Covered Cheatham-Platinum Stents Research Articles

Abstract 12561: Intravascular Lithotripsy Use for Percutaneous Fontan Pathway Rehabilitation in an Adult With Fontan Pathway Obstruction

Introduction: Fontan pathway obstruction is a serious complication characterized by an anatomical or functional narrowing anywhere in the cavo-pulmonary pathways. Here we report the first case where an innovative Fontan conduit rehabilitation procedure with intravascular lithotripsy was used achieving a significant increase in the pathway size. Case: A 28-year-old male with tricuspid atresia status-post Fontan palliation (age 23 months) with bare metal stent implant to treat obstruction at age 15, presented with syncope, ascites and varicose veins. Imaging studies revealed a cirrhotic liver morphology and Fontan pathway obstruction with minimal diameter of 12 mm. Cardiac catheterization confirmed severe Fontan conduit obstruction in addition to LPA stenosis. Serial covered Cheatham-Platinum stents were implanted for conduit coverage followed by Palmaz stents. Non-compliant Atlas balloon dilation to 20 atm was performed without expansion of the Fontan pathway beyond 12 mm due to severe calcification. A 7.0 x 60 mm shock-wave lithotripsy balloon was added alongside the Atlas balloon to modulate the heavily calcified wall with subsequent expansion of the conduit to 21 mm after inflating the Atlas balloon to 14 atm. Discussion: Several studies demonstrated that transcatheter stenting of stenotic Fontan conduits can be safely performed. Intravascular lithotripsy has emerged as a novel therapy for the treatment of coronary vascular calcification. We report the first case of an innovative percutaneous Fontan conduit rehabilitation procedure using a lithotripsy shock wave balloon in an adult with severely calcified Fontan pathway obstruction and prior stents, achieving a 75% increase in the pathway size without significant complications. Further studies are needed to evaluate the long-term safety and efficacy of this novel approach, but this case presents an exciting option for future directions in the percutaneous treatment of Fontan pathway obstruction.

Stenting of coarctation of the aorta-"Once and for all?"

Key Points Long term hemodynamic benefit and survival are sustained in patients undergoing stenting of coarctation of the aorta with bare metal and covered Cheatham‐Platinum (CP) stents. Reintervention and complication rates are similar with both bare metal and covered CP stents. Routine advanced imaging should be performed periodically in the long‐term to assess for stent integrity and aortic wall injury, and to guide treatment/reintervention, when necessary.

Preliminary experience of transcatheter pulmonary valve replacement using domestic balloon-expandable valve

Objectives: To evaluate the feasibility and preliminary clinical results of transcatheter pulmonary valve replacement (TPVR) with the domestically-produced balloon-expandable Prizvalve system. Methods: This is a prospective single-center observational study. Patients with postoperative right ventricular outflow tract (RVOT) dysfunction, who were admitted to West China Hospital of Sichuan University from September 2021 to March 2023 and deemed anatomically suitable for TPVR with balloon-expandable valve, were included. Clinical, imaging, procedural and follow-up data were analyzed. The immediate procedural results were evaluated by clinical implant success rate, which is defined as successful valve implantation with echocardiography-assessed pulmonary regurgitation<moderate and peak trans-pulmonary pressure gradient<40 mmHg (1 mmHg=0.133 kPa). Results: A total of 5 patients were included, with 4 males, aged 14 to 37 years. The initial diagnosis included Tetralogy of Fallot (2 cases), truncus arteriosus (1 case), pulmonary atresia (1 case) and subaortic stenosis (1 case, prior Ross procedure). Four patients underwent RVOT reconstruction with homograft or artificial conduit, and one patient was treated with trans-annular patch technique. The indications of TPVR included RVOT obstruction and regurgitation (3 cases), isolated obstruction (1 case), and isolated regurgitation (1 case). Of the 4 patients with varying severity of ROVT obstruction, the average preprocedural peak jet velocity of RVOT was 3.5 m/s, and the average peak pressure gradient was 50.0 mmHg. Except for one patient, who had previously been implanted with a covered Cheatham-Platinum (CP) stent due to severe stenosis of the main pulmonary artery, other patients underwent pre-stenting with a covered CP stent before TPVR. Clinical implant success was achieved in all of the 5 patients, and there was no serious periprocedural complications. The average trans-pulmonary peak jet velocity and peak pressure gradient derived from postprocedural echocardiography was 2.3 m/s and 21.2 mmHg, respectively. All patients experienced significant symptom relief after the procedure. All patients completed 3-month follow-up, and 4 completed 6-month follow-up. There was no case of infectious endocarditis during follow-up. All patients were graded as NYHA functional class one at the latest follow-up. Conclusions: TPVR using the domestically-produced balloon-expandable Prizvalve system is safe and feasible for the treatment of patients with post-surgical RVOT dysfunction and suitable landing-zone anatomy. The safety, effectiveness, and long-term valve durability of the Prizvalve system deserve further research.

Long-term follow-up after endovascular treatment of aortic coarctation with bare and covered Cheatham platinum stents.

Endovascular treatment of aortic coarctation (CoA) in children and adults frequently requires stent implantation. The aim of this study was to analyze long-term results after CoA treatment with bare and covered Cheatham-PlatinumTM (CP) stents in our institution and to derive recommendations for the differential use of these stent types. In this retrospective single institution study, 212 patients received endovascular CoA treatment with bare (n = 71) and covered (n = 141) CP stents between September 1999 and July 2021, respectively. The indications for treatment were native CoA in 110/212 patients (51.9%) and re-coarctation after primary surgical or interventional treatment in 102/212 patients (48.1%). Median patient age at endovascular CoA treatment was 18.8 years [IQR 11.9; 35.8]. Long-term follow-up was available in 158/212 patients (74.5%) with a median follow-up of 7.3 years [IQR 4.3; 12.6]. Procedural success was achieved in 187/212 (88.2%) patients. Survival rate was 98.1% after 5, and 95.6% after 10 and 15 years, respectively. The probability of freedom from re-intervention was 93.0% after 5, 82.3% after 10 and 77.8% after 15 years, respectively. Freedom from re-interventions (44/158, 27.8%) did not differ between patients who received bare or covered CP stents (p = 0.715). Multivariable risk factor analysis identified previous CoA surgery (HR: 2.0, 95% confidence interval (CI): 1.1-3,9, p = 0.029), postdilatation (HR: 2,9, 95% CI: 1.1-6.3, p = 0.028) and age at intervention (HR: 0.96, 95% CI: 0.94-0.99, p = 0.002) as independent risk factors for re-intervention. Peri-procedural complications occurred in 15/212 (7.1%) patients (dissection/thrombosis of vascular access vessel: n = 9; bleeding: n = 1; stent dislocation: n = 2; aortic dissection/aortic wall rupture: n = 3). Long-term complications were observed in 36 patients and included stent fracture (n = 19), aneurysm formation (n = 14), endoleak (n = 1) and subclavian artery stenosis (n = 2). Peri-procedural and long-term complications did not differ between patients who received CoA treatment with bare or covered CP stents (all p > 0.05). Endovascular treatment of CoA using bare or covered CP stents can be performed safely and effectively with excellent long-term results. Survival, re-intervention and complication rate did not significantly differ between both stent types. However, individual stent selection is advisable with regard to CoA morphology and severity as well as patient age.

Evolving Utilization of Covered Stents for Treatment of Aortic Coarctation: Report From the IMPACT Registry.

Covered stent (CS) use for the transcatheter treatment of coarctation of the aorta (COA) was first described over 20 years ago. The covered Cheatham-platinum stent received Food and Drug Administration approval for COA treatment in 2016. Data collected as part of the National Cardiovascular Data Registry IMPACT registry were evaluated for contemporary usage patterns of CS for the treatment of COA from 2016 to 2021. Version 2 of the IMPACT registry was queried for all patients who underwent stent placement for treatment of COA from 2016 to 2021. Trends in CS use were evaluated by year and age of patient at the time of implant. Analysis was limited to clinical factors collected as part of the registry and was performed to identify factors associated with CS use. Data were available for 1989 case entries. Most patients (92%) received a single stent. The overall percentage of CS use in the cohort was 23% and remained consistent throughout the study period. The probability of CS use was significantly associated with increasing patient age at implant. Additional factors associated with CS use included smaller initial COA diameter, native COA, and the presence of a pseudoaneurysm. Procedural adverse event rates were low. CS use to treat COA was more common in adult patients and remained stable over the study period. Factors associated with CS use, including smaller COA diameter and aortic pseudoaneurysm, demonstrate the perceived value of CS as a tool to reduce the risk of aortic wall injury during treatment of COA.

Mesenteric arteries aneurysms rupture secondary to paradoxical hypertension after aortic coarctation stenting.

A 51-year-old female with long-term poorly controlled hypertension was found to have a systolic murmur on physical examination. A transthoracic echocardiogram showed a bicuspid aortic valve with left ventricular hypertrophy and normal ejection fraction. Computed tomography (CT) detected a critical coarctation of the aorta (Panel A). The invasive gradient through the coarctation was 80 mmHg. It was decided to treat with stent implantation (Panels B and C). A covered cheatham-platinum stent of 39 mm mounted on a balloon-in-balloon balloon of 16 × 40 mm was successfully implanted. Immediately after stent deployment, the systolic blood pressure reached 210 mmHg, despite pharmacological treatment. The day after the procedure, the patient started with abdominal pain and an emergency CT scan was performed (Panel D). Computed tomography showed a large mesenteric haematoma (with no active bleeding at that moment), a large aneurysm of the proximal ileocolic artery, and a small aneurysm of the middle colic artery. Angiography confirmed these findings (Panel E) and it was decided to embolize both aneurysms using Micro Vascular Plugs and coils, which resulted in a successful exclusion of the aneurysms but also in a lack of vascularization of the distal ileum and ascending colon (Panel F), that eventually required resection (right hemicolectomy). The possibility of aneurysms and other alterations in the vessels of patients with aortic coarctation should be considered. Whether these anomalies should be treated before stenting is still unknown. Paradoxical hypertension after stent implantation and its severe complications could be prevented by pharmacological treatment days before the intervention.

Revascularization of Left Subclavian to Common Carotid Artery Prepares for Covered Stent Implantation in Patients With Complex Aortic Coarctation.

Seven adult patients underwent a two-stage treatment of complex coarctation (CoA), including surgical revascularization of the left subclavian artery (LSA) to left common carotid artery (LCCA), followed by transcatheter covered stent implantation. The majority of patients (5 of 7, 71%) received 1 covered stent (covered Cheatham Platinum stent: 8 zig/45 mm [n = 2], 10 zig/60 mm [n = 1], 10 zig/65 mm [n = 1]; BeGraft: 24/48 mm [n = 2]). In 1 patient (14%), the implantation of 2 covered stents (BeGraft 20/48 mm) was necessary. During a median follow-up of 2.4 years (interquartile range, 0.1 to 4.9 years), complications occurred in 3 of 7 patients (43%), including an asymptomatic but severe stenosis of the LSA bypass (n = 1), a recoarctation with a mild endoleak (n = 1), and a severe endoleak (n = 1). Surgical revascularization of the LSA to the LCCA can successfully prepare for covered stent implantation in complex CoA in adult patients. This two-stage approach was feasible and safe with complications occurring in 3 of 7 patients (43%). All complications were managed by catheter reintervention only.

Covered Stents in the Management of Aortic Coarctation and Right Ventricular Outflow Tract Obstruction.

To review the use of covered stents in the treatment of coarctation of the aorta (CoA) and right ventricle to pulmonary artery (RV-PA) conduit obstruction. The only commercially available covered stent approved for treatment of CoA and dysfunctional RV-PA conduits is the covered Cheatham-Platinum stent (CCPS). Early outcomes have demonstrated its safety and have suggested its efficacy in treating or preventing aortic wall injury (AWI) or conduit disruption. A recent study of CCPS use for CoA reported a progressive risk of stent fracture over time and a risk of AWI despite the purported protection that the CCPS provides. The use of other covered stents has been reported, but large, systematic studies are lacking. CCPS use may reduce but does not eliminate the risk of conduit disruption or AWI. Structural limitations of the CCPS may predispose it to stent fracture. Access to a broad range of covered stents continues to be an unmet need in the field of congenital interventional cardiology.

Long-Term Outcomes of the Coarctation of the Aorta Stent Trials.

Long-term outcome data of stent-implantation for coarctation of the aorta are limited. We report up to 5 years of postimplant follow-up in patients enrolled into the COAST (Coarctation of the Aorta Stent Trial) and the COAST II trial (Covered Cheatham-Platinum Stents for Prevention or Treatment of Aortic Wall Injury Associated With Coarctation of the Aorta), evaluating the bare and Covered Cheatham-Platinum Stents for the treatment of coarctation of the aorta and associated aortic wall injury. Data was prospectively collected during the 2 multi-center studies, enrolling 248 patients (COAST: n=121, COAST II: n=127). Late follow-up data (48–60 month) was compared with immediate (1 month) and early (12 months) follow-up. There was a notable decrease in the use of antihypertensive medication, from 53% at immediate, to 42% at early, and 29% at late follow-up. The cumulative incidence of stent fractures was 0% immediately, 2.9% at early, and 24.4% at late follow-up. Independent predictors for stent fractures at late follow-up were age <18 years, male sex, minimum stent diameter ≥12 mm, and use of bare metal stent. The cumulative incidence of reintervention was 1.6% at immediate, 5.1% at early, and 21.3% at late follow-up. Independent predictors for reinterventions at late follow-up were age <18 years, post implantation systolic arm-leg blood pressure gradient ≥10 mm Hg, minimum stent diameter at implantation <12 mm, and initial coarctation minimum diameter <6 mm. There were 13 patients with aortic aneurysms, with a cumulative incidence of 6.3% at late follow-up. Coarctation stenting is effective at maintaining obstruction relief up to 60 months postimplant with reduction in the number of patients requiring antihypertensive medication. However, an increase in-stent fractures and reinterventions were observed between medium and long-term follow-up. Covered stents appear to confer some protection from the development of stent fractures but do not provide complete protection from late aneurysm formation. URL: https://www.clinicaltrials.gov; Unique identifiers: NCT00552812 and NCT01278303.

Correction of sinus venosus atrial septal defects with the 10 zig covered Cheatham-platinum stent - An international registry.

Covered stent correction of sinus venosus ASDs (SVASD) is a relatively new technique. Challenges include anchoring a sufficiently long stent in a nonstenotic superior vena cava (SVC) and expanding the stent at the wider SVC-RA junction without obstructing the anomalous right upper pulmonary vein (RUPV). The 10-zig covered Cheatham-platinum (CCP) stent has the advantage of being available in lengths of 5-11 cm and dilatable to 34 mm in diameter. An international registry reviewed the outcomes of 10-zig CCP stents in 75 patients aged 11.4-75.9 years (median 45.4) from March 2016. Additional stents were used to anchor the stent in the SVC or close residual shunts in 33/75. An additional stent was placed in 4/5 (80%) with 5/5.5cm CCPs, 18/29 (62%) with 6cm CCPs, 5/18 (28%) with 7cm CCPs, 5/22 (23%) with 7.5/8cm CCPs and 0/1 with an 11 cm CCP. A "protective" balloon catheter was inflated in the RUPV in 17. Early stent embolization in two patients required surgical removal and defect repair and tamponade was drained in one patient. The CT at 3months showed occlusion of the RUPV in one patient. Follow up is from 2months to 5.1 years (median 1.8 years). QP:QS has reduced from 2.5± 0.5 to 1.2± 0.36 (p < .001) and RVEDVi from 149.1± 35.4 to 95.6± 21.43 ml/m2 (p < .001). Ten-zig CCPs of 7-8cm appear to provide reliable SVASD closure with a low requirement for additional stents. Careful selection of patients and meticulous attention to detail is required to avoid complications.

Transcatheter Correction of Superior Sinus Venosus Atrial Septal Defects as an Alternative to Surgical Treatment

BackgroundThe superior sinus venosus atrial septal defect (SVASD) is characterized by deficiency of the common wall between the superior vena cava (SVC) and the right upper pulmonary vein (RUPV), which is no longer committed to the left atrium. ObjectivesThis study sought to evaluate the potential for redirecting the SVC and RUPV flow to the right and left atria, respectively, by implantation of a covered stent in the SVC. MethodsReview of 48 consecutive adult SVASD patients undergoing assessment for correction. Pre-procedural evaluation included cross-sectional imaging and ex vivo simulation using printed or virtual 3-dimensional models. ResultsTranscatheter correction was performed in 25 patients, with a further 6 awaiting stent implantation. Only 8 patients were deemed technically unsuitable. The procedure involved balloon test inflation in the anticipated stent landing zone with simultaneous transesophageal echocardiography and pulmonary venography to confirm defect closure and unobstructed pulmonary venous drainage, followed by deployment of a 10-zig covered Cheatham platinum stent. Stents of lengths between 5 and 8 cm were implanted. A second, uncovered stent was used for anchoring in 9 patients. The RUPV was protected with a high-pressure balloon during stent implantation to prevent pulmonary venous obstruction in 4 patients. The median follow-up period was 1.4 (interquartile range: 0.8 to 1.7) years, with no mortality. Stent embolization occurred in 1 patient; another required drainage of hemopericardium. Cardiac computed tomography after 3 months confirmed unobstructed pulmonary venous return. At latest follow-up, a residual shunt was present in 1 patient. ConclusionsTranscatheter correction of SVASD may be considered as an alternative to surgery in a substantial proportion of patients.

Transcatheter closure of sinus venosus atrial septal defect with anomalous pulmonary venous drainage: Innovative technique with long-term follow-up.

Surgical closure of sinus venosus atrial septal defect (SVASD) is the standard management. A safe and effective transcatheter approach will be an attractive option. To assess the feasibility and long-term safety of transcatheter closure of SVASD with anomalous pulmonary venous drainage. From July 2011 to October 2013, four patients with large SVASD and anomalous right upper pulmonary venous (RUPV) drainage underwent transcatheter closure of their defects at Ibn-Albitar Center for Cardiac Surgery, Baghdad, Iraq. Two patients with superior vena cava (SVC)-type SVASD underwent closure using covered Cheatham-Platinum (CP) stents with no need for septal occluder. The other two patients had large RA-type SVASD who underwent closure using covered CP stents only in one patient and stents and device in the other one. An angiogram in the RUPV during balloon inflation in the SVC was done to ensure that the RUPV drains back to the left atrium. The covered CP stent was mounted and hand crimped onto Z-Med™ or BIB-balloon catheters and deployed in the desired location under transesophageal echocardiography guidance. The two patients with SVC-type SVASD underwent successful closure using two overlapping covered CP stents implanted in the SVC, thus creating total septation between the SVC and the RUPV. The RA-type SVASD patients underwent closure using two overlapping covered CP stents. One with mild to moderate residual shunt that completely disappeared at 12 months follow-up after implantation of a second 45 mm CP stent. A significant residual shunt in the second patient was closed successfully using a PFO device. Transcatheter closure of SVASD through SVC stent insertion with or without subsequent device implantation is feasible and effective.

A Rare Case of Shone Complex, Where Coarctation was Treated Successfully with Covered Cheatham Platinum Stent

Shone complex is an extremely rare and severe congenital heart disease characterized by left -heart obstruction at multiple levels namely supravalvular mitral ring, parachute mitral valve, subaortic stenosis and coarctation of the aorta. We in the present case describe a patient of shone complex who underwent successful coarctoplasty with the help of BIB (balloon in balloon) dilatation catheter and covered CP (cheatham platinum) stent. The role of interventional cardiologist is to diagnose and choose the right approach for the specific patient, whether surgery, balloon or stent.

VSICON 2018 Prize Paper Abstracts

VSICON 2018 Prize Paper Abstracts

Initial assessment of a novel delivery system (NuDEL™ ®) for the covered Cheatham-Platinum stent.

The development of a bespoke system of a pre-mounted, pre-loaded covered stent may negate some of the technical challenges that complicate large-calibre stent deployment. Our preliminary results suggest that the NuDEL™ system is a safe and effective means of covered stent deployment in challenging anatomy.

25 Trans-catheter reconstruction of native interrupted aortic arch in adults

Transcatheter stenting is widely accepted treatment for coarctation of aorta in adolescents and adults, but stenting of interrupted aortic arch (IAA) is very challenging. We report 2 cases of adults, who had successful percutaneous reconstruction of IAA in our institute. Case 1 (33 year old) and case 2 (52 year old) presented with resistant systemic hypertension and subsequently diagnosed as having IAA in MRI scan. Right radial and right femoral arterial access was gained in both cases. Simultaneous angiograms in proximal and distal aortic segments confirmed IAA distal to the left subclavian artery, with a short atretic segment. After multiple failed attempts to cross the atretic segment by 0.035” Terumo wire and coronary guide wires, the atretic segment in both the cases was crossed by using radiofrequency (RF) guidewire ((Baylis MedComp Inc, Montreal, Canada). We crossed the atretic segment retrogradely from descending aorta in case 1 and antegradely from aortic arch in case 2 (Figures 1, 2). We snared the RF wire with goose neck snare and created an artero-arterial circuit. We placed the Amplatzer superstiff wire in the right subclavian artery and deployed 45mm length covered Cheatham platinum stents (NuMED Canada Inc, Canada) across the atretic segment in both the cases. Final angiogram showed good stent position with no complications and the pressure gradient across the stent was 2 mmHg. The echocardiograms 24 hours after the procedures were satisfactory with no complications. ![Abstract 25 Figure 1][1] Abstract 25 Figure 1 Showing the 3 dimensional magnetic resonance angiogram images of the aorta of the 2 cases of IAA. (A) Case 1, 33 year old man with IAA with proximal and distal stumps facing end to end. (B) Case 2, 52 year old with IAA with proximal and distal stumps facing side to side. [1]: pending:yes

Use of covered Cheatham-Platinum stents in congenital heart disease

BackgroundControversy remains regarding the use of covered stents in congenital heart disease (CHD). We evaluate the possibilities and safety of covered Cheatham-Platinum (CCP) stents in CHD. MethodsSingle-center retrospective CHD-database study of all CCP stents, 2003–2012. Three study groups: aortic coarctation (CoA), right ventricular outflow tract pre-stenting for percutaneous revalvulation (RVOT), and miscellaneous. Continuous data expressed as median (range). Results114 CCP stents in 105 patients, age 16.8years (4.2–71.2).CoA group: 54 CCP stents in 51 patients: 3/54 for aneurysm exclusion, in 51/54 covering used “prophylactically” because of increased risk for vessel tear. Overall, CCP stenting increased the coarctation diameter from 6mm (0–15) to 15mm (10–20) (p<0.001).RVOT group: 39 CCP stents in 37 patients (34 with RVOT graft, 3 with transannular patch): the graft lumen had shrunken from nominal 21mm (10–26) to 13mm (5–22); with the CCP stent the RVOT was redilated to 22mm (16–26, p<0.001 vs stenosis).Miscellaneous group: 21 CCP stents in 17 patients: closure of Fontan-circuit fenestration (n=5), restoration of superior caval vein (n=2) or pulmonary artery (n=3) patency, relief of supra-pulmonary stenosis (n=2), exclusion of aberrant pulmonary arteries (n=1), cavopulmonary conduit expansion (n=2), Blalock–Taussig shunt flow reduction (n=1), and defibrillator lead protection from sharp stents (n=1). Hybrid procedures performed in 3/17 patients. CCP stent was used as rescue treatment in 2/patients to seal iatrogenic bleeding. ConclusionCCP stents can safely be applied in CHD patients. The covering allows adequate sealing of existing or expected tears, thereby increasing the safety margin with more complete dilation.

Collapse of the advanta V12 large diameter covered stent following implantation for aortic coarctation

We report a case of collapse of the Advanta V12 Large Diameter (LD) covered stent following previous successful implantation for native aortic coarctation. This unreported complication was successfully managed with subsequent stent redilation and implantation of two covered Cheatham-Platinum stents within the collapsed Advanta V12 stent. This case highlights the importance of correct stent apposition to the aortic wall and also raises some concerns regarding the radial strength of the Advanta V12 stent.

Covered stents in the management of native coarctation of the Aorta—Intermediate and long‐term follow‐up

To evaluate the results of covered Cheatham-Platinum stent implantation in the management of native coarctation of the aorta and report intermediate and long-term follow-up. Covered stents are being used increasingly in severe and complex coarctation of the aorta mainly to reduce risk of aortic wall complications. There is, however, limited data on the intermediate and long-term outcome. Fifty-six patients received 59 covered Cheatham-Platinum stents (January 2002-December 2011) at a single center-in 54 patients as primary treatment and in 2 as a rescue. Mean age was 22.25 ± 1.2 (11-56) years and mean weight 58.6 ± 2.1 (32-99) kg. Primary end points were reduction in systolic pressure gradient and an increase in coarctation segment diameter. Changes in antihypertensive medicines and complications were recorded on follow-up. Mean coarctation segment diameter increased from 4.69 ± 0.20 to 15.1 ± 3.2 mm (P < 0.0001). The systolic gradient decreased from mean of 51.4 ± 3.4 to 4.6 ± 0.7 mm Hg (P < 0.0001). There was one death 3 days postprocedure due to cerebral anoxia. There was one dissection diagnosed 24-hr postprocedure. At a mean follow-up of 45.9 ± 3.9 (3-120) months, all stents were patent and in good position on computed tomography. Four (7.1%) patients underwent successful redilation. Antihypertensive medication was decreased or stopped in 37 (66%) patients. Covered Cheetham-Platinum stents may be used effectively as therapy of choice in selected patients with severe coarctation of the aorta. Aortic wall complications occur even with covered stents. Covered stents provide a safe alternative to conventional stenting in the intermediate and long-term and can be redilated safely to keep pace with somatic growth.

Percutaneous Balloon-Expandable Covered Stent Implantation for Treatment of Traumatic Aortic Injury in Children and Adolescents

Surgical treatment of pediatric acute traumatic aortic injury (TAI) after blunt chest trauma is standard of care. Use of endovascular stent grafts for treatment of TAI in adults is common but has important limitations in children. We sought to describe the use of balloon-expandable covered endovascular stents for treatment of TAI in children and adolescents. Participants of the multicenter Coarctation of the Aorta Stent Trial (COAST) had access to investigational large-diameter, balloon-expandable, covered stents (covered Cheatham-platinum stents; NuMed, Inc., Hopkinton, New York) on an emergency-use basis. From 2008 through 2011, 6 covered stents were implanted in 4 patients at 3 COAST centers for treatment of TAI. Median patient age was 13.5 years (range 11 to 14) and weight was 58 kg (40 to 130). All patients sustained severe extracardiac injuries that were judged to preclude safe open surgical repair of TAI. Median aortic isthmus and stent implantation balloon diameters were 16.4 mm (13.2 to 19) and 19 mm (16 to 20), respectively. Stent implantation was technically successful in all attempts. Complete exclusion of aortic wall injury was achieved in all cases. There were no access site complications. At a median follow-up of 24 months, there was 1 early death (related to underlying head trauma) and 1 patient with recurrent aortic aneurysm who required additional stent implantation. In conclusion, balloon-expandable covered-stent implantation for treatment of pediatric TAI after blunt trauma is generally safe and effective. Availability of this equipment may alter the standard approach to treatment of pediatric TAI.