TriVascular Ovation®: it's role in solving current endograft deficiencies.

Endovascular aneurysm repair (EVAR) techniques and technologies have rapidly advanced over the last two decades. The basic premise of EVAR is to durably exclude flow from the aneurysmal sac without exerting untoward effects on the non-diseased anatomy by using minimally invasive surgical techniques. However, these fundamental components have not yet been perfected with traditional stent grafts and remain important areas for further EVAR refinement. Latest-generation stent grafts are in development to accommodate these therapeutic goals. The Ovation Prime® endograft was specifically developed to address the main limitations of EVAR today by expanding EVAR eligibility, allowing least invasive treatment protocols, and protecting the proximal neck from dilatation over the long term. The purpose of this paper was to detail the primary deficiencies typically encountered with EVAR and to describe how the Ovation Prime® endograft overcomes these limitations.

The Gore Excluder AAA endoprosthesis with C3 delivery system: results in high-volume centers.

The use of endovascular aortic aneurysm repair (EVAR) has increased dramatically, chiefly because of its low perioperative morbidity compared with open surgery. Challenges to the success of EVAR remain, however, with the most important being features of the patient's infrarenal aortic neck anatomy that make optimal placement of the endoprosthesis difficult. These features include a short, wide, severely angulated, or reverse-tapered neck and the presence of calcifications or thrombus. Suboptimal endograft positioning may necessitate use of aortic cuffs, thereby increasing the time and cost of an EVAR procedure, or increase the likelihood of graft migration, which can lead to endoleaks and additional interventions. Efforts to improve outcomes of EVAR and expand its application in patients with challenging aortic neck anatomy have focused on the development of endografts and delivery systems with innovative designs. The low-permeability Gore Excluder AAA endoprosthesis with C3 delivery system, which became available in Europe and the United States in 2010, represents one such design. The C3 system allows the proximal end of the endoprosthesis to be reconstrained after insertion so that the device can, if necessary, be rotated or moved cranially or caudally. Repositioning may facilitate contralateral gate cannulation and placement of the endograft closer to the lowest renal artery (without covering its orifice), thereby possibly decreasing the risk of inadequate sealing and consequent graft migration and endoleaks. Early clinical studies of the Gore Excluder AAA endoprosthesis with C3 delivery system have yielded promising results.

Single-center experience of percutaneous abdominal aortic aneurysm repair with local anesthesia and conscious sedation: technique and results.

AIM: Totally percutaneous endovascular abdominal aortic aneurysm repair (PEVAR) by using the "Preclose" technique has been previously described. We retrospectively analyzed data, collected prospectively at our institution, regarding PEVAR via femoral artery access with local anesthesia and conscious sedation. METHODS: Between January 2001 and May 2009, 1150 patients underwent PEVAR in the endovascular suite of the cardiac catheterization laboratory at our institution. Of those procedures, 915 (79%) were performed with local anesthesia and conscious sedation. RESULTS: The majority of patients were male (87%). Their mean age was 72±10 years, and 98% had a risk status of American Society of Anesthesiologists class III or IV. The PEVAR involved bilateral percutaneous femoral access with 12F to 24F sheaths (depending on the stent-graft system). The mean total procedure time was 149 minutes. Percutaneous closure of the arterial access sites with the Prostar XL was successful in 1727 (94.3%) of the 1830 femoral arteries in which PEVAR was attempted, whereas 103 femoral arteries (5.6%) required surgical repair because adequate hemostasis was not attained at the access site. There were no procedural deaths, but 6 patients (0.6%) died within 30 days of the procedure: 3 died of intestinal ischemia, 1 of stroke, 1 of refractory ventricular arrhythmia, and 1 of worsening renal failure. Mean length of hospital stay was 1.3±2 days. CONCLUSION: PEVAR with local anesthesia and intravenous sedation is safe and feasible and should be considered for patients for whom general anesthesia poses a high risk.

Percutaneous endovascular abdominal aortic aneurysm repair: methods and initial outcomes from the first prospective, multicenter trial.

AIM: A totally percutaneous approach to endovascular abdominal aortic aneurysm repair (PEVAR) has been shown in multiple single center reports to be feasible. Nonetheless, questions regarding the broader applicability of the approach remain due to the lack of a randomized multicenter trial, thus preventing more widespread adoption. We report the methods and outcomes from the roll-in phase of the first prospective, multicenter trial of PEVAR. METHODS: Among 19 institutions participating in the PEVAR Trial (NCT01070069), 38 consecutive patients with abdominal aortic aneurysm were enrolled in a roll-in phase between April 2010 and May 2011. PEVAR procedures with adjunctive "pre-close" of the common femoral arteries (CFAs) targeted for large sheath access using the ProGlide or Prostar XL closure devices were performed using the Endologix IntuiTrak System. All patients were followed periprocedurally and to 30 days for major adverse events and access-related vascular complications. RESULTS: Patients presented at a mean age of 71 years with mean aneurysm sac diameter of 5.6cm. Technical success of the pre-close procedure was 97% (37/38 patients). In one patient, ProGlide devices failed to achieve ipsilateral CFA hemostasis, leading to bleeding requiring transfusion and surgical vascular repair. All endovascular repairs were successful. No mortality or major adverse events occurred. Other pre-close related complications occurring within 30 days included pseudoaneurysm, lower extremity ischemia, and blood transfusion. CONCLUSION: PEVAR with adjunctive 'pre-close' techniques using the ProGlide or Prostar XL devices is safe and feasible as applied in this multicenter experience. Continued evaluation in the prospective, randomized trial is warranted.

The role of leading centers for endovascular surgery in education and training for endovascular treatment of peripheral vascular disease.

The field of peripheral vascular disease (PVD) management is rapidly evolving with the advent of new endovascular techniques. These new techniques frequently involve hybrid approaches for treating complex aortic pathologies. Like many new procedures, endovascular techniques present new challenges for physicians who care for patients with complex vascular pathologies. Physicians must not only understand the disease entity, but the knowledge, expertise in and all available therapeutic options, including the new techniques being employed. To enable physicians to meet these requirements for endovascular techniques and stent-graft technology and to become credentialed to perform them, specific training requirements must be established for peripheral vascular training programs. This is a literature-based review discussing the development of interventional vascular training programs and the incorporation of catheter-based endovascular techniques.

Non-contrast computed tomography is comparable to contrast-enhanced computed tomography for aortic volume analysis after endovascular abdominal aortic aneurysm repair.

OBJECTIVES: To evaluate whether non-contrast computed tomography (NCCT) images are as reliable as contrast-enhanced computed tomography (CECT) images for the measurement of aortic volume (AV). MATERIALS AND METHODS: A total of 316 pairs of AVs were retrospectively measured from 316 consecutive patients, who underwent endovascular aneurysm repair (EVAR). A standardised multidetector computed tomography protocol was used to obtain precontrast, arterial and delay-phase images. A single blinded, experienced observer measured the AV from the lowest renal artery to the aortic bifurcation by means of the disc-summation method, using the precontrast and arterial-phase images. A second blinded observer measured the AV again in 16 randomly chosen cases. RESULTS: Both NCCT and CECT yielded similar AVs that were highly correlated (r(2) = 0.99; P < 0.0001). Bland and Altman analysis revealed a small bias (mean ± 2 standard deviations: -0.9 ± 8 ml). The intraclass correlation coefficients (all >0.99; P < 0.0001) and low repeatability coefficients indicated that the AVs were reproducible with both methods. CONCLUSIONS: The AVs measured from NCCT images were accurate and highly reproducible compared with those from CECT images. Therefore, NCCT can be a reasonable alternative to CECT for AV assessment after EVAR. This is particularly important for patients with renal insufficiency (potentially sparing them from nephrotoxic contrast agents and unnecessary radiation) or allergy to contrast agents.

Catheter aspiration thrombectomy during carotid stenting is safe and potentially efficacious: a pilot retrospective study.

AIM: Despite distal embolic protection (DEP) during carotid artery stenting (CAS), there is still an appreciable risk of stroke, especially in symptomatic patients and octogenerians. The mechanism of embolic events is possibly related to microembolization of debris remaining on or forming on stent struts. We evaluated the safety of using aspiration thrombectomy after CAS. METHODS: Between August 2006 and July 2010, 80 symptomatic and asymptomatic patients with severe carotid artery stenosis (>80%) underwent CAS utilizing DEP. After completion of CAS and before removal of DEP, an aspiration catheter was passed through the CAS segment. Both extracted volume and the DEP were visually examined. The primary endpoint was stroke and death at 30 days. These patients were divided into two groups, Group 1 (N=7) comprised those who had aspiration thrombectomy to treat no-flow or an acute neurologic change that occurred during CAS. Group 2 (N=73) comprised patients that underwent prophylactic aspiration thrombectomy. Outcomes were then compared to a control group (N=925) who had CAS with DEP, but without aspiration thrombectomy. RESULTS: Moderate to large amounts of debris were extracted from the CAS segment in the majority of thrombectomy patients (90%). There was one death (1%) and one stroke (1%) in the thrombectomy groups, while the control group had 3.0% rate of death and stroke (P=0.83). CONCLUSION: Aspiration thrombectomy recovers large to moderate amounts of debris and is safe and does not increase adverse periprocedural events. A large scale, randomized trial with magnetic resonance imaging (MRI) is needed to further investigate our findings.

Totally percutaneous aortic aneurysm repair: methods and outcomes using the fully integrated IntuiTrak endovascular system.

AIM: A totally percutaneous approach to endovascular abdominal aortic aneurysm repair (PEVAR) has been shown in multiple reports to be feasible, but carries attendant risks that appear to increase with increasing sheath size. We report our methods and sequential PEVAR case experience using a new delivery system having an integrated 19Fr introducer sheath for treatment of patients with aortic necks up to 32 mm in diameter. METHODS: A single institution, prospective, controlled evaluation was conducted in 57 consecutive patients with abdominal aortic aneurysm who underwent PEVAR between December 2008 and April 2010. All patients have been followed for at least 30 days. RESULTS: Patients presented at a mean age of 74 years with median AAA diameter of 5.4 cm preprocedurally. Calcified/tortuous access vessels were identified in 98% of patients. All PEVAR procedures with adjunctive "pre-close" use of the Prostar XL closure device were performed in a hybrid endovascular suite with patients maintained under conscious sedation and local anesthesia. The anatomically-fixed bifurcated stent graft and aortic/limb extensions as needed were implanted via the 19 Fr indwelling introducer sheath with minimal blood loss (79 mL). Technical success was 98%, with one conversion to open repair attributable to very small diameter (4 mm) access vessels. Cumulatively, major access-related complications were observed in five patients (8.8%) within 30 days. CONCLUSION: PEVAR using the IntuiTrak System with 19Fr introducer sheath with vessel closure facilitated by the Prostar XL device is feasible, even in patients with challenging access anatomy. Further evaluation in a prospective, multicenter, randomized trial is warranted.

Unusual case of AneuRx stent-graft failure two years after AAA exclusion.

PURPOSE: To present a case of type-III endoleak due to separation of modular components and suture breakage after abdominal aortic aneurysm (AAA) repair with the AneuRx stent-graft. CASE REPORT: A 58-year-old man with a 78-mm AAA underwent successful aneurysm exclusion with an AneuRx stent-graft in 1998. Because the bifurcated component migrated during deployment, an additional aortic cuff was deployed to extend the stent-graft proximally to just below the renal arteries. On routine evaluation with computed tomography at 2 years postimplantation, a type-III endoleak with anterior displacement of the stent-graft was discovered. Angiography revealed separation of the aortic cuff from the stent-graft body. The aneurysm, which had decreased to 70 mm at 6 months, had enlarged to 80 mm in diameter. The patient underwent surgical AAA repair with removal of the stent-graft. Macroscopic examination showed suture breakage and separation of the stent rings and the graft material. CONCLUSIONS: This late complication of the AneuRx endograft underscores the need for frequent imaging surveillance in all patients undergoing endoluminal AAA repair.

Preliminary results of endovascular abdominal aortic aneurysm exclusion with the AneuRx stent-graft.

OBJECTIVES: This study evaluated the clinical effectiveness of the Medtronic AneuRx stent-graft in patients with infrarenal abdominal aortic aneurysms (AAAs) who were treated in an endovascular suite. BACKGROUND: The use of endovascular stent-graft prosthesis for the treatment of AAAs is receiving increasing attention as an alternative to standard surgical repair. Endovascular treatment of AAAs offers the potential to avoid the significant morbidity and mortality associated with surgical repair. METHODS: In this series, 215 patients have undergone AAA exclusion with the AneuRx stent-graft. Six-month follow-up is available in 132 patients; one-year follow-up is available in 84 and two-year follow-up in 22. RESULTS: Of the patients, one hundred ninety-two (89%) were male; 87% had hypertension, and 58.6% were American Society of Anesthesiologists grade IV or higher. The procedural success was 99.5%; we were unable to place the device in one patient. There was no procedural or one-month mortality. There were no acute conversions to surgical repair. One patient had a non-Q-wave myocardial infarction 24 h after the procedure. Endoleaks were present in 82 patients (42%) at discharge, 15 patients (11.3%) at six months and 10 patients (11.9%) at one year. Twenty-two patients had a secondary procedure for endoleak repair of which three were conversions to surgical repair. Twelve late deaths have occurred, none due to device failure or AAA rupture. Mean hospital stay was 1.9 days. CONCLUSIONS: These results reveal that infrarenal AAAs can be safely and successfully treated in an endovascular suite with the AneuRx stent-graft. Further follow-up is needed to determine the long-term efficacy of endoluminal treatment to prevent rupture and death due to AAAs.

Bare metal stents with or without coil embolization for abdominal aortic aneurysm exclusion in high-risk patients.

The objective of the study was to determine if uncovered self-expanding metallic stents with or without polyester-covered coils can exclude abdominal aortic aneurysms (AAA). Exclusion using uncovered metal stents with or without coils has been shown to be successful in the animal model. Twelve patients underwent aneurysmal therapy with uncovered self-expanding metallic stents and polyester covered metallic coils (male, 8; female, 4; mean age, 74 +/- 8 years) because no other therapeutic alternative was available. Indications were severe aorto-iliac disease, presumptively high surgical risk due to comorbidities, a previously failed endograft attempt, and a hostile abdomen as a result of prior surgeries. Under local anesthesia, stents were introduced percutaneously via 10 or 11 Fr sheaths into the femoral artery and deployed in an overlapping fashion to cover the length of the AAA. All endoluminal procedures were successful, and no major complications were encountered. The average hospital stay was 33 +/- 21 hr. At a mean follow-up of 18 +/- 13 months, there was no rupture, leak, or evidence of aneurysm expansion in any of the patients. There was one mortality that was not AAA-related. The remaining patients had no aneurysm-related symptoms. Endoluminal exclusion of an AAA using self-expanding bare metal stents with or without coil embolization may be a viable treatment option for patients who cannot undergo standard surgical or endovascular repair. However, these data do not demonstrate that this methodology actually precludes rupture since the cohort is of small size. Cathet Cardiovasc Intervent 2001;54:12-18.

Outcomes following extracranial carotid artery stenting in high-risk patients.

BACKGROUND: Carotid artery angioplasty and stenting has become a viable alternative to carotid endarterectomy (CEA), especially for patients considered at high risk for post-operative complications. This study investigated the feasibility, safety and long-term outcome of carotid artery stenting (CAS) in high-risk patients. METHODS: From July 1995 to November 2000, sixty-two consecutive patients considered to be at high risk for post-operative complications of CEA were followed prospectively after undergoing extracranial CAS procedures. RESULTS: Sixty-two patients [37 men (60%) and 25 women (40%)] underwent a total of 69 CAS procedures. The mean age was 67 +/- 9 years (range, 32-89 years). Comorbid conditions included hypertension in 95% and severe coronary artery disease in 58%. Sixteen patients (26%) had a previous ipsilateral CEA, twenty-one percent had a history of neck radiation and 32% had a history of significant contralateral carotid artery disease. Fifty-two patients (84%) were symptomatic. All 69 CAS procedures were technically successful. The major post-operative complications were two minor strokes (2.8%), one major stroke (1.4%) and one fatal major stroke (1.4%). The mean length of follow-up was 17 months (range, 4 months to 5.6 years). Two patients (2.8%) have suffered ipsilateral neurologic events following CAS. Long-term follow-up revealed restenosis at 6 months in 4 patients (5.7%). CONCLUSIONS: Carotid artery angioplasty and stenting is safe and feasible. This procedure produces satisfactory outcomes in patients who are at high risk for post-operative complications of CEA.

Percutaneous and surgical interventions for in-stent restenosis: long-term outcomes and effect of diabetes mellitus.

OBJECTIVE: We examined long-term outcomes of patients with in-stent restenosis (ISR) who underwent different percutaneous interventions at the discretion of individual operators: balloon angioplasty (BA), repeat stent or rotational atherectomy (RA). We also examined long-term outcomes of patients with ISR who underwent coronary artery bypass surgery (CABG). BACKGROUND: In-stent restenosis remains a challenging problem, and its optimal management is still unknown. METHODS: Symptomatic patients (n = 510) with ISR were identified using cardiac catheterization laboratory data. Management for ISR included BA (169 patients), repeat stenting (117 patients), RA (107 patients) or CABG (117 patients). Clinical outcome events of interest included death, myocardial infarction, target vessel revascularization (TVR) and a combined end point of these major adverse cardiovascular events (MACE). Mean follow-up was 19+/-12 months (range = 6 to 61 months). RESULTS: Patients with ISR treated with repeat stent had significantly larger average post-procedure minimal lumen diameter compared with BA or RA (3.3+/-0.4 mm vs. 3.0+/-0.4 vs. 2.9+/-0.5, respectively, p < 0.05). Incidence of TVR and MACE were similar in the BA, stent and RA groups (39%, 40%, 33% for TVR and 43%, 40%, 33% for MACE, p = NS). Patients with diabetes who underwent RA had similar outcomes as patients without diabetes, while patients with diabetes who underwent BA or stent had worse outcomes than patients without diabetes. Patients who underwent CABG for ISR, mainly because of the presence of multivessel disease, had significantly better outcomes than any percutaneous treatment (8% for TVR and 23% for MACE). CONCLUSIONS: In this large cohort of patients with ISR and in the subset of patients without diabetes, long-term outcomes were similar in the BA, repeat stent and RA groups. Tissue debulking with RA yielded better results only in diabetic patients. Bypass surgery for patients with multivessel disease and ISR provided the best outcomes.

Percutaneous access and closure of femoral artery access sites associated with endoluminal repair of abdominal aortic aneurysms.

PURPOSE: To report longer follow-up and further experience using the Prostar XL Percutaneous Vascular Surgery (PVS) device for access and closure of large bore femoral artery access sites during endovascular repair of abdominal aortic aneurysms (AAAs). METHODS: One hundred forty-four patients (128 men; mean age 72 years, range 56-89) undergoing endovascular AAA repair had percutaneous access and closure of their 16-F femoral artery access sites using a 10-F PVS device. The first 54 patients were enrolled in the phase III trial of the AneuRx stent-graft for AAA treatment. RESULTS: The femoral artery access site was successfully closed in 136 (94.4%) patients, with only 8 patients in whom adequate hemostasis could not be obtained. One-month follow-up was available in 144 patients, 6-month in 100, and 1-year in 59. No groin or lower extremity complications have been observed in any patient who had successful closure of the femoral artery access site. CONCLUSIONS: Large-bore femoral artery access sites can be percutaneously repaired using this device, which minimizes the invasiveness of the endograft procedure.

Concomitant subclavian and coronary artery disease.

BACKGROUND: Proximal subclavian artery occlusive disease in the presence of a patent internal mammary artery used as a conduit for a coronary artery bypass graft procedure may cause reversal of internal mammary artery flow (coronary-subclavian steal) and produce myocardial ischemia. METHODS: We reviewed outcome to determine whether subclavian artery revascularization can provide effective protection from and treatment for coronary-subclavian steal. Between 1985 and 1997, 20 patients had either concomitant subclavian and coronary artery disease diagnosed before operation (group 1, 5 patients) or symptomatic coronary-subclavian steal occurring after a previous coronary artery bypass graft procedure (group 2, 15 patients). Patients in group 1 received direct subclavian artery bypass and a simultaneous coronary artery bypass graft procedure in which the ipsilateral internal mammary artery was used for at least one of the bypass conduits. Patients in group 2 received either extrathoracic subclavian-carotid bypass (5 patients, 33.3%) or percutaneous transluminal angioplasty and stenting (10 patients, 66.7%) as treatment for symptomatic coronary-subclavian steal. RESULTS: All patients were symptom-free after intervention. One patient treated with percutaneous transluminal angioplasty and stenting died of progressive renal failure. Follow-up totaled 58.5 patient-years (mean, 3.1 years/patient). In group 1, primary patency was 100% (mean follow-up, 3.7 years). In group 2, one late recurrence was treated by operative revision, yielding a secondary patency rate of 100% (mean follow-up, 2.9 years). CONCLUSIONS: Subclavian artery revascularization can provide effective protection from and treatment for coronary-subclavian steal with acceptably low operative risk. Midterm follow-up demonstrates good patency.

Percutaneous treatment of life-threatening congenital arteriovenous malformations with the Wallgraft endoprosthesis.

PURPOSE: To report the percutaneous endovascular repair of massive congenital arteriovenous malformations (AVMs) of the right arm complicated by tissue ischemia, severe edema, and life-threatening recurrent hemorrhagic episodes. METHODS AND RESULTS: A 25-year-old man with a 3-year history of symptomatic upper right arm AVMs had been treated unsuccessfully with surgical ligation and coil embolization. The arm had become massively enlarged, disfigured, severely painful, and unusable, with extension of swelling to the upper chest. Under compassionate use as part of an investigational protocol, the AVMs were closed with 6 overlapping Wallgraft endoluminal prostheses deployed in the right brachial, axillary, and subclavian arteries, preserving the vertebral and distal circulations. Unfortunately, the patient suffered numerous pulmonary emboli and died 2 days after the procedure. CONCLUSIONS: Percutaneous treatment of massive AVMs appears feasible with the Wallgraft endoprosthesis, but optimal postprocedural management of such large anomalies should include immediate venous filter placement and aggressive anticoagulation therapy with intravenous heparin.

Endovascular exclusion of abdominal aortic aneurysms: initial experience with stent-grafts in cardiology practice.

The use of an endovascular stent-graft prosthesis for the treatment of infrarenal abdominal aortic aneurysms is receiving increasing attention as an option that may avoid the significant morbidity and mortality associated with open surgical treatment. We studied the clinical effectiveness of stent-grafts in patients with infrarenal abdominal aortic aneurysms. Between October 1995 and May 1998, 33 patients underwent infrarenal abdominal aortic aneurysm exclusion with a homemade polytetrafluoroethylene-covered stent, and between November 1998 and September 1999, 56 patients underwent abdominal aortic aneurysm exclusion with the Medtronic AneuRx stent-graft. Overall, these patients represented a high-risk surgical group. The technical success rate was 100% in both groups. No patient required immediate conversion to open repair. With the polytetrafluoroethylene-covered stent, the primary success rate was 33%, and the secondary success rate was 76%. In the AneuRx group, the primary success rate was 82.8%, and the secondary success rate was 85.3% at 6 months. There was no procedural or 1-month mortality or major morbidity in either group. By showing that infrarenal abdominal aortic aneurysms can be treated safely and successfully with an endoluminal stent-graft, our early results provide additional support for the endovascular treatment of abdominal aortic aneurysms. Further follow-up studies will determine the long-term ability of such treatment to prevent aneurysmal rupture and death.