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a Department of Cardiovascular Surgery, Swiss Cardiovascular Centre, Inselspital, University Hospital Bern, and University of Bern, Bern, Switzerland
b Division of Angiology, Swiss Cardiovascular Centre, Inselspital, University Hospital Bern, and University of Bern, Bern, Switzerland
Accepted for publication January 8, 2008.
* Address correspondence to Dr Immer, Department of Cardiovascular Surgery, Inselspital, University Hospital Bern, and University of Bern, Berne, 3010, Switzerland (Email: franzimmer{at}yahoo.de).
| Abstract |
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Methods: A post hoc analysis of a prospectively collected consecutive series of 136 patients presenting with surgical diseases of the descending aorta between January 2001 and December 2005 was conducted. Fourteen patients were excluded because of involvement of the ascending aorta. Assessed treatment cohorts were TEVAR (n = 52) and OAR (n = 70). Mean follow-up was 34 ± 18 months. End points were perioperative and late mortality rates and long-term quality of life as assessed by the Short Form Health Survey (SF-36) and Hospital Anxiety and Depression Score questionnaires.
Results: Mean age was significantly higher in TEVAR patients (69 ± 10 years versus 62 ± 15 years; p = 0.002). Perioperative mortality rates were 9% (OAR) and 8% (TEVAR), respectively (p = 0.254). Accordingly, cumulative long-term mortality rates were similar in both cohorts. Overall quality-of-life scores were 93 (63–110, OAR) and 83 (60–112, TEVAR), respectively. Normal quality-of-life scores range from 85 to 115. Anxiety and depression scores were not increased after open surgery.
Conclusions: Thoracic endovascular aortic repair and OAR both provide excellent long-term results in treatment of thoracic aortic disease. Long-term quality of life, however, is reduced after thoracic aortic repair. Interestingly, TEVAR patients did not score higher in overall quality of life despite all advantages of minimized access trauma. Similarly, anxiety and depression scores are not reduced by TEVAR, possibly reflecting a certain caution against the new technology.
| Introduction |
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One of the presumed major advantages of endovascular management of thoracic aortic disease, beside its minimized access trauma, is avoidance of aortic cross-clamping and thus major iatrogenic variations of cardiac stress and arterial blood pressure with corresponding volume shifts. Hence, TEVAR allows for acceptable paraplegia rates ranging from 0% to 5% [3–6], whereas paraplegia rates after OAR used to range from 5% to 25% [7, 8]. Implementation of new protective strategies such as cerebrospinal fluid drainage, however, has decreased the incidence of paraplegia in centers of excellence after thoracic OAR to around 6% [1, 2, 9].
Health-related quality of life (QoL) is increasingly recognized as a pivotal outcome dimension after any kind of invasive treatment. After thoracic descending aortic repair, however, it has been assessed only in smaller collectives so far [10, 11]. In these series, QoL was found to be impaired after OAR. Endovascular aortic repair is commonly accredited a significant potential for alleviating postoperative QoL impairment and minimizing reactive anxiety and depression because of its minimally invasive nature. However, in several studies focussing on abdominal aortic repair, long-term QoL was at least as impaired after endovascular aortic repair as after OAR [12–16].
The aim of this single-center series was to assess outcome and postoperative long-term QoL in patients treated for diseases of the thoracic aorta by either TEVAR or OAR, and to relate them to an age-adjusted and sex-adjusted standard population.
| Patients and Methods |
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All patients were followed up systematically after intervention in annual intervals within a specialized outpatient clinic. Follow-up data were thereby recorded prospectively. Additional outpatient visits were arranged according to clinical needs.
Cross-sectional assessment of present-day QoL was performed after a mean follow-up of 34 ± 18 months using the validated German versions of both the Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression Score (HADS) questionnaires [18–20]. Questionnaires were sent a second time to nonresponders before they were contacted by phone. Outcome was analyzed according to the intention to treat.
Study End Points
Perioperative mortality and morbidity included all events within 30 days of treatment or when still in hospital. Cumulative long-term survival was assessed according to the method proposed by Kaplan and Meier [21]. Quality of life was assessed by means of the self-administered SF-36 and HADS questionnaires. Details of the validated German version of the SF-36 have been published previously [22]. The SF-36 consists of 36 short questions reflecting QoL in eight different aspects: bodily pain (2 items); mental health (5 items); vitality (4 items); social functioning (2 items); general health (5 items); physical functioning (10 items); and role functioning, both emotional (3 items) and physical (4 items). Role functioning reflects the impact of emotional and physical disability on work and regular activity (the individual's normal everyday role). Raw points generate scores for each dimension, which add up to a total raw score ranging from 0 to 100, with 100 reflecting best functioning. Raw scores then were adjusted for age and sex of the study population by multiplication with the appropriate factor based on a validated Swedish standard population (n = 8,930) according to the SF-36 manual [19], thereby generating an adjusted score. Normal values for the adjusted score range from 85 to 115. The aspects of anxiety and depression were assessed additionally with the HADS questionnaire. This questionnaire allows us to assess psychic restrictions in patients with somatic disorders [20].
Statistical Methods
Continuous variables are summarized as mean ± standard deviation when normally distributed, and as median and interquartile range when asymmetrically distributed. Categorical variables are presented as numbers and percentages. Percentages were rounded off to the whole number. Differences between continuous variables were compared by two-tailed unpaired Student's t test if normally distributed, and by Mann-Whitney U test if asymmetrically distributed. Categorical variables were compared by two-tailed Fisher's exact test. The SF-36 questionnaire was analyzed in accordance with the SF-36 manual, replacing missing values using the described algorithm [18, 19]. After adjustment for age and sex SF-36 scores were compared by means of Mann-Whitney U test. Results were stratified for modality of treatment. A probability value of less than 0.05 was considered to indicate statistical significance. Data were analyzed using SPSS for Windows, version 15.0 (SPSS, Inc, Chicago, IL).
| Results |
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In the TEVAR cohort mean intervention time was significantly shorter (182 ± 121 minutes; p < 0.001, by Mann-Whitney U test). A mean of 273 ± 157 mL of contrast media was injected during interventions, and the mean roentgenography time was 19 ± 13 minutes. Endovascular fenestrations of dissection membranes were performed in 3 patients (6%), and in 13 patients the left subclavian artery was overstented (25%). However, no patient experienced ischemic symptoms of the left arm later nor were neurologic sequelae in the vertebrobasilar region registered. The incidence of endoleaks in postoperative control computed tomography angiograms was 21% (n = 11). Four type 1 endoleaks were either converted to OAR (n = 2) or underwent endovascular revision, whereas seven type 2 endoleaks were managed conservatively.
Perioperative morbidity is outlined in Table 2 for both cohorts. Except for a significantly higher incidence of pneumonia after OAR, morbidity was comparable in both cohorts. Early revisions were necessary in around 15% of patients in both cohorts. Whereas endovascular revisions were necessary only in TEVAR patients, revisions for wound infections were more common after OAR.
Follow-Up
Average length of follow-up of survivors was 34 ± 18 months (37 ± 17 months for OAR, and 29 ± 16 months TEVAR; p = 0.021 by Mann-Whitney U test). After the first 30 postoperative days, 16 patients died during follow-up, accounting for cumulative survival rates of 90% (OAR) and 81% (TEVAR) after 1 year. Corresponding rates after 2 and 3 years were 87% and 75%, and 83% and 71%, respectively (p = 0.117, by two-tailed log-rank test; Fig 1). Causes of death are summarized in Table 3. Cumulative long-term rates of freedom from reoperation after 3 years were 98% (OAR) and 94% (TEVAR). Overall, 96 patients were eligible for QoL assessment at cross-sectional follow-up. None was lost to follow-up; therefore all were contacted and sent the SF-36 and HADS questionnaires. Seventy-five patients returned the questionnaires (78%). Five patients were unable to fill out the questionnaires because of language problems. The remaining 16 patients refused to fill out the questionnaires. However, all nonresponders were contacted by telephone and were alive.
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| Comment |
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Health-related QoL is increasingly recognized as a soft yet pivotal outcome dimension in the assessment of surgery in addition to hard end points such as morbidity and mortality rates, as it subsumes the relative importance of all intervention-related sequelae from the most important perspective, the patient's. Indeed, for the individual survivor, health-related QoL might be the single most important determinant of treatment success.
It may certainly not seem unexpected that patients would generally experience a diminished QoL after thoracic aortic repair as compared to an age-adjusted and sex-adjusted standard population. It may, however, seem surprising that no general advantages would be found in TEVAR patients given the common perception of the advantages of a minimized access trauma (Fig 2). On the contrary, in this series patients treated by TEVAR, of all things, tended to experience a comparably impaired QoL in overall physical health. Direct comparisons with the OAR cohort must certainly be judged very carefully because of possible selection bias. It is important to note, however, that TEVAR patients scored significantly lower on overall physical health (and overall QoL) than an age-adjusted and sex-adjusted standard population, whereas OAR patients scored in all integrated scores within the normal range (Table 4). This contradicts the presumed advantages of minimized access trauma. However, similar findings have been reported previously for abdominal aortic repair [15, 16]. In the OAR cohort, limitations were mainly found in emotional and physical role functions, as already reported by other groups in smaller collectives of thoracic OAR [10, 11]. However, these limitations were markedly less pronounced in our series. Astonishingly, the aspect bodily pain differed neither between the two treatment cohorts nor compared with what would be expected in an age-matched and sex-matched standard population, despite the large surgical access for open thoracic and, particularly, thoracoabdominal aortic repair. The access trauma therefore does not seem to generally entail long-term sequelae in thoracic and thoracoabdominal aortic surgery. In the TEVAR cohort, on the other hand, relative limitations were not only found in physical role and function, but also in emotional role and vitality.
Return of questionnaires was nearly 80% representative and was without difference between the treatment cohorts (p = 0.21 by two-tailed Fisher's exact test). It is common to argue, however, that an unequal distribution of underlying mental disorders might skew the individually experienced QoL unfairly and independently of the assessed disease or intervention. A comparable score in the domain Mental Health, therefore, is generally regarded as a precondition for comparability. In our series, both TEVAR (103; interquartile range, 89 to 113) and OAR (108; interquartile range, 83 to 120) patients scored not only in the same range (p = 0.75 by Mann-Whitney U test) but also in the center of what is perceived normal in an age-adjusted and sex-adjusted standard population (ie, 85 to 115). This also rebuts to a certain extent the allegation of selection bias of a particularly motivated patient group in one cohort rather than in the other.
Another obvious confounder regarding long-term QoL of course might be a difference in baseline characteristics. Although the treatment populations were comparable regarding prevalence of cardiovascular risk factors and comorbidities, they differed in demographic aspects and treated aortic disease (Tables 1, 2). The TEVAR patients were older and more often were treated in emergency situations. The OAR patients, on the other hand, were treated more often for aneurysms with larger diameters as well as for more extensive disease. Although it is true that uneven distribution of disease entities such as aortic dissections, fusiform or saccular aneurysms, or megaaortic disease may influence general outcome, it does not seem probable that these factors should impact on long-term QoL after treatment. However, the design of the SF-36 questionnaire may compensate for some of this selection bias. The SF-36 is a broadly accepted tool for QoL assessment that has been reliably validated for statistical adjustment for age and sex [18, 19]. Moreover, its nonspecific generic design renders it widely applicable independent of the underlying disease. Accordingly, it has been used successfully for QoL assessment in aortic patients previously [22, 23]. The fact that after adjustment for age and sex the OAR cohort probably represented a negative selection with more progressed and extensive local disease and still did not report lower QoL scores than the TEVAR cohort may be seen as support of the notion that minimally invasive aortic surgery does not automatically confer enhanced QoL in the long term. An explanation that is frequently offered in the literature for similar findings after abdominal aortic repair concerns the higher frequency and intensity of follow-up examinations after endovascular aortic repair. The DREAM trial, however, showed in a randomized controlled investigation of this phenomenon that poorer long-term QoL after endovascular aortic repair was not related to follow-up investigations, as both treatment arms were followed identically [16]. Similarly, the follow-up protocol in our series was very comparable for OAR and TEVAR patients. Therefore, it seems more probable that patients recovering from dramatic events such as major surgery may subjectively experience a more profound recovery after successful procedures and therefore a better relative QoL than patients who underwent less-invasive procedures.
In line with that, depression and anxiety as assessed with the HADS questionnaire were not at all decreased in TEVAR patients. A possible explanation is that a certain precariousness against a new technology with yet unknown long-term prognosis may lead to impaired QoL. However, patients with higher preexisting depression and anxiety scores could very well tend to be more often assigned to receive less-invasive procedures. It may be seen as a limitation of this study that preoperative QoL as well as anxiety and depression were not assessed systematically. However, such data have been collected in other series previously [16], and their significance is not entirely clear. There probably is no doubt that preoperative QoL data can only be collected in elective situations in a meaningful way. In the present series, a third of the patients (32%) were treated under emergency conditions. But even in elective situations the knowledge of an impending major operation may temporarily influence the QoL significantly. This may be an explanation for a relatively improved QoL after abdominal aortic aneurysm repair as observed in the DREAM trial even though patients were asymptomatic before being operated on. Because our patients returned to a near-normal or normal QoL, it seems improbable that they should have had an impaired QoL before treatment. Anyway, potentially flawed direct comparisons of the cohorts were corroborated by Z testing against an age-adjusted and sex-adjusted standard population (ie, against a normal QoL range). Still, further studies assessing preoperative QoL as well as depression and anxiety levels will help to clarify these observations.
Early mortality rates were well within reported ranges in both cohorts. According to recent reports, early mortality rates of 1% to 9% are acceptable for elective TEVAR [2, 4, 5, 24]. This is consistent with 8% found in our series for TEVAR. It is important to note, however, that almost 50% of our TEVAR patients were treated under emergency conditions, which might distort this result unfavorably: early mortality of emergency TEVAR was 12%. This compares favorably with other series, in which corresponding rates ranged from 17% to 28% [4, 25]. Similarly, long-term survival was very acceptable in both cohorts. At 1 year, cumulative mortality rates were 10% and 19% after thoracic OAR and TEVAR, respectively. This compares favorably with commonly reported mortality rates 1 year after thoracic aortic repair (18% to 24%) [2, 4, 6, 26]. Over the following 2 years, survival curves decreased in an almost parallel way to 83% and 71% (p = 0.117), even though TEVAR patients were significantly older. However, OAR patients had been treated for more progressed and extensive local disease, which is possibly reflected by a higher incidence of cardiovascular deaths during follow-up. Despite a very high percentage of OAR extending to the abdominal aorta (nearly 60%), persistently symptomatic spinal cord ischemia was found only in 3% of OAR patients postoperatively. Both drainage of cerebrospinal fluid and prevention of perioperative hypotension (ie, a mean arterial pressure <70 mm Hg) had been implemented routinely before start of the study period. The corresponding rate after TEVAR was 4% (p = 1; Table 2). These findings are comparable to results of others [1, 2, 9] and underline the importance of new neuroprotective strategies aiming at prevention of spinal cord ischemia [27].
In conclusion, both TEVAR and OAR provide excellent long-term results in the treatment of the diseased descending thoracic aorta. Long-term QoL, however, may be slightly impaired after thoracic aortic repair. Interestingly, TEVAR patients did not score higher on overall QoL despite all the advantages of minimized access trauma. Whereas OAR patients returned to a low yet normal QoL as compared to an age-adjusted and sex-adjusted standard population, TEVAR patients scored lower on overall physical health and QoL. In addition, anxiety and depression scores were not reduced by TEVAR, possibly reflecting a certain precariousness against this new technology.
| Acknowledgments |
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