Prognostic impact of precipitated cardiac decompensation in symptomatic heart failure with reduced ejection fraction and severe secondary mitral regurgitation.

BACKGROUND: Our aim was to assess the distribution of primary (with no trigger) and secondary (with a decompensation trigger) heart failure events in a severe heart failure population and their association with 2-year all-cause mortality in the Mitra.Fr study. METHODS: We included 304 patients with symptomatic heart failure, and severe mitral regurgitation and guideline directed medical therapy randomized to medical therapy alone or medical therapy with percutaneous mitral valve repair. According to the follow-up, we defined 3 categories of events: follow-up without any heart failure event, at least 1 decompensation starting with a primary heart failure decompensation or starting with a precipitated secondary heart failure event. The primary outcome was 2-years all-cause mortality. RESULTS: A total of 179 patients (59 %) had at least 1 heart failure decompensation within 24-months of follow-up. 129 heart failure decompensations (72%) were a first primary heart failure and 50 (28%) were a first secondary decompensation. Finally, 30 patients had both types of decompensations but these were not taken into account for the comparison of primary and secondary decompensations. Primary decompensations were 3-times more frequent than secondary decompensations, but the mean number of heart failure decompensations was similar in the "Primary heart failure group" compared to the "Secondary heart failure group": (1.94 ± 1.39 vs 1.80 ± 1.07 respectively; P = .480). Compared to patients without heart failure decompensation, patients with "Only primary decompensation" or with "Only secondary decompensation" had a significantly increased risk of death (HR = 4.87, 95% CI [2.86, 8.32] and 2.68 95%CI [1.64, 4.37] respectively). All-cause mortality, was not significantly different between these 2 type of decompensations (HR = 1.82, 95% CI [0.93, 3.58]; P = .082), but each additional heart failure recurrence was associated with a significant increase in mortality risk (HR = 1.27, 95% CI [1.08; 1.50]; P = .005). CONCLUSIONS: In heart failure with reduced ejection fraction and severe secondary mitral regurgitation patients, primary heart failure decompensations were 3-times more frequent compared to precipitated decompensations with a nonsignificant trend in increased risk of all-cause mortality. Our results fail to support the differentiation between primary and secondary decompensations as they seem to portend the same outcome impact.

Transcatheter aortic valve implantation using the SAPIEN 3 valve to treat aortic regurgitation: The French multicentre S3AR study.

BACKGROUND: Transcatheter aortic valve implantation now has a major role in the treatment of patients with severe aortic stenosis. However, evidence is scarce on its feasibility and safety to treat patients with pure aortic regurgitation. AIMS: We sought to evaluate the results of transcatheter aortic valve implantation using the balloon-expandable SAPIEN 3 transcatheter heart valve (Edwards Lifesciences, Irvine, CA, USA) in patients with pure aortic regurgitation on native non-calcified valves. METHODS: We conducted a retrospective and prospective French multicentre observational study. We included all patients with symptomatic severe pure aortic regurgitation on native non-calcified valves, contraindicated to or at high risk for surgical valve replacement, who underwent transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve. RESULTS: A total of 37 patients (male sex, 73%) with a median age of 81years (interquartile range 69-85years) were screened using transthoracic echocardiography and computed tomography and were included at eight French centres. At baseline, 83.8% of patients (n=31) had dyspnoea New York Heart Association class≥III. The device success rate was 94.6% (n=35). At 30days, the all-cause mortality rate was 8.1% (n=3) and valve migration occurred in 10.8% of cases (n=4). Dyspnoea New York Heart Association class≤II was seen in 86.5% of patients (n=32), and all survivors had aortic regurgitation grade≤1. At 1-year follow-up, all-cause mortality was 16.2% (n=6), 89.7% (n=26/29) of survivors were in New York Heart Association class≤II and all had aortic regurgitation grade≤2. CONCLUSION: Transcatheter aortic valve implantation using the SAPIEN 3 transcatheter heart valve seems promising to treat selected high-risk patients with pure aortic regurgitation on non-calcified native valves, contraindicated to surgical aortic valve replacement.

Prognostic value of a comprehensive geriatric assessment for predicting one-year mortality in presumably frail patients with symptomatic aortic stenosis.

Introduction: Despite suffering a severe aortic stenosis, some patients are denied either surgical or transcatheter aortic valve implantation (TAVI) therapy because of a frail condition. We aimed to identify whether a comprehensive geriatric assessment (CGA) might be useful to predict the prognosis of presumably frail patients with severe aortic stenosis. Material and methods: Between March 2011 and July 2016, 818 patients were consecutively and prospectively enrolled. 161 had a CGA and were considered for analysis. Considering combined CGA and heart team recommendations, 102 TAVI procedures were performed (TAVI group) and 59 patients constituted the no-TAVI group. The primary endpoint was all-cause mortality at 1 year. Results: There was no difference between the TAVI and the no-TAVI groups considering morphometric data, cardiovascular risk factors or symptoms. The no-TAVI group had higher surgical risk (logistic EuroSCORE1 33.4 ±17.8 vs. 22.7 ±14.9; p < 0.001) and more moderate renal insufficiency (82% vs. 57%; p = 0.001). One-year mortality was 16% in the TAVI group and 46% in the no-TAVI group (p < 0.001). Multivariate analysis revealed that history of pulmonary edema, moderate renal failure, and not having a TAVI were associated with 1-year mortality. There was an interaction between the Five-Times-Sit-to-Stand-Test (FTSST) and the effect of TAVI on mortality (p = 0.049), as FTSST was the only predictor for 1-year mortality in the no-TAVI group (HR = 0.18, 95% CI: 0.04-0.76; p = 0.019). Conclusions: One-year mortality was higher in geriatric-assessed frail patients who did not undergo TAVI. FTSST, which assesses patients' mobility, was the only prognostic marker for 1-year mortality, on top of the usual medical parameters.

Infective endocarditis in pregnant women without intravenous drug use: a multicentre retrospective case series.

OBJECTIVES: To describe the clinical features and outcomes of infective endocarditis (IE) in pregnant women who do not inject drugs. METHODS: A multinational retrospective study was performed at 14 hospitals. All definite IE episodes between January 2000 and April 2021 were included. The main outcomes were maternal mortality and pregnancy-related complications. RESULTS: Twenty-five episodes of IE were included. Median age at IE diagnosis was 33.2 years (IQR 28.3-36.6) and median gestational age was 30 weeks (IQR 16-32). Thirteen (52%) patients had no previously known heart disease. Sixteen (64%) were native IE, 7 (28%) prosthetic and 2 (8%) cardiac implantable electronic device IE. The most common aetiologies were streptococci (n = 10, 40%), staphylococci (n = 5, 20%), HACEK group (n = 3, 12%) and Enterococcus faecalis (n = 3, 12%). Twenty (80%) patients presented at least one IE complication; the most common were heart failure (n = 13, 52%) and symptomatic embolism other than stroke (n = 4, 16%). Twenty-one (84%) patients had surgery indication and surgery was performed when indicated in 19 (90%). There was one maternal death and 16 (64%) patients presented pregnancy-related complications (11 patients ≥1 complication): 3 pregnancy losses, 9 urgent Caesarean sections, 2 emergency Caesarean sections, 1 fetal death, and 11 preterm births. Two patients presented a relapse during a median follow-up of 3.1 years (IQR 0.6-7.4). CONCLUSIONS: Strict medical surveillance of pregnant women with IE is required and must involve a multidisciplinary team including obstetricians and neonatologists. Furthermore, the potential risk of IE during pregnancy should never be underestimated in women with previously known underlying heart disease.

Multicentric randomized evaluation of a tricuspid valve percutaneous repair system (clip for the tricuspid valve) in the treatment of severe secondary tricuspid regurgitation Tri.Fr Design paper.

AIMS: Tricuspid regurgitation (TR) is associated with significant morbidity and mortality. Its independent prognostic role has been repeatedly demonstrated. However, this valvular heart condition is largely undertreated because of the increased risk of surgical repair. Recently, transcatheter techniques for the treatment of TR have emerged, but their implications for the clinical endpoints are still unknown. METHODS AND RESULTS: The Tri.fr trial will be a multicentre, controlled, randomized (1:1 ratio), superior, open-label, and parallel-group study conducted in 300 patients with severe secondary TR that is considered non-surgical by heart teams. Inclusion will be possible only after core laboratory review of transthoracic and transoesophageal echocardiography and after validation by the clinical eligibility committee. A description of the mechanisms of the TR will be conducted by the core laboratory. Atrial or ventricular impacts on the severity of the secondary TR will be taken into account for the randomization. The patients will be followed for 12-month, and the primary outcome will be the Packer composite clinical endpoint [combining New York Heart Association class, patient global assessment (PGA), and major cardiovascular events]. It will test the hypothesis that a tricuspid valve percutaneous repair strategy using a clip dedicated to the tricuspid valve is superior to best guideline-directed medical therapy in symptomatic patients with severe secondary TR. CONCLUSION: Tri.fr will be the first randomized, academic, multicentre study testing the value of percutaneous correction in patients with severe secondary TR.

Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years.

AIMS: The MITRA-FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline-directed medical treatment alone. We report the 24-month outcome from this trial. METHODS AND RESULTS: At 37 centres, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm2 or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n = 152) or medical treatment alone (control group, n = 152). The primary efficacy outcome was the composite of all-cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all-cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group [hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.77-1.34]. All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (HR 1.02, 95% CI 0.70-1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (HR 0.97, 95% CI 0.72-1.30). CONCLUSIONS: In patients with severe secondary mitral regurgitation, percutaneous repair added to medical treatment did not significantly reduce the risk of death or hospitalization for heart failure at 2 years compared with medical treatment alone.

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 .).

Influence of stentless versus stented valves on ventricular remodeling assessed at 6 months by magnetic resonance imaging and long-term follow-up.

BACKGROUND: To compare the effect of stented versus stentless bioprostheses on left ventricular remodeling and assess their impact on long-term survival. METHODS: From January 2002 to December 2009, 62 severe aortic stenosis patients without coronary artery disease were randomized for bioprosthetic aortic valve replacement. After randomization, a cross-over was possible based on intraoperative data. Ventricular remodeling was studied by cardiovascular magnetic resonance imaging six months after surgery. Long-term survival was assessed by telephone survey. RESULTS: Thirty-five patients received a porcine Mosaïc® Medtronic bioprosthesis (Stented Group; Medtronic, Minneapolis, MN, USA) inserted using the usual supra-annular technique and 27 received a porcine Freestyle® Medtronic bioprosthesis (Stentless Group) inserted in the subcoronary position. Mean age was 75±3 and 73±4 years in the stentless and stented group, respectively. Nine patients who should have been implanted with a stentless bioprosthesis received a stented bioprosthesis for anatomical reasons. At 6 months, the left ventricular mass (LVM) decreased significantly in both groups (Stentless Group: 214.6±56.1g and 156.3±23g and Stented Group: 237±75.7g and 181±53.3g, respectively after surgery and at 6 months), this decrease was significantly greater in the stentless group (p=0.026). Reserve and coronary flow were increased in both groups at 6 months. Mean follow-up duration was 6.6±3.0 years and 7.2±4.0 years in the stentless and stented group, respectively. The 5-year actuarial survival was 87.5±11.7% and 82.5±17.1% for the stentless and stented group, respectively (p=0.81). CONCLUSION: Porcine stentless prosthesis results in a better LVM regression than a stented valve at 6 months without changing the long-term survival.

First report of endocarditis caused by a Pseudoclavibacter species.

We describe the first case of Pseudoclavibacter species endocarditis in a 44-year-old patient. This genus, rarely isolated from humans, confirms here its role as a human pathogen.

Myopericarditis complicated by pulmonary embolism in an immunocompetent patient with acute cytomegalovirus infection: a case report.

BACKGROUND: Primary acute cytomegalovirus infection in immunocompetent patients is common worldwide. Infection is most often asymptomatic or occurs sub-clinically with a self-limited mononucleosis-like syndrome. More rarely, the infection may lead to severe organ complications with pneumonia, myocarditis, pericarditis, colitis and hemolytic anemia. Recent cases of cytomegalovirus-associated thrombosis have also been reported sporadically in the medical literature. CASE PRESENTATION: We report here a case of simultaneous myopericarditis and pulmonary embolism in a 30-year-old man with no medical history. The patient was not immunocompromised. We discuss the possible role of acute cytomegalovirus infection in the induction of vascular damage and review relevant cases in the literature. CONCLUSION: Thrombosis in patients with acute cytomegalovirus infection may be more frequent than is generally thought. Physicians need to be aware of the possible association between acute cytomegalovirus and thrombosis in immunocompetent patients, especially in the presence of severe systemic infection, as our case illustrates.

CMR assessment after a transapical-transcatheter aortic valve implantation.

AIMS: To describe the time course of myocardial scarring after transapical-transcatheter aortic valve implantation (TA-TAVI) with the Edwards SAPIEN XT™ and the Edwards SAPIEN™ prosthesis in a 3-month follow-up study using cardiac magnetic resonance imaging (CMR). METHODS: In 20 TA-TAVI patients, CMR was performed at discharge and 3 months (3M). Cine-MRI was used for left ventricular (LV) functional assessment, and late gadolinium enhancement (LGE) imaging was employed for detecting the presence of myocardial scarring. Special attention was given to any artifacts caused by the prosthesis, which were consequently defined using a three-grade artifact scale. RESULTS: We systematically reported the presence of small LGE hyperintensity relating to the apical segment, with no variation found between discharge and 3M (2.8±1.6g vs. 2.35±1.1g). LV ejection fraction, end-diastolic, and end-systolic volumes did not significantly vary. A small area of apical akinesia was observed, with no improvement at follow-up. Whereas the Edwards SAPIEN XT™ prosthesis and the Edwards SAPIEN™ prosthesis are both constituted by metallic stenting structure, the Edwards SAPIEN™ was responsible for a larger signal void, thus potentially limiting the diagnostic performance of CMR. CONCLUSIONS: CMR may be performed safely in the context of TA-TAVI. The presence of a very small apical infarction correlating with focal akinesia was observed. As expected, the Edwards SAPIEN XT™ prosthesis was shown to be particularly suitable for CMR assessment.

Relationship between amplitude and timing of heart sounds and endocardial acceleration.

OBJECTIVE: To study the correlation between heart sounds and peak endocardial acceleration (PEA) amplitudes and timings, by modulation of paced atrioventricular (AV) delay in recipients of dual chamber pacemakers. METHODS: Ten recipients of dual chamber pacemakers implanted for high-degree AV block were studied. Endocardial acceleration (EA) and phonocardiographic and electrocardiographic signals were recorded during performance of an AV delay scan in VDD and DDD modes. RESULTS: First PEA (PEA I) and first heart sound (S1) changed similarly with the AV delay. A close intrapatient correlation was observed between S1 and PEA I amplitudes in all patients (P < 0.0001). The interpatient normalized PEA I to S1 amplitudes correlation was r = 0.89 (P < 0.0001) in DDD mode, and r = 0.81 (P < 0.0001) in VDD mode. The mean cycle-by-cycle PEA I to S1 delay was -4.3 +/- 22 ms and second PEA (PEA II) to second heart sound (S2) delay was -7.7 +/- 15 ms. CONCLUSIONS: A close correlation was observed between PEA I and S1 amplitudes and timings, and between PEA II and S2 timings. These observations support the hypothesis that PEA and heart sounds are manifestations of the same phenomena. EA might be a useful tool to monitor cardiac function.

Programming optimal atrioventricular delay in dual chamber pacing using peak endocardial acceleration: comparison with a standard echocardiographic procedure.

Optimization of programmed atrioventricular delay in dual chamber pacing is essential to the hemodynamic efficiency of the heart. Automatic AV delay optimization in an implanted pacemaker is highly desirable. Variations of peak endocardial acceleration (PEA) with AV delay at rest correlate well with echocardiography derived observations, particularly with end-diastolic filling and mitral valve closure timings. This suggests the possibility of devicing a procedure for the automatic determination of the optimal AV delay. The aim of this study was to compare a proposed algorithm for optimal AV delay determination with an accepted echocardiographic method. Fifteen patients with high degree AV block received BEST-Living pacing systems. Automatic AV delay scans were performed at rest (60-300 ms in 20-ms steps with 60 beats per step) in DDD at 90 ppm, while simultaneously recording cycle-by-cycle PEA values, which were averaged for each AV delay to obtain a PEA versus AV delay curve. Nonlinear regression analysis based on a Boltzmann sigmoid curve was performed, and the optimal AV delay (OAVD) was chosen as the sigmoid inflection point of the regression curve. The OAVD was also evaluated for each patient using the Ritter echocardiographic method. Good sigmoid fit was obtained in 13 of 15 patients. The mean OAVD obtained by the PEA sigmoid algorithm was 146.9 +/- 32.1 ms, and the corresponding result obtained by echocardiography was 156.4 +/- 34.3 ms (range 31.8-39.7 ms). Correlation analysis yielded r = 0.79, P = 0.0012. In conclusion, OAVD estimates obtained by PEA analysis during automatic AV delay scanning are consistent with those obtained by echocardiography. The proposed algorithm can be used for automatic OAVD determination in an implanted pacemaker pulse generator.