Transcatheter Aortic Valve Implantation Research Articles

Evolution and prognostic impact of left ventricular myocardial work indices after transcatheter aortic valve replacement in patients with severe aortic stenosis

Abstract Introduction Left ventricular myocardial work (LVMW) is an echocardiographic-based technique to evaluate LV function using pressure-strain loops and therefore correcting for the left ventricular (LV) afterload. LVMW indices have been shown to be of prognostic importance in patients with aortic stenosis (AS) before transcatheter aortic valve replacement (TAVR), but no data is available on the evolution and the prognostic value of these parameters after TAVR. Purpose To measure LVMW indices before and after TAVR in patients with severe AS and explore the association with outcome. Methods As previously validated, LV global longitudinal strain (GLS) and LV systolic pressure (as the sum of the brachial arterial blood pressure and mean aortic valve gradient before TAVR and as brachial arterial blood pressure after TAVR) were incorporated to build pressure-strain loops and to calculate the following LVMW indices: global work index (LV GWI), global constructive work (LV GCW), global wasted work (LV GWW) and global work efficiency (LV GWE). The endpoint was all-cause mortality. Results A total of 255 patients were included with a median age of 82 years (IQR 77-85); 51% were men and 67% presented with NYHA class III/IV. After TAVR, LVEF and LV GLS remained in average unchanged (from 56 to 55%, p=0.470 and from 13.6 to 13.2%, p=0.068). While LV GWW remained unchanged after TAVR (from 247 to 258mmHg%, p=0.080), LV GWI, LV GCW and LV GWE significantly decreased (from 1882 to 1291mmHg%, p <0.001, from 2248 to 1671mmHg%, p <0.001 and from 89 to 85%, p <0.001 respectively). During a median follow-up of 59 months (IQR 40-72), 129 patients died. Univariable Cox regression analysis identified an association between all-cause mortality and male sex, diabetes mellitus, chronic obstructive pulmonary disease (COPD), renal function, atrial fibrillation, Charlson comorbidity index, pacemaker implantation, and post-TAVR LV GLS, LV GWI and LV GCW. These clinical parameters were used as a basal multivariable Cox regression model of which on top either post-TAVR LV GLS, LV GWI or LV GCW were added. All these parameters of post-TAVR LV systolic function showed an independent association with all-cause mortality, but LV GWI demonstrated the highest increase in model predictivity (Figure 1). Given the prognostic relevance of post-TAVR LV GWI, the population was divided into LV GWI tertiles. The group with the lowest LV GWI tertile showed a significantly higher proportion of male patients, higher prevalence of atrial fibrillation and also worse pre-TAVR LVEF, LV GLS, LV GWI, LV GCW and LV GWE. Kaplan Meier survival analysis confirmed the worse survival in the group with the lowest LV GWI compared to the highest tertile (log-rank ꭓ2: 8,224, p 0.016, Figure 2). Conclusion LVMW indices change after TAVR and post-TAVR LV GLS, LV GWI, LV GCW are independently associated with all-cause mortality. Among these parameters, LV GWI yielded the highest prognostic value.

Correlation of prosthesis position on mid-term pacing burden in patients with new permanent pacemaker after TAVI

Abstract Background Prior studies suggest a strong correlation of the final prosthesis position on the occurrence of new conduction disturbances resulting in permanent pacemaker (PPM) implantation after transcatheter aortic valve implantation (TAVI). A high burden right ventricular pacing (PPM stimulation rate of > 20 %) is associated with poor long-term outcomes. So far, data about predictors influencing the PPM stimulation rate after TAVI are scarce. Purpose Thus, the purpose of this study was to evaluate the influence of the three-dimensional transcatheter heart valve (THV) position, as well as device landing zone characteristics or peri-/post-procedural factors on the stimulation rate in patients with new implanted PPM as TAVI complication. Materials: We evaluated the final THV position of 387 patients (106 with self-expanding Evolut R THV, 281 with balloon-expandable Sapien 3 THV) using fusion imaging of pre- and post-TAVI computed tomography angiography (CTA) to obtain a three-dimensional reconstruction of the THV within the native annulus region. The length of the THV above and below the native annulus was measured within the fused images to assess the implantation depth. PPM stimulation rates were examined pre-discharge and after 3 months. Patient’s clinical long-term outcome was evaluated over 5 years via standardized questionnaire as well as contacting general practitioners. Results Out of the 387 patients 112 (29%) received a new PPM pre-discharge after TAVI between 2014 and 2022. They were grouped into patients with stimulations rate below and above 20%. A stimulation rate > 20% in the PPM control before discharge and after three months was detected in 69 % and 67 % of them, respectively. Using uni- and multivariate logistic regression analysis, only new occurred third degree atrioventricular blocks (p=0.007) was identified as predictor for high burden right ventricular pacing after PPM-implantation as well as after 3 months. The implantation depth of the THV showed no influence on the PPM stimulation rate – neither the mean value nor the exact implantation depth adjacent the left, right and non-coronary cusp (P=0.455, P=0.108 and P=0.932, respectively). There were no significant differences regarding MACE between both groups during long-term follow-up; only the degree of dyspnea 5 years after TAVI was significantly higher in patients with a stimulation rate > 20% (p=0.01). Conclusion We detected no correlation of the exact three-dimensional THV position on mid-term pacing burden in 112 patients implanted with a new PPM after TAVI using CTA fusion imaging. Only a new occurred third degree atrioventricular block was a predictor for a high burden right ventricular pacing (stimulation rate >20%). These results provide important insights into which patients actually require PPM implantation after TAVI.

Socioeconomic disparity in utilization of transcatheter aortic valve replacement

Abstract Introduction Transcatheter aortic valve replacement (TAVR) is a major therapeutic option, rapidly replacing surgical aortic valve replacement (SAVR) in patients with aortic stenosis (AS) in recent years. However, the use of TAVR may vary with the socioeconomic status (SES) since new technologies are more likely to have the lower accessibility in some medico-social environments. In South Korean patients with AS, we investigated the difference in the use of TAVR based on SES and whether the difference influences clinical outcomes of patients with AS. Methods Between 2010 and 2020, 30,142 patients newly diagnosed with AS in a tertiary or regional center were investigated through the Korean National Health Insurance System (KNHIS). Patients were received either medical, SAVR or TAVR therapy for AS. The patients were categorized into 3 groups based on the insurance premium level (IPL) of the KNHIS (IPL1, <100 KW; IPL2, 100-249 KW; IPL3, ≥250KW). AS-related death was defined as death by AS, heart failure or ventricular arrhythmia. Cardiovascular (CV) death was defined as AS-related death or death by myocardial infarction or stroke. The study period was divided at year 2015, when the partial coverage for TAVR was implemented by the KNHIS. Results The numbers of patients referred to the tertiary/regional centers have continuously grown for the 11 years but the referring rate has grown even faster since 2015. The proportions of TAVR has increased while that of SAVR has decreased since 2015. TAVR was more frequently chosen by patients with a higher IPL (5.5%, 8.0% and 12.5%, respectively in the IPL1, IPL2 and IPL3, p<0.001), whereas the medical therapy appeared not affected by the IP levels. The patients in the IPL2 (odd ratio [OR] 1.33 [1.20-1.47]) and IPL3 (OR 1.65 [1.45-1.86]) had a higher chance to undergo TAVR than those in the IPL1 whereas the patients in the IPL3 was a lower chance to undergo SAVR than those in the IPL1 (OR 0.86 [0.78-0.94]). In patients with severe AS, the disparities between the IPL1 and IPL3 exaggerated (OR 1.99 [1.70-2.33]) (Figure 1). Higher IPLs were associated with lower risks of CV death and AS-related death. Time-varying Cox proportional hazard models showed that TAVR was associated with a lower risk of CV death than both medical therapy and SAVR in the entire study period and in year 2015 or later, whereas TAVR was associated with a lower risk of AS-related death than the both only in year 2015 or later, after adjustment of relevant covariates including the IPL (Figure 2). The choice of TAVR significantly medicated the associations between IPLs and the risk of CV death (responsible for 3.0% in the IPL2 and 4.1% in the IPL3). Conclusion The SES based on the IPL is independently associated with the choice of TAVR in patients with AS and the association has become stronger since 2015. The disparity in use of TAVR could mediate more frequent CV deaths in patients with the lower IPL.Figure 1Figure 2

Discordance between symptomatic response and changes in cardiac structure and function one year after transcatheter aortic valve implantation

Abstract Background Symptomatic improvement is one of the main goals of transcatheter aortic valve implantation (TAVI) in patients with severe symptomatic aortic stenosis. We hypothesized that the degree of symptomatic response after TAVI is associated with improvement in cardiac structure and function after TAVI. Purpose We aimed to evaluate 1) the change in symptomatic burden measured by New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) functional class after TAVI, 2) the change in echocardiographic structural and functional parameters after TAVI, and 3) the association of symptomatic response with echocardiographic response as well as long-term survival. Methods In patients undergoing TAVI, we assessed New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) functional class at 12 months. Symptomatic response was defined as NYHA/CCS class I or ≥ 1 improvement in NYHA/CCS class compared to baseline at 12 months. Echocardiographic images at baseline and 6-18 months post-TAVI were analysed using an automated, validated, deep-learning workflow. Logistic regression was used to assess association between change in echocardiographic parameters and symptomatic change at 12 months. The association of symptomatic response and echocardiographic changes in the first 12 months after TAVI with survival beyond 12 months, was evaluated by landmark analysis using Kaplan-Meier analysis. Results Among 868 TAVI patients (median age 80 years, 53% female), the majority (74%) had NYHA/CCS class III at baseline and 77% of patients experienced improvement in symptoms at 12 months post-TAVI (Figure 1). Patients without an improvement in symptoms more often had COPD, atrial fibrillation and more heart failure medications compared to responders. Left ventricular systolic function did not show improvement compared to baseline, whereas a modest improvement in left atrial volume index, left ventricular mass index, E/A ratio, E/e’ ratio, mean e’ and tricuspid regurgitation peak jet velocity was observed. Symptomatic response was not associated with echocardiographic response. Beyond 12 months, patients with symptomatic improvement had lower mortality than those without symptomatic improvement (1.5 vs. 2.4 per 10 patient years; p = .001), whereas changes in echocardiographic parameters were not associated with subsequent mortality (Figure 2). Conclusion Patients undergoing TAVI for symptomatic severe aortic stenosis, showed substantial symptomatic improvement at one year after the procedure, whereas only a modest improvement in echocardiographic parameters was observed. Improvement in symptoms was not associated with improvement in echocardiographic measures of cardiac structure and function. Symptomatic improvement, but not improvement in cardiac structure and function at 12 months, was a strong predictor of subsequent survival.Change in NYHA/CCS class after TAVISymptoms and echo versus mortality

Prospective evaluation of transcatheter aortic valve implantation (TAVI) with coronary alignment and impact on coronary access

Abstract Introduction Transcatheter aortic valve implantation (TAVI) with optimised coronary alignment aims to reduce coronary-commissural overlap (CCO) to facilitate future coronary intervention and reduce the risk of coronary obstruction after re-do TAVI, however, in-vivo data are lacking. Aims To determine the feasibility of TAVI with coronary alignment assessed by post-TAVI CT. Secondary endpoints included the incidence of adverse anatomical features which could impede coronary access (severe CCO and ostia below valve skirt) and their association with coronary engagement during invasive angiography. Methods 30 patients underwent TAVI with optimised coronary alignment with either ACURATE neo2 or Evolut Pro+ and invasive coronary angiography and cardiac CT performed after valve deployment. Results 15 patients received ACURATE neo2 (50%) and 26 patients (86.7%) underwent CT after TAVI. The mean inter-coronary angle was 140 (19.5)° and the median observed angular deviation from perfect alignment (0°) was 0.8° (IQR -4.5 to +10) ° with perfect alignment (±15°) observed in 21/26 cases (80.8%) and ≤mild misalignment (±30°) in 24/26 of cases (92.3%). The remaining two cases had moderate misalignment (30-45°) with no cases of severe misalignment. The angle between the coronary ostia and the nearest TAVI commissure was 46 (40 - 57) ° for the RCA and 50.5 (43 - 54) ° for the LCA which did not differ significantly from the native situation (both p>0.2), with 1 (3.8%) case of severe overlap. 46/55 (83.6%) coronary engagements were selective, 7/55 (12.7%) semi-selective and 2/55 (3.6%) unable to intubate. Non-selective engagement/unable to engage affected the RCA more than the LCA (6/27 [22.2%] vs. 3/28 [10.7%]) and was three-fold more common with the Evolut (7/29 [24.1%]) than the Acurate (2/26 [7.7%]. Coronary>commissural angle in those with unselective engagement was 43° (IQR 37 to 51°). Conclusions TAVI with optimised coronary alignment is technically feasible, safe and reduces coronary-commissural overlap which is important for future re-do TAVI procedures. Difficult coronary access was encountered more frequently following Evolut Pro+ and when engaging the RCA, but was unrelated to angular distance to nearest commissure.

Unlocking the future: machine learning models for predicting in-hospital mortality after transcatheter aortic valve replacement: a single-arm meta-analysis

Abstract Background Transcatheter aortic valve replacement (TAVR) continues to be increasingly performed. While machine learning has demonstrated utility in predicting adverse outcomes in various cardiovascular procedures, its effectiveness in predicting in-hospital mortality in TAVR remains uncertain. Purpose We aimed to examine the accuracy of machine learning in predicting in-hospital mortality in TAVR. Methods We searched PubMed and Cochrane databases up to February 2024 for observational studies assessing the diagnostic accuracy of machine learning for predicting in-hospital mortality in TAVR. Extracted data included study characteristics, patient demographics, type of predictive model used, and area under the receiver operating characteristic curves (AUC). Predictive accuracy was assessed by pooling AUC of machine-learning models across studies. AUC values ranging from 0.80 to 0.90, 0.70 to 0.80, 0.60 to 0.70, and 0.50 to 0.60 corresponded to excellent, good, fair, and poor discrimination ability, respectively (1). We used a random effects model to estimate the overall effect size with a 95% confidence interval (CI). Heterogeneity was evaluated with the I2 test.We conducted subgroup analyses based on the type of machine-learning model utilized to assess for any potential differences in predictive accuracy. Results A total of three studies were identified, comprising a study population of 70,714 patients. Across studies, eight machine learning models were utilized, consisting of three artificial neural network models, one logistic regression model, one naive Bayes model, two random forest models, and one support vector machine model. Pooled AUC showed excellent accuracy of machine learning in predicting in-hospital mortality in TAVR (0.92; 95% CI 0.90 - 0.95). Subgroup analyses revealed similar yet excellent accuracy across all types of machine learning models utilized: artificial neural network (0.92; 95% CI 0.86-0.99), logistic regression (0.92; 95% CI 0.89-0.95), naive Bayes (0.90; 95% CI 0.88-0.92), random forest (0.94; 95% CI 0.87-1.00), and support vector machine (0.94; 95% CI 0.91-0.96). Conclusion Our study suggests that utilizing machine learning can accurately predict in-hospital mortality in TAVR. Operators of TAVR procedures may benefit from incorporating machine learning prediction models in their clinical practice. Further exploration of machine learning on outcomes in TAVR is needed to verify our findings.

Incidence of aortic valve reintervention in patients with aortic stenosis undergoing TAVI vs SAVR: A systematic review and meta-analysis of randomised controlled trials

Abstract Introduction Transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) are two established treatments for severe aortic stenosis (AS). The relative comparison between TAVI and SAVR for recurrent aortic valve interventions is not well defined. Purpose We aimed to perform a systematic review and meta-analysis comparing the incidence of aortic valve reintervention in patients undergoing TAVI versus SAVR. Methods MEDLINE, Embase and Cochrane databases were searched for randomised controlled trials (RCT) that compared TAVI with SAVR for the treatment of AS reporting the occurrence of aortic valve reinterventions. We also performed a subgroup analysis of different types of TAVI prosthesis. We performed a meta-regression to evaluate the effect of age and Society of Thoracic Surgeons (STS) risk score in the outcome of interest. Statistical analysis was performed using RevMan 5.4.1 and RStudio 2023.12.1. Heterogeneity was assessed with I2 statistics. Results We included 8 RCTs with 8,698 patients, of whom 4,443 (51%) underwent TAVI. Mean follow-up ranged from 1 to 10 years. Aortic valve reintervention was significantly more common in patients treated with TAVI compared with SAVR (RR 1.89; 95%CI 1.24-2.88; p = 0.003). In a subgroup analysis stratified by balloon-expandable or self-expandable valves, there were no significant subgroup differences in their respective comparisons with TAVR (p = 0.20). In meta-regression analysis, older age (p = 0.008) and higher STS score (p = 0.009) were significantly associated with a higher incidence of aortic valve reinterventions with TAVI relative to SAVR. Conclusion In patients who undergo aortic valve replacement, TAVI is associated with a significantly higher incidence of aortic valve reinterventions relative to SAVR, particularly in populations with older age or higher STS score.

Predisposing and precipitating factors of post-operative delirium after transfemoral TAVI

Abstract Background Transcatheter aortic valve implantation (TAVI) represents the treatment of choice for aortic stenosis (AS) patients at higher age (> 75y) or with relevant comorbidities. Post-operative delirium (POD) is a frequent complication which has been associated with worse outcome. Thus, preventive options are highly needed. The aim of our single-center study was to investigate predisposing and precipitating factors of POD after transfemoral TAVI, with a focus on the influence of anaesthesia. Methods Risk factors for POD after TAVI were analysed in 2 merged cohorts of 480 study patients (43% women; mean age 80 years), enrolled in 2017-2022 (n=375, TAVI in 95% in general anaesthesia) and in 2022-2024 (n=105, TAVI in 91% in local anaesthesia). Incidence of POD was evaluated retrospectively by nursing documentation, medical records, and DRG coding. The association of demographics, comorbidities, echo parameters, procedural parameters, anaesthesia, and peri-procedural complications with POD incidence was investigated. Results In total, 29 patients (6%) developed POD, with a tendency towards a lower incidence in the later cohort (6.7% vs. 3.8%; p=0.28). Regarding baseline characteristics, patients experiencing POD were more likely to be male (p=0.03), frail (Katz Index <6, p=0.049), and to suffer from low-gradient AS (p=0.005 for paradoxical, p=0.02 for classical low-flow, low-gradient AS; see also fig. 1A). Total procedure time was significantly longer in patients with POD (median, 86 vs. 62 min, p=0.004; fig 1B), and a tendency towards a more frequent implantation of other than ballon-expandable valves could be observed (p=0.07). Concerning the role of anaesthesia, POD did not differ significantly after general anaesthesia (n=24/360, 6.7%), conscious sedation (n=1/19, 5.3%), and local anaesthesia (n=4/100, 4%) (p=0.38). Regarding procedural complications, POD patients were characterized by lower minimum hemoglobin post-TAVI (9.3 vs. 10.1 g/dl, p=0.05; fig. 1C) and higher incidences of intra-procedural resuscitation (11% vs. 2%, p=0.03), cerebrovascular accidents (10% vs. 2%, p=0.04) and new permanent pacemaker implantations (25% vs. 10%, p=0.02). In POD patients, long-term survival after TAVI was significantly reduced, with a median survival of only 2 years (Kaplan-Meier curves in fig. 2; p=0.001). Conclusions POD after TAVI stays common and unfavourable. The role of anaesthesia seems less pronounced than expected. Total procedure time and relevant anaemia after TAVI emerged as most important modifiable risk factors. Future research is warranted, since strategies to reduce precipitating factors for POD may have a significant impact on post-TAVI outcomes.Selected risk factors for PODConsequence of POD: Reduced Survival

Higher product of right ventricle to left ventricle diameter ratio and septal wall thickness is associated with increased risk of cardiovascular death in patients post TAVI

Abstract Background Right ventricular (RV) dilatation is a significant predictor for mortality in various cardiovascular diseases. Hypertrophy is common in patients undergoing transcatheter aortic valve implantation (TAVI). We tested the hypothesis that the product of right ventricle to left ventricle diameter (RV/LV) ratio and septal wall thickness (SWT) might be a determinant of cardiovascular death in TAVI patients. Methods This retrospective study enrolled 1123 patients undergoing TAVI in our department between 2009 and 2021 (mean age 81.4±5.6 year, male 51.2%). We assessed standard echocardiographic measures prior to the TAVI procedure. End-diastolic basal biventricular dimensions were measured from a standard apical 4-chamber view, and the ratio of RV dimension (RVD) to LV dimension (LVD) was calculated as the RV/LV ratio. We tested the prognostic performance of the product of RV/LV ratio and septal wall thickness (RV/LV ratio*SWT). The primary endpoint was cardiovascular (CV) death up to 2 years after TAVI. Results CV mortality was 11.8% (132/1123) at 2 years after TAVI. SWT was similar between the groups with and without CV death (11.9±1.9 vs. 11.6±1.8 mm, P=0.188). However, the RV/LV ratio (0.84±0.15 vs. 0.80±0.13, P=0.002) and RV/LV ratio*SWT (10.0±2.7 vs. 9.3±3.1 mm, P=0.005) were notably higher in the CV-death group compared to the no CV-death group. Higher RV/LV ratio*SWT remained independently associated with elevated 2-year CV mortality after TAVI (HR=1.09, 95% CI 1.01-1.17, P=0.024), while the RV/LV ratio was no longer significantly linked with CV mortality (HR=2.83, 95% CI 0.87-9.19, P=0.082) after adjusting for potential confounding factors including age, sex, and atrial fibrillation. RV/LV ratio*SWT >12.7 mm was associated with a twofold increased risk of 2-year CV mortality compared to patients with RV/LV ratio*SWT ≤12.7 mm (2-year mortality 14.4% vs. 6.0%, P<0.001; HR=2.04, 95% CI 1.25-3.32, P=0.004), regardless of age, sex, and atrial fibrillation. Conclusions Combined assessment of biventricular remodelling and left ventricular hypertrophy by calculating RV/LV ratio*SWT is of clinical importance for risk stratification of cardiovascular death among TAVI patients.

Periprocedural changes in systolic pulmonary artery pressure in transcatheter aortic valve implantation

Abstract Background Pulmonary hypertension (PH) is common in patients with aortic stenosis and associated with increased mortality following transcatheter aortic valve replacement (TAVR). PH often improves after TAVR and systolic pulmonary artery pressure (sPAP) can change, but to what extent these changes in sPAP following TAVR affect long-term prognosis is unclear. Purpose To investigate the association between periprocedural changes in sPAP and long-term prognosis after TAVR. Methods Patients undergoing TAVR between 2012-2021 from the Swedish Transcatheter Cardiac Intervention Registry (SWENTRY) were included. sPAP was estimated from echocardiography before and after TAVR and categorized as: (1) No PH before and unchanged (≤5 mmHg change) after, (2) No PH before and worsened (>5 mmHg increase) after, (3) PH before and improved (>5 mmHg decrease) after, (4) PH before and unchanged after and (5) PH before and worsened after. An sPAP cutoff at >50 mmHg was applied for PH. Patients were followed for a median of 3.1 years for the primary endpoint heart failure hospitalizations (HFH) and the secondary endpoint all-cause mortality. Cox regression analyses were performed and adjusted for age, sex, body mass index, atrial fibrillation, eGFR class, diabetes, frailty, left ventricular ejection fraction and chronic obstructive pulmonary disease. Results In total, 4926 patients were included (mean age 82 years, 50% female) among whom 2596 (53%) patients had no PH and unchanged, 864 (18%) had no PH and worsened after, 912 (19%) had PH and improved after, 401 (8%) had PH and unchanged after and 153 (3%) had PH and worsened after. The mean sPAP levels preoperatively in each group were 36, 31, 60, 58, 57 mmHg respectively. Mean change in patients with no PH and worsened was +16 mmHg, in patients with PH and improved -20 mmHg and in patients with PH and worsened +14 mmHg. Cumulative incidence rates of HFH at 5 years among the five groups were 18%, 25%, 32%, 41%, and 52%, respectively (p<0.001). In adjusted analyses, there was a stepwise increase in the risk of HFH (Figure 1A) and all-cause mortality (Figure 1B) for no PH and worsened, PH and improved, PH and unchanged and PH and worsened as compared with no PH and unchanged. Conclusion Increase of periprocedural sPAP in patients with and without known PH before TAVR was associated with worse prognosis whereas reduction of sPAP was associated with improved outcomes.

Procedural and clinical outcomes according to ultrasound-guided access in TAVI: a propensity-matched comparative sub-analysis from the PULSE registry

Abstract Background Access-related vascular and bleeding complications during transcatheter aortic valve implantation (TAVI) are associated with significant morbidity and mortality. Ultrasound-guided (USG) puncture may reduce the incidence of these events, particularly in large-bore arterial access. However, large-scale data on this approach are limited and it has not yet fully been implemented into standard clinical practice during TAVI. Purpose We compared access-related vascular and bleeding complications in USG versus fluoroscopy-guided (FG) access from a large multicenter TAVI registry. Methods The PULSE registry (Plug or sUture based vascuLar cloSurE after TAVI) retrospectively evaluated data of 9,295 patients who underwent transfemoral TAVI at 10 high-volume German heart centers from 2016 to 2021. USG and FG access were performed in 1,992 (21.4%) and 7,303 (78.6%) patients, respectively. A propensity score was used to match 1,023 FG with 1,023 USG access patients in a 1:1 fashion. The primary endpoint was a composite of minor and major vascular complications at the TAVI-access site or bleeding type II-IV. Outcomes were evaluated in accordance with the Valve Academic Research Consortium (VARC-3) definitions. Results Mean age was 81.9±6.25 years and 48.0% of patients were female. Comorbidities and clinical variables were well-balanced in matched groups. The overall risk profile was comparable in USG vs. FG (mean EuroSCORE II: 3.4 [2.1, 6.4] vs. 3.6 [2.2, 5.7], p=0.54). The primary end point occurred in 12.0% in the USG and 17.7% in the FG group, p<0.001. While major large bore access-related vascular complications did not differ significantly (3.5% vs. 4.2%, p=0.49), there was a trend towards lower minor complications for USG compared to FG (5.9% vs. 7.8%, p=0.096). Large bore access-related bleeding occurred in 5.5% versus 7.8% (p=0.04) of patients. Endovascular balloon inflation was required in 0.6% and 3.3% (p<0.001) of all large-bore access vascular complications. Stroke (1.7% vs. 1.5%, p=0.86) and stage III/IV acute kidney injury (3.0% vs. 2.2%, p=0.42) were similar in both groups. Conclusion In patients treated with transfemoral TAVI, ultrasound-guidance for gaining access was associated with lower rates of access-related vascular complications or type II-IV bleeding. Endovascular treatment was required more frequently in case of a fluoroscopy-guided approach. These findings challenge the fact that most TAVI procedures were performed with fluoroscopy-guidance.

Survival in very elderly patients with severe aortic stenosis submitted to TAVI compared to the general population

Abstract Introduction Severe aortic stenosis (AS) is the most common acquired valvular heart disease. Transcatheter aortic valve implantation (TAVI) is indicated as an alternative to surgery in patients (pts) with severe AS above 75 years old (yo) regardless of surgical risk. The prevalence of severe AS increases with age. In the very elderly, i.e. > 85yo, the presence of severe AS is often accompanied with important comorbidities and frailty. To improve pts assessment in the heart team, it is essential to characterize the outcomes of previous interventions in this challenging group of patients and that was the goal of the present study. Methods Single-center retrospective analysis, on prospectively collected data, of consecutive patients ≥85yo undergoing TAVI between 2015 to 2021. Successful TAVI, major procedural complications and 1-year mortality rates were defined according to the VARC-3 definition. Observed survival was compared to an age-matched population using life expectancy tables available at the portuguese National Statistics Institute. Simulated survival curves for an age-matched population were performed using an expected hazard rate of 0.14. This was a conservative approach assuming that mortality rate remained constant in the population during follow-up. Results A total of 767 pts underwent TAVI during the study period. Of these, 349 pts were ≥85yo and were included in our study. Median age was 87yo [IQR 86-89], 60% female (n = 211) with a median Euroscore II of 5% [IQR 4-7]. A total of 98 pts (28%) had previous coronary artery disease, 300 pts (85%) had chronic kidney disease and 22 pts (6%) had a previous stroke. Median mean aortic valve gradient was 49mmHg [IQR 42-60] and left ventricle ejection fraction was 55% [IQR 50-56]. 268 pts (77%) underwent an elective TAVI and the remaining 23% were urgent procedures after hospital admission. The transfemoral approach was used in 334 pts (96%) and 258 pts (74%) implanted a self-expanding valve. Median in-hospital time was 6 days [IQR 4-11] and most common complications were permanent pacemaker implantation (n=59, 17%) and major access-related complications (n=17, 5%). All-cause mortality at 30 days and 1 year were 2.1% (n=7) and 13.1% (n=46), respectively. This compares similarly to the group of younger pts (<85yo) which presented a 30 day and 1 year mortality of 2.8% and 12.8%, respectively. Among very-elderly, 35 pts (10%) were readmitted in the first-year post TAVI. The mean survival time in our cohort was 4.9 years compared to expected 6.2 years (figure, log-rank < 0.01). The mortality rate at one year was 13% (n = 46) in our cohort compared to expected mortality of 14% (n = 50), not statistically significant. Conclusion In this study, very old patients submitted to TAVI had a 1-year mortality rate similar to age-matched population and a mean survival time of more than 4 years, albeit inferior to an age-matched population.

Symptoms of Anxiety and Depression (SAD) in patients undergoing transcatheter aortic valve implantation. A multicentre Australian experience: The SAD-TAVI Study

Abstract Background Symptoms of anxiety and/or depression (SAD) commonly co-exist in severe aortic stenosis, associated with increased morbidity and mortality following transcatheter aortic valve implantation (TAVI). Despite this, mental health remains under-researched in the TAVI literature. Purpose To characterise the prevalence of SAD in those undergoing TAVI and identify patient phenotypes at highest risk of these symptoms. We also aimed to examine how SAD evolve following TAVI and establish factors predictive of improvement and regression in mental health. Methods Retrospective review of prospectively collected data from patients undergoing TAVI between 2018 and 2023 included in an Australian TAVI registry. Results Of 1279 patients, median age was 82 (IQR 77, 87), 41% were female and median STS score was 3.9 (2.3, 5.9). 353 (28%) patients reported moderate or worse SAD at baseline. Of this group, 260 (74%) had complete resolution in symptoms within 30-days. Body Mass Index<25 (adjusted odds ratio [aOR] 3.4, p<0.001), vascular site complications (aOR 3.4, p=0.029) and non-home discharge (aOR 2.4, p=0.036) independently predicted failed improvement in SAD. Onset of new SAD was uncommon, present in only 72 (8%) patients. Non-home discharge (19% vs 8%, p=0.006) and a composite endpoint of stroke, acute myocardial infarction, and heart-failure readmission (11% vs 4%, p=0.012) were more prevalent in this cohort. Conclusion Symptoms of anxiety and depression are common but under recognised in severe aortic stenosis. TAVI is highly effective at improving these symptoms. Regular screening for mental health should be adopted as a standard of care in TAVI.Evolution of SAD Following TAVI

A propensity score matched analysis of transcatheter aortic valve replacement in failed bioprosthetic valves

Abstract Introduction While recently published data indicate similar long-term results of transcatheter aortic valve replacement (TAVR) compared to surgical procedures, surgical aortic valve replacement (SAVR) remains the standard of care in low-risk patients. However, since life expectancy increases, a non-negligible number of patients experience bioprosthetic valve dysfunction with the need for reintervention, but long-term data of TAVR in failed bioprosthetic valves is scarce. Purpose The aim of the study was to analyse long-term data of patients with TAVR in failed bioprosthetic valves compared to patients with native valve TAVR. The primary endpoint was 6-year all-cause mortality and the main secondary endpoint was echocardiographic valve function. Methods Patients undergoing TAVR for severe aortic valve disease between December 2012 and December 2020 were retrospectively analysed. Prior TAVR or aortic valve homografts led to exclusion from the study. A 2:1 propensity score matching by the optimal neighbor matching algorithm was performed to overcome differences in baseline characteristics. Results Between December 2012 and December 2020, 3,423 patients received TAVR for severe aortic valve disease and met inclusion criteria for the study. Of those, 3,287 patients underwent native valve TAVR, whereas 136 patients experienced bioprosthetic valve dysfunction and were treated with TAVR-in-SAV. After 2:1 propensity score matching, baseline characteristics without any relation to prior SAVR were similar between both groups. Concerning postprocedural echocardiographic function, a less pronounced gradient reduction (57.0 vs. 71.0 %, p < 0.01, Figure 1) and a higher number of patients with elevated mean pressure gradient > 20 mmHg could be found after prior SAVR (19.4 vs. 3.0 %, p < 0.01). However, there was no difference regarding 6-year all-cause mortality between both groups (log rank test p = 0.8, Figure 2). Conclusions Besides a less pronounced gradient reduction and higher mean aortic pressure gradients after TAVR-in-SAV compared to patients with native valve TAVR, no differences in 6-year all-cause mortality could be observed in a propensity score matched analysis.Reduction of mean pressure gradient6-year all-cause mortality

Coronary access after Transcatheter Aortic Valve Replacement (TAVR): a systematic review and meta-analysis of observational studies

Abstract Introduction Over the past two decades, transcatheter aortic valve replacement (TAVR) has transformed the management of aortic stenosis, initially for high-risk surgical candidates and subsequently for low-risk patients. However, with the expanding indications for TAVR to younger, lower-risk patients, it is crucial to assess not only the short-term clinical outcomes but also the long-term considerations for future interventions. The prevalence of coronary artery disease (CAD) in TAVR patients is relevant, and the optimal timing of percutaneous coronary intervention (PCI) remains a question, given the technical challenges associated with coronary access in TAVR patients. Methods We conducted a systematic literature review and meta-analysis according to Cochrane Collaborations and PRISMA guidelines. We included 19 eligible trials involving 1533 patients who underwent coronary angiography after TAVR. The primary endpoint was the incidence of successful selective coronary re-access. Secondary endpoints included semi-selective and non-selective access rates. The analysis was stratified by balloon-expandable (BEVs) and self-expandable valve (SEVs) types. Results Successful coronary access after TAVR was feasible in the majority of patients, with a higher success rate observed for the left main coronary artery (LM) compared to the right coronary artery (RCA). Balloon-expandable valves demonstrated the highest success rates in coronary ostia cannulation, achieving nearly 100% success for both LM and RCA. Among self-expandable valves, the Evolut R/PRO showed superior success rates in selective coronary access (76,85% (95%CI 53,34-100%) for LM and 57,27% (95%CI 32,8-81,74%) for RCA) compared to the CoreValve (45,62% (95%CI 0-92,78%) for LM and 49,19% (95%CI 0-100%) for RCA). Notably, the majority of coronary angiograms were performed due to acute coronary syndrome, primarily non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina (UA), 26,5% for NSTEMI and 23,4% for UA, respectively. Conclusions Selective coronary engagement after TAVR is generally achievable, with BEVs demonstrating superior success rates compared to SEVs. Among self-expandable valves, the Evolut R/PRO showed better outcomes than the CoreValve. These findings provide valuable insights into post-TAVR coronary access feasibility, reducing concerns about valve selection based on this criterion

Predicting cardiovascular death 1-year after transcatheter aortic valve implantation: an artificial-intelligence based risk model

Abstract Background Prediction of cardiovascular death after transcatheter aortic valve implantation (TAVI) remains difficult. Currently, more lower risk patients are considered for TAVI and predicting not only immediate survival, but more longer-term outcomes seems important. Most developed risk tools use standard statistical approaches and focus mainly on short-term (30 days post-TAVI) outcomes. Purpose The aim of this project was to identify important predictors for worse outcomes after aortic valve replacement using machine learning features. Furthermore, we want to develop and artificial intelligence (AI) -model to predict cardiovascular death 1 year after TAVI. Methods For our analysis we used 725 patients with severe AS that underwent TAVI between 2008 and 2022 and were included in a prospective single centre observational study. Leveraging an automated machine learning framework, we systematically evaluated various machine learning algorithms including Random Forest, AdaBoost, Neural Networks, Randomized Decision Trees and and Gradient Boosting. Results We constructed prediction models utilizing three feature subsets: the top 10 most important features, the top 15 most important features (Figure 1), and all available features (n=66). Our analyses yielded area under curve (AUC) values of 0.71, 0.83, and 0.92, respectively (Figure 2). The best model was obtained by Randomized Decision Trees. NYHA classification, left ventricular ejection fraction, Charlson comorbidity index, posterior wall thickness and myocardial infarction 90-days before TAVI appeared as the most influential predictors for cardiovascular death within one year after TAVI. Conclusions Our model was able to identify the most important features indicating high risk for patients undergoing TAVI. Using the 15-feature model, we were able to accurately predict cardiovascular death 1 year after TAVI. AI-models to predict risk can be used to better inform/select patients undergoing TAVI.

Impact of protruding and ulcerated aortic atheroma on periprocedural ischemic stroke in patients undergoing transcatheter aortic valve replacement: a comprehensive analysis

Abstract Backgrounds Aortic atherosclerosis has the potential to impact both the strategy and outcomes of transcatheter aortic valve replacement (TAVR). Past research has established a correlation between the thickness and volume of aortic atheroma with periprocedural ischemic stroke and long-term mortality. However, there is limited investigation into the relationship between the morphology of aortic atheroma and outcomes following TAVR. Purpose The study aimed to assess the influence of protruding and ulcerated aortic atheroma on the occurrence of periprocedural ischemic stroke following TAVR. Methods A total of 979 patients who underwent TAVR between February 2012 and May 2019, and had retrospectively available data from contrast-enhanced computed tomography, were included in this analysis. The presence of protruding or ulcerated atheroma was evaluated across four aortic segments: ascending aorta, aortic arch, descending aorta, and abdominal aorta. Protruding aortic atheroma was defined as atheroma with a thickness exceeding 3 mm and protruding components. Ulcerated aortic atheroma was defined as atheroma presenting with ulcer-like disruption of the intima. The primary endpoint assessed was periprocedural ischemic stroke occurring within 48 hours following TAVR. Results The frequencies of protruding and ulcerated aortic atheroma were as follows: 0.2% in the ascending aorta, 6.5% in the aortic arch, 11.1% in the descending aorta, 15.7% in the abdominal aorta, and 24.2% in the entire aorta (Figure 1). Among the 979 patients analyzed, 25 (2.6%) experienced periprocedural ischemic stroke. Patients with protruding or ulcerated aortic atheroma exhibited a significantly higher incidence of periprocedural ischemic stroke compared to those without (5.5% vs. 1.6%, p=0.0010). Multivariate logistic analysis revealed that protruding or ulcerated aortic atheroma, particularly in the aortic arch, independently increased the risk of periprocedural ischemic stroke. (Table 1). Among the subset of patients (309, 34%) undergoing transfemoral TAVR (TF-TAVR) with a self-expandable valve, those with protruding or ulcerated aortic atheroma had a notably higher incidence of periprocedural ischemic stroke compared to those without (9.6% vs. 1.6%, p=0.0083). Conversely, among patients (587, 66%) undergoing TF-TAVR with a balloon-expandable valve, there was no statistically significant difference in the incidence of periprocedural ischemic stroke between those with and without protruding or ulcerated aortic atheroma (4.2% vs. 1.8%, p=0.102). Conclusions Protruding and ulcerated aortic atheroma, particularly in the aortic arch, were linked to a higher risk of periprocedural ischemic stroke post-TAVR. Consequently, careful selection of TAVR strategy, including valve type and procedural approach, is essential for patients with such aortic lesions.Figure 1Table 1

Comic-based consenting on patient-reported experience and outcome measures for transfemoral aortic valve implantation

Abstract Background The impact of an improved patient informed consent (IC) before transcatheter aortic valve implantation (TAVI) on patient-reported experience and outcome measures (PREMs and PROMs) as well as on clinical outcomes remains unclear. Purpose To investigate patient satisfaction, PREMs, PROMs and clinical outcomes in patients receiving additional illustrative graphic-based IC (comic group) compared to conventional IC (control group) for TAVI at two tertiary care centers as part of a randomised controlled trial ("TAVI-COMIC study"). Methods Adult patients undergoing elective TAVI were enrolled. Patient satisfaction and PREMs were assessed after providing IC, PROMs at 90 days after TAVI and clinical safety outcomes within 7 days after TAVI (Figure). Results Only 48 (32%) of all patients read the official usual patient information sheet. Of 299 patients undergoing TAVI, comic-based IC was performed in 152 (51%) patients. Patient satisfaction was significantly higher (29 [23-32] vs 25 [22-30] of a maximum of 32 points in the validated Client Satisfaction Questionnaire [CSQ], p<0.001) and anxiety was lower (34 [25-51] vs 39 [29-55], p<0.001 in the validated Spielberger State-Trait-Anxiety Inventory [STAI]) in the comic group. 92 (61%) patients in the comic group felt "relaxed" prior to the procedure compared to only 44 (30%) patients receiving conventional IC (p<0.001). 91 (60%) were "very satisfied" with the delivered patient IC compared to 28 (19%) patients in the control group (p<0.001). PROMs at 90 days were assessed in a subgroup of 198 (66% of total cohort) patients: The comic group had similar PROMs as the control group (e.g. general health condition, walking ability and rate of dizziness, syncope, helplessness, depression, dyspnea or angina). Clinical outcomes, such as bleeding, pneumonia, stroke, delirium, or TAVI unit and hospital length of stay, were similar in both groups. Conclusion Use of an alternative IC approach, such as medical graphic narratives, might significantly improve patient satisfaction and PREMs, while facilitating similar PROMs and procedural safety as conventional treatment strategies.

Incidence, predictors and outcomes of non-home discharge following transcatheter aortic valve implantation: a multicentre Australian experience. The NHD TAVI study

Abstract Background Patients undergoing transcatheter aortic valve implantation (TAVI) commonly experience non-home discharge (NHD), a phenomenon associated with increased health-care expenditure and possibly poorer outcomes. Despite its relevance to patients, post-TAVI NHD remains poorly explored in the literature. Purpose To characterise the incidence and predictors of NHD following TAVI, understand its impact on quality of life, and identify the proportion of patients that require long-term residential care following initial NHD. Methods Retrospective analysis of prospectively collected data of 2229 patients undergoing TAVI from 2010–2023 included in an Australian TAVI Registry. Results Median age was 82 (IQR: 78-86) years and 41% were female. 257 (11.5%) patients were not discharged home following TAVI, with incidence falling over time (R2=0.636, p<0.001). Multivariable logistic regression modelling for NHD prediction was developed with excellent calibration and discrimination (C-Statistic 0.835). Independent predictors of NHD were post-procedural stroke (adjusted odds ratio [aOR] 11.1), procedure at a private hospital (aOR 3.0), living alone (aOR 2.4), vascular access site complications (aOR 2.1), frailty (aOR 1.9), age>80 (aOR 1.8), hypoalbuminemia (aOR 1.8), NYHA III-IV (aOR 1.7) and hospital length of stay (aOR 1.1) (all p<0.05). NHD was not associated with mortality at 30-days and less than one percent of all patients required longer-term residential care. Conclusion While common following TAVI, NHD does not predict short-term mortality and most patients successfully return home within 30-days. When used appropriately, NHD may serve as a brief and effective method of optimising functional status without compromising long-term independence.Predictors of Non Home Discharge

Early echocardiographic changes and reverse remodeling after transcatheter aortic valve implantation

Abstract Introduction Our hospital is a tertiary centre performing more than 500 transcatheter aortic valve implantation (TAVI) procedures annually. In this study we present early echocardiographic changes post-TAVI. Methods Clinical data collection and comprehensive echocardiography was performed the day before and 3.5±1.6 months after TAVI. Data analysis compared pre- and post-TAVI evaluations. Results A total of 101 patients were analyzed. Mean age was 80.1±6.8 years and 40% were female. TAVI was performed transfemorally in all patients, with 83% receiving a balloon expandable valve. NYHA class improved from 2.5±0.6 to 1.4±0.5 after TAVI (p<0.001) Echocardiographic parameters are summarized in Table. Global longitudinal strain (GLS) improved from -17±4% pre-TAVI to -18±4% post-TAVI (p<0.001), with no notable change in LVEF. A significant reverse remodeling with ≥10% reduction in left ventricular mass index (LVMi) was observed in 52% of patients following TAVI (from 124±32 to 110±29 g/m2, p<0.001) (Figure). Predictors of LVMi reduction were pre-TAVI LVMi and absence of comorbid hypertension (OR=1.02, 95% CI=1-1.03, p=0.03 and OR=0.31, 95% CI=0.11-0.84, p=0.02 respectively). There was no significant improvement in diastolic function, including left atrial strain. Conclusions Early post-TAVI assessments showed significant reverse remodelling with improvements in GLS and LVMi after TAVI. Predictors of LVMi reduction post-TAVI were absence of comorbid hypertension and higher baseline LVMi. There was no notable changes in diastolic function.