[Extensive cardiac thombosis in a patient with disseminated intravascular coagulation]. / Thrombose extensive intracardiaque dans un contexte de coagulation intravasculaire disséminée.

Disseminated intravascular coagulation is a syndrome characterized by thrombin and fibrin generation which is associated with organ failure and death. Intracardiac thrombus may occur and further deteriorate prognosis. We report the case of a patient with massive intraventricular thrombus revealed by an acute ischemia of the upper left limb in a context of pulmonary adenocarcinoma complicated by a disseminated intravascular coagulation. We describe the diagnostic modalities and the fatal evolution.

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.

[Ruptured sinus of Valsalva aneurysm presenting as an idiopathic pericardial effusion]. / Rupture colmatée d'un anévrisme de valsalva d'évolution favorable après chirurgie.

Aneurysm of the sinus of Valsalva is a rare cardiac condition, which could be either acquired or congenital. The most frequent complication is a rupture into right cavities or more rarely into left cavities or pericardium. Rupture could be either asymptomatic or poorly tolerated with hemodynamic instability, acute heart failure or sudden death. We report the case of a 24-year-old patient with no past medical history presenting with a partially ruptured sinus of Valsalva into the pericardium and in whom the initial diagnosis was idiopathic pericardial effusion; we describe diagnostic modalities and management.

A Thrombus on a Journey: A Massive Thrombus in Transit With Cerebral, Coronary, and Pulmonary Embolization.

Impending paradoxical embolism is a biatrial thrombus in transit across a patent foramen ovale. It constitutes a rare clinical condition, possibly associated with multiple embolization and high mortality. We report the exceptional case of a 71-year-old-man presenting a giant impending paradoxical thrombus, complicated with pulmonary, cerebral, and coronary embolization. The patient underwent urgent surgery and was finally discharged without complications.

TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome: The TROUPER trial.

Chronic kidney disease (CKD) is associated with an increased risk of acute coronary syndrome (ACS) and cardiovascular death. CKD patients suffering from ACS are exposed to an increased risk of thrombotic recurrences and a higher bleeding rate than patients with normal renal function. However, CKD patients are excluded or underrepresented in clinical trials. Therefore, determining the optimal antiplatelet strategy in this population is of utmost importance. We designed the TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome (TROUPER) trial: a prospective, controlled, multicenter, randomized trial to investigate the optimal P2Y12 antagonist in CKD patients with ACS. Patients with stage ≥3b CKD are eligible if the diagnosis of ACS is made and invasive strategy scheduled. Patients are randomized 1:1 between a control group with a 600-mg loading dose of clopidogrel followed by a 75-mg/d maintenance dose for 1 year and an experimental group with a 180-mg loading dose of ticagrelor followed by a 90-mg twice daily maintenance dose for the same duration. The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year. Safety will be evaluated by the bleeding rate (Bleeding Academic Research Consortium). To demonstrate the superiority of ticagrelor on major adverse cardiovascular events, we calculated that 508 patients are required. The aim of the TROUPER trial is to compare the efficacy of ticagrelor and clopidogrel in stage >3b CKD patients presenting with ACS and scheduled for an invasive strategy. RCT# NCT03357874.

Optimal Timing of Intervention in NSTE-ACS Without Pre-Treatment: The EARLY Randomized Trial.

OBJECTIVES: The aim of this study was to compare a delayed and a very early invasive strategy in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS) without pre-treatment. BACKGROUND: The optimal delay of the invasive strategy in patients with NSTE-ACS remains debated and has never been investigated in patients not pre-treated with P2Y12-adenosine diphosphate receptor antagonists. METHODS: A prospective, open-label, randomized controlled trial was conducted. Altogether, 741 patients presenting with intermediate- or high-risk NSTE-ACS intended for an invasive strategy were included. The modified intention-to-treat analysis was composed of 709 patients after 32 withdrew consent. Patients were randomized 1:1 to the delayed invasive group (DG) (n = 363) with coronary angiography (CA) performed 12 to 72 h after randomization or the very early invasive group (EG) (n = 346) with CA within 2 h. No pre-treatment with a loading dose of a P2Y12-adenosine diphosphate receptor antagonist was allowed before CA. The primary endpoint was the composite of cardiovascular death and recurrent ischemic events at 1 month, as determined by a blinded adjudication committee. RESULTS: Most patients had high-risk NSTE-ACS in both groups (93% in the EG vs. 92.5% in the DG). The median time between randomization and CA was 0 h (interquartile range [IQR]: 0 to 1 h) in the EG group and 18 h (IQR: 11 to 23 h) in the DG. The primary endpoint rate was significantly lower in the EG (4.4% vs. 21.3% in the DG; hazard ratio: 0.20; 95% confidence interval: 0.11 to 0.34; p < 0.001), driven by a reduction in recurrent ischemic events (19.8% vs. 2.9%; p < 0.001). No difference was observed for cardiovascular death. CONCLUSIONS: Without pre-treatment, a very early invasive strategy was associated with a significant reduction in ischemic events at the time of percutaneous coronary intervention in patients with intermediate- and high-risk NSTE-ACS. (Early or Delayed Revascularization for Intermediate and High-Risk Non ST-Elevation Acute Coronary Syndromes; NCT02750579).

Femoral Versus Nonfemoral Peripheral Access for Transcatheter Aortic Valve Replacement.

BACKGROUND: Femoral access is the gold standard for transcatheter aortic valve replacement (TAVR). Guidelines recommend reconsidering surgery when this access is not feasible. However, alternative peripheral accesses exist, although they have not been accurately compared with femoral access. OBJECTIVES: This study compared nonfemoral peripheral (n-FP) TAVR with femoral TAVR. METHODS: Using the data from the national prospective French registry (FRANCE TAVI [French Transcatheter Aortic Valve Implantation]), this study compared the characteristics and outcomes of TAVR procedures according to whether they were performed through a femoral or a n-FP access, using a pre-specified propensity score-based matching between groups. Subanalysis during 2 study periods (2013 to 2015 and 2016 to 2017) and among low/intermediate-low and intermediate-high/high volume centers were performed. RESULTS: Among 21,611 patients, 19,995 (92.5%) underwent femoral TAVR and 1,616 (7.5%) underwent n-FP TAVR (transcarotid, n = 914 or trans-subclavian, n = 702). Patients in the n-FP access group had more severe disease (mean logistic EuroSCORE 19.95 vs. 16.95; p < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease, and renal failure. After matching, there was no difference in the rate of post-procedural death and complications according to access site, except for a 2-fold lower rate of major vascular complications (odds ratio: 0.45; 95% confidence interval: 0.21 to 0.93; p = 0.032) and unplanned vascular repairs (odds ratio: 0.41; 95% confidence interval: 0.29 to 0.59; p < 0.001) in those who underwent n-FP access. The comparison of outcomes provided similar results during the second study period and in intermediate-high/high volume centers. CONCLUSIONS: n-FP TAVR is associated with similar outcomes compared with femoral peripheral TAVR, except for a 2-fold lower rate of major vascular complications and unplanned vascular repairs. n-FP TAVR may be favored over surgery in patients who are deemed ineligible for femoral TAVR and may be a safe alternative when femoral access risk is considered too high.

Early versus delayed invasive strategy for intermediate- and high-risk acute coronary syndromes managed without P2Y12 receptor inhibitor pretreatment: Design and rationale of the EARLY randomized trial.

According to recent literature, pretreatment with a P2Y12 ADP receptor antagonist before coronary angiography appears no longer suitable in non-ST-segment elevation acute coronary syndrome (NSTE-ACS) due to an unfavorable risk-benefit ratio. Optimal delay of the invasive strategy in this specific context is unknown. We hypothesize that without P2Y12 ADP receptor antagonist pretreatment, a very early invasive strategy may be beneficial. The EARLY trial (Early or Delayed Revascularization for Intermediate- and High-Risk Non-ST-Segment Elevation Acute Coronary Syndromes?) is a prospective, multicenter, randomized, controlled, open-label, 2-parallel-group study that plans to enroll 740 patients. Patients are eligible if the diagnosis of intermediate- or high-risk NSTE-ACS is made and an invasive strategy intended. Patients are randomized in a 1:1 ratio. In the control group, a delayed strategy is adopted, with the coronary angiography taking place between 12 and 72 hours after randomization. In the experimental group, a very early invasive strategy is performed within 2 hours. A loading dose of a P2Y12 ADP receptor antagonist is given at the time of intervention in both groups. Recruitment began in September 2016 (n = 558 patients as of October 2017). The primary endpoint is the composite of cardiovascular death and recurrent ischemic events at 1 month. The EARLY trial aims to demonstrate the superiority of a very early invasive strategy compared with a delayed strategy in intermediate- and high-risk NSTE-ACS patients managed without P2Y12 ADP receptor antagonist pretreatment.

Initial experience with the WATCHMAN™ left atrial appendage system for stroke prevention in atrial fibrillation: A single-centre registry.

BACKGROUND: Left atrial appendage (LAA) closure using the WATCHMAN™ device (WM) may be considered in patients with non-valvular atrial fibrillation (AF) and a high-risk of stroke who are ineligible for long-term oral anticoagulation (OAC). AIM: To report our single-centre preliminary experience, focusing on feasibility, safety and short-term efficacy of this procedure. METHODS: Patients implanted from December 2013 to February 2014 were included. The procedure, performed under general anaesthesia, was guided by fluoroscopy and transoesophageal echocardiography (TOE). Efficacy was defined as the ability to implant the WM with no peridevice leak; safety was defined as the occurrence of in-hospital and 45-day events, including stroke, pericardial effusion and device migration. RESULTS: Twenty-three patients (mean age: 77.6 years; 16 men [69.6%]; mean CHA2DS2-VASc score: 5) underwent WM implantation. The indication was gastrointestinal bleeding in 14 (60.9%) patients, cerebral haemorrhage in eight (34.8%) and need for long-term ticagrelor after stent thrombosis on clopidgrel in one (4.3%). Procedural success was 95.7% (95% confidence interval: 77.3-100.0); efficacy was 90.9% (95% confidence interval: 71.0-98.7). The size of the implanted WATCHMAN™ device was in agreement with the prespecified size, based on measurement of the LAA, in 56.5% of cases. In five cases, the criteria were not met, but the device was successfully implanted in four of these, with a good result (80.0%). Treatment at discharge was a reduced dose of anticoagulant plus aspirin in three cases (13.0%) or antiplatelet therapy alone in 20 cases (90.9%). No adverse event occurred during the index hospitalization or at 45 days. At 45 days, the LAA was sealed in 18/19 patients (94.7%) on TOE, with no difference between those who did or did not have an implanted device of the prespecified size. CONCLUSION: When performed by an operator trained in the procedure, WM implantation appears to be safe and effective. This procedure may be considered in patients at high-risk of stroke who are ineligible for long-term OAC.

Chronic heart failure in heart transplant recipients: Presenting features and outcome.

BACKGROUND: The ageing graft frequently shows coronary lesions and a restrictive physiology. AIMS: To determine the presenting features and outcome of chronic heart failure in heart transplant recipients. METHODS: In this cohort study, we compared 44 consecutive heart transplant recipients who developed chronic heart failure more than 1 year after heart transplantation with 44 control heart transplant recipients who did not develop heart failure. RESULTS: We found that patients who developed heart failure had more frequently a history of hypertension or diabetes before transplantation. During the 12 months after transplantation, significantly more patients had moderate-to-severe acute rejections (≥ grade 2R) in the heart failure group than in the control group. At the time of heart failure diagnosis, systolic left ventricular function was preserved in 50% of patients and coronary angiography was normal or near normal in 36% of patients. Half of the 44 patients in the heart failure group died within 2 years of heart failure diagnosis. Ascites and end-stage renal failure requiring dialysis were significantly more frequent during follow-up in the heart failure group than in the control group (respectively, 10/44 vs 0/44 [P=0.001] and 18/44 vs 5/44 [P=0.003]). CONCLUSION: In heart transplant recipients presenting with heart failure, systolic left ventricular function is frequently preserved and coronary angiography is frequently abnormal, but may be normal or near normal. During follow-up, the main features of these patients are a high mortality rate after heart failure diagnosis, a frequent need for renal dialysis and frequent ascites.

Transient right internal thoracic arterial graft kink related to respiratory movements: documentation of its existence, relevance and proposed management.

In this case report, we provide the first detailed description of an intermittent mechanical kink of a right internal thoracic artery (ITA) graft to the left anterior descending coronary artery secondary to respiratory movements, and its assessment by pressure wire derived fractional flow reserve (FFR). The patient presented with recurrent unstable angina and documented anterior/anterolateral ischemia. Persistent symptoms were attributed to the ITA kink and stenting was planned on clinical grounds. However, the lesion proved not physiologically significant when FFR was assessed after intermittency related to respiratory movements was documented. Complex stenting was therefore avoided and medical therapy was prescribed for distal diagonal disease. We therefore propose that intermittency should be actively investigated when a kink is documented in a coronary bypass graft by conventional angiography (using dedicated angiographic evaluation in maximal inspiration and expiration). Furthermore, when this type of lesion is encountered, we suggest that it should be assessed physiologically using pressure wire derived FFR before potentially complex interventions are considered.