A Hybrid Operating Suite at Community Medical Center
Russell F Stahl, M.D., Carmen Sciandria, CCP, Cassandra Cuesta, BA

The Evolution of Treatment of Cardiovascular Disease Surgery for coronary artery disease (CABG), valve repair and replacement, and the treatment of aortic disease, all have a remarkable history of success and evolution. Just as with computer technology, the trend in surgery has been to become smaller, faster and better. The treatment of cardiovascular disease (CVD) is moving towards less invasive and, in many cases, catheter based technologies. First interventional radiologists, then cardiologists, and now cardiac and vascular surgeons have embraced this trend. Clinicians are encouraged by outcomes that appear to be at least as good, albeit with trade-offs, and a high level of patient acceptance. Hybrid operating rooms - rooms combining operating room sterility and functionality with fixed angiography and echocardiographic imaging- are rapidly growing in prevalence and gaining increased interest from hospital administrators. These rooms are used by cardiac surgeons, vascular surgeons, interventional cardiologists, and neuro-interventionalists, and are suited for both open and closed procedures, as well as collaborative “hybrid” procedures. Given the dynamic nature of this room, these investments require thoughtful preparation operationally and logistically, especially when planning for physician and support staff that will work and cover call in this room.
The Shift from CABG to PCI to hybrid procedures as a paradigm Twenty-five years ago, when the remarkable survival benefit of coronary revascularization was recognized and the safety profile of CABG surgery became favorable, there was an explosion of open-heart surgery programs and a rapid increase in the number of coronary bypass operations performed. At that time roughly one-third of patients diagnosed with coronary artery disease were referred for CABG surgery, with the remainder treated with either medications alone, or with percutaneous trans-catheter angioplasty (PTCA) of the coronary artery. The latter was plagued by both early and late failure, making PTCA a less favorable approach for many patients. Rapid technologic advancement, however, including the development of intra-coronary stents, transformed the percutaneous approach to a consistently successful intervention (now called PCI). The latest information indicates that PCI may be acceptable treatment even for patients with left main coronary stenosis or triple-vessel CAD, subsets that heretofore were routinely treated surgically. These data also reveal that CABG surgery remains the treatment of choice for patients with more severe and diffuse CAD (which does not fare as well with PCI) and especially for patients with complex lesions in the left anterior descending coronary artery. The superb durability and efficacy of a left internal mammary bypass to the left anterior descending coronary artery, superior to any PCI, opens the door for hybrid coronary revascularization procedures, ideally performed in a hybrid operating room. There has been a similar trend in the treatment of aortic disease, principally aneurysms of the thoracic and abdominal aorta. Not too long ago, open surgery was the only treatment modality available. Once endovascular stent placement became available, there was a rapid shift towards this approach as it reduced the likelihood of complications such as major bleeding, renal failure and paralysis. While endovascular therapies are not without trade-offs, such as vascular access complications, questions about efficacy and durability, and the need for increased surveillance imaging, the inherent attraction of less surgical trauma and faster recovery will continue to drive cardiovascular surgery in this direction. Recently, trans-catheter cardiac valve procedures have been introduced. Trans-catheter aortic valve insertion (TAVI) was launched in Europe less than 5 years ago and now represents nearly 30% of the aortic valve procedures performed there. FDA approval for the Edwards Lifescience Sapien TAVI product and procedure in the United States is expected by the end of 2011. Trans-catheter “clipping” of the mitral valve is also coming rapidly down the pike. While clinical obstacles and technical set-backs may be expected for these evolving technologies, it is obvious that heart centers in the U.S. will be expected to provide these types of services within the next ten years. Aortic stenting and TAVI procedures are optimally performed in a well-equipped hybrid operating room.
The Cardiovascular Marketplace-Northeastern Pennsylvania
The cardiovascular service landscape in Northeastern Pennsylvania(NEPA) is comprised of five-open heart surgery programs. In Lackawanna County, Community Medical Center and Regional Hospital of Scranton (RHS, formerly Mercy Hospital) compete within a limited geographical area. Great Valley Cardiology group, with a strong affiliation with RHS, offers outreach service in Wayne and Susquehanna Counties. Just fifteen miles to the south in Luzerne County, Wilkes Barre General Hospital (owned by Community Health Systems, CHS, as is RHS) and Geisenger Wyoming Valley (GWV) are in similar competition. Through its integrated physician network as well as its academic medical center in Danville, Geisenger reaches well beyond Wilkes Barre in NEPA. Fifty miles to the east of both Luzerne and Lackawanna Counties in Monroe County, Pocono Medical Center(PMC) is a relatively new program which has successfully captured a piece of the cardiovascular pie of Northeastern Pennsylvania. Of these five heart programs, only Geisenger Wyoming Valley provides what can be called a hybrid operating room. The hybrid room at GWV is used only by vascular surgeons, with no cardiac procedures currently performed there.
Some measure of the success these programs have been able to achieve is reflected by the public reporting on heart surgery volumes and outcomes provided by the Pennsylvania Health Care Cost Containment Council (PHC4). PHC4 reports validated, risk-adjusted outcomes for all open heart programs in the Commonwealth, including observed and expected rates for mortality, length-of stay, and re-admissions . For 7 out of the past 9 years CMC has achieved at least one area of “statistically significantly better” outcomes than the average heart program. Moreover, CMC has consistently achieved a better than expected (O/E) ratio of less than 1.0 in all of the areas evaluated by PHC4. The last 4 reported years cumulative observed to expected mortality ratios are summarized below:

Category CMC Mercy Geis-Dan Geis-WV WBGH
In hosp. CABG mortality 0.59 1.46 0.48 0.91 1.10
30 day CABG mortality 0.76 1.17 0.65 0.87 1.19
In hosp. Valve mortality 0.56 1.05 1.10 1.30 1.51
30 day Valve mortality 0.44 1.26 0.98 1.53 1.44 (www.phc4.org)
The Society of Thoracic Surgeons (STS) uses its huge database, with over 90% participation nationally, to provide feedback to heart programs and allow risk-adjusted comparisons. CMC is among the roughly 10% of heart programs with a 3-Star (highest) rating, indicating statistically superior overall performance. (www.sts.org). Geisenger Danville and Pocono Medical Center share this distinction.
Healthgrades, a for-profit, independent health reporting organization, uses publically available Medicare data to “evaluate” hospitals in several areas. In the cardiac arena Healthgrades provides star ratings (1, 3 or 5 stars, indicating statistically worse than, same as, or better than the average hospital treating Medicare patients) for CABG surgery, Valve surgery, PCI, treatment of AMI and treatment of CHF. Community Medical Center currently has a 5 star rating for valve surgery and a 3 star rating for all other components. The Healthgrades star ratings for other hospitals is not available to us.
CMC: Poised for a Hybrid Operating Room
The above information reflects a forward leaning cardiovascular program at CMC which has attained a high-level of quality. The cardiac surgical team at CMC has emphasized minimally invasive techniques for valve surgery for several years. The resulting outstanding mortality and low complication rates at CMC demonstrate a surgical team that will adapt to and optimally utilize a hybrid operating suite. Moreover, we have been working with our cardiology colleagues to prepare for this transition. The theme of this year’s CATCH (Convergence around Technologies for Cardiovascular Health) symposium is The Endovascular Treatment of Cardiovascular Disease. The conference provides an opportunity for CMC’s cardiovascular specialists to demonstrate their expertise and study what is coming next. Our emphasis on convergence will create the environment for success in the hybrid O.R., where many procedures require the skills of both an interventional cardiologist and a cardiovascular surgeon. Indeed, the promotion of a multidisciplinary “heart team” is what referring physicians and the public will respond to, rather than the physical room itself. A hybrid O.R. would not only be used for valve procedures, but also for coronary revascularization. As mentioned above, traditional CABG surgery has been displaced to a large extent by PCI, but there are still many patients that benefit from a surgical LIMA to LAD bypass, perhaps in conjunction with stents to other vessels. The cardiac team is already capable of performing off-pump CABG surgery, a prerequisite for minimally invasive coronary surgery (through small incisions) and hybrid coronary revascularization. The hybrid O.R. would provide the platform to take us to totally endoscopic coronary artery bypass (TECAB) procedures.

A minimally invasive mitral valve repair incision

CMC’s current vascular surgeons (Drs. Smeraldi and Stivala, and soon to include Dr Jerius) are ready to immediately leverage a hybrid O.R. They currently perform endovascular procedures such as aneurysm repair, carotid stenting, balloon maturation of arterio-venous fistulae, and lower extremity revascularization. These procedures are often performed under less than ideal conditions in the cardiac catheterization lab or in a standard operating room using portable imaging equipment. While this is a cost-effective way to begin an endovascular program, a hybrid O.R. would allow dynamic growth in volumes, efficiency, customer satisfaction and profitability. Indeed, vascular surgery will not only make the hybrid O.R. truly cost-effective, but will grow the entire cardiovascular service line. The Advisory Board has identified vascular disease as an undertreated entity and a potential driver of cardiovascular disease service lines.

Going Hybrid Embarking on the journey of constructing a hybrid operating room not only requires a substantial financial foundation, but also the dedication, acceptance and commitment of healthcare providers and administrators alike. It is very important that everyone is made aware of these aspects of the hybrid operating room prior to construction. When planning to go hybrid, the first consideration, after investment considerations, is where the room will be located. Location is an essential step in achieving OR sterility. Most hybrids have sterile fields and access to sterile processing within the sterile core housing the traditional OR’s (Ashley Ford, Advisory Board). This need for the utmost level of sterility is one of the main reasons for the hybrid OR’s price tag. The air handlers required for the room cost an additional one million dollars or thirty to forty dollars per square foot per air handler (Ashley Ford, Advisory Board).

Construction of the room requires certain specifications in order to fit all of the technology and equipment. While a standard operating room is between 600 and 750 square feet, the hybrid operating room demands anywhere from 1000 to 1200 square feet as well as lead lined walls and a ceiling capable of holding boom-mounted equipment, uni-strut reinforcement for mounted C-arm and sufficient space for HVAC duct work. These features encompass some of the technology inside the room, however, there is much more that is included beyond the room. Some of these characteristics include: externally-housed scrub sinks, adjacent control room, equipment and supplies storage room, adequate air-exchange rate and a cold room for computer equipment. Once arrangements for the construction requirements are made, the team of healthcare providers must assess and understand which procedures can be done through the use of the hybrid operating room. Two procedures that absolutely require a hybrid OR are Transcatheter Aortic Valve Replacement (Transfemoral Delivery) and Transcather Aortic Valve Replacement (Transapical Delivery). Other procedures that are suitable for a hybrid OR are minimally invasive valve repair/replacement and stent, percutaneous mitral valve repair, abdominal aortic aneurysm repair, and thoracic aortic aneurysm repair. The potential of these various procedures to grow with the use of the hybrid OR would make Community Medical Center a leader in cardiac and vascular surgeries in the area to better ensure patient safety and recovery time; thus reducing patient morbidity and mortality. The hybrid OR requires a multidisciplinary convergence with a larger specialized team. Because of the array or technology and equipment a minimum of ten people must be in the room throughout each procedure. To staff the hybrid OR, there needs to be a surgical team consisting of the cardiothoracic surgeon and a first assistant, namely another cardiothoracic surgeon or RNFA. Next, there needs to be the anesthesiology team; the anesthesiologist and two nurse anesthetists. The perfusion team should include the main perfusionist and one back-up. Next, is the interventional team comprised of a cardiologist and another first assistant. Finally, is the nursing and support staff. This grouping is made up of one or more scrub nurses, one or more OR nurses, a circulator, aa cath lab nurse and a radiology technician (Ashley Ford, Advisory Board). All of these staff members must confer with and quickly learn from one another and cannot be afraid to try new techniques (Dr. R. Stahl, CMC health system).

Patient Case Studies Vanderbilt Heart Institute was an early adopter and proponent of hybrid operating rooms. Recently, a 51 year old man was treated at Vanderbilt for aortic valve stenosis with an anomalous left circumflex coronary artery which coursed directly behind the aortic annulus. Noting that the artery was at risk for injury during aortic valve implantation, the surgeons performed the procedure in the hybrid O.R., replacing the valve using a minimally invasive surgical approach and performing a completion angiogram (in the same room, during the same anesthetic), assuring unperturbed coronary anatomy before allowing the patient to wake up and leave the O.R. He recovered uneventfully. In another case of aortic valve stenosis, an 81 year old female had a transcatheter valve inserted in the aortic annulus under fluoroscopic and trans-esophageal echocardiographic guidance, with the chest closed. Ischemic EKG changes suggested disturbance of the coronary circulation, a critical complication. The interventional cardiologist on the team was able to immediately perform angiography and stenting of the left main coronary artery, salvaging the situation. These type of complex team approaches would not be possible in conventional catherization or surgical suites.

Investment Considerations

City or Town | Point A | Point B | Point C | Point D | Point E | Point A | — | | | | | Point B | 87 | — | | | | Point C | 64 | 56 | — | | | Point D | 37 | 32 | 91 | — | | Point E | 93 | 35 | 54 | 43 | — |
“Benchmarking Hybrid Utility”

Operational Considerations-Key Steps of Hybrid O.R. Building Phase
As many stakeholders will be working in the hybrid suite, it requires a multidisciplinary approach. It is important to identify the committee members that will be involved in all aspects of planning, design, and implementation of the suite. All physicians whom are going to be users, along with ancillary staff (anesthesia, nursing, perfusion, cath lab, etc.), administrative clinical support(service line leader), finance, vendors, and facilities representatives all need to play a role in the process and sign-off on all steps throughout the development to maintain empowerment.
Once the stakeholders have been identified it is important to organize the administrators, physicians, and a member from each department to travel to site visits. The site visits should include facilities comparable to your own program. Consider all ideas from staff training, vendors & equipment, hybrid location, staffing models, case mix, and marketing.
It is important to identify a person to fulfill the role of the hybrid operating room manager, considered the gatekeeper. The manager will ensure appropriate surgical, interventional, ancillary coverage to staff the room and coverage for emergency procedures. The manager must maintain complex hybrid inventory by partnering with operating room and catheterization lab colleagues to ensure par levels. One of the most important jobs is to ensure only trained approved surgeons have access to the suite at all times. Once the room is serviceable the gatekeeper will manage the day-to-day caseload with emphasis on priority access for true hybrid and possible conversion cases.

Summary

Works Cited
There are no sources in the current document.