Orbital Atherectomy Research Articles

Contemporary Management of Severely Calcified Coronary Lesions.

Coronary artery calcification is increasingly prevalent in our patient population. It significantly limits the procedural success of percutaneous coronary intervention and is associated with a higher risk of adverse cardiovascular events both in the short-term and long-term. There are several modalities for modifying calcified plaque, such as balloon angioplasty (including specialty balloons), coronary atheroablative therapy (rotational, orbital, and laser atherectomy), and intravascular lithotripsy. We discuss each modality’s relative advantages and disadvantages and the data supporting their use. This review also highlights the importance of intravascular imaging to characterize coronary calcification and presents an algorithm to tailor the calcium modification therapy based on specific coronary lesion characteristics.

Capture of Part of a Vessel Wall by a Coronary Orbital Atherectomy System

An 82-year-old man who had undergone coronary artery bypass grafting, aortic/mitral valve replacement, and tricuspid valvuloplasty was seen for exertional angina. On angiography, a severely stenotic lesion of the distal left internal thoracic artery (LITA) was noted, which was a bypass graft to the left anterior descending (LAD) artery (Fig. 1A, arrow). The LAD artery showed chronic total occlusion (CTO; Fig. 1B, arrow). We thought that if an angioplasty for the stenotic lesion in the LITA failed, then significant damage would occur in the LAD artery area.

Human Cadaveric Model for Vessel Preparation Device Testing in Calcified Tibial Arteries

To describe an ex vivo model for vessel preparation device testing in tibial arteries. We performed orbital atherectomy (OA), intravascular lithotripsy (IVL), and plain balloon angioplasty (POBA) on human amputated limbs with evidence of concentric tibial artery calcification. The arterial segments were then harvested for ex vivo processing which included imaging with microCT, decalcification, and histology. The model was tested out in 15 limbs and was successful in 14 but had to be aborted in 1/15 case due to inability to achieve wire access. A total of 22 lesions were treated with OA on 3/22 lesions, IVL on 8/22, and POBA without vessel preparation on the remaining 11/22. Luminal gain was assessed with intravascular ultrasound and histology was able to demonstrate plaque disruption, dissections, and cracks within the calcified lesions. A human cadaveric model using amputated limbs is a feasible, high-fidelity option for evaluating the performance of vessel preparation devices in calcified tibial arteries.

TCT-277 Outcomes of Intravascular Imaging in Orbital Atherectomy; Insight From the National Readmissions Database

TCT-277 Outcomes of Intravascular Imaging in Orbital Atherectomy; Insight From the National Readmissions Database

TCT-183 Temporal Trends and Outcomes of Orbital Atherectomy in Patients With Aortic Stenosis

TCT-183 Temporal Trends and Outcomes of Orbital Atherectomy in Patients With Aortic Stenosis

TCT-187 Safety of Orbital Atherectomy in Patients With and Without Aortic Stenosis

TCT-187 Safety of Orbital Atherectomy in Patients With and Without Aortic Stenosis

Orbital atherectomy of calcified coronary ostial lesions.

To evaluate the feasibility and safety of coronary orbital atherectomy (OA) for the treatment of calcified ostial lesions. Percutaneous coronary intervention (PCI) is increasingly being completed in complex patients and lesions. OA is effective for severely calcified coronary lesions; however, there is a dearth of evidence on the use of OA in ostial lesions, especially with long-term outcome data. Data were obtained from a retrospective analysis of patients who underwent OA of heavily calcified ostial lesions followed by stent implantation from December 2010 to June 2019 at two high-volume PCI centers. Kaplan-Meier analysis was utilized to assess the primary endpoints of 30-day, 1-year, and 2-year freedom-from (FF) major adverse cardiac events (MACE: death, myocardial infarction, or target vessel revascularization), stroke, and stent thrombosis (ST). A total of 56 patients underwent OA to treat heavily calcified ostial coronary lesions. The mean age was 72 years with a high prevalence of diabetes (55%) and heart failure (36%), requiring hemodynamic support (14%). There was high FF angiographic complications (93%), and at 30-day, 1-year, and 2-year, a high FF-MACE (96%, 91%, and 88%), stroke (98%, 96%, and 96%), and ST (100%), respectively. This study represents the largest real-world experience of coronary OA use in heavily calcified ostial lesions with long-term outcomes over 2 years. The main finding in this retrospective analysis is that, despite the complex patients and lesions included in this analysis, OA appears to be a feasible and safe treatment option for calcified coronary ostial lesions.

Atherectomy overuse is a real problem

Atherectomy overuse is a real problem

Early experience with coronary debulking devices in a newcomer facility after introducing revised facility criteria in Japan.

Coronary debulking devices are essential in obtaining optimal results in percutaneous coronary intervention (PCI) for severely calcified lesions. However, since the introduction of these devices in Japan, the presence of full-time cardiovascular surgeons in their own facilities has been an essential condition (on-site surgical back-up) as the facility criteria for their use. The criteria were revised in April 2020, making their implementation possible at our hospital. Between May 2020 and January 2022, we administered PCIs using rotational atherectomy (RA) for 33 lesions in 28 patients and orbital atherectomy system (OAS) for 36 lesions in 27 patients. The most preferred strategy in our hospital is OAS via the distal radial approach using a 6Fr Glide sheath or RA via the femoral approach using a 7Fr sheath. The percentages of usable imaging modality as an initial device without lesion modification were 57.1 and 66.7% in the RA and OAS groups, respectively. In the RA procedure, 1.5- and 2.0-mm Rota burrs were more frequently adopted for the initial and second sessions, respectively. In the OAS procedure, the debulking was always initiated at a low speed. Nineteen of the 27 patients underwent additional high-speed debulking. Pre-procedural quantitative coronary angiographic analysis revealed that the minimal lumen diameter was significantly smaller in the RA than in the OAS group. Debulking procedures were successful in all patients excluding two instances of procedure-related complications in the RA group, one of which was coronary perforation safely treated via covered stent deployment without any resulting hemodynamic instability. Our early experience with coronary debulking devices with off-site surgical back-up clearly reveals the safety and feasibility of this procedure in a newcomer facility.

Directional versus orbital atherectomy of femoropopliteal artery lesions: Angiographic and intravascular ultrasound outcomes.

The aim of this study was to compare the ability of two different atherectomy modalities, the directional atherectomy system (DAS) and the orbital atherectomy system (OAS), to modify plaque and augment luminal gain as evaluated by angiography and intravascular ultrasound (IVUS) in patients with symptomatic femoro-popliteal peripheral arterial disease (PAD). Atherectomy is frequently utilized in the treatment of complex PAD. To date, there are no head-to-head comparisons of existing devices and their selection is based mostly on operator preference rather than on supportive data. This was a single-center, prospective, randomized trial designed to assess the impact of DAS in comparison to OAS on atherosclerotic plaque. Pre- and postatherectomy lesion characterization was performed by angiography and IVUS. Drug-coated balloon (DCB) angioplasty was performed after atherectomy with similar analysis repeated. Sixty patients were randomized to undergo either DAS or OAS. Pretreatment angiographic and IVUS characteristics were similar in the DAS and OAS groups. DAS led to a greater reduction in plaque volume throughout the entire lesion (5.9% vs. 1.1%, p = 0.003). This corresponded to a greater increase in total vessel and lumen volume by IVUS (161.5 mm3 vs. 50.2 mm3 , p = 0.001; 178.6 mm3 vs. 47.0 mm3 , p = 0.004, respectively), as well as a reduction in angiographic stenosis (40% vs. 70%, p < 0.001). After DCB, 10 patients required stenting for suboptimal results in the OAS group compared with twoin the DAS group (p = 0.021). Compared to OAS, DAS demonstrated a greater plaque volume reduction and luminal gain with significantly fewer stents needed post-DCB.

Coronary Orbital Atherectomy Treatment of Hispanic and Latino Patients: A Real-World Comparative Analysis

Coronary Orbital Atherectomy Treatment of Hispanic and Latino Patients: A Real-World Comparative Analysis

EE307 Orbital Atherectomy System (OAS) with Angioplasty for Critical Lower LIMB Ischemia Treatment. Budget IMPACT Analysis: From a Modelling Approach to a Hospital Reality in Italy

Critical limb ischemia (CLI) is a clinical syndrome of ischemic pain at rest or tissue loss, such as non-healing ulcers or gangrene, related to Peripheral Artery Disease (PAD). CLI has a high short-term risk of limb amputation.Mortality after amputation is extremely high and is increased in diabetic patients. An Endovascular first approach is recommended based on a lower procedural risk.

P62 LEFT ANTERIOR DESCENDING CACIFIED LESION IN A PATIENT WITH RECENT INFERIOR STEMI SUPPORTED WITH VENTRICULAR ASSISTANCE FROM IMPELLA 2.5, TREATED WITH ORBITAL ATHERECTOMY AND DRUG ELUTING STENT AND OPTIMIZED WITH IVUS CO–REGISTRATION

Abstract We present a case of a 65 years old patient with hypertension.He comes to our cath lab with an inferior STEMI treated with primary PCI of right coronary artery and we found a sub–occlusive and severly calcified lesion on proximal left anterior descending artery (LAD) and a diffused disease of its middle and distal portion (Fig 2). After collegial discussion on Heart Team we decided to proceed with a staged percutaneous revascularization on LAD. After an accurate planning we decided to proceed with a single femoral access a 14f femoral sheat was positioned on femorl artery, so we put the ventricular assistance catheter and then on the same sheat we put our 7 f guiding catheter to use only a single access for IMPELLA and for the guiding catheter (Fig. 1).The IVUS catheter doesn’t be able to cross the calcified lesion on LAD so we go on with a debulking using the orbital atherectomy of Diamond Back, with several passages antegrade and retrograde.At this point we are able to perform an IVUS Co–registration that demostrated also a critical lesion on ostial LAD.After multiple pre–dilatation to prepare the lesion we put three big drug eluting stent till 5 mm of diameter.The IVUS shows us a little malapposition so we proceed with a big non compliant balloon of 6mm with optimal result (Fig 3).In conclusion we go on with a reduction of ventricular assistance and final removal of IMPELLA catheter and closure of 14f vascular access with a single Pro–glide previously implanted.This procedure has some discussion points, first of all the possibility to treat a sub–occlusive lesion of an important non culprit artery after a few days of an acute coronary syndrome in safe mode with a ventricular assistance, that allowed us to work peacefully, being able to carry out all the maneuvers we considered appropriate (multiple balloon dilatations, IVUS evaluations, orbital atherectomy).An other point of discussion is the use of this new orbital atherectomy easy to use because with a single device,6f guiding catheter compatible, we are able to treat artery from 2.5 till 4mm only setting the rotational speed and removing not only the intraluminal calcium but also the deeper one and this allows a better stent expansion.The procedure is IVUS guided associated with angiographic images on Co–registration that allow us to obtain even more informations.The last comment is for the new stent Megatron, the only stent that are able to treat coronary artery till 6 mm.

P78 AN ANTEGRADE RECANALIZATION OF LEFT ANTERIOR DESCENDING CHRONIC TOTAL OCCLUSION WITH ORBITAL ATHERECTOMY IN PATIENT WITH SEVER LEFT VENTRICULAR DISFUNCTION

Abstract We share the case of a 71–year old man, affected by hypertension, presented in Emergency Room (ER) with chest pain. No clinical evidence of heart failure. EKG showed fast atrial fibrillation with QS complex and ST elevation in precordial leads. Echocardiogram confirmed sept and apex akinesia. Troponin I peak was 72pg/ml. In ER electrical cardioversion was efficacy performed. He was referred for invasive coronary angiography, that showed a left anterior descending (LAD) chronic total occlusion (CTO), with Rentrop grade 2 collaterals providing retrograde flow from the right coronary artery (RCA), a severe stenosis of ramus intermedius (RI) and a moderate stenosis of circumflex. A stress–echocardiogram demonstrated vitality of medio–basal anterior wall. Subsequent, recanalization procedure of LAD CTO was planned. J–CTO score was 1 (tapered calcific, lesion, &amp;lt;20mm). double radial access and ante grade approach was chosen. An EBU3.5 guiding catheter was engaged in the left coronary artery, and 8000 units of heparin administered. The iFR of Cx was 0.99, indicative of non significant myocardial ischemia. During hemodynamic evaluation of RI, a ventricular fibrillation occurred, treated by DC–SHOCK and PCI with stenting with no polymer, eluted with Biolimus A9 (3.0x24mm) with good result. The occlusion was crossed via an antegrade approach with an Asahi Gaia II wire and with microcatheter support. Gaia II was changed in favor of Asai Sion blu, and the IVUS catheter was enable of cross the lesion. Efficacy orbital atherectomy with Diamondback 260 was performed (5 ante and retro grade run at 80Krpm and a retro grade run at 120 Krpm. Ivus was able to cross the lesion. Efficacy pre–dilatation with semi and non compliant balloon (2.5–3.5mm) was performed and then stented with a 3.0 × 36 mm Bioloimu A9–eluting stent. Finally, IVUS confirmed correct stent expansion, achieving an excellent angiographic result. Patient was discharged with triple anti–thrombotic therapy, with indication to “life jacket” till the assessment at 1 month.

E-32 | Outcomes of Orbital Atherectomy for The Treatment of Severely Calcified Coronary Artery Lesions

Orbital atherectomy for the treatment and preparation of severely calcified coronary artery lesions is safe and efficacious. This study evaluated the safety and efficacy of orbital atherectomy (OA) for the treatment of severely calcified coronary artery lesions.

Abstract 346: Mri Guided Experimental Study To Determine The Mechanistic Performance Of Vessel Prep V. Poba In Infrapopliteal Lesions

Objective: To present initial results of an ongoing ex-vivo experimental study to compare vessel preparation with intravascular lithotripsy (IVL) or orbital atherectomy (OA) versus plain old balloon angioplasty (POBA) in tibial arteries. Method: We will study amputated limbs that have concentric calcification, in three arms, 1. POBA, 2. IVL, and 3. OA. Amputated limbs are first scanned on 7T MRI using UTE (Ultra-short echo time) and T2 weighted sequences to characterize target lesions with concentric calcium at high resolution. The diameter of balloon is sized based on diameter of the vessel proximal and distal to target lesion and confirmed with intravascular ultrasound (IVUS). A through-and-through wire is placed and angiography and IVUS are performed. POBA, IVL or OA is performed. In lesions with vessel prep, angioplasty is performed. All angioplasties are performed at minimum pressure required for the balloon to reach profile diameter. Finally, the ex-vivo harvested specimens are imaged in 9.4T MRI for 3-D plaque analysis prior to histologic sectioning and staining. Results: We have 7 experiments, 3 BKA and 4 AKA. Balloon angioplasty without vessel prep was performed in 3/7, OA in 2/7 and IVL in 2/7. Lesions angioplastied without vessel prep required higher than burst pressure to reach profile. Lesions treated with OA and IVL required pressures between nominal and burst to reach profile. POBA samples demonstrated plaque disruption and dissections with more luminal gain compared with lesions that underwent vessel prep prior to angioplasty. Conclusion: This study elucidates the mechanism of vessel prep and how it assists POBA in protecting the vessel wall. Vessel prep did not “debulk” or improve luminal gain substantially but required lower inflation pressures and had less uncontrolled dissections and disruptions of the vessel wall. Initial results demonstrate a compelling indication for vessel preparation in select tibial lesions with 360-degree concentric calcium.

E-5 | Orbital Atherectomy for Severely Calcified Coronary Ostial Lesions

Percutaneous coronary intervention is increasingly being completed in complex patients and lesions. Orbital atherectomy (OA) has been shown to be an effective and safe treatment for severely calcified coronary lesions to facilitate stent placement and expansion. However, there is a dearth of evidence on the use of OA in severely calcified ostial lesions. This retrospective study evaluated the feasibility and safety of OA for the treatment of severely calcified ostial coronary lesions.

E-3 | Performance of The Diamondback Coronary Orbital Atherectomy System: Insight from MAUDE Database

The Diamondback 360 Coronary Orbital Atherectomy System (Cardiovascular Systems Inc., St Paul, MN, USA) is the first and only orbital atherectomy system approved by the US FDA for treatment of severely calcified lesions. While the device has proven to be safe in clinical trials, real-world data are minimal.

Prevalence and outcomes of balloon undilatable chronic total occlusions: Insights from the PROGRESS-CTO

BackgroundThe prevalence, treatment, and outcomes of balloon undilatable lesions encountered in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) have received limited study. MethodsWe examined the clinical characteristics and procedural outcomes of balloon undilatable lesions in the Prospective Global Registry for the Study of CTO Intervention (PROGRESS-CTO, NCT02061436). ResultsOf 6535 CTO PCIs performed between 2012 and 2022, 558 (8.5%) lesions were balloon undilatable. In this subset, patients were older (mean age 67 ± 10 vs. 64 ± 10, p < 0.001) and had higher prevalence of comorbidities: diabetes mellitus (54% vs. 40%, p < 0.001), prior PCI (71% vs. 59%, p < 0.001), prior myocardial infarction (52% vs. 45%, p = 0.003), and prior coronary artery bypass graft surgery (44% vs. 25%, p < 0.001). The CTO lesion length was estimated to be 34 ± 23 mm, mean J-CTO score was 2.9 ± 1.1 and mean PROGRESS-CTO score was 1.4 ± 1.0. A cutting balloon was used in 27%, a scoring balloon in 15%, laser in 14%, rotational atherectomy in 28%, orbital atherectomy in 10%, intravascular lithotripsy in 1% and other modalities/approaches in 5%. Balloon undilatable lesions had lower technical success (90.9% vs. 93.8%, p = 0.007) and higher incidence of major adverse cardiovascular events (MACE) (composite of in-hospital death, acute myocardial infarction, stroke, re-PCI, emergency CABG, and pericardiocentesis) (5.0% versus 1.3%, p < 0.001). ConclusionApproximately 1 in 12 CTO (8.5%) lesions are balloon undilatable. Treatment of balloon undilatable lesions is associated with lower technical success and higher in-hospital MACE.

Reasons for lesion uncrossability as assessed by intravascular ultrasound.

The purpose of the current study was to use intravascular ultrasound (IVUS) to clarify anatomical and morphological lesion characteristics of uncrossable lesions. Uncrossable lesions are not always severely calcified. The prevalence of uncrossable lesions that are nonseverely calcified as well as other mechanisms for uncrossability has not been well clarified. A total of 252 de novo uncrossable lesions in native coronary arteries that underwent either rotational or orbital atherectomy due to inability of any balloon to cross the lesion and 38 lesions with severe calcium in which IVUS crossed preatherectomy were included. Severe calcium is defined as maximum arc of calcium ≥270°. Severe calcification was absent in 16% of uncrossable lesions, 83% of which had a significant vessel bend. Compared with crossable lesions with severe calcium, uncrossable lesions with severe calcium more often had a bend in the vessel (71% vs. 21%, p < 0.001) and a longer length of continuous severe calcium (median length of calcium ≥270° 3.8 mm vs. 1.9 mm, p = 0.001). Other than severe calcium (especially long continuous calcium) or a bend in the vessel, anatomical factors associated with uncrossabilty were aorto-ostial lesion location and small vessels. Uncrossable lesions are not always severely calcified. The interaction of lesion morphology (continuous long and large arcs of calcium) and vessel geometry (bend in the vessel or ostial lesion location) affect lesion crossability.