The Toronto prehospital hypertonic resuscitation-head injury and multi organ dysfunction trial (TOPHR HIT) - Methods and data collection tools

<p>Abstract</p> <p>Background</p> <p>Clinical trials evaluating the use of hypertonic saline in the treatment of hypovolemia and head trauma suggest no survival superiority over normal saline; however subgroup analyses suggest there may be a reduction in the inflammatory response and multiorgan failure which may lead to better survival and enhanced neurocognitive function. We describe a feasibility study of randomizing head injured patients to hypertonic saline and dextran vs. normal saline administration in the out of hospital setting.</p> <p>Methods/Design</p> <p>This feasibility study employs a randomized, placebo-controlled design evaluating normal saline compared with a single dose of 250 ml of 7.5% hypertonic saline in 6% dextran 70 in the management of traumatic brain injuries. The primary feasibility endpoints of the trial were: 1) baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial, 2) randomization compliance rate, 3) ease of protocol implementation in the out-of-hospital setting, and 4) adverse event rate of HSD infusion.</p> <p>The secondary objectives include measuring the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulating the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome and clinical response to HSD intervention; evaluating effects of HSD on brain atrophy post-injury and neurocognitive and neuropsychological outcomes.</p> <p>Discussion</p> <p>We anticipate three aspects of the trial will present challenges to trial success; ethical demands associated with a waiver of consent trial, challenging follow up and comprehensive accurate timely data collection of patient identifiers and clinical or laboratory values. In addition all the data collection tools had to be derived de novo as none existed in the literature.</p> <p>Trial registration number</p> <p>NCT00878631</p

Minimally Invasive Surgery: Standard of Care for Mitral Valve Endocarditis

Background. Minimally invasive surgery via right mini-thoracotomy has become the standard of care for the treatment of mitral valve disease worldwide, particularly at high-volume centers. In recent years, the spectrum of indications has progressively shifted and extended to fragile and higher-risk patients, also addressing more complex mitral valve disease and ultimately including patients with native or prosthetic infective endocarditis. The rationale for the adoption of the minimally invasive approach is to minimize surgical trauma, promote an earlier postoperative recovery, and reduce the incidence of surgical wound infection and other nosocomial infections. The aim of this retrospective observational study is to evaluate the effectiveness and the early and late outcome in patients undergoing minimally invasive surgery for mitral valve infective endocarditis. Methods. Prospectively collected data regarding minimally invasive surgery in patients with mitral valve infective endocarditis were entered into a dedicated database for the period between January 2007 and December 2022 and retrospectively analyzed. All comers during the study period underwent a preoperative evaluation based on their clinical history and anatomy for the allocation to the most appropriate surgical strategy. The selection of the mini-thoracotomy approach was primarily driven by a thorough transthoracic and especially transesophageal echocardiographic evaluation, coupled with total body and vascular imaging. Results. During the study period, 92 patients underwent right mini-thoracotomy to treat native (80/92, 87%) or prosthetic (12/92, 13%) mitral valve endocarditis at our institution, representing 5% of the patients undergoing minimally invasive mitral surgery. Twenty-six (28%) patients had undergone previous cardiac operations, whereas 18 (20%) presented preoperatively with complications related to endocarditis, most commonly systemic embolization. Sixty-nine and twenty-three patients, respectively, underwent early surgery (75%) or were operated on after the completion of the targeted antibiotic treatment (25%). A conservative procedure was feasible in 16/80 (20%) patients with native valve endocarditis. Conversion to standard sternotomy was necessary in a single case (1.1%). No cases of intraoperative iatrogenic aortic dissection were reported. Four patients died perioperatively, accounting for a thirty-day mortality of 4.4%. The causes of death were refractory heart or multiorgan failure and/or septic shock. A new onset stroke was observed postoperatively in one case (1.1%). Overall actuarial survival rate at 1 and 5 years after operation was 90.8% and 80.4%, whereas freedom from mitral valve reoperation at 1 and 5 years was 96.3% and 93.2%, respectively. Conclusions. This present study shows good early and long-term results in higher-risk patients undergoing minimally invasive surgery for mitral valve infective endocarditis. Total body, vascular, and echocardiographic screening represent the key points to select the optimal approach and allow for the extension of indications for minimally invasive surgery to sicker patients, including active endocarditis and sepsis

Epidemiology and Risk Factors for Nosocomial Infections in Left Ventricular Assist Device Recipients

Left ventricular assist devices (LVADs) have been increasingly used as a valid option to improve the prognosis and reduce the symptoms of end-stage heart failure. However, long-term complications, mostly infections and coagulation disorders, are frequent. We described the epidemiology and risk factors for nosocomial infections (NIs) in a cohort of adult patients who underwent continuous-flow LVAD implant between January 2010 and December 2017 in Turin, Italy. Secondary outcomes were the prevalence of multidrug-resistant (MDR) bacteria and mortality. Results: Overall, 64 LVADs were implanted. A total of 32 (50%) patients experienced at least one episode of NI, with a total of 46 infectious events. VAD-related infections occurred in 22 patients (68.8%). Non VAD-related NIs occurred in 12 patients (37.5%), mainly low respiratory tract infections. Length of intensive care unit admission was a risk factor for NI (OR 1.224, 95%CI; 1.049, 1.429). Gram-negative bacilli were responsible for 58.8% of VAD-related infections and 79.5% of non-VAD related infections. In sixteen patients (50%), at least one episode of infection was related to an MDR strain. INTERMACS class and length of MV were independent risk factors for NIs by MDR strains (respectively, OR 2.12, 95%CI: 1.08, 6.80; p = 0.02 and OR 1.46, 95%CI: 1.07, 5.52, p = 0.047). In-hospital mortality was 6.3%. No differences in mortality were observed between infected and non-infected patients (p = 0.61) even when caused by MDR strains (p = 0.143). Conclusion: the rate of nosocomial infections in LVAD patients is associated with the length of ICU admission, and the etiology of nosocomial infection after LVAD implant is mainly due to GNB, including a high rate of MDR strains, especially KPC-KP and MDR PA

Transcatheter Mitral Valve Implantation in Failed Transventricular Mitral Valve Repair

An 84-year-old man presented with dyspnea at rest due to severe mitral regurgitation. He first underwent transventricular mitral valve repair with the Harpoon system, which relapsed owing to rupture of neochords. He was definitively treated with transcatheter mitral valve implantation of the Tendyne system 8 months later

Incidence, predictors and outcomes of valve-in-valve TAVI: A systematic review and meta-analysis

Aims: Surgical aortic valve replacement has been the treatment of choice for patientswith aortic valve disease before the arrival of transcatheter aortic valve replacement (TAVI), although limited by degeneration of the bioprosthesis. "Redo" intervention itself is burdened by high risk of complications and valve-in-valve (ViV) TAVI could be a valid strategy of redo for patients with comorbidities. Methods and results: Two independent reviewers screened all studies investigating patients undergoing ViV TAVI. Mortality at 30 days and at 1 year was the primary end point. Of 286 studies identified, 26 articles were included in this review with a total of 1448 patients. Median age was 78.8 years, 57.7% male. Median STS score and Logistic EuroSCORE were 9.4% and 31.3% respectively. Stenosis (45%) was the leading cause of prosthesis failure. Transfemoral approach was preferred (76%), with a prevalence of balloon expandable valves (73.3%). Mean follow up was 376 days. Overall and cardiovascular mortality at 30 days was 6.5% and 5.5% respectively, while at 1 year it was 14.5% and 8.9% respectively. At meta-regression analysis study year (p <.001), Logistic EuroSCORE (p <.01) and valve diameter <= 21 mm (p b.05) at 30 days, and stenosis as reason for failure (p =.05) at 1 year were identified as possible predictors of survival. Conclusions: ViV TAVI offers a valid strategy to treat high risk patients with a failure of bioprosthesis with satisfying results in terms of short and mid-term mortality. Future studies are needed to find predictors of long term survival and outcomes in lower risk patients. (C) 2020 Elsevier B.V. All rights reserved