SAN ANTONIO — The current and lifetime prevalence of major depression is high among patients with scleroderma, an underrecognized fact that can no longer be ignored, Thierry Baubet, M.D., said at the annual meeting of the American College of Rheumatology.

Among 94 patients with systemic sclerosis seen in two French medical centers between May 2002 and May 2004, 17 (18%) had a current diagnosis of major depression, 50 (53%) had a lifetime diagnosis of major depression, and 7 (7%) had a current diagnosis of dysthymia. Moreover, 12 had a history of suicide attempts, and 31 were judged to have a moderate to severe ongoing suicide risk, he said.

The patients ranged in age from 26 to 85 years, and 81 were women. Psychiatric assessment was done using the Mini-International Neuropsychiatric Interview, the French DSM-IV, the 13-item Beck depression inventory, and the hospital anxiety and depression scale.

Additional information regarding past and current psychiatric treatment was sought with a structured questionnaire.

Fewer than half of patients with affective disorders had received psychiatric treatment, said Dr. Baubet of the psychiatric service, Avicenne Hospital, Bobigny (France).

Anxiety disorders also were common in this cohort, being diagnosed in 35 patients. Social phobia and generalized anxiety each were diagnosed in 13 patients, agoraphobia without panic disorder was diagnosed in 9, panic disorder in 6, posttraumatic stress disorder in 2, and obsessive compulsive disorder in 1. Some patients had more than one anxiety diagnosis.

Depression and anxiety are common and frequently overlooked in patients with systemic sclerosis, Dr. Baubet said in a poster session.

“Systematic screening and psychiatric treatment interventions are needed,” he said.

SAN ANTONIO — The current and lifetime prevalence of major depression is high among patients with scleroderma, an underrecognized fact that can no longer be ignored, Thierry Baubet, M.D., said at the annual meeting of the American College of Rheumatology.

Among 94 patients with systemic sclerosis seen in two French medical centers between May 2002 and May 2004, 17 (18%) had a current diagnosis of major depression, 50 (53%) had a lifetime diagnosis of major depression, and 7 (7%) had a current diagnosis of dysthymia. Moreover, 12 had a history of suicide attempts, and 31 were judged to have a moderate to severe ongoing suicide risk, he said.

The patients ranged in age from 26 to 85 years, and 81 were women. Psychiatric assessment was done using the Mini-International Neuropsychiatric Interview, the French DSM-IV, the 13-item Beck depression inventory, and the hospital anxiety and depression scale.

Additional information regarding past and current psychiatric treatment was sought with a structured questionnaire.

Fewer than half of patients with affective disorders had received psychiatric treatment, said Dr. Baubet of the psychiatric service, Avicenne Hospital, Bobigny (France).

Anxiety disorders also were common in this cohort, being diagnosed in 35 patients. Social phobia and generalized anxiety each were diagnosed in 13 patients, agoraphobia without panic disorder was diagnosed in 9, panic disorder in 6, posttraumatic stress disorder in 2, and obsessive compulsive disorder in 1. Some patients had more than one anxiety diagnosis.

Depression and anxiety are common and frequently overlooked in patients with systemic sclerosis, Dr. Baubet said in a poster session.

“Systematic screening and psychiatric treatment interventions are needed,” he said.

SAN ANTONIO — The current and lifetime prevalence of major depression is high among patients with scleroderma, an underrecognized fact that can no longer be ignored, Thierry Baubet, M.D., said at the annual meeting of the American College of Rheumatology.

Among 94 patients with systemic sclerosis seen in two French medical centers between May 2002 and May 2004, 17 (18%) had a current diagnosis of major depression, 50 (53%) had a lifetime diagnosis of major depression, and 7 (7%) had a current diagnosis of dysthymia. Moreover, 12 had a history of suicide attempts, and 31 were judged to have a moderate to severe ongoing suicide risk, he said.

The patients ranged in age from 26 to 85 years, and 81 were women. Psychiatric assessment was done using the Mini-International Neuropsychiatric Interview, the French DSM-IV, the 13-item Beck depression inventory, and the hospital anxiety and depression scale.

Additional information regarding past and current psychiatric treatment was sought with a structured questionnaire.

Fewer than half of patients with affective disorders had received psychiatric treatment, said Dr. Baubet of the psychiatric service, Avicenne Hospital, Bobigny (France).

Anxiety disorders also were common in this cohort, being diagnosed in 35 patients. Social phobia and generalized anxiety each were diagnosed in 13 patients, agoraphobia without panic disorder was diagnosed in 9, panic disorder in 6, posttraumatic stress disorder in 2, and obsessive compulsive disorder in 1. Some patients had more than one anxiety diagnosis.

Depression and anxiety are common and frequently overlooked in patients with systemic sclerosis, Dr. Baubet said in a poster session.

“Systematic screening and psychiatric treatment interventions are needed,” he said.

SEATTLE — A 12-week course of sildenafil citrate in adults with pulmonary arterial hypertension significantly improved 6-minute walking distance and mean pulmonary artery pressure, and had favorable effects on New York Heart Association functional class, H. Ardeschir Ghofrani, M.D., reported at the annual meeting of the American College of Chest Physicians.

“Sildenafil was not only highly effective in achieving improvement in 6-minute walking distance, but it also showed a very favorable safety profile,” he said in an interview.

It appears to be a very “good drug” for treating pulmonary arterial hypertension, but as promising as these data appear, physicians should not use the drug off label, as “this really should be addressed in controlled trials,” Dr. Ghofrani said.

In a multicenter, international trial, Dr. Ghofrani and his associates enrolled 278 patients with pulmonary hypertension and randomized them to placebo or sildenafil three times daily for 12 weeks.

Most of the patients (75%) were female, and the average age was 49. Overall, 63% had primary pulmonary hypertension and 30% had connective tissue disease. Most of the patients (58%) had New York Heart Association functional class III disease and 39% had class II disease.

Of the 278 patients, 70 took placebo t.i.d., 69 took 20 mg sildenafil t.i.d., 68 took 40 mg sildenafil t.i.d., and 71 took 80 mg sildenafil t.i.d.

The primary end point was change from baseline at week 12 in exercise capacity as measured by 6-minute walking distance.

Compared with patients who took a placebo, those assigned to take sildenafil had significant improvements in 6-minute walking distance.

The mean placebo-corrected treatment effect was 45 meters in the 20-mg group, 46 meters in the 40-mg group, and 50 meters in the 80-mg group.

“The improvements were slightly more pronounced in patients who had lower 6-minute walking distances at baseline, showing improvements up to 80 meters in the 80-mg group, whereas the patients who were doing better at baseline still had significant improvements,” said Dr. Ghofrani of Giessen, Germany, who is a paid consultant to Pfizer, which manufactures sildenafil.

All sildenafil doses reduced mean pulmonary artery pressure by week 12. The mean reductions were 2.7 mm Hg in the 20-mg group, 3.0 mm Hg in the 40-mg group, and 5.1 mm Hg in the 80-mg group.

The proportion of patients who improved by at least one New York Heart Association functional class was 35% in the sildenafil group and 7% in the placebo group.

The investigators also observed a trend toward decreased hospitalizations and improvements in shortness of breath during exercise among patients on sildenafil.

The most common adverse events experienced by patients on sildenafil, compared with those on placebo, were headache, flushing, dyspepsia, and back pain.

Pfizer Global Research and Development funded the study.

SEATTLE — A 12-week course of sildenafil citrate in adults with pulmonary arterial hypertension significantly improved 6-minute walking distance and mean pulmonary artery pressure, and had favorable effects on New York Heart Association functional class, H. Ardeschir Ghofrani, M.D., reported at the annual meeting of the American College of Chest Physicians.

“Sildenafil was not only highly effective in achieving improvement in 6-minute walking distance, but it also showed a very favorable safety profile,” he said in an interview.

It appears to be a very “good drug” for treating pulmonary arterial hypertension, but as promising as these data appear, physicians should not use the drug off label, as “this really should be addressed in controlled trials,” Dr. Ghofrani said.

In a multicenter, international trial, Dr. Ghofrani and his associates enrolled 278 patients with pulmonary hypertension and randomized them to placebo or sildenafil three times daily for 12 weeks.

Most of the patients (75%) were female, and the average age was 49. Overall, 63% had primary pulmonary hypertension and 30% had connective tissue disease. Most of the patients (58%) had New York Heart Association functional class III disease and 39% had class II disease.

Of the 278 patients, 70 took placebo t.i.d., 69 took 20 mg sildenafil t.i.d., 68 took 40 mg sildenafil t.i.d., and 71 took 80 mg sildenafil t.i.d.

The primary end point was change from baseline at week 12 in exercise capacity as measured by 6-minute walking distance.

Compared with patients who took a placebo, those assigned to take sildenafil had significant improvements in 6-minute walking distance.

The mean placebo-corrected treatment effect was 45 meters in the 20-mg group, 46 meters in the 40-mg group, and 50 meters in the 80-mg group.

“The improvements were slightly more pronounced in patients who had lower 6-minute walking distances at baseline, showing improvements up to 80 meters in the 80-mg group, whereas the patients who were doing better at baseline still had significant improvements,” said Dr. Ghofrani of Giessen, Germany, who is a paid consultant to Pfizer, which manufactures sildenafil.

All sildenafil doses reduced mean pulmonary artery pressure by week 12. The mean reductions were 2.7 mm Hg in the 20-mg group, 3.0 mm Hg in the 40-mg group, and 5.1 mm Hg in the 80-mg group.

The proportion of patients who improved by at least one New York Heart Association functional class was 35% in the sildenafil group and 7% in the placebo group.

The investigators also observed a trend toward decreased hospitalizations and improvements in shortness of breath during exercise among patients on sildenafil.

The most common adverse events experienced by patients on sildenafil, compared with those on placebo, were headache, flushing, dyspepsia, and back pain.

Pfizer Global Research and Development funded the study.

SEATTLE — A 12-week course of sildenafil citrate in adults with pulmonary arterial hypertension significantly improved 6-minute walking distance and mean pulmonary artery pressure, and had favorable effects on New York Heart Association functional class, H. Ardeschir Ghofrani, M.D., reported at the annual meeting of the American College of Chest Physicians.

“Sildenafil was not only highly effective in achieving improvement in 6-minute walking distance, but it also showed a very favorable safety profile,” he said in an interview.

It appears to be a very “good drug” for treating pulmonary arterial hypertension, but as promising as these data appear, physicians should not use the drug off label, as “this really should be addressed in controlled trials,” Dr. Ghofrani said.

In a multicenter, international trial, Dr. Ghofrani and his associates enrolled 278 patients with pulmonary hypertension and randomized them to placebo or sildenafil three times daily for 12 weeks.

Most of the patients (75%) were female, and the average age was 49. Overall, 63% had primary pulmonary hypertension and 30% had connective tissue disease. Most of the patients (58%) had New York Heart Association functional class III disease and 39% had class II disease.

Of the 278 patients, 70 took placebo t.i.d., 69 took 20 mg sildenafil t.i.d., 68 took 40 mg sildenafil t.i.d., and 71 took 80 mg sildenafil t.i.d.

The primary end point was change from baseline at week 12 in exercise capacity as measured by 6-minute walking distance.

Compared with patients who took a placebo, those assigned to take sildenafil had significant improvements in 6-minute walking distance.

The mean placebo-corrected treatment effect was 45 meters in the 20-mg group, 46 meters in the 40-mg group, and 50 meters in the 80-mg group.

“The improvements were slightly more pronounced in patients who had lower 6-minute walking distances at baseline, showing improvements up to 80 meters in the 80-mg group, whereas the patients who were doing better at baseline still had significant improvements,” said Dr. Ghofrani of Giessen, Germany, who is a paid consultant to Pfizer, which manufactures sildenafil.

All sildenafil doses reduced mean pulmonary artery pressure by week 12. The mean reductions were 2.7 mm Hg in the 20-mg group, 3.0 mm Hg in the 40-mg group, and 5.1 mm Hg in the 80-mg group.

The proportion of patients who improved by at least one New York Heart Association functional class was 35% in the sildenafil group and 7% in the placebo group.

The investigators also observed a trend toward decreased hospitalizations and improvements in shortness of breath during exercise among patients on sildenafil.

The most common adverse events experienced by patients on sildenafil, compared with those on placebo, were headache, flushing, dyspepsia, and back pain.

Pfizer Global Research and Development funded the study.

WASHINGTON — A new minimally invasive surgical technique could considerably improve the prognosis for infants born with hypoplastic left heart syndrome, Emile Bacha, M.D., said at a conference for science reporters sponsored by the American Medical Association.

Hyperplastic left heart syndrome (HLS), one of the most severe congenital heart defects, occurs in approximately 0.016%–0.036% of all live births in the United States, said Dr. Bacha, a pediatric cardiologic surgeon at the University of Chicago.

HLS is most often treated with a set of three extremely invasive, delicate open-heart surgical procedures aimed at providing unobstructed outflow to the heart via a single ventricle system and unobstructed pulmonary venous return, while shunting a portion of the blood away to feed the lungs and provide gas exchange.

Stage I, the Norwood operation, is performed within days of life. Stage II, the Glenn operation, follows at 6 months, while the stage III Fontan operation is done at 24 months.

Although 80%-90% of infants survive the Norwood stage I, about 10%-15% die before reaching the second procedure. Many infants who survive the entire series have below average IQ, abnormal neurologic development, and diminished quality of life.

Hybrid therapy, a combination of interventional cardiology and pediatric cardiac surgery techniques, replaces the traditional open-heart Norwood stage I operation with a palliative beating-heart procedure, he explained. Rather than cooling the body and putting the newborn on heart bypass for a lengthy period, the hybrid stage I is conducted in a specially outfitted catheterization laboratory that includes extra-corporeal circulation membrane oxygenation pump backup. (See illustration.)

Dr. Bacha and his colleague Ziyad M. Hijazi, M.D., have performed the procedure on 10 high-risk newborns (weight 2.2–3.3 kg) with HLS, of whom 6 also had aortic atresia, and 3 each had a major noncardiac anomaly, poor ventricular function, and/or weight less than 2.5 kg. Two were older than 30 days, one presented in shock, and one was born at less than 34 weeks' gestation. One infant died in the hospital following the procedure, resulting in the same hospital survival rate as the traditional Norwood stage I. Another died before reaching the second stage. Seven of the remaining eight have now undergone the Glenn stage II, of whom six have survived.

The Glenn and Fontan procedures are still necessary after hybrid stage I, but Dr. Bacha believes the elimination of one of three traumatic “pump runs” over the first 2 years of life and the postponement of the first beyond the neonatal period may reduce the neurologic complications often associated with bypass procedures.

The hybrid procedure itself and the length of hospital stay were considerably shorter than with the traditional Norwood procedure. One disadvantage of the hybrid technique is that the Glenn procedure is more complicated, since the aortic arch must be reconstructed while the previously implanted stent is removed.

“You're now doing the open-heart surgery on a 3− to 6-month-old, rather than a 5-day-old. … That is a huge difference in terms of sensitivity to trauma and brain maturity,” Dr. Bacha said. Several newer technologies, including therapeutic ultrasound and absorbable stents, will improve the feasibility of the procedure, he said.

EMILY BRANNAN, ILLUSTRATION

WASHINGTON — A new minimally invasive surgical technique could considerably improve the prognosis for infants born with hypoplastic left heart syndrome, Emile Bacha, M.D., said at a conference for science reporters sponsored by the American Medical Association.

Hyperplastic left heart syndrome (HLS), one of the most severe congenital heart defects, occurs in approximately 0.016%–0.036% of all live births in the United States, said Dr. Bacha, a pediatric cardiologic surgeon at the University of Chicago.

HLS is most often treated with a set of three extremely invasive, delicate open-heart surgical procedures aimed at providing unobstructed outflow to the heart via a single ventricle system and unobstructed pulmonary venous return, while shunting a portion of the blood away to feed the lungs and provide gas exchange.

Stage I, the Norwood operation, is performed within days of life. Stage II, the Glenn operation, follows at 6 months, while the stage III Fontan operation is done at 24 months.

Although 80%-90% of infants survive the Norwood stage I, about 10%-15% die before reaching the second procedure. Many infants who survive the entire series have below average IQ, abnormal neurologic development, and diminished quality of life.

Hybrid therapy, a combination of interventional cardiology and pediatric cardiac surgery techniques, replaces the traditional open-heart Norwood stage I operation with a palliative beating-heart procedure, he explained. Rather than cooling the body and putting the newborn on heart bypass for a lengthy period, the hybrid stage I is conducted in a specially outfitted catheterization laboratory that includes extra-corporeal circulation membrane oxygenation pump backup. (See illustration.)

Dr. Bacha and his colleague Ziyad M. Hijazi, M.D., have performed the procedure on 10 high-risk newborns (weight 2.2–3.3 kg) with HLS, of whom 6 also had aortic atresia, and 3 each had a major noncardiac anomaly, poor ventricular function, and/or weight less than 2.5 kg. Two were older than 30 days, one presented in shock, and one was born at less than 34 weeks' gestation. One infant died in the hospital following the procedure, resulting in the same hospital survival rate as the traditional Norwood stage I. Another died before reaching the second stage. Seven of the remaining eight have now undergone the Glenn stage II, of whom six have survived.

The Glenn and Fontan procedures are still necessary after hybrid stage I, but Dr. Bacha believes the elimination of one of three traumatic “pump runs” over the first 2 years of life and the postponement of the first beyond the neonatal period may reduce the neurologic complications often associated with bypass procedures.

The hybrid procedure itself and the length of hospital stay were considerably shorter than with the traditional Norwood procedure. One disadvantage of the hybrid technique is that the Glenn procedure is more complicated, since the aortic arch must be reconstructed while the previously implanted stent is removed.

“You're now doing the open-heart surgery on a 3− to 6-month-old, rather than a 5-day-old. … That is a huge difference in terms of sensitivity to trauma and brain maturity,” Dr. Bacha said. Several newer technologies, including therapeutic ultrasound and absorbable stents, will improve the feasibility of the procedure, he said.

EMILY BRANNAN, ILLUSTRATION

WASHINGTON — A new minimally invasive surgical technique could considerably improve the prognosis for infants born with hypoplastic left heart syndrome, Emile Bacha, M.D., said at a conference for science reporters sponsored by the American Medical Association.

Hyperplastic left heart syndrome (HLS), one of the most severe congenital heart defects, occurs in approximately 0.016%–0.036% of all live births in the United States, said Dr. Bacha, a pediatric cardiologic surgeon at the University of Chicago.

HLS is most often treated with a set of three extremely invasive, delicate open-heart surgical procedures aimed at providing unobstructed outflow to the heart via a single ventricle system and unobstructed pulmonary venous return, while shunting a portion of the blood away to feed the lungs and provide gas exchange.

Stage I, the Norwood operation, is performed within days of life. Stage II, the Glenn operation, follows at 6 months, while the stage III Fontan operation is done at 24 months.

Although 80%-90% of infants survive the Norwood stage I, about 10%-15% die before reaching the second procedure. Many infants who survive the entire series have below average IQ, abnormal neurologic development, and diminished quality of life.

Hybrid therapy, a combination of interventional cardiology and pediatric cardiac surgery techniques, replaces the traditional open-heart Norwood stage I operation with a palliative beating-heart procedure, he explained. Rather than cooling the body and putting the newborn on heart bypass for a lengthy period, the hybrid stage I is conducted in a specially outfitted catheterization laboratory that includes extra-corporeal circulation membrane oxygenation pump backup. (See illustration.)

Dr. Bacha and his colleague Ziyad M. Hijazi, M.D., have performed the procedure on 10 high-risk newborns (weight 2.2–3.3 kg) with HLS, of whom 6 also had aortic atresia, and 3 each had a major noncardiac anomaly, poor ventricular function, and/or weight less than 2.5 kg. Two were older than 30 days, one presented in shock, and one was born at less than 34 weeks' gestation. One infant died in the hospital following the procedure, resulting in the same hospital survival rate as the traditional Norwood stage I. Another died before reaching the second stage. Seven of the remaining eight have now undergone the Glenn stage II, of whom six have survived.

The Glenn and Fontan procedures are still necessary after hybrid stage I, but Dr. Bacha believes the elimination of one of three traumatic “pump runs” over the first 2 years of life and the postponement of the first beyond the neonatal period may reduce the neurologic complications often associated with bypass procedures.

The hybrid procedure itself and the length of hospital stay were considerably shorter than with the traditional Norwood procedure. One disadvantage of the hybrid technique is that the Glenn procedure is more complicated, since the aortic arch must be reconstructed while the previously implanted stent is removed.

“You're now doing the open-heart surgery on a 3− to 6-month-old, rather than a 5-day-old. … That is a huge difference in terms of sensitivity to trauma and brain maturity,” Dr. Bacha said. Several newer technologies, including therapeutic ultrasound and absorbable stents, will improve the feasibility of the procedure, he said.

EMILY BRANNAN, ILLUSTRATION

MUNICH — A novel surgical method reduces the left ventricular volume of patients with cardiomyopathy without using ventriculectomy.

The surgery realigns the papillary muscles of the left ventricle and reduces left ventricular volume by placing three sutures through the trabeculae around the bases of the anterior and posterior muscles, Diane Barker, M.B., said at the annual congress of the European Society of Cardiology.

The procedure, which involves graded placation of the papillary muscle through a small, apical incision, usually takes about 15–20 minutes, said Dr. Barker, a cardiologist at Leeds (England) General Infirmary. The suturing also reduces functional mitral regurgitation. It is generally combined with coronary bypass grafting.

Unnikrishnan R. Nair, M.B., who developed the new technique, has used it to treat 30 patients in Leeds since 1998. Follow-up has ranged from 12 to 58 months, with an average of 28 months. One patient died within 30 days of the procedure from sepsis. Another patient developed atrial fibrillation following surgery. All of the other patients had improvements in their left ventricular function and in their clinical status, and none developed ventricular arrhythmias, Dr. Barker reported. Three patients died 4–24 months following surgery, but the deaths appeared unrelated to surgery. The average age of the patients was 61 years, and three-quarters were men. All of the patients had ischemic cardiomyopathy. The average left ventricular volume of patients before the surgery was 271 mL; after surgery, 230 mL. Before surgery, the patients had heart failure with an average New York Heart Association functional classification of 2.8; after surgery, the average was 1.4.

To better assess this surgery, Dr. Barker and Dr. Nair compared 8 patients who underwent suturing of papillary muscle plus bypass surgery with 32 similar patients treated with bypass surgery only. (See box.)

Exercise duration improved among patients who underwent papillary muscle suturing compared with those who had bypass surgery only. Peak oxygen capacity rose among the patients treated with papillary muscle suturing compared with those who had bypass surgery only. Cardiac reserve rose among patients treated compared with the control group.

The next step is to test the surgery's safety and efficacy in a randomized, controlled study, Dr. Barker said.

This image shows the placement of the sutures through the trabeculae.

This image shows the sutures being tied in the novel procedure.

This image shows the surgical incision being repaired. Photos courtesy Dr. Unnikrishnan R. Nair

MUNICH — A novel surgical method reduces the left ventricular volume of patients with cardiomyopathy without using ventriculectomy.

The surgery realigns the papillary muscles of the left ventricle and reduces left ventricular volume by placing three sutures through the trabeculae around the bases of the anterior and posterior muscles, Diane Barker, M.B., said at the annual congress of the European Society of Cardiology.

The procedure, which involves graded placation of the papillary muscle through a small, apical incision, usually takes about 15–20 minutes, said Dr. Barker, a cardiologist at Leeds (England) General Infirmary. The suturing also reduces functional mitral regurgitation. It is generally combined with coronary bypass grafting.

Unnikrishnan R. Nair, M.B., who developed the new technique, has used it to treat 30 patients in Leeds since 1998. Follow-up has ranged from 12 to 58 months, with an average of 28 months. One patient died within 30 days of the procedure from sepsis. Another patient developed atrial fibrillation following surgery. All of the other patients had improvements in their left ventricular function and in their clinical status, and none developed ventricular arrhythmias, Dr. Barker reported. Three patients died 4–24 months following surgery, but the deaths appeared unrelated to surgery. The average age of the patients was 61 years, and three-quarters were men. All of the patients had ischemic cardiomyopathy. The average left ventricular volume of patients before the surgery was 271 mL; after surgery, 230 mL. Before surgery, the patients had heart failure with an average New York Heart Association functional classification of 2.8; after surgery, the average was 1.4.

To better assess this surgery, Dr. Barker and Dr. Nair compared 8 patients who underwent suturing of papillary muscle plus bypass surgery with 32 similar patients treated with bypass surgery only. (See box.)

Exercise duration improved among patients who underwent papillary muscle suturing compared with those who had bypass surgery only. Peak oxygen capacity rose among the patients treated with papillary muscle suturing compared with those who had bypass surgery only. Cardiac reserve rose among patients treated compared with the control group.

The next step is to test the surgery's safety and efficacy in a randomized, controlled study, Dr. Barker said.

This image shows the placement of the sutures through the trabeculae.

This image shows the sutures being tied in the novel procedure.

This image shows the surgical incision being repaired. Photos courtesy Dr. Unnikrishnan R. Nair

MUNICH — A novel surgical method reduces the left ventricular volume of patients with cardiomyopathy without using ventriculectomy.

The surgery realigns the papillary muscles of the left ventricle and reduces left ventricular volume by placing three sutures through the trabeculae around the bases of the anterior and posterior muscles, Diane Barker, M.B., said at the annual congress of the European Society of Cardiology.

The procedure, which involves graded placation of the papillary muscle through a small, apical incision, usually takes about 15–20 minutes, said Dr. Barker, a cardiologist at Leeds (England) General Infirmary. The suturing also reduces functional mitral regurgitation. It is generally combined with coronary bypass grafting.

Unnikrishnan R. Nair, M.B., who developed the new technique, has used it to treat 30 patients in Leeds since 1998. Follow-up has ranged from 12 to 58 months, with an average of 28 months. One patient died within 30 days of the procedure from sepsis. Another patient developed atrial fibrillation following surgery. All of the other patients had improvements in their left ventricular function and in their clinical status, and none developed ventricular arrhythmias, Dr. Barker reported. Three patients died 4–24 months following surgery, but the deaths appeared unrelated to surgery. The average age of the patients was 61 years, and three-quarters were men. All of the patients had ischemic cardiomyopathy. The average left ventricular volume of patients before the surgery was 271 mL; after surgery, 230 mL. Before surgery, the patients had heart failure with an average New York Heart Association functional classification of 2.8; after surgery, the average was 1.4.

To better assess this surgery, Dr. Barker and Dr. Nair compared 8 patients who underwent suturing of papillary muscle plus bypass surgery with 32 similar patients treated with bypass surgery only. (See box.)

Exercise duration improved among patients who underwent papillary muscle suturing compared with those who had bypass surgery only. Peak oxygen capacity rose among the patients treated with papillary muscle suturing compared with those who had bypass surgery only. Cardiac reserve rose among patients treated compared with the control group.

The next step is to test the surgery's safety and efficacy in a randomized, controlled study, Dr. Barker said.

This image shows the placement of the sutures through the trabeculae.

This image shows the sutures being tied in the novel procedure.

This image shows the surgical incision being repaired. Photos courtesy Dr. Unnikrishnan R. Nair

SAN FRANCISCO — In some patients being evaluated for chest pain, stress tests might be avoided through the use of an algorithm designed to predict the probability of cardiac ischemia, David D. Moyer-Diener and his associates said at the annual meeting of the American College of Emergency Physicians.

In a prospective, observational cohort study of consecutive patients evaluated at a chest pain center, investigators obtained Acute Coronary Ischemia-Time Insensitive Predictive Instrument (ACI-TIPI) scores and conventional chest pain work-ups on 1,478 low- or intermediate-risk patients for whom acute myocardial ischemia had been ruled out. The treating physicians were blinded to the ACI-TIPI scores, and patients underwent conventional evaluations including serial enzyme tests and provocative cardiac testing.

Among 400 patients who had ACI-TIPI scores of 20 or less, 265 were men younger than age 35 years or women younger than age 45 years, and 217 underwent provocative cardiac testing. None of the 265 patients developed an acute coronary syndrome within 30 days, as determined by phone calls to patients and reviews of records and the Social Security Death Index.

If clinicians had used an ACI-TIPI score of 20 or less in these subsets of young patients to exclude provocative cardiac testing and had sent these patients home, 15% of all stress tests in the study cohort could have been avoided without causing any harm, said Mr. Moyer-Diener, a medical student at the University of Michigan, Ann Arbor, who conducted the study with Michael G. Mikhail, M.D., and associates at the university.

At the meeting, physicians on a separate panel discussing cutting-edge research both praised and criticized the study.

“There's been a lot of debate about just how useful” an ACI-TIPI score is, said Charles V. Pollack Jr., M.D., chair of emergency medicine at Pennsylvania Hospital, Philadelphia. Many emergency physicians would rather not have a quantitative number related to the risk of ischemia on a patient's chart, he said, because if the case sparks a lawsuit, they would rather defend their clinical impression that the patient didn't have ischemia.

The ACI-TIPI was designed to predict the probability of cardiac ischemia on a 0− to 100-point scale, to serve as support or a “second opinion” in clinical decision making. The way ACI-TIPI was used in the study to identify patients who don't need further tests “is not really the use for which it was designed,” but the idea is intriguing, Dr. Pollack said.

Jerome R. Hoffman, M.D., lauded the investigators for trying to identify a strategy to cut down on the many unnecessary tests performed for chest pain evaluation that are not backed by evidence-based medicine. “It's very hard to get us out of that rut,” said Dr. Hoffman, professor of emergency medicine at the University of California, Los Angeles.

In practical terms, however, physicians are unlikely to adopt these criteria for avoiding stress tests. An ACI-TIPI score of 20 or less is associated with a 19% risk of acute myocardial ischemia, Dr. Hoffman explained. For medicolegal reasons, physicians will not feel comfortable sending patients home if that number appears on a patient's chart.

“That, more than anything, makes me question the value of an ACI-TIPI— other than as a research tool,” Dr. Hoffman said.

Previous studies have shown that physicians were from two to three times more likely to admit patients if given an ACI-TIPI score to include in the patient's chart, said Ian G. Stiell, M.D., of the University of Ottawa. On the other hand, it's “refreshing” to hear skepticism about widespread use in the United States of stress tests, chest pain units, and prolonged cardiac monitoring, he added.

Dr. Pollack noted that the current study claimed to exclude patients with acute myocardial ischemia. “I think that's a dangerous statement,” he said, “because ordinarily that is done in a chest pain center by measuring serial troponin levels, which excludes only necrosis. It doesn't exclude ischemia.”

SAN FRANCISCO — In some patients being evaluated for chest pain, stress tests might be avoided through the use of an algorithm designed to predict the probability of cardiac ischemia, David D. Moyer-Diener and his associates said at the annual meeting of the American College of Emergency Physicians.

In a prospective, observational cohort study of consecutive patients evaluated at a chest pain center, investigators obtained Acute Coronary Ischemia-Time Insensitive Predictive Instrument (ACI-TIPI) scores and conventional chest pain work-ups on 1,478 low- or intermediate-risk patients for whom acute myocardial ischemia had been ruled out. The treating physicians were blinded to the ACI-TIPI scores, and patients underwent conventional evaluations including serial enzyme tests and provocative cardiac testing.

Among 400 patients who had ACI-TIPI scores of 20 or less, 265 were men younger than age 35 years or women younger than age 45 years, and 217 underwent provocative cardiac testing. None of the 265 patients developed an acute coronary syndrome within 30 days, as determined by phone calls to patients and reviews of records and the Social Security Death Index.

If clinicians had used an ACI-TIPI score of 20 or less in these subsets of young patients to exclude provocative cardiac testing and had sent these patients home, 15% of all stress tests in the study cohort could have been avoided without causing any harm, said Mr. Moyer-Diener, a medical student at the University of Michigan, Ann Arbor, who conducted the study with Michael G. Mikhail, M.D., and associates at the university.

At the meeting, physicians on a separate panel discussing cutting-edge research both praised and criticized the study.

“There's been a lot of debate about just how useful” an ACI-TIPI score is, said Charles V. Pollack Jr., M.D., chair of emergency medicine at Pennsylvania Hospital, Philadelphia. Many emergency physicians would rather not have a quantitative number related to the risk of ischemia on a patient's chart, he said, because if the case sparks a lawsuit, they would rather defend their clinical impression that the patient didn't have ischemia.

The ACI-TIPI was designed to predict the probability of cardiac ischemia on a 0− to 100-point scale, to serve as support or a “second opinion” in clinical decision making. The way ACI-TIPI was used in the study to identify patients who don't need further tests “is not really the use for which it was designed,” but the idea is intriguing, Dr. Pollack said.

Jerome R. Hoffman, M.D., lauded the investigators for trying to identify a strategy to cut down on the many unnecessary tests performed for chest pain evaluation that are not backed by evidence-based medicine. “It's very hard to get us out of that rut,” said Dr. Hoffman, professor of emergency medicine at the University of California, Los Angeles.

In practical terms, however, physicians are unlikely to adopt these criteria for avoiding stress tests. An ACI-TIPI score of 20 or less is associated with a 19% risk of acute myocardial ischemia, Dr. Hoffman explained. For medicolegal reasons, physicians will not feel comfortable sending patients home if that number appears on a patient's chart.

“That, more than anything, makes me question the value of an ACI-TIPI— other than as a research tool,” Dr. Hoffman said.

Previous studies have shown that physicians were from two to three times more likely to admit patients if given an ACI-TIPI score to include in the patient's chart, said Ian G. Stiell, M.D., of the University of Ottawa. On the other hand, it's “refreshing” to hear skepticism about widespread use in the United States of stress tests, chest pain units, and prolonged cardiac monitoring, he added.

Dr. Pollack noted that the current study claimed to exclude patients with acute myocardial ischemia. “I think that's a dangerous statement,” he said, “because ordinarily that is done in a chest pain center by measuring serial troponin levels, which excludes only necrosis. It doesn't exclude ischemia.”

SAN FRANCISCO — In some patients being evaluated for chest pain, stress tests might be avoided through the use of an algorithm designed to predict the probability of cardiac ischemia, David D. Moyer-Diener and his associates said at the annual meeting of the American College of Emergency Physicians.

In a prospective, observational cohort study of consecutive patients evaluated at a chest pain center, investigators obtained Acute Coronary Ischemia-Time Insensitive Predictive Instrument (ACI-TIPI) scores and conventional chest pain work-ups on 1,478 low- or intermediate-risk patients for whom acute myocardial ischemia had been ruled out. The treating physicians were blinded to the ACI-TIPI scores, and patients underwent conventional evaluations including serial enzyme tests and provocative cardiac testing.

Among 400 patients who had ACI-TIPI scores of 20 or less, 265 were men younger than age 35 years or women younger than age 45 years, and 217 underwent provocative cardiac testing. None of the 265 patients developed an acute coronary syndrome within 30 days, as determined by phone calls to patients and reviews of records and the Social Security Death Index.

If clinicians had used an ACI-TIPI score of 20 or less in these subsets of young patients to exclude provocative cardiac testing and had sent these patients home, 15% of all stress tests in the study cohort could have been avoided without causing any harm, said Mr. Moyer-Diener, a medical student at the University of Michigan, Ann Arbor, who conducted the study with Michael G. Mikhail, M.D., and associates at the university.

At the meeting, physicians on a separate panel discussing cutting-edge research both praised and criticized the study.

“There's been a lot of debate about just how useful” an ACI-TIPI score is, said Charles V. Pollack Jr., M.D., chair of emergency medicine at Pennsylvania Hospital, Philadelphia. Many emergency physicians would rather not have a quantitative number related to the risk of ischemia on a patient's chart, he said, because if the case sparks a lawsuit, they would rather defend their clinical impression that the patient didn't have ischemia.

The ACI-TIPI was designed to predict the probability of cardiac ischemia on a 0− to 100-point scale, to serve as support or a “second opinion” in clinical decision making. The way ACI-TIPI was used in the study to identify patients who don't need further tests “is not really the use for which it was designed,” but the idea is intriguing, Dr. Pollack said.

Jerome R. Hoffman, M.D., lauded the investigators for trying to identify a strategy to cut down on the many unnecessary tests performed for chest pain evaluation that are not backed by evidence-based medicine. “It's very hard to get us out of that rut,” said Dr. Hoffman, professor of emergency medicine at the University of California, Los Angeles.

In practical terms, however, physicians are unlikely to adopt these criteria for avoiding stress tests. An ACI-TIPI score of 20 or less is associated with a 19% risk of acute myocardial ischemia, Dr. Hoffman explained. For medicolegal reasons, physicians will not feel comfortable sending patients home if that number appears on a patient's chart.

“That, more than anything, makes me question the value of an ACI-TIPI— other than as a research tool,” Dr. Hoffman said.

Previous studies have shown that physicians were from two to three times more likely to admit patients if given an ACI-TIPI score to include in the patient's chart, said Ian G. Stiell, M.D., of the University of Ottawa. On the other hand, it's “refreshing” to hear skepticism about widespread use in the United States of stress tests, chest pain units, and prolonged cardiac monitoring, he added.

Dr. Pollack noted that the current study claimed to exclude patients with acute myocardial ischemia. “I think that's a dangerous statement,” he said, “because ordinarily that is done in a chest pain center by measuring serial troponin levels, which excludes only necrosis. It doesn't exclude ischemia.”

The revelation in September that the popular arthritis drug rofecoxib (Vioxx) more than doubles the risk of myocardial infarction led to its withdrawal by Merck and to a reevaluation of the safety of other cyclooxygenase-2 inhibitors. In the aftermath, many have questioned why the Food and Drug Administration and Merck had not paid more attention to earlier results that also raised safety concerns.

Regardless of the conclusions reached by the various investigators, “More safety experience is going to be required, and there may be more cautionary labels not for what has been seen but for what is not known.

“The issues brought forth by Vioxx will ultimately drip down to almost everything we do. But we mustn't overlook the fact that a huge number of patients have taken the drug and been exposed to increased risk,” Barry Massie, M.D., chief of cardiology at the Veterans Affairs Medical Center, San Francisco, told CARDIOLOGY NEWS.

The revelation in September that the popular arthritis drug rofecoxib (Vioxx) more than doubles the risk of myocardial infarction led to its withdrawal by Merck and to a reevaluation of the safety of other cyclooxygenase-2 inhibitors. In the aftermath, many have questioned why the Food and Drug Administration and Merck had not paid more attention to earlier results that also raised safety concerns.

Regardless of the conclusions reached by the various investigators, “More safety experience is going to be required, and there may be more cautionary labels not for what has been seen but for what is not known.

“The issues brought forth by Vioxx will ultimately drip down to almost everything we do. But we mustn't overlook the fact that a huge number of patients have taken the drug and been exposed to increased risk,” Barry Massie, M.D., chief of cardiology at the Veterans Affairs Medical Center, San Francisco, told CARDIOLOGY NEWS.

The revelation in September that the popular arthritis drug rofecoxib (Vioxx) more than doubles the risk of myocardial infarction led to its withdrawal by Merck and to a reevaluation of the safety of other cyclooxygenase-2 inhibitors. In the aftermath, many have questioned why the Food and Drug Administration and Merck had not paid more attention to earlier results that also raised safety concerns.

Regardless of the conclusions reached by the various investigators, “More safety experience is going to be required, and there may be more cautionary labels not for what has been seen but for what is not known.

“The issues brought forth by Vioxx will ultimately drip down to almost everything we do. But we mustn't overlook the fact that a huge number of patients have taken the drug and been exposed to increased risk,” Barry Massie, M.D., chief of cardiology at the Veterans Affairs Medical Center, San Francisco, told CARDIOLOGY NEWS.

NEW ORLEANS — Antithrombotic treatment, in the form of the low-molecular-weight heparin reviparin, has been shown for the first time to safely improve the outcomes of patients with an acute MI.

“Although heparin is often routinely used to treat patients with an acute myocardial infarction, the incremental benefit from heparin or newer antithrombotics has been poorly defined,” Jeffrey L. Anderson, M.D., said at the annual scientific sessions of the American Heart Association.

The new findings show that reviparin “clearly improves the outcomes of patients who undergo thrombolysis with streptokinase or urokinase,” said Dr. Anderson, associate chief of the division of cardiology at LDS Hospital in Salt Lake City.

But the value of adding reviparin or a similar agent remains in doubt when patients are treated with the fibrin-specific drugs most often used for thrombolysis in the United States, such as alteplase (tissue plasminogen activator), reteplase, and tenecteplase. That's because this new trial, conducted in India, China, Pakistan, and several South American countries and involving 15,570 patients, included only about 100 patients treated with a fibrin-specific thrombolytic drug. Close to 80% of the patients received acute treatment to clear their coronary thrombus, but this treatment was primarily streptokinase in about 50% of patients, urokinase in about 23% of patients, and primary percutaneous intervention in about 6% of patients.

Despite this limitation, the results showed that “reviparin is a simple, inexpensive therapy that is globally applicable for treating acute myocardial infarction,” said Salim Yusuf, D.Phil., director of the division of cardiology at McMaster University in Hamilton, Canada, and lead investigator for the study.

Reviparin is marketed by Abbott Pharmaceuticals under the name Clivarine in several countries in Europe and Asia, but is not approved for U.S. use. Abbott provided the reviparin, but otherwise, the study had no commercial funding.

The study enrolled patients with ST-segment-elevation MI or new bundle branch block who presented within 12 hours of symptom onset. All patients were to be treated with aspirin, and they could also be treated with a regimen designed to produce reperfusion in their blocked coronary arteries. The average age of the patients was 59 years, and the average time from symptom onset to treatment was 4.8 hours, with 61% of patients treated within 6 hours. Aspirin was used on 97% of patients, 72% received an ACE inhibitor, 66% received a lipid-lowering drug, 60% received a β-blocker, and 55% received a thienopyridine, most commonly clopidogrel.

Patients were randomized to treatment with reviparin or placebo by subcutaneous injection b.i.d for 7 days; 76% of patients received the full 7-day course.

The study's primary end point was the incidence of death, repeat MI, or stroke during the 7 days of treatment. The rate of these outcomes was 11.0% in the placebo group and 9.6% in the reviparin group—a statistically significant relative reduction of 13%, Dr. Yusuf reported. Patients treated with reviparin also had a 13% relative reduction in the study's secondary end point, which included death, repeat MI, stroke, or ischemic ECG changes. Treatment with reviparin was also associated with a significant 11% relative reduction in death alone.

The protective effect from reviparin treatment extended to 30 days after the start of treatment. At that time, the rate of death, repeat MI, or stroke was 13.6% in the placebo group and 11.8% in the reviparin group, again a statistically significant 13% relative reduction. These results showed that “stopping therapy after 7 days was not associated with any rebound,” Dr. Yusuf said.

Like all antithrombotic drugs, reviparin boosted the rate of bleeding events. The rate of life-threatening or major bleeds not included in the primary outcomes after 7 days of treatment was 0.1% in the placebo group, compared with 0.2% in the reviparin group. The increased risk of important bleeding events was small, compared with the overall benefit, he noted.

Another noteworthy finding was that the faster treatment with reviparin started the greater the benefit. Patients who started treatment within 2 hours of symptom onset had a 30% relative drop in the primary end point. This relative benefit fell to 20% when treatment began 2–4 hours and to 15% when treatment began within 4–8 hours. The benefit completely disappeared when treatment was delayed beyond 8 hours.

An inevitable question is whether treatment with the low-molecular-weight heparins approved for use in the United States would confer the same benefits. “It's a tricky issue, because low-molecular-weight heparins are very heterogeneous compounds. You need to know the exact dosage to use.” Dr. Yusuf said.

NEW ORLEANS — Antithrombotic treatment, in the form of the low-molecular-weight heparin reviparin, has been shown for the first time to safely improve the outcomes of patients with an acute MI.

“Although heparin is often routinely used to treat patients with an acute myocardial infarction, the incremental benefit from heparin or newer antithrombotics has been poorly defined,” Jeffrey L. Anderson, M.D., said at the annual scientific sessions of the American Heart Association.

The new findings show that reviparin “clearly improves the outcomes of patients who undergo thrombolysis with streptokinase or urokinase,” said Dr. Anderson, associate chief of the division of cardiology at LDS Hospital in Salt Lake City.

But the value of adding reviparin or a similar agent remains in doubt when patients are treated with the fibrin-specific drugs most often used for thrombolysis in the United States, such as alteplase (tissue plasminogen activator), reteplase, and tenecteplase. That's because this new trial, conducted in India, China, Pakistan, and several South American countries and involving 15,570 patients, included only about 100 patients treated with a fibrin-specific thrombolytic drug. Close to 80% of the patients received acute treatment to clear their coronary thrombus, but this treatment was primarily streptokinase in about 50% of patients, urokinase in about 23% of patients, and primary percutaneous intervention in about 6% of patients.

Despite this limitation, the results showed that “reviparin is a simple, inexpensive therapy that is globally applicable for treating acute myocardial infarction,” said Salim Yusuf, D.Phil., director of the division of cardiology at McMaster University in Hamilton, Canada, and lead investigator for the study.

Reviparin is marketed by Abbott Pharmaceuticals under the name Clivarine in several countries in Europe and Asia, but is not approved for U.S. use. Abbott provided the reviparin, but otherwise, the study had no commercial funding.

The study enrolled patients with ST-segment-elevation MI or new bundle branch block who presented within 12 hours of symptom onset. All patients were to be treated with aspirin, and they could also be treated with a regimen designed to produce reperfusion in their blocked coronary arteries. The average age of the patients was 59 years, and the average time from symptom onset to treatment was 4.8 hours, with 61% of patients treated within 6 hours. Aspirin was used on 97% of patients, 72% received an ACE inhibitor, 66% received a lipid-lowering drug, 60% received a β-blocker, and 55% received a thienopyridine, most commonly clopidogrel.

Patients were randomized to treatment with reviparin or placebo by subcutaneous injection b.i.d for 7 days; 76% of patients received the full 7-day course.

The study's primary end point was the incidence of death, repeat MI, or stroke during the 7 days of treatment. The rate of these outcomes was 11.0% in the placebo group and 9.6% in the reviparin group—a statistically significant relative reduction of 13%, Dr. Yusuf reported. Patients treated with reviparin also had a 13% relative reduction in the study's secondary end point, which included death, repeat MI, stroke, or ischemic ECG changes. Treatment with reviparin was also associated with a significant 11% relative reduction in death alone.

The protective effect from reviparin treatment extended to 30 days after the start of treatment. At that time, the rate of death, repeat MI, or stroke was 13.6% in the placebo group and 11.8% in the reviparin group, again a statistically significant 13% relative reduction. These results showed that “stopping therapy after 7 days was not associated with any rebound,” Dr. Yusuf said.

Like all antithrombotic drugs, reviparin boosted the rate of bleeding events. The rate of life-threatening or major bleeds not included in the primary outcomes after 7 days of treatment was 0.1% in the placebo group, compared with 0.2% in the reviparin group. The increased risk of important bleeding events was small, compared with the overall benefit, he noted.

Another noteworthy finding was that the faster treatment with reviparin started the greater the benefit. Patients who started treatment within 2 hours of symptom onset had a 30% relative drop in the primary end point. This relative benefit fell to 20% when treatment began 2–4 hours and to 15% when treatment began within 4–8 hours. The benefit completely disappeared when treatment was delayed beyond 8 hours.

An inevitable question is whether treatment with the low-molecular-weight heparins approved for use in the United States would confer the same benefits. “It's a tricky issue, because low-molecular-weight heparins are very heterogeneous compounds. You need to know the exact dosage to use.” Dr. Yusuf said.

NEW ORLEANS — Antithrombotic treatment, in the form of the low-molecular-weight heparin reviparin, has been shown for the first time to safely improve the outcomes of patients with an acute MI.

“Although heparin is often routinely used to treat patients with an acute myocardial infarction, the incremental benefit from heparin or newer antithrombotics has been poorly defined,” Jeffrey L. Anderson, M.D., said at the annual scientific sessions of the American Heart Association.

The new findings show that reviparin “clearly improves the outcomes of patients who undergo thrombolysis with streptokinase or urokinase,” said Dr. Anderson, associate chief of the division of cardiology at LDS Hospital in Salt Lake City.

But the value of adding reviparin or a similar agent remains in doubt when patients are treated with the fibrin-specific drugs most often used for thrombolysis in the United States, such as alteplase (tissue plasminogen activator), reteplase, and tenecteplase. That's because this new trial, conducted in India, China, Pakistan, and several South American countries and involving 15,570 patients, included only about 100 patients treated with a fibrin-specific thrombolytic drug. Close to 80% of the patients received acute treatment to clear their coronary thrombus, but this treatment was primarily streptokinase in about 50% of patients, urokinase in about 23% of patients, and primary percutaneous intervention in about 6% of patients.

Despite this limitation, the results showed that “reviparin is a simple, inexpensive therapy that is globally applicable for treating acute myocardial infarction,” said Salim Yusuf, D.Phil., director of the division of cardiology at McMaster University in Hamilton, Canada, and lead investigator for the study.

Reviparin is marketed by Abbott Pharmaceuticals under the name Clivarine in several countries in Europe and Asia, but is not approved for U.S. use. Abbott provided the reviparin, but otherwise, the study had no commercial funding.

The study enrolled patients with ST-segment-elevation MI or new bundle branch block who presented within 12 hours of symptom onset. All patients were to be treated with aspirin, and they could also be treated with a regimen designed to produce reperfusion in their blocked coronary arteries. The average age of the patients was 59 years, and the average time from symptom onset to treatment was 4.8 hours, with 61% of patients treated within 6 hours. Aspirin was used on 97% of patients, 72% received an ACE inhibitor, 66% received a lipid-lowering drug, 60% received a β-blocker, and 55% received a thienopyridine, most commonly clopidogrel.

Patients were randomized to treatment with reviparin or placebo by subcutaneous injection b.i.d for 7 days; 76% of patients received the full 7-day course.

The study's primary end point was the incidence of death, repeat MI, or stroke during the 7 days of treatment. The rate of these outcomes was 11.0% in the placebo group and 9.6% in the reviparin group—a statistically significant relative reduction of 13%, Dr. Yusuf reported. Patients treated with reviparin also had a 13% relative reduction in the study's secondary end point, which included death, repeat MI, stroke, or ischemic ECG changes. Treatment with reviparin was also associated with a significant 11% relative reduction in death alone.

The protective effect from reviparin treatment extended to 30 days after the start of treatment. At that time, the rate of death, repeat MI, or stroke was 13.6% in the placebo group and 11.8% in the reviparin group, again a statistically significant 13% relative reduction. These results showed that “stopping therapy after 7 days was not associated with any rebound,” Dr. Yusuf said.

Like all antithrombotic drugs, reviparin boosted the rate of bleeding events. The rate of life-threatening or major bleeds not included in the primary outcomes after 7 days of treatment was 0.1% in the placebo group, compared with 0.2% in the reviparin group. The increased risk of important bleeding events was small, compared with the overall benefit, he noted.

Another noteworthy finding was that the faster treatment with reviparin started the greater the benefit. Patients who started treatment within 2 hours of symptom onset had a 30% relative drop in the primary end point. This relative benefit fell to 20% when treatment began 2–4 hours and to 15% when treatment began within 4–8 hours. The benefit completely disappeared when treatment was delayed beyond 8 hours.

An inevitable question is whether treatment with the low-molecular-weight heparins approved for use in the United States would confer the same benefits. “It's a tricky issue, because low-molecular-weight heparins are very heterogeneous compounds. You need to know the exact dosage to use.” Dr. Yusuf said.

Interventional cardiology gained ground this year as an alternative to coronary artery bypass graft surgery, as drug-eluting stents were shown to reduce restenosis rates. This and other advances in devices, such carotid stents with distal protection, could have a far-reaching impact on the health care system (including costs) as more patients undergo percutaneous interventions. For example, drug-eluting stents have “thrown a monkey wrench in the hospitals economic projections about their angioplasty business because there is a higher cost up front to acquire these stents, and with reduced amounts of restenosis, they have less repeat business,” John M. Flack, M.D., of Wayne State University, Detroit, told CARDIOLOGY NEWS.

With new devices and technologies, boundaries between interventional cardiologists, interventional radiologists, vascular surgeons, and neurologists are disappearing, leading specialty societies to establish competency requirements to protect patients as well as turf. Even the Food and Drug Administration is getting into the act, with training criteria physicians must meet before they can implant Guidant's Acculink carotid stent.

Interventional cardiology gained ground this year as an alternative to coronary artery bypass graft surgery, as drug-eluting stents were shown to reduce restenosis rates. This and other advances in devices, such carotid stents with distal protection, could have a far-reaching impact on the health care system (including costs) as more patients undergo percutaneous interventions. For example, drug-eluting stents have “thrown a monkey wrench in the hospitals economic projections about their angioplasty business because there is a higher cost up front to acquire these stents, and with reduced amounts of restenosis, they have less repeat business,” John M. Flack, M.D., of Wayne State University, Detroit, told CARDIOLOGY NEWS.

With new devices and technologies, boundaries between interventional cardiologists, interventional radiologists, vascular surgeons, and neurologists are disappearing, leading specialty societies to establish competency requirements to protect patients as well as turf. Even the Food and Drug Administration is getting into the act, with training criteria physicians must meet before they can implant Guidant's Acculink carotid stent.

Interventional cardiology gained ground this year as an alternative to coronary artery bypass graft surgery, as drug-eluting stents were shown to reduce restenosis rates. This and other advances in devices, such carotid stents with distal protection, could have a far-reaching impact on the health care system (including costs) as more patients undergo percutaneous interventions. For example, drug-eluting stents have “thrown a monkey wrench in the hospitals economic projections about their angioplasty business because there is a higher cost up front to acquire these stents, and with reduced amounts of restenosis, they have less repeat business,” John M. Flack, M.D., of Wayne State University, Detroit, told CARDIOLOGY NEWS.

With new devices and technologies, boundaries between interventional cardiologists, interventional radiologists, vascular surgeons, and neurologists are disappearing, leading specialty societies to establish competency requirements to protect patients as well as turf. Even the Food and Drug Administration is getting into the act, with training criteria physicians must meet before they can implant Guidant's Acculink carotid stent.

NEW ORLEANS — Just 4% of U.S. acute MI patients transferred from one hospital to another for primary percutaneous intervention are treated within 90 minutes as recommended in recent guidelines, Brahmajee K. Nallamothu, M.D., reported at the annual scientific sessions of the American Heart Association.

This finding from the large National Registry of Myocardial Infarction (NRMI) database indicates an urgent need for improved process-of-care systems in order to minimize time delays for transferred MI patients, said Dr. Nallamothu of the University of Michigan, Ann Arbor.

PCI, when performed expeditiously, yields outcomes clearly superior to thrombolytic therapy. But at present, only about 20% of U.S. acute care hospitals have the capacity to perform primary PCI.

When a patient presents to a hospital without such capacity, the only options are on-site thrombolysis or immediate transfer to another facility for the procedure.

The pro-transfer argument is bolstered by several favorable European randomized controlled trials. However, these trials were conducted in countries with better-organized care and shorter transfer distances than are the norm in the United States. As a result, total door-to-balloon times in the randomized trials was only about 90 minutes. And the great majority of transferred American patients don't even come close to that speed of care.

Dr. Nallamothu's analysis of the NRMI-3 and −4 cohorts underscores that point. Of 4,278 consecutive acute MI patients transferred for primary PCI at 419 hospitals participating in the registry, only 4.2% had a door-to-balloon time of 90 minutes or less, as recommended in the recently issued AHA/American College of Cardiology guidelines (J. Am. Coll. Cardiol. 2004;44:671–719). The median door-to-balloon time was 180 minutes. Only 16.2% of transferred patients had a door-to-balloon time of 120 minutes or less, as recommended in earlier AHA/ACC guidelines. The great bulk of the time delay occurred because of prolonged transit times. More than 50% of transferred patients had transfer times in excess of 120 minutes.

NRMI is an ongoing project funded by Genentech. Dr. Nallamothu's study was supported by the National Heart, Lung, and Blood Institute.

NEW ORLEANS — Just 4% of U.S. acute MI patients transferred from one hospital to another for primary percutaneous intervention are treated within 90 minutes as recommended in recent guidelines, Brahmajee K. Nallamothu, M.D., reported at the annual scientific sessions of the American Heart Association.

This finding from the large National Registry of Myocardial Infarction (NRMI) database indicates an urgent need for improved process-of-care systems in order to minimize time delays for transferred MI patients, said Dr. Nallamothu of the University of Michigan, Ann Arbor.

PCI, when performed expeditiously, yields outcomes clearly superior to thrombolytic therapy. But at present, only about 20% of U.S. acute care hospitals have the capacity to perform primary PCI.

When a patient presents to a hospital without such capacity, the only options are on-site thrombolysis or immediate transfer to another facility for the procedure.

The pro-transfer argument is bolstered by several favorable European randomized controlled trials. However, these trials were conducted in countries with better-organized care and shorter transfer distances than are the norm in the United States. As a result, total door-to-balloon times in the randomized trials was only about 90 minutes. And the great majority of transferred American patients don't even come close to that speed of care.

Dr. Nallamothu's analysis of the NRMI-3 and −4 cohorts underscores that point. Of 4,278 consecutive acute MI patients transferred for primary PCI at 419 hospitals participating in the registry, only 4.2% had a door-to-balloon time of 90 minutes or less, as recommended in the recently issued AHA/American College of Cardiology guidelines (J. Am. Coll. Cardiol. 2004;44:671–719). The median door-to-balloon time was 180 minutes. Only 16.2% of transferred patients had a door-to-balloon time of 120 minutes or less, as recommended in earlier AHA/ACC guidelines. The great bulk of the time delay occurred because of prolonged transit times. More than 50% of transferred patients had transfer times in excess of 120 minutes.

NRMI is an ongoing project funded by Genentech. Dr. Nallamothu's study was supported by the National Heart, Lung, and Blood Institute.

NEW ORLEANS — Just 4% of U.S. acute MI patients transferred from one hospital to another for primary percutaneous intervention are treated within 90 minutes as recommended in recent guidelines, Brahmajee K. Nallamothu, M.D., reported at the annual scientific sessions of the American Heart Association.

This finding from the large National Registry of Myocardial Infarction (NRMI) database indicates an urgent need for improved process-of-care systems in order to minimize time delays for transferred MI patients, said Dr. Nallamothu of the University of Michigan, Ann Arbor.

PCI, when performed expeditiously, yields outcomes clearly superior to thrombolytic therapy. But at present, only about 20% of U.S. acute care hospitals have the capacity to perform primary PCI.

When a patient presents to a hospital without such capacity, the only options are on-site thrombolysis or immediate transfer to another facility for the procedure.

The pro-transfer argument is bolstered by several favorable European randomized controlled trials. However, these trials were conducted in countries with better-organized care and shorter transfer distances than are the norm in the United States. As a result, total door-to-balloon times in the randomized trials was only about 90 minutes. And the great majority of transferred American patients don't even come close to that speed of care.

Dr. Nallamothu's analysis of the NRMI-3 and −4 cohorts underscores that point. Of 4,278 consecutive acute MI patients transferred for primary PCI at 419 hospitals participating in the registry, only 4.2% had a door-to-balloon time of 90 minutes or less, as recommended in the recently issued AHA/American College of Cardiology guidelines (J. Am. Coll. Cardiol. 2004;44:671–719). The median door-to-balloon time was 180 minutes. Only 16.2% of transferred patients had a door-to-balloon time of 120 minutes or less, as recommended in earlier AHA/ACC guidelines. The great bulk of the time delay occurred because of prolonged transit times. More than 50% of transferred patients had transfer times in excess of 120 minutes.

NRMI is an ongoing project funded by Genentech. Dr. Nallamothu's study was supported by the National Heart, Lung, and Blood Institute.

Women who presented to Michigan hospitals with acute ST-segment elevation myocardial infarction waited significantly longer than men to undergo emergency angioplasty—and even men waited too long according to Mauro Moscucci, M.D., the lead, investigator in the study.

“We have an ideal target for quality improvement, something we can easily try to correct,” said Dr. Moscucci, who presented the data at the scientific sessions of the American Heart Association and discussed the findings in a later interview. “If we can improve our treatment times, we can substantially reduce the risk of death.”

Dr. Moscucci and his associates analyzed data collected on 1,551 patients who had primary percutaneous coronary intervention for acute ST-segment elevation during a 20-month period ending in June 2004. Patients had the procedure at 1 of the 16 hospitals participating in the regional Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

The investigators found that only 26% of the 442 women who had an emergency angioplasty—and 34% of the 1,069 men—had the procedure within the 90-minute time frame recommended by the American Heart Association and the American College of Cardiology.

On average, women waited more than 118 minutes before treatment began, compared with 106 minutes for men.

Patients of both sexes whose angioplasty began within 90 minutes of arrival at the hospital had a 50% lower risk of dying in the hospital than those who waited longer, said Dr. Moscucci, director of interventional cardiology at the University of Michigan Cardiovascular Center, Ann Arbor.

“Since there's been such a focus on angioplasty recently, we wondered whether the recommended door-to-balloon time of 90 minutes was still significant in terms of survival,” he said. “We found that it's still an important predictor of in-hospital mortality, and that perhaps we're not doing as well as we should.”

Women in the study were more than twice as likely as men to die in the hospital; their mortality rate was about 7%, compared with about 3% in men. When the investigators adjusted for the average older age of women and the higher frequency of comorbidities, they still found higher in-hospital mortality rates for women, Dr. Moscucci said.

The gender-difference findings augment a growing body of research showing that women with heart attacks seek care later, present more often with atypical symptoms and comorbidities such as severe diabetes, and face delays in treatment, he said.

In addition to the greater delays in treatment, the Michigan study showed that it takes longer for women to get to an emergency department in the first place. Women reported that their symptoms started an average of 105 minutes before they got to the emergency department; the average time for men was 85 minutes.

Dr. Moscucci said that hospital procedures for activating cardiac catheterization labs vary significantly. Labs could be activated faster—which, along with faster diagnosis, would help hasten door-to-balloon times—if more ambulances had the capability to automatically read or transmit ECGs and if more hospitals allowed emergency physicians and not just cardiologists to activate the labs directly, he said.

A recent survey of more than 1,000 women older than 35 years showed that only 47% of women who had head, neck, back, and jaw pain—typical heart attack symptoms— would call their doctor, and just 35% would call 911 or visit an emergency department.

“Women and their families still need a great deal of education. Their symptoms can be very atypical—perhaps only weakness, difficulty breathing, or dizziness,” said Michael J. Bresler, M.D., professor of emergency medicine at Stanford (Calif.) University. Women in whom heart attack is diagnosed “should be rushed to the cath lab or quickly given a lytic drug if immediate catheterization isn't available,” he said.

Women who presented to Michigan hospitals with acute ST-segment elevation myocardial infarction waited significantly longer than men to undergo emergency angioplasty—and even men waited too long according to Mauro Moscucci, M.D., the lead, investigator in the study.

“We have an ideal target for quality improvement, something we can easily try to correct,” said Dr. Moscucci, who presented the data at the scientific sessions of the American Heart Association and discussed the findings in a later interview. “If we can improve our treatment times, we can substantially reduce the risk of death.”

Dr. Moscucci and his associates analyzed data collected on 1,551 patients who had primary percutaneous coronary intervention for acute ST-segment elevation during a 20-month period ending in June 2004. Patients had the procedure at 1 of the 16 hospitals participating in the regional Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

The investigators found that only 26% of the 442 women who had an emergency angioplasty—and 34% of the 1,069 men—had the procedure within the 90-minute time frame recommended by the American Heart Association and the American College of Cardiology.

On average, women waited more than 118 minutes before treatment began, compared with 106 minutes for men.

Patients of both sexes whose angioplasty began within 90 minutes of arrival at the hospital had a 50% lower risk of dying in the hospital than those who waited longer, said Dr. Moscucci, director of interventional cardiology at the University of Michigan Cardiovascular Center, Ann Arbor.

“Since there's been such a focus on angioplasty recently, we wondered whether the recommended door-to-balloon time of 90 minutes was still significant in terms of survival,” he said. “We found that it's still an important predictor of in-hospital mortality, and that perhaps we're not doing as well as we should.”

Women in the study were more than twice as likely as men to die in the hospital; their mortality rate was about 7%, compared with about 3% in men. When the investigators adjusted for the average older age of women and the higher frequency of comorbidities, they still found higher in-hospital mortality rates for women, Dr. Moscucci said.

The gender-difference findings augment a growing body of research showing that women with heart attacks seek care later, present more often with atypical symptoms and comorbidities such as severe diabetes, and face delays in treatment, he said.

In addition to the greater delays in treatment, the Michigan study showed that it takes longer for women to get to an emergency department in the first place. Women reported that their symptoms started an average of 105 minutes before they got to the emergency department; the average time for men was 85 minutes.

Dr. Moscucci said that hospital procedures for activating cardiac catheterization labs vary significantly. Labs could be activated faster—which, along with faster diagnosis, would help hasten door-to-balloon times—if more ambulances had the capability to automatically read or transmit ECGs and if more hospitals allowed emergency physicians and not just cardiologists to activate the labs directly, he said.

A recent survey of more than 1,000 women older than 35 years showed that only 47% of women who had head, neck, back, and jaw pain—typical heart attack symptoms— would call their doctor, and just 35% would call 911 or visit an emergency department.

“Women and their families still need a great deal of education. Their symptoms can be very atypical—perhaps only weakness, difficulty breathing, or dizziness,” said Michael J. Bresler, M.D., professor of emergency medicine at Stanford (Calif.) University. Women in whom heart attack is diagnosed “should be rushed to the cath lab or quickly given a lytic drug if immediate catheterization isn't available,” he said.

Women who presented to Michigan hospitals with acute ST-segment elevation myocardial infarction waited significantly longer than men to undergo emergency angioplasty—and even men waited too long according to Mauro Moscucci, M.D., the lead, investigator in the study.

“We have an ideal target for quality improvement, something we can easily try to correct,” said Dr. Moscucci, who presented the data at the scientific sessions of the American Heart Association and discussed the findings in a later interview. “If we can improve our treatment times, we can substantially reduce the risk of death.”

Dr. Moscucci and his associates analyzed data collected on 1,551 patients who had primary percutaneous coronary intervention for acute ST-segment elevation during a 20-month period ending in June 2004. Patients had the procedure at 1 of the 16 hospitals participating in the regional Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

The investigators found that only 26% of the 442 women who had an emergency angioplasty—and 34% of the 1,069 men—had the procedure within the 90-minute time frame recommended by the American Heart Association and the American College of Cardiology.

On average, women waited more than 118 minutes before treatment began, compared with 106 minutes for men.

Patients of both sexes whose angioplasty began within 90 minutes of arrival at the hospital had a 50% lower risk of dying in the hospital than those who waited longer, said Dr. Moscucci, director of interventional cardiology at the University of Michigan Cardiovascular Center, Ann Arbor.

“Since there's been such a focus on angioplasty recently, we wondered whether the recommended door-to-balloon time of 90 minutes was still significant in terms of survival,” he said. “We found that it's still an important predictor of in-hospital mortality, and that perhaps we're not doing as well as we should.”

Women in the study were more than twice as likely as men to die in the hospital; their mortality rate was about 7%, compared with about 3% in men. When the investigators adjusted for the average older age of women and the higher frequency of comorbidities, they still found higher in-hospital mortality rates for women, Dr. Moscucci said.

The gender-difference findings augment a growing body of research showing that women with heart attacks seek care later, present more often with atypical symptoms and comorbidities such as severe diabetes, and face delays in treatment, he said.

In addition to the greater delays in treatment, the Michigan study showed that it takes longer for women to get to an emergency department in the first place. Women reported that their symptoms started an average of 105 minutes before they got to the emergency department; the average time for men was 85 minutes.

Dr. Moscucci said that hospital procedures for activating cardiac catheterization labs vary significantly. Labs could be activated faster—which, along with faster diagnosis, would help hasten door-to-balloon times—if more ambulances had the capability to automatically read or transmit ECGs and if more hospitals allowed emergency physicians and not just cardiologists to activate the labs directly, he said.

A recent survey of more than 1,000 women older than 35 years showed that only 47% of women who had head, neck, back, and jaw pain—typical heart attack symptoms— would call their doctor, and just 35% would call 911 or visit an emergency department.

“Women and their families still need a great deal of education. Their symptoms can be very atypical—perhaps only weakness, difficulty breathing, or dizziness,” said Michael J. Bresler, M.D., professor of emergency medicine at Stanford (Calif.) University. Women in whom heart attack is diagnosed “should be rushed to the cath lab or quickly given a lytic drug if immediate catheterization isn't available,” he said.