Cheatham-Platinum Stent Research Articles

Aortic Arch Bare Metal Stenting in a 10-Years-Old Boy with DiGeorge Syndrome Using Overdrive External Pacing

Introduction: In the last decade, percutaneous stent placement has become the standard for treating CoA after childhood. However, stent placement as a treatment for aortic arch hypoplasia has only been described in small series and case reports. Case Report: A nine-year-old boy with DiGeorge syndrome (BW 50 kg, BL 140 cm, BSA 1.4 m2) was admitted to our hospital due to planned heart catheterisation with aortic arch stenting. In the neonatal period, he underwent complete surgical correction of the IAA type B with perimembranous VSD. During the follow-up period, the progressive narrowing of the aortic arch was observed with gradually increasing systolic pressure gradient (PG) on the echocardiography examination (PG 55 mmHg). The cardiac catheterization was performed under general anaesthesia. The peak-to-peak gradient was estimated at 32 mmHg (AoAsc 128/78 mmHg; AoDsc 96/68 mmHg). Aortography pointed out tubular hypoplasia of the aortic arch between branches (17 mm in length) with localized narrowing right behind the first aortic branch, 6 mm in diameter, and post-stenotic dilatation. The stenosis was resolved using a 22mm long uncovered Cheatham Platinum (CP) stent crimped on a 12 mm Balloon-in-Balloon (BiB) catheter with additional flaring of the distal stent part (Figure 1B and C). During the stent implantation, an overdrive external pacemaker (wire was placed into the right ventricle anterograde across the right femoral vein) was used. Control angiography relieved satisfying anterograde flow across the aorta and aortic branches. The peak-to-peak gradient after stenting was 10 mmHg. Conclusion: Although technically challenging, carefully analyzing the arch and vessel morphology allows the dilation of the transverse aortic arch hypoplasia and stenosis using a bare metal stent with good angiographic and hemodynamic results and without complications.

Standardized Bench Test Evaluation of Biomechanical Characteristics of Stents Used in Right Ventricular Outflow Tract Revalvulation.

Pre-stenting of the right ventricular outflow tract (RVOT) is commonly performed before percutaneous pulmonary valve implantation (PPVI), to relieve obstruction, prevent valved stent fractures, and provide a landing zone. This study aimed to evaluate the biomechanical characteristics of the stents currently used to perform pre-stenting of the RVOT. We assessed five commercially available stents: Cheatham-Platinum Stent ("CP Stent"), AndraStent XL, AndraStent XXL, Optimus XL, and Optimus XXL. Following stent deployment at nominal pressure, radial and longitudinal elastic recoils and radial resistance were measured. The bending stiffness of the stents crimped onto the balloons was also evaluated. Three samples were tested for each stent. Our study showed no significant difference between the stent platforms in terms of radial elastic recoil, which was relatively low (< 10%). The longitudinal elastic recoil was also low for all the devices (< 5%). Significant differences were observed in radial resistance (P < 0.001). CP Stent and AndraStent XL exhibited the highest radial resistances. The bending stiffnesses of the stents crimped on their balloons were significantly different (P < 0.00001). Optimus XL and XXL were more flexible than the other stents. This study highlights the significant differences between the stents currently used in RVOT pre-stenting. Stents with good radial resistance are preferred, especially for calcified vessels, and flexibility is crucial for tortuous vessels. We proposed an algorithm for selecting the most suitable stent according to the need for radial force and flexibility, which will help inform clinicians considering RVOT revalvulation.

Balloon-expandable cheatham-platinum stents versus self-expandable nitinol stents in coarctation of aorta: 3-year outcome of a randomized clinical trial

Abstract Introduction Although stenting showed early promising results in the treatment of patients with coarctation of aorta (CoA), its long-term benefit it is scarcely studied. Previously, we have shown, balloon-expandable stents (BES) and self-expandable (SES) stents were both effective and safe during 12-month follow up in the treatment of native CoA. Purpose To report the 3-year outcomes of BES versus SES stents in patients with native CoA. Methods Adult patients with de novo native CoA were randomized into Cheatham-platinum BES and uncovered nitinol SES groups in this parallel-group, open-label, blinded endpoint randomized clinical trial. All randomized patients were assigned to the 3-year structural follow up, consisted of clinical examination (including blood pressure measurement), exercise test for detecting masked hypertension, aortic CT angiography and transthoracic echocardiography. The 3-year incidence of recoarctation of aorta, thoracic aortic aneurysm formation, and residual hypertension were reported as the main long-term outcomes. Results Of the 92 patients initially randomized, 71 patients were participated in 3-year structural follow-up (Figure 1). Residual hypertension, defined as a persistent need for antihypertensive drugs at 3-year were significantly higher in BES (25 (71.4%) versus 17 (47.2%) patients (risk ratio (RR), 1.51, 95% confidence interval (CI), [1.00 to 2.26], p= 0.03) (Figure 2). Apart from five patients diagnosed with recoarctation during the first year of follow-up, no new cases of recoarctation were detected between 1 to 3-year follow up. Of note 2 of 3 patients with recorctation in the BES group, needed a second reintervention during the long-term follow up. Thoracic aortic aneurysm formation was not different in both stent types (4 (11.4%) versus 2 (5.6%) patients (RR, 2.06, 95% CI, [0.40 to 10.52], p= 0.37). Three-year median differences of ascending aorta and aortic arch were not different between the two groups. Conclusion Overall, both BES and SES were safe and effective in the long-term follow up. The rate of recoarctation was low even in the long-term follow up, which were safely reintervene. A hypothesis-generating difference were detected between two types of stents on residual hypertension which needs to be verified in larger studies.Baseline Characteristics and Study Flow3-year Outcomes

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.

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.

Evaluating the Effectiveness of Stenting for Aortic Coarctation

Coarctation of the aorta (CoA) is a congenital cardiovascular malformation involving narrowing of the thoracic aorta just distal to the left subclavian artery. The aim of our study was to evaluate the hemodynamic effects of endovascular treatment for CoA by using invasive aortic catheterization. All patients with CoA who underwent treatment by aortic stent implantation between September 1, 2003, and February 1, 2019, at the "Onassis Cardiac Surgery Center," in Athens, Greece, were evaluated. Patients were treated with either bare (uncovered) Cheatham-Platinum (bCP) or covered Cheatham-Platinum (cCP) stent implantations. Invasive aortic pressure measurements were recorded before and after the endovascular intervention. A total of 48, eight zig CP stents, comprising 24 bCP and 24 cCP stents were implanted in 47 patients. The mean aortic diameter (mm) at the CoA lesion increased from 9.7 ± 3.3 to 19.2 ± 2.9 mm (p <0.01) after the endovascular procedure. The invasive mean blood pressure (BP; mm Hg) from catheterization in the descending aorta increased (before = 114.2 ± 12.8 vs. after = 135.5 ± 28.1; p <0.01), while the invasive mean BP (mm Hg) from catheterization in the ascending aorta was decreased (before = 156.8 ± 25.0 vs. after = 138.4 ± 27.5; p <0.01) after the intervention. The mean aortic BP gradient decreased in both types of stents after intervention (BP gradient among patients with cCP stents = 30.9 +/- 23.6 mmHg and BP gradient among patients with bCP stents = 38.0 +/-23.1 mmHg). However, there was no statistically significant difference between the two types of stents; p = 0.36. Invasive aortic catheterization provided evidence that endovascular stenting with either bare or covered stents is efficient in treating patients with CoA.

Periprocedural and short-term outcomes of stenting of coarctation of the aorta in adults

Background: Coarctation of the aorta (CoA) is a rare congenital heart disease for which ballooning or surgery is recommended in the early stages of life, however, in adult patients, stenting has emerged as the treatment of choice. Data on various techniques and outcomes of stenting in CoA in Indian patients are scarcely available. Materials and Methods: Seven adult patients of CoA treated at our center with stenting between the years 2018 and 2022 were retrospectively studied. All patients were analyzed for their clinical presentation, coarctation segment anatomy, use of various techniques for stent deployment, perioprocedural outcomes, and 3-month echocardiography (ECHO)-based follow-up with the study of gradients and clinical features. The use of various hardware to facilitate stenting was studied, and predictors of successful stenting were also defined in the analysis. Results: The mean age of the coarctation patients was 19.1 ± 3.7 years with a male-to-female ratio of 3:4. The mean systolic blood pressure at baseline was 162.5 ± 12.6 mm of Hg and mean diastolic blood pressure of 95.7 ± 5.3 mm of Hg. The mean peak systolic gradient across the coarctation segment at baseline was 46 ± 8.2 mm of Hg. Combined antegrade and retrograde access was used for stenting of CoA in four patients (57%). Good-sized isthmus was present in only three patients (42%), and balloon predilatation was required in three patients (42%). The use of combined antegrade and retrograde route, good-sized isthmus, and adequate balloon predilatation were predictors of successful wire crossing and stent deployment across the coarctation segment. The mean ECHO-based follow-up gradient at 3 months was 9.2 ± 2.5 mm of Hg. Conclusions: Stenting for native CoA with the use of Cheatham-platinum stents in adult patients is a highly effective and safe therapy. Longer-term follow-up studies are required to show the exact incidence of stent fracture and aneurysm formation after stenting.

Hybrid repair of a giant left subclavian artery aneurysm and arch coarctation in a patient with Larsen syndrome.

A 34-year-old male was admitted to our emergency department with progressively aggravated hoarseness and sudden onset of chest and neck pain. General examination was remarkable for severe scoliosis (Panel A) and a blood pressure gradient of >20 mmHg between upper and lower extremities. Computed tomography angiography (CTA) revealed a giant left subclavian artery (LSA) aneurysm (55 × 47 mm, asterisk), aortic arch coarctation, and severely tortuous descending aorta. In addition, an isolated left vertebral artery (ILVA) arose from the arch (Panel B-C). Whole-exome sequencing analysis identified p.Gly488Ser mutation in FLNB, indicating a diagnosis of Larsen syndrome. Considering the patient’s refusal of open surgery and the acutely worsening symptoms due to the pending rupture of the LSA aneurysm, a less-invasive hybrid approach was accepted as reasonable by interdisciplinary consensus. First, through the right femoral artery, a 20 F sheath (W.L. Gore and Associates, Newark, Del) was advanced across the arch coarctation, facilitating the delivery of the aortic stent. Then, a Gore cTAG stent was implanted at the arch distal to the innominate artery orifice, followed by a balloon-expandable Cheatham-Platinum stent (NuMED, Hopkinton, USA) deploying at the coarctation segment. Second, the membrane of the cTAG stent was penetrated with an aspiration biopsy needle through the left common carotid artery (LCCA). The fenestration was then expanded by balloons and LCCA was stented with a 120 × 40 mm covered endograft (Panel D–F; Supplementary material online, Video S1). After the endovascular procedures, the ILVA was anastomosed end-to-side to LCCA. Finally, the distal outlet of LSA aneurysm was ligated, and a bypass from LCCA to distal LSA was performed with a 6 mm Gore-Tex prosthetic graft (Panel G). Completion angiography (Panel H; Supplementary material online, Video S2) and postoperative CTA (Panel I) confirmed exclusion of the aneurysm and patency of all the supra-arch vessels. The postoperative course was uneventful and the patient was discharged on the 4th day after surgery.

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.

Feasibility of Transcatheter Closure of Large Secundum Atrial Septal Defect with Absent Superior or Inferior Rim.

Introduction Surgical closure of a large secundum atrial septal defect (ASD) with an absent superior or inferior rim is the standard method of management, but transcatheter closure of such a defect is possible and feasible. Objectives To evaluate the feasibility, effectiveness, and safety of transcatheter closure of large secundum ASD with an absent superior or inferior rim through implantation of a cheatham platinum (CP) stent at the entrance of the superior vena cava (SVC) or inferior vena cava (IVC) into the right atrium (RA) to create a suitable rim for subsequent complete closure of the defect using a septal occluder. Patients and Methods. This case series was carried out at Ibn Al-Bitar Center for Cardiac Surgery, Baghdad, Iraq from 2014 to 2019, five patients underwent such transcatheter approach for closure of large secundum ASD with the absent superior or inferior rim by implantation of CP stent at the entrance of vena cave into the RA. Result The ages and weights of patients who were enrolled in this study ranged from 9–31 years (15.2 ± 9 years) and 31.5–62 kg (42.6 ± 12 kg). Three patients had absent superior rims, and the other two had absent inferior rims. The Qp/Qs was ranged from 1.9–3.2 (2.78 ± 0.29), and the mean pulmonary arterial pressure ranged from 22–29 mmHg (25.4 ± 3 mmHg). The defects with an absent superior rim were closed successfully by implantation of CP stents of 45, 45, and 39 mm to create a rim which supported the left atrial disc of 30, 38, and 32 mm atrial septal occluder (ASO), respectively, while large secundum ASD with an absent inferior rim could be effectively closed by implantation of two overlapping bare CP stents of 45 mm to create an IVC rim that supported 34 mm and 30 mm atrial septal occluder. Conclusion and recommendation. Transcatheter closure of large secundum ASD with absent superior or inferior rim is possible and effective by implantation of covered and bare CP stents at the entrance of SVC and IVC, respectively. Although these procedures are relatively difficult and challenging, especially in the closure of large defects associated with absent inferior rim, they carry a high risk of stent migration (8 zig, 45 mm), so we recommend using a CP-stent (10 zig, 60 mm).

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.

Case report of a Gore-Tex TCPC conduit dissection causing severe stenosis

BackgroundThe patient is a 15-year-old male with situs inversus, dextrocardia, bilateral superior caval veins, atrioventricular discordance with a single outlet, large perimembranous ventricular septal defect, aortic override, pulmonary atresia, and right aortic arch. The complex anatomy with a Ventricular Septal Defect (VSD) distant from the aorta (unsuitable for baffling to the aorta) meant he was unsuitable for biventricular repair and proceeded down a univentricular palliation pathway.Case summaryPost-total cavopulmonary connection his clinical course was uneventful until the age of 5 when he developed fatigability with desaturation. An accessory hepatic vein was surgically banded with improved saturations and exercise tolerance. At the age of 15, cardiovascular magnetic resonance (CMR) was performed to investigate borderline saturations and as workup for transition to adult services. Cardiovascular magnetic resonance and cardiac computed tomography (CT) imaging demonstrated an eccentric thrombus causing stenosis of the extracardiac conduit and a thrombus outside of the lumen contained by the thin outer membrane of the Gore-Tex conduit. Collateralization suggested this was longstanding. Cardiac catheterization demonstrated a 4 mm × 6 mm stenosis at the junction of the conduit with the pulmonary arteries. The region was successfully balloon dilated and stented with a 34 mm-long Cheatham Platinum stent, with no complications.DiscussionTo date, this is the first documented case of a dissecting thrombus of a Gore-Tex graft in the literature. This case emphasizes the need for anticoagulation and serial cross-sectional imaging (CT or CMR) in Fontan patients with prosthetic grafts throughout a patients’ lifetime.

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.

Cheatham-Platinum 10-zig stents for transcatheter treatment of congenital heart diseases: A new tool to widen the spectrum of treatable conditions

ObjectivesTo report our experience using the 10-zig C-P stents in children and adults with congenital heart disease. BackgroundThe use of stents in congenital heart disease has become widespread since the 1990s and a large range of stents has been designed for a variety of indications. In many situations there is a need for stents that can be dilated to large diameters without excessive shortening. Cheatham-Platinum (10-zig C-P) (NuMED, Hopkinton, NY, USA.) stents may fulfil this requirement. MethodsBetween January 2015 and January 2020, 17 patients with congenital heart disease were treated using a 10-zig C-P stent at our center. (6 Females 13 males; (median age 33 years (range 10–69 years); median weight 85 kgs (range 25–119 kg). Indications for use of the 10-zig stents were right ventricular outflow tract (RVOT) interventions in 8 subjects and aortic coarctation in 9 patients. Results1) Right ventricular outflow tract stenting. Ten right ventricular outflow tract stents (2 also had implantation of transcatheter valves in the same procedure) were implanted in 8 patients. All the RVOT interventions were in preparation for a transcatheter pulmonary valve. Median fluoroscopy and procedure times were 41 min (range 31–131 min) and 164 min (range 152–361 min), respectively. One patient had distal perforation of a pulmonary artery due to guide-wire injury and required blood products. Two subjects showed stent fracture during follow-up needing further stent implantation. 2) Aortic Coarctation. Nine stents were implanted in 9 patients. The median fluoroscopy and procedure times were 36 min (range 11–75 min) and 164 min (range 95–225 min), respectively. The median peak systolic gradient reduced from 33 mmHg (range 15–60 mmHg) to 3 mmHg (range 0–4 mmHg) (p < 0.001). ConclusionsOur experience shows that the 10-zig Cheatham-Platinum stents can be used successfully and safely in congenital heart diseases.

Comparison between cheatham-platinum stent and self-expandable uncovered nitinol stent in patients with coarctation of aorta – a randomized controlled trial

Abstract Background Endovascular treatment is considered the main therapeutic approach for native coarctation of aorta (CoA) in adult patients. Balloon-expandable stents (BE) have been introduced as the primary choice for coarctoplasty. However during the recent years, self-expandable (SE) stents with acceptable radial force have been suggested as an alternative. Still, no randomized controlled (RCT) trials have compared the efficacy and safety of both strategies. Methods The present study is a prospective, single center, parallel-group, open-label RCT on patients with native CoA (Figure). Patients were randomized into Bare Cheatham-Platinum Stents and Uncovered Nitinol Stent (SE). All patients were scheduled to be followed in 1-, 6-, 12-month and 36-month intervals. The present report, focuses on the one-year outcome of the study. Results Of 101 patients with native CoA referred to our center, 93 patients have been randomized into BE- (47 patients) and SE-arm (46 patients). One year follow up is scheduled to be completed on March 2020. In the preliminary analysis of 62 patients, 1 intraprocedural stent migration has occurred in each group. No aortic perforation was detected in the study. Vascular access site complications were similar between the two groups (3 (6.3%) in BE versus 1 (2.1%) in SE, p value= 0.432). One nonfatal stroke occurred in BE group. No mortality or bailout surgical repair happened in one year study in the two groups. One patient with re-coarctations were detected during one year follow up in each of the groups (p value=0.210). No aortic pseudoaneurysm or aneurysmal formation were observed in 12-month follow up aortic CT angiography. Conclusion The preliminary results showed no significant difference in efficacy and safety of both treatment modalities. The final result is pending. Study Flow Chart Funding Acknowledgement Type of funding source: None

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.