- Email: [email protected]
Registry
CHAPTER 19
Registry BOB TAHARA, MD, FSVS, FACS, RVT, RPVI • JEFFREY G. CARR, MD, FACC, FSCAI
INTRODUCTION Office-based endovascular centers (OECs) also known as outpatient interventional suites (OISs) or officebased labs (OBLs) have continued to grow throughout the United States with an accompanying shift from inpatient and hospital-based care to outpatient and office-based interventions.1,2 This has included marked increase in the number of outpatient peripheral interventional procedures, cardiac diagnostic/interventional procedures, dialysis interventions, interventional oncology-related procedures and a wide array of both superficial and deep venous procedures. As this shift has become more pronounced, there has been a corresponding increase in concern and focus on quality of care provided in the outpatient sites of service. This focus has included questions on appropriateness, patient selection, procedural conduct and safety, and ultimately outcome measures.2,3 While there have been multiple peer-reviewed publications documenting the safety and efficacy of office-based interventions, the majority of these papers report results from a single center or data from relatively small series.4,5 A broad-based multicenter documentation of interventional experience in an office or freestanding facility has been elusive and challenging but is desirable. Participation in a Quality Clinical Data Registry (QCDR) is one option that can be utilized to address some of these questions and concerns on a broader basis. Generally speaking, a clinical data registry enables the collection of clinically relevant data about a specific disease state, condition, or procedure(s) with the goal of documenting and understanding basic patient characteristics and demography, disease morphology and expression, risks and exacerbating factors, procedural characteristics, and outcomes. Specific registries may also concentrate on tracking data such as safety and efficacy, complications, cost data, and any other cogent variables and factors. The data can then be analyzed to allow the assessment and provide useful information regarding real-world practice patterns, clinical pathways
or guidelines, risk stratification, cost-benefit ratios, optimal use of new or existing treatments or devices, and potential contraindications. In addition to the analytics and pure scientific utility of clinical registries, there are a growing number of federal regulations which require data reporting through a QCDR. Registry participation may also be used to satisfy some or all of the requirements attendant to the Merit-Based Incentive Payment System (MIPS) as mandated by the Medicare Access and CHIPs Reauthorization Act (MACRA) which was signed into law in 2015.6
Desired Features and Value of Clinical Data Registries Ideally a clinical data registry should have several desirable characteristics: 1) Reasonably easy data entry 2) Collection of the clinically relevant variable information in a manner that makes sense to the participating clinician 3) Scalable architecture which allows or already incorporates implementation of different modules or modalities to accommodate changing care patterns 4) Adequate and timely reporting and analytics 5) Reasonable cost basis 6) Data that support a site’s quality improvement functions and the ability to satisfy statutory and/or regulatory reporting requirements We will broadly examine some of these characteristics and then describe specific currently available clinical data registries which are in use and applicable to the OEC/OIS.
REGISTRY CHARACTERISTICS Data Entry For a clinical data registry to have any utility at all, one must first enter relevant data into the registry! Data entry is fundamentally impacted by the design and
Office-Based Endovascular Centers. https://doi.org/10.1016/B978-0-323-67969-5.00019-8 Copyright © 2020 Elsevier Inc. All rights reserved.
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architecture of a particular database. Initially, many databases or tracking programs were individually hosted on hardware resident in a particular hospital, facility, or office leading to implementations that were potentially “one off” and limited by both the systems utilized as well as the technical support personnel and programmers available to that site. Additionally, these databases were proprietary to the group or institution and inherently were limited in scope. Modern “big data” paradigms have fundamentally shifted this architecture to a virtual, cloud-based hosting environment that now encompasses a wide array of SQL and NoSQL database architectures allowing accumulation and rapid processing of a staggering number of variables and data points. The majority of currently available clinical data registries utilize a web-based electronic data collection (EDC) format. The advantage of this approach is wide accessibility of data from any device capable of running a compatible web browser, near instant upload of the entered information into the database, and the ability to edit entries if appropriate. Typically, current registries incorporate fairly robust security provisions with granular role-based permissions that allow both clinicians and their ancillary staff to enter and review patient data during and after entry into the EDC. Disadvantages include the need for reasonably robust Internet access, the need for accurately typing in free text if required or making appropriate menu or drop-down selections, difficulties with passwords and usernames, and any or all of the attendant technical difficulties websites may experience. Web-based EDCs frequently incorporate multiple entry mechanisms including free text, numerical data, multiple choice selections, and/or menu-based options. Free entry options for both textual strings and numerical data allow a basically unlimited and a long range of data entry. Disadvantages of free entry include the interjection of variability in format and values that could potentially render the data difficult or impossible to analyze, transcriptional errors, and a greater time/ typing requirement. Menu-based or multiple-choice options allow for standardization of values, formats, and speedy entry but decrease the possible data entry range as compared with free entry. Even more efficient and idealized mechanism for data entry potentially is either by direct transfer or some type of export/import facility of structured data transfer from an electronic medical record (EMR) into the registry database. Advantages of this approach would include an elimination of transcriptional or selection errors, elimination of hand entry and the attendant savings in both personnel time and costs.
Disadvantages include direct transfer of data which was erroneously entered into the EMR, a host of potential technical hurdles to implementation, and the cost of implementation on a widespread basis. At the current time, despite data transfer standards such as HLA7, there is substantial variation between different EMR products’ capability to store their own data, database architecture support, and implementation of data transfers and/or exports. This functionally leads to a situation where each individual product requires individual programming or mapping to enable a direct transfer or export/import functionality, which in turn substantially increases the cost of implementation. Smaller organizations, offices, or physician practices rarely have the resources to implement these types of transfers at the local level and larger organizations may have a host of competing technical demands. Both scenarios often preclude development of transfer and/or export/import facilities to a clinical registry. Despite these technical hurdles, there will likely be automatic electronic transfer of data from EMRs into clinical registries in the future to improve efficiencies and reduce the burden of data entry duplication.
REGISTRY ARCHITECTURE While a complete discussion of back-end database architecture is beyond the scope of this chapter, we will briefly explore characteristics the authors believe are desirable in a clinical data registry. Both SQL and NoSQL database engines provide advantages and disadvantages in the architecture of the database. Both types are broadly incorporated into several clinical data registries, allow appropriate queries and data analysis, and have mature enterprise level support for clinical registry vendors. Regardless of the basic database engine used, it is absolutely essential that the database structure incorporates appropriate relationships between the variables and between different table and file structures so that proper analytics can be performed. This basic structure generally needs to be established very early in the database design phase and essentially requires some understanding of desired and required analysis of data as the end product. Data should be collected based on the questions that are being asked and need an answer. Development of various database modules for different disease states and procedures is a basic requirement to meet the evolving needs of the OEC/OIS/OBL. Considering the range of cardiovascular procedures that are currently performed in outpatient environment, there is a need for either (1) individual clinical registry
CHAPTER 19 for specific category of disease/interventions or (2) more comprehensive registries that have multiple disease-specific/intervention-specific modules. Using multiple individual registries for each specific type of disease or intervention rapidly complicates the logistics, data entry complexity, staff time, and cost of participation for practices or sites that perform multiple types of interventions that include peripheral arterial, venous, cardiac, dialysis access, and other interventions. A possibly easier and more cost-effective option would be to utilize a clinical data registry that has a common entry and cost structure but incorporates multiple modules to report on different disease processes or interventions. Potential required modules include peripheral arterial interventions, diagnostic coronary angiography and coronary interventions, cardiac rhythm interventions/management, dialysis access formation and interventions, and superficial/deep venous interventions. Unfortunately, as detailed further in this chapter, no single clinical registry currently fulfills and supports all of these module requirements.
REPORTING AND ANALYTICS The ability to analyze the raw data entered into a clinical data registry is another basic required function. Ideally this reporting would update either in realtime or on a regular and frequently scheduled basis, be available for viewing online and provide the ability to download reports and results, provide participating clinicians with information that is meaningful and answers cogent clinical questions. The ability to benchmark individual physicians, groups or virtual groups against the aggregated data may provide valuable insights into care patterns, utilization rates, and allows the reporting of data for quality assurance/improvement activities. Basic reporting should allow analysis of patient demographics, risk factors, disease severity, identification of complications and complication rates, and intervention-specific outcome measures. More sophisticated analytics may provide subgroup analysis which allows drilling down to an individual risk or morphology in an effort to find optimal treatment modalities and minimize complication potential. For example, basic reporting could give a range and average of patient ages, incidence of diabetes and/or hypertension etc., and the overall complication rate for a particular intervention such as angioplasty. More detailed analysis might provide a more granular report. It may be possible to study patient outcomes using a specific device or modality for a specific subset
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of patients, i.e., vessel patency at various intervals while using a particular atherectomy device or stent in patients over the age of 70 with elevated LDL levels. Reports may take a multitude of forms ranging from simple tabular results to very sophisticated visualizations using a variety of line graphs, bar graphs, or pie charts (Fig. 19.1). Interactive reporting where queries or graphs can be clicked on to drill down to more granular details is often desired by clinicians. Well-designed clinical reporting dashboards help consolidate reporting in an accessible manner and simplify viewing of both site-specific and aggregated results. Leveraging cloud-based computing resources so that all of the CPU-intensive computation is performed on the hosting server is faster and more scalable than downloading raw data and performing the analysis on a local machine or device. Additionally, mobile-optimized websites can potentially offer this type of reporting accessible via handheld devices allowing the data to be viewed at the bedside and across different locations.
REGULATORY/STATUTORY REQUIREMENTS Clinical data registries can be used to meet certain federal requirements. QCDRs are a subset of all existing clinical data registries and can be used to report data satisfying a portion of the MIPS requirements that were established under MACRA. A clinical data registry may nominate itself to the Center for Medicare Services (CMS) in order to be considered for QCDR status. If the registry meets CMS-defined requirements, it may be granted QCDR status which allows the registry to be used by eligible clinicians/groups for MIPS reporting. These requirements are posted on the CMS website. Reporting requirements have changed significantly since originally approved in 2015. There are additional ongoing requirements to maintain QCDR status including meeting and conference participation, documentation review and revision, auditing functions, and quality measure reviews that must be conducted in accordance with the current CMS regulations and guidance. The authors anticipate that there will continue to be quite a bit of fluidity in the QCDR/ MIPS/MACRA reporting and qualification requirements in the future and that the one constant we can count on is that, there will be changes in reporting requirements. Notwithstanding these challenges, possessing a designated QCDR status is a highly desirable quality for registries.
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13239
9397
Last
Total Procedures
Total Subjects
Maintena... 2.92%
Ambulatory...
98.2%
Procedure Type
Procedure Indication
Site of Service
View Subject Details
Date
Interventional Planned Diag...
Acute Ischemia 3.16%
?
Home Hospital...
10,000
Procedure Success
Office (Free s..
Age
0K
5,000
59 Total
Claudication 61.86%
Overall Complication Rate
10K
Hospital Transfer Rate
11789
1.518%
0.45% Rate
Hospital Transfers
>65 76.86%
View Complication Details
14K 0K 0K
Dist... 0.0... CLI 12.51...
<65 21.56%
Select
Discharge Disposition
1989
Minor Tissu... 14.06%
1
No filters applied
0
27 20
Sex at Birth
Rutherford Classification (Chronic)
1.1%
Total Lesions
Left 5K
Female 39.5%
Male 59.3%
ASA Class 864
15
Urgent Elective Emergent 1984
1
3/25/2019 12:58:04 PM Refresh Timestamp (UTC)
3K 1237 2K 637
2654 1K
500
Total Interventions View Intervention Details
10 0
1,000
39423
17
Right
4K
View Lesion Details
Left and Right
19555
527
18 19
1699
631
1054
0K
0 0
5
0
2
4
6
FIG. 19.1 Screenshots of Outpatient Endovascular and Interventional Society (OEIS) National Registry
Dashboard.
Currently Available and Applicable Clinical Data Registries There are several clinical data registries that are currently in operation and support in whole or part many of the interventions being performed in outpatient settings. Some of these are outpatient focused, i.e., Outpatient Endovascular and Interventional Society (OEIS) National Registry, while others really began and are primarily focused on hospital-based care but allow for outpatient case data entry, i.e., VQI. Some are split between the inpatient and outpatient intervention, i.e., National Cardiovascular Data Registry (NCDR). Some registries are very specific to single disease entities, i.e., American Vein and Lymphatic Society (AVLS formerly ACP) Venous Registry and NCDR peripheral vascular intervention (PVI) Registry. Some have started with a particular facet of care and have plans to add modules, i.e., OEIS National Registry currently enrolls only peripheral arterial interventions but has plans to add coronary and rhythm management, venous, and dialysis modules. Unfortunately, no single registry that is currently available meets the requirements of all the procedures carried out in OEC. We briefly summarize the key attributes of the currently available registries.7
OEIS National Registry The OEIS was founded in 2013 for the express purpose of promoting high-quality patient-centric care in the outpatient interventional suite. Membership in this organization is deliberately multidisciplinary and primarily composed of vascular surgeons, interventional cardiologists, and interventional radiologists performing cases in an outpatient or office environment. To advance the goal of reporting outcomes and serve as a platform for research, the OEIS National Registry was conceived and became operational in January 2017. The first module to come online was the Peripheral Arterial Interventions module. This collects and analyzes data related to lower extremity arterial intervention in the outpatient and office sites of service. The registry is structured around a NoSQL back end (MongoDB, MongoDB Inc.) with a proprietary web-based EDC (Syncrony-Syntactx Corporation) which is utilized by participating sites for data entry and accessing reports. The registry allows for exporting of raw data and completed analytics. Aggregated and site-specific data/analytic dashboards are available online to participating sites, and some summary data are available publicly. Direct export/import from EMRs is not currently available but is under development at the time of this publication. Reporting is currently in
CHAPTER 19 the form of a set of fairly sophisticated dashboards which allow the participating sites/clinicians to view the results of a defined set of CMS-approved quality measures, patient demographic and comorbidity data, procedural and interventional data, complications, and long-term outcomes such as patency and amputation rates. Interactive dashboards allow subgroup analysis. At the time of this writing, the registry has 62 sites and has enrolled nearly 17,000 peripheral arterial intervention cases in its first 2 years of existence. The OEIS NR is an approved QCDR and supports reporting of CMS-approved Quality Measures and Improvement Activities as part of MIPS. This provides a vehicle for registry subscribers to submit their performance on certified quality measures to receive an adjustment for reimbursement for their Medicare cases. Costs to subscribe to the OEIS registry are modest with a defined monthly fee, a discount for active OEIS members, and zero setup fees. At the time of writing, the monthly OEIS member rate is $175.00/month per site. Further information can be found by accessing the OEIS NR webpages at https:// oeisociety.com/oeis-national-registry/.
The Vascular Quality Initiative8,9 The Vascular Quality Initiative (VQI) was originally created in 1982 as a regional effort by the Vascular Study Group of New England (VSGNE) to track, standardize, and improve vascular care and outcomes. The VQI underwent further development in content, scope, and platform and was subsequently adopted by the Society of Vascular Surgery (SVS) in 2011. The VQI is now more than a registry and is a formally recognized Patient Safety Organization (PSO). It currently offers 12 modules including AAA, TEVAR, carotid interventions (both CEA and CAS), venous interventions, hemodialysis access, peripheral vascular interventions (PVIs), infrainguinal and suprainguinal bypass, and others. Additional modules being actively developed include a noninvasive vascular ultrasound module and vascular medicine management module. VQI has robust support from the SVS. PSO is an LLC owned and administered by SVS with a formal governance and administrative structure for the PSO itself. A formal VQI Research Committee exists and is active in directing and facilitating data harvest and publications documenting results from enrolled cases. The PSO also has established specific Arterial and Venous Quality Councils and has a number of ongoing Quality Initiatives that are actively managed. The database structure is SQL based for transactions and NoSQL for the actual analytics. The EDC is webbased and currently developed and administered by
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M2S (West Lebanon, NH). Collected data fields are both comprehensive and detailed which requires a significant investment in staff time for data entry and typically requires institutional support. VQI has recently developed a “basic” input version which reportedly markedly decreases the collected data points in response to user concerns about the time required for data entry in the office/outpatient venue. Direct EMR imports/exports are not yet fully enabled. The registry does allow for exporting of data and completed analytics in various formats. Aggregated and site-specific data/analytic dashboards are available online to participating sites, and some summary data are publicly available. The dashboard reports are comprehensive, and subgroup analysis is available. At the time of this writing, the VQI has 557 participating centers, 18 regional groups, and over 576,000 entered cases including about 183,000 peripheral interventions. The overwhelming majority of these enrolled cases were performed in inpatient hospital setting in North America and none of the modules is outpatient specific. VQI is an approved QCDR and supports reporting of CMSapproved Quality Measures and Improvement Activities as part of MIPS. Costs, however, are substantial with an initial setup fee of $5000.00 and a subscription fee of $2500.00 per module utilized. Some variable discounts are available dependent on institution and number of participating centers subscribed via a particular site. VQI is the most comprehensive and expensive registry for PVI. Further information can be found by accessing the VQI website at https://www.vqi.org/about/.
National Cardiovascular Data Registry10 The National Cardiovascular Data Registry (NCDR) was originally developed in 1997 by the American College of Cardiology (ACC). The original focus was on cardiology-specific intervention and has been expanded to currently offer eight hospital-based registries including acute STEMI/NSTEMI interventions, elective percutaneous coronary intervention, implantable cardioverter-defibrillator, congenital heart disease, and PVIs. There is also a module for atrial fibrillation ablation and a module jointly managed with the Society for Thoracic Surgery (STS) analyzing transcatheter valve therapies. There are two outpatient-specific registries which track (1) outpatient medical management of coronary artery disease, hypertension, heart failure, atrial fibrillation, and diabetes, and (2) a diabetes-specific registry which is used to track diabetes care across a wider spectrum of providers, not simply cardiology. Currently, there is no outpatient-specific procedural module or registry.
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The database structure and back end are not disclosed. Data entry is enabled via a web-based EDC or hospitals may choose from several software/service vendors to enable transfer from hospital EMR and internal data collection methods into the applicable NCDR registry. Collected data fields are extensive and detailed but there has been significant development allowing EMR import/exports particularly from the outpatient registry modules and thus often minimizing staff data entry time. Basic analytics and dashboard functions are available for each applicable registry within the NCDR portfolio and more extensive reporting is available. Public reporting of aggregate data is not available. Site-specific reporting has been made voluntary but reporting without explicit hospital permission is not allowed. Custom analytics with relatively sophisticated drill down capabilities are available but require both time and additional costs to develop and generate. At the time of this writing, NCDR has more than 2400 participating hospitals. The two outpatient-specific registry modules, PINNACLE Registry and the Diabetes Collaborative Registry, are designated QCDRs and support reporting for MIPS requirements. The web address for NCDR is https://cvquality.acc.org/NCDR-Home. The cost for NCDR is $5920 per annum for the PVI Registry with a one time implementation fee of $1000. Additional information may be found at https://www. ncdr.com.https://www.ncdr.com
XL-PAD Registry11,12 The XL-PAD Registry was launched with the support of an NIH grant and seeks to publish clinical data related to PVI from participating sites. The registry was designed to close enrollment after 14,000 patients were entered and was designed to describe three main clinical outcomes (1) to compare stent versus nonstent outcomes as a composite of repeat revascularization and ipsilateral target limb amputation at 12 months postintervention, (2) to compare stent versus nonstent composite outcomes including death, myocardial infarction, and the outcomes listed in (1), and finally (3) to compare functional outcomes including walking distance and Rutherford classification for stent versus nonstent interventions. The registry utilizes approximately 60 sites for enrolling the 14,000 patients. The database structure appears to be an SQLtype database and the web-based EDC is based on data entry utilizing the University of Texas Southwestern REDCap program. The XL-PAD requires mandatory submission to a core lab to adjudicate angiographic findings and degree of stenosis for interventions. The registry is limited to
infrainguinal peripheral arterial interventions and specifically excludes failed attempts at revascularization, surgical bypass procedures, or when only the iliac artery is treated. Dashboards and site-specific analytics are not available nor does it appear that there is the ability to export either raw data or analytics. As of the writing of this document, this registry is not a CMS-certified QCDR. More information can be found at the XL-PAD website https://www.xlpad.org/studies-and-research.
The PRO Registry13 The PRO Registry is AVLS registry that is used for superficial venous disease interventions and therapies. The AVLS was originally founded in 1985 as the North American Society of Phlebology and subsequently in 1997 changed its name to the American College of Phlebology. In 2018, the name was changed to AVLS. The PRO Registry was initiated in 2014 and as of this writing has over 24,000 superficial venous procedures entered including over 18,000 endovenous thermal ablations and 6000 chemical ablations. The registry also incorporates reporting of noninterventional therapy such as compression and noninterventional treatment modalities for venous ulcers. The registry database structure is an SQL at the back end. There is a web-based EDC that allows manual entry of data, but the AVLS encourages usage of import/export directly from a limited number of EMRs that have been certified to work with the registry system. The overwhelming majority of data currently entered into the registry has been inputted via EMR import/export. A current listing of those EMR products is posted on the AVLS PRO Registry webpage at www.veinandlymph.org. Aggregated and physician-specific dashboards and analytics are available, and these data are incorporated into the AVLS quality initiatives and research programs. The PRO Registry is not currently a QCDR and consequently, there is no provision for MIPS reporting incorporated into the registry product. Costs are $4000 for non-AVLS members and $2000 per annum per participating physician for an AVLS member. There is no setup fee and discounts on subscription costs are available for physicians that contribute to the Foundation for Venous and Lymphatic Disorders. More information can be found at the AVLS website https://www.veinandlymph.org.
Summary and Conclusions Clinical data registries are a growing and vital part of the value-based healthcare era. The available clinical data registries have grown and evolved to support specific
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TABLE 19.1
Summary Table Comparing Registries. Registry
Outpatient Specific?
Peripheral Arterial Module?
Venous Module?
Cardiac Module?
Dialysis Module?
Additional Modules?
Direct EMR Import
QCDR
Setup Fees
OEIS NR
Yes
Yes
Planned
Planned
Planned
No
No
Yes
No
SVS VQI
No
Yes
Yes
No
Yes
Multiple, 12 total
No
Yes
Yes
NCDR
No
Yes
No
Yes
No
STS, medical Rx, etc.
No
No
Yes
XL-PAD
No
Yes
No
No
No
No
No
No
No
AVLS PRO
No
No
Yes
No
No
No
Yes
No
No
procedure-based interventions in hospital and outpatient settings. It is essential to ensure that increasing volume of high-quality data that is generated is captured in a registry in a way that accurately portrays the real-world conduct and outcomes of cardiovascular and PVIs in the office and outpatient environment. As the number of outpatient procedures continues to increase, there is mounting interest by patients, physicians, and healthcare organizations to optimize care in this setting. The aim of the participants and the registries is to be able to perform procedures in any setting for the right indications, resulting in optimal outcomes, be cost-effective, and provide data for future innovation. Additionally, clinical data registries are useful tools in continuous quality improvement in any organization. There is also mounting pressure on the physicians brought about by payers and regulatory agencies to furnish clinical data points so that reasonable decisions regarding insurance coverage, appropriateness, and quality assurance can be made. Registries have been developed in part to help answer these and many other questions. As described in this chapter, currently available registries vary in their complexity, cost, and comprehensiveness, and span a wide range of structures and formats (Table 19.1). It is incumbent on physicians and organizations offering procedures in the outpatient setting to participate and actively enter data into the registry most appropriate or germane to the cases being performed. Challenges remain in creating uniform reporting standards, enhancing the electronic transfer of desired data points from EMRs directly into the various databases, and in translating the analytic results to quality care
metrics and healthcare policy decisions that benefit the patients and make sense to the clinicians. Ultimately, registry supported analytics and lessons learned can provide the platforms and roadmaps for providing optimum care in a cost-effective manner to this very complex group of patients with cardiovascular disease.
REFERENCES 1. National trends in lower extremity bypass surgery, endovascular interventions, and major amputations Goodney, P.P. et al. J Vasc Surg, Volume 50, Issue 1, 54e60. 2. Jones WS, et al. Trends in settings for peripheral vascular intervention and the effect of changes in the outpatient prospective payment system. J Am Coll Cardiol. 2015;65: 920e927. 3. The disproportionate growth of office-based atherectomy Mukherjee, Dipankar et al. J Vasc Surg, Volume 65, Issue 2, 495e500. 4. Office-based endovascular suite is safe for most procedures Jain, Krishna et al J Vasc Surg, Volume 59, Issue 1, 186 e 191. 5. Treatment outcomes and lessons learned from 5134 cases of outpatient office-based endovascular procedures in a vascular surgical practice. L., Peter et al. Vascular Volume 25, Issue 2, 115e122. 6. https://www.cms.gov/Medicare/Quality-Initiatives-Patient -Assessment-Instruments/Value-Based-Programs/MACRAMIPS-and-APMs/MACRA-MIPS-and-APMs.html. Accessed May 2019. 7. https://oeisociety.com/oeis-national-registry/. Accessed May 2019. 8. https://www.vqi.org/wp-content/uploads/VQI-SummarySides-March-2019.pdf. Accessed May 2019. 9. https://www.vqi.org/wp-content/uploads/YearinReview2017-18-Digital.pdf. Accessed May 2019.
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10. https://cvquality.acc.org/NCDR-Home/Registries. Accessed May 2019. 11. https://clinicaltrials.gov/ct2/show/NCT01904851 XL-PAD clinical trial listing. Accessed May 2019.
12. https://www.xlpad.org/s/XLPAD-Manual.pdf. XL-PAD user manual Accessed May 2019. 13. http://www.phlebology.org/member-resources/acp-provenous-registry. Accessed May 20129.
Registry BOB TAHARA, MD, FSVS, FACS, RVT, RPVI • JEFFREY G. CARR, MD, FACC, FSCAI
INTRODUCTION Office-based endovascular centers (OECs) also known as outpatient interventional suites (OISs) or officebased labs (OBLs) have continued to grow throughout the United States with an accompanying shift from inpatient and hospital-based care to outpatient and office-based interventions.1,2 This has included marked increase in the number of outpatient peripheral interventional procedures, cardiac diagnostic/interventional procedures, dialysis interventions, interventional oncology-related procedures and a wide array of both superficial and deep venous procedures. As this shift has become more pronounced, there has been a corresponding increase in concern and focus on quality of care provided in the outpatient sites of service. This focus has included questions on appropriateness, patient selection, procedural conduct and safety, and ultimately outcome measures.2,3 While there have been multiple peer-reviewed publications documenting the safety and efficacy of office-based interventions, the majority of these papers report results from a single center or data from relatively small series.4,5 A broad-based multicenter documentation of interventional experience in an office or freestanding facility has been elusive and challenging but is desirable. Participation in a Quality Clinical Data Registry (QCDR) is one option that can be utilized to address some of these questions and concerns on a broader basis. Generally speaking, a clinical data registry enables the collection of clinically relevant data about a specific disease state, condition, or procedure(s) with the goal of documenting and understanding basic patient characteristics and demography, disease morphology and expression, risks and exacerbating factors, procedural characteristics, and outcomes. Specific registries may also concentrate on tracking data such as safety and efficacy, complications, cost data, and any other cogent variables and factors. The data can then be analyzed to allow the assessment and provide useful information regarding real-world practice patterns, clinical pathways
or guidelines, risk stratification, cost-benefit ratios, optimal use of new or existing treatments or devices, and potential contraindications. In addition to the analytics and pure scientific utility of clinical registries, there are a growing number of federal regulations which require data reporting through a QCDR. Registry participation may also be used to satisfy some or all of the requirements attendant to the Merit-Based Incentive Payment System (MIPS) as mandated by the Medicare Access and CHIPs Reauthorization Act (MACRA) which was signed into law in 2015.6
Desired Features and Value of Clinical Data Registries Ideally a clinical data registry should have several desirable characteristics: 1) Reasonably easy data entry 2) Collection of the clinically relevant variable information in a manner that makes sense to the participating clinician 3) Scalable architecture which allows or already incorporates implementation of different modules or modalities to accommodate changing care patterns 4) Adequate and timely reporting and analytics 5) Reasonable cost basis 6) Data that support a site’s quality improvement functions and the ability to satisfy statutory and/or regulatory reporting requirements We will broadly examine some of these characteristics and then describe specific currently available clinical data registries which are in use and applicable to the OEC/OIS.
REGISTRY CHARACTERISTICS Data Entry For a clinical data registry to have any utility at all, one must first enter relevant data into the registry! Data entry is fundamentally impacted by the design and
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architecture of a particular database. Initially, many databases or tracking programs were individually hosted on hardware resident in a particular hospital, facility, or office leading to implementations that were potentially “one off” and limited by both the systems utilized as well as the technical support personnel and programmers available to that site. Additionally, these databases were proprietary to the group or institution and inherently were limited in scope. Modern “big data” paradigms have fundamentally shifted this architecture to a virtual, cloud-based hosting environment that now encompasses a wide array of SQL and NoSQL database architectures allowing accumulation and rapid processing of a staggering number of variables and data points. The majority of currently available clinical data registries utilize a web-based electronic data collection (EDC) format. The advantage of this approach is wide accessibility of data from any device capable of running a compatible web browser, near instant upload of the entered information into the database, and the ability to edit entries if appropriate. Typically, current registries incorporate fairly robust security provisions with granular role-based permissions that allow both clinicians and their ancillary staff to enter and review patient data during and after entry into the EDC. Disadvantages include the need for reasonably robust Internet access, the need for accurately typing in free text if required or making appropriate menu or drop-down selections, difficulties with passwords and usernames, and any or all of the attendant technical difficulties websites may experience. Web-based EDCs frequently incorporate multiple entry mechanisms including free text, numerical data, multiple choice selections, and/or menu-based options. Free entry options for both textual strings and numerical data allow a basically unlimited and a long range of data entry. Disadvantages of free entry include the interjection of variability in format and values that could potentially render the data difficult or impossible to analyze, transcriptional errors, and a greater time/ typing requirement. Menu-based or multiple-choice options allow for standardization of values, formats, and speedy entry but decrease the possible data entry range as compared with free entry. Even more efficient and idealized mechanism for data entry potentially is either by direct transfer or some type of export/import facility of structured data transfer from an electronic medical record (EMR) into the registry database. Advantages of this approach would include an elimination of transcriptional or selection errors, elimination of hand entry and the attendant savings in both personnel time and costs.
Disadvantages include direct transfer of data which was erroneously entered into the EMR, a host of potential technical hurdles to implementation, and the cost of implementation on a widespread basis. At the current time, despite data transfer standards such as HLA7, there is substantial variation between different EMR products’ capability to store their own data, database architecture support, and implementation of data transfers and/or exports. This functionally leads to a situation where each individual product requires individual programming or mapping to enable a direct transfer or export/import functionality, which in turn substantially increases the cost of implementation. Smaller organizations, offices, or physician practices rarely have the resources to implement these types of transfers at the local level and larger organizations may have a host of competing technical demands. Both scenarios often preclude development of transfer and/or export/import facilities to a clinical registry. Despite these technical hurdles, there will likely be automatic electronic transfer of data from EMRs into clinical registries in the future to improve efficiencies and reduce the burden of data entry duplication.
REGISTRY ARCHITECTURE While a complete discussion of back-end database architecture is beyond the scope of this chapter, we will briefly explore characteristics the authors believe are desirable in a clinical data registry. Both SQL and NoSQL database engines provide advantages and disadvantages in the architecture of the database. Both types are broadly incorporated into several clinical data registries, allow appropriate queries and data analysis, and have mature enterprise level support for clinical registry vendors. Regardless of the basic database engine used, it is absolutely essential that the database structure incorporates appropriate relationships between the variables and between different table and file structures so that proper analytics can be performed. This basic structure generally needs to be established very early in the database design phase and essentially requires some understanding of desired and required analysis of data as the end product. Data should be collected based on the questions that are being asked and need an answer. Development of various database modules for different disease states and procedures is a basic requirement to meet the evolving needs of the OEC/OIS/OBL. Considering the range of cardiovascular procedures that are currently performed in outpatient environment, there is a need for either (1) individual clinical registry
CHAPTER 19 for specific category of disease/interventions or (2) more comprehensive registries that have multiple disease-specific/intervention-specific modules. Using multiple individual registries for each specific type of disease or intervention rapidly complicates the logistics, data entry complexity, staff time, and cost of participation for practices or sites that perform multiple types of interventions that include peripheral arterial, venous, cardiac, dialysis access, and other interventions. A possibly easier and more cost-effective option would be to utilize a clinical data registry that has a common entry and cost structure but incorporates multiple modules to report on different disease processes or interventions. Potential required modules include peripheral arterial interventions, diagnostic coronary angiography and coronary interventions, cardiac rhythm interventions/management, dialysis access formation and interventions, and superficial/deep venous interventions. Unfortunately, as detailed further in this chapter, no single clinical registry currently fulfills and supports all of these module requirements.
REPORTING AND ANALYTICS The ability to analyze the raw data entered into a clinical data registry is another basic required function. Ideally this reporting would update either in realtime or on a regular and frequently scheduled basis, be available for viewing online and provide the ability to download reports and results, provide participating clinicians with information that is meaningful and answers cogent clinical questions. The ability to benchmark individual physicians, groups or virtual groups against the aggregated data may provide valuable insights into care patterns, utilization rates, and allows the reporting of data for quality assurance/improvement activities. Basic reporting should allow analysis of patient demographics, risk factors, disease severity, identification of complications and complication rates, and intervention-specific outcome measures. More sophisticated analytics may provide subgroup analysis which allows drilling down to an individual risk or morphology in an effort to find optimal treatment modalities and minimize complication potential. For example, basic reporting could give a range and average of patient ages, incidence of diabetes and/or hypertension etc., and the overall complication rate for a particular intervention such as angioplasty. More detailed analysis might provide a more granular report. It may be possible to study patient outcomes using a specific device or modality for a specific subset
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of patients, i.e., vessel patency at various intervals while using a particular atherectomy device or stent in patients over the age of 70 with elevated LDL levels. Reports may take a multitude of forms ranging from simple tabular results to very sophisticated visualizations using a variety of line graphs, bar graphs, or pie charts (Fig. 19.1). Interactive reporting where queries or graphs can be clicked on to drill down to more granular details is often desired by clinicians. Well-designed clinical reporting dashboards help consolidate reporting in an accessible manner and simplify viewing of both site-specific and aggregated results. Leveraging cloud-based computing resources so that all of the CPU-intensive computation is performed on the hosting server is faster and more scalable than downloading raw data and performing the analysis on a local machine or device. Additionally, mobile-optimized websites can potentially offer this type of reporting accessible via handheld devices allowing the data to be viewed at the bedside and across different locations.
REGULATORY/STATUTORY REQUIREMENTS Clinical data registries can be used to meet certain federal requirements. QCDRs are a subset of all existing clinical data registries and can be used to report data satisfying a portion of the MIPS requirements that were established under MACRA. A clinical data registry may nominate itself to the Center for Medicare Services (CMS) in order to be considered for QCDR status. If the registry meets CMS-defined requirements, it may be granted QCDR status which allows the registry to be used by eligible clinicians/groups for MIPS reporting. These requirements are posted on the CMS website. Reporting requirements have changed significantly since originally approved in 2015. There are additional ongoing requirements to maintain QCDR status including meeting and conference participation, documentation review and revision, auditing functions, and quality measure reviews that must be conducted in accordance with the current CMS regulations and guidance. The authors anticipate that there will continue to be quite a bit of fluidity in the QCDR/ MIPS/MACRA reporting and qualification requirements in the future and that the one constant we can count on is that, there will be changes in reporting requirements. Notwithstanding these challenges, possessing a designated QCDR status is a highly desirable quality for registries.
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13239
9397
Last
Total Procedures
Total Subjects
Maintena... 2.92%
Ambulatory...
98.2%
Procedure Type
Procedure Indication
Site of Service
View Subject Details
Date
Interventional Planned Diag...
Acute Ischemia 3.16%
?
Home Hospital...
10,000
Procedure Success
Office (Free s..
Age
0K
5,000
59 Total
Claudication 61.86%
Overall Complication Rate
10K
Hospital Transfer Rate
11789
1.518%
0.45% Rate
Hospital Transfers
>65 76.86%
View Complication Details
14K 0K 0K
Dist... 0.0... CLI 12.51...
<65 21.56%
Select
Discharge Disposition
1989
Minor Tissu... 14.06%
1
No filters applied
0
27 20
Sex at Birth
Rutherford Classification (Chronic)
1.1%
Total Lesions
Left 5K
Female 39.5%
Male 59.3%
ASA Class 864
15
Urgent Elective Emergent 1984
1
3/25/2019 12:58:04 PM Refresh Timestamp (UTC)
3K 1237 2K 637
2654 1K
500
Total Interventions View Intervention Details
10 0
1,000
39423
17
Right
4K
View Lesion Details
Left and Right
19555
527
18 19
1699
631
1054
0K
0 0
5
0
2
4
6
FIG. 19.1 Screenshots of Outpatient Endovascular and Interventional Society (OEIS) National Registry
Dashboard.
Currently Available and Applicable Clinical Data Registries There are several clinical data registries that are currently in operation and support in whole or part many of the interventions being performed in outpatient settings. Some of these are outpatient focused, i.e., Outpatient Endovascular and Interventional Society (OEIS) National Registry, while others really began and are primarily focused on hospital-based care but allow for outpatient case data entry, i.e., VQI. Some are split between the inpatient and outpatient intervention, i.e., National Cardiovascular Data Registry (NCDR). Some registries are very specific to single disease entities, i.e., American Vein and Lymphatic Society (AVLS formerly ACP) Venous Registry and NCDR peripheral vascular intervention (PVI) Registry. Some have started with a particular facet of care and have plans to add modules, i.e., OEIS National Registry currently enrolls only peripheral arterial interventions but has plans to add coronary and rhythm management, venous, and dialysis modules. Unfortunately, no single registry that is currently available meets the requirements of all the procedures carried out in OEC. We briefly summarize the key attributes of the currently available registries.7
OEIS National Registry The OEIS was founded in 2013 for the express purpose of promoting high-quality patient-centric care in the outpatient interventional suite. Membership in this organization is deliberately multidisciplinary and primarily composed of vascular surgeons, interventional cardiologists, and interventional radiologists performing cases in an outpatient or office environment. To advance the goal of reporting outcomes and serve as a platform for research, the OEIS National Registry was conceived and became operational in January 2017. The first module to come online was the Peripheral Arterial Interventions module. This collects and analyzes data related to lower extremity arterial intervention in the outpatient and office sites of service. The registry is structured around a NoSQL back end (MongoDB, MongoDB Inc.) with a proprietary web-based EDC (Syncrony-Syntactx Corporation) which is utilized by participating sites for data entry and accessing reports. The registry allows for exporting of raw data and completed analytics. Aggregated and site-specific data/analytic dashboards are available online to participating sites, and some summary data are available publicly. Direct export/import from EMRs is not currently available but is under development at the time of this publication. Reporting is currently in
CHAPTER 19 the form of a set of fairly sophisticated dashboards which allow the participating sites/clinicians to view the results of a defined set of CMS-approved quality measures, patient demographic and comorbidity data, procedural and interventional data, complications, and long-term outcomes such as patency and amputation rates. Interactive dashboards allow subgroup analysis. At the time of this writing, the registry has 62 sites and has enrolled nearly 17,000 peripheral arterial intervention cases in its first 2 years of existence. The OEIS NR is an approved QCDR and supports reporting of CMS-approved Quality Measures and Improvement Activities as part of MIPS. This provides a vehicle for registry subscribers to submit their performance on certified quality measures to receive an adjustment for reimbursement for their Medicare cases. Costs to subscribe to the OEIS registry are modest with a defined monthly fee, a discount for active OEIS members, and zero setup fees. At the time of writing, the monthly OEIS member rate is $175.00/month per site. Further information can be found by accessing the OEIS NR webpages at https:// oeisociety.com/oeis-national-registry/.
The Vascular Quality Initiative8,9 The Vascular Quality Initiative (VQI) was originally created in 1982 as a regional effort by the Vascular Study Group of New England (VSGNE) to track, standardize, and improve vascular care and outcomes. The VQI underwent further development in content, scope, and platform and was subsequently adopted by the Society of Vascular Surgery (SVS) in 2011. The VQI is now more than a registry and is a formally recognized Patient Safety Organization (PSO). It currently offers 12 modules including AAA, TEVAR, carotid interventions (both CEA and CAS), venous interventions, hemodialysis access, peripheral vascular interventions (PVIs), infrainguinal and suprainguinal bypass, and others. Additional modules being actively developed include a noninvasive vascular ultrasound module and vascular medicine management module. VQI has robust support from the SVS. PSO is an LLC owned and administered by SVS with a formal governance and administrative structure for the PSO itself. A formal VQI Research Committee exists and is active in directing and facilitating data harvest and publications documenting results from enrolled cases. The PSO also has established specific Arterial and Venous Quality Councils and has a number of ongoing Quality Initiatives that are actively managed. The database structure is SQL based for transactions and NoSQL for the actual analytics. The EDC is webbased and currently developed and administered by
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M2S (West Lebanon, NH). Collected data fields are both comprehensive and detailed which requires a significant investment in staff time for data entry and typically requires institutional support. VQI has recently developed a “basic” input version which reportedly markedly decreases the collected data points in response to user concerns about the time required for data entry in the office/outpatient venue. Direct EMR imports/exports are not yet fully enabled. The registry does allow for exporting of data and completed analytics in various formats. Aggregated and site-specific data/analytic dashboards are available online to participating sites, and some summary data are publicly available. The dashboard reports are comprehensive, and subgroup analysis is available. At the time of this writing, the VQI has 557 participating centers, 18 regional groups, and over 576,000 entered cases including about 183,000 peripheral interventions. The overwhelming majority of these enrolled cases were performed in inpatient hospital setting in North America and none of the modules is outpatient specific. VQI is an approved QCDR and supports reporting of CMSapproved Quality Measures and Improvement Activities as part of MIPS. Costs, however, are substantial with an initial setup fee of $5000.00 and a subscription fee of $2500.00 per module utilized. Some variable discounts are available dependent on institution and number of participating centers subscribed via a particular site. VQI is the most comprehensive and expensive registry for PVI. Further information can be found by accessing the VQI website at https://www.vqi.org/about/.
National Cardiovascular Data Registry10 The National Cardiovascular Data Registry (NCDR) was originally developed in 1997 by the American College of Cardiology (ACC). The original focus was on cardiology-specific intervention and has been expanded to currently offer eight hospital-based registries including acute STEMI/NSTEMI interventions, elective percutaneous coronary intervention, implantable cardioverter-defibrillator, congenital heart disease, and PVIs. There is also a module for atrial fibrillation ablation and a module jointly managed with the Society for Thoracic Surgery (STS) analyzing transcatheter valve therapies. There are two outpatient-specific registries which track (1) outpatient medical management of coronary artery disease, hypertension, heart failure, atrial fibrillation, and diabetes, and (2) a diabetes-specific registry which is used to track diabetes care across a wider spectrum of providers, not simply cardiology. Currently, there is no outpatient-specific procedural module or registry.
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The database structure and back end are not disclosed. Data entry is enabled via a web-based EDC or hospitals may choose from several software/service vendors to enable transfer from hospital EMR and internal data collection methods into the applicable NCDR registry. Collected data fields are extensive and detailed but there has been significant development allowing EMR import/exports particularly from the outpatient registry modules and thus often minimizing staff data entry time. Basic analytics and dashboard functions are available for each applicable registry within the NCDR portfolio and more extensive reporting is available. Public reporting of aggregate data is not available. Site-specific reporting has been made voluntary but reporting without explicit hospital permission is not allowed. Custom analytics with relatively sophisticated drill down capabilities are available but require both time and additional costs to develop and generate. At the time of this writing, NCDR has more than 2400 participating hospitals. The two outpatient-specific registry modules, PINNACLE Registry and the Diabetes Collaborative Registry, are designated QCDRs and support reporting for MIPS requirements. The web address for NCDR is https://cvquality.acc.org/NCDR-Home. The cost for NCDR is $5920 per annum for the PVI Registry with a one time implementation fee of $1000. Additional information may be found at https://www. ncdr.com.https://www.ncdr.com
XL-PAD Registry11,12 The XL-PAD Registry was launched with the support of an NIH grant and seeks to publish clinical data related to PVI from participating sites. The registry was designed to close enrollment after 14,000 patients were entered and was designed to describe three main clinical outcomes (1) to compare stent versus nonstent outcomes as a composite of repeat revascularization and ipsilateral target limb amputation at 12 months postintervention, (2) to compare stent versus nonstent composite outcomes including death, myocardial infarction, and the outcomes listed in (1), and finally (3) to compare functional outcomes including walking distance and Rutherford classification for stent versus nonstent interventions. The registry utilizes approximately 60 sites for enrolling the 14,000 patients. The database structure appears to be an SQLtype database and the web-based EDC is based on data entry utilizing the University of Texas Southwestern REDCap program. The XL-PAD requires mandatory submission to a core lab to adjudicate angiographic findings and degree of stenosis for interventions. The registry is limited to
infrainguinal peripheral arterial interventions and specifically excludes failed attempts at revascularization, surgical bypass procedures, or when only the iliac artery is treated. Dashboards and site-specific analytics are not available nor does it appear that there is the ability to export either raw data or analytics. As of the writing of this document, this registry is not a CMS-certified QCDR. More information can be found at the XL-PAD website https://www.xlpad.org/studies-and-research.
The PRO Registry13 The PRO Registry is AVLS registry that is used for superficial venous disease interventions and therapies. The AVLS was originally founded in 1985 as the North American Society of Phlebology and subsequently in 1997 changed its name to the American College of Phlebology. In 2018, the name was changed to AVLS. The PRO Registry was initiated in 2014 and as of this writing has over 24,000 superficial venous procedures entered including over 18,000 endovenous thermal ablations and 6000 chemical ablations. The registry also incorporates reporting of noninterventional therapy such as compression and noninterventional treatment modalities for venous ulcers. The registry database structure is an SQL at the back end. There is a web-based EDC that allows manual entry of data, but the AVLS encourages usage of import/export directly from a limited number of EMRs that have been certified to work with the registry system. The overwhelming majority of data currently entered into the registry has been inputted via EMR import/export. A current listing of those EMR products is posted on the AVLS PRO Registry webpage at www.veinandlymph.org. Aggregated and physician-specific dashboards and analytics are available, and these data are incorporated into the AVLS quality initiatives and research programs. The PRO Registry is not currently a QCDR and consequently, there is no provision for MIPS reporting incorporated into the registry product. Costs are $4000 for non-AVLS members and $2000 per annum per participating physician for an AVLS member. There is no setup fee and discounts on subscription costs are available for physicians that contribute to the Foundation for Venous and Lymphatic Disorders. More information can be found at the AVLS website https://www.veinandlymph.org.
Summary and Conclusions Clinical data registries are a growing and vital part of the value-based healthcare era. The available clinical data registries have grown and evolved to support specific
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TABLE 19.1
Summary Table Comparing Registries. Registry
Outpatient Specific?
Peripheral Arterial Module?
Venous Module?
Cardiac Module?
Dialysis Module?
Additional Modules?
Direct EMR Import
QCDR
Setup Fees
OEIS NR
Yes
Yes
Planned
Planned
Planned
No
No
Yes
No
SVS VQI
No
Yes
Yes
No
Yes
Multiple, 12 total
No
Yes
Yes
NCDR
No
Yes
No
Yes
No
STS, medical Rx, etc.
No
No
Yes
XL-PAD
No
Yes
No
No
No
No
No
No
No
AVLS PRO
No
No
Yes
No
No
No
Yes
No
No
procedure-based interventions in hospital and outpatient settings. It is essential to ensure that increasing volume of high-quality data that is generated is captured in a registry in a way that accurately portrays the real-world conduct and outcomes of cardiovascular and PVIs in the office and outpatient environment. As the number of outpatient procedures continues to increase, there is mounting interest by patients, physicians, and healthcare organizations to optimize care in this setting. The aim of the participants and the registries is to be able to perform procedures in any setting for the right indications, resulting in optimal outcomes, be cost-effective, and provide data for future innovation. Additionally, clinical data registries are useful tools in continuous quality improvement in any organization. There is also mounting pressure on the physicians brought about by payers and regulatory agencies to furnish clinical data points so that reasonable decisions regarding insurance coverage, appropriateness, and quality assurance can be made. Registries have been developed in part to help answer these and many other questions. As described in this chapter, currently available registries vary in their complexity, cost, and comprehensiveness, and span a wide range of structures and formats (Table 19.1). It is incumbent on physicians and organizations offering procedures in the outpatient setting to participate and actively enter data into the registry most appropriate or germane to the cases being performed. Challenges remain in creating uniform reporting standards, enhancing the electronic transfer of desired data points from EMRs directly into the various databases, and in translating the analytic results to quality care
metrics and healthcare policy decisions that benefit the patients and make sense to the clinicians. Ultimately, registry supported analytics and lessons learned can provide the platforms and roadmaps for providing optimum care in a cost-effective manner to this very complex group of patients with cardiovascular disease.
REFERENCES 1. National trends in lower extremity bypass surgery, endovascular interventions, and major amputations Goodney, P.P. et al. J Vasc Surg, Volume 50, Issue 1, 54e60. 2. Jones WS, et al. Trends in settings for peripheral vascular intervention and the effect of changes in the outpatient prospective payment system. J Am Coll Cardiol. 2015;65: 920e927. 3. The disproportionate growth of office-based atherectomy Mukherjee, Dipankar et al. J Vasc Surg, Volume 65, Issue 2, 495e500. 4. Office-based endovascular suite is safe for most procedures Jain, Krishna et al J Vasc Surg, Volume 59, Issue 1, 186 e 191. 5. Treatment outcomes and lessons learned from 5134 cases of outpatient office-based endovascular procedures in a vascular surgical practice. L., Peter et al. Vascular Volume 25, Issue 2, 115e122. 6. https://www.cms.gov/Medicare/Quality-Initiatives-Patient -Assessment-Instruments/Value-Based-Programs/MACRAMIPS-and-APMs/MACRA-MIPS-and-APMs.html. Accessed May 2019. 7. https://oeisociety.com/oeis-national-registry/. Accessed May 2019. 8. https://www.vqi.org/wp-content/uploads/VQI-SummarySides-March-2019.pdf. Accessed May 2019. 9. https://www.vqi.org/wp-content/uploads/YearinReview2017-18-Digital.pdf. Accessed May 2019.
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10. https://cvquality.acc.org/NCDR-Home/Registries. Accessed May 2019. 11. https://clinicaltrials.gov/ct2/show/NCT01904851 XL-PAD clinical trial listing. Accessed May 2019.
12. https://www.xlpad.org/s/XLPAD-Manual.pdf. XL-PAD user manual Accessed May 2019. 13. http://www.phlebology.org/member-resources/acp-provenous-registry. Accessed May 20129.