Electrocardiographic predictors of atrial mechanical sensing in leadless pacemakers.

BACKGROUND: Leadless pacemakers (LPs) capable of VDD pacing allow for atrioventricular synchrony through mechanical sensing of atrial contraction. However, mechanical sensing is less reliable and less predictable than electrical sensing. OBJECTIVE: The purpose of this study was to evaluate P-wave amplitude during sinus rhythm from preoperative 12-lead electrocardiograms (ECGs) as a predictor for atrial mechanical sensing in patients undergoing VDD LP implantation. METHODS: Consecutive patients undergoing VDD LP implantation were included in this 2-center prospective cohort study. ECG parameters were evaluated separately and in combination for association with the signal amplitude of atrial mechanical contraction (A4). RESULTS: Eighty patients (median age 82 years; female 55%; mean body mass index [BMI] 25.8 kg/m2) were included in the study and 61 patients in the A4 signal analysis (19 patients in VVI mode during follow-up). Absolute (aVL, aVF, V1, V2) and BMI-adjusted (I, II, aVL, aVF, aVR, V1, V2) P-wave amplitudes from baseline ECGs demonstrated a statistically significant positive correlation with A4 signal amplitude (all P <.05). A combined P-wave signal amplitude of at least 0.2 mV in V1 and aVL was predictive, with specificity of 83% (95% confidence interval 67%-100%) for A4 signal ≥1 m/s2. We found a significant correlation of A4 signal amplitude and overall atrioventricular synchrony (P = .013). CONCLUSION: P-wave amplitudes in ECG leads aVL and V1 can predict A4 signal amplitude in patients with VDD LP and therefore the probability of successful AV synchronous pacing.

Prospective validation of a risk score to predict pacemaker implantation after transcatheter aortic valve replacement.

INTRODUCTION: The need for pacemaker is a common complication after transcatheter aortic valve replacement (TAVR). We previously described the Emory Risk Score (ERS) to predict the need for new pacemaker implant (PPM) after TAVR. Metrics included in the score are a history of syncope, pre-existing RBBB, QRS duration ≥140 ms, and prosthesis oversizing ≥16%. To prospectively validate the previously described risk score. METHODS: We prospectively evaluated all patients without pre-existing pacemakers, ICD, or pre-existing indications for pacing undergoing TAVR with the Edwards SAPIEN 3 prosthesis at our institution from March 2019 to December 2020 (n = 661). Patients were scored prospectively; however, results were blinded from clinical decision-making. The primary endpoint was PPM at 30 days after TAVR. Performance of the ERS was evaluated using logistic regression, a calibration curve to prior performance, and receiver operating characteristic (ROC) analysis. RESULTS: A total of 48 patients (7.3%) had PPM after TAVR. A higher ERS predicted an increased likelihood of PPM (OR 2.61, 95% CI: 2.05-3.25 per point, p < 0.001). There was good correlation between observed and expected values on the calibration curve (slope = 1.04, calibration at large = 0.001). The area under the ROC curve was 0.81 (95% CI [0.74-0.88], p < 0.001). CONCLUSIONS: The ERS prospectively predicted the need for PPM in a serial, real-world cohort of patients undergoing TAVR with a balloon-expandable prosthesis, confirming findings previously described in retrospective cohorts. Notably, the prospective performance of the score was comparable with that of the initial cohorts. The risk score could serve as a framework for preprocedural risk stratification for PPM after TAVR.

Not all traumatic brain injury patients on preinjury anticoagulation are the same.

BACKGROUND: Prognostic significance of different anticoagulants in TBI patients remains unanswered. We aimed to compare effects of different anticoagulants on outcomes of TBI patients. METHODS: A secondary analysis of AAST BIG MIT. Blunt TBI patients ≥50 years using anticoagulants presenting ICH were identified. Outcomes were progression of ICH and need for neurosurgical intervention (NSI). RESULTS: 393 patients were identified. Mean age was 74 and most common anticoagulant was aspirin (30%), followed by Plavix (28%), and coumadin (20%). 20% had progression of ICH and 10% underwent NSI. On multivariate regression for ICH progression, warfarin, SDH, IPH, SAH, alcohol intoxication and neurologic exam deterioration were associated with increased odds. Warfarin, abnormal neurologic exam on presentation, and SDH were independent predictors of NSI. CONCLUSIONS: Our findings reflect a dynamic interaction between type of anticoagulants, bleeding pattern & outcomes. Future modifications of BIG may need to take the type of anticoagulant into consideration.

EAES rapid guideline: updated systematic review, network meta-analysis, CINeMA and GRADE assessment, and evidence-informed European recommendations on the management of common bile duct stones.

BACKGROUND: Choledocholithiasis presents in a considerable proportion of patients with gallbladder disease. There are several management options, including preoperative or intraoperative endoscopic cholangiopancreatography (ERCP), and laparoscopic common bile duct exploration (LCBDE). OBJECTIVE: To develop evidence-informed, interdisciplinary, European recommendations on the management of common bile duct stones in the context of intact gallbladder with a clinical decision to intervene to both the gallbladder and the common bile duct stones. METHODS: We updated a systematic review and network meta-analysis of LCBDE, preoperative, intraoperative, and postoperative ERCP. We formed evidence summaries using the GRADE and the CINeMA methodology, and a panel of general surgeons, gastroenterologists, and a patient representative contributed to the development of a GRADE evidence-to-decision framework to select among multiple interventions. RESULTS: The panel reached unanimous consensus on the first Delphi round. We suggest LCBDE over preoperative, intraoperative, or postoperative ERCP, when surgical experience and expertise are available; intraoperative ERCP over LCBDE, preoperative or postoperative ERCP, when this is logistically feasible in a given healthcare setting; and preoperative ERCP over LCBDE or postoperative ERCP, when intraoperative ERCP is not feasible and there is insufficient experience or expertise with LCBDE (weak recommendation). The evidence summaries and decision aids are available on the platform MAGICapp ( https://app.magicapp.org/#/guideline/nJ5zyL ). CONCLUSION: We developed a rapid guideline on the management of common bile duct stones in line with latest methodological standards. It can be used by healthcare professionals and other stakeholders to inform clinical and policy decisions. GUIDELINE REGISTRATION NUMBER: IPGRP-2022CN170.

Validating the Brain Injury Guidelines: Results of an American Association for the Surgery of Trauma prospective multi-institutional trial.

INTRODUCTION: Brain Injury Guidelines (BIG) was developed to effectively use health care resources including repeat head computed tomography (RHCT) scan and neurosurgical consultation in traumatic brain injury (TBI) patients. The aim of this study was to prospectively validate BIG at a multi-institutional level. METHODS: This is a prospective, observational, multi-institutional trial across nine Levels I and II trauma centers. Adult (16 years or older) blunt TBI patients with a positive initial head computed tomography (CT) scan were identified and categorized into BIG 1, 2, and 3 based on their neurologic examination, alcohol intoxication, antiplatelet/anticoagulant use, and head CT scan findings. The primary outcome was neurosurgical intervention. The secondary outcomes were neurologic worsening, RHCT progression, postdischarge emergency department visit, and 30-day readmission. RESULTS: A total of 2,432 patients met the inclusion criteria, of which 2,033 had no missing information and were categorized into BIG 1 (301 [14.8%]), BIG 2 (295 [14.5%]), and BIG 3 (1,437 [70.7%]). In BIG 1, no patient worsened clinically, 4 of 301 patients (1.3%) had progression on RHCT with no change in management, and none required neurosurgical intervention. In BIG 2, 2 of 295 patients (0.7%) worsened clinically, and 21 of 295 patients (7.1%) had progression on RHCT. Overall, 7 of 295 patients (2.4%) would have required upgrade from BIG 2 to 3 because of neurologic examination worsening or progression on RHCT, but no patient required neurosurgical intervention. There were no TBI-related postdischarge emergency department visits or 30-day readmissions in BIG 1 and 2 patients. All patients who required neurosurgical intervention were BIG 3 (280 of 1,437 patients [19.5%]). Agreement between assigned and final BIG categories was excellent ( κ = 99%). In this cohort, implementing BIG would have decreased CT scan utilization and neurosurgical consultation by 29% overall, with a 100% reduction in BIG 1 patients and a 98% reduction in BIG 2 patients. CONCLUSION: Brain Injury Guidelines is safe and defines the management of TBI patients by trauma and acute care surgeons without the routine need for RHCT and neurosurgical consultation. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III.

Resuscitative endovascular balloon occlusion of the aorta: simulation improves performance but may require interval training to prevent skill degradation.

PURPOSE: Surgical trainees are exposed to less procedures with increasing need for simulation. Resuscitative endovascular balloon occlusion of the aorta (REBOA) has become increasingly implemented for hemorrhage control, yet most courses are catered to faculty level with little data on trainees. We propose that routine training in this critical procedure will improve trainee performance over time. METHODS: This is a prospective, observational study at a level I trauma center involving a monthly trauma procedural program. Early in the month, trainees received hands-on REBOA training; at the end, trainees underwent standardized, class-based evaluation on a perfused trainer. Score percentages were recorded (0-100%). Endpoints included early, mid and late performance (2-12 months). Paired T-test and Pearson's coefficient were used to evaluate differences and strength of association between time between training and performance. RESULTS: 25 trainees participated with 5 and 11 repeat learners in the PGY-2 and PGY-3 classes, respectively. Median early performance score was 62.5% (IQR 56-81) for PGY-2s and 91.6% (IQR 75-100) in PGY-3s. Pearson's coefficient between time between and training and score demonstrated a weak correlation in the PGY-2s (r2 = - 0.13), but was more pronounced in the PGY-3s (r2 = - 0.44) with an inflection point at 5 months. CONCLUSIONS: Routine REBOA training in trainees is associated with improvement in performance within a short period of time. Skill degradation was most pronounced in trainees who did not receive training for more than 5 months. Trainees can be successfully trained in REBOA; however, this should be done at shorter intervals to prevent skill degradation.

Outcomes Of Manifest Right Free Wall Accessory Pathway Ablation: Data From A Single Center.

BACKGROUND: Right free wall (RFW) accessory pathways (AP) typically present anatomical challenges to ablation leading to high rates of procedural failure and recovery of AP conduction. METHODS: Patients with a diagnosis of Wolff-Parkinson-White Syndrome (WPW) and a manifest RFW AP undergoing an electrophysiology study (EPS) or an ablation at our center between 01/01/2008 and 08/01/2019 were identified from our databases using diagnosis codes and manual chart review. RESULTS: Twenty-one patients with manifest RFW AP underwent EPS, all of which were targeted for ablation. Single procedure success rate was 19 / 21 (90.5%). Of the 19 successful cases, 4 (17.4%) patients were found to have recurrent right free wall pathway conduction at follow-up and each underwent a successful 2nd procedure (9.5%). Fluoroscopic and 3D electroanatomic mapping software was used in all cases to guide ablation. A 4 mm or 8 mm non-irrigated radiofrequency (RF) ablation catheter was used in 76% of cases while an 8 mm cryo-catheter was used in one case. More than one type of ablation catheter was used in four cases (16%). A steerable sheath was used in 68% of cases. CONCLUSIONS: In a tertiary center, RFW AP ablation has high acute success (>90%) but approximately 21% of patients with initially successful ablation required a 2nd procedure for recurrence of pathway conduction. A combination of a large tip ablation catheter and a steerable sheath were used in most cases.

The Emergency Surgery Score accurately predicts the need for postdischarge respiratory and renal support after emergent laparotomies: A prospective EAST multicenter study.

BACKGROUND: The Emergency Surgery Score (ESS) was recently validated as an accurate mortality risk calculator for emergency general surgery. We sought to prospectively evaluate whether ESS can predict the need for respiratory and/or renal support (RRS) at discharge after emergent laparotomies (EL). METHODS: This is a post hoc analysis of a 19-center prospective observational study. Between April 2018 and June 2019, all adult patients undergoing EL were enrolled. Preoperative, intraoperative, and postoperative variables were systematically collected. In this analysis, patients were excluded if they died during the index hospitalization, were discharged to hospice, or transferred to other hospitals. A composite variable, the need for RRS, was defined as the need for one or more of the following at hospital discharge: tracheostomy, ventilator dependence, or dialysis. Emergency Surgery Score was calculated for all patients, and the correlation between ESS and RRS was examined using the c-statistics method. RESULTS: From a total of 1,649 patients, 1,347 were included. Median age was 60 years, 49.4% were men, and 70.9% were White. The most common diagnoses were hollow viscus organ perforation (28.1%) and small bowel obstruction (24.5%); 87 patients (6.5%) had a need for RRS (4.7% tracheostomy, 2.7% dialysis, and 1.3% ventilator dependence). Emergency Surgery Score predicted the need for RRS in a stepwise fashion; for example, 0.7%, 26.2%, and 85.7% of patients required RRS at an ESS of 2, 12, and 16, respectively. The c-statistics for the need for RRS, the need for tracheostomy, ventilator dependence, or dialysis at discharge were 0.84, 0.82, 0.79, and 0.88, respectively. CONCLUSION: Emergency Surgery Score accurately predicts the need for RRS at discharge in EL patients and could be used for preoperative patient counseling and for quality of care benchmarking. LEVEL OF EVIDENCE: Prognostic and epidemiological, level III.

Ablation of manifest septal accessory pathways: a single-center experience.

BACKGROUND: Ablation of septal accessory pathways (SAPs) is associated with an increased risk of heart block. Data on outcomes of SAP ablation in adults are limited. OBJECTIVES: To describe outcomes of SAP ablation in our center. METHODS: Patients with Wolff-Parkinson-White syndrome (WPW) undergoing an EP study at our center between January 2008 and August 2019 were identified from our institutional database. Location of the pathway was noted as anteroseptal (AS), midseptal (MS), or posteroseptal (PS). Outcomes of the ablation including success, complication rates, and recurrences were also recorded. RESULTS: Thirty-three patients with SAP underwent 35 EP studies: AS (n = 13), MS (n = 5), and PS (n = 15). Thirty pathways were targeted for ablation, two of which required a 2nd procedure resulting in 32 attempts at ablation in 30 patients. In the remaining 3 patients, SAP did not have malignant features and were not targeted for ablation. Single-procedure success rate was 28/30 (93.33%): 9/10 AS, 5/5 MS, and 14/15 PS ablations. One AS pathway was successfully ablated during a 2nd procedure. Two complications were observed: 1 pericardial effusion in a patient who underwent epicardial mapping and ablation of both PS and right free wall APs. Additionally, transient 2:1 AV block occurred during an MS pathway ablation that recovered during follow-up and did not require permanent pacing procedure. CONCLUSION: In this single-center experience, ablation of manifest SAP was associated with high success rates and low complication rates. No instances of permanent heart block requiring pacing occurred.

The emergency surgery score (ESS) and outcomes in elderly patients undergoing emergency laparotomy: A post-hoc analysis of an EAST multicenter study.

INTRODUCTION: We sought to evaluate whether the Emergency Surgery Score (ESS) can accurately predict outcomes in elderly patients undergoing emergent laparotomy (EL). METHODS: This is a post-hoc analysis of an EAST multicenter study. Between April 2018 and June 2019, all adult patients undergoing EL in 19 participating hospitals were prospectively enrolled, and ESS was calculated for each patient. Using the c-statistic, the correlation between ESS and mortality, morbidity, and need for ICU admission was assessed in three patient age cohorts (65-74, 75-84, ≥85 years old). RESULTS: 715 patients were included, of which 52% were 65-74, 34% were 75-84, and 14% were ≥85 years old; 51% were female, and 77% were white. ESS strongly correlated with postoperative mortality (c-statistic:0.81). Mortality gradually increased from 0% to 20%-60% at ESS of 2, 10 and 16 points, respectively. ESS predicted mortality, morbidity, and need for ICU best in patients 65-74 years old (c-statistic:0.81, 0.75, 0.83 respectively), but its performance significantly decreased in patients ≥85 years (c-statistic:0.72, 0.64, 0.67 respectively). CONCLUSION: ESS is an accurate predictor of outcome in the elderly EL patient 65-85 years old, but its performance decreases for patients ≥85. Consideration should be given to modify ESS to better predict outcomes in the very elderly patient population.

Prospective validation of the Emergency Surgery Score in emergency general surgery: An Eastern Association for the Surgery of Trauma multicenter study.

BACKGROUND: The Emergency Surgery Score (ESS) was recently developed and retrospectively validated as an accurate mortality risk calculator for emergency general surgery. We sought to prospectively validate ESS, specifically in the high-risk nontrauma emergency laparotomy (EL) patient. METHODS: This is an Eastern Association for the Surgery of Trauma multicenter prospective observational study. Between April 2018 and June 2019, 19 centers enrolled all adults (aged >18 years) undergoing EL. Preoperative, intraoperative, and postoperative variables were prospectively and systematically collected. Emergency Surgery Score was calculated for each patient and validated using c-statistic methodology by correlating it with three postoperative outcomes: (1) 30-day mortality, (2) 30-day complications (e.g., respiratory/renal failure, infection), and (3) postoperative intensive care unit (ICU) admission. RESULTS: A total of 1,649 patients were included. The mean age was 60.5 years, 50.3% were female, and 71.4% were white. The mean ESS was 6, and the most common indication for EL was hollow viscus perforation. The 30-day mortality and complication rates were 14.8% and 53.3%; 57.0% of patients required ICU admission. Emergency Surgery Score gradually and accurately predicted 30-day mortality; 3.5%, 50.0%, and 85.7% of patients with ESS of 3, 12, and 17 died after surgery, respectively, with a c-statistic of 0.84. Similarly, ESS gradually and accurately predicted complications; 21.0%, 57.1%, and 88.9% of patients with ESS of 1, 6, and 13 developed postoperative complications, with a c-statistic of 0.74. Emergency Surgery Score also accurately predicted which patients required intensive care unit admission (c-statistic, 0.80). CONCLUSION: This is the first prospective multicenter study to validate ESS as an accurate predictor of outcome in the EL patient. Emergency Surgery Score can prove useful for (1) perioperative patient and family counseling, (2) triaging patients to the intensive care unit, and (3) benchmarking the quality of emergency general surgery care. LEVEL OF EVIDENCE: Prognostic study, level III.

The Safety and Feasibility of Same-Day Discharge After Implantation of MICRA Transcatheter Leadless Pacemaker System.

BACKGROUND: Data suggests that same day discharge after implantation of trans-venous pacemakers is safe and feasible. We sought to determine whether same day discharge was feasible and safe following implantation of Medtronic MICRA leadless pacemakers. METHODS: We retrospectively identified all patients undergoing MICRA placement at our institution between April 2014 to August 2018 (n=167). Patients were stratified into two groups: those discharged on the same day as their procedure (SD, n=25), and those observed for at least one night in the hospital (HD, n=142). The primary endpoint included a composite of major complications including: access site complications, new pericardial effusion, device dislodgement, and need for device revision up to approximately 45 days of follow up. RESULTS: SD and HD had similar age (75±13 vs. 75±13 years, p=0.923), prevalence of male sex (49 vs. 44%, p=0.669), and frequency of high-grade heart block as an indication for pacing (38 vs. 32%, p=0.596). There were more Caucasians in the SD group (72 vs. 66%, p=0.038). The rate of the composite endpoint was statistically non-significantly higher in the HD group (3.5% vs. 0.0%, p=1.00). The rates of each individual components comprising the composite endpoint were similar between groups. CONCLUSIONS: Our data suggest that in appropriately selected patients, same day discharge can occur safely following Micra leadless pacemaker implantation.

Development of a Risk Score to Predict New Pacemaker Implantation After Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to define risk factors and develop a predictive risk score for new pacemaker implantation (PMI) after transcatheter aortic valve replacement (TAVR). BACKGROUND: TAVR has become an accepted treatment alternative for patients with severe aortic stenosis at elevated surgical risk. New PMI is a common occurrence after TAVR and is associated with poorer outcomes. METHODS: All patients without prior valve procedures undergoing elective TAVR with the Edwards SAPIEN 3 at a single institution (n = 1,266) were evaluated. Multivariate analysis was performed to evaluate for predictors of PMI in this population in a derivation cohort of patients with complete data (n = 778), and this model was used to develop the Emory risk score (ERS), which was tested in a validation cohort (n = 367). RESULTS: Fifty-seven patients (7.3%) in the derivation cohort required PMI. In a regression model, history of syncope (odds ratio [OR]: 2.5; p = 0.026), baseline right bundle branch block (OR: 4.3; p < 0.001), QRS duration ≥138 ms (OR: 2.5; p = 0.017), and valve oversizing >15.6% (OR: 1.9; p = 0.041) remained independent predictors of PMI and were included in the ERS. The ERS was strongly associated with PMI (per point increase OR: 2.2; p < 0.001) with an area under the receiver-operating characteristic curve of 0.778 (p < 0.001), which was similar to its performance in the derivation cohort. CONCLUSIONS: A history of syncope, right bundle branch block, longer QRS duration, and higher degree of oversizing are predictive of the need for PMI after TAVR. Additionally, the ERS for PMI was developed and validated, representing a simple bedside tool to aid in risk stratification for patients for undergoing TAVR.

Preperitoneal balloon tamponade and resuscitative endovascular balloon occlusion of the aorta: Alternatives to open packing for pelvic fracture-associated hemorrhage.

BACKGROUND: The objective of this study was to compare the efficacy of preperitoneal balloon tamponade (PPB), resuscitative endovascular balloon occlusion of the orta (REBOA), and open preperitoneal packing (OP) in a realistic animal model of pelvic fracture-associated hemorrhage. METHODS: Thirty-nine swine underwent creation of open-book pelvic fracture and iliac vascular injury. Animals were randomized to no intervention (n = 7), OP (n = 10), PPB (n = 9), zone 1 REBOA (n = 7), and zone 3 REBOA (n = 6) at a mean arterial pressure less than 40 mm Hg from uncontrolled hemorrhage. Primary outcome was survival at 1 hour. Secondary outcomes included survival in the immediate 10 m following intervention reversal, peak preperitoneal pressure (PP), blood loss, bleed rate, and peak lactate. RESULTS: Prior to injury, no difference was measured between groups for weight, hemodynamics, lactate, and hematocrit (all p = NS). The injury was uniformly lethal without intervention, with survival time (mean) of 5 m, peak PP of 14 mm Hg, blood loss of 960 g, bleed rate of 450 g/m, and peak lactate of 2.6 mmol/L. Survival time (m) was extended to 44 with OP, 60 with PPB, and 60 with REBOA (p < 0.01). Peak PP (mm Hg) was 19 with OP, 23 with PPB, 10 with zone 1 REBOA, and 6 with zone 3 REBOA (p < 0.05). Blood loss (g) was 850 with OP, 930 with PPB, 610 with zone 1 REBOA, and 370 with zone 3 REBOA (p < 0.01). Peak lactate (mmol/L) was 3.3 with OP, 4.3 with PPB, 13.4 with zone 1 REBOA, and 5.3 with zone 3 REBOA (p < 0.01). Only 33% of zone 1 REBOA animals survived the initial 10 m after balloon deflation, compared to 60% for OP, 67% for PPB, and 100% for zone 3 REBOA (p < 0.01). CONCLUSION: Preperitoneal balloon tamponade and zone 3 REBOA are effective alternatives to OP in this animal model of lethal pelvic fracture-associated hemorrhage. Zone 1 REBOA extends survival time but with high mortality upon reversal.

Outcomes of Micra leadless pacemaker implantation with uninterrupted anticoagulation.

BACKGROUND: Implantation of the MICRA Leadless pacemaker requires the use of a 27 French introducer, blunt delivery system and device fixation to the myocardium via nitinol tines. While prior studies have proven its safety, it is unclear whether performing this procedure with uninterrupted anticoagulation exposes patients to increased risks. We sought to investigate the feasibility and safety of continuing therapeutic anticoagulation during the periprocedural period. METHODS: We evaluated all patients undergoing MICRA placement at our institution between April 2014 and August 2018 with complete follow-up data (n = 170). Patients were stratified into two groups: those on active anticoagulation (OAC, n = 26), defined as having an International normalized ratio >2.0 or having continued a direct oral anticoagulant, and those not anticoagulated (Off-OAC, n = 144). We evaluated for a composite outcome of all major complications, including access site complications and pericardial effusion. RESULTS: OAC and Off-OAC groups had similar mean age (74 ± 13 vs 75 ± 13 years; P = .914). The OAC group had a nonsignificantly lower prevalence of end-stage renal disease (8% vs 17%; P = .375) and aspirin use (27% vs 47%; P = .131). Those in the OAC group were more likely to be on warfarin than those in the Off-OAC group (81% vs 30%; P < .001). The rate of the composite endpoint was similar between the OAC and Off-OAC groups (3.8 % vs 1.4%, respectively; P = .761). Length of stay was similar between groups (1.3 ± 2.6 vs 2.3 ± 3.4 days; P = 0.108). CONCLUSION: Continuation of therapeutic anticoagulation during MICRA implantation appears to be feasible, safe and associated with shorter hospitalization among appropriately selected individuals.

Minimally invasive preperitoneal balloon tamponade and abdominal aortic junctional tourniquet versus open packing for pelvic fracture-associated hemorrhage: Not all extrinsic compression is equal.

BACKGROUND: Minimally invasive preperitoneal balloon tamponade (PPB) and abdominal aortic junctional tourniquets (AAJT) have been proposed as alternatives to open preperitoneal packing (OP) for the management of pelvic fracture-associated hemorrhage. We hypothesized that the PPB (SpaceMaker Pro) and AAJT would result in similar rates of survival and blood loss versus OP. METHODS: Thirty-two swine underwent creation of a combined open-book pelvic fracture and major iliac vascular injuries. Animals were randomized to no intervention (n = 7), OP (n = 10), PPB (n = 9), or AAJT (n = 6) at a mean arterial pressure <40 mm Hg following initiation of uncontrolled hemorrhage. Survival (up to 60 minutes + 10 minutes after intervention reversal), hemodynamics, extraperitoneal pressures, blood loss, and associated complications were compared between groups. RESULTS: Prior to injury, no difference was measured between groups for weight, hemodynamics, lactate, and hematocrit (all p > 0.05). The injury was uniformly lethal without intervention, with survival time (mean) of 5 minutes, peak preperitoneal pressure (PP) of 14 mm Hg, blood loss of 960 g, and peak lactate of 2.6 mmol/L. Survival time was 44 minutes with OP versus 60 minutes with PPB and AAJT (p < 0.01). Peak PP (mm Hg) was 19 with OP, 23 with PPB, and 23 with AAJT (p > 0.05). Blood loss (g) was 850 with OP, 930 with PPB, and 600 with AAJT (p > 0.05). Peak lactate (mmol/L) was 3.3 with OP, 4.3 with PPB, and 6.3 with AAJT (p < 0.01). Only 33% of AAJT animals survived intervention reversal versus 60% for OP and 67% for PPB (p < 0.01). Necropsy revealed bowel/bladder injury in 50% of AAJT subjects versus 0% in all other arms (p < 0.01). CONCLUSION: Preperitoneal balloon tamponade is a safe and potentially effective alternative to OP for the management of lethal pelvic fracture-associated hemorrhage. Abdominal aortic junctional tourniquet offers a similar survival benefit to PPB but has concerning rates of ischemia-reperfusion and compressive abdominal organ injury.

Impact of a novel phosphoinositol-3 kinase inhibitor in preventing mitochondrial DNA damage and damage-associated molecular pattern accumulation: Results from the Biochronicity Project.

BACKGROUND: Despite improvements in the management of severely injured patients, development of multiple organ dysfunction syndrome (MODS) remains a morbid complication of traumatic shock. One of the key attributes of MODS is a profound bioenergetics crisis, for which the mediators and mechanisms are poorly understood. We hypothesized that metabolic uncoupling using an experimental phosphoinositol-3 kinase (PI3-K) inhibitor, LY294002 (LY), may prevent mitochondrial abnormalities that lead to the generation of mitochondrial DNA (mtDNA) damage and the release of mtDNA damage-associated molecular patterns (DAMPs). METHODS: Sixteen swine were studied using LY, a nonselective PI3-K inhibitor. Animals were assigned to trauma only (TO, n = 3), LY drug only (LYO, n = 3), and experimental (n = 10), trauma + drug (LY + T) groups. Both trauma groups underwent laparotomy, 35% hemorrhage, severe ischemia-reperfusion injury, and protocolized resuscitation. A battery of hemodynamic, laboratory, histological, and bioenergetics parameters were monitored. Mitochondrial DNA damage was determined in lung, liver, and kidney using Southern blot analyses, whereas plasma mtDNA DAMP analysis used polymerase chain reaction amplification of a 200-bp sequence of the mtDNA D-loop region. RESULTS: Relative to control animals, H + I/R (hemorrhage and ischemia/reperfusion) produced severe, time-dependent decrements in hepatic, renal, cardiovascular, and pulmonary function accompanied by severe acidosis and lactate accumulation indicative of bioenergetics insufficiency. The H-I/R animals displayed prominent oxidative mtDNA damage in all organs studied, with the most prominent damage in the liver. Mitochondrial DNA damage was accompanied by accumulation of mtDNA DAMPs in plasma. Pretreatment of H + I/R animals with LY resulted in profound metabolic suppression, with approximately 50% decreases in O2 consumption and CO2 production. In addition, it prevented organ and bioenergetics dysfunction and was associated with a significant decrease in plasma mtDNA DAMPs to the levels of control animals. CONCLUSIONS: These findings show that H + I/R injury in anesthetized swine is accompanied by MODS and by significant mitochondrial bioenergetics dysfunction, including oxidative mtDNA damage and accumulation in plasma of mtDNA DAMPs. Suppression of these changes with the PI3-K inhibitor LY indicates that pharmacologically induced metabolic uncoupling may comprise a new pharmacologic strategy to prevent mtDNA damage and DAMP release and prevent or treat trauma-related MODS. LEVEL OF EVIDENCE: Therapeutic study, level III.

There's an app for that: A handheld smartphone-based infrared imaging device to assess adequacy and level of aortic occlusion during REBOA.

BACKGROUND: Advances in thermal imaging devices have made them an appealing noninvasive point-of-care imaging adjunct in the trauma setting. We sought to assess whether a smartphone-based infrared imaging device (SBIR) could determine presence and location of aortic occlusion in a swine model. We hypothesized that various levels of aortic occlusion would transmit significantly different heat signatures at various anatomical points. METHODS: Six swine (35-50 kg) underwent sequential zone 1 (Z1) aortic cross clamping as well as zone 3 (Z3) aortic balloon occlusion (resuscitative endovascular balloon occlusion of the aorta [REBOA]). SBIR images and readings (FLIR One) were taken at five anatomic points (axilla [A], subcostal [S], umbilical [U], inguinal [I], medial malleolar [M]) and were used to determine significant thermal trends 5 minutes to 10 minutes after Z1 and Z3 occlusion. Significant (p ≤ 0.05) thermal ratio patterns were identified and compared among groups, and images were reviewed for obvious qualitative differences at the various levels of occlusion. RESULTS: Body temperatures were similar during control (CON), Z1 occlusion, and Z3 occlusion, ranging from 94.0 °F to 100.9 °F (p = 0.126). No significant temperature differences were found among A, S, U, I, M points prior to and after aortic occlusions. Among the anatomical 2-point ratios evaluated, A/M and S/M ratios were the best predictors of aortic occlusion, whether at Z1 (8.2 °F, p < 0.01; 10.9 °F, p < 0.01) or Z3 (7.3 °F, p < 0.01; 8.4 °F, p < 0.01), respectively. The best predictor of Z1 versus Z3 level of occlusion was the S/I ratio (5.2 °F, p < 0.05 vs. 3.4 °F, p = 0.27). SBIR generated qualitatively different thermal signatures among groups. CONCLUSION: SBIR was capable of detecting thermal trends during Z1 and Z3 aortic occlusion by using an anatomical 2-point thermal ratio. There were also easily recognized qualitative differences between control and occlusion images that would allow immediate determination of adequate occlusion of the aorta. SBIR represents a potential inexpensive and accurate tool for assessing perfusion, adequate REBOA placement, and even the aortic level of occlusion.

Diastolic pulmonary gradient predicts outcomes in group 1 pulmonary hypertension (analysis of the NIH primary pulmonary hypertension registry).

BACKGROUND: Diastolic pulmonary gradient (DPG), calculated as the difference between pulmonary artery diastolic pressure and mean pulmonary capillary wedge pressure ≥ 7 mmHg is associated with pulmonary vascular disease and portends poor prognosis in heart failure (HF). The prognostic relevance of DPG in group 1 pulmonary hypertension (PH) is uncertain. METHODS: Using the Pulmonary Hypertension Connection (PHC) risk equation for 225 patients in the NIH-PPH, the 5-year probability of death was calculated, which was then compared with DPG using a Cox proportional hazards model. Kaplan-Meier survival curves were determined for two cohorts using the median DPG of 30 mmHg as cutoff, and significance was tested using the log-rank test. RESULTS: The mean age was 38.1 ± 16.0 years old, 63% female, and 72% were "white". The mean DPG was 31.6 mmHg ± 13.8 mm Hg and only 1.8% had a DPG <7 mm Hg. Increasing DPG was significantly associated with increased 5-year mortality even after adjustment for the PHC risk equation (HR 1.29 per 10 mm Hg increase). When DPG was dichotomized based on the median of 30 mm Hg, the HR for DPG >30 mm Hg with respect to 5-year mortality was 2.03. After adjustment for pulmonary artery systolic pressure (PASP), increasing DPG remained significantly associated with decreased 5 years survival (HR 1.99 for DPG > 30 mm Hg). CONCLUSIONS: DPG is independently associated with survival in group 1 PH patients even after adjustment for the PHC risk equation or PASP. Patients with increased DPG had a 2-fold increased risk of mortality. The use of DPG for guiding treatment and prognosis in group 1 PH should be further investigated.

Preperitoneal balloon tamponade for lethal closed retroperitoneal pelvic hemorrhage in a swine model: A comparable and minimally invasive alternative to open pre-peritoneal pelvic packing.

BACKGROUND: The management of massive pelvic fracture-associated hemorrhage is extremely challenging, particularly in the unstable patient. We sought to characterize and compare the efficacy of a minimally invasive preperitoneal balloon technique (MIB) to standard open packing. METHODS: Twenty-six swine were randomized to control (C), open preperitoneal packing technique (OP), and MIB groups. A closed extraperitoneal iliac vascular injury followed by intervention + resuscitation over a 120-minute OP and MIB efficacy was assessed by procedure time, hemodynamics, extraperitoneal tamponade pressures (ETPs), blood loss, and survival. Angiography was performed in select animals, and ETPs were also measured in humans undergoing MIB placement for an elective procedure. RESULTS: Baseline parameters (mean arterial pressure [MAP] 29, 38, and 38 mm Hg; cardiac index [CI] 3.5, 3.8, and 4.2; and EPTs 5, 4, and 5 mm Hg) were similar among C, OP, and MIB groups, respectively (all p's > 0.05). The OP and MIB groups had markedly improved MAP and CI versus C. MIB generated significantly higher ETP (28 vs 17 mm Hg), was faster to deploy (164 vs 497 seconds), and had lower total blood loss versus OP (0.7 vs 1.2 L, all p's < 0.05). OP and MIB had equivalent survival times that were significantly improved versus C (91 and 116 vs 43 minutes, p < 0.05). Survival to 2 hours was 80% with OP versus 100% in the MIB group. Angiography showed no active extravasation in both study groups, but controlled partial deflation of the MIB allowed easy visualization of extravasation. Minimally invasive preperitoneal balloon inflation in five human subjects demonstrated a significant increase in mean ETP from 2.4 to 31 mm Hg (p < 0.01). CONCLUSION: Minimally invasive preperitoneal balloon tamponade was as effective as OP in improving hemodynamics and prolonging survival times, and performed superiorly to OP in time to placement, blood loss, and generation of tamponade pressures. The MIB allows for controlled deflation and reinflation to facilitate angiographic interventions, and may represent a promising new bedside intervention in this patient population.