Trends in the Use of Recombinant Activated Factor VII and Prothrombin Complex Concentrate in Heart Transplant Patients in Virginia.

OBJECTIVES: To explore trends in intraoperative procoagulant factor concentrate use in patients undergoing heart transplantation (HTx) in Virginia. Secondarily, to evaluate their association with postoperative thrombosis. DESIGN: Patients who underwent HTx were identified using a statewide database. Trends in off-label recombinant activated factor VII (rFVIIa) use and on-label and off-label prothrombin complex concentrate (PCC) use were tested using the Mantel-Haenszel test. Multivariate logistic regression was used to test for an association between procoagulant factor concentrate administration and thrombosis. SETTING: Virginia hospitals performing HTx. PARTICIPANTS: Adults undergoing HTx between 2012 and 2022. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among 899 patients who required HTx, 100 (11.1%) received off-label rFVIIa, 69 (7.7%) received on-label PCC, and 80 (8.9%) received off-label PCC. There was a downward trend in the use of rFVIIa over the 10-year period (p = 0.04). There was no trend in on-label PCC use (p = 0.12); however, there was an increase in off-label PCC use (p < 0.001). Patients who received rFVIIa were transfused more and had longer cardiopulmonary bypass time (p < 0.001). Receipt of rFVIIa was associated with increased thrombotic risk (odds ratio [OR] 1.92; 95% CI 1.12-3.29; p = 0.02), whereas on-label and off-label PCC use had no association with thrombosis (OR 0.98, 95% CI 0.49-1.96, p = 0.96 for on-label use; and OR 0.61, 95% CI 0.29-1.30, p = 0.20 for off-label use). CONCLUSIONS: Use of rFVIIa in HTx decreased over the past decade, whereas off-label PCC use increased. Receipt of rFVIIa was associated with thrombosis; however, patients who received rFVIIa were more severely ill, and risk adjustment may have been incomplete.

The Society of Thoracic Surgeons Definition of Failure to Rescue Should Consider Including Cardiac Arrest.

BACKGROUND: Failure to rescue (FTR) is a new quality measure in The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database. The STS defines FTR as death after permanent stroke, renal failure, reoperation, or prolonged ventilation. Our objective was to assess whether cardiac arrest should be included in this definition. METHODS: Patients undergoing an STS index operation in a regional collaborative (2011-2021) were included. The performance of the STS definition of FTR was compared with a definition that included the STS complications plus cardiac arrest (STS+). Centers were grouped into FTR rate terciles using the STS and STS+ definitions of FTR, and changes in their relative performance rating were assessed. RESULTS: A total of 43,641 patients were included across 17 centers. Cardiac arrest was the most lethal complication: 55.0% of patients who experienced cardiac arrest died. FTR after any complication (13 total) occurred among 884 patients. The STS definition of FTR accounted for 83% (735 of 884) of all FTR. The addition of cardiac arrest to the STS definition significantly increased the proportion of overall FTR accounted for (92.2% [815 of 884]; P < .001). Choice of FTR definition led to substantial differences in center-level relative performance rating by FTR rate. CONCLUSIONS: Mortality after cardiac arrest is not completely captured by the STS definition of FTR and represents an important source of potentially preventable death after cardiac surgery. Future quality improvement efforts using the STS definition of FTR should account for this.

Temporal Cluster Analysis of Deep Sternal Wound Infection in a Regional Quality Collaborative.

INTRODUCTION: Deep sternal wound infection (DSWI) is a rare complication associated with high mortality. Seasonal variability in surgical site infections has been demonstrated, however, these patterns have not been applied to DSWI. The purpose of this study was to assess temporal clustering of DSWIs. METHODS: All cardiac surgery patients who underwent sternotomy were queried from a regional Society of Thoracic Surgeons database from 17 centers from 2001 to 2019. All patients with the diagnosis of DSWI were then identified. Cluster analysis was performed at varying time intervals (monthly, quarterly, and yearly) at the hospital and regional level. DSWI rates were calculated by year and month, and compared using mixed-effects negative binomial regression. RESULTS: A total of 134,959 patients underwent a sternotomy for cardiac surgery, of whom 469 (0.35%) developed a DSWI. Rates of DSWI per hospital across all years ranged from 0.12% to 0.69%. Collaborative-level rates of DSWIs were the greatest in September (0.44%) and the lowest in January (0.30%). Temporal clustering was not seen across seasonal quarters (high rate in preceeding quarter was not associated with a high rate in the next quarter) (P = 0.39). There were yearly differences across all institutions in the DSWI rates. A downward trend in DSWI rates was seen from 2001 to 2019 (P < 0.001). A difference among hospitals in the cohort was observed (P < 0.001). CONCLUSIONS: DSWI are a rare event within our region. Unlike other surgical site infection, there does not appear to be a seasonal pattern associated with DSWI.

Center case volume is associated with Society of Thoracic Surgeons-defined failure to rescue in cardiac surgery.

OBJECTIVE: Our understanding of the impact of a center's case volume on failure to rescue (FTR) after cardiac surgery is incomplete. We hypothesized that increasing center case volume would be associated with lower FTR. METHODS: Patients undergoing a Society of Thoracic Surgeons index operation in a regional collaborative (2011-2021) were included. After we excluded patients with missing Society of Thoracic Surgeons Predicted Risk of Mortality scores, patients were stratified by mean annual center case volume. The lowest quartile of case volume was compared with all other patients. Logistic regression analyzed the association between center case volume and FTR, adjusting for patient demographics, race, insurance, comorbidities, procedure type, and year. RESULTS: A total of 43,641 patients were included across 17 centers during the study period. Of these, 5315 (12.2%) developed an FTR complication, and 735 (13.8% of those who developed an FTR complication) experienced FTR. Median annual case volume was 226, with 25th and 75th percentile cutoffs of 136 and 284 cases, respectively. Increasing center-level case volume was associated with significantly greater center-level major complication rates but lower mortality and FTR rates (all P values < .01). Observed-to-expected FTR was significantly associated with case volume (P = .040). Increasing case volume was independently associated with decreasing FTR rate in the final multivariable model (odds ratio, 0.87 per quartile; confidence interval, 0.799-0.946, P = .001). CONCLUSIONS: Increasing center case volume is significantly associated with improved FTR rates. Assessment of low-volume centers' FTR performance represents an opportunity for quality improvement.

Influence of heart transplant allocation changes on hospital resource utilization.

Objectives: The 2018 change in the heart transplant allocation system resulted in greater use of temporary mechanical circulatory support. We hypothesized that the allocation change has increased hospital resource utilization, including length of stay and cost. Methods: All heart transplant patients within a regional Society of Thoracic Surgeons database were included (2012-2020). Patients were stratified before and after the transplant allocation changes into early (January 2012-September 2018) and late eras (November 2018-June 2020). Costs were adjusted for inflation and presented in 2020 dollars. Results: Of 535 heart transplants, there were 410 early and 125 late era patients. Baseline characteristics were similar, except for greater lung and valvular disease in the late era. Fewer patients in the late era were bridged with durable left ventricular assist devices (69% vs 31%; P < .0001), biventricular devices (5% vs 1%; P = .047), and more with temporary mechanical circulatory support (4% vs 46%; P < .0001). There was no difference in early mortality (6% vs 4%; P = .33) or major morbidity (57% vs 61%; P = .40). Length of stay was longer preoperatively (1 vs 9 days; P < .0001), but not different postoperatively. There was no difference in median total hospital cost ($132,465 vs $128,996; P = .15), although there was high variability. On multivariable regression, preoperative extracorporeal membrane oxygenation utilization was the main driver of resource utilization. Conclusions: The new heart transplant allocation system has resulted in different bridging techniques, with greater reliance on temporary mechanical circulatory support. Although this is associated with an increase in preoperative length of stay, it did not translate into increased hospital cost.

Pulmonary Hypertension and Operative Risk in Mitral Valve and Coronary Surgery.

INTRODUCTION: Pulmonary hypertension (PHT) is a known risk factor for coronary artery bypass grafting (CABG), though less well understood for valve operations. We hypothesized PHT is associated with lower risk during mitral valve operations compared to CABG. METHODS: Patients undergoing isolated mitral valve or CABG operations (2011-2019) in a regional Society of Thoracic Surgeons (STS) database were stratified by pulmonary artery systolic pressure (PASP). The association of PASP by procedure type was assessed by hierarchical regression modeling, adjusting for STS predicted risk scores. RESULTS: Of the 2542 mitral and 11,059 CABG patients, the mitral population had higher mean STS risk of mortality (3.6% versus 2.4%, P < 0.0001) and median PASP (42 mmHg versus 32 mmHg, P < 0.0001). PASP was independently associated with operative mortality and major morbidity in both mitral and CABG patients. However, for mitral patients a 10-mmHg increase in PASP was associated with lower odds of morbidity (odds ratio: 1.06 versus 1.13), mortality (odds ratio: 1.11 versus 1.18) and intensive care unit time (4.3 versus 7.6 h) compared with CABG patients (interaction terms P < 0.0001). Among mitral patients, median PASP was higher in stenotic versus regurgitant disease (57 mmHg versus 40 mmHg, P < 0.0001). However, there was no differential association of PASP on morbidity or mortality (interaction terms P > 0.05). CONCLUSIONS: Although mitral surgery patients tend to have higher preoperative pulmonary artery pressures, PHT was associated with a lower risk for mitral outcomes compared with CABG. Further research on the management and optimization of patients with PHT perioperatively is needed to improve care for these patients.

Effect of Socioeconomic Distress on Risk-Adjusted Mortality After Valve Surgery for Infective Endocarditis.

Infective endocarditis affects patients of all socioeconomic status. We hypothesized that the Distressed Communities Index (DCI), a comprehensive assessment of socioeconomic status, would be associated with risk-adjusted mortality for patients with endocarditis. All patients with endocarditis (2001-2017) in a regional Society of Thoracic Surgeons database were analyzed. DCI scores range from 0 (no socioeconomic distress) to 100 (severe distress) and account for unemployment, poverty rate, median income, housing vacancies, education level, and business growth by zip code. The most distressed patients (top quartile, DCI > 75) were compared to all other patients. Hierarchical logistic regression modeled the association between DCI and mortality. A total of 2,075 patients were included (median age 55 years, 65.2% urgent/emergent cases, 42.7% self-pay). Major morbidity was 32.8% and operative mortality was 9.5%. Tricuspid/pulmonic valve endocarditis was present in 12.5% of cases, with significantly worse mean DCI compared to patients with left-sided endocarditis (median 55.3, IQR 20.3-77.6 vs 46.8, IQR 17.3-74.2, P = 0.016). High socioeconomic distress (DCI > 75) was associated with higher rates of major morbidity, operative mortality, increased length of stay, and higher total cost. After risk-adjustment, DCI was independently predictive of higher operative mortality for patients with endocarditis (OR 1.24 per DCI quartile increase, 95% CI 1.06-1.45, P < 0.001). Increasing DCI, an indicator of poor socioeconomic status, independently predicts increased risk-adjusted mortality and resource utilization for patients with endocarditis. Accounting for socioeconomic status allows for more accurate risk prediction and resource allocation for patients with endocarditis.

A Standardized and Regionalized Network of Care for Cardiogenic Shock.

BACKGROUND: The benefits of standardized care for cardiogenic shock (CS) across regional care networks are poorly understood. OBJECTIVES: The authors compared the management and outcomes of CS patients initially presenting to hub versus spoke hospitals within a regional care network. METHODS: The authors stratified consecutive patients enrolled in their CS registry (January 2017 to December 2019) by presentation to a spoke versus the hub hospital. The primary endpoint was 30-day mortality. Secondary endpoints included bleeding, stroke, or major adverse cardiovascular and cerebrovascular events. RESULTS: Of 520 CS patients, 286 (55%) initially presented to 34 spoke hospitals. No difference in mean age (62 years vs 61 years; P = 0.38), sex (25% vs 32% women; P = 0.10), and race (54% vs 52% white; P = 0.82) between spoke and hub patients was noted. Spoke patients more often presented with acute myocardial infarction (50% vs 32%; P < 0.01), received vasopressors (74% vs 66%; P = 0.04), and intra-aortic balloon pumps (88% vs 37%; P < 0.01). Hub patients were more often supported with percutaneous ventricular assist devices (44% vs 11%; P < 0.01) and veno-arterial extracorporeal membrane oxygenation (13% vs 0%; P < 0.01). Initial presentation to a spoke was not associated with increased risk-adjusted 30-day mortality (adjusted OR: 0.87 [95% CI: 0.49-1.55]; P = 0.64), bleeding (adjusted OR: 0.89 [95% CI: 0.49-1.62]; P = 0.70), stroke (adjusted OR: 0.74 [95% CI: 0.31-1.75]; P = 0.49), or major adverse cardiovascular and cerebrovascular events (adjusted OR 0.83 [95% CI: 0.50-1.35]; P = 0.44). CONCLUSIONS: Spoke and hub patients experienced similar short-term outcomes within a regionalized CS network. The optimal strategy to promote standardized care and improved outcomes across regional CS networks merits further investigation.

Impact of Noninvasive Respiratory Support in Patients With COVID-19 Requiring V-V ECMO.

The impact of the duration of noninvasive respiratory support (RS) including high-flow nasal cannula and noninvasive ventilation before the initiation of extracorporeal membrane oxygenation (ECMO) is unknown. We reviewed data of patients with coronavirus disease 2019 (COVID-19) treated with V-V ECMO at two high-volume tertiary care centers. Survival analysis was used to compare the effect of duration of RS on liberation from ECMO. A total of 78 patients required ECMO and the median duration of RS and invasive mechanical ventilation (IMV) before ECMO was 2 days (interquartile range [IQR]: 0, 6) and 2.5 days (IQR: 1, 5), respectively. The median duration of ECMO support was 24 days (IQR: 11, 73) and 59.0% (N = 46) remained alive at the time of censure. Patients that received RS for ≥3 days were significantly less likely to be liberated from ECMO (HR: 0.46; 95% CI: 0.26-0.83), IMV (HR: 0.42; 95% CI: 0.20-0.89) or be discharged from the hospital (HR: 0.52; 95% CI: 0.27-0.99) compared to patients that received RS for <3 days. There was no difference in hospital mortality between the groups (HR: 1.12; 95% CI: 0.56-2.26). These relationships persisted after adjustment for age, gender, and duration of IMV. Prolonged duration of RS before ECMO may result in lung injury and worse subsequent outcomes.

Isolated aortic valve replacement with bio-prostheses in patients age 50 to 65 years: a decade of statewide data on cost and patient outcomes.

BACKGROUND: Guidelines for choice of replacement valve-mechanical versus bio-prosthetic, are well established for patients aged <50 and >65 years. We studied the trends and implications of aortic valve replacement (AVR) with mechanical versus bioprosthetic valve in patients aged 50 to 65 years. METHODS: STS and cost database of 17 centers for isolated AVR surgery were analyzed by dividing them into bioprosthetic valve (BV) or mechanical valve (MV) groups. RESULTS: From 2002 to 2011, 3,690 patients had AVR, 18.6% with MV and 81.4% with BV. Use of BV for all ages increased from 71.5% in 2002 to 87% in 2011. There were 1127 (30.5%) patients in the age group 50-65 years. Use of BV in this group almost doubled, 39.6% in 2002 to 76.8% in 2011. Mean age of patients in BV group was higher (59.2±4.2 years vs. 56.7±4.3 years, P≤0.0001). Preoperative renal failure, heart failure and chronic obstructive pulmonary disease favored use of BV, whereas preoperative atrial fibrillation favored AVR with MV. Mortality (MV 2.2% vs. BV 2.36%) and other postoperative outcomes between the groups were similar. Cost of valve replacement increased for both groups (MV $26,191 in 2002 to $42,592 in 2011; BV $27,404 in 2002 to $44,257 in 2011). CONCLUSIONS: Use of bioprostheses for AVR has increased; this change is more pronounced in patients aged 50-65 years. Specific preoperative risk factors influence the choice of valve for AVR. Postoperative outcomes between the two groups were similar. Long-term implications of this changing practice, in particular, reoperation for bioprosthetic valve degeneration should be examined.

Access to Left Ventricular Assist Device: Travel Time Does Not Tell The Whole Story.

BACKGROUND: Negative health effects of traveling longer distances for surgical services have been reported. Given the high complexity of multidisciplinary care required for management of Left Ventricular Assist Device (LVAD) implantation, only 4 of 18 centers in our state perform these operations. Given the limited access we hypothesized increased travel time would adversely affect postoperative outcomes and 30-d mortality. METHODS: A statewide Society of Thoracic Surgeons database was queried to identify patients undergoing Heartmate II/III and HVAD implantation, and 725 patients were identified. Travel time was calculated by zip code. Patients were stratified into regional and distant groups by the upper quartile of travel time (1-h). Preoperative variables and outcomes were compared between the groups. Multivariate analysis was performed to evaluate the impact of travel time in risk-adjusted models of 30-d mortality. RESULTS: Median patient travel time to their LVAD center in our state is 32 min (mean 53 ± 65 min, 46 ± 71 miles). Patients in the distant group (n = 191) had lower median incomes, higher self-pay status, higher rates of medical comorbid disease. Despite these differences there was no difference between the groups in ICU and/or hospital length of stay, readmission, postoperative complications, or 30-d mortality. Multivariate regression demonstrated insurance status, age, and prior surgery predicted 30-d mortality, but not travel time. CONCLUSIONS: Despite only four centers in the state performing LVAD implantation, travel time was strongly associated with preoperative risk, and socioeconomic status but not postoperative outcomes or 30-d mortality. Therefore, increasing access should focus on insurance, and patient characteristics not travel time.

Ventricular septal rupture and cardiogenic shock complicating STEMI during COVID-19 pandemic: An old foe re-emerges.

The COVID 19 pandemic resulted in a total reduction in the number of hospitalizations for acute coronary syndromes. A consequence of the delay in coronary revascularization has been the resurgence of structural complications of myocardial infarctions. Ventricular septal rupture (VSR) complicating late presenting acute myocardial infarction (AMI) is associated with high mortality despite advances in both surgical repair and perioperative management. Current data suggests a declining mortality with delay in VSR repair; however, these patients may develop cardiogenic shock while waiting for surgery. Available options are limited for patients with VSR who develop right ventricular failure and cardiogenic shock. The survival rate is very low in patients with cardiogenic shock undergoing surgical or percutaneous VSR repair. In this study we present two late presenting ST elevation MI patients who were complicated by rapidly declining hemodynamics and impending organ failure. Both patients were bridged with venoarterial extracorporeal membrane oxygenation (ECMO) to cardiac transplant.

Preclosure technique versus arterial cutdown after percutaneous cannulation for venoarterial extracorporeal membrane oxygenation.

BACKGROUND: Arteriotomy repair through the preclosure technique during elective arterial access procedures is well documented. Outcomes associated with application of this technique to the removal of arterial access cannulas in patients undergoing urgent venoarterial extracorporeal membrane oxygenation (VA-ECMO) have not previously been reported. METHODS: We reviewed the records of consecutive patients who required VA-ECMO for cardiogenic shock. Patients were compared by use of the preclosure device (Perclose ProGlide Suture-Mediated Closure System; Abbott Vascular, Abbott Park, Ill) at time of VA-ECMO cannulation. The rate of limb complications (composite of limb ischemia, infection, and site necrosis) and secondary end points of bleeding events, pseudoaneurysm, distal part embolization, and intensive care unit length of stay after decannulation were compared between the groups. RESULTS: Ninety-nine consecutive patients managed with VA-ECMO were identified and the preclosure device was utilized in 51 of these patients. Preclosure device failure occurred in 5 instances (9.8%) and was successfully managed with surgical repair in 4 cases and endovascular intervention in another. Use of the preclosure device was associated with both fewer limb complications (odds ratio, 0.19; 95% confidence interval, 0.03-0.78) and bleeding events (odds ratio, 0.21; 95% confidence interval, 0.04-0.89). Pseudoaneurysm (n = 0) and distal part embolization (n = 1) were infrequently encountered in the cohort and no difference in intensive care unit length of stay after decannulation was noted between the groups. CONCLUSIONS: In this cohort, use of the preclosure technique in weaning from VA-ECMO was technically feasible, safe, and associated with an approximate 80% lower likelihood of limb complications and bleeding events compared with surgical removal.

Essential Information on Surgical Heart Valve Characteristics for Optimal Valve Prosthesis Selection: Expert Consensus Document From the European Association for Cardio-Thoracic Surgery (EACTS)-The Society of Thoracic Surgeons (STS)-American Association for Thoracic Surgery (AATS) Valve Labelling Task Force.

Comprehensive information on the characteristics of surgical heart valves (SHVs) is essential for optimal valve selection. Such information is also important in assessing SHV function after valve replacement. Despite the existing regulatory framework for SHV sizing and labelling, this information is challenging to obtain in a uniform manner for various SHVs. To ensure that clinicians are adequately informed, the European Association for Cardio-Thoracic Surgery (EACTS), The Society of Thoracic Surgeons (STS) and American Association for Thoracic Surgery (AATS) set up a Task Force comprised of cardiac surgeons, cardiologists, engineers, regulatory bodies, representatives of the International Organization for Standardization and major valve manufacturers. Previously, the EACTS-STS-AATS Valve Labelling Task Force identified the most important problems around SHV sizing and labelling. This Expert Consensus Document formulates recommendations for providing SHV physical dimensions, intended implant position and hemodynamic performance in a transparent, uniform manner. Furthermore, the Task Force advocates for the introduction and use of a standardized chart to assess the probability of prosthesis-patient mismatch and calls valve manufacturers to provide essential information required for SHV choice on standardized Valve Charts, uniformly for all SHV models.