Best Practice in Intravascular Lithotripsy

Intravascular lithotripsy (IVL) is a novel approach to lesion preparation of severely calcified plaques in coronary and peripheral vessels. Lithotripsy is delivered by vaporising fluid to create an expanding bubble that generates sonic pressure waves that interact with arterial calcification. Available data indicate that IVL leads to increased vessel compliance before stent implantation with high efficacy and an excellent safety profile. Since it gained the CE mark in 2017, and with improved operator experience, the use of IVL has expanded into more complex clinical situations. This review focuses on the best practice for IVL use in the cath lab, based on 3 years of experience with the technology and the latest scientific data from the Disrupt CAD clinical trials

[Cardiotoxicity of chemotherapies].

International audienceThe spectrum of chemotherapy's cardiac side effect of chemotherapy has expanded with the new combinations of cytotoxic and targeted therapies over the past 10 years. Moreover, cancer therapy administrated to "new" populations, especially elderly patients or patients with cardiovascular disease and/or coronary artery disease history, has increased considerably. According to the American College of Cardiology and American Heart Association (ACC/AHA), patients receiving chemotherapy can be considered in the A group of heart failure. Many cardiovascular adverse effects appear with cancer therapy and suspend treatment purchase, or leading to an alteration of quality of life, and increasing mortality risks. The most clinically evident cardiotoxicity and best known is the anthracyclines adverse effect. Other cytotoxic are associated with a significant risk of cardiovascular complications include alkylating agents such as 5-fluorouracil and paclitaxel. Cardiovascular adverse effects are associated with the use of targeted therapies such as tyrosine kinase inhibitors: trastuzumab, bevacizumab. At the same time, drugs used to hematological malignancies, as acid all-trans-retinoic acid and arsenic trioxide are cardiotoxics. The most serious cardiac complications of cancer therapies is heart congestive failure, mainly due to the use of anthracyclines, cyclophosphamide and trastuzumab, usually at high doses. Myocardial ischemia is mainly caused by interferon and antimetabolites. Other side effects may occur such as hypotension, hypertension, arrhythmias and conduction disturbances, pericarditis, and thromboembolic complications

Effectiveness of Screening for Abdominal Aortic Aneurysm During Echocardiography

International audienceScreening patients with abdominal aortic aneurysm (AAA) is associated with reduced AAA-related mortality, but population screening is poorly implemented. Opportunistic screening during imaging for other indications might be efficient. Single-center series reported AAA rates of 0.8% to 6.5% in patients undergoing transthoracic echocardiography (TTE), with disparities due to selection bias. In this first multicenter study, we aimed to assess the feasibility and criteria for screening AAA during TTE in real-life practice. During a week of May 2011, 79 centers participated in a nationwide survey. All patients aged ≥65 years requiring TTE for any indication were eligible, except for those with operated abdominal aorta. We defined AAA by an anteroposterior diameter of the infrarenal aorta≥30 mm. Of 1,382 consecutive patients, abdominal aorta imaging was feasible in 96.7%, with a median delay of 1.7 minutes (>3 minutes in 3.6% of cases). We found AAA in 50 patients (3.7%). Unknown AAA (2.7%) was more frequent in men than women (3.7% vs 1.3%, respectively, p=0.007) and increased by age at 2.2%, 2.5%, and 5.8% in age bands of 65 to 74, 75 to 84, and 85+ years, respectively. None of the female participants aged <75 years had AAA. Smoking status and family history of AAA were significantly more frequent among patients with AAA. The ascending aorta was larger in those with AAA (36.2±4.7 vs 34.0±5.2 mm, p=0.006), and bicuspid aortic valve and/or major aortic regurgitation were also more frequent (8% vs 2.6%, p=0.017). In conclusion, rapid AAA screening during TTE is feasible and should be limited to men ≥65 years and women≥75 years

243 Early in-hospital mortality of acute aortic syndromes: results from the French National Multicentric registry

BackgroundAcute Aortic syndromes (AAS) are life threatening diseases. Despite recent improvement in management, data are limited regarding their actual diagnosis accuracy, therapeutic and mortality. We aimed to assess determinants of in-hospital mortality in patients with AAS.MethodOur analysis was based on data from the French prospective National Multicentre Registry (14 referral French Health Care Centers) of AAS (Feb 2008 - Dec 2009). Assessment of determinants of in-hospital mortality was based on multivariable logistic regression.ResultsThe study included 278 patients (72% men) mean aged 66 (± 14) years. AAS consisted in type A dissection (AD; n = 143), type B dissection (BD; n = 90), intra mural hematoma (IMH; n = 21), complicated thoracic aneurysm (CTA; n = 20) and penetrating ulcer (PU; n = 4). Major aortic complications were cardiogenic shock and visceral malperfusion in 14.3% (n = 40) and 13.6% patients (n = 38) respectively. Disease management was medical in 35% patients, surgery (45%) or endovascular treatment (13%). Total intrahospital mortality was 21% (n = 56) [40% in CTA group, 27% in AD group, 16% in IMH group, 9% in BD group and none in PU group (p = 0.001)]. Determinants independently associated with in-hospital mortality were: type of AAS (Odds ratio = 0.34 [95% confidence interval: 0.14–0.86] for BD, OR = 1.38 [0.45–4.22] for CTA and OR = 0.46 [0.12–1.79] for IMH or PU, versus type A dissection), age above to 65 years (OR: 2.73 [1.33–5.61]), history of hypertension (OR: 0.43 [0.21–0.86]), history of aneurysm (OR: 2.47 [1.04–5.88]), cardiogenic shock (OR = 2.71 [1.18–6.24]) and visceral malperfusion syndrome (OR = 2.42 [1.01–5.78]).ConclusionDespite recent progress in diagnostic and therapeutic, acute aortic syndromes are still associated with high intrahospital mortality. This recent large multicentric study identifies higher risk patients of poor in-hospital prognosis and emphasizes the need to still improve the management of AAS

Safety and effectiveness of coronary intravascular lithotripsy in eccentric calcified coronary lesions: a patient-level pooled analysis from the Disrupt CAD I and CAD II Studies

Background!#!The aim of this study was to assess the safety and effectiveness of intravascular lithotripsy (IVL) in treating eccentric calcified coronary lesions.!##!Methods!#!Between December 2015 and March 2019, 180 patients were enrolled in the Disrupt CAD I and CAD II studies across 19 sites in 10 countries. Patient-level data were pooled from these two studies (n = 180), within which 47 eccentric lesions (26%) and 133 concentric lesions were identified.!##!Results!#!Clinical success, defined as residual stenosis &amp;lt; 50% after stenting and no in-hospital MACE, was similar between the eccentric and concentric cohorts (93.6% vs. 93.2%, p = 1.0). There were no perforations, abrupt closure, slow flow or no reflow events observed in either group, and there were low rates of flow-limiting dissections (Grade D-F: 0% eccentric, 1.7% concentric; p = 0.54). Final acute gain and percent residual stenosis were similar between the two groups. Final residual stenosis of 8.6 ± 9.8% in eccentric and 10.0 ± 9.0% (p = 0.56) in concentric stenosis confirms the significant effect of IVL in calcified coronary lesions.!##!Conclusion!#!In this first report from a pooled patient-level analysis of coronary IVL from the Disrupt CAD I and CAD II studies, IVL use was associated with consistent improvement in procedural and clinical outcomes in both eccentric and concentric calcified lesions

Mid-term outcome of de novo lesions vs. in stent restenosis treated by intravascular lithotripsy procedures: Insights from the French Shock Initiative

International audienceBackground: Intravascular lithotripsy (IVL) is a promising new technology for disrupting de-novo calcified coronary lesions (DNL) before percutaneous coronary intervention (PCI). We assessed 12-month outcomes of IVL in patients undergoing PCI for DNL or intra stent restenosis (ISR) lesions related to device underexpansion.Methods: Prospective analysis of patients in the multicentre all-comers French Shock Initiative IVL registry. The primary safety endpoints in this analysis were in-hospital and 12-month major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). The primary effectiveness endpoint was procedural success, defined as <30% residual stenosis without severe angiographic complications. Event rates were analysed for the cohort and for DNL and ISR procedures separately.Results: A total of 220 lesions were treated (76.7% DNL and 23.3% ISR) in 202 patients. Procedural success was achieved in 95.5% of patients (DNL group: 96.5%; ISR group: 92.0%). In-hospital MACE occurred in 6.4% of cases, mainly driven by periprocedural infarctions. The rate of MACE-free survival at 1 year was 86.6% in the overall cohort. Rates of target vessel (TVR) and lesion (TLR) revascularisation were 6.4% and 2.5%, respectively. The 1-year MACE rate was 91.5% in DNL group and 83.8% in ISR group.Conclusions: In this large all-comers IVL cohort, rates of in-hospital and 1-year MACE were moderate. The safety and efficiency of IVL was comparable in DNL and ISR lesions. A comparative study of the impact of IVL on outcomes appears warranted

A prospective study comparing short versus standard dual antiplatelet therapy in patients with acute myocardial infarction: design and rationale of the TARGET-FIRST trial

: Based on the latest knowledge and technological advancements, it is still debatable whether a modern revascularisation approach in the setting of acute myocardial infarction (AMI), including complete revascularisation (in patients with significant non-culprit lesions) with newer-generation highly biocompatible drug-eluting stents, requires prolonged dual antiplatelet therapy (DAPT). TARGET-FIRST (ClinicalTrials.gov: NCT04753749) is a prospective, open-label, multicentre, randomised controlled study comparing short (one month) DAPT versus standard (12 months) DAPT in a population of patients with non-ST/ST-segment elevation myocardial infarction, completely revascularised at index or staged procedure (within 7 days), using Firehawk, an abluminal in-groove biodegradable polymer rapamycin-eluting stent. The study will be conducted at approximately 50 sites in Europe. After a mandatory 30-40 days of DAPT with aspirin and P2Y12 inhibitors (preferably potent P2Y12 inhibitors), patients are randomised (1:1) to 1) immediate discontinuation of DAPT followed by P2Y12 inhibitor monotherapy (experimental arm), or 2) continued DAPT with the same regimen (control arm), up until 12 months. With a final sample size of 2,246 patients, the study is powered to evaluate the primary endpoint (non-inferiority of short antiplatelet therapy in completely revascularised patients) for net adverse clinical and cerebral events. If the primary endpoint is met, the study is powered to assess the main secondary endpoint (superiority of short DAPT in terms of major or clinically relevant non-major bleeding). TARGET-FIRST is the first randomised clinical trial to investigate the optimisation of antiplatelet therapy in patients with AMI after achieving complete revascularisation with an abluminal in-groove biodegradable polymer rapamycin-eluting stent implantation

Design and Rationale of the BIOFLOW-DAPT Trial: a Prospective, Randomized, Multicenter Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination with 1-Month Dual Antiplatelet Therapy.

The optimal duration of dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with implantation of the Orsiro Mission stent remains unclear. The BIOFLOW-DAPT (clinicaltrials.gov, NCT04137510) trial is a prospective, multi-center, randomized controlled study designed to assess the safety of the Orsiro Mission versus the Resolute Onyx stent in HBR patients. Patients are treated with DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by a single antiplatelet therapy (SAPT). The primary endpoint is the composite of cardiac death, myocardial infarction, and definite or probable stent thrombosis at 1 year. With a final sample size of 1948 HBR patients, this study is powered to assess the noninferiority of the Orsiro Mission stent with respect to the primary study endpoint. The BIOFLOW-DAPT is the first randomized clinical trial investigating 1-month DAPT duration in HBR patients after implantation of the Orsiro Mission stent.Trial Registration: ClinicalTrials.gov number, NCT04137510 Study design and key features. Patient selection starts before the index PCI, when consented patients will be randomized to the Orsiro Mission or the Resolute Onyx stent with mandated 1-month DAPT. At 1 month, eligibility is reassessed and if met, patients will discontinue DAPT and continue with P2Y12 inhibitor or aspirin monotherapy. PCI, percutaneous coronary intervention; DAPT, dual antiplatelet therapy; DES, drug-eluting stent; HBR, high bleeding risk; P2Y12i, P2Y12 inhibitor; ST, stent thrombosis