Uncomplicated Transcatheter Aortic Valve Implantation Research Articles

Contemporary European practice in transcatheter aortic valve implantation: results from the 2022 European TAVI Pathway Registry.

A steep rise in the use of transcatheter aortic valve implantation (TAVI) for the management of symptomatic severe aortic stenosis occurred. Minimalist TAVI procedures and streamlined patient pathways within experienced Heart Valve Centres are designed to overcome the challenges of ever-increasing procedural volume. The 2022 European TAVI Pathway Survey aims to describe contemporary TAVI practice across Europe. Between October and December 2022, TAVI operators from 32 European countries were invited to complete an online questionnaire regarding their current practice. Responses were available from 147 TAVI centres in 26 countries. In 2021, the participating centres performed a total number of 27,223 TAVI procedures, with a mean of 185 TAVI cases per centre (median 138; IQR 77-194). Treatment strategies are usually (87%) discussed at a dedicated Heart Team meeting. Transfemoral TAVI is performed with local anaesthesia only (33%), with associated conscious sedation (60%), or under general anaesthesia (7%). Primary vascular access is percutaneous transfemoral (99%) with secondary radial access (52%). After uncomplicated TAVI, patients are transferred to a high-, medium-, or low-care unit in 28%, 52%, and 20% of cases, respectively. Time to discharge is day 1 (12%), day 2 (31%), day 3 (29%), or day 4 or more (28%). Reported adoption of minimalist TAVI techniques is common among European TAVI centres, but rates of next-day discharge remain low. This survey highlights the significant progress made in refining TAVI treatment and pathways in recent years and identifies possible areas for further improvement.

Implementation of nurse-led early mobilisation after transcatheter aortic valve implantation: Identification of barriers to standardised practice

Abstract Funding Acknowledgements Type of funding sources: None. Background We examined the barriers of early nurse-led mobilisation after transcatheter aortic valve implantation (TAVI) to support safe next-day discharge home. Methods We conducted a prospective observational cohort study of patients treated in 2019-2021 using a standardised post-procedure nursing care standard to promote mobilisation in 4 to 6 hours after TAVI. Results are presented as mean (standard deviation) for continuous variables and as number (percentage) for categorical data; student t test was used to compare continuous variables and χ2 and Fisher exact tests were used to compare categorical variables. All analyses were performed in SAS version 9.4 (SAS Institute). Results The cohort included a convenience sample of 139 patients (64 women, 46%) mean age 82.5±6.7 years, NYHA III/IV 72 (51.8%), prior pacemaker 18 (13%), and prior SAVR 11 (7.9%). Patients were treated under local anaesthesia only (n=29, 20.9%) or conscious sedation (n=106, 76.3%) with a balloon expandable device (n=134, 96.4%) in a cardiac catheterisation laboratory (n=111, 79.9%) or hybrid operating room (n=28, 25.2%), and early recovery in cardiac telemetry (n=101, 72.7%) or critical care unit (n=38, 27.3%). Early mobilisation was achieved in 113 patients (81.3%: 4 hours: n=100, 71.9%, 4-6 hours: n=13, 9.4%); there were no significant (p≤0.05) differences in baseline characteristics between patients with early vs. late mobilisation; the primary reasons for delayed mobilisation included monitoring and/or managing cardiac conduction issues (n=6), vascular access hemostasis (n=6) and neurological status (n=4), patient preference or other self-reported issue (n=5) and nursing workload (n=5). In patients who achieved early mobilisation, 81.4% were discharge on post-operative day 1 and 86.3% by day 2, with 99.1% returning directly home. There was no significant difference in 30-day readmission between the two groups. Conclusions Early nurse-led protocol-driven mobilisation is safe and effective to facilitate rapid reconditioning and safe transition home after uncomplicated TAVI. Research is needed to better understand patient and systems-level enablers to improve standardisation of practice.

812 Contemporary Radiation Doses in Uncomplicated Transcatheter Aortic Valve Implantation Procedures

812 Contemporary Radiation Doses in Uncomplicated Transcatheter Aortic Valve Implantation Procedures

Effect on 30-Day Readmissions after Early Versus Delayed Discharge after Uncomplicated Transcatheter Aortic Valve Implantation (from the Nationwide Readmissions Database)

Early discharge after transcatheter aortic valve implantation has been shown to be safe in single-center studies and trials, but outcomes in broader clinical practice are unknown. Using the National Readmission Databases (1/2014 to 9/2015), we compared 30-day readmission rates between early (<3 days) and late (≥3 days) discharges after uncomplicated endovascular TAVR in a propensity-matched cohort. We examined factors associated with failure of early discharge by testing for interactions of patient factors with discharge strategy. Among 4,955 hospitalizations for uncomplicated TAVR, 1,857 (37%) were discharged early with substantial site-level variability (range 0% to 87%; median odds ratio 3.69). In the propensity matched cohort (n = 3,346), there were similar rates of 30-day readmission by discharge strategy (early vs late: 10.3% vs 10.6%; stratified log-rank p = 0.555). There was a statistically significant interaction between discharge strategy and number of chronic conditions (p = 0.007), where readmission rates were lower in patients discharged early in those with 0 to 4 chronic conditions, but not in those with 5 to 10 or >10. In conclusion, in a large "real-world" cohort, early discharge after uncomplicated TAVR was not associated with a higher rate of 30-day rehospitalization, yet there was significant variability across US hospitals. No patient characteristics were associated with increased risk of readmission with early discharge.

The impact of post-procedural complications on reimbursement, length of stay and mechanical ventilation among patients undergoing transcatheter aortic valve implantation in Germany.

The impact of various post-procedural complications after transcatheter aortic valve implantation (TAVI) on resource use and their consequences in the German reimbursement system has still not been properly quantified. In a retrospective observational study, we use data from the German DRG statistic on patient characteristics and in-hospital outcomes of all isolated TAVI procedures in 2013 (N=9147). The impact of post-procedural complications on reimbursement, length of stay and mechanical ventilation was analyzed using both unadjusted and risk-adjusted linear and logistic regression analyses. A total of 235 (2.57%) strokes, 583 (6.37%) bleeding events, 474 (5.18%) cases of acute kidney injury and 1428 (15.61%) pacemaker implantations were documented. The predicted reimbursement of an uncomplicated TAVI procedure was €33,272, and bleeding events were associated with highest additional reimbursement (€12,839, p<0.001), extra length of stay (14.58days, p<0.001), and increased likelihood of mechanical ventilation for more than 48h (OR 17.91, p<0.001). A more moderate complication-related impact on resource use and reimbursement was found for acute kidney injury (additional reimbursement: €5963, p<0.001; extra length of stay: 7.92days, p<0.001; ventilation >48h: OR 6.93, p<0.001) as well as for stroke (additional reimbursement: €4125, p<0.001; extra length of stay: 4.68days, p<0.001; ventilation >48h: OR 5.73, p<0.001). Pacemaker implantations, in contrast, were associated with comparably small increases in reimbursement (€662, p=0.006) and length of stay (3.54days, p=0.006) and no impaired likelihood of mechanical ventilation more than 48h (OR 1.22, p=0.156). Interestingly, these complication-related consequences remain mostly unchanged after baseline risk-adjustment. Post procedural complications such as bleeding events, acute kidney injuries and strokes are associated with increased resource use and substantial amounts of additional reimbursement in Germany, which has important implications for decision making outside of the usual clinical sphere.

A Prospective Analysis of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation

As transcatheter aortic valve implantation (TAVI) becomes more routinely used, the recommended duration of monitoring after uncomplicated TAVI remains indeterminate. Retrospective analysis suggests that discharge within 72hours is safe, but prospective data are largely lacking. We therefore prospectively assess the feasibility and safety of early discharge (within 72hours) after transfemoral TAVI using Edwards SAPIEN-XT and SAPIEN-3 prostheses. Patients undergoing elective transfemoral TAVI were assessed prospectively for early discharge home. Feasibility and safety (death or repeat hospitalization within 30days of discharge) of early discharge were assessed. Causes for failure of early discharge were assessed by prospective data collection and multivariate analysis. Of 130 patients, 76 (59%) were discharged early. Death or repeat hospitalization within 30days occurred only in 4 cases (5%) among patients who discharged early: repeat hospitalization within 30days was required in 3 early-discharge patients (4%), and there was a single death at 30days. By multivariate analysis, factors associated with delayed discharge were blood transfusion (hazard ratio 13.85, 95% CI 1.61 to 119.40, p= 0.017) and pacemaker implantation (hazard ratio 4.47, 95% CI 1.34 to 14.26, p= 0.012). In conclusion, early discharge after elective transfemoral TAVI with SAPIEN-XT/SAPIEN-3 prostheses is safe and attainable in a large proportion of patients, with no evident compromise in safety. Factors associated with failure of early discharge are postprocedural blood transfusion and permanent pacemaker implantation.

EARLY DISCHARGE AFTER TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION WITH THE EDWARDS SAPIEN-XT OR SAPIEN-3 PROSTHESIS: A PROSPECTIVE ANALYSIS OF SAFETY AND FEASIBILITY

As transcatheter aortic valve implantation (TAVI) becomes more routinely employed, the recommended duration of monitoring after uncomplicated TAVI remains indeterminate. Retrospective analysis has suggested that discharge within 72 hours of TAVI is safe, but prospective data is largely lacking in

PROGNOSTIC VALUE OF MYOCARDIAL INJURY FOLLOWING UNCOMPLICATED TRANSCATHETER AORTIC VALVE IMPLANTATION

Very few data exist about the clinical significance of myocardial injury (MI) occurring after transcatheter aortic valve implantation (TAVI) procedures. We sought to determine the incidence and the prognostic value of MI associated with uncomplicated TAVI. Overall 68 consecutive patients (age 81.1&

Sequential trans‐catheter aortic valve implantation and abdominal aortic aneurysm repair

Aortic stenosis in the elderly population is an increasing problem, with many patients being considered too high risk for surgery, and therefore being denied treatment. A percutaneous method of treatment in the form of trans-catheter aortic valve implantation (TAVI) is becoming an increasingly attractive option in this group of patients. Although, TAVI has been shown to be successful and improve cardiovascular haemodynamics, assessment of other comorbidities in this susceptible group of patients is essential to ensure good clinical outcomes. The presence of an abdominal aortic aneurysm (AAA) in our patient was an example of an important comorbidity which could have a significant impact on the outcome of TAVI, if not managed appropriately. The increased systolic pressure post successful TAVI will result in an increased strain within the AAA with an increased risk of rupture. Therefore, a timely management strategy for the AAA was necessary. Our case is of sequential TAVI followed by Endovascular aneurysm repair (EVAR). The patient underwent uncomplicated TAVI. There was complete abolition of trans-aortic gradient. EVAR was successfully undertaken three weeks post TAVI. The patient made an excellent recovery and remained well at six months follow-up. Our case highlights the importance of a detailed assessment in all patients prior to consideration for TAVI and the importance of having a management strategy for both pathologies tailored to the patient. This case demonstrates the benefits of development of trans-catheter techniques for two different conditions. Future developments including reduction of sheath size reduction and EVAR and TAVI device evolution, may enable simultaneous treatment of aortic stenosis and abdominal aortic aneurysm as a combined percutaneous procedure under local anaesthetic.

In‐hospital complications after transcatheter aortic valve implantation revisited according to the valve academic research consortium definitions

To determine the occurrence of in-hospital complications after transcatheter aortic valve implantation (TAVI) according to the Valve Academic Research Consortium (VARC) criteria in addition to the length of stay (LOS). The absence of uniformity in endpoint definitions challenges the comparison between previously reported major adverse cerebro- and cardiovascular event rates after TAVI. To address this, in 2009, the VARC was established aiming to provide standardized endpoint definitions for TAVI clinical trials. Between November 2005 and September 2010, we prospectively enrolled 150 consecutive patients who underwent TAVI with the Medtronic CoreValve System in our institution. Complications, prosthetic valve associated endpoints, and therapy-specific endpoints were defined according to the definitions provided by the VARC. The mean age (±SD) was 81 (±7) years and 55% were female. Thirty-day or in-hospital mortality was 11%, and the 30-day combined safety endpoint was 22%. Seventy-six patients (51%) had ≥1 cardiovascular and/or noncardiovascular complication of whom 16 also underwent a new permanent pacemaker implantation (PPI). In the 74 patients with uneventful TAVI, 12 patients (8%) underwent PPI. TAVI was truly uneventful in 62 patients (41%). Bleeding complications were observed most frequently (31%), followed by acute kidney injury (18%), vascular complications (16%), and stroke/TIA (11%). The median LOS in patients with a complicated and a truly uncomplicated TAVI was 14.0 (8.0-20.5) and 8.0 (7.0-10.8) days, respectively (P < 0.001). TAVI was associated with ≥1 cardiovascular and/or noncardiovascular event in 51% of the patients; new PPI was needed in another 8%, and TAVI was truly uncomplicated in 41%. Complications and need for new PPI significantly prolonged LOS.

Incidence, Predictive Factors, and Prognostic Value of Myocardial Injury Following Uncomplicated Transcatheter Aortic Valve Implantation

This study sought to: 1) determine the incidence, degree, and timing of the rise in serum cardiac markers of myocardial injury associated with uncomplicated transcatheter aortic valve implantation (TAVI); and 2) evaluate the predictive factors and prognostic value of myocardial injury associated with TAVI. Very few data exist on the occurrence and clinical relevance of myocardial injury during TAVI procedures. A total of 101 patients who underwent successful TAVI (transfemoral [TF] approach, n = 38; transapical [TA] approach, n = 63) were included. Creatine kinase-MB (CK-MB) and cardiac troponin T (cTnT) levels were determined at baseline and at 6 to 12, 24, 48, and 72 h following TAVI. TAVI was associated with some degree of myocardial injury in 99% of the patients (TF: 97%, TA: 100%) as determined by a rise in cTnT (maximal value, 0.48 μg/l, interquartile range [IQR]: 0.24 to 0.82 μg/l) and in 77% of the patients (TF: 47%, TA: 95%) as determined by a rise in CK-MB (maximal value, 18.6 μg/l; IQR: 11.0 to 27.4 μg/l). TA approach and baseline renal dysfunction were associated with a higher increase in biomarkers of myocardial injury (p < 0.01 for both). A larger myocardial injury was associated with a smaller improvement of left ventricular ejection fraction (LVEF) (p < 0.01). The degree of rise in cTnT was an independent predictor of cardiac mortality at 9 ± 10 months of follow-up (hazard ratio: 1.14 per each increase of 0.1 μg/l, 95% confidence interval: 1.02 to 1.28, p = 0.028). TAVI was systematically associated with some degree of myocardial injury, with TA approach and baseline renal dysfunction determining a higher increase in biomarkers of myocardial injury. A greater degree of myocardial injury was associated with less improvement in LVEF and a higher cardiac mortality at follow-up.