Exploring the rapid expansion of office-based laboratories and peripheral vascular interventions across the United States.

OBJECTIVE: To characterize the relationship between office-based laboratory (OBL) use and Medicare payments for peripheral vascular interventions (PVI). METHODS: Using the Centers for Medicare and Medicaid Services Provider Utilization and Payment Data Public Use Files from 2014 to 2017, we identified providers who performed percutaneous transluminal angioplasty, stent placement, and atherectomy. Procedures were aggregated at the provider and hospital referral region (HRR) level. RESULTS: Between 2014 and 2017, 2641 providers performed 308,247 procedures. The mean payment for OBL stent placement in 2017 was $4383.39, and mean payment for OBL atherectomy was $13,079.63. The change in the mean payment amount varied significantly, from a decrease of $16.97 in HRR 146 to an increase of $43.77 per beneficiary over the study period in HRR 11. The change in the rate of PVI also varied substantially, and moderately correlated with change in payment across HRRs (R2 = 0.40; P < .001). The majority of HRRs experienced an increase in rate of PVI within OBLs, which strongly correlated with changes in payments (R2 = 0.85; P < .001). Furthermore, 85% of the variance in change in payment was explained by increases in OBL atherectomy (P < .001). CONCLUSIONS: A rapid shift into the office setting for PVIs occurred within some HRRs, which was highly geographically variable and was strongly correlated with payments. Policymakers should revisit the current payment structure for OBL use and, in particular atherectomy, to better align the policy with its intended goals.

An Update on the Management of Budd-Chiari Syndrome.

Budd-Chiari syndrome (BCS) is an uncommon condition, caused by obstruction to hepatic venous outflow. It is largely underdiagnosed, and a high index of suspicion is required for any patient with unexplained portal hypertension. The understanding of its etiology and pathology is improving with advances in diagnostic techniques. Recent studies reported an identifiable etiology in > 80% of cases. Myeloproliferative neoplasm (MPN) is the most common etiology, and genetic studies help in diagnosing latent MPN. Better cross-sectional imaging helps delineate the site of obstruction accurately. The majority of BCS patients are now treated by endovascular intervention and anticoagulation which have improved survival in this disease. Angioplasty of hepatic veins/inferior vena cava remains under-utilized at present. While surgical porto-systemic shunts are no longer done for BCS, liver transplantation is reserved for select indications. Some of the unresolved issues in the current management of BCS are also discussed in this review.

Improving 1-Year Outcomes of Infrainguinal Limb Revascularization: Population-Based Cohort Study of 104 000 Patients in England.

BACKGROUND: The availability and diversity of lower limb revascularization procedures have increased in England in the past decade. We investigated whether these developments in care have translated to improvements in patient pathways and outcomes. METHODS: Individual-patient records from Hospital Episode Statistics were used to identify 103 934 patients who underwent endovascular (angioplasty) or surgical (endarterectomy, profundaplasty, or bypass) lower limb revascularization for infrainguinal peripheral artery disease in England between January 2006 and December 2015. Major lower limb amputations and deaths within 1 year after revascularization were ascertained from Hospital Episode Statistics and Office for National Statistics mortality records. Competing risks regression was used to estimate the cumulative incidence of major amputation and death, adjusted for patient age, sex, comorbidity score, indication for the intervention (intermittent claudication, severe limb ischemia without record of tissue loss, severe limb ischemia with a record of ulceration, severe limb ischemia with a record of gangrene/osteomyelitis), and comorbid diabetes mellitus. RESULTS: The estimated 1-year risk of major amputation decreased from 5.7% (in 2006-2007) to 3.9% (in 2014-2015) following endovascular revascularization, and from 11.2% (2006-2007) to 6.6% (2014-2015) following surgical procedures. The risk of death after both types of revascularization also decreased. These trends were observed for all indication categories, with the largest reductions found in patients with severe limb ischemia with ulceration or gangrene. Overall, morbidity increased over the study period, and a larger proportion of patients was treated for the severe end of the peripheral artery disease spectrum using less invasive procedures. CONCLUSIONS: Our findings show that from 2006 to 2015, the overall survival increased and the risk of major lower limb amputation decreased following revascularization. These observations suggest that patient outcomes after lower limb revascularization have improved during a period of centralization and specialization of vascular services in the United Kingdom.

Contemporary (2009-2014) clinical outcomes after femoropopliteal bypass surgery for chronic limb threatening ischemia are inferior to those reported in the UK Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL) trial (1999-2004).

BACKGROUND: Bypass surgery (BS) remains the gold standard revascularization strategy in patients with chronic limb-threatening ischemia (CLTI) owing to infrainguinal disease. The Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-1 trial showed that, in patients with CLTI who survived for 2 years or more, BS resulted in better clinical outcomes. Despite this finding, there has been an increasing trend toward an endovascular-first approach to infrainguinal CLTI. Our aim was to investigate whether changes in practice have impacted the clinical outcomes of BS in our unit 10 years after BASIL-1. METHODS: Data for patients who underwent femoropopliteal (FP) BS in BASIL-1 (1999-2004) were retrieved from trial case record forms. The comparator contemporary series (CS) comprised all patients undergoing FP BS for CLTI in our unit between 2009 and 2014. Demographic and clinical outcome data on patients in the CS were collected from the prospectively collected hospital electronic notes. Anatomic patterns of disease in the BASIL-1 and CS cohorts were scored using the Bollinger and GLASS criteria. Statistical analysis was performed in SAS v9.4. RESULTS: There were 128 patients from BASIL-1 and 50 patients in the CS. Baseline age, gender, affected limb, and diabetes prevalence were similar, as were days spent in hospital out to 12 months and length of follow-up. BASIL-1 patients were more likely to be current smokers (P = .000) and had a higher creatinine (P = .04). The 30-day morbidity and mortality were higher in BASIL-1 (45.3% vs 22%; P = .004). There was no significant difference between BASIL-1 and CS with regard to run-off Bollinger (37.7 vs 32.1; P = .167) and IP GLASS (0 vs 0; P = .390) scores, with both groups having a median of two runoff vessels. Amputation-free survival (62% vs 28%; hazard ratio [HR], 1.86; 95% confidence interval [CI], 1.18-2.93; P = .007), limb salvage (85% vs 69%; HR, 2.31; 95% CI, 1.14-4.68; P = .02), overall survival (69% vs 35%; HR, 1.66; 95% CI, 1.00-2.74; P = .05) and major adverse limb events (67% vs 47%; HR, 1.93; 95% CI, 1.15-3.22; P = .01) were all significantly better in BASIL-1. CONCLUSIONS: Although 30-day mortality and morbidity were significantly lower, all of the examined longer term clinical outcomes after FP BS were significantly worse in the CS group a decade on from BASIL-1. Further research in the form of prospective cohort studies and randomized controlled trials is urgently required to determine if the CS data reported herein are generalizable to current vascular surgical practice and, if so, to determine the reasons for these unexpected outcomes.

Provider Trends in Atherectomy Volume between Office-Based Laboratories and Traditional Facilities.

BACKGROUND: As patient care is being increasingly transitioned out of the hospital and into the outpatient setting, there is a growing interest in developing office-based angiography suites, that is, office-based laboratories. Office-based care has been associated with increased efficiency and greater patient satisfaction, with substantially higher reimbursement directly to the physicians providing care. Prior studies have demonstrated a shift of revascularization procedures to office-based laboratories with a concomitant increase in atherectomy use, a procedure with disproportionately high reimbursement in comparison to other peripheral revascularization techniques. We sought to determine provider trends in endovascular procedure volume, settings, and shifts in practice over time, specific to atherectomy. METHODS: Using Centers for Medicare & Medicaid Services Provider Utilization and Payment Data Public Use Files from 2013 to 2015, we identified providers who performed diagnostic angiography (DA), percutaneous transluminal angioplasty (PTA), stent placement (stent), and atherectomy, and procedures were aggregated at the provider level. Trends in procedures performed in office-based laboratory and facility-based settings were analyzed. Atherectomy was specifically analyzed using the total number and proportion of office-based laboratory procedures, and providers were stratified into quintiles by case volume. RESULTS: Between 2013 and 2015, 5,298 providers were identified. Over this time period, the number of providers performing atherectomy increased 25.7%, with the highest quintile of atherectomy providers performing an average of 263 cases (range 109-1,455). The proportion of physicians who performed atherectomy only in the office increased from 39.8% to 50.7% from 2013 to 2015, whereas only 20.8% of physicians who performed DA, PTA, or stent in 2015 did so only in an office-based laboratory. Of the physicians with the highest atherectomy volume, 77.8% operated only in the office in 2015, and these physicians increased their atherectomy volume to 114.1% during the study period. Of those physicians who transitioned to a solely office-based laboratory practice over the study period, atherectomy volume increased 63.4%, which was disproportionate compared with the growth of their DA, PTA, and stent volume. CONCLUSIONS: Over this short study period, a rapid shift into the office setting for peripheral intervention occurred, with a concomitant increase in atherectomy volume that was disproportionate to the increase in other peripheral interventions. This increase in office-based laboratory atherectomy occurred in the setting of increased reimbursement for the procedure and despite a lack of data supporting superiority over PTA/stent.

Low-Dose Paclitaxel-Coated Versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: One-Year Results of the ILLUMENATE European Randomized Clinical Trial (Randomized Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon).

BACKGROUND: Numerous studies have reported favorable outcomes using drug-coated balloons (DCBs) for treatment of symptomatic peripheral artery disease of the superficial femoral and popliteal arteries. However, the treatment effect compared with an uncoated balloon has differed greatly among the randomized trials, with better outcomes observed with higher-dose DCBs. This European trial was designed to assess the safety and effectiveness of a next-generation low-dose (2-µg/mm2 surface dose of paclitaxel) DCB. METHODS: This was a prospective, randomized, multicenter, single-blinded trial. Patients were randomized (3:1) to treatment with a low-dose DCB or an uncoated percutaneous transluminal angioplasty (PTA) balloon. The primary safety end point was a composite of freedom from device- and procedure-related death through 30 days after the procedure and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months after the procedure. The primary effectiveness end point was primary patency at 12 months. RESULTS: Patients were randomized to treatment with a DCB (222 patients, 254 lesions) or uncoated PTA balloon (72 patients, 79 lesions) after successful predilatation. Mean lesion length was 7.2 and 7.1 cm, and 19.2% and 19.0% of lesions represented total occlusions, respectively. The primary safety end point was met, and superiority was demonstrated; freedom from a primary safety event was 94.1% (193 of 205) with DCB and 83.3% (50 of 60) with PTA, for a difference of 10.8% (95% confidence interval, 0.9%-23.0%). The primary effectiveness end point was met, and superiority of DCB over PTA was achieved (83.9% [188 of 224] versus 60.6% [40 of 66]; P<0.001). Outcomes with DCB were also superior to PTA per the Kaplan-Meier estimate for primary patency (89.0% versus 65.0% at 365 days; log-rank P<0.001) and for rates of clinically driven target lesion revascularization (5.9% versus 16.7%; P=0.014). CONCLUSIONS: Superiority with a low-dose DCB for femoropopliteal interventions was demonstrated over PTA for both the safety and effectiveness end points. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01858363.

Regional variation in patient selection and treatment for carotid artery disease in the Vascular Quality Initiative.

OBJECTIVE: Previous studies involving large administrative data sets have revealed regional variation in the demographics of patients selected for carotid endarterectomy (CEA) and carotid artery stenting (CAS) but lacked clinical granularity. This study aimed to evaluate regional variation in patient selection and operative technique for carotid artery revascularization using a detailed clinical registry. METHODS: All patients who underwent CEA or CAS from 2009 to 2015 were identified in the Vascular Quality Initiative (VQI). Deidentified regional groups were used to evaluate variation in patient selection, operative technique, and perioperative management. χ2 analysis was used to identify significant variation across regions. RESULTS: A total of 57,555 carotid artery revascularization procedures were identified. Of these, 49,179 patients underwent CEA (asymptomatic: median, 56%; range, 46%-69%; P < .01) and 8376 patients underwent CAS (asymptomatic: median, 36%; range, 29%-51%; P < .01). There was significant regional variation in the proportion of asymptomatic patients being treated for carotid stenosis <70% in CEA (3%-9%; P < .01) vs CAS (3%-22%; P < .01). There was also significant variation in the rates of intervention for asymptomatic patients older than 80 years (CEA, 12%-27% [P < .01]; CAS, 8%-26% [P < .01]). Preoperative computed tomography angiography or magnetic resonance angiography in the CAS cohort also varied widely (31%-83%; P < .01), as did preoperative medical management with combined aspirin and statin (CEA, 53%-77% [P < .01]; CAS, 62%-80% [P < .01]). In the CEA group, the use of shunt (36%-83%; P < .01), protamine (32%-89%; P < .01), and patch (87%-99%; P < .01) varied widely. Similarly, there was regional variation in frequency of CAS done without a protection device (1%-8%; P < .01). CONCLUSIONS: Despite clinical benchmarks aimed at guiding management of carotid disease, wide variation in clinical practice exists, including the proportion of asymptomatic patients being treated by CAS and preoperative medical management. Additional intraoperative variables, including the use of a patch and protamine during CEA and use of a protection device during CAS, displayed similar variation in spite of clear guidelines. Quality improvement projects could be directed toward improved adherence to benchmarks in these areas.

The association of Carotid Revascularization Endarterectomy versus Stent Trial (CREST) and Centers for Medicare and Medicaid Services Carotid Guideline Publication on utilization and outcomes of carotid stenting among "high-risk" patients.

OBJECTIVE: Since the 2004 approval by the United States Food and Drug Administration of carotid artery stenting (CAS), there have been two seminal publications about CAS reimbursement (Centers for Medicare and Medicaid Services guidelines; 2008) and clinical outcomes (Carotid Revascularization Endarterectomy versus Stent Trial [CREST]; 2010). We explored the association between these publications and national trends in CAS use among high-risk symptomatic patients. METHODS: The most recent congruent data sets of the Nationwide Inpatient Sample (NIS) were queried for patients undergoing carotid revascularization. The sample was limited to include only patients who were defined as "high-risk" if they had a Charlson Comorbidity Score of ≥3.0. Subgroup analyses were performed of high-risk patients with symptomatic carotid stenosis. Utilization proportions of CAS were calculated quarterly from 2005 to 2011 for NIS. Three time intervals related to Centers for Medicare and Medicaid Services guidelines and CREST publication were selected: 2005 to 2008, 2008 to 2010, and after 2010. Logistic regression with piecewise linear trend for time was used to estimate different trends in CAS use for the overall high-risk sample and for neurologically asymptomatic and symptomatic cases. Multivariate logistic regression was used to compare odds of postoperative mortality and stroke between these two procedures at different time intervals independent of confounding variables. RESULTS: During the study period, 20,079 carotid endarterectomies (CEAs) and 3447 CAS procedures were performed in high-risk patients in the NIS database. CAS utilization constituted 20.5% of carotid revascularization procedures among high-risk symptomatic patients, with a significant increase from 18.6% to 24.4% during the study period (P < .001). There was an initial increase during 2005 to 2008 in the rate of CAS compared with CEA, CAS utilization significantly decreased during 2008 to 2010 by a 3.3% decline in the odds ratio (OR) of CAS per quarter (OR, 0.967; 95% confidence interval [CI], 0.943-0.993; P = .002), and after CREST (after 2010), CAS utilization continued to increase significantly from the prepublication to the postpublication time interval. The odds of in-hospital mortality (OR, 2.56; 95% CI, 1.17-5.62; P = .019) and postoperative in-hospital stroke (OR, 1.53; 95% CI, 1.09-3.68; P = .024) were independently and significantly higher for CAS patients in the overall sample. CONCLUSIONS: The use of CAS for carotid revascularization in a high-risk cohort of patients has significantly increased from 2005 to 2011. Compared with CEA, CAS independently increased the odds of perioperative in-hospital stroke in all high-risk patients and of in-hospital mortality in symptomatic high-risk patients.

Medicare Facility Diagnosis-Related Groups Have Outpaced Individual Physician Payment.

BACKGROUND: We set out to compare the rates of Medicare reimbursement to physicians versus hospitals for several major vascular procedures over a period of 5 years. METHODS: We queried the Wolters Kluwer MediRegs database to collect Medicare reimbursement data from fiscal years 2011 to 2015. We surveyed reimbursements for carotid endarterectomy, carotid angioplasty and stenting, femoropopliteal bypass, and lower extremity fem-pop revascularization with stenting. Based on data availability, we surveyed physician reimbursement data on the national level and in both medically overserved and underserved areas. Hospital reimbursement rates were examined on a national level and by hospitals' teaching and wage index statuses. RESULTS: We found that for all 4 vascular procedures, Medicare reimbursements to hospitals increased by a greater percentage than to physicians. By region, underserved areas had lower physician reimbursements than the national average, while the opposite was true for overserved areas. Additionally, for hospital Medicare reimbursements, location in a high wage index accounted for a significant increase in reimbursement over the national average, with teaching status contributing to this increase in a smaller extent. CONCLUSIONS: These data on Medicare reimbursements indicate that payments to hospitals are increasing more significantly than to physicians. This disparity in pay changes affects both independent and academic vascular surgeons. Medicare should consider pay increases to independent providers in accordance to the hospital pay increase.

Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial.

BACKGROUND: Drug-coated balloons (DCBs) have shown promise in improving the outcomes for patients with peripheral artery disease. We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty (PTA) for the treatment of symptomatic superficial femoral and popliteal artery disease. METHODS AND RESULTS: The IN.PACT SFA Trial is a prospective, multicenter, single-blinded, randomized trial in which 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 ratio to treatment with DCB or PTA. The primary efficacy end point was primary patency, defined as freedom from restenosis or clinically driven target lesion revascularization at 12 months. Baseline characteristics were similar between the 2 groups. Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94 ± 4.89 and 8.81 ± 5.12 cm (P=0.82) and 25.8% and 19.5% (P=0.22), respectively. DCB resulted in higher primary patency versus PTA (82.2% versus 52.4%; P<0.001). The rate of clinically driven target lesion revascularization was 2.4% in the DCB arm in comparison with 20.6% in the PTA arm (P<0.001). There was a low rate of vessel thrombosis in both arms (1.4% after DCB and 3.7% after PTA [P=0.10]). There were no device- or procedure-related deaths and no major amputations. CONCLUSIONS: In this prospective, multicenter, randomized trial, DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique Identifiers: NCT01175850 and NCT01566461.

Physician specialty and variation in carotid revascularization technique selected for Medicare patients.

OBJECTIVE: Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy (CEA) for select patients with carotid atherosclerosis. We hypothesized that the choice of CAS vs CEA varies as a function of treating physician specialty, which would result in regional variation in the relative use of these treatment types. METHODS: We used Medicare claims (2002-2010) to calculate annual rates of CAS and CEA and examined changes by procedure type over time. To assess regional preferences surrounding CAS, we calculated the proportion of revascularizations by CAS, across hospital referral regions, defined according to the Dartmouth Atlas of Healthcare. We then examined relationships between patient factors, physician specialty, and regional use of CAS. RESULTS: The annual number of all carotid revascularization procedures decreased by 30% from 2002 to 2010 (3.2 to 2.3 per 1000; P = .005). Whereas rates of CEA declined by 35% during these 8 years (3.0 to 1.9 per 1000; P < .001), CAS utilization increased by 5% during the same interval (0.30 to 0.32 per 1000; P = .014). Variation in utilization of carotid revascularization varied across the Unites States, with some regions performing as few as 0.7 carotid procedure per 1000 beneficiaries (Honolulu, Hawaii) and others performing nearly 8 times as many (5.3 per 1000 in Houma, La). Variation in procedure type (CEA vs CAS) was evident as well, as the proportion of carotid revascularization procedures that were constituted by CAS varied from 0% (Casper, Wyo, and Meridian, Miss) to 53% (Bend, Ore). The majority of CAS procedures were performed by cardiologists (49% of all CAS cases), who doubled their rates of CAS during the study period from 0.07 per 1000 in 2002 to 0.15 per 1000 in 2010. CONCLUSIONS: Variation in rates of carotid revascularization exists. Whereas rates of carotid revascularization have declined by more than 30% in recent years, utilization of CAS has increased. The proportion of all carotid revascularization procedures performed as CAS varies markedly by geographic region, and regions with the highest proportion of cardiologists perform the most CAS procedures. Evidence-based guidelines for carotid revascularization will require a multidisciplinary approach to ensure uniform adoption across specialties that care for patients with carotid artery disease.

Effectiveness of revascularization of the ulcerated foot in patients with diabetes and peripheral artery disease: a systematic review.

Symptoms or signs of peripheral artery disease (PAD) can be observed in up to 50% of the patients with a diabetic foot ulcer and is a risk factor for poor healing and amputation. In 2012, a multidisciplinary working group of the International Working Group on the Diabetic Foot published a systematic review on the effectiveness of revascularization of the ulcerated foot in patients with diabetes and PAD. This publication is an update of this review and now includes the results of a systematic search for therapies to revascularize the ulcerated foot in patients with diabetes and PAD from 1980 to June 2014. Only clinically relevant outcomes were assessed. The research conformed to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, and Scottish Intercollegiate Guidelines Network methodological scores were assigned. A total of 56 articles were eligible for full-text review. There were no randomized controlled trials, but there were four nonrandomized studies with a control group. The major outcomes following endovascular or open bypass surgery were broadly similar among the studies. Following open surgery, the 1-year limb salvage rates were a median of 85% (interquartile range of 80-90%), and following endovascular revascularization, these rates were 78% (70-89%). At 1-year follow-up, 60% or more of ulcers had healed following revascularization with either open bypass surgery or endovascular techniques. Studies appeared to demonstrate improved rates of limb salvage associated with revascularization compared with the results of conservatively treated patients in the literature. There were insufficient data to recommend one method of revascularization over another. There is a real need for standardized reporting of baseline demographic data, severity of disease and outcome reporting in this group of patients.

Complication rates and center enrollment volume in the carotid revascularization endarterectomy versus stenting trial.

BACKGROUND AND PURPOSE: Evidence indicates that center volume of cases affects outcomes for both carotid endarterectomy and stenting. We evaluated the effect of enrollment volume by site on complication rates in the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST). METHODS: The primary composite end point was any stroke, myocardial infarction, or death within 30 days or ipsilateral stroke in follow-up. The 477 approved surgeons performed >12 procedures per year with complication rates <3% for asymptomatic patients and <5% for symptomatic patients; 224 interventionists were certified after a rigorous 2 step credentialing process. CREST centers were divided into tertiles based on the number of patients enrolled into the study, with Group 1 sites enrolling <25 patients, Group 2 sites enrolling 25 to 51 patients, and Group 3 sites enrolling >51 patients. Differences in periprocedural event rates for the primary composite end point and its components were compared using logistic regression adjusting for age, sex, and symptomatic status within site-volume level. RESULTS: The safety of carotid angioplasty and stenting and carotid endarterectomy did not vary by site-volume during the periprocedural period as indicated by occurrence of the primary end point (P=0.54) or by stroke and death (P=0.87). A trend toward an inverse relationship between center enrollment volume and complications was mitigated by adjustment for known risk factors. CONCLUSIONS: Complication rates were low in CREST and were not associated with center enrollment volume. The data are consistent with the value of rigorous training and credentialing in trials evaluating endovascular devices and surgical procedures. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00004732.

US nationwide trends in carotid revascularization: hospital outcome and predictors of outcome from 1998 to 2007.

OBJECTIVES: The goals of the study were to assess US nationwide trends in hospital outcome following carotid endarterectomy (CEA) and carotid angioplasty and stenting (CAS) and to determine potential predictors of outcome. METHODS: The Nationwide Inpatient Sample, constituting a 20% representative and stratified sample of non-federal US hospitals, was analyzed retrospectively from years 1998 to 2007. RESULTS: The annual number of CEA decreased (137,877-111,658) and increased for CAS (2318-14,415). Inhospital mortality following CEA decreased from 0.4% to 0.3% (P < 0.001), whereas long-term facility (LTF) discharge increased from 8.2% to 10.5% (P < 0.001). Discharge outcome improved for CAS in both categories (mortality 2-0.5%; LTF discharge 10.7-8.3%; both P < 0.001). The trend analysis revealed an increase in patient age and a worsening comorbid profile over time. Age, women, length of stay, atrial fibrillation, and carotid stenosis with infarction were important determinants of unfavorable hospital outcome. CONCLUSION: From a nationwide practice perspective, the number of carotid revascularizations fell by 10%. CEA has resulted in stable hospital mortality rates. Meanwhile, CAS has been increasingly utilized with overall improvement in short-term outcome. Our results further suggest a decrease in the number of patients with treatment-eligible carotid disease over time. However, the increasing prevalence of high-risk comorbidity in the aging population may pose a challenge to revascularization strategies.

US nationwide trends in carotid revascularization: is there a clinical opportunity cost associated with the introduction of novel medical devices?

OBJECTIVES: Nationwide practice patterns during the implementation of novel technology, such as carotid angioplasty and stenting (CAS) and embolic protection devices (EPD), and the clinical impact thereof have received less attention. METHODS: The Nationwide Inpatient Sample, constituting a 20% representative sample of non-federal US hospitals, was analyzed from years 1998 to 2007. Hospital outcome was stratified into in-hospital mortality (IHM), long-term facility discharge, and home/ short-term facility discharge (HSF). RESULTS: Discharge outcome improved for CAS over the decade. However, this improvement occurred in two phases with a period of worsening (2003-2005) in between. During this transition period, the risk of IHM following CAS was increased (RR 1.29-2.43) and was lower for good outcome (HSF: RR 0.97-0.99) when compared with 2002/2003. During the same transition period, carotid endarterectomy (CEA) was associated with a lower risk of IHM (RR 0.75-1.00), but also a lower risk of HSF (RR 0.98-0.99). CONCLUSIONS: The results lead to the hypothesis that the nationwide introduction of CAS-EPD may have been associated with temporary increases in in-hospital mortality and discharge morbidity. If such 'clinical opportunity costs' exist with the widespread introduction and adoption of new medical technology with proven efficacy in randomized trials, effective mechanisms are needed for mitigation or prevention during the transition period.

Carotid surgery in private practice: what kind of change in the last 15 years?

BACKGROUND: This retrospective study analyzes and compares the results of patients undergoing carotid endarterectomy (CE) for atherosclerotic stenosis obtained by 2 surgeons during two 5-year periods. Group 1 (G1) represents the first period (January 1994-December 1998) and group 2 (G2) represents the second period (January 2006-December 2010). Our objective was to answer the 2 following questions: (1) Has the population changed between these 2 periods with regard to age, risk factors, and symptoms? (2) Have the techniques we used in G2--local anesthesia and eversion technique--improved the results? METHODS: G1 included 682 CE procedures on 610 patients and G2 included 629 procedures on 592 patients. The following factors were analyzed in G1 and G2: distribution of age and sex, the main risk factors (diabetes and cardiovascular risk), symptomatology, the degree of stenosis, the preoperative computed tomography (CT) data, the type of anesthesia (general or local), the use of an intraoperative shunt, surgical techniques, postoperative patency, cardiac complications, central and peripheral neurologic complications, and reoperations. In conformity with the North American Symptomatic Carotid Endarterectomy Trial classifications, stenosis of >70% was included in this survey. Loops, tumors, aneurysms, and restenosis were excluded. Heparin (300 U.I./kg) was administered. Shunt placing was selective. The 3 most common techniques used were eversion, longitudinal CE with patch angioplasty, and CE with direct closure. Postoperative patency was controlled by intravenous digital angiography or duplex ultrasonography. Follow-up occurred until postoperative day 30. RESULTS: Compared with G1, the incidence of arterial hypertension, diabetes, and coronary atherosclerosis treated by angioplasty increased significantly in G2; local anesthesia replaced general anesthesia in G2, and fewer intraoperative shunts were used (P = 0.034). The technique of direct closure of the arteriotomy was no longer used. In contrast to G1, in G2 no postoperative carotid thromboses (P = 1.8) and no lethal strokes (P = 5.44) were observed. The incidence of major adverse cardiovascular events on postoperative day 30 was 1.7% in G1 compared with 0.79% in G2. The combined mortality and morbidity rate--including reoperations and peripheral neurologic deficits--was 3.95% in G1 compared with 3.81% in G2. CONCLUSION: Despite a major increase in risk factors, the combined use of local anesthesia and eversion technique, when technically feasible, improved our results in G2.

Influence of the mode of management of acute myocardial infarction on the inducibility of ventricular tachyarrhythmias with programmed ventricular stimulation after myocardial infarction.

BACKGROUND: Programmed ventricular stimulation (PVS) is a technique for screening patients at risk for ventricular tachycardia (VT) after myocardial infarction (MI), but the results might be difficult to interpret. OBJECTIVES: To investigate the results of PVS after MI, according to date of completion. METHODS: PVS results were interpreted according to the mode of MI management in 801 asymptomatic patients: 301 (group I) during the period 1982-1989, 315 (group II) during 1990-1999, and 185 (group III) during 2000-2010. The periods were chosen based on changes in MI management. Angiotensin-converting enzyme (ACE) inhibitors had been given since 1990; primary angioplasty was performed routinely since 2000. The PVS protocol was the same throughout the whole study period. RESULTS: Group III was older (61 +/- 11 years) than groups I (56 +/- 11) and II (58 +/- 11) (P < 0.002). Left ventricular ejection fraction (LVEF) was lower in group III (36.5 +/- 11%) than in groups I (44 +/- 15) and II (41 +/- 12) (P < 0.000). Monomorphic VT < 270 beats/min was induced as frequently in group III (28%) as in group II (22.5%) but more frequently than in group I (20%) (P < 0.03). Ventricular fibrillation and flutter (VF) was induced less frequently in group III (14%) than in groups I (28%) (P < 0.0004) and II (30%) (P < 0.0000). Low left ventricular ejection fraction (LVEF) and date of inclusion (before/after 2000) were predictors of VT or VF induction on multivariate analysis. CONCLUSIONS: Induction of non-specific arrhythmias (ventricular flutter and fibrillation) was less frequent than before 2000, despite the indication of PVS in patients with lower LVEF. This decrease could be due to the increased use of systematic primary angioplasty for MI since 2000.

The rise and fall of renal artery angioplasty and stenting in the United States, 1988-2009.

OBJECTIVE: Optimal management of renal artery stenosis (RAS) remains unclear. Recent randomized controlled trials have shown no clear benefit with percutaneous transluminal angioplasty with or without stenting (PTRA/S) over medical management. We hypothesize that interventions for RAS are decreasing nationally. METHODS: The Nationwide Inpatient Sample, 1988-2009, was used to identify patients with a diagnosis of renal artery atherosclerosis undergoing open surgical repair (bypass or endarterectomy) or PTRA/S. The rate of interventions, in-hospital death, and perioperative outcomes were analyzed over time. Additionally, we used individual state inpatient and ambulatory databases to better understand the influence of outpatient procedures on current volume and trends. RESULTS: We identified 308,549 PTRA/S and 33,147 open surgical repairs. PTRA/S increased from 1.9/100K adults in 1988 to 13.7 in 2006 followed by a decrease to 6.7 in 2009. Open surgical repair steadily decreased from 1.3/100K adults in 1988 to 0.3 in 2009. In 2009, PTRA/S procedures (6.4/100K adults) greatly outnumbered procedures done by open repair alone (0.1/100K), combined open renal and aortic repair (0.2/100K), and combined PTRA/S and endovascular aneurysm repair (0.3/100K). From 2005 to 2009 33,953 patients underwent PTRA/S in the states of New Jersey Maryland, Florida, and California combined. The total number of PTRA/S performed in the outpatient setting remained stable from 2005 (3.8/100K) to 2009 (3.7/100K), whereas the total number of inpatient procedures mirrored the national trend, declining from 2006 (7.9/100K) to 2009 (4.2/100K). PTRA/S had lower in-hospital mortality (0.9% vs 4.1%; P < .001) compared with open repair. PTRA/S patients were more likely to be discharged home (86.2% vs 76.3%; P < .001) and had a shorter length of stay (4.4 vs 12.3 days; P < .001). Mortality was higher after combined open renal and open aortic surgery compared to open repair alone (6.5% vs 4.1%; P < .001). Mortality was similar for combined PTRA/S and endovascular aneurysm repair compared with PTRA/S alone (1.2% vs 0.9%; P = .04). CONCLUSIONS: The performance of PTRA/S procedures for the management of RAS has decreased significantly after 2006. An increasing proportion of these procedures are performed in the outpatient setting. PTRA/S remains the dominant revascularization procedure for RAS with lower in-hospital mortality and morbidity than surgery.

Long-term outcome of vertebral artery origin stenosis in patients with acute ischemic stroke.

BACKGROUND: Vertebral artery origin (VAO) stenosis is occasionally observed in patients who have acute ischemic stroke. We investigated the long-term outcomes and clinical significance of VAO stenosis in patients with acute ischemic stroke. METHODS: We performed a prospective observational study using a single stroke center registry to investigate the risk of recurrent stroke and vascular outcomes in patients with acute ischemic stroke and VAO stenosis. To relate the clinical significance of VAO stenosis to the vascular territory of the index stroke, patients were classified into an asymptomatic VAO stenosis group and a symptomatic VAO stenosis group. RESULTS: Of the 774 patients who had acute ischemic stroke, 149 (19.3%) of them had more than 50% stenosis of the VAO. During 309 patient-years of follow-up (mean, 2.3 years), there were 7 ischemic strokes, 6 hemorrhagic strokes, and 2 unknown strokes. The annual event rates were 0.97% for posterior circulation ischemic stroke, 4.86% for all stroke, and 6.80% for the composite cardiovascular outcome. The annual event rate for ischemic stroke in the posterior circulation was significantly higher in patients who had symptomatic VAO stenosis than in patients who had asymptomatic stenosis (1.88% vs. 0%, p = 0.046). In a multivariate analysis, the hazard ratio, per one point increase of the Essen Stroke Risk Score (ESRS) for the composite cardiovascular outcome, was 1.46 (95% CI, 1.02-2.08, p = 0.036). CONCLUSIONS: Long-term outcomes of more than 50% stenosis of the VAO in patients with acute ischemic stroke were generally favorable. Additionally, ESRS was a predictor for the composite cardiovascular outcome. Asymptomatic VAO stenosis may not be a specific risk factor for recurrent ischemic stroke in the posterior circulation. However, VAO stenosis may require more clinical attention as a potential source of recurrent stroke when VAO stenosis is observed in patients who have concurrent ischemic stroke in the posterior circulation.

Neurointerventional procedural volume per hospital in United States: implications for comprehensive stroke center designation.

BACKGROUND AND PURPOSE: Availability of neurointerventional procedures is recommended as a necessary component of a comprehensive stroke center by various regulatory guidelines that also emphasize adequate procedural volumes. We studied the volumes of neurointerventional procedures performed in various hospitals across the United States with subsequent comparisons with rates of minimum procedural volumes recommended by various professional bodies or used in clinical trials to ensure adequate operator experience. METHODS: We reviewed the Nationwide Inpatient Sample database in the United States for the years 2005 to 2008. Using International Classification of Disease-Clinical Modification, 9th revision, and Medicare severity diagnosis-related group codes, we identified among hospitals that admit stroke patients those that met the minimum criteria for overall and individual procedural volumes specified in various guidelines. We then compared the characteristics between the high-volume hospitals that performed at least 100 cervicocerebral angiograms and met ≥1 other procedural criterion (n=79) and low-volume hospitals (n=958). RESULTS: Proportions of hospitals that met individual procedural volume criteria over the 4-year period according to procedure were: cervicocerebral angiography (7.0%-7.8%); endovascular acute ischemic stroke treatments (0.4%-2.6%); carotid angioplasty/stent placement (3.0%-5.3%); intracranial angioplasty/stent placement (0.3%-1.3%); and aneurysm embolization (1.3%-2.6%). There were significant trends for increasing numbers of all the endovascular procedures except intracranial angioplasty/stent placement over the course of 4 years. The high-volume hospitals were more likely to be urban teaching hospitals (70.9% versus 13.1%; P<0.001), had larger bed size (79.7% versus 26.9%; P<0.001), and had significantly higher rates of hemorrhagic stroke admissions and lower rates of transient ischemic attack admissions. Urban teaching location/status (OR, 8.92; CI, 4.3-18.2; P<0.001) and large bed size (OR, 4.40; CI, 2.0-9.5; P<0.001) remained as independent predictors of a high-volume hospital when adjusted for age, gender, risk factors, and stroke subtype. CONCLUSIONS: There are very few hospitals in the United States that meet all the neurointerventional procedural volume criteria for all endovascular procedures recommended to ensure adequate operator experience. Our results support the creation of specialized regional centers for ensuring adequate procedural volume within treating hospitals.