Safety and cost-effectiveness of early discharge after primary angioplasty in low risk patients with acute myocardial infarction. PAMI-II Investigators. Primary Angioplasty in Myocardial Infarction.

OBJECTIVES: The second Primary Angioplasty in Myocardial Infarction (PAMI-II) study evaluated the hypothesis that primary percutaneous transluminal coronary angioplasty (PTCA), with subsequent discharge from the hospital 3 days later, is safe and cost-effective in low risk patients. BACKGROUND: In low risk patients with myocardial infarction (MI), few data exist regarding the need for intensive care and noninvasive testing or the appropriate length of hospital stay. METHODS: Patients with acute MI underwent emergency catheterization with primary PTCA when appropriate. Low risk patients (age <70 years, left ventricular ejection fraction >45%, one- or two-vessel disease, successful PTCA, no persistent arrhythmias) were randomized to receive accelerated care (admission to a nonintensive care unit and day 3 hospital discharge without noninvasive testing [n = 237] or traditional care [n = 234]). RESULTS: Patients who received accelerated care had similar in-hospital outcomes but were discharged 3 days earlier (4.2+/-2.3 vs. 7.1+/-4.7 days, p = 0.0001) and had lower hospital costs ($9,658+/-5,287 vs. $11,604+/-6,125 p = 0.002) than the patients who received traditional care. At 6 months, accelerated and traditional care groups had a similar rate of mortality (0.8% vs. 0.4%, p = 1.00), unstable ischemia (10.1% vs. 12.0%, p = 0.52), reinfarction (0.8% vs. 0.4%, p = 1.00), stroke (0.4% vs. 2.6%, p = 0.07), congestive heart failure (4.6% vs. 4.3%, p = 0.85) or their combined occurrence (15.2% vs. 17.5%, p = 0.49). The study was designed to detect a 10% difference in event rates; at 6 months, only a 2.3% difference was measured between groups, indicating an actual power of 0.19. CONCLUSIONS: Early identification of low risk patients with MI allowed safe omission of the intensive care phase and noninvasive testing, and a day 3 hospital discharge strategy, resulting in substantial cost savings.

A prospective, randomized evaluation of prophylactic intraaortic balloon counterpulsation in high risk patients with acute myocardial infarction treated with primary angioplasty. Second Primary Angioplasty in Myocardial Infarction (PAMI-II) Trial Investigators.

OBJECTIVES: A large, international, multicenter, prospective, randomized trial was performed to determine the role of prophylactic intraaortic balloon pump (IABP) counterpulsation after primary percutaneous transluminal coronary angioplasty (PTCA) in acute myocardial infarction (AMI). BACKGROUND: Previous studies have suggested that routine IABP use after primary PTCA reduces infarct-related artery reocclusion, augments myocardial recovery and improves clinical outcomes. METHODS: Cardiac catheterization was performed in 1,100 patients within 12 h of onset of AMI at 34 clinical centers. Clinical and angiographic variables were used to stratify patients undergoing primary PTCA into high and low risk groups. High risk patients were then randomized to 36 to 48 h of IABP (n = 211) or traditional care (n = 226). The study had 80% power to detect a reduction in the primary end point from 30% to 20%. RESULTS: There was no significant difference in the predefined primary combined end point of death, reinfarction, infarct-related artery reocclusion, stroke or new-onset heart failure or sustained hypotension in patients treated with an IABP versus those treated conservatively (28.9% vs. 29.2%, p = 0.95). The IABP strategy conferred modest benefits in reduction of recurrent ischemia (13.3% vs. 19.6%, p = 0.08) and subsequent unscheduled repeat catheterization (7.6% vs. 13.3%, p = 0.05) but did not reduce the rate of infarct-related artery reocclusion (6.7% vs. 5.5%, p = 0.64), reinfarction (6.2% vs. 8.0%, p = 0.46) or mortality (4.3% vs. 3.1%) and was associated with a higher incidence of stroke (2.4% vs. 0%, p = 0.03). IABP use did not result in enhanced myocardial recovery as assessed by paired admission to predischarge and 6-week rest and exercise left ventricular ejection fraction. CONCLUSIONS: In contrast to previous studies, a prophylactic IABP strategy after primary PTCA in hemodynamically stable high risk patients with AMI does not decrease the rates of infarct-related artery reocclusion or reinfarction, promote myocardial recovery or improve overall clinical outcome.

Randomized prospective evaluation of prolonged versus abbreviated intravenous heparin therapy after coronary angioplasty.

OBJECTIVES: This study was designed to prospectively evaluate the routine use of continuous heparin therapy after successful uncomplicated coronary angioplasty. BACKGROUND: The use of such therapy varies among institutions and may increase the incidence of complications. Evaluation of the risks and benefits of abbreviated heparin therapy combined with early sheath removal after coronary angioplasty is necessary to determine optimal postprocedure care. METHODS: We prospectively studied 284 patients who were scheduled for elective coronary angioplasty. Historical, clinical, physiologic and angiographic data were gathered. All patients received an initial bolus of heparin and then were randomized during the procedure to receive either no additional heparin therapy or an adjusted 24-h infusion. On the basis of specific criteria, additional heparin was not withheld if procedural results suggested an increased risk for complications. RESULTS: Two hundred thirty-eight patients completed the study; 46 others were excluded in the catheterization laboratory because of unfavorable procedural results. The patients with abbreviated (n = 118) and 24-h (n = 120) therapy did not differ with respect to demographic and angiographic findings. However, the former had fewer bleeding complications (0% vs. 7%, p < 0.001) and were discharged earlier (mean +/- SD 23 +/- 11 h vs. 42 +/- 24 h, p < 0.001). One patient in this group had a major complication shortly after angioplasty. The mean savings in hospital charges in the abbreviated therapy group was $1,370 ($6,093 +/- $1,772 vs. $7,463 +/- $1,782, p < 0.001). CONCLUSIONS: Omission of routine heparin therapy after successful coronary angioplasty reduces bleeding complications without increasing patient risk. Earlier discharge and significant cost savings are possible under proper conditions.

Angioplasty of the proximal left anterior descending coronary artery: initial success and long-term follow-up.

From 1984 to 1987, 537 consecutive patients (mean age 58 years; range 34 to 79) underwent angioplasty for proximal left anterior descending coronary artery disease. The procedure was clinically successful in 516 (96.1%). Procedural complications included myocardial infarction (2.2%; Q wave 0.9%, non-Q wave 1.3%), in-hospital bypass surgery (3%) and death (0.4%). Follow-up was obtained in 534 patients (99.8%) for a mean duration of 44 months (range 8 to 75). Follow-up cardiac catheterization, performed in 391 patients (76%), demonstrated a 39.6% angiographic restenosis rate. Ninety-eight (19%) of the patients with a clinically successful result required additional revascularization for recurrent left anterior descending artery disease by angioplasty (12.8%) or coronary artery bypass grafting (4.7%), or both (1.5%). During follow-up there was a 2.5% incidence rate of myocardial infarction (anterior myocardial infarction 1.6%), and 27 patients (5.2%) died, 14 (2.7%) of cardiac causes. The actuarial 5-year cardiac survival rate was 97%, freedom from cardiac death and myocardial infarction was 94% and freedom from cardiac death, myocardial infarction, coronary artery bypass surgery and repeat left anterior descending artery angioplasty was 77%. At last follow-up 76% of patients were free of angina and 88% reported sustained functional improvement. Angioplasty is an effective treatment for proximal left anterior descending coronary artery disease that has a high success rate, low incidence of procedural complications and provides excellent long-term cardiac survival, freedom from cardiac events and sustained functional improvement.

Cystic medial necrosis of the aorta in patients without Marfan's syndrome: surgical outcome and long-term follow-up.

A retrospective analysis was performed to determine the surgical outcome and long-term follow-up of patients with documented cystic medial necrosis of the aorta. Ninety-three patients were diagnosed as having cystic medial necrosis at the Cleveland Clinic between July 1963 and December 1987 (72% men aged 26 to 77 years, mean 55). Patients who met the standard diagnostic criteria for Marfan's syndrome were deliberately excluded. Sixty-eight percent of the patients had a diastolic murmur and chest roentgenogram revealed a dilated aortic arch in 58% and cardiomegaly in 63%. Cardiac catheterization in 76 patients demonstrated aortic root dilation in 78%, aortic regurgitation in 72%, aortic dissection in 32% and coronary artery disease in 32%. Ninety patients underwent surgery including composite graft repair with reimplantation of the coronary arteries in 34%. Follow-up, obtained on 90 (97%) of the 93 patients, ranged in duration from 0 to 137 months (mean 29). Thirty-four of the 90 patients died (age range 30 to 75 years, mean 60). Ninety-four percent of the known causes of death were related to the cardiovascular system; 65% were the result of aortic dissection or rupture or sudden death. Ninety-six percent of survivors were in New York Heart Association functional class I or II. Overall estimated survival at 1, 3 and 5 years was 72.2%, 63.5% and 57.4%, respectively. Actuarial survival in patients who underwent composite graft reconstruction was 84% at 5 years. The presence of a diastolic murmur at initial presentation was associated with a poor prognosis (p = 0.03).(ABSTRACT TRUNCATED AT 250 WORDS)

Marfan's syndrome: natural history and long-term follow-up of cardiovascular involvement.

A retrospective analysis was undertaken to define the natural history and long-term follow-up of a group of patients with Marfan's syndrome. Eighty-four patients were diagnosed between January 1959 and June 1987 as having Marfan's syndrome; 68% were male; their ages ranged from 2 to 67 years (mean 26.6). Sixteen patients constituted the early surgical group (those who underwent surgery before 1979; mean age 36.1 years). Nineteen patients constituted the late surgical group (surgery in 1979 or later; mean age 33.3 years). The nonsurgical group comprised 49 patients (mean age 19.3 years). Fifty-seven percent of the patients had a diastolic murmur and 38% had cardiomegaly at presentation. Fifty-seven percent underwent cardiac catheterization, which revealed aortic root dilation (85%), aortic regurgitation (73%), aortic dissection (33%) and mitral regurgitation (36%). Thirteen of the 19 patients in the late surgical group received a composite graft repair of the ascending aorta as compared with only 2 of the 16 in the early surgical group. Follow-up information was obtained on 81 (96%) of 84 patients; the follow-up time was 2 to 332 months (mean 99). Thirty-one of the 81 patients died at age 3 to 63 years (mean age 35 years); 87% of the known causes of death were related to the cardiovascular system. Sixty-one percent of deaths were the result of aortic dissection or rupture or sudden cardiac death. Of the 50 survivors, 98%, including all patients in the late surgical group, were in functional class I or II. Overall survival at 5, 10 and 15 years after operation was 78.4%, 57.1% and 49.5%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)