Shockwave Intravascular Lithotripsy Research Articles

Lithotripsy-Assisted Transcatheter Mitral Valve Replacement for Severe Mitral Annular and Valve Calcification.

Transcatheter mitral valve replacement (TMVR) is evolving; however, limitations include severe calcification of the mitral valve leaflets and mitral annular calcification (MAC), which may be associated with incomplete valve expansion. Shockwave intravascular lithotripsy (IVL)-assisted percutaneous mitral valvuloplasty to treat calcific mitral stenosis has been reported. We describe the first human use of IVL-assisted transseptal TMVR with the Intrepid valve to treat a severely calcified mitral valve in a patient with severe stenosis and regurgitation. An 83-year-old man with rheumatic heart disease and severe MAC (MAC score, 10; calcium volume score, 7756 cm3) presented with combined mitral stenosis and regurgitation (valve area, 1.5 cm2; 3+ mitral regurgitation [MR]) and medically refractory heart failure symptoms and was enrolled into the APOLLO (Transcatheter Mitral Valve Replacement With the Medtronic Intrepid TMVR System in Patients With Severe Symptomatic Mitral Regurgitation) trial of Intrepid valve TMVR. Transseptal implantation of a 48-mm Intrepid valve was facilitated by Shockwave IVL delivered via two 8.0 × 60-mm M5+ balloons placed across the mitral annulus before implantation. Cerebral embolic protection during IVL and valve implant was provided by a Sentinel device and left subclavian balloon occlusion. Despite initial postimplant valve frame deformation and moderate central MR, postdilation achieved valve frame expansion and reduced MR. Echocardiography and computed tomography performed before hospital discharge and at 30 days show progressive valve frame expansion in the anteroposterior dimension, increased valve area, and resolution of MR. Intravascular lithotripsy of severe MAC before self-expanding TMVR may enhance annular compliance, mitigate fibroelastic recoil, and minimize TMVR valve frame deformation. Although promising, further study is required before IVL is considered a routine adjunct for TMVR in severe MAC.

870 COMBINING PERCUTANEOUS CORONARY INTERVENTION AND TRASCATHETER AORTIC VALVE REPLACEMENT PROCEDURES: THE IMPORTANCE OF INTRAVASCULAR LITHOTRIPSY

Abstract Background Calcified coronary artery disease and severe valvular aortic stenosis (AS) often coexist. For instance, severely calcified lesions may strongly influence the revascularization strategy in patients undergoing transcutaneous aortic valve replacement (TAVR). Shock wave intravascular lithotripsy (S-IVL) (Shockwave Medical Inc. Santa Clara, CA) is the only technology available that cracks both medial and intimal calcium while minimizing trauma to the vessel wall, thus allowing a safe plaque debulking. We report a case of percutaneous coronary intervention (PCI) and TAVR in the same procedure, where S-IVL has been used to treat a heavily calcified lesion and optimize stent under-expansion. Case Report A 79 years-old male patient with a history of diabetes mellitus type 2, hypertension, and peripheral artery disease, was admitted to our institution with symptomatic severe AS and severe calcified left anterior descending (LAD) artery lesion at CT scan. Deemed eligible for TAVR, Heart Team planned a percutaneous coronary intervention (PCI) of LAD and TAVR in the same procedure. Through the left radial artery, coronary angiography confirmed 90% stenosis of the LAD at the central segment. Accordingly, pre-dilatation of the stenosis was performed with a 2.5×12 mm non-compliant balloon (NCB) and, because of the severe calcification, S-IVL with a 3.0×12 mm balloon inflated at 4-6 Atmospheres (ATM), delivering 40 pulses. Following, a 3.5×18-mm drug-eluting stent was implanted at 18 ATM. After implantation, an inadequate expansion of the stents was observed, which persisted despite post-dilation with 3.75×8 mm NCB at high-pressure. Bail-out S-IVL was then performed with the 3.0×12 mm balloon inflated at 4-6 ATM, delivering 40 pulses in-stent, followed by a further stent post-dilated with a 3.75×8 mm NCB up to 20 ATM. The final angiogram showed a satisfactory stent expansion. Since the low contrast volume was used, we decided to go ahead with transfemoral TAVR. Therefore, through the left femoral artery access, a 34-mm self-expandable Evolut R valve was implanted. Transthoracic echocardiography showed optimal valve implantation with a trivial periprosthetic leak. No complications were observed after the procedures and the patient was discharged after 6 days with 6 months of mandated dual antiplatelet therapy (Aspirin and Clopidogrel). Discussion In this case, the bail-out use of S-IVL was essential for an optima stent implantation, allowing TAVR procedure and avoiding prolonged theoretical antithrombotic therapy underlying suboptimal stent implantation. Despite encouraging initial results, future large studies with long-term observation are required to evaluate the safety and efficacy of S-IVL in this scenario.

Rota-Lithotripsy as a Novel Bail-Out Strategy for Highly Calcified Coronary Lesions in Acute Coronary Syndrome.

Heavily calcified lesions in acute coronary syndrome (ACS) still represent a challenging subset for percutaneous coronary intervention (PCI). Rota-lithotripsy-a marriage of rotational atherectomy and intravascular lithotripsy-has recently been introduced to clinical practice as a novel therapeutic option. This study is among the to present the 6-month clinical outcomes of rota-lithotripsy when performed in the ACS setting. The study cohort consisted of 15 consecutive ACS patients who underwent a rota-lithotripsy-PCI due to the presence of a highly calcified, undilatable lesion. The procedural success ratio reached 100%. During the 6-month follow-up, in two of the patients, instances of MACE (major adverse cardiac events) occurred, including one fatal event. Additionally, during the observation period, one target lesion failure, due to subacute stent thrombosis, was identified. Rotational atherectomy with the subsequent use of shockwave intravascular lithotripsy appears to be a safe and effective therapeutic bail-out option for the management of highly calcified coronary artery lesions. Despite, these initial favorable outcomes, carrying out a large number of studies with long-term observations is still necessary in order to establish the potential benefits and shortcomings of rota-lithotripsy.

Shockwave intravascular lithotripsy (IVL) for calcified coronary lesions; a real world multicentre European study with long term follow up

Abstract Background The presence of calcium in atherosclerotic plaques is a challenge for successful angioplasty and is an independent risk factor for restenosis and stent thrombosis. Despite conventional tools (non-compliant, scoring and cutting balloons and rotational atherectomy), cracking calcium can still be challenging and incomplete. Intra-vascular lithotripsy (IVL) has shown promising results, although long-term data on safety and efficacy from real-world is lacking. Purpose This study was undertaken to report long-term outcomes following use of IVL from a European multi-centre experience. Methods This was a multicentre, retrospective observational study in which we enrolled all patients treated with shockwave lithotripsy from November 2018 to June 2021. Procedural success, complications and in hospital events were evaluated. The clinical outcomes during follow-up included cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR), and major adverse cardiac event (MACE) (composite of cardiac death, TVMI, and TVR). Result A total of 272 patients were treated with IVL, with a mean age of 72 9.1 years and 78.5% (n=216) were male. Forty percent (n=110) were diabetic while 16% (n=45) had chronic kidney disease. Acute coronary syndrome was the presentation in 36% (n=99) while 51% (n=141) had stable angina. De novo lesions accounted for 78% (n=215) of the cases and the remainder were in-stent restenosis (21%; n=58). The LAD was the commonest artery treated 50% (n=139) followed by RCA 24% (n=68). Intracoronary imaging was performed in 33% of cases. Upfront IVL strategy was adopted in 37% (n=101) while 63% (n=171) were bail out procedures due to inadequate pre dilatation. Adjuvant rotational atherectomy was used on 31 (11.4%) cases. Procedural success was achieved in 96% (260) cases with major complications in 8 cases (perforation requiring covered stent in 3 patients) but there was no in-hospital mortality. Clinical outcomes over the median follow up of 641 days are shown in the table. Conclusion This is the largest multicentre registry with long term follow up. It has demonstrated that IVL appears to be safe with high success rates, low rates of complication and no in-hospital mortality. The long-term follow-up show promising results with low rates of hard-endpoints and revascularization rates. Funding Acknowledgement Type of funding sources: None.

Intravascular Lithotripsy as a Novel Treatment Method for Calcified Unprotected Left Main Diseases-Comparison to Rotational Atherectomy-Short-Term Outcomes.

Background: The unprotected calcified Left Main disease represents a high-risk subset for percutaneous coronary intervention (PCI), and it is associated with a higher number of periprocedural complications and an increased rate of in-stent thrombosis and restenosis. Adequate lesion preparation plays a crucial role in achieving a favorable PCI outcome. Rotational Atherectomy (RA) is a well-established plaque-modifying method; nevertheless, the data regarding the effectiveness of RA in LM diseases is scarce. Recently, the novel ShockWave-Intravascular-Lithotripsy(S-IVL) device has been introduced to the PCI armamentarium in order to modify the calcified plaque. Methods: We performed a retrospective evaluation of 44 consecutive subjects who underwent the LM-PCI, and who were supported by either the RA or S-IVL. Results: The Rota group consisted of 29 patients with a mean syntax score of 28.0 ± 7.5. The S-IVL group was composed of 15 subjects with a syntax score of 23.3 ± 13.0 There were no statistical differences regarding MACE between the RA and Shockwave arms of the in-hospital group (10.3% vs. 6.7%), or in the six month (17.2% vs. 13.3%) follow-up group. Conclusions: RA and S-IVL could be safe and effective therapeutic strategies for calcified LM disease. Further studies with a higher number of participants and longer follow-up times are warranted to establish the potential benefits of RA and S-IVL for the management of LM stenosis.

Management of Densely Calcified Coronary Lesions using OPN–NC Balloon and Shockwave Intravascular Lithotripsy Procedure

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.

Efficacy of shockwave C2 coronary intravascular lithotripsy for management of severely calcified left anterior descending stenosis

Severely calcified coronary lesions remain a formidable hurdle for percutaneous coronary intervention as it averts the stent delivery and complete stent apposition. To overcome this Achilles heel of an interventional cardiology, a current US FDA approved method named shockwave intravascular lithotripsy (S-IVL; Shockwave Medical, Inc) is used for its treatment. Herein, we report a case of a 53-year-old dyslipidemic male with severely calcified left anterior descending artery (LAD) lesion that was successfully treated with S-IVL and drug-eluting stent implantation. At first, the patient was presented with complaints of chest pain and breathlessness. His coronary angiogram revealed heavily calcified stenosis in diffuse mid LAD—completely totally occluded mid-diagonal (D) 1 that was checked through retrograde filling via collateral and calcified stenosis in ostial D2, mild stenosis in ostial left circumflex and mild stenosis at distal before crux 50% stenosis in dominant right coronary artery. Following this, it was decided to proceed with primary percutaneous coronary intervention with S-IVL to LAD. After successful delivery of S-IVL to LAD, a Tetriflex sirolimus eluting stent (Sahajanand Medical Technologies Ltd., Surat, India) was successfully implanted at LAD. Finally, the patient’s condition was stabilized and discharged after two days of index procedure.

Acoustic energy and cardiac electrophysiology: Ultrasonic cardiac pacing and novel shockwave ablation catheters.

Sonic shockwaves (SSW) can cause cardiac pacing. This observation first came to notice with the early urologic lithotripters and later with the cumulative use of shockwaves to treat calcified coronary lesions. There have been multiple observations of cardiac pacing and tachyarrhythmias occurring during SSW delivery using the Shockwave Intravascular Lithotripsy system. The underlying mechanism of cardiac cell depolarization by SSW is still under debate. At the end of the last decade, we are witnessing this technology in electrophysiology with the WiSE-CRT system that uses sonic waves to synchronize the ventricles and novel shockwave ablation catheters that can treat tachyarrhythmia foci with minor collateral damage.

TCTAP A-054 Shockwave Intravascular Lithotripsy as a Novel Strategy for the Treatment of Stent Underexpansion Caused by Calcified Plaques

TCTAP A-054 Shockwave Intravascular Lithotripsy as a Novel Strategy for the Treatment of Stent Underexpansion Caused by Calcified Plaques

TCTAP A-044 Novel Use of Shockwave Intravascular Lithotripsy With Drug Coated Balloon Angioplasty in De Novo Calcified Coronary Lesions

TCTAP A-044 Novel Use of Shockwave Intravascular Lithotripsy With Drug Coated Balloon Angioplasty in De Novo Calcified Coronary Lesions

Successful shockwave intravascular lithotripsy of an under-expanded stent after a month from primary implantation.

Successful shockwave intravascular lithotripsy of an under-expanded stent after a month from primary implantation.

Real-World Experience of Coronary Shockwave Lithotripsy (S-IVL) for Calcified Coronary Lesions

Coronary shockwave intravascular lithotripsy (S-IVL) is a novel method of calcium modification with a role still being defined in day-to-day percutaneous coronary intervention (PCI) given its cost and availability in the Australian healthcare system. Our aim was to describe the real-world use of coronary S-IVL.

272 Combined rotational atherectomy and intravascular lithotripsy for heavy calcified coronary artery

Abstract Aims Percutaneous coronary intervention (PCI) of heavily calcified coronary lesions still represents a challenge for interventional cardiologists, with higher risk of immediate complications, late failure due to stent underexpansion or malapposition and consequent poor clinical outcome. Rotational atherectomy (RA) is a well-known calcium debulking modality. However, when coronary plaques present a significant amount of circumferential deep calcium, RA alone may not be able to achieve adequate lesion preparation. The combined use of intravascular lithotripsy (IVL) and RA, a technique called ‘Rotatripsy’, can be an effective approach in order to enable optimal stent implantation. We present a case of a calcific right coronary artery (RCA) PCI successfully treated by ‘Rotatripsy’ technique. Methods and results A 78-years-old man presented to our emergency department complaining of acute chest pain and dyspnoea. The electrocardiogram revealed ST-segment elevation in aVR and a diffuse ST-segment depression. Transthoracic echocardiography showed left ventricular anterior, septal, and apical walls akinesia. An urgent coronary angiography showed a critical distal left main (LM) stenosis involving the left anterior descending (LAD) artery ostium and a heavy calcified dominant RCA with two tandem sub-occlusive stenosis in the mid segment (Figure 1A). An immediate PCI with two drug eluting stents (DES) in the LM and LAD was performed. The patient was scheduled two days later for RCA PCI. RCA was engaged via left radial approach with a 6-Fr AL1 guiding catheter and the lesions were crossed with a Sion Blue wire. Using a Finecross MG microcatheter, an extra-support Rotawire was placed distally in the RCA. However, after multiple rotablation with 1.5 mm burr (Figure 1B), the mid segment lesion (Figure 1C) was still undilatable with a 3.5 mm non-compliant balloon (NCB) at 22 atm showing a partial dog bone effect (Figure 1D). We decided to attempt adjunctive IVL for calcium debulking. Using a Finecross MG and the trapping technique, a Gran Slam wire was placed distally; a 4.0 mm IVL balloon was delivered at the undilatable lesion and 80 pulses were applied (Figure 1E). Once the IVL treatment was completed (Figure 1F), a 4.0 mm NCB was inflated to 20 atm to further dilate the segment with an optimal expansion (Figure 1G). Finally, a DES Synergy 4.0 × 48 mm was implanted (Figure 1H) and it was post-dilated with a 4.5 mm NCB inflated to 22 atm (Figure 1I) with a perfect angiographic result (Figure 1J). Conclusions Coronary calcifications can lead to stent underexpansion, which is related to a higher rate of future complications, such as restenosis or thrombosis. If conventional lesion dilatations are not effective, alternative techniques should be considered (cutting balloon, scoring balloon, RA, orbital atherectomy, IVL). In case of circumferential deep calcium plaques, RA may not be able to achieve an adequate lesion preparation. RA allows the treatment of intimal calcium and permits to cross balloons or stents through severe lesions. However, when adequate expansion of the balloons is not achieved after RA, Shockwave IVL, that is not usually able to cross critical stenosis due to its bulky profile, represents an optimal complementary device, in order to fracture deep calcium and facilitate stent delivery and optimal expansion. In this case, we have successfully used the hybrid approach called ‘Rotatripsy’, which combines RA and IVL, in order to avoid more aggressive RA, which would have required the use of 7-Fr guiding catheter setting and may have increased the risk of complications.

TCT-273 Impact of Shockwave Intravascular Lithotripsy Induced Calcium Fracture for Treatment of Stent Underexpansion Mediated In-Stent Restenosis

TCT-273 Impact of Shockwave Intravascular Lithotripsy Induced Calcium Fracture for Treatment of Stent Underexpansion Mediated In-Stent Restenosis

TCT-120 Optical Coherence Tomography Characterization of Shockwave Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD OCT Substudies

TCT-120 Optical Coherence Tomography Characterization of Shockwave Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD OCT Substudies

Impella protected percutaneous coronary intervention onthe last remaining highly calcified coronary artery facilitated by shockwave intravascular lithotripsy andlevosimendan infusion.

Impella protected percutaneous coronary intervention onthe last remaining highly calcified coronary artery facilitated by shockwave intravascular lithotripsy andlevosimendan infusion.

Shockwave intravascular lithotripsy facilitated percutaneous coronary intervention in patients with calcified coronary artery disease: a systematic review and meta-analysis of observational studies

Abstract Background Percutaneous coronary intervention (PCI) outcomes for patients with significant coronary artery calcification (CAC) have been consistently inferior compared to patients without significant CAC. Shockwave Intravascular Lithotripsy (S-IVL) system offers a novel option for lesion modification of severely calcified plaques but supporting evidence on safety and efficacy of this technology is narrow. The aim of this study is to assess S-IVL safety and efficacy in patients with severe CAC undergoing PCI. Methods We systematically searched MEDLINE, ClinicalTrials.gov and the Cochrane Library to identify studies assessing the efficacy and safety of S-IVL in adult patients with calcified coronary artery disease undergoing PCI. We excluded those studies assessing the effect of S-IVL in patients with under-expanded coronary stents and/or in-stent restenosis. Results The largest meta-analysis to date was performed. All studies were observational since no relevant randomized controlled trials have been published so far. Nine studies were included in our qualitative synthesis, while 7 of them, in a total of 794 enrolled patients, were used in the quantitative synthesis. Frequency of peri-procedural outcomes of interest was low: a) coronary dissection: 2.52%, b) coronary perforation: 3.0%, c) MI: 3.51%. Relative frequency of 1-month MACE was 5.59% and cardiovascular death 1.01%. S-IVL resulted in a significant increase in the in-stent post-IVL minimum lumen diameter by 1.67 mm, a significant decrease in the in-stent post-IVL vessel diameter stenosis by 53.60%, and a significant increase in the in-stent post-IVL acute gain by 1.68 mm. OCT analysis confirmed a significant decrease in area stenosis post-IVL by 19.71% and calcium angle by 22.14o and a significant increase in lumen area by 1.62 mm2, without however affecting maximum calcium thickness. When we compared post-stent post-IVL vs. pre-stent post-IVL OCT results, we demonstrated a further significant decrease in area stenosis by 35.89% and in calcium angle by 20.33o, a significant increase in lumen area by 2.74 mm2 and a neutral effect on maximum calcium thickness. Conclusion Shockwave Intravascular lithotripsy offers a significant improvement in coronary lumen to facilitate stent delivery and deployment in severely calcified coronary arteries. Although S-IVL appears to be associated with a low incidence of complications and MACE based on our present findings, further evidence from RCTs and longer-term follow-up is required to advocate its routine use in patients with severe CAC. Funding Acknowledgement Type of funding sources: None.

INITIAL EXPERIENCE WITH THE USE OF INTRAVASCULAR LITHOTRIPSY FOR CORONARY CALCIUM MODIFICATION

<h3>BACKGROUND</h3> The treatment of calcified coronary arteries remains challenging. Shockwave intravascular lithotripsy (IVL) has recently been approved by Health Canada. It is emerging as a safe and effective coronary calcium modification modality. In this study, we report our experience with introducing this technology at our centre. <h3>METHODS AND RESULTS</h3> Between January 2020 and April 2021, we prospectively identified all consecutive cases, where IVL was used. Demographic, clinical and procedural data including complications were collected in a dedicated electronic database. Four interventional cardiologists treated 22 patients (31 lesions) with IVL. The mean age of patients was 70.9 years (53-94 years) and 68% were male. Acute coronary syndromes were the indication for intervention in 16 patients (73%) and stable angina in 6 (27%). Of all patients, hypertension was present in 96%, dyslipidemia in 73%, diabetes in 41%, and chronic kidney disease in 23%. All lesions treated with IVL were de novo native artery lesions. However, 6 patients had prior CABG. Femoral access was used in 5 cases while 17 cases were done via radial access. IVL was used in the LMS (26%), LAD (39%), LCx (19%) and RCA (16%). During the first 9 months, all procedures were planned with a multidisciplinary team discussing the suitability of IVL after the initial diagnostic angiogram (9 procedures). Overall, 13 procedures (59%) were planned and 9 (41%) received IVL treatment ad hoc. All lesions were pre-dilated with semi-compliant or non-compliant balloons and 1 lesion (5%) needed high pressure OPN pre-dilatation to facilitate crossing with the IVL balloon. After IVL delivery, non-compliant balloons were used in 7 patients (32%), Additional rotational atherectomy was not required. The average number of shock wave pulses delivered was 74 (range: 40-80 pulses). Less than 20% residual stenosis (angiographic success) was achieved in all cases. Stents were deployed in all IVL treated patients. Fifteen patients (68.2%) were discharged home within 24 hours. Acute complications occurred in 4 patients. Coronary perforation complicated the delivery of a stent and was treated with a covered stent. One IVL balloon ruptured after delivering 40 pulses with no adverse consequences. Another patient developed a retroperitoneal hematoma. One patient re-presented seven days after IVL treatment with in-stent thrombus, required urgent CABG, but died 2 days postoperatively. <h3>CONCLUSION</h3> Coronary calcium modification using IVL is effective in facilitating stent expansion. Technical success rates are high. Patients needing IVL treatment are high risk patients who develop known procedure related complications.

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

BackgroundWe present the use of intravascular lithotripsy as a treatment for highly calcified superior mesenteric artery stenosis.Case presentationA 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.ConclusionIntravascular 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 evidence4, Case Report

Shockwave Intravascular Lithotripsy in large vessels with eccentric calcium using intravascular imaging: A case series

Shockwave Intravascular Lithotripsy in large vessels with eccentric calcium using intravascular imaging: A case series