完全穿刺技术在腹主动脉瘤腔内修复术中的应用

目的 探讨应用Perclose ProGlide缝合器完全穿刺技术行腹主动脉瘤腔内修复术的安全性和有效性.方法 2008年5月至2010年4月,36例腹主动脉瘤患者完全穿刺下行腔内修复术治疗.其中男性30例,女性6例;平均年龄68岁.所应用的支架型血管包括:3例Endurant,13例Talent,20例Zenith.18～24 F的鞘管预置两把ProGlide,14～16 F的鞘管预置单把ProGlide.缝合动脉切口时取出鞘管并将线结下滑收紧.统计技术成功率、相关并发症及手术操作时间.术后3、6、9、12个月及其后每年进行CT血管造影随访.结果 20例局部麻醉,16例全身麻醉.68条股动脉共应用128把ProGlide,其中38条股动脉各应用2把,8条各应用3把,2条各应用4把,20条各应用1把.63条股动脉(63/68,92.6%)技术操作成功,2条中转切开缝合,3条出现血肿,无需手术处理.平均随访时间(12±3)个月.1例于术后3个月出现无症状的动脉夹层.结论 完全穿刺技术在腹主动脉瘤腔内修复术中的应用是安全和有效的.由于可能需要切开缝合,建议在杂交手术室中操作.     

新型覆膜支架在腹主动脉瘤腔内修复中的应用

目的 总结腹主动脉瘤腔内修复术使用Endurant支架的经验及体会.方法 回顾分析2010年5月至2011年5月北京协和医院血管外科收治的19例肾下腹主动脉瘤使用Endurant支架行腔内修复术的病例特点、术后并发症和近期随访结果.结果 19例患者均获得手术成功,其中9例为复杂解剖形态的病例.术中同时进行的肾动脉支架、髂内动脉栓塞和髂动脉扩张也均获得成功.术后无Ⅰ、Ⅲ和Ⅳ型内漏发生,4例残余Ⅱ型内漏留待观察.围手术期无死亡病例,30 d并发症主要包括血栓消耗性凝血功能障碍,心肌梗死合并心衰,伤口感染和血肿.全组随访1～12个月,无死亡病例.8例患者完成至少1次CT动脉重建(computer tomography angiography,CTA)检查,5例动脉瘤体直径缩小,3例无改变.1例患者出现单侧髂腿延长支闭塞,行股股动脉转流.1例患者出现继发性ⅠB型内漏,继续观察.结论 腹主动脉瘤腔内修复术使用Endurant支架安全,有效.Endurant支架增加了对于复杂解剖形态的病例的手术成功率,近期疗效满意.     

Endotension after endovascular aneurysm repair: the Ancure experience

PURPOSE: The expansion of aneurysms after endovascular repair is a consequence of persistent sac pressure, usually resulting from an endoleak. Several authors have suggested that sac expansion can occur even in the absence of endoleak, referring to this phenomenon as endotension. This study undertakes a review of the largest US endograft trial data to better define the significance of aneurysm expansion in the absence of endoleak. METHODS: The core laboratory imaging database from the Ancure (Guidant) endovascular graft Phase I and Phase II trials approved by the Food and Drug Administration was reviewed with attention to aneurysm size and endoleak. Aneurysm size was measured with standardized two-dimensional computed tomography (CT) scan at the area of largest initial aneurysm diameter. Endoleak was detected with CT scans, color duplex ultrasound scans, and angiography in selected cases. Patients were evaluated at baseline, 3 months, 6 months, 12 months, and every 12 months thereafter. An endograft was classified as leaking if any endoleak was detected with any modality at any time point. RESULTS: A total of 658 patients were entered into these protocols and the data submitted to the core laboratory. A control group of 120 conventional aortic patients and a group of 62 without baseline CT data were excluded from further analysis. Of the remaining 476 patients, 144 (60 tube, 60 bifurcated, and 24 mono-iliac) were free of endoleak at all intervals and had baseline CT measurements to allow comparison. Overall, the average size decrease in this nonleaking group was 9.9 +/- 9.4 mm (range, -50.6-11.1 mm) at a mean follow-up of 23.3 months. Evaluation for overall aneurysm expansion revealed 17 patients who had an increase of 2.3 +/- 2.9 mm (range, 0.3-11.1 mm) at a mean follow-up of 14.1 months. Only two patients without evidence of endoleak exhibited growth of more than 5 mm at maximum follow-up (7.6 mm at 12 months and 11.1 mm at 36 months). Additional analysis of sealed endoleaks and late endoleaks failed to demonstrate any group with expansion in the absence of detectable endoleak. CONCLUSIONS: Endotension appears to be rare in this large series of prospectively evaluated endografts. From this review, endotension seems more likely to represent missed endoleak than true aneurysm expansion in the absence of perigraft flow.     

Mid-term outcomes of endovascular popliteal artery aneurysm repair

OBJECTIVE: This study documents mid-term outcomes of a series of endovascular popliteal aneurysm repairs compared with concurrent results of open surgical repair. METHODS: A retrospective chart review was done of all popliteal artery aneurysm repairs since January 1, 2000. Patency was defined as continued presence of palpable pulses or maintenance of postoperative ankle-brachial index +/- 0.15. Statistical methods included chi(2), t test, Fisher's exact test, and Kaplan-Meier plots with log-rank comparison. RESULTS: A total of 56 popliteal artery aneurysm repairs were performed. All endovascular popliteal aneurysm repairs (EVPAR, n = 15) were performed using Viabahn endoprostheses. Patients with open repair (OR, n = 41) underwent surgical bypass and aneurysm exclusion with great saphenous vein (n = 26), short saphenous vein (n = 3), or polytetrafluoroethylene (n = 12), through either a medial (n = 28) or posterior (n = 13) approach. All urgent cases received open repair. Technical success was 100% in both groups. Mean follow-up was 16.5 +/- 3 months (range, 0.5 to 56 months). Aneurysm size, location, and outflow were similar between groups. Primary patency, secondary patency, and survival did not differ between groups. Endoleaks were observed in three (20%) of 15 endovascular cases, and type I and III endoleaks were treated with additional endografts. CONCLUSION: To our knowledge, this represents the largest United States series of EVPAR to date. Early mid-term results of elective endovascular repair of popliteal artery aneurysms are encouraging. Further studies are warranted to define optimal indications for EVPAR and to generate long-term outcomes for this technique.     

Totally percutaneous aortic aneurysm repair: experience and prudence

OBJECTIVE: Totally percutaneous aortic aneurysm repair has been shown to be technically feasible, with low morbidity. Complications from percutaneous arterial closure are not insignificant, however, and can be fatal. We sought to evaluate our experience with this technique, compare it with the published literature, and identify factors associated with conversion to open repair and complications. METHODS: A retrospective review of a prospectively collected database was performed. All patients who underwent percutaneous closure of large-bore-sheath (>12F) access sites with off-label use of a suture-mediated closure device (Prostar XL) between December 2002 and August 2005 were reviewed. Outcome measures evaluated were rates of technical success, conversion to open femoral arterial repair, and complications. Axial diameter measurements of the accessed vessels were assessed with computed tomographic (CT) angiography both before and after the procedure. Patient variables were compared by using chi2, Fisher exact, and paired and independent samples t tests where appropriate. The mean follow-up interval was 1.5 years. RESULTS: During the study period, 49 patients underwent percutaneous closure of 79 large-bore-sheath access sites after successful endovascular aneurysm repair. Seven patients (14%) were morbidly obese (body mass index >35 kg/m2). Successful closure was achieved in 74 access sites (93.7%). Percutaneous closure was unsuccessful in five access sites (6.3%), all of which required open femoral repair at the same setting. Two converted patients experienced complications (4.1%): one retroperitoneal hematoma requiring transfusion of blood products and one iliac artery injury leading to death from myocardial infarction. Both of these patients were morbidly obese. Both complications occurred after closure of larger than 20F sheath sites. Morbid obesity and sheath size greater than 20F were associated with a significantly increased complication rate (P = .02 and P = .01, respectively). No thrombotic or infectious complications occurred in this series. Upon comparison of preoperative and postoperative CT angiograms, one (1.3%) small pseudoaneurysm was detected. No arteriovenous fistulas or hematomas larger than 3 cm were detected. The pseudoaneurysm occurred after closure of a 20F sheath access site. There were no significant differences in minimum intraluminal (7.38 +/- 1.8 vs 7.48 +/- 1.8) or maximum extraluminal (11.25 +/- 2.8 vs 12.02 +/- 2.7) diameters between preoperative and postoperative CT angiograms, respectively. CONCLUSIONS: Totally percutaneous aortic aneurysm repair is technically feasible in most cases, with no effect on the luminal diameter of the accessed femoral artery. Complications occur more often in morbidly obese patients and with sheaths larger than 20F. These complications can be minimized with meticulous technique and good patient selection. The capability for expeditious open femoral arterial repair is mandatory with this approach.     

腔内隔绝术治疗主动脉瘤的初步经验

目的 探讨腔内隔绝术(EVAR)治疗主动脉瘤的方法、手术适应证,并评价其治疗效果.方法 回顾性分析2003年3月～2008年3月行EVAR术治疗65例主动脉瘤患者的临床资料;其中主动脉夹层动脉瘤33例(stanfnrd B),胸主动脉瘤4例,肾下腹主动脉瘤28例.结果 65例动脉瘤EVAR手术均获得成功,33例夹层动脉瘤的假腔在术后造影立刻消失,28例腹主动脉瘤及4例胸主动脉瘤瘤体成功隔绝.随访3～24个月,1例患者术后2个月死亡,其余患者未发现支架移位或内漏.结论 动脉瘤的EVAR术治疗具有创伤小、操作可行及效果确切等优点,早期疗效满意,但远期疗效有待于临床进一步观察.严格选择手术适应证是手术成功的关键.     

Initial experience with endovascular aneurysm repair: Comparison of early results with outcome of conventional open repair

Purpose: To determine the safety, effectiveness, and problems encountered with endovascular repair of abdominal aortic aneurysm (AAA). Initial experience with endoluminal stent grafts was examined and compared with outcome for a matched concurrent control group undergoing conventional operative repair of AAA. Methods: Over a 3-year period, 30 patients underwent attempts at endovascular repair of infrarenal AAA. Of the 28 (93%) successfully implanted endografts, 8 were tube endografts, 8 bifurcated grafts, and 12 aortouniiliac grafts combined with femorofemoral bypass. Most of the procedures were performed in the past year because the availability of bifurcated and aortoiliac endografts markedly expanded the percentage of patients with AAA who might be treated with endoluminal methods. The follow-up period ranged from 1 to 44 months, with a mean value of 11 months. Results: Endovascular procedures demonstrated significant advantages with respect to reduced blood loss (408 versus 1287 ml), use of an intensive care unit (0.1 versus 1.75 days), length of hospitalization (3.9 versus 10.3 days), and quicker recovery (11 versus 47 days). Although the total number of postoperative complications was identical for the two groups, the nature of the complications differed considerably. Local and vascular complications characteristic of endovascular repair could frequently be corrected at the time of the procedure and tended to be less severe than systemic or remote complications, which predominated among the open surgical repair group. On an intent-to-treat basis, 23 (77%) of the 30 AAAs were successfully managed with endoluminal repair. The seven (23%) failures were attributable to two immediate conversions caused by access problems, three persistent endoleaks, one late conversion caused by AAA expansion, and one late rupture. Conclusions: Although less definitive than those for conventional operations, these early results suggest that endovascular AAA repair offers considerable benefits for appropriate patients. The results justify continued application of this method of AAA repair, particularly in the treatment of older persons at high risk. (J Vasc Surg 1998;27:992-1005.)     

Impact of suprarenal neck angulation on endovascular aneurysm repair outcomes

BackgroundHostile infrarenal proximal neck (β) anatomy of abdominal aortic aneurysm has been associated with increased risk of aneurysm-related complications after endovascular aneurysm repair (EVAR). However, there is a paucity of literature addressing the suprarenal angle (α). The aim of this study was to evaluate short- and long-term outcomes after EVAR in patients with severe suprarenal neck angulation (α >60 degrees).MethodsA retrospective review of the medical records of 561 patients who underwent EVAR between January 2005 and December 2017 was performed. The main exclusion criteria were preoperative aneurysm rupture and fenestrated or branched endograft placement. High-resolution computed tomography images of 452 patients were available. Patients were grouped into angulated (α >60 degrees) and nonangulated (α ≤60 degrees) groups. The primary end point was freedom from type IA endoleak. Secondary end points included 30-day mortality, long-term survival, primary clinical success, and freedom from aneurysm rupture and graft migration. Primary clinical success was defined according to Society for Vascular Surgery guidelines as clinical success without the need for an additional or secondary surgical or endovascular procedure.ResultsOf 452 patients, 45 (10%) were included in the angulated group (α >60 degrees). Median follow-up time was 34 months (interquartile range, 14-56 months). Compared with patients in the nonangulated group, those in the angulated group had larger neck diameter at the level of the renal arteries (mean [standard deviation], 25.6 [3.8] mm vs 24.6 [3.4] mm; P = .06) and increased β angle (mean [standard deviation], 50.5 [22.9] degrees vs 41.6 [23.9] degrees; P = .01). The 3-year freedom from type IA endoleak estimate was 80.2% for the angulated group compared with 97.8% for the nonangulated group (P < .001). The angulated group showed significantly higher 30-day mortality (11.1% vs 0.25%; P < .001).The 3-year results showed that patients in the nonangulated group had higher rates of primary clinical success (90.2% vs 67.1%; P < .001), freedom from rupture (99% vs 97.1%; P = .02), freedom from migration (100% vs 92.4%; P < .001), and long-term survival (91.6% vs 75.8%; P = .006) compared with those in the angulated group. After adjustment for age, sex, neck diameter, and β angle, severe suprarenal neck angulation was associated with higher odds of type IA endoleak (adjusted hazard ratio, 8.9; 95% confidence interval [CI], 2.9-27), loss of primary clinical success (adjusted hazard ratio, 4.8; 95% CI, 2.6-8.9), and 30-day mortality (adjusted odds ratio, 52.5; 95% CI, 5.3-514) compared with α ≤60 degrees (all P < .001).ConclusionsThis is the first report to show a significant increase in operative mortality in patients undergoing EVAR with severely angulated suprarenal neck. Patients who survive the operation are at increased risk of secondary interventions. These findings suggest that EVAR should be used with caution in patients with severe α angulation and underpin the role of close follow-up in this particular population.     

Extending endovascular aneurysm repair to more patients without better outcomes

ObjectiveThis study quantifies the survival and outcomes associated with endovascular aneurysm repair (EVAR) patients treated in two eras. We hypothesized that both end points will improve over time.MethodsPatients receiving EVAR between January 2003 and May 2017 contained within the Vascular Quality Initiative data set were examined. Those patients treated between January 2003 and December 2007 were included in the early era, and those treated between January 2012 and December 2015 were considered late era. Baseline demographics, technical variables, and outcomes were compared with appropriate statistical tests. Survival was estimated with Kaplan-Meier life-table analysis. Cox proportional hazards modeling analyzed the relationship between repair era and survival; the repair era's significance was further examined in matched cohorts generated by coarsened exact matching and propensity scoring.ResultsEarly era (n = 787) patients demonstrate decreased estimated survival in comparison to those treated in the late era (n = 20,066; log-rank, P < .001). Repair in the late era was not an independent predictor of survival in the Cox model (hazard ratio, 1.06; 95% confidence interval, 0.23-4.95; P = .94). Three different matching methods confirmed a nonsignificant contribution of treatment era to survival suggested by the initial Cox model (all P > .05). Total hospital stays were longer in the late era (3.1 vs 4.2 days; P < .001). Postoperative myocardial infarction and surgical site infections decreased in frequency in the late group, although postoperative vasopressor use became more frequent (all P < .05). Operations became 20% faster, required 27% less contrast material and 29% less crystalloid, and lost 30% less blood over time (all P < .05).ConclusionsAlthough EVAR volume increased significantly over time, post-EVAR outcomes of patients do not differ between the early era, 2003 to 2007, and the late era, 2012 to 2015. Aspects of surgical performance improved, but this did not translate into a measurable benefit to patients. Length of hospital stay unexpectedly increased over time.     

Long-term outcomes after endovascular abdominal aortic aneurysm repair: the first decade

OBJECTIVE: The proper role of endovascular abdominal aortic aneurysm repair (EVAR) remains controversial, largely due to uncertain late results. We reviewed a 12-year experience with EVAR to document late outcomes. METHODS: During the interval January 7, 1994 through December 31, 2005, 873 patients underwent EVAR utilizing 10 different stent graft devices. Primary outcomes examined included operative mortality, aneurysm rupture, aneurysm-related mortality, open surgical conversion, and late survival rates. The incidence of endoleak, migration, aneurysm enlargement, and graft patency was also determined. Finally, the need for reintervention and success of such secondary procedures were evaluated. Kaplan-Meier and multivariate methodology were used for analysis. RESULTS: Mean patient age was 75.7 years (range, 49-99 years); 81.4% were male. Mean follow-up was 27 months; 39.3% of patients had 2 or more major comorbidities, and 19.5% would be categorized as unfit for open repair. On an intent-to-treat basis, device deployment was successful in 99.3%. Thirty-day mortality was 1.8%. By Kaplan-Meier analysis, freedom from AAA rupture was 97.6% at 5 years and 94% at 9 years. Significant risk factors for late AAA rupture included female gender (odds ratio OR, 6.9; P = 0.004) and device-related endoleak (OR, 16.06; P = 0.009). Aneurysm-related death was avoided in 96.1% of patients, with the need for any reintervention (OR, 5.7 P = 0.006), family history of aneurysmal disease (OR, 9.5; P = 0.075), and renal insufficiency (OR, 7.1; P = 0.003) among its most important predictors. 87 (10%) patients required reintervention, with 92% of such procedures being catheter-based and a success rate of 84%. Significant predictors of reintervention included use of first-generation devices (OR, 1.2; P < 0.01) and late onset endoleak (OR, 64; P < 0.001). Current generation stent grafts correlated with significantly improved outcomes. Cumulative freedom from conversion to open repair was 93.3% at 5 through 9 years, with the need for prior reintervention (OR, 16.7; P = 0.001) its most important predictor. Cumulative survival was 52% at 5 years. CONCLUSIONS: EVAR using contemporary devices is a safe, effective, and durable method to prevent AAA rupture and aneurysm-related death. Assuming suitable AAA anatomy, these data justify a broad application of EVAR across a wide spectrum of patients.     

Clinical experience with a bifurcated endovascular graft for abdominal aortic aneurysm repair

Purpose: The purpose of this study was to test a transfemoral system of bifurcated endovascular graft insertion for aortic aneurysm repair.Methods: Bifurcated endovascular grafts were inserted through bilateral femoral artery cutdowns in 41 patients. The results were assessed by completion angiography and follow-up computed tomography.Results: The second half of the study included more aneurysms 6 cm or larger (p < 0.05) and more instances of short proximal neck (p < 0.05), proximal neck angulation (p < 0.05), and iliac angulation (p < 0.05). Despite the increasingly challenging anatomy, the results were better in the second half of the study as illustrated by the lower overall combined morbidity/mortality rate (15% vs 50%) and higher overall success rate (85% versus 65%). The mortality rate for the series as a whole was 7.5%. Mean follow-up was 18.8 months for the first 20 patients and 10.9 months for the second 20. The commonest complication in the first half of the study was graft thrombosis (n = 5). This complication was absent from the second half of the study because of routine adjunctive stenting. Two patients died of complications of endovascular repair. In both cases aneurysm rupture on the third postoperative day was associated with coagulopathy and angiographic signs of perigraft leak.Conclusion: Aneurysm exclusion with a bifurcated endovascular graft was feasible in a wide range of patients, but when the aneurysm was not entirely excluded from the circulation, the risk of rupture persisted. (J Vasc Surg 1996;24:655-66.)     

Cost-minimization study of the percutaneous approach to endovascular aortic aneurysm repair

ObjectivePercutaneous access for endovascular aortic aneurysm repair (P-EVAR) is less invasive compared with surgical access for endovascular aortic aneurysm repair (S-EVAR). P-EVAR has been associated with shorter recovery and fewer wound complications. However, vascular closure devices (VCDs) are costly, and the economic effects of P-EVAR have important implications for resource allocation. The objective of our study was to estimate the differences in the costs between P-EVAR and S-EVAR.MethodsWe used a decision tree to analyze the costs from a payer perspective throughout the course of the index hospitalization. The probabilities, relative risks, and mean difference summary measures were obtained from a systematic review and meta-analysis. We modelled differences in surgical site infection, lymphocele, and the length of hospitalization. Cost parameters were derived from the 2014 National Inpatient Sample using “International Classification of Diseases, 9th Revision, Clinical Modification” codes. Attributable costs were estimated using generalized linear models adjusted by age, sex, and comorbidities. A sensitivity analysis was performed to determine the robustness of the results.ResultsA total of 6876 abdominal and thoracic EVARs were identified. P-EVAR resulted in a mean cost savings of $751 per procedure. The mean costs for P-EVAR were $1287 (95% confidence interval [CI], $884-$1835) and for S-EVAR were $2038 (95% CI, $757-$4280). P-EVAR procedures were converted to open procedures in 4.3% of the cases. The P-EVAR patients had a difference of −1.4 days (95% CI, −0.12 to −2.68) in the length of hospitalization at a cost of $1190/d (standard error, $298). The cost savings of P-EVAR was primarily driven by the cost differences in the length of hospitalization. In the base case, four VCDs were used per P-EVAR at $200/device. In the two-way sensitivity analysis, P-EVAR resulted in cost savings, even when 1.5 times more VCDs had been used per procedure and the cost of each VCD was 1.5 times greater. In our probabilistic sensitivity analysis, P-EVAR was the cost savings strategy for 82.6% of 10,000 Monte Carlo simulations when simultaneously varying parameters across their uncertainty ranges.ConclusionsP-EVAR had lower costs compared with S-EVAR and could result in dramatic cost savings if extrapolated to the number of aortic aneurysms repaired. Our analysis was a conservative estimate that did not account for the improved quality of life after P-EVAR.     

Cost disparity between open repair and endovascular aneurysm repair for abdominal aortic aneurysm: a single-institute experience in Japan

Purpose

We conducted this study to compare the cost of open surgical repair (OR) with that of endovascular aneurysm repair (EVAR) of an abdominal aortic aneurysm (AAA).

Methods

Between January 2007 and November 2008, 70 patients underwent open repair and 57 patients underwent EVAR. We evaluated the total cost, including that of the Diagnosis Procedure Combination (DPC), that of the surgical procedure, that of materials such as grafts and guide wires, and that of the anesthesia.

Results

The mean costs for OR versus EVAR were as follows: DPC, ??632370 versus ??490050, respectively, which was significant; anesthesia, ??123540 versus ??86220, respectively (P?Conclusions New technologies should not only be clinically effective, but also cost effective. EVAR is less invasive clinically, but the cost of endovascular prostheses and other materials remains high.