Healthcare Economics & Outcomes Research



A commitment to leadership





At CSI, we’re on a mission to improve healthcare access and care for coronary artery disease (CAD) and peripheral artery disease (PAD). We’re on a mission to educate patients and physicians. We’re on a mission to improve access and patient outcomes and to deliver value. We collaborate with providers and policy makers to help ensure fair and accurate reimbursement for treatment.

We support groundbreaking research as well as its subsequent publication and presentation to the healthcare community. CSI leaders present at the International Society for Pharmacoeonomics and Outcomes Research (ISPOR) each year.

CSI is a proud supporter of the CardioVascular Coalition, and we continually seek out like-minded industry groups to advance CAD and PAD treatment.


Improving PCI Outcomes for Patients with Complex CAD

At CSI, we’re dedicated to helping reduce severe arterial calcium and enable successful stent delivery to help optimize stent expansion and PCI outcomes. Much of the research surrounding endovascular treatments for CAD exclude patients with severely calcified lesions.

At CSI, we’re focused on developing solutions for this difficult-to-treat population and studying the effectiveness and patient outcomes using orbital atherectomy technology.



Leading the Way for Racial Healthcare Equity in PAD


Peripheral artery disease (PAD) affects up to 18 million people in the US, according to estimates.22 And the numbers will continue to increase:

  • PAD primary or secondary visits expected to top 1.7 million by 202027
  • PAD and PAD-associated leg amputations visits expected to reach 70,000 by 202027

Some studies suggest that African-Americans may not feel the symptoms as early as Caucasians, therefore they do not seek treatment as early.34

CSI seeks to identify racial and ethnic disparities in PAD treatment through our dedicated research and legislative advocacy efforts.

African-Americans & Hispanics are 2X as likely to be amputated as Caucasians29

HEOR PAD-related Amputations By Race | amCharts

Analysis of amputation rates for the treatment of patients with a primary diagnosis of PAD, using the Healthcare Cost and Utilization Project (HCUP) inpatient database from 2006-2013.



CSI’s Dedication to Research

Clinical research supports our goal of informing health policy. We seek to understand the disease state and patient factors. We find ways to help save limbs and advocate for better access to care in the African-American, Hispanic and Native American communities.

Important findings of our recent research determine that:

  • African-Americans are twice as likely and Hispanics are 50% more likely to be amputated than Caucasians as a result of advanced PAD28
  • Results suggest African-Americans and Hispanics have less access to care because they are being admitted when sicker and more likely on an emergent basis28
  • Caucasians were generally older (average age 70.3 vs. 67.8), wealthier, had less severe diseases and a lower mortality risk than African-Americans or Hispanics28
  • African-Americans have an average number of 1,503 PAD-related amputations per year29
  • The amputation rate per minority translates into aggregate healthcare costs of up to $1.12 billion29


2011

• Introduced New Reimbursement/Procedure Codes

2012

• Promoted International Efforts

2013

• Supported OEIS
• Supported Coding to Increase Medicare Payments

2014

• Helped Create Cardiovascular Coalition
• Proposed CLI/Amputation Payment Model

2015

• Helped Form CLI Medical Society
• Met With CMS
• Presented to (MEDCAC)

2016

• Worked with CMS on Mandated Screening Strategy

2017

• Worked with Congress on PAD Medicare Coverage Legislation

Cardiovascular Coalition

A CardioVascular Coalition Charter Member

The CardioVascular Coalition (CVC) understands that PAD is a leading and preventable cause of death in the US. CSI – along with national physician, provider and advocacy organizations – created the CVC to improve the awareness of and prevention of PAD.

As a coalition, we will secure patient access to high-quality, cost-effective interventional treatment for PAD. To help achieve this goal, the CVC currently operates 211 CardioVascular Centers in 31 states.


States with CardioVascular Centers


Supporting Value-based Technology

The CSI team is committed to assisting healthcare policymakers and healthcare providers in evaluating the economic impact of utilizing orbital atherectomy technology. Our team can provide the background and resources you need to evaluate procedures.

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
  • Complaince360-Economic
    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)

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, 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.