At the time of its inception, it was more the exception than the rule to find a cardiac cath lab in a community hospital. Patients usually had the procedures done at tertiary care centers.
"The belief in the past was that one should not perform a cardiac catheterization in a setting without cardiac surgery on site," said Amanda Savage, RN, the lab's interim manager.
Officials at Melrose-Wakefield Hospital (MWH), a member of Hallmark Health, recognized a need in the local community. On the map, Boston's tertiary care hospitals are approximately 12 miles from Melrose-Wakefield Hospital. But those 12 miles can be fraught with traffic, not to mention expensive downtown parking.
Savage lauds cath lab director Salil Midha, MD, for persevering in talks with the Massachusetts Department of Public Health (DPH) to get the lab going.
In 1999, lab and hospital officials sought an expanded role for the lab, again to serve a community need. At the time, the cath lab was only approved to perform non-emergency diagnostics. Patients who presented with acute MIs were transferred directly from Melrose-Wakefield to a tertiary care facility.
Carl Turissini, MD, the lab's interventional director, reviewed 50 cases transferred from Melrose to Boston for the time it took for the occluded vessel to be opened. He found it took 3-4 hours. Transportation, both vehicle availability and transport time, was a major cause of the delay in treating these acute patients.
"Time is muscle," Ancona pointed out, in reference to the progression of dying cardiac muscle during a heart attack.
Another Hill to Climb
Officials began the rigorous 5-year process of securing approval from DPH to perform emergency angioplasties.
Savage estimated they reviewed more than 200 medical records to gather data supporting the belief there was enough of a demand in the community. The process was "long and arduous but rightfully so," she said.
"What we were asking to do was to place a balloon in a coronary artery and abort a heart attack without the presence of cardiac surgery in our institution; it's not a benign thing," she continued. "However, over the years, it has been proven throughout other states that this can be done safely with no higher rate of morbidity or mortality. And it's serving our community in a very appropriate manner."
To gain approval, the lab had to meet certain conditions set by DPH. Melrose- Wakefield established an agreement with its tertiary care hospital, Massachusetts General Hospital (MGH) in Boston, stating MGH would accept patients who required a higher level of care than what Melrose-Wakefield provided.
The staff of the cath lab at Caritas Norwood Hospital was extremely helpful and generous with their time, knowledge and experience, Savage noted. The staff shared their successes and opportunities for improvement and, "were a very valuable resource."
Another condition of participation required, the lab to submit outcomes data to the American College of Cardiology's National Cardiovascular Data Registry. In preparation for primary angioplasty, Melrose-Wakefield participated in the CPORT trial conducted by Thomas Aversano, MD, at The Johns Hopkins University School of Medicine and its Heart Institute. The nationwide research concluded that emergency angioplasty performed in community hospitals without surgical back-up was safe with no increased risk of morbidity or mortality, according to Savage.
Getting the Green Light
In January 2004, the cath lab was granted permission to perform emergency angioplasties.
The clinical team chose to resume a 7 a.m.-3 p.m. schedule, as they had done previously, and set up a 24/7 on-call roster. The first procedures were back-toback patients on April 19, 2004. All the hard work and preparation paid off, with two successful angioplasties and excellent patient outcomes.
The learning curve was immense. On top of performing emergency angioplasties, the lab had recently acquired new equipment, including hemodynamic monitoring and X-ray machines.
It was "literally a new lab," Savage said. "The CCL staff was absolutely committed to providing primary angioplasty."
The staff not only worked on the processes and logistics inherent in developing the program, but also went to MGH cardiac cath lab for 4 weeks of education and training on new equipment and procedures.
Going With the Flow Although the lab's clinical staff has increased, there are only 5 full-time positions — three RNs and two radiology techs — in addition to the doctors. (There are also two per diem nurses and one per diem radiology tech.)
Two nurses and a radiology tech are on-call simultaneously. The cath lab staff includes Grace Ancona, RN, Kathy Minahan, RN, Ron Mendes, RN, Beth Quinlan, RT, and Mary Ellen Raduazzo, RN. Each take calls an average of 15 days per month. Nurses in tertiary care hospitals' cardiac cath labs are typically on-call once every few weeks and 1 weekend a month.
The flow is unpredictable.
"We could go 2 weeks without being called in, but then there was a Saturday when we were called in for three different cases," Ancona said.
The nurses must call immediately following a page and arrive at the lab, dressed and ready, within 30 minutes.
Savage said support from other departments has been essential. The program would not be successful without the support of the emergency department. The ED staff identifies, treats, prepares and initiates the on-call process for patients with an ST elevation MI.
"The door to balloon times would not be what they are without the expertise and efficiency of the ED," Savage said. At Melrose-Wakefield the average door-toballoon time for emergency angioplasties is 90 minutes or less.
The team was ready for the next rung in the ladder.
Although the lab had performed diagnostic angioplasties on a non-emergency basis since it opened in 1993, it was not permitted to administer a therapeutic intervention if needed. DPH reasoned elective interventions could wait for an opening at a tertiary care hospital.
"In order to get to the point where we are at now with elective angioplasties, we had to be successful performing emergency angioplasties," Savage explained.
The lab received the go-ahead for elective angioplasty in less than 8 months through the hard work and diligence of Steve Kapfhammer, executive vice president of Melrose-Wakefield; Carl Turissini, MD, interventional director; Ken Shastany, MS, RN, former director endovascular services; and the entire cath lab staff.
On Sept. 8, 2006, the cardiac cath lab performed its first elective angioplasty. On that day, there were 4 scheduled cases which yielded 2 elective angioplasties.
In order to obtain permission to provide elective angioplasty, DPH required all designated community hospitals to participate in the MASS COMM Trial. The trial, run by Harvard Clinical Research Institute and funded by the seven participating hospitals, will monitor the safety and efficacy of elective angioplasties at hospitals without on-site cardiac surgery.
There is strict criteria determined by HCRI in which elective angioplasty can be provided. Participation in the trial requires tremendous diligence to information gathering, data entry and follow-up.
"Regardless, it is worth it; we have continuity from diagnostic to intervention to home for our patients," Savage said.
Patients who elect to be a part of the study are aware they have an average of 1- in-4 chance of being sent to a tertiary care facility downtown should they need an intervention. The cardiologist performs the diagnostic procedure and then identifies whether the patient will require elective angioplasty. The staff open a sealed envelope, which is computer randomized as to whether the angioplasty can be performed on site or the patient must be transferred.
Patients who opt out of the study are sent to a tertiary care facility for interventions. The study will conclude when it reaches 6,000 participants from all seven participating community hospitals
Despite ever-present challenges, the Melrose-Wakefield staff is determined to provide the best service it can for the hospital's community. In the future, a second interventional lab will be added. Presently, there is only one procedure room with a small pre/post-procedure area.
But staff also are thankful for what they have achieved since the lab first opened in the year of the hospital's centennial anniversary.
"This program is a true collaboration of all departments in the hospital and a great reflection of the commitment of Hallmark Health Systems to our patients," Savage concluded.
Michelle Apuzzio is a frequent contributor to ADVANCE.