Rationale and design of the ULYSS trial: A randomized multicenter evaluation of the efficacy of early Impella CP implantation in acute coronary syndrome complicated by cardiogenic shock.

CONTEXT: Despite 20 years of improvement in acute coronary syndromes care, patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) remains a major clinical challenge with a stable incidence and mortality. While intra-aortic balloon pump (IABP) did not meet its expectations, percutaneous mechanical circulatory supports (pMCS) with higher hemodynamic support, large availability and quick implementation may improve AMICS prognosis by enabling early hemodynamic stabilization and unloading. Both interventional and observational studies suggested a clinical benefit in selected patients of the IMPELLAⓇ CP device within in a well-defined therapeutic strategy. While promising, these preliminary results are challenged by others suggesting a higher rate of complications and possible poorer outcome. Given these conflicting data and its high cost, a randomized clinical trial is warranted to delineate the benefits and risks of this new therapeutic strategy. DESIGN: The ULYSS trial is a prospective randomized open label, 2 parallel multicenter clinical trial that plans to enroll patients with AMICS for whom an emergent percutaneous coronary intervention (PCI) is intended. Patients will be randomized to an experimental therapeutic strategy with pre-PCI implantation of an IMPELLAⓇ CP device on top of standard medical therapy or to a control group undergoing PCI and standard medical therapy. The primary objective of this study is to compare the efficacy of this experimental strategy by a composite end point of death, need to escalate to ECMO, long-term left ventricular assist device or heart transplantation at 1 month. Among secondary objectives 1-year efficacy, safety and cost effectiveness will be assessed. CLINICAL TRIAL REGISTRATION: NCT05366452.

Prognostic value of cardiovascular magnetic resonance T1 mapping and extracellular volume fraction in nonischemic dilated cardiomyopathy.

BACKGROUND: Heart failure- (HF) and arrhythmia-related complications are the main causes of morbidity and mortality in patients with nonischemic dilated cardiomyopathy (NIDCM). Cardiovascular magnetic resonance (CMR) imaging is a noninvasive tool for risk stratification based on fibrosis assessment. Diffuse interstitial fibrosis in NIDCM may be a limitation for fibrosis assessment through late gadolinium enhancement (LGE), which might be overcome through quantitative T1 and extracellular volume (ECV) assessment. T1 and ECV prognostic value for arrhythmia-related events remain poorly investigated. We asked whether T1 and ECV have a prognostic value in NIDCM patients. METHODS: This prospective multicenter study analyzed 225 patients with NIDCM confirmed by CMR who were followed up for 2 years. CMR evaluation included LGE, native T1 mapping and ECV values. The primary endpoint was the occurrence of a major adverse cardiovascular event (MACE) which was divided in two groups: HF-related events and arrhythmia-related events. Optimal cutoffs for prediction of MACE occurrence were calculated for all CMR quantitative values. RESULTS: Fifty-eight patients (26%) developed a MACE during follow-up, 42 patients (19%) with HF-related events and 16 patients (7%) arrhythmia-related events. T1 Z-score (p = 0.008) and global ECV (p = 0.001) were associated with HF-related events occurrence, in addition to left ventricular ejection fraction (p < 0.001). ECV > 32.1% (optimal cutoff) remained the only CMR independent predictor of HF-related events occurrence (HR 2.15 [1.14-4.07], p = 0.018). In the arrhythmia-related events group, patients had increased native T1 Z-score and ECV values, with both T1 Z-score > 4.2 and ECV > 30.5% (optimal cutoffs) being independent predictors of arrhythmia-related events occurrence (respectively, HR 2.86 [1.06-7.68], p = 0.037 and HR 2.72 [1.01-7.36], p = 0.049). CONCLUSIONS: ECV was the sole independent predictive factor for both HF- and arrhythmia-related events in NIDCM patients. Native T1 was also an independent predictor in arrhythmia-related events occurrence. The addition of ECV and more importantly native T1 in the decision-making algorithm may improve arrhythmia risk stratification in NIDCM patients. Trial registration NCT02352129. Registered 2nd February 2015-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02352129.

Mitral valve-in-valve and valve-in-ring procedures: Midterm outcomes in a French nationwide registry.

OBJECTIVES: Report contemporary outcomes in patients included in the Mitragister registry and treated with transcatheter mitral valve implantation for failed surgical annuloplasty rings or deteriorated bioprosthesis. BACKGROUND: Midterm survival rates have been reported, but little is known about contemporary morbimortality endpoints. METHODS: The primary safety outcome was the technical success rate. The primary efficacy composite endpoint was a composite of cardiovascular mortality and heart failure hospitalizations. RESULTS: From 2016 to 2021, 102 patients (median age: 81 [74;84] years, 61% female, Euroscore II 11.0% [7.8;16.0]) undergoing valve-in-valve (ViV; n = 89) or valve-in-ring (ViR; n = 13) procedures were consecutively included. At baseline, ViR group patients had worse left ventricular ejection fraction (50% vs. 60%; p = 0.004) and more frequently severe regurgitation (46% vs. 15%; p = 0.014). The primary safety outcome was 95%: 77% and 98% in the ViR and ViV populations, respectively, (p = 0.014). At intermediate follow-up (6-12 months) clinical improvement was notable, 88% of the patients were in NYHA class ≤ II (vs. 25% at baseline; p < 0.001). At a mean follow-up of 17.1 ± 11.0 months, the primary efficacy composite reached 27%. By multivariate analysis, paravalvular leak (PVL) was the only independent predictor (hazard ratio: 2.39, 95% confidence interval: 1.08-5.29; p = 0.031) while ViR was not found statistically associated (p = 0.456). CONCLUSIONS: This study confirms the safety and efficacy of the mitral ViV procedure. ViR patients appear at higher risk of procedural complications. The presence of PVL could be associated with markedly worse midterm prognosis. Whatever the intervention, procedural strategies to reduce PVL incidence remain to be assessed to prevent latter adverse outcomes.

Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation.

BACKGROUND: In patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous mitral-valve repair improves clinical outcomes in this patient population is unknown. METHODS: We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm2 or a regurgitant volume of >30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group; 152 patients) or to receive medical therapy alone (control group; 152 patients). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months. RESULTS: At 12 months, the rate of the primary outcome was 54.6% (83 of 152 patients) in the intervention group and 51.3% (78 of 152 patients) in the control group (odds ratio, 1.16; 95% confidence interval [CI], 0.73 to 1.84; P=0.53). The rate of death from any cause was 24.3% (37 of 152 patients) in the intervention group and 22.4% (34 of 152 patients) in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77). The rate of unplanned hospitalization for heart failure was 48.7% (74 of 152 patients) in the intervention group and 47.4% (72 of 152 patients) in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56). CONCLUSIONS: Among patients with severe secondary mitral regurgitation, the rate of death or unplanned hospitalization for heart failure at 1 year did not differ significantly between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone. (Funded by the French Ministry of Health and Research National Program and Abbott Vascular; MITRA-FR ClinicalTrials.gov number, NCT01920698 .).

Left ventricular function after correction of mitral regurgitation: Impact of the clipping approach.

AIMS: Functional mitral regurgitation (FMR) is associated with poor outcome in systolic heart failure (HF) patients. Percutaneous edge-to-edge mitral valve repair (PMVR) in Mitra-Fr study failed to prove any beneficial effect over optimal medical treatment (OMT) but win in COAPT study. Nevertheless, little is known about the effect of PMVR on LV performance and mechanics in HF patients with severe secondary MR. METHOD AND RESULTS: Thirty-seven patients with severe FMR undergoing PMVR were included and compared (according to indices of LV myocardial function and the relationship between LV-size and the degree of regurgitation) to nineteen patients with FMR treated by OMT. Both groups were clinically comparable. At 6-month follow-up, cardiac index such as LV global constructive work (GCW) improved significantly in both groups (1.86 vs 2.13 L/min/m2 , P = .02, 1.73 vs 2.28 L/min/m2 P = .002 and 977 vs 1101 mm Hg.%, P = .003, 967 vs 1110 mm Hg.%, P = .002 for PMVR and OMT groups, respectively) whereas left ventricular (LV) end-systolic volume index, LV ejection fraction, and global longitudinal strain were not different. Receiver operating characteristics in PMVR with LVEF ≤ 35% subgroup analysis demonstrated that global work index (GWI) had the best ability to identify patients with worse evolution (AUC = 0.882; P = .009), confirmed by univariable logistic regression, particularly for patients with GWI < 482 mm Hg.%. CONCLUSION: Echocardiographic characteristics at 6-month follow-up are not different when compare PMVR and OMT for HF patients with severe FMR. A low global work index might be a tool for discouraging the implantation of clips for this indication.

Predicting the development of in-hospital cardiogenic shock in patients with ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention: the ORBI risk score.

Aims: To derive and validate a readily useable risk score to identify patients at high-risk of in-hospital ST-segment elevation myocardial infarction (STEMI)-related cardiogenic shock (CS). Methods and results: In all, 6838 patients without CS on admission and treated by primary percutaneous coronary intervention (pPCI), included in the Observatoire Régional Breton sur l'Infarctus (ORBI), served as a derivation cohort, and 2208 patients included in the obseRvatoire des Infarctus de Côte-d'Or (RICO) constituted the external validation cohort. Stepwise multivariable logistic regression was used to build the score. Eleven variables were independently associated with the development of in-hospital CS: age >70 years, prior stroke/transient ischaemic attack, cardiac arrest upon admission, anterior STEMI, first medical contact-to-pPCI delay >90 min, Killip class, heart rate >90/min, a combination of systolic blood pressure <125 mmHg and pulse pressure <45 mmHg, glycaemia >10 mmol/L, culprit lesion of the left main coronary artery, and post-pPCI thrombolysis in myocardial infarction flow grade <3. The score derived from these variables allowed the classification of patients into four risk categories: low (0-7), low-to-intermediate (8-10), intermediate-to-high (11-12), and high (≥13). Observed in-hospital CS rates were 1.3%, 6.6%, 11.7%, and 31.8%, across the four risk categories, respectively. Validation in the RICO cohort demonstrated in-hospital CS rates of 3.1% (score 0-7), 10.6% (score 8-10), 18.1% (score 11-12), and 34.1% (score ≥13). The score demonstrated high discrimination (c-statistic of 0.84 in the derivation cohort, 0.80 in the validation cohort) and adequate calibration in both cohorts. Conclusion: The ORBI risk score provides a readily useable and efficient tool to identify patients at high-risk of developing CS during hospitalization following STEMI, which may aid in further risk-stratification and thus potentially facilitate pre-emptive clinical decision making.

Effectiveness of Extracorporeal Life Support for Patients With Cardiogenic Shock Due To Intractable Arrhythmic Storm.

OBJECTIVES: Extracorporeal life support is used for patients with severe heart failure as a bridge to heart transplantation or recovery. We aimed at analyzing the efficacy and safety of extracorporeal life support to treat refractory arrhythmic storm responsible for cardiogenic shock in patients resistant to antiarrhythmic drugs. DESIGN: Retrospective study. SETTING: University Hospital of Rennes, France. PATIENTS: Patients with refractory arrhythmic storm admitted between January 2005 and March 2015. INTERVENTIONS: Patients with intractable refractory arrhythmic storm and cardiogenic shock despite optimal medical therapy were implanted with an extracorporeal life support. Patients' characteristics and outcomes after extracorporeal life support implantation were analyzed. MEASUREMENTS AND MAIN RESULTS: Twenty-six patients (23 men, 52.4 ± 9.2 yr old) were included, most of them having ischemic cardiomyopathy (65.4%). Stable sinus rhythm restoration was immediate in 61.5% of patients and occurred after a median time of 3 hours after extracorporeal life support implantation for the remaining ones. Thirteen patients (50%) eventually died, none of them due to extracorporeal life support-related complications, but mostly due to the occurrence of multiple organ failure, and occurred after a median time of 4 days. The remaining 13 patients (50%) had extracorporeal life support withdrawn after 6.7 ± 3.6 days and were discharged after 34.7 ± 14.7 days after admission. Patients with repetitive ventricular tachycardia/ventricular fibrillation episodes alternating with periods of sinus rhythm at the time of implantation had a better survival than those in refractory ventricular fibrillation (p = 0.017). CONCLUSIONS: This is the largest database of patients temporary implanted with extracorporeal life support for refractory arrhythmic storm responsible for cardiogenic shock resistant to antiarrhythmic drugs. It provides efficient hemodynamic support and survival rate after the implantation is 50%.

Recognition and significance of pathological T-wave inversions in athletes.

BACKGROUND: Pathological T-wave inversion (PTWI) is rarely observed on the ECG of healthy athletes, whereas it is common in patients with certain cardiac diseases. All ECG interpretation guidelines for use within athletes state that PTWI (except in leads aVR, III and V1 and in V1-V4 when preceded by domed ST segment in asymptomatic Afro-Caribbean athletes only) cannot be considered a physiological adaptation. The aims of the present study were to prospectively determine the prevalence of cardiac pathology in athletes presenting with PTWI, and to examine the efficacy of cardiac magnetic resonance in the work-up battery of further examinations. METHODS AND RESULTS: Athletes presenting with PTWI (n=155) were investigated with clinical examination, ECG, echocardiography, exercise testing, 24h Holter ECG, and cardiac magnetic resonance. Cardiac disease was established in 44.5% of athletes, with hypertrophic cardiomyopathy (81%) the most common pathology. Echocardiography was abnormal in 53.6% of positive cases, and cardiac magnetic resonance identified a further 24 athletes with disease. Five athletes (7.2%) considered normal on initial presentation subsequently expressed pathology during follow-up. Familial history of sudden cardiac death and ST-segment depression associated with PTWI were predictive of cardiac disease. CONCLUSIONS: PTWI should be considered pathological in all cases until proven otherwise, because it was associated with cardiac pathology in 45% of athletes. Despite echocardiography identifying pathology in half of these cases, cardiac magnetic resonance must be considered routine in athletes presenting with PTWI with normal echocardiography. Although exclusion from competitive sport is not warranted in the presence of normal secondary examinations, annual follow-up is essential to ascertain possible disease expression.

Echocardiographic estimation of pulmonary pressure in patients with severe tricuspid regurgitation.

OBJECTIVES: The estimation of systolic pulmonary artery pressure (sPAP) by transthoracic echocardiography (TTE) is challenging in patients with severe tricuspid regurgitation (TR). The study aimed to determine the reliability of the assessment of sPAP by TTE in this population. METHODS: This study was a single-centre analysis of consecutive patients at the University Hospital of Rennes with right heart catheterisation and TTE, performed with a maximum delay of 48 hours. Lin's concordance coefficient (LCC) and Bland-Altman analysis were used to compare the values. RESULTS: After applying the exclusion criteria, 236 patients were included in the analysis (age 71±11.5 years old; male 56%). The two principal indications were TR (34.3%) and mitral regurgitation (32.2%). The correlation between the two procedures was good in the total population (LCC=0.80; 95% limits of agreement (LOA): 0.74, 0.84), but weaker in the 78 patients (33%) with severe TR (LCC=0.67; 95% LOA: 0.49, 0.80), with a propensity to an underestimation by TTE. An elevated right atrial pressure (RAP) was associated with an underestimation by TTE of about 8 mmHg. The presence of a 'V-wave cut-off' sign on continuous-wave Doppler (OR=3.74; 95% CI 1.48, 9.30; p<0.01), found exclusively in patients with severe TR, was an independent predictor of sPAP misestimation by TTE. CONCLUSION: The reliability of the estimation of sPAP in patients with severe TR could be altered by high RAP which cannot be estimated with current thresholds.

Transcatheter aortic valve implantation in severe aortic stenosis does not necessarily reverse left ventricular myocardial damage: data of long-term follow-up.

AIMS: Aortic stenosis (AS) is causing myocardial damage and replacement is mainly indicated based on symptoms. Non-invasive estimation of myocardial work (MW) provides a less afterload-dependent too for assessing myocardial function. We sought to look at the impact of transcatheter aortic valve implantation (TAVI) on the myocardium at long-term follow-up and according to current indications. METHODS AND RESULTS: We conducted an observational, cross-sectional, single-centre study. Patients were selected based on the validated indication for a TAVI. Standardized echocardiographies were repeated. A total of 102 patients were included. The mean age was 85 years, 45% were female, 68% had high blood pressure, and 52% had a coronary disease. One-fifth was suffering from low-flow-low-gradient AS. A follow-up was performed at 22 ± 9.5 months after the TAVI. No TAVI dysfunction was observed. Left ventricular (LV) ejection fraction was stable (62 ± 8%), and global longitudinal strain had improved (-14.0 ± 3.7 vs. -16.0 ± 3.6%, P < 0.0001). No improvement of the MW parameters was noticed (LV global work index 2099 ± 692 vs. 2066 ± 706 mmHg%, P = 0.8, LV global constructive 2463 ± 736 vs. 2463 ± 676 mmHg%, P = 0.8). Global wasted work increased [214 (149; 357) vs. 247 (177; 394) mmHg%, P = 0.0008]. CONCLUSION: In a population of severe symptomatic AS patients who had undergone a TAVI, the non-invasive myocardial indices that assess the LV performance at long-term follow-up did not improve. These results are questioning the timing of the intervention and the need for more attention in the pharmacological management of these AS patients.

Right atrial and right ventricular strain: prognostic value depends on the severity of tricuspid regurgitation.

AIMS: Assessing right heart function is challenging, particularly when significant tricuspid regurgitation (TR) is present. Among available echocardiographic techniques for assessment, literatures suggests that strain imaging may be more reliable and less susceptible to loading conditions. Thus, we aimed to assess the validity of RA and RV strain relative to conventional metrics as well as their utility in predicting patient outcomes in TR. METHODS: We studied 262 consecutive patients (mean age 74 ± 11.2 years, 53% male) who underwent same-day echocardiography and right heart catheterization between 2018 and 2023. We compared right heart strain to traditional metrics of RV function and subsequently correlated RA and RV strain to heart failure (HF)-related death or hospitalization, whichever came first. RESULTS: Over a mean follow-up of 34 ± 15 months, there were 103 deaths and HF hospitalizations. Both RA and RV strain were correlated with echocardiographic and invasive measures of right heart function. Across all patients, preserved RA strain was associated with lower risk of adverse outcomes (HR 0.763, 95% CI 0.618-0.943). Similarly, preserved RV strain was correlated with better outcomes, though this was only statistically significant in patients without severe TR or pulmonary hypertension (HR 2.450, 95% CI 1.244-4.825). Moreover, abnormal ratios of RV strain to pulmonary pressures and RV size were significantly correlated with adverse outcomes (p < 0.05 each). CONCLUSION: RA and RV strain are independently correlated with echocardiographic and invasive measures of cardiac function. Moreover, preserved RA and RV strain are likely associated with better clinical outcomes.

The admission level of CRP during cardiogenic shock is a strong independent risk marker of mortality.

Inflammatory processes are involved not only in coronary artery disease but also in heart failure (HF). Cardiogenic shock (CS) and septic shock are classically distinct although intricate relationships are frequent in daily practice. The impact of admission inflammation in patients with CS is largely unknown. FRENSHOCK is a prospective registry including 772 CS patients from 49 centers. One-month and one-year mortalities were analyzed according to the level of C-reactive protein (CRP) at admission, adjusted on independent predictive factors. Within 406 patients included, 72.7% were male, and the mean age was 67.4 y ± 14.7. Four groups were defined, depending on the quartiles of CRP at admission. Q1 with a CRP < 8 mg/L, Q2: CRP was 8-28 mg/L, Q3: CRP was > 28-69 mg/L, and Q4: CRP was > 69 mg/L. The four groups did not differ regarding main baseline characteristics. However, group Q4 received more often antibiotics in 47.5%, norepinephrine in 66.3%, and needed more frequently respiratory support and renal replacement therapy. Whether at 1 month (Ptrend = 0.01) or 1 year (Ptrend < 0.01), a strong significant trend towards increased all-cause mortality was observed across CRP quartiles. Specifically, compared to the Q1 group, Q4 patients demonstrated a 2.2-fold higher mortality rate at 1-month (95% CI 1.23-3.97, p < 0.01), which persisted at 1-year, with a 2.14-fold increase in events (95% CI 1.43-3.22, p < 0.01). Admission CRP level is a strong independent predictor of mortality at 1 month and 1-year in CS. Specific approaches need to be developed to identify accurately patients in whom inflammatory processes are excessive and harmful, paving the way for innovative approaches in patients admitted for CS.NCT02703038.

Characteristics, management, and mid-term prognosis of older adults with cardiogenic shock admitted to intensive care units: Insights from the FRENSHOCK registry.

BACKGROUND: The incidence of heart failure and cardiogenic shock (CS) in older adults is continually increasing due to population aging. To date, prospective data detailing the specific characteristics, management and outcomes of CS in this population are scarce. METHODS: FRENSHOCK is a prospective registry including 772 CS patients from 49 centers. We studied 1-month and 1-year mortality among patients over 75-year-old, adjusted for independent predictors of 1-month and 1-year mortalities. RESULTS: Out of 772 patients included, 236 (30.6%) were 75 years old or more (mean age 81.9 ± 4.7 years, 63.6% male). Compared to patients <75 years old, older adults had a higher prevalence of comorbidities including hypertension, dyslipidemia, chronic kidney disease, and history of heart disease. Older adults were characterized by a lower blood pressure, as well as higher creatinine and lower haemoglobin levels at presentation. Yet, they were less likely to be treated with norepinephrine, epinephrine, invasive ventilation, and renal replacement therapy. They showed a higher 1-month (aHR: 2.5 [1.86-3.35], p < 0.01) and 1-year mortality (aHR: 2.01 [1.58-2.56], p < 0.01). Analysis of both 1-month and 1-year mortality stratified by age quartiles showed a gradual relationship between aging and mortality in CS patients. CONCLUSION: A third of patient with CS in critical care unit are older than 75 years and their risk of death at one month and one year is more than double compared to the younger ones. Further research is essential to identify best therapeutic strategy in this population. NCT02703038.

Clinical effects of permanent pacemaker implantation after transcatheter aortic valve implantation: Insights from the nationwide FRANCE-TAVI registry.

BACKGROUND: The influence of permanent pacemaker implantation upon outcomes after transcatheter aortic valve implantation (TAVI) remains controversial. AIMS: To evaluate the impact of permanent pacemaker implantation after TAVI on short- and long-term mortality, and on the risk of hospitalization for heart failure. METHODS: Data from the large FRANCE-TAVI registry, linked to the French national health single-payer claims database, were analysed to compare 30-day and long-term mortality rates and hospitalization for heart failure rates among patients with versus without permanent pacemaker implantation after TAVI. Multivariable regressions were performed to adjust for confounders. RESULTS: A total of 36,549 patients (mean age 82.6years; 51.6% female) who underwent TAVI from 2013 to 2019 were included in the present analysis. Among them, 6999 (19.1%) received permanent pacemaker implantation during the index hospitalization, whereas 232 (0.6%) underwent permanent pacemaker implantation between hospital discharge and 30days after TAVI, at a median of 11 (interquartile range: 7-18) days. In-hospital permanent pacemaker implantation was not associated with an increased risk of death between discharge and 30days (adjusted odds ratio: 0.91, 95% confidence interval: 0.64-1.29). At 5years, the incidence of all-cause death was higher among patients with versus without permanent pacemaker implantation within 30days of the procedure (adjusted hazard ratio: 1.13, 95% confidence interval: 1.07-1.19). Permanent pacemaker implantation within 30days of TAVI was also associated with a higher 5-year rate of hospitalization for heart failure (adjusted subhazard ratio: 1.17, 95% confidence interval: 1.11-1.23). CONCLUSIONS: Permanent pacemaker implantation after TAVI is associated with an increased risk of long-term hospitalization for heart failure and all-cause mortality. Further research to mitigate the risk of postprocedural permanent pacemaker implantation is needed as TAVI indications expand to lower-risk patients.

Cardiogenic shock and infection: A lethal combination.

BACKGROUND: Cardiogenic shock and sepsis are severe haemodynamic states that are frequently present concomitantly, leading to substantial mortality. Despite its frequency and clinical significance, there is a striking lack of literature on the outcomes of combined sepsis and cardiogenic shock. METHODS: FRENSHOCK was a prospective registry including 772 patients with cardiogenic shock from 49 centres. The primary endpoint was 1-month all-cause mortality. Secondary endpoints included heart transplantation, ventricular assistance device and all-cause death rate at 1year. RESULTS: Among the 772 patients with cardiogenic shock included, 92 cases were triggered by sepsis (11.9%), displaying more frequent renal and hepatic acute injuries, with lower mean arterial pressure. Patients in the sepsis group required broader use of dobutamine (90.1% vs. 81.2%; P=0.16), norepinephrine (72.5% vs. 50.8%; P<0.01), renal replacement therapy (29.7% vs. 14%; P<0.01), non-invasive ventilation (36.3% vs. 24.4%; P=0.09) and invasive ventilation (52.7% vs. 35.9%; P=0.02). Sepsis-triggered cardiogenic shock resulted in higher 1-month (41.3% vs. 24.0%; adjusted hazard ratio: 1.94, 95% confidence interval: 1.36-2.76; P<0.01) and 1-year (62.0% vs. 42.9%; adjusted hazard ratio 1.75, 95% confidence interval 1.32-2.33; P<0.01) all-cause death rates. No significant difference was found at 1year for heart transplantation or ventricular assistance device (8.7% vs. 10.3%; adjusted odds ratio 0.72, 95% confidence interval 0.32-1.64; P=0.43). In patients with sepsis-triggered cardiogenic shock, neither the presence of a preexisting cardiomyopathy nor the co-occurrence of other cardiogenic shock triggers had any additional impact on death. CONCLUSIONS: The association between sepsis and cardiogenic shock represents a common high-risk scenario, leading to higher short- and long-term death rates, regardless of the association with other cardiogenic shock triggers or the presence of preexisting cardiomyopathy.

Optimal Heart Failure Medical Therapy and Mortality in Survivors of Cardiogenic Shock: Insights From the FRENSHOCK Registry.

BACKGROUND: The effects of pharmacological therapy on cardiogenic shock (CS) survivors have not been extensively studied. Thus, this study investigated the association between guideline-directed heart failure (HF) medical therapy (GDMT) and one-year survival rate in patients who are post-CS. METHODS AND RESULTS: FRENSHOCK (French Observatory on the Management of Cardiogenic Shock in 2016) registry was a prospective multicenter observational survey, conducted in metropolitan French intensive care units and intensive cardiac care units. Of 772 patients, 535 patients were enrolled in the present analysis following the exclusion of 217 in-hospital deaths and 20 patients with missing medical records. Patients with triple GDMT (beta-blockers, renin-angiotensin system inhibitors, and mineralocorticoid receptor antagonists) at discharge (n=112) were likely to have lower left ventricular ejection fraction on admission and at discharge compared with those without triple GDMT (n=423) (22% versus 28%, P<0.001 and 29% versus 37%, P<0.001, respectively). In the overall cohort, the one-year mortality rate was 23%. Triple GDMT prescription was significantly associated with a lower one-year all-cause mortality compared with non-triple GDMT (adjusted hazard ratio 0.44 [95% CI, 0.19-0.80]; P=0.007). Similarly, 2:1 propensity score matching and inverse probability treatment weighting based on the propensity score demonstrated a lower incidence of one-year mortality in the triple GDMT group. As the number of HF drugs increased, a stepwise decrease in mortality was observed (log rank; P<0.001). CONCLUSIONS: In survivors of CS, the one-year mortality rate was significantly lower in those with triple GDMT. Therefore, this study suggests that intensive HF therapy should be considered in patients following CS.

Sex disparities in cardiogenic shock: Insights from the FRENSHOCK registry.

BACKGROUND: Cardiogenic shock (CS) is the most severe form of acute heart failure. Discrepancies have been reported between sexes regarding delays, pathways and invasive strategies in CS complicating acute myocardial infarction. However, effect of sex on the prognosis of unselected CS remains controversial. OBJECTIVES: The aim was to analyze the impact of sex on aetiology, management and prognosis of CS. METHODS: The FRENSHOCK registry included all CS admitted in 49 French Intensive Care Units (ICU) and Intensive Cardiac Care Units (ICCU) between April and October 2016. RESULTS: Among the 772 CS patients included, 220 were women (28.5%). Women were older, less smokers, with less history of ischemic cardiac disease (20.5% vs 33.6%) than men. At admission, women presented less cardiac arrest (5.5 vs 12.2%), less mottling (32.5 vs 41.4%) and higher LVEF (30 ± 14 vs 25 ± 13%). Women were more often managed via emergency department while men were directly admitted at ICU/ICCU. Ischemia was the most frequent trigger irrespective of sex (36.4% in women vs 38.2%) but women had less coronary angiogram and PCI (45.9% vs 54% and 24.1 vs 31.3%, respectively). We found no major difference in medication and organ support. Thirty-day mortality (26.4 vs 26.5%), transplant or permanent assist device were similar in both sexes. CONCLUSION: Despite some more favorable parameters in initial presentation and no significant difference in medication and support, women shared similar poor prognosis than men. Further analysis is required to cover the lasting gap in knowledge regarding sex specificities to distinguish between differences and inequalities. NCT02703038.

Cardiogenic shock and chronic kidney disease: Dangerous liaisons.

BACKGROUND: Chronic kidney disease (CKD) is one of the leading causes of death worldwide, closely interrelated with cardiovascular diseases, ultimately leading to the failure of both organs - the so-called "cardiorenal syndrome". Despite this burden, data related to cardiogenic shock outcomes in CKD patients are scarce. METHODS: FRENSHOCK (NCT02703038) was a prospective registry involving 772 patients with cardiogenic shock from 49 centres. One-year outcomes (rehospitalization, death, heart transplantation, ventricular assist device) were analysed according to history of CKD at admission and were adjusted on independent predictive factors. RESULTS: CKD was present in 164 of 771 patients (21.3%) with cardiogenic shock; these patients were older (72.7 vs. 63.9years) and had more comorbidities than those without CKD. CKD was associated with a higher rate of all-cause mortality at 1month (36.6% vs. 23.2%; hazard ratio 1.39, 95% confidence interval 1.01-1.9; P=0.04) and 1year (62.8% vs. 40.5%, hazard ratio 1.39, 95% confidence interval 1.09-1.77; P<0.01). Patients with CKD were less likely to be treated with norepinephrine/epinephrine or undergo invasive ventilation or receive mechanical circulatory support, but were more likely to receive renal replacement therapy (RRT). RRT was associated with a higher risk of all-cause death at 1month and 1year regardless of baseline CKD status. CONCLUSIONS: Cardiogenic shock and CKD are frequent "cross-talking" conditions with limited therapeutic options, resulting in higher rates of death at 1month and 1year. RRT is a strong predictor of death, regardless of preexisting CKD. Multidisciplinary teams involving cardiac and kidney physicians are required to provide integrated care for patients with failure of both organs.

Acute and Chronic Changes in Myocardial Work Parameters in Patients with Severe Primary Mitral Regurgitation Undergoing Transcatheter Edge-to-Edge Repair.

BACKGROUND: The noninvasive assessment of myocardial work (MW) allows for the evaluation of left ventricular (LV) performance by considering the effect of LV afterload. This study aims to evaluate the acute and chronic impact of transcatheter edge-to-edge repair (TEER) on MW parameters and LV remodeling in patients with severe primary mitral regurgitation (PMR). METHODS: A total of 71 patients (age: 77 ± 9 years, females: 44%) with moderate-to-severe or severe PMR (effective regurgitant orifice: 0.57 ± 0.31 cm2; regurgitant volume: 80 ± 34 mL; LV end-systolic diameter: 42 ± 12 mm) underwent TEER after a global assessment by the heart team. MW indices were evaluated before the procedure, at hospital discharge, and at 1-year follow-up. LV remodeling was described as the percentage variation in LVEDV between baseline and 1-year follow-up. RESULTS: TEER caused an acute reduction in LVEF, global longitudinal strain (GLS), global MW index (GWI), work efficiency (GWE), and mechanical dispersion (MD) and a significant increase in wasted work (GWW). One year after the procedure, GLS, GWI, GWE, and MD recovered, whereas GWW remained significantly impaired. Baseline GWW (ß = -0.29, p = 0.03) was an independent predictor of LV reverse remodeling at 1-year follow-up. CONCLUSIONS: In patients with severe PMR undergoing TEER, the acute reduction in LV preload causes significant impairment to all the parameters of LV performance. Baseline GWW was the only independent predictor of LV reverse remodeling, suggesting that a lower myocardial energetic efficiency in the context of chronic preload increase might impact the left ventricular response to mitral regurgitation correction.