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J Am Coll Cardiol, 2004; 43:1062-1067, doi:10.1016/j.jacc.2003.10.040
© 2004 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: CONGENITAL HEART DISEASE

Long-term outcome (up to 15 years) of balloon angioplasty of discrete native coarctation of the aorta in adolescents and adults

Mohamed Eid Fawzy, MD, FRCP (Lond), FACC, FESC*,*, Mahmoud Awad, MD*, Walid Hassan, MD, FACC*, Yusuf Al Kadhi, MBBS, DABR{dagger}, Mohamed Shoukri, PhD{ddagger} and Fadel Fadley, FRCPC*

* Department of Cardiovascular Diseases, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
{dagger} Department of Radiology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia
{ddagger} Department of Biostatistics, Clinical Epidemiology, and Scientific Computing, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia

Manuscript received July 9, 2003; revised manuscript received September 6, 2003, accepted October 6, 2003.

* Reprint requests and correspondence: Dr. Mohamed Eid Fawzy, Department of Cardiovascular Diseases (MBC-16), King Faisal Specialist Hospital and Research Center, P.O. Box 3354, Riyadh 11211, Saudi Arabia.
robosa{at}kfshrc.edu.sa


   Abstract
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 Abstract
Methods
 Results
 Discussion
 References
 
OBJECTIVES: This study evaluated the long-term follow-up results of balloon angioplasty (BA) in adolescent and adult patients with discrete coarctation of the aorta.

BACKGROUND: Although the immediate and intermediate term results of BA for patients with aortic coarctation (AC) have been encouraging, there is a paucity of data on long-term follow-up results.

METHODS: This basis of this study was follow-up of 49 patients (mean age, 22 ± 7 years) undergoing BA for discrete AC at median interval of 10.2 years, including cardiac catheterization, magnetic resonance imaging, and Doppler echocardiography.

RESULTS: No early or late deaths occurred. Balloon angioplasty produced a reduction in peak AC gradient from 66 ± 23 mm Hg (95% confidence interval [CI]: 59.5 to 72.7) to 10.8 ± 7 mm Hg (95% CI: 8.8 to 12.5) (p < 0.0001). Follow-up catheterization 12 months later revealed a residual gradient of 6.2 ± 6 mm Hg (95% CI: 4.4 to 7.9) (p < 0.001). Four patients (7.5%) with suboptimal initial outcome with peak gradient >20 mm Hg had successful repeat angioplasty. Aneurysm developed at the site of dilation in four patients (7.5%). Magnetic resonance imaging follow-up results revealed no new aneurysm or appreciable changes in the size of pre-existing aneurysms, and no recoarctation was observed. Also, no appreciable changes in the Doppler gradient across the AC site were noted. The blood pressure had normalized without medication in 31 (63%) of the 49 patients.

CONCLUSIONS: Long-term results of BA for discrete AC are excellent and should be considered as first option for treatment of this disease.

Abbreviations and Acronyms
  AC = aortic coarctation
  BA = balloon angioplasty
  BP = blood pressure
  CI = confidence interval
  MRI = magnetic resonance imaging

Surgery for coarctation of the aorta was first described in 1945 (1). Since that time, several surgical procedures have been advocated, each associated with a variable risk of restenosis or aneurysm formation (2–8). Balloon angioplasty (BA) has been added as a viable alternative to surgery in 1982 (9), and it is currently considered to be a safe and effective treatment option for coarctation. With encouraging immediate- and intermediate-term results (10–19), we have previously reported intermediate follow-up results at a mean 5.2 years (18), but reports on long-term results are scarce (20). The purpose of this study is to report on long-term follow-up results of up to 15 years in a sizeable series of patients with native coarctation of the aorta undergoing BA. To our knowledge, this is the longest follow-up series reported in this group of patients.


   Methods
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 Abstract
 Methods
Results
 Discussion
 References
 
Study subjects.   Between July 1986 and July 2001, 60 consecutive adolescent and adult patients with native coarctation of the aorta were seen at King Faisal Specialist Hospital; 6 patients were referred to surgery, 3 of whom had a long tubular coarctation segment, and the remaining 3 patients had interrupted aortic arch. The remaining 54 patients with discrete coarctation underwent BA.

The indication for dilation included angiographic evidence of significant discrete coarctation or a coarctation pressure gradient >20 mm Hg or both at cardiac catheterization in addition to systemic hypertension not controlled by medical treatment. All demographic, hemodynamic, echocardiographic, and magnetic resonance imaging (MRI) follow-up data were encoded in a prospective database program.

Initial evaluation.   Clinical evaluation before angioplasty included right arm blood pressure (BP) measurement, chest radiograph, 12-lead electrocardiogram, and echocardiographic examination with measurement of the Doppler gradient across the coarctation.

BA technique.   The technique used for BA has been previously reported (11,18). An angioplasty balloon is selected with a diameter equal to that of the isthmus or 1 to 2 mm smaller than the diameter of the descending thoracic aorta at the level of the diaphragm. After heparin 2,000 IU was given intravenously, the angioplasty catheter balloon was inserted and inflated by hand for 5 to 10 s until the stenotic waist disappeared. Hemodynamic measurements and biplane aortic angiography were performed immediately before and after coarctation angioplasty, with special precaution to avoid manipulating the tip of the catheter or guide wire over the area of the freshly dilated coarctation.

Follow-up evaluation.   Follow-up studies including clinical evaluation, right arm BP measurement with standard sphygmomanometer, chest radiography, and echocardiographic examination with measurement of Doppler coarctation gradient were performed annually for up to 15 years. Repeat cardiac catheterization with measurement of the gradient across the site of coarctation and aortography was performed one year after dilation. Magnetic resonance imaging was carried out after one year at the time of repeat catheterization and annually thereafter up to 15 years after dilation to scrutinize for aneurysm formation and to measure the diameter of the aorta at the site of previous coarctation.

Statistical methods.   Data are presented as mean value ± SD and 95% confidence interval (CI). The paired Student t test was used to compare data before and after angioplasty and at follow-up. Statistical analysis was performed using commercially available software (S-PLUS Insightful Software, Seattle, Washington). The Bland and Altman test (21) was used to assess the agreement between MRI readings.


   Results
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 Abstract
 Methods
 Results
Discussion
 References
 
Study subjects.   Fifty-four adolescent and adult patients (40 males) underwent BA for native discrete coarctation of the aorta during a 15-year period. Their ages ranged from 15 to 55 (22 ± 7) years. In one patient, dissection developed early in our experience and required immediate surgical repair without sequelae; she was excluded from the analysis. Apart from bicuspid aortic valve found in 21 patients (40%), additional congenital heart defects were present in 6 patients (small ventricular septal defect in 2 patients, subaortic membrane in 2 patients, moderate mitral regurgitation in 1 patient). All patients were hypertensive (systolic BP, 150 to 260 mm Hg).

Immediate results.   There were no immediate or late deaths. Thrombosis of the right femoral artery developed in one patient and required surgical thromboembolectomy. The peak catheter coarctation gradient decreased from 66 ± 23 mm Hg (95% CI: 59.5 to 72.7) to 10.8 ± 7.0 mm Hg (95% CI: 8.8 to 12.8) (p < 0.0001) (Table 1). Balloon dilation was considered successful when the region of coarctation was enlarged on repeat angiography after angioplasty and the coarctation pressure gradient decreased to ≤20 mm Hg. Of the 53 patients, 49 (92.5%) met these criteria at first dilation. Neither paradoxical hypertension nor mesenteric vasculitis was encountered after angioplasty.


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  		Table 1 Immediate and Intermediate Follow-Up Results

 
The systolic pressure in the aorta above the coarctation site decreased from a mean of 170 ± 21 mm Hg (95% CI: 163 to 175) to 132 ± 16.5 mm Hg (95% CI: 128 to 137) (p < 0.0001).

Suboptimal initial outcome.   Suboptimal initial outcome, defined as immediate residual coarctation systolic gradient >20 mm Hg, was noted in four of the 53 patients (7.5%). An undersized balloon catheter was used in three patients because an appropriately sized balloon catheter was not available at the time of the procedure early in our experiences. The transverse aortic arch and isthmus were reasonably well developed, evaluated visually from aortogram in these four patients like the rest of the study patients.

Intermediate results.   Two patients (living abroad) were lost to follow-up.

Catheter coarctation gradient.   Follow-up catheterization and angiography were performed one year after dilation in 50 patients. One refused repeat catheterization. The gradient across the coarctation site was further decreased to 6.2 ± 6 mm Hg (95% CI: 4.4 to 7.9, p < 0.0001) (Table 1). In comparison with values immediately after dilation, there was no further change in the systolic pressure in the aorta above the coarctation site (130 ± 15.7 mm Hg [95% CI: 124 to 133, p = 0.19]) (Table 1).

Doppler coarctation gradient.   The Doppler gradient across the coarctation site decreased from 57.6 ± 17.7 mm Hg (95% CI: 52.5 to 62.6) before angioplasty to 16.0 ± 8.4 mm Hg (95% CI: 13.6 to 18.5) one year after angioplasty (p < 0.0001).

Suboptimal initial outcome.   Suboptimal initial outcome was encountered in four patients (7.5%). In three of them, the anatomy of the coarctation is discrete, the aortic arch and isthmus are of reasonable size, and the initial suboptimal relief of obstruction is due to the small size balloon used in the first attempt. Repeat dilation with appropriately sized balloon catheter was carried out six months later. In all three, the gradient decreased to 5 to 15 mm Hg and remained low at repeat catheterization 12 months later. The fourth patient, in whom the morphology of coarctation in a biplane aortogram at restudy one year later was deemed unsuitable for angioplasty (Fig. 1), underwent surgical repair. This was the only patient who had single-plane aortogram at the initial dilation.



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  		Figure 1 (A) Aortogram in left anterior oblique view showing apparently discrete coarctation (arrow). (B) Aortogram of the same patient in posterior anterior view showing long tortuous coarctation (arrow) not suitable for balloon angioplasty.

 
Aneurysm.   The follow-up angiogram and MRI at one year after dilation were scrutinized for aneurysm at the site of BA. A total of four aneurysms were observed both on angiography and MRI, giving an incidence of 7.8%. The aneurysms were very small bulge in three patients measuring 2 to 2.3 cm in diameter. The fourth patient, who had a 4-cm aneurysm, underwent surgical repair. None of the aneurysms could be detected on chest X-ray film.

Long-term follow-up results.   Two patients of the 51 underwent surgery at one year after dilation. One patient had aneurysm, and the other had suboptimal initial outcome. The remaining 49 patients were followed-up for a median of 10.2 (9.1 ± 4.4) years; 25 patients were followed-up for a median of 13.4 (mean ± SD 12.9 ± 1.4); range, 10.2 to 15.3 years.

MRI.   The site of previous coarctation is shown to be well-dilated in all 49 patients (Fig. 2). No significant changes in the diameter of the aorta at the site of coarctation at one year (13.5 ± 3.1 mm [95% CI: 12.5 to 14.4]) and at the last follow-up (13.9 ± 3.3 mm [95% CI: 13.0 to 14.9]) was noted. There is agreement between these two values using the Bland and Altman method (p = 0.43) (Table 2).



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  		Figure 2 Serial magnetic resonance imaging (A) five years after balloon angioplasty, (B) 10 years after balloon angioplasty, (C) 15 years after balloon angioplasty, and (D) magnetic resonance angiography 15 years after balloon angioplasty of the same patient. Note that the site of previous coarctation (arrow) is well dilated, with no change in the diameter of the aorta at coarctation site.

 

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  		Table 2 Echocardiographic and MRI Intermediate and Long-Term Results

 
Aneurysms.   Follow-up MRI studies revealed no new aneurysm at the site of angioplasty or appreciable change in the size of the pre-existing aneurysms (Fig. 3).



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  		Figure 3 Follow-up magnetic resonance imaging shows (A) small aneurysm (arrow) at two years after dilation, and (B) at 14 years after dilation, no appreciable change in size of the aneurysm was noted.

 
Doppler coarctation gradient.   The Doppler coarctation gradient decreased slightly at the last follow-up in comparison with the value at one year after dilation from 16.0 ± 8.4 mm Hg (95% CI: 13.6 to 18.5) to 13.0 ± 6.9 mm Hg (95% CI: 11 to 15.0) (p < 0.01) (Table 2). This was most probably due to the remodeling of the aorta after angioplasty.

Normalization of BP.   The BP was normal (<140/90 mm Hg) without medication in 31 patients (63%). The remaining patients required one or two medications to control their BP.


   Discussion
Top
 Abstract
 Methods
 Results
 Discussion
References
 
This study has demonstrated excellent long-term results of BA in adolescents and adults with discrete native coarctation of the aorta, and we propose that it should be used as a first option for the treatment of this disease.

Coarctation restenosis.   Recoarctation is a common complication after angioplasty and surgical repair in infants and children (2,4), in whom recoarctation rate after angioplasty may range from 15% to 30% (16,22,23). Recoarctation is infrequent in adults. Several investigators reported no recoarctation after angioplasty in adult patients (17,19,20). A finding that is corroborated by our study, however, we encountered suboptimal initial outcome in four patients (7.8%); in three patients, an undersized balloon catheter had been used in initial dilation. These three patients underwent repeat angioplasty with appropriate-sized balloon catheter, and results were satisfactory and have remained so. The fourth patient who had unsuitable morphology, discovered after performing biplane aortogram one year after dilation, underwent successful surgical repair. No recoarctation was observed on long-term follow-up using MRI; we previously demonstrated the accuracy of MRI in diagnosing recoarctation in comparison to angiography (24). Also, there was no change in the diameter of the coarctation site at median follow-up of 10.2 years after angioplasty compared with that at one year. The Doppler gradient at the site of coarctation decreased slightly at the last follow-up compared with one year after dilation probably due to remodeling of the aorta.

Aneurysm formation.   Aneurysm formation at the dilation site has remained a long-term concern. Although early studies by Cooper et al. (25) and Brandt et al. (26) reported high incidence of aneurysm formation, most investigators have reported aneurysm formation incidence varying between 1.8% to 6% (12–14,27,28), which is consistent with our result (7.8%). No aneurysms were encountered by Koerselman et al. (17) and Walhout et al. (19). Three of the four aneurysms in the present series were small bulges, nondetectable on chest radiography and without an appreciable change in size at follow-up MRI up to 14 years.

Media tear and cystic medial necrosis have been postulated as potential causes of aneurysm formation (9,29,30). It has been suggested that aneurysm development may be caused by the use of an oversized balloon or misinterpretation of native anatomic irregularities in the aortic contour as aneurysm (31). Two of our four patients who had aneurysm were treated with larger balloon catheter. However, one patient developed a 4-cm aneurysm despite the fact that an appropriate-sized balloon catheter was used for angioplasty. Although development of aneurysm after BA is of concern, aneurysms are also known to develop after surgical repair of coarctation especially after patch aortoplasty, with incidence varying from 9% to 30% (2–8). The postsurgical aneurysms are defined as a ratio >1.5 of the repair site to the descending aorta at the level of the diaphragm (5,6). Close follow-up is required for patients with or without aneurysms, and we found that MRI is a reasonable, noninvasive imaging modality for follow-up of patients who underwent coarctation angioplasty (24).

Normalization of the BP.   Blood pressure came down to normal in 63% of our patients without medication. These findings concur with those of Schrader et al. (27) who reported a 79% rate of normalization of BP after angioplasty and Walhout et al. (19) who encountered hypertension requiring medication in six of 18 adult patients (33%). Contrary to the findings of Schräader et al. (27), we found no relation between persistence of hypertension and a residual gradient ≥30 mm Hg. In our 18 patients with persistent hypertension, the residual gradient was ≤20 mm Hg. We previously demonstrated that patients in whom BP became normal after angioplasty also had a normal response of BP to exercise, and regression of left ventricular hypertrophy (32). Hypertension in the absence of residual coarctation appears to be related to the duration of preangioplasty hypertension, which can be explained by insufficient resetting of the baroreceptors after angioplasty (19). The incidence of late hypertension after surgical repair of coarctation in adults varies between 33% to more than 50% (2,33,34).

Comparison with stent implantation.   The indications for stent implantation are not clearly defined (35). Possible indications include long segment and tortuous coarctation, and recurrent aortic coarctation (AC) after surgical repair. We did not attempt balloon dilation of such patients. Recoarctation is rare in adult and adolescent patients with discrete coarctation treated by BA. The incidence of aneurysm formation after stent implantation reported by Suarez de Lezo et al. (36) at mean of 25 months follow-up was 7%, an incidence similar to that of BA. We think there is no role for stent implantation for discrete native coarctation in adolescent and adult patients.

Compared with surgery, BA offer less burden to the patient, with short in-hospital stay varying from one to two days. This also applies to the financial costs of the angioplasty that are relatively low (37).

Conclusions.   This study demonstrated excellent long-term results of BA for native discrete coarctation in adolescent and adult patients, when compared against historical control subjects. The results of BA compare favorably with reported results of surgical repair and are associated with less morbidity and lower cost. We recommend BA as the first option for treatment of discrete coarctation in adolescent and adult patients.


   Acknowledgments
 
The authors thank Lydia B. Robosa and Jovett M. Lopez for their secretarial assistance.


   References
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 Abstract
 Methods
 Results
 Discussion
 References
 

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Right arrow Articles by Fadley, F.

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