After successful training, the next hurdle to start a PFO closure program at an institution with no prior experience may be the necessity to have dedicated privileges. This is unlikely to be the case at an academic institution. However, it is very well likely that the only “spelled out” interventional cardiology privileges at a non-academic institution will only include coronary procedures. Hence, given the potentially lengthy process of writing dedicated privileges and having those approved by the appropriate committees, it is important to start the conversation with the department chief and medical staff early. This ties into another critically important component, administrative support. Starting a new PFO closure program or even structural heart program is associated with upfront costs. To facilitate acquisition of costly equipment and utilization of other resources, financial and organizational support from the administration is key. The administrators and department chief should be well informed of the goals of the PFO closure program, as potential adverse events during the early aspect of the program may have a negative effect on the hospital.

As mentioned earlier, it is preferable if a PFO closure program is embedded into an adult congenital heart disease or structural heart disease program. As outlined in SCAIs’ core curriculum document that describes requirements for an interventional fellowship in structural and adult congenital heart disease, compared to percutaneous coronary interventions, structural heart interventions are small-volume procedures that should not be performed by all operators. With the overlap in skill set, equipment use and need for ancillary support and imaging, embedding PFO closure into a larger structural heart or congenital program makes it easier to accomplish. Nevertheless, stand-alone PFO closure programs, even operating at low volume can operate safely, as described by Aslam et al. [3]. These authors describe their experience of starting a PFO closure program in a rural area. The proceduralists had a background in coronary interventions, each performing over 200 procedures per year. Performing about one PFO closure case per month, the authors reported the outcomes of 52 patients undergoing PFO closure during a 4 year period. No device related complications occurred. The complete closure rate at 6 months was over 90 %. The authors concluded that PFO closure can be performed infrequently in smaller centers. This was attributed to the simplicity of the PFO closure procedure, experience of interventionalists with other percutaneous cardiac procedures, and perhaps good fortune.

Another benefit of embedding PFO closure into a larger structural heart program is the potential of institutional support for a mid-level provider, such as a nurse practitioner or physician assistant. A mid-level provider is very valuable for patient education, procedure scheduling, outcome tracking and follow-up. Depending on the structure of such a program, the nurse practitioner or physician assistant can be the coordinator for office staff, hospital nursing staff, and patients.

A minimal amount of equipment has to be available to start a PFO closure program safely. This begins with the occluders themselves. Occluder devices cost about $6,000 each. To have common size ranges of two frequently used devices available; the hospital needs to invest about $60,000 upfront. Commonly, manufacturer representatives have a select number of devices readily available in the form of trunk stock. This is the preferred option for a new program, as it avoids a higher start-up cost. Obtaining devices on consignment from the manufacturer is another cost-containing way to have the required occluders available. However, companies may not offer this option to new programs. If the trunk stock option is unavailable, it is possible to judge the size of the PFO closure devices required based on pre-procedural transesophageal echocardiograms. Purchasing a small range of devices (two to three) will usually suffice to close the PFO with the correct occluder. The left over stock can be kept on the shelf, allowing a slow but steady growth of devices available over time, avoiding the upfront cost. This is the same way closure devices for atrial septal defects can be accumulated, which requires an even wider range of occluders to allow “ad hoc” closure procedures. Imaging equipment to guide the PFO closure procedure is another consideration. Single plane X-ray is usually complemented by either intracardiac or transesophageal echocardiography. If one chooses to use transesophageal echocardiography, a capable echo machine, sonographer, echocardiographer and anesthesiologist or certified nurse anesthetist are also necessary. An analysis of cost has been published comparing those two imaging techniques for the purpose of atrial septal defect closure [4]. Although this analysis suggests that transesophageal echo may be less expensive, in real life it is much simpler to schedule a procedure using intracardiac echo guidance rather than transesophageal echo due to the smaller number of individuals involved. For intracardiac echocardiography, the operator manipulates the imaging catheter and may also run the machine panel if it is placed in close proximity and has a sterile cover placed over the keyboard. Alternatively, a cath lab nurse or technologist can be trained to run the echo machine if a dedicated sonographer is unavailable. If a mid-level provider is available to support the program, the nurse practitioner or physician assistant can also be trained to run the echo machine during the procedure. Finally, ancillary equipment, such as specialty wires, catheters, snares, pericardiocentesis kit and dedicated retrieval systems have to be available. Table 30.2 summarizes a list of suggested equipment necessary for a safe PFO closure procedure. It is advisable to store all equipment in a shared space, such as a mobile cart as the support staff in the cardiac catheterzation laboratory may not be familiar enough with rarely used equipment in an otherwise primarily “coronary dominated” environment. Prior to actually starting with the first PFO closure procedure, it is important to have a plan in place for the rare event of an embolized device. In some cases, an embolized device may not be removable percutaneously. Rarely, this situation may require urgent cardiac surgery, hence teaming up with a surgeon to provide backup is crucial. Similarly, education of the cardiac catheterization laboratory personnel and telemetry nurses, prior to performing the first procedure, is helpful. A simple handout, email or educational video should be sufficient. A mid level provider can function independently in this capacity to educate health care providers prior to any procedure.