Cardiac Procedures in Ambulatory Surgical Centers

Some regulations require the ASC to be located near enough to a hospital to transport a patient within 60 minutes. However, a 60-minute delay may jeopardize the health - or life - of a patient with complications requiring immediate, specialized treatment.

In addition to myocardial infarction (heart attack), serious cardiac complications that may occur during cardiovascular procedures in ASCs include pericardial effusion and tamponade; ventricular fibrillation and dysrhythmias; embolization of stents; cardiogenic shock; retroperitoneal hemorrhage; aortic or sinus of Valsalva rupture; and coronary artery dissections, in which a tear forms in a cardiac artery.

Serious potential peripheral/endovascular complications include iliac vein rupture and retroperitoneal bleeds; embolization of vascular closure devices; thrombus or flow limiting dissections; embolism of inferior vena cava (IVC) filter into right ventricle; deep vein thrombosis (DVT) and pulmonary embolisms.

As life-threatening emergencies may require specialized medical care, ASCs are generally required to have a contract in place with a receiving hospital. However, the patient may not survive a 60-minute delay while in transit to a hospital, raising safety questions about measures taken before the procedure and during treatment. Physicians, health care administrators, patients, and insurers are understandably concerned about preventing medical malpractice.

In recent years, the Centers for Medicare & Medicaid Services (CMS) expanded ASC coverage for cardiac interventional procedures including catheterization procedures, endovenous ablation, and pacemaker placements. Cardiologists are now shifting percutaneous coronary interventions (PCI) procedures - also known as angioplasty - to ASCs due to expanded CMS coverage. While these procedures are generally safe, the potential risks for vulnerable patient populations warrants further study. The risks and benefits of PCI received an uptick in attention during 2020 after CMS authorized ASC coverage.

Each year, more than 600,000 PCI procedures are performed in the US, costing more than $12 billion. Potential overuse may pose undue risk to patients. Professional medical organizations including the American College of Cardiology and American Heart Association have addressed concerns by formulating appropriate use criteria (AUC).
Emerging Cardiology Safety Concerns

Recent articles in the Journal of the American College of Cardiology and JACC Cardiovascular Interventions discuss the focused attention that physicians are devoting to PCI safety in the ASC setting. It is essential to analyze data stratified by patient subgroups to identify demographic traits, clinical characteristics, and comorbidities that may be associated with greater risks of complications. Research is ongoing, and identifying high-risk patients may prompt doctors to reconsider the procedure or setting.

Patient safety is also paramount for the Society for Cardiovascular Angiography and Interventions (SCAI) which supports CMS payments for PCI in ASCs, so long as the quality of care equals that of a hospital-based outpatient setting. While the SCAI generally considers PCI procedures in the ASC setting safe, the SCAI, like other organizations, notes the value of further study to identify patients at high risk.

AUC development and patient subgroup assessments facilitate cost containment and patient safety measures. For example, safety data from recent clinical trials discussed in JAMA may lead to modified AUCs for PCI. Researchers evaluated the ISCHEMIA clinical trial data from 2018 - 2019 to assess the appropriateness of PCI among patients with stable ischemic heart disease (SIHD). PCIs were classified as appropriate, maybe appropriate, or rarely appropriate. Based on current AUC definitions, 3.3% of PCI patients were classified as rarely appropriate; yet under modified AUC definitions, 22.3% were classified as rarely appropriate. This marked increase was largely due to a reclassification of asymptomatic patients. The American College of Cardiology notes that updating AUC and guidelines to remain consistent with evidence from clinical trials may decrease costs and risks.

The role of financial motivation to perform unnecessary procedures that pose undue risk has received considerable attention. In fact, several hospitals and clinicians were penalized under the US False Claims Act for questionable Medicare billing for PCI procedures deemed unnecessary, according to a recent JAMA article.

DISCLAIMER:Dr. Dalawari shares interesting and relevant medical-legal news in the press. He also shares case verdicts & settlements from the public record. He has no professional or personal relationship to the cases.