Randomized comparison of coronary stenting with balloon angioplasty in selected patients with acute myocardial infarction

BACKGROUND: Although the benefits of primary angioplasty in acute myocardial infarction have been demonstrated, several areas for improvement remain. Therefore, a prospective randomized trial comparing primary stenting with balloon angioplasty in patients with acute myocardial infarction was conducted. METHODS AND RESULTS: Patients with acute myocardial infarction were randomly assigned to undergo either primary stenting (n=112) or balloon angioplasty (n=115). The clinical end points were death, recurrent infarction, subsequent bypass surgery, or repeat angioplasty of the infarct-related vessel. The overall mortality rate at 6 months was 2%. Recurrent infarction occurred in 8 patients (7%) after balloon angioplasty and in 1 (1%) after stenting (P=0.036). Subsequent target-vessel revascularization was necessary in 19 (17%) and 4 (4%) patients, respectively (P=0.0016). The cardiac event-free survival rate in the stent group was significantly higher than in the balloon angioplasty group (95% versus 80%; P=0.012). CONCLUSIONS: In selected patients with acute myocardial infarction, primary stenting can be applied safely and effectively, resulting in a lower incidence of recurrent infarction and a significant reduction in the need for subsequent target-vessel revascularization compared with balloon angioplasty.     

Tandem balloon dilatation for childhood achalasia

BACKGROUND: There are no previous reports of tandem balloon dilatation in childhood achalasia. OBJECTIVE: To report the treatment of four cases of paediatric achalasia using tandem balloon dilatation of the lower oesophageal sphincter. A review of the literature since 1986 was undertaken to compare outcomes of balloon dilatation and surgery. MATERIALS AND METHODS: A retrospective review of the patients diagnosed with this condition and treated at our institution over the past 6 years: all four patients were treated by balloon dilatation of the lower oesophageal sphincter using two or three balloons in tandem. The definition of technical success was demonstration of a waist at 1-1.5 atmospheres of inflation pressure followed by abolition of the waist at higher pressures. Where this was unable to be achieved using a single balloon, two or three balloons in tandem were used. RESULTS: No patient required oesophagomyotomy, and symptomatic control has been good to excellent in three of four patients. No significant side effects were encountered. CONCLUSIONS: Balloon dilatation and surgery have similar success rates in paediatric achalasia. Because of the low morbidity associated with balloon dilatation, the procedure should be considered as first line treatment of this condition. If the lower oesophageal sphincter is stretched insufficiently using a single balloon, tandem balloon dilatation should be utilised.     

Newly developed blocking balloon catheter for PTA of internal carotid artery

We have developed a new blocking balloon system for percutaneous transluminal angioplasty (PTA) of the internal carotid artery (ICA). A latex balloon (BALT) is attached on the top of a Superselector infusion-type catheter (TORAY) which is used as a blocking balloon catheter. It can be navigated into the distal part of the ICA under torque control as well as flow control by withdrawing the core wire. Our PTA procedure is as follows, 1) insert the sheath catheter 8-9 F in size, 2) insert the PTA balloon catheter (Accent balloon, Cook) with a blocking balloon catheter through the sheath catheter, 3) navigate the blocking balloon into the distal part of the ICA, 4) introduce the PTA balloon to the stenotic portion after occlusion of the distal ICA by the blocking balloon, 5) PTA, 6) wash the lumen of the ICA with saline, 7) deflate the blocking balloon and withdraw the system. We performed PTA for 5 ICA lesions in 4 cases and got successful dilatations for all of them without complications. Our blocking balloon system is useful for performing the PTA of the ICA safely.     

Factors associated with fatalities and injuries from hot-air balloon crashes

CONTEXT: Despite the increased popularity of hot-air balloon flight, data on injuries and fatalities associated with hot-air balloon crashes are limited. OBJECTIVE: To determine factors associated with injury and death in hot-air balloon crashes. DESIGN: Retrospective review of data collected from reports and investigations by the Civil Aeronautics Board and the National Transportation Safety Board. STUDY SUBJECTS: Individuals involved in US hot-air balloon crashes from 1964 to 1995. MAIN OUTCOME MEASURES: Total number of crashes and factors associated with fatality or serious injury. RESULTS: From 1964 to 1995, a total of 495 hot-air balloon crashes involving 1533 persons were reported and included 92 fatalities and 384 serious injuries. Pilot error or incapacitation was determined subjectively by crash investigators to contribute to 85.1% of the crashes. In univariate analysis, collision with the ground was the most significant predictor of a fatality or serious injury (P<.001), and power-line contact was the most significant predictor of fatality (P<.001). In multiple logistic regression, only the type of object struck by a balloon predicted a fatal crash or a fatality or serious injury. CONCLUSIONS: Although a number of factors likely contribute to increased severity of hot-air balloon crashes, the object struck during a crash is most predictive of fatality or serious injury. Preventive efforts are needed to decrease future injuries.     

Comparison between the use of unifoil double balloon and bifoil balloon in successful mitral valvuloplasty by balloon catheter

PURPOSE: To compare immediate and long term results balloon mitral valvuloplasty (BMV) using double balloon or bifoil balloon. METHODS: One hundred and thirteen consecutive cases of BMV used aleatory double balloon (group DB--55 cases) or bifoil balloon (group BF--16 cases). Patients were similar regarding to age, sex, valvopaty etiology, functional class and echocardiographic score. Seventy one (63%) patients achieved 12 months follow-up. RESULTS: In group DB there were 2 (4%) insuccess, 2 (4%) cardiac tamponade and 2 (4%) deaths, 91% patients had immediate criteria of success. Mitral valve area (MVA) increased from 0.8 to 1.69cm2 and mitral gradient (G) by echodopplercardiographic (ECHO) decreased from 17.9 to 4.8mmHg. Three (5%) patients developed severe mitral regurgitation (MR) and needed surgical intervention. At follow-up 2 (4%) developed mitral restenosis. MVA estimated by ECHO study after one year follow-up was inferior to 1.15cm2 in 15 (32%) cases, between 1.5 and 2.0cm2 in 17 (37%) and superior to 2.0cm2 in 14 (31%). In group BF there were 2 (12.5%) insuccess, 4 (25%) developed severe MR occurring 1 death immediate post-operative mitral valve replacement. Among 14 (87%) success cases, MVA increased from 0.8 to 1.89cm2 and G decreased from 18 to 6.4mmHg. Lately 2 (12.5%) needed surgical intervention because significative MR. At 12th month follow-up the ECHO study showed that in one (10%) case MVA was < 1.5cm2, and in 3 (27%) cases was between 1.5 and 2.0cm2. CONCLUSION: There were similar good results in both groups, however group DB had more restenosis, cardiac tamponade and vascular complications and group BF had more severe MR.     

Prevention of balloon damage during initiation of intra-aortic balloon counterpulsation

Damage to an intra-aortic balloon occurred on two occasions in 93 insertion procedures. The complication was recognized before gas embolization occurred, and neither patient suffered ill effects. On both occasions the balloon was holed when pinched by artery forceps applied to the 'dacron' graft.     

Device to limit inflation of a pulmonary artery catheter balloon

OBJECTIVE: The most serious complication seen with pulmonary artery catheters is rupture of the pulmonary artery. The effectiveness of an external safety balloon added to the pulmonary artery balloon inflation port was tested. DESIGN: The external balloon is designed to inflate and absorb excess volume from the inflation syringe after the internal balloon contacts the vessel wall. When the catheter tip is in a small pulmonary artery, expansion of the external balloon indicates that the catheter tip is in a noncompliant or small vessel. SETTING: The external balloon was tested in a bench simulation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The pulmonary artery balloon was slowly inflated inside 2.6-, 3.0-, 4.7-, 8.6-, and 11.6-mm internal diameter polyvinyl chloride tubes, with and without the external safety device in place. Without the external balloon, the average balloon pressure was 1647 +/- 145 (SD) mm Hg in the 2.6-mm vessel. With the external balloon in use, the maximum pulmonary artery balloon pressure was 473 +/- 7.2 mm Hg in the 2.6-mm vessel. CONCLUSIONS: The external balloon can limit balloon pressures within the pulmonary artery and identify when excessive volumes are being forced into the pulmonary artery balloon.     

The Windkesselventricle with guiding balloon as a new approach for assisted circulation

A simple method was developed to aid the patient with low cardiac output syndrome following cardiac surgery. The concept was shown to be feasible in electric circulatory analog studies and verified in 20 dog experiments. A Dacron graft (end-to-side) through the right second intercostal space connects the ascending aorta to the subcutaneously implanted, ellipsoidal-shaped artifical ventricle. A spherical polyurethane balloon is positioned in the aorta distal to the Dacron graft via the femoral artery. The ventricle and balloon are pneumatically driven synchronously with the ECG. In natural systole the balloon is inflated, occluding the aorta, and the artificial ventricle sucks the entire stroke volume. In natural diastole the balloon deflates and the artificial ventricle ejects the blood into the peripheral arteries. With this system it is possible to maintain a normal systemic pressure and have high hemodynamic efficiency. The left ventricular systolic pressure is 85 percent unloaded. The systolic wave is turned 180 degrees to the natural. After treatment, the device can be removed without thoracotomy.     

Intimal hyperplasia after balloon injury is attenuated by blocking selectins

BACKGROUND: Cell adhesion molecules facilitate the adherence of platelets and leukocytes to the vascular endothelium in response to injury. Restenosis after balloon angioplasty is thought to represent the response to vascular injury. The role of cell adhesion in this process is unclear. METHODS AND RESULTS: This study was performed in New Zealand White rabbits that underwent balloon angioplasty of the iliac artery. Expression of the cell adhesion molecule E-selectin on endothelium was determined by immunohistochemistry and increased at 6 hours with a peak expression 24 to 48 hours after balloon injury, returning to baseline by 1 week. The expression of L-selectin on circulating leukocytes, measured by flow cytometry, was significantly increased at 48 hours, with return to baseline by 1 week. In seven animals, the selectins were blocked with an analogue of sialyl-Lewis(x) given as an I.V. bolus of 10 mg/kg followed by 2 mg x kg(-1) x h(-1) I.P. infusion for 7 days. After 4 weeks, compared with control animals, the study group had a larger lumen area (57.7 versus 44.7 mm2, P<.05), smaller intima area (9.0 versus 19.2 mm2, P<.01), smaller intima/media ratio (0.4 versus 1.0, P<.01), and a smaller percent area stenosis (15.6% versus 34.3%, P<.01). CONCLUSIONS: The cell adhesion molecules E-selectin and L-selectin are expressed after balloon injury. Blockade of the selectins has a favorable effect on the response to vascular injury.     

Determinants of successful balloon valvotomy in infants with critical pulmonary stenosis or membranous pulmonary atresia with intact ventricular septum

OBJECTIVES: This study reviewed our experience with percutaneous balloon valvotomy in infants with critical pulmonary stenosis or membranous pulmonary atresia with intact ventricular septum and defined the anatomic and hemodynamic characteristics of infants in whom this procedure is successful and provides definitive therapy. BACKGROUND: Unlike children with valvular pulmonary stenosis, the follow-up of infants with critical pulmonary stenosis undergoing percutaneous balloon valvotomy is limited. METHODS: Between December 1987 and August 1992, percutaneous balloon valvotomy was attempted in 12 infants with critical pulmonary stenosis (n = 10) or pulmonary atresia with intact ventricular septum (n = 2). Two outcome groups were identified: Group A patients are acyanotic, have mild residual pulmonary stenosis and have not required operation; Group B patients have required operation. RESULTS: Of the 12 infants, 11 had a successful balloon valvotomy procedure. Group A patients (n = 7) have a residual gradient of 22 +/- 18.7 mm Hg (mean +/- SD) at follow-up of 3.2 years (range 1.2 to 5.0). In Group B (n = 5), operation was required for inability to cross the pulmonary valve (n = 1) or persistent severe hypoxemia for > or = 2 weeks after valvotomy (n = 4). Significant differences (p < or = 0.01) between the two groups (Group A vs. Group B) were identified in pulmonary valve annulus (Z value) 8.1 mm (-1.1) versus 5.5 mm (-3.4); tricuspid valve annulus (Z value) 14.0 mm (0.8) versus 8.8 mm (-1.8); right ventricular volume 65 versus 29 ml/m2; and Lewis index 10.9 versus 8.9. CONCLUSIONS: Percutaneous balloon valvotomy is effective and likely to provide definitive therapy in infants with critical pulmonary stenosis or membranous pulmonary atresia with intact ventricular septum who have a tricuspid valve annulus > 11 mm, pulmonary valve annulus > or = 7 mm and right ventricular volume > 30 ml/m2.     

PTCA in angulated segments: effects of balloon material, balloon length, and inflation sequence on straightening forces in an in vitro model

We sought to determine the effect of balloon material, balloon length, and inflation sequence on the straightening forces generated during percutaneous transluminal coronary angioplasty (PTCA) in angulated segments. Using an in vitro model consisting of a curved channel (3/4" radius) with a displaceable pressure sensor, we examined four different balloon materials: compliant (POC), semicompliant (PE600 and Duralyn), and noncompliant (PET), two balloon lengths (20 mm and 40 mm), and two inflation sequences (rapid and slow) with continuous recording of straightening force during each balloon inflation. Three balloons were tested for each combination of materials, length, and inflation sequence. Long balloons exerted significantly lower straightening forces. There were significantly higher straightening forces with noncompliant, particularly short, balloons. Varying the inflation sequence had no significant effect. For PTCA in angulated segments: (1) long balloons produce lower straightening force, (2) noncompliant balloons produce higher straightening force, particularly with short balloons, and (3) varying the inflation sequence has no significant effect on straightening force.     

Potent HIV protease inhibitors incorporating high-affinity P2-ligands and (R)-(hydroxyethylamino)sulfonamide isostere

We performed percutaneous balloon pericardiotomy and pulmonary valvuloplasty in a woman affected with cardiac and pericardial involvement from a primary pulmonary adenocarcinoma. Pericardial window was indicated for a recurrent, symptomatic, pericardial effusion. Valvular stenosis was severe and related to metastatic infiltration of cardiac tissue. Open surgery was avoided and the procedures were completed in two steps under local anesthesia in less than 60 min. The patient had no recurrence of pulmonary stenosis or pericardial effusion at 7 months post treatment. Transcatheter techniques are successful in helping to manage malignant diseases with cardiac metastasis, particularly in critically-ill patients. It may become the preferred treatment for avoiding a more invasive procedure for patients with a limited life expectancy.     

Intraesophageal balloon distension test in Chagas' disease patients with noncardiac chest pain

Patients with Chagas' disease often have chest pain as a prominent symptom. The objective of this study was to compare the results of intraesophageal balloon distension in chagasic and nonchagasic patients with chest pain not caused by coronary obstruction. We studied 40 patients with chest pain and angiographically normal coronary arteries, 25 with a positive serologic test for Chagas' disease (Chagas group, 16 women, mean age 53+/-10 years), and 15 with a negative serologic test (control group, 11 women, mean age 46+/-10 years). All patients had radiologic and endoscopic examinations of esophagus, stomach, and duodenum, esophageal manometry with the acid infusion test in the distal esophagus, and intraesophageal balloon distension. None of them had esophageal dilation or any signs of cardiovascular disease. A 25-mm-long latex balloon located 10 cm above the lower esophageal sphincter was inflated and deflated over a period of 10 sec at 1-ml increments of air until the subjects reported chest pain or to a maximum volume of 20 mi. The test caused chest pain in 14 subjects in the control group (93%) and in 12 in the Chagas' disease group (48%, P < 0.05). The mean volume of air that caused chest pain was 10+/-3 ml in the control group and 15+/-4 ml in the Chagas' disease group (mean+/-SD, P < 0.05). The maximum intraesophageal pressure during the examination was higher in Chagas' disease patients with chest pain during balloon distension (60 +/- 21 mm Hg) than in patients who did not have chest pain (37 +/-18 mm Hg, P < 0.05) and did not differ from the control group (48+/-16 mm Hg, P > 0.05). With the other examinations there was no difference between groups or between patients with or without chest pain during the balloon distension test. Although esophagitis was observed in 47% of patients in the control group and in 40% of the Chagas' disease group, the acid infusion test was positive in 27% of patients in the control group and in 4% of patients in the Chagas' disease group. We conclude that, as compared to a group of patients with similar chest pain, chagasic patients are less sensitive to esophageal distension. Thus, it is unlikely that their chest pain is related to esophageal mechanisms.     

Newly-developed catheter for cardio-renal assist during intraaortic balloon counterpulsation

A new catheter was developed for the cardio-renal assist during intra-aortic balloon counterpulsation. The catheter consists of both a large balloon of conventional IAB (TMP balloon) located at the distal end of the catheter and an additional small balloon 10 cm distant from the large balloon with common lumen and single shaft. Experimental study was carried out in the mock circulatory system simulating the descending aorta employing a conventional IAB catheter as a control. It was demonstrated that the flow in the mid portion between both balloons could be increased maximally by as much as 28% of that of the control under the continuous flow and 214% under the pulsatile flow. The double balloon catheter was considered to improve the renal perfusion as well as the coronary perfusion.     

Coronary-artery stenting compared with balloon angioplasty for restenosis after initial balloon angioplasty. Restenosis Stent Study Group

BACKGROUND: Intracoronary stenting reduces the rate of restenosis after angioplasty in patients with new coronary lesions. We conducted a prospective, randomized, multicenter study to determine whether intracoronary stenting, as compared with standard balloon angioplasty, reduces the recurrence of luminal narrowing in restenotic lesions. METHODS: A total of 383 patients who had undergone at least one balloon angioplasty and who had clinical and angiographic evidence of restenosis after the procedure were randomly assigned to undergo standard balloon angioplasty (192 patients) or intracoronary stenting with a Palmaz-Schatz stent (191 patients). The primary end point was angiographic evidence of restenosis (defined as stenosis of more than 50 percent of the luminal diameter) at six months. The secondary end points were death, Q-wave myocardial infarction, bypass surgery, and revascularization of the target vessel. RESULTS: The rate of restenosis was significantly higher in the angioplasty group than in the stent group (32 percent as compared with 18 percent, P= 0.03). Revascularization of the target vessel at six months was required in 27 percent of the angioplasty group but in only 10 percent of the stent group (P=0.001). This difference resulted from a smaller mean (+/-SD) minimal luminal diameter in the angioplasty group (1.85+/-0.56 mm) than in the stent group (2.04+/-0.66 mm), with a mean difference of 0.19 mm (P=0.01) at follow-up. Subacute thrombosis occurred in 0.6 percent of the angioplasty group and in 3.9 percent of the stent group. The rate of event-free survival at 250 days was 72 percent in the angioplasty group and 84 percent in the stent group (P=0.04). CONCLUSIONS: Elective coronary stenting was effective in the treatment of restenosis after balloon angioplasty. Stenting resulted in a lower rate of recurrent stenosis despite a higher incidence of subacute thrombosis.     

Dissection of the aorta complicating intra-aortic balloon counterpulsation

A 61-year-old man with recent myocardial infarction complicated by a ventricular aneurysm and recurrent ventricular tachycardia underwent intra-aortic balloon counterpulsation prior to angiography and left ventricular aneurysmectomy. A dissecting aneurysm of the descending aorta adjacent to the position of the balloon catheter was found at autopsy. No intimal tear or cystic medial degeneration of the aorta was present to account for the dissection. The authors suggest that lateral and shearing forces generated by inflation of the balloon could result in dissection of the aorta.     

Endoscopic treatment of oesophagoairway fistula with oesophageal balloon prosthesis

OBJECTIVE: To describe our experience with a cuffed oesophageal prosthesis in the management of malignant oesophagoairway fistulas. DESIGN: Retrospective study. SETTING: Teaching hospital, Denmark. SUBJECTS: Nine patients treated with a balloon cuffed oesophageal prosthesis during the period 1987-93. MAIN OUTCOME MEASURES: Endoscopic assessment of the fistula compared with the results and complications of treatment. RESULTS: The prosthesis were inserted without complications. Eight patients had total relief of aspiration and were able to eat a semisolid diet. Three patients needed reintervention. Patients with little or no stenosis of the tumour seemed to be at considerable risk of dislodgement of the tube and those with large fistulas developed protrusion of the balloon into the tracheal lumen. CONCLUSION: Intubation with the cuffed oesophageal prosthesis is safe and relatively inexpensive. Other treatments should be considered in patients with minor stenosis of the tumour or a large fistula.     

Pneumatic balloon dilation in achalasia: a prospective comparison of balloon distention time

OBJECTIVE: Duration of Inflation in pneumatic balloon dilatation as treatment of achalasia has been variable ranging from 15 s to 6 min. A 60 s duration appears to be most often used. We compared the efficacy of dilation of achalasia with either 6- or 60-s inflation duration using a Rigiflex dilator of 3.0 cm diameter. METHODS: Eighty-one consecutive patients were prospectively studied in a randomized fashion, 41 in the 60-s group (A) and 40 patients in the 6-s group (B). Mean age of group A was 43 +/- 16.2 yr and of group B was 40 +/- 16.4 yr. Symptoms of dysphagia, chest pain, heartburn, regurgitation, and night cough were evaluated at basal (before dilation), 1- and 6-month intervals after dilation in both groups. Barium swallow was done to assess esophageal emptying 1 wk before dilation and 5 min postdilation in both groups. RESULTS: Significant and sustained improvement was seen for all symptoms in both groups. In addition, the degree of improvement in symptom scores between the two groups was similar. Barium esophagram in both groups at basal and immediately postdilation showed significant improvement in barium emptying but there was no significant difference between the two groups, indicative of equal efficacy in both distention times. Two patients needed repeat dilatation in group A and one in group B, with one drop out from group A, who was lost to follow-up, and was excluded from the analysis. No perforation occurred. CONCLUSION: Short duration of pneumatic balloon dilatation (6-s) is as effective as longer duration (60-s) in treatment of achalasia.     

Endoscopic treatment of choledocholithiasis in patients with Billroth II gastrectomy by dilatation with papillary balloon

Two patients with Billroth II gastrectomy and choledocholithiasis are presented. Treatment with endoscopic retrograde cholangiography and dilatation with papillary balloon allowed lithiasis extraction. The evolution following the procedure was favorable with no complications being observed. The advantages and disadvantages of papillary balloon dilatation in comparison with endoscopic sphincterotomy are reviewed.     

Comparison of primary coronary stenting to primary balloon angioplasty with stent bailout for the treatment of patients with acute myocardial infarction

This study compares the immediate and long-term outcomes of a primary coronary stenting strategy with primary balloon angioplasty with stent bailout in the treatment of patients with acute myocardial infarction (AMI). One hundred forty-seven consecutive patients who underwent primary balloon angioplasty with stent bailout (n = 94) or primary stenting (n = 53) for AMI were clinically followed for 8.1 +/- 5.7 and 8.5 +/- 4.5 months, respectively. Immediate results, as well as in-hospital and long-term ischemic events (death, reinfarction, and repeat revascularization) were compared between both groups. Angiographic success was 91.5% in the balloon angioplasty group and 94% in the stent group. In-hospital and late follow-up combined ischemic events were 22 of 94 (23%) versus 0 of 53 (0%); p < 0.001 and 33 of 78 (42%) versus 13 of 53 (25%), p = 0.04 for the balloon angioplasty and stent groups, respectively. At 6 months, the cumulative probability of repeat target lesion revascularization was higher in the balloon angioplasty group (47% vs 18%, p = 0.0006) as was the probability of late target revascularization (36% vs 18%, p = 0.046); the cumulative event-free survival after 6 months was significantly lower in the balloon angioplasty group (44% vs 80%, p = 0.0001). This study demonstrates that a primary stent placement strategy in patients with AMI is safe, feasible, and superior to primary balloon angioplasty with stent bailout. Primary stenting results in a larger postprocedural minimal luminal diameter, a lower early and late recurrent ischemic event rate, and a lower incidence of target lesion revascularization at follow-up.