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Although second-generation everolimus-eluting stents (EESs) have demonstrated superiority over first-generation paclitaxel-eluting stents for a broad subset of patients and lesions, it is unclear whether the same applies to sirolimus-eluting stents (SESs). The present study compared the long-term clinical outcomes between EESs and SESs in patients with small coronary artery disease. A cohort of 643 patients treated with EESs (220 patients with 245 lesions) or SESs (423 patients with 523 lesions) in small vessel lesions (defined as those receiving stents ≤2.5 mm) were retrospectively analyzed. The end points included target lesion revascularization, target vessel revascularization, major adverse cardiovascular events (all-cause death, myocardial infarction, or target lesion revascularization), and definite stent thrombosis at 1 year of follow-up. The baseline characteristics were generally similar between the 2 groups, except that more systemic hypertension was seen in the EES group and more patients had a family history of coronary artery disease in the SES group. The 1-year target lesion revascularization (5.6% vs 4.8%, p = 0.68) and target vessel revascularization (5.6% vs 7.6%, p = 0.33) rates showed no significant differences between the EES and SES groups. Overall major adverse cardiovascular events occurred in 9.1% of the EES- and 8.6% of SES-treated patients (p = 0.83). This similar major adverse cardiovascular events rate remained after adjustment. The rate of stent thrombosis was 0% in the EES group and 1.2% in the SES group (p = 0.17). In conclusion, EESs demonstrated comparable clinical outcomes to those of SESs in small vessel interventions. The absence of stent thrombosis among patients treated with EESs suggests a good safety profile for this second-generation drug-eluting stent, which should be carefully studied in a larger series of patients with small vessel disease., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI) commonly receive a loading dose of either clopidogrel or prasugrel, in addition to aspirin. The present study aimed to assess the safety of reloading prasugrel in patients who had initially received a loading dose of clopidogrel compared to prasugrel loading alone. The study included a cohort of 606 consecutive patients with acute coronary syndrome who had received a 60-mg loading dose of prasugrel before PCI. These patients were then categorized into clopidogrel preloading (300 or 600 mg) followed by prasugrel reloading (CP-load group, n = 90) and prasugrel loading only (P-load group, n = 516). Both groups received a 10-mg maintenance dose of prasugrel after PCI. The primary end point was in-hospital Thrombolysis In Myocardial Infarction-defined major bleeding. The secondary end points were other in-hospital bleeding complications and major cardiovascular events. Patients in the CP-load group compared to the P-load group were younger, with lower rates of cardiovascular risk factors. Significantly more patients in the CP-load group presented with biomarker-positive myocardial infarction (80.0% vs 30.6%, p ≤0.001) and cardiogenic shock (5.6% vs 1.4%, p = 0.022). No significant differences (p = NS) were seen in Thrombolysis In Myocardial Infarction major bleeding (2.6% vs 2.8%), Thrombolysis In Myocardial Infarction major or minor bleeding (12.2% vs 7.0%), the need for blood transfusion (2.6% vs 2.1%), and vascular complications (1.3% vs 2.0%) between groups. The CP-load group experienced more in-hospital major adverse cardiac events (5.6% vs 1.6%, p = 0.031), urgent coronary artery bypass grafting (3.3% vs 0.2%, p = 0.011), and longer hospital and intensive care unit stays. In conclusion, preloading with clopidogrel should not be prohibitive to reloading with prasugrel in patients presenting with acute coronary syndrome and undergoing PCI with respect to bleeding and vascular complications., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Aims: We hypothesized that patients with a history of either alarming or nuisance bleeding events, compared to those with no history of bleeding, would have lower levels of on-treatment platelet reactivity (aspirin and a thienopyridine)., Methods and Results: In total, 42 patients with no bleeding, 34 with nuisance bleeding, and 14 with alarming bleeding underwent platelet reactivity testing 1 month to 1 year after PCI with light transmission aggregometry (LTA 5 and 20 μM adenosine disphosphate [ADP]), vasodilator stimulated phosphoprotein phosphorylation (VASP) and VerifyNow P2Y12. Clinical and demographic characteristics of the 3 groups were generally similar, except that patients with alarming bleeding were less likely to be Caucasian; only 6 patients (6.7%) were taking prasugrel. There was considerable overlap between no bleeding, nuisance bleeding and alarming bleeding groups with respect to on-treatment platelet reactivity. Furthermore, there was no difference in the median platelet reactivity values for all assays. Prevalence of high on-treatment platelet reactivity did not differ among the 3 groups; 32.6% of patients had high on-treatment platelet reactivity as measured by LTA with 5 μM ADP (P=.91); 40.0% as measured by VASP (P=.35); and 35.6% as measured by VerifyNow P2Y12 (P=.61)., Conclusion: The use of platelet reactivity assays to identify patients on thienopyridine therapy at higher risk of bleeding is an unfounded strategy., (Copyright © 2013. Published by Elsevier Inc.)

Background: Recent reports indicate that the transapical approach for transcatheter aortic valve replacement may be associated with elevated cardiac enzymes, poor recovery of left ventricular function, and poor outcomes. The aim of this study was to evaluate whether transapical access is associated with apical dysfunction and to assess consequences on patient outcomes., Methods: In patients undergoing transapical aortic valve replacement, apical regional function was retrospectively assessed using the three standard echocardiographic long-axis views. Patients with abnormal baseline apical motion were excluded. Apical regional wall motion abnormality was assessed on preprocedural (baseline), immediate postprocedural (early [6 ± 2 days]), and late postprocedural (late [95 ± 76 days]) examinations. Apical regional wall motion abnormalities were categorized as normal, hypokinesis, or akinesis., Results: A total of 58 patients undergoing transapical aortic valve replacement were included in the present analysis. Of those, 16 (28%) developed early apical dysfunction. There were no differences in baseline characteristics between the patients who developed early apical dysfunction and those who did not. Patients who received 26-mm valves were more likely to develop apical dysfunction (40% vs. 69%, P = .05). In total, 50% of patients with apical dysfunction (eight of 16) had complete recovery of apical function but tended to have lower ejection fractions (50% vs. 60%, P = .045) at long-term follow-up. No difference in short-term or long-term mortality was detected in these small patient cohorts., Conclusions: Myocardial injury during transapical access resulted in apical dysfunction early after the procedure in 28% of patients. This apical dysfunction was transient in half of the patients and was associated with a decrease in left ventricular function but did not affect mortality., (Copyright © 2013 American Society of Echocardiography. Published by Mosby, Inc. All rights reserved.)

While multi-detector cardiac computed tomography angiography (MDCCTA) prior to reoperative cardiac surgery (RCS) has been associated with improved clinical outcomes, its impact on hospital charges and length of stay remains unclear. We studied 364 patients undergoing RCS at Washington Hospital Center between 2004 and 2008, including 137 clinically referred for MDCCTA. Baseline demographics, procedural data, and perioperative outcomes were recorded at the time of the procedure. The primary clinical endpoint was the composite of perioperative death, myocardial infarction (MI), stroke, and hemorrhage-related reoperation. Secondary clinical endpoints included surgical procedural variables and the perioperative volume of bleeding and transfusion. Length of stay was determined using the hospital's electronic medical record. Cost data were extracted from the hospital's billing summary. Analysis was performed on individual categories of care, as well as on total hospital charges. Data were compared between subjects with and without MDCCTA, after adjustment for the Society of Thoracic Surgeons score. Baseline characteristics were similar between the two groups. MDCCTA was associated with shorter procedural times, shorter intensive care unit stays, fewer blood transfusions, and less frequent perioperative MI. There was additionally a trend towards a lower incidence of the primary endpoint (17.5 vs. 24.2 %, p = 0.13) primarily due to a lower incidence of perioperative MI (0 vs. 5.7 %, p = 0.002). MDCCTA was also associated with lower median recovery room [$1,325 (1,250-3,302) vs. $3,217 (1,325-5,353) p < 0.001] and nursing charges [$6,335 (3,623-10,478) vs. $6,916 (3,915-14,499) p = 0.03], although operating room charges were higher [$24,100 (22,300-29,700) vs. $23,500 (19,900-27,700) p < 0.05]. Median total charges [$127,000 (95,000-188,000) vs. $123,000 (86,800-226,000) p = 0.77] and length of stay [9 days (6-19) vs. 11 days (7-19), p = 0.21] were similar. Means analysis demonstrated a strong trend towards lower mean total hospital charges [$163,000 (108,426) vs. $192,000 (181,706), p = 0.06] in the MDCCTA group. In conclusion, preoperative MDCCTA is associated with a number of improved perioperative outcomes and does not significantly effect the length of stay or total hospital charges during the index hospitalization.

Objectives: This study aims to determine how excimer laser coronary atherectomy (ELCA) performs in the drug-eluting stent (DES) era., Background: For more than 20 years, ELCA has been used for coronary intervention. With developments in the coronary intervention field, the role of ELCA is in question., Methods: The study includes 119 patients with 124 lesions who underwent percutaneous coronary intervention (PCI) with ELCA in our institution from January 2004 to May 2011., Results: The main indications for ELCA use were saphenous vein graft (SVG) (45 lesions), acute myocardial infarction (AMI) (7 lesions), chronic total occlusion (CTO) (32 lesions), in-stent restenosis (ISR) (15 lesions), and calcified de-novo lesions (25 lesions). High success rates were recorded for the SVG, AMI, CTO, ISR, and calcified lesion indications (91.1%, 85.7%, 93.8%, 86.7%, and 80%; respectively). ELCA related complications were reported in 10 patients (8%); four dissections, three no-reflow phenomena, two perforations, and one thrombus formation., Conclusion: ELCA is an alternative solution with acceptable performance in the treatment of complex coronary lesions not ideally suitable for balloon angioplasty., (Copyright © 2013. Published by Elsevier Inc.)

The randomized TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel-Thrombolysis In Myocardial Infarction (TRITON-TIMI) 38 trial compared prasugrel and clopidogrel in patients with acute coronary syndrome undergoing percutaneous coronary intervention (PCI). Patients treated with prasugrel had fewer ischemic events but more procedure-related bleeding. In the present study, we aimed to determine the effect of bivalirudin on bleeding in patients treated with prasugrel. A total of 692 patients with consecutive acute coronary syndrome underwent PCI with stent implantation and were anticoagulated with bivalirudin. The patients were divided into 2 groups according to the antiplatelet regimen (clopidogrel or prasugrel) chosen during or just after PCI. The bleeding complications during hospitalization were tabulated. Ischemic events were analyzed during hospitalization and at 30 days. Prasugrel was used in 96 patients (13.9%) and clopidogrel in 596 (86.1%). The clinical and procedural characteristics were similar, although the clopidogrel patients more often reported systemic hypertension (p = 0.01), previous PCI (p <0.001), and chronic renal insufficiency (p = 0.05). During hospitalization, the bleeding and ischemic complication rates were similar and low in both groups (major in-hospital complications 4.2% for clopidogrel vs 2.1% for prasugrel, p = 0.6; Thrombolysis In Myocardial Infarction major bleeding 2.5% vs 2.1%, p = 1.00; Thrombolysis In Myocardial Infarction minor bleeding 4.2% vs 5.2%, p = 0.6). At 30 days, no differences were found in ischemic events between both groups (target vessel revascularization/major adverse cardiac events 5.4% vs 2.1%, p = 0.2). In conclusion, prasugrel, when given after bivalirudin as the intraprocedural antithrombin agent for patients with acute coronary syndrome undergoing PCI, is as safe and effective as clopidogrel., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Transcatheter aortic valve implantation is a novel therapeutic approach for high-risk patients with severe symptomatic aortic stenosis. The success rate of this new procedure is high; however, procedural complications can occur and may result in devastating outcomes. Here, we report a case of transfemoral catheter aortic valve implantation using the Edwards SAPIEN valve complicated by severe intravalvular leak due to immobile cusp associated with shock. We treated with a second valve that embolized and deployed in the descending aorta. A third valve was then deployed within the first with elimination of aortic regurgitation and immediate hemodynamic improvement., (Copyright © 2012 Wiley Periodicals, Inc.)

Background: Surgical retroperitoneal access to the iliac artery may provide an alternative route for transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis and prohibitively small common femoral arteries., Methods: Consecutive patients undergoing TAVR via the femoral approach were divided into two groups; standard percutaneous access (n=103) and surgical retroperitoneal access (n=15) for patients in whom dilators could not be advanced without resistance. For retroperitoneal access, proximal groin vessels were exposed surgically and direct puncture was performed. The sheath was tunneled from the level of the initial inguinal puncture site in order to achieve coaxial entry of the sheath into the vessel., Results: Baseline characteristics were similar in both groups. Procedural characteristics were insignificantly different between groups; although, procedure time was longer (34 min), while fluoroscopy time and contrast utilization were lower in the retroperitoneal access group. There was no outcome difference between groups., Conclusions: Surgical retroperitoneal access is a reasonable alternative for transcatheter aortic valve replacement in high-risk patients with aortic stenosis who have poor percutaneous access options due to peripheral vascular disease., (Copyright © 2013. Published by Elsevier Inc.)

Drug-eluting stents have shown promising clinical results in the treatment of coronary artery disease, including in women. Studies with first-generation drug-eluting stents, however, have reported higher rates of stent thrombosis (ST). The aim of this study was to evaluate the safety and efficacy of second-generation everolimus-eluting stents (EES) versus first-generation sirolimus-eluting stents (SES) in women. The study included 1,649 women; 1,152 (70%) received SES and 497 (30%) received EES. In-hospital and 1-, 6-, and 12-month clinical outcomes were analyzed and compared. Correlates of major adverse cardiac events and ST were identified. Baseline clinical characteristics were similar between stent types, although more peripheral vascular disease and family history of coronary artery disease were seen in the SES group, while more unstable angina pectoris at initial diagnosis was more prevalent in the EES group. The EES group had more type C and distal lesions. There was a higher rate of target vessel revascularization and major adverse cardiac events in the SES group (14.7% vs 10.8%, p = 0.04) at 1 year. ST tended to be higher in the SES group (1.5% vs 0.4%, p = 0.06) at 6 and 12 months. After adjustment, multivariate analysis indicated that the EES group was less likely to have target vessel revascularization and major adverse cardiac events (hazard ratio 0.67, 95% confidence interval 0.47 to 0.95, p = 0.024) and had lower rates of ST (hazard ratio 0.09, 95% confidence interval 0.01 to 0.70, p = 0.022) at 1 year. In conclusion, contemporary use of EES in women is associated with improvement in efficacy and safety profiles compared to SES; however, a large randomized trial is needed to confirm this conclusion., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objective: This study aimed to describe the safety and feasibility of transcatheter "thrombin-blood patch" (TBP) injection to treat catheterization-related arterial vascular access perforation., Background: Vascular access complications are infrequent but potentially life threatening conditions related to percutaneous procedures. Surgical vascular repair are associated with high rates of morbidity and mortality due to advanced cardiovascular disease., Methods: From October 2007 to July 2010 we studied 23 patients who presented active access arterial bleeding after percutaneous procedures and underwent transcatheter angiographic guided TBP injection across the entry site of the arterial perforation as a primary approach., Results: The mean age of the population was 67 years, predominantly female (78.3%) with high rate of comorbidities including diabetes (30.4%), prior coronary revascularization (50.0%), chronic renal failure (43.5%), and heart failure (56.5%). Thirteen patients (56.5%) developed severe hypotension after the index procedure. The repair procedure had a mean duration of 82 ± 57 minutes. TBP was injected in all patients. One case additionally required covered-stent to obtain hemostasis. Angiographic success was achieved in the 23 patients; however, one case required a second intervention due to recurrent bleeding, which was effectively treated using covered-stent. All patients were discharged alive and no major cardiovascular events, including myocardial infarction/stroke, were observed., Conclusions: Transcatheter "thrombin-blood patch" injection is a safe, novel technique that allows prompt percutaneous approach to treat catheterization-related arterial perforation. This strategy appears particularly attractive to treat patients who cannot tolerate "open" vascular reconstruction and repair., (Copyright © 2012 Wiley Periodicals, Inc.)

Objectives: This study aimed to determine whether the elective insertion of an intra-aortic balloon counter pulsation (IABP) device at the time of myocardial revascularization in patients presenting with an acute anterior ST-elevation myocardial infarction (STEMI) without cardiogenic shock has any impact on the in-hospital rate of cardiac mortality., Background: The role of IABP in patients presenting with an acute MI without cardiogenic shock remains ill defined., Methods: The present study comprised 605 consecutive patients who underwent primary percutaneous coronary intervention for an anterior STEMI without cardiogenic shock. Patients who received IABP at the time of their coronary revascularization (n=105) were compared to those who had not (n=500). Patients with stable angina, unstable angina, non-STEMI, non-anterior STEMI, and cardiogenic shock were excluded., Results: The two cohorts were well matched for the conventional risk factors for coronary artery disease. Although the left ventricular ejection fraction was significantly lower in the patients who received IABP (0.32±0.11 vs. 0.39±0.12; P<0.001), the two cohorts were well matched for history of MI, coronary revascularization, and chronic renal impairment. Following propensity scoring, the in-hospital rate of cardiac death was similar between the two cohorts (5.6% vs. 0%; P=.12) as was the rate of vascular complications. Major bleeding was significantly greater in the IABP cohort (10.0% vs. 0%; P=.01) leading to a greater transfusion requirement (14.9% vs. 2.9%; P=.01)., Conclusion: The adjunctive use of an IABP in patients presenting with an acute anterior STEMI without cardiogenic shock may not be associated with an in-hospital mortality benefit., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background and Aim of the Study: Severe aortic regurgitation (AR) is a contraindication for balloon aortic valvuloplasty (BAV). As the effects of mild and moderate AR are unknown, the study aim was to determine the effects of BAV in patients with mild and moderate AR., Methods: A total of 263 consecutive patients with symptomatic severe aortic stenosis (AS) who underwent BAV was included in the study. The patients were stratified into three groups according to their pre-procedural degree of AR, as assessed echocardiographically., Results: The study groups included pre-BAV with no AR (n = 76; 28.9%), mild AR (n = 180; 68.4%), and moderate AR (n = 7; 2.7%). There were no differences in the baseline characteristics of the groups, with a mean age of 81.9 +/- 9.0 years and a Society of Thoracic Surgeons score of 12.9 +/- 6.0. Among patients with no AR pre-BAV, 48.7% developed mild AR post-BAV, while 4.5% of those with mild AR pre-BAV developed moderate AR (p < 0.001). The majority of patients (93%) had mild AR both pre- and post-BAV. Only two patients developed severe AR post-BAV. A good agreement existed between the categories of AR pre- and post-BAV (weighted kappa = 0.54, 95% CI, 0.43-0.65). The degree of AR post-BAV did not impact on the mortality rates of mild AR (41.1%), moderate AR (46.9%), or severe AR (63.6%) (p = 0.31)., Conclusion: It is safe to perform BAV in patients with mild and moderate AR. About half of all patients with no AR may develop mild AR, the majority will remain in mild AR, and a small percentage will develop moderate or severe AR.

Disturbances in atrioventricular conduction and the additional need for a permanent pacemaker are recognized complications after transcatheter aortic valve replacement (TAVR). We analyzed the incidence of postprocedural conduction disorders and the need for permanent pacemaker implantation in patients undergoing TAVR with the Edwards SAPIEN valve. In 125 consecutive patients with symptomatic, severe aortic stenosis undergoing TAVR, a standard 12-lead electrocardiogram was obtained before and serially after the procedure. The cohort was divided into 2 groups with regard to the post-TAVR appearance of conduction disturbances, defined as left bundle branch block, right bundle branch block, fascicular hemiblock, atrioventricular block, and the need for a permanent pacemaker. The patients with and without conduction disturbances were compared. After TAVR, 19 patients (15.2%) met the study definition of a "new conduction defect" and 5 patients (4%) required a permanent pacemaker because of an advanced atrioventricular block. New left bundle branch block appeared in 5 patients (4%) and left anterior hemiblock in 9 (7.2%). No new right bundle branch block or left posterior hemiblock was observed. Although most baseline, echocardiographic, and procedural characteristics were equally distributed, the patients with new conduction disturbances more often had diabetes mellitus and peripheral vascular disease. Also, they more often were taking an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker, and the procedure was performed more often with apical access (12 [63.2%] vs 7 with femoral access [36.8%], p = 0.002). In conclusion, although the incidence of conduction disturbances was high after TAVR using the Edwards SAPIEN valve, with a significant increase in the rate of left bundle branch block and left anterior hemiblock, the need for permanent pacemaker implantation after TAVR with this valve remained low., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: Percutaneous coronary intervention (PCI) of complex lesions (i.e., American College of Cardiology/American Heart Association class type C) remains challenging and the outcome may be compromised. The use of intravascular ultrasound (IVUS) to guide PCI was suggested to improve outcome., Methods: A cohort of 1,984 patients who underwent PCI to type C lesions in our center from April 2000 to March 2010 was identified. Using propensity score matching with clinical and angiographic characteristics, we identified 637 patients who underwent IVUS guidance and 637 patients who had only angiographic guidance PCI. Major adverse cardiovascular events (MACE), a composite end-point of all-cause mortality, Q-wave myocardial infarction and target lesion revascularization, were compared between the 2 groups., Results: After propensity score matching, baseline clinical and angiographic characteristics were well matched. Patients undergoing IVUS-guided PCI had less predilatation and more postdilatation, and were treated more often with cutting balloon. Final diameter stenosis was significantly smaller in the IVUS-guided group (3 ± 11% vs. 7 ± 19%, P < 0.001), resulting in higher angiographic success compared with the non-IVUS-guided group (97.9% vs. 94.8%, P < 0.001). The incidence of MACE was significantly lower in the IVUS-guided group compared to the angiography-guided group (11.0% vs. 15.6%, P = 0.017) as was cardiac death (1.9% vs. 4.4%, P = 0.010)., Conclusion: IVUS-guided PCI for complex type C lesions is associated with better outcome and should be considered for these lesions., (©2012, Wiley Periodicals, Inc.)

Recent randomized clinical trials have demonstrated that transcatheter aortic valve implantation (TAVI) reduces mortality in high-risk patients with aortic stenosis who are not candidates for aortic valve replacement (AVR). In similar patients who are acceptable candidates for AVR, TAVI provides equivalent outcomes to AVR. In this study, 900 patients with severe aortic stenosis at high surgical risk were evaluated as possible candidates for TAVI. Of these, 595 (66.1%) had neither TAVI nor AVR and constituted the medical arm. In addition to the best available conservative care, 345 patients (39.3%) in this group had balloon aortic valvuloplasty. The AVR arm consisted of 146 patients (16.2%) and the TAVI arm of 159 patients (17.6%). The AVR group had significantly lower clinical risk compared to the medical and TAVI groups, with lower mean age, Society of Thoracic Surgeons score, and logistic European System for Cardiac Operative Risk Evaluation score. Patients in the medical and balloon aortic valvuloplasty group had significantly higher B-type natriuretic peptide levels compared to those in the AVR and TAVI groups and had, on average, lower ejection fractions. The medical and balloon aortic valvuloplasty group was followed for a median of 206 days; the mortality rate was 46.6% (n = 277). The AVR group was followed for 628 days; 39 patients died (26.7%). In 399 days of follow-up, the mortality rate in the TAVI group was 30.8% (n = 49). In conclusion, patients with severe AS who did not undergo TAVI or AVR had high mortality. In properly selected patients, TAVI and AVR improve outcomes. Renal failure is the strongest correlate for adverse outcomes, irrespective of treatment group., (Copyright © 2012. Published by Elsevier Inc.)

Background: Retroperitoneal hemorrhage (RPH) is a serious but infrequent complication of percutaneous coronary intervention (PCI). This study aimed to describe the clinical outcomes of patients who developed RPH following PCI in the current practice era, with particular focus on treatment strategies and the related prognostic value of abdominal/pelvic computed tomography (CT)., Methods: Among 20,904 patients undergoing PCI, we identified 93 RPH (0.45%) confirmed by CT or by unequivocal surgical findings. We identified three groups with RPH for comparison: patients who developed refractory shock (systolic blood pressure <80 mm Hg for ≥30 min despite fluids and vasopressors, n = 16 [17.2%]); patients with transient hypotension (<30 min, n = 34 [36.6%]); and patients without hypotension (n = 43 [46.2%]). The primary endpoint was a composite of in-hospital mortality, myocardial infarction, and cerebral vascular accident (CVA)., Results: Baseline clinical, angiographic, and procedural characteristics were similar among the three groups. Patients who developed refractory shock had significantly more bleeding quantified by abdominal/pelvic CT (P < 0.001), had a higher rate and amount of red blood cell transfusion (P < 0.001), and were managed invasively more frequently (68.7%) than the rest of the population. The primary endpoint trended higher in patients presenting with refractory shock; however, this difference was not statistically significant. The volume of bleeding quantified by CT and the timing of imaging diagnosis did not correlate with the primary endpoint. Red blood cell transfusion, but not clopidogrel discontinuation, was associated with the primary endpoint., Conclusions: RPH remains as a serious complication of PCI and is associated with high rates of mortality and morbidity independently of the therapeutic strategy. In patients who were hemodynamically stable, RPH volume as quantified by non-contrast abdominal/pelvic CT did not contribute to prognosis., (Copyright © 2011 Wiley Periodicals, Inc.)

Background: Several patients undergoing permanent pacemaker (PPM) implantation/upgrade present with difficult access due to sub- or total central vein occlusion. Our institution has used the endovascular approach to recanalize central veins to allow for subsequent PPM implantation. Here we aim to describe the feasibility and safety of using this approach to allow for PPM implantation/upgrade., Methods: From October 2006 to November 2010, 50 consecutive patients who underwent central vein recanalization prior to PPM implantation were included in this analysis., Results: The population's mean age was 70 years, with a high rate of comorbidities including chronic renal failure (52.0%), congestive heart failure (64.0%), diabetes (33.3%) and peripheral vascular disease (36.0%). The endovascular recanalization procedure was performed via femoral access in all patients; however adjuvant brachial access was required in 13 cases and subclavian vein in one. Subclavian vein (74.5%) followed by innominate vein (21.6%) were the most common locations/target for recanalization. Successful vein recanalization followed by successful PPM implantation/upgrade was achieved in 48 patients (96.0%) without peri-procedural complications. Two patients died during the hospitalization, one due to severe respiratory failure and a second due to complicated end-stage renal disease, although neither was related to the endovascular procedure. No other event, including myocardial infarction, cerebral-vascular accident, bleeding/transfusion, or renal failure was identified., Conclusions: This study proved the feasibility and safety of the endovascular approach to recanalize central veins in patients with poor vascular access to allow for further PPM implantation/upgrade., (Copyright © 2012. Published by Elsevier Inc.)

Aims: Most transcatheter aortic valve replacement (T-AVR) using the Edwards SAPIEN transcatheter heart valve (Edwards Lifesciences, Irvine, CA) is done under general anesthesia. The present study aimed to examine the feasibility and safety of T-AVR under monitored anesthesia care and aimed to compare the clinical outcome to the outcome of patients who underwent general anesthesia., Methods: The analysis included 92 consecutive patients undergoing T-AVR via the transfemoral approach guided by transesophageal echocardiography using the Edwards SAPIEN valve. The cohort was divided into two groups: I, monitored anesthesia care (n=70; 76.1%) and II, intubation (n=22; 23.9%). Monitored anesthesia care was given by anesthesiologists in one of two protocol regimens: Ketamine & Propofol or Dexmedetomidine. The crossover rate to general anesthesia and the clinical outcome of these two groups were compared., Results: Baseline clinical characteristics of the two groups were similar, except for higher logistic EuroSCORE and prior stroke in the monitored anesthesia care group. Surgical access of the femoral artery was performed in 15 (68.1%) from the general anesthesia group and in 24 (34.2%) from the monitored anesthesia care group, p=0.05. The median procedure duration was significantly lower in the monitored anesthesia care group (91 vs. 155 min, p=0.008) and there was a trend to lower median intensive care unit stay and hospital stay (27 vs. 72 h, p=0.07 and 5 vs. 7.5 days, p=0.06, respectively). Of the patients with monitored anesthesia care, 8 (11.4%) converted to general anesthesia., Conclusion: T-AVR using the Edwards SAPIEN valve can be performed in the majority of cases with controlled monitored anesthesia care, thereby avoiding the necessity of general anesthesia and resulting in shorter procedure time and in-hospital length of stay., (Copyright © 2012. Published by Elsevier Inc.)

Objective: To compare access site complications with the Micropuncture 21 gauge (G) needle set to the standard 18G needle in patients undergoing percutaneous coronary intervention (PCI) using the femoral approach., Background: Vascular access site complications are the most common problems after PCI. The Micropuncture 21G needle set was recently introduced to minimize such complications., Methods: A cohort of 3,243 consecutive patients was studied. Patients receiving thrombolytics, IIb/IIIa antagonist, coumadin, or intra-aortic balloon pump were excluded. Micropuncture access was used in 544 patients and standard 18G needle in 2,699. All access sites were managed with a vascular closure device. Primary endpoints included vascular perforation or limb ischemia requiring repair, retroperitoneal bleeding, pseudoaneurysm, arteriovenous fistula, and groin hematoma (>4 cm)., Results: Patients undergoing PCI with Micropuncture were at higher risk: they were older (65.9 ± 9 vs. 64.7 ± 11.8, P = 0.03); had lower body surface area (1.9 ± 0.2 vs. 2.0 ± 0.3, P = 0.02); more prevalent peripheral vascular disease [119 (21.9%) vs. 380 (14.1%), P < 0.001] and renal failure [106 (19.6%) vs. 318 (11.8%), P < 0.001]. Overall, there was no significant difference in the access site complications rate using Micropuncture vs. standard needle, 7 (1.3%) vs. 27 (1.0%), respectively, P = 0.54. The Micropuncture group had significantly higher retroperitoneal bleeding, 0.7% vs. 0.18%, P = 0.04. After multivariable adjustment, only age remained significantly associated with vascular complications (OR 1.03, P = 0.04)., Conclusions: Femoral access using the Micropuncture technique did not reduce the incidence of vascular complications and the marginally higher than expected retroperitoneal bleeding is based on very small numbers. The routine use of the Micropuncture set and its technique should be revisited., (Copyright © 2012 Wiley Periodicals, Inc.)

The aim of this study was to investigate the relation between intravascular ultrasound (IVUS) findings and the no-reflow phenomenon and long-term outcome after percutaneous coronary intervention (PCI) of saphenous vein graft (SVG) lesions. No reflow was defined as Thrombolysis In Myocardial Infarction grade 0, 1, or 2 flow after PCI. Of 311 patients who underwent IVUS before and after stenting, no reflow was observed in 39 patients (13%). Degenerated SVG (62% vs 36%, p = 0.002), IVUS-detected intraluminal mass (82% vs 43%, p <0.001), culprit lesion multiple plaque ruptures (23% vs 6%, p <0.001), and tissue prolapse (51% vs 35%, p = 0.043) were observed more frequently in patients with no reflow. In multivariate logistic regression analysis, an intraluminal mass (odds ratio [OR] 4.84, 95% confidence interval [CI] 1.98 to 10.49, p = 0.001), culprit lesion multiple plaque ruptures (OR 3.46, 95% CI 1.46 to 8.41, p = 0.014), and degenerated SVGs (OR 3.17, 95% CI 1.17 to 6.56, p = 0.024) were the independent predictors of no reflow after PCI. At 5-year clinical follow-up, rates of death (14, 36%, vs 55, 20%, p = 0.036) and myocardial infarction (13, 33%, vs 52, 19%, p = 0.039) were significantly higher in the no-reflow group. However, rate of target vessel revascularization was not significantly different between the 2 groups (15, 38%, vs 90, 33%, p = 0.3). IVUS-detected intraluminal mass, multiple plaque ruptures, and degenerated SVGs were associated with no reflow in SVG lesions after PCI. In conclusion, no reflow was associated with poor long-term clinical outcomes after PCI for SVG lesions., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: The Placement of Aortic Transcatheter Valves (PARTNER) trial showed that among high-risk patients with aortic stenosis, the 1-year survival rates are similar with transcatheter aortic-valve replacement (TAVR) and surgical replacement. However, longer-term follow-up is necessary to determine whether TAVR has prolonged benefits., Methods: At 25 centers, we randomly assigned 699 high-risk patients with severe aortic stenosis to undergo either surgical aortic-valve replacement or TAVR. All patients were followed for at least 2 years, with assessment of clinical outcomes and echocardiographic evaluation., Results: The rates of death from any cause were similar in the TAVR and surgery groups (hazard ratio with TAVR, 0.90; 95% confidence interval [CI], 0.71 to 1.15; P=0.41) and at 2 years (Kaplan-Meier analysis) were 33.9% in the TAVR group and 35.0% in the surgery group (P=0.78). The frequency of all strokes during follow-up did not differ significantly between the two groups (hazard ratio, 1.22; 95% CI, 0.67 to 2.23; P=0.52). At 30 days, strokes were more frequent with TAVR than with surgical replacement (4.6% vs. 2.4%, P=0.12); subsequently, there were 8 additional strokes in the TAVR group and 12 in the surgery group. Improvement in valve areas was similar with TAVR and surgical replacement and was maintained for 2 years. Paravalvular regurgitation was more frequent after TAVR (P<0.001), and even mild paravalvular regurgitation was associated with increased late mortality (P<0.001)., Conclusions: A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients. The two treatments were similar with respect to mortality, reduction in symptoms, and improved valve hemodynamics, but paravalvular regurgitation was more frequent after TAVR and was associated with increased late mortality. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

Background: Transcatheter aortic-valve replacement (TAVR) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The outcomes beyond 1 year in such patients are not known., Methods: We randomly assigned patients to transfemoral TAVR or to standard therapy (which often included balloon aortic valvuloplasty). Data on 2-year outcomes were analyzed., Results: A total of 358 patients underwent randomization at 21 centers. The rates of death at 2 years were 43.3% in the TAVR group and 68.0% in the standard-therapy group (P<0.001), and the corresponding rates of cardiac death were 31.0% and 62.4% (P<0.001). The survival advantage associated with TAVR that was seen at 1 year remained significant among patients who survived beyond the first year (hazard ratio, 0.58; 95% confidence interval [CI], 0.36 to 0.92; P=0.02 with the use of the log-rank test). The rate of stroke was higher after TAVR than with standard therapy (13.8% vs. 5.5%, P=0.01), owing, in the first 30 days, to the occurrence of more ischemic events in the TAVR group (6.7% vs. 1.7%, P=0.02) and, beyond 30 days, to the occurrence of more hemorrhagic strokes in the TAVR group (2.2% vs. 0.6%, P=0.16). At 2 years, the rate of rehospitalization was 35.0% in the TAVR group and 72.5% in the standard-therapy group (P<0.001). TAVR, as compared with standard therapy, was also associated with improved functional status (P<0.001). The data suggest that the mortality benefit after TAVR may be limited to patients who do not have extensive coexisting conditions. Echocardiographic analysis showed a sustained increase in aortic-valve area and a decrease in aortic-valve gradient, with no worsening of paravalvular aortic regurgitation., Conclusions: Among appropriately selected patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR reduced the rates of death and hospitalization, with a decrease in symptoms and an improvement in valve hemodynamics that were sustained at 2 years of follow-up. The presence of extensive coexisting conditions may attenuate the survival benefit of TAVR. (Funded by Edwards Lifesciences; ClinicalTrials.gov number, NCT00530894.).

Background: A fractional flow reserve (FFR) of <0.8 is currently used to guide revascularization in lesions with intermediate coronary stenosis. Whether there is an intravascular ultrasound (IVUS) measurement or a cutoff value that can reliably determine which of these intermediate lesions requires intervention is unclear., Aims: We assessed IVUS measurement accuracy in defining functional ischemia by FFR., Methods: The analysis included 205 intermediate lesions (185 patients) located in vessel diameters >2.5 mm. Positive FFR was considered present at <0.8. IVUS measurements were correlated to the FFR findings in intermediate lesions with 40%-70% stenosis. Fifty-four (26.3%) lesions had FFR<0.8., Results: There was moderate correlation between FFR and IVUS measurements, including minimum lumen area (MLA) (r=0.36, P<.001), minimum lumen diameter (MLD) (r=0.25, P=<.001), lesion length (r=-0.43, P<.001), and area stenosis (r=-0.33, P=.01). A receiver operating characteristic curve (ROC) identified MLA<3.09 mm(2) (sensitivity 69.2%, specificity 79.5%) as the best threshold value for FFR<0.8. The correlation between FFR and IVUS was better for large vessels compared to small vessels. ROC analysis identified the best threshold value for FFR<0.8 of MLA<2.4 mm(2) [area under curve (AUC)=0.74] in lesions with reference vessel diameters of 2.5-3 mm, MLA<2.7 mm(2) (AUC=0.77) in lesions with reference vessel diameters of 3-3.5 mm, and MLA<3.6 mm(2) (AUC=0.70) in lesions with reference vessel diameters >3.5 mm., Conclusion: Anatomic measurements of intermediate coronary lesions obtained by IVUS show a moderate correlation to FFR values. The correlation was better for larger-diameter vessels. Vessel size should always be taken into account when determining the MLA associated with functional ischemia., (Copyright © 2012. Published by Elsevier Inc.)

Data from randomized clinical trials have shown the safety and efficacy of the XIENCE V in selected populations. However, limited data are available comparing the XIENCE V to the first-generation CYPHER sirolimus-eluting stent. This study aimed to assess the long-term safety and clinical efficacy of the XIENCE V everolimus-eluting stent compared to first-generation stents in an unselected patient population. This retrospective analysis included 6,069 patients treated with CYPHER, TAXUS, and XIENCE stents from 2003 to 2009 at our institution. The patients were followed up for ≥1 year after the index procedure. The baseline characteristics were generally comparable among the 3 groups, with the exception of a significantly greater prevalence of diabetes mellitus, systemic hypertension, and a history of angioplasty and coronary bypass surgery among the XIENCE patients. The XIENCE patients also had a twofold greater rate of type C lesions. One-year follow-up data were available for 82% of the patients. The 1-year major adverse cardiovascular events rate was 9.3% for the XIENCE stent versus 9.8% for the CYPHER stent and 11.5% for the TAXUS stent (p = 0.11). Mortality was lower in the XIENCE group than in the CYPHER and TAXUS groups (3.6% vs 4.9% vs 7.2%, respectively, p <0.001), and target lesion revascularization was similar (5.9% vs 5.2% vs 5.6%, respectively; p = 0.34). Stent thrombosis was lower in the XIENCE patients (0.2% vs 1.2% vs 0.7%, p = 0.007). In conclusion, in a contemporary United States clinical practice with an unselected patient population, use of the XIENCE V stent was associated with an improved safety profile and reduction of all-cause mortality and stent thrombosis compared to first-generation drug-eluting stents. The XIENCE V failed to demonstrate superiority for overall major adverse cardiovascular events, Q-wave myocardial infarction, and revascularization rates., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: Previous studies have not addressed vessel response >5 mm distal to the stent edge. Therefore, we investigated the impact of paclitaxel-eluting stents (PES) versus bare metal stents (BMS) on distal vessels in the serial intravascular ultrasound substudies of TAXUS IV, V, and VI., Methods and Results: TAXUS IV, V, and VI were double-blind, randomized, multicenter, controlled trials comparing PES with BMS. In their intravascular ultrasound substudies, 103 patients (54 BMS, 49 PES) had intravascular ultrasound data ≥10 mm distal to the stent both postprocedure and at 9 months follow-up. Baseline characteristics were similar between the 2 groups. Multilevel modeling was used to account for the variation between patients and within patients among distal segments. Effect of stent type, time, and their interaction was tested using a mixed effect model controlling for distal segments. Postprocedure lumen and vessel were not significantly different between PES versus BMS; however, lumen (P=0.006) and vessel (P=0.0001) were significantly reduced for BMS at 9-month follow-up but not for PES. Conversely, there was a significant plaque increase from postprocedure to 9-month follow-up for PES (P=0.0008) but not for BMS. These vessel responses were statistically consistent among 0- to 5-mm versus 5- to 10-mm versus 10- to 15-mm segments distal to the stent in both groups., Conclusions: PES use was associated with plaque increase from baseline to 9-month follow-up >5 mm distal to the stent along with positive remodeling, whereas BMS use was associated with negative remodeling and no plaque increase. These vessel responses were consistent in 5-mm long subsegments: 0 to 5 mm versus 5 to 10 mm versus 10 to 15 mm distal to the stent., Clinical Trial Registration: URL: HTTP://WWW.CLINICALTRIAL.GOV. Unique identifiers: TAXUS IV: NCT00292474; TAXUS V: NCT00301522; TAXUS VI: NCT00297804.

Objectives: This study aimed to test whether advanced cardiovascular injection (ACI) via 4 French (Fr) catheters is more advantageous than manual injection with 6 Fr catheters., Background: For coronary angiography, proponents of contrast media ACI believe it utilizes smaller-diameter catheters when compared with manual injection, without compromising the quality of the angiogram, and has the potential to reduce the amount of contrast used and lessen the use of closure devices., Methods: In a prospective study, 200 consecutive patients referred for elective coronary angiography were randomized to standard 6 Fr catheters with manual injection versus 4 Fr catheters with ACI. The study's primary endpoint is the quality of the coronary angiogram. Secondary endpoints include groin complications, utilization of closure devices, and volume of contrast media. Thirty-six patients who underwent ad hoc percutaneous coronary intervention were excluded from the analysis., Results: The final analysis included 80 patients treated with 4 Fr catheters with ACI and 84 patients treated with 6 Fr catheters with manual injection. The groups had similar demographic and clinical characteristics. The quality of the angiogram was similar between groups with the exception of more left coronary sinus flush with 4 Fr catheters (3.57 ± 1.1 vs. 2.98 ± 0.9, P < 0.001) and less closure device use with 4 Fr (25 vs. 71.4%, P < 0.01) compared to 6 Fr catheters. The procedure duration, volume of contrast used, vascular complications, and time to ambulation were similar between groups (all P > 0.05)., Conclusions: 4 Fr diagnostic catheters with ACI offer similar quality coronary angiograms, similar rates of vascular complications, procedure duration, contrast used, and time to ambulation, but have a significantly lesser need for closure devices compared to the 6 Fr system with manual injection., (Copyright © 2011 Wiley-Liss, Inc.)

Background: Failed percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) is associated with adverse outcome. With recent improvements in PCI techniques, the incidence and predictors for failed primary PCI are unclear., Methods: A clinical database of consecutive patients who underwent primary or rescue PCI from 1993 to 2011 was used to compare patients with successful versus failed PCI. Clinical follow-up was obtained in-hospital, at 30 days and at 1 year., Results: Of 2900 patients fulfilling our inclusion criteria, 111 (3.98%) had failed PCI. Patients who had failed PCI were older (65 vs. 61 years), were more likely to be women (46% vs. 32%), were more likely to have previous peripheral vascular disease (19% vs. 11%), previous PCI (29% vs. 20%), and were more likely to present with cardiogenic shock (25% vs. 11%) (all P < 0.05). Multivariable logistic regression analysis identified female gender (OR 1.54; 95% CI 1.01-2.38), cardiogenic shock (2.07; 1.22-3.49), previous PCI (1.71; 1.08-2.70), and type C lesion (2.47; 1.60-3.82) as independent predictors of PCI failure. The in-hospital (18% vs. 4%) and long-term mortality (48% vs. 14%) were worse in the failed PCI group compared to the successful group (P < 0.05)., Conclusion: In patients with STEMI, primary PCI failure is uncommon. It is associated with worse short- and long-term clinical outcome compared with a successful procedure. Special care should be taken when PCI is performed in women at higher risk for failure when presenting with STEMI., (©2012, Wiley Periodicals, Inc.)

Percutaneous coronary intervention of degenerated saphenous vein grafts remains relatively high risk when compared to native vessel interventions, despite advances in pharmacotherapy and embolic protection. This article discusses the phenomenon of distal embolization that seems to plague saphenous vein graft interventions, reviews device-based strategies for embolic protection, and offers a perspective on the utility of percutaneous saphenous vein graft intervention in both elective and acute settings.

Background: End-stage renal disease (ESRD) is known to correlate with poor outcome in patients undergoing percutaneous coronary intervention (PCI). This study examines the impact of diabetes mellitus (DM) on the long-term outcome of patients with ESRD on chronic hemodialysis., Methods: A cohort of patients with ESRD on chronic hemodialysis, who underwent PCI with drug-eluting stents, was followed for 1 year. The clinical outcome in this population was compared retrospectively based on the presence of DM. Major adverse cardiac events (MACE) as the composite of all-cause death, Q-wave myocardial infarction and target lesion revascularization (TLR), as well as TLR as an individual outcome, were the main end points of the study., Results: In the study cohort (n = 198), 48.5% had DM. Diabetic patients were more commonly female. The lesion characteristics were similar between groups except for more frequent saphenous vein graft intervention in nondiabetics. At 1-year follow-up there was no difference in the rate of MACE between diabetic and nondiabetic patients (40.4% vs. 39.3%, respectively, p = 0.89), driven primarily by a very high mortality rate (1-year overall mortality of 33.5%). After adjustment for the relevant clinical co-variables, DM was not associated with the composite end point. However, diabetic patients had a significantly higher incidence of 1-year TLR compared to nondiabetics (13.8% vs. 3.6%, respectively, p = 0.04)., Conclusion: The prognosis of patients with ESRD after PCI is dismal with a very high overall mortality rate regardless of the presence of DM. Patients with ESRD appear to be at higher risk for the need of revascularization., (©2011 Wiley Periodicals, Inc.)

The penetration rate of devices in general, and in transcatheter aortic valve replacement (TAVR) specifically, is significantly delayed in the United States of America (USA) compared with in Europe. This is mostly due to the mission statement of the regulatory agencies in the USA, which requires very rigorous clinical testing of a device prior to its approval. The USA had a major role in the development and evaluation of this technology and USA research has enabled clinicians inside and outside of the USA to conduct a concise scientifically based assessment of the performance of TAVR devices in terms of safety and efficacy. In the following review, we provide data on the development of TAVR in the USA, revealing the critical role the USA has played in this extraordinary process., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

Background: Patients with severe aortic stenosis (AS) and prior cardiac surgery undergoing aortic valve replacement (AVR) are at high risk. Transapical AVR might reduce the risk in patients not suitable for the transfemoral approach. We aimed to describe the fluoroscopy and left anterior descending artery (LAD) angiography guidance technique for transapical AVR access and the initial related procedural results., Methods: Patients with severe AS and prior cardiac surgery undergoing transapical AVR using LAD angiographic-guided apical puncture were analyzed (n=9). Additional guidance was added to the standard technique as follows. Minithoracotomy was performed at the level of the intercostal space in closer relationship to the apex identified by fluoroscopy. LAD angiography was performed at the time that the area of interest was recognized by radiopaque marker to ensure puncture lateral to the LAD. Apical needle puncture was performed under fluoroscopy guidance directed towards the aortic root., Results: The population had a mean age of 83 years and was more frequently male (89%) with a high-risk profile (mean Society of Thoracic Surgeons score of 11%). Two patients received the 23-mm Edwards SAPIEN valve, and seven patients received the 26-mm SAPIEN device. All nine patients underwent successful implantation of transcatheter aortic valves with virtual abolishment of transaortic gradient, without procedural complications., Conclusion: Fluoroscopy and angiography for guidance of the transapical approach facilitate a safe and rapid access to the apex, insuring no risk of damage to the LAD or to large diagonals., (Copyright © 2012. Published by Elsevier Inc.)

Transcatheter aortic valve implantation (TAVI) has been introduced as an alternative to conventional surgery for high-risk patients with aortic stenosis. A recently published randomized clinical trial demonstrated reduction of mortality in high-risk or inoperable patients when compared to medical treatment or balloon aortic valvuloplasty. Despite this evidence of superiority, the rate of TAVI complications is high, and perhaps the most devastating of the nonfatal complications is cerebral injury. This review will compare the incidence of stroke and "silent" cerebral injury after surgical aortic valve replacement and after TAVI and will discuss mechanisms that can lead to cerebral injury during these procedures and subsequently how to prevent this with new protection devices., (Copyright © 2012. Published by Elsevier Inc.)

Background: The optimal percutaneous treatment of drug-eluting stent (DES) in-stent restenosis (ISR) and the correlates for recurrent DES ISR remain unclear., Methods and Results: From 2003 to 2008, 563 patients presenting with recurrent symptoms of ischemia and angiographic ISR after DES implantation were included. Of these, 327 were treated with re-DES (58.1%), 132 underwent vascular brachytherapy (23.4%), and 104 were treated with conventional balloon angioplasty (18.5%). Variables associated with target lesion revascularization at 1 year were explored by individual proportional hazard models. This population presents a high prevalence of comorbidities, including diabetes (43.7%), previous myocardial infarction (MI) (45.8%), coronary bypass graft surgery (39.2%), chronic renal failure (18.8%), and heart failure (17.3%). Baseline clinical characteristics were balanced among the 3 groups; however, patients undergoing vascular brachytherapy presented with more complex lesions and a higher prevalence of prior stent/vascular brachytherapy failure than did the rest of the population. The overall incidence of recurrent DES failure at 1-year follow-up was 12.2%, which was similar among the 3 groups (P=0.41). The rate of the composite end point (death, Q-wave-MI and target lesion revascularization) at 1-year follow-up was 14.1% for re-DES, 17.5% for vascular brachytherapy, and 18.0% for conventional balloon angioplasty (P=0.57). After univariable analysis tested the traditional known covariates related to ISR, none of them were associated with repeat target lesion revascularization., Conclusions: Recurrence of ISR after DES treatment failure is neither infrequent nor benign, and optimal therapy remains unclear and challenging. Given the absence of traditional risk factors for ISR in this population, further research is required to elucidate both the correlates involved in DES ISR and the optimal treatment for this condition.

Background: High on-treatment platelet reactivity is an established risk factor for adverse cardiac events in patients taking clopidogrel following percutaneous coronary intervention (PCI)., Methods: Two hundred patients underwent platelet reactivity testing with VerifyNow P2Y12, vasodilator-stimulated phosphoprotein phosphorylation (VASP), and light transmission aggregometry (LTA) with both 5 and 20 μM of adenosine diphosphate (ADP) following PCI. High on-treatment platelet reactivity was defined as a maximum platelet aggregation ≥46% for LTA ADP 5 μM or ≥60% for 20 μM; platelet reactivity index (PRI) ≥50% for VASP; and platelet reactivity units ≥235 for VerifyNow. Correlation between assays was tested using Spearman coefficients (ρ); agreement among tests in regards to high on-treatment platelet reactivity was evaluated with Kappa statistics (κ)., Results: All Spearman correlations had P values <0.001, although ρ ranged from 0.60-0.86. The incidence of high on-treatment platelet reactivity was 39.3% with VASP, 27.3% with VerifyNow, 23.1% with LTA ADP 5 μM, and 16.2% with LTA ADP 20 μM. The strongest correlation was between LTA ADP 5 μM and LTA ADP 20 μM (κ= 0.53, 95% CI 0.37-0.68); the weakest was between VASP and LTA ADP 5 μM (κ= 0.33, 95% CI 0.19-0.47). Overall, the level of agreement between assays was in the moderate to poor range., Conclusion: Despite evidence that the most commonly used tests are correlated, agreement among tests is modest at best and demonstrates they are not interchangeable. , (©2011, Wiley Periodicals, Inc.)

Background: The primary inclusion criteria from both the Society of Thoracic Surgeons (STS) score and the logistic EuroSCORE are currently used to identify high-risk and inoperable patients eligible for transcatheter aortic valve implantation (TAVI). We aimed to examine the correlation between STS and logistic EuroSCOREs and their performance characteristics in patients referred for TAVI., Methods: The study cohort consisted of 718 high-risk patients with severe aortic stenosis who were considered for participation in a TAVI clinical trial. The performance of the STS and logistic EuroSCOREs was evaluated in three groups: (a) medical management or balloon aortic valvuloplasty (BAV), 474 (66%); (b) 133 patients (18.5%) with surgical aortic valve replacement (AVR); (c) 111 (15.4%) with TAVI. The mean age was 81.8 ± 8.1 years, and 394 (54.8%) were female., Results: The mean STS score was 11.5 ± 6.1, and the mean logistic EuroSCORE was 39.7 ± 23.0. Pearson correlation coefficient showed moderate correlation between the STS and logistic EuroSCOREs (r = 0.61, P < .001). At a median follow-up of 190 days (range, 67-476), 282 patients (39.2%) died. The STS and logistic EuroSCOREs were both higher in patients who died as compared to those in survivors (13.1 ± 6.2 vs.10.0 ± 5.8 and 43.4 ± 23.1 vs. 37.5 ± 22, respectively; P < .001). The observed and predicted 30-day mortality rates in the medical/BAV group were 10.1% observed, 12.3% by STS and 43.1% by logistic EuroSCORE. In the surgical AVR group, the rates were 12.8% observed, 8.4% by STS and 25.6% by logistic EuroSCORE. In the TAVI group, the rates were 11.7% observed, 11.8% by STS and 41.2% by logistic EuroSCORE. The odds ratio (OR) for 30-day mortality in the medical/BAV group was 1.05 (P = .01) with STS and 1.003 (P = .7) with logistic EuroSCORE. In the surgical AVR group, the OR was 1.09 (P = .07) with STS and 1.007 (P = .6) with logistic EuroSCORE. In the TAVI group, the OR was 1.14 (P = .03) with STS and 1.03 (P = .04) with logistic EuroSCORE., Conclusion: In high-risk patients with severe aortic stenosis, STS score is superior to the logistic EuroSCORE in predicting mortality. Clinical judgment should play a major role in the selection of patients with severe aortic stenosis for the different therapeutic options., (Copyright © 2011. Published by Elsevier Inc.)

Coronary perforation (CP) is a rare but catastrophic event that may be influenced by the procedural anticoagulation regimen. This study compared the consequences of CP in patients who underwent anticoagulation with bivalirudin (BIV; a nonreversible direct thrombin inhibitor with a shorter 1/2-life than heparin) to those in patients who underwent anticoagulation with heparin (HEP) at time of CP. Patients with CP were identified from 33,613 procedures available in our institutional angioplasty registry. The outcome of this group was compared based on anticoagulation regimen (BIV vs HEP). The primary end point for this analysis was the composite of in-hospital death, cardiac tamponade, or emergency cardiac surgery. Overall a cohort of 69 patients (0.2%) with CP was identified. BIV was the intraprocedural anticoagulant in 41 patients, whereas HEP was used in 28. Baseline characteristics were comparable between groups except for a higher frequency of systemic hypertension and hypercholesterolemia in the BIV group. Procedural characteristics were also similar including lesion complexity and perforation severity. Nearly 1/2 of CPs in each group was managed with prolonged balloon inflation alone. Protamine was used in 46% of HEP-treated patients. Covered stents tended to be used more frequently in the BIV group (p = 0.061). The primary composite end point was similar between groups (odds ratio 1.42, 95% confidence interval 0.47 to 4.29, p = 0.53). However, there was a lower rate of cardiac surgery requirement in BIV-treated patients (p = 0.037). In conclusion, our study suggests that choice of procedural anticoagulant agent does not influence outcome when CP occurs. Therefore, use of BIV should not be discouraged in patients undergoing high-risk intervention for perforations., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Previous research has suggested that obesity is associated with increased high on-treatment platelet reactivity. We therefore tested platelet reactivity in 251 patients with VerifyNow P2Y12, vasodilator-stimulated phosphoprotein phosphorylation, and light transmission aggregometry with adenosine diphosphate 5 and 20 μM 6 to 24 hours after percutaneous coronary intervention. High on-treatment platelet reactivity was defined as a maximum platelet aggregation ≥46% for light transmission aggregometry with adenosine diphosphate 5 μM or ≥60% for 20 μM, platelet reactivity index ≥50% for vasodilator-stimulated phosphoprotein phosphorylation, and P2Y12 reaction units ≥235 for VerifyNow. The relation between body mass index (BMI) and platelet reactivity values was examined with Spearman coefficients; BMI and high on-treatment platelet reactivity were assessed with Student's t test. Multivariable logistic regression for high on-treatment platelet reactivity was also performed. Average BMI was 30.3 ± 5.9 kg/m² and 44% of patients had a BMI ≥30 kg/m². Overall there was very poor correlation between BMI and on-treatment platelet reactivity, with Spearman coefficients ranging from 0.08 to 0.10. BMI was also not associated with the various definitions of high on-treatment platelet reactivity. Multivariable logistic regressions showed no association between BMI and high on-treatment platelet reactivity. In conclusion, and contrary to previous reports, we found no association whatsoever between BMI and on-treatment platelet reactivity as quantified by a variety of platelet function tests., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: The adjunctive use of eptifibatide in patients undergoing primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) remains controversial. We therefore set out to determine the safety and efficacy of eptifibatide in this population., Methods: The study comprised 857 consecutive patients who underwent primary PCI for STEMI at the Washington Hospital Center. Three hundred eighteen patients also received adjunctive therapy with eptifibatide. Patients who had received thrombolysis prior to undergoing cardiac catheterization were excluded. The primary end-point was all-cause mortality and the composite of all-cause mortality or Q-wave MI. The primary safety end-point was the rate of thrombolysis in myocardial infarction (TIMI) major bleeding., Results: The eptifibatide group was younger, had a higher body mass index, and a lower proportion of patients with systemic hypertension, diabetes mellitus, previous history of ischemic heart disease, coronary revascularization, and congestive heart failure. This cohort also used bivalirudin less often (23.3% vs. 72%; P < 0.001). Following multivariable analysis, the eptifibatide group had a significantly lower rate of all-cause mortality (hazard ratio 0.55; 95% confidence interval 0.34-0.89; P = 0.01) and the composite of all-cause mortality or Q-wave MI (hazard ratio 0.59; 95% confidence interval 0.37-0.95; P = 0.03) at 6 months. The rate of TIMI major bleeding was similar in both groups (hazard ratio 0.54; 95% confidence interval 0.25-1.17; P = 0.12)., Conclusion: The adjunctive use of eptifibatide in patients presenting with STEMI may be associated with improved clinical outcomes. (J Interven Cardiol 2011;24:351-356)., (©2011, Wiley Periodicals, Inc.)

Background: Despite significant advances in stent technology and pharmacotherapy, drug-eluting stent thrombosis (DES-ST) remains a major complication of percutaneous coronary intervention (PCI) and commonly presents as ST-elevation myocardial infarction (STEMI). There are currently little data comparing the in-hospital outcomes of patients presenting with STEMI due to DES-ST with those due to de novo coronary artery disease (CAD)., Methods: Our study comprised 985 consecutive patients who underwent primary PCI for STEMI, 102 of whom were diagnosed as having a definite DES-ST. The primary end-point was the in-hospital composite of death or recurrent myocardial infarction (MI). The secondary end-point was the in-hospital maximum rise in creatine kinase (myocardial band [MB] fraction) and troponin I., Results:  The DES-ST group had a higher proportion of patients with diabetes mellitus, hypercholesterolemia, history of ischemic heart disease, coronary revascularization, and chronic renal impairment. The adjusted primary end-point was higher in the DES-ST cohort (12.7% vs. 7.4%; P = 0.05). The 2 cohorts did not differ in the secondary end-point. The independent predictors of the primary end-point were age (hazard ratio [HR]= 1.04; 95% confidence interval [CI]= 1.01 - 1.06; P = 0.005), cardiogenic shock (HR = 11.5; 95% CI = 6.38 - 20.07, P < 0.001), and lesions involving the left anterior descending coronary artery (HR = 1.8; 95% CI = 1.03 - 3.13, P = 0.04). DES-ST was not an independent predictor of the primary end-point (HR = 1.18; 95% CI = 0.53-2.63, P = 0.38)., Conclusions: Patients with STEMI secondary to DES-ST have a poorer in-hospital outcome than do patients in whom STEMI is due to de novo CAD. This difference may be predominantly driven by differences in the baseline characteristics between these cohorts. (J Interven Cardiol 2011;24:320-325)., (©2011, Wiley Periodicals, Inc.)

Percutaneous intervention carries a higher risk of distal embolization and poorer outcome in saphenous vein grafts (SVG) than in native coronary vessels. Embolic protection devices (EPD) have demonstrated value in decreasing the risk of embolization and post-procedural enzymes elevation after SVG intervention. Although there is ample evidence to support the routine use of EPD for SVG interventions, frequently those devices are not utilized or cannot be used because of technical reasons. As we previously reported, the "undersized stenting" approach seems to be an attractive strategy when EPD cannot be used. We present a case with severe SVG degeneration that illustrates the feasibility of this strategy., (Copyright © 2011 Wiley-Liss, Inc.)

Objectives: To compare complication rates of a collagen-mediated closure device, suture-mediated closure technique and manual compression for access site management following balloon aortic valvuloplasty (BAV)., Background: Vascular complications, including perforation, limb ischemia, ateriovenous fistulas, and pseudoaneurysm, are a common source of morbidity in patients undergoing BAV with large bore femoral artery access. The available options for closure of the access site include manual compression, suture-mediated closure devices, and recently reported collagen-based closure devices., Methods: The study cohort consisted of 333 patients with severe aortic stenosis undergoing BAV. Patients were divided into four groups according to access closure method: (1) Manual compression in 64 (19.2%); (2) Proglide 6 Fr in 162 (48.6%); (3) Angio-Seal 8 Fr in 89 (26.75%); and (4) Prostar 10 Fr in 18 (5.4%)., Results: There were no significant differences in baseline characteristics among the groups; although the Prostar group was had more males and the Angio-Seal group reported a lower incidence of renal failure and peripheral vascular disease. The Angio-Seal group had shorter procedural duration times compared with the other groups. In the Angio-Seal group (n = 47, 52.8%), a 10 Fr sheath size was primarily used to access the femoral artery, as compared with the manual compression and Proglide groups, which used a 12 Fr sheath in 29 (45.3%) and 66 patients (40.7%), respectively. A 13 Fr sheath was used in the Prostar group (n = 11, 61.1%), P < 0.001. The device failure rate was significantly higher in the Proglide group (n = 20, 12.3%) as compared with Angio-Seal (n = 3, 3.3%) and Prostar groups (n = 1, 5.5%), P = 0.03. Serious vascular complications requiring intervention were significantly higher in the manual compression group (n = 11, 17.1%) compared with the Proglide (n = 11, 6.7%), Angio-Seal (n = 5, 5.6%), and Prostar groups (n = 5, 1%), P < 0.001. The requirement for blood transfusion in the Angio-Seal group was significantly lower (n = 7, 7.8%) as compared with the manual compression (n = 20, 31.2%), Proglide (n = 35, 21.6%), and Prostar groups (n = 5, 27.7%), P < 0.001., Conclusion: In our case series, collagen-based closure devices and suture-mediated closure devices had fewer vascular complications than manual compression for hemostasis following BAV. Patient selection for collagen-based versus suture-mediated closure requires further study., (Copyright © 2011 Wiley-Liss, Inc.)

Objectives: We sought to describe characteristics of patients presenting with an acute MI from a SVG culprit, compared with a native culprit., Background: Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) results in worse outcomes than native vessel PCI, but outcomes of such patients with acute myocardial infarction (MI) setting are not well-described., Methods: Patients presenting with ST-elevation or non-ST-elevation MI undergoing PCI from 2000 to 2010 were retrospectively analyzed to identify the culprit as a SVG vs. native vessel. Multiple linear regression was used to identify predictors of peak troponin-I level. Cox proportional hazards regression was used to identify predictors of 30-day mortality and 1-year major adverse cardiac events (MACE)., Results: 192 patients underwent PCI for a SVG culprit, compared with 4,001 with a native culprit. After multivariable adjustment, SVG culprit remained significantly associated with lower levels of the logarithm of the peak troponin (β = -0.17, SE = 0.07, P = 0.02). The likelihood of MACE was higher in SVG vs. native culprits in patients with small to modest troponin elevations. Patients with a SVG culprit also suffered higher unadjusted rates of mortality at 30 days (14.3% vs. 8.4%, P = 0.03) and MACE at 1 year (36.8% vs. 24.5%, P = 0.005); a modest effect upon mortality and MACE remained after multivariable adjustment., Conclusion: Even minimal elevations of troponin in patients with a SVG culprit may portend a poorer prognosis than in patients with a native culprit. The risk of PCI in this setting is driven by mortality and arises from both substantial comorbidities and the SVG itself., (Copyright © 2011 Wiley-Liss, Inc.)

Compared to paclitaxel-eluting stents (PESs) and sirolimus-eluting stents (SESs), a paucity of data exists regarding the clinical outcome of everolimus-eluting stents (EESs) in unselected patients with the entire spectrum of obstructive coronary artery disease. The present study cohort included 6,615 consecutive patients at Washington Hospital Center who underwent coronary artery stent implantation with EESs (n = 519), PESs (n = 2,036), or SESs (n = 4,060). Patients who received bare metal stents, zotarolimus-eluting stents, or 2 different drug-eluting stent types were excluded. The analyzed clinical end points were death, death or Q-wave myocardial infarction, target lesion revascularization (TLR), target vessel revascularization, definite stent thrombosis, and major adverse cardiac events, defined as the composite of death, Q-wave myocardial infarction, or TLR at 1 year. The groups were well matched for the conventional risk factors for coronary artery disease, except for systemic hypertension, which differed among the groups. The unadjusted end points for EESs and PESs were death (4.5% vs 7.1%; p = 0.03), TLR (3.4% vs 4.6%; p = 0.24), target vessel revascularization (5.6% vs 7.1%; p = 0.46), death or Q-wave myocardial infarction (4.5% vs 7.4%; p = 0.02), and definite stent thrombosis (0.0% vs 0.7%; p = 0.09). The unadjusted end points for EES and SES were death (4.5% vs 5.2%; p = 0.45), TLR (3.4% vs 5.8%; p = 0.3), target vessel revascularization (5.6% vs 8.6%; p = 0.05), death or Q-wave myocardial infarction (4.5% vs 5.4%; p = 0.39), and definite stent thrombosis (0.0% vs 1.08%; p = 0.003). The rates of major adverse cardiac events were similar among the 3 groups. After multivariate analysis, the rate of death or Q-wave myocardial infarction between the EES and PES groups was no longer significant (hazard ratio 1.14, 95% confidence interval 0.59 to 2.20, p = 0.70). In conclusion, the results of the present study suggest the use of EES in routine clinical practice is both safe and effective but offers no clinically relevant advantage in terms of hard end points compared to PES or SES., (Copyright © 2011 Elsevier Inc. All rights reserved.)

The clinical safety and efficacy of clopidogrel reloading in patients receiving long-term clopidogrel therapy who present with acute coronary syndromes and undergo percutaneous coronary intervention have not yet been evaluated. The study cohort comprised 1,368 consecutive patients receiving long-term clopidogrel therapy (75 mg/day) who had presented with acute coronary syndromes and underwent coronary artery stent implantation. In total, 926 patients were given a 600-mg clopidogrel loading dose (reload cohort) before cardiac catheterization, while 442 patients were not reloaded (no-reload cohort). Patients who had presented with cardiogenic shock or stable angina were excluded. The 2 cohorts were well matched for the conventional risk factors for coronary artery disease. The analyzed clinical end points of death (1.1% vs 0.9%, p = 0.77), death or Q-wave myocardial infarction (0.9% vs 0.9%, p = 1.0), target lesion revascularization (0.2% vs 0.8%, p = 0.45), target vessel revascularization (1.1% vs 1.1%, p = 1.0), and major adverse cardiac events (2.0% vs 1.8%, p = 0.8) were similar between the no-reload and reload groups at 30 days. The in-hospital rates of major bleeding and gastrointestinal bleeding were also similar between the 2 cohorts. There were no cases of definite stent thrombosis. In conclusion, patients receiving long-term clopidogrel therapy who present with acute coronary syndromes do not gain any clinical benefit from additional reloading with clopidogrel., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Aims: Fractional flow reserve (FFR) of <0.8 or 0.75 is currently used to guide revascularisation in lesions with intermediate coronary stenosis. We assessed whether there is an intravascular ultrasound (IVUS) measurement that can reliably be used to predict when patients should undergo intervention., Methods and Results: The analysis included 92 intermediate lesions (84 patients) located in vessel diameters >2.5 mm. Positive FFR was considered present at <0.8 and 0.75. IVUS minimum lumen area (MLA) was correlated to the FFR findings in intermediate lesions with 40-70% stenosis. The mean FFR value was 0.89 ± 0.08. Twenty-four patients (26.1%) had FFR <0.8; 17 (18.5%) <0.75. Positive correlations between FFR and IVUS measurements included MLA (r = 0.34, p<0.001), minimum lumen diameter (MLD) (r=0.31, p=0.004), lesion length (r=-0.5, p<0.001), and area stenosis (r=-0.31, p=0.01). There was no significant correlation between FFR and quantitative coronary angiography in MLD (r=0.19, p=0.06), diameter stenosis (r=0.08, p=0.4), or lesion length (r=-0.14, p=0.17). A receiver operating characteristic curve identified MLA <2.8 mm2 (sensitivity 79.7%, specificity 80.3%) as the best threshold value for FFR <0.75; and MLA <3.2 mm2 as best for FFR <0.8 (sensitivity 69.2%, specificity 68.3%)., Conclusions: Anatomic measurements of intermediate coronary lesions obtained by IVUS show a moderate correlation to FFR values, although they differ according to vessel size. IVUS MLA may be used as an alternative to FFR when assessing the need for intervention in intermediate coronary lesion. Vessel size, however, should always be taken into account.