Effectiveness, safety, and patient reported outcomes of a planned investment procedure in higher-risk chronic total occlusion percutaneous coronary intervention: Rationale and design of the invest-CTO study.

BACKGROUND: The anatomical complexity of a chronic total occlusion (CTO) correlates with procedural failure and complication rates. CTO modification after unsuccessful crossing has been associated with subsequent higher technical success rates, but complication rates remain high with this approach. While successful CTO percutaneous coronary intervention (PCI) has been associated with improved angina and quality of life (QOL) this has not been demonstrated in anatomically high-risk CTOs. Whether a planned CTO modification procedure, hereafter named Investment procedure, could improve patient outcomes has never been investigated. STUDY DESIGN: Invest-CTO is a prospective, single-arm, international, multicenter study, evaluating the effectiveness and safety of a planned investment procedure, with a subsequent completion CTO PCI (at 8-12 weeks), in anatomically high-risk CTOs. We will enroll 200 patients with CTOs defined as high-risk according to our Invest CTO criteria at centers in Norway and United Kingdom. Patients with aorto-ostial lesions, occlusion within a previous stent, or a prior attempt at target vessel CTO PCI within 6 months will be excluded. The co-primary endpoints are cumulative procedural success (%) after both procedures, and a composite safety endpoint at 30 days after completion CTO PCI. Patient reported outcomes (PROs), treatment satisfaction, and clinical endpoints will be reported. CONCLUSION: This study will prospectively evaluate the effectiveness and safety of a planned two staged PCI procedure in the treatment of high-risk CTOs and may have the potential to change current clinical practice.

Baseline frailty status and outcomes important for shared decision-making in older adults receiving transcatheter aortic valve implantation, a prospective observational study.

AIMS: The objective of this study was to examine baseline frailty status (including cognitive deficits) and important clinical outcomes, to inform shared decision-making in older adults receiving transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We conducted a prospective, observational study of 82 TAVI patients, recruited 2013 to 2015, with 2-year follow-up. Mean age was 83 years (standard deviation (SD) 4.7). Eighteen percent of the patients were frail, as assessed with an 8-item frailty scale. Fifteen patients (18%) had a Mini-Mental Status Examination (MMSE) score below 24 points at baseline, indicating cognitive impairment or dementia and five patients had an MMSE below 20 points. Mean New York Heart Association (NYHA) class at baseline and 6 months was 2.5 (SD 0.6) and 1.4 (SD 0.6), (p < 0.001). There was no change in mean Nottingham Extended Activities of Daily Living (NEADL) scale between baseline and 6 months, 54.2 (SD 11.5) and 54.5 (SD 10.3) points, respectively, mean difference 0.3 (p = 0.7). At 2 years, six patients (7%) had died, four (5%, n = 79) lived in a nursing home, four (5%) suffered from disabling stroke, and six (7%) contracted infective endocarditis. CONCLUSIONS: TAVI patients had improvement in symptoms and maintenance of activity of daily living at 6 months. They had low mortality and most patients lived in their own home 2 years after TAVI. Complications like death, stroke, and endocarditis occurred. Some patients had cognitive impairment before the procedure which might influence decision-making. Our findings may be used to develop pre-TAVI decision aids.

Frailty Status and Patient-Reported Outcomes in Octogenarians Following Transcatheter or Surgical Aortic Valve Replacement.

BACKGROUND: Frailty status and patient-reported outcomes are especially pertinent in octogenarians following transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) to guide treatment decisions and promote patient-centred care. AIM: We aimed to determine if frailty changed 6 months after aortic valve replacement (AVR) in octogenarians, and to describe changes in self-rated health according to frailty status in patients who underwent TAVI or SAVR. METHOD: In a prospective cohort study, frailty and self-rated health were measured one day prior to and 6 months after AVR. Frailty status was measured with the Study of Osteoporotic Fracture index. Self-rated health was measured comprehensively with the disease-specific Minnesota Living with Heart Failure Questionnaire, the generic Medical Outcomes Study Short Form-12 questionnaire (SF-12), and two global questions from The World Health Organization Quality of Life Instrument Abbreviated. RESULTS: Data were available for 143 consecutive patients (mean age 83±2.7 years, 57% women; 45% underwent TAVI). At baseline, 34% were robust, 27% prefrail, and 39% frail. Overall, there was no change in the distribution of frailty status 6 months after baseline (p=0.13). However, on an individual level 65 patients changed frailty status after AVR (40 patients improved and 25 declined). Improvement in frailty status was common in prefrail (33%; n=13) and frail patients (48%; n=27). Patients had improved self-rated health after AVR, with significant differences between frailty states both at baseline (SF-12 physical: 37.4 [robust], 33.1 [prefrail], 31.6 [frail], p=0.03); SF-12 mental: 51.9 [robust], 50.8 [prefrail], 44.5 [frail], p<0.001); and at the 6-month follow-up (SF-12 physical: 45.4 [robust], 38.3 [prefrail], 32.1 [frail], p<0.001); SF-12 mental: 54.9 [robust], 49.6 [prefrail], 46.8 [frail], p=0.002). CONCLUSIONS: Advanced treatment performed in a high-risk population allowed people to improve their self-rated health. Although frailty is associated with poor self-rated health, frailty status does not equal negative outcomes. The frail patients were those who improved most in self-rated physical and mental health. They had the lowest baseline self-rated health scores and had therefore the most to gain.

Shared Decision-Making and Patient-Reported Outcome Measures in Valvular Heart Disease.

Patient-centered health care emphasizes shared decision-making (SDM), incorporating both clinical evidence and patient preferences and values. SDM is important in heart valve disease, both because there might be more than one treatment option and due to the importance of adherence after intervention. We aimed to describe patient information and involvement in decision-making about care and recording of patient-reported outcome measures (PROMs) in valve interventions. The opinion piece and recommendations are based upon literature review and our own experience from specialist valve clinics. Before a valve intervention, adequate patient information, discussion of the various treatment options and exploring patient preferences, in line with the concept of SDM, may improve post-intervention quality of life. After intervention, patients with prosthetic heart valves require adequate counseling and close follow-up to make them more confident and competent to manage their own health, as well as to maintain the efficacy of treatment provided. PROMs inform SDM before and improve care after valve intervention, focusing on outcomes beyond mortality and morbidity. SDM may improve post-intervention quality of life. Formal PROMs questionnaires inform SDM, quantify patient centered changes and should be used more often in clinical practice and research. A thorough assessment of baseline frailty status in patients scheduled for valve intervention is essential and may affect postoperative outcome.

Alpha-2-adrenergic receptor agonists for the prevention of delirium and cognitive decline after open heart surgery (ALPHA2PREVENT): protocol for a multicentre randomised controlled trial.

INTRODUCTION: Postoperative delirium is common in older cardiac surgery patients and associated with negative short-term and long-term outcomes. The alpha-2-adrenergic receptor agonist dexmedetomidine shows promise as prophylaxis and treatment for delirium in intensive care units (ICU) and postoperative settings. Clonidine has similar pharmacological properties and can be administered both parenterally and orally. We aim to study whether repurposing of clonidine can represent a novel treatment option for delirium, and the possible effects of dexmedetomidine and clonidine on long-term cognitive trajectories, motor activity patterns and biomarkers of neuronal injury, and whether these effects are associated with frailty status. METHODS AND ANALYSIS: This five-centre, double-blind randomised controlled trial will include 900 cardiac surgery patients aged 70+ years. Participants will be randomised 1:1:1 to dexmedetomidine or clonidine or placebo. The study drug will be given as a continuous intravenous infusion from the start of cardiopulmonary bypass, at a rate of 0.4 µg/kg/hour. The infusion rate will be decreased to 0.2 µg/kg/hour postoperatively and be continued until discharge from the ICU or 24 hours postoperatively, whichever happens first.Primary end point is the 7-day cumulative incidence of postoperative delirium (Diagnostic and Statistical Manual of Mental Disorders, fifth edition). Secondary end points include the composite end point of coma, delirium or death, in addition to delirium severity and motor activity patterns, levels of circulating biomarkers of neuronal injury, cognitive function and frailty status 1 and 6 months after surgery. ETHICS AND DISSEMINATION: This trial is approved by the Regional Committee for Ethics in Medical Research in Norway (South-East Norway) and by the Norwegian Medicines Agency. Dissemination plans include publication in peer-reviewed medical journals and presentation at scientific meetings. TRIAL REGISTRATION NUMBER: NCT05029050.

A novel geriatric assessment frailty score predicts 2-year mortality after transcatheter aortic valve implantation.

AIMS: Established surgical scores have limitations in delineating risk among candidates for transcatheter aortic valve implantation (TAVI). Assessment of frailty might help to estimate the mortality risk and identify patients likely to benefit from treatment. The aim of the study was to develop a frailty score to guide the decision for TAVI. METHODS AND RESULTS: We conducted a prospective observational study in patients ≥70 years referred for TAVI during 2011-15. A Heart Team had declined the patients for open heart surgery due to high risk but accepted them for TAVI. Prior to the procedure, a geriatric assessment (GA) was performed. Based on this, an 8-element frailty score with a 0-9 (least frail-most frail) scale was developed. A total of 142 patients, 54% women, mean age 83 (standard deviation 4) years, with severe and symptomatic aortic stenosis were assessed. All-cause 2 year mortality was 11%. The novel GA frailty score predicted 2-year mortality in Cox analyses, also when adjusted for age, gender, and logistic EuroSCORE [hazard ratio (HR) 1.75, 95% confidence interval (CI): 1.28-2.42, P < 0.001]. A receiver operating characteristic (ROC) curve analysis indicated that a GA frailty score cut-off at ≥4 predicted 2-year mortality with a specificity of 80% (95% CI: 73-86%) and a sensitivity of 60% (95% CI: 36-80%). The area under the curve was 0.81 (95% CI 0.71-0.90). CONCLUSION: A novel 8-element GA frailty score identified gradations in survival in patients declined for open heart surgery. Patients with higher GA frailty scores had significantly higher 2-year mortality after TAVI.

Conditions for autonomous choice: a qualitative study of older adults' experience of decision-making in TAVR.

BACKGROUND: Patient autonomy is a leading principle in bioethics and a basis for shared decision making. This study explores conditions for an autonomous choice experienced by older adults who recently underwent trans-catheter aortic valve replacement (TAVR). METHODS: Qualitative study entailing semi-structured interviews of a purposive sample of ten older (range 73-89, median 83.5 years) adults after TAVR (median 23 days). The study setting was a cardiac department at a university hospital performing TAVR since 2010. Analysis was by systematic text condensation. RESULTS: Even when choice seemed hard or absent, TAVR-patients deliberately took the chance offered them by processing risk assessment, ambivalence and fate. They regarded declining the treatment to be worse than accepting the risk related to the procedure. The experience of being thoroughly advised by their physician formed the basis of an autonomous trust. The trust they felt for the physicians' recommendations mitigated ambivalence about the procedure and risks. TAVR patients expressed feelings consistent with self-empowerment and claimed that it had to be their decision. Even so, choosing the intervention as an obligation to their family or passively accepting it was also reported. CONCLUSIONS: Older TAVR patients' experience of an autonomous decision may encompass frank tradeoff; deliberate physician dependency as well as a resilient self-view. Physicians should be especially aware of how older adults' subtle cognitive declines and inclinations to preserve their identities which can influence their medical decision making when obtaining informed consent. Cardiologists and other providers may also use these insights to develop new strategies that better respond to such inherent complexities.

Changes in self-reported health and quality of life in octogenarian patients one month after transcatheter aortic valve implantation.

BACKGROUND: In addition to favourable results regarding mortality and morbidity it is important to identify the impact transcatheter aortic valve implantation (TAVI) has on patients' quality of life. AIMS: The aims were: (i) to describe clinical characteristics, self-reported health and quality of life in octogenarians before TAVI intervention; (ii) to determine changes in self-reported health and quality of life one month after TAVI; and (iii) to establish the clinical importance of the findings. METHODS: A prospective cohort study was conducted on consecutively enrolled octogenarians with severe aortic stenosis undergoing TAVI ( N = 65). Self-reported health and quality of life were recorded at baseline and one month later using two global questions from the World Health Organization Quality of Life Instrument Abbreviated (WHOQOL-BREF), the generic Short Form Health 12 and the disease-specific Minnesota Living with Heart Failure Questionnaire. RESULTS: One month after TAVI, WHOQOL-BREF showed that self-reported health improved moderately ( p < 0.001), while quality of life improved slightly, but not statistically significantly ( p = 0.06). There were changes in all Short Form Health 12 domains, except social functioning and role emotional. The estimated changes were 3.6 to 5.8 with large confidence intervals. The Physical Component Summary increased statistically significantly from baseline to 30 days (30.6-34.7; p = 0.02), but the Mental Component Summary did not (46.9-50.0; p = 0.13). CONCLUSION: Despite being an advanced treatment performed in a high risk population, TAVI in octogenarians improves short-term self-reported global health and generic physical health and quality of life. These patient-reported outcomes have importance, particularly in this age group.