| | International controlled clinical trial of thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-year resultsPresented at the Sixty-first Annual Meeting of the Society for Vascular Surgery, Baltimore, Md, Jun 7-10, 2007. Received 8 June 2007; accepted 18 October 2007. PurposeThis trial evaluated the safety and effectiveness of thoracic endovascular aortic repair (TEVAR) with a contemporary endograft system compared with open surgical repair (open) of descending thoracic aortic aneurysms and large ulcers. MethodsForty-two international trial sites enrolled 230 subjects with descending thoracic aortic aneurysms or ulcers. The study compared 160 TEVAR subjects treated with the Zenith TX2 Endovascular Graft (William Cook Europe, ApS, Bjaeverskov, Denmark) with 70 open subjects. Subjects were evaluated preprocedure, predischarge, 1, 6, and 12 months, and yearly through 5 years with medical examination, laboratory testing, chest radiographs, and computed tomography scans. Mortality rates, prespecified severe morbidity composite index, major morbidity, clinical utility, aneurysm rupture, and secondary interventions were compared. The TEVAR subjects were evaluated by a core laboratory for device performance, including change in aneurysm size, endoleak, migration, and device integrity. ResultsThe 30-day survival rate was noninferior (P < .01) for the TEVAR group compared with the open group (98.1% vs 94.3%). The severe morbidity composite index was lower for TEVAR (0.2 ± 0.7 vs 0.7 ± 1.2; P < .01). Cumulative major morbidity scores were significantly lower at 30 days for the TEVAR group compared with the open group (1.3 ± 3.0 vs 2.9 ± 3.6, P < .01). The TEVAR patients had fewer cardiovascular, pulmonary, and vascular adverse events, although neurologic events were not significantly different. Clinical utility for the TEVAR patients was superior to that of the open patients. No ruptures or conversions occurred in the first year. Reintervention rates were similar in both groups. At 12 months, aneurysm growth was identified in 7.1% (8/112), endoleak in 3.9% (4/103), migration (>10 mm) in 2.8% (3/107), and other device issues were rare. None of the patients with migration experienced endoleak, aneurysm growth, or required a secondary intervention. ConclusionsThoracic endovascular aortic repair with the TX2 is a safer and effective alternative to open surgical repair for the treatment of anatomically suitable descending thoracic aortic aneurysms and ulcers at 1 year of follow-up. Device performance issues are infrequent, but careful planning and regular follow-up with imaging remain a necessity. Thoracic endovascular aortic repair (TEVAR) is evolving at a rapid pace and has the potential to revolutionize the treatment of thoracic aneurysms, similar to the development of open surgical repair. The estimated incidence of thoracic aortic aneurysms is approximately 6/100,000 person-years, the risk of rupture for large aneurysms is up to 74% in patients without repair, and >90% of patients do not survive rupture.1 Dedicated clinicians have refined open surgical repair over decades and have developed a better understanding of spinal cord injury and techniques to mitigate this risk.2 These concerted efforts have resulted in significant improvement in the care of patients with thoracic aneurysms, but open repair is still associated with considerable morbidity and mortality in the elective and emergency setting, which has led physicians to seek improved and less invasive methods of treatment.3, 4, 5, 6 Although TEVAR offers potential for aneurysm exclusion while avoiding thoracotomy and aortic cross-clamping with the resulting sequelae, careful clinical trials are necessary to fully evaluate this new technology. The TEVAR device studied in this trial, the Zenith TX2 Endovascular Graft (William Cook Europe, ApS, Bjaeverskov, Denmark), has been in clinical use for several years and has undergone several iterations of the implant and delivery system. Single-center experience with the device shows promising results for feasibility and safety.7 We designed and conducted a nonrandomized, controlled, multicenter, international trial to compare outcomes between patients treated by TEVAR with the TX2 and open repair to support regulatory approval of this device in the United States. The 1-year analyses are presented in this article. We had free access to the data, analyzed the data in concert with the sponsor, interpreted the analyses, wrote and edited the manuscript, and selected the presentation venue and journal submission. Material and methods  Detailed description of the TEVAR device, deployment system, trial design with inclusion and exclusion criteria, definitions, repair techniques, and statistical analysis has been published.8 Device description Briefly, the Zenith TX2 Endovascular Graft is a one- or two-piece tubular endovascular graft. The stent grafts are constructed of full-thickness woven polyester fabric sewn to self-expanding stainless steel Cook Z Stents with braided polyester and monofilament polypropylene suture. The TX2 device is fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. In addition, the Cook Z Stents contain barbs at the distal and proximal ends to augment the necessary attachment and seal of the graft to the vessel wall. The deployment system allows staged, rapid placement of the TX2 in the often-tortuous thoracic aorta from a transfemoral approach. Trial design The study is a nonrandomized, controlled, multicenter, international trial designed to evaluate the safety and effectiveness of the TX2, a contemporary thoracic aortic endograft, in patients with descending thoracic aneurysms ≥5 cm, rapid growth ≥5 mm/y, or ulcers ≥10 mm in depth and 20 mm in diameter. Type I thoracoabdominal aneurysms were eligible if the placement of endograft fabric was planned to be above the visceral vessels or if there was no planned mesenteric revascularization with open repair. The primary end points were 30-day survival and 30-day rupture-free survival. Secondary end points included 30-day morbidity and clinical utility. Definitions Fifty-seven prespecified events were considered in calculating a composite morbidity score (Table I). Because all 57 events were weighted equally when calculating the composite score, but not of the same clinical severity, a subset of severe morbid events (Table II) were identified in part from reporting standards for endovascular aneurysm repair.9 These were considered in calculating a severe morbidity composite index that would be more clinically relevant when endovascular and open aortic repair operations were compared. •Endoleaks were classified as types I through IV according to the standard definitions.10 •Device migration was defined as caudal or cranial movement of the proximal or distal components of the endoprosthesis >10 mm relative to anatomic landmarks identified on the first technically adequate postoperative computed tomography (CT) scan.9 •Aneurysm sac size change was evaluated by comparing the major axis (or ulcer depth for ulcers) obtained from the three-dimensional (3D) reconstructed image perpendicular to the centerline of flow demonstrating the largest major diameter from the first postoperative CT scan to CT scans obtained at subsequent time points. •An increase in size was defined as an increase >5 mm in the major diameter. | | |  | Category | Event type | |
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| Cardiovascular | 1. Q-wave myocardial infarction | | | | 2. Non-Q-wave myocardial infarction | | | | 3. Congestive heart failure | | | | 4. Arrhythmia requiring intervention or new treatment | | | | 5. Cardiac ischemia requiring intervention | | | | 6. Inotropic support | | | | 7. Refractory hypertension (systolic blood pressure ≥160 despite receiving medication) | | | | 8. Cardiac event involving arrest, resuscitation, or balloon pump | | | Pulmonary | 9. Ventilation >24 hours | | | | 10. Reintubation | | | | 11. Pneumonia requiring antibiotics | | | | 12. Supplemental oxygen at time of discharge | | | | 13. Chronic obstructive pulmonary disease | | | | 14. Pleural effusion requiring treatment | | | | 15. Pulmonary edema requiring treatment | | | | 16. Pneumothorax | | | | 17. Hemothorax | | | | 18. Pulmonary event requiring tracheostomy or chest tube | | | Renal | 19. Urinary tract infection requiring antibiotic treatment | | | | 20. Renal failure requiring dialysis | | | | 21. Serum creatinine rise >30% from baseline resulting in a persistent value >2.0 mg/dL | | | | 22. Permanent dialysis, hemofiltration, or kidney transplant | | | Gastrointestinal | 23. Bowel ischemia | | | | 24. Gastrointestinal infection requiring treatment | | | | 25. Gastrointestinal bleeding requiring treatment | | | | 26. Paralytic ileus >4 days | | | | 27. Bowel resection | | | Neurologic | 28. Stroke | | | | 29. Transient ischemic attack/reversible ischemic neurologic deficit | | | | 30. Carotid artery embolization/occlusion | | | | 31. Paraparesis | | | | 32. Paraplegia | | | Vascular | 33. Pulmonary embolism | | | | 34. Pulmonary embolism involving hemodynamic instability or surgery | | | | 35. Vascular injury | | | | 36. Aneurysm leak/rupture | | | | 37. Aneurysm or vessel leak requiring re-operation | | | | 38. Pseudoaneurysm requiring surgical repair | | | | 39. Increase in aneurysm size >0.5 cm relative to first post-procedure measurement | | | | 40. Aortoesophageal fistula | | | | 41. Aortobronchial fistula | | | | 42. Aortoenteric fistula | | | | 43. Arterial thrombosis | | | | 44. Embolization resulting in tissue loss or requiring intervention | | | | 45. Amputation involving more than the toes | | | | 46. Deep vein thrombosis | | | | 47. Deep vein thrombosis requiring surgical or lytic therapy | | | | 48. Hematoma requiring surgical repair | | | | 49. Hematoma requiring receipt of blood products | | | | 50. Coagulopathy requiring surgery | | | | 51. Postprocedure transfusion | | | Wound | 52. Wound infection requiring antibiotic treatment | | | | 53. Incisional hernia | | | | 54. Lymph fistula | | | | 55. Wound breakdown requiring débridement | | | | 56. Seroma requiring treatment | | | | 57. Wound complication requiring return to the operating room | | | | |
| | | | Organ system | Event | |
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| Cardiovascular | 1.Q-wave myocardial infarction 2.Cardiac event involving arrest, resuscitation, or balloon pump | | | Pulmonary | 3.Ventilation >72 hours or reintubation 4.Pulmonary event requiring tracheostomy or chest tube | | | Renal | 5.Permanent dialysis, hemofiltration, or kidney transplant | | | Gastrointestinal | | | | Neurologic | 7.Stroke or severe impairment (paraplegia) | | | Vascular | 8.Amputation involving more than the toes 9.Aneurysm or vessel leak requiring reoperation 10.Deep vein thrombosis requiring surgical or lytic therapy 11.Pulmonary embolism involving hemodynamic instability 12.Coagulopathy requiring surgery | | | Wound | 13.Wound complication requiring return to the operating room | | | | |
Device integrity was assessed using chest radiograph and 3D reformatted CT imaging. Repair techniques The endovascular and open surgical aneurysm/ulcer repair techniques consisted of institutional standard of care executed within the limits of the study protocol. Statistical analysis Analyses were performed using SAS 8.2 software (SAS Institute, Cary, NC) and have been described in detail previously.8 Continuous variables were reported as means and standard deviations unless otherwise noted, and P values were calculated using standard t tests. Dichotomous and polytomous variables were reported as percentages, and P values were calculated using the Fisher exact test. Propensity score analysis was used to account for variables with the potential to influence outcome, such as age, sex, and American Society of Anesthesiologists (ASA) class, and confirm the results of statistical comparison for each primary and secondary study end point. Specifically, a propensity score was calculated for each patient and then used as a covariate in a statistical model to assess the treatment effect in the presence of the propensity score. Results Enrollment began on March 30, 2004, and was completed on July 6, 2006. The results reported here reflect data received as of September 12, 2007. A total of 160 patients for endovascular repair and 70 patients for open surgical repair were enrolled at 42 institutions. Enrollment for 51 of 70 open patients (73%) was retrospective, but the treatment groups were reasonably concurrent, with 81% of open patients treated within the period of TEVAR enrollment. Patient characteristics Evaluation of pre-existing conditions or risk factors showed similar preoperative demographic, medical, and laboratory characteristics in the TEVAR and open study groups, with a few exceptions. As summarized in Table III, patients in the TEVAR group were older (P < .01), weighed more (P = .02), had a larger body mass index (P = .03), and had more previous access site surgery (P = .02), whereas patients in the open group had a higher incidence of prior thoracic surgery or trauma (P < .01). The preprocedure hemoglobin (g/dL) was higher in the TEVAR patients than in the open patients (13.5 ± 1.6 vs 13.0 ± 1.6, P = .03); however, both values were within the normal range for hemoglobin measurements. The TEVAR patients had a lower ASA classification (P < .01) and higher Society for Vascular Surgery/International Society for Cardiovascular Surgery risk score (P = .03). Aneurysm/ulcer characteristics Both the endovascular treatment group and open surgical control group had patients with aneurysms (86% and 90%) and patients with ulcers (14% and 10%), with the distribution in morphology being similar between the two groups (P = .40). As summarized in Table IV, the distribution in primary location (proximal, middle, or distal) of the aneurysm or ulcer was different between groups (P = .02). Specifically, the percentage of patients with a proximal location was lower in the TEVAR group compared with the open group (22.5% vs 36.9%). The major axis diameter of the aneurysm was not different between the two groups (P = .20; Table IV), but the ulcer depth was smaller for the TEVAR group than the open group (14 ± 4.7 mm vs 21 ± 7.8 mm, P = .01). Protocol-driven anatomic differences included smaller mean neck diameters, such as at 30 mm distal to the left common carotid artery (P < .01) and 30 mm proximal to the celiac axis artery (P < .01), in the TEVAR group compared with the open group. Procedure details All patients in the open group required general anesthesia, while in the TEVAR group, 71.3% received general and 28.7% had regional anesthesia (P < .01). An access conduit was used for device insertion in 9.4% (15 of 160), which included 14 patients with an iliac conduit and one patient with an aortic conduit. A cutdown was used for device insertion in 88.1% (141 of 160), and percutaneous access was used in 2.5% (4 of 160). The endovascular graft was successfully implanted in 98.8% (158 of 160) of patients. In one case, the implanting physician decided not to perform a previously planned access conduit owing to small access vessels and calcification and terminated the case without attempting to insert the introducer. In the second case, advancing the introducer through the iliac limb of an in situ open abdominal aortic aneurysm graft was not possible. Of the 158 TX2 patients who were successfully treated, 59.5% (94 of 158) received a two-piece device and 40.5% (64 of 158) received a one-piece device, consisting of a proximal main body component in 38.0% (60 of 158), a one-piece main body component in 1.9% (3 of 158), and a proximal main body extension in 0.6% (1 of 158). The use of spinal cord protection was at the physician’s discretion. A spinal drain was used in 25.6% (41 of 160) of patients in the TEVAR group compared with 77.1% (54 of 70) in the open group. In addition, 34.3% (24 of 70) of open patients had some variation of hypothermia, and 31.4% (22 of 70) had distal aortic perfusion for spinal cord protection. Procedure time was shorter with TEVAR compared with open (114 ± 46 minutes vs 244 ± 92 minutes, P < .01). The anesthesia time was also shorter for TEVAR compared with open (183 ± 67 minutes vs 366 ± 125 minutes, P < .01). The cross-clamp time for the open group was 44 ± 28 minutes. The distribution in proximal graft location was not significantly different between groups. In one open patient, the graft was sewn proximal to the left common carotid artery (LCCA), which required hypothermic circulatory arrest; this maneuver was unplanned. In the open group, 4.3% (3 of 70) underwent hypothermic circulatory arrest during aneurysm repair. The distribution in distal graft location was different between groups (P < .01). All patients in the TEVAR group had a distal graft location that was proximal to the celiac artery. The distal graft location was above the celiac artery in 66 open patients (94.3%) and below the celiac artery in 4 (5.7%); and of these, only one patient required mesenteric vessel reconstruction of the celiac axis, superior mesenteric artery, and right renal artery; the graft was beveled in the other three. Procedural blood loss (216 ± 293 mL vs 2538 ± 2179 mL, P < .01) and the need for packed red blood cells (3.1% vs 87.1%, P < .01) were lower for TEVAR compared with open repair. Six open patients underwent hypothermic circulatory arrest, had a proximal graft location above the LCCA, or had a distal graft location below the celiac. Recognizing that inclusion of open surgical control patients with these characteristics could potentially bias outcome in favor of TEVAR, subanalyses were performed in which these patients were excluded from the primary and secondary end point comparisons. The subanalyses confirmed that there was no effect on outcome resulting from the inclusion of the open surgical control patients with any of these three factors. Therefore, these six open patients were included in the analyses. Mortality The 30-day survival estimate from all-cause mortality was noninferior (P < .01) in the endovascular treatment group compared with the open surgical control group (98.1% vs 94.3%). Propensity score analysis confirmed noninferior 30-day survival for the endovascular treatment group. The 365-day survival estimate from all-cause mortality was 91.6% in the endovascular group and 85.5% in the open surgical group, as illustrated in Fig 1 (log-rank = 0.15). The 365-day survival estimate from aneurysm-related mortality was 94.2% in the endovascular group and 88.2% in the open surgical group, as illustrated in Fig 2 (log-rank = 0.12). All aneurysm-related deaths were considered procedure-related by the clinical events committee, and no deaths were considered device-related. Severe morbidity composite index The 30-day severe morbidity composite index (cumulative mean number of events per patient) was markedly lower in the endovascular treatment group compared with the open surgical control group (0.2 ± 0.7 vs 0.7 ± 1.2; P < .01). The percentage of patients who experienced a severe morbid event was more than one-third lower with TEVAR compared with open repair (9.4% vs 33%, P < .01). Kaplan-Meier estimates for freedom from individual severe morbid events at 365 days were significantly lower (P < .05) in the open group compared with the TEVAR group for ventilation >72 hours, pulmonary event requiring tracheostomy or chest tube, reintubation, stroke, and paraplegia (Table V). Stroke Stroke occurred in four TEVAR patients; all had general cardiovascular risk factors, none had history of TIA or carotid endarterectomy, all had proximal location of the graft distal to the left subclavian artery, one had a brain biopsy 11 days after TEVAR, and three of the patients died. Paraplegia Two TEVAR patients experienced paraplegia after treatment of the aneurysm. The aneurysms in both patients were in the mid-descending thoracic aorta, there was no history of abdominal aneurysm repair, the proximal aspect of the grafts were deployed distal to the left subclavian artery, and no spinal drains were used. In the first patient, approximately 70% of the descending aorta was covered by the graft and paraplegia developed on postoperative day 0; in the second patient (who also had a stroke), approximately 100% of the descending aorta was covered by the graft and paraplegia developed on postoperative day 3. Both patients died. Paraparesis Seven patients in the TEVAR group were diagnosed with paraparesis ≤30 days. Four had a history of AAA repair, three had a spinal drain placed, and two had a proximal graft location that was proximal to the left subclavian artery (one did and one did not have subclavian revascularization). One patient died without resolution of the paraparesis at postoperative day 37 of septicemia complicated by respiratory failure. Paraparesis resolved in the other six patients. Clinical utility As some might expect from a less-invasive procedure, all clinical utility measures were superior in the TEVAR group compared with the open surgical repair group (Table VIII). Propensity score analysis confirmed superior clinical utility in the TEVAR group. Rupture There were no early or late ruptures with either TEVAR or open through 365 days. Secondary interventions The percentage of patients requiring reintervention through 12 months was similar (P = .74) for endovascular repair (4.4%, 7 of 158) and open surgical repair (5.7%, 4 of 70), and included three endovascular patients and three open surgical patients requiring secondary intervention ≤7 days of the initial aneurysm repair. In the TEVAR group, seven patients underwent secondary interventions, including one patient who underwent two secondary interventions for treatment of a distal type I endoleak (bare stent placement and stent placement/coil embolization/distal extension placement). The other six endovascular patients had reintervention for proximal type I endoleak (proximal main body extension placement), distal type I endoleak (molding balloon angioplasty and distal extension placement), type III endoleak (angiogram to rule out endoleak), iliac artery occlusion (femorofemoral bypass), aneurysm growth but no detectable endoleak (distal extension placement in overlap and distal end of in situ graft), and a proximal aortic pseudoaneurysm (proximal extension placement). There were no open conversions in the TEVAR group through 365 days. Three open surgical control patients underwent re-exploration for bleeding, and one underwent custom endograft placement for an aortoesophageal fistula. Change in aneurysm or ulcer size At 12 months, aneurysm/ulcer size decreased for 48% (54 of 112) of the patients and remained unchanged for 45% (50 of 112). Aneurysm growth was identified in 7.1% (8 of 112) at 12 months. Two of these patients have had follow-up at 24 months and do not have sac growth compared with baseline, one has been re-treated for distal type I endoleak, one has been re-treated for growth, and four have not had further follow-up. In the latter four patients, there is no detectable endoleak at 12 months or evidence of graft infection, but the aortic neck diameter at the actual graft placement does not meet the recommended oversizing of at least 10%. Each of these four patients also has an inverted funnel-shaped proximal aortic neck or a funnel-shaped distal neck. Migration Proximal or distal graft migration of >10 mm was noted in 2.8% (3 of 107) through 12 months, consisting of two cases of caudal migration of the proximal graft and one case of cranial migration of the distal graft. None have been associated with endoleak or increase in aneurysm size, and none have had secondary intervention. All three patients have aortic neck diameter at the actual graft placement that does not meet the recommended oversizing of at least 10%. All three also have placement of the pertinent barbed stent in a neck that is either an acutely angled segment or in an area of thrombus. Device integrity Device integrity was assessed at each examination period through 12 months. None of the patients have had stent fracture, barb separation, stent-to-graft separation, or component separation. One patient (0.8%) has distal bare stent strut entanglement from predischarge through 12 months, which is not associated with migration, endoleak, or the need for secondary intervention. It is unclear whether the entanglement is related to a device failure, barb entanglement during loading, movement during deployment, or very tortuous anatomy. Device patency No patients have had loss of patency through 12 months. A kink was noted in 1.6% (2 of 123) of patients at 12 months and compression was noted in 0.9% (1 of 108), but none of these three patients have adverse clinical sequelae or required a secondary intervention. The compression is a concentric constriction of one mid-body stent of the device not associated with tortuosity or flow limitation with expansion of the stents above and below the compressed segment. This should be distinguished from the phenomena of endovascular graft collapse described in the literature.11 Discussion This study was designed to assess the safety and effectiveness of TEVAR with the Zenith TX2 Endovascular Graft by comparing the mortality, morbidity, and clinical utility of the two test groups. This study assessed key variables with respect to device performance in the endovascular treatment group, including change in aneurysm/ulcer size, endoleak, migration, device integrity, and secondary interventions. Overall survival with TEVAR was statistically not inferior to open surgical repair at 30 days and was similar at 1 year. Aneurysm-related survival was also similar in both groups. The analysis with the severe composite morbidity index was prespecified by physicians experienced in thoracic aortic disease treatment and was designed to capture the sentinel types of complications that are classically reported in the surgical literature. The index avoids dilution by less-severe adverse events and focuses on the truly important problems that surgeons encounter when treating these patients (Table II). This trial revealed significantly fewer sentinel events with TEVAR compared with open repair. This striking reduction was seen in both the cumulative number of events per patient (0.2 ± 0.7 vs 0.7 ± 1.2; P < .01) and the frequency of at least one event (9.4% vs 33%, P < .01). When measuring all major adverse events, morbidity at 30-days was lower in the patients receiving endovascular treatment than the patients having open surgical repair. The cumulative number of events per patient was lower with TEVAR, as well as the chance of having at least one adverse event. The reduction with TEVAR was primarily in fewer cardiovascular, pulmonary, and vascular adverse events. Stroke and paraplegia remain critical clinical concerns that are often fatal after descending thoracic aneurysm repair. These are well-recognized complications associated with open surgical repair that result from insult to the brain or spinal cord. Endovascular repair also has risk of stroke because instrumentation of the arch is often necessary and stroke may be caused from air or atheroma that embolize to the brain. Similarly, spinal cord damage is a known complication with TEVAR, although it may more often be a partial deficit, be delayed in onset, and has improved in some patients.17, 18 Although not statistically different, the point estimates of patients experiencing the most debilitating permanent neurologic events ≤30 days are intriguing (Table VII); specifically, the percentage of stroke (2.5% vs 8.6%, P = .07) and paraplegia (1.3% vs 5.7%, P = .07) ≤30 days trended lower with TEVAR with the TX2 compared with open repair. However, more TEVAR patients experienced paraparesis, defined as weakness but still able to walk (4.4% vs 0%, NS). These rates are interesting because there are more than double the percentage of distal thoracic aneurysms in the TEVAR group compared with the open group. In contrast to the spinal ischemic event rate with open repair reported in other multicenter TEVAR studies,12 the rate of spinal ischemic events in the open group from this study appeared to be largely comparable with those reported in several large single-center experiences (1.5%-6.3%),2, 6, 13, 14, 15 even though 28 institutions contributed at least one open patient. Nonstatistically significant differences between open and TEVAR in spinal ischemic events have been reported previously.16, 17 Clearly, more knowledge about these rare events is needed, and larger, higher-powered studies will be required to prove if such specific complications are more or less frequent with TEVAR. The benefits in clinical utility with TEVAR are often overlooked because of focus on survival and neurologic disability. Nonetheless, all measures of clinical utility were substantially better with TEVAR compared with open surgical repair. These advantages of less invasive treatment have been frequently confirmed in other literature reports.12,16,17 These factors often weigh importantly in the decision making of patients and their families who may be taking care of them during a prolonged recovery. The evaluation of effectiveness for TEVAR includes hard end points (rupture and reinterventions) and surrogates that may predict later effectiveness (core laboratory assessment of device performance). There were no aneurysm ruptures in either group, and no immediate or delayed conversions to open repair through 1 year. Reintervention rates were similar in both groups, and no unusual motives or types of reinterventions were encountered.17 Core laboratory assessment of rates of aneurysm sac change, endoleak, migration, device integrity, and loss of patency were all suitably low.18, 19 Most type I and III endoleaks were addressed in the first year with endovascular reintervention, and none required conversion. Endotension may be related to undetectable endoleak through the seal zone or transfer of pressure to the aneurysm by thrombus in the seal zone and was associated with adverse neck anatomy and sizing that did not meet recommended guidelines. Migration was similarly associated with adverse neck anatomy and sizing that did not meet recommended guidelines. Further study with longer follow-up will help definitively identify specific etiologies for these infrequent events, although at the 1-year time point, it appears that proper selection and assessment of neck anatomy, appropriate sizing of devices, and deployment at the initially targeted neck site may be important in achieving durable exclusion. Conclusion One-year results of this trial demonstrate similar overall and aneurysm-related survival with TEVAR using the TX2 compared with open repair. Significant reductions in severe and major adverse events contributed to improved clinical utility with TEVAR compared with open surgical repair. There were no ruptures or conversions in the endovascular treatment group, and reintervention rates were similar in both groups. Radiographic findings of sac enlargement, endoleak, migration, and other device issues were infrequent but underscore the value of careful procedure planning and regular follow-up with imaging before and after TEVAR. These 1-year results provide reasonable assurance that the TX2 is a safer and effective alternative to open surgical repair. Patient follow-up beyond 1-year remains on-going and is essential for assessing long-term performance and the durability of these early benefits. Author contributions Conception and design: JM, RC, MD, RM, LS Analysis and interpretation: JM, RC, MD, RM, LS, SS Data collection: JM, RC, MD, RM, LS Writing the article: JM, RC, MD, RM, LS Critical revision of the article: JM, RC, MD, RM, LS, SS Final approval of the article: JM, RC, MD, RM, LS, SS Statistical analysis: SS Obtained funding: JM, RC, MD, RM, LS Overall responsibility: JM We gratefully acknowledge the contributions of the study site investigators and coordinators (see Appendix, online only), MED Institute for its assistance in the preparation of this article, and the core laboratory. Appendix Additional material for this article may be found online at www.jvascsurg.org.. | | | | Institution | Principal investigator | Co-investigator(s) | Research coordinator(s) | |
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| Albany Medical Center Albany, NY | Manish Mehta, M.D. | Benjamin Chang, M.D. Kathleen Ozsvath, M.D. Philip Paty, M.D. Dhiraj Shah, M.D. R. Clement Darling III, M.D. Paul Kreienberg, M.D. Sean P. Roddy, M.D. Yaron Sternbach, M.D. | Debbie Hill | | | Arizona Heart Institute Phoenix, Ariz | Venkatesh Ramaiah, M.D. | Edward B. Diethrich, M.D. Julio Rodriguez-Lopez, M.D. Jeffrey Alpern, D.O. | James Williams | | | Austin Health Victoria, Australia | Andrew Roberts, M.D. | Gary Fell, M.D. Neil Roberts, M.D. George Matalanis, M.D. Michael Hoare, M.D. | Helen Kavnoudias | | | Baylor College of Medicine Houston, Tex | Joseph Coselli, M.D. | Scott A. LeMaire, M.D. | Catherine Cheung | | | Cleveland Clinic Foundation Cleveland, Ohio | Sean Lyden, M.D. | Roy Greenberg, M.D. Vikram Kashyap, M.D. Daniel Clair, M.D. Timur Sarac, M.D. Sunita Srivastava, M.D. Eric Roselli, M.D. Bruce Lytle M.D. Lars Svensson, M.D. | Christopher Chura Shona Bathurst | | | Dartmouth Hitchcock Medical Center Lebanon, NH | Mark Fillinger, M.D. | Daniel B. Walsh, M.D. Mark C. Wyers, M.D. Eva M. Rzucidio, M.D. Richard J. Powell, M.D. Robert M. Zwolak, M.D. Brian W. Nolan, M.D. | Anne Alexander | | | Duke University Medical Center Durham, NC | Richard McCann, M.D. | None | Carla Blackwell | | | Emory University Hospital Atlanta, Ga | Ross Milner, M.D. | Elliot Chaikof, M.D., Ph.D. Karthikeshwar Kasirajan, M.D. | Sandra Greenwood | | | Hospital of the University of Pennsylvania Philadelphia, Pa | Ronald M. Fairman, M.D., F.A.C.S. | Edward Y. Woo, M.D. Omaida C. Velazquez, M.D. Jeffery P. Carpenter, M.D. Joseph E. Bavaria, M.D. Alberto Pochettino, M.D. | Linda Mark | | | Lenox Hill Hospital New York, NY | Richard M. Green, M.D. | Viken Nichan Pamoukian, M.D. Sriram Sadasivan Iyer, M.D. | Betsy Klinger | | | Massachusetts General Hospital Boston, Mass | Richard Cambria, M.D. | Alan D. Hilgenberg, M.D. Glenn M. LaMuraglia, M.D. Christopher J. Kwolek, M.D. Thomas E. MacGillivray, M.D. David C. Brewster, M.D. Mark Conrad, M.D. | Jennifer Finn Nicole Lutz Cynthia Monahan | | | Mayo Clinic Foundation Jacksonville, Fla | Albert Hakaim, M.D., M.C.S, F.A.C.S. | W. Andrew Oldenburg, M.D. | Diane Cooper | | | Medical University of Warsaw Warsaw, Poland | Jacek Szmidt, M.D., Ph.D. | Zbigniew Galazka, M.D., Ph.D. | Tomasz Jakimowicz, M.D., Ph.D. | | | Meritcare Hospital Fargo, ND | Corey Teigen, M.D. | Ajit Damle, M.D. Jim Burdine, M.D. Roxanne V. Newman, M.D. | Gail Waagen | | | Newark Beth Israel Medical Center Newark, NJ | Bruce Brener, M.D. | Frederic Sardari, M.D. | Debbie Cook | | | New York University Medical Center New York, NY | Neal Cayne, M.D. | Alfred T. Culliford, M.D. Charles F. Schwartz, M.D. Mark A. Adelman, M.D. Aubrey C. Galloway, Jr., M.D. Glenn R. Jacobowitz, M.D. Matthew M. Nalbandian, M.D. Thomas S. Maldonado, M.D. Caron R. Rockman, M.D. Greg H. Ribakove, M.D. Patrick J. Lamparello, M.D. Juan B. Grau , M.D. | Jacqueline Bott | | | New York Presbyterian Hospital New York, NY | James F. McKinsey, M.D. | Ross T. Lyon, M.D. Harry L. Bush, M.D. Peter L. Faries, M.D. K. Craig Kent, M.D. Nicholas Morissey, M.D. Roman Nowygrod, M.D. Alan Steward, M.D. Craig Smith, M.D. | | | | Northwestern Memorial Hospital Chicago, Ill | Mark Eskandari, M.D. | Mark D. Morasch, M.D. Thomas Gleason, M.D. | | | | Ochsner Clinic New Orleans, LA | W. Charles Sternbergh III, M.D. | P. Michael McFadden, M.D. | John McCuistion | | | Ohio State University Columbus, Ohio | Patrick Vaccaro, M.D., F.A.C.S. | Jean E. Starr, M.D., F.A.C.S. William Smead, M.D. | Diane Gawron | | | Peter Lougheed Centre Calgary, Alberta | Randy Moore, M.D. | Paul F. Petrasek, M.D. | Mona Motamedi | | | Riverside Methodist Hospital Columbus, Ohio | Gary Ansel, M.D. | Barry S. George, M.D., F.A.C.C. Geoffrey B. Blossom, M.D. Charles F. Botti, M.D., F.A.C.C Mark Alfonso, M.D. Daniel R. Watson, M.D. Mitchell Silver, D.O. | Peter Polverini Amanda Terry | | | San Raffaele Hospital Milano, Italy | Germano Melissano, M.D. Roberto Chiesa, M.D. | Efrem Civilini, M.D. Enrico Maria Marone, M.D. | Luca Bertoglio, M.D. | | | Sentara Norfolk General Hospital Norfolk, Va | F. Noel Parent, M.D. | C. Scott McEnroe, M.D. Greg Barber, M.D. Rasesh Shah, M.D. George Meier, M.D. Robert Gayle, M.D. Marc Glickman, M.D. Richard DeMasi, M.D. Gordon Stokes, M.D. Michael Marcinczyk, M.D. Jean Panneton, M.D. Martin Fogle, M.D. | Janice Devlin | | | St. Vincent Hospital Indianapolis, Ind | Katharine Krol, M.D. | A. Joel Feldman, M.D. John Fehrenbacher, M.D. Kannan Natarajan, M.D. Jeffrey Cooke, M.D. David Heimansohn, M.D. Keith Allen, M.D. | Beverly Cearley | | | Stanford University Medical Center Stanford, Calif | Daniel Sze, M.D., Ph.D. | D. Craig Miller, M.D. Joan Frisoli, M.D., Ph.D. R. Scott Mitchell, M.D. Stephen T. Kee, M.D. Lawrence Hofmann, M.D. | Archana Verma, M.D. | | | Strong Memorial Hospital Rochester, NY | Karl Illig, M.D. | Howard Massey, M.D. Michael Singh, M.D. David Waldman, M.D. Jeffery Rhodes, M.D. Peter Knight, M.D. George Hicks, M.D. Mark Davies, M.D. | JoAnne McNamara | | | Swedish Medical Center/Medical Center of Aurora Englewood, Colo | David J. Porter, M.D. | Bradley O. Hofer, M.D. Kenneth T. Bing, M.D. Shriram M. Nene, M.D. Dennis J. Griffin, M.D. Eric S. Malden, M.D. John G. Propp, M.D. Myles S. Guber, M.D. Dominic C. Yee, M.D. James M. Luethke, M.D. Joseph R. Steele, M.D. Randolph Kessler, M.D. | Carol Greenwald, M.D. | | | Thomas Jefferson University Hospital Philadelphia, Penn | Paul J. DiMuzio, M.D. | James T. Diehl, M.D. R. Anthony Carabasi III, M.D. Joseph V. Lombardi, M.D. | Sharon Molotsky | | | University of California, San Francisco/VA Medical Center San Francisco, CA | Darren Schneider, M.D. | Joseph Rapp, M.D. Timothy A.M. Chuter, M.D. Scot Merrick, M.D. | Ilana Hettena Shelly Dwyer | | | Union Memorial Hospital Baltimore, Md | Frank J. Criado, M.D., F.A.C.S. | Gregory S. Domer, M.D. Nancy S. Clark, M.D. | Sheetal Vinayek | | | University of Florida Gainesville, Fla | W. Anthony Lee, M.D. | Charles Klodell, M.D. Thomas Beaver, M.D. James Seeger, M.D. Thomas Huber, M.D. Peter Nelson, M.D. Thomas Martin, M.D. | Nancy Hanson | | | University Hospital Ostrava Ostrava, Czech Republic | Vaclav Prochazka, M.D., Ph.D. (R) | Radim Brat, M.D., Ph.D. | Erik Petrikovits | | | University of Maryland Medical Center Baltimore, Md | David G. Neschis, M.D. | Michael P. Lilly, M.D. William R. Flinn, M.D. Patrick Malloy, M.D. Steven Busittil, M.D. | Melita Braganza | | | University of Michigan Hospital Ann Arbor, Mich | David Williams, M.D. | Peter Henke, M.D. Himanshu Patel, M.D. Gilbert Upchurch, M.D. Enrique Criado-Palleres, M.D. | LaDonna Austin | | | University of North Carolina Hospital Chapel Hill, NC | Mark Farber, M.D. | William A. Marston, M.D. Robert R. Mendes, M.D. Joseph J. Fulton, M.D. | Dianne Glover | | | University of Pittsburgh Medical Center Pittsburgh, Pa | Michel Makaroun, M.D. | Jae-Sung Cho, M.D. Navyash Gupta, M.D. Robert Rhee, M.D. Luke Marone, M.D. Ellen Dillavou, M.D. | Nita Missig-Carroll | | | University of Texas Health Science Center Houston, Texas | Ali Azizzadeh, M.D. | Hazim J. Safi, M.D. | Jennifer Goodrick Deepak Juneja, M.D. Charles C. Miller, III | | | University of Virginia Charlottesville, Va | Alan H. Matsumoto, M.D. | Benjamin Peeler, M.D. John Angle, M.D. Klaus Hagspiel, M.D. Curtis Tribble, M.D. John Kern, M.D. Michael Dake, M.D. Irving Kron, M.D. Kenneth Cherry, M.D. Nancy Harthun, M.D. | Peggy Doherty | | | Vancouver Hospital and Health Sciences Center Vancouver, British Columbia | Michael Martin, M.D. | Michael T. Janusz, M.D. | Karen Thomson | | | Washington Hospital Center Washington, DC | Lowell Satler, M.D. | Joseph Barbowicz, M.D. Nelson L. Bernardo | Katrina King | | | Washington University School of Medicine St. Louis, Mo | Luis Sanchez, M.D. | Brian Rubin, M.D. John Curci, M.D. Patrick Geraghty, M.D. Eric Choi, M.D. Gregorio Sicard, M.D. Mark Moon, M.D. | Christine Cooke Patty Nieters | | | | |
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a Northwestern University Feinberg School of Medicine, Chicago, Ill b Massachusetts General Hospital, Boston, Mass c University of Virginia, Charlottesville, Va e Cleveland Clinic Foundation, Cleveland, Ohio d University of Calgary, Calgary, Alberta f MED Institute, West Lafayette, Ind.  Reprint requests: Jon S. Matsumura, MD, Department of Surgery, Northwestern University Feinberg School of Medicine, 201 E Huron, Ste 10-105, Chicago, IL 60611.
Competition of interest: Dr Matsumura received research funding or consulting fees from Abbott Vascular, Bard, Cook Inc, Cordis, Ev3, W. L. Gore & Associates, and Medtronic. Dr Cambria has research support or consulting from Cook Inc, W. L. Gore & Associates, and Medtronic. Dr Dake has received consulting fees from W. L. Gore & Associates, Abbott Vascular Devices, Medtronic, AngioDynamics, Ev3 Inc, and research grants for clinical trial contracts (no personal remuneration other than expenses as part of conducting trial from Cook, Medtronic and W. L. Gore). Dr Moore received proctor fees from Cook Inc for device training. Dr Svensson received honoraria from Edwards and Medtronic. Dr Snyder is employed by MED Institute Inc, a Cook Group company. PII: S0741-5214(07)01693-X doi:10.1016/j.jvs.2007.10.032 © 2008 The Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved. | |
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