Dataset Information

Percutaneous endovascular treatment of infrainguinal PAOD: Results of the PSI register study in 74 German vascular centers.

ABSTRACT:

Background

The percutaneous infrainguinal stent (PSI) register study aimed to collate all percutaneous endovascular procedures for infrainguinal peripheral arterial occlusive disease (PAOD) conducted in 74 German vascular centers between September and November 2015 (3 months). In order to obtain representative results all consecutive treatment procedures had to be submitted by the participating trial centers.

Material and methods

This was a prospective, nonrandomized multicenter study design. All patients suffering from intermittent claudication (IC, Fontaine stage II) or critical limb ischemia (CLI, Fontaine stages III and IV) were included. Trial centers with less than 5 cases reported within the 3?month trial period or centers that could not ensure the submission of all treated patients were excluded.

Results

In the final assessment 2798 treated cases from 74 trial centers were reported of which 65 (87.8?%) centers were under the leadership of a vascular surgeon. Approximately 33?% of the interventions in centers under the leadership of vascular surgeons were conducted by radiologists. Risk factors, especially chronic renal disease, diabetes and cardiac risk factors were significantly different between patients with IC and CLI. Of the patients with Fontaine stage II PAOD 41.3?% had 3 patent crural vessels compared to only 10.8?% of patients with Fontaine stage IV. With respect to peri-interventional complications, percutaneous endovascular treatment of IC was a safe procedure with severe complications in less than 1?% and no fatalities. Only 4.5?% of the procedures were conducted under ambulatory conditions. In the supragenual region self-expanding bare metal stents, standard percutaneous transluminal angioplasty (PTA) and drug-coated balloons were the most frequently used procedures. For interventions below the knee, standard PTA was the most commonly employed treatment.

Conclusion

The main aim of the PSI study was to obtain a realistic picture of percutaneous endovascular techniques used to treat suprapopliteal and infrapopliteal PAOD lesions and to describe the treatment procedures used by vascular specialists in Germany. To investigate the change in trends for treatment over time, this study has to be repeated in the future in order to test how quickly the results of randomized studies can be implemented in practice.

SUBMITTER: Behrendt CA

PROVIDER: S-EPMC5306226 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Publications

Percutaneous endovascular treatment of infrainguinal PAOD: Results of the PSI register study in 74 German vascular centers.

Behrendt C-A CA Heidemann F F Haustein K K Grundmann R T RT Debus E S ES

Gefasschirurgie : Zeitschrift fur vaskulare und endovaskulare Chirurgie : Organ der Deutschen und der Osterreichischen Gesellschaft fur Gefasschirurgie unter Mitarbeit der Schweizerischen Gesellschaft fur Gefasschirurgie 20161028 Suppl 1

<h4>Background</h4>The percutaneous infrainguinal stent (PSI) register study aimed to collate all percutaneous endovascular procedures for infrainguinal peripheral arterial occlusive disease (PAOD) conducted in 74 German vascular centers between September and November 2015 (3 months). In order to obtain representative results all consecutive treatment procedures had to be submitted by the participating trial centers.<h4>Material and methods</h4>This was a prospective, nonrandomized multicenter s ...[more]

PMID: 28715513

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Project description:Unplanned hospital readmissions following surgical interventions are associated with adverse events and contribute to increasing health care costs. Despite numerous studies defining risk factors following lower extremity bypass surgery, evidence regarding readmission after endovascular interventions is limited. This study aimed to identify predictors of 30-day unplanned readmission following infrainguinal endovascular interventions.We identified all patients undergoing an infrainguinal endovascular intervention in the targeted vascular module of the American College of Surgeons National Surgical Quality Improvement Program between 2012 and 2014. Perioperative outcomes were stratified by symptom status (chronic limb-threatening ischemia [CLI] vs claudication). Patients who died during index admission and those who remained in the hospital after 30 days were excluded. Indications for unplanned readmission related to the index procedure were evaluated. Multivariable logistic regression was used to identify preoperative and in-hospital (during index admission) risk factors of 30-day unplanned readmission.There were 4449 patients who underwent infrainguinal endovascular intervention, of whom 2802 (63%) had CLI (66% tissue loss) and 1647 (37%) had claudication. The unplanned readmission rates for CLI and claudication patients were 16% (n = 447) and 6.5% (n = 107), respectively. Mortality after index admission was higher for readmitted patients compared with those not readmitted (CLI, 3.4% vs 0.7% [P < .001]; claudication, 2.8% vs 0.1% [P < .01]). Approximately 50% of all unplanned readmissions were related to the index procedure. Among CLI patients, the most common indication for readmission related to the index procedure was wound or infection related (42%), whereas patients with claudication were mainly readmitted for recurrent symptoms of peripheral vascular disease (28%). In patients with CLI, predictors of unplanned readmission included diabetes (odds ratio, 1.3; 95% confidence interval, 1.01-1.6), congestive heart failure (1.6; 1.1-2.5), renal insufficiency (1.7; 1.3-2.2), preoperative dialysis (1.4; 1.02-1.9), tibial angioplasty/stenting (1.3; 1.04-1.6), in-hospital bleeding (1.9; 1.04-3.5), in-hospital unplanned return to the operating room (1.9; 1.1-3.5), and discharge other than to home (1.5; 1.1-2.0). Risk factors for those with claudication were dependent functional status (3.5; 1.4-8.7), smoking (1.6; 1.02-2.5), diabetes (1.5; 1.01-2.3), preoperative dialysis (3.6; 1.6-8.3), procedure time exceeding 120 minutes (1.8; 1.1-2.7), in-hospital bleeding (2.9; 1.2-7.4), and in-hospital unplanned return to the operating room (3.4; 1.2-9.4).Unplanned readmission after endovascular treatment is relatively common, especially in patients with CLI, and is associated with substantially increased mortality. Awareness of these risk factors will help providers identify patients at high risk who may benefit from early surveillance, and prophylactic measures focused on decreasing postoperative complications may reduce the rate of readmission.

Project description:ObjectiveTo evaluate the success of initiation of adjunctive brivaracetam in patients who required a change in antiepileptic drug (AED) regimen and substituted at least one AED with brivaracetam.MethodsIn this retrospective noninterventional study conducted in specialized epilepsy centers across Germany, patients initiated adjunctive brivaracetam between February 15, 2016, and August 31, 2016, as part of an intended change in AED regimen. The primary effectiveness variable was the proportion of patients who continued on brivaracetam after 3 months, and withdrew at least one AED either before or within 6 months after brivaracetam initiation.ResultsFive hundred and six patients had at least one brivaracetam dose and were included in the safety set (SS). Four hundred and seventy patients started to reduce the dose of one AED before/after brivaracetam initiation, had at least one concomitant AED at brivaracetam initiation, and were included in the full analysis set (FAS) for effectiveness analyses. At baseline, patients had a median of seven lifetime AEDs and a median of 3.8 seizures/28 days. In the SS, 85.2% of patients withdrew one AED before/after initiation of brivaracetam, most commonly levetiracetam (49.4%). 46.2% of patients substituted another AED with brivaracetam within 24 hours (fast withdrawal). The proportions of patients (FAS) who continued on brivaracetam after 3 and 6 months and withdrew one AED were 75.5% and 46.6%, respectively. After 6 months, 32.1% of patients were 50% responders; 13.0% were seizure-free. In the SS, 34.6% of patients reported treatment-emergent adverse events (TEAEs); 21.9% had TEAEs that were assessed by the treating physician as drug-related. Incidences of behavioral AEs before (3-month baseline) and after brivaracetam initiation in patients who withdrew levetiracetam were 19.2% and 8.0%, respectively (5.0% and 7.7% in patients who withdrew other AEDs).SignificanceBrivaracetam was effective and well-tolerated in patients who required a change in AED drug regimen and initiated adjunctive brivaracetam in German clinical practice.

Project description:Background/aimsInformed clinical guidance and health policy relies on clinicians, policymakers, and guideline developers finding comprehensive clinical evidence and linking registrations and publications of the same clinical trial. To support the finding and linking of trial evidence, the World Health Organization, the International Committee of Medical Journal Editors, and the Consolidated Standards of Reporting Trials ask researchers to provide the trial registration number in their publication and a reference to the publication in the registration. This practice costs researchers minimal effort and makes evidence synthesis more thorough and efficient. Nevertheless, trial evidence appears inadequately linked, and the extent of trial links in Germany remains unquantified. This cross-sectional study aims to evaluate links between registrations and publications across clinical trials conducted by German university medical centers and registered in ClinicalTrials.gov or the German Clinical Trials Registry. Secondary aims are to develop an automated pipeline that can be applied to other cohorts of trial registrations and publications, and to provide stakeholders, from trialists to registries, with guidance to improve trial links.MethodsWe used automated strategies to download and extract data from trial registries, PubMed, and results publications for a cohort of registered, published trials conducted across German university medical centers and completed between 2009 and 2017. We implemented regular expressions to detect and classify publication identifiers in registrations, and trial registration numbers in publication metadata, abstracts, and full-texts.ResultsIn breach of long-standing guidelines, 75% (1,418) of trials failed to reference trial registration numbers in both the abstract and full-text of the journal article in which the results were published. Furthermore, 50% (946) of trial registrations did not contain links to their results publications. Seventeen percent (327) of trials had no links, so that associating registration and publication required manual searching and screening. Overall, trials in ClinicalTrials.gov were better linked than those in the German Clinical Trials Registry; PubMed and registry infrastructures appear to drive this difference. Trial registration numbers were more likely to be transferred to PubMed metadata from abstracts for ClinicalTrials.gov trials than for German Clinical Trials Registry trials. Most (78%, 662/849) ClinicalTrials.gov registrations with a publication link were automatically indexed from PubMed metadata, which is not possible in the German Clinical Trials Registry.ConclusionsGerman university medical centers have not comprehensively linked trial registrations and publications, despite established recommendations. This shortcoming threatens the quality of evidence synthesis and medical practice, and burdens researchers with manually searching and linking trial data. Researchers could easily improve this by copy-and-pasting references between their trial registrations and publications. Other stakeholders could build on this practice, for example, PubMed could capture additional trial registration numbers using automated strategies (like those developed in this study), and the German Clinical Trials Registry could automatically index publications from PubMed.

Project description:OBJECTIVE:The optimal initial revascularization strategy remains uncertain for patients with peripheral arterial disease. The purpose of this study was to evaluate current nationwide selection and perioperative outcomes of patients undergoing bypass or endovascular intervention for infrainguinal disease in those with no prior ipsilateral revascularization. METHODS:Patients undergoing nonemergent first-time infrainguinal revascularization were identified in the Targeted Vascular module of the National Surgical Quality Improvement Program (NSQIP) for 2011 to 2014 and stratified by symptom status (chronic limb-threatening ischemia [CLTI] or claudication). Patients treated with endovascular intervention were compared with those who underwent bypass. Multivariable logistic regression was used to evaluate current selection of patients and to establish independent associations between first-time procedures and postoperative outcomes. RESULTS:Of 5998 first-time infrainguinal revascularizations performed, 3193 were bypass procedures (63% for CLTI) and 2805 were endovascular interventions (64% for CLTI). Current patient characteristics associated with an endovascular-first approach as opposed to bypass-first in CLTI patients were age ?80 years, tissue loss, nonsmoking, functional dependence, diabetes, dialysis, and tibial lesions, whereas age ?80 years, nonwhite race, nonsmoking, diabetes, and tibial lesions were associated with an endovascular approach for claudication. In comparing first-time endovascular intervention with bypass, there was no difference in 30-day mortality in CLTI patients (univariate: 2.1% vs 2.2%; adjusted: odds ratio [OR], 0.7; 95% confidence interval [CI], 0.4-1.1) or claudication patients (0.3% vs 0.6%). Among CLTI patients, endovascular-first intervention was associated with lower rates of major adverse cardiovascular event (3.6% vs 4.7%; OR, 0.6; 95% CI, 0.4-0.9), surgical site infection (0.9% vs 7.7%; OR, 0.1; 95% CI, 0.1-0.2), bleeding (8.5% vs 17%; OR, 0.4; 95% CI, 0.3-0.5), unplanned reoperation (13% vs 17%; OR, 0.7; 95% CI, 0.5-0.8), and unplanned readmission (17% vs 18%; OR, 0.8; 95% CI, 0.7-0.9). Patients with claudication undergoing endovascular-first intervention also had lower rates of major adverse cardiovascular event (0.8% vs 1.6%; OR, 0.4; 95% CI, 0.2-0.95), surgical site infection (0.7% vs 6.6%; OR, 0.1; 95% CI, 0.04-0.2), bleeding (2.3% vs 6.0%; OR, 0.3; 95% CI, 0.2-0.5), unplanned reoperation (4.3% vs 6.6%; OR, 0.6; 95% CI, 0.4-0.9), and unplanned readmission (5.9% vs 9.0%; OR, 0.6; 95% CI, 0.4-0.8). Conversely, endovascular-first intervention was associated with a higher rate of secondary revascularizations within 30 days for CLTI (4.3% vs 3.1%; OR, 1.6; 95% CI, 1.04-2.3) but not for claudication (2.6% vs 1.9%; OR, 1.7; 95% CI, 0.9-3.4). CONCLUSIONS:An endovascular-first approach as a revascularization strategy for infrainguinal disease was associated with substantially lower early morbidity but not mortality, at the cost of higher rates of postoperative secondary revascularizations. As a national representation of first-time revascularizations, this study highlights the early endovascular perioperative benefit, although more robust long-term data are needed to adopt either one strategy or the other in select patients with peripheral arterial disease.

Project description:Purpose: To investigate the outcomes of orbital atherectomy (OA) for the treatment of patients with peripheral artery disease (PAD) manifesting as claudication or chronic limb-threatening ischemia (CLTI). Materials and Methods: The database from the LIBERTY study (ClinicalTrials.gov identifier NCT01855412) was interrogated to identify 503 PAD patients treated with any commercially available endovascular devices and adjunctive OA for 617 femoropopliteal and/or infrapopliteal lesions. Cox regression analyses were employed to examine the association between baseline Rutherford category (RC) stratified as RC 2-3 (n=214), RC 4-5 (n=233), or RC 6 (n=56) and all-cause mortality, target vessel revascularization (TVR), major amputation, major adverse event (MAE), and major amputation/death at up to 3 years of follow-up. The mean lesion lengths were 78.7±73.7, 131.4±119.0, and 95.2±83.9 mm, respectively, for the 3 groups. Results: After OA, balloon angioplasty was used in >98% of cases, with bailout stenting necessary in 2.0%, 2.8%, and 0% of the RC groups, respectively. A small proportion (10.8%) of patients developed angiographic complications, without differences based on presentation. During the 3-year follow-up, claudicants were at lower risk for MAE, death, and major amputation/death than patients with CLTI. The 3-year Kaplan-Meier survival estimates were 84.6% for the RC 2-3 group, 76.2% for the RC 4-5 group, and 63.7% for the RC 6 group. The 3-year freedom from major amputation was estimated as 100%, 95.3%, and 88.6%, respectively. Among CLTI patients only, the RC at baseline was correlated with the combined outcome of major amputation/death, whereas RC classification did not affect TVR, MAE, major amputation, or death rates. Conclusion: Peripheral artery angioplasty with adjunctive OA in patients with CLTI or claudication is safe and associated with low major amputation rates after 3 years of follow-up. These results demonstrate the utility of OA for patients across the spectrum of PAD.

Dataset Information

Percutaneous endovascular treatment of infrainguinal PAOD: Results of the PSI register study in 74 German vascular centers.

Background

Material and methods

Results

Conclusion

Publications

Percutaneous endovascular treatment of infrainguinal PAOD: Results of the PSI register study in 74 German vascular centers.

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