Stent or angioplasty after recanalization of chronic coronary occlusions? (The SARECCO Trial).

This study tests whether stent implantation without anticoagulation after catheter recanalization of coronary occlusions can improve outcome compared with balloon angioplasty alone. One hundred ten patients were randomly assigned to angioplasty alone (no stent group) or stent implantation (stent group) after successful recanalization and balloon angioplasty. The type of stent and angioplasty technique utilized were decided by the operator. The acute procedural success in both groups was 100%. The acute minimal lumen diameter (MLD) was 1.85 +/- 0.44 mm in the no stent group versus 2.54 +/- 0.53 mm in the stent group (p <0.01). The diameter stenosis was 21 +/- 13% versus 3 +/- 14% (p <0.01). This was achieved not only by the stent implantation itself but primarily by a larger maximum balloon diameter in the stent group after stent implantation (3.32 +/- 0.55 mm vs 2.86 +/- 0.4 mm, p <0.05). After 4 months, the MLD was 1.15 +/- 0.73 mm in the no stent group versus 1.81 +/- 0.9 mm in the stent group (p <0.01). The diameter stenosis was 56 +/- 29% versus 34 +/- 28% (p <0.01). After 2 years, event-free survival was 26% in the no stent group and 52% in the stent group (p <0.05). Thus, acute and long-term procedural and angiographic success of stent implantation without anticoagulation after recanalization of total coronary occlusions is superior to that of balloon angioplasty alone. This beneficial effect is mainly the result of the larger balloon diameters, which may be used after stent implantation.

A randomized trial comparing the impact of a nonionic (Iomeprol) versus an ionic (Ioxaglate) low osmolar contrast medium on abrupt vessel closure and ischemic complications after coronary angioplasty.

OBJECTIVES: To assess the effect of nonionic versus ionic contrast media on abrupt vessel closure and major ischemic complications after coronary angioplasty. BACKGROUND: There is a continuous debate about the "thrombogenic potential" of nonionic contrast media. The results of both in vitro and in vivo investigations are incongruent. METHODS: We prospectively evaluated the outcomes of 2,000 patients undergoing percutaneous transluminal coronary angioplasty (PTCA). According to a randomized, double-blind protocol, they received either iomeprol (nonionic; n = 1,001) or ioxaglate (ionic; n = 999). Intracoronary thrombus before PTCA was found more often in the iomeprol group (4.2% vs 2.7%, p = 0.04). No other significant differences between both groups were observed with regard to pre-PTCA clinical and angiographic characteristics. RESULTS: The frequency of reocclusions necessitating repeat angioplasty occurring either in laboratory (2.9% with iomeprol and 3.0% with ioxaglate) or out of laboratory (3.1% vs 4.1%) was not significantly different. The rate of major ischemic complications was also comparable after both contrast media (emergency bypass surgery: 0.8% vs 0.7%, myocardial infarction: 1.8 vs 2.0%, cardiac death during hospital stay: 0.2% vs 0.2%). In the iomeprol group, more patients had dissections post-PTCA (30.2% vs 25.0%, p = 0.01) and more patients received intracoronary stents (31.6% vs 25.7%, p = 0.004). Allergic reactions requiring treatment occurred only in the ioxaglate group (0.0% vs 0.9%, p = 0.002). CONCLUSIONS: The nonionic contrast medium was not associated with a higher rate of abrupt vessel closure requiring repeat angioplasty, or major ischemic events. These data suggest that nonionic contrast media do not increase the risk of thrombotic complications in patients undergoing coronary interventions.

Initial clinical experience with the new EBI (BARD-XT) flexible coronary stent: acute results and follow-up.

The EBI (BARD-XT, C.R. Bard, Murray Hill, NJ) stent is a new radiopaque balloon expandable coronary stent with high resistance to external radial forces. It does not shorten significantly with expansion and allows stent implantation in bifurcation lesions. A total of 28 EBI stents were implanted in 23 lesions in 21 patients. Indications for stent implantation were acute closure in 1, threatened closure in 15, and electively in 7 lesions. In 2 cases, the lesion involved a bifurcation where a stent was implanted in both vessels. All patients received aspirin and ticlopidine. No anticoagulant therapy was given. The stenting procedure was successful in 22 of 23 lesions. No complications occurred with the exception of 1 patient with a thrombotic reocclusion within 1 hr after stent implantation and 1 patient with a temporary occlusion of a side branch. The mean minimal luminal diameter (MLD) increased from 0.74+/-0.46 mm before balloon dilatation to 1.27+/-0.62 mm before stent implantation and 2.32+/-0.57 mm after stent implantation. Percent stenosis decreased from 71+/-19% before angioplasty to 46+/-25% after angioplasty to 5+/-8% after stent implantation. MLD at the time of follow-up angiography after 4 months was 1.98+/-0.77 mm and percent stenosis was 26+/-21%. Restenosis of more than 50% occurred in 2 lesions. In these lesions, a second percutaneous transluminal coronary angioplasty was performed. Advantages of this stent are its flexibility together with an acceptable radial strength as well as enabling radiopacity without obscuring the arterial lumen. Stenting of bifurcation lesions is possible.

Transcatheter closure of patent ductus arteriosus with the Rashkind occluder. Acute results and angiographic follow-up in adults.

We performed catheter closure of a patent ductus arteriosus with a Rashkind occluder in 51 adult patients (aged 14 to 76 years). The diameter of the ductus ranged from 2 to 13 mm (mean 4.5 +/- 2.0 mm), QP:QS from 1.0 to 2.6 (mean 1.6 +/- 0.3). The procedure was successful in 50/51 patients, in one of them at a second attempt. In one patient, the ductus could not be closed even with additional occluders. This patient was sent for surgery. In two patients with a large ductus, two Rashkind umbrellas were implanted simultaneously. Immediately after ductus closure, there was a residual shunt in 40/50 patients decreasing to 26/50 after 20 min. Two of the patients with a residual shunt suffered from haemolysis. In 16 patients, the residual shunt disappeared spontaneously within some months. In 15 patients, additional occluders (a second occluder in 12, a third occluder in one, and a fourth and fifth occluder in another) were implanted during the initial procedure or during follow-up. All patients were followed until angiography proved complete closure of the ductus. At the time of the last follow-up angiogram, the ductus was occluded in 49/50 patients; one patient refused a follow-up angiogram. Ductus occlusion with the Rashkind umbrella can be considered a technique with a high success rate and low rate of complications in adults. However, a residual shunt is not uncommon. Additional occluders have to be implanted in many patients.

Brachial artery approach for transluminal angioplasty of the internal carotid artery.

One possible problem in internal carotid angioplasty is inaccessibility of the lesion due to elongation of the aortic arch, the brachiocephalic trunk, or the carotid artery itself. A new approach to performing angioplasty of the right or left internal carotid artery utilizing the brachial artery was used after failure of the transfemoral approach in 5 lesions (4 patients). The common carotid artery was cannulated with performed 5F catheters. Angioplasty was performed with a conventional balloon dilatation catheter. If required, a Wall stent was implanted to optimize the angiographic result. After failure of the conventional transfemoral technique, the brachial technique permitted successful angioplasty of the ipsilateral internal carotid artery in 4 lesions and the contralateral internal carotid artery in 1 lesion. In 1 patient, a stent was implanted. No complications occurred. The mean stenosis diameter decreased from 77.8 +/- 6.3% to 17.8 +/- 9.1%. Doppler sonography performed 4-6 months later showed no restenosis. The brachial artery approach seems to be a suitable alternative to the femoral technique.

Recanalization of chronic coronary occlusions using a laser wire.

Between August, 1993-December, 1994, recanalization of a chronically occluded coronary artery was attempted in 412 patients, with an overall success rate of 77%. The main reason for failure was subintimal tracking of the guide wire. However, in 13 patients, advancing the guide wire was not possible either subintimally or in the former true lumen. In 8 of these 13 patients with failed conventional recanalization, a second attempt was made using a 0.018" laser wire. The suspected occlusion duration was 6 wk-6 yr, and the occlusion length 6-21 mm. Successful crossing of the occlusion was achieved in 7 of 8 patients. One patient experienced pericardial hematoma without severe clinical consequences. Adjunctive conventional laser angioplasty and/or balloon dilatation led to a residual stenosis of < 50% in 7 patients. The laser wire technique may become an important new method for recanalizing chronic total coronary occlusions in selected patients.

-Occlusion of atrial septal defect with a new occlusive device-. / Verschluss des Vorhofseptumdefektes mit einem neuen Okklusionssystem.

An atrial septum defect was closed with an ASDOS (Babic) occluder in 13 patients aged from 22 to 67 years. The diameters of the ASD ranged from 12 to 36 mm, the left to right shunt from 35% to 70%. With one exception, the occluder could be implanted in all patients. Two patients with an oversized ASD (diameter 31 and 36 mm respectively) had to be operated after 8 h and 2 weeks, respectively. In one patient, a small asymptomatic hemopericardium was detected after 24 h by routine echocardiogram and in another patient a single umbrella arm fracture was noticed by routine x-ray 4 months after the implantation. No further complications occurred. Follow-up is now 3 months to 1 year. With one exception, there was no residual shunt as measured by oximetry.

Transcatheter closure of large atrial septal defects with the Babic system.

An improved 10 Fr version of the atrial septal defect (ASD) occlusion system consisting of two umbrellas for transvenous introduction over the long veno-arterial guide-wire was used to attempt closure in five adult patients with large defects (26-35 mm). The umbrellas are made of nitinol wire frame and a thin membrane of microporous polyurethane. Supported by the metal cannula and guided by selective left atriography, the umbrellas of 45-60 mm were placed individually into the atria and screwed together at the septum level by means of a torquer catheter. Positioning and screwing on, unscrewing, separating, and repositioning the umbrellas up to 17 times were needed to anchor the prosthesis correctly in a patient. The prosthesis could be implanted primarily in all patients (in one at second session). Dislodgement of a 60 mm prosthesis and left atrial perforation with a 55 mm prosthesis required surgery in two patients 8 hours and 2 weeks post procedure, respectively. A single umbrella-arm fracture was noticed in one patient 4 months after the implantation. All five patients were free of symptoms at follow-up after 7-10 months. Transcatheter closure of large ASDs is technically feasible with this system. The morbidity is mainly associated with the implantation of very large umbrellas.

Transcatheter closure of oversized persistent ductus arteriosus by simultaneous delivery of two Rashkind umbrella devices.

Transcatheter closure of persistent ductus arteriosus (PDA) with a diameter of > 9 mm is considered to be impossible or at least difficult with the occlusion systems that are currently available. We report a simple technique for occluding oversized PDAs with two diameter of 13 mm was successfully occluded in a 40-year-old man. Complete closure without residual shunt was documented by echocardiogram and angiogram.

[A simplified catheter technique for the occlusion of a large persistent ductus arteriosus]. / Eine einfache Kathetertechnik zum Verschluss eines grossen Ductus arteriosus persistens.

Transcatheter occlusion of a persistent ductus arteriosus with a diameter of more than 9 mm is considered difficult or impossible with the currently available techniques. Usually, these patients have to be operated. We used a simple technique to occlude a 13-mm ductus using two Rashkind umbrellas introduced simultaneously through the left and right femoral veins. Complete closure was demonstrated by echo- and angiography.

[Long term dilatation after unsuccessful percutaneous transluminal coronary angioplasty]. / Langzeitdilatation bei erfolgloser perkutaner transluminaler Koronarangioplastie.

Between August 1991 and December 1993, a total of 7011 percutaneous transluminal coronary angioplasties (PTCA) were performed. In 24 of them, the acute results were unsatisfactory, an autoperfusion balloon catheter was tolerated without complications and prolonged inflation (30 min to one hour) brought no improvement. In these 24 patients (22 men, two women; mean age 60 [33-81] years) the duration of inflation was, if possible, increased to at least 6 hours. In three patients the inflation had to be terminated after 2 or 4 hours, respectively, because of angina or for technical reasons. In 18 of the 24 patients subsequent angiography demonstrated residual restenosis of less than 50%, with a mean degree of stenosis of 18 +/- 14%. But lasting dilatation was not achieved in 6 patients: occlusion persisted in one and marked residual stenosis in two patients, while stent implantation was required in three. These results indicate that, in case of dissection or acute occlusion with failure after prolonged balloon inflation of 30 to 60 min, extending the duration of inflation to many hours can often produce good results so that stent implantation can be avoided.

[Non-surgical closure of atrial septal defect in adults. Experiences with the Rashkind and the Sideris occluder]. / Nicht-operativer Verschluss des Vorhofseptumdefektes bei Erwachsenen. Erfahrungen mit dem Rashkind- und dem Sideris-Okkluder.

The possibility of closing an atrial septal defect in adults by means of a percutaneously introduced catheter with an umbrella-type occluder was tested in seven consecutive patients with this defect (two men and five women, aged 35 to 69 years). The diameter of the defect (echocardiographic measurement) ranged from 7 to 25 mm, the left to right shunt from 11% to 54% of pulmonary flow and the pulmonary artery pressure from 24/8 to 110/25 mmHg. In one patient no attempt was made to close the defect because of its size (invasively measured: 40 mm). In another patient the method failed. Closure was successful in four of the patients (left to right shunt < 5%), while in a fifth patient a haemodynamically significant residual shunt (38%) remained, but was closed 2 months later with a second occluder. In one of the patients a portion of the device embolized to the pulmonary artery from which it was removed by catheter.--Thus the intervention was successful in five of six patients. This experience suggests that this type of occluder can also be used successfully in adults.

[Severe mechanical hemolysis after incomplete ductus arteriosus closure: implantation of a second Rashkind occluder]. / Schwere mechanische Hämolyse nach inkomplettem Duktusverschluss: Implantation eines zweiten Rashkind-Okkluders.

A 72 year-old female patient with a persistent ductus arteriosus suffered from a severe mechanical hemolysis after incomplete PDA closure with a Rashkind occluder. The residual shunt was closed with a second occluder 2 days later. Hemolysis was stopped immediately; complete closure of the duct was confirmed by color Doppler 6 weeks and 6 months later.

Bone and gallium scans in mastocytosis: correlation with count rates, radiography, and microscopy.

Mastocytosis (urticaria pigmentosa) was proven in a patient suffering from severe back pain. A bone scan showed diffusely increased bone activity. Count rates were also abnormally elevated over several areas of the skeleton. Radiographs were consistent with mastocytosis in bone.

[Vagal tone in symptomatic sinus node dysfunction (author's transl)]. / Rolle des Vagotonus bei der symptomatischen Sinusknotendysfunktion.

Under investigation in this study were the role of vagal tone in symptomatic sinus node dysfunction and the relationship between hypersensitive carotid sinus reflex (HCSR) and sick sinus syndrome (SSS). In 168 symptomatic patients (pts) resting heart rate (HR), maximal corrected sinus node recovery time (CSRTmax) and maximal carotid sinus pressure results (CSPmax) were determined before and after Atropine, 1 mg i.v. (A). According to test results, 103 pts had HCSR (1), 33 had HCSR + SSS (II), 30 pts had isolated SSS (III) and 20 pts with normal test results served as controls (IV). Mean age was the same in groups I--IV (p greater than 0.05). Groups I--III had a HR less than or equal to 60 bpm, rising 31% after A in groups I--IV, but absolute values were below those in group IV. In groups I--III CSP normalized after A and CSRT remained unchanged (p greater than 0.05). We conclude that increased vagal tone plays but one role in groups I--III and the combination HCSR + SSS seems rather frequent. Specific testing clearly separated HCSR from SSS.

[The significance of electrophysiologic findings and clinical course in symptomatic sinus node dysfunction (author's transl)]. / Die Bedeutung elektrophysiologischer Befunde und der klinische Verlauf bei der symptomatischen Sinusknotendysfunktion.

Under investigation in this study were the relationship between hypersensitive carotid sinus reflex (HCSR) and sick sinus snydrome (SSS), the significance of clinical symptomatology versus electrophysiologic test results and the natural course of both syndromes. In 186 symptomatic patients (pts) resting heart rate, maximal corrected sinus node recovery time (CSRTmax) and maximal carotid sinus pressure results (CSPmax) were determined. According to test results, 103 pts had HCSR (I), 33 had HCSR + SSS (II), 30 pts had SSS (III), and 20 pts with normal test results served as controls (IV). Mean age was the same in groups I--IV (p greater than 0.05). Groups I--III had a heart rate less than or equal to 60 bpm. There was no correlation between patients test data and the occurrence of syncopes in each of groups I--III (p greater than 0.05). In 16 pts with SSS, test results remained unchanged 16 months later (p greater than 0.05). More pts (31%) in group II died in a shorter period of time after pacer application (1.4 +/- 1 year) than pts with AV III degrees block (25%, 1.8 +/- 1.6 years) after pacer application. We conclude that the combination HCSR + SSS seems rather frequent. Specific testing separated HCSR from SSS, but failed to predict syncopes and thereby cannot aid in the indication for pacer application. The 16 months prognosis of SSS proved unfavorable. Mortality after pacer application in HCSR + SSS seems less favorable than in AV III degrees block (p less than 0.05), but depends largely on the severity of associated diseases.