Predicting renal function response to renal artery stenting.

OBJECTIVE: The Cardiovascular Outcomes in Renal Atherosclerotic Lesions Trial found no benefit of renal artery stenting (RAS) over medical therapy, although it was underpowered to detect a benefit among patients with chronic kidney disease (CKD). A post hoc analysis demonstrated improved event-free survival after RAS for patients whose renal function improved by 20% or more. A significant obstacle to achieving this benefit is the inability to predict which patients' renal function will improve from RAS. The objectives of the current study were to identify predictors of renal function response to RAS. METHODS: The Veteran Affairs Corporate Data Warehouse was queried for patients who underwent RAS between 2000 and 2021. The primary outcome was improvement in renal function (estimated glomerular filtration rate [eGFR]) after stenting. Patients were categorized as responders if the eGFR at 30 days or greater after stenting increased by 20% or more compared with before stenting. All others were nonresponders. RESULTS: The study cohort included 695 patients with a median follow-up of 7.1 years (interquartile range, 3.7-11.6 years). Based on postoperative change in eGFR, 202 stented patients (29.1%) were responders, and the remainder (n = 493 [70.9%]) were nonresponders. Before RAS, responders had a significantly higher mean serum creatinine, lower mean eGFR, and higher rate of decline of preoperative GFR in the months before stenting. After stenting, responders had a 26.1% increase in eGFR, compared with before stenting (P < .0001), which remained stable during follow-up. In contrast, nonresponders had a progressive 5.5% decrease in eGFR after stenting. Logistic regression analysis identified three predictors of renal function response to stenting: (1) diabetes (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.44-0.91; P = .013), (2) CKD stages 3b or 4 (OR, 1.80; 95% CI, 1.26-2.57; P = .001), and (3) rate of decline in preoperative eGFR per week before stenting (OR, 1.21; 95% CI, 1.05-1.39; P = .008). CKD stages 3b and 4 and the rate of decline in preoperative eGFR are positive predictors of renal function response to stenting, whereas diabetes is a negative predictor. CONCLUSIONS: Based on our data, patients in CKD stages 3b and 4 (eGFR 15-44 mL/min/1.73 m2) are the only subgroups with a significant probability of improved renal function after RAS. The rate of decline of preoperative eGFR over the months before stenting is a powerful discriminator of patients who are most likely to benefit from RAS. Specifically, patients with a more rapid decrease in eGFR before stenting have a significantly greater probability of improved renal function with RAS. In contrast, diabetes is a negative predictor of improved renal function, so interventionalists should be circumspect about RAS in diabetic patients.

Hyperphosphatemia and its relationship with blood pressure, vasoconstriction, and endothelial cell dysfunction in hypertensive hemodialysis patients.

BACKGROUND: Hyperphosphatemia occurs frequently in end-stage renal disease patients on hemodialysis and is associated with increased mortality. Hyperphosphatemia contributes to vascular calcification in these patients, but there is emerging evidence that it is also associated with endothelial cell dysfunction. METHODS: We conducted a cross-sectional study in hypertensive hemodialysis patients. We obtained pre-hemodialysis measurements of total peripheral resistance index (TPRI, non-invasive cardiac output monitor) and plasma levels of endothelin-1 (ET-1) and asymmetric dimethylarginine (ADMA). We ascertained the routine peridialytic blood pressure (BP) measurements from that treatment and the most recent pre-hemodialysis serum phosphate levels. We used generalized linear regression analyses to determine independent associations between serum phosphate with BP, TPRI, ET-1, and ADMA while controlling for demographic variables, parathyroid hormone (PTH), and interdialytic weight gain. RESULTS: There were 54 patients analyzed. Mean pre-HD supine and seated systolic and diastolic BP were 164 (27), 158 (21), 91.5 (17), and 86.1 (16) mmHg. Mean serum phosphate was 5.89 (1.8) mg/dL. There were significant correlations between phosphate with all pre-hemodialysis BP measurements (r = 0.3, p = .04; r = 0.4, p = .002; r = 0.5, p < .0001; and r = 0.5, p = .0003.) The correlations with phosphate and TPRI, ET-1, and ADMA were 0.3 (p = .01), 0.4 (p = .007), and 0.3 (p = .04). In our final linear regression analyses controlling for baseline characteristics, PTH, and interdialytic weight gain, independent associations between phosphate with pre-hemodialysis diastolic BP, TPRI, and ET-1 were retained (ß = 4.33, p = .0002; log transformed ß = 0.05, p = .005; reciprocal transformed ß = -0.03, p = .047). CONCLUSIONS: Serum phosphate concentration is independently associated with higher pre-HD BP, vasoconstriction, and markers of endothelial cell dysfunction. These findings demonstrate an additional negative impact of hyperphosphatemia on cardiovascular health beyond vascular calcification. TRIAL REGISTRATION: The study was part of a registered clinical trial, NCT01862497 (May 24, 2013).

Low Insertional Torque and Early Dental Implant Failure.

PURPOSE: There is lack of uniformity regarding the ideal insertional torque with which dental implants need to be placed. The purpose of this retrospective analysis is to compare the incidence of early dental implant failures with an insertional torque less than 30 N-cm to implants placed with an insertional torque 30 N-cm or greater. METHODS: A retrospective cohort study was conducted to evaluate dental implants placed between 2015 and 2016 at the Veterans Affairs North Texas Health Care System in Dallas. The primary predictor variable was dental implant insertional torque, measured at the time of implant placement as either greater than or equal to 30 N-cm or less than 30 N-cm. The primary outcome variable was early implant failure, defined as implant exfoliation noted by the patient or failure due to implant movement or pain necessitating explantation before prosthesis loading. The study conducted a time-to-event analysis to examine a group difference in time to implant failure between insertional torque group greater than or equal to 30 N-cm and less than 30 N-cm using Kaplan-Meir curves and a frailty model. The time to follow-up was censored at 6 months. RESULTS: One hundred three patients had 214 implants placed, with early failures occurring in 14 implants (6.5%). Implants placed with an insertional torque less than 30 N-cm were nearly 14 times more likely to have an early failure compared to implants placed with an insertional torque 30 N-cm or greater (hazard ratio = 13.909; 95% confidence interval, 1.835 to 105.416), which was statistically significant (P = .0108). CONCLUSIONS: The results of this retrospective cohort study suggest that insertional torque values less than 30 N-cm are associated with early dental implant failures. Future, prospective studies will be performed to further elucidate the association between insertional torque and early dental implant failure.

Immature platelets as a biomarker for disease severity and mortality in COVID-19 patients.

COVID-19, caused by SARS-CoV-2, is a contagious life-threatening viral disease that has killed more than three million people worldwide to date. Attempts have been made to identify biomarker(s) to stratify disease severity and improve treatment and resource allocation. Patients with SARS-COV-2 infection manifest with a higher inflammatory response and platelet hyperreactivity; this raises the question of the role of thrombopoiesis in COVID-19 infection. Immature platelet fraction (IPF, %) and immature platelet counts (IPC, ×109 /l) can be used to assess thrombopoiesis. This study investigates whether the level of thrombopoiesis correlates with COVID-19 severity. A large cohort of 678 well-characterized COVID-19 patients was analyzed, including 658 (97%) hospitalized and 139 (21%) admitted to the intensive care unit (ICU). Elevated percentage IPF at presentation was predictive of length of hospitalization (P < 0·01) and ICU admission (P < 0·05). Additionally, percentage IPF at the peak was significantly higher among ICU patients than non-ICU patients (6·9 ± 5·1 vs 5·3 ± 8·4, P < 0·01) and among deceased patients than recovered patients (7·9 ± 6·3 vs 5·4 ± 7·8, P < 0·01). Furthermore, IPC at the peak was significantly higher among ICU patients than non-ICU patients (18·5 ± 16·2 vs. 13·2 ± 8·3, P < 0·05) and among patients on a ventilator than those not (22·1 ± 20·1 vs.13·4 ± 8·4, P < 0·05). Our study demonstrated that elevated initial and peak values of percentage IPF and IPC might serve as prognostic biomarkers for COVID-19 progression to severe conditions.

Impact of dual antiplatelet therapy after lower extremity revascularization for chronic limb-threatening ischemia.

OBJECTIVE: The optimal antiplatelet regimen after lower extremity revascularization in patients with chronic limb-threatening ischemia (CLTI) is unknown because current recommendations are based on extrapolation of data from trials in coronary artery disease and stroke. METHODS: We identified all patients undergoing an elective lower extremity revascularization for CLTI in the Vascular Quality Initiative registry discharged on a mono antiplatelet agent (MAPT) or dual antiplatelet therapy (DAPT). RESULTS: From 2003 to 2018, 50,890 patients underwent revascularization procedures for CLTI, and were discharged on MAPT or DAPT. Of these, 33,781 patients underwent endovascular therapy (EVT), and 17,109 patients underwent open surgery (OS) procedures. The rate of major amputation at 30 days in the target limb in the EVT group was 0.3% and 0.4% in the OS group (P = .22). On Kaplan-Meier analyses, patients on MAPT at discharge had a higher risk of 1-year major amputation compared with DAPT after EVT but not after OS procedures. Patients on MAPT had lower overall survival and amputation-free survival at 30 days and 1 year compared with DAPT after both EVT and OS. At 1 year, the MAPT group was at higher risk for target lesion reintervention after EVT compared with the DAPT group (15.9% vs 13%; P = .0012). There was no significant difference in thrombosis at 1 year between the MAPT and DAPT groups either after EVT (3.9% vs 3.7%; P = .3048) or OS (3.1% vs 3.2%; P = .2893). On Cox regression analysis, DAPT was associated with improved survival but not major amputation after both EVT and OS. CONCLUSIONS: In patients with CLTI, DAPT at the time of discharge has a positive impact on amputation-free survival and overall survival after both EVT and OS as well as target lesion reintervention after EVT. DAPT was not associated with a positive impact on major amputation after either EVT or OS.

Estimating the optimal timing of surgery from observational data.

Infants with hypoplastic left heart syndrome require an initial Norwood operation, followed some months later by a stage 2 palliation (S2P). The timing of S2P is critical for the operation's success and the infant's survival, but the optimal timing, if one exists, is unknown. We attempt to identify the optimal timing of S2P by analyzing data from the Single Ventricle Reconstruction Trial (SVRT), which randomized patients between two different types of Norwood procedure. In the SVRT, the timing of the S2P was chosen by the medical team; thus with respect to this exposure, the trial constitutes an observational study, and the analysis must adjust for potential confounding. To accomplish this, we propose an extended propensity score analysis that describes the time to surgery as a function of confounders in a discrete competing-risk model. We then apply inverse probability weighting to estimate a spline hazard model for predicting survival from the time of S2P. Our analysis suggests that S2P conducted at 6 months after the Norwood gives the patient the best post-S2P survival. Thus, we place the optimal time slightly later than a previous analysis in the medical literature that did not account for competing risks of death and heart transplantation.

Estimating the optimal timing of surgery by imputing potential outcomes.

Hypoplastic left heart syndrome is a congenital anomaly that is uniformly fatal in infancy without immediate treatment. The standard treatment consists of an initial Norwood procedure (stage 1) followed some months later by stage 2 palliation (S2P). The ideal timing of the S2P is uncertain. The Single Ventricle Reconstruction Trial (SVRT) randomized the procedure used in the initial Norwood operation, leaving the timing of the S2P to the discretion of the surgical team. To estimate the causal effect of the timing of S2P, we propose to impute the potential post-S2P survival outcomes using statistical models under the Rubin Causal Model framework. With this approach, it is straightforward to estimate the causal effect of S2P timing on post-S2P survival by directly comparing the imputed potential outcomes. Specifically, we consider a lognormal model and a restricted cubic spline model, evaluating their performance in Monte Carlo studies. When applied to the SVRT data, the models give somewhat different imputed values, but both support the conclusion that the optimal time for the S2P is at 6 months after the Norwood procedure.

Effect of Abdominal Aortic Aneurysm Size on Mid-Term Mortality After Endovascular Repair.

BACKGROUND: Previous studies have suggested that large preoperative AAA size may impact late survival after elective EVAR. It is unclear, however, whether this association applies to patients with smaller AAA between 5.0-5.5 cm, who constitute a substantial portion of patients undergoing elective EVAR. The purpose of this study was to delineate the effect of AAA size between 5.0 and 5.5 cm on mid-term mortality after EVAR by analyzing a large national cohort, the Vascular Quality Initiative (VQI) database. METHODS: Using the Vascular Quality Initiative (VQI) national database, patients who underwent EVAR for intact AAA between 2003 and 2018 were identified and stratified based on maximal AAA diameter into 3 groups: Group 1 (4.0 cm ≤ AAA <5.0 cm); Group 2 (5.0 cm ≤ AAA < 5.5 cm); and Group 3 (AAA ≥ 5.5 cm). Cox proportional hazard model and propensity score matching method were used to estimate AAA size effect on all-cause mortality at 1, 3, and 5 years after EVAR while adjusting for potential confounders. RESULTS: The study included 32,398 patients, of whom 81% were men with a mean age of 74. The most common group who underwent EVAR was Group 2 (5.0 cm ≤ AAA < 5.5 cm). Larger AAA size was associated with male sex (75% versus 79% versus 84%, for Groups 1, 2, and 3 respectively; P < 0.0001) and with coronary artery disease (27% versus 29% versus 31%, for Groups 1, 2, and 3 respectively, P< 0.0001); but was negatively associated with active smoking (33% versus 31% versus 30%, for Groups 1, 2, and 3, respectively, P< 0.001). While 10% of the largest and smallest AAA groups (Groups 3 and 1, respectively) were symptomatic, only 5% of patients in Group 2 were symptomatic (P < 0.01). Adjusted Cox proportional hazard modeling revealed that patients in Group 2 were at significantly lower risk of 5-year mortality when compared to patients in Group 3 (HR 0.66, 95% CI 0.61-0.72, P< 0.01), while similar in risk when compared to patients in Group 1 (HR 1.11, 95% CI 0.93-1.32, P= 0.26). CONCLUSION: Our analysis found that over 40% of EVAR in the national VQI cohort were performed for AAA < 5.5 cm, with the greatest number of patients undergoing EVAR at AAA size 5.0-5.5cm. Patients with AAA size 5.0-5.5 cm had better 5-year survival outcomes than patients with AAA ≥ 5.5 cm, and similar survival to patients with small AAA between 4.0-5.0 cm.

A Factor Analysis of the Suicide Cognitions Scale in Veterans with Military Sexual Trauma-Related Posttraumatic Stress Disorder.

The Suicide Cognitions Scale (SCS) assesses suicide-specific cognitions which may drive suicide risk. Nonetheless, prior work has been mixed regarding optimal factor structure. Additionally, this measure has not been validated for use with veterans with military sexual trauma-related posttraumatic stress disorder (MST-related PTSD), a population that is at elevated risk for suicidal self-directed violence (SDV). This study sought to determine the optimal factor structure of the SCS for use with veterans with MST-related PTSD as well as its psychometric properties. An exploratory factor analysis revealed a four-factor structure, including unlovability, unbearability, unsolvability, and negative urgency. The SCS also demonstrated excellent internal consistency and good convergent validity. This study identified a novel factor, negative urgency, which may explain some of the predictive power of the SCS found in previous research. This paper provides initial support for a four-factor structure of the SCS among those with MST-related PTSD. Additional work remains necessary in evaluating the SCS as a tool for detecting risk for future suicidal SDV among veterans with MST-related PTSD.

Comparative Outcomes of Supera Interwoven Nitinol vs Bare Nitinol Stents for the Treatment of Femoropopliteal Disease: Insights From the XLPAD Registry.

Purpose: To report a propensity score analysis comparing outcomes of the Supera interwoven nitinol stent to bare nitinol stents (BNS) in the femoropopliteal segment. Materials and Methods: A retrospective study was conducted utilizing data extracted from the Excellence in Peripheral Artery Disease (XLPAD) registry (ClinicalTrials.gov identifier NCT01904851) on 871 patients (mean age 65.1 years; 713 men) who underwent femoropopliteal balloon angioplasty with either Supera stent implantation in 118 limbs or other contemporary BNS in 753 limbs between January 2006 and December 2016. All patients in both groups were matched for baseline demographic and clinical characteristics in a 1:1 propensity score matching using the nearest neighbor method to create the 118-patient matched BNS cohort. One-year outcomes included all-cause mortality, target vessel revascularization (TVR), and target limb revascularization (TLR). An additional core laboratory analysis was conducted to measure the deployed length of Supera stents. Results: In unmatched data, the Supera stent group had a numerically lower rate of TVR (7.6% vs 13.4%, p=0.08) and a significantly lower 1-year TLR rate (7.6% vs 16.2%, p=0.02) compared to the BNS group. Both groups had similar 1-year mortality (2.5% vs 2.7%, p=0.9). Kaplan-Meier analysis demonstrated that the Supera group had a significantly lower risk of TVR (p=0.02) and TLR (p=0.002) than the BNS group. After propensity matching, the 1-year TVR estimate was lower for Supera stents (7.6% vs 12.7%, p=0.08) and significantly lower for TLR (7.6% vs 13.6%, p=0.04) than the BNS group. There was no statistically significant association between Supera stent elongation (>10% of the labeled stent length) and 1-year risk of TLR (p=0.6). Conclusion: Supera stent usage in femoropopliteal intervention was associated with reduced risk of 1-year repeat target limb revascularization compared with BNS treatment in both unmatched and matched cohorts.

Comparison of open and endovascular procedures in patients with critical limb ischemia on dialysis.

OBJECTIVE: Peripheral artery disease is a common comorbidity in patients with end-stage renal disease (ESRD), but there is a paucity of data comparing outcomes of different interventions in this group of patients. In this study, we examined perioperative outcomes of lower extremity endovascular revascularization (ER) and open revascularization (OR) in dialysis patients with critical limb ischemia (CLI). METHODS: Patients on dialysis and undergoing ER and OR for CLI from 2011 to 2015 were identified in the American College of Surgeons National Surgical Quality Improvement Program dataset. Patient demographics, comorbidities, anatomic features, and perioperative outcomes were compared between ER and OR procedures. RESULTS: From 2011 to 2015, 1021 lower extremity revascularizations were performed in dialysis patients with CLI. In this group, 535 were ER (53%) and 486 were OR (47%) procedures. Although demographic characteristics such as age and gender were similar between the two groups, there was a higher proportion of Caucasians and African Americans in the OR group. Patients undergoing open and endovascular procedures had similar rates of hypertension, congestive heart failure, diabetes, chronic obstructive pulmonary disease, and bleeding disorders. A minority of procedures (4%) were emergencies, which were distributed equally between the two groups. Preoperative aspirin usage was higher in the ER group (84% vs 78%; P = .024), beta-blocker use was higher in the OR group (79% vs 74%; P = .08), and statin use was similar between the two groups (72% in OR and 70% in ER; P = .54). On risk-adjusted multivariate analysis, OR was associated with a lower rate of major amputation (5.97% vs 11.78%; odds ratio, 0.48; 95% confidence interval [CI], 0.26-0.85), but a higher rate of postoperative bleeding (29.6% vs 8.97%; odds ratio, 2.86; 95% CI, 1.8-4.35) and wound complications (15% vs 3%; odds ratio, 4.5; 95% CI, 2.38-8.3). The 30-day mortality and cardiovascular morbidity were similar between the two groups. CONCLUSIONS: In patients with ESRD with CLI, OR is associated with a lower risk of major limb amputation but a higher rate of postoperative wound complications and bleeding, compared with ER. Cardiovascular complications, 30-day mortality, reinterventions and readmissions were similar between the two groups. In patients with ESRD with CLI, OR should be considered as an option for limb salvage if feasible. Long-term outcomes comparing the two types of procedures are needed.

Atherectomy in below-the-knee endovascular interventions: One-year outcomes from the XLPAD registry.

BACKGROUND: Use of atherectomy for the treatment of peripheral arterial disease (PAD) is increasing as an adjunctive treatment to either conventional or drug-coated balloon angioplasty. There is limited data on atherectomy outcomes in below-the-knee (BTK) endovascular interventions. METHODS: Data from the multicenter Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) were analyzed to examine predictors of atherectomy use and its associated 1-year patency rate. We analyzed 518 BTK procedures performed between January 2005 and December 2016. RESULTS: Overall a total of 518 BTK procedures were treated in 430 patients, and 43% of interventions used atherectomy. African American patients were less likely (13% vs 25%; |standard residual| = 3.41) to be treated with atherectomy. Use of atherectomy was lower in chronic total occlusive (CTO) lesions (48% vs 58%; P = 0.02). There were no significant associations of baseline comorbidities, critical limb ischemia (CLI), ankle-brachial index, number of BTK vessel run-off, or vessel location with atherectomy use. Compared with patients without atherectomy, use of atherectomy was associated with lower incidence of repeat target limb intervention at 1 year after adjusting for age, CLI, in-stent restenosis, heavy calcification, presence of diffuse disease, and CTO lesion traits (Hazard Ratio 0.41, 95% confidence interval 0.23-0.72; P < 0.01). CONCLUSIONS: Compared with no atherectomy, use of atherectomy in BTK interventions is associated with lower rates of 1-year repeat target limb revascularization. These findings require confirmation in prospective, randomized clinical studies.

Effects of Abdominal Aortic Aneurysm Size on Mid- and Long-term Mortality After Endovascular Aneurysm Repair.

PURPOSE: To investigate the effect of abdominal aortic aneurysm (AAA) size on mid- and long-term survival after endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: Retrospective data were collected from 325 consecutive patients (mean age 69.7 ± 8.5 years; 323 men) who underwent EVAR for intact AAA at a single institution between January 2003 and December 2013. The primary endpoint was death at 3, 5, and 10 years after EVAR. Optimal cutoff points for AAA size and age were determined using receiver operating characteristics (ROC) curves. Time to event analyses (Kaplan-Meier curves and Cox proportional hazard models) were employed to determine any differences in all-cause mortality outcomes between AAA size groups. Cox models were adjusted for age and other comorbidities (hypertension, hyperlipidemia, coronary artery disease, smoking status, symptomatic status, and creatinine); the outcomes are reported as the hazard ratio (HR) with 95% confidence interval (CI). RESULTS: The cohort was dichotomized according to the ROC analysis, which defined an optimal cutoff point of 5.6 cm for AAA size and >70 years for age. The mean follow-up period post EVAR was 45.5±29.2 months. In total, 134 (41.2%) patients died during the 10-year follow-up. Thirty-day mortality was 1.1% (2/184) in the patients with AAA <5.6 cm and 2.1% (3/141) in patients with AAA ≥5.6 cm (p=0.45). All-cause mortality was not significantly affected by comorbidities. However, AAA size ≥5.6 cm was associated with increased 3-year mortality risk (HR 1.59, 95% CI 1.001 to 2.52, p<0.049) but not 5-year (HR 1.44, 95% CI 0.98 to 2.10, p=0.062) or 10-year mortality (HR 1.28, 95% CI 0.91 to 1.80, p=0.149). After adjusting for comorbidities, AAA size ≥5.6 cm was no longer significantly associated with morality at any time point. Using a larger size cutoff (AAA size ≥6.0 cm) resulted in improved statistical significance in the unadjusted model. In the adjusted Cox model, AAA size ≥6.0 cm was significantly associated with increased risk of mortality at 3 years (HR 1.67, 95% CI 1.01 to 2.77, p<0.047), but not at longer time points. CONCLUSION: Our study demonstrates that midterm survival after EVAR is significantly and independently associated with AAA size even after correcting for comorbidities. However, in the long term, preoperative AAA size is not an independent predictor of mortality.

Rate of Secondary Intervention After Open Versus Endovascular Abdominal Aortic Aneurysm Repair.

BACKGROUND: Although long-term durability and improved perioperative outcome of endovascular abdominal aortic aneurysm (AAA) repair has been demonstrated, some studies have suggested an increased rate of secondary interventions compared with open AAA repair. More recent data suggest that rates between the two modalities may be similar. We investigated the rate of secondary intervention in patients undergoing endovascular aortic aneurysm repair (EVAR) or open AAA repair for intact AAA and the effect of secondary intervention on long-term mortality in these two groups of patients. METHODS: A retrospective, single-institution review was conducted between January 2003 and December 2012. Secondary intervention was defined as any intervention within 30 d of the procedure or an AAA repair-related procedure after 30 d, which included repair of endoleaks and incisional hernia repair. Group differences in demographic and baseline characteristics were examined using Cochran-Mantel-Haenszel and Wilcoxon rank sum tests for categorical and continuous variables, respectively. RESULTS: A total of 342 patients underwent operative repair of intact AAA. Two hundred seventy four patients underwent EVAR and 68 patients underwent open AAA repair. The mean age overall was 68.6 y and was not significantly different between the two repair groups. The overall rate of secondary intervention was significantly lower in the EVAR group compared with the open AAA repair group (11% versus 27%, P = 0.001). In the EVAR group, 30 patients underwent 37 secondary interventions. In the open repair group, 18 patients underwent 20 reinterventions. The most common secondary intervention was repair of type 2 endoleak (n = 13, 4.7% of patients) after EVAR and incisional hernia repair (n = 4, 5.9% of patients) after open AAA repair. Most secondary interventions (15/20) after open AAA repair occurred within 30 d, whereas most secondary intervention (33/37) after EVAR occurred after 30 d. Comparison of late (>30 d) reintervention between the two groups revealed a significantly lower rate of secondary intervention after open AAA repair (27.8% of all reinterventions after open versus 86.7% of all reinterventions after EVAR, P < 0.001). The overall 10-y mortality rate was 39.1%, and not statistically different between the two repair groups. Estimated survival analysis demonstrated no significant effect of secondary intervention on mortality after EVAR (logrank P = 0.45). Secondary intervention after open repair did not significantly affect long-term survival (logrank P = 0.05). CONCLUSIONS: This study highlights the dramatic change in practice pattern in AAA repair over time. In this study, patients treated with EVAR had a significantly lower overall rate of secondary intervention compared with patients treated with open AAA repair. This was likely secondary to increased perioperative morbidity and mortality and a bias toward more complex patients in the open repair group. In the long term, however, there were significantly fewer reinterventions after open AAA repair. Secondary interventions did not affect long-term survival after EVAR.

Adjunctive stent use during endovascular intervention to the femoropopliteal artery with drug coated balloons: Insights from the XLPAD registry.

With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran-Mantel-Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or 'bail-out') versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for 'bail-out' indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary 'real-world' adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851.

Comparative assessment of patient outcomes with intraluminal or subintimal crossing of infrainguinal peripheral artery chronic total occlusions.

This study compares procedural complications and clinical outcomes between subintimal crossing versus intraluminal crossing during endovascular treatment of infrainguinal peripheral artery chronic total occlusions (CTO). We identified 1335 CTO interventions in 1001 patients from the multicenter Excellence in Peripheral Artery Disease (XLPAD) registry from January 2005 to October 2015. Outcomes included 30-day and 12-month all-cause death, non-fatal myocardial infarction or stroke, peripheral artery stent, or vessel, thrombosis (ST), need for any target limb endovascular or surgical revascularization, target limb major amputation and procedural complications. A subintimal crossing technique was necessary in 388 lesions (27% overall in 1335 lesions; 34% ( n=351) in 1023 femoropopliteal lesions, and 12% ( n=37) in 312 infrapopliteal lesions, p<0.01) with a lower procedural ( p<0.01) and technical ( p<0.01) success than the intraluminal in both femoropopliteal and infrapopliteal interventions. There were no significant differences in procedural complications, major adverse cardiac events, or clinically driven target limb revascularization at 1 year between the two groups, except a higher residual dissection rate in the subintimal crossing group than the intraluminal group in femoropopliteal target vessels ( p = 0.04).

Medical student reflections on geriatrics: Moral distress, empathy, ethics and end of life.

Medical students' early clinical encounters may influence their perceptions of geriatrics. This study examines reflective essays written by 3rd-year medical students on required clinical rotations. Using content analysis, the authors analyzed the essays' thematic content. The authors then used chi-squared analysis to compare themes with geriatric patients (age 60+) to themes with other age groups. One hundred twenty out of 802 essays described a geriatric patient. The most common geriatric themes were (1) death and dying, (2) decision making, (3) meaningful physician-patient interactions, (4) quality of care, and (5) professional development. Geriatric essays were more likely to discuss death/dying and risk-benefit themes and less likely to discuss abuse. Geriatric essays were more likely to describe students' moral distress. Geriatric essays with moral distress were more likely to include empathy themes compared to geriatric essays without moral distress. Geriatric patients may pose unique ethical challenges for early clinical students.

Major Limb Outcomes Following Lower Extremity Endovascular Revascularization in Patients With and Without Diabetes Mellitus.

PURPOSE: To determine whether diabetes mellitus has an independent impact on major limb outcomes at 1 year after endovascular treatment of lower extremity peripheral artery disease (PAD). METHODS: The study involved 1906 consecutive patients (mean age 66 years; 1469 men) enrolled in the observational Excellence in Peripheral Artery Disease (XLPAD) registry ( ClinicalTrials.gov identifier NCT01904851) between January 2005 and October 2015 after undergoing index endovascular procedures in 2426 limbs for arterial occlusive disease. Patient outcomes included 12-month target limb amputation (above ankle) and target limb revascularization as well as all-cause death. Kaplan-Meier analysis and adjusted Cox proportional hazard models were used for time-to-event analysis of outcomes for the entire study sample as well as for the critical limb ischemia (CLI) and claudication subgroups. Results of the Cox regression models are reported as the hazard ratio (HR) and 95% confidence interval (CI). RESULTS: Diabetics undergoing endovascular procedures had higher rates of comorbid conditions (p<0.001), CLI (p<0.001), heavily calcified lesions (p=0.002), multivessel disease (p=0.030), and fewer infrapopliteal runoff vessels (p<0.001). Regression analysis after adjusting for confounders revealed significantly higher target limb major amputation in diabetics compared with nondiabetics (HR 5.02, 95% CI 1.44 to 17.56, p=0.011). However, repeat revascularization rates were similar. When considering CLI and claudication subgroups, diabetes was associated with a nonsignificant increased risk of 12-month major amputation only for patients presenting with CLI (HR 3.48, 95% CI 0.97 to 12.51, p=0.056). Diabetes was also associated with an increased risk of 12-month all-cause mortality in the overall study sample (HR 4.64, 95% CI 2.01 to 10.70, p<0.001) and in the CLI subgroup (HR 14.15, 95% CI 3.16 to 63.32, p<0.001) but not in the claudication subgroup (HR 1.42, 95% CI 0.45 to 4.54, p=0.552). CONCLUSION: Diabetes increases the risk of major amputation and all-cause death at 12 months following endovascular revascularization in patients with symptomatic PAD. These risks are especially heightened in patients presenting with CLI.

Reactions of Oklahoma City bombing survivors to media coverage of the September 11, 2001, attacks.

OBJECTIVE: This study explored the effects of media coverage of a terrorist incident in individuals remote from the location of a major attack who had directly experienced a prior terrorist incident. METHOD: Directly-exposed survivors of the 1995 Oklahoma City bombing, initially studied six months after the incident, and indirectly-affected Oklahoma City community residents were assessed two to seven months after the September 11, 2001, attacks. Survivors were assessed for a diagnosis of bombing-related posttraumatic stress disorder (PTSD) at index and follow up, and emotional reactions and September 11 media behavior were assessed in all participants. RESULTS: Among the three investigated forms of media (television, radio, and newspaper), only television viewing was associated with 9/11-related posttraumatic stress reactions. Exposure to the Oklahoma City bombing was associated with greater arousal in relation to the September 11 attacks, and among survivors, having developed bombing-related PTSD was associated with higher scores on all three September 11 posttraumatic stress response clusters (intrusion, avoidance, and arousal). Although time spent watching television coverage of the September 11 attacks and fear-related discontinuation of media contact were not associated with Oklahoma City bombing exposure, discontinuing September 11 media contact due to fear was associated with avoidance/numbing in the full sample and in the analysis restricted to the bombing survivors. CONCLUSION: Surviving a prior terrorist incident and developing PTSD in relation to that incident may predispose individuals to adverse reactions to media coverage of a future terrorist attack.

Do medical student stress, health, or quality of life foretell step 1 scores? A comparison of students in traditional and revised preclinical curricula.

THEORY: We explored the theory that measures of medical students' well-being and stress from different types of preclinical curricula are linked with performance on standardized assessment. HYPOTHESES: Self-reported stress and quality of life among sophomore medical students having different types of preclinical curricula will vary in their relationships to USMLE Step 1 scores. METHOD: Voluntary surveys in 2010 and 2011 compared self-reported stress, physical and mental health, and quality of life with Step 1 scores for beginning sophomore students in the final year of a traditional, discipline-based curriculum and the 1st year of a revised, systems-based curriculum with changed grading system. Wilcoxon rank sum tests and Spearman rank correlations were used to analyze data, significant at p <.05. RESULTS: New curriculum students reported worse physical health, subjective feelings, leisure activities, social relationships and morale, and more depressive symptoms and life stress than traditional curriculum students. However, among curriculum-related stressors, few differences emerged; revised curriculum sophomores reported less stress working with real and standardized patients than traditional students. There were no class differences in respondents' Step 1 scores. Among emotional and physical health measures, only feelings of morale correlated negatively with Step 1 performance. Revised curriculum students' Step 1 scores correlated negatively with stress from difficulty of coursework. CONCLUSIONS: Although revised curriculum students reported worse quality of life, general stress, and health and less stress from patient interactions than traditional students, few measures were associated with performance differences on Step 1. Moreover, curriculum type did not appear to either hinder or help students' Step 1 performance. To identify and help students at risk for academic problems, future assessments of correlates of Step 1 performance should be repeated after the new curriculum is well established, relating them also to performance on other standardized assessments of communication skills, professionalism, and later clinical evaluations in clerkships or internships.