Preliminary results of the Austrian National Registry regarding the novel iCover bridging stent graft in fenestrated endovascular aortic repair.

OBJECTIVE: Bridging stentgrafts (BSGs) are one of the primary limiting factors regarding long-term results after fenestrated endovascular aortic repair (fEVAR). This study aims to report for the first time the outcome of a novel BSG called iCover from a national, multicentric retrospective database. METHODS: A cohort of 58 patients received 212 BSGs for the renovisceral arteries in fEVAR. Patients were followed-up clinically and with computed-tomography angiography. Study end points were mortality, occurrence of complications, technical success of the BSG implantation, defined as successful deployment with vessel patency and absence of type 1c, 3b, and 3c endoleak, and stability over the follow-up. RESULTS: Three BSG unrelated mortalities (5.1 %), four BSG unrelated major complications (6.8 %) and five minor complications (8.6 %) occurred. The technical success of iCover was 207/212 (97.6 %), target vessel patency was 100 % over a follow-up of 4.0 months, and no late BSG related endoleak was detected. In two cases, the BSG was dislodged from the balloon and could be parked in a safe position without further sequelae (0.9 %). CONCLUSION: The iCover represents a feasible BSG for fEVAR with an excellent safety profile and technical success rate in the early phase. Prudent post-dilatation and monitoring of the proximal and distal stent ends can potentially further improve outcome. Longer follow-up series are necessary.

The Randomized Freeway Stent Study: Drug-Eluting Balloons Outperform Standard Balloon Angioplasty for Postdilatation of Nitinol Stents in the SFA and PI Segment.

PURPOSE: The prospective randomized multicenter Freeway study evaluated the possible hemodynamic and clinical benefits of primary stent insertion followed by percutaneous transluminal angioplasty (PTA) with drug-eluting balloons (DEB) over post-stent insertion PTA with standard balloons in the treatment of symptomatic femoropopliteal arteriosclerotic lesions. METHODS: In total, 204 patients in 13 centers in Germany and Austria were enrolled and randomized to primary stenting followed by either FREEWAY™ drug-eluting balloon or standard PTA balloon angioplasty. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 6 months; the secondary endpoints include TLR rate at 12 months and primary patency, shift in Rutherford classification, ankle-brachial index (ABI) and major adverse events (MAE) at 6 and 12 months. Lesion characteristics and vessel patency were analyzed by an independent and blinded corelab. RESULTS: At 6-month and 12-month follow-up, TLR rate was lower in the DEB arm compared to standard PTA but did not reach statistical significance (4.1% vs. 9.0% p = 0.234 and 7.9% vs. 17.7% p = 0.064, respectively). Primary patency was significantly better for patients treated with the DEB at 6 months (90.3% vs. 69.8% p = 0.001) and 12 months (77.4% vs. 61.0% p = 0.027). Improvement in Rutherford classifications was likewise significantly better for patients in the DEB group at 6 (94.9% vs. 84.3% p = 0.027) and 12 months (95.5% vs. 79.9% p = 0.003). The percentage of patients with an improved ABI of 1.0-1.2 was significantly higher in the DEB group compared to the PTA group at 6 months (55.3% vs. 35.3%; p = 0.015) but without significant difference at 12 months (48.2% vs. 32.9%; p = 0.055). At 6 months, rate of major adverse events (MAE) was 1% in both arms, and at 12 months 2.2% for the DEB and 3.8% for the PTA group. CONCLUSION: The Freeway Stent Study shows that the usage of DEB as a restenosis prophylaxis seems to be safe and feasible. The 12-month follow-up results give a clear sign in favor of the DEB group.

Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: the VIASTAR trial.

PURPOSE: The hypothesis that covered stents are superior to bare-metal stents (BMS) in long femoropopliteal artery disease was tested. The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol (TPP) analysis only. METHODS: A prospective, randomized, single-blind, multicenter study evaluated 141 patients with symptomatic peripheral arterial disease (PAD) after treatment with heparin-bonded covered stents (VIABAHN(®) Endoprosthesis) or BMS. Clinical outcomes and patency rates were assessed at 1, 6, 12, and 24 months. Mean lesion length was 19.0 ± 6.3 cm in the VIABAHN(®) versus 17.3 ± 6.6 cm in the BMS group. RESULTS: The 24-month primary patency rates in the VIABAHN(®) and BMS group were: intention-to-treat 63.1 (95 % CI 0.52-0.76) versus 41.2 % (95 % CI 0.29-0.57; log rank p = 0.04) and TPP 69.4 (95 % CI 0.58-0.83) versus 40.0 % (95 % CI 0.28-0.56; log rank p = 0.004). Freedom from target-lesion-revascularization (TLR) was 79.4 (95 % CI 0.70-0.90) versus 73.0 % (95 % CI 0.63-0.85) for VIABAHN(®) versus BMS (log rank p = 0.37). For the TPP group in lesions ≥20 cm, the 24-month patency rates were 65.2 (95 % CI 0.50-0.85) versus 26.7 % (95 % CI 0.12-0.59; log rank p = 0.004) for VIABAHN(®) versus BMS, and freedom from TLR was 80.0 (95 % CI 0.68-0.94) versus 61.9 % (95 % CI 0.44-0.87; log rank p = 0.13). The ankle brachial index was 0.89 ± 0.18 versus 0.91 ± 0.17 (p = 0.76) at 24-month in the VIABAHN(®) versus the BMS group, respectively. CONCLUSION: At 24-month, this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS, however, without a significant impact on clinical outcomes and TLR rate (Reg. Nr. ISRCTN48164244).

Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease).

OBJECTIVES: The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than bare-metal stents (BMS) in long femoropopliteal artery disease was tested. BACKGROUND: Although endovascular treatment of short superficial femoral artery lesions revealed excellent results, efficacy in long lesions remains unsatisfactory. METHODS: In a prospective, randomized, single-blind, multicenter study, 141 patients with symptomatic peripheral arterial disease were assigned to treatment with heparin-bonded, covered stents (Viabahn 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months. RESULTS: Mean ± SD lesion length was 19.0 ± 6.3 cm in the Viabahn group and 17.3 ± 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4%. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9% (95% confidence interval [CI]: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p = 0.11); treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23 [95% CI: 1.14 to 4.34) (log-rank test p = 0.009). In lesions ≥20 cm, (TransAtlantic Inter-Society Consensus class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p = 0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p = 0.004). Freedom from target lesion revascularization was 84.6% for Viabahn (95% CI: 0.72 to 0.91) versus 77.0% for BMS (95% CI: 0.63 to 0.85; p = 0.37). The ankle-brachial index in the Viabahn group significantly increased to 0.94 ± 0.23 compared with the BMS group (0.85 ± 0.23; p < 0.05) at 12 months. CONCLUSIONS: This randomized trial in symptomatic patients with peripheral arterial disease who underwent endovascular treatment for long femoropopliteal lesions demonstrated significant clinical and patency benefits for heparin-bonded covered stents compared with BMS in lesions ≥20 cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which was flawed by major protocol deviations in 8.5% of the patients, the difference was not significant. (GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease; ISRCTN48164244).

Asymptomatic cerebral lesions during pulmonary vein isolation under uninterrupted oral anticoagulation.

AIMS: Left atrial radiofrequency ablation has been shown to carry a risk of asymptomatic cerebral lesions. No data exist in patients under continued oral anticoagulation during the ablation procedure. The aim of this study was to quantify the amount of silent cerebral lesions assessed by pre-procedural and post-procedural magnetic resonance imaging (MRI) in patients under therapeutic international normalized ratio (INR) and to identify clinical or procedural parameters that correlate with cerebral embolism. METHODS AND RESULTS: A total of 131 consecutive patients undergoing catheter ablation for paroxysmal (n = 80, 61.1%) or persistent (n = 51, 38.9%) atrial fibrillation were included in the study. Pulmonary vein antrum isolation (PVI), roofline, mitral isthmus line, and complex fractionated atrial electrogram (CFAE) ablation using 3.5 mm open-irrigated tip catheters were performed, as needed. All patients underwent pre-procedural and post-procedural cerebral MRI. Post-procedural MRI revealed new embolic lesions in 16 patients (12.2%), all of them asymptomatic. Clinical parameters showing a significant correlation with cerebral embolism in univariate analysis were age (P = 0.027), persistent atrial fibrillation (vs. paroxysmal; P = 0.039), and spontaneous echo contrast in transesophageal echocardiography (P = 0.029). Significant procedural parameters were electric cardioversion (P = 0.041), PVI only (P = 0.008), and ablation of complex atrial electrograms (P = 0.005). Independent risk factors in multivariate analysis were age (P = 0.009), spontaneous echo contrast (P = 0.029) and CFAE ablation (P = 0.006). CONCLUSION: Radiofrequency ablation in patients under continued oral therapeutic anticoagulation is associated with a substantial risk of silent embolism detected by cerebral MRI. Therefore, continuation of oral anticoagulation is not able to prevent cerebral embolism. A variety of different clinical and procedural factors seem to contribute to the risk of cerebral lesions.

Anastomotic pseudoaneurysms after surgical reconstruction: outcomes after endovascular repair of symptomatic versus asymptomatic patients.

PURPOSE: To compare perioperative and follow-up outcomes of symptomatic versus asymptomatic patients following endovascular repair of anastomotic pseudoaneurysms (APAs) of the abdominal aorta and iliac arteries. METHODS: We retrospectively evaluated 17 patients (two women), with a mean age of 66.2 years (range 30-83 years). Endovascular treatment was performed in ten symptomatic, and seven asymptomatic patients electively. Data included technical success, perioperative (within 30 days) mortality and morbidity, as well as stent graft-related complications, reinterventions, and survival in follow-up. RESULTS: Bifurcated (n = 13), aortomonoiliac (n = 3) endoprosthesis and one aortic cuff were implanted with a primary technical success rate of 100%. The overall in-hospital mortality and morbidity rate was 11.8% and 35.3%. The mean survival was 36.5 (range 0-111) months. There was a clear trend toward a lower overall survival within hospital and at one and three years for symptomatic patients compared to asymptomatic patients. (47.7 (CI: 0-138.8) versus 52.6 (CI: 28.5-76.8) months (p = 0.274)). During follow-up, late stent graft related complications were observed in six patients (35.3%) necessitating eight endovascular reinterventions. Additional three patients with primary fistulas between the APA and the intestine were treated by late surgical revision. CONCLUSION: Endovascular therapy of APAs represents a considerable alternative to open surgical repair. Short proximal anchoring zones still pose a risk for endoleaks and unintentional overstenting of side branches with commercially available devices, but this might be overcome by use of fenestrated and branched stent grafts in elective cases.

Austrian Joint ÖGGH-ÖGIR-ÖGHO-ASSO position statement on the use of transarterial chemoembolization (TACE) in hepatocellular carcinoma.

Transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) is one of the most frequently applied standard treatments for this disease. The role for TACE is fairly well defined within the most widely used treatment algorithm for HCC, die Barcelona Clinic Liver Cancer (BCLC) staging system and treatment algorithm. But no general treatment algorithm will go into the technical details of any procedure and several patients will not fit ideally into the patient groups predefined in BCLC or any other treatment algorithm. Furthermore, indications and contraindications sometimes are viewed differently by the various medical specialties involved in taking care of such patients. We present here the joint expert position statement of the Austrian Societies of Gastroenterology and Hepatology (ÖGGH), Interventional Radiology (ÖGIR), Hematology and Oncology (ÖGHO), and Surgical Oncology (ASSO) on the technical aspects, indications, and contraindication for the use of TACE in the management of HCC.

Carotid stent fracture: diagnosis and management.

With increasing numbers of carotid stent implantations, stent fractures likely will be detected in this vessel region. The authors report two cases of stent fracture: one balloon expandable and one self expandable stent fractured and caused symptoms. CT angiography identified the stent fractures. One partial stent fracture in the internal carotid artery caused a significant restenosis. One complete stent fracture in the common carotid artery caused neurological symptoms, but no significant restenosis. Computerized tomographic angiography (CTA) findings were confirmed by conventional angiography and treated by repeated stent implantation. In a 12-month follow-up period, both patients remained further neurologically asymptomatic and there was no restenosis in duplex sonography or CTA.

Partial nephrectomy using renal artery perfusion for cold ischemia: functional and oncologic outcomes.

PURPOSE: We present our series on the safety and long-term oncologic and functional outcomes of laparoscopic partial nephrectomy using renal artery perfusion for cold ischemia. PATIENTS AND METHODS: Of 94 patients who underwent laparoscopic partial nephrectomy at our center between August 2000 and September 2006, 28 procedures were performed using cold ischemia and are included in this review. Mean age was 57.8 years (range 22-80 yrs). Mean tumor size was 2.67 cm (range 1.5-5 cm). Five patients had an imperative indication for partial nephrectomy. Eight tumors were hilar. Cold ischemia was achieved through renal artery catheterization followed by intraoperative artery clamping and perfusion with 4 degrees C lactated Ringer solution with mannitol. RESULTS: Mean ischemia time was 40.8 min (range 25-101 min). Mean estimated blood loss was 241 mL (range 50-1000 mL). Three patients underwent conversion to open surgery, but their procedures were still completed under cold perfusion. Segmental artery penetration and venous penetration took place in one patient each. Two postoperative complications occurred, including pancreatitis and pulmonary embolism; none were related to the cold perfusion. Oncologic outcome revealed 100% disease-specific survival for 45 months median followup. Functional studies showed a mild decrease in renal creatinine clearance with improvement 1 month after surgery. Nuclear scans showed functional kidney moiety in all but one patient. CONCLUSION: Intraoperative cold ischemia for laparoscopic partial nephrectomy using arterial perfusion is safe and feasible. It constitutes a viable alternative for complex tumors when ischemia time is expected to exceed 30 minutes. We provide proof of principle confirming the protective effect of cold perfusion to prevent parenchymal damage.

Does carotid stent cell design matter?

BACKGROUND AND PURPOSE: Carotid stent cell design has recently been suggested to be a determinant of periprocedural and early postprocedural neurologic complications. We investigated the impact of closed- versus open-cell stent design on neurologic adverse events and mortality after carotid artery stenting. METHODS: We studied 1684 consecutive patients (1010 asymptomatic, 674 symptomatic) from 10 European centers who underwent carotid artery stenting with either closed-cell (n=859, 51%) or open-cell (n=825, 49%) design stents. Rates of transient ischemic attack, stroke, and death on the day of the procedure (acute events) and from day 1 to day 30 after the procedure (subacute events) were analyzed (95% CIs). RESULTS: Combined transient ischemic attack, stroke, or death rates, and stroke or death rates within 30 days of treatment were 6.1% (95% CI, 5.0 to 7.2) and 3.1% (95% CI, 2.3 to 3.9) for the closed-cell design versus 4.1% (95% CI, 3.2 to 5.0) and 2.4% (95% CI, 1.7 to 3.1) for the open-cell design stents (P=0.077, P=0.38), respectively, without significant differences in asymptomatic and symptomatic patients. By propensity-score-adjusted multivariable analysis, the open-cell carotid stent design was not associated with a differential risk for combined acute and subacute neurologic complications compared with closed-cell stents (adjusted odds ratio=0.84, P=0.53). When analyzed separately, the risk for acute events on the day of the procedure (adjusted odds ratio=0.83, P=0.57) and the risk for subacute events at days 1 to 30 (adjusted odds ratio=1.61, P=0.51) also were not significantly different between the groups. CONCLUSIONS: Current data do not support the superiority of a specific carotid stent cell design with respect to neurologic complications, stroke, and mortality risk.

Laparoscopic nephron sparing surgery: evolution in a decade.

OBJECTIVE: To present our experience with laparoscopic nephron sparing surgery (NSS) over a decade. METHODS: Seventy-eight patients underwent NSS since 1994. Two techniques were used-partial nephrectomy without ischemia (group 1) in 29 patients, and with ischemia (group 2) which was in cold or warm ischemia in 24 and 25 patients respectively. The mean tumour size was 1.97 and 2.2 cm in groups 1 and 2 respectively. Renal reconstruction evolved in our hands during this period. We changed many technical details and now we depend more on clips for securing the sutures rather than free hand knotting. RESULTS: The mean operative time was 162 and 216 minutes in groups 1 and 2 respectively. Mean ischemia time for patients with cold and warm ischemia was 44.9 and 33.8 minutes respectively. 3 patients in group 2 were converted to open surgery. Mean blood loss was 254 and 212 ml for group 1 and 2 respectively with two major bleedings in group 2. Minor intra-operative complication occurred in 3 patients, and major and minor postoperative complication in 15 patients. At a mean follow-up of 23.9 and 12.2 months for groups 1 and 2 respectively there was no recurrence. CONCLUSION: Warm and cold ischemia have widened the indications for laparoscopic NSS to more complex tumours and allow renal reconstruction with acceptable complication rate.

Incidence, management, and outcome in significant pulmonary vein stenosis complicating ablation for atrial fibrillation.

This study summarizes our results in diagnosing and treating pulmonary vein stenosis complicating ablation for atrial fibrillation in 6 of 92 patients. Patients with significant pulmonary vein narrowing underwent either dilatation or dilatation plus stenting. Pulmonary vein intervention produced a favorable clinical course over the following 7 +/- 2 months despite significant restenosis in 2 patients.

Laparoscopic partial nephrectomy in cold ischemia: renal artery perfusion.

PURPOSE: Laparoscopic partial nephrectomy represents a feasible option for patients with small renal masses. We describe our initial experience with laparoscopic partial nephrectomy in cold ischemia achieved by renal artery perfusion. MATERIALS AND METHODS: From November 2001 to March 2003 laparoscopic partial nephrectomy in cold ischemia was performed in 15 patients with renal cell carcinoma. Cold ischemia was achieved by continuous perfusion of Ringers lactate at 4C through the renal artery, which was clamped. Tumor excision was performed in a bloodless field with biopsy taken from the tumor bed. The collecting system was repaired if needed. Renal reconstruction was performed by suturing over hemostatic bolsters. RESULTS: All procedures were successfully completed laparoscopically by our new technique. Mean operative time was 185 minutes (range 135 to 220). Mean ischemia time was 40 minutes (range 27 to 101). Estimated mean intraoperative blood loss was 160 ml (range 30 to 650). Entry to the collecting system in 6 patients was repaired intraoperatively. Additional vascular repair was done in 2 patients. There were no significant postoperative complications. Postoperative followup in 8 patients showed that the renal parenchyma was not damaged by the ischemic period. CONCLUSIONS: Our initial experience of incorporating cold ischemia via arterial perfusion into laparoscopic partial nephrectomy shows the feasibility and safety of the technique. We believe that this approach has the potential to make laparoscopic partial nephrectomy for renal cell carcinoma safe and reliable.

Emergency stent-graft placement for impending rupture of the descending thoracic aorta.

PURPOSE: To present initial experience with emergent stent-graft placement for impending rupture of the descending thoracic aorta. CASE REPORTS: Intramural hematoma (IMH) of the descending thoracic aorta was diagnosed by transesophageal echocardiography and computed tomography in 3 patients with acute onset of severe thoracic pain. Because of signs of impending rupture, e.g., pleural effusion, sustained pain, or transadventitial bleeding, the patients underwent emergency stent-graft placement, which was successful in all cases. No procedure-related complications were observed. Follow-up to 18 months has revealed no evidence of endoleak, and all patients remain free of symptoms. CONCLUSIONS: Emergency stent-graft placement may be a promising alternative to conventional surgery in patients with impending aortic rupture due to IMH.