Interventional procedure overview of intravascular lithotripsy for calcified arteries in peripheral arterial disease
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Other relevant studies
Other potentially relevant studies to the IP overview that were not included in the main evidence summary (tables 2 and 3) are listed in table 5 below.
Case reports have been excluded unless they describe a safety outcome.
Article | Number of patients and follow up | Direction of conclusions | Reason study was not included in main evidence summary |
|---|---|---|---|
Adams G, Shammas N, Mangalmurti S et al. (2020) Intravascular lithotripsy for treatment of calcified lower extremity arterial stenosis: initial analysis of the Disrupt PAD III study. Journal of Endovascular Therapy 27: 473–80 | Prospective single-arm trial n=200 (220 lesions) Follow up: end of procedure | There was a 3.4 mm average acute gain at the end of procedure; the final mean residual stenosis was 24%. Angiographic complications were rare, with only 2 type D dissections and a single perforation after drug-coated balloon inflation (unrelated to the IVL procedure). There was no abrupt closure, distal embolisation, no reflow, or thrombotic event. | Study is included in systematic review by Wong et al., 2022. |
Armstrong EJ, Soukas PA, Shammas N et al. (2020) Intravascular lithotripsy for treatment of calcified, stenotic iliac arteries: a cohort analysis from the Disrupt PAD III study. Cardiovascular Revascularization Medicine 21: 1262–68 | Prospective cohort study n=118 (200 lesions) Follow up: end of procedure | Acute results in calcified iliac lesions confirm a consistent reduction in stenosis with few complications, similar to findings in other peripheral arteries. IVL assisted large bore access facilitates endovascular procedures that result in reduced morbidity and mortality. The outcomes suggest that IVL is a safe and effective option for calcified, stenotic iliac disease. | Subgroup analysis of the Disrupt PAD 3 observational study. Study is included in systematic review by Wong et al., 2022. |
Aru RG, Tyagi SC (2022) Endovascular treatment of femoropopliteal arterial occlusive disease: Current techniques and limitations. Seminars in Vascular Surgery 35: 180–89 | Review | The data on IVL fails to show any clinical superiority over PTA and raises the question of its applicability in a real-world cohort with long-segment infrainguinal arterial disease. Coupled with drug-coated devices, IVL and atherectomy show varying degrees of short- to mid-term success in the management of long-segment, highly calcified femoropopliteal lesions, and more robust studies are essential in determining their optimal utility. | No meta-analysis. The relevant cited studies have been included in tables 2, 3 and 5. |
Bosiers M (2019) Is vessel prep necessary before treating the superficial femoral artery? The Journal of Cardiovascular Surgery 60: 557–66 | Review | Adequate vessel preparation is mandatory, especially in complex SFA lesions to improve stent or DCB outcome. Different devices and balloons exist and are especially favourable in 'no-stenting' zones. It is unclear which device performs better in different types of lesions. | Only 1 study on IVL is included. |
Brodmann M, Holden A, Zeller T (2018) Safety and feasibility of intravascular lithotripsy for treatment of below-the-knee arterial stenoses. Journal of Endovascular Therapy 25: 499–503 | Prospective single-arm trial n=20 Follow up: 30 days | All treated lesions had residual diameter stenosis of 50% or less after the procedure. Vascular complications were minimal with only 1 type B dissection reported and 2 stents placed. The early results of this pilot study demonstrated that calcified, stenotic infrapopliteal arteries can be safely and successfully treated with IVL. | Small study, which is included in systematic review by Wong et al., 2022. |
Brodmann M, Schwindt A, Argyriou A et al. (2019) Safety and feasibility of intravascular lithotripsy for treatment of common femoral artery stenoses. Journal of Endovascular Therapy 26: 283–87 | Case series n=21 | Post treatment mean diameter stenosis was 21%, representing an acute mean lumen gain of 3.1 mm (range 0.7 to 5.2 mm). There were 5 type B (non-flowing-limiting) dissections reported. | Small study, which is included in systematic review by Wong et al., 2022. |
Brodmann M, Werner M, Holden A et al. (2019) Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: results of Disrupt PAD II. Catheterization and Cardiovascular interventions 93: 335–42 | Prospective single-arm trial n=60 Follow up: 12 months | IVL demonstrated compelling safety with minimal vessel injury, and minimal use of adjunctive stents in a population with complex, difficult to treat PAD. | Small study, which is included in systematic review by Wong et al., 2022. |
Chugh Y, Khatri JJ, Shishehbor MH et al. (2021) Adverse events with intravascular lithotripsy after peripheral and off-label coronary use: a report from the FDA MAUDE database. The Journal of Invasive Cardiology 33: e974-e977 | Review of events reported on US Food and Drug Administration Manufacturer and Device User Experience database. | There were 20 reports related to use of IVL in peripheral artery disease interventions. Device malfunction was the most common adverse event reported. Partial balloon or catheter dislodgment was the most common mode of IVL device failure, followed by balloon rupture. There were single reports of vessel rupture, stroke, thrombus formation and peripheral embolisation but it was unclear if they were related to IVL. | The denominator for the events is unknown, so the actual adverse event rate is unknown. Balloon rupture, device error and dissection are already included as safety outcomes in the key evidence. |
Colacchio EC, Salcuni M, Gasparre A et al. (2022) Midterm results of intravascular lithotripsy for severely calcified common femoral artery occlusive disease: a single-center experience. Journal of Endovascular Therapy doi.org/10.1177/ 15266028221105188 | Prospective case series n=10 (12 limbs) | Median stenosis reduction=56% (IQR 50 to 61). There was 1 target lesion revascularisation. The mean upgrade in Rutherford class was 2.7. No target vessel and access site complications were reported, as well as no distal embolisation. One death and 1 major amputation occurred over the follow-up period, both in the same person. | Studies with more people are included. |
Dini CS, Tomberli B, Mattesini A et al. (2019) Intravascular lithotripsy for calcific coronary and peripheral artery stenoses. EuroIntervention 15: 714–21 | Review | IVL delivered at low atmospheric pressures can circumferentially fracture calcium, augmenting expansion in severely calcified lesions. | No meta-analysis. The relevant cited studies have been included in tables 2, 3 and 5. |
Giannopoulos S, Armstrong EJ (2022) Intravascular lithotripsy for optimal angioplasty of infrapopliteal calcified lesions. The Journal of Invasive Cardiology 34: e132–141 | Review (9 studies) and case series (n=4) | The IVL results from the DISRUPT trials are encouraging, showing that IVL can improve acute luminal gain and facilitate endovascular therapy. Therefore, these studies strongly indicate that IVL could have a crucial role in the management of below-the-knee disease, as infrapopliteal lesions are often complicated with moderate or severe calcification. Additional studies with standardised treatment protocols and long-term follow-up data are necessary before recommending PTA with adjunctive IVL as the first-line treatment for all calcified infrapopliteal lesions. | Results were not pooled because of between-study differences in design, comparisons made and reporting methods. |
Hatzis CM, George JM, Ilonzo N et al. (2021) Intravascular lithotripsy in the treatment of lower extremity peripheral arterial disease. Surgical Technology International 39: 308–12 | Review and case reports | The data supporting the use of IVL, particularly for calcified, lower extremity occlusive lesions and as an adjunct to facilitate large-bore arterial access, is rapidly growing. Further analysis of the comparative effectiveness will help elucidate where it fits into the overall treatment pathway. | No meta-analysis. The relevant cited studies have been included in tables 2, 3 and 5. |
Holden A (2019) The use of intravascular lithotripsy for the treatment of severely calcified lower limb arterial CTOs. The Journal of Cardiovascular Surgery 60: 3–7 | Review | Shockwave IVL is a promising technology for managing calcified arterial lesions in peripheral arteries. Learnings from clinical trials to date include an excellent safety profile and the need to dilate 1.1:1 compared with nominal to optimise acute results. | No meta-analysis. A more recent systematic review is included. |
Kassimis G, Didagelos M, De Maria GL et al. (2020) Shockwave intravascular lithotripsy for the treatment of severe vascular calcification. Angiology 71: 677–88 | Review | IVL is unique among all current technologies in its ability to modify calcium circumferentially and transmurally. The IVL balloon is easy to use, with predictable results. | No meta-analysis. The relevant cited studies have been included in tables 2, 3 and 5. |
Khan MS, Baig M, Moustafa A et al. (2022) Intravascular lithotripsy in calcified subclavian and innominate peripheral artery disease: a single-centre experience. Cardiovascular Revascularization Medicine 40: 37–41 | Retrospective case series n=7 (13 lesions) | IVL facilitated acute procedural success without any procedural complications in severely calcified stenoses of the subclavian and innominate vasculature. | Small, retrospective case series. |
Khan S, Li B, Salata K et al. (2019) The current status of lithoplasty in vascular calcifications: a systematic review. Surgical Innovation 26: 588–98 | Systematic review n=211 (9 studies) | Recent studies suggest that lithoplasty is a promising intervention to decrease vessel stenosis, with minimal occurrence of major adverse events. | A more recent systematic review is included. |
Nasiri A, Kim H, Gurusamy V et al. (2022) Management of calcification: rational and technical considerations for intravascular lithotripsy. Techniques in Vascular and Interventional Radiology 25: 100841 | Review and case series n=5 | Early data and early experience suggest that IVL may be a valuable tool in the treatment of calcific vessels and may enhance patency rates and improve outcomes in these vessels while minimising complications. Long-term data is lacking. | No meta-analysis. The relevant cited studies have been included in tables 2, 3 and 5. |
Price LZ, Faries PL, McKinsey JF et al. (2019) The epidemiology, pathophysiology, and novel treatment of calcific arterial disease. Surgical Technology International 34: 351–58 | Review | Catheter-based lithotripsy shows promise in the treatment of symptomatic PAD. This technology may help expand eligibility for transfemoral interventions such as transcatheter aortic valve replacement and endovascular aortic aneurysm repair. | No meta-analysis. The relevant cited studies have been included in tables 2, 3 and 5. |
Radaideh Q, Shammas NW, Shammas GA et al. (2019) Safety and efficacy of lithoplasty in treating severely calcified iliac arterial disease: A single center experience. Vascular Disease Management 16: e55–57 | Retrospective case series n=7 Follow up: 30 days | Shockwave lithoplasty to the iliac arteries showed excellent procedural success and no complications. Full stent expansion was noted, and this result was comparable to the expected stent diameter per the manufacturer's specifications. | Small, retrospective case series. Study is included in systematic review by Wong et al., 2022. |
Radaideh Q, Shammas NW, Shammas WJ et al. (2021) ShockwaveTM lithoplasty in combination with atherectomy in treating severe calcified femoropopliteal and iliac artery disease: a single-center experience. Cardiovascular Revascularization Medicine 22: 66–70 | Retrospective cohort study n=24 Follow up: 18 months | The combination of atherectomy and shockwave IVL followed by adjunctive drug-coated balloon is safe and appears to be effective in treating severe calcified disease with acceptable target lesion revascularisation on long term follow-up in severe femoropopliteal disease. | Study is included in systematic review by Wong et al., 2022. |
Topfer L-A, Spry C (2016) New technologies for the treatment of peripheral artery disease. In: CADTH Issues in Emerging Health Technologies. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2016. 172. 2018 Apr 1 2018 Apr 1. | Review | Currently there is a lack of good quality, comparative evidence to guide clinical practice on many of the new endovascular technologies used to treat PAD. | More recent studies are included. |
Vazquez Sosa CE, Malik A, Sreenivasan J et al. (2022) Intravascular lithotripsy in peripheral artery disease. Cardiology in Review DOI: 10.1097/ CRD.0000000000000483 | Review | IVL is a novel, promising and less invasive atherectomy modality that can be safely and effectively use in calcified common femoral, femoropopliteal, and infrapopliteal stenoses potentially with a significant luminal gain. It helps with plaque modification to improve balloon expansion and target vessel patency. Further larger studies are needed to evaluate the long-term benefits and its use in infrapopliteal lesions and other patient population like people with in-stent or graft restenosis. | No meta-analysis. The relevant cited studies have been included in tables 2, 3 and 5. |
Vedani S, Haligur D, Jungi S et al. (2023) Intravascular lithotripsy: a powerful tool to treat peripheral artery calcifications. The Journal of Cardiovascular Surgery doi: 10.23736/S0021-9509.22.12535-8 | Review | IVL is a safe and effective approach in the treatment of highly calcified arteries with excellent results and low rates of related complications, such as embolisation, dissection, and perforation. However, it seems to require adjunctive therapies to enhance long-term patency as well as an adequate sizing. | No meta-analysis. The relevant cited studies have been included in tables 2, 3 and 5. |
Virk HUH, Tabaza L, Almas T et al. (2021) Contemporary role of intravascular lithotripsy in the management of peripheral artery disease. Current Treatment Options in Cardiovascular Medicine 23: 47 | Review | IVL is an innovative modality developed to improve the treatment success of calcified PAD with a favourable safety and efficacy profile across multiple clinical studies. Further larger scale studies are warranted to confirm durability of these results and directly compare IVL with presently available calcium-modifying agents. | No meta-analysis. The relevant cited studies have been included in tables 2, 3 and 5. |
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