Cardiovascular Outcomes Research Research Articles

What Can We Do About Cardiogenic Shock?

Cardiogenic shock (CGS) remains a significant clinical problem in cardiovascular medicine. Although history shows event rates have improved, they remain substantial. In 1942, the observations of Stead1 of shock syndrome resulting from failure of the heart were published, and death at this time in CGS was expected, that is, it was reported at 100%. Goldberg et al2 in 1977 to 1985 reported in-hospital mortality rates from CGS of 74% to 81%. Since the introduction of early percutaneous coronary intervention (P-PCI) for ST-segment–elevation myocardial infarction (STEMI), there has been a reduction in mortality from CGS. Even so, in the SHOCK trial (Should we Emergently Revascularise Occluded arteries for Cardiogenic Shock), the 30-day mortality of CGS patients randomized to early revascularization was 46.7%,3 and it has not changed in the past 16 years despite further pharmacological development (such as the TRIUMPH study4 [A Phase III International, Multi-Center, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Nitric Oxide Synthase Inhibition With Tilarginine Acetate Injection in Patients With Cardiogenic Shock Complicating Acute Myocardial Infarction] testing the inducible nitric oxide synthase inhibitor tilarginine) and the introduction and testing of devices to support the myocardium such as the Intra Aortic Balloon Pump (eg, as in the IABP-II study5 [Intra-Aortic Balloon Pump]). Indeed to add to the problem, there have been data to suggest that CGS rates are rising. Kolte et al6 reported in 2014 that among 1,990,486 reviewed patients, the incidence of CGS rose from 6.5% in 2003 to 10.1% in 2010, which is likely to be because of improvements in very early mortality associated with P-PCI. Further insights come from Kunadian et al,7 who analyzed the data from the UK British Cardiovascular Intervention Society (BCIS) National Cardiovascular Outcomes Research (NICOR) database and also reported …

Cardiovascular Immunotherapy and the Role of Imaging.

Despite significant advances in prevention and treatment, cardiovascular diseases (CVDs) remain the most common cause of death in the United States.1–3 In part, and compared with treatment developments in oncology, this is because of the lack of current generation CVD precision therapies.4–6 Most CVDs are caused by atherosclerosis, a disease process that causes thickening of the arterial wall because of inflammation and lipid accumulation, resulting in plaque formation.7,8 Macrophage dynamics plays a central role in atherosclerosis progression, vessel wall destabilization, and—as has been recently discovered—plaque aggravation because of myocardial infarction.9–11 Therefore, and despite current standardized treatments, ≈25% of patients who had myocardial infarction or stroke will experience secondary major adverse cardiovascular events, often more harmful than the primary event.12–14 To break this vicious cycle, innovative and tailored therapeutic strategies are needed. Various targeted immunotherapies that showed anticancer potential in in vitro screens also displayed in vivo potential in mouse models. Such proof-of-concept studies in validated syngeneic mouse tumor models not only provide information on in vivo efficacy but also disclose the targeted immunotherapies’ underlying mechanism of action and safety profile. However, immunotherapies’ high costs and the identification of amendable patients compromise clinical translation.15,16 Continued and focused efforts are needed to understand patient responsiveness and reduce high dropout rates in trials. A parallel effort focused on the development of novel imaging tools that can guide patient selection may offer a potential solution. Positron emission tomography (PET) can be used to trace immunotherapies. So-called immunoPET uses antibodies, developed for cancer treatment, that selectively recognize a specific epitope on target cells. The antibodies are labeled with radioactive isotopes, such as zirconium-89 or iodine-124, with relatively long decay half-lives of 3.27 and 4.18 days, respectively, to …

PCSK9 Mutations in Familial Hypercholesterolemia: from a Groundbreaking Discovery to Anti-PCSK9 Therapies.

In 2003, Abifadel et al. (Nat. Genet. 34:154-156, 2003) identified PCSK9, encoding proprotein convertase subtilisin/kexin type 9, as the third causal gene for autosomal dominant hypercholesterolemia. This review focuses on the main steps from this major breakthrough in familial hypercholesterolemia (FH) to the latest clinical trials with the anti-PCSK9 antibodies. The year 2015 was remarkable in cardiovascular disease through the field of cholesterol. Nearly 30years after the discovery of statins, a new class of effective lipid-lowering drugs has emerged: the anti-PCSK9 antibodies. The discovery of the first gain-of-function mutations of PCSK9 in FH rapidly became the center of interest of researchers worldwide. Preclinical and clinical studies launched by pharmaceutical companies led to the first three anti-PCSK9 antibodies, two of which (evolocumab and alirocumab) reduce LDL cholesterol levels by 50-60% and received FDA and European Medicines Agency approvals in 2015 on top of statin therapy. Recently, results of the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, the outcome trial of evolocumab over 2.2years, showed a reduction of 15-20% in the risk of major cardiovascular outcomes in high-risk patients receiving statin therapy. Results of ODYSSEY OUTCOMES trial, evaluating the effect of alirocumab in 18,000 patients with established CVD are also eagerly awaited in 2018. The evolution of research on PCSK9, starting from the discovery of the first set of mutations in PCSK9 in FH in 2003, is an amazing example of successful translational research. It shows how rigorous and powered genetic analyses can lead to the discovery of a new class of lipid-lowering drugs that give hope in fighting high cholesterol levels and their cardiovascular complications.

TCT-49 Long-term valve function 5-9 years after transcatheter aortic valve implantation: data from the UK-TAVI Registry. On behalf of the National Institute for Cardiovascular Outcomes Research (NICOR)

Little is known about the long-term durability of trans-catheter aortic heart valves, particularly beyond 5 years. In the UK 100% of cases are recorded on the UK TAVI database, and annual follow-up trans-thoracic echocardiography (TTE) is recommended. Data on all patients undergoing TAVI in the UK

Training cardiovascular outcomes researchers: A survey of mentees and mentors to identify critical training gaps and needs

Many young investigators are interested in cardiovascular (CV) outcomes research; however, the current training experience of early investigators across the United States is uncertain. From April to November 2014, we surveyed mentees and mentors of early-stage CV outcomes investigators across the United States. We contacted successful grantees of government agencies, members of professional organizations, and trainees in CV outcomes training programs. A total of 185 (of 662) mentees and 76 (of 541) mentors completed the survey. Mentees were equally split by sex; most had completed training >3 years before completing the survey and were clinicians. Mentors were more likely women, mostly ≥20 years posttraining, and at an associate/full professor rank. Mentors reported devoting more time currently to clinical work than when they were early in their career and mentoring 2-4 people simultaneously. More than 80% of mentees started training to become academicians and completed training with the same goal. More than 70% of mentees desired at least 50% research time in future jobs. More than 80% of mentors believed that future investigators would need more than 50% time dedicated to research. Most mentees (80%) were satisfied with their relationship with their mentor and reported having had opportunities to develop independently. Mentors more frequently than mentees reported that funding cutbacks had negatively affected mentees' ability to succeed (84% vs 58%). Across funding mechanisms, mentees were more optimistic than mentors about securing funding. Both mentees and mentors reported greatest preparedness for job/career satisfaction (79% for both) and publications (84% vs 92%) and least preparedness for future financial stability (48% vs 46%) and work-life balance (47% vs 42%). Survey findings may stimulate future discourse and research on how best to attract, train, and retain young investigators in CV outcomes research. Insights may help improve existing training programs and inform the design of new ones.

How well does early-career investigators' cardiovascular outcomes research training align with funded outcomes research?

Outcomes research training programs should prepare trainees to successfully compete for research funding. We examined how early-career investigators' prior and desired training aligns with recently funded cardiovascular (CV) outcomes research. We (1) reviewed literature to identify 13 core competency areas in CV outcomes research; (2) surveyed early-career investigators to understand their prior and desired training in each competency area; (3) examined recently funded grants commonly pursued by early-career outcomes researchers to ascertain available funding in competency areas; and (4) analyzed alignment between investigator training and funded research in each competency area. We evaluated 185 survey responses from early-career investigators (response rate 28%) and 521 funded grants from 2010 to 2014. Respondents' prior training aligned with funded grants in the areas of clinical epidemiology, observational research, randomized controlled trials, and implementation/dissemination research. Funding in community-engaged research and health informatics was more common than prior training in these areas. Respondents' prior training in biostatistics and systematic review was more common than funded grants focusing on these specific areas. Respondents' desired training aligned similarly with funded grants, with some exceptions; for example, desired training in health economics/cost-effectiveness research was more common than funded grants in these areas. Restricting to CV grants (n=132) and National Heart, Lung, and Blood Institute-funded grants (n=170) produced similar results. Identifying mismatch between funded grants in outcomes research and early-career investigators' prior/desired training may help efforts to harmonize investigator interests, training, and funding. Our findings suggest a need for further consideration of how to best prepare early-career investigators for funding success.

The emerging role of proprotein convertase subtilisin/kexin type-9 inhibition in secondary prevention: from clinical trials to real-world experience.

The recent advent of a highly efficacious class of low-density lipoprotein cholesterol (LDL-C) lowering agents, the proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibitors, has transformed dyslipidaemia management in patients with cardiovascular disease as well as those with familial hypercholesterolemia. Recent positive results of the landmark Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk cardiovascular outcome trial with evolocumab as an add-on to statin therapy demonstrate further reduction of cardiovascular events. Additional safety outcomes from this large randomized trial, as well as the EBBINGHAUS substudy, allay fears of neurocognitive disorder as an adverse effect of achieving very low LDL-C levels with these agents. Widespread clinical adoption of PCSK9 inhibitors will depend on the results from ongoing and planned cardiovascular efficacy and safety trials with PCSK9 inhibitors. In addition, understanding the practical challenges and barriers to usage of these injectable agents by high cardiovascular risk patients will also affect clinical adoption of this class of agents. Analysis of cost-benefit models, along with anticipated updates to practice guidelines for dyslipidaemia management are likely to strengthen the clinical utility of PCSK9 inhibitors. Importantly, the potency of this new class of agents provides a huge opportunity to extend further the 'lower LDL-C is better' hypothesis in an effort to reduce rates of cardiovascular morbidity and mortality on a population level.

Application of PCSK9 Inhibitors in Practice: Challenges and Opportunities.

Although the discovery of proprotein convertase subtilisin/kexin type 9 (PCSK9) and development of therapeutic antagonists represent a major triumph of modern clinical medicine, efforts to implement PCSK9 inhibitors (PCSK9i) in patient care have been sobering. This practical guide examines the barriers and opportunities for the successful application of pharmacological inhibition of PCSK9 in clinical practice through introduction of a new model of care delivery—the PCSK9i clinic. Historically, the foundation of primary and secondary prevention of atherosclerotic cardiovascular disease (ASCVD) has consisted of therapeutic lifestyle changes in combination with pharmacological therapy focused on lipid modulation, specifically low-density lipoprotein cholesterol (LDL-C) lowering.1 In 2015, the Food and Drug Administration (FDA) approved a new class of cholesterol-lowering medications, PCSK9i, to great anticipation. The seminal discovery in 2003 by Abifadel et al2 linked gain-of-function mutations in the PCSK9 gene with autosomal dominant hypercholesterolemia. This finding uncovered PCSK9 as a key player in cholesterol homeostasis, a circulating protein with the strongest influence on plasma LDL-C concentration.3 PCSK9 directly interacts with the low-density lipoprotein receptor and enhances its degradation by targeting it for destruction by the lysosome and halting its efficient recycling. Because PCSK9 causes degradation of the low-density lipoprotein receptor, inhibiting its action prolongs the lifespan of the low-density lipoprotein receptor and leads to profound reductions in plasma LDL-C levels. The ultimate culmination of this work was the regulatory approval of 2 monoclonal antibody inhibitors of PCSK9 (alirocumab and evolocumab). More recently, the randomized, placebo-controlled trial, FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), demonstrated improved ASCVD outcomes when evolocumab was added to background treatment with a statin. The combination of statin plus evolocumab resulted in a significant absolute and relative risk reduction in both the primary composite end point (cardiovascular death, myocardial infarction, stroke, and hospitalization …

Priorities for Cardiovascular Outcomes Research: A Report of the National Heart, Lung, and Blood Institute's Centers for Cardiovascular Outcomes Research Working Group.

The Centers for Cardiovascular Outcomes Research (CCORs) held a meeting to review how cardiovascular outcomes research had evolved in the decade since the National Heart, Lung, and Blood Institute 2004 working group report and to consider future directions. The conference involved representatives from governmental agencies, outcomes research thought leaders, and public and private healthcare partners. The main purposes of this meeting were to (1) advance collaborative high-yield, high-impact outcomes research; (2) identify priorities and barriers to important cardiovascular outcomes research; and (3) define future needs for the field. This report highlights the key topics covered during the meeting, including an examination of the recent history of outcomes research, an evaluation of the current academic climate, and a vision for the future of cardiovascular outcomes research.

Advances in the management of dyslipidemia.

Cardiovascular disease is the leading cause of morbidity and mortality in the United States and therapies aimed at lipid modification are important for the reduction of cardiovascular risk. There have been many exciting advances in lipid management over the recent years. This review discusses these recent advances as well as the direction of future studies. Several recent clinical trials support low-density lipoprotein cholesterol (LDL-c) reduction beyond maximal statin therapy for improved cardiovascular outcomes. Ezetimibe reduced LDL-c beyond maximal statin therapy and was associated with improved cardiovascular outcomes for high-risk populations. Further LDL-c reduction may also be achieved with proprotein convertase subtilisin/kexin type-9 (PCSK9) inhibition and a recent trial, Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER), was the first to show reduction in cardiovascular events for evolocumab. Additional outcome studies of monoclonal antibody and RNA-targeted PCSK9 inhibitors are underway. Quantitative high-density lipoprotein cholesterol (HDL-c) improvements have failed to have clinical impact to date; most recently, cholesteryl ester transfer protein inhibitors and apolipoprotein infusions have demonstrated disappointing results. There are still ongoing trials in both of these areas, but some newer therapies are focusing on HDL functionality and not just the absolute HDL-c levels. There are several ongoing studies in triglyceride reduction including fatty acid therapy, inhibition of apolipoprotein C-3 or ANGTPL3 and peroxisome proliferator-activated receptor-α agonists. Lipid management continues to evolve and these advances have the potential to change clinical practice in the coming years.

Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) and Its Inhibitors: a Review of Physiology, Biology, and Clinical Data.

Atherosclerotic cardiovascular disease (ASCVD) remains the number one killer in the western world. Low-density lipoprotein cholesterol (LDL-C) reduction with statins and ezetimibe has been shown to reduce the risk of cardiovascular events. Now, proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mabs) are available for high-risk individuals with ASCVD or familial hypercholesterolemia on maximally tolerated statin therapy but requiring greater LDL-C reduction. PCSK9 mab outcome trial results from the Further Cardiovascular Outcomes Research with PCSK9 Inhibitions in Subjects with Elevated Risk (FOURIER) study, which was presented at the American College of Cardiology in March 2017, which demonstrated a decrease of 15% in primary and 20% secondary end points over a 2-year period [1••]. These results firmly demonstrated additional benefit beyond maximally tolerated statin therapy in high-risk individuals. Thus, management of LDL-C will soon become more complex, as a new class of medication is added to our standard armamentarium. This review explores the discovery of PCSK9, its biology and physiology, and the development of the PCSK9 mabs.

Coverage and Cardioprotective Benefits of PCSK9 Take Center Stage at the American College of Cardiology Meeting.

With news breaking at the American College of Cardiology’s Annual Scientific Session that evolocumab lowered cardiovascular events compared with placebo but did not reduce deaths in the FOURIER trial (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), the debate about the place of PCSK9 (proprotein convertase subtilisin–kexin type 9) inhibitors in practice and their high price is unlikely to end soon. The highly anticipated results showed a 15% reduction in cardiovascular events, and results from a sister trial showed no increase in neurocognitive problems, providing much needed information for clinicians using this drug in their practices. But the results, which were less favorable than many hoped, are unlikely to resolve the ongoing challenges posed by the high cost of this class of drugs and the reticence of payers to cover it. “This drug presents challenges to the health system,” said Harlan Krumholz, MD, SM, a cardiologist and health policy researcher at Yale University. “It is effective, but not miraculous. The benefit will seem substantial to some and modest to others, like many preventive interventions, but, in this case, there is the added issue that the cost is high.” Data showing that PCSK9 inhibitors evolocumab and alirocumab could slash low-density lipoprotein levels led to US Food and Drug Administration approval for both drugs in 2015. But the drugs, which are approved for patients with familial hypercholesterolemia or high-risk …

Klinická štúdia FOURIER

A new group of hypolipidemic substances, i.e. PCSK9 protein inhibitors, is now coming into use in clinical practice, to what extent a high residual cardiovascular risk remains also in patients treated with statins. The FOURIER study (Further cardiovascular OUtcomes Research with PCSK9 Inhibition subjects with Elevated Risk) is the first event study which has shown that evolocumab (PCSK9 antibody) further significantly reduces serum LDL cholesterol and subsequently also cardiovascular morbidity and mortality: (a) composite primary goal (cardiovascular mortality, incidence of heart attacks, strokes, hospitalizations for unstable angina, coronary revascularization) by 15 % (p < 0.001), (b) secondary goal (cardiovascular mortality, incidence of heart attacks, strokes) by 20 % (p < 0.001), (c) the treatment effect increased with length of treatment, and (d) the treatment was safe. The study has therefore confirmed that further reduction of serum LDL cholesterol by means of evolocumab significantly reduces incidence of cardiovascular events in patients with elevated risk. This treatment is primarily needed for individuals with elevated cardiovascular risk.Key words: atherosclerosis - evolocumab - cardiovascular diseases - LDL cholesterol - PCSK9 inhibitors.

PCSK9 Inhibition to Reduce Cardiovascular Risk: Tempering Expectations.

> Evolocumab and clinical outcomes in patients with cardiovascular disease > > Sabatine et al > > N Engl J Med . Published online ahead of print March 17, 2017. > Cardiovascular efficacy and safety of bococizumab in high-risk patients > > Ridker et al > > N Engl J Med . 2017;376:1527–1539. The first large clinical outcomes trials of proprotein convertase subtilisin–kexin type 9 (PCSK9) inhibitors have demonstrated that these drugs, when taken with statins, reduce cardiovascular events by 15% to 20% more than statins alone. However, this event reduction is less than expected for such a large decrease in low-density lipoprotein cholesterol (LDL-C), and the reasons for this disconnect between LDL-C lowering and cardiovascular events remain unclear. Future trials should clarify the degree of clinical benefit to be expected from PCSK9 inhibitors. Two years ago, in these pages, we discussed the results of very early clinical outcome trials of the PCSK9 monoclonal antibodies evolocumab and alirocumab.1 These drugs both reduced LDL-C levels by slightly >60% on top of statin therapy and reduced cardiovascular events by ≈50%.2,3 We noted that although these results engendered great expectations, both of these studies were preliminary, with a small number of end points, short follow-up, and other important limitations.1 As often happens with life in general, our great expectations have been tempered by 2 recent reports. The FOURIER trial (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) enrolled 27 564 patients with atherosclerotic cardiovascular disease and LDL-C levels ≥70 mg/dL who were receiving statin therapy.4 Patients were randomly assigned to receive double-blind treatment with evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or placebo as subcutaneous injections. The primary composite end point was cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization and the median duration of follow-up …

United Kingdom: coronary and structural heart interventions from 2010 to 2015.

In the United Kingdom, a clinical data set is completed for every patient undergoing coronary intervention and certain structural interventions, and sent to central servers in the National Institute for Cardiovascular Outcomes Research (NICOR) on behalf of the British Cardiovascular Intervention Society (BCIS). These data are linked to the national mortality register. In addition, data are obtained about the structure of healthcare provision using an annual survey. Analyses of these data are provided for different audiences in several formats. Public reports of individual consultant operator activity and risk-adjusted outcomes from percutaneous coronary intervention (PCI) have also been produced annually since 2012. Transcatheter aortic valve implantation (TAVI) has been performed since 2007. Over 2,000 cases were performed in 2015, giving a rate of 30 per million population. Complications to discharge have fallen as case mix has changed and technologies improved. While the mean age has remained about 81 years, the logistic EuroSCORE of patients treated by TAVI has fallen from about 22 in 2010 to 18 in 2015. Tracked 30-day mortality was 3.7% in 2014. Left atrial appendage occlusion and patent foramen ovale (PFO) closure for stroke, and the use of the MitraClip® system (Abbott Vascular, Santa Clara, CA, USA) for mitral regurgitation have been funded through a process called "commissioning through evaluation".

A New Approach to PCSK9 Therapeutics.

PCSK9 inhibition is an effective therapy to reduce LDL cholesterol (LDL-C) and cardiovascular events. A recent study shows that one or two doses of inclisiran, a long-acting synthetic small-interfering RNA (siRNA) that selectively targets hepatic PCSK9, causes a sustained reduction of plasma LDL-C for up to 6 months. Pending further studies of safety and efficacy, this may represent an important addition to the armamentarium for inhibiting PCSK9.

Acute type A aortic dissection in the United Kingdom: Surgeon volume-outcome relation

ObjectivesSurgery for acute type A aortic dissection (ATAD) carries a high risk of operative mortality. We examined the surgeon volume-outcome relation with respect to in-hospital mortality for patients presenting with this pathology in the United Kingdom. MethodBetween April 2007 and March 2013, 1550 ATAD procedures were identified from the National Institute for Cardiovascular Outcomes Research database. A total of 249 responsible consultant cardiac surgeons from the United Kingdom recorded 1 or more of these procedures in their surgical activity over this period. We describe the patient population and mortality rates, focusing on the relationship between surgeon volume and in-hospital mortality. ResultsThe mean annual volume of procedures per surgeon during the 6-year period ranged from 1 to 6.6. The overall in-hospital mortality rate was 18.3% (283/1550). A mortality improvement at the 95% level was observed with a risk-adjusted mean annual volume >4.5. Surgeons with a mean annual volume <4 over the study period had significantly higher in-hospital mortality rates in comparison with surgeons with a mean annual volume ≥4 (19.3% vs 12.6%; P = .015). ConclusionsPatients with ATAD who are operated on by lower-volume surgeons experience higher levels of in-hospital mortality. Directing these patients to higher-volume surgeons may be a strategy to reduce in-hospital mortality.

Increasing Medical Trainees' Empathy Through Volunteerism and Mentorship.

Background:Within medical education, there have been recent calls for increased understanding and exposure to poverty to increase trainees’ empathy toward the underserved. Students participating in Michigan Cardiovascular Outcomes Research and Reporting Program research program volunteered at World Medical Relief (WMR) in Detroit, Michigan, a nonprofit organization which recycles medical equipment for developing countries and within greater Detroit. Participants’ perceptions of the underserved were measured before and after the experience.Methods:Preliminary questionnaires were given to participants prior to and after exposures at WMR. Questionnaires examined participants’ attitudes toward the underserved, knowledge of medical supply reuse, and their perceived ability to impact change. P values of <.025 were considered significant.Results:A total of 39 participants completed the survey, 77% previously volunteered, 33% had volunteered internationally. Participants were >4× more likely than previously to have knowledge of the variety of recycled medical supplies at WMR. Prior to volunteering, 48.7% of participants gave little thought to how excess medical supplies could be collected versus 0% after exposure. Participants were 1.5× more likely to agree that the experience was enhanced working with their peers and 2.7× more likely to consider starting their own organization/intervention for medical supply donations. Those participants that never previously volunteered were 1.3× more likely to do so with encouragement from a mentor.Conclusions:Encouraging exposure to such service programs resulted in enhanced knowledge of community resources and increased motivation to participate in outreach and belief of individual responsibility to care for the underserved. Incorporating volunteerism into traditional education programs offers the opportunity to build awareness and interest in students reaching out to the underserved.

TCT-333 Percutaneous Coronary Intervention in Octogenarians: A Risk Scoring System to Predict Outcomes in the Elderly On behalf of the British Cardiovascular Intervention Society (BCIS), and the National Institute for Cardiovascular Outcomes Research (NICOR)

TCT-333 Percutaneous Coronary Intervention in Octogenarians: A Risk Scoring System to Predict Outcomes in the Elderly On behalf of the British Cardiovascular Intervention Society (BCIS), and the National Institute for Cardiovascular Outcomes Research (NICOR)

Development and Validation of Elective and Nonelective Risk Prediction Models for In-Hospital Mortality in Proximal Aortic Surgery Using the National Institute for Cardiovascular Outcomes Research (NICOR) Database

To facilitate patient choice and the risk adjustment of consultant outcomes in aortic operations, reliable predictive tools are required. Our objective was to develop a risk prediction model for in-hospital mortality after operation on the proximal aorta. Data for 8641 consecutive UK patients undergoing proximal aortic operation from the National Institute for Cardiovascular Outcomes Research database from April 2007 to March 2013 were analyzed. Multivariable logistic regression was used to identify independent predictors of in-hospital mortality. Model calibration and discrimination were assessed. In-hospital mortality was 4.6% in elective operations and 16.5% in nonelective operations. In the elective model, previous cardiac operation (adjusted odds ratio [OR] 4.1, 95% confidence interval [CI]: 3.0 to 4.7) and ejection fraction greater than 30% (adjusted OR 2.3, 95% CI: 1.7 to 3.1) were the strongest predictors of mortality (p<0.001). The area under the receiver operating characteristic (AUROC) curve was 0.805 (95% CI: 0.802 to 0.807) with a bias-corrected value of 0.795. Model calibration was acceptable (p= 0.427) on the basis of the Hosmer-Lemeshow goodness-of-fit test. In the nonelective model, salvage operations (adjusted OR 9.9, 95% CI: 6.5 to 15.2) and previous cardiac operation (adjusted OF 3.9, 95% CI: 3.0 to 5.0) were the strongest predictors of mortality (p < 0.001). The AUROC curve was 0.761 (95% CI: 0.761 to 0.765) with a bias-corrected value of 0.756, and model calibration was also found to be acceptable (p= 0.616). We propose the use of these risk models to improve patient choice and to enhance patients' awareness of risks and risk-adjust aortic operation outcomes for case-mix.