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A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review.

ABSTRACT: OBJECTIVE:The accurate measurement of reintervention after endovascular aneurysm repair (EVAR) is critical during postoperative surveillance. The purpose of this study was to compare reintervention rates after EVAR from three different data sources: the Vascular Quality Initiative (VQI) alone, VQI linked to Medicare claims (VQI-Medicare), and a "gold standard" of clinical chart review supplemented with telephone interviews. METHODS:We reviewed the medical records of 729 patients who underwent EVAR at our institution between 2003 and 2013. We excluded patients without follow-up reported to the VQI (n = 68 [9%]) or without Medicare claims information (n = 114 [16%]). All patients in the final analytic cohort (n = 547) had follow-up information available from all three data sources (VQI alone, VQI linked to Medicare, and chart review). We then compared reintervention rates between the three data sources. Our primary end points were the agreement between the three data sources and the Kaplan-Meier estimated rate of reintervention at 1 year, 2 years, and 3 years after EVAR. For gold standard assessment, we supplemented chart review with telephone interview as necessary to assess reintervention. RESULTS:VQI data alone identified 12 reintervention events in the first year after EVAR. Chart review confirmed all 12 events and identified 18 additional events not captured by the VQI. VQI-Medicare data successfully identified all 30 of these events within the first year. VQI-Medicare also documented four reinterventions in this time period that did not occur on the basis of patient interview (4/547 [0.7%]). The agreement between chart review and VQI-Medicare data at 1 year was excellent (? = 0.93). At 3 years, there were 81 (18%) reinterventions detected by VQI-Medicare and 70 (16%) detected by chart review for a sensitivity of 92%, specificity of 96%, and ? of 0.80. Kaplan-Meier survival analysis demonstrated similar reintervention rates after 3 years between VQI-Medicare and chart review (log-rank, P = .59). CONCLUSIONS:Chart review after EVAR demonstrated a 6% 1-year and 16% 3-year reintervention rate, and almost all (92%) of these events were accurately captured using VQI-Medicare data. Linking VQI data with Medicare claims allows an accurate assessment of reintervention rates after EVAR without labor-intensive physician chart review.

SUBMITTER: Columbo JA

PROVIDER: S-EPMC6481637 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review.

Columbo Jesse A JA Kang Ravinder R Hoel Andrew W AW Kang Jeanwan J Leinweber Kathleen A KA Tauber Karissa S KS Hila Regis R Ramkumar Niveditta N Sedrakyan Art A Goodney Philip P PP

Journal of vascular surgery 20180615 1

<h4>Objective</h4>The accurate measurement of reintervention after endovascular aneurysm repair (EVAR) is critical during postoperative surveillance. The purpose of this study was to compare reintervention rates after EVAR from three different data sources: the Vascular Quality Initiative (VQI) alone, VQI linked to Medicare claims (VQI-Medicare), and a "gold standard" of clinical chart review supplemented with telephone interviews.<h4>Methods</h4>We reviewed the medical records of 729 patients w ...[more]

PMID: 29914838

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Project description:ObjectivePatients who undergo endovascular abdominal aortic aneurysm repair (EVR) remain at risk for reintervention and rupture. We sought to define the 5-year rate of reintervention and rupture after EVR in the Vascular Quality Initiative (VQI).MethodsWe identified all patients in the VQI who underwent EVR from 2003 to 2015. We linked patients in the VQI to Medicare claims for long-term outcomes. We stratified patients on baseline clinical and procedural characteristics to identify those at risk for reintervention. Our primary outcomes were 5-year rates of reintervention and late aneurysm rupture after EVR. We assessed these with Kaplan-Meier survival estimation.ResultsWe studied 12,911 patients who underwent EVR. The mean age was 75.5 years, 79.9% were male, 3.9% were black, and 89.1% of operations were performed electively. The 5-year rate of reintervention for the entire cohort was 21%, and the 5-year rate of late aneurysm rupture was 3%. Reintervention rates varied across categories of EVR urgency. Patients who underwent EVR electively had the lowest 5-year rate of reintervention at 20%. Those who underwent surgery for symptomatic aneurysms had higher rates of reintervention at 25%. Patients undergoing EVR emergently for rupture had the highest rate of reintervention, 27% at 4 years (log-rank across the three groups, P < .001). Black race and aneurysm size of 6.0 cm or greater were associated with significantly elevated reintervention rates (black, 31% vs white, 20% [log-rank, P < .001]; aneurysm size 6.0 cm or greater, 27% vs all others, <20% [log-rank, P < .001]). There were no significant associations between age or gender and the 5-year rate of reintervention.ConclusionsMore than one in five Medicare patients undergo reintervention within 5 years after EVR in the VQI; late rupture remains low at 3%. Black patients, those with large aneurysms, and those who undergo EVR urgently and emergently have a higher likelihood of adverse outcomes and should be the focus of diligent long-term surveillance.

Project description:Abstract Objective To evaluate long term outcomes (reintervention and late rupture of abdominal aortic aneurysm) of aortic endografts in real world practice using linked registry claims data. Design Observational surveillance study. Setting 282 centers in the Vascular Quality Initiative Registry linked to United States Medicare claims (2003-18). Participants 20 489 patients treated with four device types used for endovascular abdominal aortic aneurysm repair (EVAR): 40.6% (n=8310) received the Excluder (Gore), 32.2% (n=6606) the Endurant (Medtronic), 16.0% (n=3281) the Zenith (Cook Medical), and 11.2% (n=2292) the AFX (Endologix). Given modifications to AFX in late 2014, patients who received the AFX device were categorized into two groups: the early AFX group (n=942) and late AFX group (n=1350) and compared with patients who received the other devices, using propensity matched Cox models. Main outcome measures Reintervention and rupture of abdominal aortic aneurysm post-EVAR; all patients (100%) had complete follow-up via the registry or claims based outcome assessment, or both. Results Median age was 76 years (interquartile range (IQR) 70-82 years), 80.0% (16 386/20 489) of patients were men, and median follow-up was 2.3 years (IQR 0.9-4.1 years). Crude five year reintervention rates were significantly higher for patients who received the early AFX device compared with the other devices: 14.9% (95% confidence interval 13.7% to 16.2%) for Excluder, 19.5% (18.1% to 21.1%) for Endurant, 16.7% (15.0% to 18.6%) for Zenith, and early 27.0% (23.7% to 30.6%) for the early AFX. The risk of reintervention for patients who received the early AFX device was higher compared with the other devices in propensity matched Cox models (hazard ratio 1.61, 95% confidence interval 1.29 to 2.02) and analyses using a surgeon level instrumental variable of >33% AFX grafts used in their practice (1.75, 1.19 to 2.59). The linked registry claims surveillance data identified the increased risk of reintervention with the early AFX device as early as mid-2013, well before the first regulatory warnings were issued in the US in 2017. Conclusions The linked registry claims surveillance data identified a device specific risk in long term reintervention after EVAR of abdominal aortic aneurysm. Device manufacturers and regulators can leverage linked data sources to actively monitor long term outcomes in real world practice after cardiovascular interventions.

Project description:Open conversion after endovascular aortic aneurysm repair (EVAR-c) is performed nonelectively in up to 60% of cases. EVAR-c has been reported to have significantly greater risk of postoperative morbidity and mortality than primary aortic repair, but few data exist on outcomes for symptomatic or ruptured presentations. This study determined outcomes and identified predictors of postoperative major adverse cardiac events (MACEs) and mortality for patients undergoing nonelective EVAR-c compared with nonelective primary aortic repair (PAR) in the Vascular Quality Initiative (VQI).All VQI patients undergoing urgent/emergency EVAR-c or urgent/emergency PAR from 2002 to 2014 were reviewed. Urgent presentation was defined by repair ≤24 hours of a nonelective admission, and emergency operations had clinical or radiographic evidence, or both, of rupture. End points included in-hospital MACE (myocardial infarction, dysrhythmia, congestive heart failure) and 30-day mortality. Possible covariates identified on univariate analysis (P < .2) were entered into a multivariable model, and stepwise elimination identified the best subset of predictors. Generalized estimating equations logistic regression analysis was used to determine the relative effect of EVAR-c compared with PAR on outcomes.During the study interval, we identified 277 EVAR-c, and 118 (43%) underwent urgent/emergency repair. nonelective PAR was performed in 1388 of 6152 total (23%). EVAR-c patients were older (75 ± 9 vs 71 ± 10 years; P < .0001), more likely to be male (84% vs 74%; P = .02), and had a higher prevalence of hypertension (88% vs 79%; P = .02) and coronary artery disease (38% vs 27%; P = .01). No differences in MACE (EVAR-c, 31% [n = 34] vs PAR, 30% [n = 398]) or any major postoperative complication (EVAR-c, 57% [n = 63] vs PAR, 55% [n = 740]; P = .8) were found; however, 30-day mortality was significantly greater in EVAR-c (37% [n = 41]) than in (PAR, 24% [n = 291]; P = .003), with an odds ratio (OR) of 2.2 (95% confidence interval [CI], 1.04-4.77; P = .04) for EVAR-c. Predictors of any MACE included age (OR, × 1.03 for each additional year; 95% CI, 1.01-1.03; P = .0002), male gender (OR, 1.3; 95% CI, 1.03-1.67; P = .03), body mass index ≤20 kg/m2 (OR, 1.8; 95% CI, 1.13-2.87; P = .01), chronic obstructive pulmonary disease (OR, 1.2; 95% CI, 0.86-1.80; P = .25), congestive heart failure (OR, 1.5; 95% CI, 0.98-2.34; P = .06), preoperative chronic β-blocker use (OR, 1.3; 95% CI, 0.97-1.63; P = .09), and emergency presentation (OR, 2.3; 95% CI, 1.8-3.01; area under the curve, 0.70; P < .0001). Significant predictors for 30-day mortality were age (OR × 1.07 for each additional year; 95% CI, 1.05-1.09; P < .0001), female gender (OR, 1.6; 95% CI, 1.01-2.46; P = .04), preoperative creatinine >1.8 mg/dL (OR, 1.6; 95% CI, 1.04-2.35; P = .03), an emergency presentation (OR, 4.8; 95% CI, 2.93-7.93; P < .0001), and renal/visceral ischemia (OR, × 1.1 for each unit increase log (time-minutes); 95% CI, 1.02-1.22; area under the curve, 0.84; P = .01).Nonelective EVAR-c patients are older and have higher prevalence of cardiovascular risk factors than PAR patients. Similar rates of postoperative complications occur; however, urgent/emergency EVAR-c has a significantly higher risk of 30-day mortality than nonelective PAR. Several variables are identified that predict outcomes after these repairs and may help risk stratify patients to further inform clinical decision making when patients present nonelectively with EVAR failure.

Project description:ObjectivesPeripheral artery disease is estimated to affect 237 million individuals worldwide. Critical limb ischaemia, also known as chronic limb threatening ischaemia is a consequence of the progression of peripheral artery disease which occurs in ∼21% of patients over a five-year period. The aim of this systematic review is to assess the use of additional below-the-ankle angioplasty in comparison to the use of above-the-ankle angioplasty alone, and the subsequent rates of amputation, wound healing, restenosis, rest pain, reintervention and complications.MethodsThis systematic review was undertaken in accordance with PRISMA guidelines following a registered protocol (CRD42019154893). Online databases were searched using a search strategy of 20 keywords. Included articles reported the outcome for inframalleolar (pedal artery, pedal arch, plantar arteries) angioplasty with additional proximal angioplasty in comparison to proximal angioplasty alone. GRADE assessment was applied to assess the quality of the evidence.ResultsAfter screening 1089 articles, 10 articles met the inclusion criteria. Comparative performance assessment of below-the-ankle with above-the-ankle versus above-the-ankle angioplasty alone was undertaken in 3 articles, with the remaining 7 articles reporting outcomes of below-the-ankle with above-the-ankle angioplasty with no distinct comparator group. Significant decrease in major lower limb amputation at the last follow-up in the below-the-ankle group when compared with the above-the-ankle angioplasty alone group was observed in a single study (3.45% vs. 14.9%, p < 0.05). Improved wound healing rate at follow-up in the below-the-ankle group versus above-the-ankle angioplasty alone group was also reported in a single study (59.3% vs. 38.1%, p < 0.05). Subsequent rate of amputation after below-the-ankle angioplasty has been estimated as 23.5%.ConclusionTo date, there is a lack of studies assessing inframalleolar interventions and their use in improving limb salvage, wound healing and symptomatology. Prospective RCTs should be undertaken with adequate participant numbers to be sufficiently powered and report clinically important end-points.

Project description:BackgroundThe linkage of registries to Medicare claims data can help extend follow-up for patients receiving medical devices. In the present study, we tested and validated an algorithm that does not require patient identifiers to link data from a national vascular registry and Medicare claims data.MethodsWe used data from the Vascular Quality Initiative (VQI), a registry capturing data from >600 centers for several different vascular procedures, and Medicare claims from 2003 to 2018. We restricted the study to patients aged ≥65 years who had fee-for-service entitlement at their procedure. We performed an indirect linkage to combine the VQI and Medicare data at the patient level using a sequential algorithm based on the patient's date of birth, sex, zip code, procedure date, and procedure facility. We compared the indirectly linked cohort against a reference standard of a cohort directly linked using Social Security numbers. We calculated the matching rate and accuracy overall and before and after October 2015 when the International Classification of Diseases, 10th revision (ICD-10) system was adopted in the United States.ResultsA total of 144,045 VQI-Medicare-linked patients were in the reference standard cohort. Using the indirect linking algorithm, we matched 133,966 of the 144,045 VQI patients to their Medicare claims with a matching rate of 93.0%. Of the 133,966 patients, 133,104 were correctly matched (matching accuracy, 99.4%). The matching rate was higher when the indirect linkage was implemented using the ICD-10 coded data than using the ICD-9 coded data (94.0% vs 92.2%). The accuracy of the indirect linkage remained high for all procedure modules after the ICD-10 coding change (overall, 99.4%; range, 99.0%-99.7%).ConclusionsIn the present study, we successfully used indirect identifiers to link the VQI data to Medicare claims with >90% success and >99% accuracy. When direct linkage of the registry claims data using Social Security numbers is not possible because of availability or confidentiality, or both, our algorithm for indirect linkage provides a suitable alternative. The matching rate and accuracy will help ensure the accuracy of long-term follow-up and the completeness and representativeness of linked databases for relevant research and quality improvement initiatives.

Project description:BackgroundEndovascular aneurysm sealing (EVAS), using the Nellix endovascular aneurysm sealing system, has been associated with high reintervention and migration rates. However, prior reports have suggested that EVAS might be related to a lower all-cause mortality compared with endovascular aneurysm repair (EVAR). In the present study, we examined the 5-year all-cause mortality trends after EVAS and EVAR.MethodsWe compared the 333 EVAS patients in the EVAS-1 Nellix U.S. investigational device exemption trial with 16,497 infrarenal EVAR controls from the Vascular Quality Initiative, treated between 2014 and 2016, after applying the exclusion criteria from the investigational device exemption trial (ie, hemodialysis, creatinine >2.0 mg/dL, rupture). As a secondary analysis, we stratified the patients by aneurysm diameter (<5.5 cm and ≥5.5 cm). We calculated propensity scores after adjusting for demographics, comorbidities, and anatomic characteristics and applied inverse probability weighting to compare the risk-adjusted long-term mortality using Kaplan-Meier and Cox regression analyses.ResultsAfter weighting, the EVAS group had experienced similar 5-year mortality compared with the controls from the Vascular Quality Initiative (EVAS vs EVAR, 18% vs 14%; hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.71-1.7; P = .70). The subgroup analysis demonstrated that for patients with an aneurysm diameter of <5.5 cm, EVAS was associated with higher 5-year mortality compared with EVAR (19% vs 11%; HR, 2.4; 95% CI, 1.7-4.7; P = .013). In patients with an aneurysm diameter of ≥5.5 cm, EVAS was associated with lower mortality within the first 2 years (2-year mortality: HR, 0.29; 95% CI, 0.13-0.62; P = .002). However, compared with EVAR, EVAS was associated with higher mortality between 2 and 5 years (HR, 1.9; 95% CI, 1.2-3.0; P = .005), with no mortality difference at 5 years (18% vs 17%; HR, 0.82; 95% CI, 0.4-1.4; P = .46).ConclusionsWithin the overall population, EVAS was associated with similar 5-year mortality compared with EVAR. EVAS was associated with higher mortality for those with small aneurysms (<5.5 cm). For those with larger aneurysms (≥5.5 cm), EVAS was initially associated with lower mortality within the first 2 years, although this advantage was lost thereafter, with higher mortality after 2 years. Future studies are required to evaluate the specific causes of death and to elucidate the potential beneficial mechanism behind sac obliteration that leads to this potential initial survival benefit. This could help guide the development of future grafts with better proximal fixation and sealing that also incorporate sac obliteration.

Dataset Information

A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review.

Publications

A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review.

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