Procedural and clinical outcomes of patients undergoing a TAVI in TAVI procedure: Rationale and design of the multicentre, prospective, observational ReTAVI registry.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly being used in younger patients and those with lower peri-procedural risk, meaning more patients will live long enough to experience structural valve deterioration (SVD) of the bioprosthesis, indicating repeated TAVI. Experience of repeated TAVI-transcatheter heart valve (THV) implantation into an index THV is limited. This registry aims to assess the peri-procedural and short-term safety, efficacy and durability of repeated TAVI. METHODS: The ReTAVI Prospective observational registry is an investigator-initiated, multicentre, international, prospective registry of patients undergoing repeated TAVI using balloon-expandable SAPIEN prosthesis to evaluate procedural and short-term safety, efficacy and durability as well as anatomical and procedural factors associated with optimal results. The registry will enrol at least 150 patients across 60 high-volume centres. Patients must be ≥18 years old, have had procedural success with their first TAVI, have index THV device failure, intend to undergo repeated TAVI and be considered suitable candidates by their local Heart Team. All patients will undergo a 30-day and 12-month follow-up. The estimated study completion is 2025. CONCLUSIONS: The registry will collect pre-, peri-, postoperative and 12-months data on patients undergoing repeated TAVI procedures with THVs for failure of the index THV and determine VARC-3-defined efficacy and safety at 30 days and functional outcome at 12 months. The registry will expand existing data sets and identify patient characteristics/indicators related to complications and clinical benefits for patients with symptomatic severe calcific degenerative aortic stenosis.

Subclinical cognitive impairment in chronic kidney disease is associated with frailty and reduced quality of life.

BACKGROUND: Cognitive impairment (CI) in chronic kidney disease (CKD) is highly prevalent and is associated with multiple limitations to patients as well as a higher mortality, more days of hospitalisation and a lower quality of life. Frailty in CKD is associated with adverse health outcomes and is also highly prevalent. The aim of our study was to determine the prevalence and characteristics of CI and relate the findings to frailty, mobility, muscle strength and health-related quality of life (HRQOL). METHODS: Non-dialysis patients with CKD stages 3-5 were prospectively evaluated for inclusion. Excluded were patients with other cognitive disorders, signs of overt uraemic encephalopathy, severe infection and hyponatraemia. All patients underwent psychometric testing (five different tests): assessments of mobility, strength and frailty and an evaluation of HRQOL. Based on the number of pathological psychometric test results, we established two different definitions of CI: subclinical uraemic encephalopathy 1 (SUE1: one pathological test) and subclinical uraemic encephalopathy 2 (SUE2: two or more pathological test results). RESULTS: Sixty-two patients were included [median age 66 years (interquartile range 57-75), male 55%]. Most patients had CKD stage 3 (48%; stage 4: 32%; stage 5: 19%). CI was highly prevalent (SUE1: 60%; SUE2: 42%) and associated with a higher risk of falls (pathological tandem gait test; SUE1: 50% versus 16%, P = .023; SUE2: 69% versus 15%, P = .001), lower muscle strength (SUE2-pathological: 39% versus 7%, P = .008), frailty (SUE1: 59% versus 28%, P = .038; SUE2: 67% versus 33%, P = .028) and HRQOL. CONCLUSION: CI is highly prevalent in non-dialysis CKD patients. Even mild CI is associated with decreased mobility, muscle strength and HRQOL and increased frailty.

COVID-19 and acute kidney injury in German hospitals 2020.

INTRODUCTION: The SARS-CoV-2 pandemic is a major challenge for patients, healthcare professionals, and populations worldwide. While initial reporting focused mainly on lung involvement, the ongoing pandemic showed that multiple organs can be involved, and prognosis is largely influenced by multi-organ involvement. Our aim was to obtain nationwide retrospective population-based data on hospitalizations with COVID-19 and AKI in Germany. MATERIALS & METHODS: We performed a query of G-DRG data for the year 2020 via the Institute for the hospital remuneration system (Institut für das Entgeltsystem im Krankenhaus GmbH, InEK) data portal and therefore included hospitalizations with a secondary diagnosis of RT-PCR proven COVID-19 infection, aged over 15 years. We included hospitalizations with acute kidney injury (AKI) stages 1 to 3. Age-specific and age-standardized hospitalization and in-hospital mortality rates (ASR) per 100.000 person years were calculated, with the German population of 2011 as the standard. RESULTS: In 2020, there were 16.776.845 hospitalizations in German hospitals. We detected 154.170 hospitalizations with RT-PCR proven COVID-19 diagnosis. The age-standardized hospitalization rate for COVID-19 in Germany was 232,8 per 100.000 person years (95% CI 231,6-233,9). The highest proportion of hospitalizations associated with COVID-19 were in the age group over 80 years. AKI was diagnosed in 16.773 (10.9%) of the hospitalizations with COVID-19. The relative risk of AKI for males was 1,49 (95%CI 1,44-1,53) compared to females. Renal replacement therapy (RRT) was performed in 3.443 hospitalizations, 20.5% of the hospitalizations with AKI. For all hospitalizations with COVID-19, the in-hospital mortality amounted to 19.7% (n = 30.300). The relative risk for in-hospital mortality was 3,87 (95%CI 3,80-3,94) when AKI occurred. The age-standardized hospitalization rates for COVID-19 took a bimodal course during the observation period. The first peak occurred in April (ASR 23,95 per 100.000 person years (95%CI 23,58-24,33)), hospitalizations peaked again in November 2020 (72,82 per 100.000 person years (95%CI 72,17-73,48)). The standardized rate ratios (SRR) for AKI and AKI-related mortality with the overall ASR for COVID-19 hospitalizations in the denominator, decreased throughout the observation period and remained lower in autumn than they were in spring. In contrast to all COVID-19 hospitalizations, the SRR for overall mortality in COVID-19 hospitalizations diverged from hospitalizations with AKI in autumn 2020. DISCUSSION: Our study for the first time provides nationwide data on COVID-19 related hospitalizations and acute kidney injury in Germany in 2020. AKI was a relevant complication and associated with high mortality. We observed a less pronounced increase in the ASR for AKI-related mortality during autumn 2020. The proportion of AKI-related mortality in comparison to the overall mortality decreased throughout the course of the pandemic.

Risk of overanticoagulation during acute kidney injury in patients treated with vitamin K antagonists.

BACKGROUND: Vitamin K antagonists (VKAs) are still in use for oral anticoagulation, but not all indications allow their replacement by direct oral anticoagulants. Although formal dose reduction is not required in patients with impaired kidney function, case reports indicate that acute kidney injury (AKI) might be associated with derailment of VKA therapy. METHODS: The study retrospectively collected patients from a tertiary nephrology care centre who experienced AKI while being treated with VKA. In these individuals, the international normalized ratio (INR) as a measure of anticoagulant effect during renal failure was compared with a reference time point with stable kidney function. RESULTS: A total of 100 patients with AKI and ongoing VKA therapy met the inclusion criteria. The majority (76%) of patients had AKI with CKD. Volume depletion (n = 43), septic renal failure (n = 22), decompensated heart failure (n = 18) and toxic renal damage (n = 11) were the most important causes of AKI. The average INR values at the time of AKI were higher than at the reference time point [median 3.17 (range 1.10-13.0) versus 2.24 (1.07-5.17); P < 0.0001]. Fifty-four patients had INR values above the recommended therapeutic range for their indication at the time point of AKI. Bleeding complications occurred in 24 patients during AKI and the VKA dose had to be reduced in 55. Women, patients with low body mass index and patients with diabetes were predisposed to overanticoagulation during AKI. CONCLUSIONS: The effect of AKI on anticoagulation by VKA has not been systematically described. This risk should be considered in patients at high risk for AKI.

Systemic inflammation in acute cardiorenal syndrome: an observational pilot study.

AIMS: Acute cardiorenal syndrome (CRS) with and without consideration of the volume state was assessed with regard to inflammatory parameters. METHODS AND RESULTS: Blood samples from patients with acute CRS (Ronco type 1 or 3, Group 1, n = 15), end-stage renal disease (Group 2, n = 12), hypertension (Group 3, n = 15), and, in a second cohort, with acute CRS and hypervolemia (Group 4, n = 9) and hypertension (Group 5, n = 10) were analysed with regard to lipopolysaccharide-binding protein (LBP), interleukins (ILs), and monocyte function (flow cytometry) both on admission (all groups) and on discharge (Groups 1 and 4). By discharge, one Group 1 patient died. LBP (ANOVA for Groups 1-3: P = 0.001) and IL-6 (Kruskal-Wallis for Groups 1-3: P < 0.0001) were higher in Group 1 (LBP: 11.7 ± 2.0 µg/mL; IL-6: 15.0 ± 6.1 pg/mL) and in Group 2 (LBP: 10.4 ± 1.4 µg/mL; IL-6: 14.6 ± 3.8 pg/mL) than in Group 3 (LBP: 5.8 ± 0.4 µg/mL; IL-6: 1.8 ± 0.4 pg/mL). In a direct comparison, the proportion of activated monocytes (CD14 and CD16 positive) was higher in Group 1 (6.9% ± 0.7%) vs. Group 3 (5.1% ± 0.6%; P = 0.018). Group 4 patients had higher IL-6 plasma levels (34.2 ± 10.1 pg/mL) than Group 1 patients (15.0 ± 6.1 pg/mL; P = 0.03). All other findings obtained in CRS groups (Groups 1 and 4) were comparable. CONCLUSIONS: In acute CRS, a state of systemic inflammation was found, which is comparable with the end-stage renal disease situation. In comparison with hypertensive controls, a monocytic activation was found in acute CRS regardless of volume state.

Oliguric acute kidney injury as a main symptom of bradycardia and arteriosclerosis resolved by pacemaker implantation: a case report.

INTRODUCTION: Cardiovascular comorbidities regularly determine renal function. We report a case of acute kidney injury (Acute Kidney Injury Network stage 3) due to an intermittent third-degree atrioventricular block, which had not been diagnosed before. CASE PRESENTATION: A 76-year-old Caucasian man with liver cirrhosis due to non-alcoholic fatty liver disease, and type-2 diabetes was cognitively impaired and had reduced vigilance presumably caused by hepatic encephalopathy and/or Alzheimer dementia. Within 2 years, two hospitalizations occurred for syncope attributed to orthostatic failure and hypovolemia. During the last hospitalization, oliguric acute kidney injury occurred. Sonography ruled out a post-renal cause. His renal resistive index was 1.0; his heart rate was below 50 beats per minute. After cessation of beta-blocker therapy, Holter electrocardiogram showed a new intermittent third-degree atrioventricular block with pauses for less than 3 seconds. Pacemaker insertion resolved his acute kidney injury, despite resumption of beta-blocker therapy. During four months of follow-up, syncope has not occurred, and vigilance was stable. However, his renal resistive index of 1.0 remained. CONCLUSIONS: Here, typical neurologic symptoms of bradycardia were misclassified. Diagnostic work-up of oliguric acute kidney injury revealed intermittent third-degree heart block. The pathomechanism of acute kidney injury relates to relevant bradycardia and increased vascular stiffness attenuating arterial diastolic renal blood flow.