Primary Technical Failure Research Articles

Removal of Partially Deployed Supera Stents: Case-Based Review and Technical Considerations

Purpose: Maldeployment of the Supera stent system can result in primary technical failure, inferior primary patency, and poorer patient outcomes. The purpose of this article is to present a case series illustrating the conditions required to perform optimal stent deployment, and if necessary, undertake successful stent removal following maldeployment. Technique: Two key failures of effective Supera deployment are elongation and invagination. Several technical factors should be considered to reduce the risk of maldeployment: aggressive target vessel predilation, the use of multiple fluoroscopic views, slow deployment with controlled forward pressure applied on the delivery device, “sandwich packing” of the stent above and below target lesions, and the “pulling back” of invagination. To successfully retrieve a partially deployed stent, 3 factors should be considered: the percentage of the stent already deployed, the distance from the distal tip of the introducing sheath to the proximal extent of the deployed stent, and the severity of proximal vessel disease. The higher these factors, the greater the risk of stent detachment and failed retrieval. Conclusion: In this series of 6 cases of maldeployment, the removal of a partially deployed Supera stent appeared to be feasible and safe, with success dependent on selected technical and anatomical considerations.

Drug Coated Balloons vs. Conventional Balloon Angioplasty for Bypass Vein Graft stenosis – A Randomized Controlled Trial

Introduction - Stenosis and restenosis are known complications of endovascular treatment of native arteries and bypass vein grafts in peripheral arterial disease (PAD). (1,2) This may lead to loss of the bypass graft, which can be a problem due to the limited availability of autologous vein material. Drug-coated balloons seem to be effective in the treatment of native artery stenosis (3). The biomechanical and anatomical properties of vein grafts differ greatly from native arteries, and less is known about the potential of drug-coated devices in this field. One randomized trial did not demonstrate benefit from use of DCBs over BA in bypass vein grafts. (4) Similar results were observed in a retrospective study comparing BA to DCB in peripheral grafts (5). The aim of this study was to evaluate the effect of drug-coated balloons in the treatment of vein graft stenoses. Design: Single-center, parallel, randomized controlled trial. Block randomized by sealed envelope 1:1. Methods - 60 patients treated for primary or recurrent stenosis in venous bypass grafts were randomized to drug-coated balloon (DCB) (n=30) or standard balloon angioplasty (BA) (n=30). Follow-up was 1 year. Primary outcome measures were target lesion revascularization (TLR) and graft occlusion. Primary assisted patency and secondary patency were also assessed. Results - 57 cases were ultimately included in the study. 3 randomized cases were excluded due to primary technical failure (graft rupture during predilatation and bail-out stenting (N=2), aborted procedure (N=1)). Six patients died during follow-up (DCB 4, BA 2) and one patient underwent major amputation (BA group). 23 patients underwent re-revascularization of the same segment (DCB 10/29, 34.5 % vs. BA 13/28, 46.4 %, p=0.333). The overall TLR-rate at one year was 34.5 % and 46.4 % in the DCB and BA groups respectively (p=0.33). 5/57 (8.8 %) grafts occluded during the follow-up, 1/29 (3.4 %) and 4/28 (14.3 %) in the DCB and BA groups respectively (p=0.36). Secondary patency was 100 % in the DCB group compared to 89.3% in the BA group (p=0.076). In subanalysis including only de novo lesions TLR was significantly lower in grafts that were treated with DCB compared to BA (15 % vs. 18.9 %, P=0.03). Conclusion - There is a trend toward benefit from DCBs in the treatment of graft stenosis; this difference is significant in previously untreated lesions. There has been hesitation towards using drug-coated balloons as a first choice in the treatment of graft stenosis. Our results suggest that this hesitation might be unfounded, especially in de novo lesions. More data is needed to accurately select which lesions will benefit from DCBs. Furthermore; histological studies on paclitaxel uptake and response in the arterialized venous wall are warranted.

Drug-Coated versus Plain Balloon Angioplasty in Bypass Vein Grafts (the DRECOREST I-Study)

Stenosis is a known complication in bypass vein grafts for peripheral arterial disease. The aim of this study was to evaluate the effect of drug-coated balloons (DCBs) in the treatment of vein graft stenoses. DCBs may prevent restenosis in arterial lesions. One small prospective and larger retrospective and registry studies have failed to show benefit from DCBs in vein grafts. Prospective data are scarce. Sixty patients treated for primary or recurrent stenosis in venous bypass grafts were randomized to DCB (n=30) or standard balloon angioplasty (BA) (n=30). Follow-up was 1year. The primary outcome measure was target lesion revascularization (TLR). Secondary outcome measures were assisted primary patency and secondary patency and graft occlusion. Fifty-seven patients were analyzed. Three patients were excluded due to primary technical failure (2 DCB, 1 BA). Overall TLR rate was 34.5% and 46.4% in the DCB and BA groups, respectively (P=0.33). Five (8.8%) grafts occluded during follow-up (1 DCB, 4 BA). Assisted primary patency was 93.1% (DCB) versus 85.7% (BA) (P=0.362) and secondary patency was 100% (DCB) versus 89.3% (BA) (P=0.076). Subgroup analysis showed a significant benefit from DCB in the treatment of primary stenosis (TLR rate 15.0% vs. 18.9%, P=0.03). There was no significant benefit from DCBs for treatment of vein graft stenosis compared to BA, although a trend in favor of DCBs could be seen. ClinicalTrials.govNCT03023098.

A pilot proof-of-concept study of a modified device for one-step endoscopic ultrasound-guided biliary drainage in a new experimental biliary dilatation animal model.

To evaluate the technical feasibility of a modified tapered metal tip and low profile introducer for one-step endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) in a new experimental biliary dilatation porcine model. A novel dedicated device for one-step EUS-guided biliary drainage system (DEUS) introducer has size 3F tapered catheter with size 4F metal tip for simple puncture of the intestinal wall and liver parenchyma without graded dilation. A self-expandable metal stent, consisting of both uncovered and nitinol-covered portions, was preloaded into DEUS introducer. After establishment of a biliary dilatation model using endoscopic hemoclips or band ligation with argon plasma coagulation in 9 mini-pigs, EUS-BD using a DEUS was performed following 19-G needle puncture without the use of fistula dilation devices. One-step EUS-BD was technically successful in seven pigs [7/9 (77.8%) as intention to treat] without the aid of devices for fistula dilation from the high body of stomach or far distal esophagus to the intrahepatic (n = 2) or common hepatic (n = 5) duct. Primary technical failure occurred in two cases that did not show adequate biliary dilatation. In seven pigs with a successful bile duct dilatation, the technical success rate was 100% (7/7 as per protocol). Median procedure time from confirmation of the dilated bile duct to successful placement of a metallic stent was 10 min (IQR; 8.9-18.1). There were no immediate procedure-related complications. Modified tapered metal tip and low profile introducer may be technically feasible for one-step EUS-BD in experimental porcine model.

Percutaneous Closure of Large Femoral Artery Access with Prostar XL in Thoracic Endovascular Aortic Repair

To investigate the technical success rate of Prostar XL for closure of large (≥20F) femoral vascular access sites in thoracic endovascular aortic repair (TEVAR) procedures. This was a single-center consecutive case series. All TEVAR procedures at Uppsala University Hospital 2006-2010 were registered prospectively. Reoperations and cases with open closure technique were excluded. Primary (early) technical failure was defined as closure failure requiring immediate (on-table) open surgical repair; late access-related complication occurred thereafter. The medical records, pre- and postoperative computed tomography images were reviewed retrospectively. A total of 164 TEVAR procedures were identified, of which 118 (71%) had a median 22F (range 20-26F) access site sealed with tandem Prostar XL. The indications for TEVAR were dissection (47%), aneurysm (42%), trauma (8%), and miscellaneous (3%). Median follow-up time was 10 months (range 1-62). Primary technical failure occurred in 10 of 118 (8%). These cases were converted to cut-downs and surgical repair (n = 7), femoral fascia suturing (n = 2), and external compression with the Femo-Stop device (n = 1). Hypertension was associated with primary failure (p = .005), and a trend was observed for high age (p = .078) and increased groin subcutaneous fat layer (p = .077). Late access-related complications included pseudo-aneurysms (n = 12), small hematomas (n = 7), superficial groin infections (n = 2), and deep venous thrombosis (n = 1). None of the late complications required surgical treatment. The access closure technique with tandem Prostar XL for large access sites during TEVAR is safe, in experienced hands. Few technical failures and few late complications occur, and they are usually benign.

Subintimal Angioplasty of Infrainguinal Arterial Occlusions for Critical Limb Ischemia: Long-Term Patency and Clinical Efficacy

To evaluate long-term patency and clinical efficacy of subintimal angioplasty (SAP) of occluded infrainguinal arteries 3 years post procedure. One hundred eighty-one patients (92 men; median age 79 years) underwent attempted SAP in 193 limbs with occluded infrainguinal arteries during the period 1999 to 2001. Nearly half (83, 46%) of the patients had diabetes. Most (172, 95%) had critical ischemia (Fontaine classification>II). All patients surviving at least 3 years after the procedures were followed in January 2005 with questionnaires, clinical examinations, ankle-brachial index measurements, and duplex ultrasonography. All data were collected prospectively and analyzed retrospectively. The primary technical success in the entire cohort was 77% (148/193). Thirty-day mortality was 10% (19/181); 113 (62%) patients died before the 3-year follow-up. In the 68 (38%) survivors (71 limbs), patency at 49.2 months (IQR 40.8-57.6) was 40% (26/65 limbs imaged by duplex). The TASC classification did not affect technical or clinical outcomes. Forty-six (68%) of the survivors presented with clinical improvement (lower Fontaine classification at postoperative follow-up versus baseline). The limb salvage at >3 years was 86% in the 58 primarily successful SAPs and 38% in the 13 procedures that failed initially. SAP is a minimally invasive option for patients with critical limb ischemia. A primary technical success is essential for good clinical outcome and primary technical failure is more devastating than late occlusion. TASC classification and length of the SAP are of poor predictive value. More data are needed to confirm the efficacy of SAP.

Subintimal Angioplasty of Infrainguinal Arterial Occlusions for Critical Limb Ischemia:Long-term Patency and Clinical Efficacy

To evaluate long-term patency and clinical efficacy of subintimal angioplasty (SAP) of occluded infrainguinal arteries 3 years post procedure.One hundred eighty-one patients (92 men; median age 79 years) underwent attempted SAP in 193 limbs with occluded infrainguinal arteries during the period 1999 to 2001. Nearly half (83, 46%) of the patients had diabetes. Most (172, 95%) had critical ischemia (Fontaine classification>II). All patients surviving at least 3 years after the procedures were followed in January 2005 with questionnaires, clinical examinations, ankle-brachial index measurements, and duplex ultrasonography. All data were collected prospectively and analyzed retrospectively.The primary technical success in the entire cohort was 77% (148/193). Thirty-day mortality was 10% (19/181); 113 (62%) patients died before the 3-year follow-up. In the 68 (38%) survivors (71 limbs), patency at 49.2 months (IQR 40.8-57.6) was 40% (26/65 limbs imaged by duplex). The TASC classification did not affect technical or clinical outcomes. Forty-six (68%) of the survivors presented with clinical improvement (lower Fontaine classification at postoperative follow-up versus baseline). The limb salvage at >3 years was 86% in the 58 primarily successful SAPs and 38% in the 13 procedures that failed initially.SAP is a minimally invasive option for patients with critical limb ischemia. A primary technical success is essential for good clinical outcome and primary technical failure is more devastating than late occlusion. TASC classification and length of the SAP are of poor predictive value. More data are needed to confirm the efficacy of SAP.

Percutaneous transluminal rotational atherectomy in the treatment of peripheral vascular disease using a transluminal endatherectomy catheter (TEC): Initial results and angiographic follow-up

To evaluate the clinical results of percutaneous transluminal rotational atherectomy in the treatment of peripheral vascular disease. Rotational atherectomy was performed in 39 patients aged 39-87 years (mean 66.6 years). A total of 71 lesions (43 stenoses and 28 occlusions) were treated in 40 limbs. Additional balloon angioplasty was required in 54% of lesions. Fifteen patients (37.5%) presented in Fontaine stage II, 10 patients (25%) in Fontaine stage III and 15 patients (37.5%) in Fontaine stage IV. Rotational atherectomy at 750 rpm was carried out over a 0.014-inch guidewire with continuous aspiration into a vacuum bottle. Follow-up angiography and color flow Doppler examinations were performed in 22 patients (23 limbs) after a mean period of 6 months (range 2-14 months). There was one primary technical failure. In 36 of 40 lesions there was a good angiographic result with residual stenoses in less than 30%. In 70 lesions treated by rotational atherectomy, however, 54% showed residual stenoses of 30%-50% and these cases required additional balloon angioplasty. The mean ankle-brachial index improved significantly (p << 0.001) from 0.49 before the procedure to 1.01 after the procedure. A single distal embolus, related to primary recanalization, occurred and there were two large inguinal hematomas. Cumulative clinical patency after 6 months was 83.8% and cumulative angiographic patency after 6 months was 79.1%. Percutaneous rotational atherectomy is a promising approach for the treatment of chronic peripheral vascular disease. Further prospective, randomized studies are necessary to compare percutaneous transluminal angioplasty with this new technical approach.

Radiologically guided balloon dilation of gastrointestinal strictures. Part II. Results of long-term follow-up.

Balloon dilation catheters were used to treat 94 gastrointestinal strictures in 92 patients over a 6-year period. Long-term follow-up data were obtained for 80 of these patients, with a mean follow-up period of 389 days. Overall, of the patients who underwent a successful dilation procedure, 83% remained symptom free after 1 year, and 69% after 2 years. The location of the stricture did not significantly influence the long-term outcome, nor did procedure characteristics, aside from primary technical failure. Both patients with malignant strictures and those whose strictures were associated with an anastomosis were more likely than other patients to have recurrent symptoms.

Sliding screw-plate for fixation of femoral neck fracture

Ninety-eight fractures of the femoral neck treated with a sliding screw-plate system were followed from 6 to 65 months. Two cases developing deep infection and four cases of primary technical failure were reoperated. Union was encountered in 80/92 of the fractures; 13/80 of the united fractures developed necrosis of the femoral head. Serious complications were thus encountered in 31/98 of the fractures, and 27 of these were reoperated. On the basis of comparison with reports on other methods for internal fixation, the sliding screw-plate method is recommended for fixation of femoral neck fractures.