What Really Matters to Survivors of Acute Type A Aortic Dissection-A Survey of Patient-Reported Outcomes in the Dutch National Aortic Dissection Advocacy Group.

(1) Background: Type A acute aortic dissection (TAAAD) almost always requires emergency surgery, and postoperative complications are common. Quality assurance systems tend to measure only the hard outcomes, e.g., complications and mortality. Our aim was to assess the health-related quality of life of TAAAD survivors. (2) Methods: An anonymized, Dutch language, web-based survey was sent out to all of the participants of the 2022 Annual Meeting of the Dutch National Aortic Dissection (DNAD) advocacy group via their own representatives. The survey was divided into five sections: patient information, global satisfaction, surgery, including complications, and the recovery period. (3) Results: Ninety members of the DNAD group attended the meeting. Seventy-five (83%) participated in the survey, and the responses from 61 (81%) were available for analysis. Despite hindrances in their daily life (complications, changes in physical, cognitive, and social functioning), patients were satisfied with their treatment, and all would undergo the procedure again. In addition they requested better post-discharge guidance and communication (4) Conclusion: The emphasis lies in equipping patients with knowledge about potential outcomes and effective coping strategies. This underscores the importance of communication and expectation management, in line with established literature.

Does Regular Practice with a "Flexible Bronchoscopy Simulator" Improve Fibreoptic Intubation Skills in Experts and Novices? A Randomized Controlled Study.

BACKGROUND: The appropriate management of a "difficult airway" remains a challenge for novices and experienced anaesthetists. With the current available airway technologies, e.g., video laryngoscopy, flexible bronchoscopy (fibreoptic intubation (FOI)) for endotracheal intubation is decreasing, likely diminishing caregiver skills. We investigated whether bronchoscopy simulator training improved FOI skills. METHODS: 72 volunteers, consisting of anaesthetists, anaesthesia residents, and nurses, performed six exercises on a bronchoscopy simulator. At baseline and after 12 months, the six exercises included one serious game (to train agility), two basic airways, and three difficult airways. After a baseline assessment, subjects were randomly allocated to the intervention group (with) or control group without bronchoscopy simulator training every six weeks for 10 min using a preloaded serious game. The primary outcome was the difference in the time to reach the carina after 12 months, as measured objectively by the simulator. The level of stress and FOI confidence after 12 months were secondary outcomes. RESULTS: The control and intervention groups had a similar time to reach the carina in difficult airway cases and the reported stress levels, at baseline and 12 months, showed no difference. In contrast, the intervention group's self-reported confidence in FOI skills improved more. CONCLUSIONS: Although participants rated higher in confidence, practicing FOI skills on an airway simulator with an agility game did not increase their performance in simulated challenging airway instances.

International Survey on Perioperative Management of Patients With Infective Endocarditis.

OBJECTIVES: To estimate the current practice in the perioperative management of patients undergoing cardiac surgery due to infective endocarditis. DESIGN: A prospective, open, 24-item, web-based cross-sectional survey. SETTING: Online survey endorsed by the European Association of Cardiothoracic Anesthesiology and Intensive Care (EACTAIC). PARTICIPANTS: Members of the EACTAIC. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A total of 156 responses from 44 countries were received, with a completion rate of 99%. The response rate was 16.6%. Most respondents (76%) practiced cardiac anesthesia in European hospitals, and most respondents stated that a multidisciplinary endocarditis team was not established at their center, that cardiac anesthesiologists appeared to be involved infrequently in those teams (36%), and that they were not involved in decision-making on indication and timing of surgery (88%). In contrast, the cardiac anesthesiologist performed intraoperative antibiotic therapy (62%) and intraoperative transesophageal echocardiography (90%). Furthermore, there was a relative heterogeneity concerning perioperative monitoring, as well as for coagulation and transfusion management. CONCLUSIONS: This international survey evaluated current practice among cardiac anesthesiologists in the perioperative management of patients with infective endocarditis and the anesthesiologist's role in multidisciplinary decision-making. Heterogeneity in treatment approaches was identified, indicating relevant knowledge gaps that should encourage further clinical research to optimize treatment and postoperative outcomes in this specific population.

Patients with infective endocarditis undergoing cardiac surgery have distinct ROTEM profiles and more bleeding complications compared to patients without infective endocarditis.

BACKGROUND: The coagulation system is crucial in the pathogenesis of infective endocarditis and undergoes significant changes during course of the disease. However, little is known about the implications of those changes in the perioperative period. Aim of the present study was to delineate the specific coagulation patterns and their clinical consequence in patients undergoing cardiac surgery due to infective endocarditis. METHODS: In this single-centre, exploratory, prospective observational study, we investigated the incidence and degree of coagulopathy in patients with (n = 31) and without infective endocarditis (n = 39) undergoing cardiac valve surgery. The primary outcome was the differences between these two groups in rotational thromboelastometry (ROTEM) results before, during and after surgery. The secondary outcomes were the differences between the groups in heparin sensitivity, bleeding complications, and transfusion requirements. RESULTS: Most ROTEM parameters in EXTEM, INTEM and FIBTEM assays were significantly altered in patients with infective endocarditis. Clotting time in the EXTEM assay was significantly prolonged in the endocarditis group at all time-points, while all clot firmness parameters (A5, A10 and MCF) were significantly increased. The heparin sensitivity index was significantly lower in the endocarditis group (median index 0.99 vs 1.17s. IU-1.kg-1, p = .008), indicating increased heparin resistance. Patients with infective endocarditis had more bleeding complications as assessed by the universal definition of perioperative bleeding score (OR 3.0, p = .018), and more patients with endocarditis underwent early re-exploration (p = .018). CONCLUSIONS: The findings of this exploratory investigation show significantly altered coagulation profiles in patients with infective endocarditis, with concomitant hyper- and hypocoagulability. Furthermore, the incidence of bleeding complications and transfusion requirements were increased in patients with endocarditis. These results show the potential of ROTEM to detect coagulation abnormalities in patients with infective endocarditis. Existing point-of-care coagulation testing guided algorithms for optimizing perioperative coagulation management possibly need to be adjusted for these high-risk patients undergoing cardiac surgery.

Surveillance of high-risk early postsurgical patients for real-time detection of complications using wireless monitoring (SHEPHERD study): results of a randomized multicenter stepped wedge cluster trial.

Background: Vital signs measurements on the ward are performed intermittently. This could lead to failure to rapidly detect patients with deteriorating vital signs and worsens long-term outcome. The aim of this study was to test the hypothesis that continuous wireless monitoring of vital signs on the postsurgical ward improves patient outcome. Methods: In this prospective, multicenter, stepped-wedge cluster randomized study, patients in the control group received standard monitoring. The intervention group received continuous wireless monitoring of heart rate, respiratory rate and temperature on top of standard care. Automated alerts indicating vital signs deviation from baseline were sent to ward nurses, triggering the calculation of a full early warning score followed. The primary outcome was the occurrence of new disability three months after surgery. Results: The study was terminated early (at 57% inclusion) due to COVID-19 restrictions. Therefore, only descriptive statistics are presented. A total of 747 patients were enrolled in this study and eligible for statistical analyses, 517 patients in the control group and 230 patients in the intervention group, the latter only from one hospital. New disability at three months after surgery occurred in 43.7% in the control group and in 39.1% in the intervention group (absolute difference 4.6%). Conclusion: This is the largest randomized controlled trial investigating continuous wireless monitoring in postoperative patients. While patients in the intervention group seemed to experience less (new) disability than patients in the control group, results remain inconclusive with regard to postoperative patient outcome due to premature study termination. Clinical trial registration: ClinicalTrials.gov, ID: NCT02957825.

Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic (TRACE II): study protocol for a multicentre prospective observational study.

INTRODUCTION: During the COVID-19 pandemic many non-acute elective surgeries were cancelled or postponed around the world. This has created an opportunity to study the effect of delayed surgery on health conditions prior to surgery and postsurgical outcomes in patients with postponed elective surgery. The control group of the Routine Postsurgical Anesthesia Visit to Improve Patient Outcome (TRACE I) study, conducted between 2016 and 2019, will serve as a control cohort. METHODS AND ANALYSIS: TRACE II is an observational, multicentre, prospective cohort study among surgical patients with postponed surgery due to COVID-19 in academic and non-academic hospitals in the Netherlands. We aim to include 2500 adult patients. The primary outcome will be the 30-day incidence of major postoperative complications. Secondary outcome measures include the 30-day incidence of minor postoperative complications, 1 year mortality, length of stay (in hospital, medium care and intensive care), quality of recovery 30 days after surgery and postoperative quality of life up to 1 year following surgery. Multivariable logistic mixed-effects regression analysis with a random intercept for hospital will be used to test group differences on the primary outcome. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Review Board of Maastricht University Medical Centre+ and Amsterdam UMC. Findings will be presented at national and international conferences, as well as published in peer-reviewed scientific journals, with a preference for open access journals. Data will be made publicly available after publication of the main results. TRIAL REGISTRATION NUMBER: NL8841.

Prospective Observational Cohort Study on Dorsal Root Ganglion Stimulation in Chronic Postsurgical Pain: Results of Patient-Reported Outcomes at Two Years.

OBJECTIVES: This study aimed to determine the long-term effects of dorsal root ganglion (DRG) stimulation on pain, physical function, and quality of life in patients with chronic postsurgical pain. We hypothesized that the effects of DRG stimulation would be sustainable through two years of follow-up. MATERIALS AND METHODS: This prospective observational cohort will include 30 patients, at least 18 years old, scheduled to receive DRG stimulation in two Dutch hospitals. A minimum pain score of 50 mm on a 100-mm visual analog scale was required. Following written informed consent, patients completed validated questionnaires on pain, physical function, and quality of life at baseline, one year, and two years. Change over time was analyzed using mixed model statistics, with Tukey-Kramer correction. A p-value of <0.05 was considered statistically significant. RESULTS: Follow-up was completed by 22 of 30 enrolled patients. Pain scores decreased at one year (-38 ± 7, 95% CI [-51 to -25], p < 0.001) and two years (-29 ± 6, 95% CI [-42 to -17], p < 0.001) compared with those at baseline. Physical function measured with pain severity and interference decreased at one and two years (-2.5 ± 0.5, 95% CI [-3.3 to -1.5], p < 0.001, and -2.3 ± 0.5, 95% CI [-3.3 to -1.3], p < 0.001, respectively). Quality of life increased over time (0.22 ± 0.05, 95% CI [11-33], p < 0.001, at one year; 0.21 ± 0.05, 95% CI [10-31], p = 0.001, at two years). CONCLUSIONS: DRG stimulation in chronic postsurgical pain is associated with a sustainable reduction in pain and an improvement in physical function and in quality of life, through two years of follow-up.

A Comparison of 1000 Hz to 30 Hz Spinal Cord Stimulation Strategies in Patients with Unilateral Neuropathic Leg Pain Due to Failed Back Surgery Syndrome: A Multicenter, Randomized, Double-Blinded, Crossover Clinical Study (HALO).

INTRODUCTION: Multicenter, randomized, double-blinded crossover study. The Netherlands (ClinicalTrials.gov NCT02112474). We hypothesized that the pain suppressive effects of 1000 Hz and 30 Hz spinal cord stimulation (SCS) strategies are equally effective in patients with chronic, neuropathic, unilateral leg pain after back surgery. METHODS: Thirty-two patients (18-70 years, minimum leg pain 50 mm on 100 mm visual analog scale (VAS), minimal back pain) were randomized (1:1) to start 1000 Hz or 30 Hz neurostimulation for 9 days. After a 5-day washout, they crossed over, for another 9 days. Primary outcome was pain suppression (mean of VAS scores 4×/day) during the crossover period. The main investigators were blinded to strategy allocation, patients were blinded to the outcome, a blinded assessor analyzed the primary outcome. RESULTS: The primary outcome was analyzed in 26 patients. There was no period effect (delta 4 mm, p = 0.42, 95% CI [- 5, 13]), allowing direct intrapatient comparison of the treatment effect (delta 1 mm, p = 0.92, 95% CI [- 13, 14]). Ninety-two percent of patients in both periods experienced greater than 34% pain suppression (minimal clinically important difference, MCID). Secondary outcomes (22 patients): pain suppression and improved quality of life were sustained at 12 months; both were statistically significant and clinically relevant. Fifty percent of patients had greater than 80% pain suppression (p < 0.001). At study termination, all events were resolved; no unanticipated events were reported. Medtronic provided a grant for additional study costs. CONCLUSION: We conclude that our hypothesis regarding the effect of 1000 Hz and 30 Hz stimulation strategies on pain suppression was confirmed. Both stimulation strategies led to a large, sustainable, clinically relevant pain suppression and improvement in quality of life.

Therapy-Related Explants After Spinal Cord Stimulation: Results of an International Retrospective Chart Review Study.

OBJECTIVES: Clinical trials of spinal cord stimulation (SCS) have largely focused on conversion from trial to permanent SCS and the first years after implant. This study evaluates the association of type of SCS and patient characteristics with longer-term therapy-related explants. MATERIALS AND METHODS: Implanting centers in three European countries conducted a retrospective chart review of SCS systems implanted from 2010 to 2013. Ethics approval or waiver was obtained, and informed consent was not required. The chart review recorded implants, follow-up visits, and date and reasons for any explants through mid-2016. Results are presented using Cox regression to determine factors associated with explant for inadequate pain relief. RESULTS: Four implanting centers in three countries evaluated 955 implants, with 8720 visits over 2259 years of follow-up. Median age was 53 years; 558 (58%) were female. Explant rate was 7.9% per year. Over half (94 of 180) of explants were for inadequate pain relief, including 32/462 (6.9%) of implants with conventional nonrechargeable SCS, 37/329 (11.2%) with conventional rechargeable and 22/155 (14.2%) with high-frequency (10 kHz) rechargeable SCS. A higher explant rate was found in univariate regression for conventional rechargeable (HR 1.98, p = 0.005) and high-frequency stimulation (HR 1.79, p = 0.035) than nonrechargeable SCS. After covariate adjustment, the elevated explant rate persisted for conventional rechargeable SCS (HR 1.95, p = 0.011), but was not significant for high-frequency stimulation (HR 1.71, p = 0.069). CONCLUSIONS: This international, real-world study found higher explant rates for conventional rechargeable and high-frequency SCS than nonrechargeable systems. The increased rate for conventional rechargeable stimulation persisted after covariate adjustment.

Altering Conventional to High Density Spinal Cord Stimulation: An Energy Dose-Response Relationship in Neuropathic Pain Therapy.

OBJECTIVES: To examine whether converting from conventional Spinal Cord Stimulation (SCS) to High Density (HD) SCS reduces neuropathic pain over a period of 12 months in patients with failed SCS therapy. METHODS: Retrospective, open label, single center, consecutive case series of 30 neuropathic pain patients (Failed Back Surgery Syndrome [FBSS], Complex Regional Pain Syndrome [CRPS], and polyneuropathy [NP]). Patients with an initial adequate response to conventional SCS, but in whom pain increased over time, were included (Numeric Rating Scales [NRS] >6). These patients were stimulated with HD-SCS parameters and followed-up for 12 months. We report pain intensity, measured with NRS, before SCS implantation, 1 and 3 months after starting SCS with conventional stimulation, and after 1, 6, and 12 months of HD SCS. RESULTS: Pain reduction with conventional stimulation was initially adequate (NRS mean 8.6 to 5.3 at three months postimplant) but increased over time to a mean NRS of 7.7 at the time of reprogramming. NRS scores decreased significantly to 4.3 (p = 0.015) after reprogramming from conventional SCS (30 Hz, 300 µsec, 3.0 V) to HD SCS (409 Hz, range 130-1000 Hz, 409 µsec, 2.4V) in the patients still using HD-SCS at 12 months. In the nonresponders (patients who stopped HD-SCS for any reason), 76% had a diagnosis of FBSS. Almost half of the patients aborting HD-SCS preferred to feel paresthesias despite better pain relief. There was a significant difference between nonresponders and responders regarding the amount of electrical energy delivered to the spinal cord. CONCLUSION: Neuropathic pain suppression is significantly enhanced after converting from failed conventional SCS to HD SCS in patients with FBSS, CRPS, and NP over a measured period of 12 months. There appears to be a dose-related response between the amount of energy delivered to the spinal cord and clinical effect.