Clinical Conference Proceedings: 15th Biennial International Andreas Gruentzig Society Meeting.

The International Andreas Gruentzig Society is an educational society of physicians and scientists interested in cardiovascular and related fields. Members cooperate in the advancement of knowledge and education through research, publication, study, and teaching in the fields of cardiovascular disease. This summary reflects the proceedings from the recent scientific meeting to assess current clinical problems and propose future directions and possible solutions.

Multidisciplinary approach to the diagnosis and management of patients with peripheral arterial disease.

Peripheral arterial disease (PAD) is frequently diagnosed after permanent damage has occurred, resulting in a high rate of morbidity, amputation, and loss of life. Early and ongoing diagnosis and treatment is required for this progressive disease. Lifestyle modifications can prevent or delay disease progression and improve symptoms. Limb-sparing endovascular interventions can restore circulation based on appropriate diagnostic testing to pinpoint vascular targets, and intervention must occur as early as possible to ensure optimal clinical outcomes. An algorithm for the diagnosis and management of PAD was developed to enable a collaborative approach between the family practice and primary care physician or internist and various specialists that may include a diabetologist, endocrinologist, smoking cessation expert, hypertension and lipid specialist, endovascular interventionalist, vascular surgeon, orthopedist, neurologist, nurse practitioner, podiatrist, wound healing expert, and/or others. A multidisciplinary team working together has the greatest chance of providing optimal care for the patient with PAD and ensuring ongoing surveillance of the patient's overall health, ultimately resulting in better quality of life and increased longevity for patients with PAD.

Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

OBJECTIVES: The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR). BACKGROUND: Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging. METHODS: The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure. RESULTS: Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74). CONCLUSIONS: The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. (Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [EXCITE ISR]; NCT01330628).

Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial.

OBJECTIVES: The purpose of this study is to compare post-dilation strategies of nitinol self-expanding stents implanted in the superficial femoral artery of diabetic patients with peripheral arterial disease. BACKGROUND: Endovascular treatment of superficial femoral artery disease with nitinol self-expanding stents is associated with high rates of in-stent restenosis in patients with diabetes mellitus. METHODS: We conducted a prospective, multicenter, randomized, controlled clinical trial of diabetic patients to investigate whether post-dilation of superficial femoral artery nitinol self-expanding stents using a cryoplasty balloon reduces restenosis compared to a conventional balloon. Inclusion criteria included diabetes mellitus, symptomatic peripheral arterial disease, and superficial femoral artery lesions requiring implantation of stents>5 mm in diameter and >60 mm in length. Primary endpoint was binary restenosis at 12 months, defined as ≥2.5-fold increase in peak systolic velocity by duplex ultrasonography. RESULTS: Seventy-four patients, with 90 stented superficial femoral artery lesions, were randomly assigned to post-dilation using cryoplasty (n=45 lesions) or conventional balloons (n=45 lesions). Mean lesion length was 148±98 mm, mean stented length was 190±116 mm, mean stent diameter was 6.1±0.4 mm, and 50% of the lesions were total occlusions. Post-dilation balloon diameters were 5.23±0.51 mm versus 5.51±0.72 mm in the cryoplasty and conventional balloon angioplasty groups, respectively (p=0.02). At 12 months, binary restenosis was significantly lower in the cryoplasty group (29.3% vs. 55.8%, p=0.01; odds ratio: 0.36, 95% confidence interval: 0.15 to 0.89). CONCLUSIONS: Among diabetic patients undergoing implantation of nitinol self-expanding stents in the superficial femoral artery, post-dilation with cryoplasty balloon reduced binary restenosis compared to conventional balloon angioplasty. (Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease [COBRA]; NCT00827853).

Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus Silverhawk atherectomy and adjunctive balloon angioplasty: randomized trial.

PURPOSE: Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus SilverHawk atherectomy and adjunctive PTA of de novo infrainguinal disease has not been well defined. This study was conducted to compare the two approaches. MATERIALS AND METHODS: In this prospective, two-center randomized trial of PTA versus atherectomy of infrainguinal vessels, the primary endpoint of TLR was evaluated at 1 year. Secondary endpoints included the rate of "bailout" stent placement for suboptimal acute angiographic results and the rate of target vessel revascularization (TVR). RESULTS: Fifty-eight patients were included in the study. Of these, 29 (36 vessels) were randomized to the atherectomy arm and 29 (48 vessels) to the PTA arm. Final acute angiographic success rates were 100% in the PTA arm and 97.2% in the atherectomy arm (P value not significant). There was no statistical difference in TLR (16.7% vs 11.1%) or TVR (21.4% vs 11.1%) between the PTA and atherectomy groups, respectively. Bailout stent placement was performed in 18 of 29 patients (62.1%) in the PTA arm and eight of 29 patients (27.6%) in the atherectomy arm (P = .017). Major adverse events were similar between the PTA and atherectomy arms. Finally, when embolic filter protection was used, distal macroembolization occurred in 11 of 17 patients (64.7%) treated with atherectomy versus none of 10 in the PTA group (P < .001). CONCLUSIONS: TLR and TVR at 1 year were statistically similar in atherectomy and primary PTA. Atherectomy reduced the need for bailout stent placement compared with primary PTA.

In-hospital safety and effectiveness of bivalirudin in percutaneous peripheral interventions: data from a real-world registry.

PURPOSE: To present real-world data to evaluate the safety and effectiveness of bivalirudin, a direct thrombin inhibitor, in an unselected group of patients undergoing percutaneous peripheral interventions (PPI). METHODS: Data were extracted from a prospectively collected peripheral vascular registry developed for quality assurance measures at 2 centers. Of 398 consecutive patients (195 men; mean age 69.4+/-11.3 years) who underwent PPI in a 2-year period, 369 (92.7%) received bivalirudin (0.75 mg/kg bolus followed by a 1.75 mg/kg/h infusion) and 29 (7.3%) received unfractionated heparin (UFH). In the bivalirudin sample, critical limb ischemia was present in 28.0% of patients, TASC D lesion in 29.5%, and angiographic thrombus in 7.8% of vessels. Demographic, clinical, procedural, and angiographic variables and in-hospital complications were analyzed. All in-hospital adverse events were independently adjudicated. RESULTS: Procedural success (<30% residual narrowing) was achieved in 359 (97.3%) patients receiving bivalirudin. Adverse events included stroke (1, 0.3%), acute renal failure (1, 0.3%), major bleeding (3, 0.8%), distal embolization (11, 3.0%), vascular access complications (2, 0.5%), and minor amputation (2, 0.5%). CONCLUSION: Bivalirudin had an excellent safety profile in a real-life cohort of patients undergoing PPI, including high-risk patients with critical limb ischemia and TASC D lesions. In-hospital major bleeding and other adverse events were infrequent. A randomized trial of bivalirudin versus UFH is needed to verify these results and establish bivalirudin as a standard anticoagulant in PPI.

Carotid artery stenting in high surgical risk patients using the FiberNet embolic protection system: the EPIC trial results.

OBJECTIVE: The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single-arm trial evaluated the 30-day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS). BACKGROUND: Embolic protection filters available for use during CAS include fixed and over-the-wire systems that rely on embolic material capture within a "basket" structure. The FiberNet Embolic Protection System (EPS), which features a very low crossing profile, consists of a three-dimensional fiber-based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval. METHODS: The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30-day follow-up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease. RESULTS: The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30-day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures. CONCLUSIONS: The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30-day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA).

Predictors of distal embolization in peripheral percutaneous interventions: a report from a large peripheral vascular registry.

BACKGROUND: Distal embolization (DE) commonly occurs during peripheral percutaneous interventions (PPI) of the lower-extremity arterial vessels. In this study we evaluate the predictors of DE in a large cohort of patients undergoing PPI at our center. METHODS: Patients who experienced clinically significant DE (requiring further mechanical or pharmacologic therapy as per operator judgment) were extracted from a peripheral vascular registry that prospectively tracks demographics, clinical, procedural and outcome variables on patients undergoing PPI at our medical center and compared these to patients in the same registry who did not experience DE. Univariate analysis was utilized to compare patients with and without DE. Logistic regression analysis was performed to determine the independent predictors of DE. RESULTS: Of 577 patients, 14 (2.4%) experienced clinically significant DE. By univariate analysis, patients who experienced DE had longer lesion length (130.0 +/- 123.35 mm vs. 90.05 +/- 104.94 mm; p = 0.049), more severe angiographic pretreatment lesion stenosis (91.71% +/- 14.76% vs. 85.65% +/- 14.26%; p = 0.027), reduced pretreatment TIMI flow (1.21 +/- 1.34 vs. 2.15 +/- 1.1; p = 0.001), a higher rate of prior amputations (21.4% vs. 5.9%; p = 0.052), a higher prevalence of TASC-D lesions (59.3% vs. 29.6%; p = 0.002), more angiographic thrombus (35.7% vs. 6.4%; p = 0.001), and less frequency of chronic onset of symptoms on presentation (64.3% vs. 90.6%; p = 0.009). Logistic regression analysis showed that a prior history of amputation (odds ratio [OR] 3.56, 95% confidence interval [CI] 0.87-14.47; p = 0.08), presence of thrombus (OR 5.02, 95% CI 1.53-16.42; p = 0.008) and TASC-D lesions (OR 4.31, 95% CI 1.24- 15.03; p = 0.022) were independent predictors of DE. CONCLUSION: Clinically significant DE requiring further mechanical or pharmacologic therapy occurs in approximately 2.4% of patients undergoing PPI. Patients with TASC-D lesions, angiographic thrombus and prior history of amputation are at high risk of DE.

In-hospital complications and long-term outcomes of the paclitaxel drug-eluting stent in acute ST-elevation myocardial infarction: a real-world experience from a high-volume medical center.

BACKGROUND: The paclitaxel drug-eluting stent (Taxus, Boston Scientific) is FDA approved for treatment of coronary artery disease in simple, noncomplex coronary lesions. In this registry, we sought to investigate the procedural success and long-term outcomes of patients receiving the Taxus stent in the setting of acute ST-elevation myocardial infarction (STEMI) in a busy single-center interventional program. METHODS: This is a single-center retrospective analysis of prospectively collected in-hospital data with postdischarge follow-up achieved by phone calls and review of medical records. Data were audited by an independent monitor, and outcomes were adjudicated by an experienced interventional cardiologist. All patients with STEMI over the period of 2 years (2005 and 2006) with native de novo lesions who received the Taxus stent were included. Patients receiving bare metal stents were excluded. The primary outcome was the combined end point of cardiac death, recurrent nonfatal MI, and target lesion revascularization (TLR) on follow-up. RESULTS: Of 198 patients included in this study, follow-up data were obtained in 172 (86.9%) patients. The mean age was 63+/-14.9 years. There were 59.1% males. Patients had the following cardiac risk factors: diabetes 20.7%, hypertension 60.6%, hyperlipidemia 87.8%, and current smoking 48%. In-hospital complications included death 5.1%, acute closure with stent thrombosis 1%, vascular complications 2.9%, and cardiogenic shock 6.6%. The mean follow-up period (days) was 317.3+/-239.3. The primary end point of cardiac death, nonfatal MI, and TLR was met in 12.4%. Individual end points on follow-up were cardiac death 2.5%, total death 4.9%, TLR 8.1%, target vessel revascularization 19.9%, stroke 1.2%, nonfatal MI 5%, and acute stent thrombosis 5.5% (definite 4.3%, probable 0.6%, possible 0.6%; Academic Research Consortium definition). CONCLUSION: The use of the Taxus stent in acute STEMI is associated with a low postdischarge combined end point of cardiac death, nonfatal MI, and TLR and a definite/probable 4.9% in-stent thrombosis rate, which is within the reported range of data published in "real-world" registry.

Distal embolic event protection using excimer laser ablation in peripheral vascular interventions: results of the DEEP EMBOLI registry.

PURPOSE: To report the results from a single-center prospective registry (DEEP EMBOLI) established to evaluate distal embolization during percutaneous lower extremity interventions using excimer laser ablative therapy. METHODS: Elective patients with infrainguinal occlusive disease were eligible for this registry if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. In all, 20 patients (15 women; mean age 70.9+/-10.8 years) with 28 lesions (de novo 13, restenotic 15) were enrolled and underwent treatment with laser atherectomy. SpiderFx filters were utilized before laser treatment in 18 of 20 patients and before final definitive treatment with angioplasty +/- stenting in all 20 patients. The primary angiographic outcome was a residual narrowing of <30% or 30% to 50% with <20 mmHg gradient across lesion after final treatment. The primary safety endpoint was the embolization rate produced by the laser based on the presence of clinically significant (>or=2 mm long) macrodebris in the filter. RESULTS: Adjunctive angioplasty and stenting were performed in 27 (96.4%) and 17 (60.7%) lesions, respectively. All filters were deployed and retrieved successfully, with no complications. The primary angiographic endpoint was met in 100% of patients. Macrodebris was found in 12 (66.7%) of 18 patients after treatment with the laser [4 (22.2%) filters with clinically significant emboli] and in 7 (35%) of 20 patients after adjunctive treatment [4 (20.0%) clinically significant emboli]. One (5.0%) distal embolization occurred after filter removal prior to completion of definitive treatment. CONCLUSION: Embolization does occur with laser photoablation in the lower extremity, but the rate of clinically significant macrodebris is low ( approximately 20%) and similar to that found after angioplasty and stenting. Embolic filter protection appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. Problems with filter retrieval were not encountered.

Dethrombosis of the lower extremity arteries using the power-pulse spray technique in patients with recent onset thrombotic occlusions: results of the DETHROMBOSIS Registry.

PURPOSE: To assess the presence of thrombus using intravascular ultrasound (IVUS) and evaluate the feasibility of combined thrombolysis [power-pulse spray (P-PS)] and rheolytic thrombectomy (RT) in patients with recent-onset limb ischemia (<6 months) due to total occlusion of at least 1 infrainguinal vessel. METHODS: Seventeen patients (12 women; mean age 68.3+/-10.7 years) enrolled in a prospective registry underwent IVUS imaging at baseline, after treatment with P-PS using tissue plasminogen activator and RT (AngioJet), and prior to definitive treatment of the vessel. The primary safety endpoints were major bleeding, distal embolization, vascular access complications, and renal failure. Effectiveness outcomes were (1) procedural success with a residual stenosis <30%, (2) IVUS-documented resolution of the thrombus, and (3) the combined clinical endpoint of procedure-related death, stroke, unplanned amputation, and unplanned urgent revascularization of the treated limb. RESULTS: At baseline, the majority of patients (16, 94.1%) had a definite thrombus identified by IVUS; in the remaining patient (6.3%), thrombus was likely to be present according to the IVUS scan. By angiography, 2 (11.8%) patients had a definite grade 3 thrombus and 5 (29.4%) patients had a grade 1 thrombus (modified TIMI scale) at baseline. IVUS data were available pre and post P-PS/RT in 16 (94.1%) patients. In 10 (62.5%), the thrombus was partially resolved; in 5 (31.25%), there was no apparent change. The thrombus appeared to have completely resolved in only 1 (6.3%) patient. Embolization occurred in 3 (17.6%) patients with no adverse clinical sequelae. The combined clinical endpoint was met in 1 (5.9%) of 17 patients. After final definitive treatment of the vessel, acute procedural success was 100%, with no angiographic filling defects seen. CONCLUSION: Thrombus is present in most if not all patients with a recent history of limb ischemia who are found to have an occluded culprit vessel. The application of the P-PS/RT led to partial or complete thrombus resolution in about two thirds of the patients treated. The overall safety outcome was favorable, but large studies are needed to test the effectiveness of the P-PS/RT technique prior to routine use.

Utilization of GP IIb/IIIa inhibitors in peripheral percutaneous interventions: current applications and in-hospital outcomes at a tertiary referral center.

The pattern of use of glycoprotein (GP) IIb/IIIa receptor inhibitors in peripheral percutaneous interventions (PPI) remains unclear. Data on patients who received GP IIb/IIIa inhibitors during PPI were extracted from a prospective registry that tracks demographic, angiographic and in-hospital outcomes of patients at 2 medical centers. Primary success was defined as establishing thrombolysis in myocardial infarction (TIMI) 3 flow and < 30% residual in vessels treated. Primary safety endpoints included death, unplanned amputation, vascular access complications, major bleeding and thrombocytopenia. Patients were divided into planned versus bailout use of GP IIb/IIIa inhibitors. A total of 46 patients (128 vessels) were included in this study. The procedure was performed emergently, urgently and electively in 13%, 26.1% and 60.9% of patients, respectively. The mean age was 70.9 +/- 11.2 years and 52.2% of patients were males. The patients' Rutherford-Baker Classes III, IV and V-VI were observed in 32.6%, 32.6% and 34.8%, respectively. Patients had the following comorbidities: current smokers 37%, diabetics 35.8%, dyslipidemics 71.7% and hypertensives 78.3%. Angiographic thrombus was suspected in 45.7% of patients prior to and during the procedure. The primary success endpoint was met in 66.4% of vessels and 69.6% of patients. Primary safety endpoints were as follows: death 2.2%, vascular access complication 2.2%, major unplanned amputation 0%, major bleeding 0% and thrombocytopenia 2.2%. Treatment with GP IIb/IIIa inhibitors was planned in 13 (28.3%) patients and bailout in 33 patients (71.7%). Reasons for planned GP IIb/IIIa were the presence of angiographic thrombus in 7 (53.8%) patients, advanced limb ischemia (Rutherford-Baker IV-VI) with total occlusions in 5 (38.5%) patients and acute presentation with total occlusion in 1 (7.7%) patient. Reasons for bailout were slow-flow in 16 (48.5%) patients, thrombus with no slow-flow in 12 (36.4%) patients, poor runoff in 1 (3%) patient and preventative during the procedure in 4 (12%) patients. In patients who received planned GP IIb/IIIa treatment, slow-flow occurred in 1/13 (7.7%) and embolization in 0/13 (0%) patients. We conclude that GP IIb/IIIa inhibitors were used as adjunctive therapy prior to angioplasty in critical limb ischemia patients or thrombotic lesions or as bailout in patients experiencing slow-flow and thrombus during PPI. Planned GP IIb/IIIa inhibitors appear to have favorable outcomes with a low incidence of slow-flow and embolization, however, randomized data are needed before establishing the role of GP IIb/IIIa inhibitor use in high-risk PPI.

Preventing lower extremity distal embolization using embolic filter protection: results of the PROTECT registry.

PURPOSE: To report the results from a single-center prospective registry (PROTECT) established to evaluate the safety and effectiveness of embolic filter protection (EFP) in reducing distal embolization during percutaneous lower extremity interventions. METHODS: Patients undergoing angioplasty, stenting, or SilverHawk atherectomy and adjunctive balloon angioplasty for infrainguinal occlusive disease were eligible if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. The primary angiographic outcome was the ability of the filter to prevent angiographically visible distal embolization, slow flow, and loss of distal tibial runoff with or without capturing macrodebris. RESULTS: Forty patients (23 men; mean age 71.4+/-11.5 years) with 56 lesions (42 de novo and 14 restenotic) underwent treatment with angioplasty/stenting (group A, n = 29; 43 lesions) or SilverHawk atherectomy (group B, n = 11; 13 lesions). One filter was used per patient (25 SpiderFX and 15 EmboShield). Macroembolization occurred in 22 (55.0%) patients, 11 (37.9%) in group A and 11 (100%) in group B (p<0.001). Clinically significant (> or =2 mm in diameter) macrodebris was found in 18 (45.0%) patients: 8 (27.6%) in group A and 10 (90.9%) in group B (p<0.001). All filters were retrieved successfully with no complications. One side-branch embolization occurred proximal to the filter. In another case, the filter was overfilled, resulting in no distal flow; it was retrieved, with subsequent tibial embolization when the procedure was continued without protection. CONCLUSION: Macroembolization is very frequent in patients undergoing lower extremity interventions, particularly with SilverHawk atherectomy. EFP appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. The clinical significance of these findings needs to be determined in future studies.

Elevated levels of homocysteine predict cardiovascular death, nonfatal myocardial infarction, and symptomatic bypass graft disease at 2-year follow-up following coronary artery bypass surgery.

Severe graft disease occurs in patients at a rate of approximately 15% within the first year of coronary artery bypass grafting (CABG). In this study, the authors examined predictors of the combined end point of death, nonfatal myocardial infarction (MI), and bypass graft disease at 2-year follow-up after CABG. One hundred twenty-one consecutive patients were included in this study after informed consent was obtained. In univariate analysis, there was a significantly (P<.05) higher homocysteine level (11.0 ng/mol vs 9.7 ng/mol, P=.04) in patients who met the combined end point vs those who did not. There were no statistically significant differences in the following: low-density lipoprotein cholesterol, high-sensitivity C-reactive protein, and lipoprotein(a) values; age; body mass index; smoking and diabetes status; statin or aspirin use; creatinine level; hematologic markers; left ventricular ejection fraction; number of bypass grafts; and distribution of coronary artery disease. Logistic regression analysis modeling for low-density lipoprotein cholesterol, lipoprotein(a), fibrinogen, and homocysteine showed that homocysteine value (P=.016) was an independent predictor of the primary combined end point.

Intermediate term outcomes with bifurcation coronary stenting using the paclitaxel drug-eluting stent: a single centre experience.

BACKGROUND: Percutaneous treatment of bifurcation coronary artery disease (BCD) is complex and, in the era of bare metal stents (BMS), was reported to have a high rate of repeat target lesion revascularization (TLR). Paclitaxel drug-eluting stents (PES) have been used in the treatment of BCD, with better overall outcomes than BMS. Also, acute stent thrombosis (AST), with an incidence ranging from 2.7% to 4.3%, has been reported with the use of bifurcation PES, and remains a concern in treating these patients. In the present report, intermediate term outcomes with BCD stenting using TAXUS Express (Boston Scientific, USA) PES are presented from the Genesis Medical Center. METHODS: In the present retrospective study, 518 consecutive de novo bifurcation stenting procedures are reported. They were performed in 2005 at the present institution using the TAXUS Express PES. Follow-up data on 312 patients (60.2%) was achieved through telephone interviews and reviews of medical records after a mean of 6.7 months. The primary end point of the present study was the combined end points of cardiac death, nonfatal myocardial infarction (MI) and TLR. Secondary outcomes included the individual end points of death, cardiac death, AST, target vessel revascularization (TVR), TLR, ST elevation MI and non-ST elevation MI on intermediate term follow-up. RESULTS: The mean (± SD) age of the patients was 66±12 years. Acute procedural success was 95% (main branch, 99%; side branch, 95.9%). The following intermediate term outcomes with bifurcation drug-eluting stents were: TLR, 6.7%; TVR, 12.2%; definite and probable AST, 1.6%; death, 6.7%; cardiac death, 2.9%; non-ST elevation MI, 0.7%; ST elevation MI, 2.0%; and the combined primary end point, 9.9%. The outcomes for patients who underwent main branch stenting were not statistically different from those with bifurcation stenting, with an overall combined end point favouring main branch stenting alone (5.8% versus 10.8%, P not significant). CONCLUSION: The TAXUS Express PES carry acceptable intermediate term outcomes in the treatment of BCD compared with historic controls with BMS, with low TLR, TVR and overall primary combined end point. Main branch stenting alone is safe, with a trend toward fewer adverse events than bifurcation stenting.

Interatrial septal defect closure for cerebrovascular accidents: exploring the role of various anticoagulants.

BACKGROUND: The role of different anticoagulants in reducing in-hospital complications in patients undergoing closure of interatrial septal defects (IASD) is unknown. In this study, we review our own experience with IASD closure data to determine if in-hospital complications and ambulation time are influenced by the use of various anticoagulants. METHODS: Fifty-five consecutive patients with a history of unexplainable stroke or transient ischemic attacks (TIA), with the exception of the presence of an IASD, were included in this study. Multiple variables were collected including age, gender, history of smoking, hypertension, diabetes, hypercholesterolemia, ejection fraction, anticoagulants used pre- and postprocedure, anticoagulants used during the closure procedure, shunt grade across the IASD pre- and postprocedure, defect size, and right-sided filling pressures. Descriptive analysis was performed on all variables including complications frequency and ambulation time, and compared between bivalirudin and indirect thrombin inhibitors. RESULTS: Of 55 consecutive patients included in this study, 22 patients received bivalirudin and 33 patients received unfractionated heparin (UFH) (n = 26) or enoxaparin (n = 7). The bivalirudin patients were older (60.1 vs 50.8 years; p = 0.028), with a higher incidence of interatrial septal aneurysm (75% vs. 40.7%; p = 0.037). In-hospital complications included 1 (5%) patient with a minor bleed (groin hematoma) in the bivalirudin group, and 3 patients with minor bleed (1 GI bleed, 1 groin hematoma, and 1 transient ischemia on electrocardiogram) in the non-bivalirudin group (9.1%). No patient had a major bleed that required a transfusion or prolonged hospital stay. Ambulation time was not significantly different between the two groups (7.7 +/- 5.9 hours for bivalirudin and 6.9 +/- 5.1 hours for other anticoagulants; p = NS). CONCLUSION: We conclude that bivalirudin is safe during IASD closure, with a statistically nonsignificant trend toward fewer minor complications than UFH and enoxaparin. No major bleeding occurred in either group. This could be due to the fact that IASD closure is performed via venous access that generally carries a low bleeding complication rate and allows safe early ambulation, irrespective of the anticoagulant utilized and despite the use of 10 and 11 Fr sheaths. Given that major differences do not appear to exist in this exploratory study between the anticoagulants studied, patent foramen ovale closure is currently being performed in our laboratory with UFH.

Interatrial septal defect closure for prevention of cerebrovascular accidents: impact on recurrence and frequency of migraine headaches.

BACKGROUND: Recent data suggest that percutaneous closure of interatrial septal defect (IASD) is associated with a reduction in the intensity, frequency and duration of migraine headaches. In this study we review our own data to determine if we can reproduce the relationship between IASD closure in patients with a history of a central nervous system event (stroke or a transient ischemic attack [TIA]) and migraine headaches (HA). METHODS: Fifty-eight consecutive patients with a history of unexplainable stroke or TIA with the exception of the presence of an IASD were included in this retrospective study. Multiple variables were collected including age, gender, history of smoking, hypertension, diabetes, hypercholesterolemia, ejection fraction, anticoagulant use pre- and postprocedure, shunt grade across the IASD pre- and postprocedure, defect size and right-sided filling pressures. All patients with a history of migraine HA answered the Migraine Disability Assessment Test (MIDAS), a standardized migraine questionnaire. Descriptive analysis was performed on all variables and compared among migraine and nonmigraine HA patients. Pre and post closure intensity and frequency of migraine HA were compared. RESULTS: Of 58 patients, 14 (24.14%) had migraine HAs prior to percutaneous closure. There were no significant differences among the migraine and nonmigraine HA groups except that the migraine HA sufferers were younger (p = 0.016). One patient with migraine HA died on follow up from complications of cardiomyopathy. Only 5 (38.5%) of 13 patients reported still having migraine HA post closure of IASD. The frequency (41.6 +/- 36.4 vs. 9.3 +/- 24.8; p = 0.005) and intensity (8.0 +/- 1.9 vs. 2.1 +/- 3.2; p = 0.001) of the migraine HAs were markedly reduced post closure at 759 +/- 545.6 days (range 89 to 1,433 days). There was no relationship between the shunt grade and the frequency or intensity of migraine HA. CONCLUSION: We conclude that IASD closure in patients with history of migraine HA and stroke or TIA have a marked improvement in the frequency and intensity of their HA. Migraine HA resolved in 61.54% patients post closure. Larger randomized studies are needed to confirm these findings, which could have significant implications for sufferers of migraine HA.

Long-term outcomes in treating left main trifurcation coronary artery disease with the Paclitaxel-eluting stent.

BACKGROUND: Left main trifurcation coronary artery disease stenting is a challenging and complex percutaneous procedure that has been infrequently reported. We present our own experience with left main trifurcation stenting using the Taxus paclitaxel-eluting stent (Boston Scientific). METHODS: Twenty consecutive left main trifurcation stenting procedures were performed in 2005 at our institution. The primary endpoint of the study was the combined endpoints of death, acute stent thrombosis and target lesion revascularization (TLR). Conditional logistic regression analysis was performed to determine the predictors of the primary endpoint using a number of variable combinations. RESULTS: The mean patient age was 71.7 +/- 8.9 years. The procedure was urgent in 10%, and the left main artery was unprotected in 95% of cases. Follow up was achieved in 17/20 (85%) patients, either from medical records or by phone calls. The follow-up median duration was 272 days (range 30 to 534 days). The primary endpoint was met in 5/17 (29.4%) patients. One of 19 patients (5.3%) had a sudden cardiac death 1 month after the procedure, 2/20 patients (10%) experienced an acute in-hospital stent thrombosis, and 2/17 (11.8%) patients underwent TLR. Conditional logistic regression analysis could not identify a relationship between the stenting method and the primary endpoint. The 2 patients who experienced in-hospital thrombosis were the only patients who received a clopidogrel load (600 mg) post-procedure after arrival to the floor, and were not on a glycoprotein IIb/IIIa inhibitor. All others received their clopidogrel either during the procedure (n = 7) or were on it chronically (n = 11). One patient with acute stent thrombosis did not have a kissing balloon performed post-stent deployment. CONCLUSION: Left main trifurcation stenting carries an overall high rate of adverse events and may need to be reserved for patients who are at high risk or who refuse bypass surgery. Overall TLR is low, but stent thrombosis remains a concern. Although we suspect that thrombosis could be related to failure to perform kissing balloon post-stent deployment and/or not receiving a clopidogrel load until after the procedure, the small number of patients in this study prevents us from making definite statistical conclusions about this observation.

Gender differences in adhering to national guidelines in a community lipid clinic.

The aggressive treatment of hypercholesterolemia improves morbidity and mortality in patients with a history of cardiovascular disease irrespective of gender. Electronically tracked data on 4324 patients enrolled in a community lipid clinic were analyzed for gender differences in lipid values and adherence to national guidelines in lipid management. Women were older, more likely to be diabetic and/or hypertensive, and have a family history of coronary heart disease. Women also had higher initial total cholesterol, low-density lipoprotein, and triglyceride levels and were more likely to be at goal at entry for high-density lipoprotein. Men were more likely to have coronary heart disease and lower high-density lipoprotein and were more likely to be at goal at entry for triglyceride level. There were no gender differences in low-density lipoprotein at goal at entry or rate of current smoking. All lipid parameters appeared better with age, irrespective of gender. More men than women reached goal for their low-density lipoprotein (61.5% vs 51.7%) and triglyceride (36.9% vs 25.1%) levels, whereas more women than men reached goal for their high-density lipoprotein (33.1% vs 22.2%). The authors conclude that there are significant gender differences in lipid values at entry to a community lipid clinic and in achieving National Cholesterol Education Program targets following the initiation of therapy. A possible gender-independent survivorship effect exists for low-density lipoprotein and high-density lipoprotein.