Diastolic delta best predicts paravalvular regurgitation after transcatheter aortic valve replacement as assessed by cardiac magnetic resonance: the APPOSE trial.

AIMS: Paravalvular regurgitation (PVR) is a common complication after transcatheter aortic valve replacement (TAVR) that poses an increased risk of rehospitalization for heart failure and mortality. The aim of this study was to assess the accuracy of haemodynamic indices to predict relevant PVR. METHODS AND RESULTS: In this prospective single-centre clinical trial, four haemodynamic indices of PVR measured during TAVR were assessed for their correlation with gold standard cardiac magnetic resonance (CMR)-derived regurgitant fraction (CMR-RF) at 1 month follow-up: diastolic delta (DD), heart rate-adjusted diastolic delta (HR-DD), aortic regurgitation index (ARI), and aortic regurgitation index ratio (ARI ratio). These haemodynamic indices were analysed for their ability to predict relevant PVR (defined as CMR-RF > 20%) using receiver operating characteristic (ROC) curves with corresponding area under the ROC curves (AUCs). A total of 77 patients were included and had CMR performed 41 ± 14 days after TAVR. Mean CMR-RF was 12.4 ± 9.3%. Fifteen (19.5%) patients had CMR-RF > 20%. DD had the best correlation with CMR-RF and the highest AUC to predict relevant PVR (0.82; 95% CI, 0.72-0.92), followed by HR-DD (AUC 0.78; 95% CI, 0.67-0.89), ARI (AUC 0.78; 95% CI, 0.66-0.89), and ARI ratio (AUC 0.65; 95% CI, 0.49-0.81). The optimal cut-off value for DD was 32 mmHg, with sensitivity of 69% and specificity of 77% in predicting relevant PVR. CONCLUSION: DD measured during TAVR best predicts relevant PVR. Correction for heart rate (HR-DD) or systolic blood pressure (ARI, ARI ratio) did not improve this predictive value.

Clinical Predictors for Procedural Stroke and Implications for Embolic Protection Devices during TAVR: Results from the Multicenter Transcatheter Aortic Valve Replacement In-Hospital Stroke (TASK) Study.

Background: Data to support the routine use of embolic protection devices for stroke prevention during transcatheter aortic valve replacement (TAVR) are controversial. Identifying patients at high risk for peri-procedural cerebrovascular events may facilitate effective patient selection for embolic protection devices during TAVR. Aim: To generate a risk score model for stratifying TAVR patients according to peri-procedural cerebrovascular events risk. Methods and results: A total of 8779 TAVR patients from 12 centers worldwide were included. Peri-procedural cerebrovascular events were defined as an ischemic stroke or a transient ischemic attack occurring ≤24 h from TAVR. The peri-procedural cerebrovascular events rate was 1.4% (n = 127), which was independently associated with 1-year mortality (hazards ratio (HR) 1.78, 95% confidence interval (CI) 1.06−2.98, p < 0.028). The TASK risk score parameters were history of stroke, use of a non-balloon expandable valve, chronic kidney disease, and peripheral vascular disease, and each parameter was assigned one point. Each one-point increment was associated with a significant increase in peri-procedural cerebrovascular events risk (OR 1.96, 95% CI 1.56−2.45, p < 0.001). The TASK score was dichotomized into very-low, low, intermediate, and high (0, 1, 2, 3−4 points, respectively). The high-risk TASK score group (OR 5.4, 95% CI 2.06−14.16, p = 0.001) was associated with a significantly higher risk of peri-procedural cerebrovascular events compared with the low TASK score group. Conclusions: The proposed novel TASK risk score may assist in the pre-procedural risk stratification of TAVR patients for peri-procedural cerebrovascular events.

Reduction of Gastrointestinal Bleeding in Patients With Heyde Syndrome Undergoing Transcatheter Aortic Valve Implantation.

BACKGROUND: Heyde syndrome is the co-occurrence of aortic stenosis and gastrointestinal bleeding secondary to angiodysplasias. Surgical aortic valve replacement effectively reduces bleeding, but the effects of transcatheter aortic valve implantation (TAVI) are largely unknown. This study aimed to describe the reduction of gastrointestinal bleeding in patients with Heyde syndrome after TAVI and to identify the factors associated with rebleeding. METHODS: We enrolled patients with Heyde syndrome from a prospective TAVI registry. Gastrointestinal bleeding episodes were assessed by the Bleeding Academic Research Consortium classification, and cumulative incidence functions were used to calculate cessation rates. Factors potentially associated with rebleeding were analyzed using logistic regression. Differences between Heyde and non-Heyde patients were assessed through a case-cohort study. RESULTS: Between December 2008 and June 2020, 1111 patients underwent TAVI. There were 70 patients with Heyde syndrome (6.3%). In the first year following TAVI, gastrointestinal bleeding ceased in 46 of 70 patients (62% [95% CI, 50%-74%]). Bleeding episodes decreased from 3.2 (95% CI, 2.5-4.2) to 1.6 ([95% CI, 1.2-2.2] P=0.001) and hemoglobin levels increased from 10.3 (95% CI, 10.0-10.8) to 11.3 (95% CI, 10.8-11.6) g/dL (P=0.007). Between 1 and 5 years after TAVI (35 [interquartile range, 21-51] months), 53 of 62 patients (83% [95% CI, 72%-92%]) no longer experienced gastrointestinal bleeding. Paravalvular leakage (≥mild) was associated with rebleeding risk (odds ratio, 3.65 [95% CI, 1.36-9.80]; P=0.010). Periprocedural bleeding was more common in Heyde than in control patients (adjusted odds ratio, 2.55 [95% CI, 1.37-4.73]; P=0.003). CONCLUSIONS: Patients with Heyde syndrome are at increased risk for periprocedural bleeding. Post-TAVI, gastrointestinal bleeding disappears in the majority of patients. Paravalvular leakage may curtail these clinical benefits.

Geriatric assessment in the prediction of delirium and long-term survival after transcatheter aortic valve implantation.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) has emerged as the preferred management strategy for elderly patients with severe symptomatic aortic valve stenosis. These patients are often at high risk of postoperative delirium (POD), which is associated with morbidity and mortality. Since POD may be prevented in a considerable part of these patients, identification of patients at risk is essential. The aim of current study was to identify geriatric assessment tools associated with delirium after TAVI, and long-term mortality. METHODS: Consecutive patients were preoperatively assessed by a geriatrician between 2012 and 2017. Geriatric assessment tools consisted of cognitive, functional, mobility, and nutritional tests. POD was prospectively assessed during hospitalization after TAVI. Mortality tracking was performed by consulting municipal registries. RESULTS: A total of 511 patients were included. Median age was 80 [76-84] years, 44.8% (n = 229) were male, and 14.1% (n = 72) had a history of POD. Delirium was observed in 66 (12.9%) patients. Impaired mobility was the strongest geriatric assessment tool associated with POD (adjusted odds ratio, 2.1 [1.1-4.2], P = .028) and 2-year mortality (adjusted hazard ratio, 2.5 [1.4-4.5], P = .003). Two-year survival was reduced with more than 10% in patients with impaired mobility before TAVI (79.4% vs 91.4%, P = .013). CONCLUSIONS: This study shows that impaired mobility is currently the best single predictor for POD and 2-year mortality in high-risk patients undergoing TAVI. Prospective multicenter studies are needed to optimize and to further explore the facilitation of routine use of POD predictors in TAVI pathways of care, and subsequent preventive interventions.

Aortic Regurgitation Index Ratio Is a Strong Predictor of 1-Year Mortality After Transcatheter Aortic Valve Implantation Using Self-Expanding Devices.

Grading paravalvular leak (PVL) at the time of transcatheter aortic valve implantation (TAVI) deployment is challenging. Per-procedural invasive hemodynamic measurements could serve to optimize PVL grading and predict outcome after TAVI. The aim of this study was to compare hemodynamic measures of paravalvular leak and their prognostic relevance in self-expanding TAVI devices. Between December 2008 and December 2017 consecutive patients treated for severe symptomatic aortic valve stenosis with self-expanding devices were prospectively studied. Peri-procedural hemodynamic measurements, echocardiographic data as well as clinical follow-up according to VARC-2 criteria were prospectively collected. Diastolic delta (DD), heart rate adjusted DD, aortic regurgitation index (ARI) and ARI ratio were calculated and assessed for their association with 1-year mortality. A total of 651 patients were studied. Moderate or severe paravalvular leakage was found in 4.8% of patients. ARI ratio < 0.6 (hazard ratio 1.96 [1.23-3.12], P = 0.005) was the best independent predictor of 1-year mortality. This study confirms the value of hemodynamic measures, specifically ARI ratio, for prognostication, potentially supporting procedural decision-making with regard to PVL.

Delirium After TAVR: Crosspassing the Limit of Resilience.

Patients who undergo transcatheter aortic valve replacement often are frail and elderly. Delirium is a frequently observed complication, associated with impaired recovery, prolonged hospital stay, and mortality. In different hospital settings, interventions that reduced the incidence of delirium resulted in improved clinical outcome and reduced costs. In that context, prevention, early recognition, and timely interventions could be the next step toward better outcomes of transcatheter aortic valve replacement. This review is focused on awareness and recognition of delirium, including predisposing "vulnerability" factors (such as cognitive impairment and carotid artery disease) and "trigger" factors (such as anesthesia, hemodynamic imbalance, and complications). For prevention and treatment, clinicians should focus on sleep hygiene, orientation, pain management, and early mobilization. In case of delirium, a thorough search and treatment of trigger factors is warranted. Future studies should focus on risk assessment, preventive and therapeutic interventions, and their potential benefit in terms of costs and clinical outcomes.

Clinical Outcomes of the Portico Transcatheter Aortic Valve Delivered via Alternative Access: 30-Day and 1-Year Results of the Portico ALT Study.

OBJECTIVE: The aim of this study was to report the 30-day and 1-year outcomes and performance from the Portico Alternative Access study to obtain CE approval of the alternative access delivery system. METHODS: The Portico Alternative Access study is a multicenter, prospective, non-randomized, investigational study (www.clinicaltrials.gov identifier, NCT03056573) describing 45 patients with severe symptomatic aortic valve stenosis (AS) treated with the self-expanding Portico device using subclavian/axillary access. RESULTS: Forty-five subjects (81.7 ± 5.9 years; 57.8% female; Society of Thoracic Surgeons score, 5.4 ± 4.7%) with severe, symptomatic AS had a Portico bioprosthetic aortic valve implantation attempt via axillary/subclavian access. Implantation was successful in 97.8% of subjects. At 30 days, the rate of major vascular complications at the subclavian/axillary access site was 4.4%. All-cause mortality was 2.2% at 30 days and 4.4% at 1 year. CONCLUSION: The Portico transcatheter aortic valve can be safely delivered by axillary or subclavian access with high implant success rate and low complication rates.

Incidence and predictors of vascular complications in transaxillary TAVI.

AIMS: Vascular complications are among the most commonly observed complications after TAVI. Iliofemoral vascular outcome has been described extensively. Little is known about vascular complications in transaxillary TAVI. The aim of the current study was to describe the incidence and predictors of axillary artery complications incorporating computed tomography angiography (CTA) measurements. METHODS AND RESULTS: CT analysis was performed in two hundred patients treated with transaxillary TAVI in our centre between January 2014 and December 2017. Vascular complications occurred in 37 (18.5%) patients. Patient characteristics predicting this outcome were female gender (aOR 3.88 [1.48-10.14], p=0.006) and age (aOR 1.08 [1.01-1.16], p=0.034). The CTA measurement predicting vascular complications was a sheath to artery area ratio (SAAR) equal to or larger than 1.63 (OR 3.95 [1.29-12.12], p=0.016). CONCLUSIONS: The present study describes the incidence of axillary artery complications and identifies patient characteristics associated with this outcome. CTA analysis was shown to be an important screening tool in the assessment of patient (access) eligibility. Axillary artery dimensional screening should be based on vascular luminal area assessment rather than diameter measurement alone.

Delirium After Transcatheter Aortic Valve Implantation Under General Anesthesia: Incidence, Predictors, and Relation to Long-Term Survival.

BACKGROUND/OBJECTIVES: Prospectively collected data on postoperative delirium (POD) after transcatheter aortic valve implantation (TAVI) are scarce. The aim of this study was to report the incidence and risk factors of delirium after TAVI under general anesthesia and to assess the association of POD with clinical outcome and short- and long-term survival. DESIGN: Prospective cohort study. SETTING: Academic medical center. PARTICIPANTS: A total of 703 subsequent patients undergoing TAVI under general anesthesia between 2008 and 2017. MEASUREMENTS: Delirium was assessed according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), criteria. Outcomes were postprocedural clinical outcome and short- and long-term survival (30 days and 5 years, respectively). RESULTS: POD was observed in 16.5% (116/703), was the strongest independent predictor of long-term mortality (hazard ratio = 1.91; 95% confidence interval [CI] = 1.36-2.70), and was associated with impaired 30-day and 5-year survival (92.2% vs 96.8% [P = .025] and 40.0% vs 50.0% [P = .007], respectively). Stroke and new onset of atrial fibrillation were more often observed in delirious patients (6.9% vs 1.9% and 12.1% vs 5.1%, respectively). Strongest independent predictors of POD were prior delirium (odds ratio [OR] = 2.56; 95% CI = 1.52-4.31) and aortic valve area less than 0.75 cm2 (OR = 2.39; 95% CI = 1.53-3.74). CONCLUSION: One in six patients experienced POD after TAVI under general anesthesia. POD was the strongest predictor of long-term mortality and was associated with impaired short- and long-term survival. Prior delirium and a more calcified aortic valve were the strongest independent predictors of POD. J Am Geriatr Soc 67:2325-2330, 2019.

Feasibility and Outcomes of Transcatheter Aortic Valve Implantation Using the Left Axillary Artery as Primary Access Site.

BACKGROUND: The femoral artery is generally used as primary access for transcatheter aortic valve implantation. However, peripheral artery disease often precludes femoral access. The purpose of this study was to describe clinical outcome of transcatheter aortic valve implantation using the left axillary artery (LAA) as primary access site. METHODS: From December 2008 until June 2016, data on all consecutive patients treated with a Medtronic device through the LAA at our hospital were registered, and outcome was prospectively collected according to the updated Valve Academic Research Consortium-2 criteria. Mortality check was performed nationally. RESULTS: In total, 362 patients were included (median age 80 years [range, 76 to 84]; logistic European System for Cardiac Operative Risk Evaluation 17% ± 12%). Successful axillary access was achieved in 99%. Medtronic CoreValve (86%) and Evolut R (14% [Medtronic, Minneapolis, MN]) were implanted. Major vascular complications occurred in 5% of patients, 1% was LAA related. Life-threatening bleeding and major bleeding were observed in 2% and 10%, respectively. Additional complications were new left bundle branch blood (30%), new permanent pacemaker (11%), and stroke (1%). There were 6 procedural deaths (2%) and 19 deaths (5%) within 30 days. One-year mortality rate was 19%. CONCLUSIONS: This is the first study reporting outcome after transcatheter aortic valve implantation using the LAA as default access. We conclude that it is highly feasible and safe with low rates of major vascular complications, bleeding, and stroke.

Frailty is associated with delirium and mortality after transcatheter aortic valve implantation.

OBJECTIVE: We hypothesised that frailty assessment is of additional value to predict delirium and mortality after transcatheter aortic valve implantation (TAVI). METHODS: Observational study in 89 consecutive patients who underwent TAVI. Inclusion from November 2012 to February 2014, follow-up until April 2014. Measurement of the association of variables from frailty assessment and cardiological assessment with delirium and mortality after TAVI, respectively. RESULTS: Incidence of delirium after TAVI: 25/89 (28%). Variables from frailty assessment protectively associated with delirium were: Mini Mental State Examination, (OR 0.79; 95% CI 0.65 to 0.96; p=0.02), Instrumental Activities of Daily Living (OR 0.79; 95% CI 0.63 to 0.99; p=0.04) and gait speed (OR 0.05; 95% CI 0.01 to 0.50; p=0.01). Timed Up and Go was predictively associated with delirium (OR 1.14; 95% CI 1.03 to 1.26; p=0.01). From cardiological assessment, pulmonary hypertension was protectively associated with delirium (OR 0.34; 95% CI 0.12 to 0.98; p=0.05). Multivariate logistic analysis: Nagelkerke R2=0.359, Mini Mental State Examination was independently associated with delirium. Incidence of mortality: 11/89 (12%). Variables predictively associated with mortality were: the summary score Frailty Index (HR 1.66, 95% CI 1.06 to 2.60; p=0.03), European System for Cardiac Operative Risk Evaluation (EuroSCORE) II (HR 1.14, 95% CI 1.06 to 1.22; p<0.001) and complications (HR 4.81, 95% CI 1.03 to 22.38; p=0.05). Multivariate Cox proportional hazards analysis: Nagelkerke R2=0.271, Frailty Index and EuroSCORE II were independently associated with mortality. CONCLUSIONS: Delirium frequently occurs after TAVI. Variables from frailty assessment are associated with delirium and mortality, independent of cardiological assessment. Thus, frailty assessment may have additional value in the prediction of delirium and mortality after TAVI.