What is the safety and efficacy of the use of automated fastener in heart valve surgery?

INTRODUCTION: Cor-Knot automated fastener has been used as an adjunct in heart valve surgery to eliminate the need for manual tying during valve implantation. Although reduced operative time and facilitation for minimally invasive surgery are clear benefits, whether their use translates to improved patient outcome remains debatable. This study aims to review the safety and efficacy of automated fasteners in heart valve surgeries. METHOD: Specific searches were conducted via online medical databases (Pubmed, Embase, Ovid) between 1950 and June 2019. Longitudinal studies were included that provided operative parameters. RESULTS: The initial literature search identified 3773 articles, but only eight met the inclusion criteria and were used for analysis: four studies related to aortic valve replacement (AVR), four related to mitral valve (MV) intervention (total n = 810). The meta-analysis revealed the significantly shorter aortic cross-clamp time in the Cor-knot group compared to manual tying, both in AVR and MV surgeries (P < .05). Cardiopulmonary bypass time was significantly shorter in the Cor-knot group when analyzing studies in MV surgery (weighted mean difference [WMD]: 110.0; 95% confidence interval: 12.3-207.7; P = .027) The use of Cor-Knot did not increase the risk of permanent pacemaker implantation, paravalvular leak, and 30-day mortality. The majority of studies reported no change in the length of intensive unit care and total hospital stay. CONCLUSION: We confirmed that the majority of existing literatures indicated the safety and intraoperative efficacy with automated fastener application. Nevertheless, there is currently no evidence to support automated fastened sutures can translate its intraoperative advantages to improved patient outcome.

The Accuracy of Continuous Glucose Sensors in People with Diabetes Undergoing Hemodialysis (ALPHA Study).

Objectives: Real-time and intermittently scanned continuous glucose monitoring are increasingly used for glucose monitoring in people with diabetes requiring renal replacement therapy, with limited data reporting their accuracy in this cohort. We evaluated the accuracy of Dexcom G6 and Abbott Freestyle Libre 1 glucose monitoring systems in people with diabetes undergoing hemodialysis. Methods: Participants on hemodialysis with diabetes (on insulin or sulfonylureas) were recruited. Paired sensor glucose from Dexcom G6 and Freestyle Libre 1 were recorded with plasma glucose analyzed using the Yellow Springs Instrument (YSI) method at frequent intervals during hemodialysis. Analysis of accuracy metrics included mean absolute relative difference (MARD), Clarke error grid (CEG) analysis and proportion of CGM values within 15% and 20% or 15 and 20 mg/dL of YSI reference values for blood glucose >100 or ≤100 mg/dL, respectively (% 15/15, % 20/20). Results: Forty adults (median age 64.7 [60.2-74.4] years) were recruited. Overall MARD for Dexcom G6 was 22.7% (2656 matched glucose pairs), and 11.3% for Libre 1 (n = 2785). The proportions of readings meeting %15/15 and %20/20 were 29.1% and 45.4% for Dexcom G6, respectively, and 73.5% and 85.6% for Libre 1. CEG analysis showed 98.9% of all values in zones A and B for Dexcom G6 and 99.8% for Libre 1. Conclusions: Our results indicate Freestyle Libre 1 is a reliable tool for glucose monitoring in adults on hemodialysis. Further studies are required to evaluate Dexcom G6 accuracy in people on hemodialysis.

Nickel hypersensitivity and endovascular devices: a systematic review and meta-analysis.

OBJECTIVE: Nickel allergy is common; endovascular specialists are often confronted with nickel allergic patients ahead of the implantation of endovascular devices, many of which are nickel-containing. Our aim was to elucidate whether nickel hypersensitivity is significantly associated with worse or adverse outcomes after placement of a nickel-containing endovascular device. METHODS: Inclusion criteria were: endovascular and transcatheter procedures for coronary, structural heart, neurovascular and peripheral vascular pathology involving nickel-allergic patients. All adverse outcomes were included as defined by included studies. A systematic review and meta-analysis were undertaken using a random-effects model. Searches of MEDLINE and EMBASE were conducted for articles published 1947-2019. RESULTS: 190 records were identified, 78 articles were included for qualitative synthesis and 15 met criteria for meta-analysis. Patch-test confirmed nickel allergy was associated with an increased risk of adverse outcomes following implantation of a nickel-containing endovascular device (n=14 articles, 1740 patients; OR 2.61, 95% CI 1.41 to 4.85). This finding further was observed in coronary (n=12 articles, 1624 patients; OR 1.94, 95% CI 1.16 to 3.23) and structural heart subgroups (n=2 articles, 83 patients; OR 52.28, 95% CI 1.31 to 2079.14), but not in the neurovascular subgroup (n=1 article, 33 patients; OR 3.04, 95% CI 0.59 to 15.72) or with a patient-reported history of nickel allergy (n=2 articles, 207 patients; OR 2.14, 95% CI 0.23 to 19.70). CONCLUSIONS: Patch-tested nickel allergy is associated with an increased risk of adverse outcomes following endovascular device implantation and alternative treatment options should be considered. Specialists faced with patients' self-reporting nickel allergy should consider proceeding to diagnostic patch-testing.

Medical applicant general practice experience and career aspirations: a questionnaire study.

BACKGROUND: Increasing access to general practice work experience placements for school students is a strategy for improving general practice recruitment, despite limited evidence and concerns surrounding equity of access to general practice experiences. AIMS: To examine the association between undertaking general practice experience and the perceptions of general practice as an appealing future career among prospective medical applicants. To identify socioeconomic factors associated with obtaining general practice experience. DESIGN & SETTING: Cross-sectional questionnaire study in the UK. METHOD: Participants were UK residents aged ≥16 years and seriously considering applying to study medicine in 2019/2020. They were invited to take part via the University Clinical Aptitude Test (UCAT). Questionnaire data were analysed using a linear regression of general practice appeal on general practice experience, adjusting for career motivations and demographics, and a logistic regression of general practice experience on measures of social capital and demographics. RESULTS: Of 6391 responders, 4031 were in their last year of school. General practice experience predicted general practice appeal after adjusting for career motivation and demographics (b = 0.37, standard error [SE] = 0.06, P<0.00001). General practice experience was more common among students at private (odds ratio [OR] = 1.65, 95% confidence interval [CI] = 1.31 to 2.08, P<0.0001) or grammar schools (OR = 1.33, 95% CI = 1.02 to 1.72, P = 0.03) and in the highest socioeconomic group (OR = 1.62, 95% CI = 1.28 to 2.05, P<0.0001), and less likely among students of 'other' ethnicity (OR = 0.37, 95% CI = 0.20 to 0.67, P = 0.0011). CONCLUSION: Having general practice experience prior to medical school was associated with finding general practice appealing, which supports its utility in recruitment. Applicants from more deprived backgrounds were less likely to have had a general practice experience, possibly through lack of accessible opportunities.

Prognostic Significance of Nonischemic Myocardial Fibrosis in Patients With Normal LV Volumes and Ejection-Fraction.

OBJECTIVES: This study aims to investigate the prognostic significance of late gadolinium enhancement (LGE) in patients without coronary artery disease and with normal range left ventricular (LV) volumes and ejection fraction. BACKGROUND: Nonischemic patterns of LGE with normal LV volumes and ejection fraction are increasingly detected on cardiovascular magnetic resonance, but their prognostic significance, and consequently management, is uncertain. METHODS: Patients with midwall/subepicardial LGE and normal LV volumes, wall thickness, and ejection fraction on cardiovascular magnetic resonance were enrolled and compared to a control group without LGE. The primary outcome was actual or aborted sudden cardiac death (SCD). RESULTS: Of 748 patients enrolled, 401 had LGE and 347 did not. The median age was 50 years (interquartile range: 38-61 years), LV ejection fraction 66% (interquartile range: 62%-70%), and 287 (38%) were women. Scan indications included chest pain (40%), palpitation (33%) and breathlessness (13%). No patient experienced SCD and only 1 LGE+ patient (0.13%) had an aborted SCD in the 11th follow-up year. Over a median of 4.3 years, 30 patients (4.0%) died. All-cause mortality was similar for LGE+/- patients (3.7% vs 4.3%; P = 0.71) and was associated with age (HR: 2.04 per 10 years; 95% CI: 1.46-2.79; P < 0.001). Twenty-one LGE+ and 4 LGE- patients had an unplanned cardiovascular hospital admission (HR: 7.22; 95% CI: 4.26-21.17; P < 0.0001). CONCLUSIONS: There was a low SCD risk during long-term follow-up in patients with LGE but otherwise normal LV volumes and ejection fraction. Mortality was driven by age and not LGE presence, location, or extent, although the latter was associated with greater cardiovascular hospitalization for suspected myocarditis and symptomatic ventricular tachycardia.

Comparison of outcomes following transfemoral versus trans-subclavian approach for transcatheter aortic valve Implantation: A meta-analysis.

BACKGROUND: The subclavian artery is an alternative access route for transcatheter aortic valve implantation (TAVI), with a potential advantage in patients unsuitable for traditional access routes such as the femoral artery. This study aimed to determine the safety and efficacy of the trans-subclavian (TSc) compared to the trans-femoral (TF) approach. METHODS: A systematic review was conducted on two online databases: Embase and Medline. The initial search returned 508 titles. Nine observational studies were included: n = 2938 patients (2382 TF and 556 TSc). RESULTS: Both TSc and TF groups were comparable for: 30-day mortality (Odds ratio, OR 0.75, 95% CI 0.49 - 1.16, p = 0.195); in-hospital stroke (OR 1.05, 95% CI 0.60-1.85, p = 0.859); myocardial infarction (OR 1.97, 95% CI 0.74-5.23, p = 0.176); paravalvular leaks (OR 1.20, 95% CI 0.76-1.90, p = 0.439); rates of postoperative permanent pacemaker implantation (OR 1.49, 95% CI 0.92-2.41, p = 0.105); in-hospital bleeding and meta-analysis demonstrated no significant difference between access points (OR 3.44, 95% CI 0.35-34.22, p = 0.292). Procedural time was found to be longer in the TSc group (SMD 1.02; 95% CI 0.815-1.219, p < 0.001). Major vascular complications were significantly higher in the TF group (OR 0.55, 95% CI 0.32-0.94, p = 0.029). Meta regression found no influence of the covariates on the outcomes. CONCLUSION: Subclavian access is both a safe and feasible alternative access route for TAVI with lower risks of major vascular complications. This study supports the use of subclavian access as a viable alternative in patient groups where transfemoral TAVI is contraindicated.

Prognostic Significance of Left Ventricular Noncompaction: Systematic Review and Meta-Analysis of Observational Studies.

BACKGROUND: Although left ventricular noncompaction (LVNC) has been associated with an increased risk of adverse cardiovascular events, the accurate incidence of cardiovascular morbidity and mortality is unknown. We, therefore, aimed to assess the incidence rate of LVNC-related cardiovascular events. METHODS: We systematically searched observational studies reporting the adverse outcomes related to LVNC. The primary end point was cardiovascular mortality. RESULTS: We identified 28 eligible studies enrolling 2501 LVNC patients (mean age, 46 years; male/female ratio, 1.7). After a median follow-up of 2.9 years, the pooled event rate for cardiovascular mortality was 1.92 (95% CI, 1.54-2.30) per 100 person-years. LVNC patients had a similar risk of cardiovascular mortality compared with a dilated cardiomyopathy control group (odds ratio, 1.10 [95% CI, 0.18-6.67]). The incidence rates of all-cause mortality, stroke and systemic emboli, heart failure admission, cardiac transplantation, ventricular arrhythmias, and cardiac device implantation were 2.16, 1.54, 3.53, 1.24, 2.17, and 2.66, respectively, per 100 person-years. Meta-regression and subgroup analyses revealed that left ventricular ejection fraction, not the extent of left ventricular trabeculation, had an important influence on the variability of incidence rates. The risks of thromboembolism and ventricular arrhythmias in LVNC patients were similar to dilated cardiomyopathy patients. However, LVNC patients had a higher incidence of heart failure hospitalization than dilated cardiomyopathy patients. CONCLUSIONS: Patients with LVNC carry a similar cardiovascular risk when compared with dilated cardiomyopathy patients. Left ventricular ejection fraction-a conventional indicator of heart failure severity, not the extent of trabeculation-appears to be an important determinant of adverse outcomes in LVNC patients. Registration: https://www.crd.york.ac.uk/PROSPERO/ Unique identifier: CRD42018096313.