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Questionable Long-Term Results of the Extended Provisional Extension to Induce Complete Attachment (E-PETTICOAT) Technique in the Management of Chronic Type B Aortic Dissection

Open AccessPublished:September 02, 2022DOI:https://doi.org/10.1016/j.avsg.2022.08.012

      Background

      Published interim results of the extended provisional extension to induce complete attachment (e-PETTICOAT) technique suggested favorable remodeling in chronic type B Aortic Dissection (cTBAD). This report presents long-term results of the e-PETTICOAT technique for the management of cTBAD (without aneurysmal dilatation).

      Methods

      Patients with cTBAD below the 55 mm aortic size were eligible for the management using the e-PETTICOAT technique. Follow-up was conducted at 1, 2 and 5 years based on the computed tomography angiogram. All the presurgery risk factors (entry >1 cm, inner curve entry, fusiform index >0.65, false lumen > 22 mm, aortic size >40 mm, recurrent pain or hypertension, and Stanford Dissection Risk Calculation) and postsurgery complications were examined in the study.

      Results

      A total of 20 patients underwent the e-PETTICOAT surgery. The survival rate at 1, 2, and 5 years was 75%, 70%, and 64%, respectively, and the percentage of patients without any reinterventions was 100%, 93%, and 18%. Aortic degeneration was recognized in 30%, 55%, and 85% of the patients. Only 3 of the 20 patients were alive and without any reintervention after 5 years. The receiver operating curve analysis does not indicate any factor that would predict the remodeling result in the long-term follow-up.

      Conclusions

      The use of e-PETTICOAT technique in cTBAD might not have a beneficial influence on the long-term results.

      Introduction

      Currently, there is no consensus or specific guidelines on the surgical management of chronic type B aortic dissection (cTBAD) before the aortic degeneration leads to an enlargement of the aortic diameter exceeding 55 mm.
      • Scali S.T.
      • Feezor R.J.
      • Chang C.K.
      • et al.
      Efficacy of thoracic endovascular stent repair for chronic type B aortic dissection with aneurysmal degeneration.
      ,
      • Lombardi J.V.
      • Hughes G.C.
      • Appoo J.J.
      • et al.
      Society for vascular surgery (SVS) and society of thoracic surgeons (STS) reporting standards for type B aortic dissections.
      Commonly used thoracic endovascular aortic repair (TEVAR) does not always provide satisfying long-term effects and often results in reinterventions.
      • Fanelli F.
      • Cannavale A.
      • O’Sullivan G.J.
      • et al.
      Endovascular repair of acute and chronic aortic type B dissections main factors affecting aortic remodeling and clinical outcome.
      Irrespective of the chosen initial approach to managing cTBAD (repair or best medical treatment only), at the point that the aortic diameter is >55 mm, surgical intervention such as fenestrated or branched endovascular aortic repair (F/BEVAR) or open repair
      • Durham C.A.
      • Aranson N.J.
      • Ergul E.A.
      • et al.
      Aneurysmal degeneration of the thoracoabdominal aorta after medical management of type B aortic dissections.
      is recommended.
      • Durham C.A.
      • Aranson N.J.
      • Ergul E.A.
      • et al.
      Aneurysmal degeneration of the thoracoabdominal aorta after medical management of type B aortic dissections.
      ,
      • Czerny M.
      • Schmidli J.
      • Adler S.
      • et al.
      Current options and recommendations for the treatment of thoracic aortic pathologies involving the aortic arch: an expert consensus document of the European Association for Cardio-Thoracic surgery (EACTS) and the European Society for Vascular Surgery (ESV).
      An interim report of a new technique called the extended provisional extension to induce complete attachment (e-PETTICOAT) suggested favorable remodeling of cTBAD.
      • Kazimierczak A.
      • Rynio P.
      • Jędrzejczak T.
      • et al.
      Expanded Petticoat technique to promote the reduction of contrasted false lumen volume in patients with chronic type B aortic dissection.
      In this article, we present the results of a long-term observation of patients treated with the e-PETTICOAT technique, who were diagnosed with cTBAD but were not eligible for F/BEVAR (had not reached the size threshold).

      Materials

      Patients who were included in this trial were initially diagnosed with a noncomplicated cTBAD, which according to the current guidelines would be treated conservatively, however showing signs of rapid degeneration of the aorta: presenting a growth rate of the aortic diameter of over 5 mm/6 months or 10 mm/1 year. The main exclusion criterion was the diameter of the aorta >55 mm, at which point the patients would become eligible for fenestrated endovascular aortic repair (FEVAR)/branched endovascular aortic repair (BEVAR).
      • Kazimierczak A.
      • Rynio P.
      Extended Petticoat strategy in type B aortic dissection.
      The patients of unknown disease onset or insufficient quality of the computed tomography angiogram were also excluded from the trial.

      Methods

      A retrospective observational cohort study was carried out between 2014 and 2022 at one institution. There was no control group or head-to-head comparison. We studied all the patients who were eligible for the e-PETTICOAT technique (which is a combination of STABILIZE (stent-assisted balloon-induced intimal disruption and relamination in aortic dissection repair) and parallel iliac stent-grafts placed into infrarenal aortoiliac segment). Follow-up was evaluated prospectively at 1, 2, and 5 years after the surgery and was based on an computed tomography angiogram (triphasic computerized tomography scanning with 0.5 mm slice thickness). All presurgery risk factors (summarized in Tables I and II) and postsurgery complications were analyzed in the study. Computed angiotomography was used for sizing and volumetric measurement of a true lumen (TL) and false lumen (FL) by means of region of interest options of OsiriX software (Pixmeo SARL, Bernex, Switzerland). Favorable remodeling was recognized as aortic diameter size below 55 mm in follow-up. The predicted risk of degeneration based on the Stanford aortic degeneration risk was calculated in the acute phase of the disease and compared with the observed degeneration rate after treatment.
      • Sailer A.M.
      • Van Kuijk S.M.J.
      • Nelemans P.J.
      • et al.
      Computed tomography imaging features in acute uncomplicated Stanford type-B aortic dissection predict late adverse events.
      Table ICommon radiological risk factors
      Risk factorn (%)
      Entry size >1 cm14 (70)
      Entry inner curve entry7 (35)
      Fusiform index >0.6510 (50)
      Partial FL thrombosis17 (85)
      Maximum aortic size >4 cm14 (70)
      FL >22 mm18 (90)
      Table IIFactors assessed in the Stanford aortic dissection risk calculation, which is calculated in the acute phase, for patients eligible for best medical therapy
      Assessed factorsn (%)/median (range)
      Connective tissue disease0 (0)
      Dissection angle273 (79–360)
      Perfused intercostal arteries16 (10–22)
      Maximum aortic size45 (33–54)
      Branches dissection
       LSA0 (0)
       RRA14 (70)
       LRA8 (40)
       SMA3 (15)
       CT7 (35)
       IMA5 (25)
       LICA11 (55)
       RICA9 (45)
      Stanford 1 year (%)27 (3.5–66.6)
      Stanford 2 years (%)43 (6.6–87.5)
      Stanford 5 years (%)66 (14.1–99)
      LSA, left subclavian artery; RRA, right renal artery; LRA, left renal artery; SMA, superior mesenteric artery; CT, celiac trunk; IMA, inferior mesenteric artery; LICA, left common iliac artery; RICA, right common iliac artery.

      Statistics

      All values are expressed as mean, range, and standard deviation. Shapiro-Wilk test was used to assess the normality of distributions. Comparisons of continuous variables were performed using the Wilcoxon test for dependent variables because of nonnormal data distribution. The enumerable variables were compared by Fisher’s exact test. The Kaplan-Meier estimator was used to calculate the survival function. Receiver operating curve analysis was used to assess the accuracy of the possible threshold for unfavorable remodeling predictors. Statistical significance was set at a P value <0.05. All statistical analyses were conducted using Statistica software (version 13; StatSoft; Dell, Round Rock, TX).

      Results

      Study Group and Risk Factors

      Of the 20 patients, who underwent e-PETTICOAT, the median age was 64 years (range 37–76), 17 were male, and 3 were female. The median time from the first symptoms to the surgery was 18 months (range 12–47).

      Patient Clinics

      All patients were asymptomatic. However, in 4 cases (20%), there were radiological findings of stenosis (>70%) of iliac arteries caused by FL thrombosis and TL collapse, 3 patients (15%) presented with similar findings in superior mesenteric artery (asymptomatic), and 6 had impaired patency of the renal arteries (1 patient on permanent dialysis before the onset of TBAD).

      Procedure

      All patients had signed a written consent form before the surgery and approved by the institutional review board. The e-PETTICOAT technique requires the implantation of a nitinol self-expandable Bare Metal Stent (Medicut, Pforzheim, Germany) into the visceral and infrarenal aorta (to re-expand TL). Then the thoracic stent-graft (Valiant Captivia; Medtronic, USA) is deployed proximally with overlap (to cover proximal entry tear), followed by inserting 2 covered stent-grafts (Endurant II, Iliac Extension; Medtronic) below renal arteries as parallel kissing iliac stent-grafts (to cover iliac re-entries). TEVAR proximal oversizing was usually 5% (range 2–10%), and visceral bare-metal stent extra large (BMS-XL) was usually 8% (range 5–15%). The oversizing was based on the biggest diameter of the TL. The STABILIZE technique supported the procedure by ballooning all the implants with the Reliant balloon (Medtronic).

      Early Results

      The technical success (entry coverage and TL re-expansion) rate was 100%. Three patients died during the first year (nonaorta related). The rest of the patients went into a long-term surveillance program. The volumetric and linear changes after surgery were monitored and analyzed during follow-up (Table III).
      Table IIIRadiological changes after surgery
      Assessed criteriaMedianRange
      Maximal initial thoracic aorta diameter (mm)4630–54
      Maximal thoracic aorta diameter after surgery (mm)4330–49
      Initial aorta diameter at the level of CT (mm)3622–53
      Diameter of the aorta at the level of CT after surgery (mm)3822–55
      Initial aorta diameter at the level of RA (mm)3122–43
      Aorta diameter at the level of RA after surgery (mm)3324–45
      FL perfusion volume before surgery (mL)21035–506
      FL Perfusion volume after surgery (mL)220–94
      TL perfusion volume before surgery (mL)11722–268
      TL Perfusion volume after surgery (mL)290133–501
      CT, celiac trunk; RA, renal arteries.
      TL re-expansion was achieved in all patients after surgery. On-table diagnosis of the leak to the FL was made in 9 cases originating from the right renal artery (n = 5, 25%), the left renal artery (n = 5, 25%), the superior mesenteric artery (n = 2, 10%), and the celiac trunk (n = 2, 10%).

      Follow-up

      Seven patients (35%) died during the 5-year follow-up. Total survival rates were 75%, 70%, and 63%, and survival without reinterventions were 100%, 93%, and 18% after 1, 2, and 5 years, respectively (Fig. 1). Aneurysmatic degeneration was diagnosed in 30%, 55%, and 85% of the patients after 1, 2, and 5 years respectively.
      Figure thumbnail gr1
      Fig. 1(A) Long-term survival after e-PETTICOAT. (B) Survival rate without reintervention.
      Figure thumbnail gr2
      Fig. 2Stent collapse in the visceral segment. (A, a) Celiac trunk; (b) contrast-enhanced false lumen. (B, a) Celiac trunk; (b) contrast-enhanced false lumen; (c) Medicut BMS-XL stent collapse.
      After 5 years, only 3 patients had an aortic diameter size below 55 mm (Table IV).
      Table IVDegenerative changes in the aorta in a long-term follow-up
      Assessed criteriaInitially1 year2 years5 yearsP value
      Maximum aortic size >55 mm, n (%)0 (0)6 (30)11 (55)17 (85)NS
      Number of occluded visceral branches, n (%)6 (30)2 (10)2 (10)2 (10)NS
      Volume of Contrasted FL (median in mL)210221539NS
      TL volume (median in mL)118290268302NS
      NS, not significant.

      Reinterventions

      Eight patients needed a reintervention (BEVAR procedure) in the follow-up. They received a BEVAR procedure, which required either a custom-made 5-branch stent-graft T-Branch (COOK Medical, Bloomington, USA; n = 7) or an inner branch with a combined aortic bifurcation from Jotec (Hechingen, Germany; n = 1). Custom-made devices had to be used because the parallel aortoiliac stent-grafts were positioned just below the renal arteries. It was not possible to use FEVAR devices, as proper positioning of the stent-graft and attaching it to the aortic wall at the visceral level was unfeasible because of the inserted BMS-XL (Medicut). In 5 cases, the BMS collapsed, which resulted in additional technical problems (Fig. 2).
      Furthermore, 2 patients had asymptomatic new occlusions of the renal arteries and the celiac trunk. One patient required the implementation of renal replacement therapy, despite the patency of the renal arteries.
      The difference between the observed and predicted degeneration rates appears insignificant at 85% vs. 66% (P = 0.378, Fisher’s exact test).
      In the receiver operating curve analysis, no factor was found that would predict remodeling in the long-term follow-up.

      Discussion

      The e-PETTICOAT is based on the concept of covering the distal re-entry tear and reducing the volume of the FL and was first published in 2018.
      • Kazimierczak A.
      • Rynio P.
      Extended Petticoat strategy in type B aortic dissection.
      ,
      • Jędrzejczak T.
      • Rynio P.
      • Samad R.
      • et al.
      Complete Entry and Re-entry Neutralization protocol in endovascular treatment of aortic dissection.
      The interim results (1–3 years) were promising in both chronic and acute TBAD. However, its implementation raised a significant issue regarding long-term results, whether this technique could protect against aneurysmal degeneration.
      • Verhoeven E.L.G.
      Extended Petticoat strategy in aortic dissection: when is it too much, or not enough?.
      The advantages were the feasibility and safety of the technique (it does protect the branches to the spine). One of the biggest disadvantages was however the fact that the technique comes with the risk of a leak into the FL along the visceral BMS.

      The Volumetric Assessment and Efficacy of Preventive Surgery

      After 5 years, favorable remodeling was maintained in only 3 patients, despite the fact that the interim results (after the first 2 years) suggested favorable remodeling in all the patients. The treated patients were diagnosed with a leak to the FL, but the contrast-enhanced FL volume did not change significantly. We observed a decrease in the contrast-enhanced FL volume from 21 mL after 1 year to 15 mL after 2 years, only to see it increase to 39 mL after 5 years. In patients who did not receive any surgical treatment (best medical therapy only), the degeneration rate might be lower (66%; based on Stanford calculation) than in the patients receiving our treatment (85%). Although this difference is not statistically significant, we feel it might be important. This potential bias might be related to the small number of patients or the unexpected impact the devices themselves have on remodeling. Whether the e-PETTICOAT technique has the potential to reduce the FL inflow remains unestablished. This technique allows a leak to the FL in the area covered by Bare Metal Stent, which during the first 2 years of follow-up seemed insignificant; however, in the longer follow-up, the volume of contrast-enhanced FL volume increased, which corresponded with an increased degeneration rate. Some of the patients eventually needed complex endovascular procedures with the use of custom-made devices. Therefore, the patients still need to remain in close surveillance programs. None of the patients could be considered “cured” or well protected.

      Stent Collapse

      This phenomenon was probably caused by the low radial force of the Medicut BMS-XL and severe pressure caused by the perfused FL. However, using the Medicut BMS has the advantage that it would not impede the BEVAR procedure (if it was needed in the future) because the small radial force of the stent would not compress the bridging stent.
      None of the independent factors were found to influence the late remodeling rate, including the common risk factors (Table I) and the Stanford calculation (Table II). However, these factors refer to patients with an unknown outcome, and the patients who were included in the study were known to have a bad outcome, as they had already been diagnosed with rapid degeneration. This could be the reason why the well-known predictors of aneurysmal degeneration failed to show any predictive value in our study.

      Limitation

      The obvious limitation is the small number of patients in our study and the lack of head-to-head comparison to other strategies such as TEVAR alone, best medical treatment alone, or initial BEVAR or FEVAR procedure.
      The relatively high death rate raises concern. Although the reported deaths have not been linked to the aortic dissection, the lack of postmortem examination might cast doubts on whether some of the deaths could be related to aortic disease.

      Summary

      Extensive coverage of the dissection without complete exclusion of the FL from the circulation might not protect the TL efficiently. Instead, it might even impair the outflow from the FL, which could be harmful for the aorta and have a negative effect on the long-term results. Based on our data, we cannot recommend the e-PETTICOAT technique for the management of chronic asymptomatic type B aortic dissection in patients who are not yet eligible for an F/BEVAR procedure.

      Conclusion

      The use of e-PETTICOAT technique in cTBAD might not have a beneficial influence on long-term results.

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