Neurocognitive Dysfunction After Short (<20 Minutes) Duration Hypothermic Circulatory Arrest.

BACKGROUND: It has long been held that the safe duration of hypothermic circulatory arrest (HCA) is at least 25-30 minutes. However, this is based primarily on clinical outcomes research and has not been systematically investigated using more sensitive brain imaging and neurocognitive assessments. METHODS: This exploratory sub-study of the randomized GOT ICE trial, which compared outcomes for deep versus moderate hypothermia during arch surgery, investigated the frequency of neurocognitive and structural and functional magnetic resonance imaging (MRI) deficits with short (<20 minutes) duration HCA. Neurocognitive deficit was defined as >1 standard deviation decline in >1 of 5 cognitive domains on neurocognitive testing. RESULTS: Of 228 GOT ICE patients with complete 4-week cognitive data, 74.6% (n=170/228) had HCA durations <20 minutes, including 59 randomized to deep (<20.0°C), 55 low-moderate (20.1-24.0°C), and 56 high-moderate (24.1-28.0°C) hypothermia. Of these, cognitive deficit was detected 4-weeks post-surgery in ∼40% of patients in all 3 groups [deep: 22/59 (37.3%); low-moderate: 23/55 (41.8%); high-moderate: 24/56 (42.9%)]. Furthermore, in a subset of patients with complete MRI data (n=43), baseline to 4-week post-surgery right frontal lobe functional connectivity change was inversely associated with HCA duration (range 8-17 minutes; p-FWE<0.01). CONCLUSIONS: Even short durations of HCA result in cognitive deficits in ∼40% of patients, independent of systemic hypothermia temperature. HCA duration was inversely associated with frontal lobe functional MRI connectivity, suggesting this brain region may be preferentially sensitive to HCA. Surgeons should be aware that even short durations of HCA may not provide complete neuroprotection following aortic arch surgery.

Hospital and Surgeon Surgical Valvar Volume and Survival after Multi-Valve Cardiac Surgery in Medicare Beneficiaries.

OBJECTIVE: Long-term outcomes after multi-valve cardiac surgery remain under-evaluated. METHODS: Medicare administrative claims from 2008-2019 identified beneficiaries undergoing multi-valve surgery. Operative characteristics were doubly-adjudicated using International Classification of Diseases and Current Procedural Technology codes. A multivariable flexible parametric model evaluated predictors of survival; regression standardization was performed to predict standardized survival probabilities (SSP) at varying percentiles of annual valvar volume. RESULTS: Of 476,092 cardiac surgeries involving the aortic (AVS), mitral (MVS), or tricuspid (TVS) valve, 63,083 (13.3%) were identified as involving multi-valve surgery: 22,884 MVS+TVS, 30,697 AVS+MVS, 3,443 AVS+TVS and 6,059 AVS+MVS+TVS. Surgery occurred at 1,157 hospitals by 2,922 surgeons. Annual valvar volume (total AVS+MVS+TVS) was tallied for surgeons and hospitals. Median survival varied substantially by type of multi-valve surgery: 8.09 [7.90-8.24] years in MVS/TVS, 6.65 [6.49-6.81] years in AVS/MVS, 5.77 [5.37-6.13] in AVS/TVS, and 6.02 [5.64-6.38] in AVS/MVS/TVS. SSPs were calculated across combined hospital/surgeon volume percentiles; the median SSP increased with increasing percentile of combined hospital/surgeon volume: 5%tile: 5.77 [5.58,5.98], 25%tile: 6.18 [6.07,6.28], 50%tile: 6.56 [6.44,6.68], 75%tile: 6.86 [6.75,6.97], and 95%tile: 7.58 [7.34,7.83] years, respectively. CONCLUSIONS: Survival varied significantly by type of multi-valve surgery, worsened with addition of concomitant interventions and improved substantially with increasing annual hospital and surgeon volume. Hospital volume was associated with an improved early hazard for death that abated beyond 3 months post-surgery), while surgeon volume was associated with an improved hazard for death that persisted even beyond the first post-operative year. Consideration should be given to referring multi-valve cases to high-volume hospitals and surgeons.

Five-Year Outcomes of Measured and Predicted Prosthesis-Patient Mismatch following Transcatheter Aortic Valve Implantation.

Data on the long-term outcomes of prosthesis patient mismatch (PPM) after transcatheter aortic valve implantation (TAVI) remain controversial. This study aimed to investigate the incidence and clinical outcomes of measured PPM (PPMM) and predicted PPM (PPMP) in patients who underwent TAVI. This is a retrospective analysis of 3,016 patients who underwent TAVI at a large health care system between 2012 and 2021. Effective orifice area indexed to body surface area (EOAi) was measured at discharge using the continuity equation. EOAi was predicted according to the published predictive tables for each model and size of the valve. Primary end point was 5-year survival rate. Mean age was 80 years, and 55.6% were male. The mean Society of Thoracic Surgeons risk score was 4.66%. 74.9% of patients received a balloon-expandable valve (BEV), and 25.1% received a self-expanding valve (SEV). The incidence of severe PPM was markedly lower when defined by predicted versus measured EOAi (0.8% vs 6.3%, p <0.001) and when assessed in SEV versus BEV (5.3% vs 6.6%, p = 0.02). Neither severe PPMp nor severe PPMM was associated with 5-year mortality (hazard ratio 1.26, 95% confidence interval 0.96 to 1.66, p = 0.095; hazard ratio 1.03, 95% confidence interval 0.42 to 2.49, p = 0.954, respectively), irrespective of the presence of high residual pressure gradient. Neither BEV nor SEV was associated with an increased 5-year mortality, irrespective of PPM definition or severity. In this large health care system analysis, neither severe PPMP nor severe PPMM was associated with 5-year all-cause mortality. There was no difference between BEV and SEV in terms of mortality, irrespective of the definition or severity of PPM.

The Mayo Leadership Impact Index Adapted for Matrix Leadership Structures: Initial Validity Evidence.

Importance: Physician burnout has reached crisis levels. Supportive leadership is one of the strongest drivers of physician well-being, and monitoring supervisor support is key to developing well-being focused leadership skills. Existing measures of leader support were designed within "direct report" supervision structures limiting their applicability to matrixed leadership reporting structures where direct reports are not the predominant norm. Antecedently, no measure of leadership support is validated specifically for implementation in matrixed leadership structures. Objective: Adapt and validate the Mayo Leadership Impact Index (MLII) for settings with matrixed leadership structures. Design: A psychometric validation study utilizing classical test theory and item response theory. Setting: A tripartite hospital system in the southwestern US. Participants: Physician-respondents to a 2023 cross-sectional survey. Main Outcomes and Measures: After pilot testing, the adapted MLII was examined using a unidimensional graded response model and confirmatory factor analyses. Convergent validity was investigated via correlations with professional fulfillment, perceived autonomy support, self-valuation, and peer connectedness/respect. Divergent validity was tested via correlations with burnout. Results: Of the three candidate revisions of the MLII, the 9-item adaptation was selected for its superior validity/reliability indices. Standardized Cronbach's and Ordinal alpha coefficients were 0.958 and 0.973, respectively. CFA loadings exceeded 0.70 (p < 0.001), and coefficients of variation (R2) exceeded 0.60 for all items. GRM slope parameters indicated "high" to "very high" item discrimination. Items 2, 5, and 8 were the most informative. Positive correlations of the adapted MLII with professional fulfillment, perceived autonomy support, and peer connectedness/respect were observed, supporting convergent validity. Negative correlation with overall burnout supports divergent validity. Conclusions and Relevance: The findings provide evidence of the adapted MLII's validity, reliability, and appropriateness for implementation within matrixed leadership settings. Prior to this study, no leadership support measure had been validated for use among the growing number of healthcare systems with matrixed leadership reporting structures.

Question: : What is the validity and reliability of a well-being centered leadership measure adapted for use in healthcare systems with matrixed, multiform reporting structures? Findings: : Classical test theory and item response theory analyses of cross-sectional survey data from 158 physician-respondents supported the adapted measure's construct validity. All reliability coefficients were strong. Leadership ratings positively correlated with professional fulfillment, autonomy support, self-valuation, and peer connectedness/respect, and negatively correlated with burnout. Meaning: : Findings support the adapted measure's validity and reliability. This study is the first to demonstrate a valid empirical measure of well-being centered leadership behaviors in settings with multiform, matrixed leadership structures.

Transcatheter Valve-in-Valve Replacement With Balloon- Versus Self-Expanding Valves in Patients With Degenerated Stentless Aortic Bioprosthesis.

Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been associated with favorable outcomes in patients with degenerated stentless bioprosthesis. However, whether the outcomes after ViV TAVR for failed stentless bioprosthesis differ between balloon-expandable valves (BEVs) and self-expanding valves (SEVs) remains unknown. Therefore, we retrospectively analyzed 59 consecutive patients who underwent ViV TAVR for failed stentless bioprsothesis with BEVs (n = 42) versus SEVs (n = 17) in a single-health care system between 2013 and 2022. Overall, the mean age was 70.8 years and 74.6% were men. The mean transcatheter valve size was 26.3 ± 2.2 mm for BEVs and 26.4 ± 4 mm for SEVs (p = 0.93). The mean Society of Thoracic Surgeons score was 6.0 ± 3.6 for BEVs and 7.5 ± 5.5 for SEVs (p = 0.22). Compared with patients who received BEVs, those who received SEVs had higher rates of device malposition (2.4% vs 23.5%, p <0.01), postdeployment balloon dilation (11.9% vs 35.5%, p = 0.04) and need for a second transcatheter device (2.4% vs 35.5%, p <0.01). However, both groups showed similar improvement in aortic valve function at 30-day and 1-year follow-up (incidence of 1-year severe patient-prosthesis mismatch in BEVs: 17.6% vs 14.3% in SEVs, p = 0.78). The 1- and 3-year mortality did not differ between BEVs and SEVs (11.9% vs 11.8% and 25% vs 30%, respectively, Log rank p = 0.9). In conclusion, performing ViV TAVR for failed stentless bioprsothesis is technically challenging, especially when using SEVs; however, satisfactory positioning is possible in most cases, with excellent hemodynamic and clinical outcomes with BEVs and SEVs.

Risk of Transfusion in Isolated Coronary Artery Bypass Graft: Models Developed From The Society of Thoracic Surgeons Database.

BACKGROUND: Perioperative blood transfusion is associated with adverse outcomes and higher costs after coronary artery bypass graft (CABG) surgery. We developed risk assessments for patients' probability of perioperative transfusion and the expected transfusion volume to improve clinical management and resource use. METHODS: Among 1,266,545 consecutive (2008-2016) isolated CABG operations in The Society of Thoracic Surgeons Adult Cardiac Surgery Database, 657,821 (51.9%) received perioperative transfusions of red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate, and/or platelets. We developed "full" models to predict perioperative transfusion of any blood product, and of RBC, FFP, or platelets. Using least absolute shrinkage and selection operator model selection, we built a rapid risk score based on 5 variables (age, body surface area, sex, preoperative hematocrit, and use of intra-aortic balloon pump). RESULTS: C statistics for the full model were 0.785, 0.815, 0.707, and 0.699 for any blood product, RBC, FFP, and platelets, respectively. C statistics for rapid risk assessments were 0.752, 0.785, 0.670, and 0.661 for any blood product, RBC, FFP, and platelets, respectively. The observed vs expected risk plots showed strong calibration for full models and risk assessment tools; absolute differences between observed and expected risks of transfusion were <10.8% in each percentile of expected risk. Risk assessment-predicted probabilities of transfusion were strongly and nonlinearly associated (P < .0001) with total units transfused. CONCLUSIONS: These robust and well-calibrated risk assessment tools for perioperative transfusion in CABG can inform surgeons regarding patients' risks and the number of RBC, FFP, and platelets units they can expect to need. This can aid in optimizing outcomes and increasing efficient use of blood products.

Midterm durability of valve-sparing root replacement in bicuspid and tricuspid aortic valves.

Background: Among patients with bicuspid aortic valves (BAV) who are potential candidates for valve-sparing root replacement (VSRR), the long-term durability of this technique is not well understood. This study aimed to compare the clinical and echocardiographic outcomes of VSRR in those with BAV and tricuspid aortic valve (TAV) morphology. Methods: This was a retrospective analysis of patients who underwent VSRR between 2007 and 2021 at a single center. Kaplan-Meier and log-rank analysis were used to estimate and compare freedom from mortality, progression to >2+ aortic insufficiency (AI), and reoperation between groups (BAV vs TAV). Preoperative and postoperative echocardiographic data were collected and assessed for temporal changes in mixed-effect models. Results: A total of 185 patients (BAV, n = 52, 28.1%; TAV, n = 133, 71.9%) underwent VSRR. At baseline, BAV patients were younger (42.4 ± 11.6 vs 52.3 ± 12.6 years; P < 0.01) and had more severe AI (47.9% vs 27.0%; P = 0.02). Average cardiopulmonary bypass and cross-clamp times were similar. There were no differences in rates of postoperative complications, intensive care unit or hospital days, or 30-day readmission. TAV patients' 1-, 5-, and 8-year survival rates were 99.2% [95% CI 97.8-100], 96.7% [93.5-99.9%], and 92.2% [85.6-99.3%], respectively. Overall, there were no differences between groups regarding freedom from mortality (P = 0.18), reoperation (P = 0.51), or recurrent >2+ AI (P = 0.97). . Conclusions: VSRR can be safely performed on patients with BAV and TAV morphology, yielding similar midterm freedom from mortality, recurrent >2+ AI, and reoperation. This technique should be considered in carefully selected patients with aortic root pathology and BAV anatomy when performed at experienced centers.

A Report of Salaries of Academic Cardiothoracic Surgeons Based on Race and Ethnicity.

BACKGROUND: Diversity in the physician workforce improves patient care, physician well-being, and innovation. Workforce diversity is dependent on fair compensation that is unbiased by race or ethnicity. The purpose of this study was to determine whether a disparity of representation and salary on the basis of race or ethnicity exists in academic cardiothoracic surgery. METHODS: Study investigators performed a cross-sectional analysis of data collected by the Accreditation Council of Graduate Medical Education (ACGME) and the Association of American Medical Colleges (AAMC) faculty data for US medical school faculty 2021 and 2022. Salary data were not available if an academic rank and race or ethnicity had fewer than 6 cardiothoracic surgeons. Study investigators performed a descriptive analysis of the number of faculty and compared median and mean salaries according to academic rank using a paired t test. RESULTS: Of the 758 academic cardiothoracic surgeons, 64.9% were White, 25.2% were Asian, 3.3% were Black or African American, 4.9% were Hispanic or Latino, and 1.7% were of other race or ethnicity. Cardiothoracic surgeons at the academic rank of professor were 74.6% White, 17.7% Asian, 3.4% Black or African American, 3.9% Hispanic or Latino, and 0.4% other races. Asian faculty earned 89% to 171%, Black or African American faculty earned 59% to 94%, and Hispanic or Latino faculty earned 84% to 165% of the median salary earned by White faculty. Black or African American faculty consistently and significantly (P = .002) earned lower median salaries compared with White faculty at each academic rank measured. CONCLUSIONS: The academic cardiothoracic surgery workforce lacks diversity, especially at the highest academic ranks. Salary equity among races or ethnicities is complex, requiring additional study. However, Black or African American cardiothoracic surgeons experience low representation and salary disparity at every academic rank measured.

Acute Coronary Syndrome Revascularization Strategies With Multivessel Coronary Artery Disease.

In acute coronary syndromes (ACS), revascularization is the standard of care. However, trials comparing contemporary coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) are limited. Optimal revascularization in patients with multivessel coronary artery disease (MV-CAD) presenting with ACS is unclear. This is a multicentered, retrospective observational study from a large hospital system in the United States. We abstracted data in patients with MV-CAD and ACS from 2018 to 2022 who underwent revascularization with PCI, CABG, or medical management (MM). We evaluated multivariate statistics comparing categorical variables and outcomes, including all-cause mortality and myocardial infarction (MI) at 1 year. All logistic and Cox proportional-hazard models were balanced using inverse probability treatment weights accounting for age and gender. There were 295 patients with CABG (median age 66 years [interquartile range 59.7 to 73.1]; 73% male), 1,559 patients with PCI (median age 68.3 years [interquartile range 60 to 76.6]; 69.1% male], and 307 patients with MM (median age 70 years [60.9 to 77.1] 74% male]. Patients revascularized with PCI had greater all-cause mortality at 1 year (14.1% vs 5.1%; hazard ratio 2.4, confidence interval [1.5 to 3.8], p <0.001) and similar mortality to MM (13.4%). CABG also showed a reduced 1-year MI rate compared with PCI (1.7% vs 3.9%; hazard ratio 0.36, confidence interval 0.21 to 0.61, p ≤0.001), with a similar 1-year rate of MI to MM (3.9%). In conclusion, CABG is associated with lower mortality than are PCI and MM, and repeat ACS events at 1 year in patients with ACS and MV-CAD.

Causes and Clinical Outcomes of Patients Who Failed Screening for Transcatheter Tricuspid Valve Interventions.

Transcatheter tricuspid valve intervention (TTVI) has recently emerged as a promising alternative to surgery for tricuspid regurgitation (TR). However, a significant proportion of patients fail screening for TTVI, and little is known about their characteristics and natural history. This study sought to investigate causes of screen failure and outcomes of patients declined for TTVI. This was a retrospective single-center study of 32 patients who were ineligible for participation in transcatheter tricuspid valve replacement and tricuspid transcatheter edge-to-edge repair trials. Patients were classified into 2 groups according to the therapy they received: optimized medical therapy (OMT) group or intervention group. The mean age was 82 ± 7.8 years and 68.8% were women. The most common reasons for TTVI exclusion were anatomic/procedural impediment (53.1%), inclusion criteria not met (40.6%), and multivalvular disease (6.3%). Overall, 19 patients (59.4%) did not undergo subsequent tricuspid intervention. The clinical outcomes of these patients who received OMT alone were poor, with a 1-year composite of cardiac death or heart failure readmission of 47.4%. These rates were worse than in patients who subsequently underwent an intervention, albeit not statistically significant (OMT: 47.7% vs 23.1% interventions, p = 0.3), and were significantly more pronounced in the subgroup of patients who were excluded for anatomic/procedural limitations (OMT: 70% vs 14.3% interventions, p = 0.05). In conclusion, patients ineligible for TTVI, particularly, those with anatomic/procedural limitations, and treated medically have poor outcomes. These data underscore the importance of earlier referral and support the need for further transcatheter therapy iterations.

Distal Versus Proximal Radial Artery Access for Cardiac Catheterization: 1-Year Outcomes.

Proximal radial artery (PRA) access for cardiac catheterization is safe but can jeopardize subsequent use of the artery because of occlusion. Distal radial artery (DRA) access in the anatomical snuffbox preserves the RA but safety and potential detrimental effects on hand function are unknown. We aimed to assess hand function and complications after DRA and PRA. In this single-center trial, 300 patients were randomly allocated 1:1 to cardiac catheterization through DRA or PRA. The primary end point of change in hand function from baseline to 1 year was a composite of the Quick Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, hand grip test, and thumb-forefinger pinch test. The secondary end points included access feasibility and complications. Of 216 patients with 1-year completed follow-up, 112 were randomly allocated to DRA and 104 to PRA, with balanced demographics and procedural characteristics. Both groups had similar access site bleeding rates (DRA 0% vs PRA 1.4%, p = 0.25). Radial artery occlusion occurred in 1 PRA patient versus 2 in DRA. There was no significant difference in change of hand function, median (interquartile range) hand grip (DRA 0.7 [-3 to 4.5] vs PRA 1.3 [-2 to 4.3] kg, p = 0.57), pinch grip (DRA -0.1 [-1.1 to 1] vs PRA -0.3 [-1 to 0.7] kg, p = 0.66), and Quick DASH (DRA 0 [-6.6 to 2.3] vs PRA 0 [-4.6 to 2.9] points, p = 0.58). The composite of hand function was comparable between PRA and DRA. In conclusion, DRA is a safe strategy for cardiac catheterization, with a low complication rate. Compared with PRA, there is no increased risk of hand dysfunction or radial artery occlusion at 1 year.

A comprehensive deep venous thrombosis prophylaxis regimen in isolated coronary artery bypass grafting.

Objectives: Deep venous thrombosis (DVT) is a known surgical complication that can lead to pulmonary embolism with subsequent morbidity and mortality. The incidence of DVT following coronary artery bypass grafting is unclear. Prophylaxis regimens vary and some guidelines advocate against use of routine chemoprophylaxis in patients at low-moderate risk for venous thromboembolism. We utilized postoperative lower extremity venous ultrasound to determine the incidence of DVT following coronary artery bypass grafting in patients with low- to moderate-risk of venous thromboembolism receiving aggressive postoperative DVT prophylaxis. Methods: This is a single-center, retrospective study of all patients who underwent coronary artery bypass grafting between April 2022 and January 2023. All patients who completed postoperative venous ultrasound of the bilateral lower extremities were initially included. Patients who underwent concurrent valve or aortic surgery, were at high risk of venous thromboembolism, or were receiving anticoagulation therapy for nonvenous thromboembolism indications were excluded. The primary outcome was in-hospital incidence of DVT. Secondary outcomes were rates of mortality, postoperative bleeding, and thromboembolic events from discharge to 30 days postoperatively and from 30 days to 3 months postoperatively. Results: No DVTs were observed in 211 included patients. In hospital, there were 3 significant bleeding events and 1 stroke. Following discharge there were 3 additional bleeding events, 1 death, 1 transient ischemic attack, and 1 pulmonary embolism. Conclusions: We observed a 0% rate of DVT in low- to moderate-risk patients undergoing isolated coronary artery bypass grafting and receiving a comprehensive DVT prophylaxis regimen. In hospital bleeding and other thromboembolic event rates were 2.84% and 0.47% respectively.

Predicting risk of tracheostomy after cardiac surgery: a decade of insights from nearly 10,000 patients.

Objective: Studies have shown that requiring tracheostomy following cardiac surgery has significant implications on outcomes. This study proposes a risk stratification model to predict the likelihood of requiring a tracheostomy after cardiac surgery. Methods: Patients who underwent cardiac surgery between January 2010 and December 2019 were analyzed. Kaplan-Meier analysis and log-rank test were used to estimate and compare survival between cohorts. A prediction model for the need for postoperative tracheostomy was developed with logistic regression combined with undersampling analysis. Results: A total of 9849 patients underwent cardiac surgery, and 176 (1.8%) required postoperative tracheostomy. Tracheostomy patients were older (mean age 68.4 ± 12.3 vs 65.9 ± 11.2 years; P < 0.01) and more likely female (43.8% vs 28.5%; P < 0.01). Predictors for requiring tracheostomy included hypertension (odds ratio [OR] 1.91; P = 0.05), New York Heart Association III/IV (OR 2.68; P < 0.001), chronic lung disease (OR 3.27; P < 0.001), and history of prior myocardial infarction (OR 3.32; P < 0.001). Three-year Kaplan-Meier survival was worse in patients who received tracheostomy (log-rank P < 0.001). Conclusions: A risk prediction model for requiring tracheostomy after cardiac surgery is proposed in this study. A history of New York Heart Association III/IV, chronic lung disease, and myocardial infarction as well as undergoing valve surgeries were associated with increased risk of requiring a tracheostomy.

Impact of iodinated contrast shortage on contrast-associated acute kidney injury: a single center experience.

Background: In March 2022, a COVID-19 outbreak disrupted the global supply of iodine contrast media (ICM). Healthcare systems implemented contrast-saving strategies to maintain their remaining ICM supplies. This study sought to determine the impact of contrast shortage on the incidence of contrast-associated acute kidney injury (CA-AKI). Methods: This was a retrospective study of 265 patients undergoing 278 percutaneous coronary interventions (PCI) during 4-month periods prior to (9/1/2021 to 12/31/2021) and during (5/1/2022 to 8/31/2022) contrast shortage at a single center. The primary endpoint was the incidence of CA-AKI between study periods. Results: A total of 148 and 130 PCIs were performed before and during contrast shortage, respectively. The incidence of CA-AKI significantly decreased from 11.5% to 4.6% during contrast shortage (P = 0.04). During the shortage, average contrast volume per PCI was significantly lower (123 ± 62 mL vs 88 ± 46 mL, P < 0.001), while coronary imaging was significantly higher (34.3% vs 50%, P = 0.009) compared to preshortage. All-cause mortality at discharge was comparable between study periods (2.8% vs 3.3%, respectively; P = 0.90). Conclusion: The scarcity of ICM for PCI procedures in this single-center experience was associated with a significant increase in the utilization of intravascular imaging and a significant reduction in CA-AKI.

Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest Trial (GOT ICE): A Randomized Clinical Trial Comparing Outcomes After Aortic Arch Surgery.

BACKGROUND: Deep hypothermia has been the standard for hypothermic circulatory arrest (HCA) during aortic arch surgery. However, centers worldwide have shifted toward lesser hypothermia with antegrade cerebral perfusion. This has been supported by retrospective data, but there has yet to be a multicenter, prospective randomized study comparing deep versus moderate hypothermia during HCA. METHODS: This was a randomized single-blind trial (GOT ICE [Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest]) of patients undergoing arch surgery with HCA plus antegrade cerebral perfusion at 4 US referral aortic centers (August 2016-December 2021). Patients were randomized to 1 of 3 hypothermia groups: DP, deep (≤20.0 °C); LM, low-moderate (20.1-24.0 °C); and HM, high-moderate (24.1-28.0 °C). The primary outcome was composite global cognitive change score between baseline and 4 weeks postoperatively. Analysis followed the intention-to-treat principle to evaluate if: (1) LM noninferior to DP on global cognitive change score; (2) DP superior to HM. The secondary outcomes were domain-specific cognitive change scores, neuroimaging findings, quality of life, and adverse events. RESULTS: A total of 308 patients consented; 282 met inclusion and were randomized. A total of 273 completed surgery, and 251 completed the 4-week follow-up (DP, 85 [34%]; LM, 80 [34%]; HM, 86 [34%]). Mean global cognitive change score from baseline to 4 weeks in the LM group was noninferior to the DP group; likewise, no significant difference was observed between DP and HM. Noninferiority of LM versus DP, and lack of difference between DP and HM, remained for domain-specific cognitive change scores, except structured verbal memory, with noninferiority of LM versus DP not established and structured verbal memory better preserved in DP versus HM (P = 0.036). There were no significant differences in structural or functional magnetic resonance imaging brain imaging between groups postoperatively. Regardless of temperature, patients who underwent HCA demonstrated significant reductions in cerebral gray matter volume, cortical thickness, and regional brain functional connectivity. Thirty-day in-hospital mortality, major morbidity, and quality of life were not different between groups. CONCLUSIONS: This randomized multicenter study evaluating arch surgery HCA temperature strategies found low-moderate hypothermia noninferior to traditional deep hypothermia on global cognitive change 4 weeks after surgery, although in secondary analysis, structured verbal memory was better preserved in the deep group. The verbal memory differences in the low- and high-moderate groups and structural and functional connectivity reductions from baseline merit further investigation and suggest opportunities to further optimize brain perfusion during HCA. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02834065.