Objectives: Patients undergoing surgery for severe aortic stenosis (SAS) can be treated with either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). The choice of procedure depends on several factors, including the clinical judgement of the heart team and patient preferences, which are captured by actively informing and involving patients in a process of shared decision making (SDM). We synthesised the most up-to-date and accessible evidence on the benefits and risks that may be associated with TAVI versus SAVR to support SDM in this highly personalised decision-making process. Design: Systematic review and meta-analysis. Data sources: MEDLINE (Ovid), Embase (Ovid) and the Cochrane Central Register of Controlled Trials (CENTRAL; Wiley) were searched from January 2000 to August 2020 with no language restrictions. Reference lists of included studies were searched to identify additional studies. Eligibility criteria: Randomised controlled trials (RCTs) that compared TAVI versus SAVR in patients with SAS and reported on all-cause or cardiovascular mortality, length of stay in intensive care unit or hospital, valve durability, rehospitalisation/reintervention, stroke (any stroke or major/disabling stroke), myocardial infarction, major vascular complications, major bleeding, permanent pacemaker (PPM) implantation, new-onset or worsening atrial fibrillation (NOW-AF), endocarditis, acute kidney injury (AKI), recovery time or pain were included. Data extraction and synthesis: Two independent reviewers were involved in data extraction and risk of bias (ROB) assessment using the Cochrane tool (one reviewer extracted/assessed the data, and the second reviewer checked it). Dichotomous data were pooled using the Mantel-Haenszel method with random-effects to generate a risk ratio (RR) with 95% CI. Continuous data were pooled using the inverse-variance method with random-effects and expressed as a mean difference (MD) with 95% CI. Heterogeneity was assessed using the I ² statistic. Results: 8969 records were retrieved and nine RCTs (61 records) were ultimately included (n=8818 participants). Two RCTs recruited high-risk patients, two RCTs recruited intermediate-risk patients, two RCTs recruited low-risk patients, one RCT recruited high-risk (≥70 years) or any-risk (≥80 years) patients; and two RCTs recruited all-risk or ‘operable’ patients. While there was no overall change in the risk of dying from any cause (30 day: RR 0.89, 95% CI 0.65 to 1.22; ≤1 year: RR 0.90, 95% CI 0.79 to 1.03; 5 years: RR 1.09, 95% CI 0.98 to 1.22), cardiovascular mortality (30 day: RR 1.03, 95% CI 0.77 to 1.39; ≤1 year: RR 0.90, 95% CI 0.76 to 1.06; 2 years: RR 0.96, 95% CI 0.83 to 1.12), or any type of stroke (30 day: RR 0.83, 95% CI 0.61 to 1.14;≤1 year: RR 0.94, 95% CI 0.72 to 1.23; 5 years: RR 1.07, 95% CI 0.88 to 1.30), the risk of several clinical outcomes was significantly decreased (major bleeding, AKI, NOW-AF) or significantly increased (major vascular complications, PPM implantation) for TAVI vs SAVR. TAVI was associated with a significantly shorter hospital stay vs SAVR (MD −3.08 days, 95% CI −4.86 to −1.29; 4 RCTs, n=2758 participants). Subgroup analysis generally favoured TAVI patients receiving implantation via the transfemoral (TF) route (vs non-TF); receiving a balloon-expandable (vs self-expanding) valve; and those at low-intermediate risk (vs high risk). All RCTs were rated at high ROB, predominantly due to lack of blinding and selective reporting. Conclusions: No overall change in the risk of death from any cause or cardiovascular mortality was identified but 95% CIs were often wide, indicating uncertainty. TAVI may reduce the risk of certain side effects while SAVR may reduce the risk of others. Most long-term (5-year) results are limited to older patients at high surgical risk (ie, early trials), therefore more data are required for low risk populations. Ultimately, neither surgical technique was considered dominant, and these results suggest that every patient with SAS should be individually engaged in SDM to make evidence-based, personalised decisions around their care based on the various benefits and risks associated with each treatment. PROSPERO registration number: CRD42019138171.

Background: Motor and cognitive deficits and consequently mobility problems are common in geriatric patients. The currently available methods for diagnosis and for the evaluation of treatment in this vulnerable cohort are limited. The aims of the ComOn (COgnitive and Motor interactions in the Older populatioN) study are (i) to define quantitative markers with clinical relevance for motor and cognitive deficits, (ii) to investigate the interaction between both motor and cognitive deficits and (iii) to assess health status as well as treatment outcome of 1000 geriatric inpatients in hospitals of Kiel (Germany), Brescia (Italy), Porto (Portugal), Curitiba (Brazil) and Bochum (Germany). Methods: This is a prospective, explorative observational multi-center study. In addition to the comprehensive geriatric assessment, quantitative measures of reduced mobility and motor and cognitive deficits are performed before and after a two week’s inpatient stay. Components of the assessment are mobile technology-based assessments of gait, balance and transfer performance, neuropsychological tests, frailty, sarcopenia, autonomic dysfunction and sensation, and questionnaires to assess behavioral deficits, activities of daily living, quality of life, fear of falling and dysphagia. Structural MRI and an unsupervised 24/7 home assessment of mobility are performed in a subgroup of participants. The study will also investigate the minimal clinically relevant change of the investigated parameters. Discussion: This study will help form a better understanding of symptoms and their complex interactions and treatment effects in a large geriatric cohort.

The study was approved by the institutional review board (IRB) at the University Medical Center Campus Kiel, Kiel, Germany (reference number: AZ D 559/18) and registered at the German Clinical Trials Register (reference number: DRKS00022222). Objective. Unilateral pulmonary edema (UPE) is a complication after minimally invasive mitral valve surgery (MIMVS). We analyzed the impact of this complication on the short- and long-term outcome over a 10-year period. Methods. We retrospectively observed 393 MIMVS patients between 01/2009 and 12/2019. The primary endpoint was a radiographically and clinically defined UPE within the first postoperative 24 h, secondary endpoints were 30-day and long-term mortality and the percentage of patients requiring ECLS. Risk factors for UPE incidence were evaluated by logistic regression, and risk factors for mortality in the follow-up period were assessed by Cox regression. Results. Median EuroSCORE II reached 0.98% in the complete MIMVS group. Combined 30-day and in-hospital mortality after MIMVS was 2.0% with a 95, 93 and 77% survival rate after 1, 3 and 10 years. Seventy-two (18.3%) of 393 patients developed a UPE 24 h after surgery. Six patients (8.3%) with UPE required an extracorporeal life-support system. Logistic regression analysis identified a higher creatinine level, a worse LV function, pulmonary hypertension, intraoperative transfusion and a longer aortic clamp time as predictors for UPE. Combined in hospital mortality and 30-day mortality was slightly but not significantly higher in the UPE group (4.2 vs. 1.6%; p = 0.17). Predictors for mortality during follow-up were age ≥ 70 years, impaired RVF, COPD, drainage loss ≥ 800 mL and length of ventilation ≥ 48 h. During a median follow-up of 4.6 years, comparable survival between UPE and non-UPE patients was seen in our analysis after 5 years (89 vs. 88%; p = 0.98). Conclusions. In-hospital outcome with UPE after MIMVS was not significantly worse compared to non-UPE patients, and no differences were observed in the long-term follow-up. However, prolonged aortic clamp time, worse renal and left ventricular function, pulmonary hypertension and transfusion are associated with UPE.

Background: Active infective endocarditis (IE) is a serious disease associated with high mortality. The current study represents our experience over 18 years with surgical treatment for active infective native and prosthetic valve endocarditis (INVE, IPVE). Method: Analysis of 413 patients (171 with IPVE vs. 242 with INVE) who underwent cardiac surgery due to IE between 2002 and 2020. Results: Patients with IPVE were significantly older (64.9 ± 13.2 years vs. 58.3 ± 15.5 years; p < 0.001) with higher EuroSCORE II (21.2 (12.7; 41.8) vs. 6.9 (3.0; 17.0); p < 0.001)) and coronary heart disease (50.6% vs. 38.0%; p < 0.011). Preoperative embolization was significantly higher within INVE (35.5% vs. 16.4%; p < 0.001) with high incidence of cerebral embolization (18.6% vs. 7.6%; p = 0.001) and underwent emergency curative surgery than the IPVE group (19.6% vs. 10.6%; p < 0.001). However, patients with IPVE were significantly represented with intracardiac abscess (44.4% vs.15.7%; p < 0.001). Intraoperatively, the duration of surgery was expectedly significantly higher in the IPVE group (356 min vs. 244 min.; p = 0.001) as well as transfusion of blood (4 units (0–27) vs. 2 units (0–14); p < 0.001). Post-operatively, the incidence of bleeding was markedly higher within the IPVE group (700 mL (438; 1163) vs. 500 mL (250; 1075); p = 0.005). IPVE required significantly more permanent pacemakers (17.6% vs. 7.5%: p = 0.002). The 30-day mortality was higher in the IPVE group (24.6% vs. 13.2%; p < 0.003). Conclusion: Patients with INVE suffered from a higher incidence of cerebral embolization and neurological deficits than patients with IPVE. Surgical treatment in INVE is performed mostly as an emergency indication. However, patients with IPVE were represented commonly with intracardiac abscess, and had a higher indication of pacemaker implantation. The short- and long-term mortality rate among those patients was still high.

(1) Background: Surgery for infective endocarditis (IE) is associated with considerable mortality and it is controversial whether the female gender is predictive for a worse outcome. This large single-center study investigated the impact of sex on outcomes after surgery for IE. (2) Methods: 413 patients (25.4% female) were included into this retrospective observational study. Univariate and multivariable analyses identified sex-specific risk factors for 30 day and late mortality. Survival was estimated by the Kaplan-Meier-method. (3) Results: Women presented more often with mitral valve infection (p = 0.039). Men presented more frequently with previous endocarditis (p = 0.045), coronary heart disease (p = 0.033), and aortic valve infection (p = 0.005). Blood transfusion occurred more frequently intraoperatively in women (p < 0.001), but postoperatively in men (p = 0.015) and men had a longer postoperative stay (p = 0.046). Women showed a higher 30 day mortality than men (p = 0.007) and female gender was predictive for 30 day mortality (OR 2.090). Late survival showed no sex-specific difference (p = 0.853), and the female gender was not an independent predictor for late mortality (p = 0.718). Risk factors for early and late mortality showed distinct sex-specific differences such as increased preoperative CRP level in women and culture-negative IE in men.