ABSTRACT
OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) has emerged as a viable option of treatment for uncomplicated type B aortic dissection (UTBAD) due to the potential for inducing favorable aortic remodeling. The aim of this study is to compare outcomes of UTBAD treated medically or with TEVAR in either the acute (1 to 14 days) or subacute period (2 weeks to 3 months). METHODS: Patients with UTBAD between 2007 and 2019 were identified using the TriNetX Network. The cohort was stratified by treatment type (medical management; TEVAR during the acute period; TEVAR during the subacute period). Outcomes including mortality, endovascular reintervention, and rupture were analyzed after propensity matching. RESULTS: Among 20,376 patients with UTBAD, 18,840 were medically managed (92.5%), 1099 patients were in the acute TEVAR group (5.4%), and 437 patients were in the subacute TEVAR group (2.1%). The acute TEVAR group had higher rates of 30-day and 3-year rupture (4.1% vs 1.5%; P < .001; 9.9% vs 3.6%; P < .001) and 3-year endovascular reintervention (7.6% vs 1.6%; P < .001), similar 30-day mortality (4.4% vs 2.9%; P < .068), and lower 3-year survival compared with medical management (86.6% vs 83.3%; P = .041). The subacute TEVAR group had similar rates of 30-day mortality (2.3% vs 2.3%; P = 1), 3-year survival (87.0% vs 88.8%; P = .377) and 30-day and 3-year rupture (2.3% vs 2.3%; P = 1; 4.6% vs 3.4%; P = .388), with significantly higher rates of 3-year endovascular reintervention (12.6% vs 7.8%; P = .019) compared with medical management. The acute TEVAR group had similar rates of 30-day mortality (4.2% vs 2.5%; P = .171), rupture (3.0% vs 2.5%; P = .666), significantly higher rates of 3-year rupture (8.7% vs 3.5%; P = .002), and similar rates of 3-year endovascular reintervention (12.6% vs 10.6%; P = .380) compared with the subacute TEVAR group. There was significantly higher 3-year survival (88.5% vs 84.0%; P = .039) in the subacute TEVAR group compared with the acute TEVAR group. CONCLUSIONS: Our results found lower 3-year survival in the acute TEVAR group compared with the medical management group. There was no 3-year survival benefit found in patients with UTBAD who underwent subacute TEVAR compared with medical management. This suggests the need for further studies looking at the necessity for TEVAR when compared with medical management for UTBAD as it is non-inferior to medical management. Higher rates of 3-year survival and lower rates of 3-year rupture in the subacute TEVAR group compared with the acute TEVAR group suggest superiority of subacute TEVAR. Further investigations are needed to determine the long-term benefit and optimal timing of TEVAR for acute UTBAD.
Subject(s)
Aortic Aneurysm, Thoracic , Aortic Dissection , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Humans , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Treatment Outcome , Endovascular Procedures/adverse effects , Risk Factors , Retrospective Studies , Time Factors , Aortic Dissection/diagnostic imaging , Aortic Dissection/surgeryABSTRACT
OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) has become a mainstay of treatment for a variety of thoracic aortic pathologies. Expansion of the proximal aortic neck after endovascular repair of abdominal aortic aneurysms has been demonstrated; however, dilatation of the proximal aortic neck after TEVAR has not been well described. We sought to describe remodeling of the proximal neck following TEVAR. METHODS: This is a retrospective, single institution review of patients who underwent TEVAR for thoracic aortic aneurysm (TAA) and dissection with aneurysmal degeneration from 2010 to 2019. Postoperative computed tomography scans were reviewed and aortic diameter was measured in orthogonal planes using 3-dimensional centerline reconstruction software. The primary outcome was change in aortic diameter at the proximal aortic neck as compared to the initial postoperative computed tomography scan. Clinical and operative data were analyzed to identify factors associated with significant neck dilatation. RESULTS: Of 87 patients who underwent TEVAR during the study period, 30 met inclusion criteria. Median follow up was 20.5 months. Median age was 67 years, and 15 patients (50%) were female. The proximal aortic neck experienced an overall increase over time in aortic diameter. Five mm distal to the graft showed the greatest rate of expansion, with a median increase of 1.3, 2.9, and 6.2 mm at one year, two years, and three years, respectively. When comparing patients who had mean expansion at this location of >2.0 mm/year to patients who did not, a higher percentage had dissection pathology (81.8% vs. 31.6%, P = 0.008), had graft placement at aortic landing zone 2 (36.4% vs. 5.3%, P = 0.028), and were smokers (100% vs. 52.6%, P = 0.006). Higher percent oversizing was shown to be associated with significant aortic neck dilatation for true aneurysms only. CONCLUSIONS: Aortic neck dilatation occurs over time for the majority of patients following TEVAR with the distal neck experiencing the highest rate of expansion. Dissection pathology, aortic landing zone 2, and smoking were found to be associated with a higher rate of neck dilatation.
Subject(s)
Aorta, Thoracic/surgery , Aortic Aneurysm, Thoracic/surgery , Aortic Dissection/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Vascular Remodeling , Aged , Aortic Dissection/diagnostic imaging , Aortic Dissection/physiopathology , Aorta, Thoracic/diagnostic imaging , Aorta, Thoracic/physiopathology , Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/physiopathology , Aortography , Computed Tomography Angiography , Databases, Factual , Dilatation, Pathologic , Female , Humans , Male , Middle Aged , Retrospective Studies , Risk Assessment , Risk Factors , Smoking/adverse effects , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVES: Endovascular therapies are increasingly used in patients with complex multilevel disease and chronic limb-threatening ischemia (CLTI). Infrageniculate bypass with autologous vein conduit is considered the gold standard in these patients. However, many patients often lack optimal saphenous vein, leading to the use of nonautologous prosthetic conduit. We compared limb salvage and survival rates for patients with CLTI undergoing first time revascularization with either open nonautologous conduit or endovascular intervention. METHODS: We retrospectively reviewed consecutive patients undergoing first time endovascular or open surgical revascularization at our institution between 2009 and 2016. Patients were divided into endovascular intervention or open bypass with nonautologous conduit (NAC) cohorts. Primary endpoints were amputation-free survival (AFS), freedom from reintervention, primary patency, and overall survival. Propensity scoring was used to construct matched cohorts. Outcomes were evaluated using Kaplan-Meier and Cox Proportional Hazards models. RESULTS: A total of 125 revascularizations were identified. There were 65 endovascular interventions and 60 NAC bypasses. In unmatched analysis, there was an elevated risk of perioperative MI (7% vs. 0%, Pâ¯=â¯0.05) and amputation (10% vs. 2%, Pâ¯=â¯0.04) for the NAC groups compared to the endovascular group. In matched analysis, endovascular patients had a lower incidence of 30-day amputation (1.5% vs. 10% Pâ¯=â¯0.04) and length of stay (median days, 1 vs. 9, P < 0.01) compared to the open cohort. While not statistically significant, the endovascular group trended towards increased rates of two-year AFS (76% vs. 65%, Pâ¯=â¯0.07) compared to the NAC group. There was no significant difference in overall survival when the endovascular cohort was compared to NAC (85% vs. 77%, Pâ¯=â¯0.29) patients. In matched Cox analysis, nonautologous conduit use was associated with an increased risk of limb loss (HR 2.03, 95% CI 0.94-4.38, Pâ¯=â¯0.07) compared to endovascular revascularization. CONCLUSIONS: An "endovascular first" approach offers favorable perioperative outcomes and comparable AFS compared to NAC and may be preferable when autologous conduit is unavailable.
Subject(s)
Blood Vessel Prosthesis Implantation , Endovascular Procedures , Ischemia/surgery , Peripheral Arterial Disease/surgery , Aged , Amputation, Surgical , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/instrumentation , Blood Vessel Prosthesis Implantation/mortality , Chronic Disease , Clinical Decision-Making , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Endovascular Procedures/mortality , Female , Humans , Ischemia/diagnostic imaging , Ischemia/mortality , Limb Salvage , Male , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/mortality , Propensity Score , Risk Assessment , Risk Factors , Stents , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: The ability to ambulate following major lower extremity amputation, either below (BKA) or above knee (AKA), is a major concern for all prospective patients. This study analyzed ambulatory rates and risk factors for nonambulation in patients undergoing a major lower extremity amputation. METHODS: A retrospective review of 811 patients who underwent BKA or AKA at our institution between January 2009 and December 2014 was conducted. Demographic information and co-morbid conditions, including the patients' functional status prior to surgery, at 6 months, and at latest follow up were recorded. Following exclusion criteria, 538 patients were included. Patients who were either independent or used an assistive device were considered ambulatory, while those who were completely wheelchair-dependent or bed-bound were considered nonambulatory. RESULTS: Pre-operatively, 83.1% of BKA patients were ambulatory, significantly more so than those undergoing AKA (44.9%, P < 0.0001). At 6-month follow-up these percentages dropped to 58.0% and 25.2%, respectively, for all patients. For patients who were ambulatory pre-operatively, 182/246 (73.9%) of BKA and 32/51 (62.7%) of AKA remained so post-amputation. Of those patients with both 6-month and greater than 1-year follow-up, there was no change in ambulatory status between the 2 time periods. On multivariable logistic regression, age greater than 70 years and female sex were associated with nonambulation post-operatively (P = 0.001, P = 0.015, respectively). None of the co-morbid conditions recorded (diabetes, renal insufficiency, end-stage renal disease, peripheral vascular disease, or body mass index > 35) was found to have a statistically significant correlation with post-operative ambulation using multivariable analysis. CONCLUSIONS: The majority of ambulatory patients undergoing a major amputation were able to remain ambulatory. Patients who failed to ambulate 6 months after their amputation, failed to resume ambulating. Age greater than 70 and female sex were found to have a statistically significant association with becoming nonambulatory following surgery.
Subject(s)
Amputation, Surgical/adverse effects , Dependent Ambulation , Lower Extremity/surgery , Mobility Limitation , Aged , Aged, 80 and over , Female , Functional Status , Humans , Male , Middle Aged , Recovery of Function , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
Patients suspected of having an acute aortic syndrome in the ED typically undergo CT of the chest/abdomen/pelvis. However, the overwhelming majority of these exams are negative. With the help of clinical decision support, we implemented a new radiologist monitored 'aortic dissection screening protocol' that forgoes routine abdominopelvic imaging in order to reduce radiation dose without compromising diagnostic accuracy. The purpose of the present study is to assess the performance of this protocol. A retrospective analysis was performed to study the effect of the dissection screening protocol on the diagnostic yield, radiation and contrast dose on a total of 835 ED patients who underwent CT scans for suspected aortic dissection over a 48-week study period immediately before and after implementation of the protocol. 3.4% (28/835) of examinations were positive for an acute aortic syndrome over the 48-week study period with no difference in positivity before and after implementation of the 'aortic dissection screening' protocol, 3.0% vs. 3.7%, respectively (pâ¯=â¯0.57). There was a 14.6% reduction in median radiation dose and a 16% decrease in contrast volume utilization for the total ED population who underwent CT for aortic dissection using any protocol in the period after implementation of the 'aortic dissection screening' protocol. Aortic dissection CT in the ED is negative in the overwhelming majority of cases. A monitored 'aortic dissection screening' protocol that initially images the chest only significantly reduced contrast and radiation dose without reducing diagnostic accuracy for ED patients who underwent CT for aortic dissection.
Subject(s)
Aortic Dissection/diagnostic imaging , Computed Tomography Angiography , Aged , Antineoplastic Combined Chemotherapy Protocols , Aortography , Contrast Media , Cytarabine , Decision Support Systems, Clinical , Female , Humans , Male , Middle Aged , Radiation Dosage , Radiation Exposure , Retrospective Studies , Thioguanine , Tomography, X-Ray Computed/methodsABSTRACT
BACKGROUND: With increased focus on the opioid crisis, it was our goal to describe rates and risk factors for postoperative use of opioids in patients undergoing abdominal aortic aneurysm (AAA) repair as well as identify pain modalities that are underutilized. METHODS: We retrospectively analyzed perioperative analgesic prescriptions for endovascular (EVAR) and open AAA repair between January 1, 2010 and January 1, 2018. Patients' baseline opioid use, demographics, and medical comorbidities were obtained. The EVAR group was further subdivided into percutaneous (pEVAR) and cutdown (cEVAR) groups. Primary outcomes were postoperative and discharge pain medication prescriptions. Relative rates of opioid prescribing were obtained through the electronic medical record and normalized into morphine milligram equivalents (MMEs). RESULTS: Of the 128 patients analyzed in the entire cohort, 21.8% (n = 28) underwent open repair and 78.12% (n = 100) underwent EVAR (46 pEVAR, 54 cEVAR). As expected, open repair had increased postoperative pain reported compared to EVAR (2.67 ± 0.75 vs. 0.96 ± 0.19, P < 0.01). Adjunctive epidural reduced postoperative pain for open repair (0.77 ± 0.48 vs. 3.50 ± 0.96, P < 0.01). EVAR had less postoperative opioid prescriptions compared to open repair (35.0% vs. 77.3%, P < 0.01). In the endovascular group, there was no difference between postoperative opioid prescription based on access, pEVAR versus cEVAR (65.8% vs. 80.1%, P = 0.11). When stratifying patients by number of cutdowns, patients with bilateral cutdown as opposed to a single cutdown received more opioid prescriptions than pEVAR patients (84.44% vs. 65.8%, P = 0.036). Of those receiving opioids, the average MME for open repair was 320.94 mg compared to 28.82 mg for EVAR (P < 0.01). Those undergoing percutaneous repair had significantly less MME use during hospitalization compared to femoral cutdown (17 ± 3.52 vs. 31.90 ± 5.43 mg, P < 0.01). Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and ketorolac, were rarely used in the postoperative period for open or EVAR (8.3% vs 1.1%). Percutaneous EVAR patients reported less pain at discharge compared to cEVAR patients (0.18 ± 0.12 vs. 0.88 ± 0.29, P = 0.036). Open and EVAR had comparable low rates of NSAID and acetaminophen prescriptions at discharge. Open patients had longer postoperative length of stay compared to EVAR patients (9.82 ± 1.27 vs. 3.86 ± 0.47, P < 0.01). pEVAR had a shorter length of postoperative course compared to cEVAR (3.2 ± 0.26 vs. 4.12 ± 0.30, P < 0.01). Patients undergoing EVAR with use of pain medications amounting to <20 MME had a significantly shorter length of stay. CONCLUSIONS: This single institutional retrospective study evaluated pain prescription patterns for patients undergoing AAA repair. AAA patients are predominantly treated with opioid pain medications with few adjunctive therapies. Intraoperative epidural and pEVAR may aid in decreasing the total MME used; however, the total number of opioids prescribed is similar for pEVAR and cEVAR despite the difference in approach. Clinicians must consider alternative nonopioid based pain management strategies.
Subject(s)
Analgesics, Opioid/administration & dosage , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation/adverse effects , Endovascular Procedures/adverse effects , Health Services Misuse , Pain, Postoperative/prevention & control , Practice Patterns, Physicians' , Aged , Aged, 80 and over , Drug Utilization , Female , Humans , Length of Stay , Male , Pain, Postoperative/diagnosis , Pain, Postoperative/etiology , Retrospective Studies , Time Factors , Treatment OutcomeABSTRACT
BACKGROUND: The U.S. Preventive Services Task Force (USPSTF) guidelines are the most widely used criteria for screening for abdominal aortic aneurysms (AAA). However, when the USPSTF criteria are applied retrospectively to a group of patients who have undergone treatment for AAA, there are many patients who satisfy none of the AAA screening criteria. The more sensitive Society for Vascular Surgery (SVS) guidelines have expanded the criteria for screening for AAA with the hope of capturing a greater fraction of those individuals who can undergo treatment for their AAA before presenting with AAA rupture. We sought to identify the number of patients who would have been identified as having criteria for screening for AAA by both the USPSTF and SVS criteria, in a cohort of patients who have undergone treatment for AAA. METHODS: We assessed demographic, comorbidity, and perioperative complication data for all patients undergoing endovascular and open AAA repair in the Vascular Quality Initiative. Patients meeting each of the screening criteria were identified. Clinical factors and demographic variables were collected. RESULTS: We identified 55,197 patients undergoing AAA repair in the Vascular Quality Initiative, including 44,602 patients who underwent endovascular aneurysm repair (EVAR) and 10,595 patients undergoing open repair. Of these, the USPTF guidelines would have identified fewer than one-third of patients (32% EVAR and 33% open repair). Applying the SVS guidelines increased the number meeting criteria for screening by 6% and 12% for the EVAR and open repair cohorts, respectively. Finally, adoption of the expanded SVS guidelines (including the "weak recommendations") would have identified an additional 34% of EVAR patients and 21% of open AAA repair patients. Use of the expanded criteria would have resulted in 27% of patients undergoing EVAR and 33% of patients undergoing open AAA repair who would not have met any screening criteria. In EVAR patients not meeting the criteria, 52% were younger than 65 years had a history of heavy smoking. Of all those who did not meet screening criteria, ruptured AAA was twice as prevalent as those who met screening criteria (8.5% vs 4.4%; P ≤ .0001). CONCLUSIONS: Expanding established USPSTF screening guidelines to include the expanded SVS criteria may potentially double the number of patients identified with AAA. Smokers under the age of 65, and elderly patients 70 and older with no smoking history, represent two groups with AAA and potentially twice the risk of presenting with rupture.
Subject(s)
Aortic Aneurysm, Abdominal/diagnostic imaging , Decision Support Techniques , Mass Screening/standards , Practice Guidelines as Topic/standards , Ultrasonography/standards , Age Factors , Aged , Aortic Aneurysm, Abdominal/epidemiology , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Canada/epidemiology , Clinical Decision-Making , Endovascular Procedures , Female , Guideline Adherence/standards , Humans , Male , Middle Aged , Non-Smokers , Predictive Value of Tests , Prevalence , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Smokers , Smoking/adverse effects , Smoking/epidemiology , United States/epidemiologyABSTRACT
BACKGROUND: The aim of this study is to evaluate the performance and predictors of failure of paclitaxel drug-eluting stents and paclitaxel-coated balloons in the treatment of long-segment femoropopliteal disease. We report a retrospective cohort analysis of patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in lesions >100 mm, which were not included in any of the pivotal trials. METHODS: Ninety-seven patients with peripheral vascular disease (Rutherford III-VI) underwent long-segment (≥100 mm) femoropopliteal drug-eluting stent (DES) implantation or angioplasty with drug-coated balloons (DCB). Patients were followed after their initial procedure for target lesion restenosis, defined as a reduction in lumen diameter by greater than 50% as measured by duplex ultrasonography (ratio >2). RESULTS: The median length of the affected arterial segments was 110 mm (interquartile range [IQR] 100-150, absolute range 100-260) using up to 4 overlapping stents. During the median 13-month follow-up (IQR 7-16), no early thrombotic occlusions occurred within 30 days, but 28 (29%) patients developed a target lesion restenosis after 1 year. Cumulative primary patency at 6 and 12 months was 87% and 71% overall, respectively. The cumulative patency during the same follow-up periods varied between patients treated with different paclitaxel modalities with 88% and 80% primary patency in patients treated with DES (n = 63) versus 81% and 49% in patients treated with DCB (n = 21) (adjusted hazard ratio 2.46, P = 0.03). Lesion length, concurrent tibial intervention, and recurrent target lesions were not associated with restenosis. CONCLUSIONS: Short-term outcomes in patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in long lesions, mirror results from the clinical trials. The primary patency observed in patients treated with DES was significantly higher than in patients treated with DCB.
Subject(s)
Angioplasty, Balloon/instrumentation , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Drug-Eluting Stents , Femoral Artery/physiopathology , Ischemia/therapy , Paclitaxel/administration & dosage , Peripheral Arterial Disease/therapy , Popliteal Artery/physiopathology , Vascular Patency , Aged , Angioplasty, Balloon/adverse effects , Cardiovascular Agents/adverse effects , Critical Illness , Databases, Factual , Female , Femoral Artery/diagnostic imaging , Humans , Ischemia/diagnostic imaging , Ischemia/physiopathology , Male , Middle Aged , Paclitaxel/adverse effects , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Popliteal Artery/diagnostic imaging , Prosthesis Design , Recurrence , Retrospective Studies , Time Factors , Treatment OutcomeSubject(s)
Clinical Competence , Education, Medical, Graduate , Internship and Residency , Quality Indicators, Health Care , Surgeons/education , Vascular Surgical Procedures/education , Attitude of Health Personnel , Cost-Benefit Analysis , Curriculum , Health Care Costs , Health Knowledge, Attitudes, Practice , Humans , Quality Indicators, Health Care/economics , Surgeons/economics , Surgeons/psychology , Vascular Surgical Procedures/economics , WorkloadABSTRACT
OBJECTIVE: The aim of this study was to evaluate the performance of paclitaxel-eluting stents (PESs) and paclitaxel-coated balloons (PCBs) on amputation-free survival in patients with critical limb ischemia (CLI). METHODS: A retrospective review of all patients with Rutherford stage 5 and 6 limb ischemia undergoing endovascular revascularization with paclitaxel-related technology, both PES and PCB, was carried out over a 4-year period. Clinical grading was determined by Rutherford classification and the Society for Vascular Surgery's Wound, Ischemia, and foot Infection (WIfI) scoring system. Clinical and angiographic follow-up was reviewed based on intention-to-treat analysis. The primary endpoint of this study was amputation-free survival at 12 months. Secondary endpoints included wound healing, freedom from target lesion revascularization, and patency of target vessels at 12 months. Follow-up occurred at 3, 6, and 12 months postoperatively. Target lesion patency was defined as <50% stenosis, based on a duplex velocity ratio of less than or equal to 2. Postoperative ankle-brachial index (ABI) and duplex ultrasound were performed to verify successful treatment. Outcomes were evaluated using Kaplan-Meier and Cox proportional-hazards models. RESULTS: A total of 88 limbs were revascularized in 88 patients. Drug-eluting stent (DES) was used as the sole drug technology in 56 patients (60.7% men, median age 70.5 years) and drug-coated balloon (DCB) was used as the sole drug technology in 32 patients (46.9% men, median age 66 years). Baseline demographics were well matched except for a higher prevalence of occluded target lesions in the DES group (41.1% vs. 12.5%; P = 0.004). Limbs were treated for Rutherford stage 5 CLI in 71.6% and stage 6 CLI in 28.4%. Univariate analysis identified no dependent factors affecting limb salvage, except for the use of DCBs. After 12 months of follow-up, amputation-free survival was significantly higher in the DES group than in the DCB group (88.5% vs. 71.1%; P = 0.0443). Wound healing rates after 1 year were also higher in the DES group (83.9% vs. 59.4%; P = 0.0198). Freedom from target lesion revascularization was no different between patients treated with DESs and patients treated with DCBs (90.6% vs. 85.7%; P = 0.518). Primary patency at 12 months in patients treated with DESs was significantly higher than in patients treated with PCBs (80.4% vs. 58.1%; P = 0.0255). CONCLUSIONS: Overall, drug technology represents a viable option for patients with CLI; a cohort not represented in major randomized trials. In our experience, femoropopliteal lesions treated with DESs have higher primary patency rates than those treated with DCBs. This was found to support higher amputation-free survival rates in patients treated with paclitaxel DESs than those treated with paclitaxel DCB. The use of paclitaxel DESs for CLI was also associated with significantly improved wound healing compared with DCBs. Our data suggest improved outcomes with DESs compared with DCBs; however, these patients represent a nonrandomized, heterogenous group that were treated with the operator's best judgment.
Subject(s)
Amputation, Surgical , Angioplasty, Balloon/instrumentation , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Drug-Eluting Stents , Ischemia/therapy , Paclitaxel/administration & dosage , Peripheral Arterial Disease/therapy , Vascular Access Devices , Aged , Amputation, Surgical/adverse effects , Amputation, Surgical/mortality , Angioplasty, Balloon/adverse effects , Angioplasty, Balloon/mortality , Cardiovascular Agents/adverse effects , Clinical Decision-Making , Critical Illness , Female , Humans , Ischemia/diagnosis , Ischemia/mortality , Limb Salvage , Male , Middle Aged , Paclitaxel/adverse effects , Patient Selection , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/mortality , Progression-Free Survival , Prosthesis Design , Retrospective Studies , Risk Factors , Time Factors , Vascular PatencySubject(s)
Arteriovenous Shunt, Surgical/economics , Blood Vessel Prosthesis Implantation/economics , Health Care Costs , Medicare Access and CHIP Reauthorization Act of 2015/economics , Physician Incentive Plans/economics , Reimbursement, Incentive/economics , Renal Dialysis/economics , Arteriovenous Shunt, Surgical/legislation & jurisprudence , Blood Vessel Prosthesis Implantation/legislation & jurisprudence , Health Care Costs/legislation & jurisprudence , Humans , Medicare Access and CHIP Reauthorization Act of 2015/legislation & jurisprudence , Physician Incentive Plans/legislation & jurisprudence , Policy Making , Reimbursement, Incentive/legislation & jurisprudence , United StatesSubject(s)
Arteriovenous Shunt, Surgical/economics , Blood Vessel Prosthesis Implantation/economics , Episode of Care , Health Care Costs , Medicare Access and CHIP Reauthorization Act of 2015/economics , Renal Dialysis/economics , Arteriovenous Shunt, Surgical/adverse effects , Arteriovenous Shunt, Surgical/legislation & jurisprudence , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/legislation & jurisprudence , Health Care Costs/legislation & jurisprudence , Humans , Medicare Access and CHIP Reauthorization Act of 2015/legislation & jurisprudence , Renal Dialysis/adverse effects , United StatesABSTRACT
BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is an important life-saving modality for patients with cardiopulmonary failure. Vascular complications, including clinically significant limb ischemia, may occur as a result of femoral artery cannulation for venoarterial (VA) ECMO. This study examines our institutional experience with femoral VA ECMO and the development of ipsilateral limb ischemia. METHODS: We performed a retrospective review of all consecutive patients undergoing femoral VA ECMO between 2011 and 2016. The primary endpoint was clinical evidence of limb-threatening ischemia. Multivariate logistic regression analysis was used to identify predictors for limb ischemia after cannulation. RESULTS: Between March 2011 and September 2016, 154 patients underwent femoral cannulation for VA ECMO. Overall in-hospital mortality was 59.7%. Clinically significant ipsilateral limb ischemia occurred in 34 (22%) patients; 7 required four-compartment fasciotomy, and 3 of these patients required amputation. On univariate analysis, a history of pulmonary disease, peripheral arterial disease, and stroke or transient ischemic attack was significantly associated with clinical limb ischemia. On multivariate analysis, younger age (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.93-0.99), diabetes (OR, 2.77; 95% CI, 1.08-7.12), pulmonary disease (OR, 3.86; 95% CI, 1.38-10.78), and peripheral arterial disease (OR, 13.68; CI, 2.75-68.01) were associated with limb ischemia. Lack of prophylactic distal perfusion catheter and arterial cannula size were not independently associated with limb ischemia. CONCLUSIONS: Femoral ECMO cannulation can be associated with significant limb ischemia necessitating surgical intervention. Younger patients, as well as those with a history of diabetes, pulmonary disease, and peripheral arterial disease, may be at increased risk for this complication.
Subject(s)
Catheterization, Peripheral/adverse effects , Extracorporeal Membrane Oxygenation/adverse effects , Femoral Artery , Ischemia/etiology , Lower Extremity/blood supply , Adult , Age Factors , Aged , Catheterization, Peripheral/mortality , Comorbidity , Extracorporeal Membrane Oxygenation/mortality , Female , Femoral Artery/physiopathology , Femoral Artery/surgery , Hospital Mortality , Humans , Ischemia/mortality , Ischemia/physiopathology , Ischemia/surgery , Male , Middle Aged , Punctures , Regional Blood Flow , Retrospective Studies , Risk Factors , Treatment OutcomeABSTRACT
BACKGROUND: The objective of the study was to analyze causes and outcomes of malpractice claims against vascular surgeons in the United States. METHODS: Cases entered into the Westlaw database from January 1, 1999 to December 31, 2014 were reviewed. Search terms "vascular" and "surgeon" were used. Data were compiled on the allegation, subject matter, and outcome of each case. Additional data including demographics of the defendant were obtained from the U.S. News Health reports on practicing physicians. RESULTS: Of a total of 785 cases identified from the Westlaw database using the search terms "vascular" and "surgeon", 485 (61.8%) were identified where a vascular surgeon was the defendant or expert witness. Of these, 135 (27.8%) had a vascular surgeon identified as a defendant. Among these 135 cases, 88 (65.2%) were found for the defendant with 31 (23%) and 15 (11.1%) being found for the plaintiff or settled, respectively. Of the 31 cases found for the plaintiff, the median award was $750,000 and mean award was $1,830,000. Mean time from incident to verdict was 4.8 years. The most common procedures which led to litigation were open or endovascular peripheral revascularization (PR) (14.8%), carotid interventions (CIs) (11.85%), aortic interventions (AI) (11.1%), vascular trauma (9.63%), dialysis access (8.15%), and venous surgery (5.93%). The most common allegation was "failure to diagnose and treat" (48.9%), followed by complication of open surgery (31.85%) and negligent procedure (25.19%). The most common injuries reported were death (31.85%), major amputation (23.7%), neurovascular injury (14.8%), and bleeding (5.9%). CONCLUSIONS: Analysis of vascular surgery malpractice litigation in the Westlaw database revealed details regarding the subject matter and outcomes of these cases. Through this closed claims analysis, the most common procedures leading to litigation were found to be PR, CI, and AI and not thoracic outlet syndrome procedures as commonly believed. Furthermore, the most common allegations were a "failure to diagnose and treat" and "open surgical complication". Analysis of the salient features and outcomes in these cases can provide a framework for heightened awareness of issues which lead to malpractice claims and can ultimately improve patient care and safety.
Subject(s)
Compensation and Redress/legislation & jurisprudence , Insurance, Liability/legislation & jurisprudence , Malpractice/legislation & jurisprudence , Medical Errors/legislation & jurisprudence , Professional Misconduct/legislation & jurisprudence , Surgeons/legislation & jurisprudence , Vascular Surgical Procedures/legislation & jurisprudence , Databases, Factual , Humans , Insurance, Liability/economics , Malpractice/economics , Medical Errors/economics , Patient Safety/legislation & jurisprudence , Risk Assessment , Surgeons/economics , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/economics , Vascular Surgical Procedures/mortalitySubject(s)
Centers for Medicare and Medicaid Services, U.S./economics , Endovascular Procedures/economics , Health Care Costs , Ischemia/economics , Ischemia/therapy , Peripheral Vascular Diseases/economics , Peripheral Vascular Diseases/therapy , Reimbursement Mechanisms/economics , Vascular Surgical Procedures/economics , Endovascular Procedures/classification , Humans , Ischemia/classification , Ischemia/diagnosis , Peripheral Vascular Diseases/classification , Peripheral Vascular Diseases/diagnosis , Time Factors , Treatment Outcome , United States , Vascular Surgical Procedures/classificationABSTRACT
BACKGROUND: The aim of this study was to analyze malpractice litigation trends and to better understand the causes and outcomes of suits involving inferior vena cava filters (IVCF) to prevent future litigation and improve physician education. METHODS: Jury verdict reviews from the Westlaw database from January 1, 2000, to December 31, 2015, were reviewed. The search term "inferior vena cava filter" was used to compile data on the demographics of the defendant, plaintiff, allegation, complication, and verdict. RESULTS: A total of 156 cases were identified. Duplicates and cases in which the IVCF was incidentally included were excluded from the analysis. Forty-nine cases involving either failure to place or a complication of IVCF placement were identified. Throughout the last 15 years, there has been increased number of jury verdicts toward IVCF. The most frequent defendants were internal medicine physicians (38%), vascular surgeons (19%), and cardiothoracic surgeons (12%). The most frequent claims were denied treatment or delay in treatment (in 35% of cases), negligent surgery (in 24% of cases), and failure to diagnose and treat complications (in 24% of cases). Of these, the most frequent specific claims were failure to place IVC filter (41%), implantation failure such as misplacement and/or misaligned implant (24%), erosion of IVC/retroperitoneal bleed (6%), and discontinuation of anticoagulation prematurely (6%). Seventeen cases (35%) were found for the plaintiff, with median awards worth of $1,092,500. In the 21 cases where pulmonary embolism (PE) was involved (43% of cases), 19 were fatal (90%). Of the fatal PE cases, 8 cases ended with verdicts in favor of the plaintiff (42%). Both nonfatal PE cases were won by the defense. CONCLUSIONS: IVCF placement with subsequent PE and death results in verdicts that favor the plaintiffs. This study emphasizes that adequate and transparent communication regarding preoperative planning, decision for IVCF placement, and informed consent may reduce the frequency of litigation. Public awareness of complications related to the placement of IVCF is increasing largely and spurned by aggressive advertising and marketing by plaintiff attorneys. Conditions for which IVCF placement is contemplated carry significant risk of malpractice litigation.
Subject(s)
Insurance, Liability/legislation & jurisprudence , Malpractice/legislation & jurisprudence , Medical Errors/legislation & jurisprudence , Postoperative Complications , Prosthesis Implantation/legislation & jurisprudence , Time-to-Treatment/legislation & jurisprudence , Vena Cava Filters , Compensation and Redress/legislation & jurisprudence , Delayed Diagnosis/legislation & jurisprudence , Humans , Insurance, Liability/economics , Malpractice/economics , Medical Errors/economics , Postoperative Complications/diagnosis , Postoperative Complications/economics , Postoperative Complications/mortality , Postoperative Complications/therapy , Prosthesis Implantation/adverse effects , Prosthesis Implantation/economics , Prosthesis Implantation/instrumentation , Risk Factors , Time-to-Treatment/economics , Vena Cava Filters/adverse effects , Vena Cava Filters/economicsABSTRACT
OBJECTIVE: The unplanned 30-day readmission rate is a marker of quality of patient care across many disciplines. Data regarding risk factors for unplanned readmission after major lower extremity amputation (LEA) are limited. We evaluated predictors of readmission at our institution after major LEA. METHODS: We conducted a retrospective review of all patients undergoing above-knee amputation (AKA) or below-knee amputation (BKA) between November 2009 and November 2014. Patient demographic variables were collected. Predictors of unplanned 30-day readmission and stump complications were determined by multivariable logistic regression. RESULTS: A total of 811 patients were identified (AKA, 325; BKA, 486). Of these, 739 patients were included in the final analysis after excluding 30-day decedents without readmission. The overall 30-day readmission rate was 28.8% (AKA 27.9%; BKA 29.4%; P = .730). Stump complications accounted for 28.6% of readmissions (16.5% of AKA; 35.8% of BKA; P = .004). Other common diagnoses included nonsurgical site infection (33.8%), exacerbation of congestive heart failure (7.0%), and diabetes-related complications (6.1%). Surgical intervention was performed on 61% of stump complications (35.9% of AKA readmitted with stump complications; 68.7% of BKA readmitted with stump complications). BKA stump complications were converted to AKAs in 34.1% of cases (3.2% of the total BKA). None of the AKA stump complications required a higher level of amputation (ie, hip disarticulation). Independent predictors of all 30-day readmission included coronary artery disease and end-stage renal disease. American Society of Anesthesiologists class 3 as compared with class 4 was protective. Independent predictors of 30-day readmission for stump complications included rest pain and BKA. Patients who underwent BKA, rest pain as an indication for amputation, and having an occluded bypass graft were predictors of having a stump complication requiring surgery. CONCLUSIONS: The 30-day readmission rate after major LEA is high, with wound infections accounting for a significant proportion of these readmissions. There was no difference in readmission rates based on level of amputation. Those undergoing BKA were more likely to present with stump complications requiring a surgical intervention, and often a higher level of amputation. Identification of high-risk patients may play a role in reducing postoperative readmissions and stump complications.