Waterford Regional Hospital is a 474 bed hospital, serving a population of 460,000 on a regional basis. They were the first hospital in Europe to install new St Jude Medical Wireless PressureWire system called Aeris.

Interview

Here at Coronary Heart we have been watching closely the development and roll-out of the new St Jude Medical Wireless PressureWire system called Aeris. After the recent success of the FAME trial which showed measuring FFR provided significant improvements in patient treatment, there has been an increase in the usage of FFR devices, particularly the SJM PressureWire (formerly Radi).

As with any angiography procedure, time saving is critical. That is why the clever boffins at Radi came up with an even more efficient FFR system called Aeris. Cath Lab workflow is simplified by instant, wireless integration with the GE Mac-Lab® hemodynamic recording system, and with a simple software upgrade the FFR results can be stored in the existing hemodynamic recording archive along with the procedural information.

The Waterford Regional Hospital in Ireland was the first hospital in Europe to install this integrated system. We spoke with the Regional Development Manager for Cardiology, Ms Catherine Dwyer, and Consultant Cardiologist, Dr Patrick Owens about their new Aeris system, and also a few other departmental questions we know you would be interested in.

What are the sizes of your Cardiology Department and Hospital?
Waterford Regional Hospital is a 474 bed hospital, serving a population of 460,000 on a regional basis. Three outlying hospitals provide additional beds. The cardiology department consists of a six bedded coronary care unit, a six bedded day ward, a cardiac cath lab, and the cardiac department for non-invasive tests.

How many staff?
Regional Cardiac Cath Lab Administrator, two on site Interventional cardiologists, and two visiting cardiologists once a week, Chief I Cardiac Catheterisation Technician (daily rotation of one cardiac technician from the Cardiac Dept) Clinical Specialist Radiographer, (rotation of Radiographers from Radiology Dept). One Clinical Nurse Manager, and 4 nursing staff working within this area. The implementation responsibility and working of FFR as part of the MAC lab is within the Technicians remit and training has been completed.

Types of procedures?
We perform diagnostic coronary angiography, angioplasty and stenting, IVUS, PressureWire and rotablation, basic and advanced cardiac pacing, including defibrillator implantations, and advanced structural interventional cardiology, specifically ASD/PFO closures. We also provide extensive non-invasive imaging, in the form of transthoracic, transoesophageal and dobutamine stress echocardiography.

Types of equipment used?
GE Innova 2100, Mac-Lab, CA 1000 workstation, Centricity Image Archive Total integrated cardiology management (Tomcat), DICOM work lists / work flow with immediate access to cardiology results across all sites within the region. Pressure wire is Aeris.

How many procedures are performed a year?
Our unit has just begun operating for five days a week, we estimate between 1500 - 2,000 angiograms per year, 400 to 500 PCIs per year, and between 200 and 300 device implantations.

Do you have cardiac surgical back-up onsite? If not, where is the patient transferred to?
No. On table emergencies would be transferred to Dublin or Cork.

What new procedures have you implemented into the department recently?
Given that the lab is newly opened, we are currently implementing extensive protocols for all aspects of cath lab and acute coronary management.

How does the lab handle haemostasis?
For radial work, vascular closure is obtained using the TR band, the angioseal is utilised for closure of femoral puncture sites.

You recently upgraded the new GE MacLab with integrated wireless FFR measurement with Aeris from SJM. What are the advantages?
The new wireless system is much more user-friendly, is much less cumbersome to calibrate, and because the wire is not “tethered”, the wire is much more easy to manipulate.

The FAME study showed that routine FFR significantly improved outcomes after (DES) stenting in Multi-Vessel Disease. Do you currently routinely use FFR when stenting equivocal lesions and will results from the FAME trial have an effect on your work practices?
I routinely use FFR estimation for equivocal lesions, and as a way of guiding appropriate therapy. The results from the FAME trial would corroborate that clinical approach FAME study, international, multi-centre using FFR guided angio vs angio alone showed that costs savings were made in the FFR group by an overall statistical score of 14%. This was mainly down to reduction in stenting by 30% in the FFR group.

Other advantages include:

• Reduction in the length of hospital stay in the FFR group.
• Reduction in the procedural costs of the procedure (guidewires and other products) in the FFR group.
• Reduction in the use of pharmaceuticals such as contrast agents – this was statistically significant in the FFR group.
• Reduction in the number of readmissions in the FFR group post procedure.
• Significant reduction in the number of patients requiring revascularization (either rePCI or CABG).

Clinical Argument

• Significant reduction in MI and death in the FFR group by 35%
• Significant reduction in overall MACE in the FFR group by 30%

These are very important clinical statistics and are creating a sea-change within cardiology globally in the strategic treatment of patients with expected increased rates of FFR usage by 50% in 2010.

What protocols has your department implemented to reduce door-to-balloon time?
We do not currently perform 24/7 primary angioplasty. During working hours, the casualty department is instructed to contact the cath lab immediately upon the arrival of an ST elevation myocardial infarction.

Achievements
The Regional Cardiac Catheterisation Laboratory operates with optimum clinical and administrative efficiency by coupling the highest level of clinical expertise and state of the art patient record management. That essential combination has directly resulted in the highest standards of patient care including timely interventions and superior outcomes for all patients presenting for this critical service in the south east area. Acknowledging this cath lab service has only operated on a 3-days per week basis (due to budget limitations), the accrued benefits from that restricted cath lab service over the past 18months is exemplary in the context of any similar service elsewhere; this is testified through the activity statistics, range of procedures and sample anecdotal evidence above. This critical service now desperately needs the requisite minimum funding to allow it expand those services and thus realise its overdue acknowledged objective. Since October 14 2009 we have opened the cath lab 5 days per week with a full range of services.

What is the best part of working at your facility?
Participating in a program that delivers modern cardiology care to the population of the South East of Ireland.

PressureWire for FFR & FAME Explained

The PressureWire™ Certus and PressureWire™ Aeris aid in the diagnosis of coronary artery blockages by measuring Fractional Flow Reserve (FFR). FFR measurement indicates the severity of blood flow blockages in the coronary arteries, allowing physicians to better identify which specific lesion or lesions are responsible for a patient’s ischemia, a deficiency of blood supply to the heart caused by blood restriction. The PressureWire technology will help physicians determine the ideal treatment option for their patients during coronary interventions, such as stent procedures.
St. Jude Medical recently launched the next-generation of the PressureWire Certus -- the only FFR measurement system used in the recent FAME (Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation) study, which found both superior clinical outcomes and reduced healthcare costs in patients whose treatment was based on FFR rather than angiography alone. The combined risk of death or myocardial infarction (heart attack) was 34% lower for patients whose treatment was guided by PressureWire technology prior to coronary stenting; also, there was a difference of about $2,000, or 14%, in healthcare costs between the two patient groups after one year. The Gen 7 PressureWire includes modifications to the design and functionality to help provide physicians with improved handling and more versatility
The PressureWire Aeris is a first-of-its-kind wireless FFR measurement system which requires no additional equipment or cabling in the cardiac catheterization laboratory. The elimination of additional equipment and cabling has the potential to simplify set-up and increase procedural efficiencies.