Background Intravascular lithotripsy (IVL) has been demonstrated effective and safe in the treatment of balloon-crossable calcified coronary lesions. However, a significant subset of patients still experiences suboptimal technical results and subsequent target lesion failure (TLF), leaving a gap in our understanding of procedural success drivers. Objectives This study sought to identify factors independently associated with technical failure and 12-month TLF in calcified coronary lesions treated with IVL-assisted percutaneous coronary intervention. Methods From the multicenter BENELUX-IVL registry (NCT06577038), we included patients with complete quantitative coronary analysis. The primary technical endpoint was technical failure (unsuccessful IVL delivery, residual stenosis >30%, or procedural complications). The primary clinical endpoint was 12-month TLF (cardiac death, target-vessel myocardial infarction, or ischemia-driven revascularization). Results A total of 571 patients (including 595 target lesions) were included. Technical failure occurred in 60 (10.5%) of the lesions, whereas 12-month TLF was reported in 41 (7.2%) cases. Multivariable analysis identified multivessel disease (OR: 1.39; 95% CI: 1.02-1.90), in-stent lesions (OR: 1.94; 95% CI: 1.14-3.30), and the absence of intravascular imaging (OR: 1.95; 95% CI: 1.13-3.40) as independent determinants of technical failure. Left circumflex (HR: 2.97; 95% CI: 1.49-5.92), in-stent target lesions (HR: 2.01; 95% CI: 1.02-3.52), technical failure (HR: 2.42; 95% CI: 1.26-4.61), diabetes mellitus (HR: 2.35; 95% CI: 1.23-4.47), reduced estimated glomerular filtration rate (HR: 0.98; 95% CI: 0.97-0.99), and younger age (HR: 0.95; 95% CI: 0.92-0.98) emerged as factors independently associated with TLF. Conclusions Our findings demonstrate that residual risk in IVL-assisted percutaneous coronary intervention is driven by a distinct interplay of modifiable and nonmodifiable factors, rather than inherent limitations of the technology itself.

AIMS:Structural valve degeneration (SVD) is the leading cause of late bioprosthetic valve failure. Lipoprotein(a) [Lp(a)] contributes to native aortic valve calcification, but its role in SVD is unclear. We investigated whether elevated Lp(a) is associated with SVD after bioprosthetic aortic valve replacement (AVR) and whether this differs between stenotic and regurgitant phenotypes. METHODS AND RESULTS:We studied 174 bioprosthetic AVR patients with available Lp(a) levels over a median echocardiographic follow-up of 7.3 years (1372 studies). SVD was defined by VARC-3 criteria, and associations were analysed with Fine-Gray competing risk models. Lp(a) was evaluated categorically (≤ or > 125 nmol/L) and continuously using spline modelling. During follow-up, 40 patients developed SVD (22 stenotic, 9 mixed, and 9 regurgitant). The 15-year cumulative incidence was 51% with a median onset at 14.8 years. Elevated Lp(a) was associated with a higher risk of overall SVD (62% vs. 47%; SHR 2.06, 95% CI 1.09-3.91; P = 0.026) and specifically with stenotic/mixed phenotypes (SHR 2.57, 95% CI 1.26-5.23; P = 0.009). No association was observed with regurgitant phenotypes (SHR 0.85, 95% CI 0.19-3.92; P = 0.84). After multivariable adjustment, elevated Lp(a) remained an independent predictor of stenotic/mixed SVD (adjusted SHR 3.00, 95% CI 1.48-6.07; P = 0.002). Spline modelling showed a linear dose-response, with each 25 nmol/L increase in Lp(a) conferring 13% higher risk. CONCLUSION:Elevated Lp(a) is independently associated with long-term risk of stenotic/mixed SVD. These findings highlight Lp(a) as a promising biomarker of prosthetic valve vulnerability and support investigation of emerging Lp(a)-lowering therapies to improve valve durability.

BACKGROUND AND AIMS:This study aims to provide the most comprehensive assessment to date of interventional cardiology practices across European Society of Cardiology (ESC) national society member countries, with a focus on infrastructure, procedural volumes, temporal trends (2013-22), regional disparities, and adherence to guideline-recommended care. METHODS:The third edition of the ESC-European Association of Percutaneous Cardiovascular Interventions Atlas presents data from 50 ESC national society member countries, collected through a dedicated 2023 survey of national cardiac societies and interventional working groups. Data were subjected to a rigorous multi-step quality control process to ensure consistency and accuracy. Key metrics include interventional resources, such as the number of hospitals with catheterization laboratories, trained personnel, and the proportion of women in the interventional workforce; procedural volumes and types, including percutaneous coronary intervention (PCI), primary PCI, transcatheter aortic valve implantation, transcatheter mitral valve procedures, transcatheter tricuspid valve procedures; and procedural characteristics, including arterial access site, use of intracoronary imaging, physiological lesion assessment, and sex-specific data on patient care delivery. RESULTS:Despite the ongoing expansion of structural heart transcatheter interventions, PCI remains the dominant procedure, accounting for >90% of all percutaneous cardiovascular interventions. Percutaneous coronary intervention volumes showed limited variation across ESC member countries and demonstrated no significant association with gross national income per capita. In contrast, important regional disparities were observed in the use of transcatheter aortic valve implantation, transcatheter mitral valve procedures, and transcatheter tricuspid valve procedures with procedure rates strongly correlated with gross national income (r = .86; r = .63; and r = .64). Workforce data revealed that while women constitute 39% of all cardiologists, they represent only 10% of interventional cardiologists across ESC member countries. Although interventional cardiology has helped reduce female disparity in access compared with cardiac surgery, inequalities persist, e.g. <30% of PCI recipients are women, despite women representing >40% of patients with ischaemic heart disease. Temporal trend analysis showed a narrowing gap in PCI and primary PCI volumes between regions, reflecting improved access across all economic strata. However, growth in structural valve interventions remained disproportionately concentrated in wealthier countries. CONCLUSIONS:The third edition of the ESC-European Association of Percutaneous Cardiovascular Interventions Atlas highlights significant progress in percutaneous cardiovascular interventions across Europe but also underscores persistent disparities. These findings reinforce the need for balanced investment strategies, harmonized training, greater sex equity, and enhanced data infrastructures to support more equitable and evidence-based cardiovascular care.

BACKGROUND:Intravascular lithotripsy (IVL) has demonstrated efficacy in treating balloon-crossable calcified coronary lesions by inducing calcium fractures and improving coronary artery compliance (CACom). However, a direct comparison between IVL and non-compliant (NC) balloon angioplasty with respect to compliance modification has not yet been reported. METHODS:From the BENELUX-IVL prospective registry (NCT06577038), patients with calcified coronary artery lesions treated with IVL under intravascular ultrasound (IVUS) guidance were selected. CACom was calculated as the systo-diastolic change in luminal area (ΔA), measured using IVUS, divided by the corresponding change in aortic pressure (ΔP). CACom was assessed at three time points: (1) before NC balloon inflation (baseline), (2) after NC balloon inflation but prior to IVL (post-NC), and (3) after IVL pulse delivery (post-IVL). The NC balloon effect was defined as the difference between post-NC and baseline CACom; the IVL effect was defined as the difference between post-IVL and post-NC CACom. RESULTS:Twenty-four patients, for a total of 28 lesions, were pertinent for inclusion. CACom increased from 0.17 [0.12-0.23] mm2/mmHg at baseline to 0.32 [0.25-0.52] mm2/mmHg post-NC, and to 0.65 [0.44-0.84] mm2/mmHg post-IVL. The median NC effect was 0.14 [0.10-0.28] mm2/mmHg (p <0.01), and the IVL effect was 0.23 [0.13-0.37] mm2/mmHg (p <0.01). The IVL effect was significantly greater than the NC effect (p = 0.03). CONCLUSIONS:sequential NC balloon angioplasty and IVL significantly improved coronary compliance, with IVL yielding a greater compliance gain, supporting its role in optimizing lesion preparation in calcified coronary arteries.

Diabetes mellitus (DM) is associated with increased coronary calcification and adverse outcomes after percutaneous coronary intervention (PCI), yet the performance of intravascular lithotripsy (IVL) in this high-risk population remains insufficiently defined. This study, conducted within the all-comers BENELUX-IVL registry, evaluated the safety and efficacy of IVL-assisted PCI in patients with and without DM. The primary endpoint was major adverse cardiovascular events (MACE) at 1 and 2 years, defined as cardiovascular death, nonfatal myocardial infarction, or clinically driven target vessel revascularization. Secondary endpoints included procedural outcomes, complications, and all-cause mortality. A total of 574 patients were included, of whom 193 (33.6%) had DM and 381 (66.4%) did not. Procedural (87.0% vs 89.5%; p = 0.381) and device success (95.3% vs 97.9%; p = 0.087) were similar between groups. Post-PCI minimum lumen diameter (2.80 ± 0.59 vs 2.95 ± 0.70 mm; p = 0.027) and area (6.0 [4.80 to 7.75] vs 6.6 [4.98 to 8.90] mm²; p = 0.045) were smaller in patients with DM. Thirty-day MACE was higher among diabetics (3.1% vs 0.3%; p = 0.007), whereas 1- and 2-year MACE and mortality rates were comparable. Diabetes was not independently associated with mortality (adjusted OR 1.51; p = 0.17). In conclusion, IVL-assisted PCI is safe and effective in diabetic patients, with long-term outcomes comparable to those without diabetes, although the higher early MACE risk, particularly in type 1 DM, warrants careful procedural planning and follow-up.

BACKGROUND:Intravascular lithotripsy (IVL) has demonstrated excellent results in treating calcified coronary lesions. However, specific focus on different calcification patterns is still limited. The aim of our study was to evaluate the procedural and clinical outcomes of IVL in treating concentric vs. eccentric calcifications. METHODS:The BENELUX-IVL prospective registry enrolled patients aged ≥18 years who underwent IVL. For this study, patients who underwent both IVL and intravascular ultrasound (IVUS) before and after the procedure were selected. Based on IVUS-derived calcium arc quantification, patients were categorized into two groups: concentric calcification (>180°) and eccentric calcification (≤180°). The primary technical endpoint was technical success, defined as successful IVL catheter crossing of the target lesion with residual stenosis <30%, with final TIMI 3 flow. The primary efficacy endpoint was the incidence of major adverse cardiac events (MACE) at 12-month follow-up. RESULTS:A total of 455 patients were enrolled in the registry, of whom 136 (29.9%) met the inclusion criteria for the study. Concentric calcifications were more prevalent (83.1% vs. 16.9%, P < 0.01). The median SYNTAX score was similar between the two groups [19 (10-29) vs. 20 (12-31), P = 0.64]. Technical success was achieved similarly between the two calcification patterns (93.0% vs. 95.7%, P = 0.98). At 12-month follow-up, MACE (6.2% vs. 4.3%, P = 0.66), cardiac death (1.8% vs. 4.3%, P = 0.44), and target vessel revascularization (4.4% vs. 4.3%, P = 0.99) were similar. CONCLUSION:IVUS-guided percutaneous coronary intervention of calcified lesions treated with IVL demonstrates comparable procedural outcomes and low adverse clinical event rates in both concentric and eccentric calcification patterns. However, further studies are warranted to draw definitive conclusions regarding long-term clinical outcomes.

Intravascular lithotripsy (IVL) is increasingly used to treat coronary artery calcification (CAC). This study aimed to identify clinical and procedural factors associated with IVL treatment success. This retrospective analysis included 454 patients (73 ± 9 years, 75% male) treated with IVL from the multicenter BENELUX-IVL registry (May 2019 to February 2024). Treatment success was defined as achieving residual coronary diameter stenosis < 30% and luminal gain, assessed by quantitative coronary analysis (QCA). Linear and binary logistic regression analyses were performed to identify factors associated with these outcomes. The mean luminal gain was 1.9 ± 0.9 mm, and residual diameter stenosis < 30% was achieved in 354 (90%) lesions. Stenting after IVL for therapy completion (p < 0.001), intracoronary imaging (ICI) guidance (p = 0.024) and chronic total occlusions (CTOs; p < 0.001) were associated with increased luminal gain, while bifurcation lesions (p = 0.029) were associated with decreased luminal gain. Long (> 20 mm) lesions (p = 0.034) and post-IVL stenting for therapy completion (p = 0.041) were associated with a residual diameter stenosis < 30%, while aorto-ostial lesions (p = 0.014) were negatively associated with this outcome. Technical IVL parameters such as inflation pressure and number of pulses delivered were not significantly associated with treatment success. Stenting after IVL for therapy completion, ICI guidance and CTOs were associated with increased luminal gain, while bifurcation lesions were linked to decreased luminal gain. Long lesions and post-IVL stenting for therapy completion were associated with residual diameter stenosis < 30%, while the presence of aorto-ostial lesions was negatively associated with this outcome. Technical IVL-related procedural factors did not significantly impact treatment success.

Background An accurate assessment of intermediate left main (LM) stenoses is crucial for revascularization decision-making. However, data on LM revascularization strategy according to instantaneous wave-free ratio (iFR) are limited. This study aimed to evaluate the safety of deferring LM revascularization according to iFR. Methods The PHYNAL study is a prospective, multicenter registry that included consecutive patients with intermediate LM stenosis who underwent coronary physiology assessment. Patients in whom the treatment strategy (revascularization versus deferral) was based on the iFR cutoff of 0.89 were considered for the current subanalysis. The primary endpoint was major adverse cardiac events (MACE), a composite outcome including all-cause death, non-fatal myocardial infarction (MI), and target lesion revascularization (TLR). Secondary endpoints were cardiac death and each component of the primary endpoint. Results The study population consisted of 240 patients: 188 in the deferred and 52 in the revascularized groups. At a median follow-up of 24 months (IQR: 21 to 25 months), MACE occurred in 19 patients (10 %) in the deferred and 8 patients (16 %) in the revascularized groups (HR: 1.56; 95 % CI: 0.67 to 3.60; p = 0.30) with no significant difference. Rate of all-cause death was 5 % in the deferred versus 12 % in the revascularized groups (p = 0.1), cardiac death 3 % versus 8 % (p = 0.2), non-fatal MI 1 % versus 2 % (p = 0.4), and TLR 5 % versus 2 % (p = 0.5). Conclusions Deferring LM revascularization according to iFR is safe. Patients in whom LM revascularization is deferred based on iFR have comparable clinical outcomes to patients who undergo LM revascularization according to iFR.

AIMS:Patients with end-stage renal disease (ESRD) and atrial fibrillation present a challenge for thromboembolic prevention, given their elevated risks of both thromboembolism and bleeding. Anticoagulants carry a higher bleeding risk in this population without clear evidence of thromboembolic benefit. This study aims to define the role of left atrial appendage occlusion (LAAO) as a preventive strategy for patients with ESRD. METHODS AND RESULTS:A systematic literature review was conducted to identify studies reporting outcomes in patients with ESRD who underwent LAAO. Meta-analyses of aggregate and individual patient data were performed to evaluate acute and long-term outcomes and compare them with those of patients without ESRD. Seventeen studies reporting data from 24 127 patients, including 1047 with ESRD, were included. Procedural complications were more common in patients with ESRD (RR 2.23; P = 0.02), with a pooled rate of 4% (95% CI, 1-9%). There was no significant difference in thromboembolic event rates during follow-up between the groups (IRR 1.44; P = 0.16), but major bleeding incidence was higher among patients with ESRD (IRR 1.84; P < 0.01). Individual patient-level data from seven studies comprising 4745 patients (268 with ESRD) were obtained and analysed. Similarly, there was no significant association between ESRD and stroke/TIA incidence (HR, 1.22; 95% CI, 0.66-2.26), but major bleeding was higher on patients with ESRD (HR, 1.65; 95% CI, 1.01-2.69). CONCLUSION:LAAO represents a feasible option for thromboembolic prevention in patients with ESRD, although these patients have an increased risk of complications and bleeding.

BACKGROUND:Given the poor prognosis of tricuspid regurgitation (TR) patients, there is growing interest in addressing TR, particularly since the emergence of novel transcatheter tricuspid valve interventions for patients at high risk for surgery. AIMS:The TRICURE first-in-human (FIH) study evaluates the initial feasibility and clinical safety of the Topaz transcatheter tricuspid valve replacement (TTVR) system in treating TR. Featuring a novel dual-stent design, the system is specifically engineered for the unique anatomy of the tricuspid valve. It has a flexible outer stent with low radial force designed to accommodate annular dynamics and conform to the non-circular, variable shapes of the tricuspid valve, coupled to a rigid inner stent aiming to maintain valve function integrity. METHODS:TRICURE FIH is a prospective, multicentre, first-in-human study with follow-up extending to 5 years. The primary safety endpoint is a composite measure including all-cause mortality, heart failure rehospitalisation, and reintervention for failed tricuspid therapy at 30 days. The primary performance endpoint is device success, defined as a TR reduction ≥1 grade with no more than moderate TR post-procedure. RESULTS:A total of 20 patients were enrolled. The procedure time (from delivery system insertion to removal) was 35±16 minutes. At 30 days, the primary safety endpoint, a composite of major adverse events, was observed in 35%, and the primary performance endpoint was successfully achieved in all patients (100%), with all patients having a TR reduction of at least 3 grades, and none of the patients having more than mild TR post-procedure. No device-related pacemaker implant was reported. An exemplary case report demonstrates complete elimination of TR and a reverse remodelling of the right ventricle of 19% at 6 months. CONCLUSIONS:The TRICURE FIH study provides evidence of the feasibility and safety of a novel TTVR system. Outcomes need to be confirmed in a larger series. (ClinicalTrials.gov: NCT05126030).

Background:This study aimed to evaluate the incidence of complications associated with intravascular lithotripsy (IVL) therapy, assess clinical outcomes, and identify predictors of complications in a real-world patient cohort. Methods:Patients undergoing IVL between May 2019 and September 2024 were enrolled from the BENELUX-IVL registry and categorized based on the occurrence of complications following IVL and concomitant therapy. End points were achievement of residual diameter stenosis <30% on quantitative coronary analysis and major adverse cardiovascular events (MACE) at 1-year follow-up. Kaplan-Meier and binary logistic regression analyses were performed to compare outcomes and to identify predictors of complications. Results:The study included 509 patients (73 ± 9 years, 75% male). Complications occurred in 33 patients (6%), of which 6 complications occurred immediately after IVL (1%). The most frequent complications were flow-limiting coronary dissections (n = 9, 2%), hemodynamic instability (n = 9, 2%), and coronary perforations (n = 7, 1%). These were effectively managed with 30 interventions, resulting in favorable procedural outcomes. Among patients with complications and available quantitative coronary analysis data, residual diameter stenosis <30% was achieved in 28 of 29 lesions (97%). One-year cumulative MACE was 11% (39 patients) and was significantly higher in patients with complications (P < .001), mainly driven by in-hospital events (P < .001). Larger predilatation balloon diameters (P = .032) were associated with complications. Conclusions:In this real-world registry, complications following IVL and concomitant therapy were infrequent. Patients with procedural complications had significantly higher 1-year MACE, primarily driven by in-hospital events. Larger predilatation balloon diameters were a significant predictor of complications.

Percutaneous left atrial appendage closure (LAAC) is increasingly used as a valuable intervention to prevent cardioembolic stroke among patients with atrial fibrillation who are poor candidates for long-term anticoagulation. The safety of the procedure has significantly improved over time; nevertheless, device embolisation remains a severe complication that still occurs in around 0.1% of cases. Its management must be rapid and effective in order to reduce mortality. The anatomical location of the embolised device dictates the technical approach for retrieval and has a major impact on the clinical outcome of patients. Percutaneous recapture is the main approach in case of an aortic or left atrial embolisation, while emergent surgery should be performed if the device becomes entangled in the mitral apparatus with poor haemodynamics unsolved by transcatheter device mobilisation into the left ventricular (LV) cavity. In cases of LV embolisation and stable haemodynamics, a transfemoral or transseptal retrieval may be attempted. The equipment for retrieval is key to success: all cath labs performing LAAC procedures should be equipped with minimum 16 Fr sheaths, steerable sheaths, single-loop snares and grasping tool devices. This paper includes a summary of the European Left Atrial Appendage Closure Club consensus recommendations for LAAC device embolisation management.

Intravascular lithotripsy (IVL) has emerged as a viable treatment option for calcified coronary lesions. This study aimed to identify clinical and procedural factors associated with major adverse cardiovascular events (MACE) following IVL. This retrospective analysis included 583 patients (72.9 ± 9 years, 74% male) treated with IVL for 612 lesions from the multicenter BENELUX-IVL registry (May 2019-December 2024). Kaplan-Meier analysis was performed to evaluate survival probability. Binary logistic regression analysis was performed to identify predictors of MACE, including cardiac death, nonfatal myocardial infarction (MI) or clinically driven target vessel revascularization (TVR) at 1-year follow-up. Patients presented with acute coronary syndrome in 246 cases (42%), while a variety of target lesions was treated, including in-stent lesions (n = 185, 30%), aorta-ostial lesions (n = 148=24%), bifurcation lesions (n = 135, 22%) and chronic total occlusions (CTOs)(n = 45, 7%). MACE occurred in 44 patients (11%) at 1-year and in 53 patients (18%) at 2-years follow-up. Occurrence of procedural complications (p <0.001), CTOs (p = 0.020), in-stent lesions (p = 0.044), post-IVL plaque modification (p = 0.003) and greater postprocedural residual diameter stenosis on fluoroscopy (p = 0.006) were associated with the occurrence of MACE, while MI in the medical history (p = 0.001) was negatively associated with MACE. Following treatment with IVL in a real-world registry, clinical outcomes up to 2-years follow-up were favorable. Procedural complications, CTOs, in-stent lesions, performance of post-IVL plaque modification and greater postprocedural residual diameter stenosis on fluoroscopy were independent risk factors for experiencing MACE at 1-year follow-up. In contrast, a history of MI was associated with a lower risk of MACE.

Background:Intravascular lithotripsy (IVL) has been demonstrated to be effective in treating balloon-crossable calcified coronary lesions by inducing calcium fractures and facilitating stent expansion (SE), theoretically by improving coronary artery compliance (CACom). Direct evidence of this theory has not yet been provided. Methods:From the BENELUX-IVL prospective registry (NCT06577038) enrolling patients with calcified coronary artery lesions treated with IVL, intravascular ultrasound-guided cases were selected. CACom was calculated as the systo-diastolic change in the luminal area (ΔA), measured using intravascular ultrasound, relative to the corresponding change in aortic pressure (ΔP). Measurements were taken directly before (pre-CACom) and after (post-CACom) IVL therapy at the most calcified segment, where IVL pulses were administered. The primary end point was CACom modification (ΔCACom), defined as post-CACom - pre-CACom, with a correlation analysis between ΔCACom and new fractures as a key exploratory aim. Secondary analysis included assessing whether ΔCACom could predict SE at the minimum stent area (MSA) and the eccentricity index. Results:Coronary artery compliance significantly improved after IVL therapy (median ΔCACom 0.33 [0.19-0.70] mm2/mm Hg; P < .01). Lesions showing new calcium fractures presented significantly greater ΔCACom compared to those without. ΔCACom and new calcium fractures were significantly correlated (R = 0.466; P < .01). In univariate analysis, ΔCACom was found to be a significant predictor for SE at MSA (P < .01), MSA (P = .015), and SE >80% (P = .025), but not eccentricity index (P = .157). At multivariate analysis, ΔCACom was an independent predictor of SE (R = 0.420; P = .044) and SE >80% at MSA (OR, 6.58 [1.24-34.90]; P = .043). Conclusions:In heavily calcified coronary lesions treated with IVL, ΔCACom is an independent predictor of SE.

Background:Patients of advanced age are frequently underrepresented or excluded from major clinical trials, leading to limited evidence in this population and a reliance on data extrapolated from younger populations. The present study aims to compare and evaluate the safety and efficacy of intravascular lithotripsy (IVL) for the treatment of calcified coronary lesions in individuals of advanced age and in younger populations. Methods:In this post-hoc analysis, from the ongoing prospective, multicenter BENELUX-IVL registry involving nine hospitals across four countries in the European Union, patients undergoing percutaneous coronary intervention (PCI) with intravascular lithotripsy (IVL) were retrospectively stratified into two groups: advanced age (≥80 years) and younger (<80 years). The primary technical endpoint was technical success, defined as successful IVL catheter crossing of the target lesion with residual stenosis <30%. The primary safety endpoint was in-hospital major adverse cardiac events (MACE). This study is registered with ClinicalTrials.gov, number NCT06577038. Findings:Between January 2019 and April 2025, 583 patients underwent PCI with IVL; of these, 147 (25.2%) patients were aged ≥80 years (advanced age cohort), and the remaining 436 (74.8%) were aged <80 years (younger cohort). Compared to younger patients, the advanced age cohort had higher SYNTAX score (23 [IQR 15-32] vs. 18 [IQR 11-28], p = 0.01) and more comorbidities. Intraprocedural complications (severe dissection, abrupt vessel closure, and perforation) were low in both groups, with no significant differences between them. Technical success was comparable between the advanced age and younger populations (87.8% vs. 90.6%, RR: 0.97 (0.91-1.04), p = 0.32). In-hospital MACE rates were similar between the advanced age and younger cohorts (1.4% vs. 2.1%, RR: 0.64 (0.19-2.18), p = 0.59), and these results remained consistent at 1-year follow-up (6.1% vs. 8.0%, RR: 0.76 (0.38-1.55) p = 0.51). Interpretation:In patients of advanced age, IVL for calcified coronary lesions demonstrates a favorable safety and efficacy profile, with high technical success and low rates of device-related adverse events. Nonetheless, larger studies with extended follow-up are warranted to confirm these findings and establish long-term outcomes. Funding:This work was funded through a research grant from Shockwave Medical.

BACKGROUND:Intravascular lithotripsy (IVL) is increasingly utilized for the treatment of heavily calcified coronary lesions. However its use in conjunction with temporary mechanical circulatory support (tMCS) remains underexplored. OBJECTIVE:This study aims to evaluate the current use of tMCS and IVL for the treatment of heavily calcified coronary lesions. METHOD:From the BENELUX-IVL prospective registry, patients who underwent IVL during PCI and required tMCS during the procedure were selected. The primary technical endpoint was procedural success <30%, defined as a composite of device success (the ability to deliver the IVL catheter across the target lesion, and delivery of IVL pulses without angiographic complications) with residual stenosis <30%, final Thrombolysis In Myocardial Infarction grade 3 flow, and no in-hospital major adverse cardiovascular events (MACE). The primary clinical outcome was in-hospital MACE, including cardiac death, non-fatal myocardial infarction, or target lesion revascularization. RESULTS:Between May 2019 and March 2024, a total of 454 patients were included, of whom 12 (2.6%) necessitated tMCS (for a total of 13 tMCS devices). Upon admission, the mean LV-EF was 39.5 ± 11.9%. The median Syntax score was 37 (25-49). A bail-out indication was the most common reason for tMCS initiation (58.3%), even if none was directly started due to IVL-related complications. Microaxial Flow Pump was the main utilized device (75%), followed by VA-ECMO (25%) and IABP (8.3%). One case required both VA-ECMO and Impella due to a coronary perforation complicated by cardiac tamponade. Procedural success < 30% was achieved in 91.6% of the cases. MACE occurred in one patient (8.3%). CONCLUSION:In a large cohort of patients with complex heavily calcified coronary lesions requiring IVL, the need for tMCS was low (2.6%), with the main indication being bail-out.