Editor’s Choice – Recommendations for Registry Data Collection for Revascularisations of Acute Limb Ischaemia: A Delphi Consensus from the International Consortium of Vascular Registries

Objective

To develop a minimum core data set for evaluation of acute limb ischaemia (ALI) revascularisation treatment and outcomes that would enable collaboration among international registries.

Methods

A modified Delphi approach was used to achieve consensus among international multidisciplinary vascular specialists and registry members of the International Consortium of Vascular Registries (ICVR). Variables identified in the literature or suggested by the expert panel, and variables, including definitions, currently used in 15 countries in the ICVR, were assessed to define both a minimum core and an optimum data set to register ALI treatment. Clinical relevance and practicability were both assessed, and consensus was defined as ≥ 80% agreement among participants.

Results

Of 40 invited experts, 37 completed a preliminary survey and 31 completed the two subsequent Delphi rounds via internet exchange and face to face discussions. In total, 117 different items were generated from the various registry data forms, an extensive review of the literature, and additional suggestions from the experts, for potential inclusion in the data set. Ultimately, 35 items were recommended for inclusion in the minimum core data set, including 23 core items important for all registries, and an additional 12 more specific items for registries capable of capturing more detail. These 35 items supplement previous data elements recommended for registering chronic peripheral arterial occlusive disease treatment.

Conclusion

A modified Delphi study allowed 37 international vascular registry experts to achieve a consensus recommendation for a minimum core and an optimum data set for registries covering patients who undergo ALI revascularisation. Continued global harmonisation of registry infrastructure and definition of items allows international comparisons and global quality improvement. Furthermore, it can help to define and monitor standards of care and enable international research collaboration.

Link

https://www.ejves.com/article/S1078-5884(19)30122-4/fulltext

International Consortium of Vascular Registries Consensus Recommendations for Peripheral Revascularisation Registry Data Collection

Objective/Background

To achieve consensus on the minimum core data set for evaluation of peripheral arterial revascularisation outcomes and enable collaboration among international registries.

Methods

A modified Delphi approach was used to achieve consensus among international vascular surgeons and registry members of the International Consortium of Vascular Registries (ICVR). Variables, including definitions, from registries covering open and endovascular surgery, representing 14 countries in ICVR, were collected and analysed to define a minimum core data set and to develop an optimum data set for registries. Up to three different levels of variable specification were suggested to allow inclusion of registries with simpler versus more complex data capture, while still allowing for data aggregation based on harmonised core definitions.

Results

Among 31 invited experts, 25 completed five Delphi rounds via internet exchange and face to face discussions. In total, 187 different items from the various registry data forms were identified for potential inclusion in the recommended data set. Ultimately, 79 items were recommended for inclusion in minimum core data sets, including 65 items in the level 1 data set, and an additional 14 items in the more specific level 2 and 3 recommended data sets. Data elements were broadly divided into (i) patient characteristics; (ii) comorbidities; (iii) current medications; (iv) lesion treated; (v) procedure; (vi) bypass; (vii) endarterectomy (viii) catheter based intervention; (ix) complications; and (x) follow up.

Conclusion

A modified Delphi study allowed 25 international vascular registry experts to achieve a consensus recommendation for a minimum core data set and an optimum data set for peripheral arterial revascularisation registries. Continued global harmonisation of registry infrastructure and definition of items will overcome limitations related to single country investigations and enhance the development of real world evidence.

Link: https://www.ejves.com/article/S1078-5884(18)30213-2/fulltext

International Consortium of Vascular Registries

The International Consortium of Vascular Registries (ICVR) has rapidly developed into a global collaborative. Given the importance of vascular devices for public health, this is a priority direction for regulators, manufacturers, payers and patients advocacy groups. It is an innovative effort building on successes achieved in orthopedics and promotes cohesion among international registries. The ICVR will enable a collaboration of stakeholders to create a sustainable global system to evaluate the safety and efficacy of new and existing vascular devices and procedures, while promoting innovation and quality improvement.

Link: https://link.springer.com/article/10.1007/s00772-018-0475-8

The Challenge of Data Privacy Compliant Registry Based Research

Large scale use of real world data in vascular research projects has become a central point for discussion among scientific collaborations worldwide. As there is a distinct diversity of patients with various vascular diseases undergoing a broad range of diagnostic and treatment approaches, it remains unclear whether results from randomised controlled trials (RCTs) can always reflect the non-homogeneous treatment reality. In addition, the design of a RCT is not suited for quality improvement. To improve the paucity of evidence and to implement quality improvement in vascular maintenance, several national registries and international collaborations such as VASCUNET (including 12 registries in Europe, Australia, and New Zealand) or the International Consortium of Vascular Registries (ICVR) are collecting an increasing amount of data.

Link: https://www.ejves.com/article/S1078-5884(18)30116-3/abstract

The Strengths and Limitations of Claims Based Research in Countries With Fee for Service Reimbursement

Summary

Recently, data privacy compliance, as well as the strengths and limitations of registry based research in vascular medicine have been scrutinised,1–3 and health insurance claims, as a source of real world evidence, regain the attention of the scientific community. In several European countries health insurance claims and statutory hospital episode statistics are becoming accessible for secondary research.4

Link: https://www.ejves.com/article/S1078-5884(18)30350-2/abstract

International Variations in Amputation Practice: A VASCUNET Report

Objectives
To study international differences in incidence and practice patterns as well as time trends in lower limb amputations related to peripheral arterial disease and/or diabetes mellitus.

Methods
Data on lower limb amputations during 2010–2014 were collected from population based administrative data from countries in Europe and Australasia participating in the VASCUNET collaboration. Amputation rates, time trends, in hospital or 30 day mortality and reimbursement systems were analysed.

Results
Data from 12 countries covering 259 million inhabitants in 2014 were included. Individuals aged ≥ 65 years ranged from 12.9% (Slovakia) to 20.7% (Germany) and diabetes prevalence among amputees from 25.7% (Finland) to 74.3% (Slovakia). The mean incidence of major amputation varied between 7.2/100,000 (New Zealand) and 41.4/100,000 (Hungary), with an overall declining time trend with the exception of Slovakia, while minor amputations increased over time. The older age group (≥65 years) was up to 4.9 times more likely to be amputated compared with those younger than 65 years. Reported mortality rates were lowest in Finland (6.3%) and highest in Hungary (20.3%). Countries with a fee for service reimbursement system had a lower incidence of major amputation compared with countries with a population based reimbursement system (14.3/100,000 versus 18.4/100,000, respectively, p < .001).

Conclusions
This international audit showed large geographical differences in major amputation rates, by a factor of almost six, and an overall declining time trend during the 4 year observation of this study. Diabetes prevalence, age distribution, and mortality rates were also found to vary between countries. Despite limitations attributable to registry data, these findings are important, and warrant further research on how to improve limb salvage in different demographic settings.

Link: https://www.ejves.com/article/S1078-5884(18)30260-0/fulltext 

The Impact of Centralisation and Endovascular Aneurysm Repair on Treatment of Ruptured Abdominal Aortic Aneurysms Based on International Registries

Objectives

Current management of ruptured abdominal aortic aneurysms (RAAA) varies among centres and countries, particularly in the degree of implementation of endovascular aneurysm repair (EVAR) and levels of vascular surgery centralisation. This study assesses these variations and the impact they have on outcomes.

Materials and methods

RAAA repairs from vascular surgical registries in 11 countries, 2010–2013, were investigated. Data were analysed overall, per country, per treatment modality (EVAR or open aortic repair [OAR]), centre volume (quintiles I V), and whether centres were predominantly EVAR (≥50% of RAAA performed with EVAR [EVAR(p)]) or predominantly OAR [OAR(p)]. Primary outcome was peri-operative mortality. Data are presented as either mean values or percentages with 95% CI within parentheses, and compared with chi-square tests, as well as with adjusted OR.

Results

There were 9273 patients included. Mean age was 74.7 (74.5–74.9) years, and 82.7% of patients were men (81.9–83.6). Mean AAA diameter at rupture was 7.6 cm (7.5–7.6). Of these aneurysms, 10.7% (10.0–11.4) were less than 5.5 cm. EVAR was performed in 23.1% (22.3–24.0). There were 6817 procedures performed in OAR(p) centres and 1217 performed in EVAR(p) centres. Overall peri-operative mortality was 28.8% (27.9–29.8). Peri-operative mortality for OAR was 32.1% (31.0–33.2) and for EVAR 17.9% (16.3–19.6), p < .001, and the adjusted OR was 0.38 (0.31–0.47), p < .001. The peri-operative mortality was 23.0% in EVAR(p) centres (20.6–25.4), 29.7% in OAR(p) centres (28.6–30.8), p < .001; adjusted OR = 0.60 (0.46–0.78), p < .001. Peri-operative mortality was lower in the highest volume centres (QI > 22 repairs per year), 23.3% (21.2–25.4) than in QII-V, 30.0% (28.9–31.1), p < .001. Peri-operative mortality after OAR was lower in high volume centres compared with the other centres, 25.3% (23.0–27.6) and 34.0% (32.7–35.4), respectively, p < .001. There was no significant difference in peri-operative mortality after EVAR between centres based on volume.

Conclusions

Peri-operative mortality is lower in centres with a primary EVAR approach or with high case volume. Most repairs, however, are still performed in low volume centres and in centres with a primary OAR strategy. Reorganisation of acute vascular surgical services may improve outcomes of RAAA repair.

Link: http://www.ejves.com/article/S1078-5884(18)30050-9/fulltext

 

Assessment of International Outcomes of Intact Abdominal Aortic Aneurysm Repair over 9 Years

BACKGROUND:

Case mix and outcomes of complex surgical procedures vary over time and between regions. This study analyses peri-operative mortality after intact abdominal aortic aneurysm (AAA) repair in 11 countries over 9 years.

METHODS:

Data on primary AAA repair from vascular surgery registries in 11 countries for the years 2005-2009 and 2010-2013 were analysed. Multivariate adjusted logistic regression analyses were carried out to adjust for variations in case mix.

RESULTS:

A total of 83,253 patients were included. Over the two periods, the proportion of patients ≥80 years old increased (18.5% vs. 23.1%; p < .0001) as did the proportion of endovascular repair (EVAR) (44.3% vs. 60.6; p < .0001). In the latter period, 25.8% of AAAs were less than 5.5 cm. The mean annual volume of open repairs per centre decreased from 12.9 to 10.6 between the two periods (p < .0001), and it increased for EVAR from 10.0 to 17.1 (p < .0001). Overall, peri-operative mortality fell from 3.0% to 2.4% (p < .0001). Mortality for EVAR decreased from 1.5% to 1.1% (p < .0001), but the outcome worsened for open repair from 3.9% to 4.4% (p = .008). The peri-operative risk was greater for octogenarians (overall, 3.6% vs. 2.1%, p < .0001; open, 9.5% vs. 3.6%, p < .0001; EVAR, 1.8% vs. 0.7%, p < .0001), and women (overall, 3.8% vs. 2.2%, p < .0001; open, 6.0% vs. 4.0%, p < .0001; EVAR, 1.9% vs. 0.9%, p < .0001). Peri-operative mortality after repair of AAAs <5.5 cm was 4.4% with open repair and 1.0% with EVAR, p < .0001.

CONCLUSIONS:

In this large international cohort, total peri-operative mortality continues to fall for the treatment of intact AAAs. The number of EVAR procedures now exceeds open procedures. Mortality after EVAR has decreased, but mortality for open operations has increased. The peri-operative mortality for small AAA treatment, particularly open surgical repair, is still considerable and should be weighed against the risk of rupture.

Link: https://www.ncbi.nlm.nih.gov/pubmed/28416191

Editor’s Choice – Carotid Stenosis Treatment: Variation in International Practice Patterns

OBJECTIVES:

The aim was to determine current practice for the treatment of carotid stenosis among 12 countries participating in the International Consortium of Vascular Registries (ICVR).

METHODS:

Data from the United States Vascular Quality Initiative (VQI) and the Vascunet registry collaboration (including 10 registries in Europe and Australasia) were used. Variation in treatment modality of asymptomatic versus symptomatic patients was analysed between countries and among centres within each country.

RESULTS:

Among 58,607 procedures, octogenarians represented 18% of all patients, ranging from 8% (Hungary) to 22% (New Zealand and Australia). Women represented 36%, ranging from 29% (Switzerland) to 40% (USA). The proportion of carotid artery stenting (CAS) among asymptomatic patients ranged from 0% (Finland) to 26% (Sweden) and among symptomatic patients from 0% (Denmark) to 19% (USA). Variation among centres within countries for CAS was highest in the United States and Australia (from 0% to 80%). The overall proportion of asymptomatic patients was 48%, but varied from 0% (Denmark) to 73% (Italy). There was also substantial centre level variation within each country in the proportion of asymptomatic patients, most pronounced in Australia (0-72%), Hungary (5-55%), and the United States (0-100%). Countries with fee for service reimbursement had higher rates of treatment in asymptomatic patients than countries with population based reimbursement (OR 5.8, 95% CI 4.4-7.7).

CONCLUSIONS:

Despite evidence about treatment options for carotid artery disease, the proportion of asymptomatic patients, treatment modality, and the proportion of women and octogenarians vary considerably among and within countries. There was a significant association of treating more asymptomatic patients in countries with fee for service reimbursement. The findings reflect the inconsistency of the existing guidelines and a need for cooperation among guideline committees all over the world.

Link: https://www.ncbi.nlm.nih.gov/pubmed/28274551

Few internal iliac artery aneurysms rupture under 4 cm

OBJECTIVE:

This study investigated the diameter of internal iliac artery (IIA) aneurysms (IIAAs) at the time of rupture to evaluate whether the current threshold diameter for elective repair of 3 cm is reasonable. The prevalence of concomitant aneurysms and results of surgical treatment were also investigated.

METHODS:

This was a retrospective analysis of patients with ruptured IIAA from seven countries. The patients were collected from vascular registries and patient records of 28 vascular centers. Computed tomography images taken at the time of rupture were analyzed, and maximal diameters of the ruptured IIA and other aortoiliac arteries were measured. Data on the type of surgical treatment, mortality at 30 days, and follow-up were collected.

RESULTS:

Sixty-three patients (55 men and 8 women) were identified, operated on from 2002 to 2015. The patients were a mean age of 76.6 years (standard deviation, 9.0; range 48-93 years). A concomitant common iliac artery aneurysm was present in 65.0%, 41.7% had a concomitant abdominal aortic aneurysm, and 36.7% had both. IIAA was isolated in 30.0%. The mean maximal diameter of the ruptured artery was 68.4 mm (standard deviation, 20.5 mm; median, 67.0 mm; range, 25-116 mm). One rupture occurred at <3 cm and four at <4 cm (6.3% of all ruptures). All patients were treated, 73.0% by open repair and 27.0% by endovascular repair. The 30-day mortality was 12.7%. Median follow-up was 18.3 months (interquartile range, 2.0-48.3 months). The 1-year Kaplan-Meier estimate for survival was 74.5% (standard error, 5.7%).

CONCLUSIONS:

IIAA is an uncommon condition and mostly coexists with other aortoiliac aneurysms. Follow-up until a diameter of 4 cm seems justified, at least in elderly men, although lack of surveillance data precludes firm conclusions. The mortality was low compared with previously published figures and lower than mortality in patients with ruptured abdominal aortic aneurysm.

Link: https://www.ncbi.nlm.nih.gov/pubmed/28010870