Interventional procedure overview of intravascular lithotripsy for calcified arteries in peripheral arterial disease
Closed for comments This consultation ended on at Request commenting lead permission
Evidence summary
Population and studies description
This interventional procedures overview is based on about 800 people who had the procedure from 1 systematic review and meta-analysis (Wong 2022), 1 individual patient-level pooled meta-analysis (Madhavan 2020), 1 randomised controlled trial (Tepe 2021 and 2022), 1 prospective single-arm trial (Adams 2022), 2 retrospective cohort studies (Baig 2022, Stavroulakis 2023), 1 prospective single centre registry (Aftanski 2023) and 1 case report (Faccenna 2021). The single-arm trial by Adams et al. (2022) is included in both meta-analyses. The randomised controlled trial by Tepe et al. (2021) is also included in the meta-analysis by Wong et al. (2022). All 5 studies included in the individual patient-level pooled meta-analysis by Madhavan et al. (2020) were also included in the meta-analysis by Wong et al. (2022).
This is a rapid review of the literature, and a flow chart of the complete selection process is shown in figure 1. This overview presents 9 studies as the key evidence in table 2 and table 3, and lists 24 other relevant studies in table 5.
The evidence included studies from Europe, Australia, New Zealand and the US. The study populations were mostly men, and they included a high proportion of people with cardiovascular risk factors, such as hypertension and dyslipidaemia.
The meta-analysis by Wong et al. (2022) included 9 studies on IVL for PAD, 1 of which was a randomised controlled trial (Disrupt PAD III). Of the 9 studies, 6 reported the proportion of total occlusions, which ranged from 13% to 57%. The definition of vessel calcification varied across studies. Three studies adjudicated the angiographic results using the PARC criteria, 2 defined severe calcification as radiopacities noted before injection of contrast, 2 defined it as bilateral calcifications of at least 3 cm, and the remaining 2 studies did not specify their definition. The superficial femoral artery was the vessel most commonly treated, accounting for 48% of procedures. Two studies reported lesions in the iliac arteries only and 1 reported lesions in the common femoral arteries only. The overall quality of the included studies was described as fair, indicating a moderate risk of bias.
The individual patient-level pooled data analysis by Madhavan et al. (2020) included data from 5 prospective single-arm studies. Most people had Rutherford class 3 (59%) before intervention, and 25% of people presented with CTLI (Rutherford class 4 to 6). Lesions were in the iliac artery (9%), common femoral artery (13%), superficial femoral artery (54%), popliteal (17%), and infrapopliteal artery (7%). The mean lesion length was 87.4 mm and mean minimal luminal diameter at baseline was 1.15 mm with baseline diameter stenosis of 79%. Most lesions were considered severely calcified. IVL was used as a standalone treatment in 51% of procedures.
The randomised controlled trial by Tepe et al. (2021 and 2022) compared IVL to PTA for vessel preparation before definitive treatment with a drug-coated balloon or stenting, in people with moderate or severe calcification in a femoropopliteal artery. The first paper reported outcomes at 30 days after the procedure and the second reported outcomes at 1 and 2 years. People in the study, duplex ultrasound core laboratory readers, and the Clinical Events Committee were blinded to treatment allocation. The mean age of the study population was 72 years, 74% were men, 93% presented with claudication (Rutherford class 2 to 3), 7% presented with ischaemic pain at rest (Rutherford class 4), 86% had severely calcified lesions, and mean lesion length was 99 mm. There were no statistically significant differences in baseline characteristics in the 2 treatment groups, apart from lesion location. Popliteal artery involvement was more prevalent in the IVL group (18% compared with 10% in the PTA group, p=0.03). The mean ABI at baseline was 0.74 in the IVL group and 0.77 in the PTA group.
The study by Adams et al. (2022) is a subanalysis of the prospective Disrupt PAD III Observational Study, which is included in the systematic review by Wong et al. (2022). The subanalysis focused on lesions in the infrapopliteal arteries. The study was designed to assess procedural safety and acute procedural success, so it did not include long-term outcomes. CLTI (Rutherford class 4 to 6) was present in 69% of people. The mean ABI at baseline was 0.81. The mean lesion length was 64.7 mm with moderate to severe calcification in 69% of lesions by the PARC criteria. The overall mean reference vessel diameter was 3.1 mm, the mean minimum lumen diameter was 0.5 mm, and the mean diameter stenosis was 83%. IVL was used as a standalone treatment in 77% of procedures.
The retrospective cohort study by Baig et al. (2022) only included lesions in the common femoral artery and follow up was 18 months. Most people presented with lifestyle-limiting Rutherford class 3 claudication (70%) rather than CLTI (30%). The mean ABI at baseline was 0.67. The estimated mean stenosis at baseline was 77% and 11% of lesions were chronic total occlusions. Adjunct use of drug-coated balloons was 83% and atherectomy was used in 39% of lesions.
The retrospective cohort study by Stavroulakis et al. (2023) included treatment with IVL and drug-coated balloon for calcified femoropopliteal disease (47% involved the popliteal artery). The mean follow-up was 12 months. Most people (56%) presented with CLTI (Rutherford class 4 to 6). The mean ABI at baseline was 0.64. The median lesion length was 77 mm and 20% of the lesions were chronic total occlusions. Regarding the severity of calcification, 2 (3%) lesions were classified as PACSS class 1, 9 (13%) were PACSS class 2, 33 (47%) were PACSS class 3, and 22 (31%) were PACSS class 4.
The prospective registry by Aftanski et al. (2023) included people with severe calcification and long, multilevel peripheral stenoses. The follow-up period was 6 months. All lesions were highly calcified, corresponding to a PACSS score of 3 to 4 in 80% (68/85) and 15% (n=13) were chronic total occlusions. Most lesions (68%) were in the superficial femoral artery. The mean ABI at baseline was 0.6. The mean lesion length was 102.5 mm with mean stenosis of 85%. IVL alone was used on 49 lesions (58%).
The case report by Faccenna et al. (2021) described a painful thigh haematoma after IVL followed by using 2 drug-coated balloons in the superficial femoral artery.
Table 2 presents study details.
Study no. | First author, date country | Patients (male: female) | Age | Study design | Inclusion criteria | Intervention | Follow up |
|---|---|---|---|---|---|---|---|
1 | Wong C, 2022 Included studies from Australia, Austria, Europe, Germany, New Zealand and US | n=681; 769 lesions (9 studies) 73% men (weighted mean) | 72 years (weighted mean) | Systematic review and meta-analysis Search date: February 2021 Design of included studies (as described): 1 randomised controlled trial (Disrupt PAD III), 1 prospective cohort study, 4 single-arm trials, 2 case series and 1 retrospective study. | Clinical trials or case series that evaluated IVL for treating clinical PAD in iliac, femoral, popliteal, or infrapopliteal arterial stenoses; studies reporting vessel diameter before and after the procedure; studies reporting the frequency of complications with IVL; studies published in English. | IVL in lower limb extremity arterial stenoses. 48% of procedures were on the superficial femoral artery. | 30 days to 18 months (not reported in 3 studies). |
2 | Madhavan M, 2020 Country not reported for individual studies | n=336 (5 studies) 76% men | Mean 72.9 years | Individual patient-level data pooled meta-analysis 5 prospective single-arm studies (DISRUPT PAD 1, 2, 3, BTK, and CFA) | Patients with extensive (moderate to severe) peripheral artery calcification treated by IVL. | Peripheral IVL as standalone therapy (51%) or with other therapies, including balloon angioplasty, specialty balloons, drug-coated balloons, atherectomy, as well as peripheral stenting. 54% of procedures were on the superficial femoral artery. | Mean reported for 3 studies (36, 183 and 350 days) |
3 and 4 | Tepe G, 2021 and 2022 Austria, Germany, New Zealand, and US (45 centres) | n=306 74% men (226/306) | Mean 72 years | Randomised controlled trial, comparing vessel preparation with IVL or PTA before definitive treatment with a drug-coated balloon or provisional stenting (Disrupt PAD III). Randomisation and treatment took place between February 2017 and May 2020. | Symptomatic leg claudication or rest pain (Rutherford class 2 to 4) and angiographic evidence of 70% stenosis or more within the superficial femoral or popliteal artery, lesion length up to 180 mm (up to 100 mm for chronic total occlusion), reference vessel diameter 4 to 7 mm, and moderate or severe calcification (graded using the PARC criteria). |
Vessel preparation with a low-pressure lithotripsy balloon (Shockwave Medical Inc., US).
A standard PTA balloon was used, sized at 1:1 relative to reference vessel diameter. | 30 days, 1 and 2 years |
5 | Adams G, 2022 Germany, New Zealand and US (15 centres) | n=101 (114 lesions) 75% men (76/101) | Mean 72.5 years | Prospective single-arm study (Disrupt PAD III Observational Study). Subanalysis of cohort with calcification of infrapopliteal arteries. Study enrolment was between November 2017 and August 2018. | Claudication or CLI (defined as Rutherford category 4 to 6) and at least moderate calcification as assessed by angiography, within infrapopliteal arteries. Calcification was graded using the PARC criteria. | IVL (using the Shockwave S4 IVL catheter, Shockwave Medical Inc., US). 77% of procedures used standalone IVL therapy. A stent was used in 11% of procedures and drug-coated balloons in 15%. | To hospital discharge |
6 | Baig M, 2022 US | n=50 (54 lesions) 74% men (37/50) | Mean 75 years | Single centre retrospective cohort study. Procedures were done between January 2018 and March 2020. | Indication for revascularisation for either lifestyle limiting Rutherford class 3 claudication symptoms or CLTI. Symptomatic common femoral artery lesions needing IVL with adjunct drug-coated balloon angioplasty or atherectomy for angiographic stenosis more than 50% were included. | IVL was used in all procedures (using the peripheral IVL system, Shockwave Medical Inc., US), adjunct drug-coated balloon angioplasty was used in 61% (n=33), adjunct drug-coated balloon with atherectomy in 22% (n=12), and adjunct atherectomy alone was used in 17% (n=9) of procedures. | 18 months |
7 | Stavroulakis K, 2023 Germany | n=55 (71 lesions) 49% men (27/55) | Mean 75 years | Retrospective cohort study. Procedures were done between February 2017 and September 2020. | People had treatment with IVL and DCB for calcified femoropopliteal lesions. Exclusions: Patients with in-stent restenosis, aneurysm formation in the target lesion, isolated common or deep femoral artery disease or bypass anastomosis stenosis; people having IVL and primary scaffolding or IVL as standalone therapy. | IVL (using Shockwave Medical Peripheral IVL System, Shockwave Medical, US) and DCB (selection was left to the discretion of the treating physician). | Mean 12 months |
8 | Aftanski P, 2023 Germany | n=51 (85 lesions in 61 limbs) 78% men (40/51) | Mean 71 years | Prospective single centre registry. Procedures were done between December 2018 and January 2021. | Rutherford category 2 to 5. All lesions were highly calcified, corresponding to a PACSS score of 3 to 4 in 80% (68/85) of lesions (80%) and 13 (15%) were total occlusions. | IVL, using the peripheral IVL system, Shockwave Medical Inc., US. Access was gained either transfemoral or through the left brachial artery. 58% (49/85) of procedures used IVL as a standalone therapy. 68% of procedures were on the superficial femoral artery. | 6 months |
9 | Faccenna F, 2021 Italy | n=1 (a man) | 66 years | Case report | Previously unreported complication – thigh haematoma | IVL of superficial femoral artery (using peripheral IVL system balloon catheter, Shockwave Medical Inc., US). The procedure was repeated 3 times in different segments. | 30 days |
Efficacy outcomes | Safety outcomes | |
|---|---|---|
Weighted mean diameter stenosis
Mean reduction in diameter stenosis=59.3% (95% CI 53.3% to 65.3%; I2=95%) Overall pooled event rate for stent placement=15.9% (95% CI 5.2% to 39.3%) Target lesion revascularisation
12-month patency rate (freedom from 50% or more restenosis) = 54.5% in 1 study, which improved to 62.9% after technique was optimised. |
| |
Madhavan M, 2020 | Successful IVL delivery=99.7% (335/336); 5 studies Outcomes immediately after procedure (4 studies), mean (SD)
Final outcomes (5 studies), mean (SD)
There was no noted reduction in the number of post-procedure runoff vessels to suggest embolisation. There was no statistically significant difference in final diameter stenosis in people who had adjunctive therapies in addition to IVL compared with IVL alone (p=0.46). Subgroup analysis – severe calcification (PARC criteria)
| Periprocedural complications (5 studies, 358 lesions)
Dissection types D to F were described as flow-limiting.
There were no reports of thrombus, distal embolisation, abrupt closure or no reflow. There were no emergent revascularisations or amputations of target limbs in patients with this data available before discharge (n=115). |
Tepe G, 2021 and 2022 | Procedural success (residual stenosis 30% or less without flow-limiting dissection, as evaluated by the angiographic core laboratory; primary end point)
Mean residual stenosis after vessel preparation
Proportion of vessels with residual stenosis 30% or less after vessel preparation
Requirement for dilation after vessel preparation
Provisional stent placement after vessel preparation
Final mean residual stenosis after drug-coated balloon or stent placement
At the 30-day follow up visit, haemodynamic, functional, and quality-of-life parameters were generally comparable between the groups except for change in EQ-5D visual analogue scale, which favoured the IVL group (9.1 compared with 4.3; p=0.01). Clinically driven target lesion revascularisation within 30 days
Both were because of reocclusion and were treated with stent placement. Primary patency at 1 year
Freedom from clinically driven target lesion revascularisation at 1 year
Freedom from restenosis at 1 year
Change in ABI from baseline at 1 year
Primary patency at 2 years
Freedom from clinically driven target lesion revascularisation at 2 years
Freedom from restenosis at 2 years
Both groups showed marked clinical improvement in ABI, walking impairment questionnaire, EQ-5D, and Rutherford category, but there were no statistically significant differences in the change from baseline to 1 year between the 2 groups. | Any dissection after vessel preparation
Flow-limiting dissection after vessel preparation
Any dissection after drug-coated balloon or stent final angiography
No dissections after drug-coated balloon or stent final angiography were flow-limiting. Major adverse events at 30 days
Mortality There were no deaths within 30 days. Major adverse events at 1 year
|
Adams G, 2022 | Final angiographic outcomes
| Bailout stenting=10.9% (11/101) There were no reports of flow-limiting dissection, peroration, distal embolisation, slow flow, no reflow or abrupt closure. |
Baig M, 2022 | Cumulative clinically driven target lesion revascularisation at 18 months = 16.6% (9/54; primary outcome). 18-month cumulative freedom from clinically driven target lesion revascularisation (Kaplan–Meier estimate) = 80.6% (95% CI 69.1% to 92%) There were no statistically significant differences regarding adjunct therapy identified on univariate logistic regression analysis. Residual angiographic residual stenosis less than 30%after procedure = 100% (54/54) Mean ABI
| Procedural complications
There were 9 deaths within 18 months of the procedure, none of which were related to procedural complications. |
Stavroulakis K, 2023 | Technical success=87.3% (62/71); defined as residual stenosis less than 50% in the absence of arterial perforation and flow-limiting dissection. Procedural technical success=97.2% (69/71); defined as residual stenosis less than 30% in the absence of arterial perforation of the treated segment. Median ABI at discharge=1.00 (IQR 0.93 to 1.00) Outcomes at 12 months: Primary patency=81% (95% CI 70% to 90%) Freedom from target lesion revascularisation=92% (95% CI 86% to 99%) Secondary patency rate=98% (95% CI 95% to 100%) Amputation-free survival rate=89% (95% CI 81% to 97%) Freedom from major amputation=98%(95% CI 95% to 100%) Overall survival=89% Clinical status at last follow-up:
| Bailout stenting=7.0% (5/71) Complications
There were no reinterventions before discharge. |
Aftanski P, 2023 | Mean acute lumen gain after procedure=2.6 mm Mean reduction in stenosis after procedure=42.1% Mean final stenosis=42.4% Mean ABI
Mean walking distance on treadmill test
Target vessel revascularisation during follow up period=5.9% (3/51) | Complications
Problems with IVL delivery
|
Faccenna F, 2021 | Completion angiography showed a good immediate result, with no significant (more than 30%) residual stenosis and no flow-limiting dissection. | Painful thigh haematoma was reported 1 week after the procedure. The patient was offered oral nonsteroidal anti-inflammatory drug and topical heparinoid, and dual antiplatelet therapy was not discontinued. At 30 days, planned follow up showed complete haematoma resolution, pain relief and normal distal pulses. |
Procedure technique
All studies used the peripheral IVL system (Shockwave Medical Inc, US) but the technique was adapted over time, including sizing and lesion coverage, to give optimal results. In some studies, adjunctive techniques such as balloon angioplasty, drug-coated balloons and atherectomy were used.
Studies that used IVL to allow access for an endovascular cardiac procedure were not included in this review.
Efficacy
Procedural or technical success
Procedural or technical success was reported in 3 studies. In the meta-analysis of 336 people, IVL was successfully delivered in all but 1 person (Madhavan 2020). In the randomised controlled trial of 306 people, procedural success (determined by the angiographic core laboratory as residual stenosis 30% or less without flow-limiting dissection) was 66% (96/146) in the IVL group and 50% (67/133) in the PTA group (p=0.01; Tepe 2021). In the cohort study of 55 people (71 lesions) with femoropopliteal lesions by Stavroulakis et al. (2023), technical success (defined as residual stenosis less than 50% in the absence of arterial perforation and flow-limiting dissection) was 87% (62/71). Procedural technical success (defined as residual stenosis less than 30% in the absence of arterial perforation of the treated segment) was 97%.
Reduction in diameter stenosis
The gain in lumen diameter or percentage reduction in diameter stenosis after IVL was reported in 4 studies. In the systematic review and meta-analysis of 681 people, the mean reduction in diameter stenosis was 59% (95% CI 53% to 65%, I2=95%; Wong 2022). In the meta-analysis of 336 people, the difference in diameter stenosis immediately after IVL from baseline was 50% (95% CI 48% to 52%, p<0.0001). The acute gain in lumen diameter was 2.7 mm. At the final follow up, the difference in diameter stenosis from baseline was 55% (95% CI 53% to 57%, p<0.0001) and gain in lumen diameter was 3.1 mm (Madhavan 2020). In the single-arm study of 101 people with infrapopliteal lesions, the mean acute gain in lumen diameter was 2.0 mm (Adams 2022). In the registry of 51 people, the mean acute lumen gain after the procedure was 2.6 mm and the mean reduction in stenosis was 42% (Aftanski 2023).
Residual stenosis
Residual stenosis was reported in 5 studies. In the meta-analysis of 336 people, the mean diameter stenosis was 29% immediately after IVL and 24% at final follow up. The proportion of vessels with diameter stenosis less than 50% was 96% (236/246) immediately after IVL, increasing to 99% (323/327) at final follow up (Madhavan 2020). In the randomised controlled trial of 306 people, mean residual stenosis after vessel preparation was 27% in the IVL group and 31% in the PTA group (p=0.04). The proportion of vessels with residual stenosis 30% or less was 66% (97/146) with IVL and 52% (69/133) with PTA (p=0.02). The final mean residual stenosis after using a drug-coated balloon or stent placement was similar in both groups (22% with IVL and 21% with PTA; p=0.39; Tepe 2021). In the single-arm study of 101 people with infrapopliteal lesions, the mean residual stenosis was 23% and 99% (95/96) of lesions had residual stenosis less than 50% (Adams 2022). In the cohort study of 50 people with common femoral artery lesions, all 54 lesions had residual stenosis less than 30% after IVL with adjunct coated balloon angioplasty or atherectomy (Baig 2022). In the registry of 51 people, the mean final stenosis was 42% (Aftanski 2023).
Stent placement
The rate of stent placement was reported in 2 studies. In the meta-analysis of 681 people, the overall pooled event rate for stent placement was 16% (95% CI 5% to 39%; Wong 2022). In the randomised controlled trial of 306 people, the rate of stent placement was 5% (7/153) in the IVL group and 18% (28/153) in the PTA group (p<0.001; Tepe 2021).
Target lesion revascularisation
Target lesion revascularisation was reported in 5 studies. In the systematic review by Wong et al. (2022), 1 study reported no target lesion revascularisation at 30 days and another reported a rate of 1%. At 12 months, rates were 9% in 1 study and 21% in another, reducing to 9% after the technique was optimised. At 18 months, 1 study reported a rate of 32%. The 12-month patency rate (freedom from 50% or more restenosis) was 55% in 1 study, improving to 63% after the technique was optimised.
In the randomised controlled trial of 306 people, 1 person who had IVL and 1 who had PTA had clinically driven target lesion revascularisation within 30 days (Tepe 2021). At 1 and 2 years, the rate of freedom from clinically driven target lesion revascularisation was similar in the 2 groups. The primary patency rate was 81% (99/123) in the IVL group and 68% (87/128) in the PTA group at 1 year (p=0.017) and 70% (78/111) in the IVL group and 51% (58/113) in the PTA group at 2 years (p=0.003; Tepe 2022). In the cohort study of 50 people with common femoral artery lesions, cumulative clinically driven target lesion revascularisation at 18 months was 17% (9/54). The Kaplan–Meier estimate of freedom from clinically driven target lesion revascularisation at 18 months was 81% (96% CI 69% to 92%; Baig 2022). In the cohort study of 55 people with femoropopliteal lesions, freedom from target lesion revascularisation at 12 months was 92% (95% CI 86% to 99%). The primary patency rate at 12 months was 81% (95% CI 70% to 90%) and the secondary patency rate was 98% (95% CI 95% to 100%; Stavroulakis 2023). In the registry of 51 people, the target vessel revascularisation was 6% (3/51) at 6‑month follow up (Aftanski 2023).
ABI
Mean or median ABI scores after the procedure were reported in 3 studies. In the cohort study of 50 people with common femoral artery lesions, the mean ABI changed from 0.67 at baseline (n=44) to 0.87 at 6 months (n=27) and 0.96 at 12 months (n=21, p=0.002; Baig 2022). In the cohort study of 55 people with femoropopliteal lesions, the median ABI at discharge was 1.00 (IQR 0.93 to 1.00; Stavroulakis 2023). In the registry of 51 people, the mean ABI changed from 0.6 at baseline (n=58) to 0.8 at day 1 after the procedure (n=56) and 0.8 at 6-month follow up (n=49, p<0.001; Aftanski 2023).
Safety
Dissection
The pooled event rate for flow-limiting dissection was 1% (95% CI 1% to 3%, I2=0%) in the systematic review of 681 people (Wong 2022). The rate of any dissection was 15% (48/328) in the meta-analysis of 336 people (Madhavan 2020). The rate of any dissection was 19% (27/146) after IVL and 32% (43/133) after PTA in the randomised controlled trial of 306 people. The rate of flow-limiting dissections was 1% (2/146) after IVL and 7% (9/133) after PTA (p=0.03; Tepe 2021). Flow-limiting dissection needing stent replacement was reported in 1 person in the cohort study of 50 people with common femoral artery lesions (Baig 2022). Flow-limiting dissection was reported in 3% (2/71) and non-flow-limiting dissection was reported in 4% (3/71) of lesions in the cohort study of 55 people with femoropopliteal lesions (Stavroulakis 2023). The rate of any dissection was 13% (11/85) of lesions and the rate of flow-limiting dissection was 1% (1/85) in the registry of 51 people (Aftanski 2023).
Amputation
There was 1 minor amputation reported in a study of 20 people included in the systematic review of 681 people (Wong 2022).
Perforation
There was 1 perforation reported in the systematic review of 681 people, but it was considered unrelated to the IVL (Wong 2022). Perforation was reported in 1 person in the cohort study of 55 people with femoropopliteal lesions (Stavroulakis 2023).
Embolisation
Peripheral embolisation was reported in 1 person in the cohort study of 55 people with femoropopliteal lesions (Stavroulakis 2023).
Problems with IVL delivery
Rupture of the IVL balloon was reported in 10% (6/61) of lesions and an IVL device error was reported in 3% (2/61) of lesions in the registry of 51 people (Aftanski 2023).
Haematoma
A painful thigh haematoma that was reported 1 week after IVL and resolved within 30 days, was described in a case report (Faccenna 2021).
Anecdotal and theoretical adverse events
Expert advice was sought from consultants who have been nominated or ratified by their professional society or royal college. They were asked if they knew of any other adverse events for this procedure that they had heard about (anecdotal), which were not reported in the literature. They were also asked if they thought there were other adverse events that might possibly occur, even if they had never happened (theoretical).
They listed the following anecdotal or theoretical adverse events:
Access site complications
Thrombosis
Microembolisation or distal embolisation of calcium
Vessel perforation, rupture or dissection
Potential for development of aneurysms
Twelve professional expert questionnaires for this procedure were submitted. Find full details of what the professional experts said about the procedure in the specialist advice questionnaires for this procedure.
Validity and generalisability
The evidence included a randomised controlled trial that was powered to show superiority of IVL compared with PTA, before using a drug-coated balloon or stenting. People in the study, duplex ultrasound core laboratory readers and the Clinical Events Committee were blinded to treatment allocation. The results of this study may not be generalisable to people with CLTI caused by calcified, stenotic infrapopliteal lesions because of the inclusion criteria.
The evidence included IVL being used at different locations, including iliac and femoropopliteal arteries.
Most studies described IVL being used with adjunctive procedures for at least some of the lesions. One study excluded procedures that used it as a standalone therapy (Stavroulakis 2023).
The inclusion criteria varied between studies. Most people had moderate to severe calcification, and some had total occlusion. Some people presented with claudication rather than CLI.
The definition of calcification varied between studies.
Although all the studies used the same IVL system, the technique was modified over time to improve outcomes. This included modification of the IVL generator to enable 300 pulses to be delivered instead of 180 pulses.
There was some evidence with follow up beyond 12 months.
Studies that described IVL being used for large bore transfemoral access or for indications other than PAD were not included.
Three studies reported funding from Shockwave Medical, Inc., US (Adams 2022, Madhavan 2020, Tepe 2021 and 2022).
Ongoing trials with sample size of 50 or more
Use of ultrasound lithotripsy to treat calcified peripheral arterial disease (ISRCTN76218607); prospective cohort study; UK; n=60; study completion date June 2023.
Prospective, multi-center, single-arm study of the Shockwave Medical peripheral intravascular lithotripsy (IVL) system for treatment of calcified peripheral arterial disease (PAD) in below-the-knee (BTK) arteries (NCT05007925); prospective single-arm study; US, Germany; n=250; study completion date October 2025.
Physician-initiated PMCF trial investigating shockwave intravascular lithotripsy and a drug eluting vascular stent system deployment for heavily calcified femoropopliteal disease (NCT05291247); prospective cohort study; Germany; n=50; study completion date October 2024.
CTA_IIT_CRUSH PAD: Real-world outcomes following use of the shockwave intravascular lithotripsy (IVL) technology in calcified common femoral lesions (NCT05145478); prospective cohort study; US; n=50; study completion date June 2024.
Prospective, Multi-center, Single-arm Feasibility Study of the Shockwave Medical Mini S Peripheral Intravascular Lithotripsy (IVL) System (NCT05058456); single-arm feasibility study; Australia, New Zealand; n=50; study completion date August 2024.
How are you taking part in this consultation?
You will not be able to change how you comment later.
You must be signed in to answer questions