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Sex-based disparities in outcomes are reported for various cardiovascular procedures. This study aimed to assess the difference in outcomes in patients who underwent WATCHMAN device implant based on sex. Patients who underwent WATCHMAN device placement, from 2016 to 2018, were identified from the National Inpatient Sample database. The primary outcome was inpatient mortality, and the secondary outcomes were the length of stay (LOS), hospitalization cost (HOC), and periprocedural complications. A logistic regression model was built to perform an adjusted analysis for the outcomes. A total of 12,327 patients underwent WATCHMAN device placement. Female patients were older and more likely to have hypertension (p <0.01) and less likely to have peripheral arterial disease (5.6 vs 7.2, p <0.01), chronic kidney disease (21% vs 26%, p <0.01), and diabetes (18% vs 20%, p = 0.03) and were also at a higher risk for certain periprocedural complications, including pericardiocentesis and anemia requiring blood transfusion (p <0.01 for all). In the unadjusted analysis, the female sex was associated with longer LOS (1.5 vs 1.3 days, p <0.01) and inpatient mortality (0.23 vs 0.10, p = 0.05). The HOC was numerically higher in women but statistically nonsignificant ($120,791 vs $118,554, p = 0.1). In the stepwise, backward, multivariate regression analysis, the female sex  was an independent risk factor for higher LOS (1.5 vs 1.3 days, p <0.01, 95% confidence interval 1.3 to 1.4) after adjusting for potential confounders. The inpatient mortality and HOC were similar between 2 groups after adjusting for potential cofounders in the multivariate regression analysis. Our study suggests that the female sex is an independent risk factor for longer LOS among patients hospitalized for WATCHMAN device placement., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to declare., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Introduction Cardiac troponin (cTn) forms an essential part of the diagnostic criteria for myocardial infarction (MI). Type 1 MI is a primary coronary arterial event, whereas type 2 MI is due to coronary oxygen supply/demand mismatch, which is common in trauma patients. In addition, cTn may be elevated for many reasons other than MI. cTn elevations in trauma may not be specific for MI amenable to revascularization. The aim of this study is to determine which subset of trauma patients benefits from measuring cTn, and which patients with elevated cTn benefit from ischemic workup. Methods This is a retrospective cohort study. All patients on the trauma service of a level 1 trauma center with cTn elevated above the upper reference value of 0.032 ng/ml from July 2017 through December 2020 were selected. Baseline characteristics were recorded. The main outcomes were cardiology determination of the etiology of elevated cTn and patient survival. Logistic regression was used for multivariate analysis. Results One hundred forty-seven (147; 1.1%) of 13746 trauma patients had maximum cTn over the 99th percentile. Forty-one (27.5%) of the 147 had ischemic changes on electrocardiogram (ECG). Sixty-four (43.0%) had chest pain. In 81 (55.1%) cases, cTn was ordered without a clearly justified indication. One hundred thirty-seven patients (93.3%) received a cardiology consult. Two (1.5%) of 137 patients had a type 1 MI, which was diagnosed by ECG and clinical symptoms before cTn results were available. One hundred thirty-five patients were evaluated for cardiac ischemia based on elevated cTn. In 91 (66.4%) cases, the elevated cTn was attributed to a cardiac oxygen supply/demand mismatch. The etiology was cardiac contusion for 26 (19.0%), with the rest attributed to various other trauma-related causes. The cardiology consult changed management for 90 (65.7%) patients, mainly consisting of further evaluation by echocardiogram for 78 (57.0%) patients. Elevated cTn was a significant independent predictor of death with an adjusted odds ratio of 2.6 (p=0.002). Conclusion Isolated cTn values in trauma are most often due to type 2 MI resulting from trauma-related issues, such as tachycardia and anemia, which affect myocardial oxygen supply and demand. Changes in management generally consisted of further workup and interventions such as monitoring and pharmacologic treatment. Elevated cTn in this cohort never led to revascularization but was valuable to identify patients who required more intensive monitoring, longer-term follow-up, and supportive cardiac care. More selective ordering of cTn would improve specificity for patients requiring specialized cardiac care., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Culhane et al.)

Competing Interests: Declaration of competing interest The authors have no conflicts of interest.

Background: Because of the COVID-19 pandemic, cath labs have had to modify their workflow for elective and urgent patients., Methods: We surveyed 16 physicians across 3 hospitals in our healthcare system to address COVID-19 related concerns in the management of interventional and structural heart disease patients, and to formulate system wide criteria for deferring cases till after the pandemic., Results: Our survey yielded common concerns centered on the need to protect patients, cath lab staff and physicians from unnecessary exposure to COVID-19; for COVID-19 testing prior to arrival to the cath lab; for clear communication between the referring physician and the interventionalist; but there was initial uncertainty among physicians regarding the optimal management of ST elevation myocardial infarction (STEMI; percutaneous coronary intervention versus thrombolytics). Patients with stable angina and hemodynamically stable acute coronary syndromes were deemed suitable for initial medical management, except when they had large ischemic burden. Most transcatheter aortic valve implantations (TAVI) were felt appropriate for postponement except in symptomatic patients with aortic valve area <0.5 cm 2 or recent hospitalization for heart failure (HF). Most percutaneous mitral valve repair (pMVR) procedures were felt appropriate for postponement except in patients with HF. All left atrial appendage closure (LAAC) and patent foramen ovale (PFO)/atrial septal defect (ASD) closure procedures were felt appropriate for postponement., Conclusion: Our survey of an experienced team of clinicians yielded concise guidelines to direct the management of CAD and structural heart disease patients during the initial phases of the COVID-19 pandemic., (Copyright © 2020 Elsevier Inc. All rights reserved.)

There is growing interest in "minimalist" transcatheter aortic valve implantation (M-TAVI), performed with conscious sedation instead of general anesthesia (GA-TAVI). We assessed the impact of M-TAVI on procedural efficiency, long-term safety, and quality of life (QoL) in 477 patients with severe aortic stenosis (82 years, women 50%, STS 5.0), who underwent M-TAVI (n = 278) or GA-TAVI (n = 199). M-TAVI patients were less likely to have NYHA Class ≥3, valve-in-valve TAVI, and receive self-expanding valves. M-TAVI was completed without conversion to GA in 269 (97%) patients. M-TAVI was more efficient that GA-TAVI including shorter lengths of stay (2 vs 3 days, p <0.0001), higher likelihood of being discharged home (87% vs 72%, p <0.0001), less use of blood transfusions (10% vs 22%, p = 0.0008), inotropes (13% vs 32%, p <0.0001), contrast volume (50 vs 90 ml, p <0.0001), fluoroscopy time (20 vs 24 minute, p <0.0001), and need for >1 valves (0.4 vs 5.5%, p = 0.0004). At 1-month, death/stroke (M-TAVI vs GA-TAVI 4.0 vs 6.5%) and a "safety composite" end point (death, stroke, transient ischemic attack, myocardial infarction, new dialysis, major vascular complication, major or life-threatening bleeding, and new pacemaker: 17.6% vs 21.1%) were similar (p = NS for both). At a median follow-up of 365 days, survival curves showed similar incidence of death/stroke as well as the safety composite end point between the groups. QoL scores were similar at baseline and 1-month after TAVI. In multivariable analyses, M-TAVI showed significant improvements in all parameters of procedural efficiency. In conclusion, M-TAVI is more efficient than GA-TAVI, with similar safety at 1-month and long-term, and similar QoL scores at 1 month., (Copyright © 2020 Elsevier Inc. All rights reserved.)

A significant body of data has emerged in the area of Percutaneous Left Atrial Appendage Occlusion (LAAO). In this article, we present an overview of the most notable publications along with a review of the most important publications on LAAO in 2016. We also present important historical data such as landmark clinical studies, review of most utilized occlusion devices, and important clinical studies that are underway., (© 2017, Wiley Periodicals, Inc.)

Transcatheter aortic valve replacement (TAVR) has emerged as an attractive option for patients with severe symptomatic aortic stenosis (AS) who are either at high risk or extreme risk for surgical aortic valve replacement (SAVR). This article summarizes the major advances in TAVR that were published or reported in 2015., (© 2015, Wiley Periodicals, Inc.)

In order to keep the interventional community up-to-date with the overwhelming amount of new data, we have selected where we believe to be the most important publications in percutaneous coronary intervention from January 1, 2015 to mid-November 2015. We hope that this will serve as an important overview of 2015, and ongoing reference for future years., (© 2016, Wiley Periodicals, Inc.)

It is now clearly established that Thin-Capped Fibroatheromas (TCFAs) lead to most Acute Coronary Syndromes (ACSs). The ability to selectively intervene on TCFAs predisposed to rupture and ACSs would dramatically alter the practice of cardiology. While the ability of OCT to identify thin walled plaques at micron scale resolutions has represented a major advance, it is a misconception that it can reliably identify TCFAs. One major reason is that the 'diffuse border' criteria currently used to determine 'lipid plaque' is almost undoubtedly from high scattering in the intima and not because of core composition (necrotic core). A second reason is that, rather than looking at lipid collections, studies need to be focused on identifying necrotic cores with OCT. Necrotic cores are characteristic of TCFAs and not lipid collections. Numerous other OCT approaches are available which can potentially accurately assess TCFAs, but these have not been aggressively pursed which we believe likely stems in part from the misconceptions over the efficacy of 'diffuse borders'.

Aortic valve stenosis is the most common form of valvular heart disease in the elderly population and occurs frequently in conjunction with coronary artery disease. The standard treatment option for patients with these two conditions has been surgical aortic valve replacement and coronary artery bypass grafting. The arrival of transcatheter aortic valve replacement has considerably shifted the treatment paradigms. Nevertheless, a lot of questions remain unanswered regarding the management of coronary artery disease in the setting of the transcatheter options for severe aortic stenosis. This article includes a comprehensive review of the literature and seeks to describe the actual knowledge on the topic of aortic stenosis and concomitant coronary artery disease., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

The fields of interventional cardiology and cardiac surgery have witnessed remarkable technological achievements. We describe the case of a patient who underwent several such milestones over a period of nearly five decades. From a Vineberg operation in 1969, to coronary artery bypass graft surgery in 2000, and finally, transcatheter aortic valve replacement in 2013, her medical history illustrates the impact of such landmarks, at times when few other options existed.

Objectives: We derived a formula for maximal suggested door-in-door-out time (DIDO) for hospitals that do not perform primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)., Background: Efforts to minimize DIDO at non-PCI hospitals can improve door-to-balloon time (D2B). Targeting a maximal suggested DIDO for a transferring hospital can influence reperfusion strategy., Methods: We examined time to treatment intervals for 193 STEMI patients who underwent primary PCI at our hospital. D2B in transferred patients (D2BT ) was divided into 3 intervals: transferring hospital DIDO, inter-hospital transport time, and interventional time. We defined maximal suggested DIDO as the maximum DIDO that would allow PCI with D2BT ≤ 120 minutes., Results: D2B was higher in transfer compared to on-site patients (147 ± 52 vs. 75 ± 44 minutes, P < 0.0001). In transfer patients, treatment time intervals were: DIDO 80 ± 42 minutes, transport time 37 ± 18 minutes, interventional time 35 ± 16 minutes. The greatest variability in D2BT was related to DIDO. We estimated that maximal suggested DIDO = [120 - (transport time plus interventional time)]. Using a fixed interventional time of 40 minutes, we simplified this as: maximal DIDO = 80 - transport time. Maximal suggested DIDO for 4 transferring hospitals in our network ranged from 1 to 65 minutes. DIDO under the hospital-specific threshold was the strongest predictor of achieving D2BT <120 minutes., Conclusions: Transferring hospitals' maximal suggested DIDO is variable, and can be calculated from inter-hospital transport time. Instead of a universal target DIDO (e.g., <30 minutes), maximal suggested DIDO can be calculated individually for each non-PCI hospital within a STEMI network., (© 2013, Wiley Periodicals, Inc.)

Background: In patients with acute ST-elevation myocardial infarction (STEMI) needing early coronary artery bypass graft (CABG) surgery, it is unknown whether primary percutaneous balloon angioplasty (PTCA)-without stent implantation-allows safe transition to subsequent CABG., Methods: We examined acute STEMI patients enrolled in the Stent-PAMI and CADILLAC trials to study the differences in the early clinical events between those treated with primary PTCA (n = 1494) or primary stenting (n = 1488)., Results: Baseline clinical and pre- and post-procedural angiographic features including post-intervention TIMI 3 flow rates were similar in the 2 groups with the exception of higher median infarct-artery residual stenosis in the PTCA group (26% [IQR 19%-34%] vs. 18% [IQR 11-25%], P < .001]. Provisional stenting was required in 16% of patients in PTCA group, while stents could not be implanted in 2% of the stent group. Sixty-percent of PTCA patients had stent-like balloon result. The rate of 30-day ischemia-driven target vessel revascularization was higher in the PTCA group (4.3% vs. 2.0%, P < .001 [4.6% vs 2.3%, P < .001 among patients with multivessel disease and 3.4% vs. 2.0%, P = .044 in patients with stent-like balloon results]) while 30-day major adverse cardiac events (6.2% vs 4.9%), death (1.8% versus 2.8%), and reinfarction (0.9% vs. 0.7%) were similar in the 2 groups., Conclusions: Compared with primary stenting, primary PTCA of infarct artery in STEMI patients was associated with significant increase in ischemia-driven target vessel revascularization (ITVR) rate, yet with no increased risk of major adverse cardiac events, reinfarction or death. Thus, provided close surveillance is maintained and prompt treatment initiated for early ischemic events, PTCA (particularly in those with stent-like balloon result) may be a reasonable and safe option in STEMI patients needing early CABG., (Copyright © 2013 Mosby, Inc. All rights reserved.)

Objectives: We sought to compare the safety and effectiveness of everolimus-eluting stents (EES) versus first generation drug-eluting stents (FG-DES; sirolimus-eluting stent [SES] or paclitaxel-eluting stent [PES])., Methods: In 2,126 patients undergoing percutaneous coronary intervention (PCI), we compared the 2-year incidence of stent thrombosis (ST) and target vessel revascularization (TVR) between the EES versus FG-DES groups. Secondary end-points included all-cause death, myocardial infarction (MI), death or MI, and major adverse cardiovascular events (MACE, including death, MI, ST, or TVR). Further, we evaluated these end-points in 2 propensity-matched subgroups: EES versus SES; EES versus PES., Results: Complete 2-year follow-up was available in 1,911 (90%) patients. Compared to FG-DES, implantation of EES was associated with trends towards lower ST (0.9% vs. 2.8%, P = 0.068) and TVR (3.8% vs. 7.2%, P = 0.052), which persisted after adjustment for baseline differences (for ST, adjusted hazard ratio, HR 0.32; 95% confidence interval, 95% CI 0.10-1.02, P = 0.053; for TVR, HR 0.40; 95% CI 0.22-0.75, P = 0.004). Compared to SES, EES implantation was associated with lower TVR and a trend towards lower ST. Compared to PES, EES implantation was associated with less ST and TVR and trends towards lower death/MI and MACE. In the EES group, no ST was seen after the first 3 months., Conclusions: The use of EES compared to FG-DES appears to be associated with reductions in ST and TVR at 2-year follow-up. Improved outcomes with EES are observed in comparison with SES as well as PES., (© 2013, Wiley Periodicals, Inc.)

Hybrid coronary revascularization, which involves minimally invasive direct coronary artery bypass surgery using the left internal mammary artery to left anterior descending and percutaneous coronary intervention using drug-eluting stents for the remaining diseased coronary vessels, is an innovative approach to decrease the morbidity of conventional surgery. Little information is available to guide hospital managers and physician leaders in implementing a hybrid revascularization program. In this article, we describe the people-process-technology issues that managers and leaders are likely to encounter as they develop a hybrid revascularization program in their practice., (©2012, Wiley Periodicals, Inc.)

Early readmissions (ERs) impose a huge cost to the health care system, lower patients' quality of life, and may be an indicator of quality of initial care. We performed this single-center study to assess the incidence, predictors, and implications of 30-day readmission after percutaneous coronary intervention (PCI) in a tertiary care rural setting. In 4,262 consecutive patients who underwent PCI, we evaluated 30-day readmission rates and assessed demographic, clinical, and angiographic correlates of ER. Using Cox regression analyses, we estimated the multivariable impact of an ER on 1-year all-cause mortality and major adverse events (MACEs; death, myocardial infarction, target vessel revascularization, stent thrombosis). ER occurred in 486 patients (11.4%) including 366 (8.6%) for cardiac reasons and 120 (2.8%) for noncardiac reasons. Multivariable models predicting any readmission, cardiac readmission, and noncardiac readmission had c-statistic values of 0.63, 0.63, and 0.68, respectively. One-year mortality and MACEs were higher in the readmitted versus not readmitted patients (7.9% vs 3.2%, 18 vs 9.7%, p <0.0001 for the 2 comparisons). ER had a significant and independent impact on 1-year mortality (adjusted hazards ratio 2.2, 95% confidence interval 1.4 to 3.4) and MACEs (hazards ratio 2.2, 95% confidence interval 1.8 to 2.8). In conclusion, readmission within 30 days after PCI is common and frequently related to cardiac causes. Patients who require an ER after PCI have higher 1-year mortality and MACEs., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: The long-term safety and effectiveness of drug-eluting stents (DES) versus bare metal stents (BMS) in non-ST-segment elevation myocardial infarction (NSTEMI) beyond 2 years after percutaneous coronary intervention (PCI) is unknown., Methods:  We studied 674 NSTEMI patients who underwent successful PCI with DES (n = 323) or BMS (n = 351). The primary study end-points were time to occurrence of death or nonfatal recurrent myocardial infarction (MI), and stent thrombosis (ST). Secondary end-points included time to occurrence of target vessel revascularization (TVR) and any major adverse cardiovascular event (MACE, defined as the composite of death, MI, ST, TVR)., Results:  The DES and BMS groups were well matched except that DES patients received dual antiplatelet therapy for a longer duration and had smaller final vessel diameter. In survival analysis, at a mean follow-up of 1333 ± 659 days after PCI, the DES group had similar incidence of death/myocardial infarction (24% vs. 27%, log rank p = 0.23) and ST (4.0% vs. 2.6%, p = 0.18) as the BMS group. The DES patients had lower incidence of TVR (8.1% vs. 17%, p = 0.0018) but similar MACE (26% vs. 37%, p = 0.31). In multivariable analysis, DES vs. BMS implantation showed no significant impact on death/myocardial infarction [adjusted hazards ratio (HR) 1.0, 95% confidence intervals (CI) 0.7-1.4], ST (HR 1.7; CI 0.7 - 4.0), or MACE (HR 0.8; CI 0.6 - 1.1). However, TVR was lower in the DES group (HR 0.4; CI 0.3 - 0.7)., Conclusion: In patients presenting with NSTEMI, DES implantation appears to be as safe as BMS implantation at long-term follow-up. In addition, DES are effective in reducing TVR compared to BMS., (©2011, Wiley Periodicals, Inc.)

Background: The optimal dose of aspirin therapy after percutaneous coronary intervention (PCI) remains unclear. We sought to compare the effectiveness and safety of low and high doses of aspirin in preventing adverse outcomes after PCI., Methods: We studied 2,820 consecutive patients who underwent coronary stenting for stable or unstable coronary artery disease (excluding cardiogenic shock) discharged alive without any complications between 2001 and 2007. Patients were categorized based on the discharge aspirin dose into low-dose (81 mg/day, N = 313) or high-dose (162-325 mg/day, N = 2,507) groups. The primary end-points (adjusted using Cox Proportional Hazard and propensity scores) were major adverse cardiovascular events (MACE; a composite of death, myocardial infarction [MI], stent thrombosis [ST], or target vessel revascularization) and net adverse clinical events (NACE; a composite of MACE and thrombolysis in myocardial infarction [TIMI][major or minor] bleeding) at 1 year., Results: In the low-dose versus high-dose groups, MACE occurred in 8.6 versus 9.2% (log rank P = 0.71) and NACE in 11 versus 10% (log rank P = 0.58). In multivariable analysis, low-dose aspirin was not associated with worse outcomes (adjusted HR [95% CI] 0.74 [0.49-1.14] for MACE; 1.03 [0.71-1.50] for NACE)., Conclusion: Low-dose aspirin, as prescribed in this study of routine practice, was not associated with worse outcomes compared to high-dose aspirin. (J Interven Cardiol 2011;24:307-314)., (©2011, Wiley Periodicals, Inc.)

Background: Thrombocytopenia following percutaneous coronary intervention (PCI) is an underappreciated condition that is often clinically challenging. There are no guidelines on the management of patients with this condition., Objective: To review recent data in etiologies, risk factors, prevention, management, and prognostic implications of thrombocytopenia following PCI., Evidence Acquisition: Search of MEDLINE, EMBASE, the Cochrane Database, and Google Scholar using the term thrombocytopenia + PCI and other relevant keywords to identify systematic reviews, clinical trials, cohort studies, case series, and case reports. The review was limited to English-language articles published between January 1980 and June 2009. Articles on patients with baseline thrombocytopenia prior to PCI were excluded., Evidence Synthesis: Thrombocytopenia is not infrequent following PCI. The typical patient with post-PCI thrombocytopenia is on multiple therapies that can potentially cause a decrease in the platelet count. Identification of the cause is critical because management of the condition varies significantly based on the etiology. The severity of the thrombocytopenia also determines the clinical management of the patient. Several observational studies have demonstrated the adverse prognostic impact of the complication on clinical outcomes and have identified risk factors., Conclusions: Judicious use of therapies that can cause thrombocytopenia, efficient detection of the cause of the decrease in platelet count, and appropriate management of the condition can potentially improve the quality of care and outcomes following PCI. Further research into risk factors that predispose post-PCI patients to developing thrombocytopenia is warranted., (©2010, Wiley Periodicals, Inc.)

The Impella 2.5 catheter is a percutaneously implanted left ventricular assist device cleared by the Food and Drug Administration to provide circulatory support for up to 6 hours. The presence of aortic stenosis is deemed to be a contraindication to its use, and ongoing clinical trials exclude patients with an aortic valve area of 1.5 cm(2) or less. We describe a case of severe aortic stenosis with an estimated valve area of 0.9 cm(2) and severe ischemic cardiomyopathy in whom the Impella catheter was successfully used for high-risk multivessel percutaneous coronary intervention.

Previous studies have shown impressive short- and medium-term outcomes from drug-eluting stent (DES) implantation in coronary artery disease. We assessed long-term outcomes from DES versus bare metal stent (BMS) implantation in standard and off-label lesions. In 2,345 patients who survived event-free for > or = 30 days after stent implantation for standard (n = 1,540, 66%) or off-label (805, 34%) lesions, we assessed time to occurrence of death, myocardial infarction (MI), death or MI, stent thrombosis, target vessel revascularization (TVR), and major adverse cardiovascular events (defined as composite of all study outcomes). Comparisons were made between standard and off-label lesion subsets and between DES and BMS in lesion subsets. Multivariable differences in outcomes between DES versus BMS were assessed using propensity-adjusted proportional hazards regression. Median follow-up duration was 3.4 years. Stenting of off-label lesions was associated with uniformly worse outcomes than stenting of standard lesions. After adjustment for lesion classification, propensity to receive DES, and baseline differences, DES implantation was associated with statistically significant decreases in death (adjusted hazard ratio 0.71, 95% confidence interval 0.51 to 0.98), TVR (hazard ratio 0.58, 95% confidence interval 0.39 to 0.85 for off-label subset; hazard ratio 0.33, 95% confidence interval 0.24 to 0.46 for standard subset), and major adverse cardiovascular events (hazard ratio 0.51, 95% confidence interval 0.42 to 0.61), without increase in MI, death/MI, or stent thrombosis. Elective TVR occurred in 272 patients and resulted in only 1 early death. In conclusion, compared with BMS, use of DES is associated with clinical benefit in standard and off-label lesions at late follow-up. Decrease in elective TVR does not explain the apparent mortality benefit from DES implantation.

Background: Studies of percutaneous coronary intervention (PCI) routinely report major adverse cardiovascular events (MACE), but not major adverse noncardiac events (MANE) after PCI. MANE, such as post-PCI bleeding and contrast nephropathy, adversely influence survival, but are not recognized as a standard composite of complications. We assessed the feasibility and prognostic utility of deriving a composite of MANE., Methods: In 985 consecutive patients who underwent PCI, we estimated the incidence and prognostic impact of in-hospital MACE (myocardial infarction [MI] target vessel revascularization, or stroke) and MANE (defined as thrombolysis in myocardial infarction [TIMI], bleeding [major or minor], or contrast nephropathy) and their impact on long-term survival., Results: The incidence of MANE was >6-fold greater than MACE (9.5% vs 1.5%). Independent correlates of MANE included age, female gender, peripheral vascular disease, lower left ventricular ejection fraction, and use of an intraaortic balloon pump (IABP) during PCI. Of 973 patients who survived the index hospitalization, death occurred in 169(17%) at a median follow-up of 4.0 years. MANE (but not MACE) showed a significant relation with survival; 34 of 85 patients with MANE compared to 135 of 888 patients without MANE died during follow-up (40% vs 15%, log-rank P < 0.0001). After adjustment for several baseline clinical features, the occurrence of MANE was independently associated with a significant increase in long-term mortality (adjusted hazards ratio [HR]= 1.72, CI = 1.05-2.83) and myocardial infarction (adjusted HR = 3.43, CI = 1.55-7.58)., Conclusions: After PCI, MANE are common and carry grave long-term prognostic significance. Our findings emphasize the need to monitor and report MANE, in addition to MACE, in PCI-related trials.

Objectives: We assessed outcomes of patients undergoing drug-eluting stent (DES) vs. bare metal stent (BMS) implantation for complex lesions excluded from pivotal clinical trials of DES., Background: Although DES improve target vessel revascularization (TVR) and major adverse cardiovascular events (MACE) compared to BMS in randomized trials, data on safety and efficacy of DES in complex lesions are insufficient., Methods: In a single-center registry of 1,354 patients who underwent stent implantation for complex lesions between July 2001 and December 2005, we compared the incidence of death, death or myocardial infarction (MI), stent thrombosis [definite or probable by the Academic Research Consortium (ARC) criteria], TVR, and MACE between patients who received DES (n = 483) versus those who received BMS (n = 871). Mean duration of follow-up was 494 versus 838 days in DES and BMS groups, respectively., Results: Clinical outcomes in DES versus BMS groups were as follows: death 5.2% versus 11.5% (log-rank P = 0.042); death/MI 11.2% versus 16.7% (P = 0.47), stent thrombosis 2.9% versus 2.6% (P = 0.61), TVR 6.6 versus 18.5% (P < 0.0001), MACE 14.9% versus 29.7% (P = 0.0002), respectively. After adjustment for baseline differences, DES implantation was associated with lower TVR (adjusted hazards ratio HR = 0.38, 95% CI 0.26-0.56, P < 0.0001) and MACE (HR = 0.56, CI 0.42-0.74, P < 0.0001) without significant impact on other outcomes. In 933 patients who underwent DES (n = 483) or BMS (n = 450) implantation in the year 2003 or later, DES implantation similarly lowered TVR and MACE without affecting other outcomes., Conclusions: Our findings support the safety and efficacy of DES in patient subsets excluded from pivotal randomized clinical trials of DES.

Contrast-induced nephropathy (CIN) after percutaneous coronary intervention (PCI) has multiple definitions. We attempted to identify the optimal definition of CIN. In 985 patients undergoing PCI (derivation group), we assessed the prognostic significance of 4 commonly used contemporary definitions of CIN (increases in serum creatinine after PCI [deltaCr] >1.0 mg/dl, >0.5 mg/dl, and >25% after PCI; and the American College of Cardiology National Cardiovascular Data Registry definition) with respect to 6-month major adverse cardiovascular events (MACEs) and all-cause mortality (at 863 +/- 324 days). Incidence of CIN ranged widely (2.0% to 15%) depending on the definition used. Only 2 definitions (deltaCr >0.5 mg/dl, >25%) consistently correlated with study outcomes. Using these 2 definitions, we devised a new grading system (grade 0 deltaCr 25% but 0.5 mg/dl). Nephropathy grades (0 vs 1 vs 2) showed significant correlation with 6-month MACEs (12.4 vs 19.4 vs 28.6%, p = 0.003) and all-cause mortality (10.2 vs 10.4 vs 40.9%, p <0.0001). In multivariate analyses, the grading system showed an independent association with MACEs and mortality. The prognostic value of nephropathy grades was prospectively confirmed in an independent validation group of 539 patients. In conclusion, of the 4 contemporary definitions of CIN, only deltaCr >25% and >0.5 mg/dl consistently predicted adverse events after PCI. By unifying these 2 definitions, we devised a novel nephropathy grading system that is predictive of 6-month MACEs and all-cause mortality after PCI.

We evaluated the utility of a routine postprocedure course of unfractionated heparin after primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) in patients not receiving glycoprotein IIb/IIIa inhibitors. In the CADILLAC study, 2,082 patients with AMI who underwent primary PCI were randomized to receive stents versus percutaneous transluminal coronary angioplasty (PTCA), each with or without abciximab. In a subset of 976 patients who did not receive abciximab, we compared outcomes of patients who received postprocedural heparin (n = 758; 78%; median duration 2 days) with those who did not. In 421 patients treated with PTCA, postprocedural heparin use was associated with lower in-hospital major adverse cardiac events (MACEs; 5.3% vs 11.4%, p = 0.069), 1-year MACEs (22% vs 31%, p = 0.08), and decreased in-hospital moderate/severe bleeding (2.3% vs 8.9%, p = 0.01). By multivariate analyses, heparin use correlated with freedom from in-hospital and 1-year MACEs in patients after PTCA. In contrast, in 555 patients who underwent stenting, postprocedural heparin use was associated with increased bleeding and hospitalization costs without a decrease in early or late MACEs. In conclusion, in patients with AMI treated with coronary stenting without glycoprotein IIb/IIIa inhibitors, routine postprocedural heparin was not associated with any significant benefits and may be safely omitted. However, in a subset of patients treated with PTCA, postprocedural heparin use was independently associated with fewer in-hospital and 1-year MACEs.

Little is known about the influence of stenting versus balloon angioplasty on long-term outcomes (particularly mortality) after primary percutaneous coronary intervention (PCI). We evaluated 2,087 patients with ST-elevation myocardial infarction enrolled in various Primary Angioplasty in Myocardial Infarction (PAMI) trials in the United States, who underwent primary PCI. The main outcome was all-cause mortality at 5 years, obtained through the National Death Index. Of the 2,087 patients, stenting was performed in 692 (33%). The absolute difference in the hospital (2.2% vs 3.3%), 1-year (3.3% vs 5.2%), and 5-year (10% vs 13%) mortality rates favored patients receiving a stent versus conventional balloon therapy, with the difference increasing with time. A multivariate Cox model identified stent use (vs balloon alone) as an independent correlate of lower 5-year mortality (hazard ratio 0.60, 95% confidence interval 0.42 to 0.85). The absolute reduction in mortality was greatest in the highest risk group. In conclusion, compared with balloon angioplasty, stenting during primary PCI not only resulted in better angiographic and short-term outcomes, but also in a sustained beneficial effect on mortality at 5 years. These data support the routine use of coronary stenting in most patients undergoing primary PCI, when feasible.

Patients with acute myocardial infarction (AMI) often have multiple co-morbidities that influence outcome. We sought to evaluate the impact of peripheral vascular disease (PVD) on the outcome of patients with AMI treated with primary angioplasty. We evaluated 3,716 patients with AMI who underwent emergency catheterization with planned primary angioplasty in the Primary Angioplasty in Myocardial Infarction trials. Patients with a history of PVD (claudication, stroke, or transient ischemic attack) were compared with patients without PVD. Of the 3,716 patients, 394 (10.6%) had PVD and were older, more often women, and more frequently had a history of diabetes mellitus, hypertension, smoking, congestive heart failure, angina, myocardial infarction, and coronary revascularization. They presented more often with a heart rate >100 beats/min, Killip class >1, lower ejection fraction, and multivessel disease. No difference was found in stent use, final percentage of stenosis, or Thrombolysis In Myocardial Infarction 3 flow. Patients with PVD had a twofold increased in-hospital mortality (5.3% vs 2.6%, p = 0.0021). The difference remained significant at 1 month, 6 months, and 1 year (12.6% vs 6%, p < 0.0001). In multivariate logistic regression analysis, a history of PVD was an independent predictor of in-hospital mortality and death at 1 year (odds ratio 1.64, 95% confidence interval 1.04 to 2.57, p = 0.032). In conclusion, patients with AMI with PVD have increased co-morbidities and higher mortality despite treatment with primary angioplasty. The presence of PVD is an independent predictor of in-hospital mortality and death at 1 year.

The presence of bundle branch block (BBB) has been associated with poor outcomes in patients who have acute myocardial infarction. Whether this is true in the angioplasty era is not known. We sought to evaluate the outcome of patients with acute myocardial infarction and BBB who were treated with primary angioplasty. We evaluated 3,053 patients who underwent emergency catheterization in the PAMI trials. Patients who had left BBB (n = 48, 1.6%) on presenting electrocardiogram were compared with patients who had right BBB (n = 95, 3.1%) or no BBB (n = 2,910, 95.3%). Patients who had BBB were older and more frequently had diabetes mellitus, peripheral vascular disease, and previous coronary artery bypass grafting. They had lower ejection fraction and more multivessel disease. There were no significant differences in door-to-balloon time, final Thrombolysis In Myocardial Infarction flow grade or stent use. In-hospital major adverse cardiac events (death, ischemic target vessel revascularization, and reinfarction) were higher in patients who had BBB due primarily to increased in-hospital death (left BBB 14.6%, right BBB 7.4%, no BBB 2.8%, p < 0.0001). In multivariate logistic regression analysis, left BBB was an independent predictor of in-hospital death (odds ratio 5.53, 95% confidence interval 1.89 to 16.1, p = 0.002). In conclusion, patients who have acute myocardial infarction and BBB have increased co-morbidities and higher mortality rates despite treatment with primary angioplasty. Despite early identification of multivessel disease with triage to angioplasty or coronary artery bypass grafting, if necessary, similar treatment times, and final Thrombolysis In Myocardial Infarction grade 3 flow, the presence of left BBB on admission electrocardiogram in patients who have acute myocardial infarction is an independent predictor of in-hospital mortality. Because 85% of deaths in patients who have left BBB occur within the first week, these patients should be recognized early and receive prompt and aggressive treatment.