ABSTRACT
OBJECTIVE: Percutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals. METHODS: The DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease. Prespecified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization) at 1 year. RESULTS: We enrolled 202 patients at 32 sites with 200 treated with the DETOUR system. The mean lesion length was 32.7 cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety end point was met with a 30-day freedom from major adverse event rate of 93.0%. The 1-year primary effectiveness end point was met with 72.1% primary patency at 12 months. Primary-assisted and secondary patency were 77.7% and 89.0%, respectively, at 12 months. The 12 month deep venous thrombosis incidence was 4.1% with no pulmonary emboli reported. Venous quality-of-life scores showed no significant changes from baseline. There was a Rutherford improvement of at least one class through 12 months in 97.2% of patients. The mean ankle-brachial index also improved from 0.61 to 0.95 during this period. There were marked improvements in quality-of-life and functional status measures. CONCLUSIONS: The DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.
Subject(s)
Femoral Artery , Peripheral Arterial Disease , Popliteal Artery , Vascular Patency , Humans , Popliteal Artery/surgery , Popliteal Artery/physiopathology , Popliteal Artery/diagnostic imaging , Femoral Artery/surgery , Femoral Artery/physiopathology , Femoral Artery/diagnostic imaging , Peripheral Arterial Disease/surgery , Peripheral Arterial Disease/physiopathology , Peripheral Arterial Disease/diagnostic imaging , Male , Female , Aged , Prospective Studies , Time Factors , Middle Aged , Treatment Outcome , Endovascular Procedures/adverse effects , Endovascular Procedures/instrumentation , Quality of Life , Risk FactorsABSTRACT
OBJECTIVE: Atherectomy has become commonplace as an adjunct to interventional treatments for peripheral arterial disease, but the procedures have been complicated by risks including distal embolization and arterial perforation. This study aimed to examine the safety and effectiveness of a novel atherectomy system to treat femoropopliteal and below-knee peripheral arterial disease. METHODS: The Revolution Peripheral Atherectomy System (Rex Medical LP, Conshohocken, Pa) was studied in 121 patients with 148 femoropopliteal and below-knee lesions, enrolled at 17 United States institutions. Technical success was defined when the post-atherectomy angiographic stenosis was ≤50%, as assessed by an independent core laboratory. Major adverse events were adjudicated by an independent Clinical Events Committee. RESULTS: Among 148 site-identified target lesions in 121 patients, 21.4% were in the superficial femoral artery, 13.7% involved the popliteal artery, and 67.9% were in tibial arteries; 3.1% involved more than one segment. Technical success was 90.2%, with stenoses decreasing from 73% ± 19% at baseline to 42% ± 14% after atherectomy. Adjunctive treatment after atherectomy included angioplasty with uncoated balloons in 91%, drug-coated balloons in 11%, bare stent deployment in 8%, and drug-eluting stent placement in 3%. Procedural success (<30% residual stenosis) was achieved in 93.7% of target lesions. Complications during the procedure included one target vessel perforation and two distal embolizations; each of which were adjudicated by the Clinical Events Committee as unrelated to the device and were not visualized angiographically by the core laboratory. Freedom from major adverse events was 97.3% through 30 days. The Kaplan-Meier estimates of primary, assisted primary, and secondary patency were 81.6%, 87.7%, and 91.6% at 6 months, respectively. CONCLUSIONS: The use of the Revolution Peripheral Atherectomy System was associated with few procedural complications and a high rate of success at the index procedure and through 6 months.
Subject(s)
Atherectomy/instrumentation , Femoral Artery , Peripheral Arterial Disease/therapy , Popliteal Artery , Tibial Arteries , Aged , Aged, 80 and over , Angiography , Atherectomy/adverse effects , Equipment Design , Female , Femoral Artery/diagnostic imaging , Femoral Artery/physiopathology , Humans , Male , Middle Aged , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/physiopathology , Popliteal Artery/diagnostic imaging , Popliteal Artery/physiopathology , Prospective Studies , Tibial Arteries/diagnostic imaging , Tibial Arteries/physiopathology , Time Factors , Treatment Outcome , United States , Vascular PatencyABSTRACT
Britain's unexpected vote to leave the European Union (Brexit) in June 2016 has proved divisive and damaging both within the United Kingdom and internationally. Across two correlational studies, the current research proposed a model to explain the Brexit vote, with attitudes to immigration and willingness to disagree (WD) as direct predictors of the referendum result, and internal (IMS) and external (EMS) motivation to respond without prejudice as indirect predictors. Study 1 (N = 353) and Study 2 (N = 363) both showed good fit with the model and, respectively, explained 48% and 46% of the referendum result. More positive attitudes to immigration predicted a vote to remain. Higher IMS and lower EMS predicted a vote to remain, fully mediated by attitudes to immigration. In Study 1, lower WD also predicted a vote to remain, both directly and indirectly via attitudes to immigration, although this was not replicated in Study 2. These results are discussed both in relation to the Brexit result, and the implications for motivation to respond without prejudice, WD, and political correctness more generally.
Subject(s)
Attitude , Emigration and Immigration , Motivation , Politics , Prejudice , Adolescent , Adult , Aged , Aged, 80 and over , European Union , Female , Humans , Male , Middle Aged , Surveys and Questionnaires , United Kingdom , Young AdultABSTRACT
We describe a case of an intraductal mucoepidermoid carcinoma arising from a minor salivary gland of the oral cavity. This is a rare presentation, and our literature review identified only a single previously documented case. To the best of our knowledge, this is the first reported case to be verified by immunohistochemistry demonstrating myoepithelial or basal cells around all the neoplastic units.
Subject(s)
Carcinoma, Mucoepidermoid , Salivary Gland Neoplasms , Salivary Glands, Minor , Humans , ImmunohistochemistryABSTRACT
BACKGROUND: Pleomorphic adenomas occurring in the adult nasopharynx are rare, with our literature search identifying only 11 previous English-language reports. We document the unusual case of a large nasopharyngeal pleomorphic adenoma that was resected using radiofrequency coblation via an endoscopic transnasal approach. METHODS: A 39-year-old male presented with worsening nasal congestion, intermittent otalgia, and a progressive change in voice. Flexible nasendoscopy showed a large homogeneous mass occupying the postnasal space, and computed tomography confirmed a 28 × 31 × 22 mm nasopharyngeal tumour. The biopsy-proven benign tumour was locally dissected using a coblator-assisted transnasal approach. RESULTS: Histology confirmed complete excision of a myoepithelial-rich pleomorphic adenoma. The patient was symptom-free postoperatively, and no signs of recurrence were seen at one-year follow-up. CONCLUSIONS: This is a useful addition to the existing literature on surgical procedures used to treat benign pathology in the nasopharynx. The minimally invasive technique was well tolerated and had favourable patient outcomes.
ABSTRACT
For individuals in exclusive romantic relationships, the dynamics of sexual experimentation are nuanced. Extradyadic behavior outside of a relationship may be perceived as cheating or infidelity, with much of those perceptions driven by the biological sex of the perceiver. This study significantly reframes seminal research on perceptions of cheating with third-party friends by Kruger et al. (2013), to further nuance an evolutionary threat-based model. In doing so, this furthers our understanding of the associated perceptions of individuals in heterosexual relationships when confronted by partners' cheating with their same-sex cross-orientation friends. Results indicate that perceptions of same-sex infidelity vary widely depending on the nature of the behaviors, with decreasing attribution given to sexual and erotic behaviors, close relational behaviors, and casual social interaction behaviors, respectively. Implications are discussed for a variety of sexual communities, as well as the impact of gender and relational status on perceptions of infidelity.
Subject(s)
Heterosexuality/psychology , Sexual Partners , Social Perception , Adolescent , Adult , Deception , Female , Friends , Humans , Male , Young AdultSubject(s)
Dentigerous Cyst/surgery , Mandibular Condyle/surgery , Mandibular Diseases/surgery , Masseter Muscle/surgery , Molar, Third/surgery , Parotid Gland/surgery , Tooth Eruption, Ectopic/surgery , Follow-Up Studies , Humans , Imaging, Three-Dimensional/methods , Male , Middle Aged , Radiography, Panoramic/methods , Surgical Flaps/surgery , Tomography, X-Ray Computed/methodsABSTRACT
BACKGROUND: Secondary hemorrhage after a dehisced vascular reconstruction is a dreaded complication, yet few reports describe the initial management and outcome of casualties with ruptured grafts from military wounds. We aimed to report a single-center experience of graft ruptures after evacuation of casualties to a tertiary hospital in the continental United States. METHODS: Trauma records of US combat casualties were retrospectively reviewed from April 2005 to August 2007. Casualties who underwent an extremity vascular reconstruction in Iraq or Afghanistan and experienced a ruptured graft were included. RESULTS: Ten graft ruptures (mean time, 14 days) occurred during the study period. All casualties were males with penetrating injuries by secondary blast effects (5, 50%) or gunshot wounds (5, 50%). Mean age and Injury Severity Score were 28.2 years (range, 20-41 years) and 21.1 (range 10-32), respectively. Repairs were performed on the superficial femoral (4, 40%), popliteal (2, 20%), brachial (1, 10%), axillary (1, 10%), iliac (1, 10%), and common femoral (1, 10%) arteries using reversed saphenous vein grafts (10, 100%). Initial management included control of hemorrhage and extra-anatomic reconstruction with a vein graft (4), prosthetic graft (4), end-to-end anatomosis (1), or primary amputation (1). Secondary complications in those 10 limbs requiring reintervention included 4 thrombotic graft failures (40%), and 1 transfemoral amputation from a graft infection. Ruptures were frequently associated with long-bone fractures (6, 60%), large soft tissue open wounds (5, 50%) and infection (7, 70%). At a mean follow-up of 37 months, the amputation rate in this series was 30%, with an amputation-free survival of 70%. CONCLUSION: Contaminated military wounds with bony fractures may predispose a graft of any type (vein or prosthetic) to anastomotic dehiscence. Wounds must be carefully debrided, and when grafts cannot be covered with viable muscle, they should be routed around the zone of injury. LEVEL OF EVIDENCE: Therapeutic study, level V.
Subject(s)
Blood Vessel Prosthesis , Blood Vessels/injuries , Extremities/injuries , Hemorrhage/surgery , Military Personnel , Vascular Surgical Procedures/methods , Wounds, Penetrating/surgery , Adult , Extremities/blood supply , Follow-Up Studies , Hemorrhage/etiology , Humans , Iraq War, 2003-2011 , Male , Prosthesis Failure , Reoperation , Retrospective Studies , Time Factors , United States , Young AdultABSTRACT
Damage control surgery with the principles of expeditious control of hemorrhage and contamination, followed by predominant crystalloid resuscitation in the intensive care unit has saved the lives of many severely injured trauma patients. Unfortunately, crystalloid resuscitation has too often led to worsening of coagulopathy in the setting of vascular injury. The recent conflicts in Iraq and Afghanistan have created injured patients with severe vascular injury and massive soft tissue destruction creating early and profound coagulopathy associated with high rates of mortality. An alternative strategy, known as damage control resuscitation, with the principal resuscitation of a 1:1 ratio of packed red blood cells and fresh frozen plasma has been developed during these conflicts. This method is associated with decreased mortality and improved limb salvage in military and civilian trauma patients.
Subject(s)
Blood Component Transfusion , Military Medicine , Resuscitation , Vascular System Injuries/therapy , Afghan Campaign 2001- , Coagulants/administration & dosage , Erythrocyte Transfusion , Factor VIIa/administration & dosage , Humans , Iraq War, 2003-2011 , Limb Salvage , Resuscitation/adverse effects , Resuscitation/methods , Resuscitation/mortality , Treatment Outcome , Vascular System Injuries/blood , Vascular System Injuries/mortalityABSTRACT
OBJECTIVE: We evaluated the results of thoracic endovascular aneurysm repair (TEVAR) to determine what anatomic factors influenced the clinical outcomes. METHODS: Preoperative computed tomography (CT) angiograms of 65 patients who underwent TEVAR were analyzed using 3-dimensional imaging. The proximal and distal neck, thoracic aneurysm, and iliac arteries were measured for angulation, diameter, length, calcification, and tortuosity. Immediate technical success and clinical success were measured. RESULTS: Immediate technical success was achieved in 91% (59 of 65) of the patients analyzed. One patient died in the operating room during treatment of rupture. Clinical success was achieved in 83% (54 of 65) of patients at follow-up. Four patients had small endoleaks with no sac enlargement at follow-up. One patient was converted to open repair. Severe iliac calcification was found to be significant for deployment failure. The mean follow-up is 8 months (1-36 months). CONCLUSION: Increased iliac calcification and increased iliac tortuosity correlate with an inability to successfully deploy the device.
Subject(s)
Aortic Aneurysm, Thoracic/diagnostic imaging , Aortic Aneurysm, Thoracic/surgery , Aortography/methods , Blood Vessel Prosthesis Implantation , Tomography, X-Ray Computed , Aortic Aneurysm, Thoracic/mortality , Blood Vessel Prosthesis Implantation/adverse effects , Blood Vessel Prosthesis Implantation/mortality , Calcinosis/diagnostic imaging , Humans , Iliac Artery/diagnostic imaging , Imaging, Three-Dimensional , Predictive Value of Tests , Prosthesis Failure , Radiographic Image Interpretation, Computer-Assisted , Retrospective Studies , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
A 32-year-old man with Marfan syndrome presented with enlarging, asymptomatic bilateral subclavian artery aneurysms. He has an extensive surgical history including aortic arch and descending thoracic aorta replacement. The L aneurysm was treated first with an L carotid-vertebral artery vein bypass, aneurysm debranching, and stent-graft repair of aneurysm via the L brachial artery approach. The R aneurysm was treated by placing a stent graft from the proximal R common carotid artery across the R subclavian artery origin and landing in the prosthetic innominate bypass graft via an L common carotid artery conduit. An aneurysm debranching and R carotid-subclavian artery bypass completed the procedure. A proximal type I endoleak was detected in the R aneurysm sac on follow-up computed tomography angiography. This was treated with sternotomy, aorta to L common carotid artery bypass, stent graft removal, and oversewing of the R subclavian artery origin. The patient recovered uneventfully. Subclavian artery aneurysms are rarely diagnosed in patients with Marfan disease. Although durability remains unproven, hybrid repair should be considered in patients with subclavian artery aneurysms, to minimize the morbidity commonly associated with open repair.
Subject(s)
Aneurysm/surgery , Marfan Syndrome/complications , Subclavian Artery/surgery , Adult , Aneurysm/diagnostic imaging , Aneurysm/etiology , Blood Vessel Prosthesis , Blood Vessel Prosthesis Implantation/instrumentation , Carotid Artery, Common/surgery , Device Removal , Humans , Ligation , Male , Prosthesis Failure , Reoperation , Saphenous Vein/transplantation , Stents , Sternotomy , Subclavian Artery/diagnostic imaging , Tomography, X-Ray Computed , Treatment Outcome , Vascular Surgical Procedures/adverse effects , Vascular Surgical Procedures/instrumentation , Vertebral Artery/surgeryABSTRACT
OBJECTIVE: We reviewed our institution's experience with carotid artery pseudo-occlusion (CAPO), to investigate whether internal carotid artery (ICA) end-diastolic velocity (EDV) as measured by duplex ultrasonography, was a predictor of need for further intervention. METHODS: From February 2003 to January 2008, 7478 patients underwent duplex ultrasonographic evaluation of their carotid arteries. Diagnosis of CAPO included the appearance of a narrow flow jet (string sign) on power doppler images, low velocities in the ICA and additional criteria listed below. RESULTS: Ten patients (0.13%) were identified as having a CAPO. All patients were asymptomatic and had an EDV<78 cm/s. Occlusion or functional occlusion was identified in nine patients on contrast imaging studies. Eight of these patients were treated medically without neurologic complication on follow-up. Two patients were treated with interventions and were asymptomatic at follow up. The mean follow up for the entire group was 12 months. CONCLUSIONS: Although this is a low volume study, there is evidence to suggest that asymptomatic patients with low EDV in the setting of carotid artery pseudo-occlusion found of duplex, may be safely managed medically.
Subject(s)
Carotid Artery, Internal/diagnostic imaging , Carotid Stenosis/diagnostic imaging , Ultrasonography, Doppler, Color , Aged , Aged, 80 and over , Blood Flow Velocity , Carotid Artery, Internal/physiopathology , Carotid Stenosis/physiopathology , Carotid Stenosis/therapy , Female , Humans , Male , Middle Aged , Predictive Value of Tests , Radiography , Regional Blood Flow , Retrospective Studies , Treatment OutcomeABSTRACT
Popliteal artery injury is a known but rare complication of elective orthopedic procedures. This case report describes the diagnosis and treatment of a popliteal artery pseudoaneurysm and arteriovenous fistula after a tibial lengthening osteotomy in a 7-year-old boy.