Intra-operative Use of Hemopatch®: Interim Results of a Nationwide European Survey of Surgeons.

INTRODUCTION: Haemostasis is a critical part of surgery. Haemostatic agent selection is based upon a number of factors including surgeon's experience and choice. This post-marketing survey determined surgeons' intraoperative use and perception of Hemopatch® (Baxter Healthcare Corporation, Deerfield, IL), a resorbable collagen-based sealing haemostat. METHODS AND PARTICIPANTS: A one-arm questionnaire was distributed to European general, cardiac, pulmonary, and urologic surgeons who used Hemopatch® to achieve haemostasis in situations where bleeding control by pressure, ligature, or conventional procedures had been ineffective or was impractical. Responses were summarized for patient characteristics, surgical procedures/techniques, and surgeons' assessment of Hemopatch® regarding their overall satisfaction and utilization characteristics of Hemopatch®. RESULTS: Of 1028 responses received from seven European countries, the majority were from Germany (47.3%) or Italy (36%). Most cases were in males (60.7%), 50-75 years of age (61.8%), performed by an open approach (82.5%), with 52.7% general-, 16.2% cardiac-, 7.5% lung, 19.5% urologic-type procedures and 3.7% other/unknown. Successful haemostasis after two minutes of approximation occurred in 93.3% of patients (86.8%-96.9% across surgical subtypes), with similar rates by approach (93.1% open; 94.1% minimally-invasive), and patient's use of anticoagulant and/or antiplatelet agents (87.9% - 93.1%). Over 92% of surgeon's rated Hemopatch® as "excellent" or "good" in assessments of overall satisfaction, haemostasis efficacy, ease of preparation, ease of handling, flexibility/pliability, and tissue adherence. These characteristics were rated as excellent or good by 81% or more of surgeons in analyses by surgical subspecialty and surgical approach of open or minimally invasive. CONCLUSIONS: Hemopatch® provides effective haemostasis across a variety of surgical procedures, both in open- and minimally-invasive, as well as in patients receiving anticoagulant and/or antiplatelet agents. Surgeon's generally rated their overall satisfaction with Hemopatch®, its haemostatic efficacy, and other characteristics as "much better" or "better" than their previously used haemostat.

Floseal only versus in combination in spine surgery: a comparative, retrospective hospital database evaluation of clinical and healthcare resource outcomes.

OBJECTIVE: Flowable agents such as Floseal® (F) are often reserved as adjuncts to non-flowable agents (i.e. gelatin (G) sponges and thrombin (T)) when bleeding is not sufficiently controlled. Based on their perceived positive impact, it is postulated that flowable agents alone may result in better clinical and resource utilization outcomes. Clinical and health-care utilization outcomes were compared in this retrospective analysis of spine surgery cases with charges for Floseal only (FO) and F + G/T. METHODS: The United States Premier Hospital Database was searched for adult spine surgeries performed between October 2010 and September 2015 with FO or F and G/T charges. To obtain an unbiased treatment estimate, 1:1 propensity-score matching was used to identify FO and F + G/T cohorts. The cohorts were compared for rates of intraoperative, perioperative, postoperative and transfusion; blood loss-related, serious and other complications; hospital length-of-stay (LOS), surgical time, and volume of hemostat charged. RESULTS: Among 40,335 spine surgeries, 15,105 FO and F + G/T matched pairs were compared. Significantly (p < 0.0001) lower percentages of FO than F + G/T cases received intraoperative (1.4% vs. 2.5%), perioperative (1.6% vs. 2.8%), postoperative (1.6% vs 3.0%), and any transfusion (2.3% vs. 4.3%). FO cases had significantly less blood loss complications than F + G/T cases (0.5% vs. 0.8%, p = 0.0022) and significantly (p < 0.0001) shorter hospital LOS (-0.45 days), surgical time (-39.0 min), and used less hemostat (-12.5 mL). CONCLUSIONS: Results from this observational hospital database analyses indicate that FO use in spine surgery is associated with lower blood transfusion use and blood loss complications compared to its use with adjunct non-flowable hemostatic agents. The shorter hospital stay, reduced surgical time, and less hemostat volume health-care utilization outcomes that favored FO versus combination use may translate to health system cost savings. Further validation of these findings using controlled clinical trials and cost-consequence studies is warranted. CLINICAL RELEVANCE: The use of flowable hemostatic agents alone may result in better clinical and possibly economic outcomes in spine surgery.

Cost-effectiveness analysis of a sealing hemostat patch (HEMOPATCH) vs standard of care in cardiac surgery.

BACKGROUND: A recent randomized controlled trial showed that patients undergoing ascending aorta surgery treated with HEMOPATCH to control bleeding had a significantly better hemostasis success rate than with dry or wet gauze compression or similar standard of care (SOC). OBJECTIVE: To compare the cost-effectiveness using two different agents for hemostasis (HEMOPATCH vs dry or wet gauze compression or similar SOC) in cardiac surgery from the European hospital perspective. METHODS: A literature-based cost-effectiveness model estimating average cost per successful hemostasis event was developed based on the hemostasis efficacy difference (HEMOPATCH = 97.6%, SOC = 65.8%, p < .001). Additional clinically significant end-points studied in the trial (blood transfusions and surgical revisions) were also analyzed. It was assumed that each surgery utilized two units of HEMOPATCH (dimensions of 4.5 × 9 cm) and two units of SOC. Product acquisition costs for HEMOPATCH and SOC were included along with outcome-related costs derived from the literature and inflation-adjusted to 2017 EUR and GBP. Results are presented for an average hospital with an annual case load of 574 cardiac surgeries. One-way and probabilistic sensitivity analyses were performed. RESULTS: Considering only product acquisition cost, HEMOPATCH had an incremental cost-effectiveness ratio (ICER) of €1,659, €1,519, €1,623, and £1,725 per hemostasis success when compared to SOC for Italy, Spain, France, and the UK, respectively. However, when considering the cost and potential difference in the frequency of transfusions and revisions compared to SOC, the use of HEMOPATCH was associated with an annual reduction of six revisions and 60 transfusions, improving the ICER to €1,440, €1,222, €1,461, and £1,592, respectively. Sensitivity analysis demonstrated model robustness. CONCLUSIONS: This analysis supports the use of HEMOPATCH over SOC in cardiac surgery in European hospitals to improve hemostasis success rates and potential cost offsets from reduced transfusions, complications, and surgical revisions.

Tolerability of atorvastatin in a population aged > or =65 years: a retrospective pooled analysis of results from fifty randomized clinical trials.

OBJECTIVE: The aim of this study was to compare the safety profile of atorvastatin calcium at 4 doses with that of placebo in elderly patients (age, > or =65 years). METHODS: A single pooled database (Pfizer Atorvastatin Clinical Program Database) of 50 published and unpublished completed clinical trials was analyzed retrospectively. Tolerability data from male and female study participants aged > or =65 years at the time of study enrollment were extracted from this database and grouped based on treatment: atorvastatin 10, 20, 40, or 80 mg/d, or placebo. Analyses included comparisons of treatment-related and serious adverse events (AEs) of the musculoskeletal, hepatic, and renal systems. Descriptive statistics were employed. No inferential statistical analyses were performed. RESULTS: A total of 5924 patients were included in the pooled analysis (range of mean age, 71-74 years; white race, 5437 [91.8%]; female sex, 2506 [42.3%]; treatment with atorvastatin 10 mg/d, n = 2042; atorvastatin 20 mg/d, n = 667; atorvastatin 40 mg/d, n = 522; atorvastatin 80 mg/d, n = 1698; and placebo, n = 995). The overall AE profiles appeared similar with all atorvastatin doses and placebo. The proportions of patients experiencing at least 1 treatment-related AE were 16.1%, 10.2%, 11.3%, 15.0%, and 15.3% in the atorvastatin 10-, 20-, 40-, and 80-mg/d, and placebo groups, respectively. The rates of discontinuation due to treatment-associated AEs appeared comparable between all doses of atorvastatin and placebo (2.1% vs 1.7%). Serious AEs were rare (< or =1.0%) and seldom led to withdrawal. The prevalence of treatment-associated myalgia was low in all treatment groups (< or =1.8%). None of the patients experienced persistent creatine kinase elevations >10-fold the upper limit of normal (x ULN), and no cases of myopathy or rhabdomyolysis were reported. The rates of patients with persistent elevation >3 x ULN) of hepatic aminotransferases were 0.1%, 0%, 0.2%, 0.5%, and 0.2% in the atorvastatin 10-, 20-, 40-, and 80-mg/d, and placebo groups, respectively. Although the prevalences of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevations appeared slightly higher in the 80-mg/d group (3.2% vs < or =0.9% in all other groups), specific musculoskeletal and hepatic AEs were rare (< or =3.0%). CONCLUSIONS: This pooled analysis of 50 published and unpublished studies in elderly patients found that the overall prevalences of AEs did not appear to increase with dose and appeared comparable to that observed with placebo. Although the prevalences of ALT/AST elevations appeared slightly higher in the 80-mg/d group (3.2% vs < or =0.9% in all other groups), specific musculoskeletal and hepatic AEs were rare (< or =3.0%). The rates of discontinuation appeared comparable between all 4 doses of atorvastatin and placebo. The results of this analysis support the favorable safety profile of atorvastatin across the full dose range in patients aged > or =65 years.

Reduced mortality rates after intensive statin therapy in managed-care patients.

OBJECTIVE: To evaluate whether intensive statin therapy in a managed-care setting produces greater clinical benefit than more moderate statin use. METHODS: Adults hospitalized for a coronary heart disease (CHD) event were identified from a longitudinal database of pharmaceutical and medical claims. Propensity scores representing a patient's likelihood of receiving statin therapy were calculated. Statin-treated patients were those who received statin therapy within 30 days of hospital discharge after a CHD event, had been supplied with statin therapy for at least 10 days during the follow-up period, and received statin therapy for at least 10 days before the first recurrent CHD event. Standard or intensive statin therapy was identified according to low-density lipoprotein cholesterol reductions expected with statin dose. Patients in the standard and intensive groups were matched by propensity scores to patients not receiving statin therapy after discharge. Patients in the standard statin therapy group were also matched to patients who received intensive statin therapy. Mortality rates after hospital discharge were compared in all matched groups. RESULTS: Patients treated with standard therapy experienced a 32% reduction in risk of death compared with patients not receiving statin therapy (P = 0.003). Patients who received intensive statin therapy after a CHD event experienced a 42% reduction in risk of mortality (P = 0.002) versus those not receiving statin therapy. Compared with standard therapy, intensive statin treatment further reduced the risk of death by 29% (P = 0.020). CONCLUSIONS: High risk CHD patients benefit from intensive statin therapy in a real-world, managed-care cohort, confirming the results of randomized clinical trials.