Transcatheter Aortic Valve Implantation Research Articles

Asian Pacific Society of Cardiology Position Statement on the Use of Transcatheter Aortic Valve Implantation in the Management of Aortic Stenosis

Transcatheter aortic valve implantation (TAVI) has been established as an effective treatment modality in patients with severe aortic stenosis and the uptake of TAVI is rapidly growing in the Asia-Pacific region. However, there exists a heterogeneity in the management of aortic stenosis and the use of TAVI among countries in the region. Reasons for these differences include anatomical variations, disparity in healthcare resources and infrastructure and the lack of consensus on the optimal management of aortic stenosis in the Asia-Pacific region. Hence, an Asian Pacific Society of Cardiology (APSC) working group, including a multidisciplinary group of general and interventional cardiologists, cardiac surgeons and imaging specialists, developed a position statement on the recommendations for TAVI in the management of aortic stenosis. The APSC expert panel reviewed and appraised the available evidence using the Grading of Recommendations Assessment, Development, and Evaluation system. Recommendations were developed and put to an online vote. Consensus was reached when 80% of votes for a given recommendation were in support of ‘agree’ or ‘neutral.’ The resulting 28 statements provide guidance for clinical practitioners in the region on the use of TAVI in the treatment of patients with aortic stenosis.

Cardiac arrest in adult cardiology patients receiving anaesthetic care: analysis from the 7th National Audit Project (NAP7) of the Royal College of Anaesthetists.

The 7th National Audit Project of the Royal College of Anaesthetists studied peri-operative cardiac arrest because of existing knowledge gaps in this important topic. This applies in particular to cardiology patients receiving anaesthetic care, because numbers, types and complexity of minimally invasive interventional procedures requiring planned and unplanned anaesthesia in the cardiac intervention suite is increasing. We analysed collected data to determine the epidemiology, clinical features, management and outcomes of peri-operative cardiac arrest in adult patients receiving anaesthetic care for cardiology procedures. There were 54 reports of peri-operative cardiac arrest in adult patients receiving anaesthetic care for cardiology procedures, accounting for 54/881 (6.1%) of all reports to NAP7. The estimated incidence (95%CI) of cardiac arrests in this group was 1/450 or 0.22 (0.17-0.29)%. These patients were older than other adult patients in the NAP7 population, with a notably high proportion of patients of Asian ethnicity when compared with the remaining NAP7 cohort (9/54, 17% vs. 35/709, 5%). Rates of extracorporeal membrane oxygenation cardiopulmonary resuscitation were low (3/53, 6%). A common theme was that of logistical issues and teamworking, with reporters commenting on the difficulties of remote and/or unfamiliar locations and communication issues between specialties, on occasion resulting in poor teamworking and a lack of focus. The NAP7 panel review identified several other common themes which included: cardiogenic shock; late involvement of anaesthesia in the case; and transcatheter aortic valve implantation. Cardiology procedures requiring anaesthesia care account for < 1% of anaesthesia activity but generate 6% of all peri-operative cardiac arrests. The incidence of cardiac arrest was disproportionately high in cardiological procedures requiring anaesthetic care. The nature of the cardiac arrest reports to NAP7 indicate that logistical and human factors in multidisciplinary teams in the cardiac intervention suite merit addressing to improve care.

Transcatheter Aortic Valve Replacement: Latest Advances and Prospects

Aortic stenosis is the most common degenerative valvular heart disease leading to surgery or transcatheter therapy in Europe and North America [...]

Asian Pacific Society of Cardiology Position Statement on the Use of Transcatheter Aortic Valve Implantation in the Management of Aortic Stenosis

Asian Pacific Society of Cardiology Position Statement on the Use of Transcatheter Aortic Valve Implantation in the Management of Aortic Stenosis

Predicting new-onset persistent conduction disturbance following transcatheter aortic valve replacement: the usefulness of FEOPS finite element analysis

BackgroundDespite the frequency of persistent new-onset conduction disturbances after transcatheter aortic valve replacement (TAVR), few preoperative methods of prediction exist.MethodsPatients who underwent TAVR in the Department of Cardiology of the Second Affiliated Hospital of the Army Medical University from December 2020 to September 2021 and postoperative aortic root modeling via the FEOPS finite element analysis were included in this single-center case–control study, divided into persistent conduction disturbances (PCD) and non-PCD groups according to their pre- and postoperative electrocardiograms in the first month. Risk factors affecting PCD were identified by comparing the baseline data of these two groups, including echocardiograms, computed tomography angiography of the aortic root, surgical decision-making, and FEOPS data. Independent risk factors were screened using logistic regression modeling, and the receiver operating characteristic (ROC) curve was used to test the predictive ability.ResultsA total of 56 patients were included in this study, 37 with bicuspid aortic valve (BAV) and 19 with trileaflet aortic valve (TAV), with 17 cases of PCD. The contact pressure index (CPI) of FEOPS, valve oversize ratio, differences between membranous interventricular septum length and implantation depth (ΔMSID) and valve implantation depth were statistically different (P < 0.05). CPI could be used as an independent risk factor for PCD (P < 0.05), and the ROC curve comparison showed that the CPI was more predictive (AUC = 0.806, 95% CI: 0.684–0.928, P = 0.001).ConclusionsThe CPI of FEOPS has better predictive value for new-onset conduction disturbance after TAVR compared to other known predictors.

Analysis of the Correlation between In-hospital Adverse Events and Transcatheter Aortic Valve Replacement Outcomes

Analysis of the Correlation between In-hospital Adverse Events and Transcatheter Aortic Valve Replacement Outcomes

Gastrointestinal Angiodysplasia Resolution After Transcatheter Aortic Valve Implantation

Heyde syndrome is the cooccurrence of aortic stenosis and gastrointestinal bleeding secondary to vascular lesions, including angiodysplasias. Several studies have demonstrated cessation of gastrointestinal bleeding after transcatheter aortic valve implantation (TAVI), but the etiology and effects on vascular lesions are largely unknown. To examine the associations of TAVI with gastrointestinal vascular lesions and identify factors associated with recovery among patients with iron deficiency anemia and severe aortic stenosis. In this prospective, single-center cohort study, patients with iron deficiency anemia on the TAVI waiting list from September 2020 to February 2022 were assessed by capsule endoscopy. Those with vascular lesions were reassessed 6 months after TAVI. Endoscopic images were anonymized and evaluated by 2 independent researchers. Data were analyzed from September 2022 to August 2024. TAVI. The primary outcome was the mean difference in the number of vascular lesions before vs after TAVI. A total of 24 patients (mean [SD] age, 77.4 [7.1] years; 18 [75.0%] male) underwent capsule endoscopy, and vascular lesions were present in 18 patients (75.0%). TAVI was performed in 15 of 18 patients with vascular lesions, of whom 11 agreed to a second capsule endoscopy. The mean (SD) number of vascular lesions across the gastrointestinal tract decreased from 6.4 (5.6) lesions before TAVI to 2.0 (2.1) lesions 6 months after TAVI (P = .04). The number of vascular lesions decreased in 9 of 11 patients (81.8%), including 6 patients (54.5%) who no longer had typical angiodysplasias. Resolution of angiodysplasias was less frequent in patients who had multiple valvular heart disease before TAVI (0 of 3 patients) vs those without multiple valvular heart disease (6 of 8 patients [75.0%]) and in patients with significant paravalvular leakage after TAVI (2 of 5 patients [40.0%]) vs those without significant leakage (4 of 6 patients [66.7%]). In this cohort study of 24 patients with iron deficiency anemia and severe aortic stenosis, angiodysplasias were present in 75.0% of patients. TAVI was associated with reduced size and number of angiodysplasias in these patients. These findings suggest that TAVI not only improves aortic stenosis but may also reduce gastrointestinal bleeding by resolving vascular lesions, offering a dual benefit for patients with Heyde syndrome.

Validation of the Valve Academic Research Consortium High Bleeding Risk Definition in Patients Undergoing TAVR.

Background: The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) has recently introduced a consensus document that outlines risk factors to identify high bleeding risk (HBR) in patients undergoing transcatheter aortic valve replacement (TAVR). The objective of the present study was to evaluate the prevalence and predictive value of the VARC-HBR definition in a contemporary, large-scale TAVR population. Methods: Multicenter study including 10,449 patients undergoing TAVR. Based on consensus, twenty-one clinical and laboratory criteria were identified and classified as major or minor. Patients were stratified as at low, moderate, high, and very high bleeding risk according to VARC-HBR definition. The primary endpoint was the rate of BARC type 3 or 5 bleeding at 1 year, defined as the composite of peri-procedural (within 30 days) or late (after 30 days) bleeding. Results: Patients with at least one VARC-HBR criterion (n=9,267, 88.7%) had a higher risk of BARC 3 or 5 bleeding, proportional to the severity of risk assessment (10.8%, 16.1%, and 24.6% for moderate, high, and very high-risk groups, respectively). However, a comparable rate of bleeding events was observed in the low-risk and moderate-risk groups. The area under ROC curve was 0.58. Patients with VARC-HBR criteria also exhibited a gradual increase in 1-year all-cause mortality, with an up to 2-fold increased mortality risk for high and very high-risk groups (HR: 1.33, 95% CI: 1.04-1.70; and HR: 1.97, 95% CI: 1.53-2.53, respectively). Conclusions: The VARC-HBR consensus offered a pragmatic approach to guide bleeding risk stratification in TAVR. The results of the present study would support the predictive validity of the newly definition and promote its application in clinical practice to minimize bleeding risk and improve patient outcomes.

Outcomes of Balloon-Expandable Transcatheter Aortic Valve Replacement in Younger Patients in the Low-Risk Era

Guidelines advise heart team assessment for all patients with aortic stenosis, with surgical aortic valve replacement recommended for patients younger than 65 years or with a life expectancy greater than 20 years. If bioprosthetic valves are selected, repeat procedures may be needed given limited durability of tissue valves; however, younger patients with aortic stenosis may have major comorbidities that can limit life expectancy, impacting decision-making. To characterize patients younger than 65 years who received transcatheter aortic valve replacement (TAVR) and compare their outcomes with patients aged 65 to 80 years. This retrospective registry-based analysis used data on 139 695 patients from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry, inclusive of patients 80 years and younger undergoing TAVR from August 2019 to September 2023. Balloon-expandable valve (BEV) TAVR with the SAPIEN family of devices. Comorbidities (heart failure, coronary artery disease, dialysis, and others) and outcomes (death, stroke, and hospital readmission) of patients younger than 65 years compared to patients aged 65 to 80 years. In the years surveyed, 13 849 registry patients (5.7%) were younger than 65 years, 125 846 (52.1%) were aged 65 to 80 years, and 101 725 (42.1%) were 80 years and older. Among those younger than 65, the mean (SD) age was 59.7 (4.8) years, and 9068 of 13 849 patients (65.5%) were male. Among those aged 65 to 80 years, the mean (SD) age was 74.1 (4.2) years, and 77 817 of 125 843 patients (61.8%) were male. Those younger than 65 years were more likely to have a bicuspid aortic valve than those aged 65 to 80 years (3472/13 755 [25.2%] vs 9552/125 001 [7.6%], respectively; P < .001). They were more likely to have congestive heart failure, chronic lung disease, diabetes, immunocompromise, and end stage kidney disease receiving dialysis. Patients younger than 65 years had worse baseline quality of life (mean [SD] Kansas City Cardiomyopathy Questionnaire score, 47.7 [26.3] vs 52.9 [25.8], respectively; P < .001) and mean (SD) gait speed (5-meter walk test, 6.6 [5.8] seconds vs 7.0 [4.9] seconds, respectively; P < .001) than those aged 65 to 80 years. At 1 year, patients younger than 65 years had significantly higher readmission rates (2740 [28.2%] vs 23 178 [26.1%]; P < .001) and all-cause mortality (908 [9.9%] vs 6877 [8.2%]; P < .001) than older patients. When propensity matched, younger patients still had higher 1-year readmission rates (2732 [28.2%] vs 2589 [26.8%]; P < .03) with similar mortality to their older counterparts (905 [9.9%] vs 827 [10.1%]; P = .55). Among US patients receiving BEV TAVR for severe aortic stenosis in the low-surgical risk era, those younger than 65 years represent a small subset. Patients younger than 65 years had a high burden of comorbidities and incurred higher rates of death and readmission at 1 year compared to their older counterparts. These observations suggest that heart team decision-making regarding TAVR for most patients in this age group is clinically valid.

Comparison of strategies for vascular ACCESS closure after transcatheter aortic valve implantation: the ACCESS-TAVI randomized trial.

Data from randomized trials investigating different access closure strategies after transfemoral transcatheter aortic valve implantation (TF-TAVI) remain scarce. In this study, two vascular closure device (VCD) strategies to achieve hemostasis after TF-TAVI were compared. The ACCESS-TAVI (Comparison of Strategies for Vascular ACCESS Closure after Transcatheter Aortic Valve Implantation) is a prospective, multicenter trial in which patients undergoing TF-TAVI were randomly assigned to a strategy with a combined suture-/plug-based VCD strategy (suture/plug group) using one ProGlideTM/ProStyleTM (Abbott Vascular) and one Angio-Seal® (Terumo) versus a suture-based VCD strategy (suture-only group) using two ProGlidesTM/ProStylesTM. The primary endpoint was a composite of major or minor access site-related vascular complications during index hospitalization according to Valve Academic Research Consortium (VARC)-3 criteria. Key secondary endpoints included time to hemostasis, VARC-3 bleeding type ≥2 and all-cause mortality over 30 days. Between September 2022 and April 2024, 454 patients were randomized. The primary endpoint occurred in 27% (62/230) in the suture/plug group and 54% (121/224) in the suture-only group (relative risk [RR] 0.55 [95% confidence interval: 0.44;0.68]; p<0.001). Time to hemostasis was significantly shorter in the suture/plug group compared to the suture-only group (108±208 s vs. 206±171 s; p <0.001). At 30 days, bleeding type ≥2 occurred less often in the suture/plug group compared to the sutureonly group (6.2% vs. 12.1%, RR 0.66 [0.43;1.02]; p=0.032), with no significant difference in mortality. With regard to the composite of major or minor access-related vascular complications, a combined suture-/plug-based VCD strategy was superior to a suturebased VCD strategy for vascular access closure in patients undergoing TF-TAVI.

Comparison of patients with occlusive or hemorrhagic access site complications requiring reintervention after percutaneous transfemoral transcatheter aortic valve implantation.

Background: Transcatheter aortic valve implantation (TAVI) via transfemoral (TF) access is increasingly integral to aortic valve disease treatment, expanding beyond high-risk patients. Despite technical advancements, access-related vascular complications, occurring in approximately 10% of TAVI procedures, remain a substantial challenge. Objective: This study investigated the clinical and morphological characteristics of percutaneous TF-TAVI patients experiencing occlusive (OC) and hemorrhagic (HC) complications managed with surgical or endovascular reintervention. Methods: The cohort included patients from a Dutch and a German tertiary referral hospital, managed with TF-TAVI procedures between 2017 and 2021 that required reintervention for OC or HC. Demographics, comorbidities, procedural details, and preoperative imaging data were collected and compared between groups. Results: Among 109 TF-TAVI patients, 32 with OC and 77 with HC required reintervention. The OC group presented significantly smaller access arterial diameters (common femoral artery: OC 6.7 mm vs. HC 8.9 mm, p<.001; external iliac artery: OC 7.2 mm vs. HC 8.3 mm, p<.001; common iliac artery: OC 9.4 mm vs. HC 10.5 mm, p=.012) while the HC group presented higher tortuosity index (TI) (OC 1.24 vs. HC 1.30; p=.017). No differences were observed regarding baseline characteristics, vessel calcification or vascular closure device use. Conclusions: In patients requiring reintervention following TF-TAVI, smaller arterial diameters were associated with OC, while higher TI was linked to HC. These findings emphasize the importance of preoperative imaging in developing individualized prevention strategies.

Severe angulation of the descending aorta with a kink: Buddy wire is key for a successful transfemoral transcatheter aortic valve replacement.

Severe angulation of the descending aorta with a kink: Buddy wire is key for a successful transfemoral transcatheter aortic valve replacement.

Cerebral Embolic Protection by Geographic Region

Transcatheter aortic valve replacement (TAVR) is an established treatment option for many patients with severe symptomatic aortic stenosis; however, debris dislodged during the procedure can cause embolic stroke. The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated. To explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR. This post hoc analysis of a prospective, postmarket, randomized clinical trial evaluating TAVR performed with or without the CEP took place at 51 hospitals in the US, Europe, and Australia from February 2020 to January 2022. Patients with symptomatic aortic stenosis treated with transfemoral TAVR were included. Randomization was stratified according to center, operative risk, and intended TAVR valve type. Patients were excluded if the left common carotid or brachiocephalic artery had greater than 70% stenosis or if the anatomy precluded placement of the CEP device. Data for this post hoc study were analyzed from August to October 2024. TAVR with or without CEP. The primary end point was the rate of all stroke events at hospital discharge or 72 hours post-TAVR, whichever came first. Neurological examinations were performed at baseline and postprocedure to identify stroke, disabling stroke, and other neurological outcomes. The Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) trial enrolled and randomized 3000 patients (1803 [60.1%] male; mean [SD] age, 78.9 [7.8] years): 1833 in the US cohort (TAVR alone: 919, TAVR with CEP: 914) and 1167 patients in the outside the US (OUS) cohort (TAVR alone: 580, TAVR with CEP: 587). Patients in the US cohort were younger, more predominantly male, had a lower prevalence of atrial fibrillation, and had a higher prevalence of bicuspid aortic valve, diabetes, and peripheral vascular disease compared with the OUS cohort. In the main trial, the incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group, and there was no interaction by geographic region. In this post hoc analysis, patients treated with CEP in the US cohort exhibited a 50% relative risk reduction for overall stroke and a 73% relative risk reduction for disabling stroke compared to TAVR alone; a treatment effect on stroke risk reduction was not observed in the OUS cohort. The PROTECTED TAVR trial could not show that the use of CEP had a significant effect on the incidence of periprocedural stroke during TAVR. Although there was no significant interaction by geographic region, this exploratory post hoc analysis suggests a trend toward greater stroke reduction in the US cohort but not in the OUS cohort. These findings are hypothesis generating, and further research is needed to determine if regional differences in patient characteristics or procedural practices affect CEP efficacy. ClinicalTrials.gov Identifier: NCT04149535.

Long-Term Durability of Transcatheter Aortic Valve Prostheses in Patients With Bicuspid Versus Tricuspid Aortic Valve.

Currently, there is a lack of evidence for the long-term bioprosthetic valve durability of patients with bicuspid aortic valve (BAV) following transcatheter aortic valve replacement (TAVR). This study aimed to evaluate hemodynamic outcome, structural valve deterioration, and bioprosthetic valve failure during long-term follow-up after TAVR in patients with BAV versus patients with tricuspid aortic valve (TAV). Patients with BAV and TAV who underwent TAVR between 2012 and 2020, with echocardiography followed for at least 3 years, were included. Baseline characteristics, long-term valve hemodynamic performance, structural valve deterioration, and bioprosthetic valve failure were compared between patients with BAV and TAV. A total of 170 patients with BAV and 145 patients with TAV were included. The mean duration of follow-up for patients with BAV and TAV was 5.2±1.8 and 5.0±1.7 years. No significant differences were observed in the rates of structural valve deterioration and bioprosthetic valve failure between patients with BAV and TAV: structural valve deterioration, BAV 20 (11.8%) versus TAV 16 (11.0%) at last follow-up (P=0.861); bioprosthetic valve failure, BAV 3 (1.8%) versus TAV 7 (4.8%) at last follow-up (P=0.196). More than moderate intravalvular aortic regurgitation (1.8% versus 4.8%, P=0.196) and paravalvular leak (6.5% versus 3.4%, P=0.305) were rare in both patients with BAV and patients with TAV. This study indicated satisfactory long-term valve durability of TAVR in patients with BAV. Comparable hemodynamic outcome, structural valve deterioration, and bioprosthetic valve failure could be achieved in patients with BAV and TAV during long-term follow-up after TAVR.

Uncrossable aortic stenosis during transcatheter aortic valve replacement: application of balloon-assisted tracking technique.

Uncrossable aortic stenosis during transcatheter aortic valve replacement: application of balloon-assisted tracking technique.

Transcatheter versus surgical aortic valve replacement in aortic stenosis patients requiring mechanical circulation support: a nationwide Japanese study

Abstract Introduction Transcatheter aortic valve replacement (TAVR) has demonstrated comparable clinical outcomes to surgical aortic valve replacement (SAVR) in patients with aortic stenosis (AS). However, previous trials excluded patients who had required mechanical circulatory support (MCS) for cardiogenic shock. Thus, the clinical feature of aortic valve replacement requiring MCS and the efficacy of TAVR compared to SAVR has not been fully exhibited in AS patients. Purpose This study investigated the demography and clinical outcomes comparing TAVR and SAVR for AS demanding MCS. Methods The current study was an observational retrospective study using Japanese nationwide data from the Japanese Registry Of All cardiac and vascular Diseases-Diagnostic Procedure Combination (JROAD-DPC). Between April 1, 2012, and March 31, 2022, AS patients undergoing TAVR or SAVR who required MCS were evaluated. The primary outcome was 30-day mortality. In addition, we assessed ischemic stroke, hemorrhagic stroke during hospitalization. Result During the period, 80,752 patients (TAVR=36,546 and SAVR=44,206) were identified. The frequency of MCS (intra-aortic balloon pumping and/or extracorporeal membrane oxygenation) was 3.0% (1,097 patients) of the TAVR group and 4.8% (2,133 patients) of the SAVR group. In the TAVR group, 78% of patients were implanted balloon-expandable valve and 7.1% of patients were transapical apical approach. TAVR was performed in older (median age: 85 years vs. 76 years, p&amp;lt;0.001), lower body mass index (BMI) (median BMI: 21.5 kg/m2 vs. 22.7 kg/m2, p&amp;lt;0.001), and more female patients (42% vs. 27%, p&amp;lt;0.001) than SAVR. The 30-day mortality was lower in TAVR than SAVR (12% in TAVR and 19% in SAVR, p&amp;lt;0.001) (Figure). After adjusting age, gender, TAVR was significantly associated with decreased 30-day mortality compared to SAVR (adjusted HR 0.52 (0.41–0.67), p&amp;lt;0.001). In contrast, the incidence of ischemic stroke and hemorrhagic stroke were comparable in 2 groups (ischemic stroke; 4.2% in TAVR vs. 4.1% in SAVR, p=0.93 and hemorrhagic stroke; 0.3% vs. 0.3%, respectively). Conclusion According to nationwide real-world clinical data on aortic valve replacement for AS, the frequency of patients requiring MCS due to cardiogenic shock was 3.0% in the TAVR group and 4.8% in the SAVR group. Our findings demonstrated short-term outcomes following TAVR for patients requiring MCS for cardiogenic shock was better than those following SAVR.

Survival penalty in patients undergoing transcatheter versus surgical aortic valve replacement: is it just a question of frailty? Insights from a large cohort with demographic matching

Abstract Background Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are the reference treatments for aortic stenosis. Conflicting data exist on late survival results of these two techniques. While randomised controlled trials (with highly selected patients) assert the non-inferiority of TAVR, real-world data from large registries (with potential uncorrected confounders) suggest the opposite. Comparing the survival rates of SAVR and TAVR with those of a matched reference population could help circumvent potential biases of direct procedural comparisons and quantify the impact of frailty on post-operative survival. Purpose Our study aims to compare the 5-year overall survival rates of SAVR, non-frail TAVR, and frail TAVR patients with the survival of their demographically matched reference population. Methods This study included all consecutive patients undergoing either SAVR or TAVR at a tertiary hospital between January 2010 and December 2021. Each patient underwent a comprehensive geriatric assessment by an experienced geriatric team, from which a Clinical Frailty Scale (CFS) was derived using a validated classification tree. Frailty was defined as a CFS ≥ 6, in accordance with ESC guidelines. The patients were stratified into 3 subgroups: SAVR, non-frail TAVR, and frail TAVR patients. For each subgroup, a corresponding reference population was generated using national actuarial tables to ensure individual-level matching based on age, gender, and year of observation. Survival of each subgroup was then compared to its corresponding reference population over a 5-year period using standardized mortality ratios (SMR) and one-sample logrank tests. Results Our cohort included 1183 SAVR, 254 non-frail TAVR, and 151 frail TAVR patients, with mean ages of 74.1, 85.4, and 85.7 years, and median EuroSCORE II of 2.0%, 4.2%, and 5.4%, respectively. Survival of SAVR patients was equivalent to the reference population (80.1 vs 80.9% survival; SMR = 1.06 [0.89 – 1.25]; p = 0.454; Figure 1A). Similarly, non-frail TAVR patients also achieved survival rates comparable to those of the reference population (50.9 vs 54.0% survival; SMR = 0.94 [0.76 – 1.18]; p = 0.549; Figure 1B). However, frail TAVR patients faced a significantly reduced survival rate (41.7% vs 54.0% survival; SMR = 1.48 [1.15 – 1.90]; p &amp;lt; 0.001; Figure 1C). The frailty of this subgroup could therefore explain a 48% increase in mortality risk compared with their reference population after 5 years. Conclusions Treating non-frail patients with aortic stenosis through TAVR or SAVR restores life expectancy to levels comparable with their reference population, challenging results from other real-world registries. In contrast, TAVR in frail patients is associated with worse survival, raising the question of treatment futility in this specific subgroup. Refining the selection of frail patients who may benefit from TAVR remains an important clinical challenge.

Transcatheter vs. surgical aortic valve replacement in patients with aortic stenosis and cardiogenic shock.

Patients with aortic stenosis (AS) and cardiogenic shock (CS) are an extremely high-risk population with a poor prognosis in the absence of definitive therapy. We aimed to compare the outcomes of transcatheter aortic valve replacement (TAVR) with those of surgical aortic valve replacement (SAVR) in patients with AS-CS. We queried the Nationwide Readmission Database (2016-21) to identify patients hospitalized for AS-CS who underwent isolated TAVR or SAVR. In-hospital outcomes of TAVR vs. SAVR were compared using multivariable regression and propensity-matching analyses. Ninety-day readmissions were compared using a Cox proportional hazards regression model. A total of 16 161 patients were hospitalized for AS-CS, of whom 6470 (40.0%) underwent isolated TAVR and 9691 (60.0%) underwent isolated SAVR. From 2016 through 2021, the proportion of TAVR increased from 29.5 to 46.5% and the proportion of SAVR correspondingly decreased in AS-CS (Ptrend < 0.01). After adjustment for baseline characteristics, TAVR was associated with lower odds of stroke [adjusted odds ratio (aOR) 0.63, 95% confidence interval (CI) 0.47-0.84], acute kidney injury (aOR 0.80, 95% CI 0.69-0.93), and major bleeding (aOR 0.54, 95% CI 0.40-0.71) and higher odds of vascular complications (aOR 1.56, 95% CI 1.23-1.97) compared with SAVR. In-hospital mortality, myocardial infarction, permanent pacemaker placement, and 90-day all-cause and heart failure readmissions showed similar rates between TAVR and SAVR. However, hospital length of stay was shorter and total costs and non-home discharges were lower with TAVR than with SAVR. This nationwide observational analysis showed that TAVR is increasingly performed in patients with AS-CS and is associated with similar rates of in-hospital mortality and 90-day readmissions but lower rates of in-hospital complications and resource utilization compared with SAVR.

Transcatheter versus surgical aortic valve replacement in patients younger than 65 years: analysis from the national inpatient sample database

Abstract Background Data on the relative utilization and outcomes of transcatheter aortic valve replacement (TAVR) versus surgical AVR (SAVR) in patients &amp;lt;65 years are limited. Purpose To compare the relative utilization and outcomes of TAVR versus SAVR in patients &amp;lt;65 years in the United States. Methods We queried the National Inpatient Sample (2016-2020) to identify patients &amp;lt;65 years hospitalized for isolated AVR. In-hospital outcomes of TAVR versus SAVR were compared using multivariable regression and propensity-matching analyses. Results Of 74,155 patients aged &amp;lt;65 years hospitalized for isolated AVR, 17,300 (23.3%) underwent isolated TAVR, and 56,855 (76.7%) underwent isolated SAVR. From 2016-2020, the use of TAVR increased, while the use of SAVR decreased in patients &amp;lt;65 years (both ptrend&amp;lt;0.01). Factors independently associated with TAVR selection in patients &amp;lt;65 years included female sex, congestive heart failure, pulmonary disease, renal failure, liver disease, cancer, and prior revascularization. Factors independently associated with SAVR selection included bicuspid aortic valve. After adjustment for baseline characteristics, TAVR was associated with lower odds of in-hospital mortality (adjusted odds ratio [aOR] 0.61, 95% confidence interval [CI] 0.38-0.97), stroke (aOR 0.58, 95% CI 0.38-0.90), acute kidney injury (aOR 0.41, 95% CI 0.34-0.49), and major bleeding (aOR 0.62, 95% CI 0.38-0.96), and higher vascular complications compared with SAVR (aOR 2.39, 95% CI 1.75-3.24). Length of stay was shorter and nonhome discharges were lower with TAVR (all p&amp;lt;0.01). Similar findings were observed in the propensity-matched cohort. Conclusions This nationwide observational analysis showed that TAVR is a feasible treatment option for patients &amp;lt;65 years with lower in-hospital mortality and resource utilization compared with SAVR.Central Illustration

Temporal trends of aortic valve replacement modalities by age group in the United-States 2015 - 2023

Abstract Background/Introduction Transcatheter aortic valve implantation (TAVI) has led to a paradigm shift in treating aortic stenosis (AS) across patients of all surgical-risk categories. To guide the clinical decision, the ACC/AHA guidelines recommended an age group classification; with SAVR being recommended in patients &amp;lt; 65 years, and TAVI being favored over SAVR in patients &amp;gt; 80 years. In patients between 65-80 years, both modalities are to be considered after shared decision making. The impact of those guidelines-derived age group classification on the contemporary AVR practice remains of interest and is dynamically changing. Purpose This study aims to examine the temporal trends in the modality of AVR (TAVI vs SAVR) in the U.S. among different age groups using a contemporary nationwide database. Methods We conducted a retrospective study using de-identified data from the Vizient Clinical Database, which gathers patient and hospital data from more than 1000 medical Centre. We analysed TAVI and SAVR procedures from October 1, 2015, to November 30, 2023, excluding patients under 18. We examined the national trends of TAVI vs SAVR in 3 age groups (&amp;lt;65, 65-80, &amp;gt;80 years) with AS. Trend analysis was performed using linear regression. This study was deemed exempt from the requirements of 45 CFR 46.104(d) by The Miriam Hospital Institutional Review Board given that it involved de-identified data. Results During the study period, 467,832 underwent AVR (TAVI n= 252,834, SAVR n= 214,998). The patient and hospital characteristics by age group are summarized in the Table. We observed a significant rise in TAVI adoption from 33.5% in 2015 to 59.96% in 2023. However, the pattern of temporal trends varied among different age groups. In patients &amp;gt; 80 years, TAVI showed a steep rise from 69.95% in 2015 to 92.96% in 2023 (p&amp;lt;0.002). The 65-80 years age cohort demonstrated the most pronounced growth in TAVI, rising from 26.23% in 2015 to about 60% in 2020 (p.001), after which a plateau in percentage was observed. TAVI in patients &amp;lt;65 years has also been increasingly adopted, rising from 7.18% in 2015 to 19.12% in 2020 (p&amp;lt;0.002), however, followed with a slight downtrend to 16.36% in 2023 (Figure). Conclusion In this most contemporary analysis from the U.S., we demonstrate an increase in the adoption of TAVI across all age groups over the study period, with the steepest rise observed in patients between 65-80 years of age. Since the 2020 ACC/AHA guidelines, there has been a gradual downtrend in the utilisation of TAVI in patients &amp;lt;65 years of age indicating a possible change in practice based on scientific societal recommendations. The stabilization in TAVI percentage in the age groups 65-80 years and &amp;gt; 80 years in the last few years may hint towards approaching equilibrium between TAVI and SAVR for these age groups.Proportions of AVR across age groups