Right Ventricular Assist Device With an Oxygenator for the Management of Combined Right Ventricular and Respiratory Failure: A Systematic Review.

BACKGROUND: Severe lung disease frequently presents with both refractory hypoxemia and right ventricular (RV) failure. Right ventricular assist device with an oxygenator (OxyRVAD) is an extracorporeal membrane oxygenation (ECMO) configuration of RV bypass that also supplements gas exchange. This systematic review summarises the available literature regarding the use of OxyRVAD in the setting of severe lung disease with associated RV failure. METHODS: PubMed, Embase, and Google Scholar were queried on September 27, 2023, for articles describing the use of an OxyRVAD configuration. The main outcome of interest was survival to intensive care unit (ICU) discharge. Data on the duration of OxyRVAD support and device-related complications were also recorded. RESULTS: Out of 475 identified articles, 33 were retained for analysis. Twenty-one articles were case reports, and 12 were case series, representing a total of 103 patients. No article provided a comparison group. Most patients (76.4%) were moved to OxyRVAD from another type of mechanical support. OxyRVAD was used as a bridge to transplant or curative surgery in 37.4% and as a bridge to recovery or decision in 62.6%. Thirty-one patients (30.1%) were managed with the dedicated single-access dual-lumen ProtekDuo cannula. Median time on OxyRVAD was 12 days (interquartile range 8-23 days), and survival to ICU discharge was 63.9%. Device-related complications were infrequently reported. CONCLUSION: OxyRVAD support is a promising alternative for RV support when gas exchange is compromised, with good ICU survival in selected cases. Comparative analyses in patients with RV failure with and without severe lung disease are needed.

Hyperventilation testing in the diagnosis of vasospastic angina: A clinical review and meta-analysis.

BACKGROUND: Given the limited access to invasive vasospastic reactivity testing in Western Countries, there is a need to further develop alternative non-invasive diagnostic methods for vasospastic angina (VSA). Hyperventilation testing (HVT) is defined as a class IIa recommendation to diagnose VSA by the Japanese Society of Cardiology. METHODS: In this systematic review and meta-analysis reported according to the PRISMA statement, we review the mechanisms, methods, modalities and diagnostic accuracy of non-invasive HVT for the diagnostic of VSA. RESULTS: A total of 106 articles published between 1980 and 2022 about VSA and HVT were included in the systematic review, among which 16 were included in the meta-analysis for diagnostic accuracy. Twelve electrocardiogram-HVT studies including 804 patients showed a pooled sensitivity of 54% (95% confidence intervals [CI]; 30%-76%) and a pooled specificity of 99% (95% CI; 88%-100%). Four transthoracic echocardiography-HVT studies including 197 patients revealed a pooled sensitivity of 90% (95% CI; 82%-94%) and a pooled specificity of 98% (95% CI; 86%-100%). Six myocardial perfusion imaging-HVT studies including 112 patients yielded a pooled sensitivity of 95% (95% CI; 63%-100%) and a pooled specificity of 78% (95% CI; 19%-98%). Non-invasive HVT resulted in a low rate of adverse events, ventricular arrhythmias being the most frequently reported, and were resolved with the administration of nitroglycerin. CONCLUSIONS: Non-invasive HVT offers a safe alternative with high diagnostic accuracy to diagnose VSA in patients with otherwise undiagnosed causes of chest pain.

STICH3C: Rationale and Study Protocol.

BACKGROUND: Coronary artery bypass grafting (CABG) is the recommended mode of revascularization in patients with ischemic left ventricular dysfunction (iLVSD) and multivessel disease. However, contemporary percutaneous coronary intervention (PCI) outcomes have improved with the integration of novel technologies and refinement of revascularization strategies, and PCI is often used in clinical practice in this population. There is a lack of evidence from randomized trials comparing contemporary state-of-the-art PCI versus CABG for the treatment of iLVSD and multivessel disease. This was the impetus for the STICH3C trial (Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy), described here. METHODS: The STICH3C trial is a prospective, unblinded, international, multicenter trial with an expected sample size of 754 participants from ≈45 centers. Patients with multivessel/left main coronary artery disease and iLVSD with left ventricular ejection fraction ≤40% considered by the local Heart Team appropriate for and amenable to revascularization by both modes of revascularization will be randomized in a 1:1 ratio to state-of-the-art PCI or CABG. RESULTS: The primary end point is the composite of death from any cause, stroke, spontaneous myocardial infarction, urgent repeat revascularization, or heart failure readmission, summarized as a time-to-event outcome. The key hierarchical end point is time to death and frequency of hospitalizations for heart failure. The key safety outcome is a composite of major adverse events. Disease-specific quality-of-life and health economics measures will be compared between groups. Participants will be followed for a median of 5 years, with a minimum follow-up of 4 years. CONCLUSIONS: STICH3C will directly inform patients, clinicians, and international practice guidelines about the efficacy and safety of CABG versus PCI in patients with iLVSD. The results will provide novel and broad evidence, including clinical events, health status, and economic assessments, to guide care for patients with iLVSD and severe coronary artery disease. REGISTRATION: URL: https://clinicaltrials.gov/; Unique identifier: NCT05427370.

Non-invasive diagnosis of vasospastic angina.

Vasospastic angina (VSA), or variant angina, is an under-recognized cause of chest pain and myocardial infarction, especially in Western countries. VSA leads to a declined quality of life and is associated with increased morbidity and mortality. Currently, the diagnosis of VSA relies on invasive testing that requires the direct intracoronary administration of ergonovine or acetylcholine. However, invasive vasoreactivity testing is underutilized. Several non-invasive imaging alternatives have been proposed to screen for VSA. This review aims to discuss the strengths and limitations of available non-invasive imaging tests for vasospastic angina.

Association Between Right Ventricular Dysfunction and Adverse Outcomes in Peripartum Cardiomyopathy: Insights From the BRO-HF Quebec Cohort Study.

Background: Peripartum cardiomyopathy (PPCM) is associated with severe morbidity and mortality, and the significance of right ventricular (RV) involvement is unclear. We sought to determine whether RV systolic dysfunction or dilatation is associated with adverse clinical outcomes in women with PPCM. Methods: We conducted a multicentre retrospective cohort study examining the association between echocardiographic RV systolic dysfunction or dilatation at the time of PPCM diagnosis and clinical outcomes. Clinical endpoints of interest were the need for mechanical support, recovery of left ventricular ejection fraction at follow-up, and a combined endpoint of hospitalization for heart failure, cardiac transplant, or death. Results: A total of 67 women, median age 30 years (interquartile range: 7), were diagnosed with PPCM between 1994 and 2015 in 17 participating centres. Twin pregnancies occurred in 11%; 62% of women were multiparous; and 24% had preeclampsia. RV systolic function was impaired in 18 (27%) and dilated in 8 (12%). Seven women required ventricular assistance, and 8 experienced the composite outcome during follow-up (25 [interquartile range 61] months). RV dysfunction was associated with the need for mechanical support (odds ratio 10.10 (95% confidence interval: 1.86-54.81), P = 0.007), but neither RV dysfunction nor dilatation was associated with left ventricular ejection fraction recovery, the need for cardiac transplant, heart failure hospitalization, or death. Conclusions: RV dysfunction is associated with the need for mechanical support in women with PPCM. These findings may improve risk stratification of complications and clinical management.

Introduction: La cardiomyopathie du péripartum (CMP-PP) est associée à la morbidité grave et à la mortalité, mais on ignore l'importance de l'atteinte ventriculaire droite (VD). Nous avons cherché à déterminer si la dysfonction systolique ou la dilatation VD sont associées aux résultats cliniques défavorables chez les femmes atteintes de CMP-PP. Méthodes: Nous avons mené une étude de cohorte rétrospective multicentrique sur l'association entre la dysfonction systolique ou la dilatation VD à l'échographie au moment du diagnostic de CMP-PP et les résultats cliniques. Les critères cliniques d'intérêt étaient la nécessité d'une assistance mécanique, la récupération de la fraction d'éjection ventriculaire gauche (FEVG) au suivi et un critère combiné d'hospitalisation liée à l'insuffisance cardiaque (IC), la transplantation cardiaque ou la mort. Résultats: Un total de 67 femmes, dont l'âge médian était de 30 ans (écart interquartile [EI] : 7), ont reçu un diagnostic de CMP-PP entre 1994 et 2015 dans 17 centres participants. Les grossesses gémellaires sont survenues chez 11 % ; 62 % de femmes étaient multipares ; et 24 % souffraient de prééclampsie. La fonction systolique VD était compromise chez 18 (27 %) femmes et le VD, dilaté, chez huit (12 %) femmes. Sept femmes ont eu besoin d'une assistance ventriculaire, et huit ont subi le critère composite durant le suivi (25 [EI : 61] mois). La dysfonction VD a été associée à la nécessité d'une assistance mécanique (rapport de cotes 10,10 [intervalle de confiance à 95 % : 1,86-54,81], P = 0,007), mais ni la dysfonction ni la dilatation VD n'ont été associées à la récupération de la FEVG, à la nécessité d'une transplantation cardiaque, à une hospitalisation liée à l'IC ou à la mort. Conclusions: La dysfonction VD est associée à la nécessité d'une assistance mécanique chez les femmes atteintes de CMP-PP. Ces conclusions peuvent permettre d'améliorer la stratification des risques de complications et la prise en charge clinique.

Percutaneous Mechanical Circulatory Support in Post-Myocardial Infarction Cardiogenic Shock: A Systematic Review and Meta-analysis.

BACKGROUND: Cardiogenic shock (CS) complicates 5%-10% of acute myocardial infarction (AMI) and is the leading cause of early mortality. It remains unclear whether percutaneous mechanical support (pMCS) devices improve post-AMI CS outcome. METHODS: A systematic review of original studies comparing the effect of pMCS on AMI-CS mortality was conducted with the use of Medline, Embase, Google Scholar, and the Cochrane Library databases. RESULTS: Of 8672 records, 50 were retained for quantitative analysis. Four additional references were added from other sources. Four references reported a significant mortality reduction with intra-aortic balloon pump (IABP) in patients with failed primary percutaneous coronary intervention (pPCI) or managed with thrombolysis. Meta-analyses showed no advantage of Impella over conventional therapy (pooled OR 0.55, 95% CI 0.20-1.46; I2 = 0.85) and increased mortality compared with IABP (pooled OR 1.32; 95% CI 1.08-1.62; I2 = 0.85). No study reported a mortality advantage for extracorporeal membrane oxygenation (ECMO) over conventional therapy, IABP, or Impella support. Early mortality might be improved with the addition of IABP or Impella to ECMO. Bleeding Academic Research Consortium ≥ 3 bleeding was increased with every pMCS strategy. CONCLUSIONS: The current evidence is of poor to moderate quality, with only 1 in 5 included articles reporting randomised data and several reporting unadjusted outcomes. Yet, there is some evidence to favour IABP use in the setting of thrombolysis or with failed pPCI, and adding IABP or Impella should be considered for patients requiring ECMO.

Electroanatomical Navigation to Minimize Contrast Medium or X-Rays During Stenting: Insights From an Experimental Model.

Stents can be effectively implemented with no x-rays or contrast medium. Modified stents were successfully implanted in 9 of 11 attempted targets (82%) (7 carotid and 4 coronary arteries) using an impedance-sensitive navigation system and optical coherence tomography. Electroanatomical navigation systems can be used to assist interventionalists in performing arterial stenting while minimizing x-ray and contrast use, thereby potentially enhancing safety for both patients and catheterization laboratory staff members.

PCI in Patients With Heart Failure: Current Evidence, Impact of Complete Revascularization, and Contemporary Techniques to Improve Outcomes.

Coronary artery disease (CAD) is the most common cause of left ventricular systolic dysfunction (LVSD) and heart failure (HF). Revascularization with coronary artery bypass grafting (CABG) reduces all-cause mortality compared with medical therapy alone for these patients. Despite this, CABG is performed in a minority of patients with HF, partly due to patient unwillingness or inability to undergo major cardiac surgery and partly due to physician reluctance to refer for surgery due to high operative risk. Percutaneous coronary intervention (PCI) is a less-invasive method of revascularization that has the potential to reduce periprocedural complications compared with CABG in patients with HF. Recent advances in PCI technology and technique have made it realistic to achieve more complete revascularization with PCI in high-risk patients with HF, although no randomized controlled clinical trials (RCTs) of PCI in HF compared with either medical therapy or CABG have been performed. In this review, we discuss the currently available evidence for PCI in HF and the association between the extent of revascularization and clinical outcomes in HF. We also review recent advances in PCI technology and techniques with the potential to improve clinical outcomes in HF. Finally, we discuss emerging clinical trial evidence of revascularization in HF and the large, persistent evidence gaps that should be addressed with future clinical trials of revascularization in HF.

Variability in Reassessment of Left Ventricular Ejection Fraction After Myocardial Infarction in the Acute Myocardial Infarction Quality Assurance Canada Study.

Importance: Persistently depressed left ventricular ejection fraction (LVEF) after myocardial infarction (MI) is associated with adverse prognosis and directs the use of evidence-based treatments to prevent sudden cardiac death and/or progressive heart failure. Objective: To assess adherence with guideline-recommended LVEF reassessment and to study the evolution of LVEF over 6 months of follow-up. Design, Setting, and Participants: This was a multicenter cohort study at Canadian academic and community hospitals with on-site cardiac catheterization services. Patients with type 1 acute MI and LVEF less than or equal to 45% during the index hospitalization were enrolled between January 2018 and August 2019 and were followed-up for 6 months. Data analysis was performed from May 2020 to September 2021. Exposures: Baseline clinical factors, in-hospital care and LVEF, and site-specific features. Main Outcomes and Measures: The main outcomes were receipt of repeat LVEF assessment by 6 months and the presence of a persistent LVEF reduction at 2 thresholds: LVEF less than or equal to 40%, prompting consideration of additional medical therapy for heart failure, or LVEF less than or equal to 35%, prompting referral for implanted cardioverter defibrillator in addition to medical therapy. Results: This study included 501 patients (mean [SD] age, 63.3 [13.0] years; 113 women [22.6%]). Overall, 370 patients (73.4%) presented with STEMI, and 454 (90.6%) had in-hospital revascularization. The median (IQR) baseline LVEF was 40% (34%-43%). Of 458 patients (91.4%) who completed the 6-month follow-up, 303 (66.2%; 95% CI, 61.7%-70.5%) had LVEF reassessment, with a range of 46.7% to 90.0% across sites (χ213 = 19.6; P = .11). Participants from community hospitals were more likely than those from academic hospitals to undergo LVEF reassessment (73.6% vs 63.2%; χ21 = 4.50; P = .03), as were those with worse LVEF at baseline. Follow-up LVEF improved by an absolute median (IQR) of 8% (3%-15%). However, 103 patients (34.1%) met the definitions of clinically relevant LVEF reduction, including 52 patients (17.2%) with LVEF less than or equal to 35% and 51 patients (16.9%) with LVEF of 35.1% to 40.0%. Conclusions and Relevance: In this cohort study, approximately 1 in 3 patients with at least mild LVEF reduction after acute MI did not undergo indicated LVEF reassessment within 6 months, suggesting that programs to improve the quality of post-MI care should include measures to ensure that indicated repeat cardiac imaging is performed. In those with follow-up imaging, clinically relevant persistent LVEF reduction was identified in more than one-third of patients.

A novel method to interpret early phase trials shows how the narrowing of the coronary sinus concordantly improves symptoms, functional status and quality of life in refractory angina.

BACKGROUND: Reduction of the coronary sinus was shown to improve angina in patients unsuitable for revascularisation. We assessed whether a percutaneous device that reduces the diameter of the coronary sinus improved outcomes across multiple endpoints in a phase II trial. METHODS: We conducted a novel analysis performed as a post hoc efficacy analysis of the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) trial, which enrolled patients with Canadian Cardiovascular Society (CCS) class 3-4 refractory angina. We used four domains: symptoms (CCS Angina Scale), functionality (total exercise duration), ischaemia (imaging) and health-related quality of life. For all domains, we specified a meaningful threshold for change. The primary endpoint was defined as a probability of ≥80% that the reducer exceeded the meaningful threshold on two or more domains (group-level analysis) or that the average efficacy score in the reducer group exceeded the sham control group by at least two points (patient-level analysis). RESULTS: We randomised 104 participants to either a device that narrows to coronary sinus (n=52) or a sham implantation (n=52). The reducer group met the prespecified criteria for concordance at the group level and demonstrated improvement in symptoms (0.59 CCS grade, 95% credible interval (CrI)=0.22 to 0.95), total exercise duration (+27.9%, 95% CrI=2.8% to 59.8%) and quality of life (stability +11.2 points, 95% CrI=3.3 to 19.1; perception +11.0, 95% CrI=3.3 to 18.7). CONCLUSIONS: The reducer concordantly improved symptoms, functionality and quality of life compared with a sham intervention in patients with angina unsuitable for coronary revascularisation. Concordant analysis such as this one can help interpret early phase trials and guide the decision to pursue a clinical programme into a larger confirmatory trial. TRAIL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT01205893.

Treatment strategies in ischaemic left ventricular dysfunction: a network meta-analysis.

OBJECTIVES: The optimal revascularization strategy for patients with ischaemic left ventricular systolic dysfunction (iLVSD) remains controversial. We aimed to compare percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) and medical therapy (MT) in a network meta-analysis. METHODS: All randomized controlled trials and observational studies comparing any combination of PCI, CABG and MT in patients with iLVSD were analysed in a frequentist network meta-analysis (generic inverse variance method). Primary outcome was mortality at longest available follow-up. Secondary outcomes were cardiac death, stroke, myocardial infarction (MI) and repeat revascularization (RR). RESULTS: Twenty-three studies were included (n = 23 633; 4 randomized controlled trials). Compared to CABG, PCI was associated with higher mortality [incidence rate ratio (IRR) 1.32, 95% confidence interval (CI) 1.13-1.53], cardiac death (IRR 1.65, 95% CI 1.18-2.33), MI (IRR 2.18, 95% CI 1.70-2.80) and RR (IRR 3.75, 95% CI 2.89-4.85). Compared to CABG, MT was associated with higher mortality (IRR 1.52, 95% CI 1.26-1.84), cardiac death (IRR 3.83, 95% CI 2.12-6.91), MI (IRR 3.22, 95% CI 1.52-6.79) and RR (IRR 3.37, 95% CI 1.67-6.79). Compared to MT, PCI was associated with lower cardiac death (IRR 0.43, 95% CI 0.24-0.78). CABG ranked as the best revascularization strategy for mortality, cardiac death, MI and RR; MT ranked as the strategy associated with the lowest incidence of stroke. Left ventricular ejection fraction, year of study, use of drug-eluting stents did not affect relative treatment effects. CONCLUSIONS: CABG appears to be the best therapy for iLVSD, although mainly based on observational data. Definitive randomized controlled trials comparing CABG and PCI in iLVSD are required. PROSPERO REGISTRATION ID: 132414.

Immediate vs Delayed Stenting in ST-Elevation Myocardial Infarction: Rationale and Design of the International PRIMACY Bayesian Randomized Controlled Trial.

BACKGROUND: Primary percutaneous coronary intervention is used to restore blood flow in the infarct-related coronary artery, followed by immediate stenting to prevent reocclusion. Stents implanted in thrombus-laden arteries cause distal embolization, which paradoxically impairs myocardial reperfusion and ventricular function. Whether a strategy of delayed stenting improves outcomes in patients with acute ST-elevation myocardial infarction (STEMI) is uncertain. METHODS: The Primary Reperfusion Secondary Stenting (PRIMACY) is a Bayesian prospective, randomized, open-label, blinded end point trial in which delayed vs immediate stenting in patients with STEMI were compared for prevention of cardiovascular death, nonfatal myocardial infarction, heart failure, or unplanned target vessel revascularization at 9 months. All participants were immediately reperfused, but those assigned to the delayed arm underwent stenting after an interval of 24 to 48 hours. This interval was bridged with antithrombin therapy to reduce thrombus burden. In the principal Bayesian hierarchical random effects analysis, data from exchangeable trials will be combined into a study prior and updated with PRIMACY into a posterior probability of efficacy. RESULTS: A total of 305 participants were randomized across 15 centres in France and Canada between April 2014 and September 2017. At baseline, the median age of participants was 59 years, 81% were male, and 3% had a history of percutaneous coronary intervention. Results from PRIMACY will be updated from the patient-level data of 1568 participants enrolled in the Deferred Stent Trial in STEMI (DEFER; United Kingdom), Minimalist Immediate Mechanical Intervention (MIMI; France), Danish Trial in Acute Myocardial Infarction-3 (DANAMI-3; Denmark), and Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST Segment-Elevation Myocardial Infarction (INNOVATION, South Korea) trials. CONCLUSIONS: We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.

The Robin Hood effect!

Results from this analysis support the hypothesis that the reduction of the coronary sinus redistributes coronary flow in the myocardium. The results from this analysis must be interpreted with caution; while being the first report of its kind, the small sample size and methodological flaws limit the generalizability of the findings. Future studies should investigate the use of the coronary sinus reducer to improve myocardial function in patients with ischemic cardiomyopathy.

Left ventricular mechanics in the acute phase of Takotsubo cardiomyopathy: distinctive ballooning patterns translate into different diastolic properties.

Although apical and midventricular Takotsubo cardiomyopathies (TTCs) share common triggers and pathophysiological features, little is known about the potential differences in left ventricular (LV) mechanistic properties between these TTC phenotypes. We sought to investigate whether LV systolic and/or diastolic function, as assessed invasively by left heart catheterization (LHC), differ according to ballooning patterns in the acute phase of TTC. One hundred and fourteen TTC patients were retrospectively identified between January 2009 and December 2015 at the University Hospital of Strasbourg, France. A comprehensive list of LV quantitative parameters was derived from LHC analysis for each patient. We examined 2 groups of patients according to ballooning patterns in the acute phase of TTC: patients with apical ballooning ("Apical group"; n = 76) and those with midventricular ballooning ("Midventricular group"; n = 38). LV minimal diastolic pressure (8.72 ± 6.72 vs. 5.02 ± 6.08 mmHg; p = 0.004), LV end diastolic pressure (23.11 ± 8.32 vs. 18.84 ± 8.06 mmHg; p = 0.01), and LV diastolic stiffness (LV stiffness 1: 0.29 ± 0.23 vs. 18.84 ± 8.06 mmHg/mL; p = 0.04-LV stiffness 2: 0.16 ± 0.08 vs. 0.12 ± 0.05 mmHg/mL; p = 0.005) were significantly higher in patients with apical TTC than in the midventricular group. Concomitantly, these findings were associated with significantly higher BNP levels in the apical group (923.91 ± 1164.53 vs. 418.71 ± 557.75 pg/mL; p = 0.004) than in the midventricular group. In the acute phase of stress cardiomyopathy, the classic apical form of TTC is associated with poorer diastolic function compared to the midventricular ballooning variant, as assessed through direct invasive hemodynamic measurements using LHC.

Does prior coronary angioplasty affect outcomes of surgical coronary revascularization? Insights from the STICH trial.

BACKGROUND: The STICH trial showed superiority of coronary artery bypass plus medical treatment (CABG) over medical treatment alone (MED) in patients with left ventricular ejection fraction (LVEF) ≤35%. In previous publications, percutaneous coronary intervention (PCI) prior to CABG was associated with worse prognosis. OBJECTIVES: The main purpose of this study was to analyse if prior PCI influenced outcomes in STICH. METHODS AND RESULTS: Patients in the STICH trial (n = 1212), followed for a median time of 9.8 years, were included in the present analyses. In the total population, 156 had a prior PCI (74 and 82, respectively, in the MED and CABG groups). In those with vs. without prior PCI, the adjusted hazard-ratios (aHRs) were 0.92 (95% CI = 0.74-1.15) for all-cause mortality, 0.85 (95% CI = 0.64-1.11) for CV mortality, and 1.43 (95% CI = 1.15-1.77) for CV hospitalization. In the group randomized to CABG without prior PCI, the aHRs were 0.82 (95% CI = 0.70-0.95) for all-cause mortality, 0.75 (95% CI = 0.62-0.90) for CV mortality and 0.67 (95% CI = 0.56-0.80) for CV hospitalization. In the group randomized to CABG with prior PCI, the aHRs were 0.76 (95% CI = 0.50-1.15) for all-cause mortality, 0.81 (95% CI = 0.49-1.36) for CV mortality and 0.61 (95% CI = 0.41-0.90) for CV hospitalization. There was no evidence of interaction between randomized treatment and prior PCI for any endpoint (all adjusted p > 0.05). CONCLUSION: In the STICH trial, prior PCI did not affect the outcomes of patients whether they were treated medically or surgically, and the superiority of CABG over MED remained unchanged regardless of prior PCI. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov; Identifier: NCT00023595.

A disease-specific comorbidity index for predicting mortality in patients admitted to hospital with a cardiac condition.

BACKGROUND: Comorbidity indexes derived from administrative databases are essential tools of research in global health. We sought to develop and validate a novel cardiac-specific comorbidity index, and to compare its accuracy with the generic Charlson-Deyo and Elixhauser comorbidity indexes. METHODS: We derived the cardiac-specific comorbidity index from consecutive patients who were admitted to hospital at a tertiary-care cardiology hospital in Quebec. We used logistic regression analysis and incorporated age, sex and 22 clinically relevant comorbidities to build the index. We compared the cardiac-specific comorbidity index with refitted Charlson-Deyo and Elixhauser comorbidity indexes using the C-statistic and net reclassification improvement to predict in-hospital death, and the Akaike information criterion to predict length of stay. We validated our findings externally in an independent cohort obtained from a provincial registry of coronary disease in Alberta. RESULTS: The novel cardiac-specific comorbidity index outperformed the refitted generic Charlson-Deyo and Elixhauser comorbidity indexes for predicting in-hospital mortality in the derivation population (n = 10 137): C-statistic 0.95 (95% confidence interval [CI] 0.94-0.9) v. 0.81 (95% CI 0.77-0.84) and 0.86 (95% CI 0.82-0.89), respectively. In the validation population (n = 17 877), the cardiac-specific comorbidity index was similarly better: C-statistic 0.92 (95% CI 0.89-0.94) v. 0.76 (95% CI 0.71-0.81) and 0.82 (95% CI 0.78-0.86), respectively, and also numerically outperformed the Charlson-Deyo and Elixhauser comorbidity indexes for predicting 1-year mortality (C-statistic 0.78 [95% CI 0.76-0.80] v. 0.75 [95% CI 0.73-0.77] and 0.77 [95% CI 0.75-0.79], respectively). Similarly, the cardiac-specific comorbidity index showed better fit for the prediction of length of stay. The net reclassification improvement using the cardiac-specific comorbidity index for the prediction of death was 0.290 compared with the Charlson-Deyo comorbidity index and 0.192 compared with the Elixhauser comorbidity index. INTERPRETATION: The cardiac-specific comorbidity index predicted in-hospital and 1-year death and length of stay in cardiovascular populations better than existing generic models. This novel index may be useful for research of cardiology outcomes performed with large administrative databases.