Anaesthetic efficacy and postinduction hypotension with remimazolam compared with propofol: a multicentre randomised controlled trial.

Remimazolam, a short-acting benzodiazepine, may be used for induction and maintenance of total intravenous anaesthesia, but its role in the management of patients with multiple comorbidities remains unclear. In this phase 3 randomised controlled trial, we compared the anaesthetic efficacy and the incidence of postinduction hypotension during total intravenous anaesthesia with remimazolam vs. propofol. A total of 365 patients (ASA physical status 3 or 4) scheduled for elective surgery were assigned randomly to receive total intravenous anaesthesia with remimazolam (n = 270) or propofol (n = 95). Primary outcome was anaesthetic effect, quantified as the percentage of time with Narcotrend® Index values ≤ 60, during surgery (skin incision to last skin suture), with a non-inferiority margin of -10%. Secondary outcome was the incidence of postinduction hypotensive events. Mean (SD) percentage of time with Narcotrend Index values ≤ 60 during surgery across all patients receiving remimazolam (93% (20.7)) was non-inferior to propofol (99% (4.2)), mean difference (97.5%CI) -6.28% (-8.89-infinite); p = 0.003. Mean (SD) number of postinduction hypotension events was 62 (38.1) and 71 (41.1) for patients allocated to the remimazolam and propofol groups, respectively; p = 0.015. Noradrenaline administration events (requirement for a bolus and/or infusion) were also lower in patients allocated to remimazolam compared with propofol (14 (13.5) vs. 20 (14.6), respectively; p < 0.001). In conclusion, in patients who were ASA physical status 3 or 4, the anaesthetic effect of remimazolam was non-inferior to propofol.

Influence of surgical volume on outcomes in low-risk patients undergoing isolated surgical aortic valve replacement.

BACKGROUND: Intermediate- and high-risk patients undergoing isolated surgical aortic valve replacement have superior outcomes at higher-volume compared with lower-volume hospitals. This study examines the impact of hospital volume on outcomes in low-risk patients undergoing aortic valve replacement. METHODS: Using data from our 29 North Texas hospital collaborative, we examined 2066 low-risk cases (Society of Thoracic Surgeons Predicted Risk of Mortality of ≤3%) undergoing aortic valve replacement surgery between January 1, 2012, and December 31, 2017. Cases from 3 high-volume hospitals (≥200 aortic valve replacement cases total) and 26 low-volume hospitals (<200 cases total) were examined. RESULTS: Some 53.5% of the cases were at high-volume hospitals. No statistical differences were seen in the Predicted Risk of Mortality or pertinent demographics between the high-volume and low-volume hospitals. Significant differences in outcomes were seen between the 2 groups in operative mortality (2.28% vs 1.19%, P = .007), renal failure (2.14% vs 1.00%, P = .003), and readmission within 30 days (9.72% vs 6.25%, P < .001) when comparing low-volume with high-volume hospitals. In patients undergoing aortic valve replacement, undergoing the procedure in a low-volume hospital was an independent predictor for operative mortality (odds ratio, 1.95; 95% confidence interval, 1.20-3.20; P = .008) and renal failure (odds ratio, 2.25; 95% confidence interval, 1.33-3.81; P = .003). CONCLUSIONS: Operative mortality in low-risk patients undergoing aortic valve replacement is higher in low-volume compared with high-volume hospitals. The probability of a major complication, such as renal failure, is also greater in low-volume hospitals. The relationship between volume and outcomes in low-risk patients will require more research to understand the causes and design appropriate interventions.

Can use of an administrative database improve accuracy of hospital-reported readmission rates?

OBJECTIVES: Readmission rates after cardiac surgery are being used as a quality indicator; they are also being collected by Medicare and are tied to reimbursement. Accurate knowledge of readmission rates may be difficult to achieve because patients may be readmitted to different hospitals. In our area, 81 hospitals share administrative claims data; 28 of these hospitals (from 5 different hospital systems) do cardiac surgery and share Society of Thoracic Surgeons (STS) clinical data. We used these 2 sources to compare the readmissions data for accuracy. METHODS: A total of 45,539 STS records from January 2008 to December 2016 were matched with the hospital billing data records. Using the index visit as the start date, the billing records were queried for any subsequent in-patient visits for that patient. The billing records included date of readmission and hospital of readmission data and were compared with the data captured in the STS record. RESULTS: We found 1153 (2.5%) patients who had STS records that were marked "No" or "missing," but there were billing records that showed a readmission. The reported STS readmission rate of 4796 (10.5%) underreported the readmission rate by 2.5 actual percentage points. The true rate should have been 13.0%. Actual readmission rate was 23.8% higher than reported by the clinical database. Approximately 36% of readmissions were to a hospital that was a part of a different hospital system. CONCLUSIONS: It is important to know accurate readmission rates for quality improvement processes and institutional financial planning. Matching patient records to an administrative database showed that the clinical database may fail to capture many readmissions. Combining data with an administrative database can enhance accuracy of reporting.

Impact of Medicaid Expansion on Cardiac Surgery Volume and Outcomes.

BACKGROUND: Thirty-one states approved Medicaid expansion after implementation of the Affordable Care Act. The objective of this study was to evaluate the effect of Medicaid expansion on cardiac surgery volume and outcomes comparing one state that expanded to one that did not. METHODS: Data from the Virginia (nonexpansion state) Cardiac Services Quality Initiative and the Michigan (expanded Medicaid, April 2014) Society of Thoracic and Cardiovascular Surgeons Quality Collaborative were analyzed to identify uninsured and Medicaid patients undergoing coronary bypass graft or valve operations, or both. Demographics, operative details, predicted risk scores, and morbidity and mortality rates, stratified by state and compared across era (preexpansion: 18 months before vs postexpansion: 18 months after), were analyzed. RESULTS: In Virginia, there were no differences in volume between eras, whereas in Michigan, there was a significant increase in Medicaid volume (54.4% [558 of 1,026] vs 84.1% [954 of 1,135], p < 0.001) and a corresponding decrease in uninsured volume. In Virginia Medicaid patients, there were no differences in predicted risk of morbidity or mortality or postoperative major morbidities. In Michigan Medicaid patients, a significant decrease in predicted risk of morbidity or mortality (11.9% [8.1% to 20.0%] vs 11.1% [7.7% to 17.9%], p = 0.02) and morbidities (18.3% [102 of 558] vs 13.2% [126 of 954], p = 0.008) was identified. Postexpansion was associated with a decreased risk-adjusted rate of major morbidity (odds ratio, 0.69; 95% confidence interval, 0.51 to 0.91; p = 0.01) in Michigan Medicaid patients. CONCLUSIONS: Medicaid expansion was associated with fewer uninsured cardiac surgery patients and improved predicted risk scores and morbidity rates. In addition to improving health care financing, Medicaid expansion may positively affect patient care and outcomes.

Establishing a Dedicated General Thoracic Surgery Subspecialty Program Improves Lung Cancer Outcomes.

BACKGROUND: Various factors may influence outcomes after lobectomy for lung cancer. Postgraduate subspecialty training in general thoracic surgery with a focus on minimally invasive surgery (MIS) and thoracic oncology was completed by an established cardiothoracic surgeon on the hospital staff in July 2007, and principles emphasized in that training were incorporated into practice through formation of a subspecialty program. We hypothesized that establishing a dedicated general thoracic surgeon-lead subspecialty program, with focus on MIS and thoracic oncology, would improve short-term and long-term outcomes. METHODS: Patients entered into the hospital cancer registry have survival status updated annually through correspondence with patients, physicians, and searches of the Social Security Death Index and obituaries. The registry was queried for all patients undergoing lobectomy for lung cancer, 2002 to 2013, and divided into two groups for comparison, before and after, based on operation date relative to January 2008. Patients (n = 279) who had lobectomy for lung cancer were identified in the registry. Data included surgical approach (percent of video-assisted thoracoscopy [VATS]), pathologic stage, number of lymph nodes and stations sampled, hospital length of stay (LOS), and survival. χ2 statistics were used for proportions, t tests for continuous variables, and a nonparametric test for LOS. A Cox proportional hazard model was created, and survival curves were constructed using time between operation and death or last follow-up. RESULTS: Patients having lobectomy in the after group had substantially more VATS procedures (53.9% versus 9.5%), decreased LOS (median 3.5 versus 7.0 days), greater mean total lymph nodes (9.0 versus 6.3), and nodal stations (4.2 versus 2.8) sampled per patient. Thirty-day, 90-day, and 1-year survival were similar in both groups. Overall survival was better in the after group (hazard ratio [HR] 0.41, 95% confidence interval: 0.25 to 0.68), and this survival benefit remained statistically significant when comparing groups stratified by lung cancer stage (stage I: HR 0.46, stage II: HR 0.32, combined stage III to IV: HR 0.19). CONCLUSIONS: Establishing a dedicated general thoracic surgeon-lead subspecialty program, with focus on MIS and thoracic oncology, can substantially improve short-term outcomes with increased VATS utilization, decreased LOS, and increased lymph node sampling. Long-term survival was also significantly improved.

All-Suture Anchors: Biomechanical Analysis of Pullout Strength, Displacement, and Failure Mode.

PURPOSE: To evaluate the biomechanical and design characteristics of all-suture anchors. METHODS: All-suture anchors were tested in fresh porcine cortical bone and biphasic polyurethane foam blocks by cyclic loading (10-100 N for 200 cycles), followed by destructive testing parallel to the insertion axis at 12.5 mm/s. Endpoints included ultimate failure load, displacement at 100 and 200 cycles, stiffness, and failure mode. Anchors tested included JuggerKnot (1.4, 1.5, and 2.8), Iconix (1, 2, and 3), Y-knot (1.3, 1.8, and 2.8), Q-Fix (1.8 and 2.8), and Draw Tight (1.8 and 3.2). RESULTS: The mean ultimate failure strength of the triple-loaded anchors (564 ± 42 N) was significantly greater than the mean ultimate failure strength of the double-loaded anchors (465 ± 33 N) (P = .017), and the double-loaded anchors were stronger than the single-loaded anchors (256 ± 35 N) (P < .0001). No difference was found between the results in porcine bone and biphasic polyurethane foam. None of these anchors demonstrated 5 mm or 10 mm of displacement during cyclic loading. The Y-Knot demonstrated greater displacement than the JuggerKnot and Q-Fix (P = .025) but not the Iconix and Draw Tight (P > .05). The most common failure mode varied and was suture breaking for the Q-Fix (97%), JuggerKnot (81%), and Iconix anchors (58%), anchor pullout with the Draw Tight (76%), whereas the Y-Knot was 50% suture breaking and 50% anchor pullout. CONCLUSIONS: The ultimate failure load of an all-suture anchor is correlated directly with its number of sutures. With cyclic loading, the Y-Knot demonstrated greater displacement than the JuggerKnot and Q-Fix but not the Iconix and Draw Tight. JuggerKnot (81%) and Q-Fix (97%) anchors failed by suture breaking, whereas the Draw Tight anchor failed by anchor pullout (76%). CLINICAL RELEVANCE: All-suture anchors vary in strength and performance, and these factors may influence clinical success. Biphasic polyurethane foam is a validated model for suture anchor testing.

Comparison of Outcomes of Operative Therapy for Acute Type A Aortic Dissections Provided at High-Volume Versus Low-Volume Medical Centers in North Texas.

Immediate surgery is standard therapy for acute type A aortic dissections (TAAD). Because of its low incidence, many smaller cardiac surgery programs do not routinely perform this procedure because it may negatively affect outcomes. Many high-risk, low-volume (LV) surgical procedures are now preferentially performed in reference centers. We compared the outcomes of surgery for TAAD in high-volume (HV) and LV centers in a single metropolitan area to determine the optimal setting for treatment. Thirty-five of the 37 cardiac surgery programs in the Dallas Ft. Worth metropolitan area participate in a regional consortium to measure outcomes collected in the Society of Thoracic Surgeons Adult Cardiac Database. From January 01, 2008, to December 31, 2014, 29 programs had treated TAAD. Those programs performing at least 100 operations for TAAD were considered HV centers and the others LV. Surgery for TAAD was performed in 672 patients over the 7-year study period with HV centers performing 469 of 672 (70%) of the operations. Despite similar preoperative characteristics, operative mortality was significantly lower in HV versus LV centers (14.1% vs 24.1%; p = 0.001). There was no significant difference in postoperative paralysis rates (2.6% vs 4.5%; p = 0.196), stroke rates (10.7% vs 9.4%; p = 0.623), or 30-day readmission rates (12.1% vs 15.5%; p = 0.292). An improved survival rate in HV centers was maintained over a 5-year follow-up period. Surgery for TAAD in a single large metropolitan area was most commonly performed in HV centers. In conclusion, the treatment of acute thoracic aortic dissection is recommended to be performed in reference centers because of lower early and midterm mortality.

Post-septal upper eyelid loading for treatment of exposure keratopathy secondary to non-cicatricial lagophthalmos.

Exposure keratopathy may result in ocular surface dryness, pain, corneal ulceration and loss of vision. Upper eyelid loading is an effective surgical treatment for paralytic lagophthalmos but has been criticised for complications of implant exposure and poor cosmesis. We therefore reviewed the safety and efficacy of our technique of upper eyelid post-septal loading for exposure keratopathy in this context. A retrospective case notes analysis was undertaken of 38 patients who had upper eyelid loading, all with post-septal weight placement, for correction of lagophthalmos. Patient demographics, indications for surgery, outcomes and complications were analysed. The mean age of all patients was 59.6 years. Exposure keratopathy was secondary to facial nerve paralysis in all but two patients, with tumor excision being the commonest underlying aetiology (63.8%). The mean implant weight used was 1.4 grams. Pre-operatively, all 38 patients had ocular discomfort despite maximal use of lubricating eye drops but post-operatively, 29 patients (76.3%) were comfortable without any such drops. Mean lagophthalmos on blink and gentle closure improved from 7.42mm and 5.47mm pre-operatively to 2.18mm and 1.18mm post-operatively (p < 0.001). Similarly, before surgery all patients had some corneal staining but after surgery 37 patients (97.4%) had none. The gold weight was removed in four patients (10.5%), due to chronic inflammation in three and due to mild astigmatism in one. No patient had exposure of the weight and one patient had a ptosis repair 6 months after surgery. Upper eyelid loading was effective in reducing both signs and symptoms of exposure keratopathy related to lagophthalmos in our series. Patients were very satisfied with the surgical outcome and complications related to exposure and cosmesis were very rare.

The Midterm Impact of Transcatheter Aortic Valve Replacement on Surgical Aortic Valve Replacement in Michigan.

BACKGROUND: We characterized the midterm impact of transcatheter aortic valve replacement (TAVR) on surgical aortic valve replacement (SAVR) volume, patient profiles, and outcomes in Michigan. METHODS: We analyzed data obtained after SAVR (n = 15,288) and TAVR (n = 1,783) using the Michigan Society of Thoracic and Cardiovascular Surgery Quality Collaborative from 2006 to 2015. During this period, 17 of 33 hospitals developed TAVR programs. RESULTS: Annual SAVR volume increased by 38.1% at TAVR hospitals and by 20.4% at non-TAVR hospitals, (p trend < 0.001). In TAVR hospitals, the Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) decreased before (4.7% ± 5.1%) and after (3.5% ± 3.6%) initiation of TAVR (p < 0.001). Rates of 30-day mortality (pre-TAVR, 3.9% vs post-TAVR, 2.7%; p < 0.001) and renal failure (pre-TAVR, 5.2% vs post-TAVR, 3.3%; p < 0.001) but not stroke (pre-TAVR, 1.9% vs post-TAVR, 1.7%; p = 0.47) were lower after TAVR implementation. Length of stay decreased from 9.0 to 8.5 days (p < 0.001). When analyzing high-risk patients undergoing SAVR (ie, PROM >8%), neither mortality, stroke, nor renal failure was different (all p > 0.15). Despite a reduction in the STS-PROM, non-TAVR hospitals did not display changes in mortality, stroke, or renal failure for either the entire or the high-risk SAVR cohorts after initiation of TAVR in Michigan. CONCLUSIONS: TAVR implementation in Michigan has dramatically increased overall SAVR volume. This phenomenon has occurred with a concomitant decrease in preoperative risk profile and has improved early SAVR outcomes, particularly at TAVR hospitals, but surprisingly not in patients considered at high preoperative risk. As TAVR use increases, these issues may be further clarified and elucidated.

Using Puppets to Teach Schoolchildren to Detect Stroke and Call 911.

To overcome barriers to improved outcomes, we undertook an intervention to teach schoolchildren how to detect a stroke and call emergency medical services (EMS). We obtained permission from parents and guardians to use an 8-min puppet show to instruct the fourth, fifth, and sixth graders about stroke detection, symptomatology, and calling EMS. A pretest and three posttests-one immediately following the presentation, one at 3 months, and a third at 6 months-were administered. Responses from 282 students were evaluable. Significant improvements (p < .001) in knowledge were found through all posttests in identifying what parts of the body stroke affected and through the first two posttests in recognizing symptoms stroke victims experienced. Students demonstrated at pretest a high awareness of EMS and 911 (97.5%) and showed slight, but not significant, improvement over time.

A Randomized Controlled Trial of Oral Versus Intravenous Administration of a Nonnarcotic Analgesia Protocol Following Pediatric Craniosynostosis Corrections on Nausea and Vomiting Rates.

BACKGROUND: The authors' center uses a nonnarcotic postoperative regimen following craniosynostosis corrections. Despite opioid avoidance, the authors noted that some children still experienced nausea and vomiting following the oral administration of either acetaminophen or ibuprofen. This study sought to evaluate whether intravenous administration of these medications might reduce nausea and vomiting rates. METHODS: A total of 50 children undergoing craniosynostosis corrections were prospectively randomized to a control group given only oral ibuprofen (10 mg/kg) and acetaminophen (15 mg/kg), or a treatment group given only intravenous ketorolac (0.5 mg/kg) and acetaminophen (15 mg/kg). All patients were assessed for postoperative nausea and vomiting by a blinded research nurse. RESULTS: Twenty-eight patients randomized to the oral control group, and 22 to the intravenous treatment group. No statistically significant differences were identified between groups, including: age, weight, sex, before history of severe postoperative nausea and vomiting, or procedure. With similar anesthesia times there was significantly more vomiting episodes in the oral group (71% versus 41%). Using a multivariate logistic regression, controlling for age, weight and procedure, the odds ratio for vomiting in the oral control versus intravenous experimental groups was 3.61 (95% CI 1.11-1.76; P = 0.033), and for postoperative nausea was 14.0 (95% CI 1.40-71.69, P = 0.010). CONCLUSIONS: The authors found a significant reduction in nausea and vomiting among children randomized to receive intravenous medications. In addition, the intravenous delivery of medications has the theoretical advantage of insuring an effective full dose delivery. Based on these findings, our standard process is to preferentially manage all children following craniosynostosis corrections with intravenous nonnarcotics.

Outcomes of Treatment of Nonagenarians With Severe Aortic Stenosis.

BACKGROUND: Because nonagenarians with aortic stenosis (AS) often present as frail with more comorbid conditions, long-term outcomes and quality of life are important treatment considerations. The aim of this report is to describe survival and functional outcomes of nonagenarians undergoing treatment for AS by surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). METHODS: This is a retrospective analysis of all patients aged 90 years or more undergoing treatment for AS between 2007 and 2013 at two centers. Outcomes were compared between SAVR and TAVR. Long-term survival was compared with an age- and sex-matched population from the Social Security Actuarial Life Table. RESULTS: In all, 110 patients underwent treatment for isolated AS (20 SAVR and 90 TAVR). Mean age was 91.85 ± 1.80 years, and 50.9% were female. The Society of Thoracic Surgeons mean predicted risk of mortality was 11.11% ± 5.74%. Operative mortality was 10.9% (10.0% SAVR; 11.1% TAVR); 2.7% of patients had a stroke. The TAVR patients were more likely to be discharged home (75.9% versus 55.6% for SAVR, p = 0.032). Mean follow-up was 1.8 ± 1.5 years, with a 1-year and 5-year survival of 78.7% and 45.3%, respectively, which approximated the US actuarial survival. There was a significant improvement in quality of life as measured by the Kansas City Cardiomyopathy Questionnaire at 1 year compared with baseline. CONCLUSIONS: Treatment of AS approximates natural life expectancy in select nonagenarians, with no significant difference in long-term survival between SAVR and TAVR. Importantly, patient quality of life improved at 1 year. With appropriate selection, nonagenarians with severe AS can benefit from treatment.

Red blood cells and mortality after coronary artery bypass graft surgery: an analysis of 672 operative deaths.

BACKGROUND: Prior studies have implicated transfusion as a risk factor for mortality in coronary artery bypass graft surgery (CABG). To further our understanding of the true association between transfusion and outcome, we specifically analyzed the subgroup of patients who died after undergoing CABG. METHODS: A total of 34,362 patients underwent isolated CABG between January 2008 and September 2013 and were entered into a statewide collaborative database; 672 patients (2.0%) died and form the basis for this study. Univariate analysis compared preoperative and intraoperative variables, as well as postoperative outcomes, between those with and without transfusion in both unadjusted cohorts and those matched by predicted risk of mortality (PROM). Mortality was further evaluated with phase of care analysis. RESULTS: Of the 672 deaths, 566 patients (84.2%) received a transfusion of red blood cells. The PROM was 7.5% for the transfused patients versus 4.3% for those not transfused (p < 0.001). Transfused patients were older, more often female, had more emergency, on-pump, and redo procedures, and had a lower preoperative and on-bypass nadir hematocrit. Most other demographics were similar between the groups. Postoperatively, transfused patients were ventilated longer, had more renal and multisystem organ failure, and were more likely to die of infectious and pulmonary causes after longer intensive care unit and overall lengths of stay. CONCLUSIONS: Significant differences in PROM and the postoperative course leading to death between those with and without transfusion suggest the role of transfusion may be secondary to other patient-related factors. Recognizing that the relationship between transfusion and outcome after CABG remains incompletely understood, these findings are suggestive of a complex interaction of many variables.

The effect of chemotherapy on health-related quality of life in mesothelioma: results from the SWAMP trial.

BACKGROUND: The effect of chemotherapy on health-related quality of life (HRQoL) in malignant pleural mesothelioma (MPM) is poorly understood. Patient-individualised prognostication and prediction of treatment response from chemotherapy is useful but little evidence exists to guide practice. METHOD: Consecutive patients with MPM who were fit for first-line chemotherapy with pemetrexed and cisplatin\carboplatin were recruited and followed up for a minimum of 12 months. This study focussed on the HRQoL outcomes of these patients using the EQ-5D, EORTC QLQ-C30 and LC13. RESULTS: Seventy-three patients were recruited of which 58 received chemotherapy and 15 opted for best supportive care (BSC). Compliance with HRQoL questionnaires was 98% at baseline. The chemotherapy group maintained HRQoL compared with the BSC group whose overall HRQoL fell (P=0.006) with worsening dyspnoea and pain. The impact of chemotherapy was irrespective of histological subtype although those with non-epithelioid disease had worse HRQoL at later time points (P=0.012). Additionally, those with a falling mesothelin or improvement on modified-RECIST CT at early follow-up had a better HRQoL at 16 weeks. CONCLUSIONS: HRQoL was maintained following chemotherapy compared with a self-selected BSC group. Once chemotherapy is initiated, a falling mesothelin or improved RECIST CT findings infer a quality-of-life advantage.