How to Effectively Decrease Patient Co-Payments of High-Cost Drugs Through Innovation: Lessons From the Karmanos Specialty Pharmacy.

PURPOSE: High-cost drugs impose a financial burden on patients with cancer. Karmanos Specialty Pharmacy (KSP) developed a process to automate financial assistance (FA) applications to decrease patient drug cost. We evaluate the outcomes of this program on cost to patients and payers. METHODS: This is an observational, retrospective study of the KSP claims data set from January to December 2019, accessed by 13 statewide cancer centers within Michigan. Drug cost of patients, payers, FA (funds to lower patient drug cost), and types of FA were obtained. A subset analysis was performed to determine drug delivery times. RESULTS: In 2019, 869 prescriptions and 1,722 prescription fills were provided to 463 patients through KSP. The total cost of drug claims was approximately $10 million US dollars (USD) among Medicare patients (58%), approximately $3.4 million USD for privately insured patients (20%), and approximately $3.7 million USD for Medicaid patients (22%). Twenty-seven percent of patients (22% of all prescription fills) required additional FA with initial total co-payment claims of $335,216 USD. $280,988 USD of FA was obtained, which substantially lowered total patient costs by 81%. $250,818 USD of FA obtained was from foundation grants (327 fills), and $21,441 USD from manufacturer co-pay cards (47 fills). An additional $12,260 USD (12 fills) from a Karmanos Patient Assistance Fund was used. There was high dependence on foundation grant assistance among Medicare patients (33% of claims). In a subset analysis, the median time from prescription written to delivery to the patient was < 7 days (0-56 days). CONCLUSION: Twenty-seven percent of patients (22% of prescriptions fills) in 2019 required additional FA for high-cost drugs. KSP substantially reduced patient cost by implementing an efficient process using additional pharmacy assistants to obtain FA.

Syringe plunger contamination by hazardous drugs: a comparative study.

AIM: The purpose of this study was to perform a comparative cyclophosphamide contamination level test with Becton Dickinson® syringe plungers with Phaseal® Closed System Transfer Devices and Equashield® syringe plungers under routine oncological compounding conditions. METHOD: The ChemoGlo™ sampling kit and analysis services were used to test for cyclophosphamide contamination levels on the syringe plungers of Becton Dickinson® Phaseal and Equashield® syringes that underwent cycles of drug transfer in a Forma Class II, 2A Biological Safety Cabinet. Prior to testing, the syringes were divided into three equal groups for the Equashield® and Becton Dickinson® syringes. A 50 mL aliquot of cyclophosphamide was drawn into each syringe and then injected back into the cyclophosphamide vial. This drug transfer procedure was immediately repeated twice for the syringes in group 1, four times for group 2, and eight times for group 3. After the completion of the drug transfers with the Equashield® and Becton Dickinson® Phaseal syringes, the plungers were retracted back to the nominal syringe marking, and a wipe test of the exposed plunger was done using the ChemoGlo™ sampling kit. RESULTS: Significant contamination levels of 2000 ng and greater were detected on most Becton Dickinson® syringe plungers with Phaseal® Closed System Transfer Devices, whereas all Equashield® syringes remained uncontaminated at undetectable levels.

Effect of hospital volume on in-hospital mortality for renal artery bypass.

BACKGROUND: A recent report determined that the nationwide mortality for renal artery bypass (RAB) is surprisingly high-10%. We hypothesized that operative mortality for RAB is related to the volume of such operations performed in each center. METHODS: The Nationwide Inpatient Sample was analyzed to identify patients undergoing RAB for the years 2000-2005. In-hospital mortality for RAB was compared between hospitals. RESULTS: During the study period, RAB was performed on 7413 patients with an overall in-hospital mortality of 9.6%. The multivariate logistic regression analyses revealed that after adjusting for surgical risk, increasing hospital volume was significantly associated with decreased in-hospital mortality for RAB (odds ratio 0.98; 95% confidence interval, 0.96-0.99; P=.015). CONCLUSIONS: Patient risk profile and hospital volume are critical determinants of in-hospital mortality for RAB, which should be factored into decision making for patients requiring intervention for renovascular disease.

Influence of plasma exchange on the disposition of the fourth generation cephalosporin cefepime.

Cefepime, a fourth generation cephalosporin, is widely used in hematology and oncology patients. These patients may require plasma exchange (PE) for indications such as chemotherapy- or cancer-induced thromobotic thrombocytopenic purpura to name a few. To date, no pharmacokinetic evaluation has been conducted assessing cefepime's disposition during PE. A 2 g IV cefepime single dose was given to patients undergoing therapeutic PE. Two hours from cefepime dose administration, plasma concentration was measured. PE was then instituted and cefepime plasmapheresate concentration was measured at the completion of the PE session. Cefepime levels were measured using HPLC. The percentage removed by PE was calculated as: amount removed/2 g dose. Ten adult patients were analyzed: median age (range): 52 years (33-67) and median weight (range); 82.85 kg (47-120). PE indications were: myasthenia gravis (n = 3), transverse myelitis (n = 2), multiple sclerosis (n = 1), chronic inflammatory demyelinating polyneuropathy (n = 1), idiopathic thrombocytopenic purpura (n = 1), thrombotic thrombocytopenic purpura (n = 1), and humoral rejection post cadaveric renal allograft (n = 1). All patients except one had a creatinine clearance >60 mL/min. One patient was excluded from the pharmacokinetic analysis owing to loss of venous access during PE. For the remaining nine patients, total plasma volume removed was 3.5 L (range: 2.5-3.5) and duration of PE was 120 min (range: 94-209). The cefepime removed by PE was 3.7% (range: 2.1-6.7). A strong correlation was found between cefepime plasma concentration prior to PE and the amount of drug removed (r = 0.96, r(2) = 0.92; p<0.05). The above results suggest that, under the studied conditions, cefepime removal by PE is clinically insignificant (approximately 4% of total 2 g dose).

Percutaneous access for endovascular abdominal aortic aneurysm repair: can selection criteria be expanded?

Previous reports suggest that percutaneous access for endovascular abdominal aortic aneurysm repair (P-EVAR) is as safe as open access (O-EVAR) in patients with favorable femoral anatomy. Severe femoral artery calcification and obesity have been considered relative contraindications to P-EVAR, but these criteria have not been evaluated. The purpose of this study was to assess the postoperative anatomic changes associated with P-EVAR versus O-EVAR using three-dimensional (3-D) computed tomographic (CT) reconstruction and to evaluate the overall results of the two procedures in a group of patients with suboptimal femoral anatomy. During a recent 26-month period, 173 patients underwent EVAR at our institutions, including 35 P-EVARs. Of these, 22 (63%) had complete pre- and postoperative CT imaging of the femoral arteries. These subjects were compared to 22 matched controls who underwent O-EVAR during the same period. Automated 3-D reconstructions were used to measure the following anatomic femoral artery parameters before and after EVAR: arterial depth, calcification score, minimum diameter and area, and maximum diameter and area. Of the 88 study arteries, 50 underwent open access and 38 percutaneous access (Proglide, n=11; Prostar XL, n=27). Both groups were similar regarding sheath size, number of components, operative time, blood loss, and length of stay. Significantly more O-EVAR subjects suffered groin complications (p=0.02), including five hematomas, two wound infections, two femoral thromboses, and one vessel which required patch repair. In the P-EVAR group there was only one hematoma, which was managed conservatively. There was no difference between the P-EVAR and O-EVAR groups with respect to femoral artery calcification (Agatston scores 667+/-719 vs. 945+/-1,248, p=0.37). Obesity (body mass index >30) was documented in six (27%) of both the P-EVAR and O-EVAR groups (p=nonsignificant). Pre- and postoperative CT-derived anatomic data showed a significant decrease in the minimal vessel area with O-EVAR compared to P-EVAR (p=0.02). This study demonstrates that patients with obesity or severely calcified femoral arteries can be successfully treated percutaneously with fewer minor groin complications.

Influence of age, aneurysm size, and patient fitness on suitability for endovascular aortic aneurysm repair.

Prior to approval by the U.S. Food and Drug Administration of larger endografts (main body diameters up to 36 mm), small abdominal aortic aneurysms (AAAs, <5.5 cm) were shown to be more suitable for endovascular repair (EVAR) than large AAAs (> or =5.5 cm). The purpose of this study was to assess changes in EVAR suitability with the potential use of larger endografts in unselected consecutive patients. The influence of age, aneurysm size, and patient fitness on EVAR suitability was also assessed. We studied 186 male patients referred for evaluation of nonruptured AAAs who underwent contrast-enhanced computed tomographic scans with three-dimensional reconstructions. Morphologicall AAA features and neck characteristics were measured according to Society for Vascular Surgery reporting standards to determine EVAR suitability. Patient fitness for repair was assessed using the customized probability index, a validated fitness score for vascular surgery procedures. Suitability for EVAR was determined by neck anatomy, iliac artery morphology, and total aortic aneurysm angulation and tortuosity according to the clinicians' experience and current practice. The median age of the study cohort was 72 years (interquartile range [IQR] 65-79 years). The median maximum AAA diameter was 5.4 cm (IQR 4.1-5.9). Median fitness score was +7 (IQR -7 to +14). EVAR suitability for large AAAs significantly increased with larger endografts (35-63%, p<0.001). Changes in EVAR suitability for small AAAs were not significant (69-75%, p=0.06). Maximum AAA diameter was not an independent predictor for EVAR suitability with larger endografts after adjusting for neck anatomy. Aortic neck length (odds ratio [OR]=1.2, 95% confidence interval [CI] 1.1-1.2) and diameter (OR=0.78, 95% CI 0.63-0.96) were the only independent predictors for EVAR suitability with larger endografts. Age, AAA size, and fitness did not differ between patients suitable and unsuitable for EVAR with larger endografts. In conclusion, introduction of larger endografts (up to 36 mm in main body diameter) in the United States has resulted in significantly increased anatomic suitability for EVAR for large AAAs. Conversely, suitability has not significantly changed for small AAAs. Overall, EVAR suitability is not influenced by age, aneurysm size, or patient fitness.

Trends and outcomes of concurrent carotid revascularization and coronary bypass.

BACKGROUND: The management of concurrent carotid and coronary artery disease is controversial. Although single-center observational studies have revealed acceptable outcomes of combined carotid endarterectomy (CEA) and coronary artery bypass grafting (CABG), community-based outcomes have been substantially inferior. Recently, carotid artery stenting (CAS) has been introduced for the management of high-risk patients with carotid stenosis, including those with severe coronary artery disease. This study was undertaken to evaluate the nationwide trends and outcomes of CAS before CABG vs combined CEA and CABG and to assess the risk for adverse events. METHODS: The Nationwide Inpatient Sample (NIS) was used to identify patients discharged after concurrent carotid and coronary revascularization procedures. All patients that underwent CAS before CABG and combined CEA-CABG during the years 2000 to 2004 were included. The type of revascularization and major adverse events (ie, in-hospital stroke and death rates) were determined by cross-tabulating discharge diagnostic and procedural codes. Risk stratification was performed using the Charlson Comorbidity Index. Weighted exact Cochrane-Armitage trend test and multivariate logistic regression were used to assess the association between types of revascularization, comorbidities, complications, and risk-adjusted mortality. RESULTS: During the 5-year period, 27,084 concurrent carotid revascularizations and CABG were done. Of these, 96.7% underwent CEA-CABG, whereas only 3.3% (887 patients) had CAS-CABG. From 2000 to 2004, the proportion of patients undergoing CAS-CABG vs CEA-CABG did not significantly changed (P = .27). Patients undergoing CAS-CABG had fewer major adverse events than those undergoing CEA-CABG. CAS-CABG patients had a lower incidence of postoperative stroke (2.4% vs 3.9%), and combined stroke and death (6.9% v. 8.6%) than the combined CEA-CABG group (P < .001), although in-hospital death rates were similar (5.2% vs 5.4%). After risk-stratification, CEA-CABG patients had a 62% increased risk of postoperative stroke compared with patients undergoing CAS before CABG (odds ratio [OR], 1.62; 95% confidence interval [CI], 1.1-2.5; P = .02). However, no differences in the risk of combined stroke and death were observed (OR, 1.26; 95% CI, 0.9-1.6; P = NS). CONCLUSION: Although CAS may currently be performed for high-risk patients, it is still infrequently used in patients who require concurrent carotid and coronary interventions. In the United States, patients who undergo CAS-CABG have significantly decreased in-hospital stroke rates compared with patients undergoing CEA-CABG but similar in-hospital mortality. CAS may provide a safer carotid revascularization option for patients who require CABG.

Operative mortality for renal artery bypass in the United States: Results from the National Inpatient Sample.

BACKGROUND: The mortality rate for renal artery bypass grafting (RABG) is reported to be 0% to 4% for patients with renovascular hypertension and 4% to 7% for patients with ischemic nephropathy. However, these data come from high-volume referral centers known for their expertise in treating these conditions. Because of the relative infrequency of these operations in most vascular surgery practices, the nationwide outcomes for RABG are not known. The purpose of this study was to define the operative mortality rate for RABG in the United States and to identify risk factors for perioperative mortality. METHODS: The National Inpatient Sample was analyzed to identify patients undergoing RABG for the years 2000 to 2004. Categoric data were analyzed using chi(2) and the Cochran-Armitage trend tests. Multivariate logistic regression analyses were performed to identify risk factors for perioperative mortality after RABG. RESULTS: During the study period, 6608 patients underwent RABG, representing a frequency of 3.51 operations per 100,000 discharges. More than two-thirds were performed at teaching hospitals (4564 vs 2,044; P < .0001). The frequency of RABG decreased by 30.7% between 2000 and 2004 (4.28 vs 2.96 RABGs per 100,000 discharges; P for trend < .0001). The in-hospital mortality for RABG was 10.0%. On univariate analysis, in-hospital mortality after RABG varied with increasing age, race, region of the country, and a preoperative history of chronic renal failure, congestive heart failure, or chronic lung disease. Logistic regression models identified advanced age (odds ratio [OR] 1.57; 95% confidence interval [CI], 1.44-1.72], female gender (OR, 1.20; 95% CI, 1.02-1.41), and a history of chronic renal failure (OR, 2.21; 95% CI, 1.75-2.78), congestive heart failure (OR, 1.94; 95% CI, 1.44-2.62), or chronic lung disease (OR, 1.40; 95% CI, 1.18-1.67) as independent markers of risk-adjusted, in-hospital mortality (P < .0001 for each of these five variables). CONCLUSIONS: Nationwide in-hospital mortality after RABG is higher than predicted by prior reports from high-volume referral centers. Advanced age, female gender, and a history of chronic renal failure, congestive heart failure, or chronic lung disease were predictive of perioperative death. For the typical vascular practice, these data may provide a rationale for lower risk alternatives, such as renal artery stenting or referral to high-volume referral centers for RABG.

Femoral vein harvest for vascular reconstructions: pitfalls and tips for success.

The femoral-popliteal vein has proved to be an excellent conduit for a variety of indications. These include in situ reconstruction of infected aortic grafts, and mesenteric, brachiocephalic, and lower-extremity bypasses. This article discusses the technical details of successful deep vein harvest. Information regarding the preoperative evaluation, postoperative surveillance, reintervention, and venous morbidity is provided. The femoral-popliteal vein graft has proven to be a durable conduit with minimal late venous morbidity.

Secondary aortoenteric fistulas versus paraprosthetic erosions: is bleeding associated with a worse outcome?

BACKGROUND: Direct communication between an aortic prosthesis and the gastrointestinal (GI) tract may present with GI bleeding (aortoenteric fistulas [AEF]) or be incidental to a graft infection (paraprosthetic erosions [PPE]). The purposes of this study were to compare the outcomes of AEF versus PPE and to determine predictors of mortality associated with these lesions. STUDY DESIGN: Since 1992, 38 patients (23 men, 15 women; mean age 67 years) presented with AEF (n=16) or PPE (n=22). RESULTS: After complete graft excision, 26 patients (8 AEF, 18 PPE) underwent in situ revascularization using femoral vein (n=24) or rifampin-soaked prosthetic graft (n=2); 12 (8 AEF, 4 PPE) underwent extraanatomic bypass. There was no significant difference in mortality for AEF versus PPE (38% versus 36%). Postoperative complications developed in 25 (66%) patients, including 10 (26%) with GI complications requiring reintervention (5 colon necrosis, 5 duodenal bleed or leak). There were no differences between AEF and PPE in operative transfusions, operative times, GI complications, ICU stay, hospital stay, or final discharge status. Multivariate stepwise logistic regression analysis revealed that GI complications (odds ratio [OR], 52.5; 95% CI, 3.5 to 781; p=0.004) and age (OR, 1.2; 95% CI, 1.02 to 1.3; p=0.026) were the only independent predictors of in-hospital mortality. CONCLUSIONS: Surgical management of AEF and PPE should be tailored to patient illness and the extent of graft infection. Mortality from both lesions is dependent on patient and technical factors, not on the mode of presentation.

Dynamic geometry and wall thickness of the aortic neck of abdominal aortic aneurysms with intravascular ultrasonography.

BACKGROUND: It is commonly assumed that the aortic wall deforms uniformly and has uniform wall thickness about the circumference. The purpose of this study was to evaluate the aortic wall motion and thickness in the infrarenal aortic neck of patients with abdominal aortic aneurysms who were undergoing endovascular repair (EVAR) and to compare the dynamic measurements of intravascular ultrasonography with the static measurements of computed tomographic angiography (CTA). METHODS: A total of 25 patients were evaluated before surgery with CTA and three-dimensional reconstructions on a Vitrea workstation, followed by intraoperative assessment of the proximal aortic neck with intravascular ultrasonography (IVUS) before EVAR. Infrarenal aortic neck dimensions on CTA were obtained at 1-mm intervals, but for the purposes of this study all dimensions on CTA were obtained 1 cm below the lowest renal artery. IVUS analysis of the proximal aortic neck was obtained with a 10-second recorded data loop of aortic wall motion. A Digital Imaging and Communications in Medicine viewer was used to view the recorded loop of aortic movement, and each image was captured and then evaluated with a SCION PCI Frame Grabber to determine aortic dimensions and wall thickness. IVUS diameters (250 measurements of each aorta) were recorded through a full continuous cardiac cycle from the epicenter of the lumen (maintaining the left renal vein in its normal anatomic configuration) in an anteroposterior (AP) direction in the area of greatest wall movement and 90 degrees perpendicular to this direction (lateral movement). RESULTS: There was significant variation in infrarenal aortic wall movement about the circumference, with 1.7 +/- 0.6 mm (range, 0.6-2.7 mm) displacement in the AP direction and 0.9 +/- 0.5 mm (range, 0.3-1.5 mm) displacement in the lateral direction (P < .001). Aortic wall thickness was greater in the region of increased AP wall motion than in the area of lesser lateral wall motion (2.3 +/- 0.6 mm vs 1.2 +/- 0.3 mm; P < .001). There was no difference between the IVUS and CTA aortic neck measurements (25.5 vs 25.6 mm; not significant) during the midpoint of the cardiac cycle of IVUS. However, at peak systole, IVUS recorded a greater diameter than CTA (26.4 vs 25.6 mm; P < .001), and at end-diastole, IVUS recorded a smaller diameter than CTA (24.7 vs 25.6 mm; P = .01). CONCLUSIONS: The infrarenal neck of aortic aneurysms deforms anisotropically during the cardiac cycle. The greatest displacement is in the AP direction and corresponds with a significantly greater wall thickness in this area. The magnitude of cyclic change in aortic diameter can be as high as 11%. Further evaluation of proximal aortic neck wall motion after EVAR is warranted to determine the interaction of various stent designs and the aortic wall.

Aggressive percutaneous mechanical thrombectomy of deep venous thrombosis: early clinical results.

OBJECTIVE: To evaluate percutaneous mechanical thrombectomy for deep venous thrombosis (DVT). DESIGN: A retrospective analysis. SETTING: Tertiary academic medical center. PATIENTS: Thirty patients with DVT who underwent percutaneous mechanical thrombectomy. INTERVENTIONS: Percutaneous mechanical thrombectomy of upper or lower extremity DVT. MAIN OUTCOME MEASURES: Thrombus removal, patency, and valvular function. Venography and intravascular ultrasonography assessed periprocedural lysis. Duplex ultrasonography assessed patency and valvular function before and after the procedure. RESULTS: Fourteen patients had iliofemoral, 6 had iliofemoropopliteal, 5 had femoropopliteal, and 5 had subclavian vein thromboses. Mean age was 50.9 years (range, 15-78 years); 10 patients (33%) had a documented hypercoagulable state. There was 100% technical success in crossing the DVT, with treatment performed in a single setting in 24 patients (80%). Mean +/- SD procedural time was 145 +/- 35 minutes; range, 55-210 minutes. Mean thrombolytic dose was 6.2 mg of tenecteplase with the Trellis-8 and 10 mg with the AngioJet. Adjunctive procedures were required in 28 patients (percutaneous transluminal angioplasty and stent placement in 17 and percutaneous transluminal angioplasty alone in 11). Recoverable inferior vena cava filters were placed in 21 patients and retrieved within 4 weeks. There were no clinically significant periprocedural pulmonary emboli; however, 5 patients (17%) had evidence of pulmonary embolism on computed tomographic angiography (all in patients without inferior vena cava filters). Venous patency was maintained in 27 patients (90%) and lower extremity valvular function was maintained in 22 (88%) of 25 treated lower limbs, with a mean follow-up of 6.2 months (range, 3-24 months). CONCLUSIONS: Percutaneous mechanical thrombectomy is effective in the treatment of acute DVT in the upper and lower extremity to restore venous patency. In the lower extremity, valvular function is maintained acutely. Continued surveillance and follow-up will be necessary to determine whether valvular function is maintained long-term.

Endovascular conversion with femorofemoral bypass as a treatment of endotension and aneurysm sac enlargement.

We report a case of a patient treated with a Gore Excluder endograft for AAA in November 2003 with subsequent aneurysm sac enlargement in the absence of an identified endoleak. The patient had a Type I endoleak treated with a Palmaz stent at the neck and later developed a Type II endoleak treated with translumbar coil embolization. This was successful with absence of pressure in the sac after the procedure and stable aneurysm size over the next nine months. Surveillance of the patient with both CT and ultrasound then revealed an increase in the aortic sac diameter in the absence of endoleak. A Cook Zenith converter was used to reline this PTFE endograft. Subsequently, imaging showed aneurysm sac shrinkage. This is a report of endotension with aneurysm expansion following Gore Excluder placement which was treated successfully with a dacron endograft.