Need for secondary interventions after endovascular repair of abdominal aortic aneurysms. Intermediate-term follow-up results of a European collaborative registry (EUROSTAR).

BACKGROUND: The frequency of secondary interventions after endovascular repair of abdominal aortic aneurysms (AAAs) was assessed and correlated with findings at clinical and imaging examination during follow-up. METHODS: Data were studied from 1023 patients with a follow-up of 12 months or longer, collected by 56 institutions in a multicentre data registry (EUROSTAR). Surveillance data were provided by the centres between September 1996 and November 1999. RESULTS: Overall, 186 patients (18 per cent) had a secondary intervention occurring a mean of 14 months after the initial endograft procedure. Twelve per cent of the interventions were transabdominal, 11 per cent consisted of an extra-anatomic bypass and 76 per cent involved a transfemoral procedure. The rates of freedom from intervention at 1, 3 and 4 years were 89, 67 and 62 per cent respectively. Migration (relative risk (RR) 8.9) and rupture (RR 22.6) were the most frequent causes of secondary transabdominal interventions. Graft limb thrombosis was the principal indication for extra-anatomic bypass (RR 37.5 for clinical evidence of graft limb thrombosis). Endoleak, graft kinking, stenosis or thrombosis and device migration were significant causes for secondary transfemoral interventions (RR 2.5-6.9). CONCLUSION: The high incidence of late secondary interventions is a cause for concern with regard to broad application of endovascular AAA repair, and emphasizes the need for lifelong surveillance.

Endovascular treatment of an aortic aneurysm ruptured into the inferior vena cava.

PURPOSE: To report the endovascular repair of a rare abdominal aortic aneurysm (AAA) rupture into the inferior vena cava. METHODS AND RESULTS: A 74-year-old man with a 6.0-cm saccular aortic aneurysm and a previously undiagnosed aortocaval fistula of more than 2 weeks' duration was treated successfully with a Vanguard bifurcated stent-graft. The aneurysm was excluded and no endoleak or communication between the aorta and inferior vena cava was seen on computed tomographic imaging at the 6-month evaluation. CONCLUSIONS: Aortic endografting in this life-threatening complication is an effective treatment option that avoids the significant blood loss encountered in conventional repair.

[Intermediate-term complications and problems after endovascular aortic stent prostheses]. / Mittelfristige Komplikationen und Probleme nach endovaskulären Aortenstentprothesen.

From August 1994 to December 1998 321 patients were treated with endovascular stentgrafts for aortic aneurysm exclusion in our hospital. Primary exclusion rate was 91% (primary leakage 8.7%) and hospital mortality was 3.7%. 6 different types of grafts were used, 5 of them commercially available. Midterm complications are due to configuration changes of the grafts, material deterioration, side branch reperfusion and changes in aortic morphology. The common pattern of clinical expression of these complications is secondary leakage (60 cases) and graft limb occlusion (37 occurrences in 30 patients). 50% of the secondary endoleaks have been treated up to now leaving the remaining patients under a thorough follow-up. Graft limb thrombosis was treated in all but three, well compensated, patients. Midterm results of the first commercially available endografts are not yet satisfying in contrast to conventional aortic repair. The recently available grafts are promising as they have a better kink resistance, no graft sutures and fewer modular components.

Time-related alterations in shape, position, and structure of self-expanding, modular aortic stent-grafts: a 4-year single-center follow-up.

PURPOSE: To report the nature and ramifications of structural and positional changes over time in tube and modular bifurcated aortic stent-grafts. METHODS: Two hundred ninety-one patients received endovascular aortic grafts (primarily Stentor/Vanguard) between August 1994 and August 1998. Follow-up surveillance (clinical and laboratory examination, biplanar noncontrast radiography, and contrast-enhanced computed tomography) has been maintained on all patients for 4 years. Changes in the configuration and position of endografts have been noted and their sequelae charted. RESULTS: Three types of endograft shape changes have been documented: mild -- slight distortions visible on plain radiographs (n = 90, 31.0%), significant -- angulations reaching 60 degrees to 90 degrees (n = 65, 22.3%), and severe -- angulations > or = 90 degrees (n = 10, 3.4%). Changes in position never gave rise to late migration at the proximal attachment site, whereas at the distal ends, the endograft easily retracted from the iliac arteries (n = 8). Structural alterations (rupture of the stent frame, sutures, or fabric, and total graft disintegration) were more common in the original Stentor model. Shape, position, and structural alterations were mutually dependent and led to secondary endoleaks (n = 26) and graft limb thrombosis (n = 37). Late surgical conversion was necessary in 3 (1.0%) patients. CONCLUSIONS: Tortuosity of the native vessels is a source of complication in long-term follow-up just as it is during implantation. Given the late appearance of complications in this patient cohort, it would seem that the durability of an endograft cannot be evaluated with < 3 years of follow-up.

Combined surgical and endovascular removal of thrombus entirely occluding a bifurcated aortic stent-graft.

PURPOSE: To explore a method combining interventional, endovascular, and conventional surgical techniques for treating a completely occluded bifurcated stent-graft after endovascular aortic aneurysm repair. METHODS AND RESULTS: A 60-year-old patient underwent endovascular repair of an abdominal aortic aneurysm (AAA) with a Talent bifurcated stent-graft. Five months later, after chronic thrombotic occlusion of the right iliac limb, he presented with acute occlusion of the entire stent-graft. Local intra-arterial infiltration thrombolysis successfully reconstituted flow through the main aortic segment and left iliac limb. With a combination of conventional surgical and intraoperative endovascular procedures, thrombectomy and recanalization of the right iliac limb was completed by stenting a severe stenosis of the proximal iliac limb. CONCLUSIONS: A combination of techniques may be essential for successful management of thrombotic complications after endovascular AAA repair.

A method for adjusting a malpositioned bifurcated aortic endograft.

PURPOSE: To report the successful application of a method to adjust a malpositioned bifurcated stent-graft after endovascular aortic aneurysm repair. METHOD AND RESULTS: A 62-year-old male patient underwent endovascular repair of a 5.1-cm abdominal aortic aneurysm (AAA) with a Vanguard bifurcated stent-graft. After complete deployment of the stent-graft, the intraoperative completion angiogram disclosed unexpected occlusion of the left renal artery. Intra-aortic adjustment of the bifurcated graft was possible with a crossover guidewire, which was pulled caudally. The method worked perfectly to restore blood flow to the left renal artery. The patient is well 16 months postoperatively without any evidence of endoleak or graft migration; the left renal artery remains open. CONCLUSIONS: A technique is demonstrated for intra-aortic repositioning of a bifurcated stentgraft to correct insufficient deployment. If required, this technique should be attempted before conversion to an open procedure.

Evaluation of endovascular abdominal aortic aneurysm repair: anatomical classification, procedural success, clinical assessment, and data collection.

PURPOSE: To detail a methodology for evaluation of endovascular abdominal aortic aneurysm (AAA) repair that has been achieved through consensus of an international multidisciplinary team of investigators. METHODS: This schema features an anatomical classification for AAAs, a definition of procedural success, and a procedure for clinical assessment, as well as the necessary data collection forms. Patient data include demographics, procedural and clinical success, complications, and follow-up. Procedural details can be related to anatomic situations, comorbid processes, devices, and effective aneurysmal exclusion. RESULTS: These data would allow assessment of the procedures, physician learning curves, procedural indications, techniques, methodologies, the relationship of indications to success and complications, devices and subsequent graft patency, and aneurysmal exclusion. CONCLUSIONS: The use of this standardized data collection system could enable physicians and industry to better understand endovascular AAA repair and ultimately improve patient care.

[Difficulties and complications in transfemoral implantation of stent prostheses in infrarenal abdominal aortic aneurysms]. / Schwierigkeiten und Komplikationen der transfemoralen Implantation von Stent-Prothesen beim infrarenalen Bauchaortenaneurysma (BAA).

Between August 31st, 1994 and January 31st 1996, 69 patients received transfemoral application of stentgrafts for treatment of AAA. Only 10 patients received tube grafts in contrast to 59 bifurcated grafts, which were assembled within the aortic lumen. All aneurysms were symptomatic, growing or sacciform. Risk factors seemed to be aggravated in comparison to conventional operations. 59 operations were technically successful, three were converted to open laparotomy, because of technical malfunction twice and misplacement once. 5 postoperative deaths occurred from multiorgan failure. 7 patients were discharged with primary persisting leakage. All patients exhibited reactions to the stentgraft deployment, which mainly referred to the clotting system and/or arterial pressure. Postoperatively nearly all patients presented a "post-implantation syndrome" over days up to 4 weeks. The observed difficulties and complications can be attributed in part to a "learning curve", in part to difficult anatomic situations, which we included in our series. During follow up at 3, 6 and 12 months 7 secondary leakages were observed, three times because of a documented desintegration, once because of suspected beginning desintegration at a stent-graft junction, and three times because of possible failure of graft material. The leakages could be repaired by interventional procedures.

[Laparoscopic cholecystectomy: a prospective study of 1,775 unselected patients]. / Laparoskopische Cholezystektomie: eine prospektive Studie an 1775 unselektierten Patienten.

1775 patients with symptomatic cholecystolithiasis were treated by laparoscopic cholecystectomy without selection or contraindications. Complications should be compared with those of conventional cholecystectomy. 73.5% of our patients were female, the median age was 62 years (min. 9, max. 91 years). They presented uncomplicated cholecystolithiasis in 85%, acute cholecystitis in 11% and cirrhotic gallbladder in 4.5%. The rate of conversion to laparotomy was 2.9% for uncomplicated cholecystolithiasis and 11% for each cholecystitis and cirrhotic gallbladders. In general 4.4% were converted. These conversions were due to complications in 0.9% (bile duct lesions 0.7%, bowel perforation 0.2%), due to adhesions or inflammatory alterations in 3%. Perioperative letality was 0.3%, but only 0.15% were related directly to the operation. Other complications were bile duct strictures 0.3%, postoperative hemorrhage 0.3%, ileus 0.2%, perforation of diaphragm/pneumothorax 0.1%. Suspected bile duct stones were proved and treated by preoperative ERCP in 5.6%. Routinely performed intraoperative cholangiography detected unsuspected stones in 4%. These were removed mostly by postoperative ERCP. We consider laparoscopic cholecystectomy a safe method for the treatment of every stage of symptomatic cholecystolithiasis. There are no contraindications, if the operation is performed by an experienced team. Intraoperative cholangiography should remain standard. Complications in unselected patients are comparable to those of conventional cholecystectomy. The rate of bile duct lesions is equal (0.7%), a further decrease is expected (learning curve). According to this data, it is no longer justified, to perform cholecystectomy primarily by laparotomy, if there is experience with the laparoscopic method. Laparotomy by itself is no complication, it should be applied only, if the surgeon considers the operation inadequate to be continued laparoscopically.

[Laparoscopic selective vagotomy (posterior truncal vagotomy and anterior linear stomach resection) in complicated duodenal ulcer]. / Laparoskopische selektive Vagotomie (hintere trunkuläre Vagotomie und vordere lineare Magenresektion) beim komplizierten Ulcus Duodeni.

32 patients with complicated duodenal ulcer (bleeding, recurrence, perforation) were treated by laparoscopic posterior truncal vagotomy and anterior linear gastric resection in our modification (access to the posterior vagus via the omental bursa) of the method of Gomez-Ferrer/Taylor. Instead of the seromyotomy along the lesser curve we resect a 1 cm broad strip out of the anterior gastric wall. In one patient with additional hiatus hernia the anterior vagal trunc was cut accidentally. Converted to laparotomy this case was completed as truncal vagotomy and pyloroplasty. No disorders of postoperative gastric emptying were found. 17 patients were followed up 6 weeks postoperatively. 14 showed complete healing of the ulcer, 2 patients showed healing in progress. A follow up after 12 months obtained information about 18 patients: 7 were free of symptoms, 11 complained about intermittent pains or fullness. 8 of these 11 patients were controlled by gastroscopy, not any ulcer or gastritis or disorder of gastric emptying could be found. We see advantages of our method over Kathkouda's modification of Taylor's procedure in the simplicity of the method, the primary hemostasis and a short operating time by using the stapler. We consider our procedure a minimal invasive, quick, safe treatment for duodenal ulcer disease with lasting effect at reasonable cost, especially in complicated cases like recurrent ulcer, bleeding or penetrating ulcer and in noncompliant patients that are not suitable for medical treatment.

Pharmacokinetics, metabolism and biliary and urinary excretion of oral ramipril in man.

In order to evaluate the pharmacokinetics and excretion of ramipril in man, 8 cholecystectomy patients aged between 53 and 68 years received 5 mg ramipril orally as a single dose. All patients had a T-drain inserted to permit bile collection; all gave their informed consent to participate in the trial. Serum samples were collected half-hourly until 2 hours, then hourly until 6 hours, then at 8, 10, 24 and 25 hours after intake. Urine was collected in 2-hour fractions until 8 hours, followed by a 4- and a 12-hour fraction. Bile was collected hourly until 6 hours, followed by a 6- and a 12-hour collecting fraction. Concentrations of ramipril and ramiprilat in serum, and determinations in urine and bile of ramipril, ramiprilat, ramipril glucuronide, ramiprilat glucuronide, diketopiperazine and diketopiperazine acid were made; total amounts excreted were calculated. Peak concentrations of ramiprilat in plasma (8.7 +/- 1.6 ng/ml) were reached after about 8 hours. AUC0-8 and AUC0-24-values were 36.5 and 111.9 ng.h/ml, respectively. Ramiprilat Cmax-concentrations were about 300-fold higher in bile than in plasma, the corresponding difference for ramipril between bile and plasma was about 4-fold. The main fractions excreted in the urine were diketopiperazine acid and ramiprilat amounting to 13.2 +/- 5.6 and 4.4 +/- 2.4%, respectively, of the dose administered. Only a very small fraction of the dose was excreted with urine as unchanged ramipril, on average 0.9 +/- 1.0%. The main fractions excreted in the bile were diketopiperazine acid, ramiprilat glucuronide and diketopiperazine, 9.0 +/- 5.3, 3.4 +/- 4.2 and 2.0 +/- 1.2% in 24 hours, respectively, of the dose administered. Only a negligible fraction of the dose (average 0.1 +/- 0.1%) was excreted with bile as unchanged ramipril. In conclusion, there is strong evidence that circulating ramipril and ramiprilat are eliminated by both the liver and the kidneys. For the patients studied it can be estimated from late collection periods that some 2/3 of circulating ramipril and ramiprilat are eliminated by the kidneys and 1/3 eliminated by the liver.

Preliminary results of biliary excretion of ramipril after T-drainage in cholecystectomy patients.

Four cholecystectomy patients, aged between 52 and 56 years, weighing between 64 and 90 kg, received 5 mg of ramipril as a single dose in order to investigate the pharmacokinetics and excretion pattern of ramipril. All patients had a T-drainage that allowed bile collection. Serum was collected at regular intervals, bile was collected hourly for 6 h followed by a 6- and 12-h fraction, and urine was collected every 2 h for 8 h followed by a 4- and 12-h fraction. The concentrations of ramipril and ramiprilat in serum and ramipril, ramiprilat, ramipril glucuronide, ramiprilat glucuronide, diketopiperazine, and diketopiperazine acid in bile and urine were determined and the amounts excreted in urine and bile over 24 h were calculated. There were great interindividual differences in maximum concentrations as well as in the time to reach maximum concentrations in plasma and bile as well as in the excretion pattern between urine and bile. The highest concentrations in bile were found for diketopiperazine acid (3,080 ng/ml) and ramipril glucuronide (2,414 ng/ml). In general, only minimal amounts of unchanged ramipril (prodrug) were detected in the bile. In the urine, the major metabolites excreted were diketopiperazine acid, ramiprilat, and diketopiperazine in amounts of 537, 188, and 124 micrograms, respectively. In bile, the main substances excreted were diketopiperazine acid and ramiprilat glucuronide, which amounted to 501 and 314 micrograms, respectively. Biliary excretion may be the explanation for the noncomplete urinary recovery of ramipril and its metabolites.

[Aneurysm of the abdominal aorta. Results of surgical therapy]. / Bauchaortenaneurysma. Ergebnisse der chirurgischen Therapie.

According to experiences in treating more than 400 patients with abdominal aortic aneurysms (AAA) following statements can be made: 1. Diagnosis of an AAA is identical with indication for surgical treatment. Only in cases of extremely high operative risk (aggravating organ deficiencies especially of heart and lungs) an expectant attitude is justified. 2. Preoperative angiography is considered to be desirable. 3. Rupture of the aneurysm depends on size and form, but small sized aneurysms can rupture as well. 4. It is of advantage to have the patients prepared preoperatively for several days for minimizing the operative risk. 5. Long follow-up results are good, the operation is able to prolong life expectancy of these patients.