Fracking compared to conventional balloon angioplasty alone for calcified common femoral artery lesions using intravascular ultrasound analysis: 12-month results.

BACKGROUND: Fracking is a novel technique to crack calcified lesions by hydraulic pressure. This study aimed to compare the performance of fracking and conventional balloon angioplasty without stenting for calcified common femoral artery (CFA) lesions using intravascular ultrasound (IVUS) analysis. METHODS: This retrospective, single-center, comparative observational study included 59 patients (67 limbs) with calcified CFA lesions treated with either fracking (n = 30) or balloon angioplasty (n = 29) between January 2018 and December 2020. The primary endpoint was 1-year primary patency. The secondary endpoints included procedure success, freedom from target lesion revascularization (TLR), procedure-related complications, and freedom from major adverse limb events (MALE). Predictors of restenosis were identified using multivariate Cox proportional hazards analysis. RESULTS: The mean follow-up duration was 403 ± 236 days. The fracking group had significantly higher incidence of 1-year primary patency (89.8% versus 49.2%, P < 0.001), procedure success (96.9% versus 74.3%, P = 0.009), and freedom from TLR (93.5% versus 74.2%, P = 0.038) than the balloon group. The rate of freedom from MALE was significantly higher in the fracking group than in the balloon group (76.9% versus 48.6%, P = 0.033). The groups had no significant difference in procedure-related complications (6.2% versus 5.7%, P = 0.928). A larger postprocedural IVUS-estimated minimum lumen area (MLA) was associated with a lower risk of restenosis (hazard ratio, 0.78; 95% confidence interval, 0.67-0.91; P < 0.001), with a cut-off value of 16.0 mm2 determined using receiver operating characteristics curve analysis. The incidence of 1-year primary patency in patients with a postprocedural MLA ≥16.0 mm2 (n = 37) was significantly higher than that in those with a postprocedural MLA < 16.0 mm2 (n = 30) (87.8% versus 44.6%, P < 0.001). CONCLUSION: This study demonstrated the superior procedural efficacy of fracking compared to balloon angioplasty in treating calcified CFA lesions. The safety outcomes after fracking were comparable to those after balloon angioplasty. Large postprocedural MLA was an independent positive predictor of patency.

Management of Calcification: Rational and Technical Considerations for Intravascular Lithotripsy.

Arterial calcification (AC) is a common complication among patients with peripheral arterial disease (PAD). AC presents various challenges to PAD treatment including an increased likelihood of vessel rupture and dissection, and by acting as a physical barrier to drug delivery by angioplasty balloons. Intravascular lithotripsy (IVL) is a novel intervention that specifically targets AC by emitting sonic pressure waves that introduce microfractures in target calcified lesions to increase arterial compliance. Preliminary data has demonstrated the safety and efficacy of IVL in PAD treatment. The present article provides a technical overview of S-IVL, as well as a case series of the treatment of AC in common iliac, common femoral, superficial femoral, aortoiliac, and peroneal arterial lesions. Each case resulted in marked improvement of luminal patency, exhibiting the efficacy IVL.

Lithoplasty-Facilitated Proximal Cap Penetration of a Calcified Chronic Total Occlusion Coronary Lesion.

We present a case of calcified chronic total occlusion of the left anterior descending coronary artery with ambiguous cap at the bifurcation with a large diagonal branch, in which intravascular lithoplasty balloon was used to modify the calcified proximal cap and facilitate wire crossing. (Level of Difficulty: Advanced.).

Interventional Treatment of Access Site Complications During Transfemoral TAVI: A Single Center Experience.

Introduction: Transcatheter aortic valve implantation (TAVI) has rapidly developed over the last decade and is nowadays the treatment of choice in the elderly patients irrespective of surgical risk. The outcome of these patients is mainly determined not only by the interventional procedure itself, but also by its complications. Material and Methods: We analyzed the outcome and procedural events of transfemoral TAVI procedures performed per year at our institution. The mean age of these patients is 79.2 years and 49% are female. All the patients underwent duplex ultrasonography of the iliac arteries and inguinal vessels before the procedure and CT of the aorta and iliac arteries. Results: Transfemoral access route is associated with a number of challenges and complications, especially in the patients suffering from peripheral artery disease (PAD). The rate of vascular complications at our center was 2.76% (19/689). Typical vascular complications (VC) include bleeding and pseudoaneurysms at the puncture site, acute or subacute occlusion of the access vessel, and dissection or perforation of the iliac vessels. In addition, there is the need for primary PTA of the access pathway in the presence of additional PAD of the common femoral artery (CFA) and iliac vessels. Balloon angioplasty, implantation of covered and uncovered stents, lithoplasty, and ultrasound-guided thrombin injection are available to treat the described issues. Conclusion: Interventional therapy of access vessels can preoperatively enable the transfemoral approach and successfully treat post-operative VC in most of the cases. Training the heart team to address these issues is a key focus, and an interventional vascular specialist should be part of this team.

The "Fracking" technique: a novel approach to crack deep calcified plaque in the common femoral artery with hydraulic pressure.

BACKGROUND: The patency achieved by conventional peripheral interventions for atherosclerotic lesions in the common femoral artery (CFA), called the "no stenting zone", is not superior to that achieved by surgical endarterectomy due to calcified plaque occupying the area. Plaque modification strategies to obtain acute gain in CFA patency provide the better clinical outcomes than standard balloon angioplasty. Atherectomy devices, which focus on the modification of superficial calcifications, contribute to the improvement of clinical outcomes. However, deep calcifications resist vessel expansion such that luminal gain is not easily achieved. MAIN TEXT: We propose a novel calcified plaque modification technique, named the "fracking technique" (FT). The term fracking refers to how a rock is fractured by the high hydraulic pressure. In this technique, deep calcifications are cracked with hydraulic pressure via a balloon indeflator through an 18-gauge needle, which punctures calcifications to achieve greater acute luminal gain. Case 1 involved an 81-year-old male with eccentric calcified plaque in the right CFA. Conventional balloon angioplasty for the lesion yielded a suboptimal minimal lumen area (MLA), which increased from 6.2 to 10.7-mm2 on intravascular ultrasound (IVUS). The FT was implemented to obtain a larger MLA. After the FT was repeated at three locations at up to 8-atm, a greater MLA of 27.1-mm2 was achieved without complications. Case 2 involved a 72-year-old male undergoing hemodialysis due to diabetes mellitus who presented with ischemic pain in his right limbs at rest due to severe stenosis with eccentric calcification in the distal CFA. The MLA on IVUS before and after balloon angioplasty was 10.0-mm2 and 13.1-mm2, respectively, and this result was still suboptimal. The FT was attempted and successfully yielded a greater MLA of 28.9-mm2 without complications. Restenosis has not been detected for 2 years follow-up period. CONCLUSIONS: The FT is an effective option for treating calcified CFA lesions to achieve a larger lumen area. Long-term follow-up studies are necessary.

Use of Shockwave Lithoplasty for a Patient With Recurrent Angina.

Current calcium modification treatments only address the burden of intimal calcium with varying degrees of success and result in an increased risk for adverse events. Here, we describe the use of shockwave intravascular lithoplasty (S-IVL) to effectively treat a severely calcified coronary artery lesion. A 59-year-old male with a history of coronary artery disease with stents presented to our hospital with angina. Diagnostic coronary angiography revealed a mid-right coronary artery (mRCA) stent with severe in-stent restenosis due to under expansion of stent with severe calcification. Due to these factors, the decision was made to reduce the calcium burden with the use of S-IVL. This is a promising technique in plaque modification of severely calcified coronary lesions with less risk of myocardial injury and mechanical vascular trauma. It is important to customize the choice of therapy based on the patient and the characteristics of the coronary lesion.

Resolving chronic stent under-expansion in calcified lesions by intravascular lithoplasty.

Severe coronary calcification is a common cause for stent under-expansion, which is associated with an increased risk of stent thrombosis and restenosis. Presently the devices for treatment of under-expanded stent due to severe calcification are rotational atherectomy and high-pressure non-compliant balloons with the limitation of potential balloon rupture and perforation risk. We report on a series of seven successful treatments of chronically under-expanded stents due to severe calcification using shockwave coronary intravascular lithoplasty (IVL). Our report suggests that IVL is a feasible and safe tool for such chronically under-expanded stents. .

Mechanical circulatory support and intravascular lithotripsy in high-risk patients undergoing percutaneous coronary intervention and transcatheter aortic valve replacement: a case series.

BACKGROUND: Patients undergoing transcatheter aortic valve replacement (TAVR) usually have multiple comorbidities, such as severely impaired left ventricular function (LVF) and heavily calcified coronary lesions. When they undergo pre-TAVR high-risk percutaneous coronary interventions (HR-PCIs) for severely calcified left main (LM) lesions, potential life-threatening intra-procedural complications associated with the different techniques available to treat calcified lesions can arise. In this setting, mechanical circulatory support proves its usefulness. However, the choice of device can be troublesome. CASE SUMMARY: We report two clinical scenarios of intravascular lithotripsy (IVL) for the treatment of heavily calcified LM coronary lesions, wherein peripheral veno-arterial extracorporeal membrane oxygenation (VA-ECMO), alone or combined with an intra-aortic balloon pump (IABP), were used as an upfront strategy to support the procedure. The use of these techniques was particularly effective during multi-vessel HR-PCIs and TAVR, and no complications occurred, which suggested their safety. DISCUSSION: These cases provide multiple insights into the strategy of using IVL + VA-ECMO, alone or with IABP, to treat heavily calcified LM coronary lesions in patients with severely compromised LVF undergoing TAVR. IVL safely and effectively overcame shortcomings related to other plaque ablation techniques, and VA-ECMO proved to be effective when facing the combination of high-risk coronary and valve interventions.

Shockwave™ Lithoplasty in Combination With Atherectomy in Treating Severe Calcified Femoropopliteal and Iliac Artery Disease: A Single-Center Experience.

BACKGROUND: Calcium is a predictor of poor outcome in the treatment of infrainguinal arterial disease. Rotational atherectomy can effectively debulk atherosclerotic calcium but is less likely to significantly modify medial and adventitial calcinosis. Shockwave IVL provides circumferential sonic pressure waves capable of disrupting deeper calcium and theoretically complements the debulking process of atherectomy. We present acute and intermediate outcome data from patients with severe femoral or iliac artery calcified disease treated with the combination of rotational atherectomy and Shockwave IVL at a single center. METHODS: This is a retrospective study of prospectively collected data on rotational atherectomy (Jetstream (Boston Scientific) and orbital atherectomy (CSI)) from a single operator at a single center with core laboratory analysis of angiographic imaging. All patients that received the combination treatment of rotational atherectomy and Shockwave IVL were included in this study. Patient follow-up was done from medical records with data extracted by an experienced research coordinator. Primary safety endpoint was freedom from major adverse events including major dissection (NHLBI C or higher), perforation, distal embolization, or major amputation defined as amputation above the ankle. Primary effectiveness endpoint was procedural success (≤ 30% residual at end of procedure). 23/24 (95.8%) patients were treated with drug coated balloons (DCB) post combination therapy. Secondary endpoint on follow-up was target lesion revascularization (TLR). RESULTS: A total of 24 patients were included. Mean age was 70.7 ± 9.9 years. Lesions were in the femoropopliteal 79.1%, common femoral 12.5% and iliac 8.3% arteries. 87.0% were claudicants and 58.3% diabetics. Chronic total occlusion was 12.5%, severe calcium 100%, lesion length 84.5 ± 37.1 mm, baseline stenosis 57.1 ± 18.9% and baseline minimal luminal diameter (MLD) 2.2 ± 1.1 mm. Patients were treated with Jetstream (n = 19) or Orbital (n = 5) atherectomy. Embolic filter was used in 58.3% of cases. Post atherectomy stenosis was 36.4 ± 17.5%, post adjunctive IVL 21.1 + 15.7%, and final stenosis 13.0 ± 10.9%. Bailout stenting was 4.6% and primary stenting 13.6% (total stenting rate 18.2%). Final MLD was 4.7 ± 0.8 mm, resulting in an acute gain of 2.5 mm. No infrapopliteal embolization or amputation was noted. At a mean follow up of 591.4 ± 175.2 days, 2 patients died (unrelated to procedure or device). Target lesion revascularization (TLR) at 12 months occurred in 2 patients or 2/22 (9%). At 18-month of follow up TLR occurred in 7/22 (31%) patients. CONCLUSION: The combination of atherectomy and shockwave IVL followed by adjunctive DCB is safe and appears to be effective in treating severe calcified disease with acceptable TLR on long term follow-up in a population of severe femoropopliteal disease.

Coronary lithoplasty for calcified lesions: real-world multicenter registry.

INTRODUCTION AND OBJECTIVES: Coronary lithoplasty (CL) is a balloon-based technique used to treat calcified lesions. This study reports the initial experience of treatment of calcified lesions with CL in an unselected and high-risk population. METHODS: This was a prospective, multicenter registry, which included all consecutive cases with calcified coronary lesions that underwent CL between August, 2018 and August, 2019. Exclusion criteria consisted of a target lesion located in a small vessel (< 2.5mm) and the presence of dissection prior to CL. Quantitative coronary angiography and intravascular ultrasound/optical coherence tomography analysis were completed by an independent central core laboratory. RESULTS: This registry included 57 patients (66 lesions). The population was elderly (72.6±9.4 years) with high proportions of patients with diabetes (56%), chronic kidney disease (35%), and multivessel disease (84%). All lesions were classified as type B/C. More than 75% of lesions were predilated with noncompliant/semicompliant balloons or cutting-balloon. Rotablator was used in 5 lesions (7.6%) prelithoplasty. On average, CL required 1.17 balloons delivering a mean of 60 pulses. Successful CL was achieved in 98%. In 13% of cases, lithoplasty balloon was broken during therapy. There were few procedural complications: 2 cases of significant dissections (none related to lithoplasty balloon rupture) were successfully treated with drug-eluting stent implantation. One patient experienced stent thrombosis 2 days after successfully undergoing target lesion revascularization. CONCLUSIONS: This is a real-world multicenter registry, which supports the feasibility, safety, and short-term efficacy of PCI for calcified coronary lesions using CL in an unselected and high-risk population with promising results.

New Innovations and Devices in the Management of Chronic Limb-Threatening Ischemia.

As the number of patients afflicted by chronic limb-threatening ischemia (CLTI) continues to grow, new solutions are necessary to provide effective, durable treatment options that will lead to improved outcomes. The diagnosis of CLTI remains mostly clinical, and endovascular revascularization remains mostly balloon-based. Multiple innovative techniques and technologies are in development or in early usage that may provide new solutions. This review categorizes areas of advancement, highlights recent developments in the management of CLTI and looks forward to novel devices that are currently under investigation.

First-in-Man Lithoplasty of a LIMA Bypass With ECMO Support in a Last-Remaining Vessel.

We report the case of a 70-year-old patient with history of chronic heart disease who underwent bypass surgery twice beforehand and was admitted due to non-ST segment elevation myocardial infarction. Angiography showed degeneration of all bypass grafts except the LIMA bypass, which showed significant ostial stenosis with severe calcification. Peri-operative risk was computed to be as high as 12.3% (STS Score). An interventional strategy was chosen: the very high-risk procedure was performed safely under the protection afforded by venoarterial ECMO and cardiac surgeons on standby using a coronary intravascular lithoplasty (IVL) balloon. After implantation of a drug eluting stent, the primary angiogram showed a satisfactory result. The patient was discharged without further complications short after the procedure and is closely followed-up.

Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study.

Purpose: To evaluate the performance of peripheral intravascular lithotripsy (IVL) in a real-world setting during endovascular treatment of multilevel calcified peripheral artery disease (PAD). Materials and Methods: The Disrupt PAD III Observational Study (ClinicalTrials.gov identifier NCT02923193) is a prospective, nonrandomized, multicenter, single-arm observational study assessing the acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of calcified, stenotic lower limb arteries. Patients were eligible if they had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. Between November 2017 and August 2018, 200 patients (mean age 72.5±8.7 years; 148 men) were enrolled across 18 sites and followed through hospital discharge. Results: In the 220 target lesions, IVL was more commonly used in combination with other balloon-based technologies (53.8%) and less often with concomitant atherectomy or stenting (19.8% and 29.9%, respectively). There was a 3.4-mm average acute gain at the end of procedure; the final mean residual stenosis was 23.6%. Angiographic complications were rare, with only 2 type D dissections and a single perforation following drug-coated balloon inflation (unrelated to the IVL procedure). There was no abrupt closure, distal embolization, no reflow, or thrombotic event. Conclusion: Use of peripheral IVL to treat severely calcified, stenotic PAD in a real-world study demonstrated low residual stenosis, high acute gain, and a low rate of complications despite the complexity of disease.

Intravascular Lithotripsy for Treatment of Calcified, Stenotic Iliac Arteries: A Cohort Analysis From the Disrupt PAD III Study.

PURPOSE: The presence of calcification in the iliac arteries is associated with decreased procedural success and increased complication risk during endovascular intervention. The objective of this study was to evaluate the safety and efficacy of peripheral intravascular lithotripsy (IVL) during endovascular treatment of iliac arterial peripheral artery disease (PAD). METHODS: The Disrupt PAD III Observational Study is a prospective, non-randomized, multi-center single-arm study to assess the 'real-world' safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of de novo calcified lesions in the peripheral arteries, with a goal of treating 1500 patients. This is an analysis of consecutive patients enrolled for treatment of an iliac artery, a specified sub-group, with at least moderate calcification and a minimum length of 20 mm. RESULTS: Between December 2017 and July 2019, 118 patients with a total of 200 lesions were enrolled across 20 sites. 101 patients were treated primarily for claudication or critical limb ischemia, while 17 patients were treated to optimize the iliac vasculature for large-bore access. All 118 patients had successful IVL catheter delivery. The average reference vessel diameter was 7.3 mm ± 1.9 mm, with an average diameter stenosis of 83.1% ± 13.4% and an average lesion length of 58.3 mm ± 57.6 mm. Severe calcification was present in 82.0% of overall cases. Stent placement was performed in 72.9% of the overall cases. As expected, the access group received less adjunctive therapies including stents (41.2%, p < 0.001). Angiographic complications were minimal with no flow-limiting dissections and a final mean residual stenosis of 12.0% ± 12.1% with no differences between the groups. CONCLUSIONS: Acute results with IVL in calcified iliac lesions suggest that it is a safe and effective option for calcified, stenotic iliac disease. IVL can be used successfully both for treatment of PAD symptoms and to optimize access for large-bore procedures.

Cracking the Plaque With Coronary Lithotripsy: Mechanistic Insights From Optical Coherence Tomography.

Coronary lithoplasty is a promising technique that can overcome issues regarding the treatment of undilatable, heavily calcified, de novo, and in-stent restenotic lesions, allowing plaque modification and successful stent deployment, as demonstrated by intravascular imaging.

Coronary Stents Underexpansion Successfully Treated With Shockwave Lithoplasty.

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.

Stent underexpansion due to heavy coronary calcification resistant to rotational atherectomy: A case for coronary lithoplasty?

Stent underexpansion is frequently observed in calcified coronary lesions and increases the risk of future adverse cardiac events. Current plaquemodification techniques might not be suitable when calcium deposition is circumferential and deep inside the vessel wall. We report a case during which coronary lithoplasty was used as an adjuvant therapy to improve severe stent underexpansion after failed atherectomy and high-pressure non-compliant balloon dilatations.

Calcific lesion preparation for coronary bifurcation stenting.

Bifurcating coronary lesions are a very common challenge in interventional cardiology because of the technical complexity in their treatment, the risk of side branch occlusion and an overall worse outcome when compared to non-bifurcating lesions. The presence of calcifications represents further complexity due to the difficulty in device delivery and stent expansion as well as enhanced risk of side branch occlusion. Rotational and orbital atherectomy, scoring and cutting balloons, coronary lithoplasty are available tools which have been introduced over the last three decades to overcome such issue. Nevertheless, their application in different contexts of bifurcations presents specific caveats and the studies directed at comparing such techniques have never been expressly oriented in the subset of the bifurcating lesion. In this paper, we review these devices and their usefulness in bifurcations by analyzing consistent data from clinical trials, and we propose a practical algorithm for the treatment of severely calcified bifurcating lesions according to their anatomical features.