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Frequency and type of interval adverse events during the waiting time to complex aortic endovascular repair

Open AccessPublished:November 15, 2021DOI:https://doi.org/10.1016/j.jvs.2021.11.041

      ABSTRACT

      Objective

      Aim of the study was to evaluate the frequency and type of adverse events that may occurs during the waiting time to complex aortic endovascular repair.

      Methods

      This is a retrospective study of all elective patients with complex aortic aneurysms (including pararenal/suprarenal, thoracoabdominal, or aortic arch aneurysms) that required a custom-made device (CMD) from Cook Medical at a tertiary referral vascular center (Nov 2010 – May 2020). The waiting time was defined as interval between date of stent-graft order and date of procedure or cancellation date. Interval adverse events were defined as any event that occurred during waiting time which led to either mortality, aneurysm rupture, or cancellation of the planned procedure.

      Results

      A total of 235 patients (mean age 72 years, 25% females) had a CMD graft ordered (201 planned as single-stage procedures). The median waiting time until surgery was 106 days (IQR:77-146) in the whole cohort and 101 days (IQR:77-140) among single-stage procedures. The planned procedure was carried out electively in 219 (93%), with an overall thirty-day elective mortality of 2% (N=5). There were 16 interval adverse events during waiting time. Of these, 10 were aneurysm ruptures and six were cancellations of the procedure owing to non-aneurysm-related deaths (3% of the entire cohort). A total of 10 interval deaths were registered (4.2%), four were aneurysm-related. Risk of rupture during waiting time (Kaplan-Meier) was 6.1% (SD 2.3) at 180 days. The median time from stent-graft order to aneurysm rupture was 101 days (IQR: 54-200 days). Out of the 10 aneurysm ruptures that occurred, six underwent emergent repair with 0% mortality at thirty-days (one open repair, one T-Branch, one physician-modified endograft, two cases in which the CMD was already available, one case in which a different CMD was available).

      Conclusions

      The median waiting time from stent-graft order to implantation was about fifteen weeks. During this time, a substantial proportion may suffer from adverse events, either related to aneurysm rupture or underlying comorbidity. Rupture risk during waiting time exceeded the risk of perioperative mortality; efforts to decrease this can therefore significantly improve outcome. A combination of different techniques may play a vital role to reduce the mortality in case of interval ruptures.

      Keywords

      INTRODUCTION

      Fenestrated-branched endovascular aortic repair (F-BEVAR) is a safe and effective therapeutic option in the treatment of complex aortic aneurysms (CAA) that involve vital side branches of the aorta
      • Oderich G.S.
      • Ribeiro M.
      • Hofer J.
      • Wigham J.
      • Cha S.
      • Chini J.
      • et al.
      Prospective, non randomized study to evaluate endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts based on supraceliac sealing zones.
      ,
      • Verhoeven E.L.
      • Katsargyris A.
      • Bekkema F.
      • Oikonomou K.
      • Zeebregts C.J.
      • Ritter W.
      • et al.
      Ten-year experience with endovascular repair of thoracoabdominal aortic aneurysms.
      , with benefits to patients as compared with standard open repair in terms of peri-operative morbidity especially in high-risk surgical candidates
      • Swerdlow N.J.
      • Wu W.W.
      • Schermerhorn M.L.
      Open and endovascular management of aortic aneurysms.
      . Indeed, F-BEVAR has satisfactory early and mid-term results and is endorsed by current clinical practice guidelines
      • Wanhainen A.
      • Verzini F.
      • Van Herzeele I.
      • Allaire E.
      • Bown M.
      • Cohnert T.
      • et al.
      Editor’s choice - European Society for Vascular Surgery (ESVS) 2019 clinical practice guidelines on the management of abdominal aorto-iliac artery aneurysms.
      . The stent-grafts are usually customized to meet patient-specific anatomical requirements and patients treated with F-BEVAR technology are usually deemed morphologically unfit for standard endovascular techniques, while also being physiologically high risk for conventional open surgery.
      Manufacturing of a patient-specific endograft is mostly a time-consuming process which includes planning, manufacturing, delivering, and implantation; this could require 2 to 4 months, thereby limiting this technology to the subset of patients that are asymptomatic and whose aneurysms are deemed to be low-risk for rupture during the waiting time.
      Despite the number of prior studies that have analyzed the technical outcomes of F-BEVAR procedures
      • Mastracci T.M.
      • Eagleton M.J.
      • Kuramochi Y.
      • Bathurst S.
      • Wolski K.
      Twelve-year results of fenestrated endografts for juxtarenal and group IV thoracoabdominal aneurysms.
      , little is known about the significance of the waiting time on the outcomes of F-BEVAR
      • Katsargyris A.
      • Uthayakumar V.
      • de Marino P.M.
      • Botos B.
      • Verhoeven E.L.
      Aneurysm rupture and mortality during the waiting time for a customized fenestrated/branched stent graft in complex endovascular aortic repair.
      ,
      • Gallitto E.
      • Faggioli G.
      • Spath P.
      • Pini r
      • Mascoli C.
      • Ancetti S.
      • et al.
      The risk of aneurysm rupture and target visceral vessel occlusion during the lead period of custom-made fenestrated/branched endograft.
      . The aim of our study was to evaluate the frequency and type of serious interval adverse events that can occur during the waiting time to complex aortic endovascular repair.

      METHODS

       Data collection

      A retrospective study was conducted of all elective patients with complex aortic aneurysms (CAA), including pararenal/suprarenal, thoracoabdominal, or aortic arch aneurysms that required planning of a custom-made stent-graft (CMD) at a single institution during the period from November 2011 through April 2020. Patients treated with off-the-shelf multibranched endografts (n=35) or physician-modified endografts (n=7) owing to symptomatic or ruptured aneurysms, who were never assessed for CMD implantation, were excluded from this study.
      The waiting time was estimated by calculating the time interval between the date of stent-graft order and the date of procedure (whether it was done electively or urgently owing to aneurysm rupture occurring during the waiting time) or cancellation date. The waiting time was calculated for all CMD orders and separately for those procedures that were not planned in staged fashion.
      Patients in whom the procedure was cancelled or not performed during the waiting time were identified and further analyzed aiming to investigate the reason for cancellation. Interval adverse events were defined as any event that occurred during waiting time which led to either mortality (aneurysm related or not), aneurysm rupture, or cancellation of the planned surgical procedure due to any cause. The cause of death for the patients who died before the procedure was obtained either from the hospital admission records (for patients who died in the hospital after treatment for their disease) or by querying a nationwide healthcare database (for the patients who died out of hospital).
      Thirty-day mortality after elective repairs (i.e. any death occurring within the initial thirty days following index intervention) was assessed with revision of inpatient and outpatient hospital records. All death dates are updated through cross-matching of individuals in the cohort using their unique personal identification number with the Swedish Death Registry which has a 100% accuracy.

       Stent-graft planning and order process

      All patients underwent thin slice computed tomography angiography (CTA) from the neck to the groin that was performed within six months before the first visit. Decisions on type of procedure was then taken during routine weekly meetings of the aortic team (which is made up by 3-8 vascular surgeon with additional participation of dedicated cardiovascular anesthesiologists if necessary) when cardiopulmonary workup was completed. Patients’ consent for the suggested procedure is then confirmed. Post-processing centerline lumen reconstructions were elaborated with a dedicated software for advanced vessel analysis (3mensio; Vascular Imaging, Bilthoven, The Netherlands).
      The CMD was planned by the same experienced surgical team who performed the procedure. Based on the specifications provided, the planning center (Cook Medical) generates a CMD technical drawing within 24-48 hours, which is then reviewed and modified if needed, and eventually signed off by the surgeon who developed the plan. Afterwards, the stent-graft is ordered and for most patients, planning and ordering of a fenestrated graft is accomplished within 1-2 weeks (Supplementary Figure 1).

       Statistical analysis

      Continuous variables were tested for normality with histograms and reported as means (with standard deviation: SD) or median (with interquartile range: IQR), accordingly. Categorical variables were reported as absolute counts (with percentage). Univariate comparison of baseline characteristics was carried out between patients who experienced rupture during waiting time versus those who did not. Statistical significance was set at alpha level (p value) <0.05. Rupture risk during waiting time was visualized in a time-to-event analysis using the Kaplan Meier method. Patients were censored at time of repair, time of death, or time of cancellation of procedure (whatever occurred first). Graphs were truncated at 180 days when 20 patients remained available for the analysis. Data analysis was performed using SPSS statistical software version 22.0 (IBM Corp, Armonk, NY).

      RESULTS

       Study cohort

      During the study period, a total of 235 patient (mean age 72 years, 25% females) had a CMD graft ordered (Table I); out of these, there were 201 single-stage procedures planned. There was a steady increase in the number of CMD ordered per year, with the mean number of grafts ordered per year that increased from 14±5 in the period 2011-2015 to 40±27 in the period 2016-2019. From 2015 onwards, complex stent-grafts for treatment of pathology involving the aortic arch were introduced into clinical practice, and there was a concomitant steady increase in the number of CMD with three-four vessel design (Figure 1).
      Table IBaseline characteristics of the patients treated with custom-made stent-grafts.
      Variable

      Mean ± SD a or Median (IQR)b

      Number (%)
      Overall (N=235)
      Females58 (25)
      Age (years) a72 ± 9
      Octogenarians44 (19)
      Ischemic heart disease73 (31)
      Congestive heart failure32 (14)
      Smoking166 (71)
      Diabetes27 (11.5)
      Chronic obstructive pulmonary disease68 (29)
      Chronic kidney disease52 (22)
      Aneurysm extent

      Arch/Descending thoracic

      Thoracoabdominal

      Pararenal/Suprarenal
      20 (9)

      62 (26)

      153 (65)
      Aneurysm diameter (mm) a63 ± 9
      Large aneurysm (diameter ≥70mm)42 (18)
      Post-dissection aneurysm29 (12)
      Figure thumbnail gr1
      Figure 1A): Total number of custom-made stent-grafts enrolled per each year. B) The custom-made devices were divided into three categories: i)Arch devices (fenestrated/branched endografts for aortic arch aneurysms); ii)FBEVAR devices (fenestrated/branched endografts with ≥3 target vessels for pararenal/suprarenal or thoracoabdominal aortic aneuysms); iii)Zenith Fenestrated (fenestrated endografts with ≤2 target vessels). *Figures showing annual numbers only report full calendar years (from 2011-2012 to 2019, excluding 2010 and 2020).

       Waiting time

      The distribution of lead days from stent-graft order to elective implantation was analyzed (Figure 2): the median waiting time was 106 days (IQR:77-146) in the whole cohort and 101 days (IQR:77-140) in the subgroup of single-stage procedures (Table II). Stratification by aneurysm diameter (<70 mm vs ≥70 mm) showed no difference (107 vs 104 days in median). The total waiting time was significantly different based on type of CMD that was planned and ordered (p=.039 for head-to-head comparison): i) Arch branch/Fenestrated TEVAR, median 136 days (IQR 97-164 days); ii) F-BEVAR with ≥three-vessel design, median 107 days (IQR 83-145 days); iii) Zenith Fenestrated with <three-vessel design, median 86 days (IQR 66-132 days).
      Figure thumbnail gr2
      Figure 2Total waiting time (median days) from stent-graft order to stent-graft implantation per each year. *Figures showing annual numbers only report full calendar years (from 2011-2012 to 2019, excluding 2010 and 2020).
      Table IISummary of events during the study-period.
      Variable

      Mean ± SD a or Median (IQR)b

      Number (%)
      Overall (N=235)
      Total cases/year a35 ± 9
      Staged repairs34 (14)
      Days of waiting time (total cases)b106 (77-146)
      Days of waiting time (single stage)b

      (N=201)
      101 (77-140)
      Elective procedure done219 (93)
      Thirty-day mortality after elective repair5 (2)
      Cancellation/Rupture during lead time

      Aneurysm rupture

      Procedure cancelled
      16 (7)

      10 (4)

      6 (3)
      Death during lead time

      Aneurysm-related

      Non-aneurysm-related
      10 (4)

      4 (2)

      6 (3)
      In 10/62 cases whose waiting time exceeded 120 days, a specific reason for delaying the procedure could be found. Reasons for postponement of the graft implantation included: four cases of unavailability of intensive care resources, one case of acute cholecystectomy, three cases of infection, and two cardiovascular events (one acute myocardial infarction, one decompensated congestive heart failure). Notably, in all these cases the CMD was eventually implanted under elective circumstances.

       Interval adverse events

      The planned procedure was carried out electively in 219 (93% cases), with an overall thirty-day elective mortality of 2% (N=5).
      There were 16 interval adverse events that occurred during waiting time (Table III). Of these, 10 were aneurysm ruptures (4% of the entire cohort) and 6 were cancellations of the planned procedure owing to non-aneurysm-related deaths (3% of the entire cohort). Risk of rupture during waiting time using Kaplan-Meier analysis (Figure 3), was estimated to be 6.1% (SD 2.3) at 180 days of waiting time. The median waiting time from stent-graft order to aneurysm rupture was 101 days (IQR: 54-200 days).
      Table IIIDetails of ruptures and cancellations occurring during the waiting time (from stent-graft order).
      YearAge

      &

      Gender
      Aneurysm DiameterDays (from stent-graft order to interval event)EventDetailsOutcome
      Aneurysm Ruptures
      201570, Male6566RuptureRepair with tBranchAlive at 30 days
      201672, Female67485RuptureNot repaired (The patient had refused to travel to the hospital to get treatment before rupture occurred)Dead
      201769, Female7291RuptureRepaired with custom-made (Stent-graft was delivered to the hospital one week prior to rupture and the elective procedure had been scheduled for the week after)Alive at 30 days
      201755, Female6777RuptureRepaired with physician-modifiedAlive at 30 days
      201772, Male6248RuptureOpen surgical repairAlive at 30 days
      201885, Male65112RuptureRepaired with custom-made (Ruptured occurred on the same day the patients was scheduled for elective repair)Alive at 30 days
      201868, Male6136RuptureRepaired with custom-made (Repair was undertaken using the device ordered for a different patient whose anatomy could match the emergent case)Alive at 30 days
      201873, Male63127RuptureNot repaired (Out-of-hospital cardiac arrest, autopsy finding)Dead
      201976, Male7057RuptureNot repaired (Out-of-hospital cardiac arrest, autopsy finding)Dead
      201975, Male72306RuptureNot repaired (Heart failure decompensation after first stage and rupture during interval to delayed second stage.)Dead
      Other Deaths
      201464, Female6237CancellationCerebral hemorrhageDead
      201579, Female63408CancellationSepsis (Underwent staged conduit- developed graft infection and deteriorated)Dead
      201580, Male60200CancellationCancerDead
      201859, Male67203CancellationCongestive heart failureDead
      201867, Male5511CancellationAcute pancreatitisDead
      201978, Female62123CancellationCongestive heart failureDead
      Figure thumbnail gr3
      Figure 3Kaplan-Meier analysis of rupture risk during waiting time. (Graphs truncated at 180 days when there were 20 patients left).
      A total of 10 interval deaths were registered, and 4 could be classified as aneurysm-related. Out of the 10 instances of aneurysm ruptures that occurred, six cases underwent emergent repair with 0% mortality at thirty days (one open surgical repair, one off-the-shelf T-Branch stent-graft, one physician-modified endograft, two cases in which the CMD had already been shipped to the hospital and was available for implantation, one case in which the CMD of a different patient was suitable for urgent implantation in the index case). No significant differences were noted in the mean diameter of those aneurysms that ruptured during waiting time as compared to those that were repaired electively (66±9 vs 62±5 mm, p=.31). Comparison of baseline characteristics between patients who experienced rupture of their aneurysm during waiting time versus those who underwent scheduled elective repair are summarized in Supplementary Table I.

      DISCUSSION

      The present study, encompassing the experience at a single high-volume academic institution, analyzed the waiting time for a F-BEVAR procedure and identified the major adverse events that occurred during the delay for implantation of a customized endovascular graft in patients with complex aortic pathologies. The median waiting time in our series of 235 consecutive cases was approximately fifteen weeks and did not change significantly over time. Our Kaplan-Meier analysis shows that waiting time adds a substantial risk of rupture, with an estimated rupture rate of 6% at 180 days. Notably, no ruptures occurred during the first 30 days from stent-graft order. All patients with aneurysm rupture who underwent emergent repair (either by open or endovascular means) survived at thirty days, thereby showing the usefulness of endovascular and open skills to treat acute symptomatic complex aortic aneurysms
      • Katsargyris A.
      • de Marino P.M.
      • Botos B.
      • Nagel S.
      • Ibraheem A.
      • Verhoeven E.L.G.
      Single center experience with endovascular repair of acute thoracoabdominal aortic aneurysms.
      . In the cases with a very long waiting time (>120 days) we could only find specific reasons in 16% that were linked to underlying medical comorbidities, thereby potentially indicating room for improvement in the overall management algorithm.
      Our findings seem largely concordant with those described recently by other groups. In the review of a single-center experience with 906 patients planned for F-BEVAR from 2010 to 2018), Katsargyris et al
      • Katsargyris A.
      • Uthayakumar V.
      • de Marino P.M.
      • Botos B.
      • Verhoeven E.L.
      Aneurysm rupture and mortality during the waiting time for a customized fenestrated/branched stent graft in complex endovascular aortic repair.
      found that 95.3% of their patients (N=862) eventually underwent the procedure as planned, with a median waiting time (from date of graft order to date of graft implantation) of 12 weeks. Thirty-seven patients (4.1%) died before the procedure, with aneurysm rupture being the cause of death in fifteen (1.7%). Similarly, Gallitto et al
      • Gallitto E.
      • Faggioli G.
      • Spath P.
      • Pini r
      • Mascoli C.
      • Ancetti S.
      • et al.
      The risk of aneurysm rupture and target visceral vessel occlusion during the lead period of custom-made fenestrated/branched endograft.
      reported on 144 patients planned for F-BEVAR from 2008 to 2017 at their institution and described a mean lead period of 90 days with five (3.8%) aneurysm ruptures occurring during the waiting time. Our reported waiting time is slightly longer than in these previous studies. There is no clear indication of why in our data, but in our center the majority of complex cases are referred from other centers in Sweden or abroad, which may contribute to the overall delay. During the waiting time there is an inherent risk of both aneurysm rupture and that the patients deteriorate from other medical conditions which might eventually lead to cancellation of the previously planned procedure.
      According to general consensus, the manufacturing process is usually 6 to 12 weeks and is generally reported as one of the major limits of the F-BEVAR technique. In our experience, the total waiting time for most cases was between eight and sixteen weeks and our waiting time has slowly increased over time. Although strong inferences about the reasons beyond such changes are not to be drawn, some reasonable explanations can still be sought. First and foremost, even at dedicated aortic centers, logistic issues might be expected and anticipated, which are likely to increase as the volume and complexity of F-BEVAR procedures increase. Indeed, in our experience the number of CMD that were planned and ordered rose during time, a process which was accompanied by a shift to more complex stent-graft designs which would entail the need for higher in-hospital resources to accomplish safe and effective operations. As expected, we found a statistically significant difference in the median waiting time based on type of custom-made stent-grafts that were ordered, a finding that could be reasonable explained by the concomitant presence of several mechanisms: the need to accommodate within the surgical schedule an increasing volume of complex aortic operations, the fact that more extensive repairs (which were prevalent in later years) would usually require more extensive infrastructural resources, and the longer pathway required to obtain devices intended for treatment of aortic arch disease since those were not directly planned at the authors’ institution but from the manufacturer’s planning center. In that sense, it is crucial that centers doing F-BEVAR have in place dedicated logistic protocols and undertake regular reviews of their results to identify potential pitfalls in their internal pathways of care.
      All CMD in this series were from a single manufacturer (Cook Medical), making any cross-comparison with waiting time for other medical devices suppliers unfeasible. There are nowadays other manufacturers that claim they can provide CMDs with shorter waiting times. Nevertheless, Cook Medical has a dedicated pathway in place for expedited ordering/shipping process which can be requested on a case-by-case basis by the treating physician based on assessment of the rupture risk. In our practice, we have during the latest years been using this for patients deemed to have a higher rupture risk or large aneurysms (usually those above 75mm of maximal diameter at time of their diagnosis). However, broader participation of industry stakeholder could represent a potential step forward to further improve the overall process of patients who are candidate to complex aortic endografting.
      The waiting time after treatment decision can be differentiated in two distinct phases, namely the time required for the endograft to be manufactured and shipped, and the time needed for the operation to be scheduled after the endograft is available at the treating facility. Therefore, we could potentially reduce the overall waiting time only by scheduling the procedures closer to the delivery date, with the aim to shorten the delay from delivery to implantation to no more than two weeks. We also do the vast majority of stent-graft planning by ourselves at the same time the patient is evaluated for physical fitness (a process which, in itself, is highly variable), in order to minimize the waiting time to the extent possible. While physicians cannot have any direct control over the former, and in-house protocols should aim to minimize the latter to the extent possible (notwithstanding that competing adverse events, as deterioration of patients’ status might also occur, which could impact the waiting time), our series also shows that having the endograft already available might represent a life-saving option for patients should rupture of the aneurysm happen during the last phase of waiting. Indeed, in two cases the aneurysms ruptured when the CMD was already available in the hospital, and the emergent repair could be accomplished without thirty-day mortality.
      Another interesting finding from our experience is that a staged FEVAR o BEVAR (usually consisting of a TEVAR preceding the CMD implantation) does not seem to delay significantly the overall time required to complete the procedure, in this material only less than one week in median. Indeed, staging the repair for thoracoabdominal aortic aneurysms is a well-acknowledged strategy to minimize the incidence of spinal cord ischemia
      • Etz C.D.
      • Zoli S.
      • Mueller C.S.
      • Bodian C.A.
      • Di Luozzo G.
      • Lazala R.
      • et al.
      Staed repair signficantly reduces paraplegia rate after extensive thoracoabdominal aortic aneurysm repair.
      , but concerns have been raised over the inherent risk for aneurysm rupture during the delay required to stage the procedure. Interestingly, we did not observe any aneurysm rupture during the staging delay, in line with what described by other groups
      • Bertoglio L.
      • Katsarou M.
      • Loschi D.
      • Rinaldi E.
      • Mascia D.
      • Kahlberg A.
      • et al.
      Elective multistaged endovascular repair of thoracoabdominal aneurysms with fenestrated and branched endografts to mitigate spinal cord ischaemia.
      .
      Independently of the cause of possible delays during waiting time, it is evident that every effort should be made to expedite the accomplishment of the procedure and that all patients undergoing a customized procedure should have their concomitant underlying medical diseases and comorbidities closely followed and treated. Indeed, almost half of the overall death events that were recorded during waiting time in our experience could be directly attributed to causes other than the aneurysm. A better selection process would be beneficial such that other severe concomitant comorbidities are noted, and planning can be aborted if futility of care is reasonably expected (especially considered that many of these patients would otherwise be turned down for open surgical repair).
      Recent studies have identified that aneurysm diameter >70mm was associated with aneurysm rupture during the lead period
      • Gallitto E.
      • Faggioli G.
      • Spath P.
      • Pini r
      • Mascoli C.
      • Ancetti S.
      • et al.
      The risk of aneurysm rupture and target visceral vessel occlusion during the lead period of custom-made fenestrated/branched endograft.
      , in a consistent fashion to previously reported data from the literature showing a diameter-related increased risk of natural complications in aortic aneurysms
      • Kuzmik G.
      • Sang A.
      • Elefteriades J.
      Natural history of thoracic aortic aneurysms.
      . Therefore, patients with an aneurysm diameter >70-75mm should be properly informed about the risk of rupture during the waiting of F-BEVAR. However, we did not find a statistically significant difference in the maximal diameter of ruptured versus non-ruptured aneurysm in our series, which could reflect a type 2 error due to the small sample size. Nevertheless, if the decision is to treat the patient, we believe that he/she should be informed of the risk of rupture during the waiting time, and that therapeutic alternatives, and their relative risks be explored and discussed. In fact, other alternative solutions to CMD exist (including off-the-shelf multibranched stent-grafts, physician-modified endografts, parallel-graft techniques, and of course open surgery), and these remain suitable in emergencies as showed by our results. Due to the fact that the observed delay with CMD aortic technology was associated to a non-negligible rupture risk, it might be reasonable to consider alternative treatment strategies for very large aneurysms that are deemed at high-risk for rupture, such as physician-modified stent-grafts or in-situ laser fenestrations, which nevertheless would come with their own intrinsic shortcomings. Unfortunately, it is not possible to determine a specific size threshold when use of patient-specific devices should be turned down based on the present material. Instead, this may be decided individually depending on other patient’s factors as well and any planned procedure should be carried out as soon as achievable once the CMD is delivered at the hospital.
      Lastly, financial issues related to procedure cancellation when a CMD has been already ordered might deserve further discussion. While each hospital must adopt those practices that better suit local and national regulations, this underlines the need to take the issues of cost into consideration when planning a F-BEVAR procedure. Indeed, the direct costs related to stent-grafts remain the most important determinant of in-hospital expenditures and should be considered in the overall decision-making
      • D’Oria M.
      • Wanhainen A.
      • DeMartino R.R.
      • Oderich G.S.
      • Lepidi S.
      • Mani K.
      A scoping review of the rationale and evidence for cost-effectiveness analysis of fenestrated-branched endovascular repair for intact complex aortic aneurysms.
      . In our practice, CMD are paid after their shipment to the treating institution, and no insurance policy was stipulated with the manufacturer for return of non-used grafts.

       Study limitations

      This study must be interpreted within the context of its inherent limitations. It is a retrospective single-center experience with a relatively small patient cohort. However, the sample size was similar to the other two comparable studies that are available in the literature and baseline and outcomes data were retrieved for 100% of the study population. Another critical issue is the definition and evaluation of the waiting time, which we considered as the time between the endograft order to the manufacturer to its implantation. Accordingly, we did not consider the period between the CTA examinations, multidisciplinary discussions on suitable type of procedure, endograft planning, and eventual order. Also, we were unable to extract the exact date of endograft delivery to the hospital for a majority of the subjects. This made us unable to analyze what amount of waiting time could be attributed to our scheduling of the surgical procedure. However, given the stability of the center’s policy during the study period (to book the procedure on the first available slot after graft delivery), we believe it is unlikely that this bias could have affected the study findings. Lastly, the waiting times observed in this series may not be generalizable for lower volume centers or to nations with different healthcare settings and regulations.

      CONCLUSIONS

      The median waiting time from stent-graft order to implantation was about fifteen weeks in this single-center experience. About 7% of patients had adverse events during waiting time, either related to rupture of their aneurysm or underlying comorbidity. To improve selection of patients and decrease the waiting time is an important task for the future. In case of ruptured aneurysms, the combination of different techniques (including off-the-shelf multibranched endografts and open surgical repair) as well as the availability of the CMD may play a vital rote to reduce the associated mortality rate.
      Figure thumbnail fx1
      Supplementary Figure 1. Clinical pathway from initial patient encounter to custom-made stent-graft implantation.
      Tabled 1Supplementary Table I. Baseline characteristics of patients with rupture during waiting time versus patients who underwent scheduled elective repair.
      Variable

      Mean ± SD a or Median (IQR)b

      Number (%)
      Ruptures (N=10)No Ruptures (N=225)P value
      Females3 (30)55 (24).69
      Age (years) a72±472±8.92
      Octogenarians1 (10)43 (19).47
      Ischemic heart disease4 (40)69 (95).46
      Congestive heart failure2 (20)30 (13)
      Smoking7 (70)159 (70).48
      Diabetes1 (10)26 (11)1.00
      Chronic obstructive pulmonary disease3 (30)65 (29).23
      Chronic kidney disease4 (40)48 (21).11
      Aneurysm extent

      Arch/Descending thoracic

      Thoracoabdominal

      Pararenal/Suprarenal
      1 (10)

      3 (30)

      6 (60)
      19 (8)

      59 (33)

      147 (66)
      .82
      Aneurysm diameter (mm) a66±962±5.31
      Large aneurysm (diameter ≥70mm)3 (30)40 (18).18
      Post-dissection aneurysm1 (10)28 (12).83

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