Vascular Medical Quality and Patient Safety

Issues of Concern

The concepts of quality and safety in vascular medicine overlap with other branches of medicine and with non-medical industries. Standards and evaluation of healthcare quality, safety, and person-centered care and the quality improvement tools and approaches that should be used in vascular medicine are reviewed elsewhere.[2] The reader is advised to be familiar with the concepts in that article, as this article applies those concepts to issues pertinent to vascular medicine.

Regulation, Administration, Fragmentation of Care, and Ethical Problems in Vascular Medicine 

Individual state medical boards and court systems uphold standards for vascular medicine healthcare providers (VHCP), with medical boards primarily enforcing VHCP ethics standards and courts primarily judging issues of VHCP negligence in adherence to state laws. 

However, most healthcare practice standards in vascular medicine are not established through the regulatory processes described above but are instead determined by guidelines from national medical specialty organizations. Organizations that publish standards for VHCPs include the following: 

• Society for Vascular Surgery (SVS) 
• American Venous Forum (the latter two organizations work in conjunction with the American College of Surgeons (ACS)) 
• Society of Interventional Radiology (an organization that works in conjunction with the American College of Radiology) 
• Cardiovascular and Interventional Radiology Society of Europe 
• European Society for Vascular Surgery 
• American College of Cardiology (ACC)
• American Registry of Radiologic Technologists
• American Society of Radiologic Technologists[3][4]

These organizations at times interact with each other to set quality guidelines. Some facets of vascular medicine quality may be addressed by only one of these organizations (e.g., an organization in Europe but not in the US). Although sometimes different types of invasive and non-invasive VCHP organizations combine to provide a comprehensive approach to publishing evidence-based guidelines, they often remain in their silos, which raises some questions about how much their guidelines are driven by evidence vs. promotion of their own society's political and financial agendas.

Healthcare facility administrators and policymakers who impact the practice of vascular medicine often pay lip service to the notion that they promote quality. Medicare, Medicaid, and private insurers (payers) manage hospitals using cost containment incentive payments, and HCP employers manage HCPs using productivity incentive metrics. Physicians who perform invasive procedures are incentivized to recommend invasive procedures that have not been shown to outperform less invasive therapies but earn the physician higher wRVUs, which translates to increased payment. Research studies confirm that cost containment and productivity-based financial incentives lead to cost-reduction and incentive-related output-increasing behaviors, respectively.[5][6] Neither type of behavior results in improved quality per se; on the contrary, both types of behavior often result in decreased quality. 

VHCPs' decision to overtreat (i.e., to offer treatment when a patient does not meet a pre-treatment predictive threshold corresponding to a high likelihood of obtaining a measurable health outcome improvement) is a common problem in vascular medicine. This is due to the factors discussed above (e.g., primarily productivity-based incentives), along with the following:

• There is misappropriation of work relative value units (wRVUs) by the persons determining wRVU values (e.g., to overvalue or undervalue types of HCP work).
• Incentives to perform services to achieve short-term benefits that have not been shown to outweigh the long-term costs or outperform alternate services. For example, a sponsored graded walking program for lower extremity chronic arterial insufficiency / supervised exercise therapy (SET)) can produce equal long-term benefits with less risk and cost than an invasive vascular procedure but more slowly.
• Pressure by a patient to take action. There are some situations in vascular medicine where invasive procedures have not improved outcomes even compared to watchful waiting. 
• The belief that treating is a way to reduce the chance of legal liability for failure to treat
• Fragmentation of care. Unlike in oncology, where committees ('tumor boards') made of representatives from different specialties debate the merit of what each type of therapy various specialist physicians can offer a patient based on published literature and personal experience, patients with vascular disease typically do not benefit from similar types of inter-profession dialogue regarding what therapy is best suited for them.
• No oath that VHCPs take or code of ethics that they agree to follow, inducing them either to know the latest evidence-based treatment options or to adhere to them even if they did.
• Numerous other causes.

The largest American healthcare insurer for persons with vascular disease, Medicare began compensating vascular healthcare providers for quality in the early 2010s. The current penalty for performing in the lowest tier of HCPs nationally with respect to Medicare performance criteria is a payment reduction of 9% from the mean payment. Whether quality incentives will approach or overtake volume incentives as the primary driver of HCP decision-making in vascular medicine remains to be seen. 

Research Problems

Research in vascular medicine poses several challenges. Technology, such as stent technology, changes quickly; demonstration of the technology's efficacy on a composite basis over time is often inadequate before the technology is offered to persons at a high cost with truly unknown safety vs. efficacy ratios (as in the case of inferior vena cava filters). The generalizability of research for determining treatment efficacy in vascular medicine is limited by myriad disease patterns that affect arteries and veins differently in different persons. The natural history of disease in persons who present with arterial insufficiency syndromes of the lower extremity and/or carotid distribution or with aneurysms tends to have a fairly high risk.

Since almost any type of treatment -- including conservative measures such as SET or the medical treatment of hypertension, cholesterol, and triglycerides -- will improve these situations, it is sometimes difficult to sort out the quality and safety issues among treatments. Although vascular medicine lends itself to randomized controlled trials (RCTs), figuring out the complexity of the disease in the research process can be sacrificed for the "easier" route of simply isolating a new treatment group and a control group and measuring a difference between them.

Safety Problems

Safety in vascular medicine (as in medicine at large) in the United States became an issue of widespread concern only after the National Academy of Medicine (at that time called the Institute of Medicine) published a report for the US Congress called "To Err is Human."[7]  

Issues that uniquely relate to vascular medicine can be divided into two categories: conservative (non-invasive) management and interventional (invasive) management.

Interventional Treatment Setting

In the interventional setting, complications include:

• Hemorrhages
• Thromboses
• Embolisms
• Pseudoaneurysms
• Fistulas

Downstream effects of vascular injuries include damage to the tissues supplied or drained by the injured vessels secondary to ischemia or infarction. 

Safety-preserving measures in the interventional setting are numerous. Three categories of safety measures are provided here.

• Communication: Verbal re-confirmation should be performed (in a team setting) with the patient that the patient identification, type of treatment, and treatment site are correct.[8]  
• Image guidance: Invasive vascular procedures continue to make greater use of image guidance to reduce the degree of invasiveness, but endovascular image-guided therapies carry their own sets of hazards. Fluoroscopic-guided procedures use radiation, which can cause tissue injuries that progress to burns and even cancer, which is reviewed in greater detail elsewhere.[9]  They also use iodinated contrast (which can injure glomeruli, known as acute kidney injury (AKI)) or carbon dioxide (which can cause tissue ischemia from air emboli).[10] Intravascular ultrasound (IVUS)-guided procedures show promise as an alternative for fluoroscopy-guided procedures that could reduce fluoroscopy-related safety hazards, especially when the costs of IVUS technology decrease to enable it to be used more often from a practice management standpoint.[11][12]
• Human factors engineering (HFE): HFE strategies are methods for tailoring job tasks to better match the ability of the person performing them so that tasks are as easy as possible to perform. HFE strategies can reduce wasted motion and time and make human actions more reliable and poka-yoke (mistake-proof). An example of this in vascular medicine is designing coaxial sheaths, dilators, catheters, guidewires, and stopcocks in a system that has seamless interchangeability of items without the ability for HCPs to connect or interchange the tools improperly.

Conservative Treatment Setting

The conservative management of vascular health includes medication, physical therapy, and diet modification. In this setting, hemorrhages, thromboses, and other drug adverse reactions are the main complications.

Patients presenting for treatment by VHCPs tend to have multiple underlying comorbid conditions, particularly hypertension, diabetes mellitus, and cardiac dysfunction. Medications for vascular conditions, such as statins, often cause side effects and affect the therapeutic window of other drugs. Although statins offer an evidence-based therapeutic advantage for reducing arterial cholesterol and inflammation and have become almost universal for treating atherosclerosis (representing one of the significant advances in clinical medicine since 1987), they frequently cause hepatotoxicity and myositis. The ACC recommends that, prior to starting a patient on a statin, a VHCP should determine the patient's baseline alanine aminotransferase (ALT) level to enable the detection of increases in this level attributable to the statin to guide future management decisions.[13]  

The ACC stated that it does not consider there to be high-quality evidence for any other particular drug side effect monitoring algorithm. It recommended lowering the intensity of statin therapy based on patients' muscle aches or other symptoms of muscle injury severity and that creatine kinase levels could be used as an adjunct management aide. 

Automated alerts based on software algorithms in electronic health records and medication ordering systems can improve safety.[14][15] The swiss cheese theory of error occurrence suggests that safety is best achieved using a system approach instead of relying on a single individual HCP.

Clinical Significance

Data Analysis From the Vascular Quality Initiative for Promotion of Quality In Vascular Medicine

In 2011, the SVS created its own patient safety organization called the Vascular Quality Initiative (VQI). The VQI enables its member institutions (that provide the VQI with their own data) to access the VQI's entire database, which extends to 2001 and includes data from nearly one million procedures. The VQI includes data from patients who have undergone vascular surgery or minimally invasive image-guided vascular procedures. Retrospective analyses from this database have risen exponentially since the first publication in 2014 and reached several hundred analyses per year as of 2021.

Nearly all of the analyses include nonrandomized data, which is poor at allowing causal inferences and does not enable accurate effect sizes to be determined.[16]  Studies finding 'important' positive associations between independent and dependent variables performed using nonrandomized data are often invalidated when subsequent randomized trials are conducted.

Many of the database analyses are traditional outcome-based assessments focusing on how different surgical/procedural techniques (including types of equipment used) did or did not affect patient outcomes. For example, one analysis found that patients undergoing superficial femoral artery endovascular stenting had fewer complications if the procedure was performed with popliteal artery access than upper extremity artery access, while the technical success of their procedures was equivalent regardless of whether the arterial access point was the popliteal artery or an upper extremity artery.[17]  

Relatively few analyses specifically investigate the processes or structures that may be responsible for the outcomes of interest. 

Nevertheless, the data have been used to evaluate many processes, structures, and outcomes pertinent to healthcare service quality, including:

• Medical management of patients undergoing surgical/endovascular procedures
• Patient risk stratification
• Health law creation and enforcement
• Cost of care and its ramifications for decisions on care reimbursement or recommendations
• Federal and other national healthcare organization guidelines/standards
• Local hospital policy on postoperative patient follow-up
• Procedure time planning
• Physician assessment and
• Patient-customer experience.

The following discussion of findings obtained from the database is organized according to the topic headings listed. The type of each cited study is included to indicate the level of evidence.

Medical Management of Patients Undergoing Surgical/Endovascular Procedures

• Drug therapy:
  • Patients prescribed aspirin and a second antiplatelet drug after revascularization procedures for severe lower extremity ischemia had higher survival rates at hospital discharge than patients administered one antiplatelet drug alone.[18] retrospective cohort] This suggests that RCT should be performed to determine whether dual antiplatelet therapy can be found to have a similar effect when confounding variables are eliminated.
  • Angiotensin-converting enzyme inhibitors (ACEIs/angiotensin receptor blockers (ARBs) were independently associated with improved survival and amputation-free survival in patients undergoing peripheral vascular intervention (PVI) for chronic limb-threatening ischemia (CLTI).[19] retrospective cohort] This suggests that an RCT should be performed to determine whether ACEs/ARBs can be found to have a similar effect when confounding variables are eliminated. 
• Oxygen-carrying capacity therapy: Patients undergoing abdominal aortic aneurysm (AAA) repair who had low preoperative hemoglobin levels were found to be more likely to have AKI than patients with normal hemoglobin levels, and patients with postoperative AKI had lower survival rates than patients without AKI.[20] case-control] This suggests that VCHPs should agree upon a minimum threshold to optimize patients' hemoglobin levels prior to performing AAA repair.

Patient Risk Stratification

• Overall disease/morbidity status: Patients who underwent endovascular AAA repair and had low Eastern Cooperative Oncology Group functional status scores had higher inpatient and one-year post-procedure mortality than similarly exposed patients who had normal scores.[21] case-control] This suggests that ECOG status is useful for predicting mortality for patients in this setting.
• Baseline anatomy status: Superficial femoral arteries with small native calibers were less likely to maintain patency after angioplasty alone than large arteries.[22] case-control] This suggests that patients with small SFAs have a higher risk for poor angioplasty outcomes.

Hospital Resource Meaningful Use

• Hospital unit services: Patients who underwent AAA repair who were treated at hospitals where all such patients were observed post-operatively in an ICU had longer lengths of stay without having improved morbidity or mortality compared to similar patients treated at hospitals where postoperative patients were selectively admitted to the ICU depending on their postoperative health status.[23] retrospective cohort] This suggests that a blanket policy of post-AAA repair ICU admission does not promote meaningful use of resources.
• Radiology services: Patients who underwent AAA repair and who underwent stress tests prior to surgery did not experience a statistically significant reduction in perioperative adverse cardiac events or mortality compared to similar patients who did not undergo stress tests.[24][25] This suggests that such tests do not constitute a meaningful use of resources.
• Anesthesiology services: Patients who underwent outpatient brachiocephalic fistula creation surgery under general surgery had increased hospital admissions and similar 1-year access occlusion and reintervention rates compared to similar patients who underwent regional anesthesia.[26] This study (and others) suggests that regional anesthesia can be a better use of resources and may improve safety compared to general anesthesia for many types of procedures not involving open repairs of the chest, abdomen, or pelvis.

Health Law Creation and Enforcement

• Patients with aortic aneurysms in states agreeing with the federal government to undergo Medicaid expansion policies were found to have higher rates of elective procedures. They decreased procedural complications compared to patients in non-Medicaid expansion states.[27] This suggests that providing patients with health insurance enables more patients to have an aneurysm repair prior to a point where performing the repair becomes risky.
• Patients with kidney failure in Medicaid expansion states were more likely to be able to undergo the algorithm recommended by the National Kidney Foundation guidelines (i.e., definitive surgical treatment without prior temporizing non-surgical pre-dialysis care) than patients in non-Medicaid expansion states. Hispanic patients, in particular, experienced this benefit.[28] This suggests that providing these patients with healthcare insurance enables them to seek treatments in their best long-term interests instead of receiving short-term emergency fixes that have less beneficial outcomes overall.
• Smoking tobacco taxes were associated with decreased cigarette use in patients seeking care for intermittent claudication.[29] This suggests that financial incentives can help modify some poor health habits in patients with vascular disease.

Cost of Care and Its Ramifications for Decisions on Care Reimbursement or Recommendations

• A comparison of Medicare claims paid between patients undergoing elective endovascular or open AAA repair between 2004 and 2015 found no long-term differences in cumulative disease-related costs. The findings suggest that recommendations and policies for endovascular vs. surgical treatment for these patients should not be based on the relative costs of these procedures at particular institutions.[30]

Federal and Other National Healthcare Organization Guidelines/Standards

• Patient screening criteria: SVS criteria were reported to be more likely to detect patients who developed AAAs than USPSTF criteria.[31] This suggests that the government should use vascular specialist physicians in their task forces instead of just general physicians when making recommendations about vascular medicine.
• Patient selection for invasive therapy: SVS guidelines state that physicians should achieve an outcome standard where they select endovascular or surgical techniques 'appropriately' to achieve at least two years of symptom-free recurrence for outpatients seeking relief from intermittent claudication in at least 50% of such patients. However, a review of the data found that, even in this group of relatively healthy patients, such 2-year periods were only achieved in about one-third of patients undergoing invasive therapy regardless of whether an endovascular or surgical technique was used.[32] This suggests that the national 'standard' is not a realistic measure of real-life outcome rates.
• Threshold parameters for determining care quality: AHRQ publishes on its website a list of patient safety indicators (potentially avoidable adverse outcomes, abbreviated as PSI), which was on its tenth revision as of 2020. Some insurance companies grade hospital performance based on whether adverse outcomes occur that match one of AHRQ's PSIs.  Review of the outcomes of 154 patients at a single hospital reported that both the American College of Surgeons' National Surgical Quality Improvement Program database and the SVS VQI database were more likely to detect "important… clinically relevant" complications from open AAA repair than AHRQ's PSI list.[33] This suggests that AHRQ's PSI list should not be used to determine hospital grades based on AAA repair surgery adverse outcomes.
• Radiation exposure tracking: Compared to the calculated air kerma (the measurement used as the 'gold standard'), the dose area product was a more accurate representation of radiation exposure than fluoroscopy time.[34] This suggests that if the organization's fluoroscopy machine provides a dose area product, then tracking that number is more relevant and useful than tracking fluoroscopy machine use times.

Local Hospital Policy on Postoperative Patient Follow-up

• Patients who were lost to follow-up after endovascular AAA repair had worse outcomes than patients who remained in clinical surveillance after the procedure.[35] This suggests that VHCPs and healthcare administrators should make a concerted effort to continue communication with patients even after the patients have undergone "definitive" invasive treatments for AAAs.

Procedure Time Planning

• Individual patient characteristics, specific surgical maneuvers, and types of complications were able to be quantified concerning how much more time they added to procedures.[36] This suggests that managers should adjust planned procedure times based on such factors.

Physician Assessment

• The number of years of experience performing a particular surgery (below-the-knee arterial reconstruction) was found to be more closely associated with achieving a low number of surgical complications than the volume of those surgeries the surgeon performed in the last year.[37] This suggests that more experienced surgeons who are doing fewer procedures can still perform as well as surgeons of any age performing more procedures and that reaching a 'magic number' on a case log for the number of procedures performed in a defined recent period is not the best predictor of procedural competency, contrary to what some hospital credentialing officials may believe. 

Patient-Customer Experience

• Patients with varicose veins who chose telemedicine evaluations prior to decisions for next steps in invasive venous therapy had equivalent outcomes to patients with similar preoperative demographics disease severity who chose traditional in-person evaluations (that require greater time and cost for the patient-customer).[38] This implies that the patient-customer experience can be improved by offering telemedicine evaluations for these patients.

Enhancing Healthcare Team Outcomes

Teamwork can improve the quality of care in vascular medicine.[39][40] The cited studies describe how a team of vascular healthcare providers working together reduced minor errors, major errors, and the unnecessary exposure of patients to risks during aneurysm repair procedures.

The beneficial effect of collaboration and good communication by members of healthcare teams is discussed by the authors elsewhere, as well as specifically in the setting of vascular medicine by other authors.[41][42]

The synchrony of quality and compensation will increase in the future but has not been significant in the field of vascular medicine to date. Healthcare providers and administrators should be aware of the areas in vascular medicine where there is room for improvement in the quality of patient care. They should be making decisions driven by data and evidence-based guidelines from appropriate national or international organizations to modify processes and structures that improve clinical outcomes and patient experiences while reducing costs. Cost containment and revenue generation should not come at the expense of patient safety.