The purpose of this study was to examine temporal trends in post-percutaneous coronary intervention (PCI) bleeding among patients with elective PCI, unstable angina (UA)/non–ST-segment elevation myocardial infarction (NSTEMI), and ST-segment elevation myocardial infarction (STEMI).
Background
The impact of bleeding avoidance strategies on post-PCI bleeding rates over time is unknown.
Methods
Using the CathPCI Registry, we examined temporal trends in post-PCI bleeding from 2005 to 2009 among patients with elective PCI (n = 599,524), UA/NSTEMI (n = 836,103), and STEMI (n = 267,632). We quantified the linear time trend in bleeding using 3 sequential logistic regression models: 1) clinical factors; 2) clinical + vascular access strategies (femoral vs. radial, use of closure devices); and 3) clinical, vascular strategies + antithrombotic treatments (anticoagulant ± glycoprotein IIb/IIIa inhibitor [GPI]). Changes in the odds ratio for time trend in bleeding were compared using bootstrapping and converted to risk ratio.
Results
An approximate 20% reduction in post-PCI bleeding was seen (elective PCI: 1.4% to 1.1%; UA/NSTEMI: 2.3% to 1.8; STEMI: 4.9% to 4.5%). Radial approach remained low (<3%), and closure device use increased marginally from 44% to 49%. Bivalirudin use increased (17% to 30%), whereas any heparin + GPI decreased (41% to 28%). There was a significant 6% to 8% per year reduction in annual bleeding risk in UA/NSTEMI and elective PCI, but not in STEMI. Antithrombotic strategies were associated with roughly half of the reduction in annual bleeding risk: change in risk ratio from 7.5% to 4% for elective PCI, and 5.7% to 2.8% for UA/NSTEMI (both p <0.001).
Conclusions
The nearly 20% reduction in post-PCI bleeding over time was largely due to temporal changes in antithrombotic strategies. Further reductions in bleeding complications may be possible as bleeding avoidance strategies evolve, especially in STEMI.
The purpose of this study was to determine appropriateness of percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery performed in New York for patients without acute coronary syndrome (ACS) or previous CABG surgery.
Background
The American College of Cardiology Foundation (ACCF) and 6 other societies recently published joint appropriateness criteria for coronary revascularization.
Methods
Data from patients who underwent CABG surgery and PCI without acute coronary syndrome or previous CABG surgery in New York in 2009 and 2010 were used to assess appropriateness and to examine the variation across hospitals in inappropriateness ratings.
Results
Of the 8,168 patients undergoing CABG surgery in New York without ACS/prior CABG who could be rated, 90.0% were appropriate for revascularization, 1.1% were inappropriate, and 8.6% were uncertain. Of the 33,970 PCI patients eligible for rating, 28% lacked sufficient information to be rated. Of the patients who could be rated, 36.1% were appropriate, 14.3% were inappropriate, and 49.6% were uncertain. A total of 91% of the patients undergoing PCI who were classified as inappropriate had 1- or 2-vessel disease without proximal left anterior descending artery disease and had no or minimal anti-ischemic medical therapy.
Conclusions
For patients without ACS/prior CABG, only 1% of patients undergoing CABG surgery who could be rated were found to be inappropriate for the procedure according to the ACCF appropriateness criteria, but 14% of the PCI patients who could be rated were found to be inappropriate, and 28% lacked enough noninvasive test information to be rated.
The authors used multidetector computed tomography (MDCT) to study the relation between culprit plaque characteristics and cardiac troponin T (cTnT) elevation after percutaneous coronary intervention (PCI).
Background
Percutaneous coronary intervention is often complicated by post-procedural myocardial necrosis manifested by elevated cardiac biomarkers.
Methods
Stable angina patients (n = 107) with normal pre-PCI cTnT levels underwent 64-slice MDCT before PCI to evaluate plaque characteristics of culprit lesions. Patients were divided into 2 groups according to presence (group I, n = 36) or absence (group II, n = 71) of post-PCI cTnT elevation ≥3 times the upper limit of normal (0.010 ng/ml) at 24 h after PCI.
Results
Computed tomography attenuation values were significantly lower in group I than in group II (43.0 [26.5 to 75.7] HU vs. 94.0 [65.0 to 109.0] HU, p < 0.001). Remodeling index was significantly greater in group I than in group II (1.20 ± 0.18 vs. 1.04 ± 0.15, p < 0.001). Spotty calcification was observed significantly more frequently in group I than in group II (50% vs. 11%, p < 0.001). Multivariate analysis showed presence of positive remodeling (remodeling index >1.05; odds ratio: 4.54; 95% confidence interval: 1.36 to 15.9; p = 0.014) and spotty calcification (odds ratio: 4.27; 95% confidence interval: 1.30 to 14.8; p = 0.016) were statistically significant independent predictors for cTnT elevation. For prediction of cTnT elevation, the presence of all 3 variables (CT attenuation value <55 HU; remodeling index >1.05, and spotty calcification) showed a high positive predictive value of 94%, and their absence showed a high negative predictive value of 90%.
Conclusions
MDCT may be useful in detecting which lesions are at high risk for myocardial necrosis after PCI.
The aim of this study was to determine the incidence and clinical characteristics of sudden cardiac death (SCD) in patients with human immunodeficiency virus (HIV) infection.
Background
As the HIV-infected population ages, cardiovascular disease prevalence and mortality are increasing, but the incidence and features of SCD have not yet been described.
Methods
The records of 2,860 consecutive patients in a public HIV clinic in San Francisco between April 2000 and August 2009 were examined. Identification of deaths, causes of death, and clinical characteristics were obtained by search of the National Death Index and/or clinic records. SCDs were determined using published retrospective criteria: 1) the International Classification of Diseases-10th Revision, code for all cardiac causes of death; and (2) circumstances of death meeting World Health Organization criteria.
Results
Of 230 deaths over a median of 3.7 years of follow-up, 30 (13%) met SCD criteria, 131 (57%) were due to acquired immune deficiency syndrome (AIDS), 25 (11%) were due to other (natural) diseases, and 44 (19%) were due to overdoses, suicides, or unknown causes. SCDs accounted for 86% of all cardiac deaths (30 of 35). The mean SCD rate was 2.6 per 1,000 person-years (95% confidence interval: 1.8 to 3.8), 4.5-fold higher than expected. SCDs occurred in older patients than did AIDS deaths (mean 49.0 vs. 44.9 years, p = 0.02). Compared with AIDS and natural deaths combined, SCDs had a higher prevalence of prior myocardial infarction (17% vs. 1%, p < 0.0005), cardiomyopathy (23% vs. 3%, p < 0.0005), heart failure (30% vs. 9%, p = 0.004), and arrhythmias (20% vs. 3%, p = 0.003).
Conclusions
SCDs account for most cardiac and many non-AIDS natural deaths in HIV-infected patients. Further investigation is needed to ascertain underlying mechanisms, which may include inflammation, antiretroviral therapy interruption, and concomitant medications.
This study was designed to compare the accuracy of 64-row contrast computed tomography (CT), invasive cineventriculography (CVG), 2-dimensional echocardiography (2D Echo), and 3-dimensional echocardiography (3D Echo) for left ventricular (LV) function assessment with magnetic resonance imaging (MRI).
Background
Cardiac function is an important determinant of therapy and is a major predictor for long-term survival in patients with coronary artery disease. A number of methods are available for assessment of function, but there are limited data on the comparison between these multiple methods in the same patients.
Methods
A total of 36 patients prospectively underwent 64-row CT, CVG, 2D Echo, 3D Echo, and MRI (as the reference standard). Global and regional LV wall motion and ejection fraction (EF) were measured. In addition, assessment of interobserver agreement was performed.
Results
For the global EF, Bland-Altman analysis showed significantly higher agreement between CT and MRI (p < 0.005, 95% confidence interval: ±14.2%) than for CVG (±20.2%) and 3D Echo (±21.2%). Only CVG (59.5 ± 13.9%, p = 0.03) significantly overestimated EF in comparison with MRI (55.6 ± 16.0%). CT showed significantly better agreement for stroke volume than 2D Echo, 3D Echo, and CVG. In comparison with MRI, CVG—but not CT—significantly overestimated the end-diastolic volume (p < 0.001), whereas 2D Echo and 3D Echo significantly underestimated the EDV (p < 0.05). There was no significant difference in diagnostic accuracy (range: 76% to 88%) for regional LV function assessment between the 4 methods when compared with MRI. Interobserver agreement for EF showed high intraclass correlation for 64-row CT, MRI, 2D Echo, and 3D Echo (intraclass correlation coefficient >0.8), whereas agreement was lower for CVG (intraclass correlation coefficient = 0.58).
Conclusions
64-row CT may be more accurate than CVG, 2D Echo, and 3D Echo in comparison with MRI as the reference standard for assessment of global LV function.
The aim of this study was to investigate whether exposure to a range of relatively low concentrations of aged secondhand smoke (SHS), similar to those encountered commonly in the community, would impair endothelial function in a concentration-dependent manner.
Background
Exposure to SHS impairs endothelial function in humans. The concentration-dependent relationship for aged SHS effects on endothelial function after an exposure of short duration is unknown.
Methods
Thirty-three healthy nonsmokers were exposed to 1 of 2 low levels of aged SHS or to conditioned filtered air for 30 min. The primary end point was change in maximal percent brachial artery flow-mediated dilation after exposure.
Results
In a linear regression model for each increase in SHS exposure by 100 μg/m3 respirable suspended particles, the absolute maximal percent brachial artery flow-mediated dilation was reduced by 0.67%. We did not find evidence of a threshold for the effect of SHS on flow-mediated dilation.
Conclusions
Short-term exposure to real-world levels of aged SHS for 30 min resulted in a concentration-dependent decrease in endothelial function as measured by flow-mediated dilation.
This study investigated the impact of procedural success on mortality following chronic total occlusion (CTO) percutaneous coronary intervention (PCI) in a large cohort of patients in the drug-eluting stent era.
Background
Despite advances in expertise and technologies, many patients with CTO are not offered PCI.
Methods
A total of 6,996 patients underwent elective PCI for stable angina at a single center (2003 to 2010), 836 (11.9%) for CTO. All-cause mortality was obtained to 5 years (median: 3.8 years; interquartile range: 2.0 to 5.4 years) and stratified according to successful chronic total occlusion (sCTO) or unsuccessful chronic total occlusion (uCTO) recanalization. Major adverse cardiac events (MACE) included myocardial infarction (MI), urgent revascularization, stroke, or death.
Results
A total of 582 (69.6%) procedures were successful. Stents were implanted in 97.0% of successful procedures (mean: 2.3 ± 0.1 stents per patient, 73% drug-eluting). Prior revascularization was more frequent among uCTO patients: coronary artery bypass grafting (CABG) (16.5% vs. 7.4%; p < 0.0001), PCI (36.0% vs. 21.2%; p < 0.0001). Baseline characteristics were otherwise similar. Intraprocedural complications, including coronary dissection, were more frequent in unsuccessful cases (20.5% vs. 4.9%; p < 0.0001), but did not affect in-hospital MACE (3% vs. 2.1%; p = NS). All-cause mortality was 17.2% for uCTO and 4.5% for sCTO at 5 years (p < 0.0001). The need for CABG was reduced following sCTO (3.1% vs. 22.1%; p < 0.0001). Multivariate analysis demonstrated that procedural success was independently predictive of mortality (hazard ratio [HR]: 0.32 [95% confidence interval (CI): 0.18 to 0.58]), which persisted when incorporating a propensity score (HR: 0.28 [95% CI: 0.15 to 0.52]).
Conclusions
Successful CTO PCI is associated with improved survival out to 5 years. Adoption of techniques and technologies to improve procedural success may have an impact on prognosis.
This study sought to examine the efficacy and safety of 3 novel devices to recanalize coronary chronic total occlusions (CTOs).
Background
Successful percutaneous coronary intervention (PCI) of CTOs improves clinical outcome in appropriately selected patients. CTO PCI success, however, remains suboptimal.
Methods
A new crossing catheter and re-entry system was evaluated in a prospective, multicenter, single-arm trial of CTO lesions refractory to standard PCI techniques. The primary efficacy endpoint was the frequency of true lumen guidewire placement distal to the CTO (technical success).
Results
Enrollment included 147 patients with 150 CTOs. The mean lesion length was 41 ± 17 mm. A crossing catheter crossed 56 lesions into the distal true lumen, and a re-entry catheter facilitated tapered-wire cannulation of the distal lumen in 59 CTOs initially crossed subintimally (77% technical success). Success in the first 75 CTOs was 67%, rising to 87% in the last 75 CTOs. Mean fluoroscopy and procedure times were 45 ± 16 min and 90 ± 12 min, respectively, each significantly shorter than in historical controls (p < 0.0001 for both). Coronary perforation occurred in 14 cases (9.3%), requiring treatment in 3 cases (prolonged balloon inflation, with additional coil embolization in 1 case). No tamponade or hemodynamic instability occurred. Six patients had periprocedural non–ST-segment elevation myocardial infarction. No emergency surgery, ST-segment elevation myocardial infarction, or cardiac reintervention occurred. Two deaths occurred within 30 days, neither as a direct result of the procedure. The 30-day major adverse cardiac event rate was 4.8%.
Conclusions
In CTOs failing standard techniques, use of a new crossing and re-entry system results in a high success rate without increasing complications.
This study sought to compare increasing doses of intracoronary (IC) adenosine or IC sodium nitroprusside versus intravenous (IV) adenosine for fractional flow reserve (FFR) assessment.
Background
Maximal hyperemia is the critical prerequisite for FFR assessment. Despite IV adenosine currently representing the recommended approach, IC administration of adenosine or other coronary vasodilators constitutes a valuable alternative in everyday practice. However, it is surprisingly unclear which IC strategy allows the achievement of FFR values comparable to IV adenosine.
Methods
Fifty intermediate coronary stenoses (n = 45) undergoing FFR measurement were prospectively and consecutively enrolled. Hyperemia was sequentially induced by incremental boli of IC adenosine (ADN) (60 μg ADN60, 300 μg ADN300, 600 μg ADN600), by IC sodium nitroprusside (NTP) (0.6 μg/kg bolus) and by IV adenosine infusion (IVADN) (140 μg/kg/min). FFR values, symptoms, and development of atrioventricular block were recorded.
Results
Incremental doses of IC adenosine and NTP were well tolerated and associated with fewer symptoms than IVADN. Intracoronary adenosine doses (0.881 ± 0.067, 0.871 ± 0.068, and 0.868 ± 0.070 with ADN60, ADN300, and ADN600, respectively) and NTP (0.892 ± 0.072) induced a significant decrease of FFR compared with baseline levels (p < 0.001). Notably, ADN600 only was associated with FFR values similar to IVADN (0.867 ± 0.072, p = 0.28). Among the 10 patients with FFR values ≤0.80 with IVADN, 5 were correctly identified also by ADN60, 6 by ADN300, 7 by ADN600, and 6 by NTP.
Conclusions
Intracoronary adenosine, at doses higher than currently suggested, allows obtaining FFR values similar to IV adenosine. Intravenous adenosine, which remains the gold standard, might thus be reserved for those lesions with equivocal FFR values after high (up to 600 μg) IC adenosine doses.
This study sought to assess the relationship of coronary angiography, intravascular ultrasound (IVUS) and fractional flow reserve (FFR) between major epicardial vessel (MV) and side branch (SB) ostial lesions.
Background
Evaluation of ostial lesions is clinically very important. However, anatomical parameters have limitations in the prediction of the functional significance of coronary stenoses.
Methods
IVUS and FFR measurement were performed in 93 lesions (MV: 38, SB: 55). Optimal angiographic and IVUS criteria and their diagnostic accuracy for functionally significant stenoses (FFR ≤0.8) were assessed.
Results
In MV ostial lesions, FFR had correlation with angiographic percent diameter stenosis (r = –0.68, p < 0.001), minimum lumen area (MLA) by IVUS (r = 0.55, p < 0.001), percent plaque burden (r = –0.42, p = 0.011), and percent area stenosis (r = –0.49, p = 0.003). Meanwhile, FFR had no correlation with angiographic percent diameter stenosis (r = –0.067, p = 0.635) and weak correlation with MLA (r = 0.30, p = 0.026) in SB ostial lesions. In MV ostial lesions, best cutoff value of angiographic percent diameter stenosis, MLA, percent plaque burden, and percent area stenosis to determine the functional significance was 53%, 3.5 mm2, 70%, and 50%. However, a statistically significant cutoff value of percent diameter stenosis and MLA could not be found in SB ostial lesions.
Conclusions
The relations between angiographic/IVUS parameters and FFR were different between MV and SB ostial lesions. Angiographic and IVUS parameters had poor diagnostic accuracy in predicting the functional significance of SB ostial lesions. (Main Branch Versus Side Branch Ostial Lesion; NCT01335659)
This study was designed to assess the prevalence of provoked exercise desaturation (PED) in patients with patent foramen ovale (PFO) referred for cardiovascular evaluation and to evaluate the impact of PFO closure.
Background
Platypnea orthodeoxia syndrome is a rare, mechanistically obscure consequence of PFO that results in oxygen desaturation during postural changes. In our clinical experience, however, it is far less common than desaturation during exercise.
Methods
This was a single-center prospective study of 50 patients with newly diagnosed PFO. Each patient underwent standardized assessment for arterial oxygen saturation with pulse oximetry during postural changes and stair climbing exercise. Provoked exercise desaturation was defined as a desaturation of at least 8% from baseline to <90%. All patients who underwent closure were reevaluated 3 months after the procedure. Those with baseline PED were similarly reassessed for desaturation at follow-up.
Results
Mean age of the cohort was 46 ± 17 years, 74% were female, 30% had migraines, and 48% had experienced a cerebrovascular event. Seventeen patients (34%) demonstrated PED. Provoked exercise desaturation patients seemed demographically similar to non-PED patients. Ten PED patients underwent PFO closure (2 surgical, and 8 percutaneous). Drop in oxygen saturation was improved by an average of 10.1 ± 4.2% after closure (p < 0.001), and New York Heart Association functional class improved by a median of 1.5 classes (interquartile range: 0.75 to 2.00, p = 0.008).
Conclusions
One-third of patients referred for assessment of PFO experience oxygen desaturation during stair exercise. Closure of PFO seems to ameliorate this phenomenon and improve functional status.
The aim of this study was to analyze the risk factors and mid-term outcomes associated with post-procedure heart blocks (PPHBs) after transcatheter closure of perimembranous ventricular septal defect (pmVSD).
Background
The development of heart blocks remains a major challenge for transcatheter closure of pmVSD.
Methods
Transcatheter closure of pmVSD was carried out in 228 patients. Electrocardiography and 24-h Holter monitoring were performed before the procedure, within 1 week after the procedure, then 1, 3, 6, and 12 months, and every year thereafter.
Results
Thirty-three patients (14.5%) who received transcatheter closure of pmVSD developed PPHBs. PPHBs included right bundle branch block (57.6%), left bundle branch block (24.2%), and atrioventricular block (18.2%). High-degree atrioventricular blocks occurred in 4 patients and recovered to normal conduction after intravenous administration of hydrocortisone. PPHBs recovered to normal conduction in 21 patients by the time of hospital discharge. Compared with the patients without PPHBs, the patients suffering PPHBs were characterized by a significantly longer distance between the aortic valve and the defect (DAVD), a shorter distance from the lower rim of the defect to the septal leaflet of the tricuspid valve (DLRD-SLTV), and a larger diameter difference between the occluder and ventricular septal defect (DDOV). The earlier the PPHBs developed after the procedure, the more difficult the recovery to normal conduction.
Conclusions
The outcome of PPHBs after transcatheter closure of pmVSD was satisfactory, as most patients recovered to normal conduction. Measurements of DLRD-SLTV, DAVD, and DDOV may be useful in predicting the incidence of PPHBs.
The goal of this study was to describe the neointimal healing on the abluminal side (ABL) of malapposed (ISA) struts and nonapposed side-branch (NASB) struts in terms of coverage by optical coherence tomography (OCT) and in comparison with the adluminal side (ADL).
Background
The neointimal healing on the ABL of ISA and NASB struts has never to our knowledge been explored in vivo and could be involved in the correction of acute malapposition. The bioresorbable vascular scaffold (BVS) is made of a translucent polymer that enables imaging of the ABL with OCT.
Methods
Patients enrolled in the ABSORB B (ABSORB Clinical Investigation Cohort B) study were treated with implantation of a BVS and imaged with OCT at 6 months. Thickness of coverage on the ADL and ABL of ISA and NASB struts was measured by OCT.
Results
Twenty-eight patients were analyzed; 114 (2.4%) struts were malapposed or at side branches. In 76 ISA struts (89.4%) and 29 NASB struts (100%), the thickness of ABL coverage was >30 μm. Coverage was thicker on the ABL than on the ADL side (101 vs. 71 μm; 95% confidence interval [CI] of the difference: 20 to 40 μm). In 70 struts (60.7%, 95% CI: 50.6% to 70.0%), the neointimal coverage was thicker on the ABL, versus only 20 struts (18.5%, 95% CI: 11.6% to 28.1%) with thicker neointimal coverage on the ADL side (odds ratio: 3.35, 95% CI: 2.22 to 5.07).
Conclusions
Most of the malapposed and side-branch struts are covered on the ABL side 6 months after BVS implantation, with thicker neointimal coverage than on the ADL side. The physiological correction of acute malapposition involves neointimal growth from the strut to the vessel wall or bidirectional.
(ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856)
The current study sought to examine inflammation at the stented segments of Nobori (Terumo Corporation, Tokyo, Japan) and Cypher (Cordis, Miami, Florida) drug-eluting stents (DES), as well as free radical production and endothelial function of the adjacent nonstented segments in a pig coronary model.
Background
Nobori is a novel DES, incorporating a biolimus A9-eluting biodegradable polymer coated only on the abluminal surface of the stent. These unique features may favorably affect inflammation and endothelial function, as compared to the currently marketed DES. Presently, pre-clinical data on direct comparison of the various generations of DES are not available.
Methods
A total of 18 DES were implanted in pig coronary arteries and subsequently explanted at 1 month. Stented segments were assessed by angiography and histology. Ex vivo vasomotor function and superoxide production in segments proximal and distal to the stent were determined. The vasoconstriction, endothelial-dependent relaxation, and endothelial-independent relaxation of proximal and distal nonstented segments were measured.
Results
Histological evaluation revealed lower inflammatory response with Nobori than with Cypher DES. There is trend for lower angiographic percentage diameter stenosis in Nobori versus Cypher groups (p = 0.054). There was increased endothelium-dependent relaxation, decreased endothelin-1–mediated contraction, and less superoxide production in the vessel segments proximal and distal to Nobori versus Cypher stents.
Conclusions
Our data show significantly lower inflammatory response in the stented segments, and rapid recovery of endothelial function of peristent segments in the Nobori group compared with Cypher DES group at 1 month in porcine coronary artery model.
This study sought to determine the efficacy of patient pelvic lead shielding for the reduction of operator radiation exposure during cardiac catheterization via the radial access in comparison with the femoral access.
Background
Cardiac catheterization via the radial access is associated with significantly increased radiation dose to the patient and the operator. Improvements in radiation protection are needed to minimize this drawback. Pelvic lead shielding has the potential to reduce operator radiation dose.
Methods
We randomly assigned 210 patients undergoing elective coronary angiography by the same operator to a radial and femoral access with and without pelvic lead shielding of the patient. Operator radiation dose was measured by a radiation dosimeter attached to the outside breast pocket of the lead apron.
Results
For radial access, operator dose decreased from 20.9 ± 13.8 μSv to 9.0 ± 5.4 μSv, p < 0.0001 with pelvic lead shielding. For femoral access, it decreased from 15.3 ± 10.4 μSv to 2.9 ± 2.7 μSv, p < 0.0001. Pelvic lead shielding significantly decreased the dose-area product–normalized operator dose (operator dose divided by the dose-area product) by the same amount for radial and femoral access (0.94 ± 0.28 to 0.39 ± 0.19 μSv x Gy–1 x cm–2 and 0.70 ± 0.26 to 0.16 ± 0.13 μSv x Gy–1 x cm–2, respectively).
Conclusions
Pelvic lead shielding is highly effective in reducing operator radiation exposure for radial as well as femoral procedures. However, despite its use, radial access remains associated with a higher operator radiation dose.
Coronary chronic total occlusions (CTOs) are frequently identified during coronary angiography and remain the most challenging lesion group to treat. Patients with CTOs are frequently left unrevascularized due to perceptions of high failure rates and technical complexity even if they have symptoms of coronary disease or ischemia. In this review, the authors describe a North American contemporary approach for percutaneous coronary interventions for CTO. Two guide catheters are placed to facilitate seamless transition between antegrade wire–based, antegrade dissection re-entry–based, and retrograde (wire or dissection re-entry) techniques, the "hybrid" interventional strategy. After dual coronary injection is performed, 4 angiographic parameters are assessed: 1) clear understanding of location of the proximal cap using angiography or intravascular ultrasonography; 2) lesion length; 3) presence of branches, as well as size and quality of the target vessel at the distal cap; and 4) suitability of collaterals for retrograde techniques. On the basis of these 4 characteristics, an initial strategy and rank order hierarchy for technical approaches is established. Radiation exposure, contrast utilization, and procedure time are monitored throughout the procedure, and thresholds are established for intraprocedural strategy conversion to maximize safety, efficiency, and effectiveness.
This study compared the prognostic role of high on-treatment platelet reactivity (HTPR) in predicting thrombotic events in a Korean population undergoing percutaneous coronary intervention (PCI) in the acute myocardial infarction (AMI) and non-AMI setting.
Background
The prognostic significance and optimal cutoff of HTPR might differ according to a given clinical condition, such as AMI and ethnicity.
Methods
On-treatment platelet reactivity was measured with a VerifyNow P2Y12 assay (Accumetrics, San Diego, California) in 1,226 patients (824 men; age 65 ± 10 years), including 413 AMI cases, 12 to 24 h after PCI between March 2008 and March 2010. The prevalence of cardiovascular (CV) events defined as a composite of death from CV causes, nonfatal myocardial infarction, or stent thrombosis at 1-year follow-up were compared according to HTPR between patients with and without AMI.
Results
The optimal cutoff for HTPR was 272 IU of the P2Y12 reaction unit (PRU) (area under the curve: 0.708; 95% confidence interval [CI]: 0.607 to 0.809, p = 0.03), which was the upper-tertile threshold. Among AMI patients, 1-year CV events occurred more frequently in patients with versus without HTPR (n = 14 [8.8%] vs. n = 1 [0.4%], p < 0.001), whereas there was no difference in the composite endpoint on the basis of HTPR in patients without AMI (n = 7 [2.8%] vs. n = 8 [1.4%], p = 0.193).
Conclusions
Increased residual platelet reactivity is related to post-discharge CV events in subjects with AMI, whereas the prognostic significance of HTPR seems to be attenuated in patients with stable coronary disease after PCI.
The authors sought to compare the effect on inhibition of platelet aggregation (IPA) of prasugrel therapy versus tirofiban bolus with or without a post-bolus short drug infusion in ST-segment elevation myocardial infarction (STEMI) patients.
Background
The degree and rapidity of IPA after prasugrel alone with or without concomitant glycoprotein IIb/IIIa inhibition in STEMI patients is unknown.
Methods
A total of 100 STEMI patients randomly received prasugrel 60 mg versus 25 μg/kg tirofiban bolus with or without post-bolus 2-h infusion of tirofiban, with or without concomitant prasugrel. IPA at light transmission aggregometry was performed throughout 24 h. The primary endpoint was IPA stimulated with 20 μmol/l adenosine diphosphate (ADP) at 30 min.
Results
At 30 min, patients in the prasugrel group showed a significantly lower IPA to 20 μmol/l ADP stimulation as compared with tirofiban-treated patients (36 ± 35 vs. 87 ± 31, p < 0.0001). Similarly, patients taking prasugrel showed a suboptimal degree of platelet inhibition for at least 2 h compared with tirofiban patients. Post-bolus tirofiban infusion was necessary to maintain a high level of IPA beyond 1 h after bolus administration if concomitant clopidogrel was given, whereas the bolus-only tirofiban and concomitant prasugrel led to the higher and more consistent IPA levels after both ADP and thrombin receptor-activating peptide stimuli than either therapy alone.
Conclusions
Our study shows that prasugrel administration leads to a suboptimal IPA for at least 2 h in STEMI patients. Yet, prasugrel, given in association with a bolus only of glycoprotein IIb/IIIa inhibitor, obviates the need of post-bolus infusion and almost completely abolishes residual variability of IPA after treatment. (Facilitation through Aggrastat By drOpping or shortening Infusion Line in patients with ST-segment elevation myocardial infarction compared to or on top of PRasugrel given at loading dOse [The FABOLUS PRO trial]; NCT01336348)
This study sought to validate the ability of the VerifyNow P2Y12 assay (Accumetrics, San Diego, California) in predicting both ischemic and bleeding events after elective percutaneous coronary intervention (PCI).
Background
High and low levels of platelet reactivity are associated with ischemic and bleeding events, respectively, after PCI.
Methods
A total of 732 patients on dual antiplatelet therapy undergoing elective PCI were recruited. Platelet reactivity was measured before PCI. The primary endpoint was the 30-day incidence of net adverse clinical events (NACE), defined as the occurrence of ischemic or bleeding events, in relation to P2Y12 reaction unit (PRU) distribution.
Results
At receiver-operating characteristic curve analysis, PRU values could significantly discriminate between patients with and without bleeding events (area under the curve [AUC]: 0.72; 95% confidence interval [CI]: 0.65 to 0.80; p < 0.0001) and those with and without ischemic events (AUC: 0.68; 95% CI: 0.61 to 0.76; p < 0.0001). The optimal cutoffs for bleeding (PRU ≤178) and ischemic events (PRU ≥239) were used to define 3 groups: low platelet reactivity (LPR) (LPR = PRU ≤178), normal platelet reactivity (NPR) (NPR = PRU 179 to 238), and high platelet reactivity (HPR) (HPR = PRU ≥239). The incidence of NACE was 14.1% in the LPR group, 7.8% in the NPR group (p = 0.025 vs. LPR group), and 15.4% in the HPR group (p = 0.005 vs. NPR group). At multivariate analysis, PRU values in the NPR group were an independent predictor of reduced risk of 30-day NACE (odds ratio: 0.47, 95% CI: 0.27 to 0.81).
Conclusions
A therapeutic window for platelet reactivity measured with the VerifyNow P2Y12 assay can be identified using specific thresholds that define a group of patients at lower risk for both ischemic and bleeding events. Adjunctive measures may be beneficial in patients with higher or lower platelet reactivity in order to improve clinical outcomes after PCI.
This study sought to assess the presence of a dose-response effect of cigarette smoking and its impact on high on-treatment platelet reactivity (HPR) in patients with diabetes mellitus treated with clopidogrel.
Background
Cigarette smoking is an inducer of cytochrome P450 1A2, a hepatic enzyme involved in clopidogrel metabolism. If cigarette smoking is associated with a dose-response effect on pharmacodynamic measures in clopidogrel-treated patients is unknown.
Methods
A total of 134 type 2 diabetes mellitus patients on maintenance aspirin and clopidogrel therapy were studied. Patients were divided into 3 groups according to cotinine levels: <3 ng/ml (nonsmokers), 3 to 199 ng/ml (light smokers), and ≥200 ng/ml (heavy smokers). Platelet function was assessed by light transmittance aggregometry, VerifyNow P2Y12 assay (Accumetrics, San Diego, California), and vasodilator-stimulated phosphoprotein. Rates of HPR were defined using established cutoff values.
Results
A dose-response effect was observed for all pharmacodynamic parameters tested. Serum cotinine levels were inversely associated with platelet reactivity as assessed by light transmittance aggregometry using 5 and 20 μmol/l adenosine diphosphate (p < 0.0001 for all). Accordingly, platelet disaggregation increased with levels of serum cotinine (p < 0.0001). Similar results were found with P2Y12 reaction units (p < 0.0001) and inhibition of platelet aggregation (p = 0.005) as defined by VerifyNow P2Y12 testing, and platelet reactivity index (p = 0.002) as assessed by vasodilator-stimulated phosphoprotein. Higher serum cotinine levels were significantly associated with lower rates of HPR, as defined according to various pharmacodynamic cutoff measures.
Conclusions
Cigarette smoking is associated with a dose-response effect on clopidogrel-induced antiplatelet effects and lower rates of HPR in diabetes mellitus patients.
The goal of this study was to investigate sex-based differences in long-term clinical and angiographic outcomes after coronary revascularization with drug-eluting stents (DES).
Background
The impact of sex on clinical and angiographic outcomes following revascularization with DES is not well established.
Methods
Individual patient data from 3 all-comers randomized DES trials (SIRTAX, LEADERS, RESOLUTE All-Comers) were pooled. Of 5,011 patients, 4,885 (97.5%) completed 2-year follow-up (1,164 women, 3,721 men). Protocol-mandated angiographic follow-up was available for 1,561 lesions (351 among women, 1,210 among men). The primary endpoint was the composite of cardiac death and myocardial infarction (MI) at 2 years.
Results
At baseline, women, as compared with men, were older, more frequently had diabetes, obesity, and hypertension, less frequently had smoking habits, previous MI, and previous surgical revascularization, and had a smaller reference diameter of the target vessel as well as a lower SYNTAX score. After adjustment for baseline differences, women and men had a similar risk of cardiac death or MI (odds ratio [OR]: 1.13, 95% confidence interval [CI]: 0.82 to 1.56, p = 0.44), cardiac death (OR: 1.04, 95% CI: 0.61 to 1.80, p = 0.87), and MI (OR: 1.07, 95% CI: 0.75 to 1.53, p = 0.71) at 2 years. Similarly, risks of target lesion revascularization (OR: 1.09, 95% CI: 0.77 to 1.54, p = 0.62), target vessel revascularization (OR: 0.88, 95% CI: 0.63 to 1.22, p = 0.43), and definite or probable stent thrombosis (OR: 0.73, 95% CI: 0.38 to 1.38, p = 0.33) were comparable for women and men. Follow-up angiography showed no differences in terms of in-stent late loss (0.18 ± 0.54 mm vs. 0.20 ± 0.99 mm, p = 0.76) and in-segment binary restenosis (8.5% vs. 8.5%, p = 0.76).
Conclusions
The unrestricted use of DES is associated with similar long-term safety and efficacy among women and men with coronary artery disease.
The goal of this study was to demonstrate superiority of sirolimus-eluting stents (SES) over bare-metal stents (BMS) and of abciximab over no abciximab in primary percutaneous coronary intervention (PCI).
Background
Drug-eluting stents (DES) are increasingly used in primary PCI, but the recommendations for use in primary PCI are based on a few randomized controlled trials with selected patients. The usefulness of abciximab in primary PCI is not established.
Methods
Nine hundred seven patients referred to the Catharina Hospital were randomized to SES or BMS, and to abciximab or no abciximab in a prospective, randomized, open 2 x 2 factorial trial with blinded evaluation. Primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), defined as the composite of death, myocardial infarction (MI), stroke, repeat revascularization, and bleeding at 1 year (stent arm) and the composite of death, target vessel MI, target vessel revascularization (TVR), and bleeding at 30 days (abciximab arm).
Results
At 1 year, the rate of MACCE was lower in the SES arm (16.5% vs. 25.8%, p = 0.001), mainly driven by less repeat revascularization (9.8% vs. 16.8%; p = 0.003) and without influencing the cumulative incidence of death and MI (5.2% vs. 5.8%; p = 0.68). At 30 days, the rate of the composite of death, target vessel MI, TVR, and bleeding was lower in the abciximab arm (8.2% vs. 12.4%, p = 0.04), mainly driven by less TVR due to less stent thrombosis (1.2% vs.7.4%, p < 0.001). However, bleeding complications occurred more frequently in the abciximab group (5.7% vs. 2.8%, p = 0.03).
Conclusions
Primary PCI with SES reduces adverse events at 1 year, mainly by reduction of repeat revascularization, whereas abciximab reduces early stent thrombosis, at the expense of more bleeding complications. (Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction [DEBATER]; NCT00986050)
This study presents long-term clinical follow-up, including binary restenosis rate and major adverse cardiovascular events, of the PACCOCATH-ISR (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons) I and II trial.
Background
The PACCOCATH-ISR trial was a first-in-human study with a drug-coated balloon catheter and the first study for the treatment of coronary ISR with a drug-coated balloon. So, far no long-term follow-up data have been presented.
Methods
This study enrolled 108 patients in a randomized, double-blinded multicenter trial on the efficacy and safety of a paclitaxel-coated balloon (3 μg/mm2 balloon surface; PACCOCATH [Bayer AG, Germany]) compared with an uncoated balloon. The main inclusion criteria were a diameter stenosis of ≥70% and <30-mm length with a vessel diameter of 2.5 to 3.5 mm. The primary endpoint was angiographic late lumen loss in-segment after 6 months. Combined antiplatelet therapy was continued only for 1 month followed by treatment with aspirin alone.
Results
During a follow-up of 5.4 ± 1.2 years, the clinical event rate was significantly reduced in patients treated with the drug-coated balloon (major adverse cardiovascular events: 59.3% vs. 27.8%, p = 0.009), which was mainly driven by the reduction of target lesion revascularization from 38.9% to 9.3% (p = 0.004).
This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease.
Background
Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described.
Methods
This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed.
Results
The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up.
Conclusions
PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization.
This study reports the results of a series of transapical mitral valve-in-valve implantations and aims to offer guidance on technical aspects of the procedure.
Background
Mitral valve reoperations due to failing bioprostheses are associated with high morbidity and mortality. Transcatheter techniques may evolve as complementary approaches to surgery in these high-risk patients.
Methods
Six patients (age 75 ± 15 years) received transapical implantation of a balloon-expandable pericardial heart valve into a degenerated bioprosthesis (range 27 to 31 mm) in mitral position at our institution. All patients were considered high risk for surgical valve replacement (logistic EuroSCORE: 33 ± 15%) after evaluation by an interdisciplinary heart team. Procedural and clinical outcomes were analyzed.
Results
Implantation was successful in all patients with reduction of mean transvalvular gradients from 11.3 ± 5.2 mm Hg to 5.5 ± 3.6 mm Hg (p = 0.016) and median regurgitation from grade 3.0 (interquartile range [IQR]: 2.7 to 3.1) to 0 (IQR: 0 to 1.0, p = 0.033) with trace paravalvular regurgitation remaining in 2 patients. Apical bleeding occurred in 2 patients requiring rethoracotomy in 1 and resuscitation in a second patient, the latter of whom died on postoperative day 6. In the remaining patients, median New York Heart Association functional class improved from 3.0 (IQR: 3.0 to 3.5) to 2.0 (IQR: 1.5 to 2.0, p = 0.048) over a median follow-up of 70 (IQR: 25.5 to 358) days.
Conclusions
With acceptable results in a high-risk population, transapical mitral valve-in-valve implantation can be considered as a complementary approach to reoperative mitral valve surgery in select patients.
This study aims to report a "real-world" experience of in hospital complications and clinical outcome of a large cohort of consecutive patients who underwent percutaneous coronary intervention (PCI) with intra-aortic balloon pump counterpulsation (IABP) support, from a tertiary care center over a 12-year period.
Background
The incidence of vascular complications in patients treated with PCI and IABP is expected to be higher due to simultaneous puncture of femoral arteries, larger IABP sheath size, and longer duration of IABP therapy.
Methods
A total of 360 consecutive patients (mean age of 65.9 ± 11.2 years; 80.6% male) who required an IABP support during percutaneous PCI were classified into 3 groups: Urgent: 133 patients (36.9%) admitted with acute coronary syndrome in whom IABP therapy was started before urgent PCI; Emergent: 56 patients (15.6%) in whom emergent IABP insertion was required to manage hypotension during PCI; and Elective: 171 patients (47.5%) with stable angina pectoris in whom IABP was inserted before elective PCI. Overall bleeding was defined according to the newest the Bleeding Academic Research Consortium (BARC) definition criteria.
Results
BARC bleeding occurred in 68 patients (19%), with the highest incidence noted in the Urgent group (31.1%), in comparison with the Emergent (26.8%) and Elective (7%) groups, p < 0.0001. Bleeding related to the IABP access site was 7.5%, which accounted for 82% of any access site–related bleeding. It was significantly higher in the Urgent group (12.8%) compared with the Elective (4.1%) and Emergent (5.4%) groups. At multivariate analysis, IABP treatment duration and renal impairment were the only independent predictors of BARC bleeding.
Conclusions
Bleeding related to the IABP access site was significantly higher in the Urgent group and accounted for more than two-thirds of overall access site–related bleeding. IABP treatment duration and renal impairment were independent predictors of overall bleeding.
Systemic hypertension is a major burden to the individual and society. Its association with major adverse cardiac and cerebral events and favorable effects of antihypertensive therapy are undisputed. However, despite multidrug therapy, blood pressures are frequently suboptimally controlled. Moreover, adverse drug effects often interfere with patients' lifestyles and affect compliance. Therefore, alternative treatment strategies have been explored. Most recently, attention has been redirected to the sympathetic nervous system (SNS) in the pathogenesis of hypertension. In addition, interruption of the renal SNS in humans with resistant hypertension has been studied with promising results. The following review provides an overview of the anatomy and physiology of the renal SNS, the rational for manipulating the SNS, and the results of therapeutic renal sympathetic denervation.
Paravalvular regurgitation affects 5% to 17% of all surgically implanted prosthetic heart valves. Patients who have paravalvular regurgitation can be asymptomatic or present with hemolysis or heart failure, or both. Reoperation is associated with increased morbidity and is not always successful because of underlying tissue friability, inflammation, or calcification. Comprehensive echocardiographic imaging with transthoracic and real-time 3-dimensional transesophageal echocardiography is key for characterizing the defect location, size, and shape. For paramitral defects, an antegrade transseptal approach can usually be guided by biplane fluoroscopy, and real-time 3-dimensional transesophageal echocardiography can usually be performed successfully. Alternative approaches to paramitral defects include retrograde transaortic cannulation or transapical access and retrograde cannulation. For oblong or crescentic defects, the simultaneous or sequential deployment of 2 smaller devices, as opposed to 1 large device, results in a higher degree of procedural success and safety because the risk of impingement on the prosthetic leaflets is minimized. Most para-aortic defects can be approached in a retrograde manner and closed with a single device. With careful anatomical assessment, procedural planning, and procedural execution, successful closure rates of 90% or more should be attainable with a low risk of device impingement on the prosthetic valve or embolization.
The aim of this study was to describe differences in treatment and in-hospital mortality of early, late, and very late stent thrombosis (ST).
Background
Early, late, and very late ST may differ in clinical presentation, management, and in-hospital outcomes.
Methods
We analyzed definite (angiographically documented) ST cases identified from February 2009 to June 2010 in the CathPCI Registry. We stratified events by timing of presentation: early (≤1 month), late (1 to 12 months), or very late (≥12 months) following stent implantation. Multivariable logistic regression modeling was performed to compare in-hospital mortality for each type of ST after adjusting for baseline comorbidities.
Results
During the study period, 7,315 ST events were identified in 7,079 of 401,662 patients (1.8%) presenting with acute coronary syndromes. This ST cohort consisted of 1,391 patients with early ST (19.6%), 1,370 with late ST (19.4%), and 4,318 with very late ST (61.0%). Subjects with early ST had a higher prevalence of black race and diabetes, whereas subjects with very late ST had a higher prevalence of white race and a lower prevalence of prior myocardial infarction or diabetes. In-hospital mortality was significantly higher in early ST (7.9%) compared with late (3.8%) and very late ST (3.6%, p < 0.001). This lower mortality for late and very late ST persisted after multivariable adjustment (odds ratio: 0.53 [95% confidence interval (CI): 0.36 to 0.79] and 0.58 [95% CI: 0.43 to 0.79], respectively).
Conclusions
Significant differences exist in the presentation and outcomes of early, late, and very late ST. Among patients with acute coronary syndromes who are undergoing percutaneous coronary intervention for angiographically documented ST, early ST is associated with the highest in-hospital mortality.
The goal of this study was to compare the long-term clinical outcome between everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) in patients with acute coronary syndromes (ACS).
Background
EES have not been directly compared with SES in ACS patients to date.
Methods
Between 2004 and 2009, 1,746 consecutive ACS patients (ST-segment elevation ACS [STE-ACS]: 33.5%; non–ST-segment elevation ACS [NSTE-ACS]: 66.5%) were treated with EES (n = 903) or SES (n = 843). Using propensity score matching, clinical outcome was compared among 705 matched pairs of ACS patients treated with EES and SES.
Results
Through 3 years, the primary endpoint—the composite of death, myocardial infarction (MI), and target vessel revascularization (TVR)—occurred in 13.8% of EES- and 17.7% of SES-treated ACS patients (hazard ratio [HR]: 0.72, 95% confidence interval [CI]: 0.54 to 0.95, p = 0.02). The difference in favor of EES was driven by a lower risk of TVR (5.7% vs. 8.8%, HR: 0.65, 95% CI: 0.43 to 0.98, p = 0.04) and a trend toward a lower risk of MI (2.1% vs. 3.3%, HR: 0.56, 95% CI: 0.29 to 1.12, p = 0.10). The risk of death (7.2% vs. 8.8%, HR: 0.75, 95% CI: 0.50 to 1.10, p = 0.14) showed no difference between EES and SES. The treatment effect in favor of EES for the primary endpoint was similar for patients with STE-ACS (16.4% vs. 18.5%, HR: 0.80, 95% CI: 0.50 to 1.27) and NSTE-ACS (12.4% vs. 17.3%; HR: 0.67, 95% CI: 0.47 to 0.96; pfor interaction = 0.56) and across major subgroups. Definite (0.4% vs. 1.8%, p = 0.03), and definite or probable stent thrombosis (3.4% vs. 6.1%, p = 0.02) were less frequent among EES- than SES-treated ACS patients.
Conclusions
Among patients with ACS, the unrestricted use of EES is associated with improved clinical outcome compared with SES during long-term follow-up to 3 years. Notably, the risk of stent thrombosis was lower among EES-treated ACS patients.
This study was designed to assess the functional significance of side branches after stent implantation in main vessels using fractional flow reserve (FFR).
Background
Little is known about the functional significance of side branches after stent implantation in main vessels in coronary bifurcation lesions.
Methods
Between May 2007 and January 2011, 230 side branches in 230 patients after stent implantation in main vessels were assessed by FFR and were consecutively enrolled.
Results
Median FFR at the side branch was 0.91 (interquartile range: 0.85 to 0.95). There was a negative correlation between the diameter stenosis (DS) by quantitative coronary angiography (QCA) and FFR of side branch (r = –0.21, p = 0.002), but only 41 (17.8%) side branches were functionally significant after stent implantation in the main vessel. Among 67 side branches with >50% DS by QCA, 19 (28.4%) had FFR ≤0.80, and among 163 side branches with ≤50% DS by QCA, 22 (13.5%) had FFR ≤0.80 after stent implantation in main vessels. On the basis of receiver-operating characteristic curves, the optimal cutoff value of DS by QCA of the side branch was 54.9%, and the area under the curve was 0.64 (95% confidence interval [CI]: 0.58 to 0.71, p < 0.001) with a 41.5% sensitivity, an 83.1% specificity, a 34.7% positive predictive value, an 86.3% negative predictive value, and a 75.7% accuracy. Multivariate binary logistic regression analysis identified DS by QCA (odds ratio [OR]: 1.04, 95% CI: 1.02 to 1.06, p = 0.001) and reference vessel diameter (OR: 0.28, 95% CI: 0.10 to 0.77, p = 0.014) before stent implantation as independent predictors of the side branches with FFR ≤0.80 after stent implantation.
Conclusions
Most side branch lesions do not have functional significance after stent implantation in the main vessel, and quantitative coronary angiography is unreliable in assessing the functional severity of these lesions.
The aim of this study was to compare clinical outcomes among unselected patients stratified in categories of body mass index, who underwent percutaneous coronary intervention (PCI) with either sirolimus-eluting or paclitaxel-eluting stents.
Background
Overweight and obesity are often considered risk factors for cardiovascular events. However, recent studies have associated obesity with better outcomes after PCI with bare-metal stents. Data from routine clinical practice using drug-eluting stents (DES) focusing on this "obesity paradox" are not available.
Methods
We used data from DES.DE (German Drug-Eluting Stent) registry to compare in-hospital and 1-year outcomes among unselected patients undergoing PCI with DES implantation. Primary endpoints were the rate of major adverse cardiac and cerebrovascular events (MACCE) (defined as the composite of death, myocardial infarction, and stroke) and target vessel revascularization (TVR).
Results
Between October 2005 and 2006, 1,436 normal weight, 2,839 overweight, and 1,531 obese patients treated with DES were enrolled at 98 sites. Baseline clinical parameters were more severe in overweight and obese patients; 1-year follow-up comparison between groups revealed similar rates of all-cause death (3.3% vs. 2.4% vs. 2.4%; p = 0.17), MACCE (7.1% vs. 5.6% vs. 5.5%; p = 0.09), and TVR in survivors (10.9% vs. 11.7% vs. 11.6%; p = 0.56) in normal weight individuals compared with overweight or obese patients. Such results persisted after risk-adjustment for heterogeneous baseline characteristics of groups and were independent of the types of DES.
Conclusions
DES.DE revealed no evidence of "obesity paradox" in a routine clinical practice using DES.
This study sought to assess the vascular function in patients with chronic total coronary occlusions (CTO) immediately after successful percutaneous recanalization and its relation with the pre-existing collateral circulation.
Background
CTOs represent a long-acting occlusion of a coronary vessel, in which the progressively developed collateral circulation may limit ischemia and symptoms. However, it is unknown if the coronary segment distal to the occlusion has a preserved vascular function.
Methods
We prospectively enrolled 19 consecutive patients, after percutaneous coronary intervention of a CTO. Luminal diameter, measured by quantitative coronary angiography, and coronary blood flow at level of epicardial coronary artery distal to the treated CTO was assessed before and after administration of acetylcholine (Ach), adenosine, and nitroglycerin (NTG). Collaterals were assessed angiographically by grading of Rentrop and of collateral connections (CC1: threadlike continuous connection; CC2: side branch–like connection).
Results
Overall, Ach and adenosine caused coronary artery vasoconstriction (p = 0.001 and p = 0.004, respectively), whereas NTG failed to induce vasodilation (p = 0.084). Coronary blood flow significantly decreased with Ach (p = 0.005), significantly increased with NTG (p = 0.035), and did not change with adenosine (p = 0.470). Patients with CC2 collaterals (n = 8) had less vasoconstriction response and reduction in coronary blood flow after Ach (p = 0.005 and p = 0.008, respectively), and better vasomotor response to NTG (p = 0.029) than patients with CC1 collaterals (n = 11).
Conclusions
Significant endothelial and smooth muscle dysfunction is present in the distal segments of successfully recanalized CTOs, and that seems to be more pronounced in the presence of a low grading of collateral circulation.
The aim of this prospective, randomized study was to evaluate the effects of telmisartan, compared with the calcium-channel blocker amlodipine, on endothelial function after coronary drug-eluting stent (DES) implantation in hypertensive patients.
Background
DES implantation impairs local endothelial function, which may be associated with future cardiovascular events. Telmisartan, which has unique peroxisome proliferator-activated-receptor-gamma–mediated effects in addition to its renin-angiotensin system–inhibition effects, has favorable effects on endothelial function.
Methods
Fifty-one hypertensive patients with coronary artery stenosis but without coronary artery spasm, treated with a sirolimus-eluting stent, were randomly assigned to either the telmisartan (25 cases) or amlodipine (26 cases) treatment groups. At baseline and at 3 months after DES implantation, endothelium-dependent and -independent vasomotion were evaluated by quantitative coronary angiography under the condition of medication withdrawal. The mean luminal diameter of a 20-mm coronary segment, beginning 5 mm distal to the stent, was measured before and after infusion of intracoronary acetylcholine (10–7, 10–6 mol/l) and then again after infusion of nitroglycerin.
Results
Blood pressure was comparable between groups at baseline and after 3 months. Vasoconstriction after acetylcholine infusion at 3 months (impaired endothelial function) was less pronounced in the telmisartan group than in the amlodipine group (p < 0.0001), although there was no significant difference between the 2 groups before DES implantation. The response to nitroglycerin did not differ between groups before or at 3 months after DES implantation.
Conclusions
Telmisartan, compared with amlodipine, significantly ameliorated endothelial dysfunction after DES implantation in terms of vasoconstriction induced by acetylcholine.
This study sought to investigate long-term outcomes after early or delayed angiography in patients with non–ST-segment elevation acute coronary syndrome (nSTE-ACS) undergoing a routine invasive management.
Background
The optimal timing of angiography in patients with nSTE-ACS is currently a topic for debate.
Methods
Long-term follow-up after early (within 2 days) angiography versus delayed (within 3 to 5 days) angiography was investigated in the FRISC-II (Fragmin and Fast Revascularization During Instability in Coronary Artery Disease), ICTUS (Invasive Versus Conservative Treatment in Unstable Coronary Syndromes), and RITA-3 (Intervention Versus Conservative Treatment Strategy in Patients With Unstable Angina or Non-ST Elevation Myocardial Infarction) (FIR) nSTE-ACS patient-pooled database. The main outcome was cardiovascular death or myocardial infarction up to 5-year follow-up. Hazard ratios (HR) were calculated with Cox regression models. Adjustments were made for the FIR risk score, study, and the propensity of receiving early angiography using inverse probability weighting.
Results
Of 2,721 patients originally randomized to the routine invasive arm, consisting of routine angiography and subsequent revascularization if suitable, 975 underwent early angiography and 1,141 delayed angiography. No difference was observed in 5-year cardiovascular death or myocardial infarction in unadjusted (HR: 1.06, 95% confidence interval [CI]: 0.79 to 1.42, p = 0.61) and adjusted (HR: 0.93, 95% CI: 0.75 to 1.16, p = 0.54) Cox regression models.
This study sought to determine whether procedural factors during percutaneous coronary intervention (PCI) are associated with the occurrence of ischemic stroke or transient ischemic attack (PCI-stroke).
Background
Stroke is a devastating complication of PCI. Demographic predictors are nonmodifiable. Whether PCI-stroke is associated with procedural factors, which may be modifiable, is unknown.
Methods
We performed a single-center retrospective study of 21,497 PCI hospitalizations between 1994 and 2008. We compared procedural factors from patients who suffered an ischemic stroke or transient ischemic attack related to PCI (n = 79) and a control group (n = 158), and matched them 2:1 based on a predicted probability of stroke developed from a logistic regression model.
Results
PCI-stroke procedures involved the use of more catheters (median: 3 [quarter (Q) 1, Q3: 3, 4] vs. 3 [Q1, Q3: 2, 3], p < 0.001), greater contrast volumes (250 ml vs. 218 ml, p = 0.006), and larger guide caliber (median: 7-F [Q1, Q3: 6, 8] vs. 6-F [Q1, Q3: 6, 8], p < 0.001). The number of lesions attempted (1.7 ± 0.8 vs. 1.5 ± 0.8, p = 0.14) and stents placed (1.4 ± 1.2 vs. 1.2 ± 1.1, p = 0.35) were similar between groups, but PCI-stroke patients were more likely to have undergone rotational atherectomy (10% vs. 3%, p = 0.029). Overall procedural success was lower in the PCI-stroke group compared with controls (71% vs. 85%, p = 0.017). Evaluation of the entire PCI population revealed no difference in the rate of PCI-stroke between radial and femoral approaches (0.4% vs. 0.4%, p = 0.78).
Conclusions
Ischemic stroke related to PCI is associated with potentially modifiable technical parameters. Careful procedural planning is warranted, particularly in patients at increased risk.
The purpose of this study was to evaluate the incidence of vascular complications and the predictors of Prostar failure for a "true percutaneous approach" in transfemoral transcatheter aortic valve implantation (TAVI).
Background
Safety and efficacy of a true percutaneous approach in transfemoral-TAVI has not been described in a large prospective cohort.
Methods
Among 264 patients included in our prospective TAVI database (October 2006 to December 2010), transfemoral-TAVI was performed in 170 patients. True percutaneous approach was performed in 142 consecutive patients since March 2008. Successful closure with Prostar was defined as adequate hemostasis without Prostar-related vascular complications. We compared the incidence of vascular complications in our early and late experience.
Results
Patients were 83.0 ± 7.2 years old and with a EuroSCORE of 24.0 ± 11.6%. The Edwards valve (Edwards Lifesciences, Irvine, California) (18- to 24-F) was used in 109 cases and the CoreValve (Medtronic, Minneapolis, Minnesota) (18-F) in 31. The sheath outer diameter to minimal femoral diameter ratio (SFAR) was 0.96 ± 0.14. Successful closure was achieved in 90.7%, and was significantly increased (95.7% vs. 85.7%, p = 0.047) in the late experience group. Cross-over to surgery was required in 3.6%. Vascular complications occurred in 20.0%, and were significantly lower in the late experience group (11.4% vs. 28.6%, p = 0.012). Major vascular complications (2.9% vs. 14.3%, p = 0.018) were decreased in the late experience group. Early experience (hazard ratio [HR]: 3.66, 95% confidence interval [CI]: 1.04 to 13.89, p = 0.047) and SFAR (HR: 110.80, 95% CI: 1.15 to 10,710.73, p = 0.044) predicted Prostar failure by univariate analysis.
Conclusions
Experience reduced major vascular complications in a true percutaneous approach for transfemoral-TAVI. Further application of this less invasive strategy is feasible and may be beneficial, in this high-risk patient cohort.
The goal of this study was to examine the safety and results of interventional procedures performed during the broadcast of live case demonstrations.
Background
Professional meetings using live case demonstrations to present cutting-edge technology are considered a valuable educational resource. There is an ongoing discussion on whether patients who are treated during live case demonstrations are exposed to a higher risk.
Methods
Between 1998 and 2010, 101 patients were treated during live transmissions from a single center in 15 invasive-cardiology conferences. Technical success was defined as the ability to effectively perform the planned procedure without any major complication. The primary endpoint of the study was the composite occurrence of death, myocardial infarction, or stroke.
Results
The interventional procedures included coronary (n = 66), carotid (n = 15), peripheral (n = 1), valvular (n = 2), congenital heart disease (n = 12), and complex electrophysiological mapping and ablation interventions (n = 7). In 4 cases, the intended procedure was not done. The procedure was technically successful in 95%. In 5 cases, the procedure was unsuccessful because of the inability to cross a chronic total occlusion. There were no deaths during the hospital stay, and the composite primary endpoint occurred in 2 patients: a minor stroke following an atrial fibrillation ablation and a rise in serum troponin levels after percutaneous coronary intervention. These results were no different from those of 66 matched controls who underwent procedures performed by the same operators but not as live case demonstrations (relative risk: 0.32; 95% confidence interval: 0.02 to 3.62, p = 0.62).
Conclusions
In this consecutive series of interventional cardiology procedures that were performed by expert operators during live demonstration courses, the procedural and 30-day clinical outcomes were similar to those found in daily practice and to those that have been reported in the contemporary published data. These results suggest that broadcasting live case demonstrations in selected patients from selected centers may be safe.
Appropriate utilization of percutaneous coronary intervention (PCI) and medical therapy is deservedly a national healthcare policy priority for the United States. Because PCI is both common and costly, appraisal of appropriateness is warranted. The initial appropriate use criteria (AUC) have been developed for coronary revascularization procedures and investigators recently reported the appropriateness for the approximately 500,000 PCI procedures performed at centers participating in the National Cardiovascular Data Registry. The AUC have broad implications for both healthcare providers and our patients and will be used as the basis for indications, referral patterns, treatment options, physician education, shared decision-making, and reimbursement for years to come. While we acknowledge the importance of thoughtfully assessing appropriateness for all medical procedures including PCI, there are a number of concerns with the current AUC and methods used to report appropriateness that warrant expanded commentary.
Chronic total occlusion recanalization still represents the final frontier in percutaneous coronary intervention. Retrograde chronic total occlusion recanalization has recently become an essential complement to the classical antegrade approach. In experienced hands, the retrograde technique currently has a high success rate with a low complication profile, despite frequent utilization in the most anatomically and clinically complex patients. Since its initial description, important changes have occurred that make the technique faster and more successful. We propose a step-by-step approach of the technique as practiced at experienced centers in North America. Because the technique can vary substantially, we describe the different alternatives to each step and offer what we perceived to be the most efficient techniques.
This study investigated the role of uncovered stent struts on late stent thrombosis (LST) after drug-eluting stent (DES) implantation with optical coherence tomography (OCT).
Background
Autopsy studies have identified delayed healing and lack of endothelialization of DES struts as the hallmarks of LST. DES strut coverage has not previously been examined in vivo in patients with LST.
Methods
We studied 54 patients, including 18 with DES LST (median 615 days after implant) undergoing emergent percutaneous coronary interventions and 36 matched DES control subjects undergoing routine repeat OCT and intravascular ultrasound (IVUS) who did not experience LST for ≥3 years. Thrombus aspiration was performed during emergent percutaneous coronary intervention before OCT and IVUS assessment.
Results
By OCT, patients with LST—compared with control subjects—had a higher percentage of uncovered (median [interquartile range]) (12.27 [5.50 to 23.33] vs. 4.14 [3.00 to 6.22], p < 0.001) and malapposed (4.60 [1.85 to 7.19] vs. 1.81 [0.00 to 2.99], p < 0.001) struts. The mean neointimal thickness was similar in the 2 groups (0.23 ± 0.17 mm vs. 0.17 ± 0.09 mm, p = 0.28). By IVUS, stent expansion was comparable in the 2 groups, although positive remodeling was increased in patients with LST (mean vessel cross-section area 19.4 ± 5.8 mm2 vs. 15.1 ± 4.6 mm2, p = 0.003). Thrombus aspiration demonstrated neutrophils and eosinophils in most cases. By multivariable analysis, the length of segment with uncovered stent struts by OCT and the remodeling index by IVUS were independent predictors of LST.
Conclusions
In this in vivo case-controlled study, the presence of uncovered stent struts as assessed by OCT and positive vessel remodeling as imaged by IVUS were associated with LST after DES.
This study sought to assess whether transradial intervention, by minimizing access-site bleeding and vascular events, improves outcomes in patients with ST-segment elevation myocardial infarction compared with the transfemoral approach.
Background
Bleeding and consequent blood product transfusions have been causally associated with a higher mortality rate in patients with myocardial infarction undergoing coronary angioplasty.
Methods
We identified all adults undergoing percutaneous intervention for acute myocardial infarction in Emilia-Romagna, a region in the north of Italy of 4 million residents, between January 1, 2003, and July 30, 2009, at 12 referral hospitals using a region-mandated database of percutaneous coronary intervention procedures. Differences in the risk of death at 2 years between patients undergoing transfemoral versus transradial intervention, assessed on an intention-to-treat basis, were determined from vital statistics records and compared based on propensity score adjustment and matching.
Results
A total of 11,068 patients were treated for acute myocardial infarction (8,000 via transfemoral and 3,068 via transradial route). According to analysis of matched pairs, the 2-year, risk-adjusted mortality rates were lower for the transradial than for the transfemoral group (8.8% vs. 11.4%; p = 0.0250). The rate of vascular complications requiring surgery or need for blood transfusion were also significantly decreased in the transradial group (1.1% vs. 2.5%, p = 0.0052).
Conclusions
In patients undergoing angioplasty for acute myocardial infarction, transradial treatment is associated with decreased 2-year mortality rates and a reduction in the need for vascular surgery and/or blood transfusion compared with transfemoral intervention.
This study investigated the impact of sheath size on the rate of radial artery occlusions (RAO) (primary objective) and other access site complications (hemorrhage, pseudoaneurysm, arteriovenous fistula) as secondary objectives after transradial coronary catheterization.
Background
The number of vascular access complications in the published data ranges from 5% to 38% after transradial catheterization.
Methods
Between November 2009 and August 2010, 455 patients 65.3 ± 10.9 years of age (62.2% male) with transradial access with 5-F (n = 153) or 6-F (n = 302) arterial sheaths were prospectively recruited. Duplex sonography was obtained in each patient before discharge. Patients with symptomatic RAO were treated with low-molecular-weight heparin (LMWH), and a follow-up was performed.
Results
The incidence of access site complications was 14.4% with 5-F sheaths compared with 33.1% with 6-F sheaths (p < 0.001). Radial artery occlusion occurred in 13.7% with 5-F sheaths compared with 30.5% with 6-F sheaths (p < 0.001). There was no difference between groups with regard to hemorrhage, pseudoaneurysms, or arteriovenous fistulas. Female sex, larger sheath size, peripheral arterial occlusive disease, and younger age independently predicted RAO in multivariate analysis. In total, 42.5% of patients with RAO were immediately symptomatic; another 7% became symptomatic within a mean of 4 days. Of patients with RAO, 59% were treated with LMWH. The recanalization rates were significantly higher in patients receiving LMWH compared with conventional therapy (55.6% vs. 13.5%, p < 0.001) after a mean of 14 days.
Conclusions
The incidence of RAO by vascular ultrasound was higher than expected from previous data, especially in patients who underwent the procedure with larger sheaths.
This study sought to evaluate post-dilation strategies in bifurcation stenting.
Background
In bifurcation stenting practice, it is still controversial how post-dilation should be performed and whether the kissing balloon (KB) technique is mandatory when only the main vessel (MV) receives a stent.
Methods
A series of drug-eluting stents (DES) (n = 26) were deployed in a coronary bifurcation model following a provisional approach. After the deployment of the stent in the MV, post-dilation with the KB technique was compared with a 2-step, sequential post-dilation of the side branch (SB) and MV without kissing.
Results
The percentage of the SB lumen area free of stent struts was similar after KB (79.1 ± 8.7%) and after the 2-step sequence (74.4 ± 11.6%, p = 0.25), a considerable improvement compared with MV stenting only without dilation of the stent at the SB ostium (30.8 ± 7.8%, p < 0.0001). The rate of strut malapposition in the ostium was 21.3 ± 9.2% after KB and 24.9 ± 10.4% after the 2-step sequence, respectively, a significant reduction compared with a simple SB dilation (55.3 ± 16.8%, p < 0.0001) or MV stenting only (47.0 ± 8.5%, p < 0.0005). KB created a significant elliptical overexpansion of the MV lumen, inducing higher stress concentration proximal to the SB. KB also led to a higher risk of incomplete stent apposition at the proximal stent edge (30.7 ± 26.4% vs. 2.8 ± 9.6% for 2-step, p = 0.0016).
Conclusions
Sequential 2-step post-dilation of the SB and MV may offer a simpler and more efficient alternative to final KB technique for provisional stenting of bifurcations.
This study sought to describe the presentation, management, and outcomes of patients presenting with angiographic definite stent thrombosis (ST) at coronary bifurcations.
Background
The development of drug-eluting stents has made it increasingly feasible to treat bifurcation lesions percutaneously. However, ST at coronary bifurcations may be associated with greater mortality than ST elsewhere.
Methods
We analyzed a multicenter California registry comprising all cases of angiographic definite ST at 5 academic hospitals from 2005 to 2010. Stenting was defined as occurring at a bifurcation if the main vessel stent crossed a side branch ≥2.0 mm in diameter (provisional single-stent approach), or if there was a prior 2-stent bifurcation approach.
Results
Among 173 cases of angiographic definite ST, we identified 20 cases of ST at coronary bifurcations. Nine of 20 bifurcation ST (45%) occurred with a stent present in both the parent and branch vessel. Eight cases had thrombus present in both the parent and side branch vessels. In-hospital mortality was much higher for subjects with bifurcation ST than ST at a nonbifurcation site (20% vs. 2%, p < 0.0001). During a median follow-up of 2.3 years, ST at a coronary bifurcation was associated with increased long-term mortality (hazard ratio [HR]: 3.3, 95% confidence interval [CI]: 1.4 to 7.7, p = 0.007) and a significantly higher risk for major adverse cardiovascular events (HR: 2.2, 95% CI: 1.04 to 4.8, p = 0.04) relative to ST at a nonbifurcation site.
Conclusions
ST at coronary bifurcations is associated with a higher in-hospital and long-term mortality than ST at nonbifurcation lesions. (Stent Thrombus in Acute Coronary Syndromes; NCT00931502)
This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher Select Plus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of bare-metal stents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients.
Background
There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR.
Methods
The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenter and international registry encompassing virtually all subsets of patients and lesions treated with at least 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis all patients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint was major adverse cardiac events and stent thrombosis rate at 1 year.
Results
Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n = 1,235, DES group, n = 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%, p < 0.001), renal insufficiency (5.8% vs. 2.3%, p = 0.003), and prior coronary artery bypass graft (20.5% vs. 11.8%, p < 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p = 0.3) and myocardial infarction (2.4% for BMS and 3.3% for DES, p = 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher in patients with DES ISR (6.9% vs. 3.1%, p = 0.003, and 1.8% vs. 0.5%, p = 0.04, respectively).
Conclusions
Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesion revascularization recurrence and no apparent safety concern.
The aim of this study was to assess the learning curve for the implantation of the percutaneous aortic valve via the transfemoral route.
Background
Transcutaneous aortic valve insertion is a fundamentally new procedure for the treatment of aortic valve stenosis. The number of cases needed to gain proficiency with concomitant ease and familiarity (i.e., the "learning curve") with the procedure is unknown.
Methods
We performed a retrospective analysis of the first 44 consecutive patients who underwent transcatheter aortic valve implantation as part of the PARTNER (Placement of Aortic Transcatheter Valves) trial at our institution between November 2008 and May 2011.
Results
The median age of the patients was 83 years (interquartile range: 77 to 87 years) and a median Society of Thoracic Surgery risk score of 9.6. Pre-procedural assessment of the aortic valve revealed a mean gradient of 53.5 mm Hg, mean aortic valve area of 0.7 mm2, and a median ejection fraction of 59.5%. Patients were divided into tertiles based on sequence. Significant decreases in median contrast volume (180 to 160 to 130 ml, p = 0.003), valvuloplasty to valve deployment time (12.0 to 11.6 to 7.0 min, p < 0.001) and fluoroscopy times, from 26.1 to 17.2 and 14.3 min occurred from tertiles 1 to 3, p < 0.001. Significant decreases in radiation doses were also seen across the 3 tertiles, p < 0.001. The 30-day mortality for the entire cohort was 11%.
Conclusions
Experience accumulated over 44 transfemoral aortic valve implantations led to significant decreases in procedural times, radiation, and contrast volumes. Our data show increasing proficiency with evidence of plateau after the first 30 cases. More studies are needed to confirm these findings.
This study sought to quantify the learning curve for the safety and effectiveness of a newly introduced vascular closure device through evaluation of the NCDR (National Cardiovascular Data Registry) CathPCI clinical outcomes registry.
Background
The impact of learning on the clinical outcomes complicates the assessment of the safety and efficacy during the early experience with newly introduced medical devices.
Methods
We performed a retrospective analysis of the relationship between cumulative institutional experience and clinical device success, defined as device deployment success and freedom from any vascular complications, for the StarClose vascular closure device (Abbott Vascular, Redwood City, California). Generalized estimating equation modeling was used to develop risk-adjusted clinical success predictions that were analyzed to quantify learning curve rates.
Results
A total of 107,710 procedures used at least 1 StarClose deployment, between January 1, 2006, and December 31, 2007, with overall clinical success increasing from 93% to 97% during the study period. The learning curve was triphasic, with an initial rapid learning phase, followed by a period of declining rates of success, followed finally by a recovery to a steady-state rate of improved device success. The rates of learning were influenced positively by diagnostic (vs. percutaneous coronary intervention) procedure use and teaching status and were affected inversely by annual institutional volume.
Conclusions
An institutional-level learning curve for the initial national experience of StarClose was triphasic, likely indicating changes in patient selection and expansion of number of operators during the initial phases of device adoption. The rate of learning was influenced by several institutional factors, including overall procedural volume, utilization for percutaneous coronary intervention procedures, and teaching status.
This study investigated the effect of furosemide-forced diuresis and intravenous saline infusion matched with urine output, using a novel dedicated device designed for contrast-induced nephropathy (CIN) prevention.
Background
CIN is a frequent cause of acute kidney injury associated with increased morbidity and mortality.
Methods
A total of 170 consecutive patients with chronic kidney disease (CKD) undergoing coronary procedures were randomized to either furosemide with matched hydration (FMH group, n = 87) or to standard intravenous isotonic saline hydration (control group; n = 83). The FMH group received an initial 250-ml intravenous bolus of normal saline over 30 min followed by an intravenous bolus (0.5 mg/kg) of furosemide. Hydration infusion rate was automatically adjusted to precisely replace the patient's urine output. When a urine output rate >300 ml/h was obtained, patients underwent the coronary procedure. Matched fluid replacement was maintained during the procedure and for 4 h post-treatment. The definition of CIN was a ≥25% or ≥0.5 mg/dl rise in serum creatinine over baseline.
Results
In the FMH group, no device- or therapy-related complications were observed. Four (4.6%) patients in the FMH group developed CIN versus 15 (18%) controls (p = 0.005). A lower incidence of cumulative in-hospital clinical complications was also observed in FMH-treated patients than in controls (8% vs. 18%; p = 0.052).
Conclusions
In patients with CKD undergoing coronary procedures, furosemide-induced high urine output with matched hydration significantly reduces the risk of CIN and may be associated with improved in-hospital outcome.
(Induced Diuresis With Matched Hydration Compared to Standard Hydration for Contrast Induced Nephropathy Prevention [MYTHOS]; NCT00702728)
The aim of this study was to examine the use of and outcomes associated with use of N-acetylcysteine (NAC) in real-world practice.
Background
The role of NAC in the prevention of contrast-induced nephropathy (CIN) is controversial, leading to widely varying recommendations for its use.
Methods
Use of NAC was assessed in consecutive patients undergoing nonemergent percutaneous coronary intervention from 2006 to 2009 in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium, a large multicenter quality improvement collaborative. We examined the overall prevalence of NAC use in these patients and then used propensity matching to link its use with clinical outcomes, including CIN, nephropathy-requiring dialysis, and death.
Results
Of the 90,578 percutaneous coronary interventions performed during the study period, NAC was used in 10,574 (11.6%) procedures, with its use steadily increasing over the study period. Patients treated with NAC were slightly older and more likely to have baseline renal insufficiency and other comorbidities. In propensity-matched, risk-adjusted models, we found no differences in outcomes between patients treated with NAC and those not receiving NAC for CIN (5.5% vs. 5.5%, p = 0.99), nephropathy-requiring dialysis (0.6% vs. 0.6%, p = 0.69), or death (0.6% vs. 0.8%, p = 0.15). These findings were consistent across many prespecified subgroups.
Conclusions
Use of NAC is common and has steadily increased over the study period but does not seem to be associated with improved clinical outcomes in real-world practice.
This study sought to assess the feasibility and safety of percutaneous edge-to-edge mitral valve (MV) repair in patients with an unacceptably high operative risk.
Background
MV repair for mitral regurgitation (MR) can be accomplished by use of a clip that approximates the free edges of the mitral leaflets.
Methods
All patients were declined for surgery because of a high logistic EuroSCORE (>20%) or the presence of other specific surgical risk factors. Transthoracic echocardiography was performed before and 6 months after the procedure. Differences in New York Heart Association (NYHA) functional class, quality of life (QoL) using the Minnesota questionnaire, and 6-min walk test (6-MWT) distances were reported.
Results
Fifty-five procedures were performed in 52 patients (69.2% male, age 73.2 ± 10.1 years, logistic EuroSCORE 27.1 ± 17.0%). In 3 patients, partial clip detachment occurred; a second clip was placed successfully. One patient experienced cardiac tamponade. Two patients developed inguinal bleeding, of whom 1 needed surgery. Six patients (11.5%) died during 6-month follow-up (5 patients as a result of progressive heart failure and 1 noncardiac death). The MR grade before repair was ≥3 in 100%; after 6 months, a reduction in MR grade to ≤2 was present in 79% of the patients. Left ventricular (LV) end-diastolic diameter, LV ejection fraction, and systolic pulmonary artery pressure improved significantly. Accompanied improvements in NYHA functional class, QoL index, 6-MWT distances, and log N-terminal pro–B-type natriuretic peptide were observed.
Conclusions
In a high-risk population, MR reduction can be achieved by percutaneous edge-to-edge valve repair, resulting in LV remodeling with improvement of functional capacity after 6 months.
