Background
A significant number of patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) suffer from extra‐aortic cardiac damage. Few studies have ...investigated strategies to quantify cardiac damage and stratify patients accordingly in different risk groups. The aim of this retrospective multicenter study was to provide a user‐friendly simplified staging system based on the proposed classification system of Généreux et al. as a tool to evaluate the prognosis of patients undergoing TAVR more easily. Moreover, we analyzed changes in cardiac damage after TAVR.
Methods
We assessed cardiac damage in patients, who underwent TAVR at the Heart Center Bonn or Düsseldorf, using pre‐ and postprocedural transthoracic echocardiography. Patients were assigned to the staging system proposed by Généreux et al. according to the severity of their baseline cardiac damage. Based on the established system, we created a simplified staging system to facilitate improved applicability. Finally, we compared clinical outcomes between the groups and evaluated changes in cardiac damage after TAVR.
Results
A total of 933 TAVR patients were included in the study. We found a significant association between cardiac damage and 1‐year all‐cause mortality (stage 0: 0% vs. stage 1: 3% vs. stage 2: 6.6%; p < 0.009). In multivariate analysis, cardiac damage was an independent predictor of 1‐year all‐cause mortality (hazard ratio: 2.0, 95% confidence interval: 1.1–3.8; p = 0.03).
Conclusions
In patients undergoing TAVR, cardiac damage is associated with enhanced mortality. A simplified staging system can help identify patients at high risk for an adverse outcome.
Summary
Background
Heart rate variability (HRV) is reduced in cirrhosis and in conditions of systemic inflammation. Whether HRV is associated with cirrhosis decompensation and development of ...acute‐on‐chronic liver failure (ACLF) is unknown.
Aims
To (a) validate wireless remote HRV monitoring in cirrhosis decompensation; (b) determine if severely reduced HRV is a surrogate for inflammation and progression of cirrhosis decompensation; (c) assess if measuring HRV determines prognosis in cirrhosis decompensation.
Methods
One hundred and eleven patients at risk of cirrhosis decompensation at two clinical sites were monitored for HRV. Standard deviation of all normal beat‐beat intervals (SDNN) reflecting HRV was assessed using remote monitoring (Isansys Lifetouch) and/or Holter ECG recording. Clinical outcomes and major prognostic scores were recorded during 90‐day follow‐up.
Results
Reduced HRV denoted by lower baseline SDNN, correlated with severity of decompensation (median 14 (IQR 11‐23) vs 33 (25‐42); P < 0.001, decompensated patients vs stable outpatient cirrhosis). Furthermore, SDNN was significantly lower in patients developing ACLF compared to those with only decompensation (median 10 (IQR9‐12) vs 16 (11‐24); P = 0.02), and correlated inversely with MELD and Child‐Pugh scores, and C‐reactive protein (all P < 0.0001) and white cell count (P < 0.001). SDNN predicted disease progression on repeat measures and appeared an independent predictor of 90‐day mortality (12 patients). An SDNN cut‐off of 13.25 ms had a 98% negative predictive value.
Conclusions
This study demonstrates that remote wireless HRV monitoring identifies cirrhosis patients at high risk of developing ACLF and death, and suggests such monitoring might guide the need for early intervention in such patients. Clinical Trial number: NIHR clinical research network CPMS ID 4949.
Aortic stenosis has pathophysiological similarities with atherosclerosis, including the deposition of cholesterol-containing lipoproteins. The resulting cholesterol crystals activate the NLRP3 ...(NOD-like receptor protein 3) inflammasome, leading to inflammation and cardiovascular diseases. We aimed to investigate the cholesterol crystal dissolution rate (CCDR) of serum in patients with aortic stenosis and to assess the prognostic value of this biomarker.
The study included 348 patients with aortic stenosis undergoing transcatheter aortic valve replacement. The CCDR was measured using flow cytometry to enumerate cholesterol crystals that were added to a serum solution, at baseline and after 2 hours of incubation. Based on the median CCDR, the cohort was stratified into high and low cholesterol crystal dissolvers. The incidence of the primary end point, a composite of 1-year all-cause mortality and major vascular complication, was significantly lower in the high CCDR group (7.3 per 100 person-years) compared with the low CCDR group (17.0 per 100 person-years,
=0.01). This was mainly driven by a lower 1-year mortality rate in patients with a high CCDR (7.3 versus 15.1 per 100 person-years,
=0.04). Unplanned endovascular interventions were significantly less frequent in high cholesterol crystal dissolvers (12.8 versus 22.6 per 100 person-years,
=0.04). Although low-density lipoprotein cholesterol levels were comparable in both groups (101.8±37.3 mg/dL versus 97.9±37.6 mg/dL,
=0.35), only patients with a low CCDR showed a benefit from statin treatment. In multivariate analysis, low CCDR (hazard ratio, 2.21 95% CI, 0.99-4.92,
=0.04) was significantly associated with 1-year mortality.
The CCDR is a novel biomarker associated with outcome in patients with aortic stenosis undergoing transcatheter aortic valve replacement. It may provide new insights into patients' anti-inflammatory capacity and additional prognostic information beyond classic risk assessment.
Background
Frailty is a multidimensional syndrome that affects mortality after aortic valve replacement (AVR). Malnutrition is often associated with the development of frailty. However, data ...regarding the association of frailty with nutritional status and underlying endocrinological dysregulation in patients with severe aortic valve stenosis are limited.
Objectives
We aimed to systematically screen for frailty and malnutrition, to evaluate for underlying endocrinological disorders and inflammation, and to assess the ability of these parameters to predict outcomes after AVR.
Methods
Our study included 373 patients undergoing transcatheter and surgical AVR. Frailty was assessed using the Fried Frailty Phenotype (FFP), Essential Frailty Toolset, Lawton‐Brody, and Katz Index. Malnutrition was measured using the Mini Nutritional Assessment (MNA‐LF) and Controlling Nutritional Status. Outcomes of interest were 30‐day and one‐year mortality.
Results
The prevalence of frailty ranged from 6.4% to 65.7% and malnutrition from 5.9% to 10.5%, depending on the evaluation tool. Both parameters were associated with higher levels of cortisol and parathormone as well as lower levels of IGF‐1, testosterone, DHEAS, and c‐reactive protein. Malnutrition was associated with increased 30‐day mortality, and both frailty and malnutrition with increased one‐year mortality. In a multivariate analysis, malnutrition measured by the MNA‐LF (OR: 2.32 95%CI: 1.19–4.53, p = 0.01) and frailty as assessed by the FFP (OR: 1.42 95%CI: 1.02–1.96, p = 0.03) were independent predictors of one‐year mortality.
Conclusion
The prevalence of frailty and malnutrition varies significantly depending on the assessment tool. Both syndromes share common endocrinological alterations. Frailty and malnutrition are independent risk factors for mortality after AVR.
In this prospective observational study, we investigated the impact of geriatric syndromes and frailty on mortality and evaluated the prognostic value of different frailty, nutritional, and geriatric ...assessment tools in high-risk patients with severe mitral valve regurgitation (MR) who were evaluated for mitral valve therapies including surgical, interventional, and conservative treatment options. We prospectively assessed multiple parameters including the CONUT Score, the Katz Index of independence in activities of daily living (ADL), the Fried Frailty Phenotype (FFP), and the Essential Frailty Toolset (EFT) Score in 127 patients with severe symptomatic MR requiring surgical/interventional treatment versus conservative monitoring. We compared their predictive value on mortality including multivariate regression analysis to identify the most suitable tool to predict outcomes in these patient groups. The frailty syndrome as assessed with the CONUT Score, Katz Index, EFT Score, and FFP was associated with higher rates of comorbidities, significantly higher risk scores such as logistic EuroSCORE, EuroSCORE II, and STS-PROM, and significantly higher mortality rates. The EFT Score and FFP were independent predictors of one-year all-cause mortality in our study cohort (EFT Score: HR 1.9, 95% CI 1.2 to 3.2;
p
= 0.01; FFP: HR 1.8, 95% CI 1.1 to 3.1;
p
= 0.015). Geriatric syndromes and frailty are associated with increased mortality in high-risk patients with symptomatic severe MR. The EFT Score and the FFP were independent predictors of one-year all-cause mortality.
Endoluminal left atrial appendage occlusion is an emerging therapy to treat patients suffering from atrial fibrillation with contraindications against oral anticoagulation. Different occlusion ...devices have been introduced into the clinical setting while comparative studies between the devices are sparse. This in vitro study compares several endoluminal left atrial appendage occlusion systems regarding 2 mechanical properties: radial (RF) and tug force (TF). Seven different occluder systems of various sizes (24 in total) underwent testing throughout their recommended sizing range. RF was measured in a commercial RF tester. TF was assessed according to a recently published bench test. RF increased with compression of the devices: The LAmbre 2228 device exerted the highest RF (8.6 N) at maximum compression of 16 mm. The lowest RF of 0.1 N was exhibited by the 27 mm Occlutech occluder at minimal compression. The highest TFs were exerted by the WaveCrest devices at maximum compression with 4.6 and 3.6 N for the 22 mm and the 27 mm device, respectively. The lowest TFs were measured for the first‐generation Occlutech devices, particularly for the 24 mm device with 1.1 N at maximum compression and 0.4 N at minimum compression. A strong positive correlation was found between the number of hooks per millimeter circumference of an occluder and its tug force (r = 0.87, P < 0.01). The analysis revealed device stability to be more dependent on anchoring structures than on RF. The wide range of mechanical properties makes comparison of current LAA occluders difficult and emphasizes the need for standardized preclinical testing to prompt clinical compatibility.
Background
Malnutrition is a hallmark of frailty, is common among elderly patients, and is a predictor of poor outcomes in patients with severe symptomatic aortic stenosis (AS). The Geriatric ...Nutritional Risk Index (GNRI) is a simple and well‐established screening tool to predict the risk of morbidity and mortality in elderly patients. In this study, we evaluated whether GNRI may be used in the risk stratification and management of patients undergoing transcatheter aortic valve replacement (TAVR).
Methods
Patients with symptomatic severe AS (n = 953) who underwent transfemoral TAVR at the University Hospital Schleswig‐Holstein Kiel, Germany, between 2010 and 2019 (development cohort) were divided into two groups: normal GNRI ≥ 98 (no nutrition‐related risk; n = 618) versus low GNRI < 98 (at nutrition‐related risk; n = 335). The results were validated in an independent (validation) cohort from another high‐volume TAVR centre (n = 977).
Results
The low‐GNRI group had a higher proportion of female patients (59.1% vs. 52.1%), higher median age (82.9 vs. 81.8 years), prevalence of atrial fibrillation (50.4% vs. 40.0%), median logistic EuroSCORE (17.5% vs. 15.0%) and impaired left ventricular function (<35%: 10.7% vs. 6.8%), lower median estimated glomerular filtration rate (50 vs. 57 mL/min/1.73 m2) and median albumin level (3.5 vs. 4.0 g/dL) compared with the normal‐GNRI group. Among peri‐procedural complications, Acute Kidney Injury Network (AKIN) Stage 3 was more common in the low‐GNRI group (3.6% vs. 0.6%, p = 0.002). After a mean follow‐up of 21.1 months, all‐cause mortality was significantly increased in the low‐GNRI group compared with the normal‐GNRI group (p < 0.001). This was confirmed in the validation cohort (p < 0.001). Low GNRI < 98 was identified as an independent risk factor for all‐cause mortality (hazard ratio 1.44, 95% CI 1.01–2.04, p = 0.043). Other independent risk factors included albumin level < median of 4.0 g/dL, high‐sensitive troponin T in the highest quartile (> 45.0 pg/mL), N‐terminal pro‐B‐type natriuretic peptide in the highest quartile (> 3595 pg/mL), grade III–IV tricuspid regurgitation, pulmonary arterial hypertension, life‐threatening bleeding, AKIN Stage 3 and disabling stroke.
Conclusions
Low GNRI score was associated with an increased risk of all‐cause mortality in patients undergoing TAVR, implying that this vulnerable group may benefit from improved preventive measures.
Objective
To investigate the rate and clinical impact of a persisting iatrogenic atrial septal defect (iASD) after percutaneous left atrial appendage occlusion (LAAO).
Background
Percutaneous LAAO is ...an alternative to oral anticoagulation (OAC) for the prevention of ischemic stroke and systemic embolism in patients with atrial fibrillation (AF). Data regarding incidence and persistence of iASD after LAAO procedures and its clinical relevance is scarce.
Methods
We retrospectively analyzed 144 patients that underwent LAAO at our center between 2009 and 2020 who had at least one follow‐up including transesophageal echocardiography (TEE). Baseline clinical, procedural data and echocardiographic characteristics in patients with and without evidence of an iASD were compared. We furthermore determined the rate of iASD persistence over time and evaluated outcomes of patients with and without spontaneous iASD closure.
Results
After a median of 92 days (IQR 75–108 days) after LAAO, 50 patients (50/144, 34.7%) showed evidence of an iASD. Patients with iASD had higher CHADS‐VASc‐scores (4.9±1.5 vs 4.2±1.2, p = 0.03), larger left atrial volumes (80.5±30.5 ml vs 67.1±19.7 ml, p = 0.01) and were more likely to have relevant mitral regurgitation (≥° II) (46.0% vs 12.3%, p = 0.001). LAAO procedures took longer (50.1±24.3 vs 41.1±17.8 min, p = 0.06) in patients with a persisting iASD. Furthermore, larger device sizes were implanted (24.3±3.4 mm vs 22.1±2.8 mm, p = 0.03). The presence of an iASD had no impact on RV dysfunction, thromboembolism or mortality. Spontaneous closure of an iASD was documented in 52.0% (26/50). Hereby, similar risk factors were identified for the persistence of an iASD in follow‐up.
The left axillary artery is an attractive alternative access route for transcatheter aortic valve replacement (TAVR) and may provide better outcomes compared to other alternatives. Nevertheless, ...there remain concerns about vascular complications, lack of compressibility, and thorax-related complications. Between March 2019 and March 2021, 13 patients underwent transaxillary TAVR for severe aortic stenosis at the University Hospital Bonn. The puncture was performed with a puncture at the distal segment of the axillary artery through the axilla, with additional femoral access for applying a safety wire inside the axillary artery. Device success was defined according to the VARC 2 criteria. The study participants were advanced in age (77 ± 9 years old), and 54% were female, with an intermediate risk for surgery (STS risk score 4.7 ± 2.0%). The average diameter of the distal segment of the axillary artery was 5.8 ± 1.0 mm (i.e., the puncture site) and 7.6 ± 0.9 mm for the proximal axillary artery. Device success was achieved in all patients. 30-day major adverse cardiac and cerebrovascular events were 0%. With complete percutaneous management, stent-graft implantation was performed at the puncture site in 38.5% of patients. Minor bleeding was successfully managed with manual compression. Moreover, no thorax-related complications, hematomas, or nerve injuries were observed. Percutaneous trans-axilla TAVR was found to be feasible and safe. This modified approach may mitigate the risk of bleeding and serious complications in the thorax and be less invasive than surgical alternatives.
Background
Despite major advances, transcatheter aortic valve replacement (TAVR) is still associated with procedure‐specific complications. Although previous studies reported lower bleeding rates in ...patients receiving protamine for heparin reversal, the optimal protamine‐to‐heparin dosing ratio is unknown.
Hypothesis
The aim of this study was a comparison of two different heparin antagonization regimens for the prevention of bleeding complications after TAVR.
Methods
The study included 1446 patients undergoing TAVR, of whom 623 received partial and 823 full heparin antagonization. The primary endpoint was a composite of 30‐day mortality, life‐threatening, and major bleeding. Safety endpoints included stroke and myocardial infarction at 30 days.
Results
Full antagonization of heparin resulted in lower rates of the primary endpoint as compared to partial heparin reversal (5.6% vs. 10.4%, p < .01), which was mainly driven by lower rates of life‐threatening (0.5% vs. 1.6%, p = .05) and major bleeding (3.2% vs. 7.5%, p < .01). Moreover, the incidence of major vascular complications was significantly lower in patients with full heparin reversal (3.5% vs. 7.5%, p < .01). The need for red‐blood‐cell transfusion was lower in patients receiving full as compared to partial heparin antagonization (10.4% vs. 15.9%, p < .01). No differences were observed in the incidence of stroke and myocardial infarction between patients with full and partial heparin reversal (2.2% vs. 2.6%, p = .73 and 0.2% vs. 0.4%, p = .64, respectively).
Conclusions
Full heparin antagonization resulted in significantly lower rates of life‐threatening and major bleeding after TAVR as compared to partial heparin reversal. The occurrence of stroke and myocardial infarction was low and comparable between both groups.
Optimal protamine‐to‐heparin dosing ratio for the prevention of bleeding complications after TAVR. Full antagonization of heparin was associated with a reduction of life‐threatening bleeding by 69% and major bleedings by 57%, compared to patients with partial heparin reversal. Whereas partial antagonization of heparin was associated with a relative increase of the post‐interventional drop in hemoglobin by 13% and red blood cell transfusion by 53%, as compared to full heparin antagonization. life‐threat., life‐threatening; RBC, red blood cell; TAVR, transcatheter aortic valve replacement.
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