Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: A multicenter systematic review and meta-analysis.

BACKGROUND: With heavily calcified coronary and peripheral artery lesions, lesion preparation is crucial before stent placement to avoid underexpansion, associated with stent thrombosis or restenosis and patency failure in the long-term. Intravascular lithotripsy (IVL) technology disrupts superficial and deep calcium by using localized pulsative sonic pressure waves, making it to a promising tool for patients with severe calcification in coronary bed. AIMS: The aim of the study is to systematically review and summarize available data regarding the safety and efficacy of IVL for lesion preparation in severely calcified coronary arteries before stenting. METHODS: This study was conducted according to the PRISMA guidelines. We systematically searched PubMed, SCOPUS, and Cochrane databases from their inception to February 23, 2023, for studies assessing the characteristics and outcomes of patients undergoing IVL before stent implantation. The diameter of the vessel lumen before and after IVL, as well as stent implantation, were analyzed. The occurrence of major adverse cardiovascular events (MACE) was assessed using a random-effects model. RESULTS: This meta-analysis comprised 38 studies including 2977 patients with heavily calcified coronary lesions. The mean age was 72.2 ± 9.1 years, with an overall IVL clinical success of 93% (95% confidence interval [CI]: 91%-95%, I2 = 0%) and procedural success rate of 97% (95% CI: 95%-98%, I2 = 73.7%), while the in-hospital and 30-days incidence of MACE, myocardial infarction (MI), and death were 8% (95% CI: 6%-11%, I2 = 84.5%), 5% (95% CI: 2%-8%, I2 = 85.6%), and 2% (95% CI: 1%-3%, I2 = 69.3%), respectively. There was a significant increase in the vessel diameter (standardized mean difference [SMD]: 2.47, 95% CI: 1.77-3.17, I2 = 96%) and a decrease in diameter stenosis (SMD: -3.44, 95% CI: -4.36 to -2.52, I2 = 97.5%) immediately after IVL application, while it was observed further reduction in diameter stenosis (SMD: -6.57, 95% CI: -7.43 to -5.72, I2 = 95.8%) and increase in the vessel diameter (SMD: 4.37, 95% CI: 3.63-5.12, I2 = 96.7%) and the calculated lumen area (SMD: 3.23, 95% CI: 2.10-4.37, I2 = 98%), after stent implantation. The mean acute luminal gain following IVL and stent implantation was estimated to be 1.27 ± 0.6 and 1.94 ± 1.1 mm, respectively. Periprocedural complications were rare, with just a few cases of perforations, dissection, or no-reflow phenomena recorded. CONCLUSIONS: IVL seems to be a safe and effective strategy for lesion preparation in severely calcified lesions before stent implantation in coronary arteries. Future prospective studies are now warranted to compare IVL to other lesion preparation strategies.

Impact of Calcium Eccentricity on the Safety and Effectiveness of Coronary Intravascular Lithotripsy: Pooled Analysis From the Disrupt CAD Studies.

BACKGROUND: Coronary intravascular lithotripsy (IVL) safely facilitates successful stent implantation in severely calcified lesions. This analysis sought to determine the relative impact of lesion calcium eccentricity on the safety and effectiveness of IVL using high-resolution optical coherence tomography imaging. METHODS: Individual patient-level data (n=262) were pooled from 4 distinct international prospective studies (Disrupt CAD I, II, III, and IV) and analyzed by an independent optical coherence tomography core laboratory. IVL performance in eccentric versus concentric calcification was analyzed by dividing calcified lesions into quartiles (≤180° [most eccentric], 181°-270°, 271°-359°, and 360° [concentric]) by maximum continuous calcium arc. RESULTS: In the 230 patients with clear imaging field on optical coherence tomography, there were no differences in preprocedure minimum lumen area, diameter stenosis, or maximum calcium thickness. The calcium length and volume index increased progressively with increasing mean and maximum continuous calcium arc (ie, concentricity). Conversely, the minimum calcium thickness decreased progressively with increasing concentricity. Post-procedure, the number of calcium fractures, fracture depth, and fracture width increased with increasing concentricity, with a 4-fold increase in the number of fractures in lesions with 360° of calcium arc compared with ≤180°. This increase in IVL-induced calcium fracture with increasing calcium burden and concentricity facilitated stent expansion and luminal gain such that there were no significant differences across quartiles. CONCLUSIONS: IVL induced calcium fractures proportional to the magnitude of coronary artery calcium, including in eccentric calcium, leading to consistent improvements in stent expansion and luminal gain in both eccentric and concentric calcified coronary lesions.

The France PCI registry: Design, methodology and key findings.

BACKGROUND: Obstructive coronary artery disease is the main cause of death worldwide. By tracking events and gaining feedback on patient management, the most relevant information is provided to public health services to further improve prognosis. AIMS: To create an inclusive and accurate registry of all percutaneous coronary intervention (PCI) procedures performed in France, to assess and improve the quality of care and create research incentives. Also, to describe the methodology of this French national registry of interventional cardiology, and present early key findings. METHODS: The France PCI registry is a multicentre observational registry that includes consecutive patients undergoing coronary angiography and/or PCI. The registry was set up to provide online data analysis and structured reports of PCI activity, including process of care measures and assessment of risk-adjusted outcomes in all French PCI centres that are willing to participate. More than 150 baseline data items, describing demographic status, PCI indications and techniques, and in-hospital and 1-year outcomes, are captured into local reporting software by medical doctors and local research technicians, with subsequent encryption and internet transfer to central data servers. Annual activity reports and scoring tools available on the France PCI website enable users to benchmark and improve clinical practices. External validation and consistency assessments are performed, with feedback of data completeness to centres. RESULTS: Between 01 January 2014 and 31 December 2022, participating centres increased from six to 47, and collected 364,770 invasive coronary angiograms and 176,030 PCIs, including 54,049 non-ST-segment elevation myocardial infarction cases and 31,631 ST-segment elevation myocardial infarction cases. Fifteen studies stemming from the France PCI registry have already been published. CONCLUSIONS: This fully electronic, daily updated, high-quality, low-cost, national registry is sustainable, and is now expanding. Merging with medicoeconomic databases and nested randomized scientific studies are ongoing steps to expand its scientific potential.

Biodegradable-Polymer or Durable-Polymer Stents in Patients at High Bleeding Risk: A Randomized, Open-Label Clinical Trial.

BACKGROUND: Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI. METHODS: The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha. RESULTS: A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P<0.0001 for noninferiority for both tests). CONCLUSIONS: Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04137510.

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.

Sodium Chloride Physiological Saline Solution Versus Water Preparations Injectable in the Use of Shockwave Intravascular Lithotripsy: A Single-Center Experience.

Background: Shockwave intravascular lithotripsy (IVL) coronary system is a very useful new technology for de novo severely calcified coronary artery plaques before percutaneous coronary intervention (PCI). The device uses a semi-compliant low-pressure balloon, integrated into a sterile catheter, to deliver by vaporizing fluid an expanding bubble that generates high-pressure ultrasonic energy by waves that create multiplane longitudinal micro-macro fractures in calcified plaques, which facilitate optimal stent placement and expansion, and luminal gain. Methods: The use of Shockwave IVL coronary system in our cardiac catheterization laboratory (Cath lab) at the "Clinique Saint-Hilaire" in Rouen, France, started in March 2019, with 42 procedures performed since this date: two patients in 2019, two patients in 2020, seven patients in 2021, 23 patients in 2022, and eight patients since the beginning of 2023. Results: We had experienced problems at the beginning of our activity for the first 11 patients (two patients in 2019, two patients in 2020, and seven patients in 2021): after less than five pulses, the shock therapy stopped. We used initially for Shockwave IVL semi-compliant low-pressure integrated balloons a mixture of 50% contrast and 50% water preparations injectable (PPI). After changing water PPI by sodium chloride physiological saline solution, we never encountered this problem again for the following 31 patients (23 patients in 2022, and eight patients since the beginning of 2023). In fact, the proper functioning of Shockwave IVL system requires ions in balloon mixture in addition to the contrast. It is thanks to the ions contained in sodium chloride physiological saline solution that the spark necessary for shocks delivery after balloon inflation is produced. Conclusions: Water PPI or sodium chloride physiological saline solution is used in angioplasty balloons in a lot of Cath labs worldwide. It is therefore essential to disseminate in the worldwide Cath lab the obligation to put in Shockwave IVL semi-compliant low-pressure integrated balloons sodium chloride physiological saline solution, rather than water PPI for optimal performance, and the importance of Shockwave Medical reporting this to interventional cardiologists.

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.

A direct wire pacing device for transcatheter heart valve and coronary interventions: a first-in-human, multicentre study of the Electroducer Sleeve.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) and complex percutaneous coronary interventions (PCI) may require cardiac pacing during device delivery, generally requiring the insertion of a temporary pacing lead via an additional venous access site. The purpose-built Electroducer Sleeve device provides direct wire pacing without the need for a temporary venous pacemaker. AIMS: This study assessed the safety of temporary cardiac pacing using the novel sleeve device during PCI. METHODS: This was a multicentre, non-randomised, prospective, first-in-human, single-arm, pilot study. The primary endpoint was analysis of a safety outcome, defined as the occurrence of haematomas or bleeding complications at the device vascular access site. Secondary endpoints included analyses of effectiveness and qualitative outcomes. RESULTS: Sixty patients (mean age: 77.9±9.6 years) from 4 centres in France were included: 39 (65%) underwent TAVI, and 21 (35%) underwent PCI. Procedures were performed using the sleeve with access through the radial (32 patients; 53.3%) or femoral arteries (26; 43.3%), or the femoral vein (2; 3.3%). Primary endpoint analysis revealed that 2 patients (3.3%) developed EArly Discharge After Transradial Stenting of CoronarY Arteries Study (EASY) grade I/Bleeding Academic Research Consortium (BARC) type I haematomas at the device access site. As a measure of effectiveness, a haemodynamic effect was observed after each spike delivery in 54 patients (90%). Analyses of other secondary endpoints showed that 2 patients (6.3%) presented asymptomatic radial artery occlusion. No allergies were reported. CONCLUSIONS: This first-in-human trial using the Electroducer Sleeve indicated that this novel, purpose-built, temporary pacing device was safe and effective. Larger prospective studies are required to confirm these findings.

[Invasive and non-invasive imaging analysis for calcified coronary artery lesions]. / Imagerie invasive et non invasive des lésions coronaires calcifiées.

Coronary calcifications are frequently identified within coronary lesions as their incidence increases with age and cardiovascular risk factors. Their location can be superficial or deep, according to different pathological process. In all cases, the presence of calcifications within the vascular wall predicts poor clinical prognosis and unfavorable evolution after percutaneous revascularization. Coronary calcifications can be analyzed by angiography, CT or intracoronary imaging (IVUS or OCT) with variable accuracies. Angiography is the most frequently used method but is not very sensitive (sensitivity close to 50%) and insufficient for their precise quantification. The CT scan is a more effective non-invasive method leading to an accurate analysis of the lesion before coronary angiography. IVUS and OCT have an excellent spatial resolution and are the most sensitive methods for the identification (present in nearly 75-80% of lesions) and quantification of calcifications. These intracoronary imaging techniques offer interesting perspectives for identification of the highest-risk lesions, PCI procedures planning (including the choice of an optimal dedicated plaque preparation devices), the monitoring of their execution and the evaluation of the immediate post-stenting results.

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

BACKGROUND: 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.

Quantitative Flow Ratio Analysis by Paramedical Compared With Medical Users.

OBJECTIVES: We aimed to validate whether quantitative flow ratio (QFR) analysis could be performed by both medical and paramedical certified users. Therefore, we compared QFR values with conventional guidewire-based fractional flow reserve (FFR) as the reference using core laboratory analysis. QFR allows FFR calculation based on the coronary angiogram. QFR analysis requires certified users with dedicated training and skills. However, the ability of medical and paramedical users to correctly analyze QFR remains unknown. METHODS: In a prospective, single-center study, we included all consecutive patients with stable coronary artery disease and indicated physiological assessment. QFR was performed and analyzed by 1 medical and 2 paramedical QFR users who were unaware of conventional pressure-guidewire FFR measurements. RESULTS: We included 67 consecutive patients and 100 lesions for assessment with QFR and FFR. Pearson's correlation coefficient of QFR performed by paramedical users compared with medical users was 0.89 (range, 0.83-0.92). A Bland-Altman analysis showed no significant bias (-0.0008). Receiver-operator characteristic curves were generated to compare the ability to predict an FFR value above or below 0.80 with QFR performed by paramedical vs medical users. When comparing FFR with QFR performed by paramedical and medical users, the values for area under the curve were 0.964 and 0.970, respectively. Intraclass correlation was 0.884. CONCLUSION: Our study showed a noticeable correlation between QFR analysis performed by QFR-certified paramedical and medical users, as compared with FFR. These data suggest that QFR analysis could be performed by certified paramedicals in order to reduce physician workload without impacting the quality of the obtained results.

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.

2-Year Results With a Sirolimus-Eluting Self-Expanding Stent for Femoropopliteal Lesions: The First-in-Human ILLUMINA Study.

OBJECTIVES: The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics. BACKGROUND: DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating. METHODS: Within a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9 cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, functional, and clinical outcomes. RESULTS: At 24 months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95% CI: 73.9%-89.6%) and 93.1% (95% CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24 months, which was associated with preserved improvements in all walking disability questionnaire scores. CONCLUSIONS: The 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676).

Head to head comparison of quantitative flow ratio using 4-French and 6-French catheters versus fractional flow reserve.

OBJECTIVES: To validate QFR using 4-F diagnostic catheters compared to using 6-F guiding catheters, with conventional guidewire-based FFR as the reference standard, using independent core laboratory analysis. BACKGROUND: Quantitative Flow Ratio (QFR) allows Fractional Flow Reserve (FFR) calculation based on the coronary angiogram, using 5- or 6-French (F) catheters. However, the use of 4-F diagnostic catheters to perform coronary angiography is currently routine in some centers. METHODS: We included all consecutive patients with stable coronary artery disease and indicated for physiological assessment. QFR was performed using a 4-F diagnostic catheter, then QFR was performed using a 6-F guiding catheter while conventional FFR was measured using a pressure guidewire. Angiograms were sent to two separate core laboratories. RESULTS: One hundred lesions in 67 consecutive patients with QFR performed using 4-F and 6-F catheters, and with conventional FFR, were included. Pearson's correlation coefficient was for QFR 4-F vs. FFR 0.91 [0.87-0.94], for QFR 6-F vs. FFR 0.90 [0.86-0.94], and for QFR 4-F vs. QFR 6-F 0.93 [0.90-0.95]. Receiver-operator characteristic curves (ROC) comparing the ability to predict an FFR value above or below 0.80 with QFR 4-F and 6-F were generated. The area under the ROC curve (AUC) vs. FFR was 0.972 [0.95-0.99] for QFR 4-F and 0.970 [0.94-0.99] for QFR 6-F. CONCLUSIONS: Our study demonstrated the feasibility of performing QFR analysis from angiograms obtained by 4-F catheters, and showed a good correlation with QFR performed using 6-F catheters as well as with conventional FFR performed using a pressure guidewire.

Pourquoi et comment j'utilise le Shockwave ?

Les lésions calcifiées coronaires ont une incidence croissante dans la pratique quotidienne de l'angioplastie coronaire et sont un des facteurs essentiels des CHIP (High Risk Percutaneous Coronary Intervention). La préparation de la plaque calcifiée est essentielle afin de permettre de bonnes expansion et apposition du stent, deux critères indispensables pour un bon résultat à court et long terme de l'angioplastie coronaire. Depuis 2017, le cathéter C2 Shockwave Medical® dispose d'un marquage CE pour la préparation des lésions coronaires calcifiées natives avant l'implantation de stent par le mécanisme de lithotripsie intravasculaire. Ce système se distingue par sa facilité d'utilisation et un très haut niveau de sécurité procédurale, se positionnant comme un challenger des techniques usuelles de préparation de la plaque calcifiée. L'objectif de cette revue est de se focaliser sur le mécanisme d'action de la lithotripsie intracoronaire, les conditions d'utilisation optimale du device et de synthétiser les données de littérature les plus récentes.

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 < 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.

Extended Pseudo-Subarachnoid Hemorrhage Post-Percutaneous Coronary Intervention.

We report the case of an extended pseudo-subarachnoid hemorrhage (PSAH) related to contrast intracerebral diffusion from blood-brain barrier breakdown on periprocedural percutaneous coronary intervention right corticofrontal ischemic stroke. PSAH is a rare and complex phenomenon, and it is important to differentiate PSAH from subarachnoid hemorrhage to avoid inappropriate treatment with potentially severe consequences. (Level of Difficulty: Beginner.).

Covered Stent Implantation for Treatment of Iliac Vein Rupture During Percutaneous Left Atrial Appendage Occlusion.

An 82-year-old woman who experienced an iatrogenic external iliac vein perforation during a left atrial appendage occlusion procedure was successfully treated by endovascular graft implantation. We report the short- and long-term outcomes of the procedure. (Level of Difficulty: Advanced.).