Use Of Intravascular Lithotripsy Research Articles

Current application and results of the combined use of intravascular lithotripsy and rotational atherectomy for the treatment of calcified coronary lesions

Abstract Background Intravascular lithotripsy (IVL) and rotational atherectomy (RA) might be used simultaneously (Rotatripsy) to treat calcified lesions during percutaneous coronary intervention (PCI), though data on the effectiveness and sequence of their use is limited. Purpose To identify indicators for the use of Rotatripsy and to assess its safety and success rates, both acutely as at one-year follow-up. Methods Patients undergoing PCI with IVL and RA across six centers in two European countries from May 2019 to December 2023 were included. Demographic, clinical, procedural and follow-up data were collected. Angiographic and intracoronary imaging (ICI) data were analyzed centrally. Efficacy endpoints included device success (delivery of the RA-burr and IVL-balloon across the target lesion and administration of therapy without related complications), technical success (TIMI 3 flow and residual stenosis <30% by quantitative coronary analysis) and procedural success (composite of technical success with absence of in-hospital major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). Safety endpoints comprised rotatripsy-related complications and MACE at one-year follow-up. Results A total of 114 patients (75±9 years, 78% male) underwent rotatripsy for 120 lesions. Patients presented with an ACS in 58(51%) cases and chronic coronary syndrome in 56(49%). The left anterior descending artery(n=66, 55%) was the most frequently treated target vessel, with diverse lesions being addressed, including bifurcations(30%), ostial(18%), CTO(7%) and in-stent(12%) lesions. The mean burr size was 1.5±0.2mm with a maximum rotational speed of 171±15k rpm and burr/vessel ratio of 0.46±0.2. IVL involved an average of 68±25 pulses and a balloon size of 3.5±0.5mm. The predominant used sequence of rotatripsy was RA followed by IVL(n=106, 88%). Among these cases, IVL was electively combined with RA in 68(57%) lesions, and used for balloon underexpansion(n=37, 31%) and stent crossing failure after RA(n=1, 1%). Additionally, IVL served as bail-out strategy after RA and stenting in 10(8%) and preceded RA in 4(3%) lesions, particularly when balloon/stent delivery failed after IVL. After rotatripsy, stents were implanted in 116(97%) lesions and drug-eluting balloon used in 3(3%). ICI was utilized in 69(58%) target lesions. Device, technical and procedural success were 97%, 94% and 93%, respectively. Therapy-related complications occurred in 4 patients(4%), and included two(2%) coronary perforations, one(1%) dissection and one(1%) burr entrapment. At one-year follow-up (present in 77(67%)), MACE was observed in 7(6%). Conclusions Rotatripsy demonstrated efficacy across diverse clinical and anatomical settings, with the majority of procedures electively employing RA before IVL. High success rates and low complication rates were observed, with few patients experiencing MACE at one-year follow-up.

Assessment of safety, efficacy and learning curve of intravascular lithotripsy in real world practice within a high volume calcium modification centre

Abstract Background There has been a rapid uptake in the use of intravascular lithotripsy (IVL) for calcium modification during percutaneous coronary intervention (PCI) due to its ease of use and excellent safety profile, particularly when compared to atherectomy devices. Purpose To review the adoption and safety of IVL in a high volume centre with established use of alternative calcium modification techniques Methods This was a retrospective analysis of all patients undergoing PCI from the introduction of IVL in January 2019 until December 2023. Patient demographics, comorbidity, procedure details and procedural complications were compared between IVL and non-IVL cases. Line charts were created to demonstrate the uptake and use of IVL per quarter compared with other established calcium modification strategies. A further line chart was created to compare the frequency of IVL use per quarter in more complex cases (left main intervention, ST elevation, treatment of in stent restenosis and in combination with rotational/orbital atherectomy). Results In the analysis timeframe there were 7,843 PCI cases performed, of which there were 301 IVL cases, 263 rotational/orbital atherectomy cases and 77 excimer laser atherectomy. IVL cases were older, more likely to have previous revascularisation (PCI (40.8% vs 57.1 % (p<0.001)) or bypass grafts 4.8% vs 8.0% (p=0.012)), diabetes mellitus (22.7% vs 33.6% (p<0.001)) and hypertension (45.4% vs 56.5% (p<0.001)). From a procedural perspective, treatment of left main and restenosis were more common with IVL compared with the rest of the cohort (7.0% vs 27.6% (p<0.001) and 8.3% vs 28.9% (p<0.001) respectively). IVL cases were more frequently guided by intracoronary imaging (intravascular ultrasound 35.9% vs 70.4% (p<0.001), optical coherence tomography 3.7% vs 18.9% (p<0.001)). Atherectomy was more frequent in IVL cases (excimer laser atherectomy 0.7% vs 7.3% (p<0.001) and rotational/orbital atherectomy 2.6% vs 22.9% (p<0.001)). Figure 1 shows the frequency of IVL use compared with other established calcium modification strategies per quarter and demonstrates the rapid and sustained uptake in IVL usage. Interestingly the use of other atherectomy techniques does not appear to have reduced. Figure 2 shows that IVL was quickly utilised in more complex calcification cases and again this has remained consistent since the introduction. Both figures demonstrate the short learning curve associated with IVL. Finally, there was no significant increase in perforation or slow/no reflow with IVL use (0.5% vs 0.7% (p=0.647) and 1.1% vs 1.3% (p=0.675) respectively) consistent with the published literature. There was an increase in documented coronary dissection with uncertain impact (3.4% vs 6.5% p=0.017). Conclusions IVL has become an essential tool within the calcium modification algorithm as a result of its ease of use, efficacy and excellent safety profile.Calcium modification per quarterFrequency of complex IVL cases

Safety, efficacy, and optical coherence tomography insights into intravascular lithotripsy for the modification of non-eruptive calcified nodules: A prospective observational study.

Non-eruptive calcium nodules (CNs) are commonly seen in heavily calcified coronary artery disease. They are the most difficult subset for modification, and may result in stent damage, malapposition and under-expansion. There are only limited options available for non-eruptive CN modification. Intravascular lithotripsy (IVL) is being explored as a potentially safe and effective modality in these lesions. This study aimed to investigate the safety and efficacy of the use of IVL for the modification of non-eruptive CNs. The study also explored the OCT features of calcium nodule modification by IVL. This is a single-center, prospective, observational study in which patients with angiographic heavy calcification and non-eruptive CN on OCT and undergoing PCI were enrolled. The primary safety endpoint was freedom from perforation, no-reflow/slow flow, flow-limiting dissection after IVL therapy, and major adverse cardiac events (MACE) during hospitalization and at 30 days. MACE was defined as a composite of cardiac death, myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR). The primary efficacy endpoint was procedural success, defined as residual diameter stenosis of <30% on angiography and stent expansion of more than 80% as assessed by OCT. A total of 21 patients with 54 non-eruptive CNs undergoing PCI were prospectively enrolled in the study. Before IVL, OCT revealed a mean calcium score of 3.7 ± 0.5 and a mean MLA at CN of 3.9 ± 2.1 mm2. Following IVL, OCT revealed calcium fractures in 40 out of 54 (74.1%) CNs with an average of 1.05 ± 0.72 fractures per CN. Fractures were predominantly observed at the base of the CN (80%). Post IVL, the mean MLA at CN increased to 4.9 ± 2.3 mm2. After PCI, the mean MSA at the CN was 7.9 ± 2.5 mm2. Optimal stent expansion (stent expansion >80%) at the CN was achieved in 85.71% of patients. All patients remained free from MACE during hospitalization and at the 30-day follow-up. At 1-year follow-up, all-cause death had occurred in 3 (14.3%) patients. This single-arm study demonstrated the safety, efficacy, and utility of the IVL in a subset of patients with non-eruptive calcified nodules. In this study, minimal procedural complications, excellent lesion modifications, and favorable 30-day and 1-year outcomes were observed.

Successful use of lithoplasty for re-expansion of covered iliac stents with unilateral occlusion.

Vessel wall calcification is associated with stent under-expansion and in-stent restenosis. The traditional approaches to treat peripheral artery calcification are percutaneous transluminal angioplasty (PTA) and atherectomy. Shockwave intravascular lithotripsy (IVL) uses sonic wave pressure to disrupt calcium of the severely calcified lesions. Published reports of IVL to treat in-stent restenosis are limited to coronary interventions and bare metal platforms. We describe the case of a 55-year-old male with extremely compressed under-expanded covered stents associated with severe wall calcification that resulted in stent occlusion. The IVL system balloon was deployed uneventfully, in a phased manner. Bilateral bare metal stents were also placed in a kissing fashion to further re-expand the arterial segments. Reintervention with IVL facilitated successful revascularization and the stent remained patent at 24 months. Our case highlights the use of IVL as an effective tool in the management of vessel wall calcification both for primary and secondary interventions.

Intravascular Lithotripsy: Approach to Advanced Calcified Coronary Artery Lesions, Current Understanding, and What Could Possibly Be Studied Next.

Calcified and resistant narrowing of arteries poses significant difficulty in performing percutaneous coronary interventions (PCIs), as they increase the risk of subpar outcomes leading to worse clinical outcomes. Despite the existence of dedicated technologies and devices, including various balloons and atherectomy systems, they often do not ensure sufficient plaque modification and ideal vessel preparation for optimal stent deployment. Intravascular lithotripsy (IVL), a technology originally developed for urological procedures, has recently been used to safely and selectively disrupt calcified depositions in both peripheral and coronary arteries by sonic waves that seamlessly transfer to nearby tissue, enhancing vessel compliance with minimal impact on soft tissues. In the coronary arteries, the use of IVL plays a role in the process of "vessel preparation" before the placement of stents, which is crucial for restoring blood flow in patients with severe coronary artery disease (CAD), and is considered a minimally invasive technique, reducing the need for open heart surgeries and associated risks and complications. Studies have shown that IVL can lead to improved procedural success rates and favorable long-term outcomes for patients with severely calcified coronary artery disease. With the advent of IVL, the disruption of severe calcification of coronary artery and stenotic lesions before stent implantations can be performed. Despite promising data for treating calcified lesions, IVL is significantly underutilized in clinical practice, long-term clinical data and extensive research are needed to validate its further safety and efficacy. In this article, we reviewed the literature discussing the use of IVL in the coronary arteries as an approach for addressing intravascular atherosclerotic plaques, particularly focusing on heavily calcified plaques that are resistant to standard initial PCI, while also evaluating its safety in comparison to alternative methods.

Intravascular lithotripsy-assisted transfemoral transcatheter aortic valve implantation after failed balloon angioplasty in patients with severe calcified peripheral artery disease.

Calcific peripheral artery disease (PAD) is a common finding in patients scheduled for transcatheter aortic valve implantation (TAVI) and often requires iliofemoral axis preparation. However, evidence about the use of intravascular lithotripsy (IVL) in this setting is scarce. The aim of this study was to describe in-hospital and mid-term outcomes of IVL-assisted transfemoral (TF)-TAVI in patients with severe calcific PAD. The study included 13 patients with severe calcified PAD who were initially scheduled for balloon angioplasty (PTA)-assisted TF-TAVI but were eventually treated with peripheral IVL between October 2020 and February 2024. Accurate analysis of preoperative computed tomography scans revealed difficult TF access routes (severe calcified PAD with minimal lumen diameter ≤ 4.5 mm, circumferential calcification along iliofemoral axis, and marked vessels tortuosity). In all cases, IVL was performed after PTA failure and allowed successful valve delivery. One patient had procedural bleeding (BARC-3a). The valve was successfully delivered without complications in 12 patients (92.3%), and no major adverse events were reported at the longest follow-up (median 18.5 months). IVL-assisted TF-TAVI may represent a feasible and safe option for patients presenting with severe aortic stenosis and severe calcified PAD. However, standardization of the access site severity as well as indications for a planned up-front IVL-assisted strategy are missing and require dedicated studies.

Contemporary Trends and Outcomes of Intravascular Lithotripsy in Percutaneous Coronary Intervention: Insights From BMC2

BackgroundWith an aging population and an increase in the comorbidity burden of patients undergoing percutaneous coronary intervention (PCI), the management of coronary calcification for optimal PCI is critical in contemporary practice. ObjectivesThis study sought to examine the trends and outcomes of coronary intravascular lithotripsy (IVL), rotational/orbital atherectomy, or both among patients who underwent PCI in Michigan. MethodsWe included all PCIs between January 1, 2021, and June 30, 2022, performed at 48 Michigan hospitals. Outcomes included in-hospital major adverse cardiac events (MACEs) and procedural success. ResultsIVL was used in 1,090 patients (2.57%), atherectomy was used in 1,743 (4.10%) patients, and both were used in 240 patients (0.57% of all PCIs). IVL use increased from 0.04% of PCI cases in January 2021 to 4.28% of cases in June 2022, ultimately exceeding the rate of atherectomy use. The rate of MACEs (4.3% vs 5.4%; P = 0.23) and procedural success (89.4% vs 89.1%; P = 0.88) were similar among patients treated with IVL compared with atherectomy, respectively. Only 15.6% of patients treated with IVL in contemporary practice were similar to the population enrolled in the pivotal IVL trials. Among such patients (n = 169), the rate of MACEs (0.0%) and procedural success (94.7%) were similar to the outcomes reported in the pivotal IVL trials. ConclusionsSince its introduction in February 2021, coronary IVL use has steadily increased, exceeding atherectomy use in Michigan by February 2022. Contemporary use of IVL and atherectomy is generally associated with high rates of procedural success and low rates of complications.

Cracking the Code of Coronary Calcium: One-year Clinical Outcomes of Intravascular Lithotripsy in All-comers and Two Complex Cohorts

Background: Severe coronary calcifications are commonly encountered in real-world populations and in left main (LM) disease, heightening complication risks including stent underexpansion. Although intravascular lithotripsy (IVL) appears safe, longer-term data in high-risk populations are lacking. The aim of this study was therefore to examine 1-year IVL outcomes for severely calcified lesions in two complex cohorts: LM stenosis and underexpanded stents (UES) during stent implantation. Methods: A registry study was carried out to examine major adverse cardiovascular events (MACEs) (MI, target vessel revascularisation [TVR], cardiac mortality). The LM and UES subgroups were compared with their counterparts in the non-LM and de novo lesion subgroups, respectively. Results: The study involved 102 participants (median age, 70 years, 68% male), and the cardiovascular burden was high (diabetes, 72%; dialysis, 18%; prior MI, 43%, median left ventricular ejection fraction, 45%). Many participants presented acutely (acute coronary syndrome, 36%; decompensated heart failure, 13%) and had complex anatomies (triple-vessel disease, 77%). The cardiovascular burden was higher in the LM and UES subgroups than in the non-LM and de novo lesion subgroups, but the rates of procedural complications and 30-day MACEs were low and were not significantly different. The 1-year MACE rate was higher in the LM group than in non-LM (29% versus 10%, p=0.042), but was non-significant after adjusting for baseline variables (OR 3.08; 95% CI [0.87–10.9]); the rates of 1-year MI, TVR and mortality did not differ from non-LM. In the UES group, 1-year MACE rate (17% versus 13%, p=0.500) was similar to that for de novo lesions. Conclusion: The preliminary data suggest that the use of IVL is reasonable when encountering stent underexpansion due to severe coronary calcifications during stent implantation. The 1-year MACE rate was higher in calcific LM stenosis, probably due to greater comorbidity burden and acute presentations.

Peripheral intravascular lithotripsy to facilitate transfemoral transcatheter aortic valve replacement – Defining optimal treatable peripheral arterial disease burden

BackgroundTransfemoral transcatheter aortic valve replacement (TF-TAVR) has proven superior to alternative access. However, some patients evaluated for TF-TAVR are unfit secondary to peripheral arterial disease (PAD). Peripheral intravascular lithotripsy (IVL) can facilitate femoral access. This study aimed to characterize optimal lesions that can be treated with IVL. MethodsSingle-center, retrospective analysis of an institutional database, queried from 1/2018 through 7/2023 for all patients who underwent TAVR. Patients who received IVL-facilitated transfemoral access were analyzed. ResultsOf 2862 TAVR cases identified, 92 (3.2 %) underwent lithotripsy. The IVL-facilitated cohort had a mean age of 78 ± 9.2 years and 45 % were female. The right common iliac artery was most treated (47). Most IVL was performed with 7-mm balloons (73.9 %). All cases were successful. 30-day mortality was 1.1 % (1/92). ConclusionsIn our cohort, complications after IVL-facilitated TF-TAVR were more common with small vessel diameter (≤4.7 mm), significant luminal loss (>50 % stenosis), and heavy calcium burden (arc calcification >180°). The findings support the use of IVL to expand the population of patients who can undergo TF-TAVR without the increased risks associated with the various forms of alternative access. Summary for annotated table of contentsIVL-facilitated TF-TAVR is safe and feasible. Despite its introduction to TAVR clinical practice in 2018, IVL-facilitated TF-TAVR is not regularly performed and could increase the population of patients eligible for TF-TAVR.

Transradial stenting of left subclavian artery origin using shockwave intravascular lithotripsy balloon plasty: Technical report and literature review

Lesions of the subclavian artery often involve pathologic stenosis due to high degrees of calcification within the vessel wall. While endovascular angioplasty and stenting is generally the preferred method for obtaining flow reconstitution, calcification of the vessel wall has proven to significantly impair the efficacy of successful stent deployment. Shockwave intravascular lithotripsy (IVL) is a technology that has been very successful in addressing this challenge in other vascular territories, however its use has yet to be approved for supra-aortic vessels such as the subclavian artery. In this report, the use of IVL for a case of subclavian steal syndrome due to a highly stenosed left subclavian artery is described along with a review of the literature. Although several cases utilizing this technology in subclavian arteries have been reported, none have described the use of a left transradial approach. Therefore the purpose of this report is to demonstrate the efficacy of IVL for supra-aortic vessels so that its benefits can be expanded to a broader patient population.

Intravascular lithotripsy-assisted percutaneous deep vein arterialization for no-option chronic limb-threatening patients and heavily calcified tibial occlusive disease.

To report the first chronic limb-threatening ischemia (CLTI) patients who underwent an intravascular lithotripsy (IVL)-assisted percutaneous deep vein arterialization (pDVA). An 81-year-old patient presented with CLTI and a heavily calcified lesion of the popliteal artery and tibioperoneal trunk (TPT), with a distal tibial and foot arch occlusion. The patient underwent IVL and drug-coated balloon angioplasty for the distal popliteal artery and of the TPT to improve the inflow prior to pDVA. The wound situation remained stable without secondary procedure until the patient`s deaths due to complications of urosepsis 3months later. A 64-year-old patient with rest pain of the left limb with a single-vessel tibial run-off (peroneal artery) and occluded pedal arch was treated with 3.5mm IVL followed by a successful pDVA as mentioned above. IVL performed in the proximal posterior tibial artery to optimize the inflow to the circuit and change the compliance of the crossing point from the arterial to the vein system. The patient underwent repeat angioplasty of the plantar vein arch 5months after the index procedure and thereafter remained asymptomatic during 2years of follow-up. The combined use of IVL and pDVA could improve the patency of the reconstruction with clinical benefits in no-option CTLI patients.

D-50 | Use of intravascular lithotripsy for management of coronary in-stent restenosis, outcomes from single center study

D-50 | Use of intravascular lithotripsy for management of coronary in-stent restenosis, outcomes from single center study

Comparison of interventional treatment options for coronary calcified nodules: A sub-analysis of the ROTA.shock trial

BackgroundThe optimal treatment for coronary calcified nodules (CNs) is still unclear. The aim of this study was to compare the modification of these lesions by coronary intravascular lithotripsy (IVL) and rotational atherectomy (RA) using optical coherence tomography (OCT). MethodsROTA.shock was a 1:1 randomized, prospective, double-arm multi-center non-inferiority trial that compared the use of IVL and RA with percutaneous coronary intervention (PCI) in severely calcified lesions. In 19 of the patients out of this study CNs were detected by OCT in the target lesion and were treated by either IVL or RA. ResultsThe mean angle of CNs was significantly larger in final OCT scans than before RA (92 ± 17° vs. 68 ± 7°; p = 0.01) and IVL (89 ± 18° vs. 60 ± 10°; p = 0.03). The CNs were thinner upon final scans than in initial native scans (RA: 17.8 ± 7.8 mm vs. 38.6 ± 13.1 mm; p = 0.02; IVL: 16.5 ± 9.0 mm vs. 37.2 ± 14.3 mm; p = 0.02). Nodule volume did not differ significantly between native and final OCT scans (RA: 0.66 ± 0.12 mm3 vs. 0.61 ± 0.33 mm3; p = 0.68; IVL: 0.64 ± 0.19 mm3 vs. 0.68 ± 0.22 mm3; p = 0.74). Final stent eccentricity was high with 0.62 ± 0.10 after RA and 0.61 ± 0.09 after IVL. ConclusionRA or IVL are unable to reduce the volume of the calcified plaque. CN modulation seems to be mainly induced by the stent implantation and not by RA or IVL.

Coronary Intravascular Lithotripsy Effectiveness and Safety in a Real-World Cohort.

Background: Coronary artery calcification is a predictor of adverse outcomes after percutaneous coronary intervention (PCI). Intravascular lithotripsy (IVL) is a promising tool for the treatment of calcified lesions. The aim of this study was to assess the effectiveness and safety of IVL. Methods: A single-center observational study of PCI procedure, with assessment of the outcomes of patients undergoing PCI using IVL, was performed. Angiographic procedural success was used as the primary effectiveness endpoint. The primary safety endpoint was defined as a composite of cardiac death, myocardial infarction and target vessel revascularization within 30 days. Results: A total of 111 patients were included. Indications for PCI spanned the spectrum of chronic (53.2%) and acute coronary syndromes (43%). Lesion preparation before IVL was performed with non-compliant (42%), cutting or OPN (14.4%) balloons and with atherectomy techniques in 11% of procedures. Intravascular imaging was used in 21.6% of procedures. The primary effectiveness endpoint was achieved in 100% and the primary safety endpoint in 3.6% of procedures. Peri-procedural complications were minimal and successfully resolved. Conclusions: IVL was an effective and safe technique for the treatment of calcified coronary lesions. These findings contribute to the growing body of evidence supporting the use of IVL in the management of these challenging scenarios.

Efficacy of intravascular lithotripsy (IVL) in coronary stenosis with severe calcification: a systematic review and meta-analysis of 38 studies

Abstract Introduction Heavily calcified coronary lesions impede appropriate stent deployment and expansion, increasing the risk of complications. Intravascular Lithotripsy (IVL) technology disrupts subendothelial calcification by using localized pulsative sonic pressure waves and is a promising technique for patients with severe coronary calcification. Purpose Our aim was to systematically review and summarize available data regarding the safety and efficacy of IVL in preparing severely calcified plaques in coronary 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 peri-procedural complications and major adverse cardiovascular events (MACE) in a 30-day period were assessed using a random-effects model. Results This meta-analysis comprised 38 studies including 2,977 patients with heavily calcified coronary lesions. The mean age was 72.2 ± 9.1 years, with an overall IVL procedural success rate of 98% (95% CI: 96%-99%, I2=69.2%) and clinical success of 96% (95% CI: 93%-98%, I2=72.2%), 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 (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 mm and 1.94 ± 1.1 mm, respectively. Peri-procedural complications were rare, with just a few cases of perforations, dissection, or no-reflow phenomena recorded. Conclusions The present meta-analysis shows that IVL constitutes an effective and safe technique for preparing severely calcified lesions before stent implantation in coronary arteries. These results support the use of IVL in the high procedural risk setting of severe coronary calcification.

Efficacy of Intravascular Lithotripsy (IVL) in peripheral lesions with severe calcification and its use in TAVI procedure: A systematic review and meta-analysis

Abstract Background Heavily calcified peripheral artery lesions increase the risk of vascular complications, constituting a severe challenge for the operator. Intravascular Lithotripsy (IVL) technology disrupts subendothelial calcification by using localized pulsative sonic pressure waves and is a promising technique for patients with severe calcification in peripheral arteries. Purpose Our aim was to systematically review and summarize available data regarding the safety and efficacy of IVL in preparing severely calcified plaques in peripheral arteries and its use in Transcatheter Aortic Valve Implantation (TAVI). 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 in peripheral vasculature. The diameter of the vessel lumen before and after IVL was estimated. The occurrence peri-procedural complications were assessed using a random-effects model. Results 20 studies with a total of 1,223 patients with heavily calcified peripheral lesions were analyzed. The mean age of the cohort was 73.8 ± 8.9 years. Successful IVL delivery achieved in 100% (95% CI: 100%-100%, I2=0%), with an increase in the luminal diameter (SMD: 4.66, 95% CI: 3.41-5.92, I2=90.8%) and reduction in diameter stenosis (SMD: -4.15, 95% CI: -4.75 to -3.55, I2=92.8%), and a described low rate of complications. There was not observed any dissection in 97% (95% CI: 91%-100%, I2=81.4%), while dissections of any type (A, B, C, or D) were observed in 6% (95% CI: 2%-10%, I2=85.3%) of the patients. Several rare cases of abrupt closure, no-reflow phenomenon, perforation, thrombus formation, and distal embolization were recorded. Finally, the subgroup analysis of patients who underwent a TAVI with IVL assistance presented successful implantation in 100% (95% CI: 100%-100%, I2=0%) of the cases, with only 4% (95% CI: 0%-12%, I2=68.96%) presented dissections of any sort. Conclusions IVL seems to be an effective and safe technique for preparing severely calcified lesions in peripheral vessels during TAVI interventions. These results support the use of IVL for amelioration of overall outcome in high vascular risk TAVI settings.

Abstract 12812: Temporal Trends of Calcium Modification Therapies in Chronic Total Occlusion Percutaneous Coronary Intervention

Introduction: Various techniques with different mechanisms of action are presently available for the modification of coronary calcium in chronic total occlusions (CTOs). Hypothesis: We sought to examine the temporal trends in the use of calcium modification therapies in a large multicenter CTO percutaneous coronary intervention (PCI) registry. Methods: We analyzed data from 13,079 CTO PCIs performed in 12,799 patients at 46 US and non-US centers between 2012 and 2023. Calcification was assessed by angiography as mild (spots), moderate (involving ≤50% of the reference lesion diameter), or severe (involving &gt;50% of the reference lesion diameter). Results: Moderate or severe calcification was present in 6,094 CTOs (46.6%). Among CTO lesions with moderate or severe calcium, one or more calcium modification techniques was used in 1,006 cases (16.9%); rotational atherectomy (7.2%, n=434), laser atherectomy (3.4%, n=203), intravascular lithotripsy (IVL) (3.4%, n=200), scoring balloon (3.0%, n=178), cutting balloon (1.8%, n=109), orbital atherectomy (1.5%, n=91), and Chocolate balloon (Teleflex, 0.3%, n=15). Over time, the use of calcium modification techniques for lesions with moderate to severe calcification increased from 2.5% in 2012 to 25.7% in 2023 (p for trend &lt;0.001), with a significant increase in the use of IVL (from 0.6% in 2020 to 16.6% in 2023; p for trend &lt;0.001) (Central Illustration). In the last 2 years (2021-2023), IVL was the most commonly used calcium modification technique followed by rotational atherectomy. Conclusions: The use of calcium modification techniques for calcified CTO lesions increased over time, with a significant increase in the use of IVL in the last years.

Abstract 18372: Peripheral Intravascular Lithotripsy to Facilitate Transfemoral Transcatheter Aortic Valve Replacement - Updated Outcomes

Background: Transfemoral transcatheter aortic valve replacement (TF-TAVR) approach has proven to be superior to alternative access[1]. However, a subset of patients being evaluated for TF-TAVR are deemed unfit secondary to peripheral arterial disease. Despite reduction of delivery system profiles to 14 - 18 Fr, current systems still pose an increased risk of access vessel injury. For patients anatomically unfit for standard transfemoral access, peripheral intravascular lithotripsy (IVL) has emerged to facilitate femoral access for TAVR. Methods: Single center, retrospective analysis of an institutional patient database, queried from 1/2018 through 12/2022 for all patients undergoing TAVR. All patients undergoing IVL facilitated lithotripsy for transfemoral access were analyzed. Results: A total 2,209 TAVR cases were identified, with 75 (3.78%) having undergone lithotripsy: 14 in 2018, 15 in 2019, 16 in 2020, 13 in 2021, and 17 in 2022. The lithotripsy cohort consisted of 45% female with mean age of 78±9.8 years. Average length of stay was 3 days. Common and external iliac lesions were the most common target (n=41/75), followed by common iliac alone (n=25/75). Majority of IVL was performed with 7-mm lithotripsy catheter (n=55/75). Procedural success was 98.7% (n=74/75). Average fluoroscopy time 31 minutes, and average total contrast infusion 87cc. Average number of pulses per lesion was 260 ±52. Mean target lesion diameter on the right 5.0 ±1.2mm and left 5.3 ±1.3mm. Average aortic valve calcium score was 2405.6 ±1260.4. Total complication rate was 28%. Complications requiring secondary vascular procedure occurred in 5.3% (n=4/75) with femoral stenosis requiring balloon dilation, external iliac pseudoaneurysm and retroperitoneal bleed secondary to common femoral pseudoaneurysm primarily repaired, and CFA occlusion required open endarterectomy. Mortality at 30-days 1.3% (n=1/75). Conclusions: This abstract aims to provide an updated report of a single institution experience for the use of IVL to facilitate transfemoral TAVR. The IVL facilitated TF-TAVR is feasible, safe, and effective at preserving the transfemoral TAVR route in patients with severe peripheral artery disease. [1] Holmes. et al. J Am Coll Cardiol, 2015. 66(25): p. 2813-2823

Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study

ObjectiveEndovascular therapy of lower extremity peripheral artery disease (PAD) is associated with higher complication rates and worse outcomes in women vs men. Although intravascular lithotripsy (IVL) has shown similarly favorable outcomes in men and women in calcified coronary arteries, there is no published safety and effectiveness data of peripheral IVL differentiated by sex. This study aims to evaluate sex-specific acute procedural safety and effectiveness following IVL treatment of calcified PAD. MethodsWe performed a secondary analysis of the multicenter Disrupt PAD III Observational Study, which assessed short-term procedural outcomes of patients undergoing treatment of symptomatic calcified lower extremity PAD with the Shockwave peripheral IVL system. Adjudicated acute safety and efficacy outcomes were compared by sex using univariate analysis performed with the χ2 test or Fisher exact test, as appropriate. ResultsA total of 1262 patients (29.9% women) were included, with >85% having moderate to severe lesion calcification. Women were older (74 vs 71 years; P < .001), had lower ankle-brachial index (0.7 vs 0.8; P = .003), smaller reference vessel size (5.3 vs 5.6 mm; P = .009), and more severe stenosis at baseline vs men (82.3% vs 79.8%; P = .012). Rates of diabetes, renal insufficiency, chronic limb-threatening ischemia, lesion length, and atherectomy use were similar in both groups. Residual stenosis after IVL alone was significantly reduced in both groups. Final residual stenosis was 21.9% in women and 24.7% in men (P = .001). Serious angiographic complications were infrequent and similar in both groups (1.4% vs 0.6%; P = .21), with no abrupt vessel closure, distal embolization, or thrombotic events during any procedure. ConclusionsThe use of IVL to treat calcified PAD in this observational registry demonstrated favorable acute safety and effectiveness in both women and men.

Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Lesions: Long-Term Sex-Specific Outcomes.

Intravascular lithotripsy (IVL) for calcified lesion preparation prior to drug-eluting stent placement has high procedural success and safety, especially in women, whereas other atheroablative approaches are associated with increased procedural complications. We sought to investigate long-term sex-based outcomes of IVL-facilitated stenting. We performed a patient-level pooled analysis of the single-arm Disrupt CAD III and IV studies. Patient baseline, procedural characteristics, and outcomes were examined according to sex at 30 days and 1 year. The primary end point was major adverse cardiac events (a composite of cardiac death, all myocardial infarction, or target vessel revascularization). Target lesion failure was defined as cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. A total of 448 patients, 106 (24%) women, were included. Women were older and less likely to be smokers. Women had smaller reference vessel diameters (2.8 mm vs 3.1 mm), shorter lesion length (23.6 mm vs 27.1 mm), and shorter total calcified length (44.4 mm vs 49.3 mm) compared with men. Post-IVL angiographic outcomes and complications were similar between women and men. At 1 year, major adverse cardiac event rates (12.3% vs 13.2%, P = .52) were not different between women and men. There were no differences between women and men (10.4% vs 11.2%; P = .43) in target lesion failure at 1 year. Use of IVL in the treatment of severely calcified lesions is associated with low rates of adverse clinical events and with similar safety and effectiveness in women and men at 1 year.