Risk Factors Associated with Adverse Outcomes after Ablative Surgery for Lymphedema.

BACKGROUND: Postmastectomy breast cancer lymphedema poses an important health threat. Historically, physical therapy was the exclusive treatment option. More recently, lymphedema surgery has revolutionized care. As a first-in-kind, multicenter report, the postmastectomy breast cancer patients' risk factors associated with postlymphedema ablative surgical outcomes were documented. METHODS: Using the New York Statewide Planning and Research Cooperative System database from 2010 to 2018, multivariable models identified the postmastectomy breast cancer lymphedema surgical patients' characteristics associated with major adverse outcomes and mortality. RESULTS: Of 65,543 postmastectomy breast cancer patients, 1,052 lymphedema surgical procedures were performed including 393 (37.4%) direct excisions and 659 (63.6%) liposuctions. Direct excision and liposuction surgical patients had median ages of 58 and 52 years, respectfully (p < 0.001). Although a 30-day operative mortality was rare (0.3%, all direct excisions), major adverse outcomes occurred in 154 patients (28.5% direct excision; 6.4% liposuction; p < 0.0001). Multivariable clinical outcomes model identified that patients with higher Elixhauser's score, renal disease, emergent admissions, and direct excision surgery had higher incidences of adverse outcomes (all p < 0.01). For those patients with 30-day readmissions (n = 60), they were more likely to have undergone direct excision versus liposuction (12.5 vs. 1.7%; p < 0.0001). The important risk factors predictive of future cellulitis/lymphangitis development included diabetes mellitus, Medicaid insurance, renal disease, prior cellulitis/lymphangitis, chronic obstructive pulmonary disease (COPD), and chronic steroid use (all p < 0.01). CONCLUSION: Lymphedema surgery carries a favorable risk profile, but better understanding the "high-risk" patients is critical. As this new era of lymphedema surgery progresses, evaluating the characteristics for adverse postoperative outcomes is an important step in our evolution of knowledge.

Cardiac Surgery in Women in the Current Era: What Are the Gaps in Care?

Cardiovascular disease remains the leading cause of morbidity and mortality for women in United States and worldwide. One in 3 women dies from cardiovascular disease, and 45% of women >20 years old have some form of CVD. Historically, women have had higher morbidity and mortality after cardiac surgery. Sex influences pathogenesis, pathophysiology, presentation, postoperative complications, surgical outcomes, and survival. This review summarizes current cardiovascular surgery outcomes as they pertain to women. Specifically, this article seeks to address whether sex disparities in research, surgical referral, and outcomes still exist and to provide strategies to close these gaps. In addition, with the growing population of women of reproductive age with cardiovascular disease and cardiovascular risk factors, indications for cardiac surgery arise in pregnant women. The current review will also address the unique issues associated with this special population.

Preoperative factors associated with worsening in health-related quality of life following coronary artery bypass grafting in the Randomized On/Off Bypass (ROOBY) trial.

For advanced coronary disease, coronary artery bypass graft (CABG) surgery generally improves patients' symptoms and long-term survival. Unfortunately, some patients experience worse health-related quality of life (HRQL) after CABG. The objective of this study is to report the frequency and risk factors associated with 1-year post-CABG HRQL deterioration. METHODS: From 2002 to 2007, 2203 "Randomized On/Off Bypass" (ROOBY) trial patients randomly received either off-pump or on-pump CABG at 18 VA medical centers. Subjects completed both baseline and 1-year Seattle Angina Questionnaire (SAQ) and the Veterans Rand 36 (VR-36) questionnaires to assess HRQL. Using previously published criteria, the rates of clinically significant changes were determined for the SAQ [angina frequency (AF), physical limitation (PL), and quality of life (QoL)] and VR36 [mental component score (MCS) and physical component score (PCS)] subscales. Multivariate regression models were then used to identify pre-CABG patient characteristics associated with worsened 1-year HRQL status for each subscale. RESULTS: Over 80% of patients had an improvement or no change in SAQ and VR-36 subscale scores 1 year after CABG. The HRQL scale-specific deterioration rates were 4.5% SAQ-AF, 16.8% SAQ-PL, 4.9% SAQ-QoL, 19.4% VR36-MCS, and 13.5% VR36-PCS. Predictors of 1-year HRQL deterioration were diabetes and smoking for the SAQ-AF; diabetes, chronic obstructive pulmonary disease (COPD), and peripheral vascular disease (PVD) for SAQ-PL; COPD and depression for the SAQ-QoL; diabetes for VR36-PCS, and history of stroke and depression for VR36-MCS. The baseline score was an independent predictor for worsening in all the subscales studied. CONCLUSIONS: Among VA patients, less than 20% experienced worse HRQL 1 year after CABG. For patients with low symptom burden at baseline, diabetes, smoking, depression, PVD, COPD, and a prior stroke, clinicians should be more cautious in pre-CABG counseling as to their anticipated HRQL improvements.

Concordance between administrative data and clinical review for mortality in the randomized on/off bypass follow-up study (ROOBY-FS).

BACKGROUND: The optimal methodology to identify cardiac versus non-cardiac cause of death following cardiac surgery has not been determined. METHODS: The Randomized On/Off Bypass Trial was a multicenter, randomized, controlled clinical trial of 2203 patients (February 2002-May 2008) comparing 1-year cardiac outcomes between off-pump and on-pump bypass surgery. In 2013, the Veterans Affairs (VA) Cooperative Studies Program funded a follow-up study to assess 5-year outcomes including mortality. Deaths were identified and confirmed using the National Death Index (NDI), VA Vital Status file, and medical records. An Endpoints Committee (EC) reviewed patient medical records and classified each cause of death as cardiac, non-cardiac, or unknown. Using pre-determined ICD-10 codes, NDI death certificates were independently used to classify deaths as cardiac or non-cardiac. Cause of death was compared between the NDI and EC classifications and concordance measured, using Kappa statistics. RESULTS: Of the 297 5-year deaths identified by the NDI and/or VA vital status file and confirmed by the EC, 219 had adequate patient records for EC cause of death determination. The EC adjudicated 141 of these deaths as non-cardiac and 78 as cardiac, while the NDI classified 150 as non-cardiac and 69 as cardiac; agreement was 77.6% (kappa 0.500; P < 0.001). CONCLUSIONS: Since concordance between EC and NDI cause of death classifications was only moderate, caution should be exercised in relying exclusively on NDI data to determine cause of death. A hybrid approach, integrating multiple information sources, may provide the most accurate approach to classifying cause of death.

Pathways Linking Post-Traumatic Stress Disorder to Incident Ischemic Heart Disease in Women: Call to Action.

Background: Post-traumatic stress disorder (PTSD) is associated with increased rates of incident ischemic heart disease (IHD) in women. Objectives: The purpose of this study was to determine mechanisms of the PTSD-IHD association in women. Methods: In this retrospective longitudinal cohort study, data were obtained from electronic health records of all U.S. women veterans who were enrolled in Veterans Health Administration care from January 1, 2000 to December 31, 2017. Propensity score matching was used to match women with PTSD to women without PTSD on age, number of prior Veterans Health Administration visits, and presence of various traditional and nontraditional cardiovascular risk factors at index visit. Cox regression was used to model time until incident IHD diagnosis (ie, coronary artery disease, angina, or myocardial infarction) as a function of PTSD and potential mediating risk factors. Diagnoses of IHD, PTSD, and risk factors were defined by International Classification of Diseases-9th or -10th Revision, and/or Current Procedural Terminology codes. Results: PTSD was associated with elevated rates of developing each risk factor. Traditional risk factors (hypertension, hyperlipidemia, smoking, diabetes) accounted for 24.2% of the PTSD-IHD association, psychiatric risk factors (eg, depression, anxiety, substance use disorders) accounted for 33.8% of the association, and all 13 risk factors accounted for 48.5% of the association. Conclusions: Traditional IHD risk factors explained a quarter of the PTSD-IHD association in women veterans, and over half of the risk of IHD associated with PTSD remained unexplained even when adjusting for a wide range of risk factors. To be actionable, factors underlying the remaining PTSD-IHD association warrant timely investigation.

Race-insurance disparities in prostate patients' magnetic resonance imaging biopsies and their subsequent cancer care: a New York State cohort study.

For organ-confined prostate cancer, socioeconomic factors influencing Magnetic Resonance Imaging (MRI)-guided biopsy utilization and downstream prostate cancer patients' care are unknown. This retrospective, observational cohort study used the New York Statewide Planning and Research Cooperative System (SPARCS) billing-code driven database to examine the impact of prostate patients' socioeconomic characteristics on prostate cancer care defined as initial biopsy, 2-month post-biopsy cancer diagnoses, and within 1-year cancer-related intervention, controlling for other risk factors. From 2011-2017, the population studied (n = 18,253) included all New York State-based, male, residents aged 18 to 75 without a prior prostatectomy receiving a first-time biopsy; 760 such patient records in 2016 were removed due to data quality concerns. Major exposures included patient age, race, ethnicity and insurance. The major outcome included receipt of MRI biopsy versus standard biopsy and for these sub-populations, subsequent 2-month post-biopsy metastatic versus non-metastatic prostate cancer diagnosis and within 1-year prostate cancer treatment (prostatectomy with or without radiation versus prostatectomy-only) were compared using dichotomous (primary) and time-to-event (secondary) endpoints. Of 17,493 patients with a first-time prostate biopsy, 3.89% had MRI guided biopsies; of the 17,128 patients with no pre-biopsy cancer diagnosis, the subsequent prostate cancer diagnosis rate was 42.59%. For 6,754 non-metastatic prostate cancer patients with 1-year follow-up, 1,674 (24.79%) received surgery (with or without radiation) and 495 (7.33%) received radiation-only. Holding other factors constant, multivariable regression models identified that race-insurance was a primary predictor of MRI-guided biopsy use. Compared to commercially insured White patients, Black patients across all insurance categories received MRI-guided biopsies less frequently; Commercially insured and self-pay Black patients also had increased chance of prostate cancer diagnosis. Across all insurers, Black patients had lower likelihood of prostatectomies. In contrast, Black and White patients with government insurance were more likely to have within 1-year radiation-only treatments versus commercially insured White patients. Thus, across the prostate cancer care continuum, race-insurance affected prostate cancer-related service utilization. Future research should evaluate the generalizability of these New York State findings.

Incidence and Prognostic Impact of Incomplete Revascularization Documented by Coronary Angiography 1 Year After Coronary Artery Bypass Grafting.

Complete revascularization (CR) at the time of coronary artery bypass graft (CABG) surgery improves long-term cardiac outcomes. No studies have previously reported angiographically confirmed CR rates post-CABG. This study's aim was to assess the impact upon long-term outcomes of CR versus incomplete revascularization (IR), confirmed by coronary angiography 1 year after CABG. Randomized On/Off Bypass Study patients who returned for protocol-specified 1-year post-CABG coronary angiograms were included. Patients with a widely patent graft supplying the major diseased artery within each diseased coronary territory were considered to have CR. Outcomes were all-cause mortality and major adverse cardiovascular events (MACE; all-cause mortality, nonfatal myocardial infarction, repeat revascularization) over the 4 years after angiography. Of the 1,276 patients, 756 (59%) had CR and 520 (41%) had IR. MACE was 13% CR versus 26% IR, p <0.001. This difference was driven by fewer repeat revascularizations (5% CR vs 18% IR; p <0.001). There were no differences in mortality (7.1% CR vs 8.1% IR, p = 0.13) or myocardial infarction (4% in both). Adjusted multivariable models confirmed CR was associated with reduced MACE (odds ratio 0.44, 95% confidence interval 0.33 to 0.58, p <0.01), but had no impact on mortality. In conclusion, CR confirmed by post-CABG angiography was associated with improved MACE but not mortality. Repeat revascularization of patients with IR, driven by knowledge of the research angiography results, may have ameliorated potential mortality differences.

The Society of Thoracic Surgeons Adult Cardiac Surgery Database: The Driving Force for Improvement in Cardiac Surgery.

Initiated in 1989, the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) includes more than 1085 participating centers, representing 90%-95% of current US-based adult cardiac surgery hospitals. Since its inception, the primary goal of the STS ACSD has been to use clinical data to track and improve cardiac surgical outcomes. Patients' preoperative risk characteristics, procedure-related processes of care, and clinical outcomes data have been captured and analyzed, with timely risk-adjusted feedback reports to participating providers. In 2006, STS initiated an external audit process to evaluate STS ACSD completeness and accuracy. Given the extremely high inter-rater reliability and completeness rates of STS ACSD, it is widely regarded as the "gold standard" for benchmarking cardiac surgery risk-adjusted outcomes. Over time, STS ACSD has expanded its quality horizons beyond the traditional focus on isolated, risk-adjusted short-term outcomes such as perioperative morbidity and mortality. New quality indicators have evolved including composite measures of key processes of care and outcomes (risk-adjusted morbidity and risk-adjusted mortality), longer-term outcomes, and readmissions. Resource use and patient-reported outcomes would be added in the future. These additional metrics provide a more comprehensive perspective on quality as well as additional end points. Widespread acceptance and use of STS ACSD has led to a cultural transformation within cardiac surgery by providing nationally benchmarked data for internal quality assessment, aiding data-driven quality improvement activities, serving as the basis for a voluntary public reporting program, advancing cardiac surgery care through STS ACSD-based research, and facilitating data-driven informed consent dialogues and alternative treatment-related discussions.

Long-term follow-up assessment of a phase 1 trial of angiogenic gene therapy using direct intramyocardial administration of an adenoviral vector expressing the VEGF121 cDNA for the treatment of diffuse coronary artery disease.

On the basis of studies in experimental animals demonstrating that AdVEGF121, an E1(-)E3(-) serotype 5 adenovirus coding the 121 isoform of vascular endothelial growth factor (VEGF), could mediate the generation of new blood vessels and reverse coronary ischemia, a clinical study of direct myocardial administration of AdVEGF121 was initiated in patients with late-stage, diffuse coronary artery disease. This study provides long-term (median, 11.8 years) follow-up on these patients. From 1997 to 1999, AdVEGF121 was administered by direct myocardial injection to an area of reversible ischemia in 31 patients with severe coronary disease, either as an adjunct to conventional coronary artery bypass grafting (group A) or as minimally invasive sole (MIS) therapy, using a minithoracotomy (group B). There was no control group; the study participants served as the control subjects. The 5- and 10-year survival was 10 of 15 (67%) and 6 of 15 (40%) for the group A patients, and 11 of 16 (69%) and 5 of 16 (31%) for group B sole therapy patients, respectively. In comparison, maximal medical therapy in comparable groups in the literature have a 3- to 5-year survival rate of 52 to 59%. For the survivors, the angina score for group A was 3.4±0.5 at time 0 and 1.9±1.0 at last follow-up, and for group B it was 3.4±0.6 and 2.0±1.1, respectively. The incidences of malignancy and retinopathy were no greater than that expected for the age-matched general population. We conclude that adenovirus-mediated VEGF direct myocardial administration to patients with severe coronary artery disease is safe, and future larger trials are warranted to assess efficacy.

Platelet activity measured by a rapid turnaround assay identifies coronary artery bypass grafting patients at increased risk for bleeding and transfusion complications after clopidogrel administration.

BACKGROUND: We sought to establish a metric for easily estimating bleeding and transfusion risks for cardiac surgery patients after antiplatelet agent use. METHODS: Deidentified records of patients who underwent coronary artery bypass grafting (CABG) at our institution (January 2010-June 2011) were searched for patients without identified risk factors for excessive bleeding who underwent documented P2Y12 testing after clopidogrel administration (n = 276). Clinical outcomes were analyzed according to whether preoperative platelet function was higher (platelet reactivity units [PRUs], ≥237) or lower (PRU, <237) and according to preoperative PRU cutoffs: high (>290, or no clopidogrel), intermediate (200-290), or low (<200). RESULTS: Eighty-five patients (57%) received allogeneic blood products at 24 hours or less postoperatively: 33 (22%) received fresh frozen plasma, and 57 (38%) received platelets. The median 12-hour chest tube output (CTO) was 350 mL (interquartile range, 260-490 mL); CTO was "high" (>437 mL) in 62 (42%) of the clopidogrel-treated patients. Lower-PRU patients were more likely to receive coagulation factors (odds ratio [OR], 2.82; P = .0004) and to have high CTO or coagulation factor transfusion (OR, 2.35; P = .02) than higher-PRU patients. Likewise, intermediate- and low-PRU patients had incrementally greater incidences of high CTO (OR, 1.72; P = .002) and coagulation factor transfusion (OR, 2.08; P < .0001) than high-PRU/no clopidogrel patients. High CTO or coagulation factor transfusion was more frequent in intermediate-PRU (OR, 2.67; P = .02) and low-PRU (OR, 5.08; P = .0002) patients than in high-PRU/no clopidogrel patients. CONCLUSIONS: Among clopidogrel-treated CABG patients, preoperative platelet function testing can identify those at increased risk for postoperative bleeding and transfusion.