Nonsurgical Reconstruction of Thoracic Aortic Dissection by StentGraft Placement
Christoph A. Nienaber, M.D., Rossella Fattori, M.D., Gunnar Lund, M.D., Christoph Dieckmann, M.D., Walter Wolf, M.D., Yskert von Kodolitsch, M.D., Volkmar Nicolas, M.D., and Angelo Pierangeli, M.D.
Background The treatment of thoracic aortic dissection is guidedby prognostic and anatomical information. Proximal dissectionrequires surgery, but the appropriate treatment of distal thoracicaortic dissection has not been determined, because surgery hasfailed to improve the prognosis.
Methods We prospectively evaluated the safety and efficacy ofelective transluminal endovascular stentgraft insertionin 12 consecutive patients with descending (type B) aortic dissectionand compared the results with surgery in 12 matched controls.In all 24 patients, aortic dissection was diagnosed by magneticresonance angiography. In each group, the dissection involvedthe aortic arch in 3 patients and the descending thoracic aortain all 12 patients. With the patient under general anesthesia,either surgical resection was undertaken or a custom-designedendovascular stentgraft was placed by unilateral arteriotomy.
Results Stentgraft placement resulted in no morbidityor mortality, whereas surgery for type B dissection was associatedwith four deaths (33 percent, P=0.09) and five serious adverseevents (42 percent, P=0.04) within 12 months. Transluminal placementof the stentgraft prosthesis was successful in all patients,with no leakage; full expansion of the stents was ensured byballoon inflation at 2 to 3 atm. Sealing of the entry tear wasmonitored during the procedure by transesophageal ultrasonographyand angiography, and thrombosis of the false lumen was confirmedin all 12 patients after a mean of three months by magneticresonance imaging. There were no deaths or instances of paraplegia,stroke, embolization, side-branch occlusion, or infection inthe stentgraft group; nine patients had postimplantationsyndrome, with transient elevation of C-reactive protein levelsand body temperature plus mild leukocytosis. All the patientswho received stentgrafts recovered, as did seven patientswho underwent surgery for type B dissection (58 percent) (P=0.04).
Conclusions These preliminary observations suggest that elective,nonsurgical insertion of an endovascular stentgraft issafe and efficacious in selected patients who have thoracicaortic dissection and for whom surgery is indicated. Endoluminalrepair may be useful for interventional reconstruction of thoracicaortic dissection.
Management of thoracic aortic dissection depends on the patient'sprognosis. Whereas patients with proximal dissections clearlybenefit from surgical repair, the therapeutic strategy for dissectionsof the aortic arch and descending thoracic aorta is far fromsettled. Given the high morbidity and intraoperative mortalityassociated with surgical resection,1,2 the consensus is to reservesurgery for cases of persistent communication without thrombosisof the false lumen3,4 or unstable (enlarging) Stanford typeB dissection.5,6,7 With both medical therapy (i.e., the useof antihypertensive agents) and surgery, however, the intermediateand long-term prognoses are poor. With medical therapy, thrombosisof the false lumen and stabilization of the aortic tube areunpredictable, and there is a risk of rupture or progressionof the dissection. Conversely, surgical resection carries therisk of both paraplegia and death.5,8,9,10
We undertook this study to test aortic reconstruction for typeB dissection by insertion of custom endoluminal stentgraftsto seal the entry site and induce thrombosis of the false lumen.With percutaneous placement, major surgery and the related morbidityand mortality were avoided in patients with classic indicationsfor surgical repair. The technique of endoluminal aortic stentgraftplacement has recently been introduced for repair of abdominaland thoracic aortic aneurysms.11,12 In the high-risk settingof aortic dissection, however, endoluminal repair is a new therapeuticstrategy.
Methods
Selection of Patients
Between October 1997 and March 1998, 12 of 24 consecutive patientswho had subacute or chronic type B aortic dissection and whohad at least one indication for surgical repair underwent electivetransluminal endovascular stentgraft placement,9,13,14and the other 12 patients, who had similar demographic and clinicalcharacteristics, underwent surgery and served as controls (Table 1).For stentgraft insertion, patients were requiredto meet the following anatomical criteria: an entry site atleast 0.5 cm distal to the left subclavian artery, suitableaccess with no substantial iliac tortuosity, and one iliac arterywithout dissection. The protocol was approved by the institutionalreview boards of the university medical centers of Hamburg andBologna, and written informed consent was obtained.
Table 1. Demographic and Anatomical Characteristics of the Patients.
Three patients in each group had previously had surgery fortype A dissection. The mean (±SD) diameter of the aortaat the entry level was 6.9±1.1 cm in the surgery groupand 6.3±0.8 cm in the stentgraft group (P=0.14).The age of the patients was 56±12 years in the surgicallytreated group and 62±11 in the stentgraft group(P=0.18). The length of the dissecting lamella was 30±12cm and 32±10 cm, respectively, with thoracoabdominalextension of the dissection in seven patients undergoing surgeryand five patients undergoing stentgraft placement (P=0.68).Transfemoral stentgrafting was offered if the aorticdissection was distal to the left subclavian artery, there wasa proximal entry to the false lumen, the true lumen was lessthan 4 cm in diameter, or a thrombus failed to form spontaneouslyin the false lumen (Table 2). All 24 patients had a maximalaortic diameter of 5.5 cm or more, luminal expansion, or recurrentpain.5,8,14 Dissection extending to the aortic bifurcation,tortuosity, or kinking did not preclude stentgraft placementas long as the iliac artery allowed access of the 22-to-27-Frenchdelivery sheath. During the recruitment period, an additional20 patients with Stanford type A dissection and 12 additionalpatients with type B dissection underwent emergency or earlysurgical repair at the two centers; thus, altogether, 21 percentof all patients, or 33 percent of patients with type B dissection,underwent stentgrafting.
Table 2. Demographic and Anatomical Characteristics of the Patients with StentGrafts.
Imaging Protocol
All the patients underwent spinecho (anatomical) magneticresonance imaging (MRI) and three-dimensional magnetic resonanceangiography after the injection of a bolus of gadoliniumdiethylenetriaminepentaacetic acid (gadolinium-DTPA; Magnevist, Schering, Berlin,Germany).16 The use of gadolinium-DTPA during data acquisitionproduces contrast-induced T1-shortening effects and eliminatessaturation problems due to slow flow or turbulence-induced signalvoids. With the use of ultrafast gradients, acquisition wasperformed with the patients holding their breath. A FLASH (fastlow-angle shot) three-dimensional sequence was used with orwithout intravenous contrast material to create maximal-intensityprojections; echo and repetition times were as short as 1.9and 4.0 msec, respectively. With a field of view of 390 to 450mm, a 512-by-512 matrix provided an in-plane resolution of 1.1-by-1.6mm. Slice thickness varied from 2 to 4 mm; a flip angle of 30degrees was selected. Imaging of 64 interpolated contiguousslices with half-k-space data acquisition in the phase-encodingdirection took 20 to 28 seconds.
Images were obtained with a 1.5-T magnetic resonance scanner(Magnetom Vision, Siemens Medical Systems, Erlangen, Germany)equipped with an ultrafast-gradient system; a body-array coilwas used for signal transmission and reception. Optimal imagequality was ensured by individual tracking of the bolus beforethe infusion of 0.25 mmol of gadolinium-DTPA per kilogram ofbody weight over a period of 10 to 14 seconds (approximatelyhalf the acquisition time). With subvolume multiplanar reconstruction,the dissecting lamella (the exact site of a communication andfalse-lumen flow) was identified in all cases. To design eachstentgraft, MRI scans and angiograms were evaluated formorphometric measurements 14±2 days before stent implantation.Follow-up MRI was performed according to an identical protocolfor all the patients to document complete closure of the interluminalcommunication or false-lumen thrombosis or leakage (Figure 1Aand Figure 1B).
Figure 1. Magnetic Resonance Angiograms Obtained before and after Placement of a StentGraft.
Panel A shows a magnetic resonance angiogram in a three-dimensional, maximal-intensity projection after the injection of gadolinium-DTPA. There is a dual, open-lumen, type B dissection; the entry to the perfused false lumen (arrowhead) is located in the distal arch directly adjacent to the left subclavian artery. The open arrow indicates the true lumen. Panel B shows a follow-up magnetic resonance angiogram obtained in the same patient three months after successful placement of a Dacron-covered stentgraft directly onto the entry of the false lumen. The entry is completely sealed by the stentgraft, and the false lumen is thrombosed. The left subclavian artery is widely patent, and the true lumen (solid arrow) has widened as evidence of aortic remodeling.
Endovascular StentGraft Prosthesis
The stentgraft prosthesis (Talent, World Medical Manufacturing,Sunrise, Fla.) was a self-expanding endoprosthesis consistingof circumferential nitinol stent springs arranged as a tubefor conformance to the lumen and covered on its exterior witha Dacron graft; the tube was customized with respect to width,length, and the configuration of each end (as a bare springor a covered web) and was compressed in a 22-to-27-French polytetrafluoroethylene(Teflon) sheath; the nitinol rings were interconnected by alongitudinal wire to ensure stabilization and separation ofall the rings and to prevent twisting. Each device was custom-madeaccording to morphometric measurements obtained from each patient'sMRI scan (Table 2).
Implantation Technique
Stentgraft placement was performed in the cardiac catheterizationlaboratory (University Hospital Hamburg) or operating room (Universityof Bologna) with the patients under general anesthesia and receivingventilation. Patients were prepared to undergo surgery in casethe procedure failed. The procedure was begun by injecting 5000U of heparin and introducing a 6-French pigtail catheter (Cordis,Hamburg, Germany) into the left subclavian artery for preciseguidance near the subclavian artery and for intraproceduralaortography. In all the patients, the femoral or distal iliacartery was surgically exposed, and a 0.89-mm (0.035-in.) guidewire was inserted. When the position of the wire in the truelumen of the aorta had been confirmed by fluoroscopy and ultrasonography,the sheath with the stent, a pusher, and a deflated large-borelatex balloon (the Talent prosthesis) was introduced. The compressedstent was advanced to the site of the interluminal communication,under guidance by simultaneous transesophageal color Dopplerimaging.
Before the stentgraft was unloaded, systolic blood pressurewas titrated to 50 mm Hg with sodium nitroprusside; as soonas blood no longer circulated through the false lumen, the stentwas expanded by balloon molding (by inflation of the balloonat 2 to 3 atm); when the web struts were fully extended andthere was no flow into the false lumen, the infusion of sodiumnitroprusside was discontinued. With the Dacron shell centeredon the interluminal communication, the stentgraft wasunloaded by holding the pusher in place and gently pulling backthe housing cartridge. To ensure optimal positioning, care wastaken to seal the entry with Dacron and to protect the leftsubclavian artery with the bare-spring end of the stentgraft.Both the sheath and the guide wire were removed, and the incisionwas closed. No additional heparin or antiplatelet medicationwas administered after completion of the procedure.
Surgical Resection
In all 12 patients who underwent surgery, access was by theleft lateral approach, with direct exposure of the dissection.1,2,9After the induction of mild hypothermia, the aorta was cross-clamped,and in 11 patients (92 percent) atriodistal or femorofemoralbypass was instituted. The dissected and dilated descendingaortic segment was replaced with Dacron grafts, and in 8 ofthe 12 patients (67 percent) the intercostal arteries were reattached;spinal cord function was not evaluated intraoperatively. Intraoperativeand follow-up outcomes are summarized in Table 3.
Table 3. Procedural Data and Intraoperative and Longer-Term Outcomes.
Statistical Analysis
Continuous variables were expressed as means ±SD andwere compared by analysis of variance. Rates of event-free survival(defined as survival without death, paraplegia, stroke, distalembolization, side-branch occlusion, or infection) were studiedwith use of the log-rank test.17 Differences between the groupsin categorical variables were analyzed by the chi-square testor Fisher's exact test; exact 95 percent confidence intervalswere determined for proportions. All P values are two-sided,and a P value of less than 0.05 was considered to indicate statisticalsignificance.
Results
Procedural Success
Transfemoral stentgraft deployment was successful andfree of complications in all 12 patients. Complete sealing ofthe entry to the false lumen was documented by color Dopplertransesophageal echocardiography and aortography. One patientreceived two stentgrafts, but no patient required anyadjunctive procedure. Initiation of thrombosis of the falselumen was observed by transesophageal ultrasonography duringthe procedure in 10 of the 12 patients (83 percent). No patientin the stentgraft group required blood transfusion orinotropic support; on average, 178±79 ml of contrastmaterial was used and fluoroscopic examination lasted 19±5minutes (range, 9 to 30). In contrast to the surgically treatedpatients, none of the patients who received a stentgrafthad a prolonged recovery from either the procedure or anesthesia;as shown in Table 3, their average length of stay in the intensivecare unit was 36±12 hours (as compared with 92±45hours in the surgery group, P<0.001), and their average lengthof stay in the hospital was 7±3 days (range, 4 to 15),as compared with 40±24 days (range, 14 to 96) in thesurgery group (P<0.001). In the stentgraft group,no patient had an adverse event, and all were able to beginwalking within three days.
Immediate and Longer-Term Outcomes
Both intraoperative and postoperative outcomes were uneventfulafter placement of the stentgrafts (Table 3). Transientpostimplantation syndrome with mild leukocytosis, elevated levelsof C-reactive protein, and moderately elevated body temperatureoccurred in 9 of the 12 patients (75 percent); the maximal C-reactiveprotein level was 148 mg per liter, and the leukocyte countwas 11±9x106 per cubic centimeter on day 4±2.A nonspecific, slight-to-moderate back-pain syndrome was describedby six patients (50 percent) and resolved within 12±5days without the use of analgesics.
Among the 12 surgically treated patients, 4 (33 percent) diedwithin 1 year after surgery (1 died perioperatively, 2 diedwithin 6 months, and 1 died of aortic rupture at 10 months).Moreover, as compared with stentgraft implantation, surgerywas associated with higher morbidity (P=0.04), longer hospitalization(P<0.001), a lower rate of physical recovery (P=0.04), andgreater need for inotropic support and blood transfusions (insix patients [50 percent]).
Intraprocedural Imaging
In addition to repeated contrast angiography during the procedure,color Doppler transesophageal echocardiography provided usefulinformation both for the exact positioning of the stentgraftand for the monitoring of flow to the entry to the false lumen:cessation of color flow indicated that the stentgrafthad been deployed. In one patient who had previously undergonereplacement of the ascending aorta, the communication was difficultto visualize, and intraprocedural success was documented byangiography only. Moreover, in all the patients both angiographyand transesophageal ultrasonography confirmed expansion of thetrue lumen by 8 to 19 mm (27 to 202 percent expansion of preimplantationwidth) at the time of stentgraft deployment. Intraproceduralultrasonography also detected thrombosis of the false lumenin 10 of the 12 patients (83 percent) by revealing high echodensity("smoke") within minutes after the entry was sealed. Finally,one small leak and four persistent distal communications tothe false lumen were identified, all of which had closed afterthree months of follow-up.
Follow-Up Imaging
At three months, spinecho MRI and three-dimensional magneticresonance angiography documented widely patent stentgraftsand complete thrombosis of the false lumen in all 12 patients.No aortic side-branch occlusion and no evidence of migrationor twisting of the stentgraft or leakage was noted. Moreover,at three months, there was clear evidence of expansion of thetrue lumen and shrinkage of the false lumen as a result of consolidationof thrombosis in all the patients, suggesting that the aortictube had been remodeled with enlargement of the reconstructedtrue lumen.
Comparison between Surgery and StentGraft Implantation
All the patients with stentgrafts resumed an active life;eight of them received antihypertensive medication, and nonewas readmitted to the hospital. In contrast, the group treatedsurgically had a 12-month mortality rate of 33 percent (95 percentconfidence interval, 9.9 to 65 percent) and a 42 percent rateof serious morbidity (95 percent confidence interval, 15 to72 percent) (P=0.09 and P=0.04, respectively, for the comparisonswith the stentgraft group). Moreover, both the time spentin the intensive care unit and the overall hospital stay weremarkedly longer among patients who underwent surgery than amongthose who underwent stentgrafting (Table 3).
Discussion
Our findings suggest that nonsurgical reconstruction may bea viable therapeutic option for patients with descending dissectionof the thoracic aorta and one or more indications for surgicalrepair, such as an aortic diameter greater than 5.5 cm, a patentprimary entry site, an expanding false lumen, or recurrent pain.2,3,5,13,14In contrast to thoracic surgery for type B dissection, transfemoralstentgrafting was not associated with early or longer-termmortality or with serious morbidity. Our preliminary analysiseven suggests that substantial cost savings could result fromthe reduced need for intensive care and the shorter hospitalstay.
Even though nonsurgical (interventional) techniques have recentlybeen introduced for the treatment of congenital aortic stenosisand coarctation and the treatment of abdominal and thoracicaneurysms,11,18 medical or surgical management is usually thetreatment chosen for dissection, and both have disappointingresults.8,9,19 Except for catheter fenestration of occlusivedistal flaps, no interventions have proved useful for managingaortic dissection.20,21
Whereas emergency surgical repair is lifesaving in ascending(type A) aortic dissection,1,2,3,4,22 both emergency surgeryand deferred surgery for descending (type B) dissection areassociated with a 6 to 67 percent mortality rate, dependingon the patient group assessed, and neither offers a substantialadvantage over medical therapy.1,6,9,14,23,24,25,26 Also, paraplegia(or paresis) occurs in 7 to 36 percent of patients who undergosurgery, depending on the extent of aortic resection and theduration of cross-clamping.1,9,24,25,27 Even with intraoperativeatriodistal bypass, reattachment of all the critical intercostalarteries, and induction of mild hypothermia, early surgicalmortality is 7.1 percent in patients with chronic type B dissectionand 8.7 percent in those with acute type B dissection.28,29,30,31Similarly, surgery-related paraplegia or paresis occurs in 2.9percent of patients with chronic type B dissection and in 19percent of those with acute cases; advanced age, excessive cross-clampingtime, and inappropriate reattachment of the great anterior radiculomedullaryartery are predictors of these adverse outcomes.31,32,33,34,35,36
With the use of percutaneous stentgrafts in our study,however, the aorta was reconstructed with an excellent outcomeand without the need for complex protective measures. Whereasboth surgical resection and medical treatment failed to producea convincing improvement in the natural course of distal dissection,sealing of the entry induced thrombosis of the false lumen andstable remodeling of the aorta.
Avoidance of Paraplegia or Paralysis
Although spinal cord dysfunction was expected to develop inapproximately 8 percent of our patients with stentgrafts,34no neurologic complications were encountered, in contrast tothe outcome in patients treated surgically. Preservation ofthe integrity of the aorta, rather than resection of the dissectedsegment, may be important to protect the spinal arteries. Theuse of short stentgrafts, 84±40 mm in length,and deployment far from vertebrae T8 to L2, further minimizedthe risk of paraplegia, as compared with the risk with surgicalgrafts, which were 220±74 mm in length (P<0.001).Most important, the stentgraft procedure took only 1.6±0.4hours, as compared with 8.0±2.0 hours for surgery (P<0.001);it circumvented the need for circulatory arrest and cross-clampingof the aorta, and the associated ischemia and potential reperfusioninjury; and it averted postoperative respiratory failure andprolonged hypotension and the associated risk of delayed paraplegia.Even successful reimplantation of the intercostal arteries andcross-clamping for less than 30 minutes have not eliminatedthe risk of paraplegia after surgery.25,26,31,35,37,38
Remodeling of the Aorta
With stentgraft implantation, aortic stability is inducedboth by thrombosis of the false lumen and by the endoprosthesisitself; a relatively short stentgraft can cover the proximalentry and induce false-lumen thrombosis over the entire lengthof the dissected aorta within three months. In our study thetrue lumen expanded substantially, from 19±7 mm to 35±3mm, and the diameter of the false lumen was reduced by retractionof the thrombus. Thus, aortic remodeling comprises an activecomponent (stent-induced expansion of the true lumen) and apassive component (retraction of the thrombus in the false lumen)and mimics the natural healing process. A thrombosed false lumenis known to be associated with a lower risk of future adverseevents and with better survival than a patent false lumen.38Conversely, a persistently perfused false lumen, as documentedby color Doppler ultrasonography, is known to be associatedwith higher mortality.3
Limitations
Although conceptually promising, the management of type B dissectionby stentgrafting lacks the support of long-term follow-updata. During several years' follow-up after stentgraftplacement for the treatment of both thoracic and abdominal aneurysms,late adverse effects were infrequent.11,12,18 Thrombosis ofrepaired aneurysms was reported in 95 percent of patients, witha periprocedural mortality of 8 percent and a six-month mortalityof 12 percent.39 We recommend nonsurgical stentgraftplacement for the treatment of type B dissection only in patientswith an indication for surgical repair and with suitable anatomicalcharacteristics (an accessible proximal entry, at least onefemoral artery without dissection, and no substantial tortuosity).Moreover, the custom design of each stentgraft currentlylimits their placement to patients undergoing elective procedures;more versatile stentgrafts will be necessary to treatacutely ill patients. Finally, sophisticated imaging techniques,such as magnetic resonance angiography, intraprocedural transesophagealechocardiography, and digital angiography, appear to be necessaryto ensure optimal results.
Clinical Application
Stentgraft placement may be a promising nonsurgical strategyfor the treatment of type B dissection. The initiation of thenatural healing process (false-lumen thrombosis) by sealingof the proximal entry induces both consolidation of the falselumen and remodeling of the aortic wall. If side-branch occlusionhas not occurred and the dissecting process has not progressed,interventional stentgraft placement may be offered toselected patients in lieu of surgical repair; with further refinementof the technique, patients with severe coexisting conditionsand high surgical risk may be considered for the procedure.Although the initial results of stentgraft treatmentof thoracic aortic dissection are promising, the concept ofnonsurgical reconstruction must be subjected to a randomizedlong-term study.
We are indebted to the staff members of the intensive care unitsand cardiothoracic units at the University Hospital Eppendorfand the Policlinico S. Orsola-Malpighi for their invaluablesupport and encouragement; and to Dr. P. Capasso, Universityof Lausanne, Professor H.G. Borst, Hannover Medical School,Dr. E. Isselbacher, Massachusetts General Hospital, Dr. B.M.Richards, Jena, and Professor T. Meinertz, University HospitalEppendorf, for fruitful criticism.
Source Information
From the Departments of Cardiology (C.A.N., G.L, Y.v.K), Diagnostic Radiology (C.D., V.N.), and Vascular Surgery (W.W.), University Hospital Eppendorf, Hamburg, Germany; and the Departments of Radiology (R.F.) and Cardiothoracic Surgery (A.P.), Policlinico S. Orsola-Malpighi, Bologna, Italy.
Address reprint requests to Dr. Nienaber at University Hospital Eppendorf, Martinistr. 52, Hamburg 20246, Germany, or at nienaber{at}uke.uni-hamburg.de.
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