The CFA Perspective

Regulation Changes to Allow California Hospitals with Cardiac Cath Labs to Perform Elective Percutaneous Coronary Interventions (PCI) without Cardiac Surgery-on-Site

Posted by Peter Rastello

11/1/14 7:33 AM

Californialaw will now allow hospitals licensed to provide emergent cardiac catheterization laboratory services to perform scheduled, elective PCI regardless of the presence of cardiac surgery-on-site.  This change reflects the standard of practice in many other states and the successful results of the 2008 California Department of Public Health Services (DPHS)-sponsored Elective Percutaneous Coronary Intervention Pilot Program that concluded in its final report, “… after completing risk adjustment, pilot hospital PCI had the same composite mortality and emergency Coronary Artery Bypass Grafting rate as non-pilot hospitals.” 


This is important news for select California“cath-only” hospitals.  Hospitals once limited to only diagnosing cardiac disease or conducting STEMI PCI procedures in the cath lab now may have a potential significant elective therapeutic capability as well. PCI is a critical cardiac service that denotes increased clinical sophistication, market growth, additional volume, and revenue.  The presence of interventional cardiology can contribute significantly to hospital growth, development and utilization. 


An eligible hospital must submit an application to the DPHS to obtain certification to participate in the PCI program.  Specific terms and conditions of participation are specified in regulation, including requirements for:  institutional volume, operator volume, target door-to-response times, rigorous quality assurance, staffing, hours of operation, availability of acute care and nursing unit back-up, clinical support, medical specialty support, reporting of data, minimum equipment and supplies and other important issues.  Before submittal, interested hospitals need to evaluate the strategic, operational, clinical, financial and political feasibility of implementing a PCI program.  Such an analysis is multifaceted and important for ultimate success.


Here at Charles Franc and Associates, we have performed numerous feasibility, planning and subsequent implementation engagements for cardiac cath labs and PCI with and without surgery-on-site. We can assess feasibility, compile the necessary information, identify the critical success factors, and assist your hospital in filing an application for participation with the State.  Additionally, CFA can provide implementation assistance as well.  These services can be done efficiently and effectively within a modest budget. 


Interested in learning more about this regulatory change and how it may benefit your hospital?  Please call Charles Franc at (949) 443-4005 for a further discussion of this important new opportunity.

Topics: PCI

New Study Cites Safety of Same-Day Discharge for Elective PCI

Posted by Peter Rastello

10/21/11 4:50 AM

According to a study recently published in the Journal of the American Medical Association, older, lower-risk patients undergoing elective PCI can be safely discharged from the hospital the same day as their procedure.  Although hospitals have begun to increase their same-day outpatient PCI rates over the last few years, among selected Medicare patients, same-day discharge is still relatively uncommon.  Study investigators observed nearly equivalent rates of mortality and rehospitalization at two and 30 days when compared with patients who stayed overnight.


The study concluded that there are a large number of patients who remain in the hospital overnight after PCI who could safely be sent home the day of their procedure.  Data was analyzed for 107,018 Medicare patients 65 years and older who underwent elective PCI and were contained in registries including those of the American College of Cardiology and Society for Cardiovascular Angiography and Interventions.  While the registries included many “straightforward” elective cases, more than one-third had a high-risk lesion, 16% underwent multiple vessel PCI and 12% had a bifurcated lesion.


Previous studies have focused on comparing early-discharge rates among patients undergoing PCI have been done outside the U.S. using radial access or single center studies with femoral access and vascular-closure devices.  Radial access has generated considerable interest (see CFA’s blog on radial access posted on March 31, 2010) so there was considerable interest on the part of researchers to ascertain whether it was necessary, regardless of access site, for PCI patients to remain in hospital overnight.


The overall prevalence of same-day discharge was 1.25%, and there was significant variation across different centers in the registry.  Rates of death and rehospitalization between the two groups were statistically similar.  The principal investigator opined that “…we need to get better at stratifying high- and low-risk patients.  When we looked at the lower-risk patients in the study, many are remaining in the hospital overnight.  In this case, the physician is probably unable to figure out who should go home early, so they keep everybody.”


Treating low-risk PCI patients as same-day outpatients would result in shorter stay, less overhead and less occupancy of a hospital bed.  CMS pays for outpatient PCI (defined as less than a 23-hour stay) and has criteria to determine who should stay overnight.  Overhead costs would also be impacted by the approach, femoral or radial.  The ideal candidate for early discharge is a patient who had successful PCI and does not require prolonged IV medications, prolonged bivalirudin infusion or prolonged monitoring for other reasons.  The patient should be ambulatory within six to eight hours and have adequate home support, including ability to return to the hospital in case of emergency.  Of interest, the principal investigator’s hospital, Duke, does not discharge patients at night or those who live more than 60 miles away from the nearest hospital.


CFA recommends that hospitals consider same-day outpatient PCI for appropriate patients and evaluate this with their interventional cardiology staff.  Included in this discussion and evaluation would be issues of patient selection, risk stratification, femoral/arterial approaches, recovery site and attendant processes, discharge criteria, patient support system post-discharge and the resulting documentation of cost savings and clinical outcomes.


For further information, refer to Rao SV, Kaltenbach LA, Weintraub WS, et al.  Prevalence and Outcomes of Same-Day Discharge after Elective Percutaneous Coronary Intervention among Older AdultsJAMA 2011:  306 (October 5, 2011):  1461-1467.


CFA invites your comments, suggestions and questions.

Topics: PCI

SYNTAX Trial – Is CABG Underused?

Posted by Peter Rastello

10/6/10 7:10 PM

We were recently discussing our years in the field of cardiovascular medicine and one of my colleagues vividly remembered the day our hospital performed its first percutaneous transluminal coronary angioplasty (PTCA) more than 30 years ago.  Our cardiovascular program was very early adopting the technology which required the hospital to send two of its best soon-to-be “interventional” cardiologists to Switzerland to learn the procedure directly from Dr. Andreas Gruentzig himself.  A new day dawned and the development and inevitable ascent of percutaneous coronary intervention (PCI) began.  With the rapid dissemination of this new technology, and the eventual addition of coronary drug-eluting stent technology, cardiologists had a new, clinically effective and cost effective tool that obviated at least some patients from having to undergo coronary artery bypass graft (CABG) surgery.  As it turned out, a lot of patients have avoided CABG since then!  According to the National Center for Health Statistics, PCI increased from about 561,000 patients in 2000 to about 1,313,000 patients in 2006 (up 134%).  CABG began its concomitant decline in volume from a high of about 607,000 patients in 2000 to a low of about 448,000 patients in 2006 (down 26%).  Not-so-gradually, a less-invasive, less expensive and safer procedure was able to eliminate a large number of more costly surgical procedures with considerably higher risks and recovery implications.  A good thing, right?


Maybe not.  The SYNTAX Trial (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) the first large trial to compare stenting and CABG directly, first reported in early 2009, has continued to stir the controversy.  The trial randomized 1,800 patients (in Europe and the U.S.) with severe CAD to either CABG or drug-eluting stents, and followed them for twelve months thereafter.  On September 12, 2010 in Geneva, additional results were reported.  The researchers conclude that tens or even hundreds of thousands of Americans are having coronary artery angioplasty and stenting every year when they should be having CABG, and the result is an extra 5,000 or more deaths annually.  The trial randomized patients with severe CAD -- triple-vessel or left main disease.  This group has remained nearly the only subset of patients that cardiologists feel compelled to refer for CABG surgery.  It has been suggested that cardiologists have long been desirous of trial results that would show that stents are just as good as CABG even in these patients.


SYNTAX seems to prove otherwise. Three years after the procedure, those that received a stent procedure were 28% more likely to suffer a major event such as a heart attack or stroke, and 46% more likely to require a repeat revascularization.  They were also 22% more likely to have a mortal event.  It seems that, for the most severe disease, surgery has a real patient advantage.   For patients with mild disease, the two procedures offer equivalent results.  But the differences were much more dramatic for patients with more severe CAD.  Approximately 50% of all patients undergoing angioplasty in the U.S. have more severe disease.  Hence, the researchers conclusion that CABG is underutilized for patients in this category.


While surgeons have touted these results, some cardiologists continue to believe that some patients with severe CAD should still be considered candidates for stenting despite the results of the trial.  They argue that some of the “endpoint events” in the study, such as the rate of stroke (lower in stents than in CABG) are more important than others and work in coronary stenting’s favor.  To this end, the SYNTAX investigators are working to develop a “SYNTAX score” that would help physicians determine which patients would benefit the most from which procedure.  It seems inevitable that additional clarification will be produced; guidelines, protocols (and perhaps even governmental and/or insurance company dictates) will be produced to reflect the SYNTAX conclusion.  Cardiac surgeons may be happy, but how far will these results go in settling this issue with cardiologists and their patients (let’s not forget the need for a well informed patient in all this), and how will this impact CABG volumes over the next few years?  Despite SYNTAX, the struggle between competing procedures and competing specialists will surely continue.  Well designed research should clarify and enlighten.  Unfortunately, no matter how good the research and compelling the findings, sometimes enlightenment is often a difficult end point to achieve.


CFA invites your thoughts and comments.

Topics: Clinical Performance Improvement, PCI, CABG