26 Procedures in the Hybrid Operating Room
Transcatheter techniques are being used increasingly as an adjunct to, rather than a replacement for, cardiac surgery; the primary aim is to improve clinical outcomes by reducing the size and number of incisions and cardiopulmonary bypass (CPB) time, without compromising the long-term results offered by conventional cardiac surgery.1 Increasingly, it is only possible to perform these hybrid procedures in suites combining conventional cardiac operating room capability with standard cardiovascular imaging equipment, particularly because most existing cardiac operating rooms and catheterization laboratories do not meet the requirements for performing both surgery and interventional imaging.2 Hybrid operating rooms first emerged in vascular surgery, driven by lack of access to interventional radiology facilities at a time of expansion in endovascular techniques; more recently, an increase in the number of hybrid procedures has emphasized the need for suites specifically designed for this purpose. This chapter provides an overview of the rationale for building a hybrid cardiovascular suite and the planning, logistics, and design challenges that must be met to create and run it successfully. There is relatively little available on the design and logistics of hybrid operating rooms in the medical literature; the reference articles,3–5 including an excellent case study by Hirsch4 and detailed review by Nollert and Wich,5 were the primary source materials for this chapter and cover most of the aspects outlined here in more depth.
Rationale
Key aspects of building design depend on the intended use of the room. Given total costs of between $2 and $4 million, there may be a desire to ensure that the room is suitable for the full gamut of cardiovascular hybrid procedures (Table 26-1) to maximize use; and key stakeholders from adult and pediatric cardiac surgery, interventional cardiology, electrophysiology, vascular surgery, and anesthesiology should, therefore, be involved in planning at the earliest stages. It is vital to decide early in the process whether the aim is to build a cardiac catheterization laboratory that can be used for surgical procedures, a cardiac operating room that may be used for cardiovascular imaging, or a true hybrid suite meeting the specifications for cardiac surgery and catheterization and designed to allow state-of-the-art imaging, intervention, and surgery to take place at the same time.
Interventional Cardiology |
Diagnostic and therapeutic cardiac catheterization, including percutaneous coronary intervention |
Diagnostic and therapeutic electrophysiology procedures, including endocardial ablation, pacemaker and defibrillator device insertion and changes |
Conventional Cardiac Surgery |
All adult and pediatric cardiac surgery |
Transplant, ventricular assist device, and extracorporeal membrane oxygenation |
Trauma surgery |
Fetal interventions |
Endovascular Surgery |
Abdominal aortic aneurysm stenting |
Thoracic aortic aneurysm stenting |
Carotid stenting |
Hybrid Procedures |
Pediatric |
Hybrid stage I procedure for hypoplastic left-heart syndrome (modified Norwood) |
Patent ductus arteriosus stenting with surgical Blalock-Taussig shunt |
Pulmonary artery stenting |
Percutaneous atrial septal defect with option to convert to on-bypass open procedure |
Preventricular ventricular septal defect closure for muscular apical septal defects |
Pulmonary valve replacement |
Adult |
Coronary artery bypass grafting in multivessel disease with either endoscopic, minithoracotomy or robotic mammary harvest, with direct or robotic left anterior descending coronary artery anastomosis, percutaneous intervention on other lesions, and operative angiography of bypass grafts |
Transcatheter aortic valve implantation |
Thoracoabdominal aneurysm stenting with surgical debranching or bypass |
Hybrid cardiovascular procedures
Coronary Revascularization
Coronary artery surgery, which represents more than 90% of adult cardiac procedures nationally, offers some scope for a hybrid approach. The impact of graft failure after coronary artery bypass grafting (CABG) is well documented. In a recent prospective, multicenter study, the 1-year failure rate of saphenous vein grafts was reported to be more than 30%, that of the left internal mammary artery 8%, and the common end point of death or new myocardial infarction was 14% in these patients compared with 1% in patients with patent grafts.6 More recent data suggested saphenous vein failure rates of more than 40% at 12 to 18 months.7 Early graft failure, present in 5% to 20% of patients at discharge from the hospital, commonly is attributed to technical error and is the rationale for completion angiography with the option for percutaneous coronary intervention before leaving the operating room. In a recent series of 366 consecutive patients undergoing CABG surgery with completion angiography, 6% of all grafts required percutaneous coronary intervention to address technical problems compromising patency (including vein valves impeding flow [n = 9], left internal mammary artery dissection [n = 6], vein graft kinks [n = 7], and incorrect location or vessel [n = 8]). In an additional 49 cases (6.2% of grafts), angiography revealed problems that could be corrected either by minor adjustments such as removing a clip or adjustment of conduit lie or by traditional surgical revision8 (see Chapter 18).
Transcatheter Valve Replacement
An emerging modality that will likely become a mainstay of hybrid operating rooms is transcatheter valve replacements.9 Aortic valve replacement is the treatment of choice for symptomatic severe aortic stenosis; medical management is associated with high mortality, and balloon valvuloplasty offers temporary symptomatic relief without any associated survival benefit. Despite the low operative mortality of isolated primary aortic valve replacement, up to 40% of patients with American Heart Association/American College of Cardiology Class I indications for aortic valve replacement are denied surgery. Reasons most commonly cited by clinicians include advanced patient age and morbidity, and this is a driving force behind the development of transcatheter aortic valve implantation. Transcatheter aortic valve replacement has been performed via either the transfemoral or transapical approach in several thousand patients in Europe, and as of 2010, the U.S. Food and Drug Administration approved the procedure in the United States (see Chapter 19).
The likelihood is that transfemoral aortic valve replacement will become the dominant treatment modality in high-risk patients requiring aortic valve replacement, greatly expanding the growing pool of eligible patients. Results have improved as both experience with the procedures and technology have developed, and currently mortality, associated stroke, major morbidity, and echocardiographic outcomes appear to offer very-high-risk and nonoperable patients a safe alternative to conventional surgery. Indications for transcatheter aortic valve implantation eventually may be expanded to lower-risk groups, based on outcomes of the large prospective clinical trials currently under way. Interventions for mitral and tricuspid valve repair are at a much earlier stage of development and are less likely to contribute significantly to the volume of hybrid procedures in the next decade.10
Hybrid Thoracic Aortic Surgery
Thoracoabdominal aortic disease increasingly is treated with hybrid procedures in which open repair, debranching, or bypasses are performed in conjunction with endovascular stenting. These procedures are particularly suited to hybrid suites capable of providing high-quality imaging, CPB capability, and optimal surgical conditions (see Chapter 21).
Hybrid Congenital Cardiac Surgery
Combined open and interventional approaches have been used successfully to treat multiple muscular ventricular septal defects, pulmonic stenosis, and hypoplastic left-heart syndrome. Hybrid techniques address the barriers to transcatheter approaches such as poor vascular access and hemodynamic compromise, as well as reduce the need for high-risk resternotomy and long CPB times (see Chapter 20).
Cardiac Electrophysiology
A hybrid suite would be the optimal location for totally endoscopic approaches to epicardial ablation combined with a modified transcatheter endocardial strategy, which may provide better long-term freedom from atrial fibrillation and stroke than patients treated using these methods in isolation, although data are currently limited to small, single-center series (see Chapter 4).
Planning
The process of building a hybrid operating room, from initial proposal to official opening, takes around 21 months (Table 26-2). All involved parties should establish a clear, early understanding of the primary role of the hybrid room, the statutory requirements, and site limitations that must be met.
Time Required | Activity |
---|---|
Months 1–6 | Agree on planning group |
Initial architectural plans and quotes produced | |
Obtain vendor quotes and costs | |
Produce business plan |