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Use of Shockwave intravascular lithotripsy for the treatment of symptomatic and severely calcified superior mesenteric artery stenosis

Use of Shockwave intravascular lithotripsy for the treatment of symptomatic and severely... Background: We present the use of intravascular lithotripsy as a treatment for highly calcified superior mesenteric artery stenosis. Case presentation: A 67-year-old diabetic man had chronic postprandial abdominal pain and weight loss. Computed tomography angiography revealed highly calcified stenosis of the superior mesenteric artery. Selective angiography confirmed severe stenosis. A Shockwave lithotripsy balloon catheter was successfully used via brachial access to modify calcified plaque and increase vascular lumen. After 12 months of follow-up the patient had gained weight and had no abdominal postprandial pain. Conclusion: Intravascular lithotripsy could be considered a new treatment modality to modify calcified lesions in the visceral arteries. More controlled studies are needed to demonstrate the efficacy, safety and feasibility of this new technology. Level of evidence: 4, Case Report Keywords: Intravascular lithotripsy, Superior mesenteric artery stenosis, Chronic mesenteric ischemia Background surgical revascularization or percutaneous transluminal Clinical manifestations of chronic mesenteric ischemia angioplasty (PTA) with or without stenting (Sreenarasim- (CMI) may present widespread symptoms such as post- haiah 2007). PTA, less invasive procedure, has associated prandial abdominal pain and weight loss when there is a complications such as thrombosis, restenosis and disloca- 60% to 75% reduction in blood flow. Superior mesenteric tion of stent (Sakorafas et al. 2008). artery (SMA) stenosis is a common finding in elderly pa- Intravascular lithotripsy (IVL) therapy was applied as a tients with atherosclerosis. Hansen found that the preva- definitive treatment for vascular stenosis in a patient lence of significant stenosis in subjects over 65 was 17.5% who had postprandial abdominal pain and weight loss (Hansen et al. 2004), with abdominal angina depending on due to intense calcification and severe stenosis in the the collaterality of SMA. Image tests as computed tomog- proximal segment of SMA. raphy angiography (CTA) or lateral projection angiog- raphy are needed to visualize the narrowing of the SMA. Case presentation If CMI is diagnosed there are two therapeutic options: The symptoms of the 67-year-old man included 9 months of postprandial abdominal pain, most severe in * Correspondence: obalboa@saludcastillayleon.es the last 2 months and 10 kg of weight loss. His comor- Division of Vascular and Interventional Radiology, Department of Radiology, bidities include diabetes and revascularized ischemic car- Hospital Universitario de León, León, Spain Full list of author information is available at the end of the article diomyopathy 7 years ago. CTA revealed an extensive © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Balboa Arregui et al. CVIR Endovascular (2021) 4:53 Page 2 of 4 Fig. 1 CTA revealed highly calcified stenosis in the proximal segment of SMA. Selective brachial access angiography confirmed severe SMA stenosis atherosclerotic disease involving aortoiliac, celiac and 6 × 60 mm balloon catheter (Shockwave Medical Inc., SMA calcification. Selective angiography revealed severe Santa Clara, California) over Traxcess 14 guidewire stenosis in the celiac and SMA, with hepatic artery ori- (Microvention-Terumo Inc., California, USA) was then ginating in the same SMA (Fig. 1). The choice of treat- placed through the SMA ostium, and 5 of 1-pulse treat- ment was a multidisciplinary team decision due to the ments were delivered to activate only the distal emitter calcification. We confirm the written informed consent and facilitate calcium fragmentation and advancement of of the patient before the start of treatment. the IVL balloon catheter (Fig. 2). Once the balloon cath- The patient was on antiplatelet therapy. Percutaneous eter had been advanced and covered all stenosis, 5 endovascular intervention of SMA was performed under complete cycles of 30 pulses were applied each cycle sedation. Vascular access was established in the right with good angiographic result (Fig. 3). The patient toler- brachial artery with 6 Fr flexor guide sheath 80 cm long ated the procedure without complications and went (Cook Medical, Bloomington, IN, USA) advanced to- home 24 h later. A month later he reported no compli- wards the abdominal aorta with distal end in front of the cations after percutaneous endovascular intervention SMA origin. A 110 cm long Shockwave Lithotripsy M5 and absence of abdominal pain. Twelve months after the Fig. 2 Shockwave Lithotripsy M5–6 × 60 mm, balloon catheter placed first through the SMA ostium, and total subsequent coverage of stenosis. Balloon inflated to 4 atm during energy emission Balboa Arregui et al. CVIR Endovascular (2021) 4:53 Page 3 of 4 Fig. 3 Control arteriography post-treatment with IVL, and MPR of CTA 12 months post-treatment procedure, the patient gained weight and has not com- months and 54–70% at 12 months, with a 95% clinical plained again of postprandial abdominal pain (Fig. 3). success rate, indicating less than 50% residual stenosis after the procedure with no evidence of acute adverse Discussion cardiac events, embolizations, thrombus formations, or Treatment of symptomatic CMI is widely accepted to pre- perforations (Brinton et al. 2019; Brodman et al. 2019). vent acute mesenteric ischemia. There is no documentation This report with the application of IVL therapy dem- on the use of IVL in the treatment of atherosclerotic disease onstrates successful revascularization in lesions that presenting as mesenteric ischemia. Open surgical repair has combine calcium thickness and a large calcium arc (270° survival rates of approximately 80% to 90% (Lejay et al. of the vessel circumference), making dilation difficult 2015). Intravascular treatment has become an alternative to with conventional therapy. open surgery. One study showed that although primary pa- tency rates were below 45%, secondary patency rates were Conclusion comparable to 94%. The presence of highly calcified ostial IVL is an emerging treatment modality that dilates calcified occlusions represents an important limitation of endovascu- lesions endovascularly. Its use in the treatment of highly cal- lar interventions (Van Petersen et al. 2010). cified SMA in patients with postprandial pain should be con- The Shockwave Lithoplasty® System IVL consists of sidered as a novel approach for patients whose traditional three components: the balloon catheter for performing endovascular treatment modalities are not optimal. More the IVL, the connecting cable for pulse therapy, and a controlled studies are needed to demonstrate the efficacy, power generator. The IVL catheter consists of an OTW safety, and feasibility of this new technology. balloon catheter, which has, inside, several emitters of Abbreviations sonic shock waves whose diffusion generates a pressure CMI: Chronic mesenteric ischemia; SMA: Superior mesenteric artery; of 50 atm. Activation of the device applies pulsed mech- CTA: Computed tomography angiography; PTA: Percutaneous transluminal angioplasty; IVL: Intravascular lithotripsy anical energy transmitted in the form of shock waves that pass through soft tissue without altering it and Acknowledgements without causing damage to the vessel. Upon reaching Not applicable. the calcified plaque, the transmitted energy generates Authors’ contributions microfractures, modifying the calcium and therefore the All authors contributed to the conception of the work, writing/revision of morphology of the artery, allowing a posterior dilation the manuscript and approved the final version of the manuscript. No with the balloon at low pressure (6 atm). funding for any author. The application of IVL technology has been reported Funding in coronary and peripheral endovascular procedures, in- This study was not supported by any funding. cluding the iliac, femoral, and renal arteries. Currently, Availability of data and materials several multicenter studies are being conducted to evalu- Not applicable. ate the safety (DISRUPT CAD II) and efficacy (DIS- RUPT CAD / PAD III) of IVL in the coronary and Declarations peripheral territories (Adams et al. 2020; Brinton et al. Ethics approval and consent to participate 2019; Brodmann et al. 2017; Armstrong et al. 2020). The All procedures performed in studies involving human participants were in first studies on its peripheral use show promising results accordance with the ethical standards of the institutional and/or national research confirming a patency of 100% after 30 days, 70–80% at 6 committee and with the 1964 Helsinki Declaration and its later amendments or Balboa Arregui et al. CVIR Endovascular (2021) 4:53 Page 4 of 4 comparable ethical standards. Institutional review board approval was obtained. This article does not contain any studies with animals performed by any of the authors. Informed consent was obtained from all individual participants included in the study. Consent for publication Consent for publication was obtained for every individual person’s data included in the study. Competing interests The authors declare that they have no conflict of interest. Author details Division of Vascular and Interventional Radiology, Department of Radiology, Hospital Universitario de León, León, Spain. Division of Vascular and Interventional Radiology, Department of Radiology, Hospital Clínico Universitario de Santiago de Compostela, A Coruña, Spain. Department of Emergencies, Hospital San Juan de Alicante, Alicante, Spain. Received: 20 January 2021 Accepted: 1 June 2021 References Adams G, Shammas N, Mangalmurti S, Bernardo NL, Miller WE, Soukas PA et al (2020) Intravascular lithotripsy for treatment of calcified lower extremity arterial stenosis: initial analysis of the Disrupt PAD III study. J Endovasc Ther 27(3):473–480. https://doi.org/10.1177/1526602820914598 PMID: 32242768 Armstrong EJ, Soukas PA, Shammas N, Chamberlain J, Pop A, Adams G et al (2020) Intravascular lithotripsy for treatment of calcified, stenotic iliac arteries: a cohort analysis from the Disrupt PAD III study. Cardiovasc Revasc Med 21(10):1262–1268. https://doi.org/10.1016/j.carrev.2020.02.026 PMID: 32147133 Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U et al (2019) Feasibility of shockwave coronary intravascular lithotripsy for the treatment of calcified coronary Stenoses. Circulation. 139(6):834–836. https://doi.org/1 0.1161/CIRCULATIONAHA.118.036531 PMID: 30715944 Brodman M, Werner M, Holden A, Tepe G, Scheinert D, Schwindt A et al (2019) Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II. Catheter Cardiovasc Interv 93:335–342. https://doi.org/10.1002/ccd.27943 PMID: Brodmann M, Werner M, Brinton TJ, Illindala U, Lansky A, Jaff MR et al (2017) Safety and performance of lithoplasty for treatment of calcified peripheral artery lesions. J Am Coll Cardiol 70(7):908–910. https://doi.org/10.1016/j.jacc.2 017.06.022. PMID: 28797363 Hansen KJ, Wilson DB, Craven TE, Pearce JD, English WP, Edwards MS et al (2004) Mesenteric artery disease in the elderly. J Vasc Surg 40(1):45–52. https://doi. org/10.1016/j.jvs.2004.03.022 PMID: 15218461 Lejay A, Georg Y, Tartaglia E, Creton O, Lucereau B, Thaveau F, Geny B, Chakfe N (2015) Chronic mesenteric ischemia: 20 year experience of open surgical treatment. Eur J Vasc Endovasc Surg 49(5):587–592. https://doi.org/10.1016/j. ejvs.2015.01.004. PMID: 25728455 Sakorafas GH, Sarr MG, Peros G (2008) Celiac artery stenosis: an underappreciated and unpleasant surprise in patients undergoing pancreaticoduodenectomy. J Am Coll Surg 206(2):349–356. https://doi.org/10.1016/j.jamcollsurg.2007.09. 002 PMID: 18222391 Sreenarasimhaiah J (2007) Chronic mesenteric ischemia. Curr Treat Options Gastroenterol 10(1):3–9. https://doi.org/10.1007/s11938-007-0051-x PMID: Van Petersen AS, Kolkman JJ, Beuk RJ, Huisman AB, CJA D, Geelkerken RH et al (2010) Open or percutaneous revascularization for chronic splanchnic syndrome. J Vasc Surg 51(5):1309–1316. https://doi.org/10.1016/j.jvs.2009.12. 064. PMID: 20304586 Publisher’sNote Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png CVIR Endovascular Springer Journals

Use of Shockwave intravascular lithotripsy for the treatment of symptomatic and severely calcified superior mesenteric artery stenosis

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Abstract

Background: We present the use of intravascular lithotripsy as a treatment for highly calcified superior mesenteric artery stenosis. Case presentation: A 67-year-old diabetic man had chronic postprandial abdominal pain and weight loss. Computed tomography angiography revealed highly calcified stenosis of the superior mesenteric artery. Selective angiography confirmed severe stenosis. A Shockwave lithotripsy balloon catheter was successfully used via brachial access to modify calcified plaque and increase vascular lumen. After 12 months of follow-up the patient had gained weight and had no abdominal postprandial pain. Conclusion: Intravascular lithotripsy could be considered a new treatment modality to modify calcified lesions in the visceral arteries. More controlled studies are needed to demonstrate the efficacy, safety and feasibility of this new technology. Level of evidence: 4, Case Report Keywords: Intravascular lithotripsy, Superior mesenteric artery stenosis, Chronic mesenteric ischemia Background surgical revascularization or percutaneous transluminal Clinical manifestations of chronic mesenteric ischemia angioplasty (PTA) with or without stenting (Sreenarasim- (CMI) may present widespread symptoms such as post- haiah 2007). PTA, less invasive procedure, has associated prandial abdominal pain and weight loss when there is a complications such as thrombosis, restenosis and disloca- 60% to 75% reduction in blood flow. Superior mesenteric tion of stent (Sakorafas et al. 2008). artery (SMA) stenosis is a common finding in elderly pa- Intravascular lithotripsy (IVL) therapy was applied as a tients with atherosclerosis. Hansen found that the preva- definitive treatment for vascular stenosis in a patient lence of significant stenosis in subjects over 65 was 17.5% who had postprandial abdominal pain and weight loss (Hansen et al. 2004), with abdominal angina depending on due to intense calcification and severe stenosis in the the collaterality of SMA. Image tests as computed tomog- proximal segment of SMA. raphy angiography (CTA) or lateral projection angiog- raphy are needed to visualize the narrowing of the SMA. Case presentation If CMI is diagnosed there are two therapeutic options: The symptoms of the 67-year-old man included 9 months of postprandial abdominal pain, most severe in * Correspondence: obalboa@saludcastillayleon.es the last 2 months and 10 kg of weight loss. His comor- Division of Vascular and Interventional Radiology, Department of Radiology, bidities include diabetes and revascularized ischemic car- Hospital Universitario de León, León, Spain Full list of author information is available at the end of the article diomyopathy 7 years ago. CTA revealed an extensive © The Author(s). 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. Balboa Arregui et al. CVIR Endovascular (2021) 4:53 Page 2 of 4 Fig. 1 CTA revealed highly calcified stenosis in the proximal segment of SMA. Selective brachial access angiography confirmed severe SMA stenosis atherosclerotic disease involving aortoiliac, celiac and 6 × 60 mm balloon catheter (Shockwave Medical Inc., SMA calcification. Selective angiography revealed severe Santa Clara, California) over Traxcess 14 guidewire stenosis in the celiac and SMA, with hepatic artery ori- (Microvention-Terumo Inc., California, USA) was then ginating in the same SMA (Fig. 1). The choice of treat- placed through the SMA ostium, and 5 of 1-pulse treat- ment was a multidisciplinary team decision due to the ments were delivered to activate only the distal emitter calcification. We confirm the written informed consent and facilitate calcium fragmentation and advancement of of the patient before the start of treatment. the IVL balloon catheter (Fig. 2). Once the balloon cath- The patient was on antiplatelet therapy. Percutaneous eter had been advanced and covered all stenosis, 5 endovascular intervention of SMA was performed under complete cycles of 30 pulses were applied each cycle sedation. Vascular access was established in the right with good angiographic result (Fig. 3). The patient toler- brachial artery with 6 Fr flexor guide sheath 80 cm long ated the procedure without complications and went (Cook Medical, Bloomington, IN, USA) advanced to- home 24 h later. A month later he reported no compli- wards the abdominal aorta with distal end in front of the cations after percutaneous endovascular intervention SMA origin. A 110 cm long Shockwave Lithotripsy M5 and absence of abdominal pain. Twelve months after the Fig. 2 Shockwave Lithotripsy M5–6 × 60 mm, balloon catheter placed first through the SMA ostium, and total subsequent coverage of stenosis. Balloon inflated to 4 atm during energy emission Balboa Arregui et al. CVIR Endovascular (2021) 4:53 Page 3 of 4 Fig. 3 Control arteriography post-treatment with IVL, and MPR of CTA 12 months post-treatment procedure, the patient gained weight and has not com- months and 54–70% at 12 months, with a 95% clinical plained again of postprandial abdominal pain (Fig. 3). success rate, indicating less than 50% residual stenosis after the procedure with no evidence of acute adverse Discussion cardiac events, embolizations, thrombus formations, or Treatment of symptomatic CMI is widely accepted to pre- perforations (Brinton et al. 2019; Brodman et al. 2019). vent acute mesenteric ischemia. There is no documentation This report with the application of IVL therapy dem- on the use of IVL in the treatment of atherosclerotic disease onstrates successful revascularization in lesions that presenting as mesenteric ischemia. Open surgical repair has combine calcium thickness and a large calcium arc (270° survival rates of approximately 80% to 90% (Lejay et al. of the vessel circumference), making dilation difficult 2015). Intravascular treatment has become an alternative to with conventional therapy. open surgery. One study showed that although primary pa- tency rates were below 45%, secondary patency rates were Conclusion comparable to 94%. The presence of highly calcified ostial IVL is an emerging treatment modality that dilates calcified occlusions represents an important limitation of endovascu- lesions endovascularly. Its use in the treatment of highly cal- lar interventions (Van Petersen et al. 2010). cified SMA in patients with postprandial pain should be con- The Shockwave Lithoplasty® System IVL consists of sidered as a novel approach for patients whose traditional three components: the balloon catheter for performing endovascular treatment modalities are not optimal. More the IVL, the connecting cable for pulse therapy, and a controlled studies are needed to demonstrate the efficacy, power generator. The IVL catheter consists of an OTW safety, and feasibility of this new technology. balloon catheter, which has, inside, several emitters of Abbreviations sonic shock waves whose diffusion generates a pressure CMI: Chronic mesenteric ischemia; SMA: Superior mesenteric artery; of 50 atm. Activation of the device applies pulsed mech- CTA: Computed tomography angiography; PTA: Percutaneous transluminal angioplasty; IVL: Intravascular lithotripsy anical energy transmitted in the form of shock waves that pass through soft tissue without altering it and Acknowledgements without causing damage to the vessel. Upon reaching Not applicable. the calcified plaque, the transmitted energy generates Authors’ contributions microfractures, modifying the calcium and therefore the All authors contributed to the conception of the work, writing/revision of morphology of the artery, allowing a posterior dilation the manuscript and approved the final version of the manuscript. No with the balloon at low pressure (6 atm). funding for any author. The application of IVL technology has been reported Funding in coronary and peripheral endovascular procedures, in- This study was not supported by any funding. cluding the iliac, femoral, and renal arteries. Currently, Availability of data and materials several multicenter studies are being conducted to evalu- Not applicable. ate the safety (DISRUPT CAD II) and efficacy (DIS- RUPT CAD / PAD III) of IVL in the coronary and Declarations peripheral territories (Adams et al. 2020; Brinton et al. Ethics approval and consent to participate 2019; Brodmann et al. 2017; Armstrong et al. 2020). The All procedures performed in studies involving human participants were in first studies on its peripheral use show promising results accordance with the ethical standards of the institutional and/or national research confirming a patency of 100% after 30 days, 70–80% at 6 committee and with the 1964 Helsinki Declaration and its later amendments or Balboa Arregui et al. CVIR Endovascular (2021) 4:53 Page 4 of 4 comparable ethical standards. Institutional review board approval was obtained. This article does not contain any studies with animals performed by any of the authors. Informed consent was obtained from all individual participants included in the study. Consent for publication Consent for publication was obtained for every individual person’s data included in the study. Competing interests The authors declare that they have no conflict of interest. Author details Division of Vascular and Interventional Radiology, Department of Radiology, Hospital Universitario de León, León, Spain. Division of Vascular and Interventional Radiology, Department of Radiology, Hospital Clínico Universitario de Santiago de Compostela, A Coruña, Spain. Department of Emergencies, Hospital San Juan de Alicante, Alicante, Spain. Received: 20 January 2021 Accepted: 1 June 2021 References Adams G, Shammas N, Mangalmurti S, Bernardo NL, Miller WE, Soukas PA et al (2020) Intravascular lithotripsy for treatment of calcified lower extremity arterial stenosis: initial analysis of the Disrupt PAD III study. J Endovasc Ther 27(3):473–480. https://doi.org/10.1177/1526602820914598 PMID: 32242768 Armstrong EJ, Soukas PA, Shammas N, Chamberlain J, Pop A, Adams G et al (2020) Intravascular lithotripsy for treatment of calcified, stenotic iliac arteries: a cohort analysis from the Disrupt PAD III study. Cardiovasc Revasc Med 21(10):1262–1268. https://doi.org/10.1016/j.carrev.2020.02.026 PMID: 32147133 Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U et al (2019) Feasibility of shockwave coronary intravascular lithotripsy for the treatment of calcified coronary Stenoses. Circulation. 139(6):834–836. https://doi.org/1 0.1161/CIRCULATIONAHA.118.036531 PMID: 30715944 Brodman M, Werner M, Holden A, Tepe G, Scheinert D, Schwindt A et al (2019) Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II. Catheter Cardiovasc Interv 93:335–342. https://doi.org/10.1002/ccd.27943 PMID: Brodmann M, Werner M, Brinton TJ, Illindala U, Lansky A, Jaff MR et al (2017) Safety and performance of lithoplasty for treatment of calcified peripheral artery lesions. J Am Coll Cardiol 70(7):908–910. https://doi.org/10.1016/j.jacc.2 017.06.022. PMID: 28797363 Hansen KJ, Wilson DB, Craven TE, Pearce JD, English WP, Edwards MS et al (2004) Mesenteric artery disease in the elderly. J Vasc Surg 40(1):45–52. https://doi. org/10.1016/j.jvs.2004.03.022 PMID: 15218461 Lejay A, Georg Y, Tartaglia E, Creton O, Lucereau B, Thaveau F, Geny B, Chakfe N (2015) Chronic mesenteric ischemia: 20 year experience of open surgical treatment. Eur J Vasc Endovasc Surg 49(5):587–592. https://doi.org/10.1016/j. ejvs.2015.01.004. PMID: 25728455 Sakorafas GH, Sarr MG, Peros G (2008) Celiac artery stenosis: an underappreciated and unpleasant surprise in patients undergoing pancreaticoduodenectomy. J Am Coll Surg 206(2):349–356. https://doi.org/10.1016/j.jamcollsurg.2007.09. 002 PMID: 18222391 Sreenarasimhaiah J (2007) Chronic mesenteric ischemia. Curr Treat Options Gastroenterol 10(1):3–9. https://doi.org/10.1007/s11938-007-0051-x PMID: Van Petersen AS, Kolkman JJ, Beuk RJ, Huisman AB, CJA D, Geelkerken RH et al (2010) Open or percutaneous revascularization for chronic splanchnic syndrome. J Vasc Surg 51(5):1309–1316. https://doi.org/10.1016/j.jvs.2009.12. 064. PMID: 20304586 Publisher’sNote Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Journal

CVIR Endovascular – Springer Journals

Published: Jun 14, 2021

Keywords: Intravascular lithotripsy; Superior mesenteric artery stenosis; Chronic mesenteric ischemia

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