RESUMO
OBJECTIVE: Arterial dissection (AD) is a known complication of peripheral vascular interventions (PVIs), but its incidence and significance have not been well-characterized. This study examines AD in the Vascular Quality Initiative database for patients treated for peripheral arterial disease. Our hypothesis is that AD is associated with decreased patency and worse limb outcomes. METHODS: The Vascular Quality Initiative PVI registry (2016-2021) was reviewed. Patients were divided based on the presence or absence of reported AD during the procedure. Trend of incidence and management of AD was derived. The characteristics and outcomes of patients with and without AD were compared. The primary endpoint was primary patency. RESULTS: There was a total of 177,790 cases, and 3% had AD. The incidence of AD significantly increased over the study period from 2.4% to 3.6% (P = .007). Endovascular therapy was used to treat AD in 83.7% of cases, 14.5% were treated medically, and only 1.8% required open surgery. Patients with AD were significantly more likely to be female (47.4% vs 39.7%; P < .001). Patient with AD were more likely to have a history of smoking (79.7% vs 77.2%; P < .001), but were significantly less likely to be on dialysis (8.2% vs 9.3%; P < .001) compared with patients without AD. Patients with AD were more likely to have femoropopliteal disease (45.2% vs 38.0%; P < .001) and undergo treatment of more complex disease as denoted by higher mean number of lesions treated (1.95 ± 1.01 vs 1.71 ± 0.89; P < .001), longer occlusion length (8 ± 16 vs 7 ± 15 cm; P < .001), and more severe TransAtlantic Inter-Society Consensus grade (Grade D: 36.2% vs 29.1%; P < .001). The proportion of stenting as a treatment modality was higher in the dissection group (55.4% vs 41.1%; P < .001). After a mean follow-up of 828 days, patients with AD had significantly lower primary patency than patients without AD. Kaplan-Meier curves demonstrated that the AD group had lower primary patency (86.9% vs 91%; P < .001) and reintervention-free survival (79.5 % vs 84.1%; P < .001) at 1 year with difference in amputation-free survival. Cox proportional hazard regression confirmed the independent association of AD with primary patency and reintervention-free survival. CONCLUSIONS: AD is more common in women and is more likely to occur during treatment of the femoropopliteal segment. AD is associated with decreased primary patency and reintervention-free survival after PVI for peripheral arterial disease.
Assuntos
Dissecção de Vasos Sanguíneos , Procedimentos Endovasculares , Doença Arterial Periférica , Humanos , Feminino , Masculino , Resultado do Tratamento , Fatores de Risco , Salvamento de Membro , Grau de Desobstrução Vascular , Estudos Retrospectivos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/epidemiologia , Doença Arterial Periférica/terapia , Procedimentos Endovasculares/efeitos adversos , Artéria Femoral/cirurgiaRESUMO
OBJECTIVE: Controversy exists regarding the value and limitations of different sites of service for peripheral artery disease treatment. We aimed to examine practice patterns associated with peripheral vascular interventions (PVIs) performed in the office-based laboratory (OBL) vs outpatient hospital site of service using a nationally representative database. METHODS: Using 100% Medicare fee-for-service claims data, we identified all patients undergoing PVI for claudication or chronic limb-threatening ischemia (CLTI) between January 2017 and December 2022. We evaluated the associations of patient and procedure characteristics with site of service using multivariable hierarchical logistic regression. We used multinomial regression models to estimate the relative risk ratios (RRRs) of site of service and intervention type (angioplasty, stent, or atherectomy) and intervention anatomic level (iliac, femoropopliteal, or tibial) after adjusting for baseline patient characteristics and clustering by physician. RESULTS: Of 848,526 PVI, 485,942 (57.3%) were performed in an OBL. OBL use increased significantly over time from 48.3% in 2017 to 65.5% in 2022 (P < .001). Patients treated in OBLs were more likely to be Black (adjusted odds ratio [aOR], 1.14; 95% confidence interval [CI], 1.11-1.18) or other non-White race (aOR, 1.13; 95% CI, 1.08-1.18), have fewer comorbidities, and undergo treatment for claudication vs CLTI (aOR, 1.30; 95% CI, 1.26-1.33) compared with patients treated in outpatient hospital settings. Physicians with majority practice (>50% procedures) in an OBL were more likely to practice in urban settings (aOR, 21.58; 95% CI, 9.31-50.02), specialize in radiology (aOR, 18.15; 95% CI, 8.92- 36.92), and have high-volume PVI practices (aOR, 2.15; 95% CI, 2.10-2.29). The median time from diagnosis to treatment was shorter in OBLs, particularly for patients with CLTI (29 vs 39 days; P < .001). The OBL setting was the strongest predictor of patients receiving an atherectomy alone (adjusted RRR [aRRR] 6.67; 95% CI, 6.59-6.76) or atherectomy + stent (aRRR, 10.84; 95% CI, 10.64-11.05), and these findings were consistent in subgroup analyses stratified by PVI indication. The OBL setting was also associated with higher risk of tibial interventions for both claudication (aRRR, 3.18; 95% CI, 3.11-3.25) and CLTI (aRRR, 1.89; 95% CI, 1.86-1.92). The average reimbursement (including professional and facility fees) was slightly higher for OBLs compared with the hospital ($8742/case vs $8459/case; P < .001). However, in a simulated cohort resetting the OBL's intervention type distribution to that of the hospital, OBLs were associated with a hypothetical cost savings of $221,219,803 overall and $2602 per case. CONCLUSIONS: The OBL site of service was associated with greater access to care for non-White patients and a shorter time from diagnosis to treatment, but more frequently performed high-cost interventions compared with the outpatient hospital setting. The benefit to patients from improved access to peripheral artery disease care in OBL settings must be balanced with the potential limitations of receiving differential care.
RESUMO
OBJECTIVE: Optimizing medical management and risk factor modification are underused strategies in patients with chronic limb-threatening ischemia (CLTI), despite evidence of improved outcomes. The Vascular Quality Initiative (VQI) registry is a tool to improve quality of vascular care. In this study, we used the VQI to evaluate trends in medical management in patients with CLTI undergoing peripheral vascular interventions (PVI), and the impact of changes in management on overall survival (OS), amputation-free survival (AFS), and limb salvage (LS). METHODS: Patients undergoing index PVI for CLTI between 2012 and 2016, with ≥24 months of follow-up were identified from the national VQI registry. Patient details including smoking status and medication use, OS, LS, and AFS were analyzed with linear-by-linear association, t test, and logistic regression. RESULTS: There were 12,370 PVI completed in 11,466 patients. There was a significant increase in infrapopliteal interventions (from 29.8% to 39.0%; P < .001) and PVI performed for tissue loss (from 59.1% to 66.5%; P < .001). The percentage of current smokers at time of PVI decreased (from 36.2% to 30.7%; P = .036). At discharge, statins were initiated in 25%, aspirin in 45%, and P2Y12 therapy in 58% of patients not receiving these medications before PVI. Over the course of follow-up, dual antiplatelet therapy (DAPT) (from 41.1% to 48.0%; P < .001), angiotensin-converting enzyme (ACE) inhibitor (from 46.2% to 51.3%; P < .001), and statin (from 70.4% to 77.5%; P < .001) use increased. Combined DAPT, ACE inhibitor and statin use increased from 33.6% to 39.6% (P ≤ .001). Significant improvement in 24-month OS and AFS was noted (OS, from 90.9% to 93.7% [P = .002]: AFS, from 81.2% to 83.1% [P = .046]), but not LS (from 89.6% to 89.0%; P = .83). Combined therapy with P2Y12 inhibitors, statins and ACE inhibitors was an independent predictor of improved OS (hazard ratio, 0.61; 95% confidence interval, 0.39-0.96; P = .034). DAPT was independent predictor of improved LS (hazard ratio, 0.83; 95% confidence interval, 0.79-0.87; P < .007). CONCLUSIONS: Antiplatelet, ACE inhibitor, and statin use increased over the study period and was associated with improved OS and AFS. LS trends did not change significantly over time, possibly owing to the inclusion of patients with a greater disease burden or inadequate medical management. Medical management, although improved, remained far from optimal and represents an area for continued development.
Assuntos
Procedimentos Endovasculares , Inibidores de Hidroximetilglutaril-CoA Redutases , Doença Arterial Periférica , Humanos , Isquemia Crônica Crítica de Membro , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Medição de Risco , Procedimentos Endovasculares/efeitos adversos , Inibidores da Agregação Plaquetária/efeitos adversos , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/terapia , Isquemia/diagnóstico , Isquemia/terapia , Fatores de Risco , Salvamento de Membro , Inibidores da Enzima Conversora de Angiotensina , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions. METHODS: We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs. RESULTS: A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75). CONCLUSIONS: Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.
Assuntos
Claudicação Intermitente , Doenças Vasculares Periféricas , Idoso , Humanos , Isquemia Crônica Crítica de Membro , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/terapia , Medicare , Estados Unidos/epidemiologiaRESUMO
OBJECTIVE: Despite societal guidelines that peripheral vascular intervention (PVI) should not be the first-line therapy for intermittent claudication, a significant number of patients will undergo PVI for claudication within 6 months of diagnosis. The aim of the present study was to investigate the association of early PVI for claudication with subsequent interventions. METHODS: We evaluated 100% of Medicare fee-for-service claims to identify all beneficiaries with a new diagnosis of claudication from January 1, 2015 to December 31, 2017. The primary outcome was late intervention, defined as any femoropopliteal PVI performed >6 months after the claudication diagnosis (through June 30, 2021). Kaplan-Meier curves were used to compare the cumulative incidence of late PVI for claudication patients with early (≤6 months) PVI vs those without early PVI. A hierarchical Cox proportional hazards model was used to evaluate the patient- and physician-level characteristics associated with late PVIs. RESULTS: A total of 187,442 patients had a new diagnosis of claudication during the study period, of whom 6069 (3.2%) had undergone early PVI. After a median follow-up of 4.39 years (interquartile range, 3.62-5.17 years), 22.5% of the early PVI patients had undergone late PVI vs 3.6% of those without early PVI (P < .001). Patients treated by high use physicians of early PVI (≥2 standard deviations; physician outliers) were more likely to have received late PVI than were patients treated by standard use physician of early PVI (9.8% vs 3.9%; P < .001). Patients who had undergone early PVI (16.4% vs 7.8%) and patients treated by outlier physicians (9.7% vs 8.0%) were more likely to have developed CLTI (P < .001 for both). After adjustment, the patient factors associated with late PVI included receipt of early PVI (adjusted hazard ratio [aHR], 6.89; 95% confidence interval [CI], 6.42-7.40) and Black race (vs White; aHR, 1.19; 95% CI, 1.10-1.30). The only physician factor associated with late PVI was a majority of practice in an ambulatory surgery center or office-based laboratory, with an increasing proportion of ambulatory surgery center or office-based laboratory services associated with significantly increased rates of late PVI (quartile 4 vs quartile 1; aHR, 1.57; 95% CI, 1.41-1.75). CONCLUSIONS: Early PVI after the diagnosis of claudication was associated with higher late PVI rates compared with early nonoperative management. High use physicians of early PVI for claudication performed more late PVIs than did their peers, especially those primarily delivering care in high reimbursement settings. The appropriateness of early PVI for claudication needs critical evaluation, as do the incentives surrounding the delivery of these interventions in ambulatory intervention suites.
Assuntos
Procedimentos Endovasculares , Doença Arterial Periférica , Humanos , Idoso , Estados Unidos/epidemiologia , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/terapia , Isquemia Crônica Crítica de Membro , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/terapia , Procedimentos Endovasculares/efeitos adversos , Fatores de Risco , Resultado do Tratamento , Medicare , Salvamento de Membro , Estudos Retrospectivos , Isquemia/diagnóstico , Isquemia/terapiaRESUMO
OBJECTIVE: At present, no data are available to support the use of tibial interventions in the treatment of claudication. We characterized the practice patterns surrounding tibial peripheral vascular interventions (PVIs) for patients with claudication in the United States. METHODS: Using 100% Medicare fee-for-service claims from 2017 to 2019, we conducted a retrospective analysis of all patients who underwent an index PVI for claudication. Patients with any previous PVI, acute limb ischemia, or chronic limb-threatening ischemia in the preceding 12 months were excluded. The primary outcome was the receipt or delivery of tibial revascularization during an index PVI for claudication, defined as tibial PVI with or without concomitant femoropopliteal PVI. Univariable comparisons and multivariable hierarchical logistic regression were used to assess the patient and physician characteristics associated with the use of tibial PVI for claudication. RESULTS: Of 59,930 Medicare patients who underwent an index PVI for claudication between 2017 and 2019, 16,594 (27.7%) underwent a tibial PVI (isolated tibial PVI, 38.5%; tibial PVI with concomitant femoropopliteal PVI, 61.5%). Of the 1542 physicians included in our analysis, the median physician-level tibial PVI rate was 20.0% (interquartile range, 9.1%-37.5%). Hierarchical logistic regression suggested that patient-level characteristics associated with tibial PVI for claudication included male sex (adjusted odds ratio [aOR], 1.23), increasing age (aOR, 1.30-1.96), Black race (aOR, 1.47), Hispanic ethnicity (aOR, 1.86), diabetes (aOR, 1.36), no history of hypertension (aOR, 1.12), and never-smoking status (aOR, 1.64; P < .05 for all). Physician-level characteristics associated with tibial PVI for claudication included early-career status (aOR, 2.97), practice location in the West (aOR, 1.75), high-volume PVI practice (aOR, 1.87), majority of practice in an ambulatory surgery center or office-based laboratory setting (aOR, 2.37), and physician specialty. The odds of vascular surgeons performing tibial PVI were significantly lower compared with radiologists (aOR, 2.98) and cardiologists (aOR, 1.67; P < .05 for all). The average Medicare reimbursement per patient was dramatically higher for physicians performing high rates of tibial PVI (quartile 4 vs quartile 1-3, $12,023.96 vs $692.31 per patient; P < .001). CONCLUSIONS: Tibial PVI for claudication was performed more often by nonvascular surgeons in high-volume practices and high-reimbursement settings. Thus, a critical need exists to reevaluate the indications, education, and reimbursement policies surrounding these procedures.
Assuntos
Procedimentos Endovasculares , Doença Arterial Periférica , Humanos , Masculino , Idoso , Estados Unidos , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/terapia , Estudos Retrospectivos , Medicare , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/terapia , Procedimentos Cirúrgicos Vasculares/efeitos adversos , Resultado do Tratamento , Fatores de Risco , Procedimentos Endovasculares/efeitos adversosRESUMO
OBJECTIVE: The Society for Vascular Surgery (SVS) clinical practice guidelines recommend best medical therapy (BMT) as first-line therapy before offering revascularization to patients with intermittent claudication (IC). Notably, atherectomy and tibial-level interventions are generally discouraged for management of IC; however, high regional market competition may incentivize physicians to treat patients outside the scope of guideline-directed therapy. Therefore, we sought to determine the association between regional market competition and endovascular treatment of patients with IC. METHODS: We examined patients with IC undergoing index endovascular peripheral vascular interventions (PVI) in the SVS Vascular Quality Initiative from 2010 to 2022. We assigned the Herfindahl-Hirschman Index as a measure of regional market competition and stratified centers into very high competition (VHC), high competition, moderate competition, and low competition cohorts. We defined BMT as preoperative documentation of being on antiplatelet medication, statin, nonsmoking status, and a recorded ankle-brachial index. We used logistic regression to evaluate the association of market competition with patient and procedural characteristics. A sensitivity analysis was performed in patients with isolated femoropopliteal disease matched by the TransAtlantic InterSociety classification of disease severity. RESULTS: There were 24,669 PVIs that met the inclusion criteria. Patients with IC undergoing PVI were more likely to be on BMT when treated in higher market competition centers (odds ratio [OR], 1.07 per increase in competition quartile; 95% confidence interval [CI], 1.04-1.11; P < .0001). The probability of undergoing aortoiliac interventions decreased with increasing competition (OR, 0.84; 95% CI, 0.81-0.87; P < .0001), but there were higher odds of receiving tibial (OR, 1.40; 95% CI, 1.30-1.50; P < .0001) and multilevel interventions in VHC vs low competition centers (femoral + tibial OR, 1.10; 95% CI, 1.03-1.14; P = .001). Stenting decreased as competition increased (OR, 0.89; 95% CI, 0.87-0.92; P < .0001), whereas exposure to atherectomy increased with higher market competition (OR, 1.15; 95% CI, 1.11-1.19; P < .0001). When assessing patients undergoing single-artery femoropopliteal intervention for TransAtlantic InterSociety A or B lesions to account for disease severity, the odds of undergoing either balloon angioplasty (OR, 0.72; 95% CI, 0.625-0.840; P < .0001) or stenting only (OR, 0.84; 95% CI, 0.727-0.966; P < .0001) were lower in VHC centers. Similarly, the likelihood of receiving atherectomy remained significantly higher in VHC centers (OR, 1.6; 95% CI, 1.36-1.84; P < .0001). CONCLUSIONS: High market competition was associated with more procedures among patients with claudication that are not consistent with guideline-directed therapy per the SVS clinical practice guidelines, including atherectomy and tibial-level interventions. This analysis demonstrates the susceptibility of care delivery to regional market competition and signifies a novel and undefined driver of PVI variation among patients with claudication.
Assuntos
Claudicação Intermitente , Doença Arterial Periférica , Humanos , Claudicação Intermitente/terapia , Claudicação Intermitente/cirurgia , Doença Arterial Periférica/terapia , Doença Arterial Periférica/cirurgia , Fatores de Risco , Procedimentos Cirúrgicos Vasculares , Aterectomia/efeitos adversos , Resultado do Tratamento , Estudos RetrospectivosRESUMO
PURPOSE: Preoperative anemia is associated with adverse outcomes after cardiac and noncardiac surgeries, but outcomes after an endovascular peripheral vascular intervention (PVI) are not well established. We aimed to assess the association of preoperative anemia with 30 day death, hospital length of stay (LOS), and overall (long term) survival in patients undergoing an endovascular PVI for peripheral artery disease. MATERIALS AND METHODS: In this retrospective, cohort study in the United States and Canada, we queried the national Vascular Quality Initiative database for all endovascular PVIs performed between 2010 and 2019, and outcomes were correlated with patients' hemoglobin (Hb) levels. Anemia was classified as mild (Hb=10-13 g/dL for men and 10-12 g/dL for women), moderate (Hb=8-9.9 g/dL), and severe (Hb<8 g/dL). RESULTS: A total of 79 707 adult patients who met study criteria underwent endovascular PVI. The mean age was 68 years, and 59% of patients were male. Anemia was documented in 38 543 patients (48%) and was mild in 27 435 (71%), moderate in 9783 (25%), and severe in 1325 (4%). The median follow-up duration was 4 years (range, 1.25-5.78 years). On univariate analysis, 30 day mortality, total LOS, and overall survival were significantly associated with the level of preoperative anemia. These associations persisted in the multivariate models. Kaplan-Meier survival analysis demonstrated an association of death with degree of anemia (p<0.001). CONCLUSION: The presence and degree of preoperative anemia were independently associated with increased 30 day mortality and LOS and decreased overall survival for patients with peripheral artery disease who had undergone endovascular PVI. CLINICAL IMPACT: The findings from this study have many implications for how to approach vascular surgery in patients with variable hemoglobin levels. Our findings will strengthen our ability to conduct accurate preoperative risk stratification for patients undergoing peripheral vascular interventions. This may also mitigate healthcare expenditures if findings are applied in a way that can lower patient length of postoperative stay while also maintaining quality of care and patient safety. Our results will also serve as guidance for clinical trials, and future prospective trials should evaluate the effect of preoperative optimization of hemoglobin as a potentially modifiable risk factor for outcomes.
RESUMO
OBJECTIVE: Despite limited evidence supporting atherectomy alone over stenting/angioplasty as the index peripheral vascular intervention (PVI), the use of atherectomy has rapidly increased in recent years. We previously identified a wide distribution of atherectomy practice patterns among US physicians. The aim of this study was to investigate the association of index atherectomy with reintervention. METHODS: We used 100% Medicare fee-for-service claims to identify all beneficiaries who underwent elective first-time femoropopliteal PVI for claudication between January 1, 2019, and December 31, 2019. Subsequent PVI reinterventions were examined through June 30, 2021. Kaplan-Meier curves were used to compare rates of PVI reinterventions for patients who received index atherectomy versus nonatherectomy procedures. Reintervention rates were also described for physicians by their overall atherectomy use (by quartile). A hierarchical Cox proportional hazard model was used to evaluate patient and physician-level characteristics associated with reinterventions. RESULTS: A total of 15,246 patients underwent an index PVI for claudication in 2019, of which 59.7% were atherectomy. After a median of 603 days (interquartile range, 77-784 days) of follow-up, 41.2% of patients underwent a PVI reintervention, including 48.9% of patients who underwent index atherectomy versus 29.8% of patients who underwent index nonatherectomy (P < .001). Patients treated by high physician users of atherectomy (quartile 4) received more reinterventions than patients treated by standard physician users (quartiles 1-3) (56.8% vs 39.6%; P < .001). After adjustment, patient factors association with PVI reintervention included receipt of index atherectomy (adjusted hazard ratio [aHR], 1.33; 95% confidence interval [CI], 1.21-1.46), Black race (vs White; aHR; 1.18; 95% CI, 1.03-1.34), diabetes (aHR, 1.13; 95% CI, 1.07-1.21), and urban residence (aHR, 1.11; 95% CI, 1.01-1.22). Physician factors associated with reintervention included male sex (aHR, 1.52; 95% CI, 1.12-2.04), high-volume PVI practices (aHR, 1.23; 95% CI, 1.10-1.37), and physicians with a high use of index atherectomy (aHR, 1.49; 95% CI, 1.27-1.74). Vascular surgeons had a lower risk of PVI reintervention than cardiologists (vs vascular; aHR, 1.22; 95% CI, 1.09-1.38), radiologists (aHR, 1.55; 95% CI, 1.31-1.83), and other specialties (aHR, 1.59; 95% CI, 1.20-2.11). The location of services delivered was not associated with reintervention (P > .05). CONCLUSIONS: The use of atherectomy as an index PVI for claudication is associated with higher PVI reintervention rates compared with nonatherectomy procedures. Similarly, high physician users of atherectomy perform more PVI reinterventions than their peers. The appropriateness of using atherectomy for initial treatment of claudication needs critical reevaluation.
Assuntos
Doença Arterial Periférica , Idoso , Aterectomia/efeitos adversos , Humanos , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/etiologia , Claudicação Intermitente/cirurgia , Masculino , Medicare , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/etiologia , Doença Arterial Periférica/cirurgia , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
OBJECTIVE: Because the treatment of intermittent claudication (IC) is elective, good short- and long-term outcomes are imperative. The objective of the present study was to examine the outcomes of endovascular management of IC reported in the Vascular Quality Initiative and compare them with the Society for Vascular Surgery guidelines for IC treatment to determine whether real-world results are within the guidelines. METHODS: Patients undergoing peripheral vascular intervention for IC from 2004 to 2017 with complete data and >9 month follow-up were included. The primary outcome measures were IC recurrence and repeat procedures performed ≤2 years after the initial treatment. RESULTS: A total of 16,152 patients met the inclusion criteria, with a mean age of 66 years. Of the 16,152 patients, 61% were men, 45% were current smokers, and 28% had been discharged without antiplatelet or statin medication. Adjusted analyses revealed that treatment of more than two arteries was associated with a shorter time to IC recurrence (hazard ratio [HR], 1.19; 95% confidence interval [CI], 1.09-1.31) and a shorter time to repeat procedures (HR, 1.25; 95% CI, 1.09-1.45). The use of atherectomy was also associated with a shorter time to IC recurrence (HR, 1.29; 95% CI, 1.08-1.33) and a shorter time to repeat procedures (HR, 1.31; 95% CI, 1.13-1.52). Discharge with antiplatelet and statin medications was associated with a longer time to IC recurrence (HR, 0.84; 95% CI, 0.78-0.91) and a longer time to repeat procedures (HR, 0.77; 95% CI, 0.69-0.87). Life-table analysis at 2 years revealed that only 32% of patients were free from IC recurrence, although 76% had not undergone repeat procedures. Stratified by anatomic treatment level, 37% of isolated aortoiliac interventions, 22% of aortoiliac and femoropopliteal interventions, 30% of isolated femoropopliteal interventions, and 20% of femoropopliteal and tibial interventions had remained free from IC recurrence at 2 years. CONCLUSIONS: Most patients treated with an endovascular approach to IC did not meet the Society for Vascular Surgery guidelines for long-term freedom from recurrent symptoms of >50% at 2 years. Many lacked preprocedure optimization of medical management. The use of atherectomy and treatment of more than two arteries were associated with poor outcomes after peripheral vascular intervention for IC, because only 32% of these patients were free from recurrent symptoms at 2 years. Even when risk factor modification is optimized before the procedure, vascular specialists should be aware of the association between atherectomy and multivessel interventions with poorer long-term outcomes and counsel patients appropriately before intervention.
Assuntos
Procedimentos Endovasculares/normas , Fidelidade a Diretrizes/normas , Claudicação Intermitente/terapia , Doença Arterial Periférica/terapia , Guias de Prática Clínica como Assunto/normas , Padrões de Prática Médica/normas , Idoso , Procedimentos Endovasculares/efeitos adversos , Feminino , Humanos , Claudicação Intermitente/diagnóstico por imagem , Claudicação Intermitente/fisiopatologia , Masculino , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Recidiva , Sistema de Registros , Retratamento , Estudos Retrospectivos , Fatores de Risco , Sociedades Médicas , Fatores de Tempo , Resultado do TratamentoRESUMO
OBJECTIVES: To study the risk factors associated with 30-readmission postperipheral vascular intervention (PVI) in peripheral artery disease (PAD). BACKGROUND: There has been a paucity of data regarding the trend and predictors of PVI readmission. METHODS: We performed an observational cohort study of patients admitted with peripheral vascular disease for PVI using the NRD for the years 2010-2014. PVI was defined as angioplasty, atherectomy, and/or stenting of lower limb vessels. RESULTS: A total of 453,278 patients (30-day readmission n = 97,235). The mean age of study population was 68.6 ± 12.2 years and included 43.8% women. The 30-day readmission post-PVI was 21.5% (p = .034). Cardiovascular causes constitute 44% of readmission. Chronic limb ischemia and intermittent claudication were two most common cardiovascular causes constituting 11.7 and 4.9% cases of readmissions. Other cardiac causes of readmissions included heart failure (4.64%), dysrhythmias (1.4%), and acute myocardial infarction (1.7%). The high-risk factors for of all-cause 30-day readmission were hypertension, CLI, diabetes, renal failure, dyslipidemia, smoking, chronic pulmonary disease, and atrial fibrillation (p < .005). Length-of-stay was greater than 5 days for 56.2 and 75.4% paid by Medicare. CONCLUSIONS: Our study shows an average yearly readmission rate of 21.5% post-PVI. Chronic comorbidities and prolonged hospitalization were associated with higher risk of readmission.
Assuntos
Readmissão do Paciente , Doença Arterial Periférica , Idoso , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Feminino , Humanos , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/epidemiologia , Claudicação Intermitente/terapia , Masculino , Medicare , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/epidemiologia , Doença Arterial Periférica/terapia , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento , Estados UnidosRESUMO
OBJECTIVE: Contrast-induced nephropathy (CIN) is a frequently used quality outcome marker after peripheral vascular interventions (PVIs). Whereas the factors associated with CIN development have been well documented, the long-term renal effects of CIN after PVI are unknown. This study was undertaken to investigate the long-term (1-year) renal consequences of CIN after PVI and to identify factors associated with renal function deterioration at 1-year follow-up. METHODS: From 2008 to 2015, patients who had PVI at our institution (who were part of a statewide Vascular Interventions Collaborative) were queried for those who developed CIN. CIN was defined by the Collaborative as an increase in serum creatinine concentration of at least 0.5 mg/dL within 30 days after intervention. Preprocedural dialysis patients or patients without postprocedural creatinine values were excluded. Preprocedural, postprocedural, and 1-year serum creatinine values were abstracted and used to estimate glomerular filtration rate (GFR). ΔGFR was defined as preprocedural GFR minus 1-year GFR. Univariate and multivariate analyses for ΔGFR were performed to determine factors associated with renal deterioration at 1 year. RESULTS: From 2008 to 2015, there were 1323 PVIs performed; 881 patients met the inclusion criteria. Of these, 57 (6.5%) developed CIN; 47% were male, and 51% had baseline chronic kidney disease. CIN resolved by discharge in 30 patients (53%). Using multivariate linear regression, male sex (P = .027) and congestive heart failure (P = .048) were associated with 1-year GFR decline. Periprocedural variables related to 1-year GFR decline included percentage increase in 30-day postprocedural creatinine concentration (P = .025), whereas CIN resolution by discharge (mean, 13.1 days) was protective for renal function at 1 year (P = .02). A post hoc analysis was performed with 50 PVI patients (randomly selected) who did not develop CIN, comparing their late renal function with that of the CIN group stratified by the periprocedural 30-day variables. Patients with CIN resolution at discharge had similar 1-year renal outcomes to non-CIN patients, whereas the CIN-persistent (at discharge) patients had greater renal deterioration at 1 year compared with non-CIN patients (P = .016). CONCLUSIONS: Male sex and congestive heart failure are risk factors for further renal function decline in patients developing CIN after PVI. The magnitude and duration of increase in creatinine concentration (CIN persistence at discharge) correlated with late progressive renal dysfunction in CIN patients, suggesting that early-resolving CIN is relatively benign.
Assuntos
Injúria Renal Aguda/induzido quimicamente , Meios de Contraste/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Taxa de Filtração Glomerular/efeitos dos fármacos , Rim/efeitos dos fármacos , Doença Arterial Periférica/terapia , Radiografia Intervencionista/efeitos adversos , Injúria Renal Aguda/diagnóstico por imagem , Injúria Renal Aguda/epidemiologia , Injúria Renal Aguda/fisiopatologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Creatinina/sangue , Progressão da Doença , Feminino , Insuficiência Cardíaca/epidemiologia , Humanos , Incidência , Rim/fisiopatologia , Masculino , Michigan/epidemiologia , Pessoa de Meia-Idade , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/epidemiologia , Estudos Retrospectivos , Fatores de Risco , Fatores Sexuais , Fatores de Tempo , Adulto JovemRESUMO
OBJECTIVES: The aim is to examine trends in procedural indication, arterial beds treated, and device usage in peripheral arterial interventions (PVIs). BACKGROUND: There is little data on indication, vascular beds treated and devices utilized for peripheral arterial interventions. METHODS: We used data from 43 hospitals participating in the BMC2 VIC registry. PVIs were separated by year and divided by arterial segment. Lower extremity PVIs were subclassified as having been performed for claudication or critical limb ischemia (CLI). Yearly device usage was also included. A repeated measure ANOVA was used to determine trends. RESULTS: 44,650 PVIs were performed from 2006 to 2013. Renal interventions decreased from 18% of interventions in 2006 to 5.6% in 2013 (P < 0.001) and femoral-popliteal increased from 54.9% in 2006 to 64.5% in 2013 (P < 0.001). No significant trend was seen for aorta-iliac or below-the-knee interventions. 58.6% of PVIs were performed for claudication in 2006 and this decreased to 44.6% in 2013 (P = 0.025). Indications for CLI were 24.1% in 2006 and 47.5% in 2013 (P < 0.001). There were significant increases in the use of balloon angioplasty (P = 0.029) and cutting/scoring balloons (P < 0.001) while cryoballoon usage decreased (P < 0.001). No significant changes were found with stenting, atherectomy, and laser. CONCLUSIONS: There is a significant increase in patients presenting with CLI. Renal artery intervention rates are decreasing while femoral-popliteal interventions are increasing. Additionally, balloon angioplasty and cutting/scoring balloon usage is increasing. © 2017 Wiley Periodicals, Inc.
Assuntos
Planos de Seguro Blue Cross Blue Shield , Extremidade Inferior/irrigação sanguínea , Doença Arterial Periférica/cirurgia , Sistema de Registros , Medição de Risco/métodos , Instrumentos Cirúrgicos/estatística & dados numéricos , Procedimentos Cirúrgicos Vasculares/instrumentação , Idoso , Feminino , Humanos , Masculino , Michigan/epidemiologia , Morbidade/tendências , Estudos Prospectivos , Fatores de Risco , Taxa de Sobrevida/tendências , Procedimentos Cirúrgicos Vasculares/tendênciasRESUMO
PURPOSE: To examine the impact of intravascular ultrasound (IVUS) utilization during lower limb endovascular interventions as regards postprocedural complications and amputation. METHODS: The study cohort was derived from the Healthcare Cost and Utilization Project Nationwide Inpatient Sample database between the years 2006 and 2011. Peripheral endovascular interventions were identified using appropriate ICD-9 procedure codes. Two-level hierarchical multivariate mixed models were created. The co-primary outcomes were in-hospital mortality and amputation; the secondary outcome was postprocedural complications. Model results are given as the odds ratio (OR) and 95% confidence interval (CI). Hospitalization costs were also assessed. RESULTS: Overall, among the 92,714 patients extracted from the database during the observation period, IVUS was used in 1299 (1.4%) patients. IVUS utilization during lower extremity peripheral vascular procedures was independently predictive of a lower rate of postprocedural complications (OR 0.80, 95% CI 0.66 to 0.99, p=0.037) as well as lower amputation rates (OR 0.59, 95% CI 0.45 to 0.77, p<0.001) without any significant impact on in-hospital mortality. Multivariate analysis also revealed IVUS utilization to be predictive of a nonsignificant increase in hospitalization costs ($1333, 95% CI -$167 to +$2833, p=0.082). CONCLUSION: IVUS use during lower limb endovascular interventions is predictive of lower postprocedural complication and amputation rates with a nonsignificant increase in hospitalization costs.
Assuntos
Procedimentos Endovasculares/estatística & dados numéricos , Extremidade Inferior/irrigação sanguínea , Doenças Vasculares Periféricas/terapia , Padrões de Prática Médica , Ultrassonografia de Intervenção/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Amputação Cirúrgica , Distribuição de Qui-Quadrado , Análise Custo-Benefício , Bases de Dados Factuais , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/economia , Procedimentos Endovasculares/mortalidade , Feminino , Custos Hospitalares , Mortalidade Hospitalar , Humanos , Salvamento de Membro , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Razão de Chances , Doenças Vasculares Periféricas/diagnóstico por imagem , Doenças Vasculares Periféricas/mortalidade , Doenças Vasculares Periféricas/cirurgia , Padrões de Prática Médica/economia , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Ultrassonografia de Intervenção/economia , Estados Unidos , Adulto JovemRESUMO
Introduction: For patients receiving Procedural Sedation and Analgesia (PSA), patient cooperation is crucial as patients remain continuously aware of operating room activity and can be asked to perform tasks such as prolonged breath-holds. This survey aimed to collect information on patient compliance with on-table instructions and its relation to periprocedural outcomes from surgeons nationwide performing peripheral vascular interventions (PVI) under PSA. Methods: A 9-question online survey was sent to 383 vascular surgeons (including both vascular surgery attendings and trainees) across the United States through REDCap from August 30 to September 21, 2021, with responses closed on October 30, 2021. The survey response was analyzed with descriptive statistics. Results: 83 (21.6%) vascular surgeons responded to the survey, of which 67 (80.7%) were attending vascular surgeons and 16 (19.3%) were vascular surgery trainees. 41 (49.4%) respondents performed 11-20 PVI cases under PSA every month, while 31 (41.0%) respondents performed 1-10 PVI cases under PSA every month. 41 (49.4%) respondents reported that in 1-10% of their cases, additional contrast and/or radiation was administered because patient moved on the table or did not cooperate with breath holds; 25 (30.1%) reported that this occurred in 11-20% of their cases, 12 (14.5%) reported that this occurred in 21-50% of their cases and 4 (4.8%) reported that this occurred in over 50% of their cases. In such cases, the majority of respondents reported a 1-10% increase in contrast volume (59.0%), radiation dosage (62.7%), sedative/analgesia administration (46.3%) and procedural time (54.9%). Of cases being converted to general anesthesia due to inadequate patient cooperation, 35 (42.2%) respondents reported between 1-5 per month, and 3 (3.6%) respondents reported between 6-10 per month. Of cases being aborted due to inadequate patient cooperation, 25 (30.1%) respondents reported between 1-5 per month, and 1 (1.2%) respondents reported between 6-10 per month. Conclusion: A significant fraction of PVI cases performed under PSA result in increased radiation and contrast exposure, sedative administration and procedural time due to inadequate patient cooperation. In certain cases, conversion to general anesthesia or case abortion is required. Further research should be performed to investigate strategies to minimize such adverse patient safety events.
RESUMO
BACKGROUND: Previous cross-sectional studies have identified wide practice pattern variations in the use of peripheral vascular interventions (PVIs) for the treatment of claudication. However, there are limited data on longitudinal practice patterns. We aimed to describe the temporal trends and charges associated with PVI use for claudication over the past 12 years in the United States. METHODS AND RESULTS: We conducted a retrospective analysis using 100% Medicare fee-for-service claims data to identify all patients who underwent a PVI for claudication between January 2011 and December 2022. We evaluated the trends in utilization and Medicare-allowed charges of PVI according to anatomic level, procedure type, and intervention settings using generalized linear models. Multinomial logistic regressions were used to evaluate factors associated with different levels and types of PVI. We identified 599 197 PVIs performed for claudication. The proportional use of tibial PVI increased 1.0% per year, and atherectomy increased by 1.6% per year over the study period. The proportion of PVIs performed in ambulatory surgical centers/office-based laboratories grew at 4% per year from 12.4% in 2011 to 55.7% in 2022. Total Medicare-allowed charges increased by $11 980 035 USD/year. Multinomial logistic regression identified significant associations between race and ethnicity and treatment setting with use of both atherectomy and tibial PVI. CONCLUSIONS: The use of tibial PVI and atherectomy for the treatment of claudication has increased dramatically in in ambulatory surgical center/office-based laboratory settings, non-White patients, and resulting in a significant increase in health care charges. There is a critical need to improve the delivery of value-based care for the treatment of claudication.
Assuntos
Claudicação Intermitente , Medicare , Humanos , Estados Unidos/epidemiologia , Claudicação Intermitente/terapia , Claudicação Intermitente/epidemiologia , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/economia , Medicare/tendências , Masculino , Feminino , Idoso , Estudos Retrospectivos , Doença Arterial Periférica/terapia , Doença Arterial Periférica/epidemiologia , Doença Arterial Periférica/diagnóstico , Doença Arterial Periférica/economia , Doença Arterial Periférica/cirurgia , Padrões de Prática Médica/tendências , Idoso de 80 Anos ou mais , Fatores de TempoRESUMO
Intermittent claudication (IC) is a phenotype of peripheral artery disease that is characterized by pain in the lower extremity muscles during activity that is relieved by rest. Medical management, risk factor control, smoking cessation, and exercise therapy have historically been the mainstays of treatment for IC, but advances in endovascular technology have led to increasing use of peripheral vascular interventions in this patient population. There are meaningful differences in published society guidelines and appropriate use criteria relevant to the management of IC, especially regarding indications for peripheral vascular interventions. The current review aims to highlight similarities and differences between major society recommendations for the management of IC, and to discuss practice trends, disparities, and evidence gaps in the use of peripheral vascular interventions for IC in the context of existing guidelines.
Assuntos
Claudicação Intermitente , Guias de Prática Clínica como Assunto , Procedimentos Cirúrgicos Vasculares , Humanos , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/normas , Europa (Continente) , Medicina Baseada em Evidências/normas , Disparidades em Assistência à Saúde/normas , Claudicação Intermitente/fisiopatologia , Claudicação Intermitente/terapia , Claudicação Intermitente/diagnóstico , Claudicação Intermitente/cirurgia , Guias de Prática Clínica como Assunto/normas , Padrões de Prática Médica/normas , Fatores de Risco , Sociedades Médicas/normas , Resultado do Tratamento , Estados Unidos , Procedimentos Cirúrgicos Vasculares/normas , Procedimentos Cirúrgicos Vasculares/efeitos adversosRESUMO
To describe an ex vivo model for vessel preparation device testing in tibial arteries. We performed orbital atherectomy (OA), intravascular lithotripsy (IVL), and plain balloon angioplasty (POBA) on human amputated limbs with evidence of concentric tibial artery calcification. The arterial segments were then harvested for ex vivo processing which included imaging with microCT, decalcification, and histology. The model was tested out in 15 limbs and was successful in 14 but had to be aborted in 1/15 case due to inability to achieve wire access. A total of 22 lesions were treated with OA on 3/22 lesions, IVL on 8/22, and POBA without vessel preparation on the remaining 11/22. Luminal gain was assessed with intravascular ultrasound and histology was able to demonstrate plaque disruption, dissections, and cracks within the calcified lesions. A human cadaveric model using amputated limbs is a feasible, high-fidelity option for evaluating the performance of vessel preparation devices in calcified tibial arteries.
Assuntos
Angioplastia com Balão , Artérias da Tíbia , Calcificação Vascular , Humanos , Cadáver , Calcificação Vascular/terapia , Aterectomia , LitotripsiaRESUMO
Conventional catheter-based interventions for treating peripheral artery disease suffer high failure and complication rates. The mechanical interactions with the anatomy constrain catheter controllability, while their length and flexibility limit their pushability. Also, the 2D X-ray fluoroscopy guiding these procedures fails to provide sufficient feedback about the device location relative to the anatomy. Our study aims to quantify the performance of conventional non-steerable (NS) and steerable (S) catheters in phantom and ex vivo experiments. In a 10 mm diameter, 30 cm long artery phantom model, with four operators, we evaluated the success rate and crossing time in accessing 1.25 mm target channels, the accessible workspace, and the force delivered through each catheter. For clinical relevance, we evaluated the success rate and crossing time in crossing ex vivo chronic total occlusions. For the S and NS catheters, respectively, users successfully accessed 69 and 31% of the targets, 68 and 45% of the cross-sectional area, and could deliver 14.2 and 10.2 g of mean force. Using a NS catheter, users crossed 0.0 and 9.5% of the fixed and fresh lesions, respectively. Overall, we quantified the limitations of conventional catheters (navigation, reachable workspace, and pushability) for peripheral interventions; this can serve as a basis for comparison with other devices.
Assuntos
Procedimentos Endovasculares , Doença Arterial Periférica , Humanos , Catéteres , Doença Arterial Periférica/terapia , Imagens de Fantasmas , Artérias , Desenho de EquipamentoRESUMO
BACKGROUND: Women with coronary artery disease are shown to have worse outcomes after percutaneous coronary intervention compared with men; however, less is known about sex-based outcomes following lower extremity peripheral vascular intervention (PVI) for symptomatic peripheral artery disease. The study aims to assess whether female sex is independently associated with periprocedural complications in patients undergoing PVI. METHODS: Analysis includes patients undergoing lower extremity PVI from September 2016 to March 2020 from the Vascular Quality Initiative registry. Multivariate logistic regression was used to assess the independent association of female sex with post-PVI complications. RESULTS: Of the 119 620 patients included, 47 316 (39.6%) were women. Analysis reflected that women were at higher risk of developing access site complications, including any hematoma (odds ratio [OR], 1.45 [1.35-1.57]), hematoma requiring transfusion (OR, 2.24 [1.82-2.76]; P<0.001), hematoma requiring surgery (OR, 1.49 [1.19-1.86]; P<0.001), pseudoaneurysm (OR, 1.69 [1.39-2.05]; P<0.001), and access site occlusion (OR, 1.89 [1.15-3.08]; P<0.001). Women also faced higher risks of target lesion dissection (OR, 1.36 [1.26-1.46]; P<0.001), above-knee amputation (OR, 1.37 [1.18-1.58]; P<0.001), and in-hospital mortality (OR, 1.21 [1.07-1.38]; P=0.003). CONCLUSIONS: In a contemporary cohort, women undergoing lower extremity PVI for symptomatic peripheral artery disease were at higher risk than men of developing periprocedural complications, including moderate or severe access site bleeding, above-knee amputation, and in-hospital mortality. This increased risk persisted despite adjustment for differences in baseline patient or procedural characteristics and warrants further investigation.