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Inadequate Sealing Is Top Reason for Endograft Explant The international newspaper for vascular specialists Issue 59 INTERNATIONAL September 2013 Alberto Muñoz: Thomas Zeller: Gustavo S Oderich: Latin America Profile Fenestrated grafts Page 14 Page 24 Page 30 Inadequate sealing is top reason for endograft explant A study looking at endovascular aneurysm repair (EVAR) graft explants has shown that most failures occur between years one and five and are caused by inadequate sealing and endoleaks. In the study, endoleaks were type I in 40% of the patients and type II in 30% of the cases ric J Turney, Department that occurs 30 days after few years,” he said. of Vascular Surgery, implantation, which implies a The study was a retrospective ECleveland Clinic, successful acute result.” review, and included data presented the data from the on type of graft, time of study at the Vascular Annual During the study period, 100 implantation, indication for Meeting (30 May–1 June patients required an endo- conversion, surgical data 2013, San Francisco, USA). graft explant. The investiga- and outcomes for 30-day He commented: “EVAR is tors looked at the overall mortality, cumulative survival, now the most common method results for this cohort and complications, and failure by for treating abdominal aortic also compared the informa- time of EVAR (less than 12 aneurysms [in the USA], tion with the original data months, between 12 months and increasing numbers of of 41 explants which were and five years, and beyond five patients are being observed published in the Journal of years). in long-term follow-up. In Vascular Surgery in 2009 There were no statistically addition, the treatment of (49[3]:p.589-95). significant difference between patients with indications the patients from 2009 and Eric J Turney outside of instructions for use Turney told delegates that the new cohort. Overall, 91% is common.” there has been a growth in the of the patients were male and The most common indication Turney noted that 71% of the The purpose of the study was number of explants, with a rise the mean age was 75 years; for graft explant was endoleak, explants were performed in an to evaluate the Cleveland Clinic in 2011 and 2012, when 14 coronary disease was the most present in 82% of patients, elective procedure, 10% were experience with late conversion cases explants were performed common comorbidity, present followed by infection (13%), urgent, 19% were emergent. between 1999 and 2012 and on each year. In the first quarter in 65%, followed by chronic acute thrombosis (3%), Amongst the emergent, 9% identify modes of failure and of 2013, 10 cases were per- obstructive pulmonary disease recurrent thrombosis (1%) were cases of rupture. predictors of outcomes. Turney formed in the Cleveland Clinic. and chronic kidney disease. and claudication (1%). The To assess the duration of the explained that “late conversion “It certainly shows the explant Supra-renal fixation was endoleaks were type I in 40% endografts, the investigators is defined as the conversion rate has accelerated in the past present in 37% of cases. of the cases and type II in 30%. Continued on page 2 TEVAR superior to medical Cook Medical therapy alone for type B re-launches Zilver PTX dissections at five years in a phased manner Results from the INSTEAD-XL trial published in Circulation: Cook Medical has begun a phased global re-launch of Cardiovascular Intervention show that thoracic endovascular Zilver PTX, the company’s drug-eluting peripheral stent, in aortic repair of uncomplicated type B dissections in addition line with the company replenishing stock levels to medical therapy is associated with improved five-year aorta- specific survival and delayed disease progression n April this year, Cook Medical system and not stent. Rate of initiated a nationwide/global occurrence of the problem was ata from the study were results of the randomized investigation Ivoluntary recall of Zilver PTX 0.043%, the company clarified. published online on 6 August of stent grafts in aortic dissection trial), based on its investigation into 13 They also highlighted that D2013. led by Christoph A Nienaber, Heart complaints of delivery system tip the problem with the delivery “Thoracic endovascular aortic repair Center Rostock, University of Rostock, separation. Two adverse events, system was solely with the (TEVAR) represents a therapeutic Rostock, Germany, wrote. including one death, occurred Zilver PTX delivery system and concept for type B aortic dissection. A total of 140 patients with stable in cases where a tip separation did not affect any other Zilver Long-term outcomes and morphology type B aortic dissection previously was reported. stent delivery system from after TEVAR for uncomplicated randomised to optimal medical Cook Medical told Vascular Cook. In April, Cook voluntarily dissection are unknown,” the authors treatment and TEVAR (n=72) vs. News that the issue was pulled all products from the of INSTEAD-XL (Endovascular repair optimal medical treatment alone (n=68) restricted to the delivery Continued on page 2 of type B aortic dissection—long-term Continued on page 2 Vascularnews.com VN App @VN_publishing facebook.com/vascularnews 2 Updates September 2013 Inadequate sealing is top reason for endograft explant Continued from page 1 indication in the majority of transabdominal approach. significance included visceral included the fact that it is a looked at the data for time patients followed by type III Clamp position was supra revascularisation, supra- retrospective single-centre since the implantation to time endoleaks.” He explained that celiac in 54% of the cases, celiac clamp, emergent analysis, that it involved of explantation of the device. the reason for the development followed by suprarenal (33%) nature of the explantation, multiple surgeons with varying The data showed that in 23 of type I endoleaks was mainly and infrarenal (13%). Forty infection and rupture. The preferences and approaches, patients the endograft failed challenging anatomy with neck four per cent of patients had negative predictors of long- and also that 61% of the in the first 12 months, in 55 outside instructions for use in some complication: 29% term survival were chronic explant procedures had been patients it failed between 12 the early failures, and disease were cardiac, 26% were obstructive pulmonary disease, performed in patients who had months and five years, and in progression at intermediate pulmonary and 9% were renal visceral revascularisation, had EVAR in other facilities 22 patients the device failed and late stages. complications. infection, emergent procedure, and, therefore, did not have beyond five years. The explantation procedure He also reported that the rupture, and also preoperative pre-implant imaging available. Turney said that, in terms characteristics were consistent overall 30-day mortality was and postoperative creatinine In his conclusions, Turney of indications for explantation across both cohorts, with 56% 17%; elective mortality was levels. said that many early failures by duration of EVAR, in the performed with retroperitoneal 9.9%. The predictors of 30-day Turney commented that were due to challenging neck first year type I endoleak was approach and 44% with a mortality with statistically the limitations of the study anatomy with inadequate seal the most frequent indication, fixation and infection. He followed by infection. He Many early failures were due to challeng- added that late failures were added, “Between years one often due to device failures and five, type I endoleak ing neck anatomy with inadequate seal or aortic disease progression. continued to be the most “Compared to the initial frequent indication, followed fixation and infection. Late failures experience, morbidity and by type III endoleaks. Beyond were also often due to device failures or mortality remain higher for five year, type I endoleak non-elective explants,” he remained the primary aortic disease progression said. Cook Medical re- TEVAR superior to medical therapy alone launches Zilver PTX for type B dissections at five years in a phased manner Continued from page 1 as an alternative to open surgery Continued from page 1 were analysed retrospectively for for managing complications of market globally. The investigation aorta-specific, all-cause outcomes, and type B dissection, “even without identified the root cause of the disease progression using landmark any randomised data, may now be problem which was that the raw statistical analysis of years two to five extended to manage stable (initially material used in the delivery after index procedure. Cox regression uncomplicated) type B dissection system was out of specification. was used to compare outcomes because the potential to remodel Vascular News has learned that a between groups; all analyses are based dissected aorta and prevent late correction has been made and a on intention to treat. expansion and malperfusion has been solution implemented. The stent The risk of all-cause mortality confirmed.” itself remains unchanged. (11.1% versus 19.3%; p=0.13), They added that with completed Potential adverse events that aorta-specific mortality (6.9% versus five-year surveillance in all survivors, may occur in cases where inner 19.3%; p=0.04), and progression any discordance of aortic remodelling delivery catheter breakage occurs (27.0% versus 46.1%; p=0.04) after with clinical outcomes after TEVAR include: possible surgery to five years was lower with TEVAR than was refuted. “These initial findings remove the catheter
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