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.

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.

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.

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.

Tricuspid regurgitation burden following transcatheter aortic valve replacement requiring early pacemaker implantation.

Background: Conduction abnormality requiring the implantation of a permanent pacemaker (PPM) is a well-known and clinically important complication of transcatheter aortic valve replacement (TAVR). However, PPM implantation may result in lead-associated tricuspid valve regurgitation (TR). This study sought to determine the incidence and progression of TR following PPM implantation after TAVR. Methods: This was a retrospective review of all echocardiograms of patients who underwent PPM following TAVR at the Baylor Scott & White hospitals from 2012 to 2021. The primary endpoint was TR progression at 30 days and 1 year. A subanalysis comparing the change in TR progression between small and large TAVR devices was also conducted. Secondary outcomes included all-cause death at 30 days and 1 year. Results: Out of the 2744 patients who underwent TAVR between April 2012 and August 2021, 177 patients (6.5%) subsequently received a new PPM. There was a statistically significant progression of TR at 1-year follow-up (McNemar's P value = 0.02). TR progression rates were comparable between the small and large valve groups at 1-year follow-up (4% vs 11%, P = 0.09, respectively). Conclusion: In this single healthcare system study, we demonstrated a significant progression of TR in patients with PPM post TAVR at 1 year.

Distal Versus Proximal Radial Artery Access for Cardiac Catheterization: 30-Day Outcomes of the DIPRA Study.

Background 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 radial artery, but safety and potential detrimental effects on hand function are unknown. Methods and Results In the DIPRA (Distal Versus Proximal Radial Artery Access for Cardiac Catheterization and Intervention) study, a single-center trial, 300 patients were randomized 1:1 to cardiac catheterization through dRA or pRA. The primary end point of change in hand function from baseline to 30 days was a composite of the QuickDASH (Quick Disabilities of the Arm, Shoulder and Hand) questionnaire, hand-grip test, and thumb forefinger pinch test. Secondary end points included access feasibility and complications; 254 of 300 patients completed follow-up at 30 days; of these, 128 were randomized to dRA and 126 to pRA with balanced demographic and procedural characteristics. Both groups had similar rates of access site bleeding (dRA 0% versus pRA 1.4%; P=0.25). Six patients with dRA failed access compared with 2 patients with pRA. Radial artery occlusion occurred in 2 pRA versus none in dRA. There were no significant differences in change in hand function, median hand-grip (dRA 0 [-3.2, 3.3] versus pRA 0.7 [-2.3, 3.3] kg; P=0.21), pinch-grip (dRA -0.3 [-1.2, 0.5] versus pRA 0 [-0.9, 0.9] kg; P=0.09), and QuickDASH (dRA 0 [-4.6, 2.3] versus pRA 0 [-4.6, 2.3] points, P=0.96). There was no significant difference in the composite of hand function between pRA and dRA. Conclusions dRA is a safe strategy for cardiac catheterization with a low complication rate. Compared with pRA, there is no increased risk of hand dysfunction at 30 days. Registration URL: https://www.ClinicalTrials.gov. Unique identifier: NCT04318990.

Outcomes of the Ross procedure in patients older versus younger than 50 years old.

OBJECTIVES: The Ross procedure is traditionally considered for young adult patients with aortic valve disease. This study compares long-term outcomes of patients undergoing the Ross procedure who are ≥50 and <50-years old. METHODS: Data were collected from 225 patients undergoing Ross procedure at a single centre from 1994 to 2019. Patients were categorized into younger (<50-years old; n = 156) and older (≥50-years old; n = 69) cohorts. Baseline demographics clinical outcomes were compared. RESULTS: The mean age was 36 ± 8.1 and 55 ± 4.2 years in the younger and older cohort, respectively. Both groups were predominantly male (58.5% vs 69.6%; P = 0.59). The younger group had a higher rate of aortic insufficiency (51% vs 26.1%; P < 0.01), and bicuspid aortic valve (81.4% vs 58.0%; P < 0.01). Aortic stenosis was more prevalent in the older cohort (25.6% vs 58.0%; P < 0.01). Operative mortality was acceptable in both groups (1.3% vs 4.3%; P = 0.15). Survival up to 10 years was not statistically different between 2 groups (96.2% vs 91.3% P = 0.16), whereas survival up to 15 years for younger patients was significantly higher (94.9% vs 85.5%; P = 0.03). After non-cardiac related deaths were excluded, survival up to 15 years (98.7% vs 91.3%; P = 0.02) was significantly lower than younger patients. In both groups, survival after the Ross procedure was similar to the age- and sex-matched US population. CONCLUSIONS: Survival up to 10 years after Ross procedure were similar, but up to 15 years was significantly higher in younger patients. The Ross procedure restored patients from both groups to expected survival. Our results suggest that at experienced centres, the Ross procedure is a safe and reasonable option for patients who are 50 years and older.

Race, neighborhood disadvantage, and survival of Medicare beneficiaries after aortic valve replacement and concomitant coronary artery bypass grafting.

BACKGROUND: Race, neighborhood disadvantage, and the interaction between these 2 social determinants of health remain poorly understood with regards to survival after aortic valve replacement with concomitant coronary artery bypass grafting (AVR+CABG). METHODS: Weighted Kaplan-Meier survival analyses and Cox proportional hazards modeling were used to evaluate the association between race, neighborhood disadvantage, and long-term survival in 205,408 Medicare beneficiaries undergoing AVR+CABG from 1999 to 2015. Neighborhood disadvantage was measured using the Area Deprivation Index, a broadly validated ranking of socioeconomic contextual disadvantage. RESULTS: Self-identified race was 93.9% White and 3.2% Black. Residents of the most disadvantaged quintile of neighborhoods included 12.6% of all White beneficiaries and 40.0% of all Black beneficiaries. Black beneficiaries and residents of the most disadvantaged quintile of neighborhoods had more comorbidities compared with White beneficiaries and residents of the least disadvantaged quintile of neighborhoods, respectively. Increasing neighborhood disadvantage linearly increased the hazard for mortality for Medicare beneficiaries of White but not Black race. Residents of the most and least disadvantaged neighborhood quintiles had weighted median overall survival of 93.0 and 82.1 months, respectively, a significant difference (P < .001 by Cox test for equality of survival curves). Black and White beneficiaries had weighted median overall survival of 93.4 and 90.6 months, respectively, a nonsignificant difference (P = .29 by Cox test for equality of survival curves). A statistically significant interaction between race and neighborhood disadvantage was noted (likelihood ratio test P = .0215) and had implications on whether Black race was associated with survival. CONCLUSIONS: Increasing neighborhood disadvantage was linearly associated with worse survival after combined AVR+CABG in White but not Black Medicare beneficiaries; race, however, was not independently associated with postoperative survival.

Vein Graft Use and Long-Term Survival Following Coronary Bypass Grafting.

BACKGROUND: Although placement of at least 1 arterial graft during coronary artery bypass grafting (CABG) has a proven survival benefit, it is unknown what degree of revascularization with saphenous vein grafting (SVG) is associated with improved survival. OBJECTIVES: The authors sought to determine whether undergoing surgery performed by a surgeon who is liberal with vein graft utilization is associated with improved survival in patients undergoing single arterial graft CABG (SAG-CABG). METHODS: This was a retrospective, observational study of SAG-CABG performed in Medicare beneficiaries from 2001 to 2015. Surgeons were stratified by number of SVG utilized per SAG-CABG into conservative (≥1 SD below mean), average (within 1 SD of mean), and liberal (≥1 SD above mean). Long-term survival was estimated using Kaplan-Meier analysis and compared among surgeon groups before and after augmented inverse-probability weighting. RESULTS: There were 1,028,264 Medicare beneficiaries undergoing SAG-CABG from 2001 to 2015 (mean age 72.0 ± 7.9 years, 68.3% male). Over time, 1-vein and 2-vein SAG-CABG utilization increased, whereas 3-vein and ≥4-vein SAG-CABG utilization decreased (P < 0.001). Surgeons who were conservative vein graft users performed a mean 1.7 ± 0.2 vein grafts per SAG-CABG, whereas those who were liberal vein graft users performed a mean 2.9 ± 0.2 vein grafts per SAG-CABG. Weighted analysis demonstrated no difference in median survival among patients undergoing SAG-CABG by liberal vs conservative vein graft users (adjusted median survival difference 27 days). CONCLUSIONS: Among Medicare beneficiaries undergoing SAG-CABG, there is no association between surgeon proclivity for vein graft utilization and long-term survival, suggesting that a conservative approach to vein graft utilization is reasonable.

Surgical treatment of infective endocarditis at comprehensive versus primary valve centers.

BACKGROUND: A recent expert consensus statement proposed designation of comprehensive and primary valve centers, with a recommendation that comprehensive centers house surgical skill and resources to treat patients with infective endocarditis (IE). We sought to compare outcomes of patients who underwent valve surgery for IE at comprehensive versus primary valve centers within a large health care system. METHODS: We reviewed 513 consecutive patients who underwent IE surgery at 8 hospitals (2 comprehensive and 6 primary valve centers) from 2014 to 2020. Outcomes from comprehensive and primary valve centers were compared after propensity score matching on the basis of patient characteristics, valve involvement, valve type, and IE treatment status. Multivariate logistic regression was used to identify risk factors for operative mortality. RESULTS: Propensity score matching generated comparable groups with similar mean Society of Thoracic Surgeons/Gaca IE risk scores among comprehensive and primary valve center cohorts. Comprehensive valve centers were more likely to perform the Bentall procedure (60.4% vs 21.7%; P < .01) when aortic root abscess was present and mitral valve repair (50.4% vs 26.3%; P < .01) in cases of mitral valve involvement. Operative mortality was significantly lower at comprehensive valve centers (6.2% vs 13.0%; P = .04), and multivariate logistic regression suggested that surgery at comprehensive valve centers was protective against operative mortality (odds ratio, 0.39; 95% confidence interval, 0.17-0.88; P = .02). Similar findings were present in a sensitivity analysis limited to patients with active IE only. CONCLUSIONS: An increased risk for operative mortality was associated with surgery performed at primary valve centers compared with comprehensive valve centers. Referral or transfer of patients with IE and surgical indications to comprehensive valve centers should be considered.

Contemporary Outcomes of Isolated Tricuspid Valve Surgery.

INTRODUCTION: Isolated tricuspid valve (TV) surgery is uncommonly performed and has historically been associated with excessive operative mortality. We previously reported improved short-term outcomes at our center. Understanding contemporary outcomes of isolated TV surgery beyond the perioperative period is essential to properly benchmark outcomes of newer transcatheter interventions. METHODS: Patients who underwent isolated TV surgery from 2007 to 2021 at a single institution were retrospectively reviewed. Survival was estimated using the Kaplan-Meier method and multivariable Cox proportional hazards regression modeling identified independent risk factors for all-cause mortality. RESULTS: Among 173 patients undergoing isolated TV surgery, 103 (60%) underwent TV repair and 70 (40%) underwent TV replacement. Mean age was 60.3 ± 18.9 y and 55 (32%) were male. The most common etiology of TV disease was functional (46%). In-hospital mortality was 4.1% (7/173), with no difference between TV repair and replacement (P = 0.06). Overall survival at 1 y and 5 y was 78.3% (111/142) and 64.5% (53/82), respectively. After median (interquartile range) follow-up of 2.0 (0.6-4.4) y, patients undergoing TV repair experienced a higher unadjusted survival as compared to those undergoing TV replacement (log-rank P = 0.02). However, after adjusting for covariates, TV replacement was not an independent predictor of all-cause mortality (hazard ratio 1.40; 95% confidence interval, 0.71-2.76; P = 0.33). CONCLUSIONS: Isolated TV surgery can be performed with lower operative mortality than historically reported. Establishing survival benchmarks from TV surgery is important in the era of developing transcatheter interventions.

Impact of improving severity of secondary mitral regurgitation on survival.

AIMS: Secondary mitral regurgitation (SMR) is frequent in patients with heart failure with reduced ejection fraction (HFrEF) and portends detrimental prognosis. Despite interventions addressing the mitral valve (MV) have been proven effective to improve survival, an important knowledge gap exists regarding the role of medical therapy (MT) in this context. Thus, we aimed at investigating the role of MT optimization in patients with SMR and HFrEF. METHODS AND RESULTS: A total of 435 patients with SMR and HFrEF were retrospectively evaluated. Of those, 158 with severe SMR were finally included, with 63 (40%) managed with MT alone and 96 (60%) with MV intervention plus MT. Echocardiography was performed after 30 days of MT optimization or MV intervention. Responders were patients with a final mitral regurgitation (MR) grade of ≤2+. Survival data were gathered through the National Database Index and patient chart review. MR severity improved in 131 patients (100% MV intervention; 57% MT) but stayed the same or worsened in 27 patients. Responders and non-responders were similar for baseline characteristics. Overall, long-term survival of responders was significantly higher than non-responders [hazard ratio (HR) 0.55, 95% confidence interval (CI) (0.32-0.96), P = 0.032]. No difference in survival was observed when evaluated by intervention type in the overall population (MT alone, n = 63; MV intervention plus MT, n = 95) [HR 0.77, 95% CI (0.48-1.26), P = 0.3], nor within responder group (MT alone, n = 36; MV intervention plus MT, n = 95) [HR 1.03, 95% CI (0.56-1.89), P = 0.94]. CONCLUSIONS: MT reduces SMR severity in 57% of the patients with severe SMR. A final SMR grade of ≤2+ is linked to improved survival, independently of the type of treatment they receive.

Assessment of TVT and STS Risk Score Performances in Patients Undergoing Transcatheter Aortic Valve Replacement.

Background: The Society of Thoracic Surgeons (STS) score has been used to risk stratify patients undergoing transcatheter aortic valve replacement (TAVR). The Transcatheter Valve Therapy (TVT) score was developed to predict in-hospital mortality in high/prohibitive-risk patients. Its performance in low and intermediate-risk patients is unknown. We sought to compare TVT and STS scores' ability to predict clinical outcomes in all-surgical-risk patients undergoing TAVR. Methods: Consecutive patients undergoing TAVR from 2012-2020 within a large health care system were retrospectively reviewed and stratified by STS risk score. Predictive abilities of TVT and STS scores were compared using observed-to-expected mortality ratios (O:E) and area under the receiver operating characteristics curves (AUCs) for 30-day and 1-year mortality. Results: We assessed a total of 3270 patients (mean age 79 ± 9 years, 45% female), including 191 (5.8%) low-risk, 1093 (33.4%) intermediate-risk, 1584 (48.4%) high-risk, and 402 (5.8%) inoperable. Mean TVT and STS scores were 3.5% ± 2.0% and 6.1% ± 4.3%, respectively. Observed 30-day and 1-year mortality were 2.8% (92/3270; O:E TVT 0.8 ± 0.16 vs STS 0.46 ± 0.09), and 13.2% (432/3270), respectively. In the all-comers population, both TVT and STS risk scores showed poor prediction of 30-day (AUC: TVT 0.68 [0.62-0.74] vs STS 0.64 [0.58-0.70]), and 1-year (AUC: TVT 0.65 [0.62-0.58] vs STS 0.65 [0.62-0.58]) mortality. After stratifying by surgical risk, discrimination of the TVT and STS scores remained poor in all categories at 30 days and 1 year. Conclusions: An updated TAVR risk score with improved predictive ability across all-surgical-risk categories should be developed based on a larger national registry.

Bloodstream and respiratory coinfections in patients with COVID-19 on ECMO.

BACKGROUND: Although several studies have characterized the risk of coinfection in COVID pneumonia, the risk of the bloodstream and respiratory coinfection in patients with COVID-19 pneumonia on extracorporeal membrane oxygenation (ECMO) supports severe acute respiratory distress syndrome (ARDS) is poorly understood. METHODS: This is a retrospective analysis of patients with COVID-19 ARDS on ECMO at a single center between January 2020 and December 2021. Patient characteristics and clinical outcomes were compared. RESULTS: Of 44 patients placed on ECMO support for COVID-19 ARDS, 30 (68.2%) patients developed a coinfection, and 14 (31.8%) patients did not. Most patients underwent venovenous ECMO (98%; 43/44) cannulation in the right internal jugular vein (98%; 43/44). Patients with coinfection had a longer duration of ECMO (34 [interquartile range, IQR: 19.5, 65] vs. 15.5 [IQR 11, 27.3] days; p = .02), intensive care unit (ICU; 44 [IQR: 27,75.5] vs 31 [IQR 20-39.5] days; p = .03), and hospital (56.5 [IQR 27,75.5] vs 37.5 [IQR: 20.5-43.3]; p = .02) length of stay. When stratified by the presence of a coinfection, there was no difference in hospital mortality (37% vs. 29%; p = .46) or Kaplan-Meier survival (logrank p = .82). Time from ECMO to first positive blood and respiratory culture were 12 [IQR: 3, 28] and 10 [IQR: 1, 15] days, respectively. Freedom from any coinfection was 50 (95% confidence interval: 37.2-67.2)% at 15 days from ECMO initiation. CONCLUSIONS: There is a high rate of co-infections in patients placed on ECMO for COVID-19 ARDS. Although patients with coinfections had a longer duration of extracorporeal life support, and longer length of stays in the ICU and hospital, survival was not inferior.

Real-world validation of fractional flow reserve computed tomography in patients with stable angina: Results from the prospective AFFECTS trial.

BACKGROUND: Fractional flow reserve computed tomography (FFRct) allows for non-invasive assessment of hemodynamically significant coronary artery disease (CAD). Real-world data regarding the diagnostic performance of FFRct is scarce. We aim to validate the diagnostic performance of FFRct against invasive coronary angiography (ICA) in patients with stable angina and an abnormal single photon emission computed tomography (SPECT) study. METHODS: This prospective, single-cohort, real-world study enrolled consecutive adult patients with stable angina and an abnormal SPECT study who were referred for ICA. Prior to ICA, FFRct analysis was performed. Sensitivity and specificity of FFRct were evaluated at the patient and vessel level against ICA. Physician intuition-based diagnosis of hemodynamically significant CAD was also documented prior to ICA. RESULTS: A total of 66 patients were enrolled; 10 were excluded due to protocol deviation or missing studies. FFRct achieved 95% sensitivity and 83% specificity at the patient level, and 78% sensitivity and 88% specificity at the vessel level. FFRct was most accurate in the left circumflex artery (sensitivity 83%, specificity 92%) and the least in the left anterior descending artery (80% sensitivity, 78% specificity). FFRct identified hemodynamically significant CAD more accurately than physician intuition (sensitivity 95% vs 84%; specificity 83% vs 46%). If physicians had been unblinded to FFRct, ICA may have been avoided in up to 53% of patients. CONCLUSION: We performed a real-world study to validate the diagnostic performance of FFRct against gold-standard invasive imaging. FFRct has high sensitivity and specificity for the diagnosis of hemodynamically significant CAD in intermediate-to-high risk patients.

A Liquid Biopsy Signature for the Detection of Patients With Early-Onset Colorectal Cancer.

BACKGROUND & AIMS: Early-onset colorectal cancer (EOCRC) is a distinct clinical and molecular entity with poor survival outcomes compared with late-onset CRC. Although the incidence of EOCRC is rising, current CRC screening strategies have several limitations in diagnostic performance for EOCRC. In view of this clinical challenge, novel and robust biomarkers for detection of EOCRC are necessary. The aim of this study was to develop a circulating micro RNA (miRNA) signature for the diagnosis of patients with EOCRC. METHODS: A systematic discovery approach by analyzing a large, publicly available, noncoding RNA expression profiling dataset (GSE115513) was used. A panel of miRNAs was identified, which was subsequently validated in blood samples from patients with EOCRC in 2 independent cohorts (n = 149) compared with controls (n = 110) and pre/postoperative plasma specimens (n = 22) using quantitative reverse-transcription polymerase chain reaction assays. RESULTS: In the discovery phase, 4 miRNAs were found to be expressed in blood samples. A combination signature of these 4 miRNAs (miR-193a-5p, miR-210, miR-513a-5p, and miR-628-3p) yielded an area under the curve of 0.92 (95% confidence interval, 0.85-0.96) for identification of EOCRC in the training cohort. The miRNA panel performance was then confirmed in an independent validation cohort (area under the curve, 0.88; 95% confidence interval, 0.82-0.93). Moreover, the miRNA panel robustly identified patients with early-stage EOCRC (P < .001). The decreased expression of miRNAs in postsurgery plasma specimens indicated their tumor specificity. CONCLUSIONS: Our novel miRNA signature for the diagnosis of EOCRC has the potential to identify patients with EOCRC with high accuracy for clinical application in the noninvasive diagnosis of EOCRC.

Effect of Preincisional Liposomal Bupivacaine Sternal Blockade on Poststernotomy Opioid Use.

BACKGROUND: Prolonged and excessive opioid use in the postoperative setting is associated with multiple complications. The use of regional analgesia may reduce postoperative opioid use. METHODS: In a placebo-controlled, double-blinded trial patients undergoing sternotomy were randomly assigned in a 1:1 ratio to receive either a liposomal bupivacaine parasternal block or a normal saline parasternal injection. The primary endpoint was total morphine milligram equivalents (MMEs) used in the immediate 72-hour postoperative period. Secondary endpoints were intraoperative opioid use, pain scores, time to reach recovery milestones, and incidence of postoperative complications. RESULTS: Twenty-five patients received a normal saline injection, and 27 patients received an anesthetic sternal block. Randomization achieved excellent balance in demographics and comorbidities between the groups. Total postoperative opioid requirements at 72 hours were similar between the treatment and control groups (25.8 ± 10.4 vs 29.4 ± 16.3 MMEs, P = .60). Intraoperative opioid requirements were also similar between the 2 groups (124.8 ± 222.5 vs 114.9 ± 148.0 MMEs, P = .86). Length of stay in the intensive care unit (3.4 ± 2.5 vs 3.5 ± 2.6 days, P = .86) and hospital (8.7 ± 5.0 vs 7.5 ± 3.0 days, P = .45), time until return of bowel function (3.7 ± 1.4 vs 3.3 ± 1.4 days, P = .42), incidence of postoperative atrial fibrillation (24% vs 22.2%, P = .88), and incidence of nausea (24% vs 33.3%, P = .46) were similar. CONCLUSIONS: Preincisional sternal blockade with liposomal bupivacaine did not reduce the amount of opioid medication administered to patients in the first 72 hours after sternotomy.

Outcomes of Extracorporeal Membrane Oxygenation in Patients With Severe Acute Respiratory Distress Syndrome Caused by COVID-19 Versus Influenza.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) can be effective for refractory acute respiratory distress syndrome (ARDS) in patients with influenza, but its utility in patients with coronavirus disease 2019 (COVID-19) is uncertain. We compared outcomes of patients with refractory ARDS from COVID-19 and influenza placed on ECMO. METHODS: We conducted a retrospective analysis of 120 patients with refractory ARDS due to COVID-19 or influenza placed on ECMO at 2 referral centers from January 2013 to October 2020. Patient characteristics and clinical outcomes were compared. The primary endpoint was survival to discharge. RESULTS: Baseline characteristics and comorbidities were similar. During the study period, 53 patients with COVID-19 and 67 patients with influenza were supported. Venovenous ECMO was the predominant initial cannulation strategy in both groups (COVID 92.5% vs influenza 95.5%; P = .5). Survival to hospital discharge was 62.3% (33 of 53 patients) in the COVID-19 group and 64.2% (43 of 67 patients) in the influenza group (P = .8). In patients successfully decannulated, median length of time on ECMO was longer in COVID-19 patients (14 [interquartile range (IQR), 9-30] days vs influenza 10.5 [IQR, 6.8-14.3] days; P = .004). Among patients discharged alive, COVID-19 patients had longer overall length of stay (COVID-19 37 [IQR, 27-62] days vs influenza 13.5 [IQR, 9.3-24] days; P = .007). CONCLUSIONS: In patients with refractory ARDS from COVID-19 or influenza placed on ECMO, there was no significant difference in survival to hospital discharge. In patients surviving to decannulation, the duration of ECMO support and total length of stay were longer in COVID-19 patients.

Distal Versus Proximal Radial Artery Access for Cardiac Catheterization and Intervention: Design and Rationale of the DIPRA Trial.

BACKGROUND: Radial artery (RA) catheterization is the access of choice over femoral artery access for most interventional vascular procedures given its safety and faster patient recovery. There has been growing interest in distal radial artery (dRA) access as an alternative to the conventional proximal radial artery (pRA) access. Preserving the RA is important which serves as a potential conduit for future coronary artery bypass surgery, dialysis conduit or preserve the artery for future cardiovascular procedures. The dRA runs in close proximity to the radial nerve, which raises the concern of potential detrimental effects on hand function. STUDY DESIGN: The Distal versus Proximal Radial Artery Access for cardiac catheterization and intervention (DIPRA) trial is a prospective, randomized, parallel-controlled, open-label, single center study evaluating the outcomes of hand function and effectiveness of dRA compared to pRA access in patients undergoing cardiac catheterization. The eligible subjects will be randomized to dRA and pRA access in a (1:1) fashion. The primary end point is an evaluation of hand function at one and twelve months follow-up. Secondary end points include rates of access site hematoma, access site bleeding, other vascular access complications, arterial access success rate, and RA occlusion at one and twelve months follow up. CONCLUSION: Effects of dRA on hand function remains unknown and it's use questionable in the presence of a widely accepted pRA. DIPRA trial is designed to determine the safety and effectiveness of dRA for diagnostic and interventional cardiovascular procedures compared to the standard of care pRA.