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1.
J Vasc Surg ; 2024 Jun 14.
Article in English | MEDLINE | ID: mdl-38880181

ABSTRACT

OBJECTIVE: Prior studies have described risk factors associated with amputation in patients with concomitant diabetes and peripheral arterial disease(DM/PAD). However, the association between the severity and extent of tissue loss type and amputation risk remains less well-described. We aimed to quantify the role of different tissue loss types in amputation risk among patients with DM/PAD, in the context of demographic, preventive, and socioeconomic factors. METHODS: Applying ICD-9 and ICD-10 codes to Medicare claims data(2007-2019), we identified all patients with continuous fee-for-service Medicare coverage diagnosed with DM/PAD. Eight tissue loss categories were established using ICD-9 and ICD-10 diagnosis codes, ranging from lymphadenitis(least severe) to gangrene(most severe). We created a Cox proportional hazards model to quantify associations between tissue loss type and one- and five-year amputation risk, adjusting for age, race/ethnicity, sex, rurality, income, comorbidities, and preventive factors. Regional variation in DM/PAD rates and risk-adjusted amputation rates was examined at the hospital referral region(HRR) level. RESULTS: We identified 12,257,174 patients with DM/PAD(48% male, 76% White, 10% prior myocardial infarction, 30% chronic kidney disease). While 2.2 million patients(18%) had some form of tissue loss, 10.0 million patients(82%) did not. The one-year crude amputation rate(major and minor) was 6.4% in patients with tissue loss, and 0.4% in patients without tissue loss. Among patients with tissue loss, one-year any amputation rate varied from 0.89% for patients with lymphadenitis to 26% for patients with gangrene. One-year amputation risk varied from two-fold for patients with lymphadenitis(aHR 1.96, 95%CI 1.43-2.69) to 29-fold for patients with gangrene(aHR 28.7, 95%CI 28.1-29.3), compared to patients without tissue loss. No other demographic variable including age, sex, race, or region incurred a hazard ratio for one- or five-year amputation risk higher than the least severe tissue loss category. Results were similar across minor and major amputation, and one- and five-year amputation outcomes. At a regional level, higher DM/PAD rates were inversely correlated with risk-adjusted five-year amputation rates(R2=0.43). CONCLUSION: Among 12 million patients with DM/PAD, the most significant predictor of amputation was presence and extent of tissue loss, with an association greater in effect size than any other factor studied. Tissue loss could be used in awareness campaigns as a simple marker of high-risk patients. Patients with any type of tissue loss require expedited wound care, revascularization as appropriate, and infection management to avoid amputation. Establishing systems of care to provide these interventions in regions with high amputation rates may prove beneficial for these populations.

2.
Ann Vasc Surg ; 108: 26-35, 2024 May 28.
Article in English | MEDLINE | ID: mdl-38815917

ABSTRACT

BACKGROUND: The COVID-19 pandemic necessitated postponement of vascular surgery procedures nationally. Whether procedure volumes have since recovered remains undefined. Therefore, our objective was to quantify changes in procedure volumes and determine whether surgical volume has returned to its prepandemic baseline. METHODS: This study was a retrospective cross-sectional study between 2018 and 2023 using the US Fee-for-Service Medicare 5% National Sample as part of the VA Disrupted Care National Project. We studied patients who underwent 1 of 3 procedures: abdominal aortic aneurysm (AAA) repair for intact aneurysms, carotid endarterectomy (CEA), and major lower extremity amputation (LEA). The case volume of each quarter of 2020-2023 was compared to its corresponding prepandemic quarter in 2019. We then performed a subanalysis of these trends by sex, age, and race. RESULTS: We identified 21,031 procedures: 4,411 AAA repair, 8,361 CEA, and 8,259 LEA. The average percent change during the baseline prepandemic period from 2018 to 2019 was -4.3% for AAA repair, -8.5% for CEA, and -2.6% for LEA. Compared to Q2 of 2019, Q2 of 2020 demonstrated that AAA repair procedures decreased by 47%, CEA by 40%, and LEA by 14%. While procedures initially rebounded in Q3 of 2020, volumes did not return to their prepandemic baseline, demonstrating a persistent volume reduction (-16% AAA, -22% CEA, and -11% LEA). Thereafter, procedure counts again declined in Q1 of 2022 (-25% AAA, -34% CEA, and -25% LEA). CONCLUSIONS: Despite a perception that vascular surgical care was singularly disrupted at the outset of the pandemic, there has been a sustained reduction in vascular surgical volume since 2019. Not only have procedure volumes not returned to prepandemic baseline but it also appears that there has been a cumulative incremental impact on overall procedure volume. The impact of these findings on long-term population health remains uncertain and necessitates a better understanding of postpandemic care delivery.

3.
J Vasc Surg ; 80(1): 125-135.e7, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38447624

ABSTRACT

OBJECTIVE: The National Coverage Determination on carotid stenting by Medicare in October 2023 stipulates that patients participate in a shared decision-making (SDM) conversation with their proceduralist before an intervention. However, to date, there is no validated SDM tool that incorporates transcarotid artery revascularization (TCAR) into its decision platform. Our objective was to elicit patient and surgeon experiences and preferences through a qualitative approach to better inform the SDM process surrounding carotid revascularization. METHODS: We performed longitudinal perioperative semistructured interviews of 20 participants using purposive maximum variation sampling, a qualitative technique designed for identification and selection of information-rich cases, to define domains important to participants undergoing carotid endarterectomy or TCAR and impressions of SDM. We also performed interviews with nine vascular surgeons to elicit their input on the SDM process surrounding carotid revascularization. Interview data were coded and analyzed using inductive content analysis coding. RESULTS: We identified three important domains that contribute to the participants' ultimate decision on which procedure to choose: their individual values, their understanding of the disease and each procedure, and how they prefer to make medical decisions. Participant values included themes such as success rates, "wanting to feel better," and the proceduralist's experience. Participants varied in their desired degree of understanding of carotid disease, but all individuals wished to discuss each option with their proceduralist. Participants' desired medical decision-making style varied on a spectrum from complete autonomy to wanting the proceduralist to make the decision for them. Participants who preferred carotid endarterectomy felt outcomes were superior to TCAR and often expressed a desire to eliminate the carotid plaque. Those selecting TCAR felt it was a newer, less invasive option with the shortest procedural and recovery times. Surgeons frequently noted patient factors such as age and anatomy, as well as the availability of long-term data, as reasons to preferentially select one procedure. For most participants, their surgeon was viewed as the most important source of information surrounding their disease and procedure. CONCLUSIONS: SDM surrounding carotid revascularization is nuanced and marked by variation in patient preferences surrounding autonomy when choosing treatment. Given the mandate by Medicare to participate in a SDM interaction before carotid stenting, this analysis offers critical insights that can help to guide an efficient and effective dialog between patients and providers to arrive at a shared decision surrounding therapeutic intervention for patients with carotid disease.


Subject(s)
Decision Making, Shared , Endarterectomy, Carotid , Interviews as Topic , Patient Preference , Stents , Humans , Female , Male , Endarterectomy, Carotid/adverse effects , Aged , Middle Aged , Patient Participation , Qualitative Research , Clinical Decision-Making , Endovascular Procedures/adverse effects , Decision Support Techniques , Health Knowledge, Attitudes, Practice , Carotid Artery Diseases/surgery , Attitude of Health Personnel , Longitudinal Studies , Physician-Patient Relations , Carotid Stenosis/surgery , Carotid Stenosis/diagnostic imaging , Treatment Outcome
4.
J Surg Res ; 296: 696-703, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38364697

ABSTRACT

INTRODUCTION: In March 2020, the American College of Surgeons recommended postponing elective procedures amid the COVID-19 pandemic. We used Medicare claims to analyze changes in surgical and interventional procedure volumes from 2016 to 2021. METHODS: We studied 37 common surgical and interventional procedures using 5% Medicare claims files from January 1, 2016, through December 31, 2021. Procedures were classified according to American College of Surgeons guidelines as low, intermediate, or high acuity, and counts were analyzed per calendar year quarter (Q1-Q4), with stratification by sex and race/ethnicity. RESULTS: We observed 1,840,577 procedures and identified two periods of marked decline. In Q2 2020, overall procedure counts decreased by 32.2%, with larger declines in low (41.1%) and intermediate (30.8%) acuity procedures. High acuity procedures declined the least (18.2%). Overall volumes increased afterward but never returned to baseline. Another marked decline occurred in Q4 2021, with all acuity levels having declined to a similar extent (40.1%, 44.2%, and 46.9% for low, intermediate, and high acuity, respectively). High and intermediate acuity procedures declined more in Q4 2021 than Q2 2020 (P = 0.002). Similar patterns were observed across sex and race/ethnicity strata. CONCLUSIONS: Two major procedural volume declines occurred between 2020 and 2022 during the COVID-19 pandemic in the United States. High acuity (life or limb threatening) procedures were least affected in the first decline (Q2 2020) but not spared in second decline (Q4 2021). Future efforts should prioritize preserving high-acuity access during times of stress.


Subject(s)
COVID-19 , Aged , Humans , United States/epidemiology , COVID-19/epidemiology , Retrospective Studies , Pandemics , Medicare
5.
J Vasc Surg ; 80(1): 81-88.e1, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38408686

ABSTRACT

OBJECTIVE: Globally, there has been a marked increase in aortic aneurysm-related deaths between 1990 and 2019. We sought to understand the underlying etiologies for this mortality trend by examining secular changes in both demographics and the prevalence of risk factors, and how these changes may vary across sociodemographic index (SDI) regions. METHODS: We queried the Global Burden of Disease Study (GBD) for aortic aneurysm deaths from 1990 to 2019 overall and by age group. We identified the percentage of aortic aneurysm deaths attributable to each risk factor identified by GBD modeling (smoking, hypertension, lead exposure, and high sodium diet) and their respective changes over time. We then analyzed aneurysm mortality by SDI region. RESULTS: The number of aortic aneurysm-related deaths have increased from 94,968 in 1990 to 172,427 in 2019, signifying an 81.6% increase, which greatly exceeds the 18.2% increase in all-cause mortality observed over the same time interval. Examination of age-specific mortality demonstrated that the number of aortic aneurysm deaths markedly correlated with advancing age. However, when considering rate of death rather than mortality count, overall age-standardized death rates decreased 18% from 2.72 per 100,000 in 1990 to 2.21 per 100,000 in 2019. Analysis of the specific risk factors associated with aneurysm death revealed that the percentage of deaths attributable to smoking decreased from 45.6% in 1990 to 34.6% in 2019, and deaths attributable to hypertension decreased from 38.7% to 34.7%. Globally, hypertension surpassed smoking as the leading risk factor. The reported rate of death was consistently greater as SDI increased, and this effect was most pronounced among low-middle and middle SDI regions (173.2% and 170.4%, respectively). CONCLUSIONS: Despite an overall increase in the number of aneurysm deaths, there was a decrease in the age-standardized death rate, demonstrating that the observed increased number of aortic aneurysm deaths between 1990 and 2019 was primarily driven by an overall increase in the age of the global population. Fortunately, it appears that the increase in overall aneurysm-related deaths has been modulated by improved risk factor modification, in particular smoking. Given the rise in aneurysm-related deaths, global expansion of vascular specialty capabilities is warranted and will serve to amplify improvements in population-based aneurysm health achieved with risk factor control.


Subject(s)
Aortic Aneurysm , Humans , Risk Factors , Aged , Middle Aged , Aortic Aneurysm/mortality , Male , Female , Aged, 80 and over , Prevalence , Risk Assessment , Adult , Time Factors , Global Health , Global Burden of Disease/trends , Cause of Death , Age Distribution , Age Factors , Young Adult , Smoking/adverse effects , Smoking/mortality , Smoking/epidemiology
6.
J Vasc Surg ; 79(3): 704-707, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37923023

ABSTRACT

BACKGROUND: Shared decision-making tools have been underused by clinicians in real-world practice. Changes to the National Coverage Determination by Medicare for carotid stenting greatly expand the coverage for patients, but simultaneously require a shared decision-making interaction that involves the use of a validated tool. Accordingly, our objective was to evaluate the currently available decision aids for carotid stenosis. METHODS: We conducted a review of the literature for published work on decision aids for the treatment of carotid disease. RESULTS: Four publications met inclusion criteria. We found the format of the decision aid impacted patient comprehension and decision making, although patient characteristics also played a role in the therapeutic decisions made. Notably, none of the available decision aids included the widely adopted transcarotid artery revascularization as an option. CONCLUSIONS: Further work is needed in the development of a widespread validated decision aid instrument for patients with carotid stenosis.


Subject(s)
Carotid Stenosis , Humans , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/surgery , Decision Support Techniques , Medicare , Stents , Treatment Outcome , United States , Vascular Surgical Procedures
7.
J Surg Res ; 292: 167-175, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37619502

ABSTRACT

INTRODUCTION: Hospital readmission after lower extremity arterial bypass (LEB) is common. Patients are often discharged to a facility after LEB as a bridge to home. Our objective was to define the association between discharge to a facility and readmission after LEB. METHODS: We used the Vascular Quality Initiative to study patients who underwent LEB from 2017 to 2022. The primary exposure was discharge location. The primary outcome was 30-d hospital readmission. RESULTS: We included 6076 patients across 147 centers. The overall 30-d readmission rate was 18%. Readmission occurred among 15% of patients discharged home, 22% of patients discharged to a rehabilitation facility, and 25% of patients discharged to a nursing home. After controlling for patient and procedural factors, there was no significant association between discharge location and 30-d readmission (rehabilitation versus home odds ratio: 1.06, 95% confidence interval: 0.87-1.29; nursing facility versus home odds ratio: 1.21, 95% confidence interval: 0.99-1.47). Female sex, end-stage renal disease, diabetes, heart failure, pulmonary disease, smoking, preoperative functional impairment, tibial bypass target, critical limb threatening or acute ischemia, and postoperative complications including surgical site infection, change in renal function and graft thrombosis were associated with an increased likelihood of readmission. CONCLUSIONS: Patients discharged home after LEB experienced a similar likelihood of readmission as those discharged to a facility. While discharge to a facility may aid in care transitions, it did not appear to lead to reduced 30-d readmissions. The recommended discharge location should be predicated on patient care needs and not as a perceived mechanism to reduce readmissions.

9.
Ann Vasc Surg ; 60: 171-177, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31201973

ABSTRACT

BACKGROUND: Postoperative mortality after open and endovascular repair of thoracic aortic dissection (AD) has been the focus of previous research. However, a little has been published on the far less common isolated abdominal aortic dissection (IAAD). The aim of our study was to identify risk factors associated with 30-day postoperative mortality in patients with IAAD. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) was queried for patients who underwent open or endovascular AD repair from January 2010 to December 2015. Information regarding patient demographics, comorbidities, preoperative laboratory values, procedure details, and postoperative complications were analyzed, and predictors of 30-day mortality were identified. Risk stratification by the type of aortic repair and surgery setting was performed, and patient characteristics associated with mortality in each setting were determined. We employed chi-squared test, Student's t-test, and Mann-Whitney U test for the univariate analysis, while the multivariate analysis was performed using a stepwise binary logistic regression test. RESULTS: There were 229 patients who met the specified criteria, 15 died within 30 days postoperatively, and 214 survived beyond the same period (mortality rate was 6.5%). Among preoperative factors, a history of chronic obstructive pulmonary disease (COPD), preoperative ventilator dependence, preoperative transfusion of ≥1 unit packed RBCs, emergent operation, and advanced American Society of Anesthesiologists (ASA) class were associated with increased risk of mortality. Postoperative complications associated with a higher risk of mortality were acute kidney injury, mechanical ventilation ≥48 hours, unplanned intubation, myocardial infarction, septic shock, and blood transfusion. On multivariate analysis, risk factors independently associated with increased risk of mortality were a history of COPD (adjusted odds ratio [AOR], 10.5; P = 0.013), postoperative acute renal failure (AOR, 12.8; P = 0.003) and septic shock (AOR, 15.3; P = 0.014). CONCLUSIONS: Multiple preoperative and postoperative factors are associated with a high risk of death after IAAD repair. A better control of COPD and prevention of postoperative acute renal failure and septic shock may result in better outcomes.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Dissection/surgery , Endovascular Procedures/mortality , Vascular Surgical Procedures/mortality , Aged , Aged, 80 and over , Aortic Dissection/mortality , Aortic Aneurysm, Abdominal/mortality , Databases, Factual , Endovascular Procedures/adverse effects , Female , Humans , Male , Middle Aged , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , United States/epidemiology , Vascular Surgical Procedures/adverse effects
10.
J Neurosurg Sci ; 63(4): 411-424, 2019 Aug.
Article in English | MEDLINE | ID: mdl-29527887

ABSTRACT

INTRODUCTION: Stroke is one of the leading causes of mortality and morbidity worldwide and requires rapid and intensive treatment to prevent adverse outcomes. Decompressive hemicraniectomy stands as the gold standard for surgical resolution of the intracranial swelling which accompanies cerebral infarction; however, the benefits of this procedure are not as well achieved in the elderly (age >65 years) compared to the younger population. EVIDENCE ACQUISITION: This is a critical review performed on all available literature relating to middle cerebral artery (MCA) stroke in the elderly with emphasis on articles examining causality of adverse outcomes in this group over younger populations. Utilizing PRISMA guidelines, we initially identified 1462 articles. EVIDENCE SYNTHESIS: After screening, four clear areas of physiological change associated with aging were identified and expounded upon as they relate to MCA stroke. These four areas include: immunological, autonomic, mitochondrial, and vascular changes. Elderly patients have a decreased and declining capacity to regulate the inflammation that develops postinfarction and this contributes to adverse outcomes from a neurological stand point. Additionally, aging decreases the ability of elderly patients to regulate their autonomic system resulting in aberrant blood pressures systemically post infarction. With age, the mitochondrial response to ischemia is exaggerated and causes greater local damage in elderly patients compared to younger populations. Finally, there are numerous vascular changes that occur with age including accumulation of homocysteine and atherosclerosis which together contributed to decreased structural integrity of the vasculature in the elderly and render decreased support to the recovery process post infarction. CONCLUSIONS: We conclude that physiological changes inherent in the aging process serve to intensify adverse outcomes that are commonly associated with strokes in the elderly. Identification and subsequent minimization of these risk factors could allow for more effective management of elderly patients, post stroke, and promote better clinical outcomes.


Subject(s)
Aging , Decompressive Craniectomy , Infarction, Middle Cerebral Artery/surgery , Stroke/surgery , Autonomic Nervous System/surgery , Decompressive Craniectomy/methods , Humans , Neurosurgical Procedures
11.
World Neurosurg ; 123: 197-207, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30576816

ABSTRACT

BACKGROUND: Parkinson disease (PD) remains a common neurodegenerative disorder. Functional neurosurgery largely arose with the introduction of deep brain stimulation (DBS) as a potential option for PD unresponsive to medical management. Biomarkers are clinical and laboratory indicators of therapeutic success or failure. OBJECTIVE: To examine the current and published literature relating to the development and use of biomarkers in monitoring and determining the efficacy of DBS in PD. METHODS: The PubMed database was systematically searched using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for systemic reviews. Studies that examined current or potential biomarkers measurable after DBS were included. Articles from 1952 to date were examined. RESULTS: The initial search identified 49 articles. Thirty articles met the inclusion criteria. Articles were subdivided into those addressing biomarkers with proven clinical usefulness and potential biomarkers that have future application. CONCLUSIONS: Biomarkers have been identified that can help to determine the effect of DBS on patients with PD. Current studies show that there are measured differences in electrophysiologic oscillations, gene expression, neuropeptide levels, metabolic function, inflammatory activity, and others in the central nervous system after DBS in PD. Local field potential and ß-band analysis stand as the clinically proven biomarkers of choice for DBS in PD. Many of the identified changes noted could be implemented as clinically useful biomarkers through which DBS may be monitored. Future studies are needed to determine which noted physiologic changes are most appropriately used as biomarkers and in which contexts they are most helpful.


Subject(s)
Deep Brain Stimulation , Parkinson Disease/diagnosis , Parkinson Disease/therapy , Animals , Biomarkers/metabolism , Humans
12.
J Vasc Surg ; 67(3): 793-798, 2018 03.
Article in English | MEDLINE | ID: mdl-29042076

ABSTRACT

OBJECTIVE: Reoperative carotid endarterectomy (CEA) can be technically challenging because of significant scarring as a consequence of the initial CEA procedure. There are limited data that describe outcomes after reoperative CEA, and as such, our goal was to determine the effect of reoperative CEA on perioperative outcomes. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database was queried for patients undergoing index and reoperative CEA between 2005 and 2014. Multivariate analysis was performed to assess the effect of reoperative CEA on outcomes including stroke, major adverse cardiovascular event, and procedure time. RESULTS: There were 75,943 index and 140 reoperative CEAs identified. No differences were found in baseline demographics or comorbidities except that the reoperative group had a higher incidence of patients with end-stage renal disease (3.6% vs 1.1%; P = .004). Prior stroke with deficit (20.8% vs 15.4%; P = .137) and without deficit (11.5% vs 9.1%; P = .43) were similar between reoperative and index CEA groups. Both the reoperative and index initial CEA cohorts had comparable rates of surgical site infection (0.7% vs 0.3%; P = .462), return to the operating room (3.6% vs 4%; P = .816), readmission with 30 days (2.1% vs 6.9%; P = .810), myocardial infarction (2.1% vs 0.9%; P = .125), and perioperative death (0.7% vs 0.9%; P = .853). The reoperative cohort had a significantly higher rate of perioperative stroke (5.0% vs 1.6%; P = .002) and a longer operative duration (137 ± 54 vs 116 ± 49 minutes; P < .001). Multivariate analysis revealed that reoperative CEA was an independent factor for postoperative stroke (odds ratio, 3.71; 95% confidence interval [CI], 1.61-8.57; P = .002), major adverse cardiovascular event (odds ratio, 2.76; 95% CI, 1.32-5.78; P = .007), and longer procedure time (means ratio, 1.21; 95% CI, 1.12-1.30; P < .001). CONCLUSIONS: Reoperative carotid surgery is associated with a longer operative time and higher risk for perioperative stroke compared with index CEA. This information informs the risk-benefit analysis for reoperation.


Subject(s)
Carotid Stenosis/surgery , Endarterectomy, Carotid/adverse effects , Operative Time , Reoperation/adverse effects , Stroke/epidemiology , Aged , Aged, 80 and over , Carotid Stenosis/diagnostic imaging , Carotid Stenosis/mortality , Chi-Square Distribution , Clinical Decision-Making , Comorbidity , Databases, Factual , Endarterectomy, Carotid/mortality , Female , Humans , Incidence , Male , Middle Aged , Multivariate Analysis , Myocardial Infarction/epidemiology , Odds Ratio , Recurrence , Reoperation/mortality , Retrospective Studies , Risk Assessment , Risk Factors , Stroke/diagnosis , Stroke/mortality , Time Factors , Treatment Outcome , United States/epidemiology
13.
Ann Vasc Surg ; 46: 43-52, 2018 Jan.
Article in English | MEDLINE | ID: mdl-29100876

ABSTRACT

BACKGROUND: The use of statin and antiplatelet medications has been advocated in patients with cerebrovascular disease as primary medical therapy and as an adjunct to carotid endarterectomy (CEA). Our goal was to assess the prevalence of preoperative statin and antiplatelet use and its effect on perioperative outcomes after CEA. METHODS: The American College of Surgeons National Surgical Quality Improvement Program targeted CEA database was queried for patients undergoing CEA between 2011 and 2014. Multivariable analysis was used to assess the effect of preoperative statin and antiplatelet use on CEA. RESULTS: There were 13,521 CEAs identified. The average age was 71 years, and 61.5% were male. More than half of patients (57.9%) were asymptomatic. Preoperative statin use was seen in 80.5% of patients, and antiplatelet use was seen in 89.3% of patients. Statin use was more common in patients with higher body mass index, independent functional status, diabetes, hypertension, bleeding disorders or anticoagulation, nonsmokers, and asymptomatic patients (P < 0.05). On univariate analysis, statin use was not associated with postoperative myocardial infarction (MI) (1.9% vs. 1.4%, P = 0.085), stroke (1.8% vs. 1.9%, P = 0.55), transient ischemic attack (TIA) (0.9% vs. 1.1%), or major adverse cardiovascular events (MACE) (4% vs. 3.6%). On multivariate analysis, preoperative statin use did not independently affect 30-day mortality (odds ratio [OR]: 0.94, 95% confidence interval [CI]: 0.55-1.6, P = 0.825), perioperative MI (OR 1.1, 95% CI 0.77-1.58, P = 0.573), stroke (OR: 0.891, 95% CI: 0.64-1.2, P = 0.42), or MACE (OR 1.03, 95% CI: 0.81-1.32, P = 0.806). Antiplatelet use was more common with male gender, nonsmoking, diabetes, hypertension, chronic obstructive pulmonary disease, dyspnea, and asymptomatic carotid disease. On univariate analysis, antiplatelet use showed no effect on 30-day mortality (0.7% vs. 1%, P = 0.28), MI (1.9% vs. 1.7%, P = 0.73), stroke (1.8% vs. 1.8%, P = 0.94), TIA (0.9% vs. 1%, P = 0.63), or MACE (3.9% vs. 4%, P = 0.8). On multivariate analysis, preoperative antiplatelet use did not independently affect 30-day mortality (OR: 0.67, 95% CI: 0.37-1.3, P = 0.19), perioperative MI (OR: 0.9, 95% CI: 0.59-1.38, P = 0.637), stroke (OR: 0.92, 95% CI: 0.61-1.4, P = 0.69), or MACE (OR: 0.88, 95% CI: 0.66-1.18, P = 0.39). CONCLUSIONS: Preoperative statin and antiplatelet use in patients undergoing CEA was more often observed in patients with higher rates of comorbidities and asymptomatic disease, and this may represent closer follow-up and engagement with primary care physicians in this patient cohort. Preoperative statin and antiplatelet use did not affect perioperative outcomes suggesting that its short-term use is not essential. In patients who are not on statins or antiplatelet medications, CEA can safely be performed before consideration is given to their initiation.


Subject(s)
Carotid Artery Diseases/surgery , Endarterectomy, Carotid , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/therapeutic use , Aged , Aged, 80 and over , Carotid Artery Diseases/diagnosis , Carotid Artery Diseases/mortality , Chi-Square Distribution , Comorbidity , Databases, Factual , Endarterectomy, Carotid/adverse effects , Endarterectomy, Carotid/mortality , Female , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Logistic Models , Male , Middle Aged , Multivariate Analysis , Myocardial Infarction/epidemiology , Odds Ratio , Platelet Aggregation Inhibitors/adverse effects , Retrospective Studies , Risk Factors , Stroke/epidemiology , Time Factors , Treatment Outcome , United States/epidemiology
14.
Future Sci OA ; 3(4): FSO223, 2017 Nov.
Article in English | MEDLINE | ID: mdl-29134114

ABSTRACT

AIM: Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays. MATERIALS & METHODS: The start-up milestones were assessed for 38 studies and analyzed. RESULTS: Total start-up time was shorter for following studies: device trials, no outsourcing, fewer ancillary services used and in interventional versus observational designs. The use of a centralized Institutional Review Board (IRB) versus a local IRB reduced time to approval. Studies that never enrolled took longer on average to finalize their budget/contract, and obtain IRB than ones that did enroll. CONCLUSION: Different features of clinical trials can affect timeline of start-up process. An understanding of the impact of each feature allows for optimization.

15.
J Vasc Surg ; 66(6): 1786-1791, 2017 12.
Article in English | MEDLINE | ID: mdl-28965800

ABSTRACT

OBJECTIVE: Readmission rates are expected to have an increasing effect on both the hospital bottom line and physician reimbursements. Safety net hospitals may be most vulnerable. We examined readmissions at 30 days, 90 days, and 1 year in a large safety net hospital to determine the magnitude and effect of short- and long-term readmission rates after lower extremity infrainguinal bypass in this setting. METHODS: All nonemergent extremity infrainguinal bypass performed at a large safety net hospital between 2008 and 2016 were identified. Patient demographic, social, clinical, and procedural details were extracted from the electronic medical record. An analysis of patients readmitted at 30 days, 90 days, and 1 year was completed to determine the details of the readmission. RESULTS: A total of 350 patients undergoing extremity infrainguinal bypass were identified. The most frequent indication was tissue loss (57%), followed by claudication (25.6%), and rest pain (17.4%). Patient insurance carriers included Medicare (61.7%), Medicaid (25.4%), and private (13%). The distal target was the popliteal and tibial artery in 52.6% and 47.4% cases, respectively. The majority of bypasses used autologous vein (73.1%). In-hospital complications included pulmonary complications (4.3%), urinary tract infection (3.1%), acute renal failure (2%), graft occlusion (2%), myocardial infarction (1.7%), bleeding (1.4%), surgical wound complications (1.1%), and stroke (0.9%). The 30-day readmission rate was 30% with the most common reasons for readmission being surgical wound complications, nonsurgical foot/leg wounds, nonextremity infectious causes, cardiac ischemia, and congestive heart failure. The 90-day readmission rate was 49.4% and the most common reasons for readmission from 31 to 90 days were nonsurgical foot/leg wounds, graft complications, surgical wound complications, cardiac ischemia, and contralateral leg morbidity. The readmission rate within 1 year was 72.2%. Readmission causes from 91 days to 1 year included graft complications, contralateral leg morbidity, nonextremity infectious, nonsurgical foot/leg wounds, cardiac ischemia, and congestive heart failure. A tibial bypass target was associated with 30-day (odds ratio [OR], 1.69; 95% confidence interval [CI], 1.06-2.69; P = .029) and 90-day (OR, 1.77; 95% CI, 1.14-2.74, P = .011) readmission. Nonprivate insurance (OR, 2.31; 95% CI, 1.17-4.57, P = .016), and critical limb ischemia (OR, 1.77; 95% CI, 1.14-2.74; P = .035) were associated with 1-year readmission. CONCLUSIONS: Short- and long-term readmission rates in a safety net setting are high. The 30-day rates in this study are higher than historically reported. This data sets baseline rates for 90-day and 1-year readmission for future analyses. Although the majority of short-term readmissions are related to the index procedure, long-term readmission rates are more frequently related to systemic comorbidities. Targeted patient interventions aimed at preventing the most common reasons for readmission may improve readmission rates, particularly among patients with nonprivate insurance. However, other risk factors, such as tibial target, may not be modifiable and a higher readmission rate may need to be accepted in this population.


Subject(s)
Intermittent Claudication/surgery , Ischemia/surgery , Lower Extremity/blood supply , Patient Readmission , Peripheral Arterial Disease/surgery , Postoperative Complications/etiology , Process Assessment, Health Care , Safety-net Providers , Vascular Grafting/adverse effects , Aged , Boston , Electronic Health Records , Female , Humans , Intermittent Claudication/diagnosis , Ischemia/diagnosis , Logistic Models , Male , Multivariate Analysis , Odds Ratio , Peripheral Arterial Disease/diagnosis , Postoperative Complications/diagnosis , Quality Indicators, Health Care , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome
17.
World Neurosurg ; 106: 509-528, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28712906

ABSTRACT

OBJECTIVE: In neurotrauma care, a better understanding of treatments after traumatic brain injury (TBI) has led to a significant decrease in morbidity and mortality in this population. TBI represents a significant medical problem, and complications after TBI are associated with the initial injury and postevent intracranial processes such as increased intracranial pressure and brain edema. Consequently, appropriate therapeutic interventions are required to reduce brain tissue damage and improve cerebral perfusion. We present a contemporary review of literature on the use of pharmacologic therapies to reduce intracranial pressure after TBI and a comparison of their efficacy. METHODS: This review was conducted by PubMed query. Only studies discussing pharmacologic management of patients after TBI were included. This review includes prospective and retrospective studies and includes randomized controlled trials as well as cohort, case-control, observational, and database studies. Systematic literature reviews, meta-analyses, and studies that considered conditions other than TBI or pediatric populations were not included. RESULTS: Review of the literature describing the current pharmacologic treatment for intracranial hypertension after TBI most often discussed the use of hyperosmolar agents such as hypertonic saline and mannitol, sedatives such as fentanyl and propofol, benzodiazepines, and barbiturates. Hypertonic saline is associated with faster resolution of intracranial hypertension and restoration of optimal cerebral hemodynamics, although these advantages did not translate into long-term benefits in morbidity or mortality. In patients refractory to treatment with hyperosmolar therapy, induction of a barbiturate coma can reduce intracranial pressure, although requires close monitoring to prevent adverse events. CONCLUSIONS: Current research suggests that the use of hypertonic saline after TBI is the best option for immediate decrease in intracranial pressure. A better understanding of the efficacy of each treatment option can help to direct treatment algorithms during the critical early hours of trauma care and continue to improve morbidity and mortality after TBI.


Subject(s)
Brain Edema/drug therapy , Brain Injuries, Traumatic/drug therapy , Intracranial Hypertension/drug therapy , Intracranial Pressure/drug effects , Barbiturates/administration & dosage , Brain Edema/diagnosis , Brain Edema/physiopathology , Brain Injuries, Traumatic/diagnosis , Brain Injuries, Traumatic/physiopathology , Humans , Intracranial Hypertension/diagnosis , Intracranial Hypertension/physiopathology , Intracranial Pressure/physiology , Mannitol/administration & dosage , Prospective Studies , Retrospective Studies , Saline Solution, Hypertonic/administration & dosage , Treatment Outcome
18.
J Cardiovasc Surg (Torino) ; 58(5): 755-762, 2017 Oct.
Article in English | MEDLINE | ID: mdl-28320201

ABSTRACT

BACKGROUND: This study was conducted to determine the risk factors, nature, and outcomes of "never events" following open adult cardiac surgical procedures. Understanding of these events can reduce their occurrence, and thereby improve patient care, quality metrics, and cost reduction. METHODS: "Never events" for patients included in the Nationwide Inpatient Sample who underwent coronary artery bypass graft, heart valve repair/replacement, or thoracic aneurysm repair between 2003-2011 were documented. These events included air embolism, catheter-based urinary tract infection (UTI), pressure ulcer, falls/trauma, blood incompatibility, vascular catheter infection, poor glucose control, foreign object retention, wrong site surgery and mediastinitis. Analysis included characterization of preoperative demographics, comorbidities and outcomes for patients sustaining never events, and multivariate analysis of predictive risk factors and outcomes. RESULTS: A total of 588,417 patients meeting inclusion criteria were identified. Of these, never events occurred in 4377 cases. The majority of events were in-hospital falls, vascular catheter infections, and complications of poor glucose control. Rates of falls, catheter based UTIs, and glucose control complications increased between 2009-2011 as compared to 2003-2008. Analysis revealed increased hospital length of stay, hospital charges, and mortality in patients who suffered a never event as compared to those that did not. CONCLUSIONS: This study establishes a baseline never event rate after cardiac surgery. Adverse patient outcomes and increased resource utilization resulting from never events emphasizes the need for quality improvement surrounding them. A better understanding of individual patient characteristics for those at risk can help in developing protocols to decrease occurrence rates.


Subject(s)
Accidental Falls , Cardiac Surgical Procedures/adverse effects , Catheter-Related Infections/etiology , Glucose Metabolism Disorders/etiology , Medical Errors , Urinary Tract Infections/etiology , Vascular Surgical Procedures/adverse effects , Accidental Falls/economics , Accidental Falls/mortality , Aged , Aorta, Thoracic/surgery , Cardiac Surgical Procedures/economics , Cardiac Surgical Procedures/mortality , Catheter-Related Infections/economics , Catheter-Related Infections/mortality , Catheter-Related Infections/therapy , Coronary Artery Bypass/adverse effects , Databases, Factual , Female , Glucose Metabolism Disorders/economics , Glucose Metabolism Disorders/mortality , Glucose Metabolism Disorders/therapy , Health Resources/economics , Health Resources/statistics & numerical data , Heart Valve Prosthesis Implantation/adverse effects , Hospital Charges , Hospital Mortality , Humans , Length of Stay , Logistic Models , Male , Medical Errors/economics , Medical Errors/mortality , Middle Aged , Multivariate Analysis , Odds Ratio , Quality Indicators, Health Care , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , United States , Urinary Tract Infections/economics , Urinary Tract Infections/mortality , Urinary Tract Infections/therapy , Vascular Surgical Procedures/economics , Vascular Surgical Procedures/mortality
19.
Vasc Endovascular Surg ; 51(1): 17-22, 2017 Jan.
Article in English | MEDLINE | ID: mdl-28100157

ABSTRACT

OBJECTIVE: Thirty-day readmission is increasingly used as a quality of care indicator. Patients undergoing vascular surgery have historically been at high risk for readmission. We analyzed hospital readmission details to identify patients at high risk for readmission in order to better understand these readmissions and improve resource utilization in this patient population. METHODS: A retrospective review and analysis of our medical center's admission and discharge data were conducted from October 2012 to March 2015. All patients who were discharged from the vascular surgery service and subsequently readmitted as an inpatient within 30 days were included. RESULTS: We identified 649 vascular surgery discharges with 135 (21%) readmissions. Common comorbidities were diabetes (56%), coronary artery disease (40%), congestive heart failure (CHF; 24%), and chronic obstructive pulmonary disease (19%). Index vascular operations included open lower extremity procedures (39%), diagnostic angiograms (35%), endovascular lower extremity procedures (16%), dialysis access procedures (7%), carotid/cerebrovascular procedures (7%), amputations (6%), and abdominal aortic procedures (5%). Average index length of stay (LOS) was 7.48 days (±6.73 days). Reasons for readmissions were for medical causes (43%), surgical complications (35.5%), and planned procedures (21.5%). Reasons for medical readmissions most commonly included malaise or failure to thrive (28%), unrelated infection (24%), and hypoxia/CHF complications (21%). Common surgical causes for readmission were surgical site infections (69%), graft failure (19%), and bleeding complications (8%). Of the planned readmissions, procedures were at the same site (79%), a different site (14%), and planned podiatry procedures (7%). Readmission LOS was on average 7.43 days (±7.22 days). CONCLUSION: Causes for readmission of vascular surgery patients are multifactorial. Infections, both related and unrelated to the surgical site, remain common reasons for readmission and represent an opportunity for improvement strategies. Improved understanding of readmissions following vascular surgery could help adjust policy benchmarks for targeted readmission rates and help reduce resource utilization.


Subject(s)
Patient Readmission , Postoperative Complications/etiology , Process Assessment, Health Care , Quality Indicators, Health Care , Vascular Surgical Procedures/adverse effects , Aged , Benchmarking , Boston , Comorbidity , Female , Humans , Length of Stay , Male , Middle Aged , Postoperative Complications/diagnosis , Postoperative Complications/therapy , Process Assessment, Health Care/standards , Quality Indicators, Health Care/standards , Retrospective Studies , Risk Factors , Time Factors , Treatment Outcome , Vascular Surgical Procedures/standards
20.
J Vasc Surg ; 65(4): 1023-1028, 2017 04.
Article in English | MEDLINE | ID: mdl-27986483

ABSTRACT

OBJECTIVE: Although endovascular repair of ruptured abdominal aortic aneurysms (rAAAs) is increasingly more prevalent and may yield better results, open repair of rAAAs is still commonly performed. Our goal was to assess the contemporary practice patterns and outcomes of open repair of rAAA. METHODS: The 2011-2014 American College of Surgeons National Surgical Quality Improvement Program targeted open AAA database was queried for all rAAAs. Patient characteristics, presentation, aneurysm details, and operative details were analyzed to identify factors that may affect outcome in this population of patients. RESULTS: We identified 404 patients who underwent open repair of rAAA. The average age was 72 ± 9.4 years, and 76.2% were male. There were 230 (56.9%) patients who presented with hypotension. The operative approach was retroperitoneal in 16.3% of cases. The proximal extents of the aneurysms were infrarenal (52.5%), juxtarenal (24.3%), pararenal (4.2%), and suprarenal (8.2%). The distal extents were aortic (38.6%), common iliac artery (34.2%), and external or internal iliac artery (8.9%). Renal, visceral, and lower extremity revascularization was performed in 6.4%, 2.2%, and 7.9% of patients, respectively. Thirty-day mortality was 35.6%, and postoperative complications included cardiac (18.3%), pulmonary (42.3%), wound complications (6.7%), acute renal failure (17.3%), and ischemic colitis (9.4%). Postoperative length of stay was 13.1 ± 12.7 days, and 30-day readmission was 4.5%. Predictors of 30-day mortality were transperitoneal approach (odds ratio [OR], 3.3; 95% confidence interval [CI], 1.38-7.89; P < .001), hypotension at presentation (OR, 2.03; 95% CI, 1.2-3.56; P = .007), and age (OR, 1.05; 95% CI, 1.02-1.09; P = .001). Transperitoneal approach also increased the risk of postoperative cardiac complications (OR, 3.25; 95% CI, 1.01-10.4; P = .047). Postoperative pulmonary complications were predicted by chronic obstructive pulmonary disease (OR, 2.06; 95% CI, 1.07-3.94; P = .03) and hypotension at presentation (OR, 1.77; 95% CI, 1.06-2.96; P = .03). CONCLUSIONS: The majority of contemporary open rAAA repairs were performed for infrarenal aneurysms. Transperitoneal approach, hypotension, and chronic obstructive pulmonary disease were associated with higher mortality and postoperative complications. Thirty-day mortality after rAAA was lower compared with historical data.


Subject(s)
Aortic Aneurysm, Abdominal/surgery , Aortic Rupture/surgery , Practice Patterns, Physicians' , Vascular Surgical Procedures , Aged , Aged, 80 and over , Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/mortality , Aortic Rupture/diagnostic imaging , Aortic Rupture/mortality , Comorbidity , Databases, Factual , Female , Hospital Mortality , Humans , Hypotension/mortality , Logistic Models , Male , Middle Aged , Multivariate Analysis , Odds Ratio , Postoperative Complications/etiology , Postoperative Complications/mortality , Pulmonary Disease, Chronic Obstructive/mortality , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome , United States , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/methods , Vascular Surgical Procedures/mortality
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