American College Of Cardiology-National Cardiovascular Data Registry Research Articles

Benchmarking as a quality of care improvement tool for patients with ST-elevation myocardial infarction: an NCDR ACTION Registry experience in Latin America.

We aim to examine the effect of benchmarking on quality-of-care metrics in patients presenting with ST-elevation myocardial infarction (STEMI) through the implementation of the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) ACTION Registry. From January 2005 to December 2017, 712 patients underwent primary percutaneous coronary intervention PCI-499 before NCDR ACTION Registry implementation (prior to 2013) and 213 after implementation. STEMI. 712 patients. Primary PCI. We examined hospital performance for the quality indicators in processes and outcomes of the management of patients presenting with STEMI. Outcome measures include door-to-balloon time (DBT), antiplatelet therapy and anti-ischemic drugs prescribed at discharge from pre-NCDR ACTION Registry to post-implementation. There was improvement in DBT, decreasing from 94min in 2012 (before NCDR adoption) to reach a median of 47min in 2017 (Ptrend<0.001). The percentage of cases with the optimal DBT of < 90min increased from 55.8% before to 90.1% after the implementation of the NCDR ACTION Registry (Ptrend<0.001). The rate of aspirin (90.3-100%, P<0.001), P2Y12 inhibitor (70.1-78.4%, P=0.02), beta-blocker (76.8-100%, P<0.001) and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (60.1-99.5%, P<0.001) prescribed at discharge increased from pre-NCDR ACTION Registry to post-implementation. Adjusted mortality before and after NCDR ACTION Registry implementation showed significant change (from 9.04 to 5.92%; P=0.027). The introduction of the ACC NCDR ACTION Registry led to incremental gains in the quality in STEMI management through the benchmarking of process of care and clinical outcomes, achieving reduced DBT, improving guideline-directed medication adherence and increasing patient safety, treatment efficacy and survival.

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

Excellent femoral outcomes when all access attempts and closure devices are performed by experienced cardiologists

Femoral access is considered less safe for access site complications than the radial access. Cardiovascular procedures have not been studied taking operator experience, defined as American Board of Internal Medicine, Interventional Cardiology certification or equivalent qualification in another country, into account. We hypothesize that the procedural results are operator dependent and excellent results are obtained when procedures are performed by experienced operators. Femoral access is higher risk than radial access based on American College of Cardiology (ACC) guidelines. Femoral access is less forgiving, as opposed to radial, as it is an end-artery, lacks easy compressibility and is more likely to cause morbidity when injured. Hence, radial is recommended over the femoral approach according to ACC practice guidelines. These guidelines are often based on the randomized studies from academic centers where trainees, with variable arterial access experience, perform the initial access stick and arterial closure device deployment. Methods: We performed a single center retrospective review of 32,446 consecutive patients undergoing invasive cardiovascular procedures done from the femoral approach using American College of Cardiology/National Cardiovascular Data Registry (ACC/NCDR) from January 1, 2006 to June 30, 2013. Only experienced operators performed the actual access site stick and the reminder of the invasive procedure. Results: Total bleeding and vascular complications were less than 1%. We define outcomes as excellent if the total bleeding and vascular complication risk is less than 1% based on previous studies discussed in the ACC guidelines. Conclusion: Excellent outcomes can be obtained from the femoral access if experienced cardiologists perform the procedure. Hence, radial arterial access over the femoral access may be selectively rather than universally recommended considering the possibility of varying level of femoral access expertise of different practices.

Surgical Candidacy and Selection Biases in Nonemergent Left Main Stenting: Implications for Observational Studies

This study sought to characterize reasons for surgical ineligibility in patients undergoing nonemergent unprotected left main (ULM) percutaneous coronary intervention (PCI) and to assess the potential for these reasons to confound comparative effectiveness studies of coronary revascularization. Although both PCI and coronary artery bypass graft surgery are treatments for ULM disease, some patients are not eligible for both treatments, which may result in treatment selection biases. In 101 consecutive patients undergoing nonemergent ULM PCI, mixed methods were used to determine the prevalence of treatment selection dictated by surgical ineligibility and to identify the reasons cited for avoiding coronary artery bypass graft surgery. We then determined whether these reasons were captured by the ACC-NCDR (American College of Cardiology-National Cardiovascular Data Registry) Cath-PCI dataset to assess the ability of this registry to account for biases in treatment selection. Finally, the association of surgical eligibility with long-term outcomes after ULM PCI was assessed. Treatment selection was dictated by surgical ineligibility in over half the ULM PCI cohort with the majority having reasons for ineligibility not captured by the ACC-NCDR. Surgical ineligibility was a significant predictor of mortality after adjustment for Society of Thoracic Surgeons (hazard ratio [HR]: 5.4, 95% confidence interval [CI]: 1.2 to 25), EuroSCORE (European System for Cardiac Operative Risk Evaluation) (HR: 5.9, 95% CI: 1.3 to 27), or NCDR mortality scores (HR: 6.2, 95% CI: 1.4 to 27). Surgical ineligibility dictating treatment selection is common in patients undergoing nonemergent ULM PCI, occurs on the basis of risk factors not captured by the ACC-NCDR, and is independently associated with worse long-term outcomes after adjusting for standard risk scores.

Enhanced Prediction of Mortality After Percutaneous Coronary Intervention by Consideration of General and Neurological Indicators

This study sought to improve methodology for predicting post-percutaneous coronary intervention (PCI) mortality. Recently, an increased proportion of post-PCI deaths caused by noncardiac causes has been suggested, often in rapidly triaged patients resuscitated from sudden cardiac death or presenting with cardiogenic shock. Older risk adjustment algorithms may not adequately reflect these issues. Consecutive patients undergoing PCI from 2000 to 2009 were randomly divided into training (n = 8,966) and validation (n = 8,891) cohorts. The 2010 ACC-NCDR (American College of Cardiology-National Cardiovascular Data Registry) mortality algorithm was applied to the training cohort and its highest risk decile, separately. Variables describing general and neurological status at admission were then tested for their additional predictive capability and new algorithms developed. These were tested in the validation cohort, using receiver-operator characteristic curve, Hosmer-Lemeshow, and reclassification measures as principal outcome measures. In-hospital mortality was 1.0%, of which 52.2% had noncardiac causes or major contributions. Baseline model C-statistics for the total and upper decile training cohorts were 0.904 and 0.830. The Aldrete score (addressing consciousness, respiration, skin color, muscle function, and circulation) and neurology scores added incremental information, resulting in improved validation cohort C-statistics (entire group: 0.883 to 0.914, p < 0.001; high-risk decile: 0.829 to 0.874, p < 0.001). Reclassification of the ACC-NCDR <90th and ≥90th risk percentiles by the new score yielded improved mortality prediction (p < 0.001 and p = 0.033, respectively). Half of in-hospital deaths in this series were of noncardiac causation. Prediction of in-hospital mortality after PCI can be considerably improved over conventional models by the inclusion of variables describing general and neurological status.

An evaluation of a distributed medical device safety surveillance system: The DELTA network study

Background Post-market medical product safety surveillance is a complex task requiring standardized data collection, prompt adverse event reporting mechanisms and appropriate methodologies to identify low frequency safety threats and risk communication. Purpose To review the design of the DELTA (Data Extraction and Longitudinal Trend Analysis) network study of the medical device safety surveillance. Methods This is a multicenter prospective observational study designed to evaluate the safety of new cardiovascular devices used during percutaneous coronary intervention (PCI) performed through continuous analysis of the routinely collected American College of Cardiology—National Cardiovascular Data Registry (ACC-NCDR) data elements. The primary endpoint of the study is detection of adverse event rates specific to several classes of new medical devices, including drug eluting coronary stents, embolic protection devices, and vascular closure devices in patients undergoing PCI. Secondary endpoints include the time-savings between the DELTA network detection of a true device safety alert and the time taken to detect the same outcome using conventional retrospective data analysis, overall sensitivity, specificity, positive predictive value and negative predictive value of the DELTA network surveillance system. Results The details of the study are described including system design, eligibility criteria, methods and components of data collection, data security and statistical methods. In addition, the methods of adjudication and verification following an adverse event alert, overall study outcomes, end points, limitations and potential advantages are discussed. Conclusion This report describes the first multicenter prospective study of a computerized safety surveillance system to monitor and evaluate the safety of new cardiovascular devices.

Acceptance, Panic, and Partial Recovery: The Pattern of Usage of Drug-Eluting Stents After Introduction in the U.S. (A Report From the American College of Cardiology/National Cardiovascular Data Registry)

Review the use of drug-eluting stents (DES) to evaluate changes in use. The DES were approved after several small studies in carefully selected patients showed dramatic reduction in in-stent restenosis. The DES were then rapidly adopted into routine practice. In 2006, 3 years after introduction, serious concerns regarding long-term safety were raised. We queried the American College of Cardiology/National Cardiovascular Data Registry (ACC/NCDR) CathPCI Registry. The percentage of DES used through mid-2009 was reviewed overall and in subgroups of patients categorized by lesion type, clinical factors, insurance, and hospital characteristics. Multivariable logistic models relating these covariates to DES usage were constructed for 3 relevant time intervals. A total of 2,247,647 coronary stent procedures were analyzed. By 2005 over 90% of first stents placed were DES. Safety concerns arising in 2006 reduced DES use to 64% of first stent placed. After publication of salutary outcomes data in 2008, usage increased to 76% by mid-2009. The logistic models demonstrated decreased likelihood of DES usage in patients with: 1) ST-segment elevation myocardial infarctions; and 2) no medical insurance. The DES usage increased for in-stent restenosis. Hospital characteristics were not associated with significant differences in DES usage. There was rapid adoption of DES into U.S. clinical practice. Concern for late stent thrombosis in 2006 significantly altered DES use with reductions seen in subgroups at risk for thrombosis and patients with no insurance. These rapid cyclic changes after DES introduction reinforce the need for continuous, timely reporting of outcomes data after the introduction of new technologies.

Tools for Guiding Clinical Practice From the American Heart Association and the American College of Cardiology

Every day, clinicians face difficult decisions on how best to manage a given patient. Important decisions include selection of the appropriate diagnostic tests, procedures, and/or treatments to improve a patient’s outcomes. Ideally, these decisions should be informed and guided by the best medical evidence. In reality, however, clinical practice tends to be highly variable.1 Concerned that a lack of standards for pacemaker implantation was leading to potential overutilization, governmental regulators asked the American Heart Association (AHA) and American College of Cardiology (ACC) in 1984 to evaluate the available evidence and develop recommendations for practice. This led to what became their first clinical practice guideline (CPG).2 Since then, the work of the ACC/AHA Task Force on Practice Guidelines has expanded markedly, currently monitoring ≈17 CPG areas (with a major focus on disease management) and determining when revisions or updates are needed to accurately reflect the evolution of evidence in cardiovascular care. Article p 1330 The process for developing CPGs was outlined in 2003.3,4 The core focus of CPG writing committees is to review and summarize the evidence in the medical literature, relying heavily on randomized controlled trials (RCTs) and when these are not available to turn to other data sources including other forms of trials, meta-analyses, and registry data. The recommendations put forth in a CPG are rigorously classified according to whether a test, procedure, or other treatment is “useful and effective” in a given setting, as well according to the level of evidence supporting this view.3 A notable example of the effort of the Task Force on Practice Guidelines to provide timely responses to a rapidly changing evidence base has been the development of focused updates, the first 3 of which dealt with ST-elevation myocardial infarction, percutaneous coronary intervention, and chronic stable angina, responding to the …

Gender differences among patients with acute coronary syndromes undergoing percutaneous coronary intervention in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR)

Although prior studies have demonstrated disparities in the management and outcomes of women with acute coronary syndrome (ACS), there are limited large-scale contemporary data on gender differences in post-intervention outcomes in this population. We analyzed patients according to 2 ACS categories, unstable angina/non-ST-elevation myocardial infarction (UA/NSTEMI) and ST-elevation myocardial infarction (STEMI) who had a percutaneous coronary intervention in the ACC-NCDR from January 1, 2004, to March 30, 2006. Of 199,690 patients, 55,691 women presented with UA/NSTEMI, and 12,335 women presented with STEMI. Clinical and angiographic characteristics, procedural and treatment patterns, and in-hospital outcomes were examined. Women presented more often with UA/NSTEMI than men (82% of women vs 77% of men, P < .0001). Despite having greater comorbidities, women in both ACS categories had fewer high risk angiographic features than men. Women were less likely to receive aspirin or glycoprotein IIb/IIIa inhibitors, and were less often discharged on aspirin or statin. For in-hospital mortality, the adjusted odds ratio for men compared to women was similar (odds ratio 0.97, P = .5). Women had higher rates of cardiogenic shock, congestive heart failure, any bleeding, and any vascular complications. Importantly, rates of subacute stent thrombosis were less in women compared to men (0.43% vs 0.57%, P = .0003). Although women had fewer high-risk angiographic features than men, they continue to have higher rates of in-hospital complications. This suggests the need for gender-tailored techniques to minimize post-intervention complications and maximize application of evidence-based antiplatelet therapies.

Abstract 3202: Gender Differences Among Patients with Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention in the ACC/NCDR PCI Registry

Background : Cardiovascular disease is the leading cause of death in women. Prior studies have demonstrated gender disparities in the management and outcomes of women with acute coronary syndromes (ACS). Objectives : We sought to explore if gender differences exist in a patient population who present with ACS and have a percutaneous coronary intervention (PCI) during hospitalization in a large, contemporary national PCI registry, the American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR). Methods : We analyzed ACS patients who had a PCI in the ACC-NCDR PCI registry from January 1, 2004 to March 30, 2006. Clinical characteristics, procedural and clinical outcomes, and concomitant medical therapies were compared between men and women according to ACS status: unstable angina (UA)/non-ST elevation MI (NSTEMI) and ST elevation MI (STEMI). Results : Of 199,690 patients with ACS who underwent PCI, women more often presented with unstable angina (57.7% vs. 53.9%), equally with NSTEMI (24.2% vs. 23.6%), and less often with STEMI (18.1% vs. 22.6%) compared with men. In both ACS categories, women were older and had a higher incidence of diabetes (insulin or non-insulin dependent), HTN, PVD, CVA, past and current CHF and renal failure. There was also a higher incidence of cardiogenic shock in women among the STEMI population. The use of drug eluting stents was similar among women and men, but women were less likely to receive aspirin, GP IIb-IIIa inhibitors, and discharge aspirin and statins compared with men. While the adjusted rate of in-hospital mortality was similar among women and men, women had higher rates of peri-procedural complications, including more cardiogenic shock, CHF, bleeding and vascular complications. Rates of subacute stent thrombosis were similar between genders. Conclusions : Women with ACS who underwent PCI were older and more likely to have comorbidities compared with men, and were more likely to have procedural complications. Whether these differences were related to the observed differences in a number of evidence-based medications or clinical characteristics among women vs. men will require further study. Adjusted rate of in-hospital mortality was similar among women and men.

The Case for Outpatient Coronary Intervention

Over the past 30 years, dramatic improvements have been achieved in the safety of percutaneous coronary intervention (PCI) procedures, despite the increasing complexity of clinical and anatomic conditions treated. The need for emergent bypass surgery has declined from 8% in 1990 to far less than 1% in the current era, and the rate of vascular complications has declined dramatically as techniques have improved and procedural experience has increased. Given the remarkable current periprocedural safety profile of elective coronary intervention, has the time come for us to consider whether outpatient PCI can be safely performed? In this issue of Circulation , investigators from the Academic Medical Center of the University of Amsterdam investigated this question as part of the Elective PCI in Outpatient Study (EPOS).1 Article p 2299 The study by Heyde and colleagues randomly assigned 800 consecutive, elective, outpatient, planned PCI patients to a strategy of either same-day discharge or routine care that included an overnight observation in the hospital. The patients and providers were blinded to the assignment until after evaluation according to predefined criteria for those patients who required additional observation or treatment. All patients eligible for same-day discharge, regardless of assignment, were then strictly observed for 4 hours and then underwent a rigorous triage evaluation to determine if same-day discharge would be appropriate. At that time, those patients who were randomized to the same-day discharge group were discharged, whereas the patients randomized to the overnight hospitalization group were kept in-hospital for observation. The investigators found that 20% of patients in both disposition arms developed one of the predefined exclusions for same-day discharge. Of the ≈80% of patients suitable for same-day discharge, none suffered a cardiac event within 24 hours after PCI, and only 3 patients suffered a vascular complication, with no differences observed in the 2 …

Frequency of Percutaneous Coronary Interventions at Facilities Without On-Site Cardiac Surgical Backup—A Report from the American College of Cardiology–National Cardiovascular Data Registry (ACC-NCDR)

The practice of performing percutaneous coronary intervention (PCI) in centers without on-site cardiac surgical backup is controversial. Using data from facilities that participated in the American College of Cardiology/National Cardiovascular Data Registry, the incidence of PCI without on-site surgical backup was evaluated. From January 1, 2001 through December 31, 2004, 39 of 449 (8.7%) centers were identified as sites that performed PCI without on-site surgical backup. By the end of 2005, 75 of 463 (16%) participating facilities were performing PCI without on-site backup. By using standardized data element definitions, it was possible to differentiate between patients who underwent elective PCI and those who had urgent nonelective PCI for acute ST-segment elevation myocardial infarction or non-ST-segment elevation myocardial infarction. This analysis showed that the number of elective and nonelective PCI procedures with or without on-site surgical backup per quarter had increased significantly (p <0.0001) from 2001 to 2004. The number of PCI procedures performed without on-site surgical backup continued to increase in 2005. In conclusion, the significant increase in elective PCIs performed at facilities without on-site surgical backup occurred despite national guidelines that state elective PCI should not be done in centers without on-site cardiac surgery.

Trends in percutaneous versus surgical revascularization of unprotected left main coronary stenosis in the drug‐eluting stent era—a report from the American College of Cardiology‐National Cardiovascular data registry (ACC‐NCDR)

We sought to determine how practice patterns for unprotected left main stenosis have changed with the advent of drug-eluting stents (DES). Percutaneous coronary intervention (PCI) of unprotected left main coronary stenosis has been controversial. We analyzed data submitted to the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) between January 1, 2002 and December 31, 2004 from 1,276,582 cardiac catheterizations at 417 institutions. Of these, 53,548 (4.2%) had left main stenosis >50% and no prior CABG. After excluding the unrevascularized, the patient sample (N = 32,562) was analyzed for PCI vs. CABG. Data was stratified by year/quarter, bare metal stent vs. DES, elective vs. urgent/emergent situations, LVEF < or > or =40%, and %left main and RCA stenosis. Of unprotected left main revascularizations from 2002 to 2004, PCI increased from 17.0% to 21.9%, while CABG decreased from 83.0% to 78.1% (P < 0.0001). In 2002, bare metal stents were used for all PCIs; in 2004, bare metal stent use was only 25.5%, while DES use was 74.5% (P < 0.0001). Of elective procedures, PCI rose from 19.1% to 27.5% while CABG fell from 80.9% to 72.5% (P < 0.0001). Similar trends, all significant, were seen in every clinical situation. In the era of DES, the rate of PCI for unprotected left main stenosis has risen, while CABG has declined. These findings are seen across varying clinical situations, including elective procedures. DES have rapidly and largely replaced bare metal stents for PCI of unprotected left mains. However, PCI is still chosen less frequently than CABG for unprotected left main revascularization.

Ad Hoc percutaneous coronary interventions in patients with stable coronary artery disease—A study of prevalence, safety, and variation in use from the American College of Cardiology National Cardiovascular Data Registry (ACC‐NCDR®)

To utilize the American College of Cardiology National Cardiovascular Data Registry (ACC-NCDR) to monitor the performance and safety of ad hoc PCIs. The performance of ad hoc PCI remains controversial. Patients' preference, cost, and vascular access issues favor an ad hoc strategy. Adequate time for thoughtful decision-making, scheduling complexity, informed consent, and physician reimbursement favor PCI on a subsequent day. We analyzed results in 68,528 patients with stable angina entered in the ACC-NCDR from 2001-2003. Ad hoc PCI was evaluated in many clinical and nonclinical subgroups. A multivariable analysis was performed to determine whether ad hoc PCI had an independent relationship with complications or procedure success. Overall, 60.6% of patients underwent ad hoc PCI. There was no difference in ad hoc PCI mortality, renal failure, or vascular complications from staged PCI. A lower percentage of patients at high vs. low risk and with vs. without renal failure underwent ad hoc PCIs (58.6% vs.63.0% and 50.7% vs. 60.9% respectively). There was wide variation in the performance of ad hoc PCIs according to payer (70.2-60.3%), hospital PCI volume (67-50.2%), hospital owner (89.7-59.6%), and geographic area (75.5-47.4%). Ad hoc PCI per se was not independently related to PCI success or complications. PCI success was related to patient/lesion related factors and not to the performance of ad hoc PCIs per se. Although ad hoc PCI can be performed in more patients than at present, this strategy will never be possible in all patients at all times.

Risk of local adverse events by gender following cardiac catheterization

To assess the reason for the relative high risk of local complications for women following cardiac catheterization by evaluating the associations between gender, sheath size, and local adverse outcomes following cardiac catheterization. The data used in this study were obtained from a portion of the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR), which included 13 878 patients who underwent cardiac catheterization at one of 59 participating cardiac catheterization institutions throughout the United States during late 2003. Rates of serious local vascular adverse events were calculated by gender following cardiac catheterization, by type of vascular hemostasis used, stratified by arterial sheath size. Serious local vascular events were reported in 3.54% of patients, most commonly hematoma (2.00%). The relative risk for women of any vascular complication was 1.40 [95%CI = 1.17, 1.67, p = 0.0002]. A statistically significant relative risk for woman was evident when collagen plug devices or manual compression alone were used as the first method for hemostasis. The rate of vascular complications increased progressively with increasing sheath size, more so in women than in men. High relative risk for women of local vascular complications following cardiac catheterization was demonstrated with use of manual compression, as well as with collagen plug devices to control femoral artery bleeding. Large sheath size is associated with both a relatively high absolute risk and a high relative risk for women. Knowledge of this information should be considered by interventional cardiologists in making decisions on how to achieve hemostasis following cardiac catheterization.

Implantable Cardioverter-Defibrillators for Primary Prevention of Sudden Death in Heart Failure

The demonstrated efficacy of implantable cardioverter-defibrillators (ICDs) for reducing sudden death in heart failure trial populations presents a critical challenge to those responsible for the allocation of healthcare resources.1–3 The current cost, multiplied by the prevalence of heart failure deemed high-risk, threatens to make this one enterprise the highest priced intervention for the Medicare population. The elegant cost-effectiveness analysis contributed by Dr Mark and colleagues from the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) in this issue of Circulation provides an exemplary insight into this challenge.4 These investigators’ favorable conclusions are consistent with those from a meta-analysis by Sanders et al5 and with the slightly more conservative implications from the recent cost-effectiveness analysis of the Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II by Zwanziger et al.6 Article p 135 This editorial will offer an alternative conclusion based on both back-of-the-envelope estimations and scrutiny of model assumptions regarding different phases of survival for heart failure populations. ICDs for primary prevention of sudden death in the heart failure population may be less cost-effective than other recommended heart failure therapies, which are prescribed to modify disease progression and symptoms, decreasing costly hospitalizations as well as mortality. Formal cost-effectiveness analysis is complex, but it may be illustrative to begin from simple considerations. A reasonable threshold for cost-effective intervention is often assigned as $40 000 per life-year saved, in line with the present article4 suggesting a cost of $38 389 per life-year saved and $41 530 per quality-adjusted life-year saved. This is approximately equal to the cost of the defibrillator device and implantation, as currently assessed for reimbursement. (The costs would be lower for the simpler device used in SCD-HeFT, which is not available now, and for outpatient implantation, which was common in SCD-HeFT but not the current standard.) This …

Mortality After Emergent Percutaneous Coronary Intervention in Cardiogenic Shock Secondary to Acute Myocardial Infarction and Usefulness of a Mortality Prediction Model

Although percutaneous coronary intervention (PCI) in the setting of cardiogenic shock has a high in-hospital mortality rate, it has been shown to decrease the mortality rate in certain subgroups. The identity and relative importance of variables that are predictive of in-hospital mortality rate after PCI for cardiogenic shock are uncertain. Accordingly, we examined data of >300,000 patients in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) that were collected from 1998 to 2002 and evaluated the outcomes in 483 consecutive patients who underwent emergency PCI for cardiogenic shock. Patients' mean age was 65 +/- 13 years, with men predominating (61%). All underwent emergency/salvage PCI in the setting of cardiogenic shock after acute myocardial infarction. Mean left ventricular ejection fraction was 30 +/- 16%. Stents were placed in 64% of patients, and thrombolytic agents were administered in 26%. Although PCI was angiographically successful in 79% of patients, the in-hospital mortality rate was 59.4%. Length of stay after PCI was 7.2 +/- 8 days. Logistic regression using all available variables identified 6 multivariate predictors of death: age (odds ratio [OR] 2.34, 95% confidence interval [CI] 1.68 to 3.28, p <0.001) for each 10-year increment, female gender (OR 1.55, 95% CI 1.00 to 2.41, p <0.001), baseline renal insufficiency (creatinine >2.0 mg/dl; OR 4.69, 95% CI 1.96 to 11.23, p <0.001), total occlusion in the left anterior descending artery (OR 1.99, 95% confidence interval 1.28 to 3.09, p <0.01), no stent used (OR 2.55, 95% CI 1.63 to 3.96, p <0.01), and no glycoprotein IIb/IIIa inhibitor used during PCI (OR 1.96, 95% CI 1.30 to 2.98, p <0.01). In a second analysis using only variables known to the clinician at the time of initial presentation, gender, age, renal insufficiency, and total occlusion of the left anterior descending coronary artery were significant. In conclusion, analysis of patients from the ACC-NCDR who underwent emergency PCI for acute myocardial infarction in the presence of cardiogenic shock shows an in-hospital mortality rate of approximately 60% when PCI is attempted.

Predictors of in-hospital mortality in 1333 patients with acute myocardial infarction complicated by cardiogenic shock treated with primary percutaneous coronary intervention (PCI): Results of the primary PCI registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK)

Although percutaneous coronary intervention (PCI) in the setting of cardiogenic shock has a high in-hospital mortality rate, it has been shown to decrease the mortality rate in certain subgroups. The identity and relative importance of variables that are predictive of in-hospital mortality rate after PCI for cardiogenic shock are uncertain. Accordingly, we examined data of >300,000 patients in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) that were collected from 1998 to 2002 and evaluated the outcomes in 483 consecutive patients who underwent emergency PCI for cardiogenic shock. Patients’ mean age was 65 ± 13 years, with men predominating (61%). All underwent emergency/salvage PCI in the setting of cardiogenic shock after acute myocardial infarction. Mean left ventricular ejection fraction was 30 ± 16%. Stents were placed in 64% of patients, and thrombolytic agents were administered in 26%. Although PCI was angiographically successful in 79% of patients, the in-hospital mortality rate was 59.4%. Length of stay after PCI was 7.2 ± 8 days. Logistic regression using all available variables identified 6 multivariate predictors of death: age (odds ratio [OR] 2.34, 95% confidence interval [CI] 1.68 to 3.28, p <0.001) for each 10-year increment, female gender (OR 1.55, 95% CI 1.00 to 2.41, p <0.001), baseline renal insufficiency (creatinine >2.0 mg/dl; OR 4.69, 95% CI 1.96 to 11.23, p <0.001), total occlusion in the left anterior descending artery (OR 1.99, 95% confidence interval 1.28 to 3.09, p <0.01), no stent used (OR 2.55, 95% CI 1.63 to 3.96, p <0.01), and no glycoprotein IIb/IIIa inhibitor used during PCI (OR 1.96, 95% CI 1.30 to 2.98, p <0.01). In a second analysis using only variables known to the clinician at the time of initial presentation, gender, age, renal insufficiency, and total occlusion of the left anterior descending coronary artery were significant. In conclusion, analysis of patients from the ACC-NCDR who underwent emergency PCI for acute myocardial infarction in the presence of cardiogenic shock shows an in-hospital mortality rate of ∼60% when PCI is attempted.

Evaluation of the American College of Cardiology/American Heart Association and the Society for Coronary Angiography and Interventions lesion classification system in the current “stent era” of coronary interventions (from the ACC-National Cardiovascular Data Registry)

In 1988 American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for Coronary Angioplasty proposed a lesion classification system to stratify lesions by difficulty and risk to better understand the outcomes of coronary interventions. It was a 3-level (A, B, and C) classification based on 11 lesion characteristics. A modification, dividing the intermediate B category into B1 and B2, is also in common use. Recently, a simplification of this classification was evaluated using the large Society for Cardiac Angiography and Interventions (SCAI) Registry (SCAI I = non-C/patent; SCAI II = C/patent; SCAI III = non-C/occluded; SCAI IV = C/occluded). The lesion classification systems were evaluated in 61,926 patients from the ACC National Cardiovascular Data Registry who underwent single-vessel percutaneous coronary intervention between January 1998 and September 2000. Stents were placed in 74.5% of patients. Logistic models for lesion success and complications were constructed and compared. The c statistic for success using the ACC/AHA original classification system was 0.69, 0.71 for the modified ACC/AHA system, and 0.75 for the SCAI classification. The range of complication and success rates was greater using the SCAI models, and the logistic models for success and complication were more robust for the SCAI system. Thus, in the large ACC-National Cardiovascular Data Registry, with a high percentage of stent usage, the simpler SCAI lesion classification provided better discrimination for success and complications than the more complex ACC/AHA lesion classification system—original or modified.

The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR)

The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR)