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Abstract Background Fracking is a novel technique to crack calcified lesions by hydraulic pressure. This study aimed to compare the performance of fracking and conventional balloon angioplasty without stenting for calcified common femoral artery (CFA) lesions using intravascular ultrasound (IVUS) analysis. Methods This retrospective, single-center, comparative observational study included 59 patients (67 limbs) with calcified CFA lesions treated with either fracking (n = 30) or balloon angioplasty (n = 29) between January 2018 and December 2020. The primary endpoint was 1-year primary patency. The secondary endpoints included procedure success, freedom from target lesion revascularization (TLR), procedure-related complications, and freedom from major adverse limb events (MALE). Predictors of restenosis were identified using multivariate Cox proportional hazards analysis. Results The mean follow-up duration was 403 ± 236 days. The fracking group had significantly higher incidence of 1-year primary patency (89.8% versus 49.2%, P

This overview article should describe current technical problems of severe infrainguinal calcifications, outline solutions for challenging and complex lesions and give an overview over currently available debulking devices which are meant to deal with calcified lesions. As a relatively new device, arterial lithoplasty is discussed.

Background: Calcium is a predictor of poor outcome in the treatment of infrainguinal arterial disease. Rotational atherectomy can effectively debulk atherosclerotic calcium but is less likely to significantly modify medial and adventitial calcinosis. Shockwave IVL provides circumferential sonic pressure waves capable of disrupting deeper calcium and theoretically complements the debulking process of atherectomy. We present acute and intermediate outcome data from patients with severe femoral or iliac artery calcified disease treated with the combination of rotational atherectomy and Shockwave IVL at a single center.Methods: This is a retrospective study of prospectively collected data on rotational atherectomy (Jetstream (Boston Scientific) and orbital atherectomy (CSI)) from a single operator at a single center with core laboratory analysis of angiographic imaging. All patients that received the combination treatment of rotational atherectomy and Shockwave IVL were included in this study. Patient follow-up was done from medical records with data extracted by an experienced research coordinator. Primary safety endpoint was freedom from major adverse events including major dissection (NHLBI C or higher), perforation, distal embolization, or major amputation defined as amputation above the ankle. Primary effectiveness endpoint was procedural success (≤ 30% residual at end of procedure). 23/24 (95.8%) patients were treated with drug coated balloons (DCB) post combination therapy. Secondary endpoint on follow-up was target lesion revascularization (TLR).Results: A total of 24 patients were included. Mean age was 70.7 ± 9.9 years. Lesions were in the femoropopliteal 79.1%, common femoral 12.5% and iliac 8.3% arteries. 87.0% were claudicants and 58.3% diabetics. Chronic total occlusion was 12.5%, severe calcium 100%, lesion length 84.5 ± 37.1 mm, baseline stenosis 57.1 ± 18.9% and baseline minimal luminal diameter (MLD) 2.2 ± 1.1 mm. Patients were treated with Jetstream (n = 19) or Orbital (n = 5) atherectomy. Embolic filter was used in 58.3% of cases. Post atherectomy stenosis was 36.4 ± 17.5%, post adjunctive IVL 21.1 + 15.7%, and final stenosis 13.0 ± 10.9%. Bailout stenting was 4.6% and primary stenting 13.6% (total stenting rate 18.2%). Final MLD was 4.7 ± 0.8 mm, resulting in an acute gain of 2.5 mm. No infrapopliteal embolization or amputation was noted. At a mean follow up of 591.4 ± 175.2 days, 2 patients died (unrelated to procedure or device). Target lesion revascularization (TLR) at 12 months occurred in 2 patients or 2/22 (9%). At 18-month of follow up TLR occurred in 7/22 (31%) patients.Conclusion: The combination of atherectomy and shockwave IVL followed by adjunctive DCB is safe and appears to be effective in treating severe calcified disease with acceptable TLR on long term follow-up in a population of severe femoropopliteal disease. [ABSTRACT FROM AUTHOR]

Purpose: The presence of calcification in the iliac arteries is associated with decreased procedural success and increased complication risk during endovascular intervention. The objective of this study was to evaluate the safety and efficacy of peripheral intravascular lithotripsy (IVL) during endovascular treatment of iliac arterial peripheral artery disease (PAD).Methods: The Disrupt PAD III Observational Study is a prospective, non-randomized, multi-center single-arm study to assess the 'real-world' safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of de novo calcified lesions in the peripheral arteries, with a goal of treating 1500 patients. This is an analysis of consecutive patients enrolled for treatment of an iliac artery, a specified sub-group, with at least moderate calcification and a minimum length of 20 mm.Results: Between December 2017 and July 2019, 118 patients with a total of 200 lesions were enrolled across 20 sites. 101 patients were treated primarily for claudication or critical limb ischemia, while 17 patients were treated to optimize the iliac vasculature for large-bore access. All 118 patients had successful IVL catheter delivery. The average reference vessel diameter was 7.3 mm ± 1.9 mm, with an average diameter stenosis of 83.1% ± 13.4% and an average lesion length of 58.3 mm ± 57.6 mm. Severe calcification was present in 82.0% of overall cases. Stent placement was performed in 72.9% of the overall cases. As expected, the access group received less adjunctive therapies including stents (41.2%, p < 0.001). Angiographic complications were minimal with no flow-limiting dissections and a final mean residual stenosis of 12.0% ± 12.1% with no differences between the groups.Conclusions: Acute results with IVL in calcified iliac lesions suggest that it is a safe and effective option for calcified, stenotic iliac disease. IVL can be used successfully both for treatment of PAD symptoms and to optimize access for large-bore procedures. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the performance of peripheral intravascular lithotripsy (IVL) in a real-world setting during endovascular treatment of multilevel calcified peripheral artery disease (PAD). Materials and Methods: The Disrupt PAD III Observational Study (ClinicalTrials.gov identifier NCT02923193) is a prospective, nonrandomized, multicenter, single-arm observational study assessing the acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of calcified, stenotic lower limb arteries. Patients were eligible if they had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. Between November 2017 and August 2018, 200 patients (mean age 72.5±8.7 years; 148 men) were enrolled across 18 sites and followed through hospital discharge. Results: In the 220 target lesions, IVL was more commonly used in combination with other balloon-based technologies (53.8%) and less often with concomitant atherectomy or stenting (19.8% and 29.9%, respectively). There was a 3.4-mm average acute gain at the end of procedure; the final mean residual stenosis was 23.6%. Angiographic complications were rare, with only 2 type D dissections and a single perforation following drug-coated balloon inflation (unrelated to the IVL procedure). There was no abrupt closure, distal embolization, no reflow, or thrombotic event. Conclusion: Use of peripheral IVL to treat severely calcified, stenotic PAD in a real-world study demonstrated low residual stenosis, high acute gain, and a low rate of complications despite the complexity of disease. [ABSTRACT FROM AUTHOR]

Background. Lithoplasty is a method of alleviating vessel stenosis by using localized high-speed pressure waves to disrupt calcium deposits. A systematic review of the literature was performed to summarize the early outcomes of lithoplasty in peripheral and coronary artery disease. Methods. We searched EMBASE, MEDLINE, and the Cochrane Central Register of Controlled Trials from database inception to July 2018 for original studies describing the use of lithoplasty. Study selection and data extraction were performed in duplicate, with a third author resolving discrepancies. Results. A total of 9 records were included from the 201 studies eligible for screening. In total, 211 patients with vascular calcification lesions underwent lithoplasty. The patients on average had an age of 73.2 years and had a maximum follow-up period of 5.5 months. Most lesions (72%, 152/212) were in peripheral artery beds, with the remainder occurring in coronary vessels. Lesioned vessels typically had severe calcium burden 62.6% (131/210), with an average initial stenosis of 76.6% (range, 68.1%-77.8%). After treatment, the average residual stenosis was 21.0% (range, 13.3%-26.2%), with a mean acute gain of vessel diameter of 2.5 mm. A limited number of type D dissections occurred, with a total of 2.4% (5/211) of patients requiring stent implantation. Conclusions. Recent studies suggest that lithoplasty is a promising intervention to decrease vessel stenosis in both peripheral artery disease and coronary artery disease, with minimal occurrence of major adverse events. Further research studies, with more rigorous study designs, are needed to determine the effectiveness of lithoplasty in vascular calcifications. [ABSTRACT FROM AUTHOR]

We report the case of a 70-year-old patient with history of chronic heart disease who underwent bypass surgery twice beforehand and was admitted due to non-ST segment elevation myocardial infarction. Angiography showed degeneration of all bypass grafts except the LIMA bypass, which showed significant ostial stenosis with severe calcification. Peri-operative risk was computed to be as high as 12.3% (STS Score). An interventional strategy was chosen: the very high-risk procedure was performed safely under the protection afforded by venoarterial ECMO and cardiac surgeons on standby using a coronary intravascular lithoplasty (IVL) balloon. After implantation of a drug eluting stent, the primary angiogram showed a satisfactory result. The patient was discharged without further complications short after the procedure and is closely followed-up. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the safety and feasibility of treating calcified infrapopliteal stenoses using an intravascular lithotripsy (IVL) system.Methods: The Disrupt BTK study was a prospective, nonrandomized, multicenter, feasibility, and safety trial that enrolled 20 patients (mean age 79.0±9.6 years; 14 men) at 3 participating sites ( ClinicalTrials.gov identifier NCT02911623). Fifteen patients had Rutherford category 5 ischemia, and all patients had moderate to severe below-the-knee arterial calcification. Patients were treated with the Shockwave Medical Peripheral IVL System and followed for 30 days. The primary safety endpoint was a composite of major adverse events through 30 days defined as death, myocardial infarction, need for emergency surgical revascularization of the target limb, or amputation of the target limb. The primary effectiveness outcome was acute reduction in the percent diameter stenosis.Results: IVL catheter delivery was successful in 19 patients. The composite of major adverse events at 30 days was 0%. The acute reduction in percent diameter stenosis of target lesions was 46.5%. All patients achieved residual diameter stenosis ≤50%. Vascular complications were minimal with only 1 type B dissection reported and 2 stents placed. None of the subjects experienced thrombus formation, abrupt closure, distal embolization, or perforation. There were no device-related complications.Conclusion: The early results of this pilot study demonstrated that calcified, stenotic infrapopliteal arteries can be safely and successfully treated with intravascular lithotripsy. [ABSTRACT FROM AUTHOR]

Heavily calcified lesions may limit optimal stent deployment resulting in stent underexpansion, thus increasing the risk of restenosis and thrombosis. We describe the case of overlapping stents underexpansion treated with a shockwave intravasuclar lithoplasty system (Shockwave Medical Inc., Santa Clara, CA, USA). A 65-year-old man with angina, underwent coronary angiography and intravascular ultrasound showing restenosis, in a site of overlapping stents, due to calcified tissue. Shockwave lithoplasty balloon was able to break calcified tissue in a site of overlapping stents, allowing subsequent vessel dilation and repeat stent implantation with optimal final stent expansion. < Learning objective > Heavily calcified lesions may limit optimal stent deployment resulting in stent underexpansion. Treating stent underexpansion or restenosis due to calcified tissue is a great challenge. Shockwave lithoplasty is effective in breaking calcified tissue also in a site of overlapping stents. The improved plaque compliance allows to repeat stent implantation with optimal final stent expansion. [ABSTRACT FROM AUTHOR]

We report the case of a stent under-expansion due to heavily calcified plaque treated with the shockwave lithoplasty system. A 77-year-old woman underwent coronary angiography, and intravascular ultrasound revealed stent under-expansion due to calcified plaque. Shockwave lithoplasty balloon was used to disrupt calcium deposits around the stent, thereby allowing a correct stent expansion with an excellent angiographic and intravascular ultrasound result. [ABSTRACT FROM AUTHOR]

Arterial calcification (AC) is a common complication among patients with peripheral arterial disease (PAD). AC presents various challenges to PAD treatment including an increased likelihood of vessel rupture and dissection, and by acting as a physical barrier to drug delivery by angioplasty balloons. Intravascular lithotripsy (IVL) is a novel intervention that specifically targets AC by emitting sonic pressure waves that introduce microfractures in target calcified lesions to increase arterial compliance. Preliminary data has demonstrated the safety and efficacy of IVL in PAD treatment. The present article provides a technical overview of S-IVL, as well as a case series of the treatment of AC in common iliac, common femoral, superficial femoral, aortoiliac, and peroneal arterial lesions. Each case resulted in marked improvement of luminal patency, exhibiting the efficacy IVL. [ABSTRACT FROM AUTHOR]

Introduction: Transcatheter aortic valve implantation (TAVI) has rapidly developed over the last decade and is nowadays the treatment of choice in the elderly patients irrespective of surgical risk. The outcome of these patients is mainly determined not only by the interventional procedure itself, but also by its complications. Material and Methods: We analyzed the outcome and procedural events of transfemoral TAVI procedures performed per year at our institution. The mean age of these patients is 79.2 years and 49% are female. All the patients underwent duplex ultrasonography of the iliac arteries and inguinal vessels before the procedure and CT of the aorta and iliac arteries. Results: Transfemoral access route is associated with a number of challenges and complications, especially in the patients suffering from peripheral artery disease (PAD). The rate of vascular complications at our center was 2.76% (19/689). Typical vascular complications (VC) include bleeding and pseudoaneurysms at the puncture site, acute or subacute occlusion of the access vessel, and dissection or perforation of the iliac vessels. In addition, there is the need for primary PTA of the access pathway in the presence of additional PAD of the common femoral artery (CFA) and iliac vessels. Balloon angioplasty, implantation of covered and uncovered stents, lithoplasty, and ultrasound-guided thrombin injection are available to treat the described issues. Conclusion: Interventional therapy of access vessels can preoperatively enable the transfemoral approach and successfully treat post-operative VC in most of the cases. Training the heart team to address these issues is a key focus, and an interventional vascular specialist should be part of this team., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Thieme, Moebius-Winkler, Franz, Baez, Schulze, Butter, Edlinger and Kretzschmar.)

Current calcium modification treatments only address the burden of intimal calcium with varying degrees of success and result in an increased risk for adverse events. Here, we describe the use of shockwave intravascular lithoplasty (S-IVL) to effectively treat a severely calcified coronary artery lesion. A 59-year-old male with a history of coronary artery disease with stents presented to our hospital with angina. Diagnostic coronary angiography revealed a mid-right coronary artery (mRCA) stent with severe in-stent restenosis due to under expansion of stent with severe calcification. Due to these factors, the decision was made to reduce the calcium burden with the use of S-IVL. This is a promising technique in plaque modification of severely calcified coronary lesions with less risk of myocardial injury and mechanical vascular trauma. It is important to customize the choice of therapy based on the patient and the characteristics of the coronary lesion., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2021, Siddiqui et al.)

Background: Highly calcific stenosis located in common femoral artery (CFA) represents a difficult target for endovascular treatment due to the possible need for stent implantation in that area., Case Summary: A 63-year-old man with history of coronary artery disease and previous multiple percutaneous transluminal angioplasties for peripheral artery disease (PAD) was admitted for recent onset left lower limb pain at rest with severe activity restriction (Leriche-Fontaine Class III and Rutherford Class III-IV). The angio-computed tomography scan showed a highly calcific stenosis of left CFA. The patient underwent lithoplasty balloon angioplasty followed by drug-eluting balloon inflation with excellent angiographic result and complete blood flow restoration. No procedural complications occurred., Discussion: Highly calcified stenosis in PAD represents a huge challenge for endovascular treatment as not all lower extremity arteries are suitable for stenting because of compressive and torsional forces associated with stent fracture and restenosis. Lithoplasty is a new technology allowing effective blood flow restoration while minimizing vessel injury., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Purpose: The Shockwave Lithoplasty System represents a novel technology combining a balloon angioplasty catheter with the use of sound waves. Evidences suggest that it is a reliable tool to overcome calcified stenosis in both peripheral and coronary arteries. Here, we describe the case of a patient with calcified innominate artery stenosis successfully treated with the Shockwave Lithoplasty System. Case Report: A 78-year-old woman with hypertension, and dyslipidemia, came to our observation for dizziness. Instrumental examinations showed critical calcified stenosis of the innominate artery. The lesion was successfully treated with the Shockwave Lithoplasty System and subsequent stent apposition. Final angiography demonstrated excellent position of the stent, good wall apposition, and confirmed patency of the right common and right vertebral artery origins. Conclusion: Our clinical experience demonstrates that Lithoplasty is safe and effective also for the treatment of supra-aortic vessels. [ABSTRACT FROM AUTHOR]

Transfemoral approach is considered the preferred route to perform transcatheter aortic valve implantation (TAVI) by most operators due to the low invasiveness and good outcome, as compared to non-transfemoral approach. However, transfemoral access is not always feasible particularly in patients with small and calcific vessels. Recently, catheter-based lithoplasty has emerged as a new technique based on the use of circumferential pulse pressure waves to disrupt calcific plaques. This technology may help to expand eligibility for transfemoral TAVI to patients with calcific ileo-femoral vessels and at high risk for non-transfemoral approach. We present the case of an 87-year-old woman with poor vascular access who successfully underwent transfemoral TAVI following lithoplasty of iliac artery., (© 2018 Wiley Periodicals, Inc.)

Background: Coronary calcified lesions may limit optimal stent deployment resulting in stent underexpansion, increasing the risk of thrombosis. The Shockwave Lithoplasty System, a new technology combining a balloon angioplasty catheter with the use of sound waves, it is able to break calcium deposits without affecting vascular soft tissue., Case Presentation: An 80-year-old Caucasian man with ST elevation myocardial infarction underwent emergent coronary angiography showing complete intrastent thrombosis at the proximal trait of LAD. After thrombus removal, it was evident that stent under-expansion at its proximal edge was caused by vascular calcification. Coronary shockwave lithoplasty was chosen to treat this lesion. After calcium deposits disruption we were able to obtain complete stent expansion., Conclusion: Our case demonstrates the usefulness and safety of the lithoplasty system in the context of ST elevation myocardial infarction., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)