A word of caution: Early failure of Magmaris® bioresorbable stent after pulmonary artery stenting

Bioresorbable scaffolds (BRS) have been advocated as the fourth revolution in interventional cardiology medical devices with promising technology to improve the treatment of coronary artery disease with an event-free future. We describe the first reported use and early collapse of the Magmaris® Resorbable Magnesium Scaffold (RMS) stent (BIOTRONIK AG, Switzerland) to relieve left pulmonary artery severe stenosis in a newborn after the Norwood procedure. The stent collapse was detected 2 weeks after implantation and urgently treated with a balloon-expandable stent. This complication raises the alarm about the need to keep implanted RMS under scrutiny. The possibility of faster scaffold resorption in small babies or lack of sufficient radial force of RMS to resist acute vessel recoil has led to ineffective relief of branch pulmonary artery stenosis and failure to enable a safe short-term bridge to Stage II palliation.     

Usefulness of stenting in aortic coarctation in patients with the Turner syndrome

We report our experience with stent implantation for treatment of aortic coarctation in patients with Turner syndrome. Ten consecutive patients with Turner syndrome and aortic coarctation (median age 12 years, range 9 to 24) underwent coarctation stenting. Of these, 6 patients were treated for isolated coarctation and 4 for recurrent coarctation (3 after balloon dilation and 1 after balloon dilation and surgical repair). Bare metal stents were implanted in 7 patients and covered stents in 3. Immediately after stent implantation, peak systolic gradient decreased from 46.1 ± 24.3 to 1.9 ± 2.1 mm Hg (p <0.001). Aortic diameter at coarctation site increased from 5.1 ± 3.2 to 15.3 ± 2.0 mm after stenting (p <0.001). There were no deaths or procedure-related complications. During a median follow-up of 30.5 months, no patient developed restenosis. Two patients developed late aortic aneurysms at the coarctation site. In conclusion, stent implantation for aortic coarctation in patients with Turner syndrome appears to be a safe and effective alternative to surgical repair. Larger cohorts and longer-term follow-up are required to determine the effects of the procedure on the aortic wall.     

Self‐expanding and balloon expandable covered stents in the treatment of aortic coarctation with or without aneurysm formation

Objectives: We describe our complete experience with covered stent implantation for aortic coarctation including short‐ to medium‐term outcomes. Background: Coarctation of the aorta is a heterogeneous disease process with multiple associated complications both with and without treatment. Covered stents have evolved to provide greater support to the aortic wall and a varied approach with choice of stent tailored to the anatomy of the patient is required. Methods: We retrospectively analyzed consecutive patient data from two congenital heart centers from March 2003 to October 2007. Results: We implanted 38 covered stents in 37 patients (20 female) of which three were self‐expanding stents. Median age was 29.6 years (9–65) with median weight of 71.5 kg (35–95). The indications for stent placement were native coarctation (n = 13); recurrent coarctation following surgical treatment (n = 11); aneurysm associated with previous coarctation surgery (n = 7); aorto‐bronchial fistula leading to acute hemoptysis (n = 2); stent fracture (n = 1); associated arterial duct (n = 2). One patient had a combination of acquired coarctation and false aneurysm. The median screening time was 10 min (3–22). The median systolic gradient of 26 mm Hg (10–60) was reduced to 4 mm Hg (0–20) postprocedure (P < 0.001). There were no deaths on median follow up of 11.5 months (1–56). One patient developed aortic rupture during the procedure and required emergency surgery. Conclusion: Covered stent implantation for treatment of aortic coarctation is safe and highly effective in selected patients. Self‐expanding stent grafts may be preferable to balloon expandable stents when there is aneurysm formation in the setting of aortopathy. © 2008 Wiley‐Liss, Inc.     

Redo sternotomy for extra-anatomical correction of aortic coarctation and mitral repair in an adult after failed endovascular treatment

Recently, extra-anatomical bypass surgery has been widely used in complicated adult aortic coarctation cases with concomitant intracardiac repair. Stent implantation has been widely used for primary aortic coarctation as well. The procedure has been shown to be effective with long term follow ups. However, failed stent implantations like stent fracture and dislodgement may complicate the clinical status and subsequent surgical procedure. Extra-anatomic bypass can provide effective results and lower morbidity in cases with concomitant intracardiac problems and stent failure. Here we present an adult aortic coarctation patient who had undergone a Bentall operation and two unsuccessful stent implantations for recurrent aortic coarctation. The patient then got an extra-anatomic bypass for aortic coarctation and concomitant mitral valve commissurotomy through median sternotomy.     

Early and mid‐term results with the growth stent—A possible concept for transcatheter treatment of aortic coarctation from infancy to adulthood by stent implantation?

Aims : Evaluation of the Growth Stent—a stent consisting of two stent halves connected by reabsorbable sutures—for the treatment of aortic coarctation in infants. Methods and Results : Surveillance study of 13 Growth Stents implanted in 12 patients aged 1–15 months (median 5 months). Body weight ranged from 3.4–12.8 kg (median 5.4 kg). Eight patients suffered from aortic (re‐)coarctation, four of them from stenosis of the aortic anastomosis after a Norwood I procedure. The follow‐up period was 24 months (11–51 months). Pressure gradients immediately after stent implantation decreased from 30 mm Hg (range 20–50 mm Hg) to 8 mm Hg (range 0–15 mm Hg). Five patients had one (3 pts) or two (2 pts) balloon dilations 3–28 months (median 12 months) after Growth Stent implantation. The median pressure gradient decreased from 25 mm Hg (range 15–30 mm Hg) to 15 mm Hg (range 5–25 mm Hg). Six patients received a large stent after 19–34 months. Median body weight was 11.8 kg (9.4–15 kg). Conclusions : The Growth Stent is suitable for the acute treatment of aortic coarctation in infants and can be overstented later on—if necessary—with a larger stent without causing restriction. © 2008 Wiley‐Liss, Inc.     

Treatment of aortic aneurysm with covered stent. Case report.

The authors present the case of a thirteen-year-old boy with aortic coarctation, which was surgically corrected at the age of 2.5 months. He subsequently developed recoarctation, which was treated with balloon dilatation. Recently, recoarctation and an aortic aneurysm were observed, which were corrected with covered stent implantation. We discuss various techniques for correction of aortic coarctation, as well as their advantages and disadvantages.     

Stent implantation for aortic coarctation complicating the Norwood operation in a 48-day-old baby.

A female infant developed severe aortic coarctation 42 days after a Norwood operation. Balloon dilatation was ineffective due to rapid recoil of the narrowing, but stent implantation completely abolished coarctation. Although the patient died because of low systemic output with high pulmonary flow 62 days after stent implantation, an autopsy showed that the implanted stent was widely patent without any restenosis. Transcatheter stent implantation should be considered for coarctation in selected situations even in early infancy.     

Bailout stenting for critical coarctation in premature/critical/complex/early recoarcted neonates

Background: Surgical repair of critical coarctation can be problematic in premature, critical, complex, or early postoperative neonates. Objectives: We aimed to review our experience with stent implantation to defer urgent surgery to an elective time. Methods: Fifteen neonates with severe aortic coarctation: five premature‐hypotrophic (1,400–2,000 g), six critical and complex cardiac malformation, four early (1 day [0–2 days]; median [range]) after surgical coarctectomy or complex arch reconstruction. Bare coronary stents (diameter 4.0 [3.5–5.0] mm; length 10 [8–16] mm) were used. Stents were removed surgically depending on clinical needs. Results: Adequate aortic flow was obtained in 15 patients. The femoral artery was preserved in 13/15 patients. Two deaths occurred before stent removal and were nonprocedure related. In patients with simple stented coarctation, the stent was removed after 2.8 [0.2–5.0] months. In complex cardiac malformation, stents were finally removed 3.0 [0.2–78] months after implantation. Surgical technique: simple coarctectomy end‐to‐end in eight, extensive arch patch reconstruction in four. One patient is awaiting stent removal. The final maximum systolic velocity (cw‐Doppler) across the aortic arch was 1.7 [1.2–2.5] m/sec. Conclusions: In premature/critical/complex neonates with severe coarctation, bailout stenting followed by early or late surgical coarctectomy appears a promising concept. © 2009 Wiley‐Liss, Inc.     

Endovascular Stenting for Native Coarctation of the Aorta Is an Effective Alternative to Surgical Intervention in Older Children

Objective. Assess the early and intermediate results with respect to blood pressure control in older children undergoing endovascular stenting for native coarctation of the aorta. Design. Eleven hypertensive patients (10 ± 3 years of age) underwent endovascular stenting via standard techniques for native coarctation of the aorta as an alternative to surgical repair. Resting and exercise assessment of blood pressure control with Doppler echocardiography was performed pre‐ and poststenting. Results. All 11 patients underwent successful stenting without complications and were able to be weaned off antihypertensive medications within a short period of time. At latest follow‐up (34 ± 26 months), all patients are normotensive at rest and during treadmill exercise stress testing. Two patients underwent uncomplicated additional stent dilation at follow‐up cardiac catheterization. Conclusion. Endovascular stenting for native coarctation of the aorta in older children is a reasonable alternative to surgical correction. During early follow‐up, stenting effectively alleviates the aortic arch obstruction with normalization of the systemic blood pressure both at rest and during maximal exercise.     

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. © 2013 Wiley Periodicals, Inc.     

Transcatheter stent implantation to treat aortic coarctation in infancy.

A ten week old girl who had previously undergone a palliative procedure for the hypoplastic left heart syndrome had unrelieved aortic coarctation that did not respond to standard balloon dilatation. Complete relief of coarctation with prompt clinical improvement was achieved with placement of an 8 mm self-expanding stent. Transcatheter stent implantation may have a role in selected patients with aortic coarctation.     

The “Dog Bone Technique” A Novel Easy and Safe Catheter Maneuver for Aortic Arch and Coarctation Stenting

Background

Various techniques are described to facilitate stable stent implantation in aortic arch stenosis or coarctation. We describe an alternative technique, which due to its unique appearance during stent implantation, we have named “Dog Bone Technique” (DBT).

Technique

The stent/balloon assembly is placed across the stenosis, the long sheath is retrieved to uncover the distal 20–50% of the stent. The balloon is inflated with the pressure inflator just to expand slightly the stent. Thereafter the sheath is pulled back and the proximal end is uncovered and partially inflated; therewith the assembly takes the typical “dog bone” shape before complete inflation and final positioning. Repositioning of the stent and control angiography is possible at each time of this procedure.

Results

Between 1/2010 and 12/2014 we implanted 91 stents in 87 patients (mean age 20.2 years). About 71 patients had native or re‐coarctation and 16 patients had transverse aortic arch stenosis. In 38 patients (44%) a pharmacological exercise test with Orciprenaline was performed during implantation resulting in high‐cardiac output. In none of the patients reduction of cardiac output by adenosine or a rapid pacing of the right ventricle was required for stable stent implantation. All stents were implanted in the targeted position using this single balloon technique. There were no acute or short‐term complications detected.

Conclusion

DBT is a safe and feasible technique for aortic stent implantation even at high‐cardiac output. Other additional techniques for stent placement are not necessary to obtain a stable final position in the target region.

     

Coarctation of the aorta treated with the Advanta V12 large diameter stent: Acute results

Objectives: To report on the early results of treatment of coarctation of the aorta by dilation with a new polytetrafluoroethylene covered stent. Background: Transcatheter dilation of aortic coarctation carries the risk of aneurysm or rupture. Covered stent implantation reduces this risk but requires a large delivery system. The Advanta V12 LD covered stent is premounted and requires a 9–11 Fr delivery system. Methods: Covered stents on balloons of a diameter sufficient to anchor the stent in the coarctation were implanted using the smallest available delivery system. Secondary dilation with larger diameter balloons was performed until the pressure gradient was <20 mm Hg and the stent was opposed to the aortic wall. Results: Twenty‐five patients with aortic coarctation underwent stent implantation. Coarctation diameter increased from (6.3 ± 3.5) mm to (14.4 ± 2.3) mm (P < 0.0001). Peak pressure gradient decreased from (25.3 ± 11.6) mm Hg to (2.5 ± 3.0) mm Hg (P < 0.0001). The stent achieved the desired diameter in all cases. There were no complications. At short‐term median follow‐up of 4.9 months, all patients are alive and well with no evidence of recoarctation or aneurysm. Conclusions: These initial results show that the covered Advanta V12LD stent is safe and effective in the immediate treatment of coarctation of the aorta through a low profile delivery system of 8–11 Fr. Long term follow up is required. © 2009 Wiley‐Liss, Inc.     

Stent implantation for aortic recoarctation--a case report

A case of a 17-year-old boy with a history of aortic coarctation, treated with surgery at the age of 10 years, is presented. Due to recoarctation, the patient underwent successful CP stent implantation.     

Covered stents in the treatment of aortic coarctation

Coarctation of the aorta can be managed in different ways depending upon the age of presentation, anatomical details of the coarctation, the aortic arch anatomy, and whether the coarctation is native or a recurrence following surgery. In infants, surgery is the preferred treatment of choice, whereas in older children and adults, percutaneous procedures, such as balloon angioplasty or stent implantation, are becoming increasingly popular methods for treating coarctation. Various types of stents have been used and this paper specifically addresses the use of covered or graft Jomed stents in a small group of patients with coarctation.     

Multi‐Drug–Resistant Hypertension Caused by Severe Aortic Coarctation Presenting in Late Adulthood

Aortic coarctation, a congenital narrowing in the region of the ligamentum arteriosium, is a rare etiology for multi‐drug–resistant hypertension in adulthood; however, advances in stenting modalities may offer long‐term improvements in morbidity and possibly even cure. We report on a female patient in her late 50s presenting with refractory hypertension and severely elevated renin levels, ultimately diagnosed with aortic coarctation and treated with percutaneous stent implantation, which resulted in successful blood pressure control with verapamil monotherapy. This case highlights the efficacy of endovascular stent implantation for the treatment of coarctation and the need for clinicians to consider this disease entity in the differential diagnosis of refractory hypertension even in late adulthood     

Endovascular stents for treatment of coarctation of the aorta: Acute results and follow‐up experience

Balloon angioplasty as treatment for coarctation of the aorta is increasingly performed. Endovascular stents have been proposed as a means of improving the efficacy and safety of the procedure. In this report, we describe one institution's immediate results and clinical follow‐up after implantation of endovascular stents. Retrospective analysis for endovascular stent placement for coarctation of the aorta between 1993 and 2002 was made. The immediate hemodynamic results and clinical follow‐up were reviewed. Thirty‐two patients underwent attempted stent placement for coarctation. Twenty‐three patients had postoperative recurrent coarctation and nine had native coarctation. The systolic gradient decreased from 31 to 1.8 mm Hg (P = 0.001) and the diameter was increased 8.1 to 13.5 mm (P–0.001). Mean follow‐up was 1.5 years. The mean follow‐up gradient as assessed by sphygomomanometry was 13.1 mm Hg. Eight patients underwent 10 successful further dilations. Complications included one stent migration and one aortic dissection. The use of stents as an adjunct to balloon angioplasty in selected patients with coarctation can be performed with low complication rates and provides excellent immediate relief of obstruction with promising follow‐up. Further dilation of these stents is possible. Long‐term follow‐up is warranted. Catheter Cardiovasc Interv 2004;62:499–505. © 2004 Wiley‐Liss, Inc.     

First‐in‐man use of a tapered endovascular stent graft for treatment of aneurysm after coarctation repair

Objectives : Endovascular stenting of aneurysms late after surgical repair of coarctation may have to deal with marked changes in aortic diameter proximal and distal to the aneurysm. We report our first‐in‐man successful use of a custom‐made tapered (variable diameter) covered stent. Methods : The aneurysm was 42 mm in diameter with a length of 40 mm. On MRI, the aorta measured 19.6 mm proximal and 13.3 mm distal to the aneurysm. The aim was to oversize the stent by 10–20%. A covered Cheatham‐platinum stent was designed so that cranial portion of the stent would expand to 22 mm and the caudal portion to 15 mm with a length of 8.5 cm when fully inflated. The stent was mounted on a balloon‐in‐balloon delivery system and was delivered through an 18 F femoral arterial sheath. Rapid‐pacing technique was used for deployment. Results : The stent was successfully deployed without complications. After deployment, the stent diameter measured 21.2 mm cranially and 15.6 mm caudally. A mild distal endoleak due to inadequate fixation of the stent graft was resolved by post dilation expanding the stent diameter to 22.1 mm and 15.9 mm, respectively. The femoral access site was closed using two percutaneous closure devices and the patient discharged the day after the procedure. Follow‐up CT‐angiography showed continued successful exclusion of the aneurysm. Conclusions : A new custom‐made balloon expandable covered stent‐design enabled successful treatment of an aortic aneurysm. This design may offer greater potential for more favorable initial angiographic results and potentially long‐term outcomes due to superior apposition to the aortic wall. © 2010 Wiley‐Liss, Inc.     

Endovascular stent placement is an acceptable alternative to reoperation in selected infants with residual or recurrent aortic arch obstruction

Objective : To describe endovascular stent placement in infants as a technically feasible option in circumstances where surgery is considered less favorable. Background : Endovascular stent placement has become established as a first line therapy for native coarctation of the aorta or recoarctation in older children where stents capable of expansion to adult size can be placed safely. Surgery remains the therapy of choice in infants and young children. The management of aortic arch obstruction in infants is, however, frequently complicated by complex anatomy or clinical condition that may make surgery or further surgery an unattractive option. There is little reported data and the implications thereof of transcatheter stent placement in aortic arch obstruction in infants. Methods : Between August 2004 and November 2009, 11 patients had aortic arch obstruction treated with endovascular stent placement. The median age and weight at first stent placement was 46 days (range 3–399 days) and 4 kg (range 1.4–8 kg), respectively. In 10 patients, surgical intervention preceded transcatheter stent placement. Four had complex aortic arch obstruction and seven had recoarctation. Results : Reduction in peak systolic gradient to <10 mm Hg was achieved in seven of 10 patients with an improvement in aortic artery diameter to >90% of adjacent aorta in all. The diameter of the arch obstruction increased from a median of 1.60 to 4.90 mm (P = 0.001) and the peak systolic gradient from 45 mm Hg to 8 mm Hg (P < 0.0001). Adverse events occurred in two patients one who required further surgical revision and a second who required placement of a second stent. The median follow up was 3.60 years (range 0.4–5.5 years) with two patients having died at 1.34 and 1.42 years poststent placement. Of the nine patients alive, six have since undergone further angioplasty at a median time interval of 0.77 years (range 0.17–2.76 years). Long‐term complications occurred in none. Conclusions : Endovascular stent placement in infants is technically feasible with good results achievable even in small babies. It should be considered as a therapeutic option in complex cases when surgical alternatives are less favorable. © 2010 Wiley‐Liss, Inc.     

Early complications of stenting in children and young adults with congenital heart disease

We report the early complications of stent implantation. Since 1/1/97 to 1/12/02, we implanted 91 stents in 76 patients. Median age and weight were 15 years (range 0.3-43) and 49 kg (range 3-96). Primary diagnosis were: pulmonary atresia with ventricular septal defect (n = 17), tetralogy of Fallot (n = 13), aortic coarctation (n = 15), transposition of the great arteries (n = 3), truncus arteriosus (n = 6), univentricular heart (n = 7), other anomalies (n = 28). Indications to stent implantation were: stenosis of the pulmonary outflow and/or pulmonary branches (n = 44), aortic recoarctation (n = 14), native aortic coarctation (n = 1), systemic venous channels obstruction (n = 14), other (n = 3). The stents were: Palmaz (n = 57), non premounted CP (n = 8), premounted CP (n = 3), Palmaz Corinthian (n = 19), self-expanding (n = 4). Procedural complications occurred in 24 patients (31%) and included: 11 balloon bursting, 8 stent slipping, 1 stent migration, 4 wall dissections. Five patients (21%) needed urgent surgery. Sixty three percent of complications occurred during pulmonary outflow or pulmonary branches stenting, 25% during stenting of the aortic arch, 12% during other procedures. All but 2 complications were observed with non premounted stents. In conclusion, the use of not premounted stents, although widely diffuse, has a not negligible incidence of complications, leading to longer procedures, to the use of a large variety of materials and needing more than occasionally a surgical solution. A larger use of premounted stents, when possible, is recommended.