Navigating the landscape of food allergies: Insights and perspectives from the AMCP Market Insights Program.

AMCP convened a panel of clinical and managed care experts to identify insights regarding the prevalence, clinical manifestations, and management approaches for immunoglobulin E-mediated food allergies. This article aims to summarize expert perspectives on health care system challenges and areas of agreement concerning the management of food allergies, and to advance payers' understanding of their role in supporting health care for patients with food allergies. Food allergy management requires dietary modification and is associated with significant patient and caregiver burdens. Emerging therapies provide hope for those living with food allergies but will likely lead to a rise in health plan pharmacy expenses. In considering the value of new treatments, it is important to consider the total cost of care and the value of preventing anaphylaxis and enhancing the patient's quality of life. Several challenges remain in identifying the appropriate patient population for treatment with newer agents and in optimizing treatment outcomes. Addressing health disparities will require standardized clinical protocols, better access to specialized allergy care, and management of comorbid conditions.

Sinus node sparing novel hybrid approach for treatment of inappropriate sinus tachycardia/postural sinus tachycardia: multicenter experience.

BACKGROUND: The ideal treatment of inappropriate sinus tachycardia (IST) and postural orthostatic tachycardia syndrome (POTS) still needs to be defined. Medical treatments yield suboptimal results. Endocardial catheter ablation of the sinus node (SN) may risk phrenic nerve damage and open-heart surgery may be accompanied by unjustified invasive risks. METHODS: We describe our first multicenter experience of 255 consecutive patients (235 females, 25.94 ± 3.84 years) having undergone a novel SN sparing hybrid thoracoscopic ablation for drug-resistant IST (n = 204, 80%) or POTS (n = 51, 20%). As previously described, the SN was identified with 3D mapping. Surgery was performed through three 5-mm ports from the right side. A minimally invasive approach with a bipolar radiofrequency clamp was used to ablate targeted areas while sparing the SN region. The targeted areas included isolation of the superior and the inferior caval veins, and a crista terminalis line was made. All lines were interconnected. RESULTS: Normal sinus rhythm (SR) was restored in all patients at the end of the procedure. All patients discontinued medication during the follow-up. After a blanking period of 6 months, all patients presented stable SR. At a mean of 4.07 ± 1.8 years, normal SN reduction and chronotropic response to exercise were present. In the 51 patients initially diagnosed with POTS, no syncope occurred. During follow-up, pericarditis was the most common complication (121 patients: 47%), with complete resolution in all cases. Pneumothorax was observed in 5 patients (1.9%), only 3 (1.1%) required surgical drainage. Five patients (1.9%) required a dual-chamber pacemaker due to sinus arrest > 5 s. CONCLUSIONS: Preliminary results of this multicenter experience with a novel SN sparing hybrid ablation of IST/POTS, using surgical thoracoscopic video-assisted epicardial ablation combined with simultaneous endocardial 3D mapping may prove to be an efficient and safe therapeutic option in patients with symptomatic drug-resistant IST and POTS. Importantly, in our study, all patients had a complete resolution of the symptoms and restored normal SN activity.

Implantation of leadless pacemakers via inferior vena cava filters is feasible and safe: Insights from a multicenter experience.

BACKGROUND: The leadless Micra transcatheter-pacing system (Micra-TPS) is implanted via a femoral approach using a 27-French introducer sheath. The Micra Transcutaneous Pacing Study excluded patients with inferior vena cava (IVC) filters. OBJECTIVE: To examine the feasibility and safety of Micra-TPS implantation through an IVC filter. METHODS: This multicenter retrospective study included patients with an IVC filter who underwent a Micra-TPS implantation. Data for clinical and IVC filter characteristics, preprocedure imaging, and procedural interventions were collected. The primary outcome was a successful leadless pacemaker (LP) implantation via a femoral approach in the presence of an IVC filter. Periprocedural and delayed clinical complications were also evaluated. RESULTS: Of the 1528 Micra-TPS implants attempted, 23 patients (1.5%) had IVC filters. The majority (69.6%) of IVC filters were permanent. Six (26.1%) patients underwent preprocedural imaging to assess for filter patency. One patient's filter was retrieved before LP implantation. The primary outcome was achieved in 21 of 22 patients (95.5%) with an existing IVC filter. An occluded IVC precluded LP implantation in one patient. Difficulty advancing the stiff guidewire or the 27-Fr sheath was encountered in five patients. These cases required repositioning of the wire (n = 2), gradual sheath upsizing (n = 2), or balloon dilation of the filter (n = 1). Postprocedure fluoroscopy revealed intact filters in all cases. During a median 6-month follow-up, there were no clinical complications related to the filter or the Micra-TPS. CONCLUSION: This multicenter experience demonstrates the feasibility and safety of Micra-TPS implantation via an IVC filter without acute procedural or delayed clinical complications.

Incidence and predictors of MRI scan utilization in MRI-conditional pacemaker recipients: A multicenter experience.

BACKGROUND: Patient characteristics, higher device cost, and vendor contracts likely prevent use of magnetic resonance imaging (MRI)-conditional pacemakers (MRC) in all pacemaker (PM)-eligible patients. We sought to identify the incidence and predictors of MRI scan utilization in MRC recipients. METHODS: Patients receiving an MRC or non-MRI-conditional PM (NMRC) at four centers were included. Incidence of MRI scans following PM insertion was obtained from hospital records and patient phone calls. RESULTS: Of 1,244 patients (74 ± 12 years, 54.6% male), 927 had MRC and 317 had NMRC. At baseline, MRC recipients had a higher incidence of atrial tachycardia and MRI risk factors (syncope, recurrent falls, neurological disease, severe musculoskeletal disease, malignancy). In the MRC group, more patients had commercial health insurance (26% vs 15%, P < 0.001). Sixty MRC patients (6.5%) had an MRI during 21 ± 17 months' follow-up. Using the Weilbull parametric survival model, the projected percentage of MRC patients receiving an MRI scan at 7- and 11-year follow-up were 45% and 73%, respectively. By multivariate regression, a prior history of MRI (odds ratio [OR] 4.5, 95% confidence interval [CI] 2.2-9.1, P < 0.001) and active smoking (OR 2.65, 95% CI 1.1-6.7, P  =  0.039) independently predicted the performance of an MRI following MRC implant. CONCLUSIONS: In this MRC cohort, MRI scan utilization during follow-up was low but projection analyses showed a higher incidence over the lifetime of the MRC. A history of prior MRI and active smoking independently predicted the performance of an MRI scan during follow-up.

Cost-effectiveness analysis of magnetic resonance imaging-conditional pacemaker implantation: Insights from a multicenter study and implications in the current era.

BACKGROUND: Magnetic resonance imaging (MRI)-conditional pacemakers (M-PPMs) grant patients greater accessibility to MRI scans. The cost-effectiveness of implanting M-PPM is unknown. OBJECTIVE: The purpose of this study was to determine the cost-effectiveness of M-PPM implantation. METHODS: Cost-effectiveness analysis was performed on patients receiving a M-PPM across 4 institutions. The incremental cost-effectiveness ratio (ICER) was calculated by dividing the sum of the total incremental cost of implanting a M-PPM vs a conventional pacemaker and the cost of MRI scans by the utility of MRI scans in terms of quality-adjusted life-years (QALY) gained. QALY and lifespan of M-PPM (7-11 years) data were obtained from the literature. The benchmark of <$100,000 per QALY was used as the threshold for cost-effectiveness. Computer modeling/simulations were used to calculate the percentage of patients required to achieve this benchmark, to extrapolate the cumulative projected percentage of patients utilizing MRI scans over the lifespan of a M-PPM via the Weibull parametric survival model, and to conduct univariate and multivariate, probabilistic sensitivity analyses. RESULTS: The ICER during the follow-up period (21 ± 17 months) was $451,569. The cost-effectiveness ICER benchmark is reached 7.0 years postimplantation, when a projected 38% of recipients would receive MRI scans. The projected percentage of patients receiving MRI scans at 11 years was 58%, yielding an ICER of $74,221 per QALY. Henceforth, assuming increased MRI usage in regular PPM based on Centers for Medicare & Medicaid Services memo CAG00399R4 and decreased cost of M-PPM, M-PPM implantation is still cost-effective, with a lifetime ICER of $49,817 per QALY. CONCLUSION: M-PPM implantation is cost-effective over the lifespan of a M-PPM based on projected usage of MRI.

Implications of Risk Evaluation and Mitigation Strategy (REMS) programs for managed care pharmacy.

In the last 2 decades, health care management has been challenged by more aggressive therapy, the increased number of specialty medications, and more stringent guidelines to monitor adverse events or health risk. To promote patient safety, various communication requirements are mandated to increase the risk awareness of patients and physicians. These include black-box warnings, "Dear Health Care Provider" letters, U.S. Food and Drug Administration (FDA) Talk Papers, MedGuides, and Risk Minimization Action Plans (RiskMAPs).

Optimising the use of beta-adrenoceptor antagonists in coronary artery disease.

beta-Adrenoceptor antagonists (beta-blockers) provide multiple benefits to patients with coronary artery disease. The 2001 American Heart Association and American College of Cardiology (AHA/ACC) guidelines for secondary prevention of myocardial infarction (MI) recommend initiating beta-adrenoceptor blockade in all post-MI patients and continuing therapy indefinitely. Atenolol and metoprolol have been shown to decrease vascular mortality in the acute-MI period. In the post-MI period timolol provided a 39% reduction in mortality in the Norwegian Multicenter Study group and propranolol was associated with a 26% reduction in mortality in BHAT (Beta-blocker Heart Attack Trial). beta-Adrenoceptor antagonist therapy results in reduction of myocardial oxygen demand and is therefore also effective for the treatment of angina pectoris. In CAST (Cardiac Arrhythmia Suppression Trial) beta-adrenoceptor antagonist therapy was associated with a significant reduction in arrhythmic death or cardiac arrest. In the post-MI amiodarone trials EMIAT (European Myocardial Infarct Amiodarone Trial) and CAMIAT (Canadian Amiodarone Myocardial Infarction Trial) there was a mortality benefit and decreased arrhythmic death in patients who received both amiodarone and beta-adrenoceptor antagonist therapy, compared with patients receiving amiodarone therapy alone. In the post-MI defibrillator (implantable cardioverter defibrillator [ICD]) trials, AVID (Antiarrhythmic Versus Implantable Defibrillator) and MUSTT (Multicenter Unsustained Tachycardia Trial), beta-adrenoceptor antagonist therapy was independently associated with improved overall survival. The exception was the ICD patients in MUSTT, and the benefit was attenuated in the amiodarone and ICD patients in AVID.AHA/ACC guidelines recommend the use of beta-adrenoceptor antagonists in all patients with symptomatic left ventricular dysfunction, based on several large, controlled heart failure trials. Extended-release metoprolol succinate reduced all-cause mortality by 34% in MERIT-HF (Metoprolol Controlled-Release/Extended-Release Randomized Intervention Trial in Heart Failure). Bisoprolol was associated with a 34% mortality benefit in CIBIS-II (Cardiac Insufficiency Bisoprolol Study II) and carvedilol was associated with a 35% mortality reduction in the COPERNICUS (Carvedilol Prospective Randomized Cumulative Survival) trial. beta-Adrenoceptor antagonists reduce perioperative mortality in patients undergoing cardiac as well as non-cardiac surgery; however, they remain underutilised. Contraindications to beta-adrenoceptor antagonist therapy include severe bradycardia, high-grade atrioventricular block, marked sinus node dysfunction and acute exacerbations of heart failure. Many of the perceived adverse effects of beta-adrenoceptor antagonists have not been substantiated by large clinical trials.beta-Adrenoceptor antagonists differ with regard to receptor selectivity, receptor affinity, lipophilicity and intrinsic sympathomimetic activity. Beneficial properties of beta-adrenoceptor antagonists may not always be extrapolated as a class effect, and patient selection and drug preparations should follow trial guidelines. The beneficial effects of beta-adrenoceptor antagonists are clearly proven in cardiac patients and those at risk for cardiac disease. They are indicated for heart failure and proven beneficial in patients undergoing cardiac and non-cardiac surgery. These benefits appear to be consistent across most patient subgroups. beta-Adrenoceptor antagonists are generally well tolerated, yet significant morbidity and mortality result from their continued underutilisation.

Thrombocytopenia in malaria.

Malaria continues to be a cause of high mortality and morbidity. Imported cases of malaria are increasing in New York City. Yet, New York physicians, when evaluating patients for fever, frequently missed the diagnosis of malaria. We evaluated the role of platelet count for predicting malarial infection. The study included patients seen between 1996 and 2000 in a New York community hospital for fever who had traveled to a malaria-endemic area. Forty patients with malaria were identified. Our study found the sensitivity of platelet count for diagnosing malaria was 100%, and the specificity was 70%. The negative predictive value was 100% and the positive predictive valve was 86%. Hence, we propose that in any patient with fever and recent travel history, platelet count is an important clue to the diagnosis of malaria. A finding of thrombocytopenia should increase the suspicion of malaria and lead to performance of more specific tests, including multiple peripheral smears and ELISA for parasite-specific antigen, etc.

Primary prevention of sudden cardiac death: trials in patients with coronary artery disease.

Over the past decade, four randomized, controlled trials have evaluated therapies for prevention of sudden cardiac death in patients with coronary disease. Three of the four trials have shown significant reductions in mortality with implanted defibrillators. Two studies failed to demonstrate any benefit from pharmacologic antiarrhythmic therapy. The results of these studies in similar patient populations have erased any doubt regarding the ability of implanted defibrillators to reduce the risk of sudden death in patients with coronary disease. Our major challenge at this time is understanding how best to utilize this therapy in order to bring the benefit to the maximum number of patients while minimizing expense.