Transcatheter Aortic Valve Implantation Registry Research Articles

Incidence, Predictors, and Outcomes of Nonhome Discharge Following Transcatheter Aortic Valve Implantation: A Multicenter Australian Experience—The NHD TAVI Study

Patients who undergo transcatheter aortic valve implantation (TAVI) commonly experience nonhome discharge (NHD), a phenomenon associated with increased health care expenditure and possibly poorer outcomes. Despite its clinical relevance in TAVI, the incidence and predictors of NHD and its impact on the quality of life remain poorly characterized. Also unknown is the proportion of patients who undergo TAVI that require long-term residential care after initial NHD. Therefore, we aimed to address these questions using a large, multicenter Australian cohort. A total of 2,229 patients who underwent TAVI from 2010 to 2023 included in the Alfred-Cabrini-Epworth TAVI Registry were analyzed. The median age was 82 (interquartile range 78 to 86) years and 41% were women. A total of 257 patients (12%) were not discharged home after TAVI, with the incidence falling over time (R2 = 0.636, p <0.001). A multivariable logistic regression model for NHD prediction was developed with excellent calibration and discrimination (C-statistic = 0.835). The independent predictors of NHD were postprocedural stroke (adjusted odds ratio [aOR] 11.05), procedure at a private hospital (aOR 3.01), living alone (aOR 2.35), vascular access site complications (aOR 2.09), frailty (aOR 1.89), age >80 years (aOR 1.82), hypoalbuminemia (aOR 1.76), New York Heart Association III to IV (aOR 1.74), and hospital length of stay (aOR 1.13) (all p <0.05). NHD was not associated with mortality at 30 days and <1% of all patients required longer-term residential care. In conclusion, although common after TAVI, NHD does not predict short-term mortality, most patients successfully return home within 30 days, and when used appropriately, NHD may serve as a brief and effective method of optimizing functional status without compromising long-term independence.

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

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

Prognostic impact of cardiac damage staging classification in each aortic stenosis subtype undergoing TAVI.

The prognostic value of cardiac damage staging classifications across the haemodynamic spectrum of severe aortic stenosis (AS) remains unknown. We aimed to investigate the prognostic impact of cardiac damage staging classifications in patients with high-gradient AS (HG-AS) and low-gradient AS (LG-AS) undergoing transcatheter aortic valve implantation (TAVI). In a prospective TAVI registry, five-year mortality was evaluated for early stages of cardiac damage (stage 0, 1, or 2) and advanced stages of cardiac damage (stage 3 or 4) in patients with HG-AS, classical low-flow (LF) LG-AS, LF LG-AS with preserved ejection fraction (pEF), and normal-flow (NF) LG-AS. Among 2,090 patients undergoing TAVI, 1,045 patients had HG-AS, 337 patients had classical LF LG-AS, 394 patients had LF LG-AS with pEF, and 314 patients had NF LG-AS. The majority of patients with classical LF LG-AS exhibited advanced cardiac damage (73.6%), followed by LF LG-AS with pEF (55.6%), NF LG-AS (51.6%), and HG-AS (50.6%). Patients with advanced stage cardiac damage had significantly higher mortality after TAVI than those with early stage cardiac damage in all subtypes of AS (adjusted hazard ratio [HRadjusted] 1.66, 95% confidence interval [CI]: 1.34-2.06 for HG-AS; HRadjusted 1.49, 95% CI: 1.02-2.16 for classical LF LG-AS; HRadjusted 1.69, 95% CI: 1.22-2.35 for LF LG-AS with pEF; and HRadjusted 1.52, 95% CI: 1.04-2.32 for NF LG-AS). Cardiac damage staging classifications stratified mortality after TAVI irrespective of AS subtype.

Long term impact of measured and predicted prosthesis patient mismatch following transcatheter aortic valve replacement

Abstract Objectives To investigate the long-term clinical impact of prosthesis-patient mismatch (PPM) in patients undergoing transcatheter aortic valve implantation(TAVI). Background Both measured and predicted effective orifice area indexed to the body surface area (EOAi) have been suggested to define PPM in patients undergoing TAVI. The impact of PPM on clinical outcomes may accumulate with extended follow-up and vary according to the definition used. Methods Patients included in a prospective TAVI registry were stratified by the presence of moderate (0.65-0.85 cm2/m2 or 0.55-0.70 cm2/m2 if obese) or severe (≤0.65 cm2/m2 or ≤0.55 cm2/m2 if obese) PPM according to echocardiographically measured EOAi (measured PPM) prior to discharge, predicted EOAi based on published EOA reference values for each valve model and size (predicted PPMTHV), or predicted EOAi based on EOA reference derived from computed tomography measurements of aortic annulus dimension (predicted PPMCT). Results In an analysis of 2,463 patients, the incidence of measured PPM (moderate: 27.0%; severe: 8.7%) was higher than the incidence of predicted PPMTHV (moderate: 11.3%; severe: 1.2%) or predicted PPMCT (moderate: 12.0%; severe: 0.1%). During a median time to death of 843 days, mortality rates at 10 years were comparable in patients with versus without measured PPM or predicted PPMCT. In contrast, patients with moderate predicted PPMTHV had a lower risk of 10-year all-cause mortality compared with those without PPM (HR: 0.69; 95% CI: 0.52-0.90). Conclusions The use of predicted as compared to measured EOAi results in a lower estimate of PPM severity in TAVI ptients. We observed no increased risk of death in patients with PPM throughout 10-year of follow-up.Incidence of PPM after TAVIImpact of Measured an Predicted PPM

Mitral annular calcification in patients with severe aortic stenosis underwent transcatheter aortic valve implantation: prevalence and association with stenosis severity

Abstract Background Patients with calcific aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) usually have calcification in other cardiac structures, especially mitral annulus. Severity of mitral annular calcification (MAC) and degree of mitral stenosis (MS) may be associated with hemodynamic effects and outcomes. Purpose We sought to investigate the prevalence of MAC in patients with severe calcific AS using mitral annular calcium score with Agatston method from cardiac computerized tomography (CT). We also aim to assess the severity grading of MAC and its association with the severity of MS evaluated by transthoracic echocardiography. Methods We conducted a retrospective cohort analysis of the TAVI registry at King Chulalongkorn Memorial Hospital between May 2013 and December 2021. Clinical information was extracted from medical records. The pre-TAVI echocardiography and cardiac CT were reviewed, as well as the mitral annular calcium score. The severity of MAC (no, mild, moderate, severe) was classified using cardiac CT per the modified Cleveland clinic classification system. The MS grading was based on the 2009 American society of echocardiography guidelines. MAC prevalence was studied. Analysis of the association between MAC and MS was conducted. Results Our cohort included a total of 188 patients (mean age of 81±8 years). 134 patients (71.3%) demonstrated evidence of MAC. 47 patients (25%) had severe MAC evaluated by cardiac CT. Among patients with severe MAC, mean age was 83±8 years, 29 patients (63%) were female, 14 patients (30%) had diabetes, and 11 (23%) of them were associated with moderate or severe MS. Patients with MAC were significantly associated with hemodynamically significant MS (moderate or severe) when compared with patients without MAC (p &amp;lt;0.001). Conclusions One-fourth of patients with severe calcific AS underwent TAVI had severe MAC. The hemodynamically significant MS was more prevalent as the severity of MAC increased. The association between MAC and long-term adverse clinical outcomes needs to be further investigated.Figure 1Figure 2

Prognostic impact of atrial fibrillation in patients with paradoxical low-flow low-gradient aortic stenosis undergoing TAVI

Abstract Background Atrial fibrillation (AF) has been associated with adverse clinical outcomes after transcatheter aortic valve implantation (TAVI). However, the impact of AF on post-TAVI flow status and clinical outcomes in patients with paradoxical low-flow low-gradient aortic stenosis (PLFLG-AS) is still unclear. Objectives The present study aimed to investigate the effect of AF on post-TAVI flow status and clinical outcomes in patients with PLFLG-AS undergoing TAVI. Methods In a prospective TAVI registry, patients with preserved left ventricular ejection fraction (LVEF ≥50%) were stratified according to the flow-gradient status and presence of AF. Results Among 2,259 TAVI patients with preserved LVEF between August 2007 and June 2021, 765 had high-gradient AS (HG-AS) (mean gradient ≥40 mmHg) and 444 had PLFLG-AS (mean gradient &amp;lt;40 mmHg and stroke volume index [SVi] &amp;lt;35 ml/m2). AF was observed in 199 patients with HG-AS (26.0%) and 190 patients with PLFLG-AS (42.8%). At 1 year after TAVI, SVi was significantly improved in PLFLG-AS patients with no AF, whereas those with AF remained low-flow status (from 25.9 ± 8.5 mL/m2 to 37.2 ± 9.9 mL/m2 and from 26.8 ± 5.1 mL/m2 to 26.1 ± 9.1 mL/m2, respectively). PLFLG-AS patients had an increased risk of all-cause mortality at 1 year after TAVI compared with those without AF (HRadjust 2.79; 95% CI 1.58-4.93). Whereas PLFLG-AS patients with no AF had a similar mortality compared with HG-AS patients with no AF (HRadjust 0.84; 95% CI 0.49-1.44). Conclusions AF was associated with worse flow status and impaired prognosis after TAVI in patients with PLFLG-AS.

Impact of COVID-19 Surge Periods on Clinical Outcomes of Transcatheter Aortic Valve Implantation

Healthcare systems adopted various strategies to minimize the impact of the COVID-19 pandemic on clinical outcomes of patients with symptomatic severe aortic stenosis referred for transcatheter aortic valve implantation (TAVI). We aimed to compare baseline characteristics and procedural and clinical outcomes of patients who underwent TAVI during COVID-19 surge periods with those of patients who underwent TAVI during the nonsurge and prepandemic periods. In the prospective Bern TAVI registry, the pandemic period was divided into surge and nonsurge periods on the basis of the mean number of occupied beds in the intensive care unit in each month and matched with 11months immediately preceding the pandemic. A total of 1,069 patients underwent TAVI between April 1, 2019 and December 31, 2021. Patients who underwent TAVI during surge periods had a higher surgical risk (Society of Thoracic Surgeons predicted risk of mortality) than that of patients who underwent TAVI during nonsurge and prepandemic periods. Diagnosis-to-procedure time (in days) was longer for patients who underwent TAVI during the surge period than during the nonsurge and prepandemic periods (95.20 ± 121.07 vs 70.99 ± 72.25 and 60.46 ± 75.43, both p <0.001). At 30days, all-cause mortality was higher in the surge than in the nonsurge group (4.9 vs 1.1%, hazard ratio 4.68, 95% confidence interval 1.55 to 14.10, p=0.006), and in the surge than in the prepandemic group (4.9 vs 1.3%, hazard ratio 3.67, 95% confidence interval 1.34 to 10.11, p=0.012). In conclusion, TAVI during COVID-19 surge periods was associated with higher Society of Thoracic Surgeons predicted risk of mortality score, delayed procedure scheduling, and increased 30-day mortality than that of TAVI during nonsurge and prepandemic periods.

Association of atrial fibrillation with survival in patients with low-flow low-gradient aortic stenosis with preserved ejection fraction undergoing TAVI.

There is limited evidence on the prognostic significance of atrial fibrillation (AF) in patients with low flow, low-gradient aortic stenosis with preserved ejection fraction (LFLG-pEF AS). We aimed to evaluate the recovery of stroke volume after transcatheter aortic valve implantation (TAVI) and clinical outcomes in patients with LFLG-pEF AS stratified by presence or absence of AF. In a prospective TAVI registry, patients with preserved left ventricular ejection fraction (LVEF≥50%) were stratified according to flow-gradient status and presence of AF. Among 2259 TAVI patients with preserved LVEF between August 2007 and June 2021, 765 had high-gradient AS (HG AS) and 444 had LFLG-pEF AS. AF was observed in 199 patients with HG AS (26.0%) and 190 patients with LFLG-pEF AS (42.8%). At 1 year, stroke volume index (SVi) was significantly improved in LFLG-pEF AS patients without AF, while SVi remained low in patients with AF (from 25.9±8.5mL/m2 to 37.2±9.9mL/m2 and from 26.8±5.1mL/m2 to 26.1±9.1mL/m2, respectively). LFLG-pEF AS patients with AF had an increased risk of 1-year all-cause mortality compared with those without AF (adjusted hazard ratio (HRadjusted) 2.57; 95% confidence interval [CI] 1.44-4.59). LFLG-pEF AS patients without AF had similar mortality compared with HG AS patients without AF (HRadjusted 0.85; 95% CI 0.49-1.46). Patients with LFLG-pEF AS and AF experienced no relevant recovery of stroke volume after TAVI, but a more than two-fold increased risk of death compared to patients with HG AS or LFLG-pEF AS without AF. https://www.clinicaltrials.gov. NCT01368250.

The Establishment of Alfred, Cabrini and Epworth Transcatheter Aortic Valve Implantation (ACE-TAVI) Registry: Description and Trends

The Establishment of Alfred, Cabrini and Epworth Transcatheter Aortic Valve Implantation (ACE-TAVI) Registry: Description and Trends

Discrepancy between invasive and echocardiographic transvalvular gradient after TAVI: Insights from the LAPLACE-TAVI registry

BackgroundEchocardiography-based transvalvular mean pressure gradient (ECHO-mPG) used to assess the forward valve function and structural valve deterioration could overestimate the true pressure gradient. This study evaluated the discrepancy between invasive and ECHO-mPG after transcatheter aortic valve implantation (TAVI) with respective valve type and size, its impact on a device success criterion, and predictors of a pressure discrepancy. MethodsWe analyzed 645 patients registered in a multicenter TAVI registry (balloon-expandable valve [BEV]: 500; self-expandable valve [SEV]: 145). The invasive transvalvular mPG was measured after valve implantation using two Pigtail catheters (CATH-mPG), while the ECHO-mPG was measured within 48 h after TAVI. Pressure recovery (PR) was calculated using the following formula: ECHO-mPG × effective orifice area (EOA)/ascending aortic area (AoA) × (1 − EOA/AoA). ResultsECHO-mPG was weakly correlated with (r = 0.29, p < 0.0001), and consistently overestimated CATH-mPG in both BEV and SEV, and respective valve sizes. The magnitude of the discrepancy was larger for BEV than SEV (p < 0.001) and smaller valves (p < 0.001). After the correction of PR using the above formula, the pressure discrepancy remained for BEV (p < 0.001) but not SEV (p = 0.10). The proportion of patients with an ECHO-mPG > 20 mmHg decreased from 7.0% to 1.6% after correction (p < 0.0001). Among the baseline and procedural variables, post-procedural ejection fraction, BEV versus SEV, and smaller valves were associated with a larger discrepancy in mPG. ConclusionsECHO-mPG could be overestimated after TAVI, especially in patients with a smaller BEV. A higher ejection fraction, BEV, and smaller valves were predictors of a pressure discrepancy between CATH- and ECHO-mPG.

Impact of right ventricular-pulmonary arterial coupling on clinical outcomes in patients undergoing transcatheter aortic valve implantation

AimsThe interplay between pulmonary hypertension (PH) and right ventricular (RV) function is reflected in an index of RV function to pulmonary artery (PA) systolic pressure (PASP). The present study aimed to assess the importance of RV-PA coupling on clinical outcomes after transcatheter aortic valve implantation (TAVI). Methods and resultsIn a prospective TAVI registry, clinical outcomes of TAVI patients with RV dysfunction or PH were stratified according to coupling or uncoupling of tricuspid annular plane systolic excursion (TAPSE) to PASP, and compared to those of patients with normal RV function and absence of PH. The median TAPSE/PASP ratio was used to differentiate uncoupling (>0.39) from coupling (<0.39). Among 404 TAVI patients, 201 patients (49.8 %) had RVD or PH at baseline: 174 patients had RV-PA uncoupling, and 27 had coupling at baseline. RV-PA hemodynamics normalized in 55.6 % of patients with RV-PA coupling and in 28.2 % of patients with RV-PA uncoupling, and deteriorated in 33.3 % of patients with RV-PA coupling and in 17.8 % of patients with no RVD, respectively, at discharge. Patients with RV-PA uncoupling after TAVI showed a trend towards an increased risk of cardiovascular death at 1 year as compared to patients with normal RV-function (HRadjusted 2.06, 95 % CI 0.97–4.37). ConclusionAfter TAVI, RV-PA coupling changed in a significant proportion of patients and is a potentially important metric for risk stratification of TAVI patients with RVD or PH. Tweet“Patients with right ventricular dysfunction and pulmonary hypertension are at increased risk of death after TAVI. Integrated right ventricular to pulmonary artery hemodynamics change after TAVI in a significant proportion of patients and is instrumental to refine risk stratification.” Clinical trial registrationhttps://www.clinicaltrials.gov: NCT01368250.

Coronary Obstruction After Transcatheter Aortic Valve Replacement: Insights From the Spanish TAVI Registry

BackgroundCoronary obstruction (CO) following transcatheter aortic valve replacement (TAVR) is a life-threatening complication, scarcely studied. ObjectivesThe authors analyzed the incidence of CO after TAVR, presentation, management, and in-hospital and 1-year clinical outcomes in a large series of patients undergoing TAVR. MethodsPatients from the Spanish TAVI (Transcatheter Aortic Valve Implantation) registry who presented with CO in the procedure, during hospitalization or at follow-up were included. Computed tomography (CT) risk factors were assessed. In-hospital, 30-day, and 1-year all-cause mortality rates were analyzed and compared with patients without CO using logistic regression models in the overall cohort and in a propensity score-matched cohort. ResultsOf 13,675 patients undergoing TAVR, 115 (0.80%) presented with a CO, mainly during the procedure (83.5%). The incidence of CO was stable throughout the study period (2009-2021), with a median annual rate of 0.8% (range 0.3%-1.3%). Preimplantation CT scans were available in 105 patients (91.3%). A combination of at least 2 CT-based risk factors was less frequent in native than in valve-in-valve patients (31.7% vs 78.3%; P < 0.01). Percutaneous coronary intervention was the treatment of choice in 100 patients (86.9%), with a technical success of 78.0%. In-hospital, 30-day, and 1-year mortality rates were higher in CO patients than in those without CO (37.4% vs 4.1%, 38.3% vs 4.3%, and 39.1% vs 9.1%, respectively; P < 0.001). ConclusionsIn this large, nationwide TAVR registry, CO was a rare, but often fatal, complication that did not decrease over time. The lack of identifiable predisposing factors in a subset of patients and the frequently challenging treatment when established may partly explain these findings.

Development and validation of explainable machine learning models for risk of mortality in transcatheter aortic valve implantation: TAVI risk machine scores.

Identification of high-risk patients and individualized decision support based on objective criteria for rapid discharge after transcatheter aortic valve implantation (TAVI) are key requirements in the context of contemporary TAVI treatment. This study aimed to predict 30-day mortality following TAVI based on machine learning (ML) using data from the German Aortic Valve Registry. Mortality risk was determined using a random forest ML model that was condensed in the newly developed TAVI Risk Machine (TRIM) scores, designed to represent clinically meaningful risk modelling before (TRIMpre) and in particular after (TRIMpost) TAVI. Algorithm was trained and cross-validated on data of 22 283 patients (729 died within 30 days post-TAVI) and generalisation was examined on data of 5864 patients (146 died). TRIMpost demonstrated significantly better performance than traditional scores [C-statistics value, 0.79; 95% confidence interval (CI)] [0.74; 0.83] compared to Society of Thoracic Surgeons (STS) with C-statistics value 0.69; 95%-CI [0.65; 0.74]). An abridged (aTRIMpost) score comprising 25 features (calculated using a web interface) exhibited significantly higher performance than traditional scores (C-statistics value, 0.74; 95%-CI [0.70; 0.78]). Validation on external data of 6693 patients (205 died within 30 days post-TAVI) of the Swiss TAVI Registry confirmed significantly better performance for the TRIMpost (C-statistics value 0.75, 95%-CI [0.72; 0.79]) compared to STS (C-statistics value 0.67, CI [0.63; 0.70]). TRIM scores demonstrate good performance for risk estimation before and after TAVI. Together with clinical judgement, they may support standardised and objective decision-making before and after TAVI.

Long-term durability of self-expanding and balloon-expandable transcatheter aortic valve prostheses: UK TAVI registry.

With expansion of transcatheter aortic valve implantation (TAVI) into younger patients, valve durability is critically important. We aimed to evaluate long-term valve function and incidence of severe structural valve deterioration (SVD) among patients ≥ 10-years post-TAVI and with echocardiographic follow-up at least 5-years postprocedure. Data on patients who underwent TAVI from 2007 to 2011 were obtained from the UK TAVI registry. Patients with paired echocardiograms postprocedure and ≥5-years post-TAVI were included. Severe SVD was determined according to European task force guidelines. 221 patients (79.4 ± 7.3 years; 53% male) were included with median echocardiographic follow-up 7.0 years (range 5-13 years). Follow-up exceeded 10 years in 43 patients (19.5%). Valve types were the supra-annular self-expanding CoreValve (SEV; n = 143, 67%), balloon-expandable SAPIEN/XT (BEV; n = 67, 31%), Portico (n = 4, 5%) and unknown (n = 7, 3%). There was no difference between postprocedure and follow-up peak gradient in the overall cohort (19.3 vs. 18.4 mmHg; p = NS) or in those with ≥10-years follow-up (21.1 vs. 21.1 mmHg; p = NS). Severe SVD occurred in 13 patients (5.9%; median 7.8-years post-TAVI). Three cases (23.1%) were due to regurgitation and 10 (76.9%) to stenosis. Valve-related reintervention/death occurred in 5 patients (2.3%). Severe SVD was more frequent with BEV than SEV (11.9% vs. 3.5%; p = 0.02), driven by a difference in patients treated with small valves (BEV 28.6% vs. SEV 3.0%; p < 0.01). Hemodynamic function of transcatheter heart valves remains stable up to more than 10 years post-TAVI. Severe SVD occurred in 5.9%, and valve-related death/reintervention in 2.3%. Severe SVD was more common with BEV than SEV.

Early acute kidney injury after transcatheter aortic valve implantation: predictive value of currently available risk scores.

Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is a frequent complication associated with adverse outcomes and mortality. Various scores have been developed to predict this complication in the coronary setting. However, none have ever been tested in a large TAVI population. This study aimed to evaluate the power of four different scores in predicting AKI after TAVI. Overall, 1535 consecutive TAVI patients from the observational multicentric "Magna Graecia" TAVI registry were included in the analysis. Of the study population, 235 (15.31%) developed AKI early. The Mehran, William Beaumont Hospital, CR4EATME3AD3, and ACEF scores were calculated retrospectively. The patients who developed TAVI-related AKI had significantly higher absolute values of all risk scores than those who did not. The receiver-operating characteristic analysis also showed a significant correlation between these four scores and AKI, but without a significant difference among all of them (p value=0.176). Nevertheless, based on their area under the curve values (≤0.604 for all), none had adequate diagnostic accuracy in predicting TAVI-related AKI. Importantly, multivariate analysis identified myocardial revascularization close to the TAVI procedure and implantation of self-expanding prostheses, as well as atrial fibrillation, low-osmolar contrast media administration, corrected contrast medium volume, and any transfusion (p value<0.05 for all) as independent risk factors for AKI. Although high values of current AKI risk scores are significantly associated with the development of this complication, these are not sufficiently accurate. Further studies are needed so that a TAVI-dedicated AKI risk score may be created.

Favorable Prognosis in Patients with Recovered Pulmonary Hypertension after TAVI: An Analysis of the LAPLACE-TAVI Registry.

Pulmonary hypertension (PH) is a common complication of aortic stenosis (AS). Despite the established association between PH and poor outcomes in patients with AS, the prognostic implication of a change in PH after transcatheter aortic valve implantation (TAVI) has been rarely evaluated. This study analyzed a prospective multi-center TAVI registry database involving six Japanese centers and used the transtricuspid pressure gradient (TRPG) obtained by echocardiography to estimate pulmonary artery systolic pressure. The participants (n = 2056) were first divided into two groups by TRPG before TAVI, a PH (-) group (TRPG &lt; 30 mmHg) (n = 1407, 61.9%) and a PH (+) group (TRPG ≥ 30 mmHg) (n = 649, 28.6%). Next, by TRPG after (4.1 ± 5.3 days) TAVI, the PH (+) group was further subdivided into two groups, Recovered PH (TRPG &lt; 30 mmHg, n = 253) and Persistent PH (TRPG after TAVI ≥ 30 mmHg, n = 396). The median follow-up duration was 1.8 years. The primary and secondary endpoints were the composite and each of cardiovascular (CV) death and heart failure hospitalization, respectively. Unadjusted Kaplan-Meier estimates with log-rank comparisons showed significantly higher cumulative incidences of primary and secondary endpoints in the Persistent PH group compared to other groups. Moreover, adjusted multivariate Cox-proportional hazard analyses showed that a decreased (-10 mmHg) TRPG after TAVI was linearly associated with a reduced risk of the primary endpoint (hazard ratio (HR): 0.76, 95% confidence interval (CI): 0.64-0.90, p = 0.0020). The findings in the present study indicate that the recovery of PH may partly contributes to the prognostic benefit of TAVI procedure in patients with AS and elevated pulmonary artery systolic pressure.

REGIONAL NERVE BLOCK FOR SUBCLAVIAN ACCESS TAVI

Transcatheter aortic valve implantation (TAVI) program has started in the UK in 2007 performing 66 cases a year, the number of cases of TAVI done every year has been exponentially increasing since then to reach 6076 cases in the year 2020. (Ludman) The UK TAVI registry has shown a nationwide shift in practice from general anaesthesia to conscious sedation for trans-femoral access TAVI, analysis has shown a fall of In-hospital mortality from 4.7 in 2012 to 1.8% in 2016 (Ludman). This shift, however, has not occurred in the same way for other arterial access like trans-subclavian or trans-axillary, which is still widely practiced in the UK under general anaesthesia. The vast majority of cases in the UK are done through the femoral access, however, finding an alternative approach is sometimes needed due to contraindication to the standard femoral approach, mostly vasculopathy, which usually indicates higher risk patient and higher likelihood of associated co-morbidities. Performing the alternative access TAVI under general anaesthesia adds more risk to the patient and in some cases could be life threatening, some of these patients could be deemed unfit for the procedure. Finding an alternative anaesthetic technique will allow these patients to have their procedures done with lower risk and have the optimum chance for quicker recovery. The technique of combining Superficial cervical plexus block, interscalene block with Pectoral block type II was first described in 2018 by Alexander et al and reproduced by Block et al in the United States in the same year to allow for performing subclavian access TAVI without general anaesthesia. The same technique was partially adopted with some modification by Vivian et al in Canada and Toscano et al in Italy in 2020 and 2021 respectively. In this manuscript we share our experience doing a series of subclavian access TAVI under regional nerve block and conscious sedation at the Freeman hospital in Newcastle upon Tyne, to our knowledge, and from literature search, this is the first time this is performed successfully in the UK as we didn't see any published reports on this technique within the country.

Abstract 14790: Impact of Pre-Frailty and Frailty in Women Undergoing TAVR: Insights From the WIN-TAVI Registry

Background: Frailty has been shown to significantly affect outcomes after transcatheter aortic valve replacement (TAVR). The impact of pre-frailty on TAVR outcomes in women is still unclear. Aim: To assess the impact of pre-frailty and frailty on outcomes in women enrolled in the Women's InterNational transcatheter aortic valve implantation (WIN-TAVI) registry. Materials and methods: WIN-TAVI was a multinational, prospective, observational registry, which enrolled women at intermediate or high preoperative risk undergoing TAVR. Patients included in this registry were divided into three groups, based on the number of fulfilled Fried frailty criteria: non-frail (no criteria, reference group), pre-frail (1-2 criteria) and frail (≥3 criteria). The primary outcome was the Valve Academic Research Consortium (VARC)-2 efficacy endpoint at 1-year after TAVR. The key secondary outcome was VARC-2 safety endpoint. Results: Out of 1,019 patients, 264 (25.9%) were pre-frail and 33 (3.2%) frail. The risk of VARC-2 efficacy endpoint at 1-year was increased in pre-frail (19.7%, HR 1.36, 95% CI 0.98-1.89) and frail (24.2%, HR 1.74, 95% CI 0.85-3.57) as compared to non-frail patients (14.9%, reference group), although it didn’t reach statistical significance. The risk of VARC-2 safety endpoint was significantly higher in pre-frail (25.8%, HR 1.43, 95% CI 1.07-1.91) and frail (42.4%, HR 2.77, 95% CI 1.60-4.80) than in non-frail subjects (19%, reference group); this difference was driven by an excess of major vascular complications and life-threatening or major bleeding in the pre-frail and frail group. In addition, in pre-frail patients hospitalizations for heart failure or valve-related symptoms at 1-year were higher than in non-frail patients. Conclusion: In women at intermediate or high preoperative risk undergoing TAVR, pre-frailty and frailty increased the risk of safety endpoints such as vascular complications and major bleeding.

Transcatheter aortic valve implantation without contrast media technique in chronic kidney disease population – pilot study

Abstract Background/Introduction Acute Kidney Injury (AKI) is frequently observed after Transcatheter aortic valve implantation (TAVI), with rates ranging from 3% to 50%. In the Brazilian TAVI Registry, the incidence of AKI following TAVI was 18%, with 4.5% requiring dialysis. Its occurrence is associated with an increase in 3-fold all-cause and cardiac death. Since AKI is related to the volume of contrast media, avoiding contrast during TAVI procedure is advisable, especially in chronic kidney disease (CKD) patients. Purpose The aims of the proposed study are to: (1) evaluate the feasibility and safety of a zero-contrast technique for CKD patients undergoing TAVI and (2) define the role of each of the non-contrast imaging modalities in the preoperative assessment for TAVI and (3) evaluate the incidence of AKI post-TAVI in this population. Methods Patients with severe symptomatic aortic stenosis (AS) and CKD stage ≥3a where evaluated for TAVI with four preoperative exams: transesophageal echocardiogram (TEE), cardiac magnetic resonance, contrast and noncontrast computed tomography (MDCT) and aortoiliac co2 angiography. After safety measures of transfemoral (TF) viability and aortic valve favorable anatomy, patients were submitted to TF-TAVI with self-expandable Evolut R/Pro. The contrast MDCT was blinded to the operators and it is checked before the procedure, at a safety checkpoint, to exclude high-risk conditions not detected by non-contrast methods. During the procedure, another safety checkpoint was accomplished. Clinical and echocardiographic outcomes were assessed at 30 days. Results Between december 2020 to december 2021, a total of 25 patients underwent TF TAVI with zero-contrast technique. Mean age of 79.9±6.1 years, 52% male, 18 patients (72%) NYHA functional class III or IV, mean STS-PROM 3.0±1.5%, 12% had severe systolic dysfunction (left ventricle ejection fraction &amp;lt;35%) and mean creatinine clearance of 49.1±7 mL/min. Self-expandable Evolut R was implanted in 80% of patients and Evolut Pro in 20% of them, the most frequent THV size was 29 mm (52%) and the mean implant depth was 6 mm in fluoroscopy and 4.5 mm in TEE. The mean procedural time was 138±56 minutes, with a median radiation dose of 6.6 mGy/cm2 [IQR, 2–6 mGy]. Definitive pacemaker was implanted in 17% of patients and AKI was seen in 6 patients (24%), with stage I (20%), stage II (4%) and no case needed hemodialysis. At 30 days, 84% were at functional class I, there was no death, one embolization requiring a second valve and the rate of device success (VARC-2) was 92%. Conclusion The proposed pilot study for transfemoral TAVI in CKD population with zero contrast technique was safe, with promising results and similar rates of success and complication, compared with the conventional TAVI approach. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): MedtronicAngiodroid

The Usefulness of the Modified Essential Frailty Toolset to Predict Late Bleeding Events after Transcatheter Aortic Valve Implantation

Frailty is strongly associated with poor short- and long-term prognoses in patients who undergo transcatheter aortic valve implantation (TAVI). However, limited data are available regarding the association between frailty and late bleeding events after TAVI. Of the 2,518 patients in the Japanese multicenter TAVI registry, 1371 patients with complete data on frailty parameters were analyzed. We developed a modified Essential Frailty Toolset (EFT) using 4 frailty parameters-gait speed, Mini-Mental State Examination (MMSE), anemia, and hypoalbuminemia-that are significant predictors of late bleeding events in this cohort. The predictive value of the modified EFT for late bleeding after TAVI was assessed in comparison with other clinical variables. Late bleeding events after TAVI occurred in 80 patients (5.8%). Gait speed, MMSE, anemia, and hypoalbuminemia were significantly associated with late bleeding. A modified EFT was developed to include these parameters, which were scored from 0 to 5 points comprising the following 4 items: gait speed (0: >1.5 m/s, 1: 1.5 to 0.75 m/s, 2: <0.75 m/s), cognition (1: MMSE <18), anemia (1: hemoglobin <13 g/100 ml in men or <12 g/100 ml in women), and malnutrition (1: albumin <3.5 g/100 ml). Multivariate Cox regression analysis revealed that the modified EFT was an independent predictor of late bleeding (adjusted hazard ratio 1.51, 95% confidence interval [CI] 1.19 to 1.92, p <0.001) In conclusion, the modified EFT was found to be a significant predictive factor for late bleeding events after TAVI. Assessment of frailty is important to predict patients with high bleeding risk after TAVI.