Role of intravascular ultrasound imaging during endovascular interventions of failing hemodialysis access grafts.

BACKGROUND: Arteriovenous (AV) access graft complications represent a serious complication in patients undergoing hemodialysis. Angiography is one method of visualizing them. However, angiography is not always an effective means of detecting lesions that occur in this context. Intravascular ultrasound (IVUS) is an adjunct modality used to identify stenoses responsible for failing access by identifying multiple stenoses, including those that are most severe. The purpose of this study was to define the value of IVUS in patients with failing AV access grafts by comparing digital subtraction angiography (DSA) alone with DSA followed by IVUS. METHODS: This was a single-center randomized study comparing IVUS with DSA in patients with failing hemodialysis access grafts. It consisted of 100 randomized hemodialysis patients presenting with failing AV access who were being considered for endovascular intervention. Interventions in the control group were guided by DSA alone, whereas interventions in the test group were guided by DSA followed by IVUS. Patients were observed for 6 months after intervention. The primary end point was the time in days to AV access graft failure after the index intervention, expressed as median and interquartile range. Secondary analyses included influence of DSA and IVUS on index procedure decision-making and percentage of patients with AV access graft reinterventions or discontinuation through 3 and 6 months. RESULTS: Median time to first AV graft reintervention or discontinuation was 61 days in the test group and 30 days in the control group (P = .16), with analysis limited to patients who experienced reintervention or discontinuation (n = 59). IVUS resulted in a change in treatment plan in 76% (44/58) of patients, with no treatment change after IVUS in 24% (14/58) of patients. At 6 months, approximately 35% of patients in both the control and test groups remained free from reinterventions (P = .88). At 6 months, approximately 75% of patients in the control group and 80% of patients in the test group remained free from AV graft discontinuation or abandonment (P = .45). CONCLUSIONS: This pilot study suggests that addition of IVUS to standard angiography during endovascular interventions of failing hemodialysis access grafts holds potential to extend the time to the first reintervention. The data support the design and execution of an adequately powered randomized trial with longer follow-up to reliably discern the clinical benefit of IVUS as an addition to standard angiography in the setting of failing AV access grafts.

Granular Cell Tumor Within an Ovarian Mature Cystic Teratoma: Report of a Unique Case and Review of the Literature.

Granular cell tumors involving the female reproductive tract are rare, with only a small number of cases described. Of the reported cases, none are documented within an ovarian mature cystic teratoma (MCT). This report documents a case of a granular cell tumor, incidentally discovered within an ovarian MCT in a 50-yr-old woman undergoing a supracervical hysterectomy and left salpingo-oophorectomy. Although malignant transformation and other secondary ovarian neoplasms in MCT have been well documented, synchronous nonovarian benign neoplasms are reported much less frequently. The histogenesis of secondary tumors arising in MCT is incompletely understood, and the current case provides additional insight, especially pertaining to schwannian and neuroectodermal tumors arising in this setting. The current case, to the best of our knowledge, represents the first report of a granular cell tumor involving a mature teratoma of any site, with the diagnosis being supported by morphologic and immunohistochemical staining characteristics.

Prospective, Randomized, Concurrently-Controlled Study of a Stent Graft versus Balloon Angioplasty for Treatment of Arteriovenous Access Graft Stenosis: 2-Year Results of the RENOVA Study.

PURPOSE: To present final, 2-year data from randomized comparison of an expanded polytetrafluoroethylene stent graft (SG) and percutaneous transluminal angioplasty (PTA) for treatment of arteriovenous graft (AVG) anastomotic stenoses. MATERIALS AND METHODS: A 28-site, prospective, controlled US study enrolled 270 patients with malfunctioning AVG anastomotic stenoses of ≥ 50%; 138 patients underwent SG placement, and 132 underwent PTA alone. Follow-up imaging and intervention were event-driven. RESULTS: The study was completed by 191 patients (97 SG, 94 PTA). Five patients were lost to follow-up or withdrew; 74 patients died during the study (38 SG, 36 PTA). At 12 months, treatment area primary patency (TAPP) was SG 47.6% versus PTA 24.8% (P < .001), access circuit primary patency (ACPP) was SG 24% versus PTA 11% (P = .007), and index of patency function (IPF) was SG 5.2 months/intervention ± 4.1 versus PTA 4.4 months/intervention ± 3.5 (P = .009). At 24 months, TAPP was SG 26.9% versus PTA 13.5% (P < .001), ACPP was SG 9.5% versus PTA 5.5% (P = .01), and IPF was SG 7.1 months/intervention ± 7.0 versus PTA 5.3 months/intervention ± 5.2; estimated number of reinterventions before graft abandonment was 3.4 for SG patients versus 4.3 for PTA patients. There were no significant differences in adverse events (P > .05) except for restenosis requiring reintervention rates of 82.6% in PTA patients versus 63.0% in SG patients (P < .001). CONCLUSIONS: At 2 years, SG use provided a sustained, greater than 2-fold advantage over PTA in treatment area and overall access patency. Time to subsequent intervention was longer in the SG group.

The clinical use of a P63/cytokeratin7/18/cytokeratin5/14 antibody cocktail in diagnostic breast pathology.

An antibody cocktail directed against p63, cytokeratin (CK)5/14, and CK7/18 is reported to be useful in distinguishing noninvasive from invasive breast lesions and for the characterization of intraductal epithelial proliferations. However, limited studies evaluate its use in clinical practice. A retrospective review of breast material at a university medical center identified cases that were immunostained with the above antibody cocktail. Additional p63 immunostaining alone was performed to further determine the utility of the antibody cocktail in the evaluation of invasion. Of 50 breast cases identified, the antibody cocktail was used to confirm or exclude invasion in 44 (88%). Twenty-two (50%) of these had easily identifiable p63/CK5/14-positive myoepithelial cells, whereas the remainder lacked such staining, confirming the diagnosis of invasive carcinoma. In 27 cases with available diagnostic material for additional p63 immunostaining, the cocktail better highlighted myoepithelial cells by staining nuclei and cytoplasm. Easier identification of invasion was also facilitated by CK7/18 expression in invasive foci, especially those composed of single cells. Ten cases were immunostained to help determine the nature of an intraductal proliferation. The cocktail demonstrated a mosaic staining pattern of both CK7/18- and CK5/14-positive epithelial cells in 3 (30%) cases consistent with usual hyperplasia; homogenous CK7/18 expression in the remaining cases supported the diagnosis of atypical ductal hyperplasia or carcinoma in situ. In summary, the p63/CK7/18/CK5/14 cocktail stain appears to be a useful tool in diagnostic breast pathology, in the evaluation of possible invasion, particularly in the setting of minute foci of invasion as well as in epithelial proliferations.

Automated 3D ultrasound enables novice users to measure arteriovenous fistula maturation parameters with comparable accuracy to conventional duplex by trained sonographers: Results of a benchtop study.

BACKGROUND: Arteriovenous fistulae (AVF) are considered the preferred hemodialysis access but up to 50% of all AVF created in the United States never mature. Doppler ultrasound (DUS) is useful for predicting fistula maturity and impending fistula failure. DUS is resource-intensive and is associated with poor compliance rates in dialysis patients, ranging from 12% to 33%. METHODS: EchoSure is an FDA-cleared 3D Doppler ultrasound device that automatically delivers quantitative blood flow and anatomic vascular information. The technology can be used at the bedside by personnel without formal sonographic training, nullifying limitations of traditional Duplex ultrasound imaging. This study compared the EchoSure system in the hands of inexpert personnel to a traditional expert-operated DUS for rapid assessment of a benchtop model vascular system with flow, diameter, and depth expected in a human AVF. RESULTS: Both Duplex and EchoSure performed within the expected tolerance of ultrasound readings (35%) for volume flow, with the average error (AE) between the observed measurement and the ground truth being 8% for Duplex and 8% for EchoSure. However, the average coefficient of variation (CV) for Duplex pooled over all flow rate measurements was 17% versus 4% for EchoSure. Regarding diameter, Duplex measurements had AE of 15% with an average CV of 6% across all measurements versus EchoSure AE of 4% and average CV of 2%. Duplex and EchoSure measurements over all depths had the same AE of 2%. The two modalities were not statistically different for depth measurement (p = 0.05) but EchoSure measured closer to the ground truth for flow rate and vessel diameter (flow: p = 0.028, ρ = -0.07; diameter: p < 0.001, ρ = 0.69). The inexpert personnel using EchoSure acquired data 62% faster than the expert sonographers using the Duplex ultrasound (141 min for Duplex vs 87 min for EchoSure). CONCLUSIONS: EchoSure may offer an accurate and convenient alternative for imaging fistulas in the clinic.

Quality of life after late invasive therapy for occluded arteries.

BACKGROUND: The open-artery hypothesis postulates that late opening of an infarct-related artery after myocardial infarction will improve clinical outcomes. We evaluated the quality-of-life and economic outcomes associated with the use of this strategy. METHODS: We compared percutaneous coronary intervention (PCI) plus stenting with medical therapy alone in high-risk patients in stable condition who had a totally occluded infarct-related artery 3 to 28 days after myocardial infarction. In 951 patients (44% of those eligible), we assessed quality of life by means of a battery of tests that included two principal outcome measures, the Duke Activity Status Index (DASI) (which measures cardiac physical function on a scale from 0 to 58, with higher scores indicating better function) and the Medical Outcomes Study 36-Item Short-Form Mental Health Inventory 5 (which measures psychological well-being). Structured quality-of-life interviews were performed at baseline and at 4, 12, and 24 months. Costs of treatment were assessed for 458 of 469 patients in the United States (98%), and 2-year cost-effectiveness was estimated. RESULTS: At 4 months, the medical-therapy group, as compared with the PCI group, had a clinically marginal decrease of 3.4 points in the DASI score (P=0.007). At 1 and 2 years, the differences were smaller. No significant differences in psychological well-being were observed. For the 469 patients in the United States, cumulative 2-year costs were approximately $7,000 higher in the PCI group (P<0.001), and the quality-adjusted survival was marginally longer in the medical-therapy group. CONCLUSIONS: PCI was associated with a marginal advantage in cardiac physical function at 4 months but not thereafter. At 2 years, medical therapy remained significantly less expensive than routine PCI and was associated with marginally longer quality-adjusted survival. (ClinicalTrials.gov number, NCT00004562.)

By the pricking of my thumbs, something wicked this way comes: sporadic cancers versus eponymous hereditary cancer predisposition syndromes.

Advances in cancer genomics have led to the recognition of a growing number of high-penetrance single-gene cancer predisposition syndromes. Frequently, the suspicion for a hereditary syndrome is raised by a strongly positive family history. However, other features, such as younger-than-usual age at diagnosis and rare histology should also prompt consideration of a genetic syndrome. Common malignancies frequently show a positive family history without an eponymous syndrome being recognized. This article reports on a case with an unusual constellation of malignancies with distinctive pathologies, which raised suspicion for an eponymous cancer pre-disposition syndrome. Absent a positive family history, a de novo mutation-an alteration in a gene that is present for the first time in a family member as a result of a mutation in a germ cell of one of the parents or in the fertilized ovum-was suspected. The authors discuss indications for genetic counseling and testing, limitations, and the evidence that supports the recommendations as formulated by working groups and the NCCN. Most frequently, these recommendations are reasonable statements based on the natural history of the disease, but without population-based studies for many rare syndromes, the actual penetrance, variable expressivity, and actual associated cancer risk are unknown.

Safe and effective HeRO graft placement: Technique and results.

OBJECTIVES: Hemodialysis Reliable Outflow (HeRO) grafts are used when venous outflow is inadequate to support conventional access. These have been perceived as complex to implant and being associated with high risk. We have evolved a defined protocol for insertion that minimizes morbidity and maximizes efficiency. METHODS: Our protocol includes staged intravenous access versus HeRO graft placement, reverse Trendelenburg positioning, subcutaneous access of the deep portion of the existing catheter, use of a stiff wire placed within the inferior vena cava, dilation of the tract to 8 mm, device lubrication, all insertion procedures directly visualized, and use of immediate access conduits with SuperHeRO connector. RESULTS: From 7/1/18 to 8/13/19, 55 HeRO grafts were placed at our institution following this protocol, average age 58 ± 15 (26-86) years (mean ± SD, range). 53 (96%) had had prior ipsilateral central access (13 by means of "inside out" 2 weeks prior) the other two had on-table access. Mean procedure time was 70 ± 26 (38-148) min. Excluding seven "complex" cases, procedure time for our first 20 cases using this protocol was 72 ± 29 min, while that of the last 28 was 62 ± 18 min (p < 0.05). One patient suffered acute CHF after unclamping; despite reclamping and ligation he died on POD 3 (mortality rate 2%). 71% were done as outpatients, and 47 of 53 evaluable patients (89%) had their grafts used within 36 h for dialysis. Only one patient (2%) has had an infection within 30 days (cellulitis). At a mean followup of 95 ± 105 (maximum 383) days, three additional patients have had graft infections requiring excision, for a total infection rate of 5/53 (9%). CONCLUSIONS: Our results suggest that HeRO graft placement can be performed with minimal morbidity and mortality on an outpatient basis. Short-term infection rates are low and 89% of patients have their grafts immediately accessed and are discharged without a catheter.

Results of first stage brachiobasilic and brachiobrachial fistula creation: Implications for staged versus single procedure decision making.

INTRODUCTION: Transposed brachiobasilic AV fistulas (BVT) have increasingly been performed in two stages. Published reports give conflicting results, perhaps in part as many reports of staged procedures eliminate those patients who "fail" the first stage (i.e. are lost to follow-up in addition to anatomic failure). METHODS: A prospectively maintained database was reviewed to identify all patients at two institutions who underwent the first stage of planned two-stage BVT by the senior author. Success in this context was defined as patients who eventually underwent second stage fistula creation, leaving the operating room after the second stage with a patent, transposed fistula. RESULTS: From October 2012 to June 2020, 218 patients underwent first-stage procedures. At the first visit, 185 (85%) of fistulas were patent, 23 (11%) were occluded, 8 (4%) of patients were lost to follow-up, and 2 (1%) died. In the interval before the second operation, another eight (4%) patients were lost to follow-up, two were cancelled for medical reasons, and two declined surgery, leaving a total of 173 patients who made it to the second stage (80%). At operation, four patients were found to have unusable veins, leaving a total of 169 patients who completed both stages. If all patients who underwent first stage are included, 77% of patients entering this pathway left the OR after their second stage with patent access. If those lost to follow-up are excluded, this number increases to 84%, while if all those lost to follow-up are assumed to mature, success increases to 85%. CONCLUSIONS: Depending on results in patients lost to follow-up, between 77% and 85% of patients undergoing first stage brachiobasilic fistulae undergo successful second stage transposition. These numbers are equivalent or slightly lower than published maturation rates for single-stage BVT, so there is little margin for failure at the second stage.

Group I mGluR-regulated translation of the neuronal glutamate transporter, excitatory amino acid carrier 1.

Recently, we demonstrated that mRNA for the neuronal glutamate transporter, excitatory amino acid carrier 1 (EAAC1), is found in dendrites of hippocampal neurons in culture and in dendrites of hippocampal pyramidal cells after pilocarpine-induced status epilepticus (SE). We also showed that SE increased the levels of EAAC1 mRNA ~15-fold in synaptoneurosomes. In this study, the effects of SE on the distribution EAAC1 protein in hippocampus were examined. In addition, the effects of Group 1 mGluR receptor activation on the levels of EAAC1 protein were examined in synaptoneurosomes prepared from sham control animals and from animals that experience pilocarpine-induced SE. We find that EAAC1 immunoreactivity increases in pyramidal cells of the hippocampus after 3 h of SE. In addition, the group I mGluR agonist, (S)-3,5-dihydroxyphenylglycine (DHPG), caused an increase in EAAC1 protein levels in hippocampal synaptoneurosomes; this effect of DHPG was much larger (~3- to 5-fold) after 3 h of SE. The DHPG-induced increases in EAAC1 protein were blocked by two different inhibitors of translation but not by inhibitors of transcription. mGluR1 or mGluR5 antagonists completely blocked the DHPG-induced increases in EAAC1 protein. DHPG also increased the levels of glutamate receptor 2/3 protein, but this effect was not altered by SE. The DHPG-induced increase in EAAC1 protein was blocked by an inhibitor of the mammalian target of rapamycin or an inhibitor of extracellular signal-regulated kinase. These studies provide the first evidence EAAC1 translation can be regulated, and they show that regulated translation of EAAC1 is up-regulated after SE.

Use of a novel immediate access dialysis graft designed to prevent needle-related complications: A first-in-man case report.

Currently, there is no vascular access that possesses all ideal qualities for hemodialysis access, but attributes particularly lacking include: ease of identification (cannulation zone), ease of access, resistance to stenosis, durable to repetitive cannulation, resistance to infection, resistance to acute needle-related injuries, and instant hemostasis. The overall value of these attributes could be appreciated in the reduction of complications (patient burden and suffering, which can also result in increased healthcare costs), and improved safety and durability. In this case report, we present a novel hemodialysis access graft that has the potential to provide the following benefits: it is designed to be self-sealing and immediately usable post implant, easy to identify, easy to access, has more durable cannulation zones, and protects from needle-related injuries. This case report describes the first-in-man use of this novel graft technology to replace a giant, thrombotic, and difficult-to-access arteriovenous fistula to provide the patient with a potentially safer and more durable access that does not require placement of a bridging dialysis catheter. This single-patient experience suggests that implantation and function of this novel graft as a hemodialysis access is feasible in a human subject with end-stage renal disease, and it suggests that the novel properties (i.e. immediate use, easy identification, easy use, cannulation zone durability, and protection from needle-related injuries) of this graft seem to function as intended.

The role of surgery for assisted maturation after endovascular and percutaneous arteriovenous fistula creation.

Even in the best of circumstances, a significant number of patients will require adjunctive endovascular and/or surgical revision prior to achieving functional patency after endovascular or percutaneous AVF creation, at least within the United States. This rate appears to be higher after percutaneous AVF than after endovascular AVF, although because published reports of the former are mostly derived from American experience and those of the latter derived from experience outside the United States, it is unclear whether these differences are due to the technique itself or cultural and/or anatomic differences in dialysis access practices and patient populations. If arterial inflow is poor, this should be corrected first. When flow is adequate (perhaps 900 cc/min) but no single vein is cannulatable, a dominant suitable vein can be superficialized or transposed. If no suitable vein is dominant (most accurately assessed by using an intraoperative flowmeter), the best vein can be used, with or without occlusion of the other veins or reimplantation into the brachial artery. Finally, if the original anastomosis remains the sole supply to the cannulated vein, the original fistula has achieved assisted primary maturation (and assisted primary patency continues), while if a new arteriovenous anastomosis has been constructed, the original fistula has failed. We point out that for this reason as well as to best utilize the upper arm for later access, endovascular and percutaneous AVFs should be constructed and maintained within an atmosphere where both surgeons and non-surgeons work together on the overall access plan.

Efficacy and safety associated with the use of the Surfacer® Inside-Out® Access Catheter System: Results from a prospective, multicenter Food and Drug Administration-approved Investigational Device Exemption study.

PURPOSE: Thoracic central venous obstruction is commonly associated with the use of central venous catheters. The Surfacer System to Facilitate Access in Venous Occlusions Study was an Food and Drug Administration-approved US Investigational Device Exemption study designed to evaluate the performance and safety of the Surfacer System when used to facilitate central venous access in patients with thoracic central venous obstruction. METHODS: Thirty patients were enrolled in this prospective, multicenter, single-arm study between December 2017 and May 2019. Device performance and adverse events were collected peri-procedurally and at discharge. Enrollment included 15 female and 15 male subjects with a mean age of 55.5 ± 12.9 (range: 30-79) years. Twenty-eight patients (93.3%) required central venous access for hemodialysis access. Locations of thoracic central venous obstruction were graded from 1 to 4 based on severity and extension of venous occlusions. Seven patients (23.3%) had type 1, 6 (20.0%) type 2, 16 (53.3%) type 3, and 1 (3.3%) type 4 obstruction. RESULTS: Successful central venous catheter placement was achieved in 27 of 30 patients (90.0%). The procedure was discontinued in three (10.0%) due to tortuous anatomy discovered intraprocedurally. All 27 patients with successful CVC placement achieved adequate catheter patency and tip positioning with a mean overall procedural time and time to achieve central venous access with the Surfacer System being 44.1 ± 30.6 and 19.1 ± 25.1 min, respectively. There were no device-related adverse events or catheter malposition. CONCLUSION: The results of the SAVEUS Study confirm the safety and efficacy of the Surfacer System and the Inside-Out procedure when used for the placement of right-sided central venous access in patients with thoracic central venous obstruction.

Impact of stress testing before percutaneous coronary intervention or medical management on outcomes of patients with persistent total occlusion after myocardial infarction: analysis from the occluded artery trial.

BACKGROUND: In the Occluded Artery Trial (OAT), 2,201 stable patients with an occluded infarct-related artery (IRA) were randomized to percutaneous coronary intervention (PCI) or optimal medical treatment alone (MED). There was no difference in the primary end point of death, reinfarction, or congestive heart failure (CHF). We examined the prognostic impact of prerandomization stress testing. METHODS: Stress testing was required by protocol except for patients with single-vessel disease and akinesis/dyskinesis of the infarct zone. The presence of severe inducible ischemia was an exclusion criterion for OAT. We compared outcomes based on performance and results of stress testing. RESULTS: Five hundred ninety-eight (27%) patients (297 PCI, 301 MED) underwent stress testing. Radionuclide imaging or stress echocardiography was performed in 40%. Patients who had stress testing were younger (57 vs 59 years); had higher ejection fractions (49% vs 47%); and had lower rates of death (7.8% vs 13.2%), class IV CHF (2.4% vs 5.5%), and the primary end point (13.9% vs 18.9%) than patients without stress testing (all P < .01). Mild-moderate ischemia was observed in 40% of patients with stress testing and was not related to outcomes. Among patients with inducible ischemia, outcomes were similar for PCI and MED (all P > .10). CONCLUSIONS: In OAT, patients who underwent stress testing had better outcomes than patients who did not, likely related to differences in baseline characteristics. In patients managed with optimal medical therapy or PCI, mild-moderate inducible ischemia was not related to outcomes. The lack of benefit for PCI compared to MED alone was consistent regardless of whether stress testing was performed or inducible ischemia was present.

Initial experience and outcome of a new hemodialysis access device for catheter-dependent patients.

OBJECTIVE: The effects of a new long-term subcutaneous vascular access device were studied in access-challenged patients who were poor candidates for fistulas or grafts due to venous obstruction. Bacteremia rates, patency, and function of the Hemodialysis Reliable Outflow (HeRO) Vascular Access Device (Hemosphere Inc, Minneapolis, Minn) were evaluated. METHODS: The HeRO device consists of a 6-mm expanded polytetrafluoroethylene graft attached to a 5-mm nitinol-reinforced silicone outflow component designed to bypass venous stenoses and enter the internal jugular vein directly, providing continuous arterial blood flow into the right atrium. The HeRO device was studied in a multicenter clinical trial to test the hypothesis that access-challenged patients would experience a statistically significant reduction in bacteremia rates compared with a tunneled dialysis catheter (TDC) literature control of 2.3/1000 days. HeRO-related bacteremia rates, adequacy of dialysis, patency, and adverse events were analyzed. RESULTS: The HeRO device was implanted in 36 access-challenged patients who were followed for a mean 8.6 months (9931 HeRO days). The HeRO-related bacteremia rate was 0.70/1000 days. All HeRO-related bacteremias occurred during the bridging period when a TDC was still implanted before HeRO graft incorporation. HeRO adequacy of dialysis (mean Kt/V) was 1.7. HeRO primary patency was 38.9%, and secondary patency was 72.2%. CONCLUSIONS: In access-challenged patients, a statistically significant reduction in HeRO-related bacteremia was noted compared with TDC literature. The device had similar function and patency compared with conventional arteriovenous graft literature.

Angiographic and clinical outcomes of drug-eluting versus bare metal stent deployment in the Occluded Artery Trial.

BACKGROUND: The majority of patients randomized to percutaneous coronary intervention (PCI) in the Occluded Artery Trial (OAT) and its angiographic substudy, the Total Occlusion Study of Canada 2 (TOSCA-2) were treated with bare metal stents (BMS). We aimed to determine if stenting of the target occlusion in OAT with drug-eluting stents (DES) was associated with more favorable angiographic results and clinical outcome when compared with treatment with BMS. METHODS: TOSCA-2 DES was a prospective nonrandomized substudy that provided 1-year angiographic comparison of late loss and reocclusion in 25 patients treated with DES and in 128 treated with BMS. In addition, all PCI-assigned patients enrolled from the time when DES were first utilized were similarly categorized (DES n = 77, and BMS n = 386) and compared using the 3-year cumulative OAT primary combined endpoint of death, myocardial infarction, or Class-IV heart failure, as well as angina. RESULTS: In-segment late loss was 0.14 +/- 0.45 mm for DES and 0.75 +/- 0.86 mm for BMS (P < 0.001). Corresponding binary restenosis rates were 13.0% and 44.3% (P = 0.005). Occlusion at 1 year was observed in 4.0 and 12.1%, respectively (P = 0.23). The 3-year cumulative primary event rate was 13.8% with DES and 12.5% with BMS (hazard ratio 1.08, 99% confidence intervals 0.44, 2.64; P = 0.83). Angina over time occurred less frequently in the DES group (P = 0.01). CONCLUSIONS: Although the reduction of late loss and trend to reduction in reocclusion with the use of DES for PCI of persistently occluded IRA 3-28 days post myocardial infarction did not translate into a signal for reduction in death, reinfarction, or Class IV heart failure, DES use was associated with less angina over time. Further follow-up is warranted.

Clinical outcomes associated with the use of the NexSite hemodialysis catheter with new exit barrier technology: Results from a prospective, observational multi-center registry study.

PURPOSE: Decreasing the risk of catheter related bloodstream infections (CRBSIs) remains a key focus for improving outcomes and reducing cost of care for hemodialysis (HD) patients. Recent studies demonstrate CRBSI rates can be improved by managing bacterial colonization at the catheter exit site. Herein we present the results of a study documenting the clinical performance of the NexSite HD catheter, a new tunneled central venous catheter which incorporates Exit Site Management (ESM) technology. METHODS: We conducted an observational study using a prospective, multi-center registry of HD patients implanted with the NexSite HD catheter. The primary endpoint for the study was CRBSI rate for a period up to 180-days following catheter placement. Secondary endpoints included device placement success rate, exit site healing, development of an exit site or tunnel infection, and early or late non-infectious catheter-related complications. All reasons for early non-elective catheter removal were recorded. RESULTS: A total of 115 HD patients at 6 sites were included in the final analysis. Cumulative catheter use was 10,924 days with a mean duration of 95 days. Seven patients experienced CRBSIs during the study period resulting in a CRBSI rate of 0.64 per 1,000 catheter-days. Seventy-four patients (64.3%) had either elective catheter removal (n = 56) or utilized the catheter for the entire 180-day observation period (n = 18). Thirty-five patients (30%) underwent non-elective device removal either due to CRBSI (n = 5), low flow (n = 16), exit site issues (n = 7), or for other causes (n = 7). Six patients died during the observation period with 1 death due to CRBSI-associated complications and the remaining 5 deaths attributed to non-device related causes. CONCLUSION: Our findings demonstrate that the NexSite HD catheter equipped with ESM technology can achieve a CRBSI rate in compliance with the NKF KDOQI (National Kidney Foundation Kidney Disease Outcome Quality Initiatives) Clinical Performance Guidelines stated goal of less than 1.0/1,000 catheter-days when used in hemodialysis patients using current standard of care nursing protocols.

Decreased complication rates using the transradial compared to the transfemoral approach in percutaneous coronary intervention in the era of routine stenting and glycoprotein platelet IIb/IIIa inhibitor use: a large single-center experience.

BACKGROUND: Studies evaluating the efficacy and safety of the transradial approach for percutaneous coronary intervention (PCI) were carried out mainly before the widespread use of stents and glycoprotein (GP) IIb/IIIa inhibitors. We sought to determine the association between the choice of the vascular access site and procedural complications after PCI performed with routine stenting and GP IIb/IIIa inhibition. METHODS: The data source was a prospective registry of 13,499 consecutive cases of PCI at the University Health Network, Toronto, Canada, from April 2000 to September 2006. Logistic regression was used to calculate the probability of selection to the radial access group. Using propensity score methodology, 3,198 patients with femoral access were randomly matched to 3,198 patients with radial access based on clinical, angiographic, and procedural characteristics. Multivariable logistic regression analysis was used to identify the independent predictors of access site-related complications. Major adverse cardiac event was defined as death, myocardial infarction, abrupt vessel closure, or coronary artery bypass surgery. RESULTS: Use of the transradial approach was associated with fewer vascular access complications (1.5% vs 0.6%, P<.001) and a shorter length of hospital stay. Multivariable analysis revealed transradial access (OR 0.39, 95% CI 0.2-0.7) to be an independent predictor of lower risk, whereas primary PCI (OR 4.36, 95% CI 1.4, 13), recent myocardial infarction (OR 2.0 95% CI 1.2, 3.4), age (per 10 years increase: OR 1.37, 95% CI 1.1-1.7) and female gender (0R 2.78 95% CI 1.7, 4.6) were independent predictors of a higher risk of access site complications. CONCLUSIONS: Use of transradial access for PCI is safe and is independently associated with a reduced rate of in-hospital access site complications and reduced length of hospital stay.

Impact of renal insufficiency on angiographic, procedural, and in-hospital outcomes following percutaneous coronary intervention.

Patients with chronic renal insufficiency (RI) have higher in-hospital mortality and major adverse cardiac event (MACE) rates after percutaneous coronary intervention (PCI). The mechanisms of this adverse course are not well understood. It was hypothesized that this worse outcome may be caused by inadequate PCI results secondary to more complex coronary anatomy in patients with RI. Baseline, procedural, and outcome variables of all PCI cases at the University Health Network are entered prospectively in the PCI Registry. All PCI cases between April 1, 2000, and October 31, 2005, excluding patients in shock, who had preprocedural creatinine clearance (CrCl) measured were included in this study (n = 10,821 of 11,023 patients). Moderate RI (CrCl <60 ml/min) was evaluated as an independent predictor of procedural outcomes, death, and MACE (defined as death, myocardial infarction, abrupt closure, or coronary artery bypass grafting). Moderate RI (CrCl <60 ml/min) independently predicted the procedural outcomes of worse residual stenosis >20% (p = 0.03), number of undeliverable stents (p = 0.003), and smallest stent diameter (p <0.001). Worst residual stenosis >20% and any undeliverable stent were significantly associated with in-hospital MACEs (odds ratio [OR] 3.97, 95% confidence interval [CI] 3.0 to 5.3, p <0.001 and OR 1.89, 95% CI 1.2 to 2.9, p = 0.002) and mortality (OR 3.82, 95% CI 2.2 to 6.7, p <0.001 and OR 3.0, 95% CI 1.6 to 5.9, p = 0.002). These risks were independent of all other measured variables. In conclusion, moderate to severe RI was a strong predictor of worse procedural results during PCI, which, in turn, were independent predictors of in-hospital MACE and mortality and independent contributors to the higher risk of in-hospital adverse events observed after PCI in patients with RI.