Ovarian hyperstimulation syndrome as a cause of acute limb ischemia.

Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic condition that can cause significant morbidity and mortality. Patients may present with a range of symptoms, including abdominal pain and distention, nausea, and vomiting that can rapidly progress to hemodynamic instability, renal failure, severe electrolyte derangements, thromboembolism, large-volume ascites, pleural effusion, and respiratory failure. We present a case of an 18-year-old woman who developed OHSS after egg donation with subsequent lower-extremity arterial thrombosis and compartment syndrome requiring fasciotomy and vascular intervention. Thus, knowledge and rapid recognition of OHSS are vital in improving patient outcomes.

Thyroid storm obscured by acute asthma exacerbation and concurrent H1N1 influenza.

We present an uncommon case of H1N1 triggered thyroid storm in a patient with previously undiagnosed Grave's Disease. This case illustrates the challenges of diagnosing thyroid storm in the emergency department and the importance of including it in the differential when treating more common diagnoses that fail to respond to usual therapies. Thyroid storm is an endocrinologic emergency and requires prompt recognition and treatment. However, it remains a diagnostic challenge as there is no laboratory test specific to thyroid storm. Diagnosis relies on clinical suspicion in corroboration with patient presentation, laboratory findings and response to therapy.

Traumatic Pneumoperitoneum After Vaginal Intercourse.

OBJECTIVES: Pneumoperitoneum with peritonitis, although uncommon, is a serious injury encountered in the pediatric emergency department. Although the patients may often appear ill or toxic, they can have normal vital signs at initial presentation. Patients with such injury can present with a variety of complaints because of the nature of referred pain. As a result, some patients may be more or less straightforward, thus illustrating the importance of obtaining a detailed history and performing a thorough physical examination. METHODS: We discuss an uncommon case report of pneumoperitoneum with peritonitis in an adolescent patient presenting with vaginal bleeding and abdominal pain hours after vigorous coitus. RESULTS: Examination under anesthesia, flexible sigmoidoscopy, and exploratory laparoscopy revealed a vaginal laceration and a 2- to 3-cm perforated area at the left edge of the vaginal laceration that involved the rectovaginal septum entering the peritoneal cavity. CONCLUSIONS: Pneumoperitoneum resulting from vaginal intercourse in an otherwise healthy adolescent female is a rare cause of peritonitis. Although it has been described in the adult literature, this case illustrates the importance of considering sexual history as a contributory factor in pediatric patients presenting with an acute abdomen.

Refinement of anatomic indications for the Nellix System for endovascular aneurysm sealing based on 2-year outcomes from the EVAS FORWARD IDE trial.

BACKGROUND: The Nellix System (Endologix, Inc, Irvine, Calif) for endovascular aneurysm sealing (EVAS) is a novel approach to abdominal aortic aneurysm treatment and conceptually different from endovascular aneurysm repair, whereby polymer is employed to fill and actively manage the abdominal aortic aneurysm sac. One-year safety and effectiveness results of the Nellix pivotal trial demonstrated encouraging outcomes with very low morbidity and mortality and high procedural and treatment success. Two-year imaging revealed a signal of migration, leading to a field safety notification issued by the manufacturer on October 21, 2016, and a dedicated root cause analysis, resulting in refinements to the instructions for use (IFU). We report the 2-year results of the investigational device exemption pivotal trial stratified according to the new and original criteria for selection of patients. METHODS: Comprehensive engineering evaluations, statistical analyses, and clinical assessments were conducted looking at patients enrolled in the pivotal trial (N = 150), roll-in cohort (N = 29), and continued access program (N = 154). All patients in all cohorts were treated on-IFU at the time of enrollment. Logistic regression models supported the mechanism that migration with Nellix is associated with a small aortic flow lumen relative to a large aneurysm thrombus burden and large aortic neck diameters. Based on these findings, refinements to the IFU criteria were applied, excluding patients with a thrombus index (maximum aneurysm sac/maximum flow lumen diameter) >1.4, aortic neck diameter >28 mm, and aortic neck conicity (>10% diameter change along the infrarenal neck) and requiring a 10-mm distal seal zone in the iliac artery. RESULTS: Freedom from all-cause mortality at 2 years was 94%. Patient outcomes were then stratified on the refined morphologic criteria and analyzed retrospectively. Two-year freedom from composite endoleak was high among both cohorts (95% on-IFU vs 92% off-IFU). Freedom from migration was 97.7% on-IFU vs 93.2% off-IFU (P = .0125). Freedom from aneurysm enlargement was 98.1% on-IFU vs 93.5% off-IFU (P value is not available because of failure of log-rank test assumptions). Composite freedom from migration, type IA endoleak, or aneurysm expansion was 95.9% among the on-IFU cohort vs 85.1% in the off-IFU cohort (P = .0017). CONCLUSIONS: Consistent with the introduction of a novel therapy, the presentation of failure modes of EVAS over time was inevitable. Using detailed imaging as well as engineering and statistical analysis, we were able to understand risk factors for adverse events specific to EVAS and defined those patients best suited for Nellix. With this EVAS-specific approach to defining IFU, on-IFU patients were identified as those with large aneurysms with little thrombus that would be prone to type II endoleaks and sac expansion with traditional devices. When treated with Nellix, these patients were predicted to experience exceptional results, especially with regard to a low composite endoleak rate and low all-cause mortality.

One-year pivotal trial outcomes of the Nellix system for endovascular aneurysm sealing.

OBJECTIVE: The Nellix EndoVascular Aneurysm Sealing (EVAS) System (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) treatment whereby polymer is used to fill the AAA sac. We report 1-year results of the investigational device exemption pivotal trial. METHODS: Eligible patients were treated at 30 sites in the United States and Europe. Inclusion criteria required an asymptomatic infrarenal AAA, with a neck length ≥10 mm and ≤60° angle, iliac artery blood lumen diameter 9 to 35 mm, access artery diameter ≥6 mm, and serum creatinine ≤2 mg/dL. Follow-up included computed tomography angiography scans at 30 days, 6 months, and 1 year that were evaluated by a core laboratory. The primary safety end point was 30-day major adverse events (MAEs), which were compared with a performance goal of <56% (the Society for Vascular Surgery open repair control group rate). The primary effectiveness end point was treatment success at 1 year, which was compared with a performance goal of >80%. Treatment success required procedural technical success and absence of AAA rupture during follow-up, conversion to open surgical repair, endoleak (type I or III) at 1 year, migration >10 mm causing complications or requiring secondary intervention, aneurysm enlargement, or secondary procedures through 1 year for resolution of endoleak, device obstruction or occlusion, or device defect. RESULTS: Of 150 treated patients, 149 (99.3%) completed 1-year follow-up. The MAEs rate at 30 days was 2.7% (95% confidence interval, 0.7%-6.7%), satisfying the primary safety end point (<56%). The 1-year treatment success was 94% (95% confidence interval, 88.6%-97.4%), achieving the primary effectiveness end point (>80%). At 1 year, key secondary outcomes included 6.7% MAEs, 4.7% serious device-related events, 1.3% AAA-related mortality, 3.7% secondary interventions, and 0.7% surgical conversions. MAEs through 1 year included death (n = 6), stroke (n = 3), bowel ischemia (n = 2), renal failure (n = 2), respiratory failure (n = 2), and myocardial infarction (n =1). One iatrogenic AAA rupture occurred and one AAA rupture was reported during follow-up. AAA sac enlargement (>5 mm) was 1.5% at 1 year. Endoleaks were present in four patients (3.1%) at 1 year (1 type Ib and 3 type II). Migration >10 mm occurred in three patients (2.3%), but none required secondary intervention. CONCLUSIONS: Outcomes with this novel endovascular therapy for AAA, the Nellix EVAS System, are encouraging. The primary safety and effectiveness end points have been met. Low morbidity, low mortality, and high procedural and treatment success were achieved despite the inevitability of a learning curve and unique risks associated with a new device and technique. Long-term follow-up is in progress.

Motor Vehicle Collision Secondary to Ventricular Dysrhythmia: A Case Report of Brugada Syndrome.

BACKGROUND: Brugada syndrome is a genetic disorder that increases an individual's risk for sudden cardiac death and ventricular dysrhythmias that was first described by the Brugada brothers in 1992. Brugada syndrome is characterized by an atypical electrocardiogram pattern that includes a bundle branch block and ST-segment elevation in the precordial leads. CASE REPORT: A 74-year-old man had a cardiac arrest at the time of a low-speed motor vehicle collision. When emergency medical services arrived, the patient was in torsades de pointes. After resuscitation and return of spontaneous circulation, the patient was transferred to a Level I trauma center. He was ultimately diagnosed with Brugada syndrome after exclusion of traumatic injuries. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: Brugada syndrome is still considered a "cannot miss" diagnosis in the emergency department, whether a patient presents with or without symptoms. In the mixed setting of trauma as a result of cardiac arrest, accurate diagnosis can be difficult due to the "chicken or the egg" dilemma.

Extreme anemia (hemoglobin 1.8 g/dL) secondary to colon cancer.

We present the case of a 34-year-old man who presented to the emergency department with complaints of generalized fatigue and palpitations, with a heart rate of approximately 100 beats per minute and an orthostatic blood pressure of 80/30 mm Hg upon standing. A hemoglobin of 1.8 g/dL was discovered. A positive fecal occult blood test led to the diagnosis of colon cancer. Once the cancer was resected, the patient's anemia resolved.

Mortality After Nontraumatic Major Amputation Among Patients With Diabetes and Peripheral Vascular Disease: A Systematic Review.

High mortality rates have been reported after major amputations of a lower limb secondary to diabetes and peripheral vascular disease. However, the mortality rates have varied across studies. A systematic review of the 5-year mortality after nontraumatic major amputations of the lower extremity was conducted. A data search was performed of Medline using OVID, CINHAL, and Cochrane, 365 abstracts were screened, and 79 full text articles were assessed for eligibility. After review, 31 studies met the inclusion and exclusion criteria. Overall, the 5-year mortality rate was very high among patients with any amputation (major and minor combined), ranging from 53% to 100%, and in patients with major amputations, ranging from 52% to 80%. Mortality after below-the-knee amputation ranged from 40% to 82% and after above-the-knee amputation from 40% to 90%. The risk factors for increased mortality included age, renal disease, proximal amputation, and peripheral vascular disease. Although our previous systematic review of the 5-year mortality after ulceration had much lower rates of death, additional studies are warranted to determine whether amputation hastens death or is a marker for underlying disease severity.

Surgical management of carotid body tumors: a 15-year single institution experience employing an interdisciplinary approach.

Cervical paragangliomas are rare neoplasms that arise from extraadrenal paraganglia in close association with the cranial nerves and extracranial arterial system of the head and neck, and therefore surgical extirpation can be challenging. A retrospective study was conducted of all patients undergoing surgical excision of a cervical paraganglioma between 2000 and 2015. The demographic characteristics, clinical features, surgical approach, and outcomes were reviewed. A total of 20 cervical paragangliomas were excised in 17 patients. There were 14 female and 3 male patients with a mean age of 56.6 ± 17.0 at the time of operation. Twelve patients had unilateral tumors and 5 patients had bilateral tumors. Familial involvement was confirmed by history or direct genetic analysis in 8 (47%) of the 17 patients. There were no malignant paragangliomas, and only 3 patients had tumors that were determined to be functional. Tumor size ranged from 1.3 to 6.0 cm. Two patients required combined arterial resection as part of complete excision of the tumor. There were no permanent operative cranial nerve injuries, no recurrences, minimal morbidity, and no mortality. In conclusion, optimal management of cervical paragangliomas should include a thorough preoperative evaluation, accurate definition of the surgical anatomy, and exclusion of synchronous paragangliomas. A combined therapeutic approach by a multidisciplinary team including surgeons and interventional radiologists provides safe and effective management of cervical paragangliomas with very low morbidity and excellent outcomes.

Results of the Nellix system investigational device exemption pivotal trial for endovascular aneurysm sealing.

OBJECTIVE: The Nellix EndoVascular Aneurysm Sealing system (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) endovascular repair whereby biocompatible polymer is employed to exclude and to seal the AAA sac. We report 30-day results of the U.S. pivotal trial. METHODS: Consecutive, eligible, consenting patients were enrolled at 29 sites in the United States and Europe. Inclusion criteria required an asymptomatic infrarenal AAA, with aortic neck length ≥10 mm and angle to the sac ≤60 degrees, aortic neck diameter of 18 to 32 mm, aneurysm blood lumen diameter ≤6 cm, common iliac artery lumen diameter of 9 to 35 mm, access artery diameter ≥6 mm, and serum creatinine level ≤2 mg/dL. Follow-up at 30 days included clinical assessment and computed tomography angiography evaluation of endoleaks and device integrity as assessed by a core laboratory. The primary safety end point is the incidence of independently adjudicated 30-day major adverse events (MAEs), with success defined as superiority with reference to the Society for Vascular Surgery open repair control group (56%). RESULTS: Between January and November 2014, 150 trial patients having a mean AAA diameter of 5.8 cm were enrolled and treated with the Nellix system with 100% procedural success. One early death (0.7%) occurred secondary to multisystem organ failure. All 149 surviving patients completed 30-day follow-up. There were no aneurysm ruptures, conversions, limb thromboses, stent fractures, or stent kinking. Five early MAEs occurred in four patients (2.7%) and included one death, bowel ischemia (1), renal failure (2), and respiratory failure (1). One (0.7%) secondary intervention to treat inadvertent coverage of a renal artery was performed. The core laboratory identified nine (6%) endoleaks (one type I, eight type II) on 30-day computed tomography angiography. Freedom from MAE was 97.3% (95% confidence interval, 93.3%-99.0%). CONCLUSIONS: In selected patients, perioperative outcomes with the Nellix system for endovascular aneurysm sealing are encouraging, with very low 30-day morbidity and mortality and high procedural success. The primary safety end point has been achieved. Longer term follow-up is in progress.

The impact of foot ulceration and amputation on mortality in diabetic patients. I: From ulceration to death, a systematic review.

A great deal of emphasis, clinical and financial, is placed on limb salvage efforts in diabetic patients suffering from lower extremity ulceration. This is because of the impression that amputation in such patients may be a proximal cause of death. While amputation is certainly a negative clinical outcome, it is not entirely clear that it causes death. In this systematic review, we examine the available literature to attempt to understand the role that the ulceration itself may play in mortality. In brief, we searched for human studies in OVID, CINAHL and the COCHRANE CENTRAL DATABASE from 1980 to 2013, looking for articles related to ulcer or wound of the foot, in patients with diabetes or peripheral vascular disease, and death. We looked for articles with 5 years of follow-up, or Kaplan-Meier estimates of 5-year mortality, and excluded reviews and letters. Articles were assessed for quality and potential bias using the Newcastle-Ottawa scale. We find that while the patient populations studied varied widely in terms of demographics and comorbidities, limiting generalisability, 5-year mortality rates after ulceration were around 40%. Risk factors for death commonly identified were increased age, male gender, peripheral vascular disease and renal disease.

Endovascular aortoiliac aneurysm repair: surgical progress through new treatment paradigms and innovative endograft design.

Effective treatment for patients with an abdominal aortic aneurysm (AAA) began more than 50 years ago through the development of prosthetic grafts, which were used to replace aneurysmal segments of diseased arteries. Open surgical repair of AAAs became the gold standard for treating this disease. In 1999, two device manufacturers received US Food and Drug Administration approval for their endovascular aneurysm repair (EVAR) devices to treat selected patients with AAA. During the next 10 years, multiple other EVAR devices received US Food and Drug Administration approval, and, now, EVAR rivals open surgical repair as the standard for treating aortoiliac aneurysm disease. The purpose of this article is to outline advances in the device technology used for EVAR procedures, identify historical progress of treatment options, recognize complications after EVAR, describe improvements in device design, and specify related nursing implications.

The management of chronic venous insufficiency with ulceration: the role of minimally invasive perforator interruption.

BACKGROUND: The purpose of this study was to analyze the long-term outcomes associated with interruption of incompetent perforator veins (IPV) using minimally invasive techniques as adjunctive therapies in the management of patients with chronic venous insufficiency (CVI). METHODS: This is a retrospective review of a prospectively maintained venous database collected over 6 years (2005-2011). The study cohort included 64 patients with CVI stage C5 or C6 who underwent minimally invasive perforator interruption with subfascial endoscopic perforator surgery (SEPS) or radiofrequency ablation of IPV (RFA-IPV) as part of the management of their CVI. All patients were referred for evaluation after having failed conservative treatment with compression dressings. Relevant patient characteristics and comorbidities were recorded along with symptom resolution, venous ulcer healing, recurrence, and surgical complications. In addition to clinic follow-up examination by a surgical provider, chart notes from other subspecialties were also reviewed. We also conducted telephone assessments in patients who had been lost to clinic follow-up in order to provide complete outcome data. RESULTS: In this subset (n = 64) of patients with CVI who had adjunctive IPV treatment, 41 (64%) underwent SEPS and 23 (36%) patients underwent RFA-IPV along with ablation of the greater saphenous vein for C5 or C6 disease. The mean patient follow-up was 37 months. There were no differences in patient demographics or risk factors. Twenty-three (88%) SEPS and 12 (100%) RFA-IPV patients (P = NS) with C6 disease went on to completely heal their venous ulcers after the procedure with an average healing time of 5.2 (SEPS) and 4.4 (RFA-IPV) months (P = NS). Overall, 7 (17%) SEPS and 6 (23%) RFA-IPV patients (P = NS) developed a recurrent ulcer after surgical treatment. Procedural complications were seen in 14 (34%) SEPS and 2 (9%) RFA-IPV patients (P = NS), mostly minor. Major complications only occurred in the SEPS group consisting of 2 major amputations caused by pain from nonhealing ulcers and 1 deep venous thrombosis. CONCLUSIONS: This study supports the premise that in patients with advanced venous disease, there may be a demonstrable benefit directly attributable to perforator interruption. Our recurrent ulceration rates are acceptable, with low complication rates in patients undergoing RFA-IPV, thereby making this procedure more attractive in patients with multiple comorbidities. We support an aggressive approach to patients with C5/C6 disease that includes perforator elimination when appropriate.

Limitations of current EVAR endografts and potential solutions for their deficiencies.

All current endovascular aneurysm repair (EVAR) devices have defined limitations that prevent the endovascular therapist from using them to treat all forms of aortoiliac aneurysm disease. Short, angulated infrarenal aortic neck pathology, occlusive disease in iliac access arteries, need for preservation of important branch vessel arterial flow, endograft migration, and endoleak all represent major impediments for successful EVAR. Need for secondary intervention after EVAR in a significant number of patients has detracted from universal acceptance for this therapy. New devices in manufacturers' pipelines may provide solutions for many of the current EVAR device deficiencies. As these new devices become more complex, meticulous patient follow-up to verify anticipated outcomes and new training paradigms for the future endovascular therapist will be required.

Influence and critique of the PIVOTAL and the EVAR 2 Trials.

Management of a condition that has potentially life-threatening consequences may not lend itself effectively to the scrutiny of a randomized clinical trial when an observation or no treatment option is offered as part of the trial. This type of trial often experiences a significant rate of crossover of subjects from no treatment to treatment, and when results are analyzed on an intent-to-treat basis, they may fail to resolve the issue under study. These trials are frequently used as Level 1 medical evidence and the potential impact on clinical decision-making and reimbursement can be quite significant and long-lasting. The authors observed this phenomenon during participation in the Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL) trial and have observed it in an analysis of the Endovascular Aneurysm Repair 2 (EVAR 2) trial. Possible solutions to mitigate the high crossover effect are offered for consideration. Some clinical conditions dealing with potentially life-threatening problems probably do not lend themselves to be studied in randomized prospective clinical trials containing an observation or no treatment arm.

One year outcomes of the United States regulatory trial of the Endurant Stent Graft System.

OBJECTIVE: To report the 1-year outcomes of the United States (US) regulatory trial of the Endurant Stent Graft System (Medtronic Vascular), a new device for the treatment of abdominal aortic aneurysms (AAA). METHODS: This was a prospective, single arm, multicenter trial conducted at 26 sites in the US. From April 2008 to May 2009, 150 patients with AAA were treated with the Endurant bifurcated stent graft. The main inclusion criteria were an AAA diameter >5 cm, proximal neck length ≥ 10 mm, bilateral iliac fixation length ≥ 15 mm, and a neck angulation of ≤ 60 degrees. A clinical events committee (CEC) adjudicated all adverse events except blood loss, and a core laboratory reviewed all imaging. The primary safety endpoint was freedom from major adverse events at 30 days, and the primary effectiveness endpoint was successful aneurysm treatment at 12 months. RESULTS: One hundred forty-nine patients (99.3%) had a successful stent graft implant, 83.3% under general anesthesia. One failure was due to inability to cannulate the contralateral gate. One patient developed a neck rupture during the procedure, but was still treated successfully. Patients were predominantly male (91.3%), elderly (mean age, 73.1 years) with significant comorbidities. Mean estimated blood loss was 185 mL (range, 0-1450 mL), with blood transfusion required in one patient. Average hospital stay was 2.1 days. At 1 month, the major adverse events rate was only 4% with no operative mortality. Serious adverse events were recorded in 43 of 150 (28.7%) patients. Cardiac (8.7%), fever (6%), urological (4.7%), pulmonary (4%), and vascular events (4%) were the most frequent. Through 12 months of follow up, there were no migrations, ruptures, or conversions. No type I or III endoleaks were identified during the first year. Fifteen of 129 patients (11.6%) had endoleaks at 6 months and 13 of 130 (10%) at 1 year, all type II except for one indeterminate endoleak. One Type II endoleak proved to be a Type IB on later angiography. Ten aneurysm related reinterventions were performed during the first year of follow up, mostly for limb thrombosis or stenosis (5) or for type II endoleak (2). Four of the procedures were endovascular. Aneurysm sac diameter decreased >5 mm at 1 year in 47% of patients and remained stable in 53%. No sac showed an increase of >5 mm. None of seven late deaths (range, 90-458 days post-implant) was adjudicated to be aneurysm related. CONCLUSION: Early results of the Endurant pivotal trial are quite encouraging and suggest a safe and effective new device for the treatment of abdominal aortic aneurysms.