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DOI: 10.1055/s-0043-1769890
Safety and Short-Term Efficacy of Intravascular Lithotripsy for Treatment of Peripheral Arterial Disease: A Systematic Review
- Abstract
- Introduction
- Materials and Methods
- Literature and Search Strategy
- Results
- Discussion
- Conclusion
- References
Abstract
Intravascular lithotripsy (IVL) is an emerging treatment for calcifications in patients with peripheral arterial disease (PAD). The objective of this article is to evaluate the safety and efficacy of IVL for PAD management by performing a systematic review of existing literature. A systematic literature search was performed using the PubMed database. A literature search was performed in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Outcomes variables analyzed in each study include preprocedure ankle–brachial index, preprocedure lesion length, preprocedure calcified length, preprocedure diameter stenosis, average number of IVL pulses, success rate, adjunctive treatments given, postprocedure diameter stenosis, acute vessel gain, and specific complications. Three-hundred fifty-seven articles were reviewed on PubMed and 14 studies were ultimately included, comprising 857 patients and 991 lesions. Thirteen of the 14 studies reported a 100% procedural success rate. Mean preprocedure lesion length was 68.94 (20-103.4) mm and mean preprocedure calcified length was 86.5 (50.5–140.9) mm. The average preprocedure diameter stenosis was 77.44% and postprocedure diameter stenosis was 26.14%. All studies reporting both pre- and postprocedure diameter stenosis stated there was a significant reduction in the vessel diameter stenosis and acute gain following IVL therapy alone. About 8.2% of patients had reported dissections and 0.29% had perforations. There was no reported distal embolization, thrombus formation, or abrupt closure of the vessel in any study. IVL appears to be a safe and effective treatment for calcified lesions in patients with PAD, with a low rate of complications and successful luminal gain for most lesions. Further prospective studies are needed to help validate the effectiveness of IVL therapy.
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Keywords
shock wave lithotripsy - peripheral arterial disease - calcifications - intravascular lithotripsyIntroduction
Multiple societal guidelines on the management of lower extremity peripheral arterial disease (PAD) have recommended that endovascular therapies be utilized as a first-choice treatment modality for several lesion types.[1] There are several available treatment modalities for plaque modification in PAD patients, including percutaneous transluminal angioplasty (PTA), drug-coated balloons (DCBs), drug-eluting stents (DES), and atherectomy. Treatment for femoropopliteal lesions has included the usage of DES and DCB,[1] [2] whereas the preferential therapies for below-the-knee lesions include DCB and PTA.[3] [4] [5] However, the treatment of more complex cases of lower extremity calcifications remains a challenge with current technology. For example, complex cases with severe calcifications often inhibit adequate Paclitaxel drug uptake in DCB therapy[6] and the treatment of thicker plaques with PTA have often resulted in dissection and the need for bailout stenting.[7] [8] [9] Additionally, several studies have identified that intravascular calcification is associated with poorer prognosis, as the calcifications can lower the procedural effectiveness of endovascular therapies and result in increased risk of distal embolization, perforation, and dissection.[10] [11] [12] [13] Some studies have also identified that the calcium itself can act as a physical barrier and impair drug absorption from DCBs, reducing the efficacy of endovascular treatment modalities.[14] [15]
Extracorporeal shock wave lithotripsy is a minimally invasive treatment that was introduced in the 1980s and has historically been used as a treatment for nephrolithiasis.[16] [17] [18] The technology emits high-intensity sonic pressure waves into the body to fragment stones without harming surrounding important soft tissue.[19] Over the past decade, this technology has been adapted to break up calcified plaques and improve the compliance of vasculature in patients with cardiovascular disease[20] [21] [22] and now in more recent years, has been used in patients with PAD. Termed intravascular lithotripsy (IVL) (Shockwave Medical, Fremont, California, United States),[23] the novel application of this existing technology serves as an adjunctive minimally invasive endovascular treatment for calcified plaques in the lower extremities of patients. It is advantageous in PAD management in that rather than mechanical vessel expansion, drug therapy, or cutting into a plaque, this device can emit sonic waves directly towards the plaque, and has the unique ability to simultaneously fracture both intimal and medial calcifications to improve vessel patency, with minimal to no surrounding tissue injury.[23]
The true efficacy of IVL is still being explored and warrants extensive investigation in larger study populations to better understand the utility of this treatment. The purpose of this study was to evaluate the safety and efficacy of IVL by conducting a systematic review of existing literature.
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Materials and Methods
A systematic review was conducted of the existing literature pertaining to the usage and safety of IVL for the treatment of calcified plaques in patients with lower extremity PAD. Literature search findings were reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines.[24] Since no human subjects were studied in this research, this systematic review was exempt from official Institutional Review Board (IRB) approval. All studies were uploaded to EndNote and were screened using the Covidence systematic review software (Veritas Health Innovation, Melbourne, Australia, www.covidence.org). Literature screening was performed by two authors, which included initial identification, abstract screening, and full-text assessment.
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Literature and Search Strategy
In March 2023, the PubMed database was queried for the literature search. The database was searched for any articles pertaining to the utilization of IVL for treatment of calcified plaques in patients with diagnosed PAD. Any article published between 1981 to 2023 was analyzed. The following string of search terms was used: ([intravascular lithotripsy] OR [lithotripsy] OR [shock wave]) AND ([peripheral] OR [lower extremity]).
Eligibility and Search Criteria
Article selection was conducted by two independent authors. Articles were selected for by first screening through all abstracts for relevance, followed by full-text assessment according to the determined inclusion and exclusion criteria. Duplicate articles were removed in Covidence.
Selected articles that were included in the systematic review met the following inclusion criteria: (1) the study enrolled adult patients (>18 years), (2) the patients in the study had a diagnosis of PAD, (3) the study consisted of patients who underwent intravascular lithotripsy alone for calcified lesions in the lower extremities, and (4) the article reported outcomes data following the IVL procedure, (5) all included articles included a minimum of 4 patients. Articles that analyzed the efficacy of lithotripsy in the context of patients with nephrolithiasis or coronary artery disease or intravascular lithotripsy in combination with another therapy were excluded. Any studies that were (1) case series including less than 4 patients, (2) individual case reports including less than 4 patients, or (3) review papers were excluded.
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Data Extraction
Data extraction was conducted on each article that was deemed eligible from full-text assessment. A custom table was generated in Microsoft Excel (version 2019; Microsoft, Redmond, Washington, United States) to organize the data extraction and ensure that the desired study characteristics were being collected. Study characteristics that were collected included: Title of article and authors, year published, type of study design, procedure performed, number of patients who received the IVL procedure, mean age of patients, ratio of male to female participants, ankle–brachial index, preprocedure lesion length (mm), preprocedure calcified length (mm), preprocedure diameter stenosis of vessel (%), average number of IVL pulses delivered, percent success rate of IVL procedure, any adjunctive treatments that were administered, post procedure diameter stenosis (%), acute gain (mm), and specific complications. In studies that determined efficacy of IVL by measuring pain-free walking distance, the pre- and post-procedure walking distance, time at which postprocedure distance was measured, and improvement in quality of life (QoL) factors were collected.[25] [26] In studies that reported IVL efficacy via improvement in the limb blood flow, pre- and postprocedure transcutaneous oxygen pressure (TcPO2), pre- and postprocedure skin perfusion pressure (SPP), and pre- and postprocedure 99mTc-TF Perfusion Index were collected.[27] Reference sections of each full text were extensively searched to ensure that no eligible papers were missed during the initial PubMed literature search.
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Statistical Analysis
Aggregate data of all outcomes variables were obtained. All average values were calculated using the weighted average mean approach. In instances where only the median and interquartile range of an outcome variable was provided, the average was calculated using Hozo's formula.[28] All standard deviation calculations were performed using Hozo's pooled standard deviation formula.[28]
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Results
Study Selection
After the duplicate studies were removed by Covidence, there were 451 published studies identified during the initial PubMed literature search. The titles and abstracts of these studies were screened, and 30 studies were deemed eligible for full-text assessment. Upon completing full-text assessment, 17 studies were ultimately included in the systematic review.[25] [26] [27] [29] [30] [31] [32] [33] [34] [35] [36] [37] [38] [39] [40] [41] [42] Papers were excluded during full-text assessment for the following reasons: did not report appropriate outcomes data (n = 6), review papers (n = 4), and full-text was unavailable (n = 2, 1 in a foreign language). [Fig. 1] shows a PRISMA chart that highlights the selection process for eligible studies, as well as reasons for exclusion.
![](https://www.thieme-connect.de/media/10.1055-s-00050442/202302/thumbnails/10-1055-s-0043-1769890-i23110171-1.jpg)
![Zoom Image](/products/assets/desktop/css/img/icon-figure-zoom.png)
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Study Characteristics
Of the 17 total eligible studies, seven studies were classified as a prospective, nonrandomized multicenter study,[29] [30] [31] [32] [33] [34] [36] seven studies were classified as a prospective nonrandomized single center study,[26] [27] [37] [38] [40] [41] [42] and three studies were classified as a randomized controlled trial (RCT; [Table 1]).[25] [35] [39] All included studies were full-text publications and were published between 2012 to 2023. There were three types of outcomes data reported amongst the studies: 14 of the 17 studies reported change in vessel diameter stenosis following IVL,[29] [30] [31] [32] [33] [34] [35] [36] [37] [38] [39] [40] [41] [42] two studies reported change in pain-free walking distance following IVL,[25] [26] and one study reported change in TcPO2, SPP, and 99mTc-TF Perfusion Index in the ischemic limb following IVL ([Table 1]).[27]
Author, year |
Study type |
Total no. patients (lesions) |
Mean age[a] |
M:F ratio |
Baseline ABI[a] |
Outcome measured |
---|---|---|---|---|---|---|
Adams et al 202029 |
NRMCS |
197 (220) |
72.5 ± 8.7 |
148:49 |
0.7 ± 0.3 |
Diameter stenosis and acute gain |
Adams 2021 |
NRMCS |
101 (114) |
72.5 ± 9.7 |
76:25 |
0.81 ± 0.33 |
Diameter stenosis and acute gain |
Aftanski 2023 |
NRSCS |
51 (85) |
71.0 ± 8.7 |
40:11 |
0.6 ± 0.26 |
Diameter stenosis and acute gain |
Armstrong et al 202031 |
NRMCS |
118 (200) |
70.4 ± 8.0 |
78:40 |
0.7 ± 0.3 |
Diameter stenosis and acute gain |
Brodmann et al 201933 |
NRMCS |
60 (60) |
71.5 ± 8.3 |
46:14 |
— |
Diameter stenosis and acute gain |
Brodmann et al 201832 |
NRMCS |
19 (21) |
79.0 ± 9.6 |
14:5 |
— |
Diameter stenosis and acute gain |
Brodmann et al 201934 |
NRMCS |
21 (21) |
71.9 ± 10.1 |
16:5 |
— |
Diameter stenosis and acute gain |
Colacchio et al 202240 |
NRSCS |
13 (15) |
75.0 ± 9.19 |
7:6 |
— |
Diameter stenosis and acute gain |
Ciccone et al 201235 |
RCT |
12 (19) |
67.0 ± 9.0 |
10:2 |
0.58 ± 0.19 |
Diameter stenosis and acute gain |
Harwood et al 201825 |
RCT |
15 (15) |
64.3 ± 9.4 |
9:6 |
0.67 ± 0.24 |
Pre and post-IVL pain-free walking distance |
Nardi et al 202136 |
NRMCS |
108 (108) |
80.5 ± 6.2 |
61:47 |
— |
Diameter stenosis and acute gain |
Radiaideh 2021 |
NRSCS |
24 (24) |
70.7 ± 9.9 |
17:7 |
0.75 ± 0.1 |
Diameter stenosis and acute gain |
Radaideh 2019 |
NRSCS |
7 (7) |
67.3 ± 6.7 |
5:2 |
0.57 |
Diameter stenosis and acute gain |
Serizawa et al 201226 |
NRSCS |
12 (19) |
71.3 ± 9.0$$$ |
10:2 |
0.57 ± 0.15 |
Pre- and post-IVL pain-free walking distance |
Stavroulakis et al 202341 |
NRSCS |
55 (71) |
75.0 ± 8.0 |
27:78 |
0.64 ± 0.41 |
Diameter stenosis and acute gain |
Tara et al 201427 |
NRSCS |
10 (10) |
71.3 ± 9.0 |
9:1 |
— |
Pre- and post-IVL transcutaneous oxygen tension, skin perfusion pressure to evaluate blood flow |
Tepe et al 202139 |
RCT |
153 (153) |
72.2 ± 8.0 |
106:47 |
0.74 ± 0.20 |
Diameter stenosis and acute gain |
Abbreviations: ABI, ankle–brachial index; IVL, intravascular lithotripsy; NRMCS, nonrandomized multicenter study; NRSCS, nonrandomized single-center study; RCT, randomized controlled trial.
a Mean calculated using Hozo's formula, using range and median ($), Standard deviation calculated using Hozo's formula, utilizing range and median ($$), Standard deviation borrowed from study of similar sample size ($$$).
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Patient Characteristics
There was a total of 976 patients among the 17 studies who received intravascular lithotripsy for treatment of calcified plaque in the lower extremity for 1162 documented calcified lesions. The mean age of patients was 72.93 ± 3.26 years, with males representing 69.6% of total patients included ([Table 1]). Six-hundred seventy-nine of the 976 enrolled patients had the locations of their lesion(s) identified. Four-hundred thirty-six patients had a single identified lesion, either in the common iliac artery (77), external iliac artery (17), left iliac artery (3), right iliac artery (4), common femoral artery (66), superficial femoral artery (191), popliteal artery (79), unnamed infrapopliteal vessel (5), anterior tibial artery (47), posterior tibial artery (26), tibioperoneal trunk (40), or the peroneal artery (21). Sixty-two patients had multiple lesions treated, including 47 with both the common and external iliac artery, 5 with both the superficial femoral and popliteal artery, 9 with the anterior tibial, posterior tibial and peroneal arteries,27 and 1 with the anterior tibial and posterior tibial arteries.27
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Effect of IVL on Vasculature Compliance
Fourteen of the 17 studies analyzed preprocedural lesion length, preprocedural calcified length, pre- and postprocedural diameter stenosis, and acute gain as the outcomes data ([Table 2]). The average preprocedure lesion length was 76.88 ± 28.66 mm, average preprocedure calcified length was 101.52 ± 38.89 mm, and average preprocedure diameter stenosis was 77.70 ± 11.56%. The average postprocedure diameter stenosis was calculated to be 24.72 ± 9.86% and the average acute gain was 2.80 ± 0.64 mm. Notably, Radaideh et al reported a 0% postprocedure diameter stenosis following IVL.[37] Eleven of the 14 studies reported a 100% procedural success rate following IVL therapy.[29] [30] [31] [32] [33] [34] [35] [36] [37] [38] [40] [42] Tepe et al reported a 65.7% procedural success rate.[39] The average number of pulses delivered throughout all the studies was 204.02 ± 55.34 pulses. Arterial dissection was the most common complication reported following IVL. There were 72 total patients who suffered from dissections following IVL procedures (7.47%). Thirty-four patients had a Grade A to C (minor) dissection (3.52%), 9 patients were reported to have a Grade D to F (major) dissection (0.93%), and 29 patients did not have a specified dissection type reported (3.0%). Nardi et al and Stavroulakis et al each reported one case of perforation following IVL.[36] [41] Stavroulakis et al also reported one case of peripheral embolization. There were no reported events thrombus formation, no-reflow, or abrupt closure of the vessel. No device related mortalities were noted.
Study |
Arteries treated[a] |
Preprocedure lesion length (mm)[b] |
Preprocedure calcified length (mm)[b] |
Preprocedure diameter stenosis (%)[b] |
Postprocedure diameter stenosis (%)[b] |
Acute gin (mm)[b] |
Procedural success rate |
Average pulses[b] |
Complications |
---|---|---|---|---|---|---|---|---|---|
Adams et al 202029 |
Common Iliac (n = 32) CFA (n = 27) SFA (n = 121) Popliteal (n = 31) Infrapopliteal (n = 5) |
103.4 ± 71.9 |
140.9 ± 89.6 |
80.8 ± 17.9 |
23.6 ± 9.7 |
3.4 ± 1.2 |
100% |
205.3 ± 122.4 |
Type D/E/F dissection (n = 2) |
Adams 2021 |
ATA (n = 39) TPT (n = 38) PTA (n =18) Peroneal (n =19) |
64.7 ± 54.7 |
52.9 ± 43.1 |
83.4 ± 15.8 |
23.3 ± 12.5 |
2.0 ± 0.7 |
100% |
138.5 ± 53.7 |
Type B dissection (n = 2) type C dissection (n = 1) |
Aftanski 2023 |
Iliac (n = 8) CFA (n = 14) PFA (n = 4) SFA (n = 58) Popliteal (n = 19) BTK (n =2) |
102.5 ± 77.2 |
— |
84.5 ± 11.0 |
42.4 ± 12 |
2.6 ± 0.9 |
100% |
257.0 ± 71.0 |
Type A/B dissection (n = 6) Type C dissection (n = 4) Type D dissection (n = 1) |
Armstrong et al 202031 |
— |
58.3 ± 57.6 |
— |
83.1 ± 13.4 |
12.0 ± 12.1 |
— |
100% |
214.4 ± 136.5 |
None |
Brodmann et al 201933 |
— |
76.9 ± 34.8 |
98.1 ± 41.7 |
78.2 ± 13.5 |
24.2 ± 5.7 |
3.0 ± 0.8 |
100% |
136.0 ± 75.0 |
Type B dissection (n = 4) Type C dissection (n = 4) Type D dissection (n = 1) |
Brodmann et al 201832 |
ATA (n = 8) PTA (n = 8) Peroneal (n = 2) TPT (n = 2) Popliteal (n = 1) |
52.2 ± 35.8 |
72.1 ± 37.6 |
72.60 ± 12.8$$$ |
26.2 ± 10.7$$$ |
1.5 ± 0.5 |
95% |
77.8 ± 58.0$$$ |
Grade B dissection (n = 1) |
Brodmann et al 201934 |
— |
37.8 ± 16.7 |
61.6 ± 30.7 |
72.3 ± 12.8 |
21.3 ± 10.7 |
3.1 ± 1.3 |
100% |
140.0 ± 58.0 |
Grade B dissection (n = 5) |
Colacchio et al 202240 |
CFA (n = 15) |
28.36* |
— |
82.18$ ± 12.22$$ |
37.8$ ± 8.07$$ |
— |
100% |
150.0* |
None |
Ciccone et al 201235 |
— |
— |
— |
93.0 ± 9.0 |
84.0 ± 13.0 |
— |
100% |
— |
— |
Nardi et al 202136 |
Common iliac (n = 35) External iliac (n =17) Common and external iliac (n = 47) CFA (n = 7) |
20.0 ± 71.9$$$ |
50.5 ± 89.6$$$ |
50.0 ± 10.7 |
25.0 ± 9.7$$$ |
— |
100% |
300.0 ± 122.4$$$ |
A-C (minor) dissection (n = 4) Type D-F (major) dissection (n = 3) Perforation (n = 1) |
Radaideh 2021 |
Common Iliac (n = 2) CFA (n = 3) SFA and popliteal (n = 5) SFA (n = 12) Popliteal (n = 2) |
84.5 ± 37.1 |
— |
57.6 ± 19.0 |
20.7 ± 3.4 |
1.9 ± 0.2 |
100% |
118.6 ± 51.9 |
Grade C or higher dissection (n = 2) |
Radaideh 2019 |
Left iliac (n = 3) Right iliac (n = 4) |
90.71* |
— |
95.0 ± 6.45 |
0 |
— |
100% |
72.14 ± 23.07 |
Grade C dissection (n = 3) |
Stavroulakis et al 202341 |
Popliteal (n = 26) Femoral (n = 45) |
95.0$ ± 30.62$$ |
— |
— |
— |
— |
97% |
— |
Perforation (n = 1) Peripheral embolization (n = 1) Any dissection (n = 5) |
Tepe et al 202139 |
— |
100.9 ± 41.0 |
129.4 ± 50.7 |
85.0 ± 12.0 |
27.3 ± 11.5 |
— |
65.7% |
228.0 ± 11.5 |
Any dissection (n = 24) |
a Artery treated: ATA, anterior tibial artery; BTK, BTK = below the knee; CFA, common femoral artery; PTA, posterior tibial artery; SFA, superficial femoral artery; TPT, tibioperoneal trunk.
b Mean calculated using Hozo's formula, using range and median ($), Standard deviation calculated using Hozo's formula, utilizing range and median ($$), Standard deviation borrowed from study of similar sample size ($$$).
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Effect of IVL on Pain-Free Walking Distance
Harwood et al and Serizawa et al analyzed outcomes related to pre- and postprocedure ambulation metrics as well as QoL. Both studies reported the postprocedure outcome 12 weeks after the treatment,[25] [26] which is shown in [Table 3]. Both studies reported a significant increase in the pain-free walking distance following the IVL procedure, and both reported that there was a significant improvement in QoL factors following IVL treatment based on patients' survey responses. Serizawa et al specifically measured the patients' quality of life using the Walking Impairment Questionnaire instead of the QoL assessment.[26]
Study |
Preprocedure pain-free walking distance (m) |
Postprocedure pain-free walking distance (m) |
Time at which postprocedure distance was measured |
Improvement in quality-of-life factors |
---|---|---|---|---|
Harwood et al 201825 |
58.1 ± 32.5 |
218.8 ± 162.3 |
12 weeks |
Yes |
Serizawa et al 201226 |
— |
171 ± 75% increase |
12 weeks |
Yes[a] |
a Walking impairment questionnaire was utilized for this study.
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Effect of IVL on Blood Flow to Ischemic Limb
Tara et al's study was the one study that reported the efficacy of IVL in the form of reporting pre- and postprocedure variables pertaining to blood flow in the ischemic limb (table not included).[27] The study measured TcPO2, SPP and 99mTc-TF Perfusion Index, and performed IVL treatment on the calf, dorsum of foot, plantar surface of the foot, and anterior tibia. There was a significant increase in postprocedure TcPO2 in the calf and dorsum of the foot following IVL; however, there was no significant increase in the postprocedure TcPO2 in the anterior tibia following IVL. There was no significant increase in post-procedure SPP following IVL in the dorsum of foot or plantar surface of the foot. There was a significant increase in the 99mTc-TF Perfusion Index in the foot following IVL treatment.
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Discussion
This systematic review aimed to analyze the safety and efficacy of intravascular lithotripsy in the management of calcified plaques in PAD patients. The overall findings of this review identified that all but three studies reported a 100% procedural success rate following an IVL procedure, with notable improvement in the vessel diameter, significant improvement in pain-free walking distance, significant increase in TcPO2 in the calf, and increased perfusion index in the foot. Two of the studies reported a 95[32] and 97%[41] technical success rate; however, Tepe et al[39] reported a 65.7% technical success rate. The lower technical success rate in this particular study may be due to nuances in the methodology compared to other studies. For example, 83% of patients in this study were treated for severe calcifications, which was a much higher proportion of severe calcifications than in other included studies. Additionally, the initial device generator used in Tepe et al was only able to deliverer a maximum of 180 pulses, and only 13 patients received pulse delivery from an updated generator software that could deliver up to 300 pulses, which may have prohibited the ability to attain technical success by defined parameters in the methodology.
In addition, the compilation of these studies has shown that IVL can successfully be used in a diverse array of vasculature in the lower extremities, including iliac, femoropopliteal, and infrapopliteal disease. This systematic review is the second known review that compiles existing literature regarding the usage of shock wave lithotripsy (Shockwave Medical, Fremont, California, United States) to treat lower extremity calcifications in patients with moderate to severe PAD. Conducted by Wong et al, the first systematic review included nine studies that supported the usage of IVL as a safe and effective approach for the treatment of calcified plaques in lower extremity PAD.[43] Our review included an additional 11 studies. Moreover, our review corroborated their results with a larger population size. Wong et al reported an average 80.76% pre-IVL diameter stenosis and 20.2% post-IVL diameter stenosis, while this study reported an average 77.70 ± 11.56% pre-IVL diameter stenosis and 24.72 ± 9.86% post-IVL diameter stenosis. A previous patient-level pooled data analysis was conducted, which showed that there was a significant reduction in the postprocedure percent diameter stenosis following IVL, from 78.8% pre-IVL to 28.6% post-IVL.[44] The current systematic review includes the largest population size to date and the greatest number of lesions, with 976 patients and 1,162 lesions.
One of the highlighted features that has supported IVL as an effective and safe treatment for plaque removal is the substantially low reported risk of postprocedural complication. There were 75 total patients (7.78%) who had a reported complication following IVL. About 3.52% of patients had a postprocedural Grade A to C (minor) dissection, 0.93% had a Grade D to F (major) dissection, two reported cases of perforation and one reported case of distal embolization. Additionally, there were no thrombus formation, no-reflow, or abrupt closure of the vessel reported. In contrast to these reported values, there have been several RCT studies showing outcomes following PTA procedures, reporting anywhere from a 45.2 to 72% rate of Grade A to C dissection[45] [46] [47] and a 29 to 30% rate of Grade C or higher dissection.[47] [48] One RCT study also reported that distal embolization occurred in 1.1% of patients who underwent PTA.[49] Additionally, a study directly comparing efficacy of IVL versus PTA showed that flow-limiting dissections occurred more frequently in the PTA group.[39] The disrupt PAD III randomized trial also reported higher procedural success following IVL in comparison to PTA after 30 days,[39] supporting the notion that IVL is more efficacious than PTA for the treatment of calcified plaques. Recently published mid-term outcomes reporting from the disrupt PAD III trial have also confirmed that primary patency at 1 year was significantly greater in the IVL arm than in the PTA arm, confirming the consistent efficacy of IVL.[50] Several RCT studies reported between a 63.8 and 74% rate of Grade A to C dissection following DCB, and between a 32.4 and 42% rate of Grade C or higher dissection.[45] [46] [51] One study also reported three cases of distal embolization and two cases of perforations following DCB therapy.[52] Additionally, several studies have identified a particularly high rate of postprocedural distal embolization following atherectomy procedures.[49] [53] [54] [55] These reported complication rates are substantially higher than the complication rates reported in our review for IVL treatment, highlighting a clear implication that IVL may provide equally effective clinical outcomes, while also minimizing complications in patients.
There were several limitations in this study that were predominantly inherent to the systematic review process. Despite the studies in this review reporting procedural success, the technical success was not defined and reported in most studies; therefore, there was no analysis conducted on these aspects of each study. In addition, this review included papers that were of various study types, resulting in clinical heterogeneity. However, it does provide a safety and efficacy data from a large cohort of patients.
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Conclusion
Overall, this review supports the utilization of intravascular lithotripsy as a safe and effective treatment modality in removing arterial calcifications in patients with PAD. The existing literature has shown that IVL successfully decreases residual diameter stenosis, increases luminal gain, increases pain-free walking distance, and improves blood flow to ischemic limbs, with minimal to no postprocedural complications. Additional high-quality prospective studies with larger patient populations are warranted to better support the effectiveness of this technique and to directly compare intravascular lithotripsy to other treatment modalities, so that we can enhance our understanding of the versatility and efficacy of this device.
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Conflict of Interest
None declared.
Note
This manuscript data was presented as an oral presentation at the 2022 Society of Interventional Radiology Annual Scientific Meeting. This work has not been previously published and is not under review elsewhere for publication.
Ethical Approval Statement
This study is a systematic review of previously published data and did not require the approval of an IRB.
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References
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- 2 Aboyans V, Ricco JB, Bartelink MEL. et al; ESC Scientific Document Group. 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries endorsed by: the European Stroke Organization (ESO) The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J 2018; 39 (09) 763-816
- 3 Mustapha JA, Finton SM, Diaz-Sandoval LJ, Saab FA, Miller LE. Percutaneous transluminal angioplasty in patients with infrapopliteal arterial disease: systematic review and meta-analysis. Circ Cardiovasc Interv 2016; 9 (05) e003468
- 4 Meneguz-Moreno RA, Ribamar Costa Jr J, Abizaid A. Drug-coated balloons: hope or hot air: update on the role of coronary DCB. Curr Cardiol Rep 2018; 20 (10) 100
- 5 Cassese S, Ndrepepa G, Liistro F. et al. Drug-coated balloons for revascularization of infrapopliteal arteries: a meta-analysis of randomized trials. JACC Cardiovasc Interv 2016; 9 (10) 1072-1080
- 6 Tzafriri AR, Garcia-Polite F, Zani B. et al. Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis. J Control Release 2017; 264: 203-210
- 7 Shammas NW, Lam R, Mustapha J. et al. Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther 2012; 19 (04) 480-488
- 8 Laird JR, Yeo KK. The treatment of femoropopliteal in-stent restenosis: back to the future. J Am Coll Cardiol 2012; 59 (01) 24-25
- 9 Scheinert D, Scheinert S, Sax J. et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol 2005; 45 (02) 312-315
- 10 Babaev A, Zavlunova S, Attubato MJ, Martinsen BJ, Mintz GS, Maehara A. Orbital atherectomy plaque modification assessment of the femoropopliteal artery via intravascular ultrasound (TRUTH Study). Vasc Endovascular Surg 2015; 49 (07) 188-194
- 11 Lee MS, Canan T, Rha SW, Mustapha J, Adams GL. Pooled analysis of the CONFIRM registries: impact of gender on procedure and angiographic outcomes in patients undergoing orbital atherectomy for peripheral artery disease. J Endovasc Ther 2015; 22 (01) 57-62
- 12 Kawaguchi R, Tsurugaya H, Hoshizaki H, Toyama T, Oshima S, Taniguchi K. Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients. Cardiovasc Revasc Med 2008; 9 (01) 2-8
- 13 Mintz GS, Popma JJ, Pichard AD. et al. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation 1995; 91 (07) 1959-1965
- 14 Fanelli F, Cannavale A, Gazzetti M. et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol 2014; 37 (04) 898-907
- 15 Tepe G, Beschorner U, Ruether C. et al. Drug-eluting balloon therapy for femoropopliteal occlusive disease: predictors of outcome with a special emphasis on calcium. J Endovasc Ther 2015; 22 (05) 727-733
- 16 Marchetti KA, Lee T, Raja N. et al. Extracorporeal shock wave lithotripsy versus ureteroscopy for management of pediatric nephrolithiasis in upper urinary tract stones: multi-institutional outcomes of efficacy and morbidity. J Pediatr Urol 2019; 15 (05) 516.e1-516.e8
- 17 Yoo DE, Han SH, Oh HJ. et al. Removal of kidney stones by extracorporeal shock wave lithotripsy is associated with delayed progression of chronic kidney disease. Yonsei Med J 2012; 53 (04) 708-714
- 18 Chung VY, Turney BW. The success of shock wave lithotripsy (SWL) in treating moderate-sized (10-20 mm) renal stones. Urolithiasis 2016; 44 (05) 441-444
- 19 Dini CS, Tomberli B, Mattesini A. et al. Intravascular lithotripsy for calcific coronary and peripheral artery stenoses. EuroIntervention 2019; 15 (08) 714-721
- 20 Sattar Y, Ullah W, Virk HUH. et al. Coronary intravascular lithotripsy for coronary artery calcifications- systematic review of cases. J Community Hosp Intern Med Perspect 2021; 11 (02) 200-205
- 21 Sattar Y, Ullah W, Mir T. et al. Safety and efficacy of coronary intravascular lithotripsy for calcified coronary arteries- a systematic review and meta-analysis. Expert Rev Cardiovasc Ther 2021; 19 (01) 89-98
- 22 Sheikh AS, Connolly DL, Abdul F, Varma C, Sharma V. Intravascular lithotripsy for severe coronary calcification: a systematic review. Minerva Cardiol Angiol 2021
- 23 Shockwave Medical Inc. Peripheral Intravascular Lithotripsy (IVL) Catheter Instructions for Use (IFU). 2018
- 24 Page MJ, McKenzie JE, Bossuyt PM. et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021; 372 (71) n71
- 25 Harwood AE, Green J, Cayton T. et al. A feasibility double-blind randomized placebo-controlled trial of extracorporeal shockwave therapy as a novel treatment for intermittent claudication. J Vasc Surg 2018; 67 (02) 514-521.e2
- 26 Serizawa F, Ito K, Kawamura K. et al. Extracorporeal shock wave therapy improves the walking ability of patients with peripheral artery disease and intermittent claudication. Circ J 2012; 76 (06) 1486-1493
- 27 Tara S, Miyamoto M, Takagi G. et al. Low-energy extracorporeal shock wave therapy improves microcirculation blood flow of ischemic limbs in patients with peripheral arterial disease: pilot study. J Nippon Med Sch 2014; 81 (01) 19-27
- 28 Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol 2005; 5 (01) 13
- 29 Adams G, Shammas N, Mangalmurti S. et al. Intravascular lithotripsy for treatment of calcified lower extremity arterial stenosis: initial analysis of the disrupt PAD III study. J Endovasc Ther 2020; 27 (03) 473-480
- 30 Adams G, Soukas PA, Mehrle A, Bertolet B, Armstrong EJ. Intravascular lithotripsy for treatment of calcified infrapopliteal lesions: results from the disrupt PAD III observational study. J Endovasc Ther 2022; 29 (01) 76-83
- 31 Armstrong EJ, Soukas PA, Shammas N. et al. Intravascular lithotripsy for treatment of calcified, stenotic iliac arteries: a cohort analysis from the disrupt PAD III study. Cardiovasc Revasc Med 2020; 21 (10) 1262-1268
- 32 Brodmann M, Holden A, Zeller T. Safety and feasibility of intravascular lithotripsy for treatment of below-the-knee arterial stenoses. J Endovasc Ther 2018; 25 (04) 499-503
- 33 Brodmann M, Werner M, Holden A. et al. Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: results of disrupt PAD II. Catheter Cardiovasc Interv 2019; 93 (02) 335-342
- 34 Brodmann M, Schwindt A, Argyriou A, Gammon R. Safety and feasibility of intravascular lithotripsy for treatment of common femoral artery stenoses. J Endovasc Ther 2019; 26 (03) 283-287
- 35 Ciccone MM, Notarnicola A, Scicchitano P. et al. Shockwave therapy in patients with peripheral artery disease. Adv Ther 2012; 29 (08) 698-707
- 36 Nardi G, De Backer O, Saia F. et al. Peripheral intravascular lithotripsy of iliofemoral arteries to facilitate transfemoral TAVI: a multicentre prospective registry. EuroIntervention 2021; 17: e1397-e1406
- 37 Radaideh Q, Shammas N, Shammas G, Shammas W. Safety and efficacy of lithoplasty in treating severely calcified iliac arterial disease: a single center experience. Vascular Disease Management. 2019; 16: E55
- 38 Radaideh Q, Shammas NW, Shammas WJ, Shammas GA. Shockwave™ lithoplasty in combination with atherectomy in treating severe calcified femoropopliteal and iliac artery disease: a single-center experience. Cardiovasc Revasc Med 2021; 22: 66-70
- 39 Tepe G, Brodmann M, Werner M. et al; Disrupt PAD III Investigators. Intravascular lithotripsy for peripheral artery calcification: 30-day outcomes from the randomized disrupt PAD III trial. JACC Cardiovasc Interv 2021; 14 (12) 1352-1361
- 40 Colacchio EC, Salcuni M, Gasparre A. et al. Midterm results of intravascular lithotripsy for severely calcified common femoral artery occlusive disease: a single-center experience. J Endovasc Ther 2022; •••: 15 266028221105188
- 41 Stavroulakis K, Bisdas T, Torsello G, Tsilimparis N, Damerau S, Argyriou A. Intravascular lithotripsy and drug-coated balloon angioplasty for severely calcified femoropopliteal arterial disease. J Endovasc Ther 2023; 30 (01) 106-113
- 42 Aftanski P, Thieme M, Klein F, Schulze PC, Möbius-Winkler S, Kretzschmar D. Intravascular lithotripsy in calcified peripheral lesions: single-center JEN-experience. Int J Angiol 2022; 32 (01) 11-20
- 43 Wong CP, Chan LP, Au DM, Chan HWC, Chan YC. Efficacy and safety of intravascular lithotripsy in lower extremity peripheral artery disease: a systematic review and meta-analysis. Eur J Vasc Endovasc Surg 2021
- 44 Madhavan MV, Shahim B, Mena-Hurtado C, Garcia L, Crowley A, Parikh SA. Efficacy and safety of intravascular lithotripsy for the treatment of peripheral arterial disease: an individual patient-level pooled data analysis. Catheter Cardiovasc Interv 2020; 95 (05) 959-968
- 45 Iida O, Soga Y, Urasawa K. et al; MDT-2113 SFA Japan Investigators. Drug-coated balloon vs standard percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal arteries: one-year results of the MDT-2113 SFA Japan Randomized Trial. J Endovasc Ther 2018; 25 (01) 109-117
- 46 Tepe G, Laird J, Schneider P. et al; IN.PACT SFA Trial Investigators. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation 2015; 131 (05) 495-502
- 47 Horie K, Tanaka A, Taguri M, Inoue N. Impact of scoring balloons on percutaneous transluminal angioplasty outcomes in femoropopliteal lesions. J Endovasc Ther 2020; 27 (03) 481-491
- 48 Karashima E, Yoda S, Yasuda S, Kajiyama S, Ito H, Kaneko T. Usefulness of the “Non-Slip Element” percutaneous transluminal angioplasty balloon in the treatment of femoropopliteal arterial lesions. J Endovasc Ther 2020; 27 (01) 102-108
- 49 Bai H, Fereydooni A, Zhuo H. et al. Comparison of atherectomy to balloon angioplasty and stenting for isolated femoropopliteal revascularization. Ann Vasc Surg 2020; 69: 261-273
- 50 Tepe G, Brodmann M, Bachinsky W. et al. Intravascular lithotripsy for peripheral artery calcification: mid-term outcomes from the randomized disrupt PAD III trial. J Soc Cardiovasc Angiograph Intervent 2022; 1 (04) 100341
- 51 Giannopoulos S, Strobel A, Rudofker E, Kovach C, Schneider PA, Armstrong EJ. Association of postangioplasty femoropopliteal dissections with outcomes after drug-coated balloon angioplasty in the femoropopliteal arteries. J Endovasc Ther 2021; 28 (04) 593-603
- 52 Dohi T, Schmidt A, Scheinert D. et al. Drug-coated balloon angioplasty in atherosclerosis patients with popliteal artery involvement. J Endovasc Ther 2018; 25 (05) 581-587
- 53 Minko P, Katoh M, Jaeger S, Buecker A. Atherectomy of heavily calcified femoropopliteal stenotic lesions. J Vasc Interv Radiol 2011; 22 (07) 995-1000
- 54 Gray WA, Garcia LA, Amin A, Shammas NW. JET Registry Investigators. Jetstream atherectomy system treatment of femoropopliteal arteries: results of the post-market JET Registry. Cardiovasc Revasc Med 2018; 19 (5 Pt A): 506-511
- 55 Korabathina R, Mody KP, Yu J, Han SY, Patel R, Staniloae CS. Orbital atherectomy for symptomatic lower extremity disease. Catheter Cardiovasc Interv 2010; 76 (03) 326-332
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Article published online:
04 September 2023
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References
- 1 Gerhard-Herman MD, Gornik HL, Barrett C. et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 2017; 135 (12) e686-e725
- 2 Aboyans V, Ricco JB, Bartelink MEL. et al; ESC Scientific Document Group. 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries endorsed by: the European Stroke Organization (ESO) The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J 2018; 39 (09) 763-816
- 3 Mustapha JA, Finton SM, Diaz-Sandoval LJ, Saab FA, Miller LE. Percutaneous transluminal angioplasty in patients with infrapopliteal arterial disease: systematic review and meta-analysis. Circ Cardiovasc Interv 2016; 9 (05) e003468
- 4 Meneguz-Moreno RA, Ribamar Costa Jr J, Abizaid A. Drug-coated balloons: hope or hot air: update on the role of coronary DCB. Curr Cardiol Rep 2018; 20 (10) 100
- 5 Cassese S, Ndrepepa G, Liistro F. et al. Drug-coated balloons for revascularization of infrapopliteal arteries: a meta-analysis of randomized trials. JACC Cardiovasc Interv 2016; 9 (10) 1072-1080
- 6 Tzafriri AR, Garcia-Polite F, Zani B. et al. Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis. J Control Release 2017; 264: 203-210
- 7 Shammas NW, Lam R, Mustapha J. et al. Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial. J Endovasc Ther 2012; 19 (04) 480-488
- 8 Laird JR, Yeo KK. The treatment of femoropopliteal in-stent restenosis: back to the future. J Am Coll Cardiol 2012; 59 (01) 24-25
- 9 Scheinert D, Scheinert S, Sax J. et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol 2005; 45 (02) 312-315
- 10 Babaev A, Zavlunova S, Attubato MJ, Martinsen BJ, Mintz GS, Maehara A. Orbital atherectomy plaque modification assessment of the femoropopliteal artery via intravascular ultrasound (TRUTH Study). Vasc Endovascular Surg 2015; 49 (07) 188-194
- 11 Lee MS, Canan T, Rha SW, Mustapha J, Adams GL. Pooled analysis of the CONFIRM registries: impact of gender on procedure and angiographic outcomes in patients undergoing orbital atherectomy for peripheral artery disease. J Endovasc Ther 2015; 22 (01) 57-62
- 12 Kawaguchi R, Tsurugaya H, Hoshizaki H, Toyama T, Oshima S, Taniguchi K. Impact of lesion calcification on clinical and angiographic outcome after sirolimus-eluting stent implantation in real-world patients. Cardiovasc Revasc Med 2008; 9 (01) 2-8
- 13 Mintz GS, Popma JJ, Pichard AD. et al. Patterns of calcification in coronary artery disease. A statistical analysis of intravascular ultrasound and coronary angiography in 1155 lesions. Circulation 1995; 91 (07) 1959-1965
- 14 Fanelli F, Cannavale A, Gazzetti M. et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol 2014; 37 (04) 898-907
- 15 Tepe G, Beschorner U, Ruether C. et al. Drug-eluting balloon therapy for femoropopliteal occlusive disease: predictors of outcome with a special emphasis on calcium. J Endovasc Ther 2015; 22 (05) 727-733
- 16 Marchetti KA, Lee T, Raja N. et al. Extracorporeal shock wave lithotripsy versus ureteroscopy for management of pediatric nephrolithiasis in upper urinary tract stones: multi-institutional outcomes of efficacy and morbidity. J Pediatr Urol 2019; 15 (05) 516.e1-516.e8
- 17 Yoo DE, Han SH, Oh HJ. et al. Removal of kidney stones by extracorporeal shock wave lithotripsy is associated with delayed progression of chronic kidney disease. Yonsei Med J 2012; 53 (04) 708-714
- 18 Chung VY, Turney BW. The success of shock wave lithotripsy (SWL) in treating moderate-sized (10-20 mm) renal stones. Urolithiasis 2016; 44 (05) 441-444
- 19 Dini CS, Tomberli B, Mattesini A. et al. Intravascular lithotripsy for calcific coronary and peripheral artery stenoses. EuroIntervention 2019; 15 (08) 714-721
- 20 Sattar Y, Ullah W, Virk HUH. et al. Coronary intravascular lithotripsy for coronary artery calcifications- systematic review of cases. J Community Hosp Intern Med Perspect 2021; 11 (02) 200-205
- 21 Sattar Y, Ullah W, Mir T. et al. Safety and efficacy of coronary intravascular lithotripsy for calcified coronary arteries- a systematic review and meta-analysis. Expert Rev Cardiovasc Ther 2021; 19 (01) 89-98
- 22 Sheikh AS, Connolly DL, Abdul F, Varma C, Sharma V. Intravascular lithotripsy for severe coronary calcification: a systematic review. Minerva Cardiol Angiol 2021
- 23 Shockwave Medical Inc. Peripheral Intravascular Lithotripsy (IVL) Catheter Instructions for Use (IFU). 2018
- 24 Page MJ, McKenzie JE, Bossuyt PM. et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021; 372 (71) n71
- 25 Harwood AE, Green J, Cayton T. et al. A feasibility double-blind randomized placebo-controlled trial of extracorporeal shockwave therapy as a novel treatment for intermittent claudication. J Vasc Surg 2018; 67 (02) 514-521.e2
- 26 Serizawa F, Ito K, Kawamura K. et al. Extracorporeal shock wave therapy improves the walking ability of patients with peripheral artery disease and intermittent claudication. Circ J 2012; 76 (06) 1486-1493
- 27 Tara S, Miyamoto M, Takagi G. et al. Low-energy extracorporeal shock wave therapy improves microcirculation blood flow of ischemic limbs in patients with peripheral arterial disease: pilot study. J Nippon Med Sch 2014; 81 (01) 19-27
- 28 Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol 2005; 5 (01) 13
- 29 Adams G, Shammas N, Mangalmurti S. et al. Intravascular lithotripsy for treatment of calcified lower extremity arterial stenosis: initial analysis of the disrupt PAD III study. J Endovasc Ther 2020; 27 (03) 473-480
- 30 Adams G, Soukas PA, Mehrle A, Bertolet B, Armstrong EJ. Intravascular lithotripsy for treatment of calcified infrapopliteal lesions: results from the disrupt PAD III observational study. J Endovasc Ther 2022; 29 (01) 76-83
- 31 Armstrong EJ, Soukas PA, Shammas N. et al. Intravascular lithotripsy for treatment of calcified, stenotic iliac arteries: a cohort analysis from the disrupt PAD III study. Cardiovasc Revasc Med 2020; 21 (10) 1262-1268
- 32 Brodmann M, Holden A, Zeller T. Safety and feasibility of intravascular lithotripsy for treatment of below-the-knee arterial stenoses. J Endovasc Ther 2018; 25 (04) 499-503
- 33 Brodmann M, Werner M, Holden A. et al. Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: results of disrupt PAD II. Catheter Cardiovasc Interv 2019; 93 (02) 335-342
- 34 Brodmann M, Schwindt A, Argyriou A, Gammon R. Safety and feasibility of intravascular lithotripsy for treatment of common femoral artery stenoses. J Endovasc Ther 2019; 26 (03) 283-287
- 35 Ciccone MM, Notarnicola A, Scicchitano P. et al. Shockwave therapy in patients with peripheral artery disease. Adv Ther 2012; 29 (08) 698-707
- 36 Nardi G, De Backer O, Saia F. et al. Peripheral intravascular lithotripsy of iliofemoral arteries to facilitate transfemoral TAVI: a multicentre prospective registry. EuroIntervention 2021; 17: e1397-e1406
- 37 Radaideh Q, Shammas N, Shammas G, Shammas W. Safety and efficacy of lithoplasty in treating severely calcified iliac arterial disease: a single center experience. Vascular Disease Management. 2019; 16: E55
- 38 Radaideh Q, Shammas NW, Shammas WJ, Shammas GA. Shockwave™ lithoplasty in combination with atherectomy in treating severe calcified femoropopliteal and iliac artery disease: a single-center experience. Cardiovasc Revasc Med 2021; 22: 66-70
- 39 Tepe G, Brodmann M, Werner M. et al; Disrupt PAD III Investigators. Intravascular lithotripsy for peripheral artery calcification: 30-day outcomes from the randomized disrupt PAD III trial. JACC Cardiovasc Interv 2021; 14 (12) 1352-1361
- 40 Colacchio EC, Salcuni M, Gasparre A. et al. Midterm results of intravascular lithotripsy for severely calcified common femoral artery occlusive disease: a single-center experience. J Endovasc Ther 2022; •••: 15 266028221105188
- 41 Stavroulakis K, Bisdas T, Torsello G, Tsilimparis N, Damerau S, Argyriou A. Intravascular lithotripsy and drug-coated balloon angioplasty for severely calcified femoropopliteal arterial disease. J Endovasc Ther 2023; 30 (01) 106-113
- 42 Aftanski P, Thieme M, Klein F, Schulze PC, Möbius-Winkler S, Kretzschmar D. Intravascular lithotripsy in calcified peripheral lesions: single-center JEN-experience. Int J Angiol 2022; 32 (01) 11-20
- 43 Wong CP, Chan LP, Au DM, Chan HWC, Chan YC. Efficacy and safety of intravascular lithotripsy in lower extremity peripheral artery disease: a systematic review and meta-analysis. Eur J Vasc Endovasc Surg 2021
- 44 Madhavan MV, Shahim B, Mena-Hurtado C, Garcia L, Crowley A, Parikh SA. Efficacy and safety of intravascular lithotripsy for the treatment of peripheral arterial disease: an individual patient-level pooled data analysis. Catheter Cardiovasc Interv 2020; 95 (05) 959-968
- 45 Iida O, Soga Y, Urasawa K. et al; MDT-2113 SFA Japan Investigators. Drug-coated balloon vs standard percutaneous transluminal angioplasty for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal arteries: one-year results of the MDT-2113 SFA Japan Randomized Trial. J Endovasc Ther 2018; 25 (01) 109-117
- 46 Tepe G, Laird J, Schneider P. et al; IN.PACT SFA Trial Investigators. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation 2015; 131 (05) 495-502
- 47 Horie K, Tanaka A, Taguri M, Inoue N. Impact of scoring balloons on percutaneous transluminal angioplasty outcomes in femoropopliteal lesions. J Endovasc Ther 2020; 27 (03) 481-491
- 48 Karashima E, Yoda S, Yasuda S, Kajiyama S, Ito H, Kaneko T. Usefulness of the “Non-Slip Element” percutaneous transluminal angioplasty balloon in the treatment of femoropopliteal arterial lesions. J Endovasc Ther 2020; 27 (01) 102-108
- 49 Bai H, Fereydooni A, Zhuo H. et al. Comparison of atherectomy to balloon angioplasty and stenting for isolated femoropopliteal revascularization. Ann Vasc Surg 2020; 69: 261-273
- 50 Tepe G, Brodmann M, Bachinsky W. et al. Intravascular lithotripsy for peripheral artery calcification: mid-term outcomes from the randomized disrupt PAD III trial. J Soc Cardiovasc Angiograph Intervent 2022; 1 (04) 100341
- 51 Giannopoulos S, Strobel A, Rudofker E, Kovach C, Schneider PA, Armstrong EJ. Association of postangioplasty femoropopliteal dissections with outcomes after drug-coated balloon angioplasty in the femoropopliteal arteries. J Endovasc Ther 2021; 28 (04) 593-603
- 52 Dohi T, Schmidt A, Scheinert D. et al. Drug-coated balloon angioplasty in atherosclerosis patients with popliteal artery involvement. J Endovasc Ther 2018; 25 (05) 581-587
- 53 Minko P, Katoh M, Jaeger S, Buecker A. Atherectomy of heavily calcified femoropopliteal stenotic lesions. J Vasc Interv Radiol 2011; 22 (07) 995-1000
- 54 Gray WA, Garcia LA, Amin A, Shammas NW. JET Registry Investigators. Jetstream atherectomy system treatment of femoropopliteal arteries: results of the post-market JET Registry. Cardiovasc Revasc Med 2018; 19 (5 Pt A): 506-511
- 55 Korabathina R, Mody KP, Yu J, Han SY, Patel R, Staniloae CS. Orbital atherectomy for symptomatic lower extremity disease. Catheter Cardiovasc Interv 2010; 76 (03) 326-332
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