Value-Based Evidence


Helping healthcare organizations see CSI products in a value-based healthcare model




Hospitals, practices and physicians face significant challenges as our healthcare system transitions from fee-for-service to value-based models. Administrators often face shifting priorities and must train staff to address a value-based care model that rewards outcomes and prevention.

The transformation is ongoing:

  • The Centers for Medicare and Medicaid (CMS) committed to disburse 50% of total payments through value-based payments by 201841
  • The Health Care Transformation Task Force, a group of some of the largest US health systems and insurers, committed to shifting 75% of its members’ business into contracts with incentives for health outcomes, quality and cost management42

Economic Evidence

Analysis of cost-effectiveness of treatment with orbital atherectomy

  • ORBIT II Economic Evidence
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    ORBIT II10 Cost-Effectiveness Analysis The analysis model looked to determine the cost-effectiveness of using the Diamondback 360® Coronary Orbital Atherectomy System (OAS), compared to Medicare data and patients in the HORIZONS-AMI and ACUITY trials, in the treatment of de novo, severely calcified lesions. Key Takeaways The ORBIT II mean index procedure costs were 17% lower, approximately $2,700 Estimated mean revascularization costs were lower by $1,240 in the base case The cost offsets in the first year, on average, fully cover the cost of the device with an additional 1.2% cost savings The study presents low-value and high-value scenarios and concludes that in even the most pessimistic scenario, OAS offers good value with a cost per life-year gained of $11,895 For PCI patients with severely calcified coronary lesions, OAS technology is likely to result in lower inpatient costs, particularly for the initial procedure and first 30 days Study Design 297 patients ≥65 years from the ORBIT II trial of 443 patients Indirectly compared to Medicare data of similar patients (n=308) using observational data for index procedure For revascularization and cardiac death in the following year, used a pooled analysis of the HORIZONS-AMI and ACUITY trials Primary objective: assess the potential cost-effectiveness of the Diamondback 360 OAS for severe coronary artery calcification by modeling: Expected cost offsets during the acute and post-acute care periods Potential reduction in patient mortality and morbidity The comparison of mortality and morbidity impacts relating to the overall cost impact of device use  
  • CONFIRM Series Economic Evidence
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    The CONFIRM registry series is a database of patients with peripheral artery disease (PAD) who were treated with orbital atherectomy in both office-based laboratories (OBLs) and hospital settings. Statistical analyses assessed the outcomes of atherectomies performed in OBL compared to hospitals. Key Takeaways Final residual stenosis after adjunctive therapy was 10%±11% in the hospital group and 11±17% in the OBL group Dissections occurred in 11.4% of the lesions in the hospital group vs. 6.5% in the OBL group Adjusted logistic regressions showed no difference in any individual or overall complication rate Orbital atherectomy treatment of PAD in an OBL was found comparable to treatment in a hospital setting Study Design Procedural data collected for 3,135 PAD patients at 212 sites in the US treated with OAS for at least one lesion Statistical analyses included Student t test for continuous measures, Chi-square test for categorical measures and logistic regression for complication rates Designed to assess the procedural outcomes of atherectomy in the OBL setting
  • COMPLIANCE 360º Economic Evidence
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    The clinical outcomes from COMPLIANCE 360º5 – a prospective, multicenter, randomized pilot study comparing Diamondback 360® Peripheral Orbital Atherectomy System (OAS) + balloon angioplasty (BA) vs. BA alone for treatment of calcified femoropopliteal lesions – were correlated with cost data and published quality of life data. Key Takeaways Stent utilization was higher with BA-alone treatment for all patients Stent placement effects subsequent procedures and increases the costs for reintervention, while limiting future treatment options The 1-year incremental cost of OAS+BA vs. BA alone was USD $549, resulting in an incremental cost-effectiveness ratio (ICER) of USD $3,441 Study Design Utilized data from COMPLIANCE 360º study subjects from nine US centers Study subjects who met all inclusion criteria and no exclusion criteria were equally randomized into the two study arms, one for OAS followed by BA and one for BA alone Key inclusion criterion: Rutherford Class  2-4 patients who had de novo lesions of ≥70% stenosis and fluoroscopically visible calcium Analyzed OAS+BA and BA-alone procedure charges, procedure time, length of stay, and stent and balloon utilization Utilized uniform billing statements (UB-04s) for hospital charges, site of service and associated medical resource utilization (MRU) Constructed a decision tree based on procedural success and outcomes through 1 year with endpoints of patency, target lesion revascularization or target vessel revascularization, and claudication with no subsequent treatment Patient Population: OAS+BA study arm: 25 subjects with 38 lesions (17 outpatient and 8 inpatient procedures) BA-alone study arm: 25 subjects with 27 lesions (19 outpatient and 6 inpatient procedures)

The Power of Data

As your hospital staff weighs crucial product and technology decisions, your purchasing decision makers need all the available information possible. CSI offers an economic model tool for our coronary device to help hospitals and physicians calculate the economic impact of our technology and programs.



Improving PAD Patient Outcomes and Reducing Costs

The Diamondback 360® Peripheral Orbital Atherectomy Systems, in combination with percutaneous angioplasty (PTA), have been shown to offer more favorable short-term and long-term patient outcomes in PAD treatment when compared head-to-head with balloon angioplasty alone:5

  • Lower percentage of patients requiring revascularization 6 and 12 months after the procedure5,6
  • Lower rate of dissections5,6
  • Reduced need for adjunctive/bail-out stenting5,6
  • Higher percentage of patients achieving ≥30% final residual stenosis5

An incremental cost analysis of OAS in the treatment of PAD11:

  • 1-year incremental cost of $549 compared to balloon angioplasty (BA)
  • Incremental cost-effectiveness ratio (ICER) of $3,441
  • ICER result well below the $50,000 threshold generally considered cost effective in the US
  • Cost to treat restenosis: $13,734 for OAS + BA vs. $20,609 for BA alone
  • Costs for a reintervention procedures higher in the BA group by $7,000

Estimated Procedure Costs and Future Costs11

(Utilizing Diamondback Peripheral OAS)

Index ProcedureMean Cost ($)

Range

(Single-lesion Population)MinimumMaximum
OAS+BA Success10,5165,39021,867
OAS+BA Failure12,03012,03012,030
BA Success6,9515,2579,468
1 Year - Cost to Treat Restenosis
OAS Revascularization13,7359,49118,254
BA Revascularization20,60919,80821,411
Clinical outcomes from COMPLIANCE 360°, a prospective, multicenter, randomized study comparing OAS+BA vs BA alone for treatment of calcified femoropopliteal lesions. Site of service, hospital charges, and associated medical resource utilization were obtained from Uniform Billing statements for index treatments and associated revascularizations out to 1 year. Hospital costs were estimated using hospital-specific, procedure-specific cost-to-charge ratios. Length of stay and procedural data were collected from participating study sites. OAS+BA n=25 and lesions=38; BA alone n=25 and lesions=27.11


Improving CAD Patient Outcomes and Reducing Costs

The annual burden of illness due to coronary artery calcification is estimated at between $1 billion and $3 billion.18 Patients with severe calcification present a greater risk of complication rates, which increases hospitalization costs.4,19

Diamondback 360® Coronary Orbital Atherectomy System (OAS) reduces severe calcium, enabling successful stent delivery to help optimize stent expansion and PCI outcomes.

The coronary OAS is the first novel technology to receive FDA approval to specifically treat severely calcified lesions.4 The Diamondback 360® Coronary OAS has a unique mechanism of action design to:

  • Treat 360˚of the vessel
  • Provide continuous flow of blood and saline during orbit, minimizing thermal injury

PCI Procedure Costs19

CategoryAverage Cost ($)
Hospitalization - All Patients15,089 ± 13,063
Hospitalization - All Patients w/out a Complication13,861 ± 9,635
Patients w/any Complication26,807 ± 27,596
Patients w/ Major Complication vs. All Other Patients
Any Death33,932 ± 40,197
Any Emergency CABG46,032 ± 35,135
Any Postoperative Stroke28,995 ± 26,181
Any Acute Renal Failure36,070 ± 33,602
Any Vascular Complication21,226 ± 20,849
Patients with Secondary Complication vs. All Other Patients
Any Septicemia56,316 ± 53,014
Any Adult Respiratory Syndrome55,375 ± 49,448

An Incremental Cost Analysis of OAS in the Treatment of CAD Found:

  • Savings could be as high as $1,118 (compared to the PCI standard of care minus the cost of the device)7
  • Average patient gaining 0.247 life-years7
  • $11,895 per life-year gained as a calculated ICER7
Results calculated based on modeled synthesis of clinical and economic data utilizing the cost of using the OAS technology in elderly (>65 years) Medicare patients with de novo severely calcified lesions compared to cost offsets. Clinical data from the ORBIT II trial using the pooled analysis of the HORIZONS-AMI and ACUITY trials for comparison. Index procedure costs from Medicare data.
Disclaimer
Example only based on national estimates. Actual reimbursement rates may vary. *Estimated Medicare national average overhead.
Please note: Reimbursement information provided by CSI is gathered from 3rd party sources and is presented for illustrative purposes only. This information does not constitute legal or reimbursement advice.
CSI makes no representation or warranty regarding this information or its completeness, accuracy, timeliness or applicability with any particular patient. CSI specifically disclaims liability or responsibility for the results or consequences of any actions taken in reliance on information in this document. CSI encourages providers to submit accurate and appropriate claims for services. Laws, regulations and payer policies concerning reimbursement are complex and change frequently.
Providers are responsible for making appropriate decisions related to coding and reimbursement submissions. Accordingly, CSI recommends that customers consult with their payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters.

Professional Education


CSIQ is the official medical education program of Cardiovascular Systems, Inc. Our goal is for you to use this information to better understand the prevalence of arterial calcium and how to treat it using our Orbital Atherectomy Systems. From group courses taught by leading orbital atherectomy experts, to personalized, one-on-one proctorships, to insightful courses, CSIQ demonstrates the value and procedural efficiency of our Orbital Atherectomy Systems. Clinical data that underscore the safety, efficacy and long-term durability of the devices is also provided.