High-speed Rotational Atherectomy Research Articles

Lower revascularization rates after high-speed rotational atherectomy compared to modified balloons in calcified coronary lesions: 5-year outcomes of the randomized PREPARE-CALC trial.

In the PREPARE-CALC trial, severely calcified lesion preparation with rotational atherectomy (RA) before biodegradable polymer sirolimus-eluting stent (SES) implantation demonstrated higher procedural success and comparable rates of acute lumen gain and late lumen loss compared to modified balloons (MB) (scoring/cutting). We aimed to analyze the 5-year outcomes of both lesion preparation strategies. PREPARE-CALC randomly assigned 200 patients 1:1 to MB or RA, followed by SES implantation. The principal endpoint of the current analysis was target vessel failure (TVF) at 5years. At 5years, MB had comparable rates of TVF to RA (19% vs. 21%, HR 1.14, 95% CI 0.60-2.16, p = 0.687). Subgroup analysis showed a lesion length treatment interaction, favoring MB for short lesions and RA for long ones (p for interaction = 0.042). Target lesion revascularization (TLR) was significantly less common with RA (12 vs. 3%, HR 0.28, 95% CI 0.08-0.98, p = 0.048). In a multivariate analysis, RA was independently protective against TLR (adj. HR 0.17, 95% CI 0.04-0.78, p = 0.022), while ostial lesions were associated with higher TLR independent of treatment strategy (adj. HR 11.3, 95% CI 2.98-42.6, p < 0.001). In patients with severely calcified coronary lesions, using MB or RA for lesion preparation followed by biodegradable polymer SES implantation was associated with comparable rates of TVF at 5years. However, a significant reduction of TLR was observed after RA. PREPARE-CALC is the first randomized trial showing potential clinical advantages of RA over MB during long-term follow-up. URL: https://www. gov . Unique identifier: NCT02502851.

Abstract 18976: In-Hospital Outcomes in Patients Undergoing Protected Left Main Percutaneous Coronary Intervention With Percutaneous Left Ventricle Assist Device Protection

Introduction: Left main disease (LMCA) is a known risk factor for patients’ poor outcomes. Percutaneous revascularization of LMCA in heart failure patients is associated with a particularly high periprocedural risk. Percutaneously introduced left ventricle assist devices (pLVAD) are a potential tool to improve patient outcomes in these high-risk procedures. Hypothesis: Our study aimed to assess short-term clinical outcomes of protected left main percutaneous coronary intervention with the use of a pLVAD. Methods: A prospective registry of patients with chronic heart failure, undergoing protected LMCA PCI included 66 patients, 89% male, the median age of 71.5 y.o, 40 (60.6%) after prior myocardial infarction, 31 (47%) after prior PCI and 12 (18.2%) after CABG, with CTO RCA in 17 (25.6%) of cases. Percutaneous LVAD was used in all patients, 72% access site was the right femoral artery, additional plaque modification techniques were used in 46 (69.7%) patients, IVL was applied in 25 (37.9%) of cases and high-speed rotational or orbital atherectomy was used in 21 (31.2%) of cases. Median of 3 [2;4] DES was implanted. Results: During the in-hospital follow-up, a significant improvement of the left ventricle ejection fraction was observed (median LVEF 30% post PCI vs22% at baseline, p&lt;0.001) as well as a significant decrease of NTproBNP levels (765 [IQR: 194, 6,370] at discharge vs 7113 pg/ml [IQR:1,945, 15,646] at baseline, p=0.01]. There was 1 in-hospital death due to cardiogenic shock. A safety monitoring revealed 11 hematomas, including 3 cases that needed vascular surgery. Bleeding according to BARC 3a was recorded in 17/66 (28%) and BARC 3b in 3/66 (5%) of cases. Conclusions: Percutaneous LVAD support is a feasible method to perform protected left main PCI with a good safety profile when applied by experienced operators A significant improvement of the LVEF can be observed after left main revascularization Further research is needed to confirm the presented results.

The Incidence of Complication in the Perioperative Period of Rotational Atherectomy in Patients With Acute Coronary Syndrome: A Retrospective Study of Low Speed Versus High Speed

The safety and efficacy of rotational atherectomy (RA) in patients with acute coronary syndrome (ACS) treated with different rotational speeds remain unclear. This was an observational retrospective registry study. Between February 2017 and January 2022, a total of 283 patients with ACS were treated with RA. The patients were divided into 2 groups: the low-speed group (130,000 to 150,000rotations/min [rpm],182 cases) and the high-speed group (160,000 to 220,000rpm, 101 cases) according to the maximum RA speed. The outcomes analyzed were procedural complications; incidence of heart failure, stent thrombosis, and cardiac death during hospitalization; and 30-day major cardiovascular and cerebrovascular events. Patients in the low-speed RA group had a higher incidence of vasospasm during RA (15.4% vs 6.9%, p=0.040), whereas the incidence of slow blood flow was higher in the high-speed RA group (16.5% vs 27.7%, p=0.031). There was no significant difference in other complications or in 30-day major cardiovascular and cerebrovascular events between the 2 groups. Moreover, logistic regression analysis identified rotational speed (160,000 to 220,000rpm) as a predictor of slow flow during RA (odds ratio 1.900, 95% confidence interval 1.006 to 3.588, p=0.048). For every 10,000-rpm increase in rotational speed, the risk of slow flow increased by 27% (odds ratio 1.273, 95% confidence interval 1.047 to 1.547, p=0.015). In conclusion, patients with ACS treated with a lower RA speed (130,000 to 150,000rpm) had a higher risk of vasospasm, whereas those treated with higher speeds (160,000 to 220,000rpm) had a higher incidence of slow flow. High rotational speed (160,000 to 220,000rpm) is an independent risk factor for slow flow during RA in patients with ACS.

High-speed rotational atherectomy versus modified balloons for plaque preparation of severely calcified coronary lesions: two-year outcomes of the randomised PREPARE-CALC trial.

High-speed rotational atherectomy versus modified balloons for plaque preparation of severely calcified coronary lesions: two-year outcomes of the randomised PREPARE-CALC trial.

TCTAP A-017 Periprocedural Myocardial Infarction or Injury in Novel Low-Speed Following High-Speed and Conventional High-Speed Rotational Atherectomy Technique for Heavily Calcified Coronary Artery Lesions – The PRIMO-ROTA Pilot Study

TCTAP A-017 Periprocedural Myocardial Infarction or Injury in Novel Low-Speed Following High-Speed and Conventional High-Speed Rotational Atherectomy Technique for Heavily Calcified Coronary Artery Lesions – The PRIMO-ROTA Pilot Study

High-speed rotational atherectomy in coronary artery calcification: The randomized ROTAXUS and PREPARE-CALC trials.

The clinical outcomes of high-speed rotational atherectomy (RA) to optimize target lesion preparation in coronary artery calcification (CAC) have been examined in several trials. This study was conducted to evaluate the safety and efficacy of RA for CAC. Patient data were pooled from ROTAXUS and PREPARE-CALC. The primary endpoint was the in-stent late lumen loss and major adverse cardiac events at 9 months. Secondary endpoints included in-segment late lumen loss, binary restenosis, strategy success, procedural duration, and contrast amount. Four hundred and forty patients were enrolled from Germany in this study, 220 patients were randomized to the RA group and 220 patients were randomized to the Control group. Despite similar baseline characteristics, significantly more patients in the Control group were crossover (14.1% vs. 2.3%, p < 0.0001), resulting in higher strategy success in the RA group (95.0% vs. 82.3%, p < 0.0001). At 9 months, in-stent late lumen loss was higher in the RA group (0.34 ± 0.52 mm vs. 0.24 ± 0.47 mm, p = 0.03) and procedural duration was longer in the RA group (76.3 ± 41.8 min vs. 67.0 ± 38.8 min, p = 0.02). major adverse cardiac events (17.8% vs. 25.2%, p = 0.06), in-segment late lumen loss (0.28 ± 0.66 mm vs. 0.17 ± 0.55 mm, p = 0.05), binary restenosis (7.3% vs. 8.2%, p = 0.71 in-stent; 7.7% vs. 9.0%, p = 0.62 in-segment), and contrast amount (215.5 ± 112.5 ml vs. 203.7 ± 96.5 ml, p = 0.24) were similar in both groups. Lesion preparation with upfront RA before drug-eluting stent implantation is feasible in CAC, is more strategy successful, and is associated with excessive in-stent late lumen loss and excellent clinical outcomes at 9 months although longer procedural duration.

Transradial versus trans-femoral access site in high-speed rotational atherectomy in Sweden

BackgroundRadial artery is the preferred access site in contemporary percutaneous coronary intervention (PCI). However, limited data exist regarding utilization pattern, safety, and long-term efficacy of transradial artery access (TRA) PCI in heavily calcified lesions using high-speed rotational atherectomy (HSRA). MethodsAll patients who underwent HSRA-PCI in Sweden between 2005 and 2016 were included. Outcomes were major adverse cardiac events (MACE, including death, myocardial infarction (MI) or target vessel revascularisation (TVR)), in-hospital bleeding and restenosis. Inverse probability of treatment weighting was used to adjust for the non-randomized access site selection. ResultsWe included 1479 patients of whom 649 had TRA and 782 transfemoral artery access (TFA) HSRA-PCI. The rate of TRA increased significantly by 18% per year but remained lower in HSRA-PCI (60%) than in the overall PCI population (85%) in 2016.TRA was associated with comparable angiographic success but significantly lower risk for major (adjusted OR 0.16; 95% CI 0.05–0.47) or any in-hospital bleeding (adjusted OR 0.32; 95% CI 0.13–0.78). At one year, the adjusted risk for MACE (HR 0.87; 95% CI 0.67–1.13) and its individual components did not differ between TRA and TFA patients. The risk for restenosis did not significantly differ between TRA and TFA HSRA-PCI treated lesions (adjusted HR 0.92; 95% CI 0.46–1.81). ConclusionHSRA-PCI by TRA was associated with significantly lower risk for in-hospital bleeding and equivalent long-term efficacy when compared with TFA. Our data support the feasibility and superior safety profile of TRA in HSRA-PCI.

Cover Image

The cover image is based on the Case Report Additional ablation effect of low-speed rotational atherectomy following high-speed rotational atherectomy on early calcifi ed in-stent restenosis: a case report by Hiroyuki Yamamoto et al., https://doi.org/10.1002/ccr3.4550.

Impact of Calcified Lesion Complexity on the Success of Percutaneous Coronary Intervention With Upfront High-Speed Rotational Atherectomy or Modified Balloons - A Subgroup-Analysis From the Randomized PREPARE-CALC Trial

Background/purposeIn the randomized PREPARE-CALC trial, lesion preparation of calcified lesions with upfront rotational atherectomy (RA) prior to drug-eluting stent (DES) implantation resulted in higher acute success as compared to a provisional modified balloon (MB) strategy. We aimed to investigate the impact of calcified lesion complexity on the treatment effect with either MB or RA. Methods/materialsTwo hundred patients were randomized to lesion preparation with either MB or RA. The study population was stratified according to lesion complexity into at least one type-C lesion or into exclusively non-type-C lesions. Endpoints were strategy success, need for bail-out RA, acute lumen gain, and late lumen loss (LLL) at 9 months. ResultsIn total, 143 patients were graded as type-C (45% patients were allocated to MB), whereas 57 patients were graded as non-type-C (61% patients were allocated to MB). In patients with at least one type-C lesion, strategy success with RA was higher than with MB (97% vs 72%, p < 0.001), but superiority of RA was not observed in patients with non-type-C lesions (100% vs 97%, p = 1.00; pinteraction = 0.001). The need for bail-out RA was higher in patients with type-C lesions (n = 15) as compared with non-type-C lesions (n = 1). Acute lumen gain, LLL, and target lesion revascularization at 9 months were not dependent on lesion complexity and upfront lesion preparation strategy. ConclusionsIn patients with calcified non-type-C lesions, the treatment strategy with RA or MB before DES implantation results in comparable success rates, whereas in type-C lesions upfront RA appears to be the superior upfront strategy.

Guiding catheter extension compatibility for high speed rotational atherectomy.

Coronary calcification is one of the features that characterize atherosclerosis. The location of a calcific plaque may vary from case to case [1]. Some distal locations may affect procedural outcomes of coronary angioplasty, resulting in impaired device deliverability. In these cases, guiding extension catheters have been widely introduced into practice to overcome the problem of poor deliverability and guiding catheter support. In some patients, calcified lesions are located distally and rotational burr deliverability is also impaired. The aim of this study was to test the commercially available guiding extension catheters in terms of compatibility of these devices with rotational atherectomy burrs outside the patient’s body.

Additional debulking efficacy of low-speed rotational atherectomy after high-speed rotational atherectomy for calcified coronary lesion.

We aimed to evaluate the additional debulking efficacy of low-speed rotational atherectomy (RA) after high-speed RA by using intravascular imaging. A total of 22 severe calcified coronary lesions in 19 patients (age, 74 ± 10years; 74% male) were retrospectively analyzed. All of these lesions underwent RA under optical coherence tomography (OCT) or optical frequency domain imaging (OFDI) guidance. At first, we performed high-speed RA with 220,000rpm until the reduction of rotational speed disappeared; then, low-speed RA with 120,000rpm using the same burr size was performed. OCT or OFDI was performed after both high-speed and low-speed RAs, and the minimum lumen area were compared. The initial and final burr sizes of high-speed RA were 1.5 (1.5-1.75) and 1.75 (1.5-2.0) mm, respectively. The number of sessions, total duration time, and maximum decreased rotational speed during high-speed RA were 11 ± 5 times, 113 ± 47s, and 4000 (3000-5000) rpm, respectively. During low-speed RA, the number of sessions, total duration time, and maximum reduction of rotational speed were 3 ± 1 times, 32 ± 11s, and 1000 (0-2000) rpm, respectively. The minimum lumen area was similar between after high-speed and after low-speed RA [2.61 ± 1.03 mm2 (after high-speed RA) vs. 2.65 ± 1.00 mm2 (after low-speed RA); P = 0.91]. Additional low-speed RA immediately after sufficient debulking by high-speed RA was not associated with increased lumen enlargement. There was no clinical efficacy of low-speed RA after high-speed RA.

Effects of high-speed rotational atherectomy in peripheral artery disease patients with calcified lesions: a retrospective multicenter registry.

Calcified lesions still remain a technical challenge even in the treatment of infrainguinal artery disease. The aim of this retrospective, multicenter observational study was to investigate interventional outcomes of a high-speed rotational atherectomy device (Rotablator™) and to compare clinical outcomes in patients who underwent Rotablator and those who did not even after failed balloon angioplasty because of underlying calcified lesions. This study enrolled patients who underwent Rotablator (Rota group) and those who did not (Non-rota group) between January 2010 and 2014 December at 12 hospitals. A total of 67 limbs and 68 lesions in 65 patients were included (Rota group; 54 limbs and 55 lesions in 52 patients, Non-rota group; 13 limbs and 13 lesions in 13 patients). In the Rota group, a technical success rate was 94.5% with a complication rate of 1.8%, and all lesions underwent subsequent postdilatation following the adjunctive use of Rotablator, and approximately half of above-the-knee lesions underwent stent implantation. The Rota group had a significantly lower clinically driven reintervention rate at 12months than the Non-rota group (26.5% vs. 58.3%, respectively, p = 0.046). In addition, Rota group showed a trend toward a higher amputation-free survival compared to the Non-rota group at 1month (Rota; 98.0% vs. Non-rota; 84.6%, respectively, p = 0.10). Rotablator was used as an adjunctive device with a high technical success and a low complication rates, and Patients who underwent Rotablator yielded a significantly lower clinically driven reintervention rate at 12months compared to those who did not even after failed balloon angioplasty.

Guiding catheter extension facilities high speed rotational atherectomy for distal right coronary artery lesion

Guiding catheter extension facilities high speed rotational atherectomy for distal right coronary artery lesion

TCT-591 A Comparison of Clinical and Coronary Physiology Characteristics in Patients With and Without Type 4a Myocardial Infarction Following High Speed Rotational Atherectomy–Assisted Percutaneous Coronary Intervention

TCT-591 A Comparison of Clinical and Coronary Physiology Characteristics in Patients With and Without Type 4a Myocardial Infarction Following High Speed Rotational Atherectomy–Assisted Percutaneous Coronary Intervention

A Novel Rotablator Technique (Low-Speed following High-Speed Rotational Atherectomy) Can Achieve Larger Lumen Gain: Evaluation Using Optimal Frequency Domain Imaging.

Background While the evaluation of burr speed was discussed regarding platelet aggregation, the association between platform speed and acute lumen gain of rotational atherectomy remains unknown. Methods Through the evaluation of the potential of low-speed rotational atherectomy (LSRA) in in-vitro experiments, minimum lumen diameter (MLD) and minimum lumen area (MLA) after conventional high-speed rotational atherectomy (HSRA group) and those after LSRA following HSRA (LSRA+HSRA group) treated by 1.5 mm burrs were measured by optical frequency domain imaging (OFDI) in 30 consecutive human lesions. Results The in-vitro experiments demonstrated that MLD and MLA after LSRA+HSRA were significantly larger (MLD: LSRA+HSRA=1.50 ±0.05 mm, HSRA= 1.43 ±0.05 mm, p=0.015; MLA: LSRA+HSRA= 1.90 ±0.17 mm2, HSRA= 1.71±0.11 mm2, and p= 0.037), requiring more crossing attempts (LSRA= 134 ±20 times, HSRA= 72 ±11 times, and p< 0.001). In human studies, there was no significance in reference vessel diameter and lesion length before the procedure between two groups. MLDs after LSRA+HSRA were significantly larger than those in HSRA (LSRA+HSRA= 1.22 ±0.16 mm, HSRA= 1.07 ±0.14 mm, and p= 0.0078), while MLAs after LSRA+HSRA tended to be larger (LSRA+HSRA= 1.79 ±0.51 mm2, HSRA= 1.55 ±0.47 mm2, and p= 0.19). There was no significance in the occurrence of in-hospital complication, including slow flow or no reflow, major dissection, and procedural myocardial infarction, between LSRA+HSRA and HSRA. Conclusions LSRA can achieve larger lumen gain compared, whereas HSRA can pass calcified lesions easily. Combination of LSRA and HSRA is a safe and feasible strategy for severely calcified lesions in clinical practice.

Successful use of last-option infrapopliteal rotational atherectomy despite microembolisation: Peripheral rotational atherectomy and microembolisation.

Calcified lesions pose a technical challenge even in contemporary endovascular intervention. A 71-year-old man who had been receiving haemodialysis required infrapopliteal revascularisation for the treatment of ischaemic infectious gangrene of the right toes. Baseline angiography suggested that the multiple stenotic lesions in the anterior tibial artery were amenable to endovascular therapy for the purpose of establishing one straight-line flow to the foot. However, even a 1.25×15 mm semi-compliant balloon catheter failed to cross and dilate the focal lesion because of the underlying severe calcification in the mid segment of the anterior tibial artery. We adjunctively used high-speed rotational atherectomy with the ROTABLATOR device (1.5 mm burr) to ablate the focal calcified lesion while paying attention to minimise the ablation length and the ablation time. Subsequent balloon angioplasty with a 2.0×40 mm balloon catheter was successful. The skin perfusion pressure in the right foot increased from 32 to 48 mmHg, suggesting a high probability of wound healing. Pathological examination of the right toe amputated on schedule found non-clinically relevant microembolisation involving a couple of cholesterol crystals (20-30 µm) located in the arterioles and capillaries of the necrotic tissue. As an adjunctive device, the ROTABLATOR could provide a last resort for limb salvage, albeit that microembolisation can occur.

Correction to: High-Speed Rotational Atherectomy Versus Modified Balloons Before Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions: The Randomized PREPARE-CALC Trial.

Correction to: High-Speed Rotational Atherectomy Versus Modified Balloons Before Drug-Eluting Stent Implantation in Severely Calcified Coronary Lesions: The Randomized PREPARE-CALC Trial.

TCT-231 The Glasgow Trans-radial Rotablation Registry – A Retrospective Analysis of High-speed Rotational Atherectomy

TCT-231 The Glasgow Trans-radial Rotablation Registry – A Retrospective Analysis of High-speed Rotational Atherectomy

TCT-235 Effect of Additional Lower-speed Rotational Atherectomy on Acute Lumen Gain in vivo and in vitro: Evaluation using OFDI

The association between the platform speed and acute lumen gain remains unknown. The purpose of this study is to evaluate the effect of additional lower-speed rotational atherectomy (RA) following conventional high-speed RA on acute lumen gain using sequential optical frequency domain imaging (OFDI

The incidence of slow flow after rotational atherectomy of calcified coronary arteries: A randomized study of low speed versus high speed.

The purpose of this randomized trial was to compare the incidence of slow flow between low-speed and high-speed rotational atherectomy (RA) of calcified coronary lesions. Preclinical studies suggest that slow flow is less frequently observed with low-speed than high-speed RA because of less platelet aggregation with low-speed RA. This was a prospective, randomized, single center study. A total of 100 patients with calcified coronary lesions were enrolled and randomly assigned in a 1:1 ratio to low-speed (140,000 rpm) or high-speed (190,000 rpm) RA. The primary endpoint was the occurrence of slow flow following RA. Slow flow was defined as slow or absent distal runoff (Thrombolysis in Myocardial Infarction [TIMI] flow grade ≤ 2). The incidence of slow flow in the low-speed group (24%) was the same as that in the high-speed group (24%) (P = 1.00; odds ratio, 1.00; 95% confidence interval, 0.40-2.50). The frequencies of TIMI 3, TIMI 2, TIMI 1, and TIMI 0 flow grades were similar between the low-speed (TIMI 3, 76%; TIMI 2, 14%; TIMI 1, 8%; TIMI 0, 2%) and high-speed (TIMI 3, 76%; TIMI 2, 14%; TIMI 1, 10%; TIMI 0, 0%) groups (P = 0.77 for trend). The incidence of periprocedural myocardial infarction was the same between the low-speed (6%) and high-speed (6%) groups (P = 1.00). This randomized trial did not show a reduction in the incidence of slow flow following low-speed RA as compared with high-speed RA (UMIN ID: UMIN000015702). © 2016 Wiley Periodicals, Inc.