Non-infarct-related artery revascularization during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: a systematic review and meta-analysis.

BACKGROUND: In patients with ST-elevation myocardial infarction (STEMI) and multivessel disease, guidelines recommend infarct-related artery (IRA) only intervention during primary percutaneous coronary intervention (PCI) except in patients with hemodynamic instability. To assess the available evidence, we performed a systematic review and meta-analysis comparing outcomes of non-IRA PCI as an adjunct to primary PCI (same sitting PCI [SS-PCI]) with IRA only PCI (IRA-PCI) in the setting of STEMI. METHODS AND RESULTS: A comprehensive search identified 14 studies [11 cohort, 3 randomized controlled trials] comprising of 35,239 patients. For cohort studies, patients undergoing SS-PCI had higher rate of anterior infarction (48% vs. 45%, P = .04) and cardiogenic shock (11% vs. 9%, P = .0001) at baseline compared with IRA-PCI. The primary composite end point of death, myocardial infarction and revascularization was higher in the SS-PCI group in the short term (OR, 1.63; CI, 1.12-2.37) and long term (OR, 1.60; CI, 1.18-2.16). However, after excluding patients with shock, there was no difference in primary endpoint for the short (OR, 1.33; CI, 0.67-2.63) and long term (OR, 1.39; CI, 0.80-2.42) follow-up. In analyses limited to randomized controlled trials, primary end point was similar during short term (OR, 0.79; CI, 0.19-3.28) and significantly lower for SS-PCI group in the long term (OR, 0.55; CI, 0.34-0.91). CONCLUSIONS: There is paucity of randomized data to guide management of STEMI patients with multivessel disease. SS-PCI group in cohort studies has higher baseline risk compared to IRA-PCI. The primary end point is higher for SS-PCI in observational cohort studies but this difference did not persist after exclusion of shock patients and for analysis limited to randomized controlled trials. These findings underscore the need of a large randomized controlled trial to guide therapy for a commonly encountered clinical situation.

Angiographic and clinical outcomes after implantation of drug eluting stents in bifurcation lesions with crush or kissing stent technique.

BACKGROUND: Long-term outcome after bifurcation stenting with drug-eluting stents (DES) for obstructive coronary artery disease is poorly understood. In this study, we report 6-9-month angiographic follow-up and long-term clinical outcomes after implantation of drug-eluting stents by crush and kissing stent technique for coronary bifurcation lesions. METHODS: Consecutive patients undergoing bifurcation stenting with DES by crush or kissing stent technique were enrolled in a prospective registry. Angiographic follow-up was obtained at 6-9 months and clinical follow-up completed for a median of 38 months. RESULTS: A total of 86 patients participated in the study. Bifurcation stenting by crush technique was performed in 73 (85%) and by kissing stent in 13 (15%) patients. Stenting of left main bifurcation was applied in 24 (28%) patients. Angiographic follow-up was completed in 75 (87%) patients and showed restenosis in the main for 8 (11%) and side branch for 20 (27%) patients. Clinical follow-up was available for a median duration of 38 months. During follow-up, 2 (2%) patients died, 4 (5%) experienced myocardial infarction (MI), and 11 (13%) underwent target vessel revascularization (TVR) with an overall major adverse cardiac event (MACE) rate of 16%. In left main cohort, angiographic restenosis occurred in 9 (37%) patients, and 3 (12%) patients required TVR. There were no deaths or stent thrombosis. A comparison of crush and kissing stent technique showed significantly higher angiographic restenosis with crush (26% vs 13% in kissing stent patients, P = 0.046) and 95% of restenosis in crush group involved ostium of the side branch. There was no difference in clinical outcomes between the crush and kissing stent groups. Final kissing balloon dilatation (FKB) was successful in 65 (89%) patients in the crush group and associated with a significant reduction in MACE (8% in FKB successful vs 37% in FKB unsuccessful, P = 0.04) during follow-up. CONCLUSION: Bifurcation stenting with crush or kissing stent technique is safe and associated with a low rate of TLR and MACE on long-term follow-up. Crush stenting is associated with a significantly higher rate of side branch restenosis compared to kissing stent technique. FKB is associated with significant reduction in MACE during follow-up.

The technique and cost of radiosurgery for the treatment of 1-3 brain metastases.

BACKGROUND: Radiosurgery can be delivered through a variety of modalities including robotic and fixed gantry Linac-based systems. They appear equally effective and safe. Thus, community need and costs remain the main determinants for choosing a given modality. We performed an economic evaluation to identify settings in which one modality could be preferred over the other. METHODS: Using local estimates of resource volumes and unit prices, we computed the incremental cost/patient of robotic radiosurgery compared to fixed-gantry radiosurgery from a payer's perspective. By varying parameters of resource volumes, we performed a probabilistic analysis stratified by number of brain lesions. in addition, we performed sensitivity analyses to examine the effect of patient volume on cost/patient. RESULTS: The cost of robotic radiosurgery was $4,783/patient, and cost of fixed-gantry radiosurgery was $5,166/patient. The mean incremental cost was $-383 (95% interval: $-670, $110) for all lesions, $78 ($23, $123) for solitary lesions, and $-610 ($-679, $-534) for multiple lesions. The cost/patient of robotic radiosurgery varied from $5,656 (low volume setting) to $4,492 (high volume setting). CONCLUSION: in settings of moderate to high volume (6-10 hours of daily operation), and in multiple lesions, robotic radiosurgery is more cost effective than fixed-gantry radiosurgery.Technique utilisée et coût de la radiochirurgie pour le traitement de 1 à 3 métastases cérébrales.

Interventional cardiology fellowship training in Canada: a report card using standardized criteria.

BACKGROUND: Several institutions in Canada offer fellowship training in interventional cardiology (IC). However, no national mechanism exists to ensure uniformity of training or assessment of final competency. METHODS: A cross-sectional survey was carried out for physicians completing IC training from 2007 to 2009. The survey used a semistructured questionnaire to determine compliance with training components recommended by Accreditation Council for Graduate Medical Education (ACGME) and American College of Cardiology (ACC). RESULTS: Sixty-six (78%) of 85 trainees from 15 programs participated in the study. All programs were affiliated with a university and associated with accredited programs in adult cardiology. Annual procedural volume of >1,500 and faculty volume of >250 were reported for 67% and 70% of programs. Annual trainee percutaneous coronary intervention volume of 250-350 was reported by 29%, 350-450 by 47%, and >450 by 24% of respondents. All respondents reported regular participation in case management rounds, and 54% reported formal instruction of structured curriculum; 91% reported participation in research, and 38% reported mandatory attendance in outpatient clinic. All respondents reported annual and 61% reported ≥2 performance evaluations per year; 45% of respondents reported formal trainee assessment of program and faculty. CONCLUSION: Canadian IC training meets ACGME/ACC recommendations for procedural volume and academic activity. However, participation in outpatient clinics and compliance with administrative requirement of faculty and program assessment by trainee was suboptimal. Formal accreditation is highly desirable to standardize program content and administration for optimal IC training.

Children with autism: effect of iron supplementation on sleep and ferritin.

To determine if there is a relationship between low serum ferritin and sleep disturbance in children with autism spectrum disorder, an 8-week open-label treatment trial with oral iron supplementation was conducted as a pilot study. At baseline and posttreatment visits, parents completed a Sleep Disturbance Scale for Children and a Food Record. Blood samples were obtained. Thirty-three children completed the study. Seventy-seven percent had restless sleep at baseline, which improved significantly with iron therapy, suggesting a relationship between sleep disturbance and iron deficiency in children with autism spectrum disorder. Sixty-nine percent of preschoolers and 35% of school-aged children had insufficient dietary iron intake. Mean ferritin increased significantly (16 microg/L to 29 microg/L), as did mean corpuscular volume and hemoglobin, suggesting that low ferritin in this patient group resulted from insufficient iron intake. Similar prevalence of low ferritin at school age as preschool age indicates that children with autism spectrum disorder require ongoing screening for iron deficiency.

The benefit of deep inspiration breath hold: evaluating cardiac radiation exposure in patients after mastectomy and after breast-conserving surgery.

BACKGROUND: This study aims to evaluate the reduction of cardiac radiation dose and volume with deep inspiration breath hold (DIBH) technique compared to free breathing (FB) in patients with left-sided breast cancer. The study also aims to evaluate whether the benefits of DIBH vary in patients who had whole breast radiotherapy (RT) after breast-conserving surgery (BCS) and those who had chest wall RT post-mastectomy (M). METHODS: FB and DIBH plans were generated for 15 consecutive post-BCS patients and 17 post-M patients who underwent RT with DIBH using varian real-time position management (RPM) system. Cardiac shields were used in all post-BCS plans, provided that clinical treatment volume coverage was not compromised, while chest wall coverage took priority in post-M plans. The prescribed dose was 50 Gy in 25 fractions for the whole breast or the chest wall. Parameters of interest were cardiac V5, mean LAD dose, maximum LAD dose, and mean heart dose. The impact of DIBH was compared in post-BCS and post-M patients using paired t tests. To gauge clinically meaningful outcome, the proportion of patients with V5 < 5 % and mean cardiac dose <2 Gy were compared using McNemar's test. RESULTS: DIBH decreased V5 by an absolute 4.5 % (2.3 vs. 6.8 %; p < 0.0001) in post-M group, and by an absolute 2.4 % (1.3 vs. 3.7 %; p = 0.0028) in post-BCS group. DIBH decreased the mean heart dose by 107.0 cGy (127.4 vs. 234.4 cGy; p = 0.0002) in post-M group, and by 58.9 cGy (82.2 vs. 141.1 cGy; p = 0.0012) in post-BCS group. DIBH decreased mean LAD by 1201.6 cGy (670 vs. 1872.5 cGy; p = 0.0006) in post-M group, and by 799.0 cGy (425.3 vs. 1224.3 cGy; p = 0.0003) in post-BCS group. DIBH also decreased max LAD dose by 1244.3 cGy (2776.0 vs. 4020.3 cGy; p = 0.0014) in post-M group, and by 1856.3 cGy (1898.7 vs. 3754.9 cGy; p = 0.0005) in post-BCS group. In post-BCS group, cardiac V5 < 5 % was achieved in 10/15 (67 %) FB patients, and in 15/15 (100 %) DIBH patients (p = 0.002), and mean heart dose <2 Gy was achieved in 12/15 (80 %) FB patients and in 15/15 (100 %) DIBH patients (p < 0.001). This compares with post-M group, in which V5 < 5 % was achieved in 6/17 (35 %) FB patients and in 16/17 (94 %) DIBH patients (p = 0.05), and mean heart dose <2 Gy was achieved in 7/17 FB (41 %) an 16/17 DIBH patients (94 %) (p = 0.03). CONCLUSION: The results of this study suggest that there is considerable reduction in cardiac exposure in most patients with DIBH compared to FB, although less reduction is observed in the post-BCS patients. The use of cardiac shields and collimators/gantry adjustments, more readily applicable for post-BCS cases, may limit the additional benefits of DIBH. In an environment where DIBH availability is limited, the result of this study supports the preferential use of DIBH in post-M patients over post-BCS patients.

Scalp Seeding Post Craniotomy and Radiosurgery for Solitary Brain Metastasis: A Case Report and Systematic Review.

BACKGROUND: Radiosurgery is being increasingly used post craniotomy for brain metastasis, instead of whole-brain radiation. We report a case of scalp metastasis following craniotomy and radiosurgery, along with a systematic review of the literature. METHODS: Our patient was a 70-year-old male who presented with a scalp metastasis, two years after craniotomy and radiosurgery, for a solitary brain metastasis from esophageal carcinoma. Using Medline® (United States National Library of Medicine, Bethesda, MD), we performed a systematic review of the literature to identify cases of isolated scalp metastases following craniotomy for brain lesions. RESULTS: The scalp metastasis was in close proximity to the craniotomy site. Workup did not show any other site of active disease. Biopsy confirmed it to be a metastasis from esophageal carcinoma. The literature review did not yield any case of isolated scalp metastasis following craniotomy and whole-brain radiotherapy or radiosurgery. However, it yielded six cases of isolated scalp metastases following craniotomy for primary brain tumors. CONCLUSION: Isolated scalp metastasis has not been reported following craniotomy and whole-brain radiotherapy for brain metastases. Our patient likely had surgical seeding during craniotomy. These surgically implanted cells could not be ablated because the radiosurgery treatment volume does not cover the surgical tract. Further research is needed to identify risk factors for surgical seeding.

Physiologic mechanisms can predict hematologic responses to iron supplements in growing children: a computer simulation model.

BACKGROUND: Iron deficiency is the most common preventable nutrition problem in developing countries. Several randomized clinical trials (RCTs) have been conducted to determine the effectiveness of various iron dosing schemes in multiple settings. OBJECTIVE: The objective was to determine whether enough is known about iron metabolism to predict hemoglobin and serum ferritin (SF) concentrations with a computer model and whether the model could be used as a substitute for new RCTs. DESIGN: Guided by the physiology of iron absorption and regulation, we used data from RCTs that tested iron Sprinkles to develop a computer model. Of 2 RCTs in Ghana, we used 1 to compute the amount of iron absorbed from a given dose in anemic and nonanemic children and the other to compute the resulting change in hemoglobin concentrations. We used this model to predict hemoglobin and SF concentrations in a new RCT in China and compared model-predicted values with actual values by using summary statistics (means and medians) and quantile-quantile plots. RESULTS: The model-predicted hemoglobin means were within +/-2 g/L, and SF medians were within +/-3 microg/L of the corresponding means and medians of the actual values. On quantile-quantile plots, the predicted hemoglobin quantiles were within +/-5 g/L, and SF quantiles were within +/-10 microg/L of the corresponding quantiles of the actual values. CONCLUSION: Our model of iron metabolism can accurately predict hemoglobin and SF concentrations after iron supplementation with Sprinkles in children; the model can thus obviate the need for repeating RCTs in multiple settings.

Economic gains of a home fortification program: evaluation of "Sprinkles" from the provider's perspective.

INTRODUCTION: This paper models the effects of a home-fortification program (using Sprinkles which contain zinc and iron and other micronutrients), in Pakistan, a country with high levels of infant mortality, anemia, and diarrhea. It uses the results of randomized trials of the effect of Sprinkles on anemia and on longitudinal prevalence of diarrhea. METHODS: Based on previous literature, the effect of Sprinkles on intermediate outcomes (diarrhea and anemia) is linked to longer-term outcomes (infant and young child mortality, and cognitive achievement and hence adult wages). Three different measures of cost effectiveness are presented: the cost per death averted (effect via zinc supplementation on reduction of longitudinal prevalence of diarrhea); the cost per 'disability adjusted life year' (DALY) saved (same modality); and the gain in earnings due to higher cognitive functioning for each dollar spent (effect via iron supplementation on reduced anemia). RESULTS: We estimated that the cost per death averted is dollars406 (dollars273-dollars3248), the cost per DALY saved is dollars12.2 (dollars8-dollars97) and the present value of the gain in earnings is dollars37 (dollars18-dollars51) for each dollar spent on the Sprinkles program. These estimates were developed for a low-income country (GDP per capita = dollars417) with a high infant mortality rate (IMR = 83/1000), high prevalence of anemia (93%), and high mean longitudinal prevalence of diarrhea (17%). DISCUSSION: These outcomes are particularly favourable in Pakistan. The outcomes are more favourable when used with children 6-12 months. Further longer-run field trials of Sprinkles with larger populations would be helpful.

The Technique, Resources and Costs of Stereotactic Body Radiotherapy of Prostate Cancer: A Comparison of Dose Regimens and Delivery Systems.

Robotic system has been used for stereotactic body radiotherapy (SBRT) of prostate cancer. Arc-based and fixed-gantry systems are used for hypofractionated regimens (10-20 fractions) and the standard regimen (39 fractions); they may also be used to deliver SBRT. Studies are currently underway to compare efficacy and safety of these systems and regimens. Thus, we describe the technique and required resources for the provision of robotic SBRT in relation to the standard regimen and other systems to guide investment decisions. Using administrative data of resource volumes and unit prices, we computed the cost per patient, cost per cure and cost per quality adjusted life year (QALY) of four regimens (5, 12, 20 and 39 fractions) and three delivery systems (robotic, arc-based and fixed-gantry) from a payer's perspective. We performed sensitivity analyses to examine the effects of daily hours of operation and in-room treatment delivery times on cost per patient. In addition, we estimated the budget impact when a robotic system is preferred over an arc-based or fixed-gantry system. Costs of SBRT were $6333/patient (robotic), $4368/patient (arc-based) and $4443/patient (fixed-gantry). When daily hours of operation were varied, the cost of robotic SBRT varied from $9324/patient (2 hours daily) to $5250/patient (10 hours daily). This was comparable to the costs of 39 fraction standard regimen which were $5935/patient (arc-based) and $7992/ patient (fixed-gantry). In settings of moderate to high patient volume, robotic SBRT is cost effective compared to the standard regimen. If SBRT can be delivered with equivalent efficacy and safety, the arc-based system would be the most cost effective system.

Biopsy versus partial versus gross total resection in older patients with high-grade glioma: a systematic review and meta-analysis.

BACKGROUND: Optimal extent of surgical resection (EOR) of high-grade gliomas (HGGs) remains uncertain in the elderly given the unclear benefits and potentially higher rates of mortality and morbidity associated with more extensive degrees of resection. METHODS: We undertook a meta-analysis according to a predefined protocol and systematically searched literature databases for reports about HGG EOR. Elderly patients (≥60 y) undergoing biopsy, subtotal resection (STR), and gross total resection (GTR) were compared for the outcome measures of overall survival (OS), postoperative karnofsky performance status (KPS), progression-free survival (PFS), mortality, and morbidity. Treatment effects as pooled estimates, mean differences (MDs), or risk ratios (RRs) with corresponding 95% confidence intervals (CIs) were determined using random effects modeling. RESULTS: A total of 12 607 participants from 34 studies met eligibility criteria, including our current cohort of 211 patients. When comparing overall resection (of any extent) with biopsy, in favor of the resection group were OS (MD 3.88 mo, 95% CI: 2.14-5.62, P < .001), postoperative KPS (MD 10.4, 95% CI: 6.58-14.22, P < .001), PFS (MD 2.44 mo, 95% CI: 1.45-3.43, P < .001), mortality (RR = 0.27, 95% CI: 0.12-0.61, P = .002), and morbidity (RR = 0.82, 95% CI: 0.46-1.46, P = .514) . GTR was significantly superior to STR in terms of OS (MD 3.77 mo, 95% CI: 2.26-5.29, P < .001), postoperative KPS (MD 4.91, 95% CI: 0.91-8.92, P = .016), and PFS (MD 2.21 mo, 95% CI: 1.13-3.3, P < .001) with no difference in mortality (RR = 0.53, 95% CI: 0.05-5.71, P = .600) or morbidity (RR = 0.52, 95% CI: 0.18-1.49, P = .223). CONCLUSIONS: Our findings suggest an upward improvement in survival time, functional recovery, and tumor recurrence rate associated with increasing extents of safe resection. These benefits did not result in higher rates of mortality or morbidity if considered in conjunction with known established safety measures when managing elderly patients harboring HGGs.

Controlling iron deficiency anemia through the use of home-fortified complementary foods.

Iron deficiency anemia (IDA) is more common in South Asian countries including India, Bangladesh and Pakistan than anywhere else in the world. During infancy and early childhood, IDA is associated with impaired psycho-motor development and cognitive function that may be irreversible. As a consequence, there is a growing awareness that IDA is one of many factors impeding socio-economic prosperity of developing nations. The combination of unacceptably high prevalence rates and inadequate preventative programs highlights the need for new effective sustainable strategies to control IDA. The burden of iron deficiency can be reduced by taking a more holistic approach that would include promotion of healthy weaning practices and use of appropriate complementary foods, together with improving the nutritional value of such foods. There is an increasing body of peer-reviewed literature to support the contention that "micronutrient Sprinkles" is an effective strategy to improve the nutritional value of home-prepared complementary foods and thus to reduce the burden of iron deficiency among children. By combining data from recently conducted randomised control trials, Sprinkles were shown to be as efficacious as iron drops for treating childhood anemia. The iron in Sprinkles is well absorbed, and Sprinkles are easy to use and well accepted by young children and their caregivers. Integrated into existing public health programs, Sprinkles has the potential to improve the effectiveness of such programs.

Fractionated stereotactic radiosurgery with concurrent temozolomide chemotherapy for locally recurrent glioblastoma multiforme: a prospective cohort study.

Local recurrence represents a significant challenge in the management of patients with glioblastoma multiforme. Salvage treatment options are limited by lack of clinical efficacy. Recent studies have demonstrated a significant response rate and acceptable toxicity with the use of fractionated stereotactic radiosurgery in this patient population. Our primary objective was to determine the efficacy and toxicity of fractionated stereotactic radiosurgery combined with concurrent temozolomide chemotherapy as a salvage treatment for recurrent glioblastoma multiforme. We prospectively collected treatment and outcome data for patients having fractionated stereotactic radiosurgery for locally recurrent glioblastoma multiforme after radical radiotherapy. Eligible patients had a maximum recurrence diameter of 60 mm without causing significant mass effect. The gross tumor volume was defined as the enhancing lesion on an enhanced fine-slice T1 (spin-lattice) magnetic resonance imaging, and a circumferential setup margin of 1 mm was used to define the planning target volume. All patients were treated using robotic radiosurgery with three dose/fractionation schedules ranging from 25 to 35 Gy in five fractions, depending on the maximum tumor diameter. Concurrent temozolomide 75 mg/m(2) was prescribed to all patients. Tumor response was judged using the Macdonald criteria, and toxicity was assessed using the CTCAE (Common Terminology Criteria for Adverse Events). A total of 31 patients were enrolled in this study. The median overall survival was 9 months, and progression-free survival was 7 months. The 6-month progression-free survival was 60% with a 95% confidence interval of 43%-77%. The a priori stratification factor of small tumor diameter was shown to predict overall survival, while time to recurrence was not predictive of progression-free or overall survival. Three patients experienced grade 3 acute toxicity that responded to increased steroid dosing. One patient experienced a grade 4 acute toxicity that did not respond to increased steroids but did respond to anti-angiogenic therapy. Fractionated stereotactic radiosurgery with concurrent temozolomide has shown good short-term clinical and radiologic control with manageable acute toxicity. This regimen appears to provide superior efficacy to either temozolomide or fractionated radiosurgery alone. The results of this study support the continued evaluation of this regimen.

Robotic radiosurgery for the treatment of 1-3 brain metastases: a pragmatic application of cost-benefit analysis using willingness-to-pay.

With the emergence of radiosurgery as a new radiotherapeutic technique, health care decision makers are required to incorporate community need, cost and patient preferences when allocating radiosurgery resources. Conventional patient utility measures would not reflect short term preferences and would therefore not inform decision makers when allocating radiosurgery treatment units. The goal of this article is to demonstrate the feasibility of cost-benefit analysis to elicit the yearly net monetary benefit of robotic radiosurgery. To calculate the yearly incremental cost of robotic radiosurgery as compared to fixed gantry radiosurgery we used direct local cost data. We assumed a standard 10 year replacement and 5% amortization rate. Decision boards summarizing the clinical scenario of brain metastases and the difference between robotic and fixed gantry radiosurgery in terms of immobilization, comfort and treatment time were then presented to a sample of 18 participants. Participants who preferred robotic radiosurgery were randomly assigned to either a low ($1) or high ($5) starting point taxation based willingness-to-pay algorithm. The yearly incremental cost of providing robotic radiosurgery was $99,177 CAD. The mean community yearly willingness-to-pay for robotic radiosurgery was $2,300,000 CAD, p = 0.03. The calculated yearly net societal benefit for robotic radiosurgery was $2,200,823 CAD. Among participants who preferred robotic radiosurgery there was no evidence of starting point bias, p = 0.8. We have shown through this pilot study that it is feasible to perform cost-benefit analysis to evaluate new technologies in Radiation Oncology. Cost-benefit analysis offers an analytic method to evaluate local preferences and provide accountability when allocating limited healthcare resources.

Characterization of operator learning curve for transradial coronary interventions.

BACKGROUND: Transradial percutaneous coronary intervention (TR-PCI) improves clinical outcomes compared to the transfemoral (TF) approach. However, inadequate training and experience has limited widespread adoption by interventional cardiologists. METHODS AND RESULTS: Clinical and procedural characteristics for TR-PCI were prospectively collected from 1999 to 2008. To identify minimum case volume for optimum clinical benefit, single-vessel TR-PCI cases were chronologically ranked and stratified into 1 to 50, 51 to 100, 101 to 150 and 151 to 300 case volume groups for operators starting the TR approach at the study institution. Cases by operators with a >300 TR-PCI case volume comprised the control group. TR-PCI failure rates, contrast use, guide usage, and fluoroscopy time were compared among groups. A total of 1672 patients underwent TR-PCI by 28 operators. TR-PCI failure occurred in 4% and was higher in the 1 to 50 case volume group compared to the 51 to 100 (P=0.007) and control (P=0.01) groups. Contrast use was greater in the 1 to 50 group (180±79 mL) compared to the 151 to 300 (157±75 mL, P=0.02) and control (168±79 mL, P=0.05) groups. Fluoroscopy time was higher in the 1 to 50 group (15±10 minutes) compared to the 101 to 150 (13±10 minutes, P=0.04) and control (12±9 minutes, P=0.02) groups. Reasons for TR-PCI failure included spasm (38%), subclavian tortuousity (16%), poor guide support (16%), failed access (10%), and radial loop (7%). Case volume was significantly correlated with TR-PCI failure (ß=-0.0076, P=0.0028), and odds of failure was reduced by 32% for each 50 increments in case volume. CONCLUSIONS: TR-PCI success depends on operator experience, and a case volume of ≥50 cases is required to achieve outcomes comparable to experienced operators. These findings have implications both for PCI operators looking to expand their skills and for defining standards for training.

Characterization of clopidogrel hypersensitivity reactions and management with oral steroids without clopidogrel discontinuation.

OBJECTIVES: The purpose of this study was to characterize clopidogrel hypersensitivity and describe its successful management with oral steroids without clopidogrel discontinuation. BACKGROUND: Hypersensitivity reactions to clopidogrel are poorly understood and present difficulty in management. METHODS: Patients diagnosed with clopidogrel hypersensitivity after percutaneous coronary intervention underwent evaluation and received oral prednisone without clopidogrel discontinuation. Cutaneous testing was performed after completion of clopidogrel therapy for diagnosis and assessment of cross-reactivity. RESULTS: Sixty-two patients representing 1.6% of the percutaneous coronary intervention population developed clopidogrel hypersensitivity during the study period. The mean age was 62 ± 11 years, 71% of patients were male, and 35% reported prior adverse drug reaction. Clopidogrel hypersensitivity manifested as generalized exanthema in 79%, localized skin reaction in 16%, and angioedema or urticaria in 5% of patients. Biopsy of affected areas demonstrated a lymphocyte-mediated delayed hypersensitivity reaction. Complete resolution of hypersensitivity reaction was observed in 61 patients (98%) with a short course of oral prednisone. Cutaneous testing confirmed delayed hypersensitivity reaction to clopidogrel in 34 (81%) and immediate hypersensitivity in 3 of 42 patients (7%) tested. Allergenic cross-reactivity was observed for ticlopidine in 10 (24%), prasugrel in 7 (17%), and both ticlopidine and prasugrel in 3 patients (7%). Histological examination showed lymphocyte-mediated hypersensitivity in abnormal patch test areas. CONCLUSIONS: Clopidogrel hypersensitivity is manifested as generalized exanthema and is caused by a lymphocyte-mediated delayed hypersensitivity in most patients. This can be managed with oral steroids without clopidogrel discontinuation. Allergenic cross-reactivity with ticlopidine, prasugrel, or both is present in a significant number of patients with clopidogrel hypersensitivity.

Comparison of abciximab and eptifibatide on angiographic and clinical outcomes in rescue percutaneous coronary intervention for failed fibrinolytic therapy.

BACKGROUND: Adjunctive administration of the glycoprotein IIb/IIIa platelet receptor antagonist (GPA), abciximab, improves outcomes in patients undergoing rescue percutaneous coronary intervention (PCI). However, it is unknown if other GPAs provide a similar benefit in this setting. OBJECTIVE: We sought to compare angiographic and clinical outcomes of patients receiving abciximab or eptifibatide as an adjunct to rescue PCI. METHODS: In this prospective, nonrandomized study, consecutive patients who underwent rescue PCI and received adjunctive preprocedural GPA comprised the study population. Thrombolysis in myocardial infarction (TIMI) flow, corrected TIMI frame count (CTFC) and myocardial blush grade (MBG) were determined before and immediately after rescue PCI. Residual ST-segment elevation at 90-120 minutes and peak creatine kinase (CK) values for 48 hours after PCI were recorded. Major adverse cardiac events (MACE) including death, reinfarction and target vessel revascularization (TVR) were determined at discharge, 1 and 6 months. RESULTS: A total of 241 patients were included in the study. 162 patients received abciximab and 79 received eptifibatide. There were no differences in baseline clinical and angiographic characteristics between groups. Post-PCI TIMI flow was similar but post-PCI CTFC was significantly lower (17 +/- 10 vs. 22 +/- 18; p = 0.01) and post-PCI MBG significantly higher (2.8 +/- 0.5 vs. 2.6 +/- 0.6; p = 0.01) in the abciximab group. Patients in the abciximab group had less ST-segment elevation (1.0 +/- 0.9 vs. 1.5 +/- 1.0 mm; p = 0.003) and lower peak CK (2,484 +/- 2,176 vs. 2,650 +/- 2,798 U/L; p = 0.001) after PCI. On multivariate analyses, abciximab administration (OR = 0.50, CI = 0.26, 0.96; p = 0.03), pre-PCI TIMI 3 flow (OR = 0.22, CI = 0.05, 0.99; p = 0.04) and female gender (OR = 0.24, CI = 0.08, 0.66; p = 0.006) were positive and cardiogenic shock (OR = 2.76, CI = 1.16, 6.58; p = 0.02) was a negative predictor of normal epicardial perfusion post PCI. Abciximab administration (OR = 0.46, CI = 0.24, 0.87; p = 0.02) and pre-PCI CTFC < 25 (OR = 0.09, CI = 0.02, 0.31, 0.0001) were positive predictors and cardiogenic shock (OR = 3.96, CI = 1.55, 10.12; p = 0.004) was a negative predictor of normal myocardial perfusion post-PCI as determined by CTFC. Abciximab administration (OR = 0.31, CI = 0.15, 0.63; p = 0.001) and pre-PCI MBG 3 (OR = 0.07, CI = 0.02, 0.23; p < 0.0001) were positive predictors of normal myocardial perfusion post-PCI as determined by MBG. In-hospital, 1- and 6-month clinical events and MACE rates did not differ between groups. CONCLUSIONS: In the setting of rescue PCI, adjunctive administration of abciximab resulted in greater improvement in angiographic and electrical estimates of myocardial perfusion and smaller infarct size compared to eptifibatide. These findings suggest that all GPA may not provide equal benefit in rescue PCI.