Management strategies for heavily calcified coronary stenoses: an EAPCI clinical consensus statement in collaboration with the EURO4C-PCR group.

Since the publication of the 2015 EAPCI consensus on rotational atherectomy, the number of percutaneous coronary interventions (PCI) performed in patients with severely calcified coronary artery disease has grown substantially. This has been prompted on one side by the clinical demand for the continuous increase in life expectancy, the sustained expansion of the primary PCI networks worldwide, and the routine performance of revascularization procedures in elderly patients; on the other side, the availability of new and dedicated technologies such as orbital atherectomy and intravascular lithotripsy, as well as the optimization of the rotational atherectomy system, has increased operators' confidence in attempting more challenging PCI. This current EAPCI clinical consensus statement prepared in collaboration with the EURO4C-PCR group describes the comprehensive management of patients with heavily calcified coronary stenoses, starting with how to use non-invasive and invasive imaging to assess calcium burden and inform procedural planning. Objective and practical guidance is provided on the selection of the optimal interventional tool and technique based on the specific calcium morphology and anatomic location. Finally, the specific clinical implications of treating these patients are considered, including the prevention and management of complications and the importance of adequate training and education.

Evaluation of the R-One robotic system for percutaneous coronary intervention: the R-EVOLUTION study.

BACKGROUND: R-One is a robotic percutaneous coronary intervention (PCI) system (CE mark 2019) designed to reduce operator radiation exposure, improve ergonomics, and accurately navigate, position, and deliver guidewires/devices during PCI. AIMS: We aimed to evaluate the safety and efficacy of the R-One system for PCI. METHODS: The European multicentre prospective R-EVOLUTION study included patients with a de novo coronary artery stenosis (length <38 mm, reference diameter 2.5-4.0 mm) undergoing stent implantation. Patients with recent ST-segment elevation myocardial infarction, ostial or left main lesion, bifurcation, severe tortuosity, or calcification were excluded. Clinical success was defined as the absence of major intraprocedural complications. Technical success was defined as the successful advancement and retraction of all PCI devices (guidewires/balloon/stents) without total manual conversion. Radiation exposure to patients, to a simulated manual operator, and to robotic PCI operators was measured. RESULTS: Sixty-two consecutive patients (B2/C lesions: 25.0% [16/64]) underwent robotic PCI. Radial access was used in 96.8% (60/62) of procedures. The mean robotic procedure duration was 19.9±9.6 min and the mean fluoroscopy time was 10.3±5.4 min. Clinical success was 100% with no complications at 30 days. Technical success was 95.2% (59/62). Total manual conversion was required in 4.8% (3/62) cases, with 1 case directly related to the robotic system. Operator radiation exposure was reduced by 84.5% under and 77.1% on top of the lead apron, compared to doses received on the patient table. CONCLUSIONS: This study suggests that robotic PCI using R-One is safe and effective with markedly lower radiation exposure to the operator. Further studies are needed to evaluate R-One in larger patient populations with more complex lesions. (ClinicalTrials.gov: NCT04163393).

Five-year clinical outcomes using the bioresorbable vascular scaffold: Insights from the FRANCE ABSORB registry.

BACKGROUND: Randomized trials comparing the first-generation absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA, USA) with a drug-eluting stent showed a moderate but significant increase in the rate of 3-year major adverse cardiac events and scaffold thrombosis, followed by a decrease in adverse events after 3 years. AIM: The objective of this study was to assess the 5-year outcomes of patients treated with at least one absorb BVS and included in the FRANCE ABSORB registry. METHODS: All patients treated in France with an absorb BVS were prospectively included in a large nationwide multicentre registry. The primary efficacy outcome was the occurrence of 5-year major adverse cardiac events. Secondary efficacy outcomes were the rates of 5-year target vessel revascularization and definite/probable scaffold thrombosis. RESULTS: Between September 2014 and April 2016, 2,070 patients were included in 86 centres (mean age 55±11 years; 80% men; 49% with acute coronary syndrome). The rates of 1-, 3- and 5-year major adverse cardiac events were 3.9%, 9.4% and 12.1%, respectively (including cardiac death in 2.5% and target vessel revascularization in 10.4%). By multivariable analysis, diabetes, oral anticoagulation, the use of multiple Absorb BVSs and the use of a 2.5mm diameter absorb BVS were associated with 5-year major adverse cardiac events. The rates of 1-, 3- and 5-year definite/probable scaffold thrombosis were 1.5%, 3.1% and 3.6%, respectively. By multivariable analysis, older age, diabetes, anticoagulation at discharge and the use of a 2.5mm diameter absorb BVS were associated with 5-year scaffold thrombosis. CONCLUSIONS: Absorb BVS implantation was associated with low rates of 1-year major adverse cardiac events, which increased significantly at 3-year follow-up. There was a clear decrease in the rates of scaffold thrombosis and major adverse cardiac events after 3 years.

Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI.

BACKGROUND: Contrast-induced nephropathy (CIN) can occur after cardiovascular procedures using contrast media, which is associated with increased morbidity and mortality. RenalGuard is a closed-loop system designed to match intravenous hydration with diuretic-induced diuresis that has shown mixed results in the prevention of CIN in previous randomized controlled trials. OBJECTIVES: The STRENGTH (Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI) study assessed whether RenalGuard (PLC Medical Systems) is superior to standard intravenous hydration for CIN prevention in patients with chronic kidney disease undergoing complex cardiovascular procedures. METHODS: STRENGTH is a multicenter, international, open-label, postmarket, prospective, randomized (1:1) study monitored by the Cardiovascular European Research Center (Massy, France) that included a total of 259 patients with moderate to severe chronic kidney disease (estimated glomerular filtration 15-40 mL/min/m2) requiring a complex coronary, structural, or peripheral procedure with an expected contrast injection of at least 3 times the estimated glomerular filtration rate. Patients were randomized to either RenalGuard or intravenous saline hydration according to current guidelines. RESULTS: The primary endpoint, the incidence of CIN at day 3 after the procedure, was similar between the 2 groups (17/107 [15.9%] in the RG group vs 15/110 [13.9%] in the control group; P = 0.62). In addition, none of the secondary endpoints differed between the 2 groups. CONCLUSIONS: In high-risk patients undergoing complex cardiovascular interventions in experienced centers, furosemide-induced high urine output with matched hydration using the RenalGuard system did not reduce the risk of CIN and adverse outcomes at 12 months compared with conventional intravenous hydration.

Comparative study of costs and resource utilization of rotational atherectomy versus intravascular lithotripsy for percutaneous coronary intervention.

BACKGROUND: Intravascular lithotripsy (IVL) is a novel alternative to rotational atherectomy (RA) for the modification of heavily calcified coronary stenoses prior to percutaneous coronary intervention (PCI). We compare the real-world resource utilization and associated costs of PCI with adjunctive RA and IVL. METHODS: We compared the resource utilization, in-lab consumable costs and procedural data of 120 patients who underwent PCI with IVL from the Disrupt-CAD II study (NCT03328949) to 60 patients who underwent PCI with RA at the Golden Jubilee National Hospital, Glasgow, UK. The RA patients were consecutive and selected on the basis of being deemed suitable for IVL by an independent interventional cardiologist experienced in the use of both techniques. RESULTS: PCI with IVL was associated with significantly lower costs than PCI with RA (mean difference £ 398 [95% CI: £ 181-615]; P<0.001). Considering between-group differences, the IVL group used 4.02 fewer balloons (P<0.001), 3.03 fewer guidewires (P<0.001), 0.52 fewer guide catheters (P=0.001), 0.22 fewer guide extensions (P=0.004) and 1.03 fewer drug eluting stents (DES) (P<0.001) per case than the RA group. The IVL group had shorter procedural duration (mean difference 13.3 min [95% CI: 3.6-23.0]; P=0.008) but longer fluoroscopy times (mean difference 4.4 min [95% CI: 1.7-7.1]; P=0.002). CONCLUSIONS: In this indirect comparison, we found that the higher initial device costs of IVL may be offset by a lower overall resource utilization. Further research is required to confirm this, and future randomized trials should include a formal health economic analysis.

High Post-Procedural Transvalvular Gradient or Delayed Mean Gradient Increase after Transcatheter Aortic Valve Implantation: Incidence, Prognosis and Associated Variables. The FRANCE-2 Registry.

Mean Gradient (MG) elevation can be detected immediately after transcatheter aortic valve implantation (TAVI) or secondarily during follow-up. Comparisons and interactions between these two parameters and their impact on outcomes have not previously been investigated. This study aimed to identify incidence, influence on prognosis, and parameters associated with immediate high post-procedural mean transvalvular gradient (PPMG) and delayed mean gradient increase (6 to 12 months after TAVI, DMGI) in the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry. The registry includes all consecutive symptomatic patients with severe aortic stenosis who have undergone TAVI. Three groups were analyzed: (1) PPMG < 20 mmHg without DMGI > 10 mmHg (control); (2) PPMG < 20 mmHg with DMGI > 10 mmHg (Group 1); and (3) PPMG ≥ 20 mmHg (Group 2). From January 2010 to January 2012, 4201 consecutive patients were prospectively enrolled in the registry. Controls comprised 2078 patients. In Group 1(n = 131 patients), DMGI exceeded 10 mmHg in 5.6%, and was not associated with greater 4-years mortality than in controls (32.6% vs. 40.1%, p = 0.27). In Group 2 (n = 144 patients), PPMG was at least 20 mmHg in 6.1% and was associated with higher 4-year mortality (48.7% versus 40.1%, p = 0.005). A total of two-thirds of the patients with PPMG ≥ 20 mmHg had MG < 20 mmHg at 1 year, with mortality similar to the controls (39.2% vs. 40.1%, p = 0.73). Patients with PPMG > 20 mmHg 1 year post-TAVI had higher 4-years mortality than the general population of the registry, unlike patients with MG normalization.

Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies.

OBJECTIVES: The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary intravascular lithotripsy (IVL). BACKGROUND: The clinical outcomes of IVL to optimize target lesion preparation in severely calcified de novo coronary stenoses have been examined in 4 prospective studies (Disrupt CAD I [NCT02650128], Disrupt CAD II [NCT03328949], Disrupt CAD III [NCT03595176], and Disrupt CAD IV [NCT04151628]). METHODS: Patient data were pooled from the Disrupt CAD studies, which shared uniform study criteria, endpoint definitions and adjudication, and procedural follow-up. The primary safety endpoint was freedom from major adverse cardiovascular events (composite of cardiac death, all myocardial infarction, or target vessel revascularization) at 30 days. The primary effectiveness endpoint was procedural success, defined as stent delivery with a residual stenosis ≤30% by quantitative coronary angiography without in-hospital major adverse cardiovascular events. Secondary outcomes included serious angiographic complications, target lesion failure, cardiac death, and stent thrombosis at 30 days. RESULTS: Between December 2015 and April 2020, 628 patients were enrolled at 72 sites from 12 countries. Presence of severe calcification was confirmed in 97.0% of target lesions with an average calcified segment length of 41.5 ± 20.0 mm. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. At 30 days, the rates of target lesion failure, cardiac death, and stent thrombosis were 7.2%, 0.5%, and 0.8%. Rates of post-IVL and final serious angiographic complications were 2.1% and 0.3%, with no IVL-associated perforations, abrupt closure, or episodes of no reflow. CONCLUSIONS: In the largest cohort of patients treated with coronary IVL assessed to date, coronary IVL safely facilitated successful stent implantation in severely calcified coronary lesions with a high rate of procedural success.

First-in-Man trial of a drug-free bioresorbable stent designed to minimize the duration of coronary artery scaffolding.

For the last two decades, various degradable stents have been proposed to treat coronary artery diseases and replace metallic stents to avoid residual foreign material after healing. To date, the right balance between suitable scaffolding and loss of radial strength soon after endothelium restoration is still an unmet need. The present article reports on the First-in-Man trial of a drug-free bioresorbable stent based on a lactic acid stereocopolymer composed of 98% l-lactyl units selected to release stress shielding earlier than in the case of homopoly(l-lactic acid). Thirty patients with single de novo coronary lesions were included in the trial. The fate of scaffolds was monitored by clinical and imaging follow-ups to assess rate of adverse events, acute recoil, late luminal loss, and late lumen recovery. There was no death, no myocardial infarction, and no stent thrombosis observed over the 36 months trial. Dismantling occurred about 3 months after implantation. Bioresorption was almost completed at 2 years. The late lumen loss observed at the end of the first year was partly compensated one year later by enlarging remodeling. At one year, a neointimal hyperplasia slightly greater than for drug-eluting metallic and bioresorbable stents was shown using optical coherence tomography. The excess of hyperplasia was discussed relative to struts thickness, absence of anti-proliferative drug, and release of degradation by-products.

Three-year clinical outcomes with the ABSORB bioresorbable vascular scaffold in real life: Insights from the France ABSORB registry.

OBJECTIVES: The aim of this study was to determine the 3-year outcomes of patients treated with Absorb bioresorbable vascular scaffold (BVS) implantation. BACKGROUND: Randomized trials and observational registries performed in patients undergoing percutaneous coronary intervention have demonstrated higher 1-year and midterm rates of device thrombosis and adverse events with BVS compared to contemporary drug eluting stent. Data on long-term follow-up of patients treated with BVS are scarce. METHODS: All patients treated with BVS were included in a large nationwide prospective multicenter registry (FRANCE ABSORB). The primary endpoint was a composite of cardiovascular death, myocardial infarction, and target lesion revascularization at 3 years. Secondary endpoints were 3-year scaffold thrombosis and target vessel revascularization (TVR). RESULTS: Between September 2014 and April 2016, 2070 patients were included (mean age 55 ± 11 years; 80% men). The indication was acute coronary syndrome (ACS) in 49% of patients. At 3 years, the primary endpoint occurred in 184 patients (8.9%) and 3-year mortality in 43 patients (2.1%). Scaffold thrombosis and TVR rates through 3 years were, respectively, 3 and 7.6%. In a multivariable analysis, independent predictors of primary endpoint occurrence were diabetes, oral anticoagulation, active smoking, absence of initial angiographic success and the association of a total BVS length ≥30 mm with the use of 2.5 mm diameter BVS. CONCLUSIONS: Although 3-year mortality was low in this ACS population, device-related events were significant beyond 1 year. Total BVS length and 2.5 mm BVS were associated with higher rates of MACE at long-term follow-up.

Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study.

BACKGROUND: The feasibility of intravascular lithotripsy (IVL) for modification of severe coronary artery calcification (CAC) was demonstrated in the Disrupt CAD I study (Disrupt Coronary Artery Disease). We next sought to confirm the safety and effectiveness of IVL for these lesions. METHODS: The Disrupt CAD II study was a prospective multicenter, single-arm post-approval study conducted at 15 hospitals in 9 countries. Patients with severe CAC with a clinical indication for revascularization underwent vessel preparation for stent implantation with IVL. The primary end point was in-hospital major adverse cardiac events (cardiac death, myocardial infarction, or target vessel revascularization). An optical coherence tomography substudy was performed to evaluate the mechanism of action of IVL, quantifying CAC characteristics and calcium plaque fracture. Independent core laboratories adjudicated angiography and optical coherence tomography, and an independent clinical events committee adjudicated major adverse cardiac events. RESULTS: Between May 2018 and March 2019, 120 patients were enrolled. Severe CAC was present in 94.2% of lesions. Successful delivery and use of the IVL catheter was achieved in all patients. The post-IVL angiographic acute luminal gain was 0.83±0.47 mm, and residual stenosis was 32.7±10.4%, which further decreased to 7.8±7.1% after drug-eluting stent implantation. The primary end point occurred in 5.8% of patients, consisting of 7 non-Q-wave myocardial infarctions. There was no procedural abrupt closure, slow or no reflow, or perforations. In 47 patients with post-percutaneous coronary intervention optical coherence tomography, calcium fracture was identified in 78.7% of lesions with 3.4±2.6 fractures per lesion, measuring 5.5±5.0 mm in length. CONCLUSIONS: In patients with severe CAC who require coronary revascularization, IVL was safely performed with high procedural success and minimal complications and resulted in substantial calcific plaque fracture in most lesions. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03328949.

Percutaneous coronary interventions with the Absorb Bioresorbable vascular scaffold in real life: 1-year results from the FRANCE ABSORB registry.

BACKGROUND: Several randomized studies have shown that bioresorbable vascular scaffold (BVS) technology is associated with an increased risk of stent thrombosis. AIM: This study aimed to assess the rates of adverse outcomes at 1 year in patients treated with the Absorb BVS (Abbott Vascular, Santa Clara, CA, USA), using data from a large nationwide prospective multicentre registry (FRANCE ABSORB). METHODS: All patients receiving the Absorb BVS in France were included prospectively in the study. Predilatation, optimal sizing and postdilatation were recommended systematically. The primary endpoint was a composite of cardiovascular death, myocardial infarction and target lesion revascularization at 1 year. Secondary endpoints were scaffold thrombosis and target vessel revascularization at 1 year. RESULTS: A total of 2072 patients at 86 centres were included: mean age 55±11 years; 80% men. The indication was acute coronary syndrome (ACS) in 49% of cases. Predilatation and postdilatation were done in 93% and 83% of lesions, respectively. At 1 year, the primary endpoint occurred in 3.9% of patients, the rate of scaffold thrombosis was 1.5% and the rate of target vessel revascularization was 3.3%. In a multivariable analysis, diabetes and total Absorb BVS length>30mm were independently associated with the occurrence of the primary endpoint, whereas oral anticoagulation and total Absorb BVS length>30mm were independently associated with occurrence of scaffold thrombosis. CONCLUSIONS: The Absorb BVS was implanted in a relatively young population, half of whom had ACS. Predilatation and postdilatation rates were high, and 1-year outcomes were acceptable.