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Table of Contents
ORIGINAL ARTICLE
Year : 2022  |  Volume : 12  |  Issue : 3  |  Page : 123-126

Management of densely calcified coronary lesions using OPN–NC balloon and shockwave intravascular lithotripsy procedure: A single-center study


Department of Cardiology, A. J. Institute of Medical Sciences and Research Centre, Mangalore, Karnataka, India

Date of Submission13-May-2021
Date of Decision22-Nov-2021
Date of Acceptance17-Dec-2021
Date of Web Publication14-Sep-2022

Correspondence Address:
Dr. Manjunath Venkataramaiah Bagur
Department of Cardiology, A. J. Institute of Medical Sciences and Research Centre, Mangalore - 575 004, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jicc.jicc_28_21

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  Abstract 


Background: Calcified coronary lesions are challenging to the interventional cardiologists to manage. Debulking the calcified lesions with Rotablation is a well known strategy. Shockwave intravascular lithotripsy (IVL) is the newer novel therapeutic procedure found to be very effective in PCI of calcified lesions. Aims and Objectives: To assess the clinical utility of Shockwave IVL in densly calcified coronary lesions. Materials and Methods: Four patients underwent PCI with Shockwave IVL for densly calcified lesions between Febraury and March of 2020 and were followed up clinically in our centre. Results: All patients are doing well clinically without any coronary events. Conclusion: Shockwave IVL is safe and accepted modality of debulking the densly calcified coronary lesions and prepare the bed for optimal stent deployment.

Keywords: Coronary calcification, intravascular lithotripsy, stent boost


How to cite this article:
Bagur MV. Management of densely calcified coronary lesions using OPN–NC balloon and shockwave intravascular lithotripsy procedure: A single-center study. J Indian coll cardiol 2022;12:123-6

How to cite this URL:
Bagur MV. Management of densely calcified coronary lesions using OPN–NC balloon and shockwave intravascular lithotripsy procedure: A single-center study. J Indian coll cardiol [serial online] 2022 [cited 2022 Oct 1];12:123-6. Available from: https://www.joicc.org/text.asp?2022/12/3/123/356060




  Introduction Top


Moderate-to-severe calcifications are found in approximately one-third of coronary lesions. Heavily calcified coronary lesions pose a challenge for optimal PCI results. Unless lesions are well prepared before stenting, the complication rates are high in underdeployed stents, which leads to higher incidence of Major Advance Coronary Events (MACE) including higher rate of target lesion revascularization (TLR) and target vessel revascularization (TVR), increased incidence of stent thrombosis, restenosis, myocardial infarction, and death.[1]

Shockwave intravascular lithotripsy system is a novel catheter-based device which uses pulsatile mechanical energy to disrupt calcified lesions. Miniature emitters placed along the length of a semicompliant balloon convert electrical energy into transient acoustic circumferential pressure pulses that disrupt both superficial and deep calcium in vascular plaque.[2] Intravascular lithotripsy (IVL) modifies calcium both circumferentially and transmurally, and it has shown to have effect on deep calcium as compared to other ablation techniques and enables low-pressure balloon dilatation of calcified stenotic de novo coronary artery lesion before stenting. It is Food and Drug Administration (FDA)-approved therapy following the results of DISRUPT CADIII trail.[3]


  Materials and Methods Top


Study population

Four patients with densely calcified lesions as evidenced by coronary angiography underwent shockwave IVL at A. J. Institute of Medical Sciences and Research Centre, Mangalore, between February and March 2020. Informed consent was taken after explaining the risk of dye allergy and procedure.

The first case [Figure 1] is a 71-year-old male with the history of hypertension and Class II effort angina with positive tread mill test with good LV function. Coronary angiogram showed 90% proximal left anterior descending (LAD) lesion. Noncompliant (NC) balloon and OPN-NC balloon were used for predilatation, and a 3.5 mm × 12 mm IVL balloon catheter with 6 cycles of 10 s each (60 pulses) was delivered to all target lesions. Following which, drug-eluting stent implantation was done.
Figure 1: Stent boost showing dense calcified proximal LAD lesion and IVL and OPN-NC balloon with stenting

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The second case [Figure 2] is a 70-year-old male with the history of diabetes and systemic hypertension, had recent history of unstable angina with mild LV systolic dysfunction. Coronary angiogram showed an 80% long calcified lesion in LAD from proximal to mid portion, NC balloon and OPN-NC balloon was used for predilatation, received all 80 pulses from mid to osteal portion of LAD using 3.0 mm × 12 mm IVL balloon catheter following which drug-eluting stent implantation was done with post dilatation.
Figure 2: Densely calcified proximal to mid LAD lesion stented after using IVL and OPN-NC ballooning

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The third case [Figure 3] is a 61-year-old male patient, hypertensive and diabetic with normal LV function with recent unstable angina, and had an 80%–90% long calcified lesion in proximal to mid portion of LAD, dilated with NC and OPN-NC balloon and a 3.0 × 12 mm IVL balloon used (6 cycles) followed by drug eluting stent implantation done with post dilatation. Used NC Balloon and OPN-NC balloon for predilatation and proceeded with 3.0 mm × 12 mm IVL balloon catheter (6 cycles), following which drug-eluting stent implantation was done with post dilatation.
Figure 3: Calcified lesion in proximal to mid LAD stented after IVL and OPN-NC ballooning

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The fourth case [Figure 4] is a 70-year-old female patient, diabetic with non-ST elevation myocardial infarction showing single-vessel disease with proximal LAD 80% calcified lesion. Predilatation of the lesion was done with NC balloon and OPN-NC balloon and shockwave IVL balloon catheter of 3.0 mm × 12 mm with 8 cycles, Due to severe calcified lesion, IVL ballon Shaft ruptured at the end of the procedurebut had no complications. Drug-eluting stent implantation was done with postdilatation.
Figure 4: Female patient with dense calcification of LAD undergoing IVL and OPN-NC balloon and stenting

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All these patients had angiographic and stent boost-supported procedure to optimize the results. Postprocedure results were satisfactory and uneventful in all four cases.

All the patients are on periodic follow-up and are clinically asymptomatic and stable. Follow-up noninvasive tests including stress myocardial perfusion imaging were done to assess for inducible ischemia and was found to be negative in all patients.


  Discussion Top


IVL balloon catheter system includes miniaturized and arrayed lithotripter that are integrated into semicompliant balloon filled with a mixture of contrast and saline which produces shockwave, providing an effective fluid–tissue interface which facilitates efficient coupling of shockwave energy and violent collapse of cavitation bubbles inside the saline contrast filled balloon that impact the surface of the calcific plaque to create micro fracture of the calcium present on both intima and media of the vessel wall so that the lesion gets prepared for stent to be deployed appropriately.[4] The IVL balloon is selected in a 1:1 ratio to the reference coronary diameter often guided by intravascular imaging for optimal lesion preparation. The coronary IVL generator is preprogramed to deliver 10 pulses in sequence at a frequency of 1 pulse/second. Post-IVL angiographic lumen gain is substantial (2 mm2) and circumferential, the diameter of vessel looks “big” after IVL, so that the size of stent can be upsized by 0.5 mm–0.75 mm, which has advantages in long term.[5],[6]

Calcified coronary lesions are difficult to dilate. Unless the lesions are well prepared before stenting, complication rates are high, which includes stent malposition, stent under expansion, polymer abrasion leading to increase MACE which includes instent restenosis, stent thrombosis, higher TLR and TVR and increased cardiac mortality.[7] Various techniques are being used till now to tackle severe calcific de novo coronary lesions, including cutting balloons, scoring balloons, and rotablation.

Rotablation can only affect intimal calcification and has no effect on deep calcification (media/adventitia). It also has limitation of prolong learning curve, complications including No-Flow, Slow-Flow phenomenon, perforation and AVB burr trapping. Recent landmark trial ROTAXUS (Rotation Atherectomy prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease[8] did not demonstrate any improvement in clinical outcomes. The incidence of late perforation is also possible in scoring balloons.[9]

IVL is relatively safe procedure. However, complications may include balloon rupture, dissection, and shocktopics (acoustic shock waves of IVL can induce localized myocardial depolarization by activation of mechanosensitive cardiomyocyte membrane ion channels resulting in atrial or ventricular ectopic beats called shocktopics)[10]

Although fluoroscopy and stent boost is used to assess the amount of calcium in the lesion in these cases, ideally intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are preferred methods to assess both intimal and deep calcium in the lesions as well as P. C. I. results.[11],[12]

Limitations

This is a single-center study with a small number of patients.

Key learning points

  1. To go completely prepared with various techniques when handling densely calcified coronary lesions, including NC balloons, OPN-NC balloons, scoring balloons, rotablation, and IVL, as we may be forced to use one or the other to get optimal result
  2. When coronary imaging facilities like IVUS and OCT are not available in cath lab, it is possible to use stent boost to assess the amount of calcification and can divide the number of pulses of IVL accordingly with max pulses given in densely calcified areas
  3. To expect complications during procedure and handle it perfectly when arises.



  Conclusion Top


Shockwave IVL is now well accepted, USFDA-approved therapy for densely calcified coronary lesions to prepare the bed for optimal stent deployment. It is a safe procedure with relatively less complications and easy learning curve. Although coronary imaging facilities like IVUS and OCT are preferred during procedure, we can use IVL without these facilities and get optimal results with the help of angiography and stent boost. Except for the cost which is high at present, the outcomes of PTCA are encouraging with satisfying long-term follow-up results.

Declaration of patient consent

The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guarantee

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, et al. Feasibility of shockwave coronary intravascular lithotripsy for the treatment of calcified coronary stenoses. Circulation 2019;139:834-6.  Back to cited text no. 1
    
2.
Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, et al. Safety and effectiveness of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: The disrupt CAD II study. Circ Cardiovasc Interv 2019;12:e008434.  Back to cited text no. 2
    
3.
Kereiakes DJ, Hill JM, Ben-Yehuda O, Maehara A, Alexander B, Stone GW. Evaluation of safety and efficacy of coronary intravascular lithotripsy for treatment of severely calcified coronary stenoses: Design and rationale for the Disrupt CAD III trial. Am Heart J 2020;225:10-8.  Back to cited text no. 3
    
4.
De Silva K, Roy J, Webb I, Dworakowski R, Melikian N, Byrne J, et al. A calcific, undilatable stenosis: Lithoplasty, a new tool in the box? JACC Cardiovasc Interv 2017;10:304-6.  Back to cited text no. 4
    
5.
Kassimis G, Raina T, Kontogiannis N, Patri G, Abramik J, Zaphiriou A, et al. How should we treat heavily calcified coronary artery disease in contemporary practice? From atherectomy to intravascular lithotripsy. Cardiovasc Revasc Med 2019;20:1172-83.  Back to cited text no. 5
    
6.
Wong B, El-Jack S, Newcombe R, Glenie T, Armstrong G, Khan A. Shockwave intravascular lithotripsy for calcified coronary lesions: First real-world experience. J Invasive Cardiol 2019;31:46-8.  Back to cited text no. 6
    
7.
Scheller B, Fontaine T, Mangner N, Hoffmann S, Bonaventura K, Clever YP, et al. A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial. Catheter Cardiovasc Interv 2016;88:51-9.  Back to cited text no. 7
    
8.
de Waha S, Allali A, Büttner HJ, Toelg R, Geist V, Neumann FJ, et al. Rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: Two-year clinical outcome of the randomized ROTAXUS trial. Catheter Cardiovasc Interv 2016;87:691-700.  Back to cited text no. 8
    
9.
Kufner S, Joner M, Schneider S, Tölg R, Zrenner B, Repp J, et al. Neointimal modification with scoring balloon and efficacy of drug-coated balloon therapy in patients with restenosis in drug-eluting coronary stents: A randomized controlled trial. JACC Cardiovasc Interv 2017;10:1332-40.  Back to cited text no. 9
    
10.
Wilson SJ, Spratt JC, Hill J, Spence MS, Cosgrove C, Jones J, et al. Incidence of “shocktopics” and asynchronous cardiac pacing in patients undergoing coronary intravascular lithotripsy. EuroIntervention 2020;15:1429-35.  Back to cited text no. 10
    
11.
Serruys PW, Katagiri Y, Onuma Y. Shaking and breaking calcified plaque: Lithoplasty, a breakthrough in interventional armamentarium? JACC Cardiovasc Imaging 2017;10:907-11.  Back to cited text no. 11
    
12.
Azzalini L, Bellini B, Montorfano M, Carlino M. Intravascular lithotripsy in chronic total occlusion percutaneous coronary intervention. EuroIntervention 2019;15:e1025-6.  Back to cited text no. 12
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4]



 

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