The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System.

BACKGROUND: A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. METHODS AND RESULTS: Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. CONCLUSIONS: Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis.

Cost-effectiveness of repeated interventions on failing arteriovenous fistulas.

OBJECTIVE: Arteriovenous fistulas (AVFs) used for hemodialysis commonly undergo multiple percutaneous and open interventions to maintain functional patency, but it is unclear whether this strategy is cost-effective. The aim of this study was to evaluate the clinical effectiveness and cost-effectiveness of performing repeated interventions vs starting a new AVF. METHODS: We reviewed all patients with mature radiocephalic, brachiocephalic, and brachiobasilic AVFs at a single academic institution between 2007 and 2015 and assessed the clinical effectiveness of each open and percutaneous intervention to maintain functional patency after the fistula was created. These data were used to parameterize a Markov simulation model to determine the cost-effectiveness for performing an open or percutaneous intervention vs creating an AVF at a new anatomic location. This model compared strategies of creating a new AVF after the first to fourth reintervention within a 1-year time window, with the reference being creation of a new AVF on the fourth reintervention. Costs were measured from Medicare's perspective, and effectiveness was measured as quality-adjusted life-years (QALYs) and time in functional access. Incremental cost-effectiveness ratios (ICERs) were calculated by taking the ratio of the difference in cost and the difference in effectiveness between two strategies. RESULTS: A total of 720 AVFs that were created during the 8-year period reached maturity, and 407 (56%) underwent at least one intervention to maintain functional patency, with the median (interquartile range) time to first reintervention of 12.6 (10-17) months. For the strategies of creating a new AVF after the first versus the fourth reintervention, payer costs ranged from $3519 to $3922 for open procedures and $2134 to $3922 for percutaneous procedures. The ICERs for open interventions on failing AVFs were $357,143/QALY after the first reintervention and $95,876/QALY after the second reintervention. The ICERs for percutaneous interventions on failing AVFs ranged from $1,522,078/QALY after the first reintervention to $443,243/QALY after the third reintervention. CONCLUSIONS: Whereas the clinical effectiveness of performing percutaneous interventions on failing AVFs diminishes after each reintervention, they are nevertheless less costly than creating a new AVF. In comparison, our data show that creating a new AVF is cost-effective after the second open reintervention procedure.

Intravascular Ultrasound Assessment of In-Stent Restenosis in Saphenous Vein Grafts.

Outcomes after percutaneous coronary interventions (PCI) in saphenous vein grafts (SVG) are inferior compared with native coronary arteries, but the mechanisms of SVG in-stent restenosis (ISR) have not been well-described. Thus, we aimed to evaluate the patterns of SVG ISR using intravascular ultrasound (IVUS) in 54 SVG ISR lesions. Stent underexpansion was defined as minimum stent area (MSA) <5 mm2. The time from stent implantation to presentation with ISR (9 BMS, 18 first-generation DES, and 27 second-generation DES) was 3.7 ± 3.0 years. IVUS-defined ISR patterns were categorized as mechanical (33%) or biological (67%). Mechanical patterns comprised 10 cases of stent underexpansion (MSA = 4.2 ± 0.9 mm2), 6 stent fractures or deformations, and 2 uncovered aorto-anastomotic lesions. Biological patterns comprised 19 cases of neoatherosclerosis, 13 excessive neointimal hyperplasia (NIH, 65 ± 11%), and 4 thrombi. Compared with biological patterns of ISR, mechanical patterns were more frequently located at the SVG anastomosis (72% vs 39%, p = 0.04) and at the SVG hinge motion site (55% vs 21%, p = 0.02). Although patients with mechanical patterns of ISR presented earlier than those with biological patterns (2.3 vs 4.4 years, p = 0.009), 61% of them were diagnosed >1 year after stent implantation. In conclusion, SVG ISR is dominated by biological patterns including neoatherosclerosis. Mechanical patterns of SVG ISR are associated with earlier presentation and location at graft anastomosis or hinge motion site.

Structured physical assessment of arteriovenous fistulae in haemodialysis access surveillance: A missed opportunity?

INTRODUCTION: Arteriovenous fistulae remain the gold standard of vascular access in haemodialysis. There is currently no consensus on standardised methods of monitoring arteriovenous fistulae. Assessment techniques and practice remain widely variable. The purpose of this study is to determine whether existing evidence supports physical assessment as an effective tool and a good predictor of arteriovenous fistulae dysfunction to allow for timely intervention and improve outcomes. METHODS: A literature search was performed using CINAHL, PubMed, Medline and BNI databases and relevant search terms. Studies included were peer-reviewed, published after 2008, in English and related to arteriovenous fistulae only. Six key papers were identified and critically analysed for validity and relevance, in relation to outcomes, assessor experience, training duration and nurses' ability to perform physical assessment. RESULTS: Physical assessment has been shown to be effective in detecting arteriovenous fistulae dysfunction and comparable to technology-based surveillance. Physical assessment techniques generally adopt a 'look, listen and feel' approach to identify arteriovenous fistulae dysfunction that includes stenosis, thrombosis, ischaemia and infections. Physical assessment is a skill that can be taught with studies showing that skill-specific training is more effective than experience alone. Cost-effectiveness analysis is lacking. CONCLUSION: The analysis of evidence demonstrates that physical assessment of arteriovenous fistulae is an effective method of detecting arteriovenous fistulae dysfunction and is a skill that can be taught. A structured physical assessment and its implementation may be significant in routine care, but research into the most effective physical assessment techniques and its impact on clinical practice in haemodialysis is required.

Optical Coherence Tomography Assessment of Glucose Fluctuation Impact on the Neointimal Proliferation After Stent Implantation in a Diabetic/Hypercholesterolemic Swine Model.

The aim of the present study was to investigate the effects of glucose fluctuation on neointimal proliferation after stent implantation by optical coherence tomography (OCT) in a diabetic/hypercholesterolemic (DM/HC) swine model.A total of 24 everolimus-eluting stents (EES) were implanted in the right coronary artery (RCA) of the animals using a 20% overstretch ratio. The 24 swines were divided into a DM-high glucose fluctuation (HGF) group (n = 8), DMlow glucose fluctuation (LGF) group (n = 8), and a control group (n = 8). Percent diameter stenosis (%DS), late loss (LL), percent area stenosis (%AS), and neointimal thickness (NIT) were analyzed. The differences in neointimal characteristics and circulating oxidative stress and inflammation biomarkers were assessed and measured.At 28 days, the highest values of %DS, LL, %AS, and NIT were achieved in the HGF group followed by the LGF group (P < 0.05) and the control group (P < 0.05). The highest frequency of the heterogeneous pattern was in the HGF group followed by the LGF group (P < 0.05) and the control group (P < 0.05). This was also the case for the oxidative stress and inflammation biomarkers.DM might have a deleterious impact on neointimal proliferation after EES implantation in this DM/HC swine model. The extent of glucose fluctuation may be related to the degree of neointimal proliferation and this needs to be further confirmed by long-term follow-up and histology.

Adding access blood flow surveillance reduces thrombosis and improves arteriovenous fistula patency: a randomized controlled trial.

PURPOSE: Stenosis is the main cause of arteriovenous fistula (AVF) failure. It is still unclear whether surveillance based on vascular access blood flow (QA) enhances AVF function and longevity. METHODS: We conducted a three-year follow-up randomized, controlled, multicenter, open-label trial to compare QA-based surveillance and pre-emptive repair of subclinical stenosis with standard monitoring/surveillance techniques in prevalent mature AVFs. AVFs were randomized to either the control group (surveillance based on classic alarm criteria; n = 104) or to the QA group (QA measured quarterly using Doppler ultrasound [M-Turbo®] and ultrasound dilution [Transonic®] added to classic surveillance; n = 103).The criteria for intervention in the QA group were: 25% reduction in QA, QA<500 mL/min or significant stenosis with hemodynamic repercussion (peak systolic velocity [PSV] more than 400 cm/sc or PSV pre-stenosis/stenosis higher than 3). RESULTS: At the end of follow-up we observed a significant reduction in the thrombosis rate in the QA group (0.025 thrombosis/patient/year in the QA group vs. 0.086 thrombosis/patient/year in the control group [p = 0.007]). There was a significant improvement in the thrombosis-free patency rate (HR, 0.30; 95% CI, 0.11-0.82; p = 0.011) and in the secondary patency rate in the QA group (HR, 0.49; 95% CI, 0.26-0.93; p = 0.030), with no differences in the primary patency rate between the groups (HR, 0.98; 95% CI, 0.57-1.61; p = 0.935).There was greater need for a central venous catheter and more hospitalizations associated with vascular access in the control group (p = 0.034/p = 0.029).Total vascular access-related costs were higher in the control group (€227.194 vs. €133.807; p = 0.029). CONCLUSIONS: QA-based surveillance combining Doppler ultrasound and ultrasound dilution reduces the frequency of thrombosis, is cost effective, and improves thrombosis free and secondary patency in autologous AVF.

[Flowmetric assessment of coronary bypass grafts in the conditions of artificial circulation and on the beating heart].

Advantages and shortcomings of aortocoronary bypass grafting on the beating heart and in the conditions of artificial circulation (AC) have long been discussed. The data on patency of bypass grafts in the remote period are indicative of comparable results of operations with and without AC or advantages of using AC. In order to determine benefits of each method it is necessary to reveal intraoperative predictors of bypass grafts occlusion in the remote period. We analyzed the results of ultrasound flowmetry of the blood flow through the left internal thoracic artery during bypass grafting of the anterior descending artery with the use of AC and on the beating heart. A retrospective study included a total of 352 patients subdivided into 2 groups: Group One was composed of 120 patients undergoing surgery in the conditions of AC and Group Two comprised 232 patients subjected to similar operations on the beating heart. Blood flow was measured with the help of flowmeter VeryQ MediStim® after termination of AC and inactivation of heparin by protamine, with systolic pressure of 100-110 mm Hg. There were no statistically significant differences between the groups by the diameter and degree of stenosis of the anterior descending artery, diameter of the left internal thoracic artery. The mean volumetric blood flow velocity (Qmean) along the shunts in Group One was higher (p=0.01). No statistically significant differences by the pulsatility index (PI) between the groups were revealed (p=0.2). A conclusion was drawn that coronary bypass grafting of the anterior descending artery by the left internal thoracic artery in the conditions of artificial circulation made it possible to achieve higher volumetric velocity of blood flow through the conduit as compared with operations on the beating heart, with similar resistance index. The immediate results of the operations with the use of the both techniques did not differ.

Costs and clinical outcomes for non-invasive versus invasive diagnostic approaches to patients with suspected in-stent restenosis.

This study compared costs and clinical outcomes of invasive versus non-invasive diagnostic evaluations for patients with suspected in-stent restenosis (ISR) after percutaneous coronary intervention. We developed a decision model to compare 2 year diagnosis-related costs for patients who presented with suspected ISR and were evaluated by: (1) invasive coronary angiography (ICA); (2) non-invasive stress testing strategy of myocardial perfusion imaging (MPI) with referral to ICA based on MPI; (3) coronary CT angiography-based testing strategy with referral to ICA based on CCTA. Costs were modeled from the payer's perspective using 2014 Medicare rates. 56 % of patients underwent follow-up diagnostic testing over 2 years. Compared to ICA, MPI (98.6 %) and CCTA (98.1 %) exhibited lower rates of correct diagnoses. Non-invasive strategies were associated with reduced referrals to ICA and costs compared to an ICA-based strategy, with diagnostic costs lower for CCTA than MPI. Overall 2-year costs were highest for ICA for both metallic as well as BVS stents ($1656 and $1656, respectively) when compared to MPI ($1444 and $1411) and CCTA. CCTA costs differed based upon stent size and type, and were highest for metallic stents >3.0 mm followed by metallic stents <3.0 mm, BVS < 3.0 mm and BVS > 3.0 mm ($1466 vs. $1242 vs. $855 vs. $490, respectively). MPI for suspected ISR results in lower costs and rates of complications than invasive strategies using ICA while maintaining high diagnostic performance. Depending upon stent size and type, CCTA results in lower costs than MPI.

Assessment of Novel Anti-thrombotic Fusion Proteins for Inhibition of Stenosis in a Porcine Model of Arteriovenous Graft.

BACKGROUND: Hemodialysis arteriovenous synthetic grafts (AVG) provide high volumetric blood flow rates shortly after surgical placement. However, stenosis often develops at the vein-graft anastomosis contributing to thrombosis and early graft failure. Two novel fusion proteins, ANV-6L15 and TAP-ANV, inhibit the tissue factor/factor VIIa coagulation complex and the factor Xa/factor Va complex, respectively. Each inhibitor domain is fused to an annexin V domain that targets the inhibitor activity to sites of vascular injury to locally inhibit thrombosis. This study's objective was to determine if these antithrombotic proteins are safe and effective in inhibiting AVG stenosis. METHODS: A bolus of either TAP-ANV or ANV-6L15 fusion protein was administered intravenously immediately prior to surgical placement of a synthetic graft between the external jugular vein and common carotid artery in a porcine model. At surgery, the vein and artery were irrigated with the anti-thrombotic fusion protein. Control animals received intravenous heparin. At 4 weeks, MRI was performed to evaluate graft patency, the pigs were then euthanized and grafts and attached vessels were explanted for histomorphometric assessment of neointimal hyperplasia at the vein-graft anastomosis. Blood was collected at surgery, immediately after surgery and at euthanasia for serum metabolic panels and coagulation chemistries. RESULTS: No acute thrombosis occurred in the control group or in either experimental group. No abnormal serum chemistries, activated clotting times or PT, PTT values were observed after treatment in experimental or control animals. However, at the vein-graft anastomosis, there was no difference between the control and experimental groups in cross-sectional lumen areas, as measured on MRI, and no difference in hyperplasia areas as determined by histomorphometry. These results suggest that local irrigation of TAP-ANV or ANV-6L15 intra-operatively was as effective in inhibiting acute graft thrombosis as intravenous administration of heparin, but failed to inhibit hyperplasia development and stenosis in AVG.

Assessment of Radial Artery Graft Patency in Symptomatic Patients.

BACKGROUND: The purpose of this study is to evaluate the patency of radial artery (RA) grafts consistent with the target vessel characteristics. METHODS: Between October 2001 and January 2012, 83 symptomatic patients or patients with positive ischemic test results underwent coronary angiography following coronary artery bypass grafting. Of these, 68 patients with 81 RA grafts at a mean 49.2 ± 31.9 months (range, 1-137 months) were evaluated. According to the location and degree of proximal stenosis, 5-year graft patency was determined by Kaplan-Meier analysis. The relationships between RA graft patency and degree of proximal stenosis, target vessel location, and inflow characteristics of grafts were assessed by means of Cox proportional hazard models. RESULTS: Mean age of the patients was 56.4 ± 10.2 years. The period between the operation and postoperative coronary angiography was 49.2 ± 31.9 months (range, 1-137 months; median, 48.8 months). There was no impact on RA patency with regard to preoperative characteristics of the patients. RA patency was higher for left coronary system compared with right system (p = 0.038; 85.5 vs. 65.4%). In addition, patency rate was statistically higher for the proximal stenosis ≥ 90% (odds ratio, 3.65; 95% confidence interval, 1.20-11.07; p = 0.018). Kaplan-Meier patency analysis showed a patency of RA as 79.2% at 5 years. CONCLUSION: RA graft patency differs with degree of preoperative native coronary artery stenosis and location of target vessel. RA grafts to not severely stenosed (< 90%) coronary system and to the right coronary territory carry a remarkably high risk of graft failure.

Clinical access assessment.

BACKGROUND: Vascular access guidelines recommend routine screening for the timely detection of stenosis using noninvasive methods, including clinical assessment (monitoring) and device-based surveillance relying on access blood flow (Qa) and static intra-access pressure (sVPR, static venous pressure ratio) measurements and duplex ultrasound (DU). METHODS: We reviewed the literature to see how monitoring compares with surveillance in terms of compliance with the World Health Organization's criteria for screening tests. RESULTS: The fundamental element of monitoring, physical examination (PE), has a fair-to-good performance in detecting stenosis in both fistulas and grafts, similar to the Qa criteria recommended in the guidelines. In fistulas, the "or" combination of a positive PE with a Qa <900 mL/min or sVPR >0.5 is more sensitive in detecting stenosis (in up to 98% of cases), making it as good as DU. In grafts, PE performed significantly less well in diagnosing stenosis than sVPR or DU.In randomized controlled trials on fistulas, Qa surveillance enables a significant halving of the risk of thrombosis and access loss by comparison with monitoring alone when Qa criteria highly sensitive to stenosis are considered. In grafts, neither Qa nor DU nor sVPR is able to reduce thrombosis or access loss rates by comparison with monitoring alone. CONCLUSIONS: Our analysis indicates that regular monitoring should be the backbone of any vascular access stenosis screening program (possibly associated with Qa and sVPR surveillance for fistulas), and PE should be part of every teaching program for caregivers involved in hemodialysis.

Comparison of intravascular ultrasound, quantitative coronary angiography, and dual-source 64-slice computed tomography in the preprocedural assessment of significant saphenous vein graft lesions.

The correlation between cardiac computed tomographic (CT) and intravascular ultrasound (IVUS) assessment of saphenous vein graft (SVG) lesions has not been studied. The aim of this study was to evaluate the accuracy of dual-source computed tomography in quantitative assessment of significant SVG lesions scheduled for percutaneous coronary intervention (PCI). Preintervention dual-source CT (DSCT) scans were performed in consecutive patients before PCI of the SVG lesion. All subjects underwent IVUS examination of the target lesion before stent implantation. Lesion characteristics were described using dual-source computed tomography, quantitative coronary angiography, IVUS, and visual estimation. Luminal areas and diameters, lesion lengths, and DSCT suggested stent dimensions were compared. Twenty-two SVG lesions were assessed in 22 patients. Minimal lumen area measured by IVUS was larger than by dual-source computed tomography (3.5 ± 1.2 vs 3.0 ± 1.2 mm(2), p = 0.04), although there was close correlation between measurements (R = 0.7, p = 0.007). Proximal and distal reference lumen diameters by IVUS and dual-source computed tomography were similar (3.3 ± 0.4 vs 3.4 ± 0.6 mm, p = 0.5, and 3.4 ± 0.6 vs 3.5 ± 0.6 mm, p = 0.4, respectively) and were well correlated (R = 0.85, p <0.0001, and R = 0.81, p <0.0001, respectively). Lesion length by IVUS averaged 18.3 ± 6.1 versus 17.6 ± 5.3 mm by dual-source computed tomography (p = 0.1). There was good correlation between mean reference lumen diameter by dual-source computed tomography and diameter of the implanted stent (R = 0.84, p = 0.0009) and a very good correlation between stent length and lesion length as assessed by dual-source computed tomography (R = 0.9, p <0.0001). In conclusion, DSCT measurements in SVGs correlate with IVUS so that DSCT scan data before PCI of an SVG lesion may be helpful in stent size selection.

Evaluation of the vessels of the lower leg before microsurgical fibular transfer. Part II: magnetic resonance angiography for standard preoperative assessment.

The peroneal artery is the dominant supply of the osteomyocutaneous fibular flap. It has been shown that there can be anatomical variants that could jeopardise the blood supply to the lower limb during harvest of the flap. To avoid postoperative ischaemia of the lower leg, preoperative evaluation of adequate collateral perfusion is essential. We investigated whether magnetic resonance angiography (MRA) accurately shows anatomical variants and pathological stenoses of the vessels of the lower leg and whether it can replace conventional invasive techniques. Conventional digital subtraction angiography (DSA) was used in a prospective study of 15 patients, and contrast-enhanced MRA postoperatively. Arteries were evaluated by three radiologists for: size of vessel at the trifurcation; hypoplastic or missing vessels; appreciable stenosis or vascular occlusion, or both; atherosclerotic malformations; and overall vascular topography. High resolution MRA enabled a reliable judgement to be made of the vessels of the lower leg. MRA definitively detected hypoplastic vessels, stenoses, occlusion, or atherosclerotic changes of the vessels, and enabled both accurate assessment of the quality of vessels and the preferred site for the harvest of the flap. As it is a low risk procedure, it can be done in the outpatient department with no risk of radiation. It can easily replace conventional DSA.

Poor outcomes with cryoplasty for lower extremity arterial occlusive disease.

OBJECTIVES: Cryoplasty has been proposed as a different therapy to address the problems of recurrent lesions. We reviewed our experience with cryoplasty to determine its outcome treating patients with lesions in native vessels and within stents. METHODS: A retrospective review of all patients undergoing cryotherapy between 2004 and 2008 was conducted. Patency was defined by at least one of the following criteria: flow through the vessel demonstrated by angiography or duplex ultrasonography, maintenance of an ankle-brachial index (ABI) greater than 0.10 above the preprocedural value, or maintenance of a palpable pedal pulse that was absent before the procedure in an asymptomatic patient. Patency, limb salvage, symptomatic improvement, and freedom from surgical bypass were determined with Kaplan-Meier survival analysis and compared by log-rank testing. Multivariate analysis was performed by Cox proportional-hazards regression. RESULTS: Eighty-eight cryoplasty procedures were performed in 71 patients, with 35 procedures for in-stent restenosis and 37 for native vessel disease. Sixteen of 88 procedures in grafts were excluded from analysis secondary to combined disease process and/or bypass graft stenosis. Lesions treated with cryoplasty had an average of 2.9 prior endovascular interventions. Eighty-five percent of the lesions were described as complex (multifocal, diffuse, or occlusion) and the mean lesion length was 15 +/- 10 cm. Initial cryoplasty technical success rate was 68% (25 of 37) for native vessels and 71% (25 of 35) for in-stent procedures. One year primary patency for the native vs stent group was 17% vs 28%, respectively (P = .18). The 1-year primary assisted patency for the native vs stent group was 28% vs 47%, respectively (P = .33). The 1-year secondary patency for the native vs stent group was 41% vs 57% (P = .42), respectively. Freedom from claudication at 1 year for the native vs stent group was 32% vs 21% (P = .80). Compared to balloon angioplasty, cryoplasty has an averaged up-cost of $1851.50 per procedure. CONCLUSION: Cryoplasty was used in patients with extensive disease and multiple prior interventions. Cryoplasty provided poor patency rates and poor relief from claudication at 1 year in this population. Overall, cryoplasty seems to be an expensive endovascular tool with marginal clinical improvement in our experience.

New device for intraoperative graft assessment: HyperEye charge-coupled device camera system.

PURPOSE: Our institution developed a new color chargecoupled device (CCD) camera system (HyperEye system) for intraoperative indocyanine green (ICG) angiography. The device consists of a combination of custommade optical filters and an ultra-high-sensitive CCD image sensor with non-Bayer color filter array (i.e., HyperEye technology), which can detect simultaneously color and near-infrared (NIR) rays from 380 to 1200 nm. Here, we demonstrate intraoperative graft assessment using the HyperEye system. METHODS: We investigated the intraoperative graft patency using both the HyperEye system and transittime flowmetry (TFM) in 51 patients between April 2007 and April 2009 while ICG dye was injected through a central venous catheter. Each patient signed a consent form before the surgery. RESULTS: We obtained intraoperative graft flows and images in 189 anastomoses of 153 grafts. Both the HyperEye system and TFM indicated the patency of the grafts in 129 grafts. Both the HyperEye system and TFM detected the abnormality of the graft in seven grafts. For the competitive flows, the HyperEye system captured to-and-fro flow fluorescence and TFM detected the retrograde waveform in 16 grafts. On the other hand, although TFM indicated the patency of the graft, the HyperEye system suspected nonoccluded graft failure in seven grafts. In contrast, although TFM detected a mean flow of <10 ml/min, the HyperEye system captured the patent perfusion fluorescence in four grafts. CONCLUSION: The HyperEye system can visualize any structural and functional failures. Our findings suggest that this device could become a useful tool for intraoperative graft assessment.

Intraoperative grafts assessment.

Graft patency strongly influences early and late outcomes after coronary artery bypass grafting (CABG) surgery. The current standard of care in CABG surgery does not require intraoperative imaging. Because coronary angiography is rarely available in the operating room (OR), other techniques have been developed to assess graft integrity intraoperatively. The 2 most commonly used are the transit time flow measurement (TTFM) and the intraoperative fluorescence imaging (IFI). The TTFM is a quantitative volume flow technique, whereas the IFI is based on the fluorescent properties of indocyanine green. TTFM cannot define the degree of graft stenosis nor discriminate between the influence of the graft conduit and the coronary arteriolar bed on the mean graft flow. IFI provides a "semiquantitative" assessment of the graft patency with images that provide some details about the quality of coronary anastomoses. Both methods are valuable in identifying only at the extremes, that is, either patent or occluded grafts, and can confirm very good grafts; however, neither method is sensitive or specific enough in identifying more subtle abnormalities. These abnormal grafts most likely have poor long-term patency and are predestined to fail. The hybrid suite has the capability of serving both as a complete surgical OR and as a catheterization laboratory. It allows for routine completion angiogram following CABG surgery and identifies abnormal grafts, providing the opportunity to revise them with percutaneous coronary intervention or surgery before leaving the OR.

Incidence and management of restenosis after treatment of unprotected left main disease with drug-eluting stents 70 restenotic cases from a cohort of 718 patients: FAILS (Failure in Left Main Study).

OBJECTIVES: This study sought to retrospectively appraise the incidence and management of restenosis after drug-eluting stent (DES) implantation for unprotected left main (ULM) disease. BACKGROUND: The promising role of DES for ULM has been reported. However, no detailed data are available on subsequent restenosis. METHODS: From the total sample of patients with ULM treated with DES, we identified those presenting with angiographic ULM restenosis. The primary end point was the long-term rate of major adverse cardiac events (MACE), that is, death, myocardial infarction (MI), or target lesion revascularization (TLR). We also adjudicated stent thrombosis according to the Academic Research Consortium. RESULTS: Post-DES restenosis in ULM occurred in 70 of 718 patients (9.7%). Of these, 59 (84.3%) were treated percutaneously (34 [48.6%] with additional DES, 22 [31.4%] with standard or cutting balloons, 2 [2.9%] with rotational atherectomy, and 1 [1.4%] with a bare-metal stent), whereas 7 (10%) patients underwent bypass surgery and 4 (5.7%) were treated medically. In-hospital MACE included no periprocedural MI and only 1 (1.4%) death. After 27.2 +/- 15.4 months, MACE occurred cumulatively in 18 (25.7%) patients, with death in 4 (5.7%), MI in 2 (2.9%), and TLR in 15 (21.4%). Patients treated with medical, interventional, and surgical therapy had the following MACE rates, respectively: 50%, 25.4%, and 14.3%. Definite, probable, and possible stent thrombosis occurred in 0 (0%), 1 (1.4%), and 1 (1.4%) patient, respectively. CONCLUSIONS: DES restenosis in the ULM artery can be managed in most cases with a minimally invasive approach, achieving favorable early and late results.

Intraoperative fluorescence imaging system for on-site assessment of off-pump coronary artery bypass graft.

OBJECTIVES: The aim of this study was to evaluate the intraoperative fluorescence imaging (IFI) system in the real-time assessment of graft patency during off-pump coronary artery bypass graft. BACKGROUND: Intraoperative fluorescence imaging is an intraoperative angiography-like imaging modality using fluorescent indocyanine green excited with laser light. Recently, assessment of graft patency using the IFI system was introduced into clinical use. The feasibility and efficacy of IFI technology in off-pump coronary artery bypass graft has not been systematically compared with other conventional diagnostic modalities. METHODS: Patients undergoing off-pump coronary artery bypass graft received IFI analysis, intraoperative transit time flowmetry, and postoperative X-ray angiography. In off-line IFI analysis, the graft washout was classified based on the number of heartbeats required for indocyanine green washout: fast washout (15 beats). RESULTS: A total of 507 grafts in 137 patients received IFI analysis. Of all the IFI analyses, 379 (75%) grafts were visualized clearly up to the distal anastomosis. With regard to anastomosis location, anterior location was associated with a higher percentage of fully analyzable images (90%). More than 80% of images were analyzable, irrespective of graft type. Six grafts with acceptable transit time flowmetry results were diagnosed with graft failure by IFI, which required on-site graft revision. All revised grafts' patency was confirmed by post-operative X-ray angiography. Conversely, 21 grafts with unsatisfactory transit time flowmetry results demonstrated acceptable patency with IFI. Graft revision was considered unnecessary in these grafts, and 20 grafts (95%) were patent by post-operative X-ray angiography. Compared with slow washout, fast washout was associated with a higher preoperative ejection fraction, use of internal mammary artery grafts, and anterior anastomosis location. CONCLUSIONS: The IFI system enables on-site assessment of graft patency, providing both morphologic and functional information. This technique may help reduce procedure-related, early graft failures in off-pump bypass patients.