Low-volume hospitals are not associated with inferior outcomes after thoracic endovascular aortic repair.

BACKGROUND: Thoracic endovascular aortic repair (TEVAR) has been increasingly used to treat complex thoracic aortic pathology. In the present study, we assessed the hospital volume's effects on the outcomes of patients who had undergone TEVAR. METHODS: Patients who had undergone TEVAR from January 2015 to December 2019 were identified from the Vascular Quality Initiative database. The participating centers were stratified by volume as low-volume hospitals (LVHs) and high-volume hospitals (HVHs). We assessed the effects of hospital volume on 30-day mortality and major postoperative complications using multivariable logistic regression analysis. RESULTS: A total of 3584 TEVAR patients (1720 asymptomatic and 1864 symptomatic or ruptured) were identified at 147 centers. The median average annual number of TEVAR cases at the LVHs and HVHs was 6 and 17 cases, respectively. No significant differences were found in 30-day mortality between the LVHs and HVHs (asymptomatic, 3.7% vs 3.7% [P = .98]; symptomatic or ruptured, 9.3% vs 7.3% [P = .13]). After adjusting for multiple clinical and anatomic factors, treatment at a LVH was not associated with increased 30-day mortality (asymptomatic: odds ratio, 0.98; 95% confidence interval, 0.52-1.87; P = .96; symptomatic or ruptured: odds ratio, 1.15; 95% confidence interval, 0.75-1.77; P = .53) nor an increased risk of major complications, including renal, neurologic, cardiac, pulmonary, and femoral artery access complications (P > .05 for all). CONCLUSIONS: Using a large national database, we have demonstrated that treatment at LVHs is not associated with inferior TEVAR outcomes compared with HVHs. The technical aspect of the procedure might play a role in the similarity of outcomes across the different institutional experiences.

Anemia as an independent predictor of adverse outcomes after carotid revascularization.

BACKGROUND: Anemia has been identified as a risk factor for postoperative morbidity and mortality after major vascular procedures. Carotid revascularization carries less cardiac morbidity and physiologic stress compared with other vascular interventions. This study evaluated the association between preoperative anemia and major adverse events after carotid revascularization. METHODS: Patients undergoing carotid endarterectomy (CEA) and carotid artery stenting (CAS) between January 2012 and June 2018 in the Vascular Quality Initiative database were identified. Anemia was defined as a preoperative hemoglobin level of <12 g/dL in women and <13 g/dL in men. Multivariable logistic analysis and 1:1 coarsened exact matching were used to study the association between preoperative anemia and in-hospital major adverse cardiac events (MACEs), defined as a composite of stroke, death, and myocardial infarction, and between anemia and 30-day mortality after CEA and CAS. RESULTS: Of 102,719 patients included in the analysis, 34.8% were anemic (CEA, 34.1%; CAS, 37.8%; P < .001). Anemic patients were older and had more medical comorbidities compared with nonanemic patients. In-hospital MACEs (2.8% vs 1.9%; P < .001) and 30-day mortality (0.9% vs 0.4%; P < .001) were higher among anemic patients. On multivariable analysis, anemia was associated with 18% higher odds of in-hospital MACEs (odds ratio, 1.18; 95% confidence interval, 1.07-1.31, P = .001) and 74% higher odds of 30-day mortality (odds ratio, 1.74; 95% confidence interval, 1.40-2.17, P < .001). Coarsened exact matching showed similar results. The association between preoperative anemia and adverse outcomes was similar in both CAS and CEA and in symptomatic and asymptomatic patients (P interaction > .05). CONCLUSIONS: Anemia is associated with increased odds of adverse events after CEA and CAS. It should be factored into the preoperative risk assessment of patients undergoing carotid revascularization. Prospective studies are needed to study the effectiveness of correcting low preoperative hemoglobin levels in these patients and the association between anemia and long-term outcomes after CEA and CAS.

Outcomes following Eversion versus Conventional Endarterectomy in the Vascular Quality Initiative Database.

BACKGROUND: Although the majority of vascular surgeons perform conventional carotid endarterectomy (c-CEA), others prefer eversion CEA (e-CEA). Despite several randomized controlled trials and single center studies, the advantage of one technique over the other is still not clearly defined. The purpose of this study is to compare the postoperative outcomes and durability of c-CEA versus e-CEA in a nationally representative cohort. METHODS: We performed a retrospective review of the Vascular Quality Initiative database between 2003 and 2018. Patients with prior ipsilateral carotid intervention (CEA and carotid artery stenting) and those undergoing concomitant procedures were excluded. Multivariable logistic and Cox-regression analyses were used to compare risk-adjusted perioperative and 1-year outcomes (stroke, death, and high-grade restenosis [>70%]) between c-CEA (using direct closure or patch angioplasty) and e-CEA. RESULTS: A total of 95,726 CEA cases were included, of which 12,050 (12.6%) were e-CEA and the remaining (87.4%) were c-CEA. Patch angioplasty was used in 94.9% of c-CEA compared with 49.7% of e-CEA (P < 0.001). On univariable analysis, no difference in perioperative outcomes was noted between the 2 approaches except for higher rates of in-hospital dysrhythmia (1.5% vs. 1.3%) and postprocedural hemodynamic instability (27.3% vs. 24.3%) after c-CEA compared with e-CEA (all P < 0.05). On the other hand, e-CEA patients were more likely to return to the operating room for bleeding (1.3% vs. c-CEA: 0.9%, P < 0.001). The outcomes of e-CEA did not differ if the common carotid artery was closed primarily or with a patch. After adjusting for potential confounders and stratifying with respect to patch use, there was no significant difference in outcomes between e-CEA and c-CEA when a patch is used in both procedures. However, when no patching was performed, e-CEA was associated with lower stroke/death at 30 days (odds ratio 0.72, 95% confidence interval [CI] 0.54-0.95, P = 0.02) and at 1 year (hazard ratio 0.75, 95% CI 0.58-0.97, P = 0.03). CONCLUSIONS: Both e-CEA and c-CEA are safe and durable techniques with similar stroke/death and restenosis rates up to 1-year of follow up, as long as c-CEA is performed with patch angioplasty. However, e-CEA is superior to c-CEA without patch angioplasty and is associated with 28% and 25% reduction in 30-day and 1-year stroke/death, respectively.

PASC in Solid Organ Transplant Recipients With Self-reported SARS-CoV-2 Infection.

BACKGROUND: Postacute sequelae of SARS-CoV-2 infection (PASC) is an increasingly recognized phenomenon and manifested by long-lasting cognitive, mental, and physical symptoms beyond the acute infection period. We aimed to estimate the frequency of PASC symptoms in solid organ transplant (SOT) recipients and compared their frequency between those with SARS-CoV-2 infection requiring hospitalization and those who did not require hospitalization. METHODS: A survey consisting of 7 standardized questionnaires was administered to 111 SOT recipients with history of SARS-CoV-2 infection diagnosed >4 wk before survey administration. RESULTS: Median (interquartile range) time from SARS-CoV-2 diagnosis was 167 d (138-221). Hospitalization for SARS-CoV-2 infection was reported in 33 (30%) participants. Symptoms after the COVID episode were perceived as following: significant trauma (53%), cognitive decline (50%), fatigue (41%), depression (36%), breathing problems (35%), anxiety (23%), dysgeusia (22%), dysosmia (21%), and pain (19%). Hospitalized patients had poorer median scores in cognition (Quick Dementia Rating System survey score: 2.0 versus 0.5, P = 0.02), quality of life (Health-related Quality of Life survey: 2.0 versus 1.0, P = 0.015), physical health (Global physical health scale: 10.0 versus 11.0, P = 0.005), respiratory status (Breathlessness, Cough and Sputum Scale: 1.0 versus 0.0, P = 0.035), and pain (Pain score: 3 versus 0 out of 10, P = 0.003). Among patients with infection >6 mo prior, some symptoms were still present as following: abnormal breathing (42%), cough (40%), dysosmia (29%), and dysgeusia (34%). CONCLUSIONS: SOT recipients reported a high frequency of PASC symptoms. Multidisciplinary approach is needed to care for these patients beyond the acute phase.

Immunogenicity and Reactogenicity After SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients Taking Belatacept.

BACKGROUND: Belatacept may impair humoral immunity, impacting the effectiveness of SARS-CoV-2 mRNA vaccines in transplant recipients. We investigated immunogenicity after SARS-CoV-2 mRNA vaccines in kidney transplant recipients who are and are not taking belatacept. METHODS: Participants were recruited between December 9, 2020, and April 1, 2021. Blood samples were collected after dose 1 and dose 2 (D1, D2) and analyzed using either an anti-SARS-CoV-2 enzyme immunoassay against the S1 domain of the SARS-CoV-2 spike protein or immunoassay against the receptor-binding domain of the SARS-CoV-2 spike protein. Stabilized inverse probability of treatment weights was used to compare immunogenicity, and a weighted logistics regression was used to calculate fold change of positive response. RESULTS: Among the 609 participants studied, 24 (4%) were taking belatacept. After dose 1, 0/24 (0%) belatacept patients had detectable antibodies, compared with 77 of 568 (14%) among the equivalent nonbelatacept population (P = 0.06). After dose 2, 1/19 (5%) belatacept patients had detectable antibodies, compared with 190/381 (50%) among the equivalent nonbelatacept population (P < 0.001). Belatacept use was associated with 16.7-fold lower odds of having a positive post-D2 titer result (P < 0.01). CONCLUSIONS: Additional measures need to be explored to protect kidney transplant recipients taking belatacept. Best safety practices should be continued despite vaccination among this population.

Safety and Reactogenicity of 2 Doses of SARS-CoV-2 Vaccination in Solid Organ Transplant Recipients.

BACKGROUND: We studied the safety and reactogenicity SARS-CoV-2 mRNA vaccines in transplant recipients because immunosuppressed patients were excluded from vaccine trials. METHODS: US transplant recipients were recruited into this prospective cohort study through social media; those who completed the full vaccine series between December 9, 2020 and March 1, 2021 were included. We collected demographics, medical history, and safety information within 7 d after doses 1 and 2 (D1, D2). Associations between characteristics and reactions were evaluated using modified Poisson regression. RESULTS: We studied 741 transplant recipients who underwent BNT162b2 (54%) or mRNA-1273 (46%) vaccination. Median (interquartile range) age was 60 (44-69) y, 57% were female, and 10% were non-White. Although local site reactions decreased after D2 (85% D1 versus 78% D2, P < 0.001), systemic reactions increased (49% D1 versus 69% D2, P < 0.001). Younger participants were more likely to develop systemic symptoms after D1 (adjusted incidence rate ratio [aIRR] per 10 y = 0.850.900.94, P < 0.001) and D2 (aIRR per 10 y = 0.910.930.96, P < 0.001). Participants who experienced pain (aIRR = 1.111.662.47, P = 0.01) or redness (aIRR = 1.833.928.41, P < 0.01) were more likely to develop an antibody response to D1 of mRNA vaccines. No anaphylaxis, neurologic diagnoses, or SARS-CoV-2 diagnoses were reported. Infections were minimal (3% after D1, <0.01% after D2). One patient reported incident acute rejection post-D2. CONCLUSIONS: In solid organ transplant recipients undergoing mRNA vaccination, reactogenicity was similar to that reported in the original trials. Severe reactions were rare. These early safety data may help address vaccine hesitancy in transplant recipients.

SARS-CoV-2 messenger RNA vaccine antibody response and reactogenicity in heart and lung transplant recipients.

BACKGROUND: While several studies have observed that solid organ transplant recipients experience diminished antibody responses to SARS-CoV-2 mRNA vaccination, data specific to heart and lung transplant (HT/LT) recipients remains sparse. METHODS: US adult HT and LT recipients completed their vaccine series between January 7 and April 10, 2021. Reactogencity and SARS-CoV-2 anti-spike antibody were assessed after a priming dose (D1) and booster dose (D2). Modified Poisson regression with robust variance estimator was used to evaluate associations between participant characteristics and antibody development. RESULTS: Of 134 heart recipients, there were 38% non-responders (D1-/D2-), 48% booster responders (D1-/D2+), and 14% priming dose responders (D1+/D2+). Of 103 lung recipients, 64% were non-responders, 27% were booster responders, and 9% were priming dose responders. Lung recipients were less likely to develop antibodies (p < .001). Priming dose antibody response was associated with younger recipient age (p = .04), transplant-to-vaccination time ≥6 years (p < .01), and lack of anti-metabolite maintenance immunosuppression (p < .001). Pain at injection site was the most commonly reported reaction (85% after D1, 76% after D2). Serious reactions were rare, the most common being fatigue (2% after D1 and 3% after D2). No serious adverse events were reported. CONCLUSIONS: HT and LT recipients experienced diminished antibody response following vaccination; reactogenicity was comparable to that of the general population. LT recipients may exhibit a more impaired antibody response than HT recipients. While current recommendations are to vaccinate eligible candidates and recipients, further studies characterizing the cell-mediated immune response and clinical efficacy of these vaccines in this population are needed.

Kidney Transplant Recipient Attitudes Toward a SARS-CoV-2 Vaccine.

A widely accepted severe acute respiratory syndrome 2 (SARS-CoV-2) vaccine could protect vulnerable populations, but the willingness of solid organ transplant recipients (SOTRs) to accept a potential vaccine remains unknown. METHODS: We conducted a national survey of 1308 SOTRs and 1617 non-SOTRs between November 11 and December 2, 2020 through the network of the National Kidney Foundation. RESULTS: Respondents were largely White (73.2%), female (61.1%), and college graduates (56.2%). Among SOTRs, half (49.5%) were unsure or would be unwilling to receive a SARS-CoV-2 vaccine once available. Major concerns included potential side effects (85.2%), lack of rigor in the testing and development process (69.7%), and fear of incompatibility with organ transplants (75.4%). Even after the announcement of the high efficacy of the mRNA-1273 vaccine (Moderna Inc.) at the time of survey distribution, likeliness to receive a vaccine only slightly increased (53.5% before announcement versus 57.8% after the announcement). However, 86.8% of SOTRs would accept a vaccine if recommended by a transplant provider. CONCLUSIONS: SOTRs reported skepticism in receiving a potential SARS-CoV-2 vaccine, even after announcements of high vaccine efficacy. Reassuringly, transplant providers may be the defining influence in vaccine acceptance and will likely have a critical role to play in promoting vaccine adherence.

A Pilot Study on the Effects of Physician Gaze on Patient Satisfaction in the Setting of Electronic Health Records.

PURPOSE: To determine the amount of time ophthalmologists using Electronic Health Records (EHRs) spend looking at the patient and its correlation on patient satisfaction. METHODS: This prospective cohort study examined 67 patients seeking care at two different ophthalmology clinics. Videos of entire office visits were recorded and each video was graded for amount of time spent by physicians gazing at the patient, computer, paper medical records, or other areas. Videos were also graded for the amount of time examining the patient, and the physician speaking during each visit. A patient satisfaction survey was administered at the end of each office encounter. Time of physician gaze to the patient was correlated to satisfaction outcome measures. RESULTS: Ophthalmologists spent 28.0% ± 21.2% of the visit looking at the computer. Overall, patient satisfaction levels were very high (4.8 ± 0.5, 5-point Likert scale). Ophthalmologists spent the same amount of time looking at patients who were extremely satisfied (28.8% ± 16.7%) as those who were not extremely satisfied (28.8% ± 15.9%). CONCLUSIONS: Ophthalmologists on EHRs spend over a third of each patient visit looking at the computer. However, patient satisfaction levels are very high. The amount of time that the ophthalmologist gazes at the patient or the computer does not appear to have an effect on patient satisfaction in this particular study. Further research still needs to be performed regarding the effects of EHRs on the patient experience. Physicians should continue to be sensitive to their patients' needs and approach the use of EHRs in patient encounters on an individual basis.

Measurement of Retinal Microvascular Blood Velocity Using Erythrocyte Mediated Velocimetry.

Changes in retinal blood flow may be involved in the pathogenesis of glaucoma and other ocular diseases. Erythrocyte mediated velocimetry (EMV) is a novel technique where indocyanine green (ICG) dye is sequestered in erythrocyte ghosts and autologously re-injected to allow direct visualization of erythrocytes for in vivo measurement of speed. The purpose of this study is to determine the mean erythrocyte speed in the retinal microvasculature, as well as the intravisit and intervisit variability of EMV. Data from 23 EMV sessions from control, glaucoma suspect, and glaucoma patients were included in this study. In arteries with an average diameter of 43.11 µm ± 6.62 µm, the mean speed was 7.17 mm/s ± 2.35 mm/s. In veins with an average diameter of 45.87 µm ± 12.04 µm, the mean speed was 6.05 mm/s ± 1.96 mm/s. Intravisit variability, as measured by the mean coefficient of variation, was 3.57% (range 0.44-9.68%). Intervisit variability was 4.85% (range 0.15-8.43%). EMV may represent reliable method for determination of retinal blood speed, potentially allowing insights into the effects of pharmacologic agents or pathogenesis of ocular diseases.

Pathological α-synuclein transmission initiated by binding lymphocyte-activation gene 3.

Emerging evidence indicates that the pathogenesis of Parkinson's disease (PD) may be due to cell-to-cell transmission of misfolded preformed fibrils (PFF) of α-synuclein (α-syn). The mechanism by which α-syn PFF spreads from neuron to neuron is not known. Here, we show that LAG3 (lymphocyte-activation gene 3) binds α-syn PFF with high affinity (dissociation constant = 77 nanomolar), whereas the α-syn monomer exhibited minimal binding. α-Syn-biotin PFF binding to LAG3 initiated α-syn PFF endocytosis, transmission, and toxicity. Lack of LAG3 substantially delayed α-syn PFF-induced loss of dopamine neurons, as well as biochemical and behavioral deficits in vivo. The identification of LAG3 as a receptor that binds α-syn PFF provides a target for developing therapeutics designed to slow the progression of PD and related α-synucleinopathies.