Transcatheter aortic valve replacement: impact of pre-procedural FEops HEARTguide assessment on device size selection in borderline annulus size cases.

OBJECTIVES: The aim of this study is to evaluate device size selection in patients within the borderline annulus size range undergoing transcatheter aortic valve replacement (TAVR) and to assess if pre-procedural patient-specific computer simulation will lead to the selection of a different device size than standard of care. BACKGROUND: In TAVR, appropriate device sizing is imperative. In borderline annulus size cases no standardised technique for tailored device size selection is currently available. Pre-procedural patient-specific computer simulation can be used, predicting the risk for paravalvular leakage (PVL) and need for permanent pacemaker implantation (PPI). METHODS: In this multicentre retrospective study, 140 patients in the borderline annulus size range were included. Hereafter, device size selection was left to the discretion of the operator. After TAVR, in 24 of the 140 patients, patient-specific computer simulation calculated the most appropriate device size expected to give the lowest risk for PVL and need for PPI. In these 24 patients, device size selection based on patient-specific computer simulation was compared with standard-of-care device size selection relying on a standardised matrix (Medtronic). RESULTS: In a significant proportion of the 140 patients (26.4%) a different device size than recommended by the matrix was implanted. In 10 of the 24 patients (41.7%) in whom a computer simulation was performed, a different device size was recommended than by means of the matrix. CONCLUSIONS: Device size selection in patients within the borderline annulus size range is still ambiguous. In these patients, patient-specific computer simulation is feasible and can contribute to a more tailored device size selection.

Assessment of the MANTA closure device in transfemoral transcatheter aortic valve replacement: a single-centre observational study.

OBJECTIVES: The present study aims to evaluate the efficacy and safety of the MANTA vascular closure device (VCD) (Teleflex, Morrisville, NC, USA) in transfemoral transcatheter aortic valve replacement (TF-TAVR). BACKGROUND: To close the femoral artery in TF-TAVR a VCD is the treatment of choice. Data involving suture-based VCDs have been extensive. Although scarce, results on the MANTA device are promising. There is no consensus yet as to whether the MANTA device is associated with fewer access-site-related vascular/bleeding complications when compared to suture-based VCDs. METHODS: In this prospective single-arm study, performed at a single centre, a total of 73 patients eligible for TF-TAVR were included and consecutively treated with the MANTA device. RESULTS: Access-site-related vascular complications were seen in 13.7% of patients treated with the MANTA device. In this group of patients only minor vascular complications were observed. Access-site-related bleeding complications were rare (6.8%), and device failure was seen in 13.7% of the patients. CONCLUSIONS: This single-centre study confirms that use of the MANTA device in TF-TAVR is feasible with an acceptable rate of access-site-related complications and no major vascular complications.

Determining clinically important differences in health-related quality of life in older patients with cancer undergoing chemotherapy or surgery.

PURPOSE: Using the EORTC Global Health Status (GHS) scale, we aimed to determine minimal clinically important differences (MCID) in health-related quality of life (HRQOL) changes for older cancer patients with a geriatric risk profile, as defined by the geriatric 8 (G8) health screening tool, undergoing treatment. Simultaneously, we assessed baseline patient characteristics prognostic for HRQOL changes. METHODS: Our analysis included 1424 (G8 ≤ 14) older patients with cancer scheduled to receive chemotherapy (n = 683) or surgery (n = 741). Anchor-based methods, linking the GHS score to clinical indicators, were used to determine MCID between baseline and follow-up at 3 months. A threshold of 0.2 standard deviation (SD) was used to exclude MCID estimates too small for interpretation. Logistic regressions analysed baseline patient characteristics prognostic for HRQOL changes. RESULTS: The 15-item Geriatric Depression Scale (GDS15), Visual Analogue Scale (VAS) for Fatigue and ECOG Performance Status (PS) were selected as clinical anchors. In the surgery group, MCID estimates for improvement and deterioration were ECOG PS (5*, 11*), GDS15 (5*, 2) and VAS Fatigue (3, 9*). In the chemotherapy group, MCID estimates for improvement and deterioration were ECOG PS (8*, 7*), GDS15 (5, 4) and VAS Fatigue (5, 5*). Estimates with * were > 0.2 SD threshold. Patients experiencing pain or malnutrition (surgery group) or fatigue (chemotherapy group) at baseline showed a significantly stable or improved HRQOL (p < 0.05) after their treatment. CONCLUSION: The reported MCID for improvement and deterioration depended on the anchor used and treatment received. The estimates can be used to evaluate significant changes in HRQOL and to determine sample sizes in clinical trials.

Adherence to geriatric assessment-based recommendations in older patients with cancer: a multicenter prospective cohort study in Belgium.

Background: In the general older population, geriatric assessment (GA)-guided treatment plans can improve overall survival, quality of life and functional status (FS). In GA-related research in geriatric oncology, studies mainly focused on geriatric screening and GA but not on geriatric recommendations, interventions and follow-up. The aim of this study was to investigate the adherence to geriatric recommendations and subsequent actions undertaken in older patients with cancer. Patient and methods: A prospective Belgian multicenter (N = 22) cohort study included patients ≥70 years with a malignant tumor upon oncologic treatment decision. Patients with an abnormal result on the geriatric screening (G8 ≤14/17) underwent GA. Geriatric recommendations were formulated based on GA results. At follow-up the adherence to geriatric recommendations was documented including a description of actions undertaken. Results: From November 2012 till February 2015, G8 screening was carried out in 8451 patients, of which 5838 patients had an abnormal result. Geriatric recommendations data were available for 5631 patients. Geriatric recommendations were made for 4459 patients. Geriatric interventions data were available for 4167 patients. A total of 12 384 geriatric recommendations were made. At least one different geriatric recommendation was implemented in 2874 patients. A dietician, social worker and geriatrician intervened most frequently for problems detected on the nutritional, social and functional domain. A total of 7569 actions were undertaken for a total of 5725 geriatric interventions, most frequently nutritional support and supplements, extended home care and psychological support. Conclusions: This large-scale Belgian study focuses on the adherence to geriatric recommendations and subsequent actions undertaken and contributes to the optimal management of older patients with cancer. We identified the domains for which geriatric recommendations are most frequently made and adhered to, and which referrals to other health care workers and facilities are frequently applied in the multidisciplinary approach of older patients with cancer.

Efficacy of salpingectomy at hysterectomy to reduce the risk of epithelial ovarian cancer: a systematic review.

BACKGROUND: It has been argued that salpingectomy would reduce the risk of epithelial ovarian cancer (EOC), based on the theory of the tube being the site of origin. OBJECTIVES: To conduct a systematic review of 'salpingectomy' associated with ovarian cancer risk and 'salpingectomy with concomitant hysterectomy' on outcomes of complications including endocrine function. SEARCH STRATEGY: A comprehensive search was conducted in PubMed, Embase, and the Cochrane library. SELECTION CRITERIA: Original studies and systematic reviews were eligible. DATA COLLECTION AND ANALYSIS: Each article was quality assessed. Data were extracted and, when possible, pooled in meta-analyses. The certainty of evidence across studies was evaluated using GRADE. MAIN RESULTS: Of 844 articles found, 11 were included. No study evaluated risk reduction for EOC after salpingectomy in conjunction with hysterectomy. Two retrospective studies reported a reduced ovarian cancer risk after indicated salpingectomy, compared with no surgery: adjusted hazard ratio 0.65 (95% confidence interval, 95% CI 0.52-0.81) and adjusted odds ratio 0.58 (95% CI 0.36-0.95). Complications did not differ between groups with or without salpingectomy, but were non-systematically reported. Ovarian endocrine function, measured with surrogate outcomes, did not differ at short-term follow-up in randomised or observational studies. The certainty of evidence was very low or low for all outcomes. CONCLUSIONS: There is currently insufficient evidence to state that opportunistic salpingectomy reduces the risk of EOC. The impact on long-term endocrine function is unknown. The heterogeneity in results and identified knowledge gaps stress the need for a prospective trial. TWEETABLE ABSTRACT: Insufficient evidence for prophylactic removal of the fallopian tubes for risk reduction of ovarian cancer.

Serial comprehensive geriatric assessment in elderly head and neck cancer patients undergoing curative radiotherapy identifies evolution of multidimensional health problems and is indicative of quality of life.

Head and neck (H&N) cancer is mainly a cancer of the elderly; however, the implementation of comprehensive geriatric assessment (CGA) to quantify functional age in these patients has not yet been studied. We evaluated the diagnostic performance of screening tools [Vulnerable Elders Survey-13 (VES-13), G8 and the Combined Screening Tool 'VES-13 + (17-G8)' or CST], the feasibility of serial CGA, and correlations with health-related quality of life evolution [HRQOL; European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ)-C30 and -HN35] during therapy in hundred patients, aged ≥65 years, with primary H&N cancer undergoing curative radio(chemo)therapy. Respectively 36.8%, 69.0%, 62.1% and 71.3% were defined vulnerable according to VES-13, G8, CST and CGA at week 0, mostly due to presence of severe grade co-morbidities, difficulties in community functioning and nutritional problems. At week 4, significantly more patients were identified vulnerable due to nutritional, functional and emotional deterioration. The CST did not achieve the predefined proportion necessary for validation. Vulnerable patients reported lower function and higher symptom HRQOL scores as compared with fit patients. A comparable deterioration in HRQOL was observed in both groups through therapy. In conclusion, G8 remains the screening tool of choice. Serial CGA identifies the evolution of multidimensional health problems and HRQOL conditions during therapy with potential to guide individualised supportive care.