The odd names mentioned in the story are::::::::::::::::::::

“ASSENT 3 Plus” or “Assessment of the Safety and Efficacy of New Thrombolytic regimens”

Lovenox

unfractionated Heparin

TNKase (Tenecteplase)

Lifepak 12

By Andrew Gorosko

WATERBURY — Waterbury Hospital and an ambulance company are participating in a medical study designed to gauge the effectiveness of promptly giving certain heart attack patients drugs to dissolve blood clots, well before the patients arrive at the hospital’s emergency room, to improve those patients’ medical outcomes.

The yearlong experiment, which begins May 1, is designed to allow the rapid diagnosis and treatment of heart attacks in the field, before heart attack patients arrive at Waterbury Hospital via ambulances with paramedics.  

To take part in the study, American Medical Response (AMR), the ambulance firm that serves Waterbury Hospital, has purchased 18 sophisticated electronic heart monitors. AMR transports patients from 14 surrounding towns to Waterbury Hospital. 

The heart monitors will produce hospital-quality electrocardiograms of patients in the field. The electrocardiograms will be transmitted via a cellular communications link to doctors at the hospital, who will determine whether a patient has had a heart attack and is a candidate to receive the drugs which dissolve the blood clots that cause heart attacks. Those drugs, known as thrombolytics, are given intravenously.

Gary Havican, emergency medical services coordinator at Waterbury Hospital, said using the advanced equipment would allow paramedics to give heart patients the thrombolytic drugs significantly sooner than those patients would receive the drugs at the hospital – provided that doctors decide the patient is medically eligible to receive the drugs, and the patient agrees to participate in the medical study. 

The hospital is participating in the study with pharmaceutical manufacturer Boehringer Ingelheim.

In the best cases, after the thrombolytic drugs are administered, the patient’s congested coronary artery will reopen, relieving the heart attack, Mr Havican said.

Last year, doctors at Waterbury Hospital administered about 100 doses of thrombolytics in the emergency room to break up blood clots in heart attack patients, he said.

Robert Retallick, AMR’s operations manager, said using the sophisticated heart monitor/defibrillators, which transmit patients’ electrocardiograms to the hospital from the field, will provide heart patients in the region with state-of-the-art emergency medical care while en route to the hospital. “Patient care is our number one concern,” he said.

The heart monitors use 12 sensors to create electrocardiograms, which are graphical electrical measurements of heart contractions. The equipment also measures oxygen levels and carbon dioxide levels in the blood. Although the devices are sophisticated, they are relatively simple to use, Mr Havican said.

Mr Retallick explained that the longer the heart muscle is deprived of oxygen due to a blood clot, the more damaged the heart muscle will become. Providing thrombolytic drugs to heart patients in the field is intended to resupply the heart with oxygen, and thus limit heart damage.

Diagnosis

After doctors at the hospital read the electronically-transmitted electrocardiogram of the patient and determine that he has had a heart attack, paramedics will ask the patient whether he wants to participate in the medical study. Lengthy medical checklists will be consulted to determine whether the patient is eligible to participate.

The medical study is specifically intended to learn which of two different blood anticoagulant drugs, either Lovenox or unfractionated Heparin, works more effectively with the thrombolytic drug known as TNKase (Tenecteplase) in a “pre-hospital environment,” Mr Havican said. There is no placebo being used in the study, he said.

Like other thrombolytic drugs, the use of TNKase poses risks for adverse side effects, including intracranial hemorrhage and stroke.  

The medical study is known as “ASSENT 3 Plus,” an acronym for “Assessment of the Safety and Efficacy of New Thrombolytic regimens.” 

Of the need to spend a substantial amount of money to buy the heart monitors for the medical study, Mr Retallick said, “It didn’t take us long to come to this financial decision.”

It cost AMR about $300,000 to purchase 18 heart monitors, he said. Having such sophisticated equipment puts the firm ahead of its competition, he added.

William Boucher, an AMR paramedic instructor, said the Lifepak 12 heart monitor to be used by AMR in the study is a well-designed device which will provide paramedics with much useful information when transporting patients to the hospital.

By using the device, AMR will “bring the emergency room to the people who are calling for it” with the goal of increased survivability, Mr Retallick said.

The heart monitor also will be useful in monitoring patients when AMR makes patient transfers from Waterbury Hospital to other hospitals for angioplasties and coronary artery bypass surgeries, Mr Retallick said.

“We’ve increased the standard of care,” Mr Havican said of AMR having the heart monitors in use. After the medical study ends, AMR and the hospital will have the benefit of having ambulances equipped with the sophisticated equipment, he said. Waterbury Hospital is the medical sponsor of AMR in the Waterbury area. AMR makes two-thirds of the ambulance arrivals at Waterbury Hospital.

During the yearlong study, the hospital expects that 10 to 12 heart attack patients will receive the thrombolytic drugs while en route to the hospital. Worldwide, the study’s goal is to have 1,000 patients participate.

Emergency Doctor

Craig Mittleman, MD, director of emergency medicine at Waterbury Hospital, said the sophisticated heart monitors will allow paramedics to rapidly and remotely provide doctors with valuable information for making patient diagnoses, thus allowing rapid medical intervention. 

 Participating in the thrombolytic drug study allows the Waterbury Hospital and AMR to upgrade their technology, he said, stressing that the equipment will remain in use after the study concludes.

Through the project, doctors will confirm patients’ heart attacks sooner, potentially allowing the drugs which break up blood clots to be given to patients sooner, Dr Mittleman said.

Early medical intervention allows more heart muscle to be salvaged, which may mean improved survivability, he said. Preserving heart muscle in a heart attack means improving a patient’s quality of life, he added.

The heart monitor would inform hospital doctors if a patient had a heart attack up to 20 minutes before that patient arrives at the hospital, Dr Mittleman said.

“You want to be able to identify and treat [a heart attack] as fast as possible,” he said.

Dr Mittleman said he would like the results of the medical study to affirm that early recognition and medical intervention in heart attacks should become the national standard of health care.

Until this medical study, the sophisticated 12-sensor electrocardiogram was only available at the hospital, Dr Mittleman said.

More than 1.1 million people in the United States suffer heart attacks each year, of which about 500,000 people die.