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European Heart Journal Advance Access originally published online on January 24, 2006
European Heart Journal 2006 27(9):1100-1105; doi:10.1093/eurheartj/ehi748
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© The European Society of Cardiology 2006. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org

The fate of systemic blood pressure in patients after effectively stented coarctation

Andreas Eicken1,*, Ulrike Pensl1, Walter Sebening1, Alfred Hager1, Thomas Genz1, Christian Schreiber2, Dieter Lang3, Harald Kaemmerer1, Raymonde Busch4 and John Hess1

1 Department of Pediatric Cardiology and Congenital Heart Disease, Deutsches Herzzentrum München, Technische Universität, Lazarettstr. 36, D-80636 Munich, Germany
2 Department of Cardiovascular Surgery, Deutsches Herzzentrum München, Technische Universität, Munich, Germany
3 Department of Pediatric Cardiology, Universitätsklinikum Ulm, Ulm, Germany
4 Department of Medical Statistics and Epidemiology, Technische Universität, München, Germany

Received 18 July 2005; revised 16 December 2005; accepted 5 January 2006; online publish-ahead-of-print 24 January 2006.

* Corresponding author. Tel: +49 89 1218 3011; fax: +49 89 1218 3013. E-mail address: eicken{at}dhm.mhn.de


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Discussion
 Limitations of the study
 Conclusion
 References
 
Aims The current study was designed to assess midterm results of stent implantation into the aorta for native and recurrent coarctation (CoA) in children and young adults.

Methods and results Forty-three patients (native CoA, 8; female, 12) were treated with stent implantation at a median age of 16.8 years (range 7.9–44.8 years). Only stents dilatable to an adult size aorta were implanted. All but two patients with functionally univentricular hearts had arterial hypertension. Exercise tests, 24-h blood pressure, clinical examination, echocardiography, and elective catheterization were used to assess follow-up. The narrowed segment was widened significantly from a median of 8 to 12.4 mm (P<0.0005). The peak-to-peak gradient between the ascending and the descending aorta was lowered significantly from a median of 22 mmHg to 1 mmHg (P<0.0005). No major complications occurred. The systolic blood pressure at the right arm was lowered significantly (P<0.0005) from 144 mmHg before stent implantation to 128 mmHg at the last visit. At a median follow-up of 30 months (3–72 months), 68% of all patients were classified to be normotensive.

Conclusion Stent implantation for selected patients with recurrent and native CoA is safe and may effectively reduce the blood pressure gradient across the CoA site. We suggest using only stents dilatable to an adult size aorta. However, arterial hypertension persists in a significant number of the patients. Impaired elastic properties of the aorta may be the cause for this finding.

Key Words: Native and recurrent coarctation • Stent • Blood pressure


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Discussion
 Limitations of the study
 Conclusion
 References
 
Since the initial report on surgical management of aortic coarctation (CoA)1 the results have improved significantly. Today, CoA-resection and extended end-to-end anastomosis yields excellent results even in newborns.2 Recurrent CoA in these young patients is reported to occur in 2.2–10%.2,3 Balloon angioplasty, described by Singer et al.4 in an infant with recurrent CoA in 1982, is the treatment of choice especially in young children with recurrent CoA.5–8 However, because of the elastic recoil properties of the aorta, restenosis occurs in up to 20–30% after angioplasty.7–9 Treatment with balloon-expandable endovascular stents is an established therapy for coronary and peripheral vessel stenosis.10 For recurrent and native aortic CoA, these stents proved to be safe and effective in small series and short to medium term follow-up studies.11–14 The aim of the current study is to determine the immediate results of stenting aortic CoA and to assess the midterm outcome after the intervention with special emphasis on arterial blood pressure.


   Methods
Top
 Abstract
 Introduction
 Methods
Results
 Discussion
 Limitations of the study
 Conclusion
 References
 
Patients
From February 1999 to July 2005, 43 patients (native CoA, 8; recurrent CoA after surgery, 35) were treated with balloon-expandable stents (Table 1). At the time of intervention, median age was 16.8 years (range 7.9–44.8 years) and median weight was 64.3 kg (range 19.9–114 kg). Sixteen patients had a bicuspid aortic valve; two additional patients needed aortic valve replacement for severe aortic regurgitation later on. Five patients had a conduit repair of the aorta, and five patients had already been reoperated for recurrent CoA. In four patients balloon angioplasty did not result in a satisfactory haemodynamic result. Two patients with recurrent CoA had Turner syndrome.


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  		Table 1 Patient characteristics

 
Indication for stent implantation and patient selection
Inclusion criteria for stent implantation consisted of a non-invasive systolic blood pressure gradient greater than 20 mmHg between the ascending and the descending aorta (peak systolic pressure proximal minus the peak systolic pressure distal to the CoA),15 and diminished femoral arterial pulses in combination with systemic arterial hypertension and characteristic cw-Doppler flow patterns of diastolic run-off in the descending aorta. In the case of significant CoA, defined as an aortic narrowing of ≥50% on angiography and additional arterial hypertension in at least the upper body part, stent implantation was performed even if the invasive peak systolic pressure gradient between the ascending and the descending aorta was less than 20 mmHg. Patients with tubular hypoplasia16 of the aortic arch or severe diameter mismatch of the aortic segments were not scheduled for stent implantation. During the study period, a total of 76 patients (age range 7.9–44.8 years) were evaluated for treatment of native CoA (n=34) and residual CoA (n=42) (Figure 1). All patients met the criteria for treatment indication. Whereas only 8/34 (23%) patients with native CoA were stented, 35/42 (83%) patients with residual CoA were treated with stent implantation. Initially, only patients with residual CoA were scheduled for the catheter intervention. After encouraging results, the indication for stent implantation was extended to patients with native CoA. In these patients there was a discrete, circumscript, membraneous-like stenosis with more or less comparable diameters of the pre- and post-stenotic aortic segments.


Figure 7481
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  		Figure 1 Flow chart of all patients with native or residual coarctation (after surgery) of the aorta (age 7.9–44.8 years) treated at the German Heart Centre between 1999 and 2005.

 
Stent implantation
Written informed consent was obtained from all patients or their parents. The intervention was carried out under general anaesthesia. The procedure has been described in detail previously.12,13 A large variety of balloons and stents were used (Table 1). Recently, the stents were fixed manually on a ‘balloon-in-balloon’ (BIB balloon) (Numed®). Depending on the balloon size, a 10–12 French long sheath (Mullins transseptal introducer Cook®) was selected. With this technique, the partly inflated balloon/stent assembly can be repositioned. For stent delivery, a balloon with the diameter of the distal aortic arch was chosen. Since general availability, only stents with rounded edges (CP-stents Numed®, Intrastents Double Strut Intratherapeutics®) were chosen to prevent ‘flaring’ of the sharp edges of the stent with injury of the aortic wall. Only stents that were dilatable to an adult size were used. To avoid any overdistension and eventual aortic aneurysm, all stents were deployed without previous balloon angioplasty.

Follow-up
Between April 2004 and June 2005, all patients after stent implantation (native or residual CoA) were invited for a protocolized follow-up examination. All patients were thoroughly physically examined at a minimum of 3 months following the intervention. In patients with a follow-up period less than 3 months only the blood pressure measurements at the right arm were assessed at hospital discharge after stent implantation. Routine follow-up examinations were scheduled 3, 6, and 12 months after the intervention. Later, yearly control examinations were performed. In all patients, the most recent blood pressure measurement at the right arm was included for assessment. Apart from a cardiological examination, special attention was paid to the blood pressure values of both arms and legs. The systolic blood pressure was taken under resting conditions using auscultation and the Doppler-technique at the arm arteries, dorsal foot arteries, or posterior tibial arteries. After an initial resting ECG all patients underwent a bicycle exercise test in sitting position. Starting with 25 W, the workload was increased every 2 min by 25 W until submaximal workload was attained, unless any adverse symptoms occurred. The actual blood pressure was measured by Riva-Rocci minute-by-minute recording on the right arm.

The in-exercise blood pressure was considered to be abnormal if it exceeded the 95th age-adopted percentile.17 Ambulatory blood pressure was measured oscillometrically over a period of 24 h (SpaceLabs 90207®). Measurements were taken every 20 min between 6 a.m. and 6 p.m. and every 60 min during the night. The day-and-night-time profiles of blood pressure and day–night rhythm were evaluated. Arterial hypertension in ambulatory 24-h blood pressure recordings was defined as a mean systolic blood pressure above the 95th percentile.18 Borderline arterial hypertension was defined as a blood pressure between the 90th and 95th percentile.18

All patients had a standardized echocardiographic examination. The cw-Doppler flow pattern was analysed for the presence of diastolic run-off. However, as residual CoA may not present as a circumscript stenosis, Doppler gradients calculated from the Bernoulli equation across the coarcation were not analysed. Left ventricular hypertrophy was defined when the left ventricular posterior wall end-diastolic diameter exceeded the 95th percentile.19

Statistics
For statistical analysis non-parametric tests (Wilcoxon test) were applied. In the three patients in whom a tubular vascular graft was inserted and in whom both anastomoses were stenotic, only the narrowest stenosis (in all patients the proximal one) was taken into account for statistical analysis of diameter increase. The invasive peak systolic gradient was assessed over the complete segment in these three patients pre- and post-stent implantation. Box plots express median, 25–75% quartiles, minimum, maximum, and outliers, respectively. In the text, groups were characterized with median (minimum and maximum) values. Statistical analysis was performed using SPSS V10.0.5 (SPSS Inc., Chicago, IL, USA). All tests were performed two-sided. Because of multiple (3) testing, Bonferroni correction was applied and the result of each test was assessed with a significance level of 1.67%.


   Results
Top
 Abstract
 Introduction
 Methods
 Results
Discussion
 Limitations of the study
 Conclusion
 References
 
Patients
Before intervention, all but two patients had arterial hypertension (defined as systolic blood pressure above the 95th percentile for age at the right arm,20 measured by sphygmomanometers), despite anti-hypertensive medication in 18/43 patients. The relatively low incidence of anti-hypertensive drug treatment in hypertensive patients is explained by suspected anatomical CoA. The two normotensive patients had a functionally univentricular heart with significant CoA (Table 1).

Stent implantation
A total of 47 stents were deployed in 43 patients (Table 1). In three patients after surgical Dacron tube interposition, two stents were needed to widen both ends of the stenosed tube. Balloons of 12–18 mm dilation diameter were selected to deliver the stents. The narrowed segment of the aorta was widened in all patients (Figure 2) from a median diameter of 8 mm (range 6–13 mm) to a median diameter of 12.4 mm (range 9–17 mm) (P<0.0005). The median systolic peak-to-peak gradient between the ascending and the descending aorta (Figure 3) was lowered in all patients from 22 mmHg (range 5–58 mmHg) to a median of 1 mmHg (range 0–10 mmHg) (P<0.0005). Six patients had an invasive systolic peak-to-peak gradient greater than 5 mmHg after stent implantation. Three of these patients had a tube graft interposition.


Figure 7482
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  		Figure 2 Angiographic diameter of the stenosed aorta before and after stent implantation. The stenosed segment was widened significantly (P<0.0005). Box plots express median, 25%, and 75% quartiles, minimum, maximum, and outliers (greater than 1.5 but less than 3 interquartile length values).

 

Figure 7483
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  		Figure 3 Invasive peak systolic gradient between the ascending and the descending aorta before and after stent implantation. The gradient was lowered significantly (P<0.0005). Box plots express median, 25 and 75% quartiles, minimum, maximum, and outliers (greater than 1.5 but less than 3 interquartile length values).

 
Complications
Three balloons ruptured during inflation. In all cases the stent could be extended by rapid manual balloon inflation with pure saline fluid. All of these stents were delivered successfully. Another stent migrated distally. It was inflated in the abdominal aorta and left in place. The CoA was then stented with a second stent. One patient showed loss of femoral artery pulsations and received thrombolytic therapy, which resulted in palpable pulsations. On the last out-patient clinic visit, this patient had no complaints and peripheral pulses on both legs were palpable.

Follow-up examinations
Complete follow-up information (clinical examination, echocardiography, 24-h blood pressure, tread mill test) was available in 37 out of 43 patients. In five patients the time elapse was too short (less than 3 months) for relevant follow-up data and one patient from abroad was lost to follow-up. In these six patients blood pressure at discharge from the hospital after stent implantation was assessed. Median follow-up time for 37 patients was 30 months (range 3–72 months). The right arm systolic blood pressure was lowered significantly (Figure 4) from a median value of 144 mmHg (range 74–200 mmHg) before stent implantation to a median value of 128 mmHg (range 93–180 mmHg) at the last follow-up visit (P<0.0005). Thirteen patients (35%) showed elevated systolic blood pressures on bicycle exercise tests. Under a median workload of 2.3 W/kg (range 0.5–3.5 W/kg), the median systolic blood pressure was 190 mmHg (range 120–280 mmHg). In ambulatory 24-h blood pressure measurements, nine patients (24%) were hypertensive, five of whom had borderline hypertension. Diastolic blood pressures were normal. However, nearly all patients had lost their circadian rhythm in 24-h blood pressure measurements (non-dipping).


Figure 7484
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  		Figure 4 Systolic blood pressure at the right arm before stent implantation and at the latest outpatient visit. The systolic blood pressure was significantly lower at the last visit (P<0.0005). Box plots express median, 25 and 75% quartiles, minimum, maximum, and outliers (greater than 1.5 but less than 3 interquartile length values).

 
Left ventricular hypertrophy assessed by M-mode echocardiography was present in one patient and borderline in eight patients. Anti-hypertensive medication was necessary in 17/37 (46%) patients. Six patients needed more than one anti-hypertensive drug. The anti-hypertensive drugs were not withdrawn during the examinations. Finally, after all examinations 25/37 patients (68%) were classified to be normotensive.

Repeated cardiac catheterization
In all patients, repeated catheterization was scheduled 12 months after stent implantation. So far, this catheterization was performed in 16/43 (37%) patients. No aneurysms were seen. A medium systolic peak-to-peak gradient of 7 mmHg (range 0–22 mmHg) was assessed. The patient with the residual gradient of 22 mmHg has a 10 mm tube graft, which is due to be exchanged in the near future. A narrowing caused by intima proliferation (1–2 mm) was seen in all patients without clinical relevance.


   Discussion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
Limitations of the study
 Conclusion
 References
 
This study shows that stent implantation in our selected patients with recurrent or native CoA was safe and effective and resulted in significant widening of the stenosed area and in significant reduction of blood pressure gradients. These results are in concordance with other previously published reports.12–14,21,22 However, the problem of persistant hypertension after CoA repair in the presence of residual stenosis but even more in the absence of a recurrent or residual stenosis, as was seen in a substantial proportion of our patients, has not been solved. Arterial hypertension in combination with left ventricular hypertrophy is an important contributor to morbidity and mortality from cardiovascular disease.23 Systolic arterial hypertension is associated with the same unfavourable outcome as an elevated diastolic or mean blood pressure.24 Patients who underwent surgical correction a long time ago or at an older age are at more risk of abnormal blood pressure responses after surgery than those operated on in early childhood.25 Twenty years after operation, only 40–50% of all patients have normal blood pressures.26 Hager et al.27 extensively studied 274 long-term survivors of CoA surgery after a mean interval of 18.4 years post-surgery and found only 48% of these patients to be normotensive.

Possible explanations for persistant arterial hypertension are a residual or recurrent CoA, a reduced aortic compliance due to scar tissue or conduit interposition and a generalized disease of the pre-stenotic upper limb arteries.

Even though contemporary surgical results are excellent2,28 and young age should not result in delay of treatment, recurrent CoA may develop at the site of the aortic suture line. Results of surgery for re-CoA have improved29 but surgery is at least associated with increased morbitity.30 In these patients stenting may be an option. It is our policy to perform stent implantation only if an adequately sized stent (dilatable to an adult size) can be used. Once bioabsorbable stents are available, this indication may be extended.31,32 Like Magee et al.13 we perform primary stent implantation without previous balloon dilation to avoid overdistension and possible aneurysm formation of the aorta.

Increased aortic stiffness and reduced compliance of the aorta after CoA-repair as demonstrated by MRI,33 transoesophageal echocardiography,34 and intravascular ultrasound35 may be another substrate for persistant arterial hypertension. Aortic stiffness is an independent cardiovascular risk factor in hypertensive patients.36 With extensive scar tissue at the site of previous CoA and after tube graft insertion for CoA, patients may have an elevated systolic and lowered diastolic blood pressure and a loss of compliance due to a stiff aortic segment. In four out of five patients with a tubular graft in this study, systolic hypertension persisted after stent implantation. One of these patients, however, had intermittant ‘claudication’ which disappeared after intervention.

A third factor that might play a role in persistant arterial hypertension in the absence of recurrent CoA is a generalized vascular dysfunction of pre-stenotic arteries. Pathological vascular reactivity at rest and under exercise conditions was already assessed in the upper limb arteries of patients after successful repair of CoA in 1976.37 Histology revealed an increase of collagen and a decrease of smooth muscle cells in pre-stenotic arteries in comparison with post-stenotic arteries at the operation.38 Impaired arterial reactivity39 and abnormal pulse wave velocity were assessed in pre-stenotic arteries.40 It remains debatable if this pathological vascular response, which is detectable even in newborns with CoA,41 is reversible after early correction or may be an expression of an intrinsic phenotype in a generalized complex vascular disease.

Systolic hypertension was present in almost all of our patients preceding the intervention. Even though the anatomical stenosis was removed completely by stent implantation, systolic arterial hypertension persisted in 13 patients. So far only short to intermediate results after successful stent implantation were presented in the literature. The incidence of persistant arterial hypertension varied between 12–71%13,21,42,43 and many patients were receiving anti-hypertensive drugs. Anti-hypertensive medication was necessary in 46% of our patients. The combined effort of medical therapy and stenting led to normal blood pressures in 68% of our patients. However, nearly all patients had lost their circadian rhythm (non-dipping) in 24-h blood pressure measurements.

The size of the dilating balloons was chosen according to the adjacent aorta. Overdilation of the aorta was avoided to prevent vessel damage. A median aortic diameter of 12 mm after stent implantation might seem small. However, 26/43 patients were below 18 years of age and hence may not have reached their final height. As only stents that are dilatable up to 20 mm in diameter were implanted, repeated stent dilatation maybe performed if necessary later on.


   Limitations of the study
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Limitations of the study
Conclusion
 References
 
As this study was not prospectively designed, the selection criteria for stenting changed. Selected patients with native CoA were also included.


   Conclusion
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Limitations of the study
 Conclusion
References
 
Arterial hypertension in long-term follow-up after CoA repair is multifactorial and the prevalence is high. Stent implantation for selected patients with residual and native CoA is safe and often effective. Anatomically a good result can be achieved. Stent implantation can excellently abolish restenosis, but may theoretically decrease compliance, at least partly explaining the finding that a significant number of patients remain hypertensive and require anti-hypertensive treatment. Regular follow-up is regarded essential in all patients after stent implantation, especially if arterial hypertension persists.

Conflict of interest: none declared.


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 Limitations of the study
 Conclusion
 References
 

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