Covered Cheatham Platinum Research Articles

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.

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.

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

Implantation of stents for postsurgical recoarctation of the aorta in adolescents and adults.

Results of stent implantation (SI) of postsurgical recoarctation of the aorta (ReCoA) are not frequently published. This study sought to retrospectively evaluate results of SI in ReCoA in older children and adults. Twenty-eight SIs were performed on 26 ReCoA patients with a median age of 23 (10-65) years. Dependent upon availability, the following stents were applied: Palmaz, Cheatham Platinum (CP), Andrastents XL/XXL (AS), Covered CP (CVCP) stents, and self-expanding stents (Smart). Generally, high-pressure balloons were applied to dilate stents. The procedure was effective in 20/26 patients (77.7%). The mean peak systolic gradient reduced from 40.5 ± 18.7 mm Hg to 13.1 ± 12.1 mm Hg (p < 0.05), and the diameter of the stenosed segment increased from 7.5 ± 3.02 mm to 13.1 ± 3.32 mm (p < 0.05). In six cases (including a patient treated with a Smart stent) transaortic pressure gradient after SI remained > 20 mm Hg (stiff postsurgical lesion). For one patient (40-year-old male), an acute dissection of the aorta occurred during balloon predilatation. Immediate CVCP implantation resolved this problem. Two more CVCPs were used - one to close a small aortic aneurysm that appeared five years after a Palmaz SI and another to stabilise a broken CP bare metal stent. There were no deaths or aortic dissections during follow-up, and most patients were able to reduce or suspend their medication for systemic hypertension. Endovascular stenting of ReCoA in adults and adolescents appears to be an acceptable method of treatment in experienced hands. However, for some patients the presence of a stiff lesion can provoke suboptimal results. Considering the serious complications that can occur after SI, all patients should have regular follow-up (including an imaging study). Covered stents should always be available in the cathlab as a rescue device when implanting stents in coarctation of the aorta patients.

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

GW25-e5117 Simultaneous Treatment of Native Aortic Coarctation Combined With Patent Ductus Arteriosus Using a Covered Stent

Stents have assumed an important role in therapeutic catheterization procedures for patients with congenital heart disease .In this article, we report on the use of a covered Cheatham-Platinum (CP) stent to treat coexistent coarctation of the aorta and patent ductus arteriosus. A 22-year-old boy

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.

Upper cavo‐pulmonary anastomosis by transcatheter technique

The aim of this animal study was to establish a shunt connection between superior vena cava (SVC) and right pulmonary artery (RPA) by transvascular intervention solely. After initial shunt creation, the establishment of the upper cavo-pulmonary anastomosis (UCPA) is the second out of three open chest operations young infants with univentricular anatomy are subjected to. To avoid the risks of reoperation with cardiovascular bypass, we sought to replace this surgical step by an interventional technique. After cannulation of jugular and femoral veins in four piglets (mean body weight of 12.5 kg) an UCPA was created by radiofrequency perforation from the SVC across the right atrium into the RPA and subsequent implantation of covered stents. The perforation was guided by biplane fluoroscopy and the perforation wire premounted with a coaxial catheter was advanced into the distal pulmonary artery and exchanged for a stiffer wire. A long sheath was brought into the RPA and an 80 mm long expanded poly-tetra-fluoro-ethylene (ePTFE)-covered Cheatham Platinum stent was then implanted connecting the SVC with the RPA. Immediate angiography showed antegrade flow from SVC to RPA. Angiographic re-evaluation after a median period of 4 weeks showed partial in-stent stenosis but patent lumina. Additionally, veno-venous collaterals from the SVC to the right atrium had developed. Histology of the explanted stents revealed parietal thrombi and mild to moderate pseudo intima proliferation inside the lumina. The transvascular creation of an upper unidirectional cavo-pulmonary anastomosis in piglets is technically feasible using standard catheterization equipment.

Closure of extracardiac Fontan fenestration by using the covered Cheatham Platinum stent

The purpose of this study was to describe our experience concerning the use of covered Cheatham Platinum (CP) stent in patients with fenestrated total cavopulmonary connection (TCPC). Closure of TCPC fenestrations has been achieved by utilizing different devices designed to close intra-cardiac or aorto-pulmonary communications. We used the covered CP stent in 6 patients with fenestrated TCPC. Median age and weight were 11 years and 38 Kg, respectively. Femoral approach was used in all but 1 patient having bilateral thrombosis of femoral veins. The CP stent was crimped on a BiB balloon in 5 patients and on a simple balloon in 1 patient. The balloon's diameter was the same size or 1-2 mm larger than the TCPT conduit, according to angiographic diameter. Mean procedural and fluoroscopy time were 41 +/- 8 and 8 +/- 2 min, respectively. Immediate full occlusion of fenestration was obtained in all patients. Mean central venous pressure was not significantly increased from 10.8 +/- 2.5 to 11.8 +/- 2.8 mm Hg and oxygen saturation significantly increased from (91.5 +/- 4.4)% to (98.5 +/- 1.9)% (P = 0.003). No procedural or intra-hospital complications occurred. In particular, no arrhythmias, systemic embolism, or acute venous thrombosis were observed. At a median follow-up of 2.8 months all patients have normal oxygen saturation and are symptom-free. The covered CP stent can be easily and effectively used for closure of TCPC fenestrations. This method has the advantage to avoid protrusion of prosthetic material into the left atrium and to prevent early or late embolism.

Covered Cheatham-Platinum Stents for Aortic Coarctation: Early and Intermediate-Term Results

This study sought to evaluate the use of covered Cheatham-platinum (CP) stents in the treatment of aortic coarctation (CoA). Aortic aneurysms and stent fractures have been encountered after surgical and transcatheter treatment for CoA. Covered stents have previously been used in the treatment of abdominal and thoracic aneurysms in adults. We implanted covered CP stents as a rescue treatment in patients with CoA aneurysms or previous stent-related complications and in patients at risk of developing complications because of complex CoA anatomy or advanced age. Thirty-three covered CP stents were implanted in 30 patients; 16 patients had had previous procedures. The remaining patients had complex or near-atretic CoA. The mean patient age and weight were 28 (+/-17.5) years (range 8 to 65 years), and 62 (+/-13) kg (range 28 to 86 kg), respectively. The systolic gradient across the CoA decreased from a mean (+/-SD) of 36 +/- 20 mm Hg before to a mean of 4 +/- 4 mm Hg after the procedure (p < 0.0001), and the diameter of the CoA increased from 6.4 +/- 3.8 mm to 17.1 +/- 3.1 mm (p < 0.0001). The follow-up period was up to 40 months (mean, 11 months). All stents were patent and in good position on computed tomography or magnetic resonance imaging performed three to six months later. In 43% of the patients antihypertensive medication was either decreased or stopped. Covered CP stents may be used as the therapy of choice in patients with complications after CoA repairs, whereas they provide a safe alternative to conventional stenting in patients with severe and complex CoA lesions or advanced age.