Delphi Consensus Study Toward a Comprehensive Classification System for Angioplasty-Induced Femoropopliteal Dissection: The DISFORM Study.

OBJECTIVES: The aim of this study was to seek expert consensus regarding the features that predict adverse outcomes in order to develop a dedicated angiographic classification system for femoropopliteal artery dissection. BACKGROUND: Dissection of the femoral and popliteal arteries is common after percutaneous angioplasty. Its classification is important. However, all current classification systems have significant limitations. METHODS: Delphi consensus methodology was performed over 3 rounds, using an expert panel of 17 interventionalists. Each was asked to rank dissection features with the potential to lead to acute technical failure and/or early restenosis and then which combination of features would require the placement of a metallic scaffold to avoid those outcomes. Results were used to develop a novel grading system and dissection treatment algorithm. RESULTS: Four main characteristics were identified from a comprehensive preliminary list. There was a good level of agreement between panelists from 773 responses (48 combinations). All panelists recommended scaffolding if a dissection produced a ≥50% diameter reduction (100%). Most recommended scaffolding if the dissection had a spiral shape (73%-100%), was severely flow limiting (93%-100%), or had complex morphology defined by long and multiple dissections (65%-100%). Multiple combinations of those features were more likely to receive a recommendation to scaffold. CONCLUSIONS: Scaffolding of a postangioplasty dissection is recommended in the presence of significant diameter reduction, spiral shape, flow impairment, or adverse morphology (DISFORM). The DISFORM classification system has been developed as a tool to provide uniform language to standardize reporting and for discussion of dissection treatment and prognosis.

Long Term Outcomes of Post-Implantation Syndrome After Endovascular Aneurysm Repair.

OBJECTIVE: The aim of this study was to investigate the association between post-implantation syndrome (PIS) and long term outcomes, with emphasis on cardiovascular prognosis. METHODS: One hundred and forty-nine consecutive patients undergoing EVAR in a tertiary institution were previously included in a study investigating the risk factors and short term consequences of PIS (defined as tympanic temperature ≥ 38°C and CRP > 10 mg/L, after excluding complications with an effect on inflammatory markers). This study was based on a prospectively maintained database. Survival status was derived from inquiry of civil registry database information and causes of death from the Dutch Central Bureau of Statistics. The primary endpoint was cardiovascular events. Secondary endpoints were overall and specific cause mortality (cardiovascular, ischaemic heart disease, AAA, and cancer related mortality). Aneurysm sac dynamics and occurrence of endoleaks were also analysed. Survival estimates were obtained using Kaplan-Meier plots and a multivariable model was constructed to correct for confounders. RESULTS: The PIS incidence was 39% (58/149). At the time of surgery, patients had a mean age of 73 ± 7 years and were predominantly male. There were no baseline differences between the PIS and non-PIS groups. The median follow up was 6.4 years (3.2 - 8.3), similar in both groups (p = .81). There was no difference in cardiovascular events for PIS and non-PIS patients (p = .63). However, Kaplan-Meier plots suggest a trend towards a higher rate of cardiovascular events in PIS patients during the first years: freedom from cardiovascular events at one year was 94% vs. 89% and at three years 90% vs. 82%. No differences were found in overall and specific cause mortality. There was a higher rate of type II endoleaks for non-PIS patients (28% vs. 9%, p = .005). Sac dynamics were similar in both groups. CONCLUSION: The results suggest that PIS is not associated with a statistically significantly higher risk of cardiovascular events. PIS had no impact on mortality. Lastly, PIS patients had fewer type II endoleaks, but sac dynamics were analogous.

Outcomes of open repair of postdissection abdominal aortic aneurysms.

BACKGROUND: Evidence to guide management of postdissection abdominal aortic aneurysms (PDAAA) is lacking. This study describes the outcomes of open repair of PDAAA. METHODS: A retrospective cohort study was conducted of all consecutive patients treated with open repair for PDAAA after a Stanford type A or type B thoracic aortic dissection between January 2006 and December 2017 in two vascular referral centers. Preceding type B dissection treatment could include conservative or surgical management. Primary outcomes were 30-day mortality, complication rates, survival, and reintervention-free survival. Survival and reintervention-free survival were analyzed using the Kaplan-Meier method. Reintervention was defined as any endovascular or surgical intervention after the index procedure. RESULTS: Included were 36 patients (27 men [75%]) with a median age of 64 years (range, 35-81 years). The 30-day mortality was 2.7%. The median follow-up was 16 months (range, 0-88 months). The postoperative course was uneventful in 21 patients (58%). The most frequent complications were postoperative bleeding requiring repeat laparotomy (n = 4), pneumonia (n = 3), congestive heart failure (n = 2), new-onset atrial fibrillation (n = 2), mesenteric ischemia requiring left hemicolectomy (n=1), and ischemic cerebrovascular accident (n = 1). Renal failure requiring hemodialysis developed in one patient. The overall survival at 1 year was 88.8%. Reintervention-free survival was 95.5% after 1 year and 88.6% after 2 years. CONCLUSIONS: Open repair of PDAAA can be performed with a low mortality rate and an acceptable complication rate, comparable with elective open repair of abdominal aortic aneurysms without dissection.

Stent graft composition plays a material role in the postimplantation syndrome.

OBJECTIVE: In patients undergoing endovascular aneurysm repair (EVAR), the postimplantation syndrome (PIS), comprising fever and inflammation, occurs frequently. The cause of PIS is unclear, but graft composition and acute thrombus formation may play a role. The objective of this study was to evaluate these possible causes of the inflammatory response after EVAR. METHODS: One hundred forty-nine patients undergoing elective EVAR were included. Implanted stent grafts differed mainly in the type of fabric used: either woven polyester (n=82) or expanded polytetrafluorethylene (ePTFE; n=67). Tympanic temperature and C-reactive protein (CRP) were assessed daily during hospitalization. PIS was defined as the composite of a body temperature of ≥38°C coinciding with CRP>10 mg/L. Besides graft composition, the size of the grafts and the volume of new-onset thrombus were calculated using dedicated software, and results were correlated to PIS. RESULTS: Implantation of grafts made of polyester was associated with higher postoperative temperature (P<.001), CRP levels (P<.001), and incidence of PIS (56.1% vs 17.9%; P<.001) compared to ePFTE. After multivariate analysis, woven polyester stent grafts were independently associated with an increased risk of PIS (hazard ratio, 5.6; 95% confidence interval, 1.6-19.4; P=.007). Demographics, amount of graft material implanted, or new-onset thrombus had no association with PIS. CONCLUSIONS: The composition of stent grafts may play a material role in the incidence of postimplantation syndrome in patients undergoing EVAR. Implantation of stent grafts based on woven polyester was independently associated with a stronger inflammatory response.

Influence of aortic valve calcium on outcome in patients undergoing peripheral vascular surgery.

Vascular surgery patients are at increased risk of adverse cardiovascular events because of silent coronary artery disease and an increased propensity for left ventricular dysfunction. The Revised Cardiac Risk Index is commonly used for preoperative risk stratification. Aortic valve calcium is associated with cardiovascular mortality in the general population. The present study evaluated the prognostic implications of aortic valve calcium on 30-day postoperative and long-term outcomes in vascular surgery patients. Echocardiographic aortic valve evaluation was completed in 1,172 vascular surgery patients. Aortic valve sclerosis was defined by the presence of thickening and/or calcium of ≥1 cusps of a tricuspid aortic valve not inducing stenosis (i.e., with a maximal velocity at continuous Doppler of <2.5 m/s). Stenosis was defined as a maximum velocity of >2.5 m/s. Troponin-T measurements and electrocardiograms were performed routinely after surgery. The study end points were the composite of postoperative cardiovascular events and long-term mortality. Aortic valve sclerosis was present in 416 patients (36%), and aortic valve stenosis was present in 30 patients (3%). After multivariate regression analyses adjusted for age, gender, Revised Cardiac Risk Index, hypertension, hypercholesterolemia, and medication use, aortic valve sclerosis was not associated with either the postoperative or long-term outcomes. In contrast, aortic valve stenosis was associated with a greater postoperative and long-term event rate (odds ratio 3.9, 95% confidence interval 1.7 to 8.7; and hazard ratio 2.1, 95% confidence interval 1.2 to 3.7, respectively). In conclusion, the present study has shown that aortic valve calcium is common in vascular surgery patients. Its presence is associated with negative postoperative and long-term outcomes.

Calcification of the abdominal aorta as an independent predictor of cardiovascular events: a meta-analysis.

CONTEXT: Abdominal aortic calcification (AAC) is a common finding in patients with atherosclerosis. OBJECTIVE: The aim of this study was to demonstrate the incremental value of AAC in predicting long term cardiovascular (CV) outcome by conducting a meta-analysis of observational studies. DATA SOURCES: MEDLINE and Cochrane databases. STUDY SELECTION: Longitudinal studies with at least 2 years of follow-up, reporting the influence of AAC on CV outcome of general population patients. DATA EXTRACTION: Four separate end points-coronary events, cerebrovascular events, all CV events and CV related death-were tested for their relationship with AAC at baseline, using weighted random effects meta-analysis. Heterogeneity was calculated using Q and I(2) statistic tests. Publication bias was assessed by funnel plot symmetry and trim and fill methods. The importance of calcium quantification was also explored (sensitivity analysis). RESULTS: 10 studies were included. An increased relative risk (RR) was found for all end points: for coronary events (five studies, n=11250) 1.81 (95% CI 1.54 to 2.14); for cerebrovascular events (four studies, n=9736) 1.37 (1.22 to 3.54); for all CV events (four studies, n=4960) 1.64 (1.24 to 2.17); and for CV death (three studies, n=4986) 1.72 (1.03 to 2.86). Analysis of studies presenting results in categories (no/minimal, moderate and severe calcification) revealed a stepwise increase in the RR for all end points. Significant heterogeneity was found in the included studies. Sources of heterogeneity were identified in the publication date, duration of follow-up, and mean age and gender differences in the included patient cohorts. CONCLUSION: Existing data suggest that AAC is a strong predictor of CV related events or death in the general population. The predictive impact is greater in more calcified aortas. The generalisability of the meta-analysis is limited by heterogeneity in the coronary events, all CV events and CV death end points.

Clinical outcome and morphologic analysis after endovascular aneurysm repair using the Excluder endograft.

OBJECTIVE: Long-term follow-up after endovascular aneurysm repair (EVAR) is very scarce, and doubt remains regarding the durability of these procedures. We designed a retrospective cohort study to assess long-term clinical outcome and morphologic changes in patients with abdominal aortic aneurysms (AAAs) treated by EVAR using the Excluder endoprosthesis (W. L. Gore and Associates, Flagstaff, Ariz). METHODS: From 2000 to 2007, 179 patients underwent EVAR in a tertiary institution. Clinical data were retrieved from a prospective database. All patients treated with the Excluder endoprosthesis were included. Computed tomography angiography (CTA) scans were retrospectively analyzed preoperatively, at 30 days, and at the last follow-up using dedicated tridimensional reconstruction software. For patients with complications, all remaining CTAs were also analyzed. The primary end point was clinical success. Secondary end points were freedom from reintervention, sac growth, types I and III endoleak, migration, conversion to open repair, and AAA-related death or rupture. Neck dilatation, renal function, and overall survival were also analyzed. RESULTS: Included were 144 patients (88.2% men; mean age, 71.6 years). Aneurysms were ruptured in 4.9%. American Society of Anesthesiologists classification was III/IV in 61.8%. No patients were lost during a median follow-up of 5.0 years (interquartile range, 3.1-6.4; maximum, 11.2 years). Two patients died of medical complications ≤ 30 days after EVAR. The estimated primary clinical success rates at 5 and 10 years were 63.5% and 41.1%, and secondary clinical success rates were 78.3% and 58.3%, respectively. Sac growth was observed in 37 of 142 patients (26.1%). Cox regression showed type I endoleak during follow-up (hazard ratio, 3.74; P = .008), original design model (hazard ratio, 3.85; P = .001), and preoperative neck diameter (1.27 per mm increase, P = .006) were determinants of sac growth. Secondary interventions were required in 32 patients (22.5%). The estimated 10-year rate of AAA-related death or rupture was 2.1%. Overall life expectancy after AAA repair was 6.8 years. CONCLUSIONS: EVAR using the Excluder endoprosthesis provides a safe and lasting treatment for AAA, despite the need for maintained surveillance and secondary interventions. At up to 11 years, the risk of AAA-related death or postimplantation rupture is remarkably low. The incidences of postimplantation sac growth and secondary intervention were greatly reduced after the introduction of the low-permeability design in 2004.

The influence of neck thrombus on clinical outcome and aneurysm morphology after endovascular aneurysm repair.

OBJECTIVE: This study investigated the influence of significant aneurysm neck thrombus in clinical and morphologic outcomes after endovascular aneurysm repair (EVAR). METHODS: The patient population was derived from a prospective EVAR database from two university institutions in The Netherlands from 2004 to 2008. Patients with significant thrombus in the neck (>2 mm in thickness in at least >25% of circumference) were identified as the thrombus group and were compared with the remaining patients without neck thrombus (no-thrombus group), treated within the same period. The primary end point was clinical success. Secondary end points included technical success and rates of decline in renal function. Detailed morphologic analysis of the aortic neck was serially performed for the thrombus group patients to assess changes in thrombus volume. RESULTS: The study included 389 patients: 43 (39 men; mean age of 72.3 years) met the criteria for the thrombus group; of these, 31 (72%) had significant thrombus in >50% of the aortic neck circumference, and 8 (19%) had circumferential thrombus >2-mm thick. Median follow-up was 3.34 years (interquartile range, 2.67-4.72). The estimated 5-year clinical success rate was 74% for the thrombus group and 62% for the no-thrombus group (P = .23). Endograft migration was more frequent in the thrombus group (P = .02). Multivariable Cox regression analysis showed a significant association between migration and use of a device without active fixation (hazard ratio, 4.9; 95% confidence interval, 1.31-18.23; P = .018) but not with the presence of neck thrombus (P = .063). No differences were found in the rates of decline in estimated glomerular filtration rate at 30 days and during follow-up between the thrombus and no-thrombus groups. The thrombus volume in the first 10 mm of aortic neck was progressively reduced over time until it was not measurable in most patients, resulting in complete circular attachment of the endograft to the vessel wall. CONCLUSIONS: Our findings suggest that the presence of aneurysm neck thrombus has no significant influence on short-term and midterm EVAR results.

Radial force measurements in carotid stents: influence of stent design and length of the lesion.

PURPOSE: To assess the differences in radial force of carotid stents and whether the length of the lesion influences the measurements. MATERIALS AND METHODS: Different models of tapered stents of similar size (length, 30 mm) were used. The tapered nitinol Acculink, Protégé, and Cristallo Ideale carotid artery stents and the straight, braided Elgiloy carotid Wallstent were compared. A measurement device consisting of three film loops along the stent body connected to aluminium rods with copper strain gauges was developed. Five stents of each type were deployed within 3-mm stenoses in simulated long (26 mm) and short (8 mm) stenoses. RESULTS: In the short stenosis simulation, the greatest radial force was seen in the Protégé stent, at 3.14 N ± 0.45, followed by the Cristallo Ideale stent (1.73 N ± 0.51), Acculink (1.16 N ± 0.21), and Wallstent (0.84 N ± 0.10; P < .001). In the long stenosis simulation, peak radial force again was highest in the Protégé stent (1.67 N ± 0.37), but the Acculink stent was second (0.95 N ± 0.12) and the Wallstent third (0.80 N ± 0.06). The Cristallo Ideale stent, in contrast to the short stenosis simulation, produced the least radial force (0.44 N ± 0.13) in the long stenosis simulation (P = .001). CONCLUSIONS: Radial forces exerted by carotid stents vary significantly among stent designs. Differences between stent types are dependent on the length of the stenosis. An understanding of radial force is necessary for a well-considered choice of stent type in each individual patient.

Preoperative left ventricular dysfunction predisposes to postoperative acute kidney injury and long-term mortality.

BACKGROUND: Both preoperative left ventricular dysfunction (LVD) and acute kidney injury (AKI) in the postoperative period are independently associated with mortality. We evaluated the prevalence and prognostic implications of AKI in a cohort of vascular surgery patients. METHODS: Before vascular surgery, 1,158 patients were screened for LVD. Development of AKI, defined by RIFLE classification, was detected by serial serum creatinine measurements at days 1 to 3 after surgery. Primary end point was cardiovascular mortality during a median follow-up of 2.2 years (interquartile range [IQR] 1.0-4.0). RESULTS: LVD was present in 558 patients (48%), and 120 patients (10%) developed postoperative AKI. Subjects with LVD developed postoperative AKI more often than patients without LVD (8% vs. 13%, p=0.01). Patients were categorized as (i) no LVD, without AKI (n=551, 48%), (ii) LVD without AKI (n=487, 42%), (iii) no LVD, with AKI (n=49, 4%) and (iv) LVD with AKI (n=71/6%). Patients with LVD prior to surgery who developed postoperative AKI had the highest cardiovascular mortality risk (hazard ratio = 4.9; 95% confidence interval, 2.9-8.2). CONCLUSION: Patients with preoperatively LVD have an increased risk of developing AKI after vascular surgery. The occurrence of AKI in patients with LVD has an incremental predictive value toward cardiovascular mortality risk during long-term follow-up.

Safety of perioperative ß-blocker use: how do ß-blockers compare in terms of side effects?

INTRODUCTION: In the perioperative setting, there is still a high incidence of adverse cardiac events due to sudden coronary plaque rupture or oxygen supply-demand imbalance. ß-Blockers play an important role in preventing these cardiac events. Discussion, however, remains on the side effects accompanying this therapy. AREAS COVERED: The evidence for perioperative use of ß-blockers is summarized in this review in terms of risk reduction, perioperative safety and current clinical use. Furthermore, data on pharmacokinetics, pharmacodynamics and pharmacogenetics are presented. EXPERT OPINION: In perioperative care, ß-blockers are recommended and can be given safely when started early in a low dose, titrated to heart rate. In the future, there could be a place for added perioperative short-acting ß-blockers to further optimize heart rate control.

Sudden death during follow-up after new-onset ventricular tachycardia in vascular surgery patients.

BACKGROUND: Vascular surgery patients are at increased risk for late sudden cardiac death. Identification of patients at risk during surgery offers the opportunity for focused therapy. METHODS: We monitored 483 vascular surgery patients who had no documented history of arrhythmias to identify perioperative new-onset ventricular tachyarrhythmia (VT) and myocardial ischemia using a continuous electrocardiographic (ECG) device for 72 hours. Cardiac risk factors, left ventricular ejection fraction (LVEF), medical therapy, inflammation status, and perioperative ischemia in relation to arrhythmia were noted in all patients. During follow-up, event-based outcomes analysis was used to describe survival. RESULTS: New-onset perioperative VT was detected in 33 patients (6.8%). A higher percentage of patients experiencing perioperative VT had reduced LVEF preoperatively than those without VT (24% vs 12%; P = .04). Additionally, fewer patients experiencing VT were receiving statins than those without (70% vs 85%; P = .02). Patients experiencing VT had a higher incidence of myocardial ischemia (30% vs 18%; P = .10). Perioperative VT was preceded by ischemia in only 60% of the cases. The overall cohort survival was 83% at 24-month follow-up (interquartile range [IQR], 1.1-1.3). Sudden cardiac death free survival among patients experiencing VT was less than in those without (79% vs 92%; P = .02). After adjusting for gender, cardiac risk factors, and type of surgery, new-onset perioperative VT was associated with sudden cardiac death (hazard ratio [HR], 2.6; 95% confidence interval [CI], 1.1-5.8). CONCLUSION: Perioperative VT is likely to be associated with late sudden cardiac death and decreased survival. Continuous perioperative ECG is an effective method to identify VT and may allow improved management of these patients.

The efficacy and safety of clopidogrel in vascular surgery patients with immediate postoperative asymptomatic troponin T release for the prevention of late cardiac events: Rationale and design of the Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echo-VII (DECREASE-VII) trial.

BACKGROUND: Major vascular surgery patients are at high risk for developing asymptomatic perioperative myocardial ischemia reflected by a postoperative troponin release without the presence of chest pain or electrocardiographic abnormalities. Long-term prognosis is severely compromised and characterized by an increased risk of long-term mortality and cardiovascular events. Current guidelines on perioperative care recommend single antiplatelet therapy with aspirin as prophylaxis for cardiovascular events. However, as perioperative surgical stress results in a prolonged hypercoagulable state, the postoperative addition of clopidogrel to aspirin within 7 days after perioperative asymptomatic cardiac ischemia could provide improved effective prevention for cardiovascular events. STUDY DESIGN: DECREASE-VII is a phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of early postoperative dual antiplatelet therapy (aspirin and clopidogrel) for the prevention of cardiovascular events after major vascular surgery. Eligible patients undergoing a major vascular surgery (abdominal aorta or lower extremity vascular surgery) who developed perioperative asymptomatic troponin release are randomized 1:1 to clopidogrel or placebo (300-mg loading dose, followed by 75 mg daily) in addition to standard medical treatment with aspirin. The primary efficacy end point is the composite of cardiovascular death, stroke, or severe ischemia of the coronary or peripheral arterial circulation leading to an intervention. The evaluation of long-term safety includes bleeding defined by TIMI criteria. Recruitment began early 2010. The trial will continue until 750 patients are included and followed for at least 12 months. SUMMARY: DECREASE-VII is evaluating whether early postoperative dual antiplatelet therapy for patients developing asymptomatic cardiac ischemia after vascular surgery reduces cardiovascular events with a favorable safety profile.

Safety of fluvastatin in patients undergoing high-risk non-cardiac surgery.

IMPORTANCE OF THE FIELD: In patients undergoing vascular surgery there is a high incidence of adverse cardiac events, due to sudden coronary plaque rupture. The non-lipid lowering or pleiotropic effects of statins can help reduce adverse cardiovascular events associated with vascular surgery. AREAS COVERED IN THIS REVIEW: The evidence for perioperative use of fluvastatin, as well as other statins, in high-risk surgery patients is summarized in this review. Data on pharmacokinetics and metabolism is presented, together with considerations on possible drug interactions in the perioperative period. WHAT THE READER WILL GAIN: The reader will gain a comprehensive understanding of the existing safety and efficacy data for fluvastatin and other statins in the perioperative period. The practical considerations of perioperative fluvastatin therapy will be presented, including potential side-effects and management of the early non-oral phase immediately post surgery. Finally, advice on when to initiate therapy and safety recommendations are offered. TAKE HOME MESSAGE: In patients scheduled for high-risk vascular surgery, fluvastatin improves postoperative outcome, reducing the incidence of myocardial damage by approximately 50% in the first 30 days following vascular surgery. In comparison with placebo, fluvastatin was not associated with a rise in liver enzymes or creatine kinase levels. To bridge the non-oral phase, an extended-release formula is recommended.