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Rationale for screening selected patients for asymptomatic carotid artery stenosis
Paraskevas, Kosmas I; Eckstein, Hans-Henning; Mikhailidis, Dimitri P; Veith, Frank J; Spence, J David
Stroke is a leading cause of death and disability worldwide. Approximately 15% of all first-ever strokes occur due to atheroembolism from a previously undetected/untreated asymptomatic carotid stenosis (ACS). Despite that, international guidelines do not recommend screening for ACS. The rationale for not recommending screening include: a) the harm associated with screening, b) the questionable clinical benefit associated with surgery, c) the lack of proven reduction in the risk of stroke, d) the large number of false positive/false negative tests, and e) the cost-effectiveness of such screening programs.A critical analysis of each of these arguments is presented. Patients with ACS have a very high risk of all-cause and cardiac mortality. Detection of ACS should not be viewed as an indication for surgery, but rather as an opportunity to implement best medical treatment (BMT) and lifestyle changes to prevent not only strokes, but also cardiac events. The implementation of screening programs for abdominal aortic aneurysms (AAAs) has led to a considerable reduction in the number of ruptured AAAs and AAA-related deaths. Similarly, screening high-risk individuals for ACS would enable timely identification of patients with ACS and implementation of BMT and lifestyle measures to prevent future strokes and cardiac events.
PMID: 31910676
ISSN: 1473-4877
CID: 4257232
International Consensus About Which Major Complications Following Abdominal Aortic Aneurysm Surgery to Discuss with Patients Prior to Surgery: A Delphi Study [Meeting Abstract]
de, Mik S M L; Stubenrouch, F E; Legemate, D A; Balm, R; Veith, F J; Ubbink, D T
Introduction - Vascular surgeons differ in the potential complications from abdominal aortic aneurysm surgery they discuss with patients prior to surgery. Typically the 'major' and the most frequently occuring complications are discussed. However, there is no uniform definition of what these 'major' complications comprise. Harmonizing the 'major' complications that are discussed with patients may improve the informed consent procedure and the shared decision-making process. This study aimed to reach consensus among vascular surgeons as to which complications are considered 'major' after surgery for an abdominal aortic aneurysm. Methods - An electronic Delphi method was used to ask vascular surgeons in Europe and North America via online questionnaires to rate specific complications as 'major' or 'minor' on a 5-point Likert scale. Consensus was reached if 80% of participants scored 1 or 2 ('minor' complication) or 4 or 5 ('major' complication). The Cochrane review of Paravastu et al.1 and reporting standards of the Society for Vascular Surgery developed by Chaikof et al.2 were used to compose lists of complications after open and endovascular abdominal aortic aneurysm surgery. Results - In the first round, 19 out of 63 invited experts participated (response rate: 30%). Participating vascular surgeons originated from a variety of countries in Europe and North-America. Vascular surgeons treating patients with abdominal aortic aneurysms reached consensus on 12 major surgical complications (Table 1). [Formula presented] Conclusion - This e-Delphi study rendered international consensus on which complications from abdominal aortic aneurysm surgery are considered 'major' by vascular surgeons. Future studies should investigate whether these complications agree with the ones patients would consider as 'major' and would want to be informed about. Adding this knowledge may close the surgeon-patient information gap and empower vascular patients to engage in shared decision-making. Until then, this current consensus will help standardize the information discussed with patients in the consultation room. References 1. Paravastu SC, Jayarajasingam R, Cottam R, Palfreyman SJ, Michaels JA, Thomas SM. Endovascular repair of abdominal aortic aneurysm. Cochrane Database Syst Rev. 2014:CD004178. 2. Chaikof EL, Blankensteijn JD, Harris PL, White GH, Zarins CK, Bernhard VM, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002; 35:1048-60.
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EMBASE:2004128799
ISSN: 1532-2165
CID: 4245492
Improved technique for sheath supported contralateral limb gate cannulation in endovascular abdominal aortic aneurysm repair
Pakeliani, David; Lachat, Mario; Blohmé, Linus; Kobayashi, Misato; Chaykovska, Lyubov; Pfammatter, Thomas; Puippe, Gilbert; Veith, Frank J; Pecoraro, Felice
Background: To present a technique of sheath supported contralateral limb gate (CLG) cannulation of modular bifurcated stent-graft in endovascular abdominal aortic repair. Materials and methods: After totally percutaneous bilateral femoral access, the 9F introducer sheath is exchanged to a 30 cm 12 fr introducer sheath over a stiff wire contralateral to the intended main stent-graft insertion side and advanced into the aorta below the lowest renal artery. Parallel to the stiff wire within the sheath an additional standard J-tip guidewire with a 5 fr Pigtail angiographic catheter is advanced to the level of the renal arteries. After main body deployment, the 12 fr introducer sheath and J-tip wire with pigtail catheter are retracted until the CLG opening level, maintaining the stiff "buddy" wire in position to support the 12 fr sheath, maintaining its distal opening close to the contralateral gate opening to achieve easy cannulation. Results: Retrospective analysis of video archive from July 2016 to February 2018 evidenced 55 recorded EVAR cases. All CLG cannulations were obtained with Standard J-tip or Terumo Glidewire wires and with Pig-Tail or Berenstein catheters. Technical success was 100 %. Mean fluoroscopy time to accomplish CLG cannulation was 37.6 33 (range 1-105) seconds. The aortic carrefour angulation on coronal axis strongly correlates with cannulation time p = <.001, with longer cannulation time for higher carrefour angulations on coronal axis (Pearson correlation coefficient 0.47). Conclusions: The use of 12 fr sheath with parallel wire introduction technique, appears to be a safe and reliable tool to facilitate CLG cannulation during EVAR procedures.
PMID: 31549917
ISSN: 0301-1526
CID: 4105402
Patient-Specific Rehearsal Feasibility Before Endovascular Repair of Ruptured Abdominal Aortic Aneurysm
Pakeliani, David; Bleuler, Andrin; Chaykovska, Lyubov; Veith, Frank J; Criado, Frank J; Lachat, Mario; Pfammatter, Thomas; Pecoraro, Felice
Purpose: To evaluate the feasibility of a patient-specific rehearsal (PsR) before emergency endovascular aneurysm repairs (eEVAR) and its influence on the operation. Materials and Methods: From February 2016 to October 2016, 10 consecutive patients (mean age 75±7.4 years; 9 men) presenting with a ruptured abdominal aortic aneurysm (rAAA) suitable for standard EVAR were enrolled in the study. A 3-dimensional (3D) model of the abdominal aorta was generated on a virtual reality simulator based on the patient's computed tomography (CT) images. Following the patient-specific simulation setup, PsR was conducted during patient admission or in parallel with the preoperative eEVAR workup. Measured outcomes were PsR feasibility only in the first 4 patients and impact on operative performance thereafter (changes in device selection, the planning process, clinical outcomes, perioperative mortality, and complication rates). Technical metrics and timing of system setup, rehearsal, interval from patient arrival to the actual procedure, and eEVAR were recorded. Results: Mean time for 3D model creation was 21.3±7.8 minutes (range 13-37); there was a significant positive relationship between aortic neck diameter and segmentation time (p=0.003). The overall mean time for simulator setup and PsR was 54±14 minutes (range 37-80); PsR alone was completed in a mean 31±40 minutes (95% confidence interval -60 to -2.2). The actual eEVAR procedure duration was 69±16 minutes (range 45-90). No delay in the actual eEVAR procedure was registered owing to the PsR pathway. In 6 patients, preprocedure rehearsal induced changes in operative strategy, including device selection, main body introduction side, and/or deployment configuration. In 4 cases, rehearsal was performed twice to achieve optimal performance. Conclusion: PsR before eEVAR was feasible in all cases and caused no time delays in the actual eEVAR procedure. PsR optimized eEVAR planning by identifying optimal strategy for stent-graft component selection and deployment.
PMID: 31478457
ISSN: 1545-1550
CID: 4069012
Comments on the current crisis with paclitaxel eluting lower extremity endovascular devices
Veith, Frank J
PMID: 31165608
ISSN: 1827-191x
CID: 3923452
Why randomized controlled trials do not always reflect reality
Paraskevas, Kosmas I; de Borst, Gert J; Veith, Frank J
OBJECTIVE:Randomized controlled trials (RCTs) constitute level I evidence and are used as the backbone of guidelines and recommendations for treatment. Although RCTs are theoretically the studies of choice for the assessment of the effectiveness of health care interventions, these trials (and their interpretation) may sometimes result in erroneous conclusions, erroneous therapeutic decisions, and incorrect recommendations. We aimed to check the applicability of the results of RCTs to everyday practice. METHODS:We reviewed the literature for studies comparing the results of RCTs with observational or population-based studies in the field of vascular surgery, focusing on two specific topics: the results of carotid artery stenting vs carotid endarterectomy for the management of carotid artery stenosis; and the results of open surgical repair vs endovascular aneurysm repair for the management of ruptured abdominal aortic aneurysms. RESULTS:We found considerable discrepancy in the results of RCTs with real-life registries and observational studies in both topics. In the management of carotid artery stenosis, observational studies reported worse outcomes after carotid artery stenting compared with carotid endarterectomy. Regarding ruptured abdominal aortic aneurysms, population-based studies reported better results for endovascular aneurysm repair compared with open repair. In contrast, RCTs in both topics reported similar results for the two procedures. CONCLUSIONS:There is evidence that RCTs sometimes do not reflect clinical reality and are therefore potentially misleading to the reader. Every RCT has to be interpreted and applied carefully using complete available evidence and good clinical judgment.
PMID: 30878256
ISSN: 1097-6809
CID: 3734712
Impact of aortic stent-graft oversizing on outcomes of the chimney endovascular technique based on a new analysis of the PERICLES Registry [Meeting Abstract]
Usai, M V; Donas, K P; Torsello, G; Veith, F J
Purpose: Chimney EVAR (ch-EVAR) is gaining ever greater acceptance. Peristent gutters leading to type IA endoleaks are an unsolved issue. Aim of the study was to analyze the impact of endograft oversizing to the occurrence of this phenomenon.
Material(s) and Method(s): Prospectively collected data over standard use of the Endurant stent-graft and balloon expandable covered stents as chimney grafts were included. The oversizing of the aortic stent-graft was divided in two groups, group A (20% and less oversizing) and group B (>20% of oversizing). Primary endpoint was the incidence of persistent type IA endoleak. Secondary endpoints were mortality and freedom from reintervention.
Result(s): Group A included 21 patients, group B 144. The mean preoperative pathology's neck length and diameter was 5.8mm (+/-4.4) vs. 4.9mm (+/-3.8) and 27.6mm (+/-4.7) vs. 24.9 mm (+/-3.7) for group A and group B, respectively. The mean length of the new sealing zone after chimney graft was similar for both groups (group A vs group B; 17.9mm vs 18.3mm, P =.21). The percentage of oversizing of the aortic stent-graft was between 13.8% and 20% vs. 22.2% and 30%, for group A and group B. Group A had more type 1A endoleaks, (14.3%) vs. group B (2.1%) based on the first follow-up imaging, P=.02. Incidence of persistent type IA endoleaks needing a reintervention was 14.3% and 1.4% for the group A and group B respectively, P =.01.
Conclusion(s): Oversizing of ideally 30% of the Endurant stent-graft is associated with significant lower incidence of type IA endoleaks requiring reintervention for patients treated by ch-EVAR
EMBASE:629259388
ISSN: 1432-086x
CID: 4102002
Coexisting hypogastric aneurysms worsen the outcomes of endovascular treatment by the iliac branch devices within the pELVIS Registry
Donas, Konstantinos P; Taneva, Gergana T; Pitoulias, Georgios A; Torsello, Giovanni; Veith, Frank J
OBJECTIVE:Hypogastric aneurysms (HAs) frequently coexist with aortoiliac aneurysms (AIAs). However, the presence of an HA is a contraindication to endovascular aneurysm treatment by iliac branch devices (IBDs) because of the risk of distal sealing-related endoleaks. No robust evidence exists in the published literature, and therefore we sought to evaluate the performance of IBDs in the presence of HAs within a multicenter registry of nine vascular centers. METHODS:Clinical and radiographic information of 804 patients with AIAs treated by IBDs was retrospectively reviewed and analyzed using prearranged, defined, and documented protocols. The treatment period was between January 2005 and April 2017. RESULTS:HA was present in 315 (32.6%) of the overall 910 deployed IBDs. Mean radiologic follow-up was 32 months. The incidence of incomplete aneurysm exclusion and type I endoleak was 3% in the HA group vs 0.7% in the non-HA group (P = .019). The 5-year freedom from IBD-related type I endoleak was 93% vs 98% in the HA group vs the non-HA group, respectively (P = .006). Subgroup analysis of the HA group revealed that use of a single distal bridging stent graft vs multiple bridging devices led to higher rate of type I endoleak (9.6% vs 2.8%; P = .031), branch occlusions (8.3% vs 0.9%; P = .009), and buttock claudication (7.6% vs 1.9%; P = .038). CONCLUSIONS:This series of AIAs with HAs is the largest reported. It shows that HAs coexisting with AIAs, when treated with IBDs, have significantly worse outcomes. Lengthening the distal landing zone with more than one bridging stent graft into the distal healthy hypogastric artery or one of its main branches improves outcomes.
PMID: 30545704
ISSN: 1097-6809
CID: 3679242
Impact of aortic stent-graft oversizing on outcomes of the chimney endovascular technique based on a new analysis of the PERICLES Registry
Donas, Konstantinos P; Usai, Marco V; Taneva, Gergana T; Criado, Frank J; Torsello, Giovanni B; Kunilis, Paul; Scali, Salvatore; Veith, Frank J
OBJECTIVE:Chimney endovascular aortic aneurysm repair is gaining ever greater acceptance. However, persistent gutters leading to type IA endoleaks represent an unsolved issue. The aim of the current study was to analyze the impact of abdominal endograft oversizing to the occurrence of this phenomenon. METHODS:The PERformance of the snorkel/chImney endovascular teChnique in the treatment of compLex aortic PathologiesES registry includes the largest experience with chimney endovascular aortic aneurysm repair from 13 vascular centers in Europe and the U.S. Prospectively collected data from centers with standard use of the Endurant stent-graft and balloon-expandable covered stents as chimney grafts only were included in the present analysis. The parameter which varied was the degree of oversizing of the aortic stent-graft classifying the cohort in two groups, group A (20% and less oversizing) and group B (>20% of oversizing). The primary endpoint was the incidence of persistent type IA endoleak needed reintervention. Secondary endpoints were all-cause mortality and freedom from reintervention. RESULTS:Group A included 21 patients while group B 144. The mean preoperative pathology's neck length and diameter was 5.8 mm (±4.4) versus 4.9 mm (±3.8) and 27.6 mm (±4.7) versus 24.9 mm (±3.7) for group A and group B, respectively. The mean length of the new sealing zone after chimney graft placement was similar for both groups (group A versus group B; 17.9 mm versus 18.3 mm, respectively, P = .21). The percentage of oversizing of the aortic stent-graft ranged between 13.8 and 20% versus 22.2 and 30%, for group A and group B, respectively. Patients of group A had more type 1A endoleaks, (14.3%) versus patients of group B (2.1%) based on the first follow-up imaging, P = .02. The incidence of persistent type IA endoleaks needing a reintervention was 14.3 and 1.4% for the group A and group B, respectively, P = .01. The mean volume of contrast medium used was greater in group A versus group B with 239 ml versus150 ml, P = .05. Additionally, 14.3% of patients of group A experienced acute renal failure compared to those in group B which was 1.0%, P = .01. CONCLUSIONS:Oversizing of ideally 30% of the Endurant stent-graft is associated with significant lower incidence of type IA endoleaks requiring reintervention for patients treated by chimney endovascular aortic aneurysm repair.
PMID: 30419183
ISSN: 1708-539x
CID: 3456792
Use of Thrombolysis in Acute Lower Extremity Ischemia With Known Distal Target Vessel for Revascularization Stenting [Meeting Abstract]
Gargiulo, Nicholas J., III; Chandramoulli, Maya; Veith, Frank J.; Lipsitz, Evan C.; Landis, Gregg S.; Flores, Lucio; Haser, Paul; Tortolani, Anthony J.; Cayne, Neal S.
ISI:000450594000027
ISSN: 0741-5214
CID: 3512152