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J Am Coll Cardiol, 2006; 47:1101-1107, doi:10.1016/j.jacc.2005.10.063 (Published online 21 February 2006).
© 2006 by the American College of Cardiology Foundation
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VIEWPOINT

The Results of Catheter-Based Therapy Compared With Surgical Repair of Adult Aortic Coarctation

John Alfred Carr, MD*

Department of Cardiovascular and Thoracic Surgery, University of Chicago, Chicago, Illinois.

Manuscript received June 24, 2005; revised manuscript received October 2, 2005, accepted October 12, 2005.

* Reprint requests and correspondence: Dr. John Alfred Carr, Department of Cardiovascular and Thoracic Surgery, University of Chicago, E-500, 5841 South Maryland Avenue, Chicago, Illinois 60637. (Email: heartandbones{at}yahoo.com).


   Abstract
Top
 Abstract
Methods
 Results
 Discussion
 Appendix
 References
 
A review was performed to compare the results of endovascular therapy (stenting and angioplasty) with surgical techniques to repair adult aortic coarctation. The immediate improvement in hypertension and the morbidity were similar across all groups. Surgical therapy was associated with a very low risk of restenosis and recurrence, whereas endovascular therapy had a much higher incidence of restenosis and the need for repeat interventions. The long-term outcome of endovascular approaches will need to be assessed in the future.

Abbreviations and Acronyms
  CI = confidence interval
  OR = odds ratio
  RR = relative risk

Endovascular stenting for thoracic aortic disease is rapidly becoming a popular and highly effective way of treating many complicated conditions, such as aneurysms, dissections, and penetrating ulcers. In the elderly and frail patients with multiple comorbidities who pose a high surgical risk, endovascular stenting shows great promise in effectively eliminating potentially lethal conditions with minimal physiologic stress. For this reason, it will no doubt continue to take on a larger and more predominant role in the surgical armamentarium for those of us who treat thoracic aortic disease in the elderly.

As pointed out by Lee and White (1) and Fann and Miller (2), the long-term durability of the stent-graft to prevent aneurysm growth, maintain false lumen obliteration, or penetrate ulcer thrombosis is unknown; however, because the life expectancy of many of these octogenarian patients is <5 to 7 years, that might be irrelevant. The short-term data from several large series of stent-graft implantation to treat descending thoracic aneurysms show a two-year survival of 73% to 76% and a three-year event-free survival of only 53% to 63% (3–6). Considering the debilitated condition of most, if not all, of these patients, the stated results are considered quite acceptable.

The same cannot be said, however, for patients with aortic coarctation. The majority of these patients are young and relatively healthy, with only chronic hypertension as a comorbidity. Unlike the elderly aneurysm/dissection population who need a less-invasive life-saving procedure, the coarctation population needs a highly durable, lifelong cure for their hypertension. So what role, if any, does aortic stent-grafting play in the treatment of native adult aortic coarctation?

In the last 10 years, there has been an explosion of reports of endovascular stenting and/or angioplasty of native coarctation in the adult (7–23). Most of these reports cite good angiographic results and a decrease in the transcoarctation pressure gradient but have very short follow-up and do not discuss the most clinically relevant factor: cure of hypertension. There is strong evidence that a good angiographic result after coarctation stenting does not necessarily equate to a decrease in systemic blood pressure. As noted by Duke et al. (24), there is a poor correlation between the increase in the coarctation diameter after stenting and any improvement in hypertension.

There has only been one randomized, multicenter study comparing angioplasty with surgical repair for coarctation, and the results showed higher recurrence rates (50% vs. 21%) and a higher incidence of persistent hypertension (49% vs. 19%) with angioplasty, whereas the complication rates were similar (25). Nevertheless, there has been a dramatic increase in the use of this modality, and it is very timely and important to examine the benefits and risks of angioplasty and stenting and compare them with the outcomes of surgical repair in order to provide the best option for our patients.


   Methods
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 Abstract
 Methods
Results
 Discussion
 Appendix
 References
 
The on-line databases of Medline and PubMed were used to search for all English language articles related to the treatment of adult and adolescent coarctation over the last 10 years, 1995 to 2005. See the Appendix for all search terms used. There were significantly more articles describing endovascular results than surgical results. Reports that focused on repair in infants and children, review articles, editorials, and those that lacked sufficient follow-up information or a clear description of what was done were excluded from analysis.

For the purposes of this review, mortality was defined as death within 30 days of the procedure, as outlined by the American College of Surgeons. Morbidity was defined as a failure to achieve the desired result or any unplanned or untoward event that required another procedure to correct, did the patient harm, created new pathology that the patient did not have previously, or increased hospital length of stay.

For all articles, the age, transcoarctation gradients, and follow-up are presented as the mean with standard deviation. The morbidity and mortality are listed as a percentage of the total patients per study as originally presented from the respective journals. The meta-analysis to determine effect size was accomplished with the statistical software package Power and Precision, Version 2 (BioStat Inc., Englewood, New Jersey). Logistic regression analysis was performed to determine the odds ratios (OR) and 95% confidence intervals (CIs) as well as the relative risk (RR) for the effect of the different therapies on hypertension, morbidity, restenosis, and repeat interventions. A two-tailed alpha of 0.05 was used, and the power of each analysis to detect this significance is presented in the Results section.

In the initial analysis, articles were separated by those that described treating patients with stenting or angioplasty alone, a combination of stenting and angioplasty, or surgical therapy. A second analysis attempted to separate patients by those with primary versus recurrent coarctation; however, whereas all of the surgical reports, except one, dealt with primary coarctation, the majority of endovascular articles described a mixed patient population of mostly primary, with a few recurrent, coarctations. Thus, separation on the basis of this characteristic was not possible, except for five endovascular articles that dealt with a pure patient sample of primary coarctation.


   Results
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 Abstract
 Methods
 Results
Discussion
 Appendix
 References
 
Since 1995, there have been 16 published English-language reports of the results of endovascular therapy for coarctation in the adolescent and adult population (Table 1), totaling 633 patients. The mean age was 22 years (SD ±6.3) with an average peak systolic gradient of 47 mm Hg (SD ±13). The mean duration of follow-up for these patients was 36 months (SD ±23). The morbidity associated with the stenting procedure ranged from 0% to 20% (mean 9%), whereas the morbidity for angioplasty was 14% to 24% (mean 19%). Combination therapy of angioplasty and stenting had a morbidity range of 17% to 22% (mean 19%). Angioplasty was associated with more complications than primary stenting (OR 2.4 ± CI 0.8, RR 2.1, with 91% power). The most common complications in both groups were traumatic aneurysm formation at the site of balloon/stent deployment and aortic dissection (Table 2). No patient developed paralysis. Three of the series reported deaths after the procedure; however, this occurred too rarely to have statistical meaning.


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  		Table 1. Results of Endovascular Therapy for Coarctation in the Adult
 

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  		Table 2. Morbidity and Mortality After Endovascular Therapy for Coarctation in the Adult
 
During this same time period, there were six published reports of the results of surgical therapy for coarctation in similar adult populations (Table 3), totaling 213 patients. The mean age was 37 (SD ±15), because the surgical patients tended to be older than the endovascular cohort (OR 2.1 ± CI 0.7, RR 1.7 with 99% power). The surgical patients also had a higher average peak systolic gradient across the coarctation (62 mm Hg, SD ±6.7) compared with both the stenting and angioplasty groups (OR 2.3 ± CI 0.8, RR 1.5). The mean duration of follow-up for these patients was 7.8 years (SD ±6.5), which was significantly longer than the endovascular reports. The morbidity associated with the surgical procedures ranged from 0% to 25% (mean 11%), with the most common complications being bleeding and recurrent laryngeal nerve injury (Table 4). No patient developed paralysis. There was one death across all of the series.


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  		Table 3. Results of Surgical Therapy for Coarctation in the Adult
 

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  		Table 4. Morbidity and Mortality After Surgical Therapy for Coarctation in the Adult
 
In a comparison of morbidity, primary stenting had the lowest risk of complications, surgery had a slightly higher risk (OR 1.3 ± CI 0.2, RR 1.2), and isolated angioplasty had a significantly higher risk (OR 2.4 ± CI 0.9, RR 2.1 with 84% power).

After stenting, the restenosis rates ranged from 0% to 25% (mean 11%), whereas the results for angioplasty and the use of both therapies were 8% to 22% (mean 15%) and 11% to 36% (mean 21%), respectively. This led to repeat interventions in the stenting, angioplasty, and combination groups in 0% to 31% (mean 14%), 10% to 18% (mean 13%), and 6% to 14% (mean 10%) of the patients, respectively. The most common reinterventions were repeat angioplasties for recurrent stenoses, additional stenting for migrations or dissections, and referral to surgery for traumatic aneurysm repair. There was no statistically higher incidence or increased risk of needing a reintervention for one method over the others.

After surgery, the restenosis rates ranged from 0% to 9% (mean 2%). There was a significantly higher risk of restenosis after stenting compared with surgery (OR 6.0 ± CI 1.8, RR 5.5) and after angioplasty compared with surgery (OR 8.6 ± CI 2.2, RR 7.5; both with 96% power). Repeat interventions were necessary in only 0.3% of the surgery patients. There was a dramatically higher risk of needing repeat interventions after stenting or angioplasty compared with surgery (stenting: OR 16.1 ± CI 2.8, with an RR of 14; angioplasty: OR 14.8 ± CI 2.7, with an RR of 13; with 95% power) (Fig. 1).


Figure 1
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  		Figure 1 Odds ratios with 95% confidence intervals.

 
Endovascular stenting led to a cure of hypertension (patients no longer requiring any medication to treat hypertension) in 18% to 88% (mean 61%), although four authors did not report their eventual effect on the patient’s blood pressure. Surgery led to a cure of hypertension in 13% to 76% (mean 64%) of the patients, although the one series with the lowest cure rate (13%) was in a significantly older cohort of patients with a mean age of 54 years. Because the follow-up in the surgical series was much longer than in the endovascular reports, comparing the incidence of (or lack of) hypertension during follow-up between the two groups is significantly skewed.


   Discussion
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 Abstract
 Methods
 Results
 Discussion
Appendix
 References
 
The common rationale for avoiding surgical repair is to prevent postoperative pain and "surgical morbidity"—an overused term, often invoked as a legitimate reason for avoiding every type of surgery, even those with extremely low morbidity, such as coarctation repair. In fact, the true morbidity of surgical coarctectomy is quite low and is actually better than that reported for stenting in several series (26–29). In the current analysis, stenting did have a slightly lower morbidity than surgery, although angioplasty was higher. Rokkas et al. (30) reported zero mortality and minimal morbidity in his surgical series, even with complicated coexisting arterial abnormalities and the use of circulatory arrest. Bauer et al. (27) reported zero mortality and morbidity after coarctation repair in a series of complicated older adults with an age range of 50 to 63 years. Since 1945, when Crafoord et al. (31) reported the very first series of adolescents and young adults undergoing coarctation repair, the surgical techniques have continually improved and the results have continued to get better. We now have outstanding results with follow-up in several long-term series reporting cures of hypertension persisting 18 to 44 years after surgical repair (26,32–34). It had been previously believed that hypertension persisted in the adult after coarctation repair, but three recent studies have shown that, after surgery, 58% to 76% of patients will be cured of hypertension and medication-free (26,35,36). On the basis of the limited follow-up of 2 to 3 years available for endovascular repair, it is premature to state that the results are similar to surgery.

The majority of surgical complications, when they did occur, were minor (i.e., vasculitis, bleeding), whereas the majority of endovascular complications could be considered more severe (i.e., dissection, traumatic aneurysm, stroke). In the past 10 years, there have not been any reports of permanent paralysis, stroke, or cardiac death after surgical repair (26–30,33,37). There was only one death reported after surgery, the result of postoperative hemorrhage. After endovascular repair, there were deaths reported (12,19,20). In addition, endovascular techniques are not without the risk of paraplegia, which has been reported after angioplasty of an aortic coarctation (38). Case reports have documented a myriad of complications after coarctation stenting, including antegrade dissection, stent collapse, delayed retrograde dissection, restenosis, and even free aortic rupture (39–43). Thus, surgery for aortic coarctation is safer than stenting.

One of the more common complications after stenting is traumatic aneurysm formation. This is because the method of aortic enlargement with angioplasty or stenting is by fracturing the intima and media of the aortic wall at the site of coarctation as well as the surrounding normal tissue (44). The torn portion of the aortic wall is then only held together by the adventitia and is prone to dilate over time. We know from histologic studies of coarctectomy specimens excised at surgery or acquired from autopsies that the aortic wall in this area is always affected by cystic medial necrosis, severely so in 67% of specimens (45). This structural defect, as well as accelerated apoptosis in the area after angioplasty, further decreases the integrity of the aortic wall and predisposes to aneurysm formation (45,46). It has been hypothesized that stenting would cover this weakened area and thereby prevent aneurysm formation (44); however, owing to the large number of reports documenting aneurysm formation after stenting, this does not appear to be true (12–16,20,21,23). What is the fate of these aneurysms? Do they continue to enlarge? The current follow-up is not long enough to say, and there have been no reports documenting the natural history of these unnatural aneurysms. It is only fair to say that not all surgical interventions, if any, are followed by post-procedural angiography, whereas all catheter-based interventions are. Therefore, excessive patch redundancy, insufficient patch width, or other technical errors will not be detected as often immediately after surgical intervention.

Another common—and concerning—complication is the presence of a residual gradient after stenting. Even mild residual stenoses with low but persistent gradients have been thought to increase the risk of cardiovascular events, such as persistent hypertension and decreased left ventricular function (47–49). Zabal et al. (10) showed that the residual gradient was the most important risk factor for having a cardiovascular event during follow-up. A residual gradient of >10 mm Hg was shown to be the best cutoff point for separation of high and low risk, with a hazard ratio of 9.6 when compared with a residual gradient of <10 mm Hg.

This makes intuitive sense, because a residual gradient is likely to get even higher with exercise. None of the patients in any of the endovascular series for native coarctation were exercise-tested after endografting, and so it is unknown if they, in fact, have exercise-induced hypertension. The authors of two surgical series did perform exercise testing in their patients after operation and found a significant incidence of exercise-induced hypertension (defined as systolic blood pressure >195 mm Hg or higher than the 95th percentile for their age and gender) in patients who were normotensive at rest (27,29). This is known to be another risk factor for the eventual development of left ventricular dysfunction and heart failure. Two studies have shown that 21% to 35% of post-coarctectomy patients with normal blood pressure at rest demonstrated exercise-induced hypertension, which they defined as systolic blood pressure >200 mm Hg (20,29). Thus, exercise testing becomes critical in any patient with a mild post-intervention gradient because its true effect might be unknown until the patient is fully active.

What might be most concerning is that the one endovascular series with the longest follow-up of more than 6 years, Macdonald et al. (17), reported a 36% restenosis rate and that only 18% of the patients were no longer being medicated for hypertension. The other series with long-term follow-up, Paddon et al. (16), did not report a restenosis rate and, although only 5 of the 16 patients in that series were taking antihypertensive medication before intervention, 4 were still taking medication afterwards. This obviously creates concern that most of these patients might be found to have a recurrence or stenosis in the future and not only require a second, potentially complicated, intervention but also suffer the effects of undiagnosed hypertension for several months to years.

Because the entire reason for intervening in patients with coarctation is to relieve the pathologic hypertension, this is the most crucial end point to examine. In most surgical series there is a consistent cure of hypertension in more than 60% of the patients (26,28,29,36,50,51). This is also a durable cure, with persistence in the maintenance of normotension in excess of 20 years or more (26,32–34). This makes it difficult to accept 40% to 60% cure rates after only 2 to 3 years of follow-up in several endovascular series (10,18,19,21).

To prevent recurrence, it logically makes sense that stenting would have better results than angioplasty, but this has not been shown to be true (19–23). The morbidity, mortality, and repeat intervention rates were just as high for stenting as they were for angioplasty or using a combination of both modalities. Although stenting protects against immediate recoil of the vessel, the long-term results were plagued by intimal hyperplasia that developed within the stent itself, leading to recurrence (12,15,17,19–23). This becomes especially important when one considers the cost-effectiveness of catheter-based therapies compared with surgery. Surgery has an extremely low incidence of recurrence, and although it initially costs more than endovascular approaches, the cost savings of endovascular therapy only apply if the repeat interventions are kept to a minimum (49).

There are a few limitations to this study. In such a pooled analysis, there is an inherent selection bias and heterogeneous patient mix. This cannot be overcome. In the absence of a prospective randomized trial, which would be very difficult, owing to the low incidence of adults with coarctation, exact patient matching and equalization of risk factors is not possible. The assumption is made that all complications were mentioned in each respective paper and that the reporting of untoward events and misadventures was honestly upheld by each author.

Conclusions.   Primary angioplasty or stenting of native adult aortic coarctation has similar but not less morbidity than surgical repair. Recurrence and reintervention rates are much higher after endovascular therapy. Both therapies seem to provide relief of hypertension with similar efficacy, at least in the short term; however, clinical equipoise does not currently exist between the two approaches and may not until the long-term outcome of stenting is discovered.


   Appendix
Top
 Abstract
 Methods
 Results
 Discussion
 Appendix
References
 
Search terms used:

Coarctectomy
Coarctation AND adolescent
Coarctation AND adult
Coarctation AND surgery
Coarctation AND angioplasty
Coarctation AND stent
Coarctation repair


   References
Top
 Abstract
 Methods
 Results
 Discussion
 Appendix
 References
 

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H. Laks, D. Marelli, M. Plunkett, and J. Myers
Adult Congenital Heart Disease
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Y.-Y. Lam, M. G Kaya, W. Li, V. S Mahadevan, A. A Khan, M. Y Henein, and M. Mullen
Effect of endovascular stenting of aortic coarctation on biventricular function in adults
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Stenting the mildly obstructive aortic arch: useful treatment or oculo-inflatory reflex?
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