American Heart JournalVolume 156, Number 5 Fawzy et al 911 Figure 1A, Magnetic resonance imaging scan of a patient with discrete coarctation (shell-like) (black arrow); notice remnant of the ductus arterious (whitearrow). B, One year after BA of the same patient, coarctation gradient decreased from 70 mm Hg to zero, notice remenant of the ductus arterious(white arrow).angiographic evidence of significant discrete aortic coarctation catheter balloon was inserted and inflated by hand for 5 towith coarctation pressure gradient N20 mm Hg at cardiac 10 seconds until the stenotic waist disappeared. Hemodynamiccatheterization. All demographic, hemodynamic, echocardio- measurements and biplane aortic angiography were performedgraphic, and MRI follow-up data were encoded in prospective immediately before and after coarctation angioplasty, withdatabase program starting in 1986. Written informed consent special precaution to avoid manipulating the tip of the catheterwas obtained from all patients before BA. or guide wire over the area of the freshly dilated coarctation.Definition Follow-up evaluation Discrete coarctation of the aorta was defined as shelf-like Two patients who came from neighboring countries were lostmorphology in MRI (Figure 1) or angiographic images. Severe to follow-up. In addition, 3 other patients underwent surgicalisthmus or transverse aortic arch hypoplasia was defined as a repair within 1 year after BA. The remaining 58 of the 63 patientsratio of the diameter of this structure to descending aorta at the were reassessed 6 months after the procedure and yearlylevel of diaphragm of b0.6.19,30 Successful outcome was defined thereafter. Their clinical evaluation was accomplished by directas peak systolic gradient after BA of ≤20 mm Hg. Aneurysm was interview of the patients at clinic visits and included assessmentdefined as an area of dilatation that was 150% of the aortic of peripheral pulse, evidence of radiofemoral delay, and supinediameter at the level of the diaphragm or a discrete secular BP measurement in the right arm. Patients on antihypertensivedilatation at that site that was not present before medication were given a trial off treatment for 1 month.the intervention.26 Fifty patients underwent repeat catheterization and biplane aortography with pressure measurement across the coarctationInitial evaluation segment, 1 year after BA. The remaining 8 patients refused Clinical evaluation before angioplasty included right arm repeat catheterization. All 58 patients had MRI and echocardio-blood pressure (BP) measurement, chest radiograph, 12-lead graphic examination annually for the first 10 years, followed byelectrocardiogram, echocardiographic examination with mea- repeat MRI, and echocardiographic examination at 2-yearsurement of the Doppler gradient across the coarctation using intervals thereafter. Their follow-up was concluded inthe precoarctation velocity (ie, ΔP (pressure difference) = December 2007.4v22 − 4v12), and MRI. Statistical analysisBalloon angioplasty technique Data are presented as the mean ± SD. The paired Student t test The technique used for BA has been previously reported.31 An was used to compare data before and after angioplasty and atangioplasty balloon was selected with a diameter equal to that of follow-up. Multiple logistic regression analysis was used tothe isthmus or 1 to 2 mm smaller than the diameter of the identify variables associated with persistence hypertension. Thedescending thoracic aorta at the level of the diaphragm. After variables included were age, gender, baseline coarctation2,000 IU of heparin was given intravenously, the angioplasty gradient, baseline BP, and residual coarctation gradient.
American Heart Journal912 Fawzy et al November 2008 Table I. Immediate and intermediate follow-up resultParameters Before BA Immediately after P 12-month later PAortic pressure above Co (mm Hg) 170 ± 20 134 ± 16 b.0001 130 ± 12.8 .18Catheter Co gradient (mm Hg) 60 ± 22 8.5 ± 8 b.0001 5 ± 6.4 .01Doppler gradient (mm Hg) 61.9 ± 17.8 16.0 ± 8.4 b.0001Co, Coarctation.Freedom from reintervention was studied using Kaplan-Meier Complicationstest. The analysis was performed with SAS Statistical Software There were no immediate deaths; one patient devel-(SAS, oped dissection of the aorta and underwent surgicalV 9.1, SAS Institute Inc, Cary, NC). A P value b.05 wasconsidered statistically significant. repair. Thrombosis of the femoral artery developed in one patient and required surgical thromboembolectomy.Results Intermediate follow-upStudy subjects Catheter coarctation gradient. Follow-up catheter- Sixty-three adolescent and adult patients (16 females) ization and angiography were performed 1 year afterunderwent BA for native discrete coarctation of the aorta dilatation in 50 patients. Eight patients refused repeatduring a 22-year period. Their ages ranged from 14 to 55 catheterization. The gradient across the coarctation site(mean 24 ± 9) years. In one patient, aortic dissection was further decreased to 5 ± 6.4 mm Hg (P = .01) (Table I).developed early in our experience and required immedi- In comparison to values immediately after dilatation, thereate surgical repair without sequelae. Apart from bicuspid was no further change in the systolic pressure in the aortaaortic valve found in 26 patients (41%), additional above the coarctation site (134 ± 16 mm Hg to 130 ±congenital heart defects were present in 7 patients (small 12.8 mm Hg, respectively; P = .18) (Table I).ventricular septal defect 2 patients, a subaortic mem- Doppler coarctation gradient. The Doppler gradi-brane in two, valvular aortic stenosis in one, and ent across the coarctation site decreased from 61.9 ±moderate mitral regurgitation in one). All patients were 17.8 mm Hg before angioplasty to 16.0 ± 8.4 mm Hghypertensive (systolic BP 150-260 mm Hg). 1 year after angioplasty (P b .0001). Restenosis. Restonosis is defined as residual gradientImmediate results N20 mm Hg at rest on follow-up catheterization. The The peak catheter coarctation gradient decreased from restenosis occurred in 5 patients (8%) and was mainly60 ± 22 mm Hg to 8.5 ± 8 mm Hg (P b .0001) in because of suboptimal initial outcome. In 4 of these57 patients (90%), and notably, gradient decreased to patients the anatomy of the coarctation was discrete, the≤20 mm Hg at first dilation. In 49 of the 57 patients aortic arch and isthmus were of reasonable size, and the(78%), the immediate coarctation gradient decreased to initial suboptimal relief of obstruction was due to the≤10 mm Hg, and in 25 patients, the gradient was zero. small size balloon used in the first attempt early in ourIn the remaining 9 patients, the gradient was N10 mm experience. Repeat dilatation with appropriately sizedHg. Six patients had gradient of 12 to 15 mm Hg and in balloon catheter was carried out 6 to 12 months later. Inthree, the gradient was 18 to 20 mm Hg. These 3 all four, the gradient decreased to 0 to 15 mm Hg andpatients had moderate degree of hypoplasia of the remained low at repeat catheterization 12 months later.isthmus. Neither paradoxical hypertension nor mesen- The fifth patient, in whom the morphology of coarctationteric vasculitis was encountered after angioplasty. The in a biplane aortogram at restudy 1 year later was deemedsystolic pressure in the aorta above the coarctation site unsuitable for angioplasty (Figure 2), underwent surgicaldecreased from a mean of 170 ± 20 mm Hg to 134 ± repair. This was the only patient who had single-plane16.0 mm Hg (P b .0001) (Table I). aortogram at the initial dilatation. Aneurysm. The follow-up angiogram and MRI atSuboptimal initial outcome 1 year after dilatation were scrutinized for aneurysm at Suboptimal initial outcome, defined as immediate the site of BA. A total of 4 aneurysms were observedresidual coarctation systolic gradient N20 mm Hg, both on angiography and MRI giving an incidence ofwas noted in 5 (8%) of the 63 patients. In four, an 7%. In 3 of these patients, the aneurysms were smallundersized balloon catheter was used in the absence of bulge measuring 2.0 to 2.3 cm in diameter. The fourthan appropriate size balloon catheter early in our patient who had a 4-cm aneurysm underwent surgicalexperiences, and one patient had narrow tortuous repair. None of the aneurysms could be detected oncoarctation segment. chest x-ray film.
American Heart JournalVolume 156, Number 5 Fawzy et al 913 Figure 2A, Aortogram in left arterior oblique view showing apparently discrete coarctation (arrow). B, Aortogram of the same patient in posterior-anteriorview showing tortuous coarctation (arrow) not suitable for BA. Long-term follow-up results. Two patients living the remaining 29 patients, the BP was controlled with oneabroad were lost to follow-up and 3 required surgery medication in 4, 2 medications in 18, and 3 medicationswithin the first year after dilatation. The remaining in 7 patients.58 patients were followed up for a median of 13.4 (mean Reintervention. Seven patients underwent repeat12 ± 7) years (range 1-22 years), 23 of those were intervention, 4 patients with recoarctation responded tofollowed up for a median of 18.3 (mean 18.5 ± 1.6) years. repeat BA, whereas one patient required surgery forOne patient who underwent BA at age 55 years died recoarctation. One patient with aneurysm underwent15 years later from stroke. surgery 1 year after BA. Aortic dissection at the time of BA Magnetic resonance imaging. The site of previous also necessitated surgical repair. Freedom from interven-coarctation is shown to be well dilated (Figures 3 and 4). tion was 89% at 1 year, and this level was maintained Aneurysms. Follow-up MRI studies revealed no new throughout the follow-up period (Figure 5).aneurysm at the site of angioplasty. Of the 4 aneurysmsthat were recognized during the first year of follow-up,1 patient underwent surgery within 1 year after BA, Discussion1 patient had aneurysm that increased in diameter from This study has demonstrated excellent long-term (up to23 to 30 mm 20 years after dilatation, and the remaining 22 years) results of BA of discrete (shelf-like) aortic2 patients had noted no appreciable changes in the size coarctation, and we propose that it should be used as firstof aneurysms. option for the treatment of discrete coarctation in the Follow-up Doppler coarctation gradient. In com- absence of severe hypoplasia of the isthmus or transverseparison to the value obtained 1 year after dilatation, the arch. Other investigators demonstrated that the outcomeDoppler coarctation gradient showed a small but in patients with discrete coarctation submitted to BA instatistically insignificant further decrease at the last whom a residual gradient of ≤10 mm Hg was achievedfollow-up study (from 16.0 ± 8.4 to 13.7 ± 4.9 mm Hg, was not significantly different from cases with discreterespectively; anatomy submitted to stent implantation.21 Surgery has aP = .064). risk profile that encourages the pursuit of less invasive Normalization of BP. The BP was normal (b140/ treatment options. Thus, an early surgical mortality rate of90 mm Hg) without medication in 29 patients (50%). In 1.3% was reported in a study covering a wide age range
American Heart Journal914 Fawzy et al November 2008 Figure 3 Serial MRI showing no restenosis or aneurysm formation up to 20 years of follow-up.beyond infancy and recoarctation, and aneurysm forma- MRI, whereas the Doppler gradient at the site oftion were noted in 5.8%.11,36 Cowley et al35 demonstrated coarctation decreased slightly at last follow-up comparedequivalent relief of obstruction and an equivalent need with 1 year after dilation probably because of remodelingfor repeat intervention for both of the aorta. Suarez de Lezo41 described neointimalsurgery and BA, but the risk of aneurysm formation was proliferation in 27% of patients after 2 to 3 years of follow-higher among patients treated with BA. In addition, up, only 3 patients developed restenosis secondary tosurgery carries a small risk of recurrent laryngeal nerve neointimal proliferation, and multiple stents were used ininjury, phrenic nerve injury, chylothorax, wound infec- infancy in each of these 3 patients. The recoarctation ratetion, postcoarctectomy syndrome, and paradoxical after surgery in the adult population is unclear and ishypertension.36 The incidence of paraplegia is approxi- likely to be higher than the reoperation rate, as detectionmately 0.5%, despite various techniques for spinal of recurrence is dependent on the thoroughness ofcord protection.37 follow-up using imaging techniques.11Coarctation restenosis Aneurysm formation Recoarctation is a common complication after both The presence of cystic medial necrosis observed in twoangioplasty and surgical repair in infants and children, thirds of the resected aortic coarctation segments42in whom recoarctation rate after angioplasty may range may provide a pathologic basis for the developmentsfrom 15% to 30%.30,38 Recoarctation is uncommon of aneurysms associated with native coarctation, afterin adults, with incidence varying from 0% to BA and stent implantation or even after surgery. Over-9%27,29,33,34,39,40—a finding that is corroborated by our stretching the coarctation is thought to increase thestudy where recoarctation was encountered in 5 patients risk of the aneurysm, rupture, and dissection. Of our(8%) all of whom had suboptimal initial outcome. No 4 patients who had aneurysms, 2 were treated with largerrecoarctation was observed on long-term follow-up using balloon catheter. However, one patient developed a 4-cm
American Heart JournalVolume 156, Number 5 Fawzy et al 915 Figure 4 Figure 5 Kaplan-Meier curve showing freedom from intervention. BA at mean follow-up 66 ± 37 (range 12-123 months).46 Multiple logistic regression analysis conducted in all 58 patients failed to identify a positive relation between persistent hypertension and residual coarctation gradientMagnetic resonance imaging scan of the aorta 22 years after BA of or baseline BP or age. Schräder et al47 reported a 79% ratediscrete coarctation in a patient. The coarctation segment is nicely of normalization of BP after BA in adolescent and adultsdilated (arrow); notice complete regression of the poststenotic with coarctation of the aorta and Walhout et al33dilatation of the descending aorta. encountered hypertension requiring medication in 6 of 18 adult patients (33%). We previously demonstrated thataneurysm despite an appropriate-sized balloon catheter patients in whom BP became normal after BA also hadwas used for angioplasty. Early studies by Cooper et al43 normal response of BP to exercise and regression of leftand Brandt et al44 reported high incidence of aneurysm ventricular hypertrophy.46 Hypertension in the absenceformation after BA; most subsequent investigators have of residual coarctation appears to be related to thereported an incidence varying between 1.8% and duration of preangioplasty hypertension, possibly related15%,24,27,28,31 concurring with our results (7%). No to insufficient resetting of the baroreceptors after BA.33aneurysms were encountered by Koerselman et al40 and Pedra et al23 demonstrated stenting, and BA wereWalhout et al.33 Aneurysm were also encountered after similarly effective to normalize BP levels, which allowedthe use of stent with an incidence varying between 1.4% either discontinuation or dosage reduction of antihyper-and 17%16-18,23-25 and also after CP covered stent tension medications. The incidence of later hypertensionimplantation.23 The natural history of a small aneurysm after surgical repair of coarctation in adults variesafter BA is unknown. In our series, the aneurysm between 33% and N50%.4,10,48increased in size in one patient on follow-up MRI 20 yearslater, and in the other 2 patients, no appreciable changes Reinterventionin size were noted. Although development of aneurysm Freedom from reintervention was 90% at 1 year andafter BA is of concern, aneurysms are also known to 87% at 5 years as reported by Ovaert et al.32 This concursdevelop after surgical repair of coarctation especially with our findings, in which we noted freedom fromafter patch aortoplasty, with incidence varying from 9% to reintervention to be 89% at 1 year and maintained30%.5,9,12 Close follow-up is required for patient with or throughout the follow-up period.without aneurysm, and we found that MRI is valuablenoninvasive imaging modality for follow-up of patientswho underwent coarctation angioplasty.45 Conclusion This study demonstrated excellent long-term (up toNormalization of the BP 22 years) results of BA for native discrete (shelf-like) Blood pressure reverted to normal without medication coarctation in adolescent and adult patients. Whenin 29 patients (50%). We have previously reported that compared against historical control subjects, the results74% of patients have normal BP without medication after of BA compare favorably with reported results of surgical
American Heart Journal916 Fawzy et al November 2008repair or stenting. Accordingly, we recommend BA as the 20. Tyagi S, Singh S, Mukhopadhyay S, et al. Self- andfirst option for treatment of discrete coarctation in balloon-expandable stent implantation for severe native coarcta-adolescent and adult patients. tion of aorta in adults. Am Heart J 2003;146:920-8. 21. Zabal C, Attie F, Rosas M, et al. The adult patient with native coarctation of the aorta balloon angioplasty or primary stenting. We thank Suzanne Tobias and Jovett Lopez for typing Heart 2003;89:77-83.the manuscript. 22. Chessa M, Carrozza M, Butera G, et al. Results and mid-long-term follow-up of stent implantation for native and recurrent coarctation of the aorta. Eur Heart J 2005;26:2728-32.References 23. Pedra CAC, Fontes VF, Esteves CA, et al. Stenting vs balloon 1. Rao PS. Coarctation of the aorta. Semin Nephrol 1995;15:87-105. angioplasty for discreet unoperated coarctation of the aorta in 2. Campbell M. 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American Heart JournalVolume 156, Number 5 Fawzy et al 917 adults: immediate and mid-term results. Catheter Cardiovasc Interv 45. Fawzy ME, Sinner WV, Rifai A, et al. Magnetic resonance imaging 2000;50:28-33. compared with angiography in the evaluation of intermediate-term41. Suárez de Lezo J, Pan M, Romero M, et al. Immediate and follow-up result of coarctation balloon angioplasty. Am Heart J 1993;126: findings after stent treatment for severe coarctation of aorta. Am J 1380-4. Cardiol 1999;83:400-6. 46. Fawzy ME, Sivanandam V, Peiters F, et al. Long-term effects of42. Isner JM, Donaldson RF, Fulton D, et al. Cystic medial necrosis in balloon angioplasty on systemic hypertension in adolescent and coarctation of the aorta: a potential factor contributing to adverse adult patients with coarctation of the aorta. Eur Heart J 1999;20: consequences observed after percutaneous balloon angioplasty of 827-32. coarctation sites. Circulation 1987;75:689-95. 47. Schräder R, Bussmann WD, Jacobi V, et al. Long-term effects of43. Cooper RS, Ritter SB, Rothe WB, et al. Angioplasty for balloon coarctation angioplasyt on arterial blood pressure in coarctation of the aorta: long-term results. Circulation 1987;75: adolescent and adult patients catheter. Cardiovasc Diagn 1995;36: 600-4. 220-5.44. Brandt III B, Marvin Jr WR, Rose EF, et al. Surgical treatment of 48. Wells WJ, Prndergast TW, Berdjs F, et al. Repair of coarctation of the coarctation of the aorta after balloon angioplasty. J Thorac aorta in adults. The fate of systolic hypertension. Am Thorac Surg Cardiovasc Surg 1987;94:715-9. 1996;61:1168-71. The following article is an AHJ Online Exclusive. Full text of this article is available at no charge at our website: www.ahjonline.comTranscatheter closure of the patent ductus arteriosus using the newAmplatzer duct occluder: Initial clinical applications in childrenBasil Thanopoulos, MD, PhD, a Nikolaos Eleftherakis, MD, a Konstantinos Tzannos, MD, b and Christodoulos Stefanadis, MD, PhD b Athens, GreeceBackground In spite of recent advances in transcatheter manage- Results The mean PDA diameter was 3.6 ± 1.3 mm (range 0.6-5ment, the occlusion of certain anatomic types of patent ductus arteriosus (PDA), mm). The mean device diameter (waist diameter) was 4.3 ± 1.4 mmespecially in infants and small children, remains a challenge. The aim of the (range 3-6 mm). Complete echocardiographic closure of the ductus at 1-study was to report initial human experience with transcatheter closure of PDA month follow-up was observed in 24 (96%) of 25 patients. Immediatelyin 25 patients using the new Amplatzer duct occluder (ADO II) (AGA Medical, after the procedure, there was a mild left pulmonary stenosis (DopplerGolden Valley, MN). gradient of 15 mm Hg) in 2 of 25 patients. No other complications were observed.Methods The median age of the patients was 3.2 years (range 0.1-5 years), and the median weight was 10.5 kg (range 3-18 kg). The device Conclusions The ADO II is a promising addition to our armamen-used is a modified ADO II made of fabric-free fine Nitinol wire net into 2 very- tarium for PDA closure. Further studies are required to document its efficacy,low-profile disks with an articulated connecting waist. Both disks are 6 mm safety, and long-term results. (Am Heart J 2008;156:917.e1-917.e6.)larger than the diameter of the connecting waist. Connecting waist diametersrange from 3 to 6 mm.