mayo Clinic sites with follow-up through July 2021. AVCS values were obtained from preoperative computed tomography of the chest. Additional clinical data were abstracted from medical records. Kaplan-Meier curves and Cox-proportional hazard regression models were employed to evaluate the effect of AVCS on long-term mortality. A total of 2543 patients were evaluated in the final analysis. Forty-one percent were women, median age was 82 years (Q1: 76, Q3: 86), 18.4% received a permanent pacemaker following TAVR, and 88.5% received a balloon expandable valve. We demonstrate an increase in mortality risk with higher AVCS after multivariable adjustment (P<0.001). When stratified by sex, every 500-unit increase in AVCS was associated with a 7% increase in mortality risk among women (adjusted hazard ratio, 1.07 [95% CI, 1.02-1.12]) but not in men. We demonstrate a notable sex difference in the association between AVCS and long-term mortality in a large TAVR patient sample. This study highlights the potential value of AVCS in preprocedural risk stratification, specifically among women undergoing TAVR. Additional studies are needed to validate this finding.

New paradigms for the sequential treatment of severe aortic stenosis: imaging-guided selection of the first intervention paves the way for lifetime management.

New paradigms for the sequential treatment of severe aortic stenosis: imaging-guided selection of the first intervention paves the way for lifetime management.

Biological Surgical Options in Young Patients for the Treatment of Severe Aortic Stenosis: Is the Jury Still Out? A Review.

Aortic interventions remain the most effective treatment for severe aortic stenosis. In the recent years, advances in bioprosthetics and newer data have reduced the cut-off age for the use of bioprosthetic valves in younger patients, but the debate on whether to favor mechanical valves in younger patients remains a constant, especially with the undesired effects and considerations of anticoagulation therapy with vitamin K antagonists in this age group. Other options like the Ross procedure are gaining traction, despite still being undervalued and necessitating expertise centers. Hemodynamic considerations and durability of these options are important to consider, especially in this age group. Regardless of the choice of the prosthesis, patient informed consent is paramount since the decision affects the lifetime management of their initial condition, and expectations given must remain realistic.

Transcatheter aortic valve replacement for bicuspid aortic valve disease: does conventional surgery have a future?

Bicuspid aortic valve (BAV) disease is the most common form of congenital heart valve defect. It is associated with aortic stenosis (AS), aortic insufficiency, and aortopathy. Treatment of severe AS requires valve replacement which historically has been performed with surgical aortic valve replacement (SAVR). Recently, transcatheter aortic valve replacement (TAVR) has emerged as a promising alternative. However, increased rates of adverse outcomes following TAVR have been shown in BAV patients with high amounts of calcification. Comparison between TAVR and SAVR in low surgical risk BAV patients in a randomized trial has not been performed and TAVR for BAV long-term performance is unknown due to lack of clinical data. Due to the complexity of BAV anatomies and the significant knowledge gap from the lack of clinical data, SAVR still has many benefits over TAVR in low surgical risk BAV patients. It also remains common for BAV patients to have an aortopathy, which currently can be treated with surgical techniques. This review aims to outline BAV associated diseases and their treatment strategies, the main TAVR adverse outcomes associated with anatomically complex BAV patients, TAVR strategies for mitigating these risks and the current state of cutting-edge 3D printing and computer modeling screening methods that can provide otherwise unobtainable preoperative information during the BAV patient selection process for TAVR.

TAVI in bicuspid aortic valve

Transcatheter aortic valve implantation (TAVI) is an established choice for the treatment of severe aortic stenosis (AS) in patients who are deemed inoperable or at high surgical risk. There are limited data for the safety and effi cacy of the method in patients with bicuspid aortic valve (BAV), the most common congenital valve defect. Patients with BAV were excluded from randomized clinical trials (RCTs), comparing TAVI to surgery due to the heterogeneous anatomy of this nosological unit and concerns about unsatisfactory procedural and clinical outcomes after TAVI. With the improvement of the design of the new generations devices, with the growing technical experience of the teams and the progress in the imaging techniques, better results and fewer complications are observed, which could be a prerequisite for expanding the indications for TAVI in patients with BAV. This review presents TAVI treatment options for patients with BAV, the results of available registers in terms of safety and effi cacy of the procedure, and future perspectives.

Investigation of Risk Factors for Postoperative Delirium after Transcatheter Aortic Valve Implantation: A Retrospective Study.

Transcatheter aortic valve implantation (TAVI) is an effective treatment for severe aortic stenosis (AS); however, postoperative delirium (POD) can worsen patient outcomes. This study aimed to examine the risk factors for POD after TAVI, including possible intervening factors. We included 87 patients (mean age: 83) who underwent TAVI between May 2014 and September 2018. POD was defined by the presence or absence of delirium on ICU admission, assessed using the Confusion Assessment Method for the ICU. Factors that showed significant differences in the univariate analysis were analyzed using a multiple logistic regression analysis. In total, 31 patients (36%) had POD after ICU admission, and 56 (64%) did not. The preoperative frailty score and aortic valve opening area (AVA) were significant risk factors for POD. The multivariate analysis also showed that both factors were independent risk factors for POD (area under the receiver operating characteristic curve: 0.805). There were no significant differences in the number of ICU days. However, postoperative hospitalization was significantly longer in the POD group (19 (17–31) days vs. 16 (13–22) days; p = 0.002). POD was associated with a narrow AVA and frailty; this suggests that frailty prevention interventions according to the AVA may be important.

Myocardial revascularization in patients with transcatheter aortic valve implantation (TAVI) and endovascular repair of thoracic aorta

Transcatheter aortic valve implantation is the main treatment for severe aortic stenosis in patients with high surgical risks. There are undeniable advantages such as minimally invasive access, better portability in patients and decreased risk of postoperative complications compare to open surgery. Unfortunately, most aortic stenoses have the same etiology with coronary artery diseases and it necessitates invasive treatment. Cardiac artery catheterization and providing of stable instrument position are complications in post TAVI patients. It is not always possible to perform angioplasty from diagnostic radial access in post TAVI patient and there is an option of changing access to femoral to provide more safe and stable position of instruments during manipulation.

Aortic stenosis post-COVID-19: a mathematical model on waiting lists and mortality

ObjectivesTo provide estimates for how different treatment pathways for the management of severe aortic stenosis (AS) may affect National Health Service (NHS) England waiting list duration and associated mortality.DesignWe constructed...

CT in Transcatheter-delivered Treatment of Valvular Heart Disease.

Minimally invasive strategies to treat valvular heart disease have emerged over the past 2 decades. The use of transcatheter aortic valve replacement in the treatment of severe aortic stenosis, for example, has recently expanded from high- to low-risk patients and became an alternative treatment for those with prohibitive surgical risk. With the increase in transcatheter strategies, multimodality imaging, including echocardiography, CT, fluoroscopy, and cardiac MRI, are used. Strategies for preprocedural imaging strategies vary depending on the targeted valve. Herein, an overview of preprocedural imaging strategies and their postprocessing approaches is provided, with a focus on CT. Transcatheter aortic valve replacement is reviewed, as well as less established minimally invasive treatments of the mitral and tricuspid valves. In addition, device-specific details and the goals of CT imaging are discussed. Future imaging developments, such as peri-procedural fusion imaging, machine learning for image processing, and mixed reality applications, are presented.

C28 THE FINANCIAL BURDEN OF NEWER GENERATION TAVI DEVICES: RESULTS FROM THE ITALIAN OBSERVANT STUDIES

Abstract Objectives To estimate the financial burden of using newer generation transcatheter aortic valve implantation (TAVI) devices compared with older generation devices. Background TAVI is becoming the standard treatment for severe aortic stenosis in symptomatic elderly patients and is increasingly offered also to younger and lower risk patients. Resource utilization in performing TAVI has become an important focus due to the high likelihood of hospital readmissions, but it is unclear whether readmissions after TAVI contribute to a significant proportion of overall costs of TAVI to the healthcare system at mid–term follow up. Methods A probabilistic Markov model was developed in order to estimate the cost consequence of introducing newer generation TAVI devices were calculated as the absolute deterministic difference between a cohort of 6,000 patients treated with the newer TAVI devices (TAVI–new scenario) and the same cohort treated with old TAVI devices (TAVI–old scenario). Transition probability and hospitalization costs were retrieved among patients enrolled in the OBSERVANT I and OBSERVANT II studies; 1898 patients treated with older generation TAVI devices and 1417 patients treated with new generation TAVI devices were compared. Outcomes were adjusted using propensity score matching. Results Propensity score matching resulted in 853 pairs, whose baseline risk factors were well balanced. The mean EuroSCORE II (6.6 vs. 6.8; p = 0.76) and the mean age (82.0 vs 82.1; p = 0.62) of older generation TAVI patients and newer generation TAVI patients were similar. The use of newer generation TAVI devices determined a significant reduction of re–hospitalizations (–30.5% re–intervention, –25.2% major re–hospitalization and –30.8% minor re–hospitalization) and mortality (–20%). These reductions were associated with significant cost savings over a 1–year period (−€4.1 million in terms of direct costs and −€19.7 million considering the additional cost of the devices). The main cost–reduction was estimated for re–hospitalization that cover 79% of the overall cost reduction in the economic analysis without the costs of the devices. Conclusions After adjusting for baseline characteristics, patients undergoing TAVI with newer generation devices had lower risk of all–cause death and re–hospitalization. These reductions are leading to significant cost savings at 1 year, mainly due to the reduction in re–hospitalization costs.

Impact of age on outcomes after transcatheter aortic valve implantation.

Usage of transcatheter aortic valve implantation (TAVI) for treatment of severe aortic stenosis is increasing across age groups. However, literature on age-specific TAVI outcomes is lacking. The purpose of this study is to assess the risks of procedural complications, mortality, and readmission in patients undergoing TAVI across different age groups. The Nationwide Readmissions Database was used to identify 84017 patients undergoing TAVI from 2016 to 2018. Patients were stratified into four age groups: younger than 70, 70-79, 80-89, and older than 90. Complications, mortality, and readmission rates were compared between groups in a proportional hazards regression model. Risk of post-procedural stroke, acute kidney injury, and pacemaker or implantable cardioverter defibrillator implantation increased with incremental age grouping. Compared with patients younger than 70, patients aged 70-79 had no significant difference in mortality, whereas patients aged 80-89 and older than 90 had an increased mortality risk [odds ratio (OR) 1.39, confidence interval (CI) 1.14-1.70, P=0.001 and OR 1.68, CI 1.33-2.12, P<0.001, respectively]. Patients aged 80-89 and older than 90 had increased overall readmission compared with patients younger than 70 (HR 1.09, CI 1.03-1.14, P=0.001 and HR 1.33, CI 1.25-1.41, P<0.001, respectively). Cardiac readmissions followed the same trend. Patients aged 80-89 and older than 90 undergoing TAVI have increased risk of readmission, complications, and mortality compared with patients younger than 70.

Preliminary clinical experience of the novel transcatheter aortic valve system Prizvalve® for the treatment of severe aortic stenosis

Objective: To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) with the novel Prizvalve® system in treating severe aortic stenosis. Methods: This is a single-center, prospective, single-arm, observational study. A total of 11 patients with severe aortic stenosis with high risk or inappropriate for conventional surgical aortic valve replacement (SAVR) were included, and TAVI was achieved with the Prizvalve® system between March 2021 and May 2021 in West China Hospital. Transthoracic echocardiography (TTE) was performed immediately after prosthesis implantation to evaluate mean transaortic gradient and maximal transaortic velocity. The device success rate was calculated, which was defined as (1) the device being delivered via the access, deployed, implanted and withdrawn, (2) mean transaortic gradient<20 mmHg (1 mmHg=0.133 kPa) or a maximal transaortic velocity<3 m/s post TAVI, and without severe aortic regurgitation or paravalvular leak post TAVI. TTE was performed at 30 days after the surgery, and all-cause mortality as well as the major cardiovascular adverse events (including acute myocardial infarction, disabling hemorrhagic or ischemic stroke) up to 30 days post TAVI were analyzed. Results: The age of 11 included patients were (78.1±6.3) years, with 8 males. A total of 10 patients were with NYHA functional class Ⅲ or Ⅳ. Devices were delivered via the access, deployed, implanted and withdrawn successfully in all patients. Post-implant mean transaortic gradient was (7.55±4.08) mmHg and maximal transaortic velocity was (1.78±0.44) m/s, and both decreased significantly as compared to baseline levels (both P<0.05). No severe aortic regurgitation or paravalvular leak was observed post TAVI. Device success was achieved in all the 11 patients. No patient died or experienced major cardiovascular adverse events up to 30 days post TAVI. Mean transaortic gradient was (9.45±5.07) mmHg and maximal transaortic velocity was (2.05±0.42) m/s at 30 days post TAVI, which were similar as the values measured immediately post TAVI (both P>0.05). Conclusions: TAVI with the Prizvalve® system is a feasible and relatively safe procedure for patients with severe aortic stenosis and at high risk or inappropriate for SAVR. Further clinical studies could be launched to obtain more clinical experience with Prizvalve® system.

Can aortic calcium score predict new conduction disturbances in pos-transcatheter aortic valve implantation?

Abstract Funding Acknowledgements Type of funding sources: None. Background Transcatheter aortic valve implantation (TAVI) may be the first line treatment for severe aortic stenosis according to overall patient characteristics. Semi-quantitative Agatston score (AS), which quantifies aortic calcium by cardiac computed tomography (CCT), has knowledgeable practical and clinical implications, and is performed in TAVI diagnostic workup. Since conduction disturbances continue to be the most frequent complication, further refinements are required to predict high-risk patients. Purpose To access if aortic AS relates with new conduction disturbances and permanent pacemaker (PPM) implantation in patients undergoing TAVI. Methods We retrospectively analyzed all patients who underwent TAVI at a tertiary center from October 2014 to November 2019; patients with previous permanent pacemaker (PPM) or had no aortic AS were excluded. Clinical and electrocardiogram (ECG) data were collected at admission and after the procedure. All categorical variables are reported as numbers and percentages. Continuous variables were analyzed using the two-tailed unpaired Student’s t-test and are reported as mean values and the standard deviation. Statistical analysis was performed using the IBM SPSS. Results 172 patients with a mean age 79 ± 9.1 years old were included (see table 1 for baseline characteristics). AS was on average 3008 ± 2262 (see table 2 for remaining diagnostic workup and procedure characteristics). Comparing AS with new conduction disturbances, no statistically significant difference was found for new complete left branch block (LBBB) (no vs new LBBB, AS: 3179 ± 2555 vs 2637 ± 1388, p= 0,15) and with new complete atrioventricular block (AVB) (no vs new AVB, AS: 2834 ± 1520 vs 4485 ± 5285, p = 0.2). Considering PPM implantation after TAVI, there was a tendency for higher AS and PPM implantation (no vs PPM implantation, AS: 2756 ± 1451 vs 4242 ± 4310, p = 0.07). In patients who had pre-ballooning, there was no difference relating to AS; however, in patients who had no pre-ballooning there was a trend to higher AS and PPM implantation (no vs PPM implantation, AS: 2417 ± 1301 vs 4616 ± 4969, p = 0.06). No statistically significant difference was found when comparing earlier (Portico, CoreValve Evolut R) vs newer valves (CoreValve Evolut Pro; Edward Sapiens 3; Accurate Neo). Conclusion Aortic calcium measured by Agatston score did not show a correlation with new LBBB or new AVB after TAVI. Nevertheless, it seems to be a trend for higher AS and PPM implantation; this was more noticeable when pre-ballooning was not performed. Further studies are needed in order to further elucidate this association. Abstract Figure. Patients baseline characteristics Abstract Figure. TAVI diagnostic workup and procedure

Carotid Duplex Poorly Predicts Stroke Risk During Transcatheter Aortic Valve Replacement

Patients undergoing surgical aortic valve replacement, in isolation or with concomitant coronary artery bypass grafting, have historically been screened for carotid artery disease prior to surgery. Over the past decade, transcatheter aortic valve replacement (TAVR) has incrementally become the predominant technique for the treatment of severe aortic stenosis. The relationship between internal carotid artery stenosis (ICAS) and risk of periprocedural stroke in the TAVR population is uncertain. We sought to evaluate our institution's outcomes with the TAVR procedure and the association with preoperative carotid duplex scan (CDS) results. A retrospective review of a single institution TAVR registry over a 5-year period was performed. All patients with pre-operative carotid imaging were included. Outcomes included in-hospital, 30-day, and 1-year stroke and all-cause mortality rates. The diagnosis of post-operative stroke was based on neurological exam and confirmed by radiologic imaging. Standard statistical analysis was performed. A total of 436 patients met inclusion criteria. The prevalence of ICAS >50% was 18.3% and 70-99% stenosis was 4.8%. The in-hospital stroke and mortality rates were 2.3% and 1.2%, respectively. The cumulative 30-day and 1- year stroke rates were 3.7% and 6%, respectively. All were ischemic in nature. Bilateral infarcts were identified in 46.2% of stroke patients and 11.5% had an ipsilateral ICAS >50%. A large majority of stroke patients (23, 88.5%) had an ipsilateral ICAS of <50%. Less than 0.5% of patients had ICAS >70% and subsequently had an ipsilateral stroke within 30 days of procedure. The preoperative CDS identified carotid lesions that met criteria for elective repair in only 4.8% of patients. Of these, 9.5% suffered a stroke in the first 30 days after surgery. Over 90% of patients who had a stroke had less than 70% stenosis present in either carotid artery and there was no correlation between degree of ICAS and risk of stroke during the follow-up period. Routine CDS prior to TAVR does not predict in-hospital or 30-day stroke. As TAVR programs evolve, expand, and proliferate across the country, routine preoperative CDS is unlikely to determine the need for pre-operative carotid revascularization or predict stroke risk.

Transcatheter Aortic Valve Replacement in Nonagenarians: A Systematic Review and Meta-Analysis.

Nonagenarians represent only a small proportion of patients included in large transcatheter aortic valve replacement (TAVR) trials, but will become a relevant future population in need of treatment due to demographic change. Thus, this study sought to evaluate outcomes of TAVR for the treatment of severe aortic stenosis (AS) in nonagenarian patients. We screened Medline/Pubmed for studies that stated specific outcomes for nonagenarians undergoing TAVR. A weighted meta-analysis was conducted, calculating pooled estimate rates using a binary random-effects model for dichotomous variables, and comparing non-dichotomous outcomes with a continuous random-effects model. Data from 23 studies including 16,094 nonagenarians were merged; 53.4% were women. Despite reasonable rates of comorbidities, Society of Thoracic Surgeons mortality risk score was 10.2 ± 5.4. Pooled estimate rate of procedural success was 94.1% (95% confidence interval [CI], 91.7-96.6), with major vascular complications occurring in 6.3% (95% CI, 2.7-9.8) and at least moderate postprocedural paravalvular leak in 7.5% (95% CI, 4.4-10.6). The rate of periprocedural stroke or transient ischemic attack was 2.6% (95% CI, 2.0-3.2). At 30 days, the pooled estimate of mortality was 6.1% (95% CI, 4.7-7.4) and a permanent pacemaker was implanted in 12.6% (95% CI, 7.6-17.6). After 1 year, the mortality rate was 20.5% (95% CI, 15.9-25.1). TAVR in nonagenarians is an effective and safe procedure, with encouraging outcomes given the general life expectancy of these patients. Currently, only selected nonagenarians are undergoing TAVR, but their number will grow as life expectancy continues to increase in the developed world. Specific research to identify ideal candidates and techniques in this cohort is needed.

Machine Learning Techniques Can Identify a High Risk Phenotype of Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation

Transcatheter aortic valve implantation (TAVI) has become the standard of care for the treatment of severe aortic stenosis (AS). Patients follow varying trajectories depending on their clinical, echocardiographic and procedural characteristics. Machine learning techniques can be used to identify phenotypes within the spectrum of aortic stenosis to identify high-risk patients.

A case of peri-prosthetic femoral fracture made operable by early treatment of severe aortic stenosis

A case of peri-prosthetic femoral fracture made operable by early treatment of severe aortic stenosis

POSC111 Cost-Minimization Analysis of Bovine and Porcine Bioprosthetic Aortic Valves for the Treatment of Severe Aortic Stenosis in Colombia

Surgical Aortic Valve Replacement (SAVR) is the recommended treatment for severe aortic stenosis according to current guidelines in Latin America. The most commonly bioprosthetic valves used today are from porcine or bovine tissue. Regarding the valve selection rational , previous studies have reported superior hemodynamic performance using bovine compared with porcine valves and long-term outcomes have been recently reported. Additionally, considering the current restricted budget scenario, a rational resource utilization is vital. Therefore, the aim of this study was to conduct a long-term costs study of both bovine and porcine valves in Colombia from a public payers perspective. A cost-minimization analysis was carried out based in a Markov model with annual cycle length to estimate costs associated to each alternative over a 15-year time horizon. The model and the transition probabilities were based in the long-term clinical results previously reported in a previous study and were validated with local clinical experts. Considered costs included the initial procedure, the valves, standard monitoring, and reoperation. A 3.5% annual discount rate was considered according to local guidelines. All costs were estimated using the Social Security (Instituto del Seguro Social) Rates Manual and are presented in 2021 COP. Bovine valves presented a cost difference of -$1,149,865 COP versus porcine valves over the 15-year time horizon, which makes them a cost-saving alternative. Bovine valves were associated to $32,031,426 COP whereas porcine valves to $33,181,291 and the main cost driver between both alternatives was the reoperation rate. Savings associated to bovine valves were presented after the 10th year. From a public healthcare payer perspective, using bovine valves in SAVR patients could represent savings after the 10th year for the Colombian healthcare system. Considering the inevitable epidemiological transition, a rational use of resources is relevant, today more than ever.

Professionals’ views on shared decision-making in severe aortic stenosis

ObjectiveTo provide insight into professionals’ perceptions of and experiences with shared decision-making (SDM) in the treatment of symptomatic patients with severe aortic stenosis (AS).MethodsA semistructured interview study was performed in...