The European Society of Cardiology quality indicators in atrial fibrillation in centers of excellence in Spain: the SEC-EXCELENTE FA registry.

INTRODUCTION AND OBJECTIVES: By 2022, 9 centers had been accredited by the Spanish Society of Cardiology for the atrial fibrillation (AF) process. Our objective was to evaluate the performance of these centers based on the quality indicators (QIs) proposed by the European Society of Cardiology (ESC) in 2020. METHODS: Adults with AF who were attended in the cardiology departments of participating centers during the second week of May 2019 were included in a retrospective registry (n=797, age 72±11 years, 60% male). Key ESC QIs were assessed. RESULTS: CHA2DS2-VASc, HAS-BLED scores, and serum creatinine levels were documented in 24.9%, 6.1%, and 96.2% of patients, respectively. Anticoagulation was appropriately prescribed in 90.6% of high-risk patients according to the CHA2DS2-VASc score, but was inappropriately prescribed in 57.8% of low-risk patients. Among all patients, 84.1% received high-quality anticoagulation. Inappropriate antiarrhythmic drugs were prescribed in 7.2% of patients with permanent AF, 2.9% of those with structural heart disease, and 0.0% of those with end-stage kidney disease. Catheter ablation was offered to 70% of patients with symptomatic paroxysmal or persistent AF after the failure or intolerance of 1 antiarrhythmic drug. All modifiable risk factors were documented in 59.3% of patients. Rates of all-cause mortality, ischemic stroke or transient ischemic attack, and major bleeding were 8.1, 0.8, and 2.56 per 100 patients/y, respectively. QIs for anticoagulation and outcomes were similar between general cardiology and tertiary referral centers. CONCLUSIONS: Although accredited centers in Spain demonstrated good performance in many of the ESC QIs for AF, there remains room for improvement. These data could serve as a starting point for enhancing the quality of care in this population.

Intermittent inotropic support with levosimendan in advanced heart failure as destination therapy: The LEVO-D registry.

AIM: Patients with advanced heart failure (AHF) who are not candidates to advanced therapies have poor prognosis. Some trials have shown that intermittent levosimendan can reduce HF hospitalizations in AHF in the short term. In this real-life registry, we describe the patterns of use, safety and factors related to the response to intermittent levosimendan infusions in AHF patients not candidates to advanced therapies. METHODS AND RESULTS: Multicentre retrospective study of patients diagnosed with advanced heart failure, not HT or LVAD candidates. Patients needed to be on the optimal medical therapy according to their treating physician. Patients with de novo heart failure or who underwent any procedure that could improve prognosis were not included in the registry. Four hundred three patients were included; 77.9% needed at least one admission the year before levosimendan was first administered because of heart failure. Death rate at 1 year was 26.8% and median survival was 24.7 [95% CI: 20.4-26.9] months, and 43.7% of patients fulfilled the criteria for being considered a responder lo levosimendan (no death, heart failure admission or unplanned HF visit at 1 year after first levosimendan administration). Compared with the year before there was a significant reduction in HF admissions (38.7% vs. 77.9%; P < 0.0001), unplanned HF visits (22.7% vs. 43.7%; P < 0.0001) or the combined event including deaths (56.3% vs. 81.4%; P < 0.0001) during the year after. We created a score that helps predicting the responder status at 1 year after levosimendan, resulting in a score summatory of five variables: TEER (+2), treatment with beta-blockers (+1.5), Haemoglobin >12 g/dL (+1.5), amiodarone use (-1.5) HF visit 1 year before levosimendan (-1.5) and heart rate >70 b.p.m. (-2). Patients with a score less than -1 had a very low probability of response (21.5% free of death or HF event at 1 year) meanwhile those with a score over 1.5 had the better chance of response (68.4% free of death or HF event at 1 year). LEVO-D score performed well in the ROC analysis. CONCLUSION: In this large real-life series of AHF patients treated with levosimendan as destination therapy, we show a significant decrease of heart failure events during the year after the first administration. The simple LEVO-D Score could be of help when deciding about futile therapy in this population.

Economic evaluation of complete revascularization versus stress echocardiography-guided revascularization in the STEACS with multivessel disease.

INTRODUCTION AND OBJECTIVES: Economic studies may help decision making in the management of multivessel disease in the setting of myocardial infarction. We sought to perform an economic evaluation of CROSS-AMI (Complete Revascularization or Stress Echocardiography in Patients With Multivessel Disease and ST-Segment Elevation Acute Myocardial Infarction) randomized clinical trial. METHODS: We performed a cost minimization analysis for the strategies (complete angiographic revascularization [ComR] and selective stress echocardiography-guided revascularization [SelR]) compared in the CROSS-AMI clinical trial (N=306), attributable the initial hospitalization and readmissions during the first year of follow-up, using current rates for health services provided by our health system. RESULTS: The index hospitalization costs were higher in the ComR group than in SelR arm (19 657.9±6236.8 € vs 14 038.7±4958.5 €; P <.001). There were no differences in the costs of the first year of follow-up rehospitalizations between both groups for (ComR 2423.5±4568.0 vs SelR 2653.9±5709.1; P=.697). Total cost was 22 081.3±7505.6 for the ComR arm and 16 692.6±7669.9 for the SelR group (P <.001). CONCLUSIONS: In the CROSS-AMI trial, the initial extra economic costs of the ComR versus SelR were not offset by significant savings during follow-up. SelR seems to be more efficient than ComR in patients with ST-segment elevation acute coronary syndrome and multivessel disease treated by emergent angioplasty. Study registred at ClinicalTrial.gov (Identifier: NCT01179126).

Comparison of predicted and observed mortality in patients with heart failure treated at a specialized unit.

INTRODUCTION AND OBJECTIVES: To analyze survival in heart failure (HF) patients treated at a specialized unit. METHODS: Prospective cohort-based study of HF patients treated at a specialized unit from 2011 to 2017. Observed 1- and 3-year mortality rates were compared with those predicted by the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) risk score. RESULTS: We studied 1280 patients, whose median MAGGIC risk score was 19 [interquartile range, 13-24]. Prescription rates of beta-blockers, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, mineralocorticoid receptor antagonists, and sacubitril-valsartan were 93%, 67%, 22%, 73%, and 16%, respectively. The MAGGIC risk score showed good discrimination for mortality at 1 year (c-statistic=0.71) and 3 years (c-statistic=0.76). Observed mortality was significantly lower than predicted mortality, both at 1 year (6.2% vs 10.9%; observed/predicted ratio=0.57; P<.001) and at 3 years (16.7% vs 27.7%; observed/predicted ratio=0.60; P<.001). This discrepancy was found in several subgroups, except in patients aged> 70 years (29.9% vs 34.7%; observed/predicted ratio=0.86; P=.126) and in patients with ejection fraction> 40% (19.6% vs 20.7%; observed/predicted ratio=0.95; P=.640). CONCLUSIONS: Mortality in HF patients treated at a specialized clinic was significantly lower than that predicted by the MAGGIC risk score.

Pulmonary Arteriovenous Malformation and Embolic Myocardial Infarction in a Patient With Hereditary Hemorrhagic Telangiectasia.

This report describes a case of embolic myocardial infarction secondary to a pulmonary arteriovenous malformation. Pulmonary arteriovenous malformations are rare and mostly congenital and are inherited as an autosomal dominant disorder known as hereditary hemorrhagic telangiectasia. Myocardial infarction is an uncommon complication in patients with untreated pulmonary arteriovenous malformations. (Level of Difficulty: Advanced.).

Prognostic Value of the Nutritional Risk Index in Heart Transplant Recipients.

INTRODUCTION AND OBJECTIVES: To study the prognostic impact of preoperative nutritional status, as assessed through the nutritional risk index (NRI), on postoperative outcomes after heart transplantation (HT). METHODS: We conducted a retrospective, single-center study of 574 patients who underwent HT from 1991 to 2014. Preoperative NRI was calculated as 1.519 × serum albumin (g/L) + 41.7 × (body weight [kg] / ideal body weight [kg]). The association between preoperative NRI and postoperative outcomes was analyzed by means of multivariable logistic regression and multivariable Cox regression. RESULTS: Mean NRI before HT was 100.9 ± 9.9. According to this parameter, the prevalence of severe nutritional risk (NRI < 83.5), moderate nutritional risk (83.5 ≤ NRI < 97.5), and mild nutritional risk (97.5 ≤ NRI < 100) was 5%, 22%, and 10%, respectively. One year post-transplant mortality rates in these 4 categories were 18.2%, 25.3%, 7.9% and 10.2% (P < .001), respectively. The NRI was independently associated with a lower risk of postoperative infection (adjusted OR, 0.97; 95%CI, 0.95-1.00; P = .027) and prolonged postoperative ventilator support (adjusted OR, 0.96; 95%CI, 0.94-0.98; P = .001). Patients at moderate or severe nutritional risk had significantly higher 1-year post-HT mortality (adjusted HR, 1.55; 95%CI, 1.22-1.97; P < .001). CONCLUSIONS: Malnourished patients have a higher risk of postoperative complications and mortality after HT. Preoperative NRI determination may help to identify HT candidates who might benefit from nutritional intervention.

Toxoplasma Gondii Serostatus in Heart Transplant Recipients: Is It an Independent Prognostic Factor?

INTRODUCTION AND OBJECTIVES: To assess the potential association between recipient Toxoplasma gondii serostatus and outcomes after heart transplant (HT). METHODS: We conducted a retrospective single-center study of 657 HT recipients from 1991 to 2015. Survival and the incidence of adverse clinical events of T. gondii-seropositive (n = 481) vs T. gondii-seronegative (n = 176) recipients were compared by means of 2 different multivariable Cox regression models. Model 1 included solely age and sex, and model 2 included other potential confounders. RESULTS: Over a median follow-up of 2903 days (interquartile range: 898-4757), 250 seropositive recipients (52%) and 72 seronegative recipients (41%) died. Univariable analysis showed increased posttransplant mortality among T. gondii-seropositive recipients (hazard ratio [HR] = 1.31; 95% confidence interval [95%CI], 1,00-1.70). After multivariable adjustment, the statistical significance of this association was lost (model 1: HR = 1.09; 95%CI, 0.83-1.43; model 2:HR = 1.12; 95%CI, 0.85-1.47). Recipient T. gondii seropositivity was independently associated with an increased risk of acute rejection (model 1: HR = 1.36; 95%CI, 1.06-1.74; model 2: HR = 1.29; 95%CI, 1.01-1.66). Multivariable models showed no statistically significant impact of recipient T. gondii serostatus on the incidence of infection, malignancy, coronary allograft vasculopathy, or the composite outcome of cardiac death or retransplant. No significant association was found between donor-recipient T. gondii serostatus matching and posttransplant outcome. CONCLUSIONS: In this study, recipient T. gondii serostatus was not an independent predictor of long-term post-HT outcome.

Analysis of variants in the HCN4 gene and in three single nucleotide polymorphisms of the CYP3A4 gene for association with ivabradine reduction in heart rate: A preliminary report.

BACKGROUND: Ivabradine, a selective bradycardic drug, inhibits the If. In patients with heart failure (HF), ivabradine reduces the risk of rehospitalization and mortality. The average heart rate (HR) reduction is 8-10 beats, although clinical trials reveal interindividual variability. The aim of the study is to identify variants associated with HR reduction produced by ivabradine in genes involved in the drug metabolism (CYP3A4) or related to the drug target (HCN4). METHODS: In an exploratory cohort (n = 11), patients started on ivabradine were genotyped and the HR reduction was studied. RESULTS: The mean HR reduction after the treatment was 18.10 ± 12.26 bpm. The HR reduction was ≥ 15 bpm in 3 patients and > 5 and < 15 bpm in 7 patients. Four synonymous variants, L12L, L520L, P852P, and P1200P, were detected in the HCN4 gene (frequency = 0.045, 0.045, and 0.681, respectively). Moreover, the CYP3A4*1F and CYP3A4*1B were found in one patient each and CYP3A4*1G was presented in 3 patients. CONCLUSIONS: This is the first study using an exploratory pharmacogenetic approach that attempts to explain interindividual variability in ivabradine HR reduction. However, more research must be undertaken in order to determine the role of variants in HCN4 and CYP3A4 genes in response to ivabradine.

Prognostic Significance of Heart Rate and its Long-term Trend in Cardiac Transplant Patients.

INTRODUCTION AND OBJECTIVES: The aim of the present study was to examine the prognostic significance of heart rate and its trend in heart transplantation. METHODS: This observational study enrolled 170 patients who received a bicaval heart transplant between 1995 and 2005; all were in sinus rhythm. The resting heart rate was determined via electrocardiography at the end of the first posttransplant year and annually until the tenth year. Cox analysis was used to evaluate the incidence of adverse events with a mean (standard deviation) follow-up of 8.9 (3.1) years. The primary study end point was the composite outcome of death or graft dysfunction. RESULTS: The resting heart rate at the end of the first posttransplant year was an independent predictor of the primary composite end point (hazard ratio=1.054; 95% confidence interval, 1.028-1.080; P<.001) and was significantly associated with total mortality (hazard ratio=1.058; 95% confidence interval, 1.030-1.087; P<.001) and mortality from cardiac causes (hazard ratio=1.069; 95% confidence interval, 1.026-1.113; P=.001), but not with graft dysfunction (hazard ratio=1.028; 95% confidence interval, 0.989-1.069; P=.161). For patients with a heart rate ≥ 105 or<90 bpm vs those with 90-104 bpm, the hazard ratios of the primary end point were 2.233 (95% confidence interval, 1.250-3.989; P=.007) and 0.380 (95% confidence interval, 0.161-0.895; P=.027), respectively. Heart rate tended to decrease in the first 10 years after transplantation (P=.001). Patients with a net increase in heart rate during follow-up showed a higher incidence of adverse events. CONCLUSIONS: An elevated heart rate is an adverse prognostic marker after heart transplantation.

Clinical evaluation of rosuvastatin in heart transplant patients with hypercholesterolemia and therapeutic failure of other statin regimens: short-term and long-term efficacy and safety results.

We conducted an observational study of 30 heart transplant recipients with serum low-density lipoprotein cholesterol (LDL-c) >100 mg/dl despite previous statin therapy, who were treated with rosuvastatin 10 mg daily (5 mg in case of renal dysfunction). Serum lipids, creatine phosphokinase (CPK), bilirubin, and hepatic enzymes were prospectively measured 2, 4, and 12 weeks after the initiation of the drug. Clinical outcomes of patients who continued on long-term rosuvastatin therapy beyond this 12-week period were reviewed in February 2015. Over the 12-week period following rosuvastatin initiation, serum levels of total cholesterol (TC) and LDL-c and the ratio TC/high-density lipoprotein cholesterol (HDL-c) decreased steadily (P < 0.001). Average absolute reductions of these three parameters were -48.7 mg/dl, -46.6 mg/dl, and -0.9, respectively. Seventeen (57%) achieved a serum LDL-c < 100 mg/dl. No significant changes from baseline were observed in serum levels of triglycerides, HDL-c, hepatic enzymes, bilirubin, or CPK. Twenty-seven (90%) patients continued on long-term therapy with rosuvastatin over a median period of 3.6 years, with no further significant variation in lipid profile. The drug was suspended due to liver toxicity in 1 (3.3%) patient and due to muscle toxicity in 2 (6.7%) patients. All adverse reactions resolved rapidly after rosuvastatin withdrawal. Our study supports rosuvastatin as a reasonable alternative for heart transplant recipients with hypercholesterolemia and therapeutic failure of other statin regimens.

Venous thromboembolism in heart transplant recipients: incidence, recurrence and predisposing factors.

BACKGROUND: A high frequency of venous thromboembolism (VTE) has been observed after lung, kidney, and liver transplantation. However, data about the incidence of this complication among heart transplant (HT) recipients are lacking. METHODS: We analyzed the incidence, recurrence, and predisposing factors of VTE in a single-center cohort of 635 patients who underwent HT from April 1991 to April 2013. Deep venous thrombosis (DVT) and pulmonary embolism (PE) were considered as VTE episodes. RESULTS: During a median post-transplant follow-up of 8.4 years, 62 VTE episodes occurred in 54 patients (8.5%). Incidence rates of VTE, DVT, and PE were, respectively, 12.7 (95% confidence interval [CI], 9.7-16.3), 8.4 (95% CI, 6.0-11.4), and 7.0 (95% CI 4.8-9.7) episodes per 1,000 patient-years. Incidence rates of VTE during the first post-transplant year and beyond were, respectively, 45.1 (95% CI, 28.9-67.1) and 8.7 (95% CI 6.2-11.2) episodes per 1,000 patient-years. The incidence rate of VTE recurrence after a first VTE episode was 30.5 (95% CI, 13.2-60.2) episodes per 1,000 patient-years. By means of multivariable Cox regression, chronic renal dysfunction, older age, obesity, and the use of mammalian target of rapamycin inhibitors were identified as independent risk factors for VTE among HT recipients. CONCLUSIONS: VTE is a frequent complication after HT, mainly during the first post-operative year. In view of a high recurrence rate, long-term anti-coagulation should be considered in HT recipients who experience a first VTE episode.

Prevention and treatment of coronary artery vasculopathy.

PURPOSE OF REVIEW: Cardiac allograft vasculopathy (CAV) is still one of the major causes of death following heart transplantation. Here, we review the recent advances in its prevention and treatment. RECENT FINDINGS: Preventive measures comprise control of classical risk factors, prophylaxis against cytomegalovirus, avoidance of graft endothelial damage during heart transplantation, and prevention of acute rejection. These measures can be effective if begun early. The treatment options for established CAV are limited, percutaneous revascularization and coronary artery bypass graft only being viable for a minority of patients because of the diffuse nature of CAV. Retransplantation is the only definitive therapy for CAV and may be considered for suitable patients with advanced CAV and allograft dysfunction. One of the most promising developments in the recent years is the use of mTOR inhibitors, which can now be regarded as effective in preventing CAV in de novo patients; their role in the treatment of established CAV is still uncertain despite some encouraging recent findings. SUMMARY: The implementation of measures and lifestyles that help prevent CAV should be a priority of postheart transplantation management. Research should urgently evaluate mTOR inhibitors for the treatment of established CAV.

Usefulness of the INTERMACS Scale for predicting outcomes after urgent heart transplantation.

INTRODUCTION AND OBJECTIVES: Our aim was to assess the prognostic value of the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) scale in patients undergoing urgent heart transplantation (HT). METHODS: Retrospective analysis of 111 patients treated with urgent HT at our institution from April, 1991 to October, 2009. Patients were retrospectively assigned to three levels of the INTERMACS scale according to their clinical status before HT. RESULTS: Patients at the INTERMACS 1 level (n=31) more frequently had ischemic heart disease (P=.03) and post-cardiothomy shock (P=.02) than patients at the INTERMACS 2 (n=55) and INTERMACS 3-4 (n=25) levels. Patients at the INTERMACS 1 level showed higher preoperative catecolamin doses (P=.001), a higher frequency of use of mechanical ventilation (P<.001), intraaortic balloon (P=.002) and ventricular assist devices (P=.002), and a higher frequency of preoperative infection (P=.015). The INTERMACS 1 group also presented higher central venous pressure (P=.02), AST (P=.002), ALT (P=.006) and serum creatinine (P<.001), and lower hemoglobin (P=.008) and creatinine clearance (P=.001). After HT, patients at the INTERMACS 1 level had a higher incidence of primary graft failure (P=.03) and postoperative need for renal replacement therapy (P=.004), and their long-term survival was lower than patients at the INTERMACS 2 (log rank 5.1, P=.023; HR 3.1, IC 95% 1.1-8.8) and INTERMACS 3-4 level (log rank 6.1, p=0.013; HR 6.8, IC 95% 1.2-39.1). CONCLUSIONS: Our results suggest that the INTERMACS scale may be a useful tool to stratify postoperative prognosis after urgent HT.

Direct transfer of ST-elevation myocardial infarction patients for primary percutaneous coronary intervention from short and long transfer distances decreases temporal delays and improves short-term prognosis: the PROGALIAM Registry.

AIMS: This study sought to evaluate the impact of a direct transfer strategy on treatment times and prognosis of patients with ST-segment elevation acute myocardial infarction (STEMI) undergoing primary percutaneous intervention (PPCI). METHODS AND RESULTS: We conducted a cohort study of 1,194 patients who underwent PPCI in our centre between May 2005 and December 2008. We studied the role of direct transfer on time to treatment and door-to-balloon delays and its effect on 30-day mortality adjusted by risk profile on admission. During this period, 255 patients (21%) experienced direct transfer (DT) from the field to the catheterisation laboratory. Patients referred directly for PPCI experienced lower median door-to-balloon delay (102 minutes vs. 125 minutes, p<0.0001) and lower time to treatment (median 189 minutes vs. 259 minutes, p<0.0001) when compared with those referred from emergency departments (ED). These differences were consistent, with respect to door-to-balloon delay and time to treatment interval, in patients from our catchment area: median 88 vs. 98 minutes, (p=0.003) and 174 vs. 219 minutes (p<0.0001) respectively, and from long-distance transfer: 110 vs. 169 minutes (p<0.0001) and 197 minutes vs. 342 minutes (p<0.0001) respectively. Patients in the DT group experienced lower 30-day mortality than patients transferred from the ED (2.7% vs. 6.8%, p=0.017). In a multivariable analysis, DT strategy was independently associated with better short-term prognosis (OR 0.33, CI95% 0.12 - 0.92). CONCLUSIONS: Direct transfer reduces time delays and improves prognosis of patients with STEMI undergoing PPCI.

Heart transplantation.

PURPOSE OF REVIEW: This paper briefly and subjectively reviews a number of the modest or tentative, but noteworthy, advances in heart transplantation that have been made during the past 18 months or so. RECENT FINDINGS: The advances reviewed concern the selection of recipients, the management of the heart transplantation waiting list, the management of donors, post-heart transplant monitoring of immunological status, the early diagnosis of rejection, the role of mammalian target of rapamycine inhibitors and induction agents, and the definition and grading of cardiac allograft vasculopathy. SUMMARY: The findings reviewed indicate progress in the clarification of issues that were in most cases already being investigated. Further studies will in general be needed before corresponding measures are adopted in clinical practice.

Mean platelet volume predicts patency of the infarct-related artery before mechanical reperfusion and short-term mortality in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

BACKGROUND AND AIMS: Patency of infarct-related artery (IRA) before mechanical reperfusion with primary percutaneous coronary intervention (PPCI) has been associated with better prognosis in patients with ST-Elevation myocardial infarction (STEMI). Mean platelet volume (MPV) increases in STEMI patients and may be associated with increased thrombotic potential. In STEMI patients scheduled for PPCI we sought to assess whether mean platelet volume (MPV), as measured at admission, correlates with "spontaneous" reperfusion of the IRA and short-term clinical outcome. METHODS: Blood samples were obtained on hospital admission in 617 consecutive patients (82% men; age 64 + or - 12 years) with STEMI, before PPCI. 372 (61%) patients were treated with the GP IIb/IIIa blocker abciximab. The main study endpoint was mortality at 30 days. RESULTS: MPV was significantly lower in patients with basal TIMI flow grade 2 -3 compared to patients with TIMI grade 0-1 (median, 9 vs. 8.5 fL, p<0.0001). After adjustment, MPV remained an independent predictor of the patency of the IRA (OR 0.63, CI 95% 0.51 - 0.78). A cut off value of 8.95 fL had a predictive negative value of 82% to identify patients with patent IRA. Using this cut point, and after adjusting for confounders, MPV was an independent predictor of 30-day mortality (HR 2.92, CI 95% 1.36 - 6.29). When patients were subdivided according to abciximab use, MPV was a marker of worse outcome but only in patients who did not receive abciximab (HR 3.67, CI 95% 1.13 - 11.49). CONCLUSION: An increased MPV is an independent predictor of both a patent IRA (TIMI flow 2 or 3 before PPCI) and 30-day mortality. This marker may be able to identify patients requiring more aggressive antiplatelet therapy.

Sudden cardiac death of two heart transplant patients with correctly functioning implantable cardioverter defibrillators.

It is unclear whether the usual criteria for implantation of implantable cardioverter defibrillators in patients at risk of sudden death can be generalized to heart transplant recipients. We describe sudden death in 2 heart transplant recipients despite correctly functioning implantable cardioverter defibrillators. The scant relevant literature is reviewed. We conclude that implantable cardioverter defibrillators are unlikely to assist heart transplant recipients with severe coronary allograft vasculopathy and poor ventricular systolic function, the group with the highest incidence of sudden death.