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Coronary stents under-expansion successfully treated with shockwave lithoplasty
CARREV-01768; No of Pages 3 Cardiovascular Revascularization Medicine xxx (xxxx) xxx
Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Coronary stents under-expansion successfully treated with shockwave lithoplasty Andrea Moretti ⁎, Michele Schiariti, Alessandra De Luca, Simone Griffo, Cesare Greco Department of Heart and Great Vessels, Sapienza University of Rome, Rome, Italy
a r t i c l e
i n f o
Article history: Received 15 October 2019 Received in revised form 13 November 2019 Accepted 3 December 2019 Available online xxxx
a b s t r a c t Calcified coronary plaque represents a challenging scenario for interventional cardiology. It is often associated with stent under-expansion during percutaneous coronary intervention. We report two cases of unexpected coronary stent under-expansion due to heavily calcified plaque, successfully treated with shockwave coronary lithoplasty. Crown Copyright © 2019 Published by Elsevier Inc. All rights reserved.
Keywords: Percutaneous coronary intervention Coronary lithoplasty Stent under-expansion
1. Case 1 A 68-years-old Caucasian man with a Canadian Cardiovascular Society (CCS) class 3 angina pectoris referred to our catheterization laboratory. His clinical history reported arterial hypertension and smoking habit. Coronary angiography was performed via right radial approach and revealed a long critical stenosis in the proximal and middle segment of left anterior descending (LAD) artery (Fig. 1A). After engaged the left coronary with a 6Fr CLS 3.5 guiding catheter (Boston Scientific, Natick, MA, USA) and easily crossed the stenosis with a pressure guidewire (Verrata, Volcano Corp, Philips, Andover, MA, USA) instantaneous wave-free ratio (iFR) was performed showing a value of 0.8. So, percutaneous coronary intervention (PCI) was performed, with a direct stenting technique: three Resolute Onyx (Medtronic, Minneapolis, MN, USA) drug-eluting stent of 2.75 × 26 mm, 3.0 × 12 mm, 3.5 × 26 mm were implanted from the middle to the proximal segment (Fig. 1B–D). Despite several conventional postdilatations with over-sized non-compliant balloons inflated at 26 atm, the angiography revealed an important stent under-expansion in the overlap site of first and second implanted stents (Fig. 1E). We tried to perform an intravascular ultrasound control (20-MHz, 2.9 Fr IVUS system, crossing profile 0.046-inch, Eagle Eye, Volcano Corp, Philips, Andover, MA, USA) but the probe was unable to cross the lesion; the minimal stent area (MSA) immediately proximal to the lesion was 3.0 mm2 (Fig. 1F). Subsequently, eight pulses of 10 sec of ultrasound energy were applied through a 2.5 mm shockwave lithoplasty balloon (Shockwave Medical, Fremont, ⁎ Corresponding author at: Department of Heart and Great Vessels, Sapienza University of Rome, Policlinico Umberto I, Viale del Policlinico 155, 00161 Rome, Italy. E-mail address: [email protected] (A. Moretti).
CA, USA) first inflated to 4 atm and then to 6 atm (Fig. 1G). Once the lithoplasty treatment was completed, a 2.75 mm non-compliant balloon was inflated to 16 atm to further dilate the segment (Fig. 1H). Final angiography showed the good result and IVUS confirm the optimal double layer stent expansion (above 90% stent expansion; MSA 5.4 mm2) (Fig. 1I–L). Patient was discharged 72 h later in good clinical condition. 2. Case 2 A 51-years-old Caucasian man was admitted to our institution because of a Killip II infero-lateral ST–segment elevation myocardial infarction (STEMI). His past medical history was characterized by arterial hypertension, type 2 diabetes mellitus and smoking habit. Urgent coronary angiography for a primary PCI was performed via the right femoral approach showing no significant obstructive lesions in the left coronary artery and a dominant right coronary artery (RCA) with an occlusion at the proximal segment (Fig. 2A). RCA was engaged with a 6-Fr JR4 guide catheter (Boston Scientific, Natick, MA, USA) and the occlusion was crossed with a 0.014-in. workhorse guidewire (Luge, Boston Scientific, Natick, MA, USA): the angiography showed a critical stenosis with a modest thrombus burden. After gently dilatations with 2.5 mm semi-compliant balloon (Fig. 2B), a Resolute Onyx (Medtronic, Minneapolis, MN, USA) drug-eluting stent of 3.5 × 34 mm was deployed at 14 atm with a complete restoration of coronary flow (Fig. 2D). Several conventional post-dilatations with a 4.0 mm noncompliant balloon inflated to 24 atm failed to expand stent struts in the middle segment, that always showed a major waist (Fig. 2E). Patient was transferred in our coronary unit in stable clinical conditions. Since a shock-wave device was not available at that time, 48 h later a second
https://doi.org/10.1016/j.carrev.2019.12.006 1553-8389/Crown Copyright © 2019 Published by Elsevier Inc. All rights reserved.
Please cite this article as: A. Moretti, M. Schiariti, A. De Luca, et al., Coronary stents under-expansion successfully treated with shockwave lithoplasty, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.006
2
A. Moretti et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
Fig. 1. (A) Cranial view of left anterior descending artery: long critical stenosis in the proximal and middle segment. (B) Resolute Onyx 2.75 × 26 mm: visible stent under-expansion at the proximal segment (white arrow). (C) Resolute Onyx 3.0 × 12 mm implantation: visible distal stent under-expansion at the overlap site (white arrow). (D) Resolute Onyx 3.5 × 26 implantation. (E) Post-dilatation with a 4.0 mm non-compliant balloon inflated to 24 atm: visible under-expansion notch (white arrow). (F) IVUS shows 270° calcifications and a MSA of 3.0 mm2 immediately proximal to the under-expansion zone. (G) Dilatation with a 2.5 mm shockwave lithoplasty balloon to 6 atm. (H) Post-dilatation with a 2.75 mm noncompliant balloon inflated to 16 atm: complete stent expansion with a good balloon profile. (I) Final angiographic result. (L) IVUS confirm good stent expansion and apposition (MSA 5.4 mm2).
coronary angiography was scheduled. The IVUS control confirmed stent under-expansion with a major in-stent diameter of 2.24 mm (MSA 2.5 mm2) (Fig. 2F). Then a coronary lithoplasty was performed: nine pulses of 10 sec of ultrasound energy were applied through a 3.5 mm shockwave lithoplasty balloon (Shockwave Medical, Fremont, CA, USA) first inflated to 4 atm and then to 6 atm (Fig. 2G). The result was optimized with a 4.0 mm non-compliant balloon at 16 atm (Fig. 2H). Final angiography and IVUS control confirmed the complete stent expansion (MSA 7.1 mm2) (Fig. 2I–L). Patient was discharged on the seventh day. 3. Discussion The presence of calcified lesions represents a challenging scenario for interventional cardiology because of high procedural risk. Coronary calcifications can lead to under-expansion of deployed stents [1]. It is
more frequently during direct stenting technique even following an inadequate balloon lesion preparation. In our first case no severe calcifications of the coronary arteries were noticeable on fluoroscopy so we decided to perform a direct. Nevertheless, an adequate pre-dilatation or an intravascular imaging lesion evaluation could avoid this unexpected stent under-expansion. In the second case, dilatation with 0.75:1 size balloon in the vessel no showed major waist, but probably a more appropriate dilatation with a 1:1 size balloon could evidence an adequate lesion preparation. In both cases, a missing or a not adequate lesion preparation associated with the lack of intracoronary lesion evaluation should be considered the reason of the non-optimal result. If conventional lesion dilatation are not effective alternative techniques should be considered (cutting balloon, scoring balloon, rotational atherectomy, coronary lithoplasty). Stent under-expansion is related with a higher rate of future complications, such as restenosis or thrombosis, so achieve a fully
Fig. 2. (A) Left anterior oblique view of right coronary artery: thrombotic occlusion at middle tract. (B) Pre-dilatation with 2.5 semi-compliant balloon. (C) Flow restoration after predilatation. (D) Resolute Onyx 3.5 × 34 mm implantation: visible under-expansion notch (white arrow). (E) Post-dilatation with a 4.0 mm non-compliant balloon inflated to 24 atm: visible under-expansion notch (white arrow). (F) IVUS show 180° calcifications and confirm stent under-expansion (MSA 2.5 mm2). (G) Dilatation with a 3.5 mm shockwave lithoplasty balloon to 6 atm. (H) Post-dilatation with a 4.0 mm non-compliant balloon inflated to 16 atm: complete stent expansion with a good balloon profile. (I) Final angiographic result. (L) IVUS confirm good stent expansion and apposition (MSA 7.1 mm2).
Please cite this article as: A. Moretti, M. Schiariti, A. De Luca, et al., Coronary stents under-expansion successfully treated with shockwave lithoplasty, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.006
A. Moretti et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
stent expansion is mandatory. Long and repeated inflations with non-compliant balloons or ultra-high-pressure balloons could resolve most cases. In these experiences non-compliant balloon inflations were ineffective and, at that moment, ultra-high pressure balloons were not available in our laboratory. Although rotational atherectomy is an option, it is not an ideal one because it is associated with increased complications due to the presence of stent struts coming in contact with the burr, particularly in freshly deployed stent [2]. Anyway, rotational atherectomy remains the last resource when lithoplasty balloon fails to cross tight lesions. The lithoplasty system is a novel plaque debulking technology that integrates angioplasty balloon catheter device with the calcium disrupting power of sonic pressure waves. Unfortunately, this device is burdened by an unfavourable crossing profile compared to that of a non-compliant balloon (0.044 ±0.002-inch vs 0.017-inch of NC Emerge, Boston Scientific, Natick, MA, USA). Recently, some authors described stents under-expansion due to calcified plaques successfully treated with coronary lithoplasty [3–6]. Our findings strengthen the value of coronary lithoplasty as a bailout procedure to treat stent underexpansion. Furthermore, in our first case this technique allows us a safe calcium debulking even through two layers of struts.
3
stent deployment remains the most important step to prevent stent under-expansion and subsequent complications. Recently, coronary lithoplasty showed to be an easy and safe technique to achieve a good lesion preparation. In our reports, coronary lithoplasty after unexpected stent under-expansion allowed us to achieve full expansion of the stent, even in the setting of a recent STEMI.
References [1] Mintz GS. Intravascular imaging of coronary. JACC Cardiovasc Imaging 2015;8(4): 461–71 Available from: https://doi.org/10.1016/j.jcmg.2015.02.003. [2] Herzum M, Cosmeleata RMB. Managing a complication after direct stenting: removal of a maldeployed stent with rotational atherectomy. Heart 2005: 4–6. [3] Morabito G, Tripolino C, Joseph E, Placido TA. Case of stent under-expansion due to calcified plaque treated with shockwave lithoplasty. Cardiology 2018:75–7. [4] Ali ZA, Mcentegart M, Hill JM, Spratt JC. Intravascular lithotripsy for treatment of stent underexpansion secondary to severe coronary calcification. Eur Heart J 2018:1–2. https://doi.org/10.1093/eurheartj/ehy747. [5] Watkins S, Good R, Hill J, Brinton TJ, Oldroyd KG. Intravascular lithotripsy to treat a severely underexpanded coronary stent. EuroIntervention 2019:124–5. [6] Salazar C, Escaned J, Tirado G, Gonzalo N. Undilatable calcific coronary stenosis causing stent underexpansion and late stent thrombosis. JACC Cardiovasc Interv 2019;12 (15):10–2.
4. Conclusion An appropriate lesion evaluation followed by an adequate lesion preparation, even with unconventional debulking techniques, prior to
Please cite this article as: A. Moretti, M. Schiariti, A. De Luca, et al., Coronary stents under-expansion successfully treated with shockwave lithoplasty, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.006
Contents lists available at ScienceDirect
Cardiovascular Revascularization Medicine
Coronary stents under-expansion successfully treated with shockwave lithoplasty Andrea Moretti ⁎, Michele Schiariti, Alessandra De Luca, Simone Griffo, Cesare Greco Department of Heart and Great Vessels, Sapienza University of Rome, Rome, Italy
a r t i c l e
i n f o
Article history: Received 15 October 2019 Received in revised form 13 November 2019 Accepted 3 December 2019 Available online xxxx
a b s t r a c t Calcified coronary plaque represents a challenging scenario for interventional cardiology. It is often associated with stent under-expansion during percutaneous coronary intervention. We report two cases of unexpected coronary stent under-expansion due to heavily calcified plaque, successfully treated with shockwave coronary lithoplasty. Crown Copyright © 2019 Published by Elsevier Inc. All rights reserved.
Keywords: Percutaneous coronary intervention Coronary lithoplasty Stent under-expansion
1. Case 1 A 68-years-old Caucasian man with a Canadian Cardiovascular Society (CCS) class 3 angina pectoris referred to our catheterization laboratory. His clinical history reported arterial hypertension and smoking habit. Coronary angiography was performed via right radial approach and revealed a long critical stenosis in the proximal and middle segment of left anterior descending (LAD) artery (Fig. 1A). After engaged the left coronary with a 6Fr CLS 3.5 guiding catheter (Boston Scientific, Natick, MA, USA) and easily crossed the stenosis with a pressure guidewire (Verrata, Volcano Corp, Philips, Andover, MA, USA) instantaneous wave-free ratio (iFR) was performed showing a value of 0.8. So, percutaneous coronary intervention (PCI) was performed, with a direct stenting technique: three Resolute Onyx (Medtronic, Minneapolis, MN, USA) drug-eluting stent of 2.75 × 26 mm, 3.0 × 12 mm, 3.5 × 26 mm were implanted from the middle to the proximal segment (Fig. 1B–D). Despite several conventional postdilatations with over-sized non-compliant balloons inflated at 26 atm, the angiography revealed an important stent under-expansion in the overlap site of first and second implanted stents (Fig. 1E). We tried to perform an intravascular ultrasound control (20-MHz, 2.9 Fr IVUS system, crossing profile 0.046-inch, Eagle Eye, Volcano Corp, Philips, Andover, MA, USA) but the probe was unable to cross the lesion; the minimal stent area (MSA) immediately proximal to the lesion was 3.0 mm2 (Fig. 1F). Subsequently, eight pulses of 10 sec of ultrasound energy were applied through a 2.5 mm shockwave lithoplasty balloon (Shockwave Medical, Fremont, ⁎ Corresponding author at: Department of Heart and Great Vessels, Sapienza University of Rome, Policlinico Umberto I, Viale del Policlinico 155, 00161 Rome, Italy. E-mail address: [email protected] (A. Moretti).
CA, USA) first inflated to 4 atm and then to 6 atm (Fig. 1G). Once the lithoplasty treatment was completed, a 2.75 mm non-compliant balloon was inflated to 16 atm to further dilate the segment (Fig. 1H). Final angiography showed the good result and IVUS confirm the optimal double layer stent expansion (above 90% stent expansion; MSA 5.4 mm2) (Fig. 1I–L). Patient was discharged 72 h later in good clinical condition. 2. Case 2 A 51-years-old Caucasian man was admitted to our institution because of a Killip II infero-lateral ST–segment elevation myocardial infarction (STEMI). His past medical history was characterized by arterial hypertension, type 2 diabetes mellitus and smoking habit. Urgent coronary angiography for a primary PCI was performed via the right femoral approach showing no significant obstructive lesions in the left coronary artery and a dominant right coronary artery (RCA) with an occlusion at the proximal segment (Fig. 2A). RCA was engaged with a 6-Fr JR4 guide catheter (Boston Scientific, Natick, MA, USA) and the occlusion was crossed with a 0.014-in. workhorse guidewire (Luge, Boston Scientific, Natick, MA, USA): the angiography showed a critical stenosis with a modest thrombus burden. After gently dilatations with 2.5 mm semi-compliant balloon (Fig. 2B), a Resolute Onyx (Medtronic, Minneapolis, MN, USA) drug-eluting stent of 3.5 × 34 mm was deployed at 14 atm with a complete restoration of coronary flow (Fig. 2D). Several conventional post-dilatations with a 4.0 mm noncompliant balloon inflated to 24 atm failed to expand stent struts in the middle segment, that always showed a major waist (Fig. 2E). Patient was transferred in our coronary unit in stable clinical conditions. Since a shock-wave device was not available at that time, 48 h later a second
https://doi.org/10.1016/j.carrev.2019.12.006 1553-8389/Crown Copyright © 2019 Published by Elsevier Inc. All rights reserved.
Please cite this article as: A. Moretti, M. Schiariti, A. De Luca, et al., Coronary stents under-expansion successfully treated with shockwave lithoplasty, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.006
2
A. Moretti et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
Fig. 1. (A) Cranial view of left anterior descending artery: long critical stenosis in the proximal and middle segment. (B) Resolute Onyx 2.75 × 26 mm: visible stent under-expansion at the proximal segment (white arrow). (C) Resolute Onyx 3.0 × 12 mm implantation: visible distal stent under-expansion at the overlap site (white arrow). (D) Resolute Onyx 3.5 × 26 implantation. (E) Post-dilatation with a 4.0 mm non-compliant balloon inflated to 24 atm: visible under-expansion notch (white arrow). (F) IVUS shows 270° calcifications and a MSA of 3.0 mm2 immediately proximal to the under-expansion zone. (G) Dilatation with a 2.5 mm shockwave lithoplasty balloon to 6 atm. (H) Post-dilatation with a 2.75 mm noncompliant balloon inflated to 16 atm: complete stent expansion with a good balloon profile. (I) Final angiographic result. (L) IVUS confirm good stent expansion and apposition (MSA 5.4 mm2).
coronary angiography was scheduled. The IVUS control confirmed stent under-expansion with a major in-stent diameter of 2.24 mm (MSA 2.5 mm2) (Fig. 2F). Then a coronary lithoplasty was performed: nine pulses of 10 sec of ultrasound energy were applied through a 3.5 mm shockwave lithoplasty balloon (Shockwave Medical, Fremont, CA, USA) first inflated to 4 atm and then to 6 atm (Fig. 2G). The result was optimized with a 4.0 mm non-compliant balloon at 16 atm (Fig. 2H). Final angiography and IVUS control confirmed the complete stent expansion (MSA 7.1 mm2) (Fig. 2I–L). Patient was discharged on the seventh day. 3. Discussion The presence of calcified lesions represents a challenging scenario for interventional cardiology because of high procedural risk. Coronary calcifications can lead to under-expansion of deployed stents [1]. It is
more frequently during direct stenting technique even following an inadequate balloon lesion preparation. In our first case no severe calcifications of the coronary arteries were noticeable on fluoroscopy so we decided to perform a direct. Nevertheless, an adequate pre-dilatation or an intravascular imaging lesion evaluation could avoid this unexpected stent under-expansion. In the second case, dilatation with 0.75:1 size balloon in the vessel no showed major waist, but probably a more appropriate dilatation with a 1:1 size balloon could evidence an adequate lesion preparation. In both cases, a missing or a not adequate lesion preparation associated with the lack of intracoronary lesion evaluation should be considered the reason of the non-optimal result. If conventional lesion dilatation are not effective alternative techniques should be considered (cutting balloon, scoring balloon, rotational atherectomy, coronary lithoplasty). Stent under-expansion is related with a higher rate of future complications, such as restenosis or thrombosis, so achieve a fully
Fig. 2. (A) Left anterior oblique view of right coronary artery: thrombotic occlusion at middle tract. (B) Pre-dilatation with 2.5 semi-compliant balloon. (C) Flow restoration after predilatation. (D) Resolute Onyx 3.5 × 34 mm implantation: visible under-expansion notch (white arrow). (E) Post-dilatation with a 4.0 mm non-compliant balloon inflated to 24 atm: visible under-expansion notch (white arrow). (F) IVUS show 180° calcifications and confirm stent under-expansion (MSA 2.5 mm2). (G) Dilatation with a 3.5 mm shockwave lithoplasty balloon to 6 atm. (H) Post-dilatation with a 4.0 mm non-compliant balloon inflated to 16 atm: complete stent expansion with a good balloon profile. (I) Final angiographic result. (L) IVUS confirm good stent expansion and apposition (MSA 7.1 mm2).
Please cite this article as: A. Moretti, M. Schiariti, A. De Luca, et al., Coronary stents under-expansion successfully treated with shockwave lithoplasty, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.006
A. Moretti et al. / Cardiovascular Revascularization Medicine xxx (xxxx) xxx
stent expansion is mandatory. Long and repeated inflations with non-compliant balloons or ultra-high-pressure balloons could resolve most cases. In these experiences non-compliant balloon inflations were ineffective and, at that moment, ultra-high pressure balloons were not available in our laboratory. Although rotational atherectomy is an option, it is not an ideal one because it is associated with increased complications due to the presence of stent struts coming in contact with the burr, particularly in freshly deployed stent [2]. Anyway, rotational atherectomy remains the last resource when lithoplasty balloon fails to cross tight lesions. The lithoplasty system is a novel plaque debulking technology that integrates angioplasty balloon catheter device with the calcium disrupting power of sonic pressure waves. Unfortunately, this device is burdened by an unfavourable crossing profile compared to that of a non-compliant balloon (0.044 ±0.002-inch vs 0.017-inch of NC Emerge, Boston Scientific, Natick, MA, USA). Recently, some authors described stents under-expansion due to calcified plaques successfully treated with coronary lithoplasty [3–6]. Our findings strengthen the value of coronary lithoplasty as a bailout procedure to treat stent underexpansion. Furthermore, in our first case this technique allows us a safe calcium debulking even through two layers of struts.
3
stent deployment remains the most important step to prevent stent under-expansion and subsequent complications. Recently, coronary lithoplasty showed to be an easy and safe technique to achieve a good lesion preparation. In our reports, coronary lithoplasty after unexpected stent under-expansion allowed us to achieve full expansion of the stent, even in the setting of a recent STEMI.
References [1] Mintz GS. Intravascular imaging of coronary. JACC Cardiovasc Imaging 2015;8(4): 461–71 Available from: https://doi.org/10.1016/j.jcmg.2015.02.003. [2] Herzum M, Cosmeleata RMB. Managing a complication after direct stenting: removal of a maldeployed stent with rotational atherectomy. Heart 2005: 4–6. [3] Morabito G, Tripolino C, Joseph E, Placido TA. Case of stent under-expansion due to calcified plaque treated with shockwave lithoplasty. Cardiology 2018:75–7. [4] Ali ZA, Mcentegart M, Hill JM, Spratt JC. Intravascular lithotripsy for treatment of stent underexpansion secondary to severe coronary calcification. Eur Heart J 2018:1–2. https://doi.org/10.1093/eurheartj/ehy747. [5] Watkins S, Good R, Hill J, Brinton TJ, Oldroyd KG. Intravascular lithotripsy to treat a severely underexpanded coronary stent. EuroIntervention 2019:124–5. [6] Salazar C, Escaned J, Tirado G, Gonzalo N. Undilatable calcific coronary stenosis causing stent underexpansion and late stent thrombosis. JACC Cardiovasc Interv 2019;12 (15):10–2.
4. Conclusion An appropriate lesion evaluation followed by an adequate lesion preparation, even with unconventional debulking techniques, prior to
Please cite this article as: A. Moretti, M. Schiariti, A. De Luca, et al., Coronary stents under-expansion successfully treated with shockwave lithoplasty, Cardiovascular Revascularization Medicine, https://doi.org/10.1016/j.carrev.2019.12.006