Ongoing Medical Therapy Research Articles

Patient-centered decision making: the role of the baseline SNOT-22 in predicting outcomes for medical management of chronic rhinosinusitis.

For patients with chronic rhinosinusitis (CRS), the decision to elect continued medical management vs surgery is complex and involves tradeoffs between benefits, risks, and overall effectiveness of each therapy. The purpose of this study is to investigate whether baseline disease-specific quality of life (QOL) can assist in predicting outcomes in patients with refractory CRS who elect continued medical management. CRS patients electing medical management were enrolled in a prospective, multi-institutional cohort study. Patients were stratified into pretreatment 22-item Sino-Nasal Outcome Test (SNOT-22) subgroups based on 10-point score increments (eg, 10 to 19, 20 to 29, 30 to 39, etc.) to capture potential outcome differences by baseline SNOT-22 disease burden. The proportion of patients achieving minimal clinically important difference (MCID≥9 points) and relative improvement (%) for each score category were calculated. Seventy-five CRS patients with a mean ± standard deviation pretreatment SNOT-22 score of 45.2 ± 16.6 were followed for a mean of 14.9 months. The majority of participants electing medical therapy failed to improve 1 MCID (57%) with a mean relative score improvement of 16%. Overall, 37% of patients maintained baseline SNOT-22 QOL status, whereas 20% of patients deteriorated >1 MCID. When treatment crossover patients (to endoscopic sinus surgery [ESS]) were included (n = 117), approximately 1 in 4 (27%) patients achieved an MCID. Results from this study suggest that the majority of CRS patients electing ongoing medical management with low baseline disease-specific QOL impairment maintain stable QOL with continued medical management. Furthermore, of CRS patients electing ongoing medical therapy, approximately 1 in 4 patients achieved MCID, whereas 1 in 5 experienced deterioration by >1 MCID.

Dietary modifications for refractory chronic rhinosinusitis? Manipulating diet for the modulation of inflammation.

An endotype of chronic rhinosinusitis (CRS) refractory to medical and surgical management is characterized by persistent T-helper 1/T-helper 17 inflammation of the sinus mucosa, which potentially facilitates colonization with dysbiotic microbial flora. Dietary interventions that target reduction of systemic inflammation are increasingly recommended as adjuncts to ongoing medical therapy in chronic disorders with a strong inflammatory component, such as cardiac disease, diabetes, and metabolic syndrome. Inflammation-reducing dietary modifications may thus be of benefit in patients with refractory CRS (RCRS). To identify nonpharmacologic approaches that implicate modification of dietary factors, potentially reducing systemic level of inflammation in RCRS. A systematic review of the literature was undertaken to identify dietary strategies for reducing inflammation in metabolic syndrome, diabetes, and cardiac disease. Mechanistic-based strategies for reducing systemic inflammation were identified and categorized to identify potential therapeutic avenues, which would be applicable to RCRS. Principal mechanisms for altering inflammation at the systemic level via dietary manipulation center around (1) increased consumption of foods with anti-inflammatory properties, and (2) modulation of the gut microbiome to reduce short-chain fatty acid secretion by dysbiotic gut flora. Recommended dietary modifications to reduce systemic markers of inflammation or to improve RCRS include alteration of macronutrient intake, alterations in consumption of meat and fats, consumption of prebiotics and probiotics, and a low-salicylate diet in the context of aspirin-exacerbated respiratory disease. Dietary modifications may offer a potential nonpharmacologic means of reducing inflammation in patients with RCRS and hence may represent a complementary adjunct to existing medical therapies. Additional prospective studies are required to further validate the concept of dietary modifications in patients with RCRS to support the findings.

Surgical Management of Epilepsy in Adolescent Patients

Surgery for the treatment of medically refractory epilepsy remains one of the most effective yet underutilized therapies in all of medicine. The pediatric and adolescent patient population, in particular, stands to benefit from early intervention to achieve the goal of seizure freedom. As per emerging guidelines from the International League Against Epilepsy, patients who now fail as few as two anti-epileptic medication trials should be referred to a surgical epilepsy center for evaluation. For these individuals, surgical intervention has been shown to offer a substantially higher rate of seizure-freedom and improved quality of life, as compared with ongoing medical therapy alone. In this context, we review here the clinical approach to medically intractable epilepsy, including the pre-operative evaluation and surgical options. Our report summarizes several resective surgical strategies including lesionectomy, temporal lobectomy and extra-temporal lobectomy, in addition to hemispherectomy techniques. We also provide an overview of several palliative surgical options, including corpus callosotomy, vagus nerve stimulation and responsive neurostimulation. We then close with a brief discussion of emerging techniques for the minimally invasive surgical epilepsy management. Overall, we advocate for early referral in the pediatric and adolescent population to a comprehensive epilepsy program to establish candidacy for surgical intervention, and we conclude that surgery is safe and effective for the management of epilepsy patients afflicted with medically refractory seizures.

Renal Artery Stenosis: Optimal Therapy and Indications for Revascularization.

Atherosclerotic renal artery stenosis (ARAS) is associated with increased cardiovascular risk and overall mortality. Manifestations of ARAS include resistant or malignant hypertension, progressive deterioration of renal function, and cardiac dysfunction syndromes of flash pulmonary edema and angina. Diagnosis rests upon non-invasive studies such as duplex ultrasonography and is confirmed using invasive renal arteriography. Regardless of the severity of ARAS, management of this entity has been a topic of contentious debate. For over two decades, the use of percutaneous revascularization to treat ARAS has been studied with various clinical trials. Though case series seem to demonstrate favorable clinical response to revascularization, the overwhelming majority of randomized clinical trials have not mirrored a robust outcome. In these trials, poor correlation is noted between the reduction of stenosis and the improvement of renovascular hypertension and glomerular filtration rate, and decrease in cardiovascular outcomes and mortality. With dichotomizing results, the explanation for these discrepant findings has been attributed to improper trial design and inappropriate patient selection. An overview of the treatment options available will be provided, with a focus on the methodology and design of clinical trials investigating the efficacy of percutaneous revascularization. Emphasis is placed on appropriate patient selection criteria, which may necessitate the use of hemodynamic lesion assessment and clinical correlation based on individualized care. When clinical equipoise exists between optimal medical therapy and revascularization, the current paradigm supports ongoing medical therapy as the treatment of choice. However, renal artery stenting remains a viable therapeutic option for those who continue to have clinical syndromes consistent with renal hypoperfusion while adequately treated with optimal medical therapy. Despite observational studies suggesting clinical benefit for this specific patient population, there remains a paucity of randomized clinical trial data. Further trials targeting the patients who are inadequately treated with optimal medical therapy need to be undertaken to confirm the efficacy of revascularization.

Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy.

Increased sympathetic and decreased parasympathetic activity contribute to heart failure (HF) symptoms and disease progression. Carotid baroreceptor stimulation (baroreflex activation therapy, BAT) results in centrally mediated reduction of sympathetic and increase in parasympathetic activity. Because patients treated with cardiac resynchronization therapy (CRT) may have less sympathetic/parasympathetic imbalance, we hypothesized that there would be differences in the response to BAT in patients with CRT vs. those without CRT. New York Heart Association (NYHA) Class III patients with an ejection fraction (EF) ≤35% were randomized (1 : 1) to ongoing guideline-directed medical and device therapy (GDMT, control) or ongoing GDMT plus BAT. Safety endpoint was system-/procedure-related major adverse neurological and cardiovascular events (MANCE). Efficacy endpoints were Minnesota Living with Heart Failure Quality of Life (QoL), 6-min hall walk distance (6MHWD), N-terminal pro-brain natriuretic peptide (NT-proBNP), left ventricular ejection fraction (LVEF), and HF hospitalization rate. In this sample, 146 patients were randomized (70 control; 76 BAT) and were 140 activated (45 with CRT and 95 without CRT). MANCE-free rate at 6 months was 100% in CRT and 96% in no-CRT group. At 6 months, in the no-CRT group, QoL score, 6MHWD, LVEF, NT-proBNP and HF hospitalizations were significantly improved in BAT patients compared with controls. Changes in efficacy endpoints in the CRT group favoured BAT; however, the improvements were less than in the no-CRT group and were not statistically different from control. BAT is safe and significantly improved QoL, exercise capacity, NTpro-BNP, EF, and rate of HF hospitalizations in GDMT-treated NYHA Class III HF patients. These effects were most pronounced in patients not treated with CRT.

Survey-Defined Patient Experiences With Aspirin-Exacerbated Respiratory Disease

Aspirin-exacerbated respiratory disease (AERD) is a chronic illness of progressive recurrent sinus disease with nasal polyps and asthma. No population-based comprehensive surveys of patients with AERD have been carried out to assess specific quality-of-life impact or perceptions of treatment benefit. This survey analyzed perceptions and quality of life in those living with AERD and queried patient observations of treatment effectiveness. The survey assessed whether dietary and nutritional support was used to manage AERD, and if so, whether there was a perceived benefit. This survey was publicized through clinics that treat patients with AERD, Web sites, and online blogs. Results are reported for 190 patients. Most subjects reported an adverse effect of AERD on quality of life. Chronic nasal symptoms followed by decreased sense of smell were reported to have the greatest impact on quality of life—in 81 (43%) and 74 (39%), respectively. Those who lost their ability to smell (n = 65; 34%) reported that they missed the enjoyment of food and eating the most. A minority indicated that a combination of medications (aspirin, leukotriene receptor antagonist, zileuton, or omalizumab) was more effective than 1 alone. Of those surveyed, 120 (63%) respondents felt that components of their diet contributed to their disease and 147 (77%) respondents reported having reactions after alcohol consumption. Patients with AERD live with frustration and report a poor quality of life in spite of several pharmacologic treatments including aspirin desensitization followed by daily aspirin. Despite ongoing medical therapy, the burden of disease in AERD remains high.

Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: Design and rationale of the ROADMAP clinical trial

Mechanical circulatory support is now a proven therapy for the treatment of patients with advanced heart failure and cardiogenic shock. The role for this therapy in patients with less severe heart failure is unknown. The objective of this study is to examine the impact of mechanically assisted circulation using the HeartMate II left ventricular assist device in patients who meet current US Food and Drug Administration-defined criteria for treatment but are not yet receiving intravenous inotropic therapy. This is a prospective, nonrandomized clinical trial of 200 patients treated with either optimal medical management or a mechanical circulatory support device. This trial will be the first prospective clinical evaluation comparing outcomes of patients with advanced ambulatory heart failure treated with either ongoing medical therapy or a left ventricular assist device. It is anticipated to provide novel insights regarding relative outcomes with each treatment and an understanding of patient and provider acceptance of the ventricular assist device therapy. This trial will also provide information regarding the risk of events in "stable" patients with advanced heart failure and guidance for the optimal timing of left ventricular assist device therapy.

Real-life Treatment Paradigms Show Infliximab Is Cost-effective for Management of Ulcerative Colitis

Infliximab is effective for induction and maintenance of response in patients with moderate to moderately severe ulcerative colitis. Previous cost analyses of infliximab treatment for ulcerative colitis used models of colectomy vs infliximab and response rates derived from early clinical trials. In real life, therapeutic options are more complex; patients frequently choose to remain in an unwell state rather than undergo colectomy, and rates of response to infliximab are generally higher than those reported from clinical trials. We evaluate the real-life cost-effectiveness of infliximab for treatment of ulcerative colitis where infliximab was readily available compared with not available, causing patients to remain in unwell states. We constructed a Markov model to simulate disease progression of patients with moderate or moderately severe ulcerative colitis who depended on corticosteroids and/or did not respond to thiopurine therapy. Utility scores and transition probabilities between health states were determined by using data from randomized controlled trials and real-life rates published by expert inflammatory bowel disease centers. Health care costs were obtained from the Ontario Case Costing Initiative and the Alberta Health Schedule of Medical Benefits documents. The incremental cost-effectiveness ratios for infliximab treatment of ulcerative colitis were $79,000 and $64,000 per quality-adjusted life year, compared with ongoing medical therapy, at 5-year and 10-year treatment time horizons, respectively. By using real-life response rates and patients' preference to avoid colectomy, infliximab therapy is a cost-effective strategy at a willingness-to-pay threshold of $80,000 for treatment of ulcerative colitis.

The Significance of Varicella Exposure History and Correlation with Serology among Patients with Inflammatory Bowel Disease: Presidential Poster

Purpose: Varicella zoster virus (VZV) infection is a significant concern in immunosuppressed IBD patients with reports of severe, disseminated, and occasionally fatal infection. The European Crohn's and Colitis Organization (ECCO) guidelines on IBD immunization recommend using patient-reported varicella exposure history as an indicator to VZV immunity, and immunization of those with a negative exposure or vaccination history. Data on accurate recall of infection with corroborative serology are scarce. We analysed the significance of prior varicella exposure in predicting VZV seroprotection in IBD patients. Methods: We conducted a retrospective review of 220 consecutive patients attending our IBD clinic from October, 2012 to May, 2013. Data including patient demographics, disease phenotype, and prior VZV exposure (infection or vaccination), including VZV antibody titres, was obtained from electronic or case notes review. Ongoing medical therapy for IBD at the time of testing was also recorded. Results: Data for VZV exposure status and tests for VZV titres was available in 71 IBD patients (Crohn's disease n=39, ulcerative colitis n=32). Of these, 55% were females, the median age was 42 years (range 21-79), and mean disease duration was 8.7 years.Twenty-seven percent of patients were on no treatment, 24% were on aminosalicylates, and 49% were on effective immunosuppression. This included 16 (46%) patients on thiopurines, one (3%) on methotrexate, five (14%) on infliximab, two (6%) on adalimumab, three (8%) on infliximab + thiopurine combination, one (3%) on infliximab + methotrexate, six (17%) on corticosteroids, and one (3%) on infliximab + prednisolone. Two-third of patients (69%) were uncertain about a prior exposure to varicella; 28% gave a definitive history, and 3% stated no previous exposure. The overall prevalence of seropositivity for VZV IgG was 62/71 (87%), with 85% seropositivity in patients receiving immunosuppressive treatment. Despite definitive VZV exposure history, 10% patients were seronegative; these patients were on combined immunosuppressive therapy with infliximab and thiopurine. A total of 14% patients on immunomodulation were VZV IgG seronegative; 40% of these on bi-modal immunosuppressive therapy. Conclusion: A significant number of patients are seronegative, despite a positive history for varicella exposure, suggesting a loss of seroprotection possibly from immunosuppression. A strategy combining varicella exposure history with serology may identify history-positive yet seronegative individuals who merit vaccination, but arguably also identify history-negative yet seropositive individuals, resulting in a lower rate of unnecessary vaccination. There is an urgent need for more data, which could influence guideline development in this area.

Surgical Cost of Care in Crohn’s Disease

The aim of the study was to evaluate the cost of surgical care and short-term outcomes of Crohn's disease(CD) in the era of laparoscopy and biologic therapy. Review of a prospective database identified CD patients that underwent surgical management. Patients were stratified into laparoscopic, open, and converted approaches. Main outcome measures were short-term patient outcomes and cost of care by approach. 92 patients were analyzed- 63.1% laparoscopic, 32.6% open, 4.3% converted. The majority was elective (100% converted, 94.8% laparoscopic, 90% open) and segmental resections (75% converted, 70.7% laparoscopic, 43.3% open). Operative times were similar between laparoscopic and open (152 minutes and 138 minutes, respectively). More open patients required ICU care (20% versus 12.1% laparoscopic and 0% converted). The median LOS was 3 (1-25) days laparoscopic, 4 (1-29) open and 4 (3-8) converted. The laparoscopic complication rate was 15.5%, readmission rate 12.1%, and reoperation rate 8.6%. The mean total hospital cost was $9,702 laparoscopic, $10,782 open, and $13,293 for converted cases (US Dollars). Laparoscopy is appropriate for most CD cases. When necessary to combine with open surgery, this results in efficient and effective patient outcomes and healthcare utilization. These results are important when weighing the cost of ongoing medical therapy versus surgical intervention.

Thyroid Dysfunction in Chinese Patients with Chronic Hepatitis C Treated with Interferon Alpha: Incidence, Long-Term Outcome and Predictive Factors

BackgroundThyroid dysfunction (TD) represents an extra-hepatic manifestation of chronic hepatitis C (CHC) and it may also be a side effect of interferon-alpha (IFN-α) based treatment. However, previous studies have shown a wide variation in the incidence of TD in patients with CHC. Furthermore, the long-term outcomes and the predictive factors of TD in patients who receive IFN-α based treatment have still not been fully studied.ObjectivesThe purpose of this study was to describe the incidence and long-term outcomes of TD in Chinese patients with CHC receiving IFN-αbased treatment. We also aimed to identify the predictive factors of TD associated with this type of therapy.Patients and MethodsA retrospective case-series study of 592 consecutive CHC patients with normal baseline thyroid functions, who received IFN-αbased therapy, was performed. Thyroid function was assessed at baseline and every three months during treatment, as well as in the follow-up after cessation of therapy. The incidence and long-term outcomes of TD were observed. The prevalence of pretreatment thyroid peroxidase antibodies (TPOAb) were assayed in a sex- and age-matched nested case-control study. Multivariable stepwise regression analysis was used to explore the independent effects of the baseline factors, on the incidence of TD.ResultsAt the end of the IFN-αbased therapy, 68 patients (11.5%) in the study had developed TD, 58 patients (85.3%) presented with subclinical TD, and only 10 patients (14.7%) developed overt thyroiditis. The thyroid function of 46 patients (67.8%) spontaneously returned to normal in the six months of follow-up and only three patients (4.4%) had persistent overt TD symptoms after the 24 month follow-up period. Multivariate stepwise analysis suggested that gender and pretreatment TPOAb were the independent factors related to the incidence of TD. Both female patients (OR, 4.31; 95%CI, 2.06–7.31; P = 1.26×10-4) and participants with a positive pretreatment TPOAb (OR = 3.9, 95%CI, 1.72–8.54, P = 0.008) had an increased risk for the development of TD.ConclusionsThe incidence of TD in Chinese patients with CHC during IFN-αbased therapy was 11.5%, the majority of which was subclinical, while only a very small group had long-term overt TD requiring ongoing medical therapy. Female gender and pretreatment TPOAb positivity are risk factors for the development of TD during IFN-αbased therapy.

Improvement in arterial stiffness following cardiac rehabilitation

BackgroundExercise has been shown to beneficially alter arterial stiffness in selected clinical settings. However, the effects of a standardized exercise protocol – “cardiac rehabilitation (CR)” – on measures of arterial stiffness in patients with established coronary heart disease (CHD) has not been well studied. MethodsUsing applanation tonometry, we studied arterial vascular properties in 26 men and 22 women (mean age 60.5±10.8years) with established CHD over a 20week CR program. All patients continued to receive their anti-anginal and vasoactive medications. In addition to standard hemodynamics we estimated central aortic pressure, central arterial pulsatility, augmentation index and arterial pulse wave velocity (PWV). ResultsAfter 20weeks of CR, there were no significant changes in resting heart rate or peripheral blood pressure. In 33 patients with at least two follow-up visits, central aortic systolic pressure was consistently lower than peripheral arterial blood pressure and decreased over the CR program time (baseline, 109±16mmHg; final, 105±14mmHg. p=0.01). Both carotid–radial (n=12) and carotid–femoral (n=21) — derived PWV decreased over the CR program (carotid–radial: baseline, 7.3±1.2m/s; final, 6.6±1.2m/s, p=0.028. carotid–femoral: baseline, 7.2±1.4m/s; final, 6.5±1.3m/s, p=0.02). ConclusionsIn this group of patients with established CHD, arterial PWV was noted to significantly decrease over a 20week CR program. This change occurred in the absence of detectable changes in peripheral blood pressure or heart rate. Decreases in PWV may serve as a sensitive indicator of improved arterial stiffness in patients with atherosclerotic arterial disease notwithstanding ongoing medical therapy.

Prevalence of and risk factors for vitamin B12 deficiency in patients with Crohnʼs disease

Crohn's disease (CD) can commonly involve the terminal ileum, which is the site of B(12) absorption. The aim of this study was to define the prevalence of vitamin B(12) abnormalities in a population with CD and to identify risk factors associated with B(12) abnormalities in CD. The medical records of 201 patients with CD evaluated at a tertiary care center were retrospectively reviewed to determine the prevalence of B(12) deficiency and to evaluate factors associated with B(12) deficiency. The prevalence of B(12) deficiency in a control population of 40 patients with ulcerative colitis was also assessed. The prevalence of an abnormal serum B(12) concentration in patients with CD was 18.4% (95% confidence interval [CI] 13.1-23.8%) compared with 5% (95% CI, 0-11.8%) (P = 0.035) in ulcerative colitis controls. Risk factors for B(12) deficiency in patients with CD included prior ileal (odds ratio [OR], 7.22; 95% CI, 1.97-26.51) or ileocolonic (OR, 5.81; 95% CI, 2.09-16.12) resection and the need for ongoing medical therapy (OR, 2.59; 95% CI, 1.03-6.47). Neither disease location nor duration was independently associated with the risk of B(12) deficiency. Vitamin B(12) abnormalities are common in patients with CD and patients with a prior ileal or ileocolonic resection are at particular risk. Routine screening for B(12) deficiency in patients with CD is warranted.

Whistler Summary: “The Slow Rate of Rapid Progress”

Whistler Summary: “The Slow Rate of Rapid Progress”

Immunohistochemical investigation of canine episcleritis

To identify macrophages, B cells and T cells in archived canine episcleral biopsies and to correlate these findings with the clinical presentation and therapeutic outcome. Archived formalin-fixed biopsies were immunohistochemically labeled for CD18, CD79a, and CD3 to identify macrophages, B cells and T cells, respectively. Slides were digitally photographed and positive cells were manually counted. Signalment, duration of illness, affected eye(s), treatment, and therapeutic outcome were reviewed for each dog. Dogs were divided into groups based on clinical presentation (unilateral episcleritis, bilateral episcleritis or nodular granulomatous episclerokeratitis (NGE). Twenty-four cases were evaluated. There were 19 episcleritis (13 unilateral, six bilateral) and five NGE cases. The mean age for clinical manifestations of unilateral episcleritis was 6.8 years, bilateral episcleritis was 8.7 years, and NGE was 3.8 years. The Cocker Spaniel was over-represented in the episcleritis groups. All NGE cases were Collies. Approximately 50% of the unilateral episcleritis cases resolved and did not require long-term therapy. Almost all cases of bilateral episcleritis and NGE required continuous medical therapy to maintain remission. There was a significantly higher percentage of B lymphocytes in biopsies from lesions that required ongoing medical therapy to maintain lesion remission than in the lesions that resolved, and for which medications were discontinued (P = 0.0471). The prognosis for resolution of NGE and bilateral episcleritis without long-term medical therapy is poor. There is a significant difference in the inflammatory cell population in episcleritis that resolved with medical therapy vs. episcleritis that required ongoing medical therapy.

Prevalence of and Risk Factors for Vitamin B12 Deficiency in Patients with Crohnʼs Disease

Purpose: Crohn's disease is an inflammatory condition of the GI tract that can commonly involve the terminal ileum which is the site of B12 absorption. The aim of this study was to define the prevalence of vitamin B12 deficiency in a population with Crohn's disease and to identify risk factors associated with B12 deficiency. Methods: Medical records of 201 patients with Crohn's disease evaluated at a tertiary care center were retrospectively reviewed to determine the prevalence of B12 deficiency and to evaluate for risk factors associated with B12 deficiency. The prevalence of B12 deficiency in a control population of 40 patients with ulcerative colitis was also assessed. Results: The prevalence of an abnormal B12 level in patients with Crohn's disease was 18.4% (95% CI 13.1–23.8%) compared with 5% (95% CI 0–11.8%) (p=.035) in ulcerative colitis controls. Risk factors for B12 deficiency in patients with Crohn's disease included prior ileal (OR, 7.22; 95%CI 1.97–26.51) or ileocolonic (OR, 5.81; 95% CI 2.09–16.12) resection and the need for ongoing medical therapy (OR, 2.59; 95% CI 1.03–6.47). Neither disease location nor duration was independently associated with the risk of B12 deficiency. Conclusions: Abnormal B12 levels are common in patients with Crohn's disease. Given the complications that can be seen with low B12 levels, and the high prevalence in this population, we would advocate that patients with Crohn's disease be screened for B12 deficiency as part of the ongoing care for the management of the Crohn's disease. Special attention should be given to those that have had a prior ileal or ileocolonic surgery.

Surgical management of chronic rhinosinusitis.

Patients with recurrent or chronic sinusitis frequently want a cure. When medical therapy has been ineffective, they often turn to surgeons for help. It is important to educate patients that surgery, although effective in some patients, does not always cure the disease. Surgery may help lessen disease frequency or severity. Surgery provides one component of an overall comprehensive plan for management of sinus disease, which frequently requires ongoing medical therapy after surgery. The goal of this article is to provide practicing allergists and immunologists with an overview of some of the surgical thinking and techniques related to sinus disease.

Classic Q wave myocardial infarction

PREVIEWOne of the most dramatic interventions in modern medicine is the treatment of acute myocardial infarction. The sustained occlusion that occurs with Q wave infarction can result in extensive damage unless coronary flow is restored early. Dr Vacek discusses the rapid response to acute Q wave infarction, including diagnostic techniques, reperfusion, patient monitoring, and ongoing medical therapy.

Locally advanced cervix cancer: chemotherapy prior to definitive surgery or radiotherapy. A single institutional experience.

Primary or neoadjuvant chemotherapy prior to definitive local therapy has potential advantages for locally advanced cervix cancer. It can downstage a cancer and allow definitive local therapy to be technically possible (surgery), or potentially more effective (radiotherapy). It can also eradicate subclinical systemic metastases. This report reviews a single institution's experience of neoadjuvant chemotherapy prior to definitive local therapy for cervix cancer over a 13-year period. One hundred and six patients were treated with this intent. The patients were analysed for their response to chemotherapy, treatment received, survival, relapse and toxicity. The chemotherapy was feasible and the majority of patients had a complete or partial response (58.5%). Eight patients did not proceed to local treatment. Forty-six patients had definitive surgery and 52 had definitive radiotherapy. The 5-year overall survival was 27% and the majority of patients died with disease. The first site of relapse was usually in the pelvis (46.2%). Late complications that required ongoing medical therapy (n=6) or surgical intervention (n=2) were recorded in eight patients (7.5%). On univariate analysis stage (P=0.04), tumour size (P=0.01), lymph node status (P=0.003), response to chemotherapy (P=0.045) and treatment (P=0.003) were all significant predictors of survival. On multivariate analysis, tumour size (P < 0.0001) and nodal status (P=0.02) were significant predictors of survival. Despite the impressive responses to chemotherapy of advanced cervix cancer, there is evidence from randomized trials that it does not improve or compromise survival prior to radiotherapy. As its role prior to surgery remains unclear, it should not be used in this setting outside a prospective randomized trial.

Quality Improvement Guidelines for Percutaneous Permanent Inferior Vena Cava Filter Placement for the Prevention of Pulmonary Embolism

PULMONARY embolism (PE) continues to be a major cause of morbidity and mortality in the United States. Estimates of the incidence of nonfatal PE range from 400,000 to 630,000 cases per year, and 50,000 to 200,000 fatalities per year are directly attributable to PE (1–4). The current preferred treatment for deep venous thrombosis and PE is anticoagulation therapy. However, as many as 20% of these patients will have recurrent PE (1,5,6). Interruption of the inferior vena cava (IVC) for the prevention of PE was first performed in 1893 with use of surgical ligation (7). Over the years, surgical interruption took many forms (ligation, plication, clipping, or stapling) but IVC thrombosis was a frequent complication after these procedures. Endovascular approaches to IVC interruption became a reality in 1967 after the introduction of the Mobin-Uddin filter (8). Many devices have since been developed for endoluminal caval interruption but, currently, there are six devices commercially available in the United States. These devices are designed for permanent placement. For detailed information regarding each of these filters, the reader is referred to several published reviews (9–12). Selection of a device requires knowledge of the clinical settings in which filters are used, evaluation of the clot trapping efficiency of the device, occlusion rate of the IVC and access vein, risk of filter migration, filter embolization, structural integrity of the device, and ease of placement. Percutaneous caval interruption can be performed as an outpatient or inpatient procedure. However, practically speaking, most filter placements will occur in the inpatient population because of ongoing medical therapy for acute thromboembolic disease or underlying illness. The IVC should be assessed with imaging before placement of a filter, and the current preferred imaging method is vena cavography. Before filter selection and placement, the infrarenal IVC length and diameter should be measured, the location and number of renal veins determined, IVC anomalies (eg, duplication) defined, and intrinsic IVC disease such as preexisting thrombus or extrinsic compression excluded. The ideal placement for the prevention of lower extremity and pelvic venous thromboembolism is the infrarenal IVC. The apex or superior aspect of any filtration device should be at or immediately inferior to the level of the renal veins according to the manufacturers’ recommendations. In specific clinical circumstances, other target locations may be appropriate. Percutaneous caval interruption is commonly accomplished through right femoral and right internal jugular vein approaches; however, other peripheral and central venous access sites can be used. Filters can be placed in veins other than the vena cava to prevent thromboembolism. Implant sites have included iliac veins, subclavian veins, superior vena cava, and IVC (suprarenal and infrarenal). This document will provide quality improvement guidelines for filter placement within the inferior vena cava because of the limited data available for implantation sites other than the IVC. The patient’s clinical condition, the type of filter available, the alternative access sites available, and the expertise of the treating physician should always be considered when the decision to place an IVC filter has been made. These guidelines are written to be used in quality improvement programs to assess percutaneous interruption of the IVC to prevent pulmonary embolism. The most important processes of care are (a) patient selecThis article first appeared in J Vasc Interv Radiol 2001; 12:137–141.