Frailty is a geriatric syndrome that diminishes the potential for functional recovery after a transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) procedure; ...however, its integration in clinical practice has been limited by a lack of consensus on how to measure it.
This study sought to compare the incremental predictive value of 7 different frailty scales to predict poor outcomes following TAVR or SAVR.
A prospective cohort of older adults undergoing TAVR or SAVR was assembled at 14 centers in 3 countries from 2012 to 2016. The following frailty scales were compared: Fried, Fried+, Rockwood, Short Physical Performance Battery, Bern, Columbia, and the Essential Frailty Toolset (EFT). Outcomes of interest were all-cause mortality and disability 1 year after the procedure.
The cohort was composed of 1,020 patients with a median age of 82 years. Depending on the scale used, the prevalence of frailty ranged from 26% to 68%. Frailty as measured by the EFT was the strongest predictor of death at 1 year (adjusted odds ratio OR: 3.72; 95% confidence interval CI: 2.54 to 5.45) with a C-statistic improvement of 0.071 (p < 0.001) and integrated discrimination improvement of 0.067 (p < 0.001). Moreover, the EFT was the strongest predictor of worsening disability at 1 year (adjusted OR: 2.13; 95% CI: 1.57 to 2.87) and death at 30 days (adjusted OR: 3.29; 95% CI: 1.73 to 6.26).
Frailty is a risk factor for death and disability following TAVR and SAVR. A brief 4-item scale encompassing lower-extremity weakness, cognitive impairment, anemia, and hypoalbuminemia outperformed other frailty scales and is recommended for use in this setting. (Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions; NCT01845207).
BACKGROUND:Older adults undergoing aortic valve replacement (AVR) are at risk for malnutrition. The association between preprocedural nutritional status and midterm mortality has yet to be ...determined.
METHODS:The FRAILTY-AVR (Frailty in Aortic Valve Replacement) prospective multicenter cohort study was conducted between 2012 and 2017 in 14 centers in 3 countries. Patients ≥70 years of age who underwent transcatheter or surgical AVR were eligible. The Mini Nutritional Assessment-Short Form was assessed by trained observers preprocedure, with scores ≤7 of 14 considered malnourished and 8 to 11 of 14 considered at risk for malnutrition. The Short Performance Physical Battery was simultaneously assessed to measure physical frailty, with scores ≤5 of 12 considered severely frail and 6 to 8 of 12 considered mildly frail. The primary outcome was 1-year all-cause mortality, and the secondary outcome was 30-day composite mortality or major morbidity. Multivariable regression models were used to adjust for potential confounders.
RESULTS:There were 1158 patients (727 transcatheter AVR and 431 surgical AVR), with 41.5% females, a mean age of 81.3 years, a mean body mass index of 27.5 kg/m, and a mean Society of Thoracic Surgeons-Predicted Risk of Mortality of 5.1%. Overall, 8.7% of patients were classified as malnourished and 32.8% were at risk for malnutrition. Mini Nutritional Assessment-Short Form scores were modestly correlated with Short Performance Physical Battery scores (Spearman R=0.31, P<0.001). There were 126 deaths in the transcatheter AVR group (19.1 per 100 patient-years) and 30 deaths in the surgical AVR group (7.5 per 100 patient-years). Malnourished patients had a nearly 3-fold higher crude risk of 1-year mortality compared with those with normal nutritional status (28% versus 10%, P<0.001). After adjustment for frailty, Society of Thoracic Surgeons-Predicted Risk of Mortality, and procedure type, preprocedural nutritional status was a significant predictor of 1-year mortality (odds ratio, 1.08 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.01–1.16) and of the 30-day composite safety end point (odds ratio, 1.06 per Mini Nutritional Assessment-Short Form point; 95% CI, 1.001–1.12).
CONCLUSIONS:Preprocedural nutritional status is associated with mortality in older adults undergoing AVR. Clinical trials are needed to determine whether pre- and postprocedural nutritional interventions can improve clinical outcomes in these vulnerable patients.
Theoretically, bioresorbable vascular scaffolds (BVSs) may provide superior long-term results compared with permanent metallic drug-eluting stents (DESs). However, whether BVSs are as safe and ...effective as metallic DESs prior to complete bioresorption is unknown.
ABSORB Japan was a single-blind, multicentre, active-controlled, randomized trial designed to support regulatory approval of the Absorb BVS in Japan. Eligible patients with one or two de novo lesions in different epicardial vessels were randomized at 38 Japanese sites in a 2:1 ratio to Absorb BVS vs. cobalt-chromium everolimus-eluting stents (CoCr-EESs). The primary endpoint was target lesion failure TLF: a composite of cardiac death, myocardial infarction attributable to target vessel, or ischaemia-driven target lesion revascularization (ID-TLR) at 12 months, powered for non-inferiority. The major secondary endpoint was angiographic in-segment late lumen loss (LLL) at 13 months. A total of 400 patients were randomized to BVSs (266 patients and 275 lesions) or CoCr-EESs (134 patients and 137 lesions). TLF through 12 months was 4.2% with BVSs and 3.8% with CoCr-EESs difference (upper one-sided 95% confidence limit) = 0.39% (3.95%); Pnon-inferiority < 0.0001. Definite/probable stent/scaffold thrombosis at 12 months occurred in 1.5% of the patients with both devices (P = 1.0), and ID-TLR for restenosis was infrequent (1.1% with BVSs and 1.5% with CoCr-EESs, P = 1.0). With 96.0% angiographic follow-up, in-segment LLL at 13 months was 0.13 ± 0.30 mm with BVSs and 0.12 ± 0.32 mm with CoCr-EESs difference (upper one-sided 95% confidence limit) = 0.01 (0.07); Pnon-inferiority < 0.0001).
In the ABSORB Japan randomized trial, 12-month clinical and 13-month angiographic outcomes of BVSs were comparable to CoCr-EESs.
ClinicalTrials.gov, number NCT01844284.
Background:The optimal implantation technique for the bioresorbable scaffold (Absorb, Abbott Vascular) is still a matter of debate. The purpose of the present study was to evaluate the effect of ...implantation technique on strut embedment and scaffold expansion.Methods and Results:Strut embedment depth and scaffold expansion index assessed by optical coherence tomography (OCT) (minimum scaffold area/reference vessel area) were evaluated in the ABSORB Japan trial (OCT subgroup: 87 lesions) with respect to implantation technique using either quantitative coronary angiography (QCA) or OCT. Strut embedment was assessed at the strut level (n=667), while scaffold expansion was assessed at the lesion level (n=81). The mean embedment depth was 63±59 µm. Balloon sizing and inflation pressure had no direct effect on strut embedment. Plaque morphology affected strut embedment nonatherosclerotic (58.9±54.3 µm), fibroatheroma (73.3±59.6 µm), fibrous plaque (59.7±51.1 µm), and fibrocalcific plaque (–3.1±61.6 µm, negative value means malapposition), P <0.001. The balloon-artery ratio positively correlated with the expansion index. This relationship was stronger when the OCT-derived reference vessel diameter (RVD) was used as a reference for balloon selection rather than the QCA-derived one predilatation (Pearson correlation r: QCA: 0.167 vs. OCT: 0.552), postdilatation (QCA: 0.316 vs. OCT: 0.717).Conclusions:Underlying plaque morphology influenced strut embedment, whereas implantation technique had no direct effect on it. Optimal balloon sizing based on OCT-derived RVD might be recommended. However, the safety of such a strategy should be investigated in a prospective trial. (Circ J 2016; 80: 2317–2326)
Abstract Objectives We compared the incidence of prosthesis–patient mismatch (PPM) between transcatheter aortic valve replacement (TAVR) using a self-expanding bioprosthesis and surgical aortic valve ...replacement (SAVR) in the CoreValve US High Risk Pivotal Trial. We sought to determine the influence of PPM on clinical outcomes. Methods Patients with severe aortic stenosis and at increased risk for surgery were randomized 1:1 to TAVR or SAVR. Postoperative PPM was defined by the effective orifice area index (EOAi) as severe PPM (EOAi ≤ 0.65 cm2 /m2 ) and no severe PPM (EOAi > 0.65 cm2 /m2 ); clinical outcomes were analyzed in the TAVR arm (n = 389) and SAVR arm (n = 353). Left ventricular mass index and regression were analyzed at baseline and 1 year. Results The incidence of severe PPM in the SAVR group at 1 year was 25.7% versus 6.2% in the TAVR group ( P < .0001). Left ventricular mass index regression at 1 year was 6.8% for TAVR and 15.1% for SAVR in patients with severe PPM. At 1 year the rate of all-cause mortality and acute kidney injury were significantly greater in all patients (TAVR + SAVR) with severe PPM compared with no severe PPM (20.6% vs 12.0% P = .0145 for death and 19.2% vs 8.5% P = .0008 for acute kidney injury). Conclusions In patients with high surgical risk and severe aortic stenosis, severe PPM is more common in patients treated with SAVR than those treated with TAVR. Patients with severe PPM are a greater risk for death and acute kidney injury than patients without severe PPM.
IMPORTANCE: Functional status is a patient-centered outcome that is important for a meaningful gain in health-related quality of life after aortic valve replacement. OBJECTIVE: To determine ...functional status trajectories in the year after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort study with a 12-month follow-up was conducted at a single academic center in 246 patients undergoing TAVR or SAVR for severe aortic stenosis. The study was conducted between February 1, 2014, and June 30, 2017; data analysis was performed from December 27, 2017, to May 7, 2018. EXPOSURES: Preoperative comprehensive geriatric assessment was performed and a deficit-accumulation frailty index (CGA-FI) (range, 0-1; higher values indicate greater frailty) was calculated. MAIN OUTCOMES AND MEASURES: Telephone interviews were conducted to assess self-reported ability to perform 22 activities and physical tasks at 1, 3, 6, 9, and 12 months after the procedure. RESULTS: Of the 246 patients included in the study, 143 underwent TAVR (74 51.7% women; mean SD age, 84.2 5.9 years), and 103 underwent SAVR (46 44.7% women; age, 78.1 5.3 years). Five trajectories were identified based on functional status at baseline and during the follow-up: from excellent at baseline to improvement at follow-up (excellent baseline-improvement), good (high baseline-full recovery), fair (moderate baseline-minimal decline), poor (low baseline-moderate decline), and very poor (low baseline-large decline). After TAVR, the most common trajectory was fair (54 37.8%), followed by good (33 23.1%), poor (21 14.7%), excellent (20 14.0%), and very poor (12 8.4%) trajectories. After SAVR, the most common trajectory was good (39 37.9%), followed by excellent (38 36.9%), fair (20 19.4%), poor (3 2.9%), and very poor (1 1.0%) trajectories. Preoperative frailty level was associated with lower probability of functional improvement and greater probability of functional decline. After TAVR, patients with CGA-FI level of 0.20 or lower had excellent (3 50.0%) or good (3 50.0%) trajectories, whereas most patients with CGA-FI level of 0.51 or higher had poor (10 45.5%) or very poor (5 22.7%) trajectories. After SAVR, most patients with CGA-FI level of 0.20 or lower had excellent (24 58.5%) or good (15 36.6%) trajectories compared with a fair trajectory (5 71.4%) in those with CGA-FI levels of 0.41 to 0.50. Postoperative delirium and major complications were associated with functional decline after TAVR (delirium present vs absent: 14 50.0% vs 11 13.4%; complications present vs absent: 14 51.9% vs 19 16.4%) or lack of improvement after SAVR (delirium present vs absent: 27 69.2% vs 31 81.6%; complications present vs absent: 10 62.5% vs 69 79.3%). CONCLUSIONS AND RELEVANCE: The findings suggest that functional decline or lack of improvement is common in older adults with severe frailty undergoing TAVR or SAVR. Although this nonrandomized study does not allow comparison of the effectiveness between TAVR and SAVR, anticipated functional trajectories may inform patient-centered decision making and perioperative care to optimize functional outcomes.
We sought to investigate two-year clinical and serial optical coherence tomography (OCT) outcomes after implantation of a fully bioresorbable vascular scaffold (BVS) or a cobalt-chromium ...everolimus-eluting stent (CoCr-EES).
In the ABSORB Japan trial, 400 patients were randomised in a 2:1 ratio to BVS (N=266) or CoCr-EES (N=134). A pre-specified OCT subgroup (N=125, OCT-1 group) underwent angio-graphy and OCT post procedure and at two years. Overall, the two-year TLF rates were 7.3% and 3.8% in the BVS and CoCr-EES arms (p=0.18), respectively. Very late scaffold thrombosis (VLST) beyond one year was observed in 1.6% (four cases: all in non-OCT-1 subgroups) of the BVS arm, while there was no VLST in the CoCr-EES arm. In three cases, OCT at the time of or shortly after VLST demonstrated strut discontinuities, malapposition and/or uncovered struts. However, the vessel healing by two-year OCT was nearly complete in both BVS and CoCr-EES arms with almost fully covered struts, and minimal malapposition. The flow area by two-year OCT was smaller in the BVS arm than in the CoCr-EES arm, mainly due to tissue growth inside the device. However, there were no differences between the BVS and CoCr-EES with regard to the quality of homogenous tissues growing inside the devices.
The rate of TLF was numerically higher in the BVS arm than in the CoCr-EES arm, although this difference was not statistically significant. VLST was observed only in the BVS arm at a rate of 1.6% between one and two years. Further studies are mandatory to investigate the risk of BVS relative to metallic stents for VLST, and the underlying mechanisms of BVS VLST.
Patients with severe carotid-artery stenosis, who are at high risk for stroke, usually undergo endarterectomy. This clinical trial compared endarterectomy and carotid stenting with the use of a stent ...with an emboli-protection device in patients with severe carotid-artery stenosis. Stenting was found to be not inferior to endarterectomy with respect to clinical outcome. Therefore, the less invasive approach may be an acceptable alternative among patients with high-risk carotid-artery stenosis.
The less invasive approach may be an acceptable alternative among patients with high-risk carotid-artery stenosis.
Several trials have shown carotid endarterectomy to be superior to medical management for the prevention of stroke in patients with symptomatic or asymptomatic carotid-artery stenosis.
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The patients in the North American Symptomatic Carotid Endarterectomy Trial (NASCET) and those in the Asymptomatic Carotid Atherosclerosis Study (ACAS) were carefully selected and had low rates of surgical complications.
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Many patients for whom surgery poses a high risk, however, routinely undergo carotid endarterectomy in clinical practice and were excluded from these trials, and such patients have outcomes that are substantially worse than those reported in these trials.
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During the past decade, carotid . . .
Stroke occurs more commonly after carotid artery stenting than after carotid endarterectomy. Details regarding stroke type, severity, and characteristics have not been reported previously. We ...describe the strokes that have occurred in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST).
CREST is a randomized, open-allocation, controlled trial with blinded end-point adjudication. Stroke was a component of the primary composite outcome. Patients who received their assigned treatment within 30 days of randomization were included. Stroke was adjudicated by a panel of board-certified vascular neurologists with secondary central review of clinically obtained brain images. Stroke type, laterality, timing, and outcome were reported. A periprocedural stroke occurred among 81 of the 2502 patients randomized and among 69 of the 2272 in the present analysis. Strokes were predominantly minor (81%, n=56), ischemic (90%, n=62), in the anterior circulation (94%, n=65), and ipsilateral to the treated artery (88%, n=61). There were 7 hemorrhages, which occurred 3 to 21 days after the procedure, and 5 were fatal. Major stroke occurred in 13 (0.6%) of the 2272 patients. The estimated 4-year mortality after stroke was 21.1% compared with 11.6% for those without stroke. The adjusted risk of death at 4 years was higher after periprocedural stroke (hazard ratio, 2.78; 95% confidence interval, 1.63-4.76).
Stroke, particularly severe stroke, was uncommon after carotid intervention in CREST, but stroke was associated with significant morbidity and was independently associated with a nearly 3-fold increased future mortality. The delayed timing of major and hemorrhagic stroke after revascularization suggests that these strokes may be preventable.
Objectives
The Multi‐center Prospective Study to Evaluate Outcomes of Moderate to Severely Calcified Coronary Lesions (MACE—Trial) was designed to provide further insight on the impact of ...calcification on procedural and long‐term percutaneous coronary intervention outcomes.
Background
Prior studies evaluating the impact of lesion calcification on percutaneous coronary intervention outcomes are limited by: retrospective nature, pooled data from multiple studies, or lack of specificity around calcification with only operator assessment and without core lab evaluation.
Methods
The MACE‐Trial was a prospective, multicenter, observational clinical study that enrolled 350 subjects at 33 sites from September 2013 to September 2015. Core lab assessed subject stratification by lesion calcification (none/mild N = 133, moderate N = 99, and severe N = 114). Endpoints were lesion success, procedural success, and 1‐year major adverse cardiac events (MACEs).
Results
Presence of severe calcification had significant impact on lesion success (83.3% versus none/mild calcification 94.7%, P = 0.006) and procedural success (86.8% versus moderate 95.0%, P = 0.028, and none/mild 97.7%, P = 0.001). 1‐year MACE rates were associated with presence of calcification in subjects with none/mild (4.7%), moderate (8.7%), and severe (24.4%) (P < 0.001) calcification; however, no difference was noted between none/mild and moderate (P = 0.237). The risk adjusted multivariable model identified severe calcification and decreasing eGFR as predictors of 30‐day and 1‐year MACE.
Conclusions
In this prospective study, patients with severe calcification had significantly worse outcomes compared to those without; however, unlike previous retrospective studies, moderate calcium resulted in similar outcomes as none/mild calcium.
Clinical Trial Registration
URL: https://clinicaltrials.gov/ct2/show/NCT01930214. Unique Identifier: NCT01930214.
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