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Open Aortic Repair After Prior Thoracic Endovascular Aortic Repair Eric E. Roselli, MD, Mohamed Abdel-Halim, MD, PhD, Douglas R. Johnston, MD, Edward G. Soltesz, MD, MPH, Roy K. Greenberg, MD, Lars G. Svensson, MD, PhD, and Joseph F. Sabik, III, MD Cleveland Clinic Heart and Vascular Institute, Cleveland, Ohio
Background. Thoracic endovascular aortic repair (TEVAR) has been applied to increasingly complex aortic pathology, resulting in an increase in late complications. We characterized patients undergoing open repair after prior TEVAR including indications, operative techniques, and outcomes. Methods. Chart review and query of a prospectively collected database identified 50 patients who underwent thoracic aortic operation after prior TEVAR. Active follow-up was supplemented by Social Security information for vital status. Results. From July 2001 to January 2012 open arch (n [ 25), descending (n [ 6), thoracoabdominal (n [ 17), or extra-anatomic bypass (n [ 2) operations were performed after previous TEVAR (median interval from TEVAR to open surgical procedure: 13.9 months; interquartile range, 0.5 to 24 months). Indications for open operation included type 1 endoleaks (n [ 19), retrograde aortic dissection (n [ 9), chronic aortic dissection with persistent growth of
the false lumen (n [ 16), and graft infection (n [ 6). Sixty percent had prior cardiovascular surgical procedures and 18% were done as emergencies. Circulatory support was required in 78% and hypothermic arrest in 48%. Hospital mortality occurred in 3 (6%) patients with no strokes and 1 patient with myocardial infarction; 5 (10%) patients required tracheostomy and 1 required dialysis. Survival was 67% at a median follow-up of 2.9 years. Conclusions. Conversion to open repair after thoracic stent-grafting may be indicated for type 1 endoleak, retrograde dissection, chronic aortic dissection with persistent false lumen growth, or graft infection. These salvage operations are complex but can be completed safely with good early outcomes and preservation of the stent-graft in most cases. Late outcomes are consistent with the chronic disease state of these patients.
T
risk of serious complications that may require conversion to open repair [5–8]. The objectives of this study were to (1) characterize patients undergoing open aortic repair after prior TEVAR, (2) describe the indications for conversion and operative techniques used, and (3) assess early and late outcomes.
horacic endovascular aortic repair (TEVAR) has become a widely accepted treatment option for patients with thoracic aortic disease and is particularly useful in those patients deemed at high risk for conventional open surgical repair [1]. As experience with these devices has evolved, the application has been expanded to increasingly more complicated anatomy (including proximal deployment within the arch and a tolerance for shorter than recommended landing zones) and pathology (such as aortic dissection) [2–4]. It is estimated that nearly two-thirds of thoracic stent grafts are deployed in situations outside the instructions for use, or “off-label.” This more daring use of TEVAR carries the
Accepted for publication Oct 11, 2013. Presented at the Poster Session of the Forty-ninth Annual Meeting of The Society of Thoracic Surgeons, Los Angeles, CA, Jan 26–30, 2013. Address correspondence to Dr Roselli, Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, 9500 Euclid Ave, Desk J4-1, Cleveland, OH 44195; e-mail: [email protected].
Ó 2014 by The Society of Thoracic Surgeons Published by Elsevier Inc
(Ann Thorac Surg 2014;97:750–7) Ó 2014 by The Society of Thoracic Surgeons
Patients and Methods Patients and Indications From July 2001 to January 2012, 50 consecutive patients underwent open aortic repair after prior TEVAR. TEVAR procedures were performed for various indications at our Dr Roselli discloses financial relationships with Medtronic, Cook Medical, and Terumo; Dr Johnston with St. Jude and Baxter; Dr Greenberg with Cook Medical; and Dr Sabik with Medtronic, Edwards Lifesciences, Abbott Vascular, Medi-Stim, and ValveXchange.
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Table 1. Patient Characteristicsa Characteristic Demographics Age, mean SD (years) Male, n (%) Comorbidities Hypertension Diabetes mellitus Smoking Coronary artery disease Carotid disease History of cerebrovascular accident Peripheral vascular disease History of congestive heart failure Renal failure (dialysis dependent) Chronic obstructive pulmonary disease Documented vascular disorderb Prior cardiovascular operation Initial indication for TEVAR Degenerative aneurysm Aortic dissection Post type A repair Type B repair Traumatic transection Mycotic aneurysm Type of stent graft used Cook Zenith Gore TAG Medtronic Talent Other N ¼ 50. (n ¼ 1).
a
b
n (%) 60.5 15 32 (64) 34 3 25 8 7 1 15 4 1 9 5 26
(68) (6) (50) (16) (14) (2) (30) (8) (2) (18) (10) (52)
15 31 9 22 3 1
(30) (62) (18) (44) (6) (2)
19 26 2 3
(38) (52) (4) (6)
Marfan’s syndrome (n ¼ 3), Loeys-Dietz (n ¼ 1), Takayasu’s
TEVAR ¼ thoracic endovascular aortic repair.
and other institutions. During this time period 758 patients underwent TEVAR procedures at our institution. These details and additional patient characteristics of interest including demographics, comorbidities, and morphology of disease are included in Table 1. These conversions to open repair were performed at a median interval of 13.9 months (range 2 days to 91 months) for a variety of reasons including type 1 endoleak (n ¼ 19), Table 2. Indications for Open Conversiona Indication
n (%)
Type 1 endoleak Proximal (1a) Distal (1b) Proximal/retrograde dissection Chronic dissection with false lumen perfusion and growth Infected stent graft Plus rupture (not mutually exclusive)
19 14 5 9 16
a
N ¼ 50.
(38) (28) (10) (18) (32)
6 (12) 5 (10)
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acute dissection of the ascending aorta (n ¼ 9), chronic aortic dissection with persistent aneurysmal growth of the false lumen (n ¼ 16), and stent graft infection (n ¼ 6) (Table 2). Of the patients with type 1 endoleak, 26% underwent open repair within the first 30 days since stent grafting. Similarly, 3 of the proximal aortic dissections occurred within the first 30 days after TEVAR, and the other 6 of these were late complications. Additionally, 1 patient who underwent hybrid thoracoabdominal repair for chronic dissection with distal aortic growth of the false lumen (6 months after descending thoracic stent grafting) developed ascending aortic dissection 1 year after the thoracoabdominal conversion. This proximal dissection was due to progression of his disease without a tear at the stent graft level, and that event is described later as an open reintervention during follow-up. Data were obtained from the prospectively maintained Cardiovascular Information Registry (CVIR) at the Cleveland Clinic. Informed consent was waived, and the study was approved by the Institutional Review Board.
Operative Techniques These patients all had extensive thoracic aortic disease and the stent graft therapy failed for a variety of reasons. Consequently, the open operations were performed on various segments of the aorta. Many of these patients required staged aortic repairs and underwent additional operations after the index operation described in this study. For consistency, the index operation referenced in this study is the first open operation involving the thoracic aorta after previous TEVAR. The operations primarily involved the aortic arch in 25 patients, the descending aorta in 6 patients, the thoracoabdominal aorta in 17 patients, or an extra-anatomic bypass in 2 patients. Eighteen percent of these operations were done as emergencies, including 5 ruptures. Circulatory support was required in 78% and deep hypothermic circulatory arrest in 48%. Nineteen patients underwent 23 concomitant procedures during the open aortic procedure. Additional operative details are presented in Table 3. REVERSE FROZEN ELEPHANT TRUNK PROCEDURE. This procedure has been previously described [5]. In short, this operation is performed with the use of deep hypothermic circulatory arrest with right axillary artery cannulation with or without selective brain perfusion based on the surgeon’s choice and the complexity of the reconstruction needed. In all of these patients, the proximal end of the stent graft is directly sutured to the native aorta after opening the proximal aorta during the circulatory arrest period. This operation was performed for type 1a endoleak in 13 patients. For this indication the proximal aorta was replaced with a prosthetic graft in all of our patients, but may also be closed primarily if the tissue is healthy. The other 9 patients treated with this technique were the proximal/ retrograde acute aortic dissections. ARCH
DEBRANCHING
WITH
ANTEGRADE
STENT
GRAFT
Arch debranching with antegrade stent graft delivery represents another option in patients with arch
DELIVERY.
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Table 3. Intraoperative and Perioperative Detailsa Detail Circulatory support, n (%) Time of cardiopulmonary bypass, mean SD (min) Time of myocardial ischemia, mean SD (min) (n ¼ 29) Left atrial to femoral partial bypass, n (%) Deep hypothermic circulatory arrest, n (%) Time of circulatory arrest, mean SD (min) Additional concomitant procedures, n (%) Coronary bypass grafting (CABG) Aortic valve replacement Aortic valve repair Aortic valve procedure and CABG Lung resection Esophagectomy Orthopedic spinal hardware removal Transfusion requirements, mean SD (units) (intra- þ postoperative) Red blood cells Platelets Fresh frozen plasma Cryoprecipitate Length of stay (LOS), mean SD (days) Hospital LOS Postoperative LOS Intensive care unit LOS Late reinterventions, n (%) Open Endovascular a
Value 39 (78) 121 75 55.5 44 10 (20) 24 (48) 20.5 24 8 3 7 2 1 1 1
9.9 5.4 6.6 1.2
full stent expansion. Usually the entire stent graft device is left in situ. If there is a bare distal stent then we remove it prior to performing the anastomosis. If the end of the stent graft is lying within too large a segment of native aorta to sew to, then a segment of the stent graft may be transected to facilitate the anastomosis that must include the device and the native aortic wall adventitia. To assure hemostasis, the proximal anastomosis to the distal surgical graft must
(16) (6) (14) (4) (2) (2) (2)
9.4 7 7.2 1.9
21.4 15.3 15.5 10.9 7.0 7.0 21 (42) 8 (16) 13 (26)
N ¼ 50.
disease [3]. This operation was performed in only one 82year-old patient in this series who presented with a ruptured aortic arch due to type 1a endoleak after stent grafting a midthoracic arch aneurysm. Prior to presenting to us with rupture, she had undergone two additional endovascular attempts at another institution to address the endoleak. These included a proximal extension stent graft and then a balloon-expandable bare metal stent, neither of which eliminated the endoleak, causing her to aorta to progress to rupture. HYBRID DISTAL RECONSTRUCTION. Hybrid distal reconstruction involves repair of the descending or thoracoabdominal aorta utilizing mostly conventional open surgical techniques, but the stent graft is left in situ with or without some modification of the device. These operations were performed through a left thoracoabdominal incision with the adjuncts of left-atrial-to-femoral-artery left heart bypass and the use of cerebrospinal fluid drainage. During these operations, the descending aorta is controlled with clamping the entire aorta and stent graft together. Location of the distal end of the stent graft is guided by intraoperative transesophageal echocardiography. The aortic aneurysm sac is opened at the distal end of the stent graft, and if chronically dissected the flap is resected to promote
Fig 1. Hybrid distal repair after stent grafting for chronic aortic dissection. (A) The in situ stent graft is sutured to the surgical graft with inclusion of the aortic wall after resection of the dissection flap to achieve full stent graft expansion. (B) Volume-rendered computed tomography angiography demonstrates the completed repair with successful anastomosis of the stent graft (upper arrow) within the aortic wall to the surgical graft (lower arrow).
include the stent graft material and the adventitial wall of native aorta. With this method of reconstruction, the preserved stent graft is analogous to a new intimal layer (Fig 1). Most of these operations were performed for chronic dissection with persistent growth of the aneurysmal false lumen; the others were done for distal type 1 endoleak [4]. CONVERSION TO CONVENTIONAL REPAIR. Five patients underwent conversion to conventional repair: 2 involving the ascending and arch, 2 involving the descending aorta, and 1 thoracoabdominal. Common to all of these operations is that the endovascular device was completely removed. The three distal stent grafts were removed due to infection. One device was initially placed into the ascending aorta to treat a pseudoaneurysm near a suture line, but later migrated in the aortic arch on follow-up computed tomography (CT) imaging. Interestingly, the pseudoaneurysm had completely resolved in the interim. The other patient had atrial septal defect closure devices placed across the origins of two different pseudoaneurysms that failed due to endoleak. EXTRA-ANATOMIC BYPASS PROCEDURES. These procedures were selected for 2 patients with severe graft infections and associated sepsis that required staged approaches to their repair. The extra-anatomic reconstruction was created to bypass the arch and descending aorta by debranching from the ascending aorta to the supra-aortic vessels above the bypass and to the retroperitoneal iliac arteries below. It is important when creating the extraanatomic bypass distally, to understand the extent of runoff so as to match the inflow conduit to the end-organ demands. Once stabilized, the patients were returned to the operating room for complete removal of the endovascular device and oversewing of the distal aortic stump. The infected field and the aortic stumps were then covered with an omental or muscular flap. One of these patients also underwent esophagectomy at the time of the second later operation.
Definitions, Follow-Up, and Statistical Analysis Type 1 endoleak was confirmed by CT and refers to lack of seal and fixation at either the proximal (type 1a) or distal (type 1b) end of the stent-grafted aorta. Patients followed at an outside institution were contacted by mail with a questionnaire every other year; questions pertained to symptoms, hospitalizations, and late vascular interventions. The Social Security Death Index was queried for the status of patients whose mortality data were not directly available through CVIR. Continuous variables were described as mean standard deviation (SD) or median (range), and categorical values as number (%). The Kaplan-Meier method was used to evaluate survival.
Results Hospital Mortality and Morbidity Hospital mortality occurred in 3 (6%) patients. One patient was an 84-year-old woman who had undergone TEVAR 64 months earlier for a degenerative
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thoracoabdominal aneurysm and that repair had included coverage of her celiac artery. Despite early success with the TEVAR, the visceral segment of her aorta continued to expand and she developed a distal type 1 endoleak with severe pain and tenderness associated with aortic palpation, and rapid aneurysmal growth with a contained rupture on CT. Despite knowing that she had some obstructive right coronary disease, the decision was made to perform a hybrid distal reconstruction through an eighth interspace incision. At the end of the operation after aortic reconstruction, sudden cardiac arrest occurred with right heart failure followed by diffuse intravascular coagulopathy and the patient died in the operating room. The second hospital death was also in a patient with distal aortic growth after failed TEVAR undergoing hybrid distal reconstruction. This patient was a 59-yearold man with a chronic dissection that presented with false lumen rupture. The initial approach during the hybrid reconstruction was to sew the surgical aortic graft directly to the previously placed stent graft like a secondstage elephant trunk repair. Severe bleeding developed intraoperatively from more proximal segments of the aorta leading to massive transfusion requirements, followed by respiratory failure and the need for extracorporeal membrane oxygenation support. The patient died on postoperative day 1. The third death occurred in a 71-year-old woman who presented with chest pain and very large symptomatic degenerative aneurysm that was treated with TEVAR. She later developed an aorto-esophageal and aorto-left main stem bronchial fistula and underwent esophagectomy with diversion, debridement, and omental patch repair of the bronchus and the aneurysm, with plans for a later aortic reconstruction given her septic state. She progressed into multiorgan failure 1 day postoperatively and died. Additional serious complications occurred in 15 patients: respiratory failure requiring tracheostomy in 5 patients and renal failure in 10, with 1 patient requiring dialysis. There were no other myocardial infarctions besides the one leading to death described above. There were no strokes or instances of spinal cord ischemia. Mean length of hospital and intensive care unit stay was 21 15 and 7 7 days, respectively (Table 3).
Intermediate Survival and Reinterventions Average follow-up was 3.1 2.6 years. Estimated survival at 6 months, 1 year, 3 years, and 5 years was 83%, 75%, 67%, and 56%, respectively (Fig 2). Twenty-one late vascular reinterventions were required during follow-up: 8 open and 13 endovascular. This included the two planned graft excisions in the extraanatomic bypass patients. The 1 patient who had ascending dissection due to progression of his disease after hybrid thoracoabdominal repair for chronic dissection was already described. Other indications for later open aortic reoperation included repair of a femoral pseudoaneurysm, two emergency repairs for one ruptured abdominal aneurysm and one contained rupture in the arch, urgent arch repair for a rapidly
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Fig 2. Estimated survival following open repair after prior thoracic endovascular aortic repair.
growing innominate aneurysm, and a David’s reimplantation for a rapidly growing root. The endovascular operations included five embolizations for endoleak, three stent graft extensions for endoleak, four additional aortic stent graft repairs for aneurysmal growth, and one rupture of a thoracic aneurysm with aorto-bronchial fistula repaired by stent grafting. The patients who underwent operations for graft infection represent the most complex of indications for conversion to open repair after TEVAR. Only 2 patients had a single open operation and are still alive without evidence of infection. One initially presented with a contained rupture of a pseudoaneurysm after failed TEVAR for posttraumatic transection, and this was associated with infected orthopedic spine hardware. The pseudoaneurysm was initially stabilized with a proximal TEVAR extension stent graft. The index open operation was a hybrid descending reconstruction that included debridement of the infected pseudoaneurysm and patch repair around the stent graft with removal of the infected vertebral hardware. One of the infected patients died before completing the planned staged reconstruction and excision of the stent graft. The rest of these patients required additional procedures, and 3 of 6 were dead at follow-up. Other causes of late death included septic complications in 6 patients due to pneumonia in 2, mesenteric ischemia in 1, urosepsis due to rectovesical fistula from prior prostate radiation in 1, and multiorgan failure of unknown source in 2. One patient died from late rupture of an abdominal aneurysm that was scheduled for repair. Three patients died of cancer-related complications, and 1 died of end-stage pulmonary disease. Two causes of late death are unknown.
Comment Although the denominator of patients undergoing TEVAR from which the currently described population
was derived is unknown, it is anticipated that an increasing number of patients will require open operation after thoracic stent grafting. This study has demonstrated that these complex open conversions can be performed safely in these high-risk patients at a high-volume aortic surgical center with a multidisciplinary approach to thoracic aortic disease. Type I endoleak was one of the most common indications for secondary surgical intervention, and most of these were proximal. All of these patients had shorter-than-recommended landing zones or other use of the stent graft device in an off-label fashion. Liberalization of indications for TEVAR will likely continue as many of the patients who present for therapy are too high risk for conventional open repair. However, using modern three-dimensional imaging reconstruction techniques, the risk of failure due to endoleak or device migration should be considered carefully [8]. Furthermore, successful use of staged and hybrid reconstruction techniques to address the complex aortic arch have been demonstrated in several series from aortic surgery centers and may offer a better option in the high-risk patient with a short landing zone [3, 5, 9–12]. Similar to the proximal endoleak patients, the patients with distal type 1 endoleak had inadequate landing zones and the stent graft devices were pushed beyond their limits of use. All 5 of the patients with rupture were from the subset that underwent operation for a type 1 endoleak: 3 type 1b and 2 type 1a. Unfortunately, in 1 of these patients the distal endoleak progressed to the point of contained rupture that mandated emergency hybrid distal reconstruction without the luxury of time necessary to address her concomitant coronary disease. These cases of rupture highlight the importance of more vigilant imaging follow-up for patients in whom the proximal or distal landing zones are less than ideal.
Most of the patients in this series (62%) underwent TEVAR for aortic dissection, an indication for which the device has only recently been approved. In our experience and others, the use of TEVAR to treat distal dissection was the most important risk factor for retrograde dissection. This finding is not surprising given the underlying aortic substrate. Reverse frozen elephant trunk procedure was most commonly performed for the patients with retrograde dissection. Many of these patients had received the devices for a chronic distal dissection with aneurysm. The use of stent grafts to treat chronic dissections with aneurysm is currently controversial because of the uncertainty of thromboexclusion of the false lumen [13, 14]. An increasing body of data suggests that the rate of false lumen thrombosis in the treated segment is about 70% and may be predicted by the extent of aorta dissected [4, 15–19]. Again, it is important to follow these patients closely for reverse remodeling of the aorta. It has been demonstrated here that if the endovascular therapy does not achieve the desired reverse remodeling, then the patients can safely be converted to a hybrid distal reconstruction. In that regard, TEVAR and open repair should be considered complementary options for the treatment of patients with chronic aortic dissection and aneurysm. The technique for a safe anastomosis during hybrid distal reconstruction (ie, leaving the stent graft in situ) is demonstrated from this experience. Clamping the thoracic aorta with a stent graft within it is feasible using an extra-large atraumatic cross-clamp in nearly any situation. Two of the hospital deaths were in patients in the subgroup undergoing this operation. One was due to bleeding complications as a result of failure to include the aortic adventitia along with the stent graft in the anastomosis. Although it is not necessary to remove the flares from the Gore graft, bare metal stents on either the Cook or Medtronic devices should be removed so the anastomosis is sewn to the cloth edge of the stent graft device. Despite the hybrid nature of the procedure, it is still a big operation. One patient had an intraoperative myocardial infarction. Nevertheless, in young patients with reasonable surgical risk, open descending or thoracoabdominal aortic repair can be performed relatively safely, even when the most extensive repair is required [20–23]. The consideration for open repair of chronic dissection is especially important, with the additional consideration that all of the retrograde acute aortic dissections in this series occurred in patients with a history of prior aortic dissection. This complication has been estimated to occur in 1.5% to 3% of patients undergoing TEVAR [24, 25]. Interestingly, the timing was variable with some happening during TEVAR hospitalization and more happening as late as a year after discharge. These findings are not different from other published experiences [24, 25]. The ability to save these patients, however, was excellent in the current series with all patients surviving until hospital discharge, including the tenth patient who had retrograde dissection a year after hybrid thoracoabdominal repair. The key to saving
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these patients is timely diagnosis and transfer to a center where the techniques of hypothermic circulatory arrest are commonly practiced. The most difficult patients to treat are those in whom a stent graft infection develops. Overall results of this complication are poor just as they are with graft infections after open thoracic aortic repair [26–28]. Although surgical principles dictate control of sepsis, removal of all infected prosthetic material, and reconstruction in a clean field, this is not always achievable because it places a huge demand on an already sick patient. Sometimes this can be accomplished with staging of the repair. If the source of infection is an aorto-esophageal fistula, however, the prognosis is particularly dismal and our experience confirms the findings of others [27, 28]. If the patients are young, otherwise healthy, and the infection is found on routine imaging before fulminant sepsis develops, then there is the opportunity to rescue them from graft infection. Typically this requires a complex series of operations and long-term antibiotics. Although hospital survival was good, late survival was less than favorable and 42% of patients required additional operations. Many of the late open and endovascular operations were performed for progression of aneurysmal degeneration either related to the presence of a chronic dissection or a known connective tissue disorder. Others had late occurrence of type 1 endoleaks consistent with the progressive nature of extensive aortic aneurysmal disease.
Limitations As a tertiary care center, the Cleveland Clinic receives patients from across the country and referred at various times during the course of treatment for their aortic disease. It is impossible to know the true incidence of these complications in such a study. Because our study was retrospective, it carries all of the implicit biases of this design. The population was relatively small and heterogenous, which limits our ability to perform a more detailed statistical analysis addressing questions like risk for reoperation or late survival. As a descriptive paper, however, this report represents a large experience with a challenging group of patients. Detailed review of this series has provided important insight to guide improved care for a population of patients that is sure to increase.
Conclusions Conversion to open repair after thoracic stent grafting may be indicated for type 1 endoleak, retrograde dissection, chronic aortic dissection with persistent false lumen perfusion and growth, or graft infection. These salvage operations are complex but can be completed safely with good early outcomes and preservation of the stent graft (hybrid repair) in most cases. Late outcomes are consistent with the chronic disease state of these patients.
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INVITED COMMENTARY In this issue of The Annals, Roselli and colleagues [1] from the Cleveland Clinic present a consecutive series of 50 patients over an 11-year period who underwent open aortic repair after thoracic endografting. The median time between thoracic endovascular aortic repair (TEVAR) and open repair was 14 months, and the indications were type I endoleak, ascending aortic dissection, chronic dissection, false lumen expansion, and stent graft infection. The types of operations performed could be broadly classified into conversion to conventional repair, reverse frozen elephant trunk, hybrid debranching procedures, and extra-anatomic bypass with subsequent stent graft removal and aortic oversew. Despite the complexity of these procedures, the authors report excellent perioperative mortality of 6%. Respiratory and renal dysfunction
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were the major nonfatal complications; impressively, there were no strokes or paraplegias. Not surprisingly, these patients were hospitalized for a prolonged time postoperatively. Many of them went on to require additional aortic operations, and the midterm overall survival is presented. This article highlights the utility and benefits of an aggressive approach to using open surgical techniques to both resolve the adverse sequelae of thoracic endografting and resolve incomplete treatment of aortic disease with endografting therapy. The results are outstanding, particularly with the absence of postoperative neurologic complications. The group’s operative techniques and success also reveal several important technical findings. They include the safety and efficacy of sewing
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Open Aortic Repair After Prior Thoracic Endovascular Aortic Repair Eric E. Roselli, MD, Mohamed Abdel-Halim, MD, PhD, Douglas R. Johnston, MD, Edward G. Soltesz, MD, MPH, Roy K. Greenberg, MD, Lars G. Svensson, MD, PhD, and Joseph F. Sabik, III, MD Cleveland Clinic Heart and Vascular Institute, Cleveland, Ohio
Background. Thoracic endovascular aortic repair (TEVAR) has been applied to increasingly complex aortic pathology, resulting in an increase in late complications. We characterized patients undergoing open repair after prior TEVAR including indications, operative techniques, and outcomes. Methods. Chart review and query of a prospectively collected database identified 50 patients who underwent thoracic aortic operation after prior TEVAR. Active follow-up was supplemented by Social Security information for vital status. Results. From July 2001 to January 2012 open arch (n [ 25), descending (n [ 6), thoracoabdominal (n [ 17), or extra-anatomic bypass (n [ 2) operations were performed after previous TEVAR (median interval from TEVAR to open surgical procedure: 13.9 months; interquartile range, 0.5 to 24 months). Indications for open operation included type 1 endoleaks (n [ 19), retrograde aortic dissection (n [ 9), chronic aortic dissection with persistent growth of
the false lumen (n [ 16), and graft infection (n [ 6). Sixty percent had prior cardiovascular surgical procedures and 18% were done as emergencies. Circulatory support was required in 78% and hypothermic arrest in 48%. Hospital mortality occurred in 3 (6%) patients with no strokes and 1 patient with myocardial infarction; 5 (10%) patients required tracheostomy and 1 required dialysis. Survival was 67% at a median follow-up of 2.9 years. Conclusions. Conversion to open repair after thoracic stent-grafting may be indicated for type 1 endoleak, retrograde dissection, chronic aortic dissection with persistent false lumen growth, or graft infection. These salvage operations are complex but can be completed safely with good early outcomes and preservation of the stent-graft in most cases. Late outcomes are consistent with the chronic disease state of these patients.
T
risk of serious complications that may require conversion to open repair [5–8]. The objectives of this study were to (1) characterize patients undergoing open aortic repair after prior TEVAR, (2) describe the indications for conversion and operative techniques used, and (3) assess early and late outcomes.
horacic endovascular aortic repair (TEVAR) has become a widely accepted treatment option for patients with thoracic aortic disease and is particularly useful in those patients deemed at high risk for conventional open surgical repair [1]. As experience with these devices has evolved, the application has been expanded to increasingly more complicated anatomy (including proximal deployment within the arch and a tolerance for shorter than recommended landing zones) and pathology (such as aortic dissection) [2–4]. It is estimated that nearly two-thirds of thoracic stent grafts are deployed in situations outside the instructions for use, or “off-label.” This more daring use of TEVAR carries the
Accepted for publication Oct 11, 2013. Presented at the Poster Session of the Forty-ninth Annual Meeting of The Society of Thoracic Surgeons, Los Angeles, CA, Jan 26–30, 2013. Address correspondence to Dr Roselli, Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, 9500 Euclid Ave, Desk J4-1, Cleveland, OH 44195; e-mail: [email protected].
Ó 2014 by The Society of Thoracic Surgeons Published by Elsevier Inc
(Ann Thorac Surg 2014;97:750–7) Ó 2014 by The Society of Thoracic Surgeons
Patients and Methods Patients and Indications From July 2001 to January 2012, 50 consecutive patients underwent open aortic repair after prior TEVAR. TEVAR procedures were performed for various indications at our Dr Roselli discloses financial relationships with Medtronic, Cook Medical, and Terumo; Dr Johnston with St. Jude and Baxter; Dr Greenberg with Cook Medical; and Dr Sabik with Medtronic, Edwards Lifesciences, Abbott Vascular, Medi-Stim, and ValveXchange.
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Table 1. Patient Characteristicsa Characteristic Demographics Age, mean SD (years) Male, n (%) Comorbidities Hypertension Diabetes mellitus Smoking Coronary artery disease Carotid disease History of cerebrovascular accident Peripheral vascular disease History of congestive heart failure Renal failure (dialysis dependent) Chronic obstructive pulmonary disease Documented vascular disorderb Prior cardiovascular operation Initial indication for TEVAR Degenerative aneurysm Aortic dissection Post type A repair Type B repair Traumatic transection Mycotic aneurysm Type of stent graft used Cook Zenith Gore TAG Medtronic Talent Other N ¼ 50. (n ¼ 1).
a
b
n (%) 60.5 15 32 (64) 34 3 25 8 7 1 15 4 1 9 5 26
(68) (6) (50) (16) (14) (2) (30) (8) (2) (18) (10) (52)
15 31 9 22 3 1
(30) (62) (18) (44) (6) (2)
19 26 2 3
(38) (52) (4) (6)
Marfan’s syndrome (n ¼ 3), Loeys-Dietz (n ¼ 1), Takayasu’s
TEVAR ¼ thoracic endovascular aortic repair.
and other institutions. During this time period 758 patients underwent TEVAR procedures at our institution. These details and additional patient characteristics of interest including demographics, comorbidities, and morphology of disease are included in Table 1. These conversions to open repair were performed at a median interval of 13.9 months (range 2 days to 91 months) for a variety of reasons including type 1 endoleak (n ¼ 19), Table 2. Indications for Open Conversiona Indication
n (%)
Type 1 endoleak Proximal (1a) Distal (1b) Proximal/retrograde dissection Chronic dissection with false lumen perfusion and growth Infected stent graft Plus rupture (not mutually exclusive)
19 14 5 9 16
a
N ¼ 50.
(38) (28) (10) (18) (32)
6 (12) 5 (10)
751
acute dissection of the ascending aorta (n ¼ 9), chronic aortic dissection with persistent aneurysmal growth of the false lumen (n ¼ 16), and stent graft infection (n ¼ 6) (Table 2). Of the patients with type 1 endoleak, 26% underwent open repair within the first 30 days since stent grafting. Similarly, 3 of the proximal aortic dissections occurred within the first 30 days after TEVAR, and the other 6 of these were late complications. Additionally, 1 patient who underwent hybrid thoracoabdominal repair for chronic dissection with distal aortic growth of the false lumen (6 months after descending thoracic stent grafting) developed ascending aortic dissection 1 year after the thoracoabdominal conversion. This proximal dissection was due to progression of his disease without a tear at the stent graft level, and that event is described later as an open reintervention during follow-up. Data were obtained from the prospectively maintained Cardiovascular Information Registry (CVIR) at the Cleveland Clinic. Informed consent was waived, and the study was approved by the Institutional Review Board.
Operative Techniques These patients all had extensive thoracic aortic disease and the stent graft therapy failed for a variety of reasons. Consequently, the open operations were performed on various segments of the aorta. Many of these patients required staged aortic repairs and underwent additional operations after the index operation described in this study. For consistency, the index operation referenced in this study is the first open operation involving the thoracic aorta after previous TEVAR. The operations primarily involved the aortic arch in 25 patients, the descending aorta in 6 patients, the thoracoabdominal aorta in 17 patients, or an extra-anatomic bypass in 2 patients. Eighteen percent of these operations were done as emergencies, including 5 ruptures. Circulatory support was required in 78% and deep hypothermic circulatory arrest in 48%. Nineteen patients underwent 23 concomitant procedures during the open aortic procedure. Additional operative details are presented in Table 3. REVERSE FROZEN ELEPHANT TRUNK PROCEDURE. This procedure has been previously described [5]. In short, this operation is performed with the use of deep hypothermic circulatory arrest with right axillary artery cannulation with or without selective brain perfusion based on the surgeon’s choice and the complexity of the reconstruction needed. In all of these patients, the proximal end of the stent graft is directly sutured to the native aorta after opening the proximal aorta during the circulatory arrest period. This operation was performed for type 1a endoleak in 13 patients. For this indication the proximal aorta was replaced with a prosthetic graft in all of our patients, but may also be closed primarily if the tissue is healthy. The other 9 patients treated with this technique were the proximal/ retrograde acute aortic dissections. ARCH
DEBRANCHING
WITH
ANTEGRADE
STENT
GRAFT
Arch debranching with antegrade stent graft delivery represents another option in patients with arch
DELIVERY.
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Table 3. Intraoperative and Perioperative Detailsa Detail Circulatory support, n (%) Time of cardiopulmonary bypass, mean SD (min) Time of myocardial ischemia, mean SD (min) (n ¼ 29) Left atrial to femoral partial bypass, n (%) Deep hypothermic circulatory arrest, n (%) Time of circulatory arrest, mean SD (min) Additional concomitant procedures, n (%) Coronary bypass grafting (CABG) Aortic valve replacement Aortic valve repair Aortic valve procedure and CABG Lung resection Esophagectomy Orthopedic spinal hardware removal Transfusion requirements, mean SD (units) (intra- þ postoperative) Red blood cells Platelets Fresh frozen plasma Cryoprecipitate Length of stay (LOS), mean SD (days) Hospital LOS Postoperative LOS Intensive care unit LOS Late reinterventions, n (%) Open Endovascular a
Value 39 (78) 121 75 55.5 44 10 (20) 24 (48) 20.5 24 8 3 7 2 1 1 1
9.9 5.4 6.6 1.2
full stent expansion. Usually the entire stent graft device is left in situ. If there is a bare distal stent then we remove it prior to performing the anastomosis. If the end of the stent graft is lying within too large a segment of native aorta to sew to, then a segment of the stent graft may be transected to facilitate the anastomosis that must include the device and the native aortic wall adventitia. To assure hemostasis, the proximal anastomosis to the distal surgical graft must
(16) (6) (14) (4) (2) (2) (2)
9.4 7 7.2 1.9
21.4 15.3 15.5 10.9 7.0 7.0 21 (42) 8 (16) 13 (26)
N ¼ 50.
disease [3]. This operation was performed in only one 82year-old patient in this series who presented with a ruptured aortic arch due to type 1a endoleak after stent grafting a midthoracic arch aneurysm. Prior to presenting to us with rupture, she had undergone two additional endovascular attempts at another institution to address the endoleak. These included a proximal extension stent graft and then a balloon-expandable bare metal stent, neither of which eliminated the endoleak, causing her to aorta to progress to rupture. HYBRID DISTAL RECONSTRUCTION. Hybrid distal reconstruction involves repair of the descending or thoracoabdominal aorta utilizing mostly conventional open surgical techniques, but the stent graft is left in situ with or without some modification of the device. These operations were performed through a left thoracoabdominal incision with the adjuncts of left-atrial-to-femoral-artery left heart bypass and the use of cerebrospinal fluid drainage. During these operations, the descending aorta is controlled with clamping the entire aorta and stent graft together. Location of the distal end of the stent graft is guided by intraoperative transesophageal echocardiography. The aortic aneurysm sac is opened at the distal end of the stent graft, and if chronically dissected the flap is resected to promote
Fig 1. Hybrid distal repair after stent grafting for chronic aortic dissection. (A) The in situ stent graft is sutured to the surgical graft with inclusion of the aortic wall after resection of the dissection flap to achieve full stent graft expansion. (B) Volume-rendered computed tomography angiography demonstrates the completed repair with successful anastomosis of the stent graft (upper arrow) within the aortic wall to the surgical graft (lower arrow).
include the stent graft material and the adventitial wall of native aorta. With this method of reconstruction, the preserved stent graft is analogous to a new intimal layer (Fig 1). Most of these operations were performed for chronic dissection with persistent growth of the aneurysmal false lumen; the others were done for distal type 1 endoleak [4]. CONVERSION TO CONVENTIONAL REPAIR. Five patients underwent conversion to conventional repair: 2 involving the ascending and arch, 2 involving the descending aorta, and 1 thoracoabdominal. Common to all of these operations is that the endovascular device was completely removed. The three distal stent grafts were removed due to infection. One device was initially placed into the ascending aorta to treat a pseudoaneurysm near a suture line, but later migrated in the aortic arch on follow-up computed tomography (CT) imaging. Interestingly, the pseudoaneurysm had completely resolved in the interim. The other patient had atrial septal defect closure devices placed across the origins of two different pseudoaneurysms that failed due to endoleak. EXTRA-ANATOMIC BYPASS PROCEDURES. These procedures were selected for 2 patients with severe graft infections and associated sepsis that required staged approaches to their repair. The extra-anatomic reconstruction was created to bypass the arch and descending aorta by debranching from the ascending aorta to the supra-aortic vessels above the bypass and to the retroperitoneal iliac arteries below. It is important when creating the extraanatomic bypass distally, to understand the extent of runoff so as to match the inflow conduit to the end-organ demands. Once stabilized, the patients were returned to the operating room for complete removal of the endovascular device and oversewing of the distal aortic stump. The infected field and the aortic stumps were then covered with an omental or muscular flap. One of these patients also underwent esophagectomy at the time of the second later operation.
Definitions, Follow-Up, and Statistical Analysis Type 1 endoleak was confirmed by CT and refers to lack of seal and fixation at either the proximal (type 1a) or distal (type 1b) end of the stent-grafted aorta. Patients followed at an outside institution were contacted by mail with a questionnaire every other year; questions pertained to symptoms, hospitalizations, and late vascular interventions. The Social Security Death Index was queried for the status of patients whose mortality data were not directly available through CVIR. Continuous variables were described as mean standard deviation (SD) or median (range), and categorical values as number (%). The Kaplan-Meier method was used to evaluate survival.
Results Hospital Mortality and Morbidity Hospital mortality occurred in 3 (6%) patients. One patient was an 84-year-old woman who had undergone TEVAR 64 months earlier for a degenerative
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thoracoabdominal aneurysm and that repair had included coverage of her celiac artery. Despite early success with the TEVAR, the visceral segment of her aorta continued to expand and she developed a distal type 1 endoleak with severe pain and tenderness associated with aortic palpation, and rapid aneurysmal growth with a contained rupture on CT. Despite knowing that she had some obstructive right coronary disease, the decision was made to perform a hybrid distal reconstruction through an eighth interspace incision. At the end of the operation after aortic reconstruction, sudden cardiac arrest occurred with right heart failure followed by diffuse intravascular coagulopathy and the patient died in the operating room. The second hospital death was also in a patient with distal aortic growth after failed TEVAR undergoing hybrid distal reconstruction. This patient was a 59-yearold man with a chronic dissection that presented with false lumen rupture. The initial approach during the hybrid reconstruction was to sew the surgical aortic graft directly to the previously placed stent graft like a secondstage elephant trunk repair. Severe bleeding developed intraoperatively from more proximal segments of the aorta leading to massive transfusion requirements, followed by respiratory failure and the need for extracorporeal membrane oxygenation support. The patient died on postoperative day 1. The third death occurred in a 71-year-old woman who presented with chest pain and very large symptomatic degenerative aneurysm that was treated with TEVAR. She later developed an aorto-esophageal and aorto-left main stem bronchial fistula and underwent esophagectomy with diversion, debridement, and omental patch repair of the bronchus and the aneurysm, with plans for a later aortic reconstruction given her septic state. She progressed into multiorgan failure 1 day postoperatively and died. Additional serious complications occurred in 15 patients: respiratory failure requiring tracheostomy in 5 patients and renal failure in 10, with 1 patient requiring dialysis. There were no other myocardial infarctions besides the one leading to death described above. There were no strokes or instances of spinal cord ischemia. Mean length of hospital and intensive care unit stay was 21 15 and 7 7 days, respectively (Table 3).
Intermediate Survival and Reinterventions Average follow-up was 3.1 2.6 years. Estimated survival at 6 months, 1 year, 3 years, and 5 years was 83%, 75%, 67%, and 56%, respectively (Fig 2). Twenty-one late vascular reinterventions were required during follow-up: 8 open and 13 endovascular. This included the two planned graft excisions in the extraanatomic bypass patients. The 1 patient who had ascending dissection due to progression of his disease after hybrid thoracoabdominal repair for chronic dissection was already described. Other indications for later open aortic reoperation included repair of a femoral pseudoaneurysm, two emergency repairs for one ruptured abdominal aneurysm and one contained rupture in the arch, urgent arch repair for a rapidly
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Fig 2. Estimated survival following open repair after prior thoracic endovascular aortic repair.
growing innominate aneurysm, and a David’s reimplantation for a rapidly growing root. The endovascular operations included five embolizations for endoleak, three stent graft extensions for endoleak, four additional aortic stent graft repairs for aneurysmal growth, and one rupture of a thoracic aneurysm with aorto-bronchial fistula repaired by stent grafting. The patients who underwent operations for graft infection represent the most complex of indications for conversion to open repair after TEVAR. Only 2 patients had a single open operation and are still alive without evidence of infection. One initially presented with a contained rupture of a pseudoaneurysm after failed TEVAR for posttraumatic transection, and this was associated with infected orthopedic spine hardware. The pseudoaneurysm was initially stabilized with a proximal TEVAR extension stent graft. The index open operation was a hybrid descending reconstruction that included debridement of the infected pseudoaneurysm and patch repair around the stent graft with removal of the infected vertebral hardware. One of the infected patients died before completing the planned staged reconstruction and excision of the stent graft. The rest of these patients required additional procedures, and 3 of 6 were dead at follow-up. Other causes of late death included septic complications in 6 patients due to pneumonia in 2, mesenteric ischemia in 1, urosepsis due to rectovesical fistula from prior prostate radiation in 1, and multiorgan failure of unknown source in 2. One patient died from late rupture of an abdominal aneurysm that was scheduled for repair. Three patients died of cancer-related complications, and 1 died of end-stage pulmonary disease. Two causes of late death are unknown.
Comment Although the denominator of patients undergoing TEVAR from which the currently described population
was derived is unknown, it is anticipated that an increasing number of patients will require open operation after thoracic stent grafting. This study has demonstrated that these complex open conversions can be performed safely in these high-risk patients at a high-volume aortic surgical center with a multidisciplinary approach to thoracic aortic disease. Type I endoleak was one of the most common indications for secondary surgical intervention, and most of these were proximal. All of these patients had shorter-than-recommended landing zones or other use of the stent graft device in an off-label fashion. Liberalization of indications for TEVAR will likely continue as many of the patients who present for therapy are too high risk for conventional open repair. However, using modern three-dimensional imaging reconstruction techniques, the risk of failure due to endoleak or device migration should be considered carefully [8]. Furthermore, successful use of staged and hybrid reconstruction techniques to address the complex aortic arch have been demonstrated in several series from aortic surgery centers and may offer a better option in the high-risk patient with a short landing zone [3, 5, 9–12]. Similar to the proximal endoleak patients, the patients with distal type 1 endoleak had inadequate landing zones and the stent graft devices were pushed beyond their limits of use. All 5 of the patients with rupture were from the subset that underwent operation for a type 1 endoleak: 3 type 1b and 2 type 1a. Unfortunately, in 1 of these patients the distal endoleak progressed to the point of contained rupture that mandated emergency hybrid distal reconstruction without the luxury of time necessary to address her concomitant coronary disease. These cases of rupture highlight the importance of more vigilant imaging follow-up for patients in whom the proximal or distal landing zones are less than ideal.
Most of the patients in this series (62%) underwent TEVAR for aortic dissection, an indication for which the device has only recently been approved. In our experience and others, the use of TEVAR to treat distal dissection was the most important risk factor for retrograde dissection. This finding is not surprising given the underlying aortic substrate. Reverse frozen elephant trunk procedure was most commonly performed for the patients with retrograde dissection. Many of these patients had received the devices for a chronic distal dissection with aneurysm. The use of stent grafts to treat chronic dissections with aneurysm is currently controversial because of the uncertainty of thromboexclusion of the false lumen [13, 14]. An increasing body of data suggests that the rate of false lumen thrombosis in the treated segment is about 70% and may be predicted by the extent of aorta dissected [4, 15–19]. Again, it is important to follow these patients closely for reverse remodeling of the aorta. It has been demonstrated here that if the endovascular therapy does not achieve the desired reverse remodeling, then the patients can safely be converted to a hybrid distal reconstruction. In that regard, TEVAR and open repair should be considered complementary options for the treatment of patients with chronic aortic dissection and aneurysm. The technique for a safe anastomosis during hybrid distal reconstruction (ie, leaving the stent graft in situ) is demonstrated from this experience. Clamping the thoracic aorta with a stent graft within it is feasible using an extra-large atraumatic cross-clamp in nearly any situation. Two of the hospital deaths were in patients in the subgroup undergoing this operation. One was due to bleeding complications as a result of failure to include the aortic adventitia along with the stent graft in the anastomosis. Although it is not necessary to remove the flares from the Gore graft, bare metal stents on either the Cook or Medtronic devices should be removed so the anastomosis is sewn to the cloth edge of the stent graft device. Despite the hybrid nature of the procedure, it is still a big operation. One patient had an intraoperative myocardial infarction. Nevertheless, in young patients with reasonable surgical risk, open descending or thoracoabdominal aortic repair can be performed relatively safely, even when the most extensive repair is required [20–23]. The consideration for open repair of chronic dissection is especially important, with the additional consideration that all of the retrograde acute aortic dissections in this series occurred in patients with a history of prior aortic dissection. This complication has been estimated to occur in 1.5% to 3% of patients undergoing TEVAR [24, 25]. Interestingly, the timing was variable with some happening during TEVAR hospitalization and more happening as late as a year after discharge. These findings are not different from other published experiences [24, 25]. The ability to save these patients, however, was excellent in the current series with all patients surviving until hospital discharge, including the tenth patient who had retrograde dissection a year after hybrid thoracoabdominal repair. The key to saving
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these patients is timely diagnosis and transfer to a center where the techniques of hypothermic circulatory arrest are commonly practiced. The most difficult patients to treat are those in whom a stent graft infection develops. Overall results of this complication are poor just as they are with graft infections after open thoracic aortic repair [26–28]. Although surgical principles dictate control of sepsis, removal of all infected prosthetic material, and reconstruction in a clean field, this is not always achievable because it places a huge demand on an already sick patient. Sometimes this can be accomplished with staging of the repair. If the source of infection is an aorto-esophageal fistula, however, the prognosis is particularly dismal and our experience confirms the findings of others [27, 28]. If the patients are young, otherwise healthy, and the infection is found on routine imaging before fulminant sepsis develops, then there is the opportunity to rescue them from graft infection. Typically this requires a complex series of operations and long-term antibiotics. Although hospital survival was good, late survival was less than favorable and 42% of patients required additional operations. Many of the late open and endovascular operations were performed for progression of aneurysmal degeneration either related to the presence of a chronic dissection or a known connective tissue disorder. Others had late occurrence of type 1 endoleaks consistent with the progressive nature of extensive aortic aneurysmal disease.
Limitations As a tertiary care center, the Cleveland Clinic receives patients from across the country and referred at various times during the course of treatment for their aortic disease. It is impossible to know the true incidence of these complications in such a study. Because our study was retrospective, it carries all of the implicit biases of this design. The population was relatively small and heterogenous, which limits our ability to perform a more detailed statistical analysis addressing questions like risk for reoperation or late survival. As a descriptive paper, however, this report represents a large experience with a challenging group of patients. Detailed review of this series has provided important insight to guide improved care for a population of patients that is sure to increase.
Conclusions Conversion to open repair after thoracic stent grafting may be indicated for type 1 endoleak, retrograde dissection, chronic aortic dissection with persistent false lumen perfusion and growth, or graft infection. These salvage operations are complex but can be completed safely with good early outcomes and preservation of the stent graft (hybrid repair) in most cases. Late outcomes are consistent with the chronic disease state of these patients.
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INVITED COMMENTARY In this issue of The Annals, Roselli and colleagues [1] from the Cleveland Clinic present a consecutive series of 50 patients over an 11-year period who underwent open aortic repair after thoracic endografting. The median time between thoracic endovascular aortic repair (TEVAR) and open repair was 14 months, and the indications were type I endoleak, ascending aortic dissection, chronic dissection, false lumen expansion, and stent graft infection. The types of operations performed could be broadly classified into conversion to conventional repair, reverse frozen elephant trunk, hybrid debranching procedures, and extra-anatomic bypass with subsequent stent graft removal and aortic oversew. Despite the complexity of these procedures, the authors report excellent perioperative mortality of 6%. Respiratory and renal dysfunction
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were the major nonfatal complications; impressively, there were no strokes or paraplegias. Not surprisingly, these patients were hospitalized for a prolonged time postoperatively. Many of them went on to require additional aortic operations, and the midterm overall survival is presented. This article highlights the utility and benefits of an aggressive approach to using open surgical techniques to both resolve the adverse sequelae of thoracic endografting and resolve incomplete treatment of aortic disease with endografting therapy. The results are outstanding, particularly with the absence of postoperative neurologic complications. The group’s operative techniques and success also reveal several important technical findings. They include the safety and efficacy of sewing
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