Initial Experience With Biologic Polymer Scaffold (Poly-4-hydroxybuturate) in Complex Abdominal Wall Reconstruction.

OBJECTIVE: To evaluate the use of the new absorbable polymer scaffold poly-4-hydroxybutyrate (P4HB) in complex abdominal wall reconstruction. BACKGROUND: Complex abdominal wall reconstruction has witnessed tremendous success in the last decade after the introduction of cadaveric biologic scaffolds. However, the use of cadaveric biologic mesh has been expensive and plagued by complications such as seroma, infection, and recurrent hernia. Despite widespread application of cadaveric biologic mesh, little data exist on the superiority of these materials in the setting of high-risk wounds in patients. P4HB, an absorbable polymer scaffold, may present a new alternative to these cadaveric biologic grafts. METHODS: A retrospective analysis of our initial experience with the absorbable polymer scaffold P4HB compared with a consecutive contiguous group treated with porcine cadaveric mesh for complex abdominal wall reconstructions. Our analysis was performed using SAS 9.3 and Stata 12. RESULTS: The P4HB group (n = 31) experienced shorter drain time (10.0 vs 14.3 d; P < 0.002), fewer complications (22.6% vs 40.5%; P < 0.046), and reherniation (6.5% vs 23.8%; P < 0.049) than the porcine cadaveric mesh group (n = 42). Multivariate analysis for infection identified: porcine cadaveric mesh odds ratio 2.82, length of stay odds ratio 1.11; complications: drinker odds ratio 6.52, porcine cadaveric mesh odds ratio 4.03, African American odds ratio 3.08, length of stay odds ratio 1.11; and hernia recurrence: porcine cadaveric mesh odds ratio 5.18, drinker odds ratio 3.62, African American odds ratio 0.24. Cost analysis identified that P4HB had a $7328.91 financial advantage in initial hospitalization and $2241.17 in the 90-day postdischarge global period resulting in $9570.07 per case advantage over porcine cadaveric mesh. CONCLUSIONS: In our early clinical experience with the absorbable polymer matrix scaffold P4HB, it seemed to provide superior clinical performance and value-based benefit compared with porcine cadaveric biologic mesh.

Splitting the Difference: Using Synthetic and Biologic Mesh to Decrease Cost in Prepectoral Immediate Implant Breast Reconstruction.

SUMMARY: Prepectoral breast reconstruction has minimized morbidity and dynamic deformities associated with submuscular implant-based breast reconstruction. However, reliance on implant coverage with acellular dermal matrix in immediate implant reconstruction remains limited by high material costs. The authors describe a technique in which anterior implant coverage in prepectoral reconstruction is split into acellular dermal matrix inferolaterally and synthetic, absorbable mesh superiorly. Use of acellular dermal matrix inferiorly provides coverage and reinforces the inframammary fold, whereas the absorbable mesh is trimmed and sutured to the acellular dermal matrix at the appropriate tension to support the implant and relieve pressure on mastectomy flaps. A retrospective review was performed on all consecutive prepectoral one-stage breast reconstructions using this technique at a single institution. Patient demographics, mastectomy and reconstruction characteristics, reconstructive outcomes, and cost of support materials were queried and analyzed. Eleven patients (21 breasts) underwent prepectoral immediate implant reconstruction with Vicryl and acellular dermal matrix anterior coverage. Average mastectomy weight was 775.8 g. Smooth, round cohesive implants were used in all cases and average implant size was 514.5 ml. Overall complication rates were low and included one minor infection (4.8 percent) and one case of minor mastectomy flap and partial nipple necrosis each (4.8 percent). Calculated cost savings of Vicryl and acellular dermal matrix anterior coverage was up to $3415 in unilateral and $6830 in bilateral cases. Prepectoral breast reconstruction using acellular dermal matrix inferiorly and Vicryl mesh superiorly is a safe technique that decreases material costs associated with support materials and allows the surgeon to precisely control the implant pocket and position. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.

BACKGROUND: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system. METHODS: A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature. RESULTS: The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost. CONCLUSIONS: The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.

Health Economic Evaluation of an Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Coronary Stent Compared to a Thin, Durable-Polymer Everolimus-Eluting Stent.

OBJECTIVES: The study estimated the health economic impact of a latest generation coronary stent with ultrathin struts and bioresorbable polymer coating. BACKGROUND: The recent BIOFLOW V trial, an international FDA approval trial (ClinicalTrials.gov: NCT02389946), has shown that an ultrathin, bioresorbable polymer sirolimus-eluting stent had a significantly lower rate of target lesion failure and target vessel-related myocardial infarction than a thin, durable polymer everolimus-eluting stent at 12 months, driven by a lower rate of peri-procedural myocardial infarction (ppMI). METHODS: We used a Markov model to project mortality and cost outcomes of that lower ppMI rate from a U.S. health system perspective over a 12-month horizon. Model parameters were derived from BIOFLOW V trial data, a systematic literature review and expert interviews. RESULTS: Use of the bioresorbable polymer sirolimus-eluting stent compared to durable polymer everolimus-eluting stent is associated with net reductions in medical cost of $124 (Interquartile Range (IQR) $97-154) per patient in 2018 US$, of which $115 (IQR $76-124) accrues to the initial admission and $10 (IQR $7-72) to cost of follow-up. The lower rate of ppMI translates into a gain of 0.000017 (IQR 0.000011-0.000022) quality-adjusted life-years (QALY) per patient. CONCLUSIONS: Lower ppMI rates of bioresorbable polymer sirolimus-eluting stent translate into reductions in direct medical cost, while improving patient outcomes. Most of the cost reduction is attributed to the initial admission with moderate savings up to 12 months post-discharge.

Cost-effectiveness analysis of biodegradable polymer versus durable polymer drug-eluting stents incorporating real-world evidence.

AIM: Compared with second-generation durable polymer drug-eluting stents (DP-DES), the cost-effectiveness of biodegradable polymer drug-eluting stents (BP-DES) remains unclear in the real-world setting. We assessed the cost-effectiveness of BP-DES in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). METHODS: We developed a decision-analytic model to compare the cost-effectiveness of BP-DES to DP-DES over 1 year and 5 years from healthcare payer perspective. Relative treatment effects during the first year post-PCI were obtained from a real-world population analysis while clinical event risks in the subsequent 4 years were derived from a meta-analysis of published studies. RESULTS: At 1 year, based on the clinical data analysis of 497 propensity-score matched pairs of patients, BP-DES were associated with an incremental cost-effectiveness ratio (ICER) of USD20 503 per quality-adjusted life-year (QALY) gained. At 5 years, BP-DES yielded an ICER of USD4062 per QALY gained. At the willingness-to-pay threshold of USD50 400 (one gross domestic product per capita in Singapore in 2015), BP-DES were cost-effective. Sensitivity analysis showed that the cost of stents had a significant impact on the cost-effectiveness of BP-DES. Threshold analysis demonstrated that if the cost difference between BP-DES and DP-DES exceeded USD493, BP-DES would not be cost-effective in patients with 1 year of follow-up. CONCLUSIONS: Biodegradable polymer drug-eluting stents were cost-effective compared with DP-DES in patients with coronary artery disease at 1 year and 5 years after PCI. It is worth noting that the cost of stents had a significant impact on the findings.

Evaluation of a steroid releasing sinus implant for the treatment of patients undergoing frontal sinus surgery for chronic rhinosinusitis.

INTRODUCTION: Management of the frontal sinus places great demands on the otolaryngologist. Given that the fronto-ethmoidal region is susceptible to recurrent inflammation, scarring, and stenosis, maintaining long-term patency of the frontal sinus is a difficult challenge. Oral and topical anti-inflammatory therapy, post-operative stenting, and 'home-brew' drug elution have been used for the treatment of the frontal sinus with mixed success. Recently an implant has been approved for post-operative placement into the frontal recess. This implant provides reliable and consistent steroid drug elution to address inflammation of the frontal recess secondary to chronic sinusitis. Areas covered: This review discusses the development and application of steroid eluting implants in the postoperative care of patients with chronic frontal sinusitis. All randomized controlled trials evaluating steroid eluting implants are discussed. Relevant supporting material discussing background, economics, safety are included. Expert commentary: Steroid eluting implants fulfill a unique niche in the treatment following frontal sinus surgery. They are shown to decrease the need for post-operative interventions and improve outcomes in patients with chronic sinusitis. There is significant potential for growth in the use of steroid eluting implants.

Economic Outcomes of Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ABSORB III Trial.

OBJECTIVES: The purpose of this study was to evaluate the economic impact of the Absorb bioresorbable vascular scaffold compared with the Xience everolimus-eluting stent in patients undergoing percutaneous coronary intervention. BACKGROUND: The ABSORB III trial (Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease) demonstrated that the Absorb scaffold was noninferior to the Xience stent with respect to target lesion failure at 1 year. Whether health care costs differ between the Absorb scaffold and the Xience stent is unknown. METHODS: We performed a prospective health economic study alongside the ABSORB III trial, in which patients undergoing percutaneous coronary intervention for stable or unstable angina were randomized to receive the Absorb scaffold (n = 1,322) or Xience stent (n = 686). Resource use data were collected through 1 year of follow-up. Costs were assessed using resource-based accounting (for procedures), MedPAR data (for other index hospitalization costs), and Medicare reimbursements (for follow-up costs and physician fees). RESULTS: Initial procedural costs were higher with the Absorb scaffold than the Xience stent ($6,316 ± 1,892 vs. $6,103 ± 1,895; p = 0.02), driven mainly by greater balloon catheter use and the higher cost of the scaffold in the Absorb group. Nonetheless, index hospitalization costs ($15,035 ± 2,992 for Absorb vs. $14,903 ± 3,449 for Xience; p = 0.37) and total 1-year costs ($17,848 ± 6,110 for Absorb vs. $17,498 ± 7,411 for Xience; p = 0.29) were similar between the 2 groups. CONCLUSIONS: Although initial procedural costs were higher with the Absorb scaffold, there were no differences in total 1-year health care costs between the 2 cohorts. Longer term follow-up is needed to determine whether meaningful cost savings emerge after scaffold resorption. (A Clinical Evaluation of Absorb™ BVS, the Everolimus-Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT01751906).

Budget impact analysis of bioabsorbable drug-eluting sinus implants following endoscopic sinus surgery.

OBJECTIVE: Propel is a bioabsorbable drug-eluting sinus implant inserted following an endoscopic sinus surgery (ESS) for chronic rhinosinusitis (CRS). The objective of this study was to estimate the budget impact of incorporating Propel post-ESS for CRS patients from a self-insured employer or third-party payer perspective. METHODS: An Excel-based budget impact model was developed. Estimates of the prevalence of CRS, rates of ESS, and effectiveness outcomes, along with direct and indirect costs from CRS were obtained from published literature. A total population of 1.5 million members was hypothesized for the analysis. All cost data were adjusted to October 2015 US dollars using the Medical Care Component of the Consumer Price Index. The cost and clinical/economic characteristics of Propel were compared to other treatments commonly used to minimize post-operative complications. The primary outcome was the incremental budget impact reported using per-member-per-month (PMPM) costs. Scenario-based, probabilistic, and one-way sensitivity analyses were performed to gauge the robustness of the results and identify the parameters with the most influence on the results. RESULTS: For a US self-insured employer or a commercial health plan of 1.5 million members, the incremental PMPM impact of incorporating Propel was estimated to range from -$0.003 to $0.036, respectively, for all members in the health plan. Sensitivity analyses identified the cost of Propel, probability of polyposis recurrence requiring medical intervention, probability of adhesion formation requiring surgical intervention, and the treatment costs for polyposis as the primary parameters influencing the results. CONCLUSION: This study has demonstrated the use of Propel following ESS procedures has a negligible impact on the budget of a US self-insured employer or payer. The upfront cost of Propel was offset by savings associated with reduced probability for polyp recurrence, adhesion formation, and their subsequent treatment.

Economic Impact of the Use of an Absorbable Adhesion Barrier in Preventing Adhesions Following Open Gynecologic Surgeries.

We used an economic model to assess the impact of using the GYNECARE INTERCEED absorbable adhesion barrier for reducing the incidence of postoperative adhesions in open surgical gynecologic procedures. Caesarean section surgery, hysterectomy, myomectomy, ovarian surgery, tubal surgery, and endometriosis surgery were modeled with and without the use of GYNECARE INTERCEED absorbable adhesion barrier. Incremental GYNECARE INTERCEED absorbable adhesion barrier material costs, medical costs arising from complications, and adhesion-related readmissions were considered. GYNECARE INTERCEED absorbable adhesion barrier use was assumed in 75% of all procedures. The economic impact was reported during a 3-year period from a United States hospital perspective. Assuming 100 gynecologic surgeries of each type and an average of one GYNECARE INTERCEED absorbable adhesion barrier sheet per surgery, a net savings of $540,823 with GYNECARE INTERCEED absorbable adhesion barrier during 3 years is estimated. In addition, GYNECARE INTERCEED absorbable adhesion barrier use resulted in 62 fewer cases of patients developing adhesions. Although the use of GYNECARE INTERCEED absorbable adhesion barrier added $137,250 in material costs, this was completely offset by the reduction in length of stay ($178,766 savings), fewer adhesion-related readmissions ($458,220 savings), and operating room cost ($41,078 savings). Adoption of the GYNECARE INTERCEED absorbable adhesion barrier for appropriate gynecologic surgeries would likely result in significant savings for hospitals, driven primarily by clinical patient benefits in terms of decreased length of stay and adhesion-related readmissions.

Beyond biologics: absorbable mesh as a low-cost, low-complication sling for implant-based breast reconstruction.

BACKGROUND: There is an intense push to decrease overall healthcare costs in the United States. Although the use of acellular dermal matrix in implant-based reconstruction has grown significantly over the past decade, potential drawbacks remain a source of debate. Matrices are costly and not universally available across institutions, whereas Vicryl mesh is widely available, relatively inexpensive, and resistant to bacteria biofilm formation. With the intent of maximizing the reconstructive and economic advantages of direct-to-implant breast reconstruction, the authors report the first experience in the literature using an absorbable mesh as an inferolateral sling. METHODS: A retrospective review was performed of the first 50 consecutive patients (76 reconstructions) who underwent implant-based breast reconstruction with Vicryl mesh from August of 2011 until June of 2012. RESULTS: Fifty patients underwent 76 direct-to-implant reconstructions with Vicryl mesh between August of 2011 and June of 2012 (mean follow-up, 1.2 years). Five breasts (6.6 percent) had complications, with only one complication resulting in implant loss (1.3 percent). Implant positioning and contour were excellent, with only two patients [three breasts (3.9 percent)] undergoing revision procedures, for size enlargement. Using costs available at the authors' institution, use of Vicryl mesh instead of acellular dermal matrix resulted in a direct material cost savings of $172,112 in 10 months. CONCLUSIONS: Results to date have been encouraging, with a low complication rate (6.6 percent) and excellent aesthetic results. The technique has resulted in $172,112 in direct material cost savings over 10 months. Continued follow-up is planned to evaluate long-term results. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

How we do it: the absorbable gelatin sponge cube, an effective and economical approach to packing in ear surgery.

INTRODUCTION: There is currently a lack of robust evidence on the best form of packing for otological surgery. We describe the use of the absorbable gelatin sponge, a packing material that does not require removal and has the benefit of being considerably cheaper compared to other common forms of ear packing. METHODS: A comparison was made of the financial cost of several forms of packing for common otological procedures. In addition, a retrospective audit of complications was undertaken of all patients in whom the absorbable gelatin sponge was used over the past three years. RESULTS: The absorbable gelatin sponge was shown to be cheaper to purchase per unit and also more economical to use. It has been the exclusive form of packing used in 519 procedures over the past three years at the William Harvey Hospital in Ashford (UK), with very few complications noted at the follow-up review. CONCLUSION: We strongly advocate using the absorbable gelatin sponge, a packing material that is kinder to the patient, has similar efficacy to other forms of packing and is also much cheaper to use compared to other common forms of packing.

To plug or not to plug: a cost-effectiveness analysis for complex anal fistula.

BACKGROUND: Complex anal fistulas are unsuitable for fistulotomy because of the risk of fecal incontinence. The anal fistula plug (AFP) has demonstrated fistula healing without sphincter division. This study aims to evaluate the cost-effectiveness of the AFP compared to the endoanal advancement flap (EAAF) as an alternative sphincter-preserving option for complex anal fistulas. METHODS: The study included 24 patients who underwent treatment for complex anal fistulas. Healing and complication rates of a prospective cohort of AFP patients (n=12) were compared to a retrospective cohort of patients who underwent EAAF (n=12). Cost data were collected after validated healthcare reporting standards. A cost-effectiveness analysis was performed, including extensive modeling of fistula healing rates. RESULTS: Both cohorts (12 AFP patients and 12 EAAF patients) had similar patient demographics and fistula characteristics. Fistula healing was achieved in 50% (5/12) of AFP patients and 33% (4/12) of EAAF patients (P=.680). Median clinical follow-up was 28 weeks for the AFP patients and 14 weeks for the EAAF patients, whereas median recurrence time was 17.6 weeks (range, 0.4-43.9) and 12.6 weeks (range, 2-34.3), respectively. Use of the AFP instead of the EAAF saved $1,588 (95% confidence interval [CI], $1,211-$1,965; P<.0001), and 1.5 hospital days per healed fistula (P=.0002). This cost-saving effect persisted and amounted to $825 (95% CI, $133-$1,517; P=.022) when the cost estimates were adjusted for the reduction in the hospital length of stay. Extensive modeling over a large range of fistula healing rates confirmed the cost-effectiveness of the AFP. CONCLUSION: The AFP is a cost-saving procedure for complex anal fistulas compared to the EAAF.

Skeletal stability in bimaxillary orthognathic surgery: P(L/DL)LA-resorbable versus titanium osteofixation.

BACKGROUND: One-year skeletal stability following bimaxillary orthognathic surgery was assessed by comparing poly(L-lactide-co-DL-lactide) to titanium osteofixation. METHODS: Thirty patients underwent osteofixation with poly(L-lactide-co-DL-lactide) copolymer and 30 had 2.0-mm titanium-miniplate osteosyntheses. Lateral cephalograms were analyzed preoperatively, postoperatively, and at 1-year follow-up. Average +/- SD values were as follows in resorbable plate-osteosyntheses (number of cases/titanium controls): for maxillary advancement, 3.5 +/- 4.1 mm (n = 19)/5.4 +/- 3.5 mm (n = 21); setback, 2.8 +/- 3.7 mm (n = 9)/1.9 +/- 1.8 mm (n = 8); elongation, 4.2 +/- 3.6 mm (n = 18)/3.7 +/- 5.2 mm (n = 14); and intrusion, 1.9 +/- 1.7 mm (n = 12)/3.3 +/- 2.7 mm (n = 13); for mandibular advancement, 4.6 +/- 3.6 mm (n = 10)/6.3 +/- 8.8 mm (n = 18); setback, 7.5 +/- 8.3 mm (n = 20)/7.2 +/- 3.2 mm (n = 12); enlargement of the mandibular angle, 11.8 +/- 9.9 degrees (n = 19)/7.9 +/- 6.6 degrees (n = 21); and reduction, 4.5 +/- 3.2 degrees (n = 9)/6.3 +/- 6.6 degrees (n = 9). RESULTS: Preoperative to postoperative landmark positions within the study and control groups differed highly significantly (p = 0.008, paired t test), yet the amount of operative movement was comparable between the study and control groups (p = 0.5, two-sided t test). Absolute instability at the advanced A-point was (study group/controls) 2.3 +/- 1.8/2.4 +/- 2 mm, setback was 2.3 +/- 1.9 mm/2.5 +/- 1.7 mm, elongation at the anterior nasal spine was 3.8 +/- 3.1 mm/3.1 +/- 3.6 mm, intrusion was 2.1 +/- 1.9 mm/2.2 +/- 1.5 mm, advancement instability at the B-point was 4.9 +/- 4.3 mm/5.1 +/- 8.2 mm, setback was 3.0 +/- 2 mm/1.7 +/- 2 mm, mandibular angle enlargement instability was 6.7 +/- 8.9 degrees/8.2 +/- 9.6 degrees, and angle narrowing was 6.8 +/- 5.2 degrees/4.2 +/- 5.9 degrees. Absolute postoperative instability did not differ significantly between the study and control groups (p = 0.6). CONCLUSIONS: Resorbable osteofixation as tested proved to be as reliable as titanium, but as the study and control groups were not matched, the results have to be interpreted as preliminary. Resorbable materials permitted clinically faster occlusal and condylar settling than standard titanium osteosyntheses, as bone segments showed slight clinical mobility up to 6 weeks postoperatively.