Transcatheter Aortic Valve Implantation Patients Research Articles

Defining high bleeding risk in patients undergoing transcatheter aortic valve implantation: a VARC-HBR consensus document.

<span style="font-size:12pt"><span style="font-family:Aptos,sans-serif">The identification and management of patients at high bleeding risk (HBR) undergoing transcatheter aortic valve implantation (TAVI) are of major importance, but the lack of standardised definitions is challenging for trial design, data interpretation, and clinical decision-making. The Valve Academic Research Consortium for High Bleeding Risk (VARC-HBR) is a collaboration among leading research organisations, regulatory authorities, and physician-scientists from Europe, the USA, and Asia, with a major focus on TAVI-related bleeding. VARC-HBR is an initiative of the CERC (Cardiovascular European Research Center), aiming to develop a consensus definition of TAVI patients at HBR, based on a systematic review of the available evidence, to provide consistency for future clinical trials, clinical decision-making, and regulatory review. This document represents the first pragmatic approach to a consistent definition of HBR evaluating the safety and effectiveness of procedures, devices and drug regimens for patients undergoing TAVI.</span></span>.

Incidence and Predictors of Readmissions to Non-Index Hospitals After Transcatheter Aortic Valve Implantation in the Contemporary Era in New South Wales, Australia

In Australia, transcatheter aortic valve implantation (TAVI) is only performed in a limited number of specialised metropolitan centres, many of which are private hospitals, making it likely that TAVI patients who require readmission will present to another (non-index) hospital. It is important to understand the impact of non-index readmission on patient outcomes and healthcare resource utilisation. We analysed linked hospital and death records for residents of New South Wales, Australia, aged ≥18 years, who had an emergency readmission within 90 days following a TAVI procedure in 2013-2022. Mixed-effect, multi-level logistic regression models were used to evaluate predictors of non-index readmission, and associations between non-index readmission and readmission length of stay, 90-day mortality, and 1-year mortality. Of 4,198 patients (mean age, 82.7 years; 40.6% female) discharged alive following TAVI, 933 (22.2%) were readmitted within 90 days of discharge. Over three-quarters (76.0%) of those readmitted returned to a non-index hospital, with no significant difference in readmission principal diagnosis between index hospital and non-index hospital readmissions. Among readmitted patients, independent predictors of non-index readmission included: residence in regional or remote areas, lower socio-economic status, having a pre-procedure transfer, and a private index hospital. Readmission length of stay (median, 4 days), 90-day mortality (adjusted odds ratio [OR] 1.04, 95% confidence interval [CI] 0.56-1.96) and 1-year mortality (adjusted OR 1.01, 95% CI 0.64-1.58) were similar between index and non-index readmissions. Non-index readmission following TAVI was highly prevalent but not associated with increased mortality or healthcare utilisation. Our results are reassuring for TAVI patients in regional and remote areas with limited access to return to index TAVI hospitals.

Platelet Reduction after Transcatheter Aortic Valve Implantation: Results from the PORTRAIT Study.

Background: An unexplained condition that follows transcatheter aortic valve implantation (TAVI) is platelet count reduction (PR). According to published research, patients with balloon-expandable valves (BEVs) had a greater PR than those with self-expandable valves (SEVs). Objectives: The purpose of this study was to investigate the incidence and clinical effects of PR following TAVI. Methods: In total, 1.122 adult TAVI patients were enrolled. Propensity score matching was carried out in a 1:1 ratio between patients with BEVs and those with SEVs. The analysis included changes in platelet count, in-hospital mortality, and early postoperative adverse events. Results: Notably, 632 patients were matched (BEV:316; SEV:316). All patients' post-procedural platelet counts changed according to a parabolic curve, using a mixed regression model for repeated analyses (estimate = -0.931; standard error = 0.421; p = 0.027). The platelet count varied comparably in patients with BEVs and SEVs (estimate = -4.276, standard error = 4.760, p = 0.369). The average time for obtaining the nadir platelet count value was three days after implantation (BEV: 146 (108-181) vs. SEV: 149 (120-186); p = 0.142). Overall, 14.6% of patients (92/632) had post-procedural platelet count <100,000/µL. There was no difference between the two prosthesis types (BEV:51/316; SEV:41/316; p = 0.266). Thrombocytopenia was found to be significantly linked to blood product transfusions, lengthier stays in the intensive care unit and hospital, and in-hospital mortality. Conclusions: TAVI, irrespective of the type of implanted valve, is linked to a significant but temporary PR. Thrombocytopenia increases the risk of serious complications and in-hospital death in TAVI patients. To explore and clarify the causes and associated effects, further prospective research is necessary.

Diagnostic performance of deep learning to exclude coronary stenosis on CT angiography in TAVI patients.

We evaluated the diagnostic performance of a deep-learning model (DLM) (CorEx®, Spimed-AI, Paris, France) designed to automatically detect > 50% coronary stenosis on coronary computed tomography angiography (CCTA) images. We studied inter-observer variability as an additional aim.CCTA images obtained before transcatheter aortic valve implantation (TAVI) were assessed by two radiologists and the DLM, and the results were compared to those of invasive coronary angiography (ICA) used as the reference standard. 165 consecutive patients underwent both CCTA and ICA as part of their TAVI work-up. We excluded the 42 (25.5%) patients with a history of stenting or bypass grafting and the 23 (13.9%) patients with low-quality images. We retrospectively subjected the CCTA images from the remaining 100 patients to evaluation by the DLM and compared the DLM and ICA results. All 25 patients with > 50% stenosis by ICA also had > 50% stenosis by DLM evaluation of CCTA: thus, the DLM had 100% sensitivity and 100% negative predictive value. False-positive DLM results were common, yielding a positive predictive value of only 39% (95% CI, 27-51%). Two radiologists with 3 and 25 years' experience, respectively, performed similarly to the DLM in evaluating the CCTA images; thus, accuracy did not differ significantly between each reader and the DLM (p = 0.625 and p = 0.375, respectively).The DLM had 100% negative predictive value for > 50% stenosis and performed similarly to experienced radiologists. This tool may hold promise for identifying the up to one-third of patients who do not require ICA before TAVI.

Transcatheter aortic valve implantation with and without mitral stenosis — A national readmission database study

IntroductionMitral valve stenosis (MS) can be concomitantly present in patients undergoing Transcatheter Aortic Valve Implantation (TAVI). Some studies have reported up to one-fifth of patients who underwent TAVI also have MS. The relationship between mitral stenosis and TAVI has led to concerns regarding increased adverse cardiac outcomes during and after the procedure. MethodsThe Nationwide Readmission Database (NRD 2016–2019) was utilized to identify TAVI patients with MS with ICD-10-CM codes. The primary outcome was a 30-day readmission rate. Secondary outcomes included predictors of all-cause readmissions, length of stay, and total hospitalization cost. We assessed readmission frequency with a national sample weighed at 30 days following the index TAVI procedure. Unadjusted and adjusted odds ratios were analyzed for in-hospital outcomes using univariate and multivariate logistic regression for study cohorts. ResultsA total of 217,147 patients underwent TAVI procedures during the queried time period of the study. Of these patients, 2140 (0.98 %) had MS. The overall 30-day all-cause readmission rate for the study cohort was 12.4 %. TAVI patients with MS had higher rates of 30-day readmissions (15.8 % vs 12.3 %, aOR 1.22, CI: 1.03–1.45, P < 0.01). Additionally, TAVI patients with MS had longer lengths of hospital stay during index admissions (5.7 vs. 4.3 days), along with higher total hospitalization costs ($55,157 vs. $50,239). In contrast, in-hospital mortality during index TAVI admission did not differ significantly between the two groups, although there was a trend toward higher mortality in the MS group (2.1 % vs. 1.5 %). Among the TAVI MS cohort, patients admitted on weekends (aOR: 1.11, 95 % CI: 1.02–1.22, P = 0.01), admitted to non-metropolitan hospitals (aOR: 1.29, 95 % CI: 1.11–1.66, P = 0.04) and presence of co-morbidities such as atrial fibrillation (AF)/flutter (aOR: 1.24, 95 % CI: 1.16–1.32, P < 0.01), chronic obstructive pulmonary disease (COPD) (aOR: 1.16, 95 % CI: 1.11–1.22, P < 0.01), prior stroke (aOR: 1.09, 95 % CI: 1.03–1.14, P < 0.01), chronic kidney disease (CKD) ≥3 (aOR: 1.16, 95 % CI: 1.11–1.22, P < 0.01), end-stage renal disease (ESRD) (aOR: 1.75, 95 % CI: 1.61–1.90, P < 0.01), and anemia (aOR: 1.23, 95 % CI: 1.18–1.28, P < 0.01) were associated with increased odds of readmission. ConclusionConcomitant MS in patients undergoing TAVI is associated with higher readmission rates and total hospital costs. This can contribute significantly to healthcare-related burdens. Further studies are required to evaluate in-hospital outcomes and predictors of readmission in patients undergoing TAVI with the presence of concomitant MS.

Baseline NT-proBNP predicts acute kidney injury following transcatheter aortic valve implantation

Background/purposeAcute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) increases morbidity and mortality. Our study aimed to investigate the role of baseline N-terminal pro B-type natriuretic peptide (NT-proBNP) as a predictor of AKI following TAVI. MethodsAll consecutive TAVI patients were included in the analysis, except patients with dialysis and those with a GFR < 15 ml/min/1.73 m2 at baseline. Rates of AKI after TAVI were assessed according to the updated valve academic research consortium definitions using AKIN classification in three stages. NT-proBNP was measured at baseline. One-year mortality rates were assessed. ResultsWe included 1973 patients treated with TAVI between January 2006 and December 2016. Median [IQR] age was 81.0 [77.0;84.0] years, the STS score was 6.2 [3.9;9.0], and the logEuroScore was 14.5 [9.0;23.0]. 30-day and one-year mortality was 5.1 % and 16.1 % for all patients, respectively. Multivariate analysis revealed that patients with NT-proBNP levels higher than two times above the upper level of normal (ULN) had an increased risk for AKI after TAVI compared to patients with NT-proBNP levels < 2× ULN (OR 1.40 [1.03–1.91]). ConclusionsRoutine assessment of baseline NT-proBNP levels might be an additional tool to identify patients at increased risk for AKI after TAVI.

Acute Kidney Injury Following Transcatheter Aortic Valve Implantation—A Contemporary Perspective of Incidence, Predictors, and Outcomes

Acute kidney injury (AKI) is a known complication following transcatheter aortic valve implantation (TAVI), associated with increased morbidity and mortality. Most of this data relates to higher-risk patients with early-generation TAVI valves. With TAVI now established as a safe and cost-effective procedure for low-risk patients, there is a distinct need for updated analysis. We aimed to assess the incidence, predictors, and outcomes of AKI in a contemporary cohort of TAVI patients, concurrently examining the role of temporal evolution on AKI. A total of 2,564 patients undergoing TAVI from 2008-2023 included in the Alfred-Cabrini-Epworth (ACE) TAVI Registry were analysed. Patients were divided into AKI and no AKI groups. Outcomes were reported according to the Valve Academic Research Consortium-3 (VARC-3) criteria. Of 2,564 patients, median age 83 (78-87) years, 57.4% men and a median Society of Thoracic Surgeons score of 3.6 (2.4-5.5), 163 (6.4%) patients developed AKI with incidence falling from 9.7% between 2008-2014 to 6% between 2015-2023 (p=0.022). On multivariable analysis, independent predictors of AKI were male sex (adjusted odds ratio [aOR] 1.89, p=0.005), congestive cardiac failure (aOR 1.52, p=0.048), estimated glomerular filtration rate 30-59 (aOR: 2.79, p<0.001), estimated glomerular filtration rate <30 (aOR 8.65, p<0.001), non-femoral access (aOR 5.35, p<0.001), contrast volume (aOR 1.01, p<0.001), self-expanding valve (aOR 1.60, p=0.045), and bleeding (aOR 2.88, p=0.005). Acute kidney injury was an independent predictor of 30-day (aOR: 6.07, p<0.001) and 12-month (aOR: 3.01, p=0.002) mortality, an association that remained consistent when excluding TAVIs performed prior to2015. Acute kidney injury remains a relatively common complication of TAVI, associated with significant morbidity and mortality even in less comorbid, contemporary practice patients.

Eventos hemorrágicos tardíos en pacientes de TAVI anticoagulados con antagonistas de la vitamina K o anticoagulantes orales de acción directa

Introduction and objectivesThe optimal chronic antithrombotic regimen for patients with atrial fibrillation undergoing transcatheter aortic valve implantation (TAVI) remains uncertain. Our aim was to compare the incidence of late bleeding events between patients on direct oral anticoagulants (DOACs) and those on vitamin-K antagonists (VKA). MethodsThis single-center observational study included TAVI patients requiring oral anticoagulation at discharge between 2015 and 2021. The primary endpoint was any clinically significant bleeding event. Secondary endpoints were stroke, heart failure, and all-cause mortality. ResultsA total of 702 TAVI procedures were performed, with 297 patients requiring oral anticoagulation at discharge. Among them, 206 (69.4%) received VKA and 91 (30.6%) received DOAC. Baseline clinical, procedural and in-hospital characteristics did not significantly differ between groups, except for better renal function among DOAC patients. The median length of follow-up was 2.8 years. The risk of bleeding events was higher in patients receiving DOACs than in those receiving VKA (HR=2.27; 95%CI, 1.21-4.26; incidence of 9.7 and 4.2 events per 100 patient-years of follow-up for DOAC and VKA patients, respectively). There were no statistically significant differences in the rates of stroke (HR, 1.28; 95%CI, 0.4-4.3), heart failure hospitalization (HR, 0.92; 95%CI, 0.46-1.86), or all-cause mortality (HR, 1.02; 95%CI, 0.68-1.55). ConclusionsIn older patients undergoing TAVI and receiving anticoagulant therapy for atrial fibrillation, the use of DOAC was associated with a higher risk of late bleeding events than VKA.

Does Comprehensive Geriatric Assessment Reduce the Incidence of Postoperative Delirium? A Quasi-experimental Study in Older Adults Undergoing Transcatheter Aortic Valve Implantation.

Postoperative delirium (POD) after transcatheter aortic valve implantation (TAVI) is frequent in older adults and associated with multiple negative outcomes including a higher mortality. We aimed to investigate whether a comprehensive geriatric assessment (CGA) prior to TAVI reduces the odds of POD and results in a positive change in self-care ability, intended to lay a foundation for future geriatric comanagement. We used a retrospective, single-center study with a quasi-experimental design enrolling patients aged 70 years and older undergoing CGA before elective TAVI, and a nonrandomized comparison group without preoperative CGA. Data on POD occurrence during the first 5 days after TAVI (primary outcome) and change in self-care ability index (SPI) between admission and discharge (secondary outcome) were collected from electronic health records and CGA data (exposure) by clinical assessment. To explore associations between (1) CGA and POD, and (2) CGA and SPI, multivariate logistic regression and linear regression models were applied adjusting for age, sex, BMI, and number of medications. Among 435 patients (mean age 81.0 ± 5.6 years, 43.6% women, median [IQR] SPI at baseline 40 [39, 40] points), POD incidence was 14.3% in the CGA group vs 18.8% in the non-CGA group (P 0.219). Undergoing CGA before TAVI was not associated with the odds for POD (OR: 1.15; 95%CI: 0.65-2.04) or improved SPI (P 0.073). We observed no association of CGA prior to TAVI with POD incidence or postoperative self-care, highlighting the need for additional studies investigating the effect of POD preventive measures in older TAVI patients integrated into a comprehensive geriatric comanagement program.

Utility of Coronary Computed Tomography Angiography in Patients Undergoing Transcatheter Aortic Valve Implantation: A Meta-Analysis and Meta-Regression Based on Published Data from 7458 Patients.

Coronary CT angiography (CCTA) may detect coronary artery disease (CAD) in transcatheter aortic valve implantation (TAVI) patients and may obviate invasive coronary angiography (ICA) in selected patients. We assessed the diagnostic accuracy of CCTA for detecting CAD in TAVI patients based on published data. Meta-analysis and meta-regression were performed based on a comprehensive electronic search, including relevant studies assessing the diagnostic accuracy of CCTA in the setting of TAVI patients compared to ICA. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), were calculated on a patient and per segment level. Overall, 27 studies (total of 7458 patients) were included. On the patient level, the CCTA's pooled sensitivity and NPV were 95% (95% CI: 93-97%) and 97% (95% CI: 95-98%), respectively, while the specificity and PPV were at 73% (95% CI: 62-82%) and 64% (95% CI: 57-71%), respectively. On the segmental coronary vessel level, the sensitivity and NPV were 90% (95% CI: 79-96%) and 98% (95% CI: 97-99%). This meta-analysis highlights CCTA's potential as a first-line diagnostic tool although its limited PPV and specificity may pose challenges when interpreting heavily calcified arteries. This study underscores the need for further research and protocol standardization in this area.

Echocardiographic predictors of outcome in severe aortic stenosis patients with preserved or reduced ejection fraction

AimsTranscatheter aortic valve implantation (TAVI) has emerged as the treatment of choice for many patients with severe symptomatic aortic stenosis. We sought to identify the echocardiographic predictors of 30-day and 1-year outcomes after TAVI in patients with preserved or reduced left ventricular ejection fraction (LVEF).MethodsThis single-centre study included 618 aortic stenosis patients (mean age 82 ± 6 years, 47.1% male; 74.8% LVEF > 50%) who underwent balloon-expandable TAVI between July 2009 and October 2018 in our hospital. All patients completed at least 6 months of follow-up by medical history review or telephone interview (median 24, quartiles 12–42 months). The primary endpoint was all-cause death.ResultsAll-cause mortality rate was 5.2% (LVEF > 50%: 4.3% vs. LVEF ≤ 50%: 7.7%, p = 0.141) at 30 days and 15.4% (LVEF > 50%: 14.7% vs. LVEF ≤ 50%: 17.3%, p = 0.443) at 12 months post TAVI. Overall all-cause mortality rate was 45.1% (LVEF > 50%: 44.6% vs. LVEF ≤ 50%: 46.8%, p = 0.643). Mean survival time post TAVI was 51 months [95% CI (48; 55)]. In TAVI patients with LVEF > 50%, multivariate Cox regression analysis revealed several independent predictors for increased risk of death after adjusting for echocardiographic and clinical covariates: TAPSE (≤ 17 vs. > 17 mm, HR 1.528, p = 0.016) and sPAP (> 30 vs. ≤ 30 mmHg, HR 1.900, p = 0.002) for overall mortality, E/E′ septal for 30-day mortality (> 21 vs. ≤ 21, HR 14.462, p = 0.010) and 12-month mortality (> 21 vs. ≤ 21, HR 1.881, p = 0.026). In TAVI patients with LVEF ≤ 50%, no independent echocardiographic predictors for outcome could be identified.ConclusionsLVEF is not a predictor of short- and long-term mortality after TAVI. In patients with preserved LVEF, left ventricular filling pressure (E/E´), systolic pulmonary artery pressure (sPAP), and TAPSE are echocardiographic risk factors for increased mortality post TAVI.Graphical abstract

Iodine contrast volume reduction in preoperative transcatheter aortic valve implantation computed tomography: Comparison with 64- and 256-multidetector row computed tomography

IntroductionThis study aimed to compare the vascular enhancement and radiation dose in preoperative transcatheter aortic valve implantation (TAVI) computed tomography (CT) with a reduced contrast medium (CM) using volume scans in 256-multidetector row CT (MDCT) with a standard CM using 64-MDCT. MethodsThis study included 78 patients with preoperative TAVI CT with either 64- or 256-MDCT. The CM was injected at 1.5 mL/kg in the 64-MDCT group and 1.0 mL/kg in the 256-MDCT group. We compared vascular enhancement of the aortic root and access routes, image quality (IQ) scores, and radiation dose in both groups. ResultsDespite the reduced CM (by 33 %) in the 256-MDCT group, the mean vascular enhancement of the right and left subclavian arteries was significantly higher than that in the 64-MDCT group [284 and 267 Hounsfield units (HU) vs. 376 and 359 HU; p < 0.05]; however, no significant differences in the mean vascular enhancement in the ascending aorta, abdominal aorta at the celiac level, and bilateral common femoral arteries were observed between the two groups (p > 0.05 for all). The median IQ scores at the aortic root were higher in the 256-MDCT group than in the 64-MDCT group (3 vs. 4; p < 0.05), and those at the femoral access routes were comparable (4 vs. 4; p = 0.33). The mean effective dose was significantly reduced by 30 % in the 256-MDCT group (23.6 vs. 16.3 mSv; p < 0.05). ConclusionIn preoperative TAVI CT, volume scans using 256-MDCT provide comparable or better vascular enhancement and IQ with a 30 % reduction in CM and radiation dose than those using 64-MDCT. Implications for practiceVolume scan using 256-MDCT for preoperative TAVI CT may reduce CM and radiation dose in TAVI patients with renal dysfunction.

One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry.

Midterm comparative analyses of the latest iterations of the most used Evolut and SAPIEN platforms for transcatheter aortic valve implantation (TAVI) are lacking. We aimed to compare 1-year clinical outcomes of TAVI patients receiving Evolut PRO/PRO+ (PRO) or SAPIEN 3 Ultra (ULTRA) devices in current real-world practice. Among patients enrolled in the OPERA-TAVI registry, patients with complete 1-year follow-up were considered for the purpose of this analysis. One-to-one propensity score matching was used to compare TAVI patients receiving PRO or ULTRA devices. The primary endpoint was a composite of 1-year all-cause death, disabling stroke and rehospitalisation for heart failure. Five prespecified subgroups of patients were considered according to leaflet and left ventricular outflow tract calcifications, annulus dimensions and angulation, and leaflet morphology. Among a total of 1,897 patients, 587 matched pairs of patients with similar clinical and anatomical characteristics were compared. The primary composite endpoint did not differ between patients receiving PRO or ULTRA devices (Kaplan-Meier [KM] estimates 14.0% vs 11.9%; log-rank p=0.27). Patients receiving PRO devices had higher rates of 1-year disabling stroke (KM estimates 2.6% vs 0.4%; log-rank p=0.001), predominantly occurring within 30 days after TAVI (1.4% vs 0.0%; p=0.004). Outcomes were consistent across all the prespecified subsets of anatomical scenarios (all pinteraction>0.10). One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke. Outcomes did not differ across the different anatomical subsets of the aortic root.

Short-Term Changes in Arterial Stiffness Measured by 2D Speckle Tracking in Patients Undergoing Transcatheter Aortic Valve Implantation.

Arterial stiffness has received increasing interest as a cardiovascular marker in patients with aortic valve stenosis (AS). So far, studies on the impact of aortic valve replacement (AVR) on arterial stiffness have been equivocal. Two-dimensional speckle tracking (2DST) is a novel, non-invasive method to measure the motion of the vessel wall. In this prospective observational study, we aimed to assess the change in arterial stiffness of the common carotid artery (CCA) measured by 2DST in patients undergoing transcatheter aortic valve implantation (TAVI). A total of 47 patients were included in the study (age 80.04 ± 6.065 years). Peak circumferential strain (CS) was significantly improved after TAVI (4.50 ± 2.292 vs. 5.12 ± 2.958, p = 0.012), as was the peak strain rate (CSR) (0.85 ± 0.567 vs. 1.35 ± 0.710, p = 0.002). Body mass index (BMI), mean arterial pressure (MAP) and hemodynamic parameters were associated with this change. 2DST results did not correlate with aortic pulse wave velocity (aPWV) or augmentation index normalized to heart rate (AIx@75), suggesting a distinct difference between arterial stiffness of the CCA and other stiffness parameters. 2DST seems to be a promising new tool to assess arterial stiffness in TAVI patients.

Concomitant percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation.

Patients undergoing transcatheter aortic valve implantation (TAVI) frequently have coronary artery disease requiring percutaneous coronary intervention (PCI). Usually, PCI and TAVI are performed in two separate procedures and current studies are investigating potential benefits regarding the order. However, the two interventions may also be performed simultaneously, thereby limiting the risk associated with repeated vascular access. Data evaluating benefit and harm of concomitant procedures are scarce. Therefore, this study aimed to evaluate concomitant PCI(coPCI) in TAVI patients regarding Valve Academic Research Consortium 3(VARC-3) endpoints and long-term mortality. A total of 2233 consecutive TAVI patients from the EVERY-VALVEregistry were analyzed according to the VARC-3 endpoint definitions. A total of 274 patients had undergone TAVI and concomitant PCI (coPCI group). They were compared to 226 TAVI patients who had received PCI within 60 days before TAVI in a stepwise approach (swPCI group) and to the remaining 1733 TAVI patients who had not undergone PCI recently (noPCI group). Overall median age was 81.4 years, median Society of Thoracic Surgeons score was 4.0%. Patients in the coPCI and in the swPCI group were predominantly male with reduced left-ventricular ejection fraction. Rates of VARC-3 composite endpoints technical success and 30-day device success were comparable between all three groups. Mortality rates at 3 years after TAVI were similar (coPCI, 34.2% vs. swPCI, 31.9% vs. noPCI, 34.0% p = 0.84). coPCI during TAVI seems comparable in a retrospective analysis. Compared to a stepwise approach, it has similar rates of composite endpoints technical success and device success as well as long-term mortality.

Multimarker Approach to Improve Risk Stratification of Patients Undergoing Transcatheter Aortic Valve Implantation

BackgroundA blood multimarker approach may be useful to enhance risk stratification in patients undergoing TAVI. ObjectivesThe objective of this study was to determine the prognostic value of multiple blood biomarkers in transcatheter aortic valve implantation (TAVI) patients. MethodsIn this prospective study, several blood biomarkers of cardiovascular function, inflammation, and renal function were measured in 362 patients who underwent TAVI. The cohort was divided into 3 groups according to the number of elevated blood biomarkers (ie, ≥ median value for the whole cohort) for each patient before the procedure. Survival analyses were conducted to evaluate the association between blood biomarkers and risk of adverse event following TAVI. ResultsDuring a median follow-up of 2.5 (IQR: 1.9-3.2) years, 34 (9.4%) patients were rehospitalized for heart failure, 99 (27%) patients died, and 113 (31.2%) met the composite endpoint of all-cause mortality or heart failure rehospitalization. Compared to patients with 0 to 3 elevated biomarkers (referent group), those with 4 to 7 and 8 to 9 elevated biomarkers had a higher risk of all-cause mortality (HR: 1.54 [95% CI: 0.84-2.80], P = 0.16, and HR: 2.81 [95% CI: 1.53-5.15], P < 0.001, respectively) and of the composite endpoint (HR: 1.65 [95% CI: 0.95-2.84], P = 0.07, and HR: 2.67 [95% CI: 1.52-4.70] P < 0.001, respectively). Moreover, adding the number of elevated blood biomarkers into the clinical multivariable model provided significant incremental predictive value for all-cause mortality (Net Reclassification Index = 0.71, P < 0.001). ConclusionsAn increasing number of elevated blood biomarkers is associated with higher risks of adverse clinical outcomes following TAVI. The blood multimarker approach may be helpful to enhance risk stratification in TAVI patients.

Comparison of MANTA versus Perclose Prostyle large-bore vascular closure devices during transcatheter aortic valve implantation.

New vascular closure devices (VCD) are being introduced for achieving hemostasis after transcatheter aortic valve implantation (TAVI). However, no safety or efficacy data have been published compared to other contemporary VCD. To compare the safety and efficacy of suture-based Perclose Prostyle as compared to plug-based MANTA device. A total of 408 consecutive TAVI patients from two high volume TAVI centers were included in the present study. Patients were grouped according to VCD: Prostyle versus MANTA. Propensity score matching (PSM) and multivariable analysis were utilized to compare clinical endpoints between the two groups. The primary endpoint was any vascular complication (VC) according to VARC-3 criteria. After PSM, a total of 264 patients were analyzed, of them 132 in each group. Overall baseline characteristics of the two groups were comparable. Primary end-point was similar between MANTA as compared to Prostyle (16.7% vs. 15.3% respectively, p = 0.888). The main driver for VC among MANTA group were minor vascular complications (15.2%). Conversely, minor and major VC contributed equally to the primary endpoint among Prostyle group (7.6%) (p = 0.013). No outcome predictors were identified in multivariate analysis. VCD for transfemoral TAVI using the new-generation Prostyle device or the MANTA device achieved comparable VARC-3 VC rates.

PP47 Experience And Its Implication For Reassessment Of The Transcatheter Aortic Valve Implantation Using Real World Data

IntroductionSouth Korea has introduced conditionality to coverage decisions for certain difficult or high-risk procedures. The transcatheter aortic valve implantation (TAVI) was included in the coverage with evidence development (CED) in 2014. This study reviewed the results of reassessment for the TAVI using real world data (RWD) and suggested its implications.MethodsHealthcare providers authorized to use the promising technologies are required to collect the RWD for suitability evaluation, safety monitoring, and cost-effectiveness, differing from the general reassessment process. In 2021, 45 healthcare providers collected clinical information for TAVI patients. Their registries were linked with the national health insurance claims, which provided data on 19 items to assess safety and effectiveness such as overall mortality, reoperation rates, hospital readmission rates, and degree of functional improvement.ResultsAccording to the Society of Thoracic Surgeons’ predicted risk of mortality (STS), 988 TAVI patients were classified into three groups; high (STS &gt;8 percent, n=347), intermediate (STS 4-8 percent, n=272), and low (STS &lt;4 percent, n=369); We compared main outcomes and estimated survival probabilities between subgroups. Within 30 days, the overall mortality rates were 4.9 percent (high), 2.6 percent (intermediate), and 1.4 percent (low); major bleeding rates were 7.6 percent (high), 6.2 percent (intermediate),and 1.4 percent (low); incidence of new atrial fibrillation were 6.8 percent (high), 4.2 percent (intermediate), and 3.2 percent (low). Based on the quantitative results using RWD and systematic review for the safety and effectiveness, TAVI is reported to have essential benefits for high-risk group and elderly patients (&gt;80 years). Whereas, intermediate and low-risk groups have out-of-pocket payment rates of 50 percent and 80 percent, respectively.ConclusionsThe reassessment system through RWD accumulation enabled the evidence-based evaluation for the TAVI. Based on the transition to CED for essential benefits, a systematic framework such as RWD collection from treatment commencement should be introduced to broaden RWD use for benefit management of medical technologies with uncertain levels of evidence. Therefore, this ensures overall quality of care and effective coverage in health.

Stroke reduction by cerebral embolic protection devices in transcatheter aortic valve implantation: a systematic review and Bayesian meta-analysis

ObjectivesThe use of cerebral embolic protection (CEP) during transcatheter aortic valve implantation (TAVI) has been studied in several randomised trials. We aimed to perform a systematic review and Bayesian meta-analysis...

On the Material Constitutive Behavior of the Aortic Root in Patients with Transcatheter Aortic Valve Implantation

BackgroundTranscatheter aortic valve implantation (TAVI) is a minimally invasive procedure used to treat patients with severe aortic valve stenosis. However, there is limited knowledge on the material properties of the aortic root in TAVI patients, and this can impact the credibility of computer simulations. This study aimed to develop a non-invasive inverse approach for estimating reliable material constituents for the aortic root and calcified valve leaflets in patients undergoing TAVI. MethodsThe identification of material parameters is based on the simultaneous minimization of two cost functions, which define the difference between model predictions and cardiac-gated CT measurements of the aortic wall and valve orifice area. Validation of the inverse analysis output was performed comparing the numerical predictions with actual CT shapes and post-TAVI measures of implanted device diameter.ResultsA good agreement of the peak systolic shape of the aortic wall was found between simulations and imaging, with similarity index in the range in the range of 83.7% to 91.5% for n.20 patients. Not any statistical difference was observed between predictions and CT measures of orifice area for the stenotic aortic valve. After TAVI simulations, the measurements of SAPIEN 3 Ultra (S3) device diameter were in agreement with those from post-TAVI angio-CT imaging. A sensitivity analysis demonstrated a modest impact on the S3 diameters when altering the elastic material property of the aortic wall in the range of inverse analysis solution.ConclusionsOverall, this study demonstrates the feasibility and potential benefits of using non-invasive imaging techniques and computational modeling to estimate material properties in patients undergoing TAVI.