Kirk Hamilton: Can you please share with us your educational background and current position?

Mark Goodman: I am one of approximately 12 individuals in the United States who have earned an accredited Ph.D. in Behavioral Medicine (with specialization in clinical neuropsychology) from the University of Maryland/Baltimore. Behavioral Medicine is a new interdisciplinary specialty combining cross-training in behavioral psychology, neurosciences, physiology and medicine. My externship and internship/residency were completed at Johns Hopkins and The Union Memorial Hospitals in Baltimore, MD. At the time of these two angioplasty restenosis risk-factor and intervention studies, I was attending clinician and faculty preceptor on the neurology/psychiatry rotation for internal medicine and family practice residents with consultation/liaison assignments to cardiology, open heart, geriatrics, CCU, and general medicine services. I was also the principal investigator conducting this grant-funded clinical cardiac research. I am fully licensed, and practicing in New Jersey-U.S.A. providing angioplasty restenosis-prone behavior modification interventions (and dementia diagnostic 2nd opinions), and continuing clinically relevant research. I am Clinical Associate Professor affliated with the University of Medicine and Dentistry of New Jersey-SOM, and am a part-time Medical Director for an automobile insurance company.

KH: When did you get interested in the role of behavior and coronary restenosis?

 

MG: My clinical assignment to open heart surgery service made me acutely aware of the now well-documented temporary and permanent mental status/neurocognitive/personality changes and long post-op recuperative period that accompany coronary artery by-pass grafting (CABG). Simultaneously, I also attended to many post percutaneous transluminal coronary angioplasty (PTCA) patients, many of whom, like my post-CABG patients, were also in their third to sixth decades of life. Obviously, the difference in post procedure sequelae were formidable. However, as the literature documents, I saw about 35% of our post-PTCA patients returning with angiographically documented repeat same-site restenosis despite repeat PTCA’s. The fate of multiple same-site PTCA restenosis is typically CABG. PTCA is a virtually painless, elegant, and beautiful procedure which immediately improves quality-of-life for those who are suitable candidates. I thought if there were a way to prevent restenosis, one could perhaps avoid CABG. However, you can’t prevent something unless you know what places one at risk for the disorder. At the time I embarked upon the risk factor intervention study in 1993, little was know about restenosis risk-factors. My research training in behavioral cardiology studying risk-factors for heart disease partly focused on Type-A coronary-prone behavior where certain predisposed individuals exhibit exaggerated/fluctuating sympathetic nervous system hyperreactivity in response to environmental stimuli. This mechanism appears to be vagal nerve mediated and an old vestige of the “Flight-Fight” phenomenon. For want of a better term, some identify this pervasive response style as “hostility.” Forty behavioral

components make up Type-A behavior pattern which is typified by being easily frustrated when one’s goals are thwarted, rapid speech, impatience, cynicism, feeling time pressured, surliness, rudeness, disagreeableness, antagonism, loud voice style, etc.. Large National Institute of Health studies ultimately demonstrated that it is this “hostility” component of the Type-A behavior which is cardio-toxic and coronary-prone. I am the first in the world to have studied the role of “coronary-prone behavior” as a risk factor for PTCA restenosis. My hypothesis was an outgrowth of my experiences attending the post-PTCA patients with persistent same-site restnosis whom I was requested to consult on initially because of their demanding, caustic personalities/behaviors, which were disruptive and a nuisance to the nursing and supportive staff during their in-patient admissions to the cardiac service.

KH: Can you tell us a little about your research and results?

MG: My Restenosis-Prone Prevention Treatment Program (May, 1997) is based upon my original risk-factor study (August, 1996) which found that individuals who have coronary-prone behavior are almost 2.5 times as likely to experience restenosis or re-narrowing of the previously balloon-dilated site within 6 to 26 weeks post-PTCA. This risk-factor is assessed by using the Type-A Structured Interview (SI), a verbally administered interactive set of pre-determined questions. The scores from the "Structured-Interview", which has been used since the 1980’s, are highly correlated with the physiologic and hemodynamic consequences associated with hostile/coronary-prone behavior responses which are antecedents to cardio-toxic blood pressure fluxuations and catecholamine cascade secretions. Currently, 4 of 5 reported pilot study volunteers are free of restenosis and other clinical cardiac events at 24 months after their final PTCA.

 

While these results seem impressive, “selection bias” is present in that I chose only those with the greatest amount of hostile/coronary-prone risk-factor behavior and at least two same-site PTCA (balloon-dilation) restenosis. The biofeedback component of my program has been successful controlling systolic hypertension, thereby reducing pharmacotherapy which may carry sexual dysfunction and depression side effects. Patients whom are mostly male, report better frustration tolerance (especially driving in traffic), weight loss via diet compliance, smoking/caffeine intake reduction, and a reported increased sense of control and calm. Patient’s spouses verify that they are easier to live with at home and experience less conflict at the workplace.

KH: What type of patient is most suitable for your program?

MG: If the individual has elevated risk-factor scores via the Type-A SI, then they are eligible as a candidate in the intervention program. I should state at the outset, this program is NOT psychotherapy. It initially consists of an educational component, explaining the results and meaning of an elevated risk-factor score on the Structured Interview, as well as the physiologic consequences of their behavioral responses to environmental challenges. Biofeedback is an integral part of the program. It is used to educate the patient with objective concrete data on how to circumvent and control the cardio-toxic/pathophysiologic consequences of PTCA restenosis-prone behavioral responses. My goal is to train the patient in techniques (non-pharmacological) that they like, can master in several hours, and which are consistent with their lifestyle, giving them the ability to control hemodynamic/blood pressure, sympathetic nervous system/adrenaline hyper-reactivity. This is coupled with easily implemented pure behavioral strategies customized to each patients’s traditional cardiac risk-factors (i.e. smoking reduction/cessation, weight loss and easy ways to increase compliance with lipid-lowering diets, etc.).

KH: Can you share other lifestyle modifications that may be of benefit in reducing restenosis?

MG: Lifestyle modifications are the goals. Research has shown us that a biological risk-factor may be modified/reduced as much as 20% through behavioral change. Smoking, the choice to consume high fat vs. a low fat diet, exercise, alcohol consumption, hypertension control as well as compliance with risk-factor reducing pharmacologics are all behaviors. Behavioral medicine has to do with changing behaviors to achieve a beneficial medical outcome. Behavioral medicine’s concerns are health promotion and disease prevention. Having multi-disciplinary training, one area I always address is quality of sleep. Sleep-wake cycles disorders are common in these patients who are so success driven, and this disorder negatively affects diet, mood, compliance, immunocompetence, and strains interpersonal relationships. In reqard to diet, I teach my patients how to shop for healthier foods in the supermarkets, and even how to determine healthier alternative when dining out or eating fast foods!

KH: How do you determine if your program is successful and what is the time frame of this determination?

MG: Restenosis following PTCA-balloon dilation is most likely to occur within 6 months, according to the literature. I waited 18 months before reporting my restenosis prevention findings because I believe this was the minimum time necessary to demonstrate clinically useful significance. Cardiologists and other physicians (as well as my PTCA patients who have not progressed to CABG) tell me they consider these pilot results to be a very positive finding. Statistically, my results are even more impressive given the small sample size, thus attesting to the “robustness” and large “effect size” that this behavioral measure has in capturing and predicting a disease hard-endpoint. I would arbitrarily set a time limit of 3 years without restenosis in evaluating whether treatment has truly been successful. Patients consider my prevention program successful even if they are able to postpone CABG and further clinical cardiac events.

KH: What are the side effects of your program, if any?

MG: None, other than restenosis, which might have occurred anyway.

KH: What is the cost of this behavioral intervention program?

MG: The assessment identification of this risk-factor via telephone or in-person interview using the same verbally administered assessments as I used in the August, 1996 Mayo Clinic Proceedings article is $300 for a 1-hour consultation. This allows adequate time to respond to questions and provide explanations and, of course education. The Restenosis Prevention Program, at $300/ per hour is comprised of approximately 8-12 hours. The fee can range from $2400-$3600 depending upon the number, and degree of severity of cardiac risk-factors requiring treatment modification intervention. The Restenosis Prevention program can be compressed into a weekend, if necessary. I am not a participating provider with any health care insurance companies, and require pre-payment in advance to reserve treatment Program time. However, my fee may potentially be reimbursable directly to the patient.

KH: What study needs to be done next to confirm your findings?

MG: A prospective study with treatment cases matched to controls on all demographics (i.e. age, gender, race, body mass index, traditional risk factors and hostility scores) including degree and site of arterial restenosis with my intervention program manipulated as the independent variable. It would be important to verify a dose response linear relationship between more intervention and more resistance to angioplasty failure for those identified with this risk-factor. Moreover, unlike in pharmacologic studies, blinding subjects to the hypothesis and covarying out variable rates of human learning are difficult in pure behavioral interventions. I am certainly amenable to suggestions from other clinical researchers.

KH: Are there any other factors, especially nutritional, that may help reduce the likelihood of restenosis after percutaneous angioplasty?

MG: Absolutely! Clinical Pearls News had a brief article in 1997 on the protective role of vitamin C in preventing PTCA restenosis. My Prevention Program includes consultation with each of my patients cardiologist regarding the latest in nutritional pharmacology with antioxidants, fish oils, parasympathomimetics, etc..