Halftime rotational atherectomy: a unique concept for diffuse long severely calcified lesions.

Rotational atherectomy (RA) is technically more difficult in a diffuse calcified lesion than in a focal calcified lesion. We hypothesized that taking a halftime can be another option for RA to the diffuse calcified lesions. Halftime was defined as at least one long break during RA, in which an operator pulled out the Rotablator system from the guide catheter before crossing the lesion. This study aimed to compare the complications between RA with and without halftime. We included 177 diffuse long severely calcified lesions (lesion lengths ≥ 30 mm) that required RA, and divided those lesions into a halftime group (n = 29) and a no-halftime group (n = 148). The primary outcome was periprocedural myocardial infarction (MI). The reference diameter was smaller in the halftime group than in the no-halftime group [1.82 (1.70-2.06) mm versus 2.17 (1.89-2.59) mm, p = 0.002]. The total run time was longer in the halftime group than in the non-halftime group [133.0 (102.0-223.0) seconds versus 71.5 (42.0-108.0) seconds, p < 0.001]. Although creatinine kinase (CK) and CK-myocardial band (MB) was significantly higher in the halftime group than in the no-halftime group [CK: 156 (97-308) U/L versus 99 (59-216) U/L, p = 0.021; CK-MB: 15 (8-24) U/L versus 5 (3-15) U/L, p < 0.001], periprocedural MI was not observed in the halftime group. In conclusion, periprocedural MI was not observed in RA with halftime. This preliminary study suggests that halftime RA may be a safe option for diffuse severely calcified lesions.

[REFORCE registry]. / Registre REFORCE.

Severe coronary artery calcification, too often underestimated, increases the complexity of percutaneous coronary interventions. Atherectomy is one of preferred approach for the preparation of calcified lesions before stent placement. Orbital atherectomy is a new method that has proven to be safe and effective in the preparation of calcium plaques (ORBIT I and ORBIT II studies). The recent introduction in France allows to perform a prospective registry named REFORCE. Its main objective is to include 300 patients in order to evaluate security and safety of the device in France during routine use.

Lifetime management of severely calcified coronary lesions: the treatment algorithm focused on the shape of calcification.

The concept of lifetime management has not been discussed in the field of percutaneous coronary intervention (PCI), because the durability of drug-eluting stent (DES) is considered to be long enough for most patients. Furthermore, even if in-stent restenosis occurs, the treatment for in-stent restenosis is simple in most cases. On the other hand, the long-term clinical outcomes after DES implantation are worse in severely calcified coronary lesions than in non-calcified lesions. Moreover, the treatment for in-stent calcified restenosis or restenosis due to stent underexpansion is not simple. The concept of lifetime management of severely calcified lesions may be necessary like that of aortic stenosis. Recently, several algorithms have been published in PCI to severely calcified lesions, partly because of the emergence of IVL. These algorithms focus on the selection of cracking and debulking devices for the preparation of stenting. However, the optimal stent expansion does not guarantee the long-term patency, when the target lesion includes calcified nodules. Stent restenosis due to calcified nodules is difficult to manage. In this review article, we propose the algorithm for severely calcified lesions focused on the shape of calcification. We do not need to hesitate stenting when multiple cracks on circumferential calcification are observed by intravascular imaging devices. However, DCB may be an option as final device in some situations, when lifetime management of severely calcified lesions is considered.

Outcomes after Percutaneous Coronary Intervention in Patients with Extremely Calcified Left Main Lesions.

Background and Objectives: Available data with regard to the outcomes of patients with severely calcified left main (LM) lesions after revascularization by percutaneous coronary intervention (PCI) when compared to non-calcified LM lesions is unclear. Materials and Methods: The present study sought to retrospectively investigate in hospital and 1 year post-intervention outcomes of patients with extremely calcified LM lesions after PCI facilitated by calcium-dedicated devices (CdD). Seventy consecutive patients with LM PCI were included. CdD requirement was based on suboptimal results after balloon angioplasty. Results: Twenty-two patients (31.4%) required at least one CdD, while nine patients (12.8%) required at least two. Intravascular lithotripsy and rotational atherectomy were the predominantly used methods(59.1% and 40.9% respectively, for in-group ratios), while ultra-high pressure and scoring balloons contributed the least to lesion preparation (9%). In 20 patients (28.5%), severe or moderate calcifications were angiographically identified, but non-compliant balloon predilation was adequate and CdD were not necessary. Total procedural time was significantly higher in CdD group (p-value 0.02). Procedural and clinical success were obtained in 100% of cases. There were no major adverse cardiac and cerebrovascular events (MACCE) recorded during hospitalization. MACCE at 1 year post-procedure were recorded in three patients (4.2% overall). All three events were documented in the control group (6.2%), and no events were recorded in CdD group (p-value 0.23). There was one cardiac death at 10 months and two target lesion revascularizations for side-branch restenosis. Conclusions: Patients with extremely calcified LM lesions treated by PCI present a favorable prognosis if angioplasty is facilitated by more aggressive lesion debulking using calcium-dedicated devices.

Coronary Lithotripsy as Elective or Bail-Out Strategy After Rotational Atherectomy in the Rota-Shock Registry.

Debulking lesions with severe coronary artery calcification (CAC) is highly recommended to obtain good procedural and long-term success. Utilization and performance of coronary intravascular lithotripsy (IVL) after rotational atherectomy (RA) has not been thoroughly studied. This study aimed to evaluate the efficacy and safety of IVL with the Shockwave Coronary Rx Lithotripsy System in lesions with severe CAC as elective or bail-out strategy after RA. This observational, prospective, single-arm, multicenter, international, open-label Rota-Shock registry included patients with symptomatic coronary artery disease and lesions with severe CAC treated by percutaneous coronary intervention, including lesion preparation with RA and IVL, at 23 high-volume centers. Primary efficacy end point was procedural success, defined as final diameter stenosis <30% by quantitative coronary angiography. Primary safety end point was freedom from serious angiographic complications, which included >National Heart, Lung and Blood Institute type B dissection, perforation, abrupt closure, slow or no flow, final thrombolysis in myocardial infarction flow <3, and acute thrombosis. A total of 160 patients were enrolled between June 2020 and June 2022. The primary efficacy end point was observed in 155 patients (96.9%). The primary safety end point occurred in 145 cases (90.6%). Dissections >National Heart, Lung and Blood Institute type B occurred in 3 patients (1.9%), whereas slow or no flow occurred in 8 (5.0%), final thrombolysis in myocardial infarction flow <3 in 3 (1.9%), and perforation in 4 patients (2.5%). Free from inhospital major adverse cardiac and cerebrovascular events, including cardiac death, target vessel myocardial infarction, target lesion revascularization, cerebrovascular accident, definite/probable stent thrombosis, and major bleeding, occurred in 158 patients (98.7%). In conclusion, IVL after RA in lesions with severe CAC was effective and safe, with a very low incidence of complications as either elective or bail-out strategy.

EXpansion of stents after intravascular lithoTripsy versus conventional predilatation in CALCified coronary arteries.

BACKGROUND: Coronary artery calcification is a strong predictor for procedural failure and is independently associated with adverse events after percutaneous coronary intervention (PCI). An important contributor to the impaired outcome is the inability to achieve optimal results due to stent underexpansion or stent deformation/fracture. Intravascular lithotripsy (IVL) has emerged as an alternative technique to change the integrity of calcified plaques. AIMS: Our aim was to investigate if pre-treatment with IVL in severely calcified lesions increases stent expansion, assessed by optical coherence tomography (OCT), when compared to predilatation with conventional and/or specialty balloon strategy. METHODS: EXIT-CALC was a prospective, single-centre, randomised controlled study. Patients with an indication for PCI and severe calcification of the target lesion were allocated to predilatation with conventional angioplasty balloons or pre-treatment with IVL, followed by drug-eluting stenting and mandatory postdilatation. Primary endpoint was stent expansion assessed by OCT. Secondary endpoints were the occurrence of peri-procedural events and major adverse cardiac events (MACE) in hospital and during follow-up. RESULTS: A total of 40 patients were included. The minimal stent expansion in the IVL-group (n = 19) was 83.9 ± 10.3% and 82.2 ± 11.5% in the conventional group (n = 21) (p = 0.630). Minimal stent area was 6.6 ± 1.5 mm2 and 6.2 ± 1.8 mm2, respectively (p = 0.406). No peri-procedural, in-hospital and 30-day follow-up MACE were reported. CONCLUSIONS: In severely calcified coronary lesions we found no significant difference in stent expansion measured by OCT when comparing IVL, as plaque modification, with conventional and/or specialty angioplasty balloons.

Comparison of Coronary Intravascular Lithotripsy and Rotational Atherectomy in the Modification of Severely Calcified Stenoses.

Debulking techniques are often necessary for successful lesion preparation in percutaneous coronary intervention. The aim of this study was to compare plaque modification of severely calcified lesions by coronary intravascular lithotripsy (IVL) with that of rotational atherectomy (RA) using optical coherence tomography (OCT). ROTA.shock was a 1:1 randomized, prospective, double-arm, multicenter noninferiority trial designed to compare final minimal stent area after IVL with RA for lesion preparation in percutaneous coronary interventional treatment of severely calcified lesions. On the basis of OCT acquired before and immediately after IVL or RA in 21 of the 70 patients included, we performed a detailed analysis of the modification of the calcified plaque. After RA and IVL, calcified plaque fractures were present in 14 of the patients (67%), with a significantly greater number of fractures after IVL (3.23 ± 0.49) than after RA (1.67 ± 0.52; p < 0.001). Plaque fractures after IVL were longer than after RA (IVL: 1.67 ± 0.43 mm vs RA: 0.57 ± 0.55 mm; p = 0.01), resulting in a greater total volume of the fractures (IVL: 1.47 ± 0.40 mm3 vs RA: 0.48 ± 0.27 mm3; p = 0.003). Use of RA was associated with a greater acute lumen gain than was use of IVL (RA: 0.46 ± 0.16 mm2 vs IVL: 0.17 ± 0.14 mm2; p = 0.03). In conclusion, we were able to show differences in plaque modification of calcified coronary lesions by OCT: although RA leads to a greater acute lumen gain, IVL induces more and longer fractures of the calcified plaque.

Planned versus unplanned rotational atherectomy for plaque modification in severely calcified coronary lesions.

BACKGROUND: Evidence on the optimal timing of RA is scarce, although increased periprocedural complications for unplanned procedures have been reported. AIMS: To compare planned versus unplanned use of rotational atherectomy (RA) for plaque modification in patients with severely calcified coronary lesions. METHODS: Procedural and 1-year follow-up data of planned (n = 562 lesions in 448 vessels of 416 patients) and unplanned (n = 490 lesions in 435 vessels of 403 patients) RA between 2008 and 2020 were analyzed using the propensity score methods. The primary composite endpoint was target lesion failure (TLF), defined as cardiovascular death (CVD), target vessel myocardial infarction (TVMI), or target lesion revascularization (TLR). RESULTS: Angiographic success was > 99% in both groups. Fluoroscopy time and contrast volume were significantly lower in planned RA (p < 0.001). Periprocedural complications including slow-flow, coronary dissection, and MI occurred in 4.8% after planned, and in 5.7% after unplanned RA. TLF occurred in 18.5% after planned, and in 14.7% after unplanned RA. Weighted subdistribution hazard ratios for TLFs revealed an unfavorable 1-year outcome for planned RA (sHR 1.62 [1.07-2.45], p = 0.023), which was driven by TLR (sHR 2.01 [1.18-3.46], p = 0.011), but not by CVD, or TVMI. No differences were observed in all-cause mortality. CONCLUSIONS: Unplanned RA was associated with favorable outcome when compared to planned RA. Thus, RA can safely be reserved for lesions that prove untreatable by conventional means. Randomized and prospective trials are needed to evaluate a predominant use of rotational atherectomy as a bailout strategy in the future.

Device indication for calcified coronary lesions based on coronary imaging findings.

Performing percutaneous coronary intervention (PCI) for calcified lesions is still a major challenge. Calcified lesions are a cause of inadequate dilatation, leading to poor short- and long-term PCI outcomes. It has been suggested that modification for calcification before stent implantation might improve outcomes by providing adequate dilation. Intravascular lithotripsy (IVL) is available under insurance reimbursement in December 2022 in Japan. IVL is one candidate for a treatment device to modify calcified lesions in addition to atherectomy, such as rotational and orbital atherectomy, and special balloons, such as scoring and cutting balloons. Although the evidence for the indications, of these devices is insufficient, they must be used appropriately in clinical practice. In this report, we propose a method for determining an indication of these devices solely as per the coronary imaging findings with intravascular ultrasound or optical coherent tomography. This consensus document represents the collective opinion of experts on the best current indications and should be changed based on future evidence. However, we believe that it represents the optimal criteria for selecting treatment options in the current situation.

Synergistic Coronary Artery Calcium Modification With Combined Atherectomy and Intravascular Lithotripsy.

BACKGROUND: Severe coronary artery calcification (CAC) remains challenging during percutaneous coronary intervention (PCI) and often requires 1 or more advanced calcium modification tools. OBJECTIVES: We describe the combination use of rotational (RA) or orbital atherectomy (OA), with intravascular lithotripsy (IVL), termed rotatripsy and orbital-tripsy, respectively, for modifying CAC prior to stent implantation during PCI. METHODS: We performed a retrospective analysis of patients treated with rotatripsy or orbital-tripsy at our center between July 2019 and March 2022. The primary efficacy endpoint was procedural success (successful stent implantation, <30% residual stenosis visually, Thrombolysis in Myocardial Infarction 3 flow; absence of types C to F dissection/perforation or loss of side branch ≥2.0mm visually) without in-hospital major adverse cardiovascular event (MACE, defined as cardiovascular death, myocardial infarction [MI], target-vessel revascularization). RESULTS: A total of 25 patients (14 rotatripsy and 11 orbital-tripsy) were included in our study. The mean age was 72.2 ± 7.6 years and 76% were men. PCI was guided by intravascular imaging in 24 patients (96%). All cases were treated with either RA or OA before utilization of IVL. Procedural success was achieved in 22 cases (88%) with 1 sidebranch loss without periprocedural MI (4%) and 2 in-patient deaths (8%) unrelated to the procedure (1 intracerebral hemorrhage and 1 cardiac arrest). CONCLUSION: We describe efficacious use of both rotatripsy and orbital-tripsy to modify severe CAC during PCI in a real-world setting. Intravascular imaging can guide appropriate use of these devices to complement each other to modify severe CAC to achieve optimal outcomes.