Elective Transcatheter Aortic Valve Implantation Research Articles

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.

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.

Prognostic utility of mid-regional pro-adrenomedullin and growth differentiation factor 15 in patients undergoing transfemoral transcatheter aortic valve implantation.

Risk prediction in patients with severe, symptomatic aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) remains an unsolved issue. In addition to classical risk scoring systems, novel circulating biomarkers like mid-regional pro-adrenomedullin (MR-proADM) and growth differentiation factor 15 (GDF-15) may be of value in assessing risk. Consecutive patients undergoing elective transfemoral TAVI were included in this prospective observational study. Baseline information, imaging findings, blood samples, and clinical outcomes were collected. Blood levels of the classical biomarkers interleukin-6 (IL-6) and high-sensitivity C-reactive peptide (hsCRP) and of the novel biomarkers MR-proADM and GDF-15 were measured and their predictive utility for mortality assessed. The study cohort consisted of 92 patients undergoing TAVI. The median age was 80.7years [IQR 77.2;83.3], and 48 (52.2%) were male. Analysis of the area under the curve (AUC) of the receiver-operating characteristics showed that the hsCRP levels discriminated poorly (AUC 0.66, 95% CI [0.52;0.8], p = 0.027), whereas all other biomarkers reached a higher level of discrimination (IL-6: AUC 0.76, 95% CI [0.66;0.86], p < 0.001; MR-proADM: AUC 0.73, 95% CI [0.61;0.85], p = 0.002; GDF-15: AUC 0.73, 95% CI [0.61;0.85], p = 0.002). Kaplan-Meier analysis in conjunction with Youden J-statistics yielded the optimal cutoff points for each biomarker to predict survival: IL-6 4.65pg/mL, hsCRP 12.9mg/L, MR-proADM 1.02nmol/L, and GDF-15 2400.1pg/mL. Novel circulating biomarkers like MR-proADM and GDF-15 may provide additional value in predicting survival after TAVI.

Urgent TAVI not associated with higher rates of conversion to urgent cardiac surgery: a systematic review and meta-analysis

Abstract Funding Acknowledgements None. Introduction Transcatheter Aortic Valve Implantation (TAVI) has been established as a therapeutic option in patients with severe Aortic valve Stenosis (AoS). Although TAVI has been associated with high procedural success, it is rarely required conversion to cardiac surgery, for the management of complications. It remains unknown whether the rate of conversion to urgent cardiac surgery is higher in patients undergoing urgent TAVI compared to elective TAVI. Purpose The aim of our systematic review and meta-analysis is to investigate whether patients treated with urgent TAVI are under higher risk for urgent conversion to cardiac surgery. Methods We systematically conducted a thorough search of three major databases (Medline, Cochrane Central Register of Controlled Trials, and Scopus) to identify studies comparing urgent and elective TAVI. Our primary endpoint in this systematic review and meta-analysis was the incidence of unanticipated, emergent conversions to open cardiac surgery during the TAVI procedure. Only studies that provided data on this endpoint were considered for inclusion in our analysis. Secondary endpoints included vascular complications, the presence of post-procedural moderate or severe aortic regurgitation, in-hospital mortality, and the device success. These secondary endpoints were evaluated during the inpatient stay of the patients. For the statistical analysis, we computed risk ratios (RR) with corresponding 95% confidence intervals (CIs). We employed a random-effects model (Mantel-Haenszel), to estimate the pooled RR. Results A total of six studies, encompassing 70,296 patients, were included in our analysis. Among them, 5,021 patients underwent an urgent TAVI procedure, while the remaining 65,275 underwent elective TAVI. During TAVI, conversion to urgent cardiac surgery did not vary significantly between the two groups (RR: 0.90, 95% CI:0.66-1.24]. Moreover, no significant differences were observed in vascular complications (RR:1.55, 95% CI: 0.92-2.61), post-procedural moderate or severe aortic regurgitation (RR:1.20, 95% CI: 0.85-1.69) and device success (RR:0.99, 95% CI: 0.98-1.00). Notably, in-hospital mortality was higher in urgent TAVR group (RR: 2.08, 95% CI: 1.69-2.56). Conclusion Our systematic review and meta-analysis have demonstrated that patients undergoing urgent TAVI are not at a higher risk for urgent cardiac surgery, device failure, vascular complications, or post-procedural moderate or severe aortic regurgitation. Notably, despite these findings, the higher in-hospital mortality observed in patients undergoing urgent TAVI suggests the presence of other factors that should be explored to account for this increased mortality.Urgent conversion to surgery

Urgent transcatheter aortic valve implantation (TAVI) is associated with increased in-hospital mortality: a systematic review and meta-analysis

Abstract Funding Acknowledgements None. Introduction Transcatheter Aortic Valve Implantation (TAVI) is recommended for patients suffering from severe aortic stenosis (AoS) as an elective procedure. Taking into consideration that AoS is associated with acute heart failure and cardiogenic stroke resistant to pharmacotherapy, urgent TAVI might be a therapeutic option. However, a few data exist regarding its safety and efficacy against this background. Purpose Aim of our systematic review and meta-analysis is to compare in-hospital mortality among patients undergoing urgent and elective TAVI. Methods We systematically screened three major databases (Medline, Cochrane Central Register of Controlled Trials and Scopus) searching for studies comparing urgent versus elective TAVI. Primary endpoint of our systematic review and meta-analysis is the in-hospital mortality. Only studies provided data about in-hospital mortality were considered for our analysis. Secondary endpoints included acute kidney injury (AKI), permanent pacemaker implantation (PPM) and ischemic stroke. All the secondary endpoints were evaluated during the first 30-days after TAVI. Risk ratio (RR) was calculated with 95% confidence intervals (CIs) and a random-effects model (Mantel-Haenzel) was used to estimate the pooled RR. Results Twelve studies, all retrospective except one, published between 2014 and 2023 were included in our analysis. A total of 133,348 patients undergoing TAVI were included in our analysis; 110,606 had elective procedure and the 22,742 urgent intervention. Mortality rate was 5.1% in urgent and 2.2% in elective group. The risk of mortality is 2.38 times higher in the urgent TAVI group compared to the elective TAVI group (RR: 2.38, 95% CI: 1.80, 3.15). Data about AKI, PPM and stroke during the first 30-days were available for 12, 11 and 11 studies, respectively. The risk for AKI is significantly higher in patients having undergone urgent TAVI (RR: 2.10, 95% CI:1.62, 2.73). No significant differences were observed in stroke incidence (RR: 1.07, 95% CI: 0.97, 1.18) and PPM (RR: 1.05, 95%CI: 0.99, 1.11) during 30-days follow-up. Conclusion To the best of our knowledge, this is the first systematic review and meta-analysis showing that urgent TAVI is associated with significantly higher in-hospital mortality rates, compared to elective TAVI. Given these results, it is advisable to prefer an elective procedure, prior disease's worsening, in order to prevent the increased risk of in-hospital mortality associated with urgent TAVI.In-hospital mortality

Clinical Outcomes of Urgent or Emergency Transcatheter Aortic Valve Implantation - Insights From the Nationwide Registry of Japan Transcatheter Valve Therapies.

Limited data are available for clinical outcomes in patients who underwent urgent or emergency transcatheter aortic valve implantation (TAVI). This study investigated in-hospital and 1-year outcomes and explored prognostic covariates in urgent/emergency TAVI using nationwide registry data.Methods and Results: Among 26,775 patients who underwent TAVI between August 2013 and December 2019, 25,495 with 1-year follow-up information were analyzed in this study. Baseline and procedural characteristics, as well as clinical adverse events, were compared between the urgent/emergency and elective TAVI groups. The primary outcome was all-cause mortality within 1 year after TAVI. Multivariable Cox regression models were constructed to identify independent predictors after urgent or emergency TAVI. Urgent or emergency TAVI was performed in 578 (2.3%) patients. The Society of Thoracic Surgeons score was significantly higher in the urgent/emergency than elective TAVI group (13.3% vs. 6.0%; P<0.001). Device success rate was comparable between the 2 groups. All-cause death-free survival within 1 year was lower in the urgent/emergency than elective TAVI group (77.2% vs. 92.2%; log rank P<0.001). Malignancy, albumin and creatinine concentrations, ejection fraction, and mean pressure gradient were associated with 1-year mortality in the urgent/emergency TAVI group. Despite higher surgical risk and more comorbidities, the procedure was successfully performed in patients undergoing urgent/emergency TAVI, although it should be noted that prognosis was worse than for elective TAVI.

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.

Transcatheter management of pure native aortic valve regurgitation in patients with left ventricular assist device.

Aortic valve regurgitation (AR) frequently complicates the clinical course after left ventricular assist device (LVAD) implantation. Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to surgical aortic valve replacement (SAVR) in this cohort with a mostly high surgical risk profile. The unique challenges in LVAD patients, such as presence of non-calcified aortic valves and annular dilatation, raise concerns about device migration and paravalvular leakage (PVL) leading to missing device success. This study evaluates procedural outcomes and survival rates in LVAD patients who underwent TAVI, emphasizing strategies to enhance device success. Between January 2017 and April 2023, 27 LVAD patients with clinically significant AR underwent elective or urgent TAVI at our centre. Primary end-points were procedural success rates, without the need for a second transcatheter heart valve (THV) and postprocedural AR/PVL. Secondary outcomes included survival rates and adverse events. Among the cohort, 14.8% received AR-dedicated TAVI devices, with none requiring a second THV. There was no intraprocedural AR, and 1 patient (25%) had AR > 'trace' at discharge. Additionally, 25.9% underwent device landing zone (DLZ) pre-stenting with a standard TAVI device, all without needing a second THV. There was no intraprocedural AR, and none to trace AR at discharge. Among the 59.3% receiving standard TAVI devices, 37.5% required a second THV. In this subgroup, intraprocedural AR > 'trace' occurred in 12.5%, decreasing to 6.25% at discharge. In-hospital mortality was 3.7%, and median follow-up survival was 388 days (interquartile range 208-1167 days). TAVI yields promising procedural outcomes and early survival rates in LVAD patients with AR. Tailored TAVI devices and pre-stenting techniques enhance procedural success. Continued research into these strategies is essential to optimize outcomes in this complex patient cohort.

Telemedical management in patients waiting for transcatheter aortic valve implantation: the ResKriVer-TAVI study design.

The majority of patients with severe aortic stenosis (AS) planned for transcatheter aortic valve implantation (TAVI) are elective outpatients. During the COVID-19 pandemic, the time between the heart team's decision and TAVI increased due to limited healthcare resources. We therefore implemented telemedical approaches to identify AS patients at risk for clinical deterioration during the waiting time. The purpose of the prospective, randomized, controlled ResKriVer-TAVI study (DRKS00027842) is to investigate whether a digital concept of telemedical interventional management (TIM) in AS patients waiting for TAVI improves the clinical outcomes. In the present article, we report the study protocol of the ResKriVer-TAVI trial. ResKriVer-TAVI will enroll AS patients planned for elective TAVI. Randomization to the TIM group or standard care will be made on the day of the heart team's decision. TIM will include a daily assessment of weight, blood pressure, a 2-channel electrocardiogram, peripheral capillary oxygen saturation, and a self-rated health status until admission for TAVI. TIM will allow optimization of medical therapy or an earlier admission for TAVI if needed. Standard care will not include any additional support for patients with AS. All patients of the TIM group will receive a rule-based TIM including standard operating procedures when a patient is crossing prespecified values of a vital sign. The primary endpoint consists of days lost due to cardiovascular hospitalization and death of any cause within 180 days after the heart team's decision. Major secondary endpoints include all-cause mortality within 365 days, the number of telemedical interventions, and adherence to TIM. Follow-up visits will be conducted at admission for TAVI as well as 6 and 12 months after the heart team's decision. ResKriVer-TAVI will be the first randomized, controlled trial investigating a telemedical approach before TAVI in patients with AS. We hypothesize that primary and secondary endpoints of AS patients with TIM will be superior to standard care. The study will serve to establish TIM in the clinical routine and to increase the resilience of TAVI centers in situations with limited healthcare resources.

Gene expression underscores the impact of impaired mobility on peri-operative/interventional complications in older cardiac patients

Abstract Background/Introduction The frailty syndrome is highly prevalent in elderly patients with heart disease. Phenotypes of physical frailty such as deterioration of mobility, strength or gait speed are relevant in clinical practice. These phenotypes are associated with a worse prognosis. The specific physiological pathways are not yet clearly understood. Transcriptomic analysis in skeletal muscle can provide information about these processes, and finally can be used to develop novel treatment options. Purpose Determination of gene expression levels in physical frailty phenotypes predictive for perioperative/interventional complications in older patients undergoing cardiac surgery (e.g. coronary artery bypass graft) or transcatheter aortic valve implantation (TAVI). Methods From 06/2021 to 07/2022, patients ≥ 70 year of age referred for elective cardiac surgery or TAVI were included in the study. At hospital admission, physical frailty was assessed in terms of low gait speed (5-meter Walk Test; ≥ 6 sec), moderately/severe impaired mobility (Timed Up-and-Go (TUG); ≥ 10 sec), and reduced handgrip strength (dynamometer; ≤ 27 kg ♂; ≤ 16 kg ♀). Total RNA was isolated and sequenced from muscle specimens (M. quadriceps femoris) collected during surgery/intervention. Perioperative complications (mortality and major morbidity) were primary endpoints. Differential gene expression analysis was performed using DESeq2, adjusted for age, sex, estimated glomerular filtration rate (eGFR) and number of comorbidities. Results 63 patients (77.6 ± 4.3 years) referred to cardiac surgery (n= 34, 54%) or TAVI (n= 29, 46%) were enrolled (Table 1). Overall, 19 patients (30.6%) were characterized as frail by low gait speed, 43 (68.3%) by moderately/severe impaired mobility, and 19 (30.2%) by low handgrip strength. In total, 37 patients (59%) experienced ≥ 1 complication (e.g. need of transfusion, atrial fibrillation, delirium); one patient died. Frail patients showed altered gene expression levels (e.g. TAVI: 89 down- and 78 up-regulated genes). Interestingly, the expression of the genes MYLK4 (Fold Change - 1.8), KANSL1-AS1 (FC 2.0) and JMJD4 (FC 1.4) were significantly altered (Figure 1) in all three phenotypes of physical frailty, but only in TAVI patients. Conclusion Dysregulation of genetic determinants in the muscle was associated with reduced mobility. The detection of corresponding biomarkers (e.g. in plasma) could improve the accuracy of detection of physical frailty phenotypes predictive for post-intervention complications in elderly patients in clinical practice.Table 1.Patient characteristicsFigure 1.Gene expression levels

Patient-reported functional and symptomatic outcomes in patients with mild cognitive disorder undergoing transcatheter aortic valve implantation - A secondary analysis of a randomized controlled trial

Abstract Background The impact of pre-existing mild cognitive disorder (MCD) on patient-reported outcome measures (PROMs) after transcatheter aortic valve implantation (TAVI) remains unclear. Purpose To investigate functional and symptomatic outcomes after TAVI in patients with or without MCD at two German tertiary care centers as part of a randomised controlled trial (TAVI-COMIC study). Methods Adult patients undergoing elective TAVI were enrolled. MCD was defined by the Montreal Cognitive Assessment (MoCA) &amp;lt;26 points. PROMs were assessed at 90 days after TAVI. Results Of 199 patients, 109 (54.8%) showed MCD. Female patients had significantly more often MCD (49.5% vs. 34.4%, p=0.046). Prior to TAVI, 21.6% reported dyspnea (NYHA class III-IV), 35.1% angina (CCS class II-IV), 41.2% dizziness and 12.6% syncope. Both patient groups reported similar improvements in general health status after TAVI: "marginally or significantly better" health status in 73.5% with MCD vs. 68.9% without MCD (p=n.s.). In multivariable logistic regression models, the number of patients reporting a "good, very good or excellent" general health status after TAVI was similar in both patient groups (p=n.s.) (Table). Similarly, post-TAVI symptoms of dyspnea, angina, dizziness or syncope were similar between both groups (each p=n.s.). Procuration and walking ability without difficulties as well as functional independence were 54% [95% Confidence Interval (CI) 0.23-0.92] (p=0.028), 55% [95% CI 0.22-0.89] (p=0.023) and 52% [95% CI 0.24-0.94] (p=0.035) less frequently reported by patients with MCD compared to patients without MCD, respectively. Of note, delirium was more frequently observed in patients with MCD within 3 days after TAVI (8.3% vs. 1.1%, p=0.049). Conclusions TAVI appeared to result in similar improvements in general health status and symptomatic PROMs in patients with and without MCD. Though, patients with MCD reported impaired functional PROMs after TAVI. More careful post-procedural care should be taken for patients with MCD to enhance functional independence in this vulnerable patient group.

Intraprocedural versus next day transthoracic echocardiography following minimalist transfemoral TAVI

BackgroundRoutine pre-discharge echocardiography (ECHO) is recommended post transcatheter aortic valve implantation (TAVI) as a baseline for future comparison. However, there is no clear guidance on the optimal timing of this study.AimThe purpose of this retrospective study was to investigate the safety and work-force efficiency of intraprocedural same-day ECHO versus next-day ECHO, following transfemoral TAVI.Methods and resultsIn this retrospective study 100 consecutive patients who underwent intraprocedural ECHO only were compared with 100 consecutive patients undergoing both intraprocedural and routine next-day ECHO following elective transfemoral TAVI. All patients received the Sapien 3/Ultra transcatheter heart valve and were treated with a minimalist procedure with conscious sedation. The composite of in-hospital mortality, urgent ECHO and new tamponade after leaving the cath lab and before discharge was not different between the two groups (4 vs. 4%, P = 1). There was no paravalvular leak more than mild in any of the cases. Length of stay was similar (1 day).ConclusionsIntraprocedural post-TAVI ECHO appears as safe as next day pre-discharge ECHO and obviates the need for a routine next day study, thereby reducing burden on echocardiography services and allows better utilisation of resources.

Anxiety and depression in patients aged 80 years and older following aortic valve therapy. A six-month follow-up study

BackgroundLittle is known about mental health following advanced cardiac procedures in the oldest patients.AimsTo study changes in anxiety and depression from baseline to one- and six-month follow-up in older patients following transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR).MethodsProspective cohort study of patients ≥ 80 years undergoing elective TAVI or SAVR in a tertiary university hospital. Anxiety and depression were assessed with the Hospital Anxiety and Depression Scale. Differences between TAVI/SAVR were analyzed using Welch’s t test or chi-squared. Changes over time and group differences were established with longitudinal models using generalized least squares.ResultsIn 143 patients (83.5 ± 2.7 years), 46% (n = 65) received TAVI. Anxiety was identified in 11% of TAVI patients at baseline. One- and six-months later, percentages were 8% and 9%. In SAVR patients, 18% had baseline scores indicating anxiety. One and six-months later, percentages were 11% and 9%. Depression was identified in 15% of TAVI patients. One- and six-months later, percentages were 11% and 17%. At baseline, 11% of SAVR patients had scores indicating depression. One- and six-months after SAVR, percentages were 15% and 12%. Longitudinal analyses showed reductions (P < 0.001) in anxiety from baseline to one-month, and stable scores between one- and six-months for both treatment groups. There was no change over time for depression among treatment groups (P = 0.21).Discussion and conclusionsSAVR or TAVI in patients ≥ 80 years was associated with anxiety reduction between baseline and follow-up. For depression, there was no evidence of change over time in either treatment group.Graphical abstract

Urgent versus Non-Urgent Transcatheter Aortic Valve Implantation Outcomes

Introduction: There are limited data about the outcomes of nonelective transcatheter aortic valve implantation (TAVI). Some studies suggest that these patients (pts) have worst results. Our purpose was to compare outcomes in pts submitted to urgent versus elective TAVI. Methods: Retrospective analysis of 298 consecutive pts submitted to TAVI between 2018 and 2021 in a single tertiary center. Baseline characteristics and outcomes were collected and compared between elective and nonelective TAVI. Results: Pts submitted to urgent TAVI (79 pts) had worse baseline characteristics, with higher EuroScore risk (9.26 vs. 5.17%, p < 0.0001), STS score (7.09 vs. 4.4%, p < 0.0001), and NT pro-natriuretic peptide B (10,168 vs. 3,241 pg/mL, p = 0.001), lower left ventricle ejection fraction (45 vs. 52%, p = 0.003), more diabetes (46.8 vs. 32.4%, p = 0.0.22), peripheral artery disease (21.5 vs. 6.8%, p < 0.0001), and poor vascular accesses (18.4 vs. 7.4%, p = 0.007). Urgent TAVI was associated with higher mortality (25.3 vs. 15.1%, p = 0.043), 30-day cardiovascular mortality (17.5 vs. 4%, p = 0.001), life-threatening bleeding (11.5 vs. 4.1%, p = 0.018), vascular complications (11.5 vs. 4.6%, p = 0.031), and longer hospital stay (28 vs. 12 days, p < 0.0001), but not with intensive care unit or post-TAVI hospital stay (5 vs. 4 days, p = 0.197 and 11 vs. 10 days, p = 0.572). When adjusted to differences in baseline characteristics, urgent TAVI was only associated with longer hospital stay (p < 0.0001). Conclusion: Pts submitted to urgent TAVI have worse short-term outcomes, but this seems to be attributable to the worse baseline characteristics instead of the urgent nature of the procedure.

Changes in muscle strength and muscle mass after transcatheter aortic valve implantation (TAVI)

Abstract Funding Acknowledgements Type of funding sources: Public hospital(s). Main funding source(s): Amsterdam UMC. Background Maintenance of muscle strength and muscle mass is important for long-term health. Periods of physical inactivity and poor dietary intake (e.g. waiting for a medical procedure) can provoke loss of muscle strength and muscle mass. Purpose We aim to determine the course of muscle strength and muscle mass in patients with severe aortic stenosis from before until six months after an elective transcatheter aortic valve implantation (TAVI). Moreover, we aim to explore baseline characteristics associated with change. Methods All patients undergoing an elective TAVI in our high-volume tertiary center were asked to participate. Included patients received three home visits (pre-procedural and 30 days and 6 months post-procedural). During these home visits, handgrip strength was measured with a handheld dynamometer. Muscle mass was determined as skeletal muscle index with a bioelectrical impedance (BIA) measurement. Multivariate mixed linear models were used to determine changes over time. A linear model adjusted for age and sex was performed to explore baseline characteristics associated with changes in muscle strength or muscle mass. Results In total 112 patients were included, mean age of the participants was 81 ± 5 years and 58% were male. The preprocedural measurement took place on a median of 48 [IQR: 19 – 79] days before the TAVI. Preprocedural handgrip strength was on average 36 kg for male and 24 kg for female patients and decreased after the TAVI (-0.12 [95% CI: -0.21, -0.02] kg/month, p=0.02). Living alone and lower hemoglobin level were predictive for a higher decrease in strength (β -2.20 [95% CI: -3.98, -0.42], p=0.02 and β 0.14 [95% CI: 0.02, 0.27] per mmol/l, p=0.03, respectively). Appendicular skeletal muscle index was 7.2 kg/m2 for males and 6.1 kg/m2 for females and did not change after TAVI (0.00 [95%CI: -0.01, 0.01] kg/m2/month, p=0.95). No baseline characteristics were associated with a change in muscle mass. Conclusion Muscle strength significantly declines and muscle mass remains the same from before until six months after the TAVI procedure. Patients living alone or patients with low hemoglobin levels are at increased risk to lose muscle strength. Future studies should focus on the prevention of strength loss, for instance with interventions focusing on nutrition and exercise around the TAVI procedure.

Characterisation of frailty phenotypes and analysis of the association with peri-operative/interventional complications in elderly cardiac patients

Abstract Funding Acknowledgements Type of funding sources: None. Background/Introduction Identifying the key frailty phenotypes that impact functional health outcomes in older cardiovascular patients (CVD) in clinical practice is a step towards solving the complex "Rubik's Cube" of frailty. It should be pointed out which frailty phenotypes representing the patient's physical (e.g. mobility, strength, gait speed), cognitive (e.g. dementia) or nutritional status (e.g. risk of malnutrition, protein levels) correlate with major complications (e.g. mortality, delirium) in elderly patients. Phenotypes of frailty that correlate with complications could be used to identify patients at higher risk of poor postoperative outcomes and could be addressed through preventive strategies (e.g. prehabilitation). Purpose Identification of physical, nutritional and cognitive frailty phenotypes and investigate the correlation with complications in elderly patients undergoing cardiac surgery (e.g. coronary artery bypass graft, isolated single valve) or transcatheter aortic valve implantation (TAVI). Methods Between 06/2021 and 07/2022, patients (77.6 ± 4.3) referred for elective cardiac surgery or TAVI were included in the study. At hospital admission, physical frailty was identified by the simultaneous presence of: low gait speed (5-meter Walk Test), moderate impaired mobility (Timed Up-and-Go), reduced handgrip (dynamometer) and legs strength (5-repetitions chair rise). Mild dementia (Mini-Mental State Examination) characterised cognitive frailty and risk of malnutrition (Mini Nutritional Assessment) plus low serum protein level (serum albumin) nutritional frailty. The primary outcome was the presence of perioperative complications (mortality and major morbidity, e.g. delirium, pneumonia). Additionally, the total number and type of complications and the length of hospital stay (LoS) were collected. Correlations between frailty phenotypes, complications and LoS were calculated (Spearman). Results In total, 63 patients were referred to cardiac surgery (n=34, 54%) or TAVI (n=29, 46%) and were included (Table 1). Overall, 20 patients (36%) were characterized as physically frail. 33 patients (52%) were found to be cognitively frail, and 17 patients (26%) identified as nutritionally frail; no significant differences were found between the surgical and TAVI groups (Figure 1). Altogether, 37 patients (59%) experienced ≥ 1 complication such as need of transfusion (n=24, 38%), atrial fibrillation (n=14, 22%), delirium (n=12, 19%), pneumonia (n=8, 13%) or renal failure (n=6, 10%); one patient died. Physical and nutritional frailty correlate with the presence and total number of complications and prolonged LoS, but only in TAVI patients (Figure 1). Conclusion If these results are confirmed in a multivariate analysis, preventive strategies targeting physical and nutritional frailty should be considered, especially in TAVI patients, to reduce the incidence of complications and prolonged LoS.

Elevated Fasting Glucose and C-Reactive Protein Levels Predict Increased All-Cause Mortality after Elective Transcatheter Aortic Valve Implantation.

Surgical aortic valve replacement in the elderly is now being supplanted by transcatheter aortic valve implantation (TAVI). Scoring systems to predict survival after catheter-based procedures are understudied. Both diabetes (DM) and underlying inflammatory conditions are common in patients undergoing TAVI, but their impact remains understudied in this patient group. We examined 560 consecutive TAVI procedures and identified eight pre-procedural factors: age, body mass index (BMI), DM, fasting blood glucose (BG), left-ventricular ejection fraction (EF), aortic valve (AV) mean gradient, C-reactive protein levels, and serum creatinine levels and studied their impact on survival. The overall mortality rate at 30 days, 1 year and 2 years were 5.2%, 16.6%, and 34.3%, respectively. All-cause mortality was higher in patients with DM (at 30 days: 8.9% vs. 3.1%, p = 0.008; at 1 year: 19.7% vs. 14.9%, p = 0.323; at 2 years: 37.9% vs. 32.2%, p = 0.304). The presence of DM was independently associated with increased 30-day mortality (hazard ratio [HR] 5.38, 95% confidence interval [CI], 1.24-23.25, p = 0.024). BG levels within 7-11, 1 mmol/L portended an increased risk for 30-day and 2-year mortality compared to normal BG (p = 0.001 and p = 0.027). For each 1 mmol/L increase in BG 30-day mortality increased (HR 1.21, 95% CI, 1.04-1.41, p = 0.015). Reduced EF and elevated CRP were each associated with increased 2-year mortality (p = 0.042 and p = 0.003). DM, elevated BG, reduced EF, and elevated baseline CRP levels each are independent predictors of short- and long-term mortality following TAVI. These easily accessible screening parameters should be integrated into risk-assessment tools for catheter-based aortic valve replacement candidates.

A new trend to reduce adverse events in patients undergoing transcatheter aortic valve implantation: cusp overlap technique: a cross sectional study.

Transcatheter aortic valve implantation (TAVI) is currently the treatment of choice for the majority of patients at moderate or high surgical risk. However, some complications occur frequently with this procedure. In this study, we aimed to assess whether the cusp-overlap view (COP) technique may be associated with a reduced incidence of some of these complications compared with the classical three-cusp view (TCV) technique. In this single-center, retrospective study we investigated; technical success, postprocedural permanent pacemaker implantation (PPMI), new-onset stroke, pericardial tamponade, arrhythmia development, acute renal failure, major bleeding, major vascular complications, procedure-related coronary obstruction, new-onset left bundle branch block (LBBB), paravalvular leak, peri-procedural myocardial infarction (MI), day of hospitalization, death, and major adverse cardiac and cerebrovascular events (MACCE) were determined as the clinical endpoints. A total of 281 consecutive patients who met the study criteria and underwent elective or emergency transfemoral TAVI using the self-expandable CoreValve Evolut valve were included. 176 consecutive patients implanted with the classical TCV technique and 105 consecutive patients implanted with the COP technique were compared. Compared with the TCV group, patients in the COP group had lower PPMI (3.8% vs. 10.8%, p = 0.039), in-hospital mortality (1.9% vs. 8.5%, p = 0.018), and 1-year death (4.8% versus 18.8%, p = 0.001), and MACCE rates (12.4% vs 31.3%, p < 0.001). The COP technique may help to reduce the conduction disturbances, PPMI requirement and complication rates that may develop following TAVI. In addition, it is an interesting result that it reduces mortality and MACCE rates in long-term follow-ups.

Emergency transcatheter aortic valve implantation for acute heart failure due to severe aortic stenosis in critically ill patients with or without cardiogenic shock.

Severe aortic stenosis can cause acute heart failure and cardiogenic shock (CS). Transcatheter aortic valve implantation (TAVI) is the standard therapy for aortic stenosis in inoperable patients. However, its role in this setting is poorly evaluated. The study purpose was to explore clinical characteristics of these patients and to assess predictors of mortality. All 2930 patients undergoing transfemoral TAVI at our centre between 2013 and 2019 were screened for critically ill patients, receiving intensive care therapy and emergency TAVI. Selected patients were subdivided into two groups, according to the presence or absence of CS. Remaining patients undergoing elective TAVI served as a comparison. Primary outcome was 90-day mortality. Out of 179 critically ill patients, 47 fulfilled criteria of CS (shock group) and 132 did not despite a severe decompensation (no shock group). Shock patients were more often male and had higher Society of Thoracic Surgeons scores [15.6, interquartile range (8.0-32.1) vs. 5.5 (3.9-8.5), P < 0.01] compared with severely decompensated patients. Ninety-day mortality was: shock group, 42.6%, vs. no shock group, 15.9%, vs. elective group, 5.3% (P < 0.01). A landmark analysis from day 90 showed similar mortality (P = 0.29). Compared with elective patients, 30-day composite endpoint device failure was higher in critically ill groups [shock group, odds ratio, 2.86 (1.43-5.36), no shock group, odds ratio, 1.74 (1.09-2.69)]. Multivariable regression revealed mechanical ventilation, haemofiltration, elevated C-reactive protein or bilirubin, and hypotension before TAVI as 90-day mortality predictors. Ninety-day mortality after TAVI in critically ill patients is increased but survivors have similar outcomes as elective patients.

Variation in access rates amongst patients groups in Wales for specialist interventions.

ObjectivesThe Welsh Health Specialised Services Committee (WHSSC) has commissioned a study to assess if there is a standard value-based approach to measure and evaluate the effectiveness of specific interventions, and whether variation exists that may indicate differences in the equity of access to these services provided to patients in Wales.&#x0D; ApproachUsing anonymised individual-level, population-scale, routinely collected electronic health record (EHR) data held within the Secure Anonymised Information Linkage (SAIL) Databank, we planned to identify amongst the population of Wales any patients experiencing percutaneous coronary intervention (PCI) and Transcatheter Aortic Valve Implantation (TAVI). We would measure associated patient outcomes 2-years before and after the intervention minus a 6-month clearance period on either side by measuring primary care attendances in general practice, and secondary care attendances in hospital, outpatient and emergency department data. To further inform the analysis, linkage to socio-demographic factors, comorbidities and lifestyle factors would be controlled for.&#x0D; ResultsPreliminary results identified 5,999 PCIs between June 2014 and March 2020. We were able to identify 1,530 as elective and 4,358 as emergency secondary care procedures. Of the elective PCIs, 184 patients had a greater number of elective hospital days pre-PCI, and 382 patients had a greater number of elective hospital days post-PCI. Of the emergency PCIs, 135 patients had a greater number of emergency hospital days pre-PCI, and 893 patients had a greater number of emergency hospital days post-PCI. For TAVI intervention, we identified 74 elective and 49 emergency procedures. 35 of the elective TAVI had greater hospital days pre-intervention, and 17 of the elective TAVI had greater hospital days post-intervention. Primary care costs slightly rose for PCI and slightly reduced for TAVI.&#x0D; ConclusionWe successfully identified interventions and measured and contrasted outcomes before and after the intervention using the SAIL Databank. For PCI, the elective intervention showed a reduced increase in bed days compared to emergency intervention. These initial findings allow us to plan an expanded analysis to examine other intervention types.