nitinol and Aortic-Coarctation

This study sought to compare the safety and efficacy of the balloon-expandable stent (BES) and the self-expandable stent (SES) in the endovascular treatment of coarctation of aorta.. Coarctoplasty with stents has conferred promising results. Although several nonrandomized studies have approved the safety and efficacy of the BES and the SES, no high-quality evidence exists for this comparison.. In the present open-label, parallel-group, blinded endpoint randomized pilot clinical trial, adult patients with de novo native aortic coarctation were randomized into Cheatham-platinum BES and uncovered nitinol SES groups. The primary outcome of the study was a composite of procedural and vascular complications. The secondary outcomes of the study consisted of the incidence of aortic recoarctation, thoracic aortic aneurysm/pseudoaneurysm formation, and residual hypertension at a 12-month follow-up.. Among 105 patients who were screened between January 2017 and December 2019, 92 eligible patients (32 women [34.8%]) with a median age of 30 years (IQR: 20-36 years) were randomized equally into the BES and SES groups. The composite of procedural and vascular complications occurred in 10.9% of the BES group and 2.2% of the SES group (odds ratio: 0.18; 95% CI: 0.02-1.62; P = 0.20). Aortic recoarctation occurred in 5 patients (5.4%), 3 patients (6.5%) in the BES group and 2 patients (4.3%) in the SES group (odds ratio: 0.65; 95% CI: 0.10-4.09; P = 0.64). Only 1 patient (1.1%) was complicated by aortic pseudoaneurysm. Hypertension control was achieved in 50% of the study population, with an equal distribution in the 2 study groups at the 12-month follow-up.. Both the BES and the SES were safe and effective in the treatment of native coarctation.

Topics: Adult; Alloys; Aortic Coarctation; Female; Humans; Platinum; Prosthesis Design; Stents; Treatment Outcome; Young Adult

Endovascular treatment of coarctation of aorta (CoA) by self-expandable Nitinol stents is one of the recognized treatment methods and may be an alternative to surgery or balloon-expandable stent implantation for CoA but there is little information about midterm to long term results of self-expandable stents.. Sixty-two patients with CoA (40 men), with a mean age of 30.7 ± 11 years, (range 17-63 years) underwent stent implantation with Optimed self-expandable Nitinol stents between 2005 and 2014. Successful outcome was defined as peak systolic pressure gradient ≤20 mmHg after stent implantation. The patients were followed-up clinically and by echocardiography and in patients, in whom there was suspicion of recoarctation, CT angiography or recatheterization was performed.. 65 stents were successfully implanted in all 62 patients. Peak systolic pressure gradient decreased from mean 62.4 ± 18 mmHg (range 35-100 mmHg) to mean 2.8 ± 5 mmHg (range 0-15 mmHg; P < 0.001). Stent displacement occurred in 3 patients during the procedure. These were managed successfully by an overlapping second stent. None of the patients had major complications such as aortic dissection, rupture, or vascular access problems. In follow up, only three patients had recoarctation, and two of these were managed successfully by balloon redilation or further stenting 16 and 18 months after the first procedure and one patient refused reintervention. There were two deaths, unrelated to the procedure, 12 and 78 months after the initial intervention. Follow-up of a mean of 45.5 ± 17 months (range 12-105 months) demonstrated no evidence of aneurysm formation or stent fracture.. Self-expandable nitinol stents for the treatment of native and recurrent CoA is safe and has good efficacy with acceptable midterm to long-term outcome.

Topics: Adolescent; Adult; Alloys; Aortic Coarctation; Aortography; Arterial Pressure; Computed Tomography Angiography; Echocardiography; Endovascular Procedures; Female; Humans; Male; Middle Aged; Prospective Studies; Prosthesis Design; Recurrence; Retreatment; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Young Adult

Endovascular treatment offers a great advantage in the management of main arteries stenoses. However, simultaneous presence of a group of anomalies may complicate the situation. Here we present a case of 21-year-old man with aortic coarctation. Radiographic imaging and angiography demonstrated aortic coarctation of the left-circumferential aortic arch, right-sided descending aorta, and Kommerell's diverticulum at the origin of right subclavian artery. These anomalies have rarely been reported to concurrently exist in the same case and the treatment is challenging. Percutaneous treatment for repair of aortic coarctation was successfully performed with deployment of self-expanding nitinol stents. Follow-up demonstrated the correction of blood pressure and improvement of the symptoms. It appears that deployment of self-expandable nitinol stents present a viable option for the management of coarcted aorta in patients having all or some of these anomalies together.

Topics: Abnormalities, Multiple; Alloys; Aneurysm; Angioplasty, Balloon; Aorta, Thoracic; Aortic Coarctation; Aortography; Cardiovascular Abnormalities; Computed Tomography Angiography; Deglutition Disorders; Diverticulum; Humans; Male; Prosthesis Design; Stents; Subclavian Artery; Treatment Outcome; Young Adult

To present perioperative and long-term results of percutaneous treatment of adult isthmic coarctation of the aorta by means of a self-expandable closed-web uncovered nitinol stent (Sinus-XL, Optimed, Esslingen, Germany).. Preoperative, perioperative, and long-term clinical and computed tomographic angiography data were collected and analyzed prospectively. A total of 52 consecutive patients were treated with the Sinus-XL stent. Mean age was 36.6 (21-67) years, peak invasive trans-coarctation of the aorta gradient was 54.7 ± 9.9 mm Hg, and upper body hypertension unresponsive to medical treatment was present in all patients. Mean stent diameter and length were 24.2 mm (22-28 mm) and 70.4 mm (40-80 mm), respectively. Eight patients (15.4%) required coarctation of the aorta predilatation. All patients underwent poststent dilatation with a noncompliant balloon. Postoperative peak gradient (3.3 ± 2.5 mm Hg) was reduced significantly (P < 0.001) and minimal aortic diameter was increased significantly (4.6 ± 1.9 versus 18.6 ± 2.5 mm; P < 0.001). All patients were discharged home (mean hospitalization, 3.5 days). At follow-up (47.6 months; 12-84), 1 (1.9%) noncardiovascular mortality was reported. Aortic computed tomography confirmed the absence of stent collapse and secondary migration and documented stability in aortic diameter (18.3 ± 2.7 mm). Thirty patients (57.7%) were completely weaned-off antihypertensive medications and their use dropped from 2.6 to 0.9 drugs/patient (P < 0.001). Ankle-brachial pressure index increased from 0.75 to 0.98 (P < 0.001).. Adult coarctation of the aorta treatment by means of a self-expandable uncovered stent is safe and durable. The peculiar stent design maintains adequate localized radial strength over time with minimal trauma on the adjacent aortic wall and negligible device-related complications. Blood pressure control optimization is immediate and persistent even at long-term follow-up.

Topics: Adult; Aged; Alloys; Angiography; Ankle Brachial Index; Aortic Coarctation; Blood Vessel Prosthesis Implantation; Diagnostic Imaging; Female; Follow-Up Studies; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Prospective Studies; Stents; Survival Analysis; Time Factors; Treatment Outcome; Young Adult

To prospectively assess the efficacy of self-expanding nitinol aortic stents in the treatment of coarctation of the aorta (CoA).. Between July 2005 and July 2008, 21 patients (14 men; mean age 19.2+/-5.5 years, range 11-34) with CoA were treated with self-expanding Sinus-Aorta stents. The predilation balloon was selected to be <5 times the stenosis diameter. The stent diameter was selected to be 20% to 30% greater than the diameter of the undiseased aorta at the level of the diaphragm.. All procedures were successfully performed without any major complications. Predilation (mean balloon diameter 12.3 mm) and postdilation (mean balloon diameter 15.4 mm) were performed in 12 and 14 procedures, respectively. The mean diameter of the stents was 21.6+/-2.3 mm (range 18-26). The mean peak transcoarctation pressure gradient decreased from 57.4+/-19.5 mmHg (range 30-100) before the procedure to 1.2+/-2.2 mmHg (range 0-7; p<0.001). Cephalad stent dislodgement with the first-generation device occurred in 3 of 12 patients; 2 were treated with a second stent overlapping the first, and the third received 3 overlapped stents after the second stent migrated distally. No stent dislodgement occurred in the subsequent 9 patients treated with longer second-generation stents with anti-jump markers. None of the patients had dissection, arterial rupture, or other complications. On follow-up, 1 (5%) patient had recoarctation and minor stent migration after 18 months; another stent was deployed successfully. No evidence of aneurysm formation was seen in 7 patients undergoing arch imaging.. CoA can be successfully and safely managed with self-expanding nitinol aortic stents without aortic wall complications. Stent malpositioning can be overcome using oversized stents with anti-jump markers.

Topics: Adolescent; Adult; Alloys; Angioplasty, Balloon; Aortic Coarctation; Aortography; Child; Female; Humans; Male; Prospective Studies; Prosthesis Design; Stents; Treatment Outcome; Young Adult

To evaluate the safety and feasibility of self-expandable stents (OptiMed) for treatment of abdominal aortic stenosis in the situations in which the aortic stenosis locates near the origin of celiac, superior mesenteric, renal and inferior mesenteric arteries.. Five consecutive patients scheduled for endovascular treatment of abdominal aortic stenosis by self-expandable nitinol stent (Sinus-Aorta/OptiMed) implantation. The diameter of the stent was chosen as 10-30% more than that of the normal portion of the aorta above the stenosis. Long stents of 60 mm or longer were chosen. After stent deployment, balloon postdilation was performed with a balloon in patients with residual gradient > 5 mm Hg.. All patients were successfully treated with the OptiMed stents. The balloon predilation was performed in one patient due to severe stenosis. The mean diameter and length of the stents deployed were 20.4 +/- 2.9 (range, 16-24 mm) and 64 +/- 8.9 (range, 60-80 mm), respectively. The balloon postdilation was performed in all cases. The mean diameter of the balloons was 13.6 +/- 1.5 (range, 12-15 mm). The mean diameter of stenosis increased from 4.8 +/- 1.9 to 14.4 +/- 1.8 mm after stent placement. The mean peak systolic gradient decreased from 46.8 +/- 31.5 mm Hg to 0.8 +/- 1.8 mm Hg. During follow-up (22.8 +/- 14.3 months), none of the patients had restenosis within the stent, occlusion of any branches of the aorta, or other related complications.. In our small series, we observed that abdominal aortic stenosis can be successfully and effectively treated with OptiMed stents in the situations in which the stenotic segment is located next to the origins of the main visceral branches of abdominal aorta.

Topics: Adult; Aged; Alloys; Angioplasty, Balloon; Aorta, Abdominal; Aortic Coarctation; Aortography; Constriction, Pathologic; Feasibility Studies; Female; Humans; Male; Middle Aged; Prosthesis Design; Regional Blood Flow; Severity of Illness Index; Stents; Tomography, X-Ray Computed; Treatment Outcome

To investigate the utility of MR and X-ray imaging for characterizing aortic coarctation and flow, and guiding the endovascular catheter to place a stent to repair the coarctation.. The descending aorta in eight dogs was looped with elastic band and tightened distal to the subclavian artery. Balanced fast field echo (bFFE) and velocity-encoded cine (VEC) MRI sequences were used for device tracking and measuring aortic flow. A T1-weighted fast-field echo sequence (T1-FFE) was used to visualize the coarctation and roadmap the aorta. Nitinol stents were guided by a nitinol guidewire and placed under MR guidance.. Aortic coarctation was visible on MR and X-ray imaging. The procedure success rate was 88%. VEC MRI measured the changes in aortic flow (baseline = 1.3 +/- 0.2, coarctation = 0.2 +/- 0.02, and stent placement = 0.8 +/- 0.1 liters/minute). A significant reduction in iliac blood pressure was measured after coarctation, but it was reversed by stent placement. The stent lumen was visible on X-ray fluoroscopy, but not on MRI.. Stent deployment to repair aortic coarctation is feasible under MR guidance. The combined use of MR and X-ray imaging is effective for anatomic and functional evaluation of aortic coarctation dilation, which may be crucial for optimal therapy.

Topics: Alloys; Analysis of Variance; Animals; Aortic Coarctation; Contrast Media; Dogs; Feasibility Studies; Fluoroscopy; Gadolinium DTPA; Magnetic Resonance Imaging; Radiography, Interventional; Stents