Impact of adverse events on health-related quality of life after left ventricular assist device implantation: An STS INTERMACS analysis.

BACKGROUND: We sought to quantify the impact of pre- and postoperative variables on health-related quality of life (HRQOL) after left ventricular assist device (LVAD) implantation. METHODS: Primary durable LVAD implants between 2012 and 2019 in the Interagency Registry for Mechanically Assisted Circulatory Support were identified. Multivariable modeling using general linear models assessed the impact of baseline characteristics and postimplant adverse events (AEs) on HRQOL as assessed by the EQ-5D visual analog scale (VAS) and the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ) at 6 months and 3 years. RESULTS: Of 22,230 patients, 9,888 had VAS and 10,552 had KCCQ reported at 6 months, and 2,170 patients had VAS and 2,355 had KCCQ reported at 3 years postimplant. VAS improved from a mean of 38.2 ± 28.3 to 70.7 ± 22.9 at 6 months and from 40.1 ± 27.8 to 70.3 ± 23.1 at 3 years. KCCQ improved from 28.2 ± 23.9 to 64.3 ± 23.2 at 6 months and from 29.8 ± 23.7 to 63.0 ± 23.7 at 3 years. Preimplant variables, including baseline VAS, had small effect sizes on HRQOL while postimplant AEs had large negative effect sizes. Recent stroke, respiratory failure, and renal dysfunction had the largest negative effect on HRQOL at 6 months, while recent renal dysfunction, respiratory failure, and infection had the largest negative effect at 3 years. CONCLUSIONS: AEs following LVAD implantation have large negative effects on HRQOL in early and late follow-up. Understanding the impact of AEs on HRQOL may assist shared decision-making regarding LVAD eligibility. Continued efforts to reduce post-LVAD AEs are warranted to improve HRQOL in addition to survival.

Timing and Outcomes of Concurrent and Sequential Biventricular Assist Device Implantation: A Society of Thoracic Surgeons Intermacs Analysis.

BACKGROUND: Biventricular heart failure remains a clinically challenging condition to manage. Available literature describing the use of durable biventricular assist device (BiVAD) support has numerous limitations hindering the development of useful treatment algorithms. Analysis of BiVAD use within a large multicenter data set is needed to clarify outcomes associated with this therapy. METHODS: The Society of Thoracic Surgeons Intermacs database was queried to identify adults aged ≥18 years who received durable circulatory support from January 1, 2010, to December 31, 2220. The data set was divided into the following cohorts: (1) left ventricular assist device (LVAD) only (n = 27,325), (2) LVAD and concurrent right ventricular assist device (RVAD) (n = 1090), and (3) LVAD and sequential RVAD (n = 556). Propensity score matching was used to compare 1-year mortality and adverse events between concurrent (n = 565) and sequential BiVADs (n = 565). RESULTS: Overall survival within 1 year was significantly worse for the BiVAD cohort compared with the LVAD-only cohort (12-month survival: 50.8% vs 82.6%; log-rank P < .001). In a propensity-matched cohort, patients implanted with a BiVAD concurrently had an improved survival compared with those implanted an LVAD and an RVAD sequentially (12-month survival: 55.8% vs 41.8%; log-rank P < .001). Early (<3 months) adverse event rates were higher among patients receiving sequential BiVADs for bleeding, infection, neurologic dysfunction, and renal dysfunction (P < .01). CONCLUSIONS: After matching for patient and disease characteristics, patients with sequential BiVAD implantation have worse outcomes than patients with concurrent BiVAD implantation.

Expectations of Surveillance for Non-BRCA Gene Mutation Carriers at Increased Risk for Breast Cancer.

BACKGROUND: The University of Alabama at Birmingham Preventative Care Program for Women's Cancer provides genetic testing, risk evaluation, and screening for breast cancer. Women diagnosed with high-risk mutations may opt to undergo active surveillance or prophylactic surgery. This decision requires understanding of the surveillance process and its potential outcomes. In this study, we report specifically on women with non-BRCA1 or BRCA2 mutations. METHODS: A retrospective, cross-sectional study was conducted of women enrolled in our program identified as high risk because of non-BRCA mutations. Events regarding genetic mutations, method of detection of suspicious lesions, number of biopsies, results of those biopsies, prophylactic surgery, and cancer diagnosis were collected. RESULTS: We identified 78 patients with asymptomatic non-BRCA deleterious mutations. Sixteen mutations were identified, with the most common being ATM, CHEK2, and PALB2. In total, 11.5% underwent prophylactic surgery and 88.5% underwent active surveillance. In the surveillance group, 63.8% had no examination or imaging to warrant biopsy, 24.6% had biopsy with benign result, and 11.6% had biopsy with malignant result. For the nine women who developed breast cancer during surveillance, six were diagnosed with ductal carcinoma in situ, two with stage I, and one with stage IIA cancer. CONCLUSIONS: Women with non-BRCA mutations enroll in prevention clinics with hopes of early detection of breast cancer. Because of increased screening, this population undergoes biopsy more frequently; however, during surveillance most do not require a biopsy. For those that do, the result is typically benign. This information can further allow women to make informed decisions about surveillance and establish realistic expectations regarding the likelihood of tissue sampling.

Is Disruptive Behavior Inherent to the Surgeon or the Environment? Analysis of 314 Events at a Single Academic Medical Center.

OBJECTIVE: In 2009, the Joint Commission mandated a process to manage disruptive behavior, as evidence suggests it undermines a culture of safety. This process often reviews only the reporter's side of the story as the truth. In this study, we compared both reporter account (RA) and involved party (IP) responses to determine if disruptive behavior was inherent to the surgeon or the hospital environment and its relationship to patient safety. METHODS: From 1/1/2015 through 12/31/2017, we prospectively recorded the RA and the IP response. This resulted in 314 reports involving 204 IPs. Four reviewers scored issues, interactions, modifiable stressors, and patient safety. Logistic regression determined factors associated with patient harm. Significance defined as P < 0.05. RESULTS: Surgical, medical, and other specialties were IPs 43%, 35%, and 22%, respectively; 73% had only one event. High-intensity environments (OR, ICU, etc.) made up 56% of the total. Perceived unprofessional or lack of communication was present in 70% and 44% of events. A significant direct relationship existed between the stress of the clinical situation and the egregiousness of the behavior (P < 0.0001). Logistic regression revealed that unclear hospital policies, the IP being a surgeon, and urgent competing responsibilities were associated with potential patient harm (P < 0.05). CONCLUSIONS: Unclear policies and urgent competing responsibilities in the surgical environment create stress, leading to conflict. Single events for the majority suggest the environment as the primary contributor. Tactics to improve stressful environments and clearly communicated policies may be more effective and sustainable than individually targeted interventions in enhancing patient safety.

Gaps in the Postoperative Conversation: A Comprehensive Review of Current Practices and the Unmet Needs of Surgeons, Families, and Waiting Room Personnel.

Perioperative communication between surgeons and caregivers is an important aspect of patient care, with postoperative conversations (POCs) being critical. Literature suggests current communication practices may be suboptimal. Identifying barriers and opportunities could improve patient and caregiver satisfaction and increase surgeon efficiency. This mixed method study included 1) prospective study of all patients undergoing a surgery at an academic medical center between September 2014 and March 2016 and 2) nominal groups of physicians, caregivers, and waiting room personnel (WRP). Nominal groups ranked standard of care themes needing intervention. Multivariate logistic regression estimated the association of surgeon and procedure characteristics with POC practices considering both location and contact method. Data on 15,820 operations showed that surgical specialty (P ≤ 0.0001), inpatient status (P ≤ 0.0001), planned discharge destination (P = 0.0003), patient race (P = 0.02), and caregiver relationship (P ≤ 0.0001) were all significantly associated with receiving a private POC. Nominal group results provided opportunities for improvement: regular updates (caregivers), locating the caregivers postoperation (surgeons), clear communication between caregivers and surgeons (WRP). This study examines the perioperative communication. Surgeons, caregivers, and WRP identified effective communication as a top intervention priority. Managing caregiver expectations, addressing concerns of WRP, and creating an efficient environment for surgeons appear to be critical components to communication.

Understanding the Value of Both Laparoscopic and Robotic Approaches Compared to the Open Approach in Colorectal Surgery.

INTRO: Although the use of laparoscopy has significantly increased in colorectal procedures, robotic surgery may enable additional cases to be performed using a minimally invasive approach. We separately evaluated the value of laparoscopic and robotic colorectal procedures compared to the open approach. METHODS: Patients undergoing nonemergent colorectal operations from 2010 to 2013 with National Surgical Quality Improvement Project data were identified. Robotic and laparoscopic procedures were separately matched (1:1) to open cases. Outcomes included 30-day composite morbidity, length of stay, operative time, and inpatient costs. Frequently used intraoperative disposable items were categorized, and significant cost contributors were identified by surgical approach. Statistical differences were determined with Chi-square and Wilcoxon signed-rank tests. RESULTS: Both laparoscopic (n = 67) and robotic (n = 45) approaches were associated with decreased composite morbidity compared to matched open cases (lap vs. open: 22.4% vs. 49.2%, P < .01; robotic vs. open: 6.7% vs. 33.3%, P < .01). Median length of stay was significantly shorter for both laparoscopic and robotic compared to open surgery (lap vs. open: 5 vs. 7 days, P < .01; robotic vs. open: 5 vs. 7 days, P < .01). Median hospital costs were similar between laparoscopic and open surgery ($13,319 vs. $14,039; P = .80) and robotic and open surgery ($13,778 vs. $13,629; P = .48). CONCLUSION: These findings illustrate the value for both laparoscopic and robotic approaches to colorectal surgery compared to the open approach in terms of short-term outcomes and inpatient costs. Advanced intraoperative disposable items such as cutting staplers and energy devices are important targets for additional cost containment.

Timed Stair Climbing Is the Single Strongest Predictor of Perioperative Complications in Patients Undergoing Abdominal Surgery.

BACKGROUND: Current methods to predict patients' perioperative morbidity use complex algorithms with multiple clinical variables focusing primarily on organ-specific compromise. The aim of the current study was to determine the value of a timed stair climb in predicting perioperative complications for patients undergoing abdominal surgery. STUDY DESIGN: From March 2014 to July 2015, three hundred and sixty-two patients attempted stair climbing while being timed before undergoing elective abdominal surgery. Vital signs were measured before and after stair climb. Ninety-day postoperative complications were assessed by the Accordion Severity Grading System. The prognostic value of stair climb was compared with the American College of Surgeons NSQIP risk calculator. RESULTS: A total of 264 (97.4%) patients were able to complete the stair climb. Stair climb time directly correlated to changes in both mean arterial pressure and heart rate as an indicator of stress. An Accordion grade 2 or higher complication occurred in 84 (25%) patients. There were 8 mortalities (2.4%). Patients with slower stair climb times had increased complication rates (p < 0.0001). In multivariable analysis, stair climb time was the single strongest predictor of complications (odds ratio = 1.029; p < 0.0001), and no other clinical comorbidity reached statistical significance. Receiver operative characteristic curves predicting postoperative morbidity by stair climb time was superior to that of the American College of Surgeons risk calculator (area under the curve = 0.81 vs 0.62; p < 0.0001). Additionally, slower patients had greater deviations from predicted length of hospital stay (p = 0.034). CONCLUSIONS: Stair climb provides measurable stress, accurately predicts postoperative complications, and is easy to administer in patients undergoing abdominal surgery. Larger patient populations with a diverse group of operations will be needed to validate the use of stair climbing in risk-prediction models.

Blood Transfusion and 30-Day Mortality in Patients With Coronary Artery Disease and Anemia Following Noncardiac Surgery.

IMPORTANCE: Although liberal blood transfusion thresholds have not been beneficial following noncardiac surgery, it is unclear whether higher thresholds are appropriate for patients who develop postoperative myocardial infarction (MI). OBJECTIVE: To evaluate the association between postoperative blood transfusion and mortality in patients with coronary artery disease and postoperative MI following noncardiac surgery. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study involving Veterans Affairs facilities from January 1, 2000, to December 31, 2012. A total of 7361 patients with coronary artery disease who underwent inpatient noncardiac surgery and had a nadir postoperative hematocrit between 20% and 30%. Patients with significant bleeding, including any preoperative blood transfusion or transfusion of greater than 4 units during the intraoperative or postoperative setting, were excluded. Mortality rates were compared using both logistic regression and propensity score matching. Patients were stratified by postoperative nadir hematocrit and the presence of postoperative MI. EXPOSURE: Initial postoperative blood transfusion. MAIN OUTCOMES AND MEASURES: The 30-day postoperative mortality rate. RESULTS: Of the 7361 patients, 2027 patients (27.5%) received at least 1 postoperative blood transfusion. Postoperative mortality occurred in 267 (3.6%), and MI occurred in 271 (3.7%). Among the 5334 patients without postoperative blood transfusion, lower nadir hematocrit was associated with an increased risk for mortality (hematocrit of 20% to <24%: 7.3%; 24% to <27%: 3.7%; and 27% to 30%: 1.6%; P < .01). In patients with postoperative MI, blood transfusion was associated with lower mortality, for those with hematocrit of 20% to 24% (odds ratio, 0.28; 95% CI, 0.13-0.64). In patients without postoperative MI, transfusion was associated with significantly higher mortality for those with hematocrit of 27% to 30% (odds ratio, 3.21; 95% CI, 1.85-5.60). CONCLUSIONS AND RELEVANCE: These findings support a restrictive postoperative transfusion strategy in patients with stable coronary artery disease following noncardiac surgery. However, interventional studies are needed to evaluate the use of a more liberal transfusion strategy in patients who develop postoperative MI.

Improved adverse postoperative outcomes with revised American College of Cardiology/American Heart Association guidelines for patients with cardiac stents.

IMPORTANCE: In 2007, the American College of Cardiology/American Heart Association guidelines were revised for patients with cardiac stents in need of subsequent surgery to recommend delaying elective noncardiac surgery by 365 days in patients with drug-eluting stents (DESs). OBJECTIVE: To examine the effect of the guidelines on postoperative major adverse cardiac events (MACEs) in subsequent noncardiac surgery. DESIGN, SETTING, AND PARTICIPANTS: Patients receiving a cardiac stent between fiscal years 2005 and 2010 were identified by International Classification of Diseases, Ninth Revision diagnosis codes in the Veterans Affairs Medical SAS data sets. The Veterans Affairs Surgical Quality Improvement Program data were used to identify subsequent operations in the 2 years following stenting. The preguideline period was defined as fiscal years 2005 through 2007 and the postguideline period was defined as fiscal years 2008 through 2010. Surgery patients admitted through the emergency department or transferred from another hospital were excluded from analyses. Overall, 16,634 elective noncardiac operations were identified (8034 [48.3%] in the preguideline period; 8600 [51.7%] in the postguideline period). MAIN OUTCOMES AND MEASURES: Composite 30-day postoperative MACEs. We used χ² tests to examine differences in bivariate frequencies and used logistic models to examine adjusted associations with 2-year postoperative MACEs. RESULTS: The median time to surgery was 364 days (interquartile range, 184-528 days). A total of 11,026 operations (66.3%) followed DES placement, and 5608 (33.7%) followed bare metal stent placement. After the guidelines' publication, surgery timing increased following DES placement from 323 to 404 days (P < .001) and decreased following bare metal stent placement from 402 to 309 days (P < .001). In addition, postoperative MACE rates decreased from 4.2% to 3.3% (P = .002). After adjusting for cardiac risk factors and procedure characteristics, there was an overall absolute risk reduction of 0.9% for MACEs (odds ratio = 0.74; 95% CI, 0.62-0.89). On further examination of trends across time, MACE rates with DES placement began to decrease prior to the guidelines' publication from 5.5% in 2005 to 4.3% in 2006 and remained stable through 2010. In contrast, MACE rates with bare metal stent placement increased from 4.3% in 2005 to 8.0% in 2007 but decreased to 4.8% following the guidelines' publication. CONCLUSIONS AND RELEVANCE: After the guidelines' publication, noncardiac surgery was delayed in patients with DESs but not bare metal stents. With a 26% reduction in MACEs following the guidelines, it would appear that the guidelines did improve postoperative outcomes; however, when examined over time, it becomes evident that there are many more factors influencing management of patients with cardiac stents in need of subsequent surgery.