Objective: The objective of this study was to review the learning curve for fenestrated-branched endovascular aortic repair (F-BEVAR) of pararenal and thoracoabdominal aortic aneurysms (TAAAs). Methods: We reviewed the clinical data of 334 consecutive patients (255 males, mean age 75 6 7 years) who underwent F-BEVAR between 2007 and 2016 in a single institution. Outcomes were analyzed in four quartiles of experience (Q1-Q4). Study outcomes included trends in patient characteristics, device design, procedural variables, 30-day mortality, and major adverse events (MAEs). Results: There were 178 patients (53%) treated for pararenal aneurysms and 156 (47%) for TAAAs. During the study period, there was a statistically significant increase in the proportion of TAAAs and in the number of vessels incorporated. Despite this, there was a steady decrease in 30-day mortality (6% in Q1 to 0% in Q4; P < .04) and in the rate of MAEs (60% in Q1 to 29% in Q4; P < .001). By linear regression analysis, there was significant decline in estimated blood loss (1358 6 1517 mL in Q1 to 486 6 520 mL in Q4; P < .001), total operating time (325 6 116 minutes in Q1 to 248 6 92 minutes in Q4; P < .001), total fluoroscopy time (121 6 59 minutes in Q1 to 85 6 39 minutes in Q4; P < .001), contrast volume (201 6 92 mL in Q1 to 160 6 61 mL in Q4; P = .002), and radiation dose (4141 +/- 2570 mGy in Q2 to 2543 +/- 1895 mGy in Q4; P < .001). Independent predictors of MAEs were total operating time (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.3-1.8; P < .001), Society for Vascular Surgery total score (OR, 1.1; 95% CI, 1.02-1.2; P = .009), and quartile 1 (OR, 3.0; 95% CI, 1.7-5.2; P < .001). Conclusions: This study demonstrates significant improvement in perioperative mortality, MAEs, procedural variables, and secondary interventions in patients treated by F-BEVAR, despite the increase in complexity of aneurysm pathology during the study period. Also, better patient selection contributed to improve outcomes.
To determine the degree of variability in physician-level average length of stay (LOS) after adjusting for multiple confounders. 2-site retrospective analysis of 3 years (2012-2015) of visit-level data for emergency department patients seen primarily by an attending physician. We excluded visits in which one or more data element was missing, illogical, or unclear; duplicate visits; and visits for intermittent/low volume providers. We compared each physician’s actual average length of stay with his or her expected average length of stay after adjusting each visit for patient age, sex, emergency severity index score, admit/discharge/transfer status, time of day, day of week, season, calendar year and site. We determined percentage deviation of actual average LOS from expected average LOS for each physician, and then grouped physicians into LOS quintiles (well below expected, below expected, approximately expected, above expected, and well above expected). We compared LOS quintiles using student’s t-test. There were 156,076 visits seen by 39 physicians at 2 sites. Deviation from expected LOS ranged from -20.4% to +18.1%. Average deviation from expected LOS for each quintile was as follows: well below expected, -12.3%; below expected, -4.5%; approximately expected, +0.3%; above expected, +7.4%; well above expected, +14.5%. Each quintile was significantly different from the quintile above or below it. After adjusting for multiple confounders, there were significant differences between physicians with respect to the degree to which actual average LOS deviated from expected average LOS.
PURPOSE:The study purpose was to review the outcomes of patients treated for thoracoabdominal aortic aneurysms using endovascular repair with fenestrated and branched stent-grafts in a single center.METHODS:We reviewed the clinical data of the first 185 consecutive patients (134 male; mean age, 75 ± 7 years) treated for thoracoabdominal aortic aneurysms using fenestrated and branched stent-grafts. Graft design evolved from physician-modified endografts (2007-2013) to off-the-shelf or patient-specific manufactured devices in patients enrolled in a prospective physician-sponsored investigational device exemption protocol (NCT 1937949 and 2089607). Outcomes were reported for extent IV and extent I to III thoracoabdominal aortic aneurysms, including 30-day mortality, major adverse events, patient survival, primary target vessel patency, and reintervention.RESULTS:A total of 112 patients (60%) were treated for extent IV thoracoabdominal aortic aneurysms, and 73 patients (40%) were treated for extent I to III thoracoabdominal aortic aneurysms. Demographics and cardiovascular risk factors were similar in both groups. A total of 687 renal-mesenteric arteries (3.7 vessels/patient) were targeted by 540 fenestrations and 147 directional branches. Technical success was 94%. Thirty-day mortality was 4.3%, including a mortality of 1.8% for extent IV and 8.2% for extent I to III thoracoabdominal aortic aneurysms (P = .03). Mortality decreased in the second half of clinical experience from 7.5% to 1.2%, including a decrease of 3.3% to 0% for extent IV thoracoabdominal aortic aneurysms (P = .12) and 15.6% to 2.4% for extent I to III thoracoabdominal aortic aneurysms (P = .04). Early major adverse events occurred in 36 patients (32%) with extent IV thoracoabdominal aortic aneurysms and 26 patients (36%) with extent I to III thoracoabdominal aortic aneurysms, including spinal cord injury in 2 patients (1.8%) and 4 patients (3.2%), respectively. Mean follow-up was 21 ± 20 months. At 5 years, patient survival (56% and 59%, P = .37) and freedom from any reintervention (50% and 53%, P = .26) were similar in those with extent IV and extent I to III thoracoabdominal aortic aneurysms. Primary patency was 93% at 5 years.CONCLUSIONS:Endovascular repair of thoracoabdominal aortic aneurysms can be performed with high technical success and low mortality and morbidity. However, the need for secondary reinterventions and continued graft surveillance represents major limitations compared with results of conventional open surgical repair. Long-term follow-up is needed before the widespread use of these techniques in younger or lower-risk patients.
Prophylactic exclusion of the LAA is often performed during cardiac surgery to reduce the risk of stroke in patients with AF. However, the clinical impact and efficacy of LAA closure for stroke protection in humans remains inconclusive. We conducted a retrospective study of 9,833 adults, mean age
Purpose: The aim of our study was to determine if longitudinal strain and strain rate (LS/LSR) provide diagnostic and prognostic value to distinguish hereditary transthyretin cardiac amyloid (HCA) from immunoglobulin light chain cardiac amyloid (ICA) in patients with preserved LVEF. Methods: Forty age and gender matched ICA and HCA patients with normal LVEF were included. LVEF, left ventricular mass index (LVMI) and NT-pro BNP were detected. Left ventricular global longitudinal strain (GLS) and strain rate (GLSR), as well as average basal, mid and apical systolic strain and SR were obtained with 2 dimensional speckle tracking echocardiography. Survival was also calculated. Results: NT-pro BNP in ICA (3537±4005 pg/ml) vs. HCA (844±1806 pg/ml) was significantly different (P<0.01); LVEF (65±7% vs. 64±7%) and LVMI (124±30 g/m2 vs. 129±41 g/m2) were not significant. There were significant differences in GLS (-12.0±4.2% vs. -13.9±2.8%, P<0.05) and GLSR (-0.73±0.22 s-1 vs.-0.84±0.18 s-1, P<0.05) between ICA and HCA group. The most significant difference was seen in apical LS (-13.1±4.3% vs. -17.3±3.3%, P<0.001) and LSR (-0.82±0.24s-1 vs.-1.02±0.23 s-1, P<0.001), in mid LS (-12.0±4.6% vs.-13.7±3.1%, P<0.05) and LSR (-0.66±0.23s-1 vs. -0.77±0.18s-1, P<0.05) as well, but not in basal LS/LSR. Patients with HCA had a better 3 year survival than those with ICA (P<0.01), the most significantly independent predictor was apical LS [cut-off -14.7%, OR 4.1 (1.37, 12.4), P<0.01], but LVMI and NT-pro BNP showed no superiority to longitudinal strain in survival. Survival curve of HCA vs. ICA Conclusions: There are regional variations in LS/LSR that can distinguish HCA from ICA. Longitudinal strain might be a good predictor for survival in patients with light chain and hereditary cardiac amyloidosis.
Purpose: To measure oral and maxillofacial surgery (OMS) chief resident case experience, including autonomy, and discover the role of this experience in developing resident confidence and determining the scope of practice on completion of training.Materials and Methods: A cross-sectional study was conducted using an online questionnaire made available to residents near the completion of their final year of training in United States OMS training programs. Predictors were the case numbers and autonomy level. Outcomes were the anticipated frequency of practice, confidence to meet the standard of care, and changes in anticipated practice scope. Each was measured in 10 domains within the scope of OMS.Results: Eighty-four residents (44%) completed the 116-item questionnaire. All respondents were "very confident" in their ability to meet the standard of care in mandibular trauma and dentoalveolar surgery. Autonomy was associated with the confidence to meet the standard of care in midface trauma, temporomandibular joint, orthognathic, cosmetic, pathology, reconstructive, and craniofacial surgery. Associations were noted between primary surgeon cases and confidence in midface trauma, temporomandibular joint, orthognathic, cosmetic, and craniofacial surgery. Case numbers were associated with an anticipated frequency of practice within the domains of midface trauma, temporomandibular joint, cosmetic, and pathology surgery.Conclusions: Results of this study suggest an association between a resident's surgical case experience (overall exposure and autonomy) and that resident's future plans for practice and confidence to meet the standard of care in this specialty. OMS training curricula should evolve to incorporate an evaluation of competence and an appropriate transfer of responsibility and experience to residents, thus maximizing confidence and future practice opportunities. (C) 2013 American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg 71:448-461, 2013
Objective: To evaluate long-term patient survival and causes of death after open (OR) or endovascular (ER) mesenteric revascularization for atherosclerotic chronic mesenteric ischemia using propensity score-matched comparison and clinical risk stratification.Methods: The clinical data of 343 patients treated with mesenteric revascularization for chronic mesenteric ischemia between 1991 and 2010 were retrospectively reviewed. Clinical, anatomical, and procedure-related variables were analyzed using a multivariate model to identify independent predictors of any-cause early and late (>30 days) mortality. Cause of death was retrieved from review of the National Death Index. Patient survival was analyzed using Society for Vascular Surgery (SVS) comorbidity scores and propensity score-matched comparison based on independent predictors of any-cause mortality.Results: There were 187 patients treated by OR and 156 patients treated by ER. Early procedure-related mortality was 2.6% (9/343), including five OR (2.7%) and four ER (2.6%) patients. Median follow-up was 96 +/- 54 months (range, 1-168 months). There were 144 late deaths, most commonly from cardiac causes in 35% (51/144), followed by cancer in 15% (21/144), pulmonary complications in 13% (19/144), and mesenteric ischemia in 11% (16/144). A further 21 patients died from various identifiable causes, and 14 patients (10%) died of unknown causes. Overall, 25 patients (7.3%) died of mesenteric-related causes, including nine early and 16 late deaths (OR, 10/187; 8.0%, and ER, 6/156; 6.4%). Multivariate analysis identified age >80, diabetes, chronic kidney disease (CKD) stage IV or V, and home oxygen therapy as independent predictors (P < .05) of any cause of death. Diabetes and CKD stage IV or V were independently associated with mesenteric-related death (P < .05). Late patient survival at 5 years in the OR and ER groups was 75% +/- 4% and 60% +/- 9% for low SVS risk (< 9), 52% +/- 8% and 43% +/- 9% for intermediate SVS risk (9-16), and 67% +/- 15% and 30% +/- 8% for high SVS risk (>16). Using propensity matched scores, 5-year survival was nearly identical for patients treated by OR (60%) or ER (57%; P = .7).Conclusions: Long-term patient survival after mesenteric revascularization was not influenced by type of arterial reconstruction. Age >80 years, diabetes, CKD stage IV or V, and home oxygen were independent predictors of any-cause mortality. Diabetes and CKD stage IV or V were independently associated with mesenteric-related death. (J Vasc Surg 2013;57:747-55.)
To identify factors affecting long-erm outcome after open surgical reconstructions (OSR) and hybrid reconstructions (HR) for chronic venous occlusions. Retrospective review of 64 OSR and HR for chronic occlusion of IF veins or IVC between January 1985 and September 2009. Primary endpoints were patency and clinical outcome. 60 patients (26 men, mean age 43 years) underwent 64 procedures. 94% had leg swelling, 90% had venous claudication, 19% had active, and 12% had healed ulcers. (CEAP Classes: C3 = 30, C4 = 12, C5 = 8, C6 = 12). Fifty-two OSRs included 29 femoro-femoral (Palma; vein: 25, PTFE: 4), 16 femoral-iliac-infrahepatic IVC (vein: 3, PTFE: 13) and 6 complex bypasses. 12 patients had HR (endophlebectomy, patch angioplasty, stents). Early reocclusion occurred after 17% of OSR and 33% HR. Discharge patency was 96% after OSR, 92% after HR. No mortality or pulmonary embolism occurred. 5-year primary and secondary patency was 43% (95% CI 29-56%) and 58% (CI 42-72%), respectively. For Palma vein grafts it was 70% and 78%, for iliofemoral and ilio-infrahepatic IVC bypasses it was 75% and 86%, and for femoro-infrahepatic IVC bypasses it was 44% and 57%, respectively. Complex OSRs and hybrid procedures had 28% and 30% 2-year secondary patency, respectively. Factors adversely affecting graft patency included prosthetic grafts, smoking, male gender and endoscopic vein harvesting. For HR stenting, CFV patch vs iliac stents only significantly increased patency. At last follow-up 60% had no venous claudication and no or minimal swelling. All ulcers with patent grafts healed. OSR and HR remain viable alternatives to endovascular procedures. Palma vein bypass and ilio-femoral or ilio-caval PTFE bypasses have excellent outcomes with symptomatic relief in over two thirds of the patients. Endoscopic vein harvest, smoking, male gender and long prosthetic grafts adversely affect outcome.
The purpose of this study was to review the management and clinical outcome of patients with aortic dissection and symptomatic or asymptomatic aortic branch compromise. We identified 104 patients (30.7%) with aortic branch compromise from a group of 339 patients who underwent surgical management of aortic dissection from January 1971 to May 2003. Patients were divided into 2 groups: symptomatic and asymptomatic aortic branch compromise, based on the presence or absence of cerebral, extremity, spinal, renal, and visceral ischemia. Clinical data and outcome were reviewed and compared in both groups. There were 74 male (77%) and 30 female patients with a mean age of 58.5 (range, 23-81) years. Aortic dissection was classified as Stanford type A in 58.7%, acute in 58.7%, and was associated with asymptomatic aortic branch compromise in 44 patients (42.3%) and symptomatic aortic branch compromise in 60 patients (57.7%). Asymptomatic and symptomatic aortic branch compromise, respectively, were distributed in the extremity (30 and 33), carotid (5 and 4), renal (21 and 28), visceral (13 and 8), and spinal (0 and 5) arteries. In the asymptomatic aortic branch compromise group, all patients had aortic graft replacement, and 9 had branch reconstructions. In the symptomatic aortic branch compromise group, treatment was aortic graft replacement (48), open fenestration (6), and endovascular treatment (6). Operative mortality rate was 9.1% (4 of 44) in the asymptomatic and 38.3% (23 of 60) in the symptomatic aortic branch compromise during the 30-year study period (P = .001), decreasing from 35.1% (20 of 57) prior to 1990 to 14.9% (7 of 47) since 1990 (P = .04). In the symptomatic group, operative mortality decreased from 56.7% (17 of 30) to 20% (6 of 30) in the same interval (P = .003). Patients treated in both treatment eras were similar except for less aortic graft replacements and more aortic fenestrations and direct branch reconstructions since 1990. Multivariate analysis revealed symptomatic aortic branch compromise group, treatment prior to 1990, Marfan syndrome, age greater than 70 years, and postoperative complications to be independently associated with increased operative mortality. Asymptomatic aortic branch compromise was not associated with increased operative mortality, but organ malperfusion was an independent risk factor for operative death. The operative mortality significantly decreased since 1990, mostly because of changes in our surgical approach, with less aortic graft replacements and more complication-directed procedures.
We consider methods for evaluating repeated markers to be used as a substitute for a clinical examination or to predict an outcome, in our case progression of breast cancer. We propose a definition of specificity and sensitivity for this setting and describe non-parametric estimators for these parameters. We then derive the theory required to obtain confidence intervals for the specificity and sensitivity of a marker and to define an asymptotically normal statistic for comparing the sensitivities of two markers at a fixed specificity. The theory allows for correlations introduced by the fact that markers may be obtained from the same patient at multiple visits and that both markers being compared may be obtained from the same patient. The work allows for an approach that complements the frequently used time dependent Cox model, which we believe, will facilitate clinical interpretation of marker data.
A screening design was used in a trial that compared a standard regimen to five experimental regimens for the treatment of advanced colorectal cancer where the endpoint was survival. The two-stage design permitted the termination of accrual to experimental regimens that failed to show promise at the first stage. It also allowed for termination of accrual to the standard regimen if an experimental regimen appeared to offer a highly significant improvement over the standard regimen. This paper presents a description of the design and the results of the trial.
Background: Renovascular disease (RVD) is associated with left ventricular hypertrophy (LVH) and left ventricular diastolic dysfunction, both of which are associated with increased mortality and cardiovascular events. However, the effects of renal artery revascularization on cardiac morphology and function are poorly understood and largely based upon retrospective studies. In order to characterize changes in ventricular function and morphology following renal artery revascularization, we identified a cohort of patients with baseline preoperative echocardiograms and studied them with repeat echocardiography at 6-12 months post- revascularization. Methods: Adult patients undergoing preoperative echocardiography and renal revascularization later than March, 2007 were identified from an operative registry and recruited to return for repeat echocardiography, blood pressure measurement, and collection of interval clinical and medication history between 6 and 12 months following renal revascularization. Repeat echocardiograms were performed and interpreted according to American Society of Echocardiography recommendations for clinical trials of heart failure and other published guidelines. Systolic function was assessed as ejection fraction (EF) calculated using the modified Simpson's method. Diastolic function was categorized as normal, mild dysfunction, moderate dysfunction, or severe dysfunction based on published guidelines. Significance of longitudinal changes in continuous echocardiogram measures was assessed using paired T-tests, while longitudinal changes in categorical measures were assessed using McNemar's test. Results: 20 patients were recruited for postoperative echocardiography at a median of 7.6 months following renal artery revascularization. Mean changes in echo parameters of ventricular morphology, ejection fraction, and diastolic function are displayed in Table 1. Accounting for variance and pre/post correlation, power to detect a ≥ 20% change in echo parameters assessed in a continuous fashion was >80% for all measures. Mean decreases in left ventricular mass (P=0.047) and left ventricular mass index (P=0.018) were observed. No significant change in EF was detected. Categorical group-wise change in DD assessed as a dichotomized outcome (normal/mild versus moderate/severe) was non-significant (P=0.0833), with two patients progressing from normal/mild to moderate/severe DD during follow-up and the remainder categorically unchanged. Conclusion: Interval decreases in left ventricular mass and left ventricular mass index were observed following renal artery revascularization, while diastolic function was largely unchanged. Regression of LVH has been associated with reduced mortality due to sudden cardiovascular death, and further investigation is required to understand the long term effects of renal revascularization on survival and ventricular function.