Assessment of the quality of life comparison between open and endovascular aortic arch surgery: a pilot study

Abstract

Background

Advancement in endovascular endografts have paved the way to the possibility of performing endovascular aortic arch repair in recent years. This has started to supersede the need for open aortic arch surgery. There remains a paucity of data looking into the quality of life comparison between open aortic arch surgery and endovascular aortic arch repair.

Method

A retrospective, observational pilot study was performed on patients who underwent endovascular inner branched aortic arch repair and open aortic arch surgery. Patients completed the RAND SF-36 questionnaire at the 6 week follow-up post-surgery. Mean score across all eight subscales were compared to the New Zealand population norm based on the New Zealand Health Survey as cited in the SoFIE-Health study.

Results

A total of 12 patients were included in this study over a 3 year period. We demonstrated that endovascular aortic arch repair is associated with a better quality of life compared to open aortic arch surgery across all eight subscales. Pain scores were found to be higher than the population normal in the endovascular aortic arch repair group while the open aortic arch surgery group had a score lower than the population norm (P < 0.01).

Conclusion

There appears to be a trend towards better quality of life following endovascular aortic arch repair compared to open aortic arch repair.

Key messages regarding feasibility

• • Assessment of quality of life following major aortic arch surgery have not been well researched or described in the medical literature.

• • Patients who underwent endovascular aortic arch surgery tended towards having a better quality of life compared to open aortic arch repair.

• • Larger cohort studies incorporating a quality of life assessment pre- and post- aortic arch surgery is warranted.

Introduction

The advancement in endovascular technology has opened up the possibility of performing endovascular aortic arch repair in recent years [1]. Traditionally, this is performed through an open surgical approach which carries high mortality and morbidity risk compared to an endovascular approach [1, 2]. The idea behind the introduction of an endovascular approach was tailored to high risk surgical candidates such as re-do sternotomy as well as in the octogenarian population [1]. The promising outcomes has since widened the indications for application of total endovascular repair of aortic arch aneurysms.

Current medical literature is quite limited in assessing the quality of life of patients who undergo aortic arch surgery. Published studies mainly focused on the quality of life post aortic arch surgery which has been shown to be comparable to the general population [2, 3]. However, current medical evidence is lacking in exploring the difference in quality of life between open and endovascular aortic arch surgery. A study published in 2021 demonstrated that in the context of acute type A dissection repair, patients who underwent an endovascular approach reported a better quality of life compared to open aortic arch surgery [4]. It remains unknown if this result is preserved in the context of elective aortic arch surgery.

Therefore, we aim to assess the quality of life in patients who underwent an elective open aortic arch surgery and comparing it to patients who underwent an endovascular inner branched aortic arch repair.

Methods

A retrospective observational pilot study was performed on patients who underwent open aortic arch surgery (OAA) and endovascular inner branched aortic arch repair (EV). All procedures were performed in Christchurch Hospital, New Zealand between December 2016 – December 2019.

In the open (OAA) group, patients underwent a frozen elephant trunk (FET) technique using the Vascutek Thoraflex hybrid graft (Vascutek, Scotland). The approach was via a standard sternotomy and then cannulation to commence the patient onto cardiopulmonary bypass and deep hypothermic circulatory arrest. The endovascular (EV) group patients underwent an endovascular aortic arch repair surgery using the Cook Zenith inner branched aortic arch endograft (Cook Medical, Bloomington, Indiana). Patients would have undergone a left common carotid artery (CCA) to left subclavian artery (SCA) bypass as a first stage procedure 6 weeks prior. The endovascular approach was performed via a percutaneous femoral approach for endograft deployment and a right common carotid artery (CCA) and left brachial artery cutdown for deployment of bridging stents. Bilateral common femoral arteries (CFA) are accessed using ProGlides (Abbott Laboratories, Chicago, Illinois). The right common femoral vein was accessed to allow for insertion of a 12Fr sheath to position the Coda balloon (Cook Medical, Bloomington, Indiana) in the right atrium. The Coda balloon was inflated and wedged into the inferior vena cava (IVC) to reduce cardiac output and achieve a controlled drop in blood pressure to below 70mmHg during endograft deployment.

Systemic heparinization was performed at the beginning and activated clotting time (ACT) was checked periodically to ensure it remains over 250s. The main endograft body was deployed between Zone 0 (proximal landing zone) and Zone 3 (distal landing zone). Sequential surgical cutdowns were performed on the right common carotid and left brachial artery to facilitate cannulation and deployment of bridging stents. A 6Fr sheath is introduced into the right common carotid artery. The right CCA was clamped distal to the puncture site and the innominate artery (IA) was bridged with a custom-made Cook Zenith bridging limb stent (Cook Medical, Bloomington, Indiana). The right CCA was flushed with heparinised saline prior to removal of the sheath and closure using 5 − 0 Prolene suture. The left brachial artery was then punctured, and the left common carotid artery (CCA) was accessed via the left CCA-SCA bypass. The left CCA was then bridged using a Fluency covered stent (BD, Franklin Lakes, New Jersey).

The decision to proceed with either OAA or EV is decided from a complex aortic multidisciplinary meeting attended by both Cardiothoracic and Vascular Surgery teams in conjunction with Radiology and the Cardiac Anaesthetic team. Indication for intervention, anatomical factors, patient comorbidities and anaesthetic fitness were considered in deciding the suitable management modality.

All patients completed the RAND SF-36 questionnaire at their 6 week post-surgery clinic follow-up. The questionnaire is developed at RAND as part of the Medical Outcomes Study (MOS) and is similar to the MOS SF-36. It consists of 36 items which is scored and then averaged together into 8 subscales to assess the health aspects of a patient [5].

Statistical analysis

Statistical tests were performed on Microsoft Excel. Mean scores for the eight subscales of the RAND SF-36 questionnaire obtained six weeks post-surgery were compared for the two interventional arms of this study using t-tests for independent means. These were than compared to the New Zealand general population SF-36 based on the SOFIE-Health study [6]. As stated in the SOFIE-Health study, there are limitations in access to raw data for the SF-36 responses in the New Zealand Health Survey and so, similar to the SOFIE-Health study, it was assumed that if the 95% confidence intervals did not overlap, there was a difference between the average scores in the present study and those of the New Zealand Health survey. Comparison between the two groups were performed using Fisher’s exact test. A p-value of < 0.05 is considered to be statistically significant.

Results

A total of 12 patients were recruited over the 3 year period. There were 8 patients in the endovascular (EV) group and 4 patients in the open (OAA) group. The median age in the EV group is 70 years old while the median age in the OAA group is 60 years old. The underlying aetiology for all 8 patients in the EV group was for degenerative aortic disease (i.e. aneurysmal disease) and in the OAA group, 3 of the patients were done for degenerative aortic disease (i.e. aneurysmal disease) while 1 patient was done secondary to an acute Type A aortic dissection secondary to an iatrogenic percutaneous coronary intervention procedure. Baseline demographics of the patients are shown in Table 1. It is noted that patients in the OAA group were younger and less co-morbid compared to patients in the EV group.

Table 1 Baseline demographics. ^EuroScore 2 in endovascular group was calculated based on n = 6 as 2 patients did not have all variables to calculate a EuroScore

The median intensive care unit (ICU) stay for the EV groups is 1 day (1–5 days) and the median hospital stay is 5 days (2–15 days). In the OAA group, the median ICU stay is 4 days (2–7 days) and the median hospital stay is 38 days (9–122 days). There were no recorded mortality in either group. Both groups have 2 recorded cases of stroke. There is one case of spinal cord ischaemia in the OAA group but no documented cases in the EV group (Table 2). There were no reported cases of wound infection, deep vein thrombosis/pulmonary embolism, myocardial infarction or return to theatre.

Table 2 Length of stay and post-operative complications

Across all eight sub-scales of the RAND SF-36 questionnaire, endovascular aortic arch repair is associated with a better quality of life post-surgery compared to open aortic arch surgery. Pain scores were greater than the population norm in the endovascular aortic arch repair group while the open aortic arch surgery group had a lower score than the population norm. This was statistically significant with a p-value < 0.01. Both groups score significantly lower than the population norm in the subscales of physical functioning, role limitation due to physical health, energy/fatigue and general health. These are not statistically significant. They did not differ in the subscales of role limitation due to emotional, emotional wellbeing and social functioning. This is shown in Fig. 1.

Fig. 1

Quality of life comparison. *denotes that in the endovascular group, patients report better pain scores compared to patients in the open group. This is statistically significant with a p value < 0.01

Discussion

Open aortic arch repair is associated with high mortality and morbidity. Current guidelines still recommend an open surgical approach especially if patients are medically fit, has a background of connective tissue disorder, concomitant valvular disease, presence of a mechanical aortic valve and a dilated ascending aorta [6]. To date, a total endovascular approach has been shown to have comparable outcomes to an open surgical approach however it remains non-superior to the latter [7, 8]. Despite this, there remains a paucity of data in assessing the effects and quality of life on the patients undergoing aortic arch surgery.

In our pilot study, we found that there appears to be a trend towards endovascular aortic arch repair having a better quality of life compared to open aortic arch surgery. This is seen across all eight subscales as demonstrated. However this was only statistically significant in one domain – pain. This is a similar finding to a previous study published in 2021 [4] however the study itself only compared the differences in quality of life post-operatively on discharge and at follow-up. Nevertheless, it demonstrates that an endovascular approach to aortic arch surgery relates to better quality of life in the post-operative period. It is worth noting that patients in the endovascular group are high risk surgical candidates who would have done worse compared to the open aortic arch repair group but have shown to have better quality of life post endovascular intervention.

One of the significant findings in our pilot study is the improvement in pain scores in the endovascular group compared to the population norm and the open group. This could potentially be explained by the quicker recovery and shorter stay in hospital with patients operated through an endovascular approach. This would potentially result in perceived improvement in pain from their disease which has now been repaired. In comparison, patients who underwent an open surgical approach would usually have a longer stay in hospital followed by pain from the surgical wound which could be perceived as debilitating compared to their pre-operative clinical state.

There were limitations to this study. The study is underpowered by the small sample size to detect a significant difference. This is due to the fact that the study was performed during the early phases of the establishment of an endovascular aortic arch service in our centre. This would account for the higher post-operative complications seen in our low volume aortic centre. It is unclear if the differences noted are purely due to the difference in the surgery alone (endovascular vs. open) or if this is due to patients in both groups being inherently different. There is potential that the difference could have been attributed to the fact that patients who are fit and well would have likely undergone open surgical repair while patients who are comorbid would have been offered an endovascular option instead. The study utilised the quality of life from the New Zealand general population as the baseline comparison to the post-operative scores. A suitable comparison would have been to obtain baseline scores from the same patients to detect if there was a significant change.

This pilot study is the first study to compare the two groups with the population norm. Despite the small sample size, our study demonstrated that endovascular aortic arch intervention appears to be associated with a better quality of life in comparison to open aortic arch surgery in the short term across all domains in general. Despite the results not being statistically significant besides one domain, this study is the first attempt at identifying whether there is a difference in quality of life following open or endovascular aortic arch repair. In the current endovascular era, this is prudent to raise awareness and pave the way for future research into this field and whether the benefits of improved quality of life is also preserved in the long term from endovascular aortic arch intervention. Future interventional studies are warranted looking to further ascertain the influence of different surgical methods and its impact on the quality of life pre and post aortic arch surgery.

Conclusion

An endovascular approach to aortic arch surgery overall appears to be associated with a better quality of life in comparison to an open surgical approach in the post-operative period up to 6 weeks. Further research is needed to ascertain if this benefit is preserved in the long term.