Incidence, determinants and consequences of delirium in older patients after transcatheter aortic valve implantation

Background: delirium is an event leading to negative health outcomes and increased mortality in patients. The aim of this study is to investigate the incidence, determinants and consequences of post-operative delirium (POD) in older patients undergoing transcatheter aortic valve implantation (TAVI). Methods: The TAVI Care and Cure program is a prospective, observational registry in patients referred for TAVI at Erasmus University Medical Centre. The presence of delirium was evaluated by daily clinical assessment by a geriatrician pre- and up to 3 days post-TAVI. Mortality data were obtained from the Dutch Civil Registry. Results: A total of 543 patients underwent TAVI between January 2014 and December 2017. Overall, the incidence of POD was 14% (75/543 patients) but declined from 18% in 2014 to 7% in 2017 (P = 0.009). Patients who developed POD were older (81.9 ± 5.8 versus 78.6 ± 8.3 years, P < 0.001), had higher prevalence of renal dysfunction and prior stroke (54% versus 40%, P = 0.02; 31% versus 18%, P = 0.01) and were more often frail (32% versus 25%, P = 0.02). From a procedural perspective, general anesthesia (odds ratios (OR), 2.31; 95% CI, 1.40–3.83; P = 0.001), non-transfemoral access (OR, 2.37; 95% CI, 1.20–4.70; P = 0.01) and longer procedural time (OR, 1.01; 95% CI, 1.01–1.02; P < 0.001) were significantly associated with POD. One-year survival rate was 68% among patients who had suffered a POD and was 85% in patients without a POD (hazard ratio’s 1.8 (95% CI 1.01–3.10), P = 0.045). Conclusion: POD frequently occurs after TAVI and is associated with increased mortality. It might be speculated that patient selection and the minimalistic approach of TAVI may reduce the frequency of delirium

Fractional flow reserve guided percutaneous coronary intervention optimization directed by high-definition intravascular ultrasound versus standard of care

Background Post percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is a significant predictor of major adverse cardiac events (MACE). The rationale for low post procedural FFR values often remains elusive based on angiographic findings alone, warranting further assessment using an FFR pullback or additional intravascular imaging. It is currently unknown if additional interventions intended to improve the PCI, decrease MACE rates. Study design The FFR REACT trial is a prospective, single-center randomized controlled trial in which 290 patients with a post PCI FFR b0.90 will be randomized (1:1) to either standard of care (no additional intervention) or intravascular ultrasound (IVUS)-directed optimization of the FFR (treatment arm). Eligible patients are those treated with angiographically successful PCI for (un)stable angina or non-ST elevation myocardial infarction (MI). Assuming 45% of patients will have a post PCI FFR b0.90, approximately 640 patients undergoing PCI will need to be enrolled. Patients with a post PCI FFR ≥ 0.90 will be enrolled in a prospective registry. The primary end point is defined as a composite of cardiac death, target vessel MI and clinically driven target vessel revascularisation (target vessel failure) at 1 year. Secondary end points will consist of individual components of the primary end point, procedural success, stent thrombosis and correlations on clinical outcome, changes in post PCI Pd/Pa and FFR and IVUS derived dimensions. All patients will be followed for 3 years. Conclusion The FFR-REACT trial is designed to explore the potential benefit of HD-IVUS-guided PCI optimization in patients with a post PCI FFR b0.90 (Dutch trial register: NTR6711). (Am Heart J 2019;213:66-72.

Long-term follow-up of quality of life in high-risk patients undergoing transcatheter aortic valve implantation for symptomatic aortic valve stenosis

Background Transcatheter aortic valve implantation (TAVI) has become the standard treatment for patients with severe symptomatic aortic stenosis (AS) considered at very high risk for surgical aortic valve replacement. The purpose of this sub-study was to evaluate long-term (> 4 years) health-related quality of life (QoL) in octogenarians who underwent TAVI. Methods A single center observational registry in twenty patients who underwent frame analysis assessment = 4 years after TAVI. Health-related QoL was evaluated, using the Short Form-36 (SF-36), the EuroQoL-5D (EQ-5D) and the visual analogue score (EQ-VAS) questionnaires. Results The mean SF-36 subscale scores at follow-up were physical functioning 40.8 ± 26.3, role physical functioning 67.7 ± 34.9, vitality 54.6 ± 21.6, general health 52.1 ± 20.4, social functioning 63.8 ± 37.7, role emotional functioning 70.2 ± 36.0, mental health 73.2 ± 23.3 and bodily pain 80.9 ± 22.9. The mean EQ-VAS score > 4 years after TAVI was 64.7 ± 15.1. With respect to functional class, 80% of the patients were in NYHA class I/II at follow-up compared to 15% prior to TAVI. Conclusions This sub-study reports a significant improvement in functional class (NYHA) in a selected group of very elderly patients > 4 years after TAVI. Furthermore, all patients showed a satisfactory QoL despite their age and multiple comorbidities. In addition, our study reveals a lower QoL when compared with the general age matched Dutch population

Simplified trans-axillary aortic valve replacement under local anesthesia – A single center early experience

Background: The axillary artery is an alternative route for patients with comorbidities and unfavorable femoral arteries who need transcatheter aortic valve replacement (TAVR). Simplified trans-axillary transcatheter aortic valve replacement (TAx-TAVR) implies a completely percutaneous approach under local anesthesia and arteriotomy closure with vascular closure techniques. Herein, we report on early experience with simplified TAx-TAVR under local anesthesia. Methods: We enrolled all consecutive patients who underwent simplified TAx-TAVR in our center. Main study parameter was the incidence of axillary access related major vascular complications within 30 days. Secondary parameters included a composite early safety endpoint, axillary access-site related vascular/bleeding complications and short-term mortality. Post TAVR axillary stent patency was evaluated during follow-up by CT-analysis. Results: Between July 2018 and April 2020, Tax-TAVR was attempted in 35 patients with a mean age of 79 years. Local anesthesia and conscious sedation were used in 91.4% (n = 32) and 8.6% (n = 3) respectively. A covered stent was needed for complete axillary hemostasis in 44.1% (n = 15). Device success was achieved in 91.2% (n = 31/34). The 30-day axillary artery major vascular and ≥major bleeding complication rates were 14% (n = 5) and 11% (n = 4). The early safety endpoint was reached in 22.9% (n = 8). Mortality rates at 30 days and six months were 2.9% and 11.6%. Computed tomography (CT) confirmed axillary stent patency during follow-up in 82% (n = 9/11). Conclusions: In patients with high/prohibitive surgical risk and unsuitable femoral access, simplified TAx-TAVR under local anesthesia offers a valuable alternative for transfemoral TAVR but requires advanced access site management techniques including covered stents. Our data suggest an unmet clinical need for dedicated TAx closure devices

TAVI Care and Cure, the Rotterdam multidisciplinary program for patients undergoing transcatheter aortic valve implantation: Design and rationale

Background: The capacity of TAVI-programs and numbers of sites performing TAVI has rapidly increased. This necessitated the initiation of the Rotterdam TAVI Care & Cure Program, aiming to improve patient-centered care during the TAVI pathway. Methods: Consenting patients with severe aortic stenosis and an indication for TAVI will be included. The TAVI Care & Cure program will facilitate prognostic contributions to improve outcomes, patient satisfaction and quality of life in patients with valvular heart disease who are treated with a transcatheter aortic valve implantation in collaboration with the departments of cardiology, cardio-thoracic surgery, anesthesiology and geriatrics. Conclusion: With a single center observational registry, we aim to assess the TAVI patient clinical pathway, focusing on pre, peri and post interventional variables including functional status and HRQoL. We will evaluate the patient's complexity by applying an extended multidisciplinary approach, which includes a systematic application of geriatric assessments of frailty and cognitive function

Impact of frailty on health-related quality of life 1 year after transcatheter aortic valve implantation

Background: Transcatheter aortic valve implantation (TAVI) brings symptom relief and improvement in health-related quality of life (HRQoL) in the majority of patients treated for symptomatic, severe aortic stenosis. However, there is a substantial group of patients that do not benefit from TAVI. The aim of this study is to investigate the impact of frailty on HRQoL 1 year after TAVI. Methods: The TAVI Care & Cure Program is an ongoing, prospective, observational study including patients referred for TAVI to our institution. A comprehensive geriatric assessment was performed to evaluate existence of frailty using the Erasmus Frailty Score (EFS). HRQoL was assessed using the EQ-5D-5 L at baseline and 1 year after TAVI. Results: 239 patients underwent TAVI and completed HRQoL assessment 1 year after TAVI. Seventy (29.3%) patients were classified as frail (EFS ≥ 3). In non-frail patients, the EQ-5D-5 L index did not change (0.71(± 0.22) to 0.68(± 0.33) points, P = 0.22); in frail patients, the EQ-5D-5 L index decreased from 0.55(±0.26) to 0.44 points (±0.33) (P = 0.022). Frailty was an independent predictor of deteriorated HRQoL 1 year after TAVI (OR 2.24, 95% CI 1.07–4.70, P = 0.003). In frail patients, the absence of peripheral artery disease (OR 0.17, 95% 0.05–0.50, P = 0.001) and renal dysfunction (OR 0.13, 95% CI 0.04–0.41, P = <0.001) at baseline was associated with improved HRQoL 1 year after TAVI. Conclusion: Frailty is associated with deterioration of HRQoL 1 year after TAVI. Notably, HRQoL did improve in frail patients with no peripheral arterial disease or renal impairment at baseline

Design and rationale of haemodynamic guidance with CardioMEMS in patients with a left ventricular assist device: the HEMO-VAD pilot study

AimsWe aim to study the feasibility and clinical value of pulmonary artery pressure monitoring with the CardioMEMS™device in order to optimize and guide treatment in patients with a HeartMate3left ventricular assist device (LVAD).Methods and resultsIn this single-centre, prospective pilot study, we will include10consecutive patients with New YorkHeart Association Class IIIb or IV with Interagency Registry for Mechanically Assisted Circulatory Support Classes2–5scheduledfor implantation of a HeartMate3LVAD. Prior to LVAD implantation, patients will receive a CardioMEMS sensor, for dailypulmonary pressure readings. The haemodynamic information provided by the CardioMEMS will be used to improvehaemodynamic status prior to LVAD surgery and optimize the timing of LVAD implantation. Post-LVAD implantation, thehaemodynamic changes will be assessed for additive value in detecting potential complications in an earlier stage (bleedingand tamponade). During the outpatient clinic phase, we will assess whether the haemodynamic feedback can optimize pumpsettings, detect potential complications, and further tailor the clinical management of these patients.ConclusionsThe HEMO-VAD study is thefirst prospective pilot study to explore the safety and feasibility of usingCardioMEMS for optimization of LVAD therapy with additional (remote) haemodynamic information

Impact of Valvulo-Arterial Impedance on Long-Term Quality of Life and Exercise Performance After Transcatheter Aortic Valve Replacement

BACKGROUND: In aortic stenosis, valvulo-arterial impedance (Zva) estimates the overall left ventricular afterload (valve and arterial component). We investigated the association of Zva (≥5 versus <5 mm Hg mL-1 m-2) on quality of life (QOL) and exercise performance (EP) ≥1 year after transcatheter aortic valve replacement (TAVR). METHODS: The study population consists of 250 TAVR patients in whom baseline Zva and follow-up QOL was prospectively assessed using EuroQOL-5-dimensions instruments; EP was assessed in 192 patients who survived ≥1 year after TAVR using questionnaires related to daily activities. In 124 patients, Zva at 1-year was also available and was used to study the change in Zva (baseline to 1 year) on QOL/EP. RESULTS: Elevated baseline Zva was present in 125 patients (50%). At a median of 28 (IQR, 17-40) months, patients with elevated baseline Zva were more limited in mobility (88% versus 71%; P=0.004), self-care (40% versus 25%; P=0.019), and independent daily activities (taking a shower: 53% versus 38%, P=0.030; walking 100 meter: 76% versus 54%, P=0.001; and walking stairs: 74% versus 54%, P=0.011). By multivariable analysis, elevated Zva predicted unfavorable QOL (lower EuroQOL-5-dimensions-Utility Index, odds ratio, 1.98; CI, 1.15-3.41) and unfavorable EP (any limitation in ≥3 daily activities, odds ratio, 2.55; CI, 1.41-4.62). After TAVR, the proportion of patients with elevated Zva fell from 50% to 21% and remained 21% at 1 year and was found to be associated with more limitations in mobility, self-care, and daily activities compared with patients with Zva <5 mm Hg mL-1 m-2. CONCLUSIONS: Elevated Zva was seen in half of patients and predicted unfavorable long-term QOL and EP. At 1 year after TAVR, the prevalence of elevated Zva was 21% but remained associated with poor QOL/EP

Valve Academic Research Consortium 3: updated endpoint definitions for aortic valve clinical research

AIMS The Valve Academic Research Consortium (VARC), founded in 2010, was intended to (i) identify appropriate clinical endpoints and (ii) standardize definitions of these endpoints for transcatheter and surgical aortic valve clinical trials. Rapid evolution of the field, including the emergence of new complications, expanding clinical indications, and novel therapy strategies have mandated further refinement and expansion of these definitions to ensure clinical relevance. This document provides an update of the most appropriate clinical endpoint definitions to be used in the conduct of transcatheter and surgical aortic valve clinical research.METHODS AND RESULTS Several years after the publication of the VARC-2 manuscript, an in-person meeting was held involving over 50 independent clinical experts representing several professional societies, academic research organizations, the US Food and Drug Administration (FDA), and industry representatives to (i) evaluate utilization of VARC endpoint definitions in clinical research, (ii) discuss the scope of this focused update, and (iii) review and revise specific clinical endpoint definitions. A writing committee of independent experts was convened and subsequently met to further address outstanding issues. There were ongoing discussions with FDA and many experts to develop a new classification schema for bioprosthetic valve dysfunction and failure. Overall, this multi-disciplinary process has resulted in important recommendations for data reporting, clinical research methods, and updated endpoint definitions. New definitions or modifications of existing & nbsp;definitions are being proposed for repeat hospitalizations, access site-related complications, bleeding events, conduction disturbances, cardiac structural complications, and bioprosthetic valve dysfunction and failure (including valve leaflet thickening and thrombosis). A more granular 5-class grading scheme for paravalvular regurgitation (PVR) is being proposed to help refine the assessment of PVR. Finally, more specific recommendations on quality-of-life assessments have been included, which have been targeted to specific clinical study designs.CONCLUSIONS Acknowledging the dynamic and evolving nature of less-invasive aortic valve therapies, further refinements of clinical research processes are required. The adoption of these updated and newly proposed VARC-3 endpoints and definitions will ensure homogenous event reporting, accurate adjudication, and appropriate comparisons of clinical research studies involving devices and new therapeutic strategies.Cardiolog