The impact of novel scoring balloon and cutting balloon after orbital atherectomy on severely calcified coronary lesion as assessed by optical coherence tomography.

BACKGROUND: Debulking devices are often followed by a scoring or cutting balloon in percutaneous coronary intervention (PCI) for severely calcified lesions. However, there are limited data on balloon preparation after orbital atherectomy (OA) assessed using optical coherence tomography (OCT). AIM: We aimed to compare the effects of a novel scoring and cutting balloon on calcified coronary lesions with OCT. METHODS: We retrospectively examined 38 patients (38 lesions) who underwent PCI with a scoring or a cutting balloon after OA. All patients underwent pre-PCI, preballooning, postballooning, and post-PCI OCT imaging. We divided the patients into novel scoring-balloon (group A: n = 22) and cutting-balloon (group B: n = 16) groups and compared the OCT findings, including minimum lumen area (MLA) and expansion ratio (MLA divided by mean reference lumen area). RESULTS: The mean patient age was 76.1 ± 8.7 years; 71.5% were male. There were no significant differences in patient background between both groups. Regarding procedural characteristics, the maximum balloon pressure was significantly higher in group A (median 23 atm, interquartile range [IQR] 18-24 vs. 12 atm [IQR: 10-12], p < 0.01). Although a calcium score of 4 was more frequently observed in group A (86.4% vs. 62.5%, p = 0.12), post-PCI MLA was comparable between both groups (3.95 mm2 [IQR: 3.27-4.41] vs. 3.43 mm2 [IQR: 2.90-4.82], p = 0.63). Furthermore, the expansion ratio was significantly greater in group A (0.83 ± 0.20 vs. 0.68 ± 0.14, p < 0.01). CONCLUSION: Despite a higher calcium score, a larger expansion ratio was achieved in patients with a novel scoring balloon than in those with a cutting balloon after OA.

The Unique Role of Cutting Balloon Angioplasty in Debulking Multiple Nodular Calcium in Osteoproximal and Mid-left Anterior Descending Coronary Artery.

We report a rare case of multiple nodular calcium in the left anterior descending coronary artery in an octogenarian presenting with unstable angina. Dilatation with the noncompliant and scoring balloon could not yield the nodular calcium and it was only the cutting balloon that could yield the nodular calcium and successful coronary angioplasty could be accomplished with good angiographic results with distal Thrombolysis in Myocardial Infarction (III) flow. This case demonstrates the unique role of cutting balloons in the angioplasty of coronary lesions with multiple nodular calcium.

Comparison of angiographic result and long-term outcome in patients with in-stent restenosis treated with cutting balloon or with scoring balloon angioplasty.

BACKGROUND: Lesion preparation with a cutting (CB) or scoring balloon (SB) is often used in patients with in-stent restenosis (ISR). However, there are no comparative studies. METHODS: We analyzed 81 patients (CB group: n = 38; SB group: n = 43) who had a calcified ISR from November 2019 to September 2021. The primary endpoint was strategy success (less than 20% residual stenosis); the secondary endpoints were major adverse cardiovascular events during the 1-year follow-up. Quantitative coronary angiography was performed to evaluate the strategy success. RESULTS: The patients in the CB group were more likely to have a severe calcified ISR (P = .001) and multiple stent layers (P = .001). A total of 64 patients (79.0%) reached the primary endpoint. Residual stenosis greater than 20% was more common in the CB group (39.5% vs 4.7%; P = .001). In the multivariate analysis, an effect of the intervention group on the achievement of the primary endpoint could be excluded (estimate 1.06; standard error 1.07; P = .322). The time interval of stent implantation prior to CB/SB (P = .007) and severe calcified ISR (P = .009) had a negative impact on reaching the primary endpoint. During the follow-up, there were no differences in rates of cardiac death (CB 2.5% vs. SB 1.2%; P = .598), acute myocardial infarction (CB 0% vs. SB 4.9%; P = .119), and target lesion failure (CB 3.7% vs SB 12.3%; P = .074). CONCLUSIONS: In our cohort, multivariate analysis showed that lesion preparation with CB or SB must be considered equivalent in terms of angiographic results. Factors like severe calcified ISR and the time interval of prior stent implantation negatively influenced the angiographic outcome.

Intramural hematoma extending from a dissection within an implanted stent: a case report treated with fenestration using a cutting balloon.

Background: Dissection after balloon dilation or stent implantation is a common complication of percutaneous coronary intervention. In general, coronary stent implantation for coronary artery dissection is safe when the dissection is completely covered by the stent, particularly when dissection occurs during pre-dilation. However, here, we report a case of severe restenosis caused by a pre-dilation hematoma that extended after stent implantation. Case summary: A 76-year-old man was diagnosed with angina on exertion and underwent percutaneous coronary intervention in the right coronary artery. After pre-dilation with a cutting balloon, non-flow-limiting dissection occurred. An everolimus-eluting stent was implanted, completely sealing the dissection, and intravascular ultrasound revealed adequate stent expansion without stent edge dissection. Two weeks after the procedure, confirmatory coronary angiography revealed severe restenosis extending from the distal stent edge to the distal right coronary artery. Intravascular ultrasound revealed a hematoma extending from the middle of the stent to the distal segment. Discussion: The patient had been on steroids for a long time. The cutting balloon used for pre-dilation may have created a deep dissection reaching the tunica media, already rendered vulnerable by steroids, potentially leading to injury to the vasa vasorum. The intramural hematoma from the bleeding vasa vasorum might have been the underlying cause of this phenomenon, as evidenced by its increase in size despite the entry of the dissection being completely sealed. Cardiologists should be aware of this possibility.

Coronary calcifications, the Achilles heel in coronary interventions.

Percutaneous coronary intervention in severely calcified coronaries has been associated with higher rates of procedural complications, including myocardial infarction and death in addition to increased frequency of coronary revascularization on an intermediate and long-term basis. The SYNTAX score, which is designed to assess the complexity of coronary artery disease and aids in choosing a revascularization method, allocates two points per lesion when there is heavy calcification present on fluoroscopy. With the advent of novel multimodality imaging technologies, the detection and evaluation of coronary calcifications improved significantly over the last decade. Several tools are now available for modifying calcified lesions including different types of dedicated balloons and atherectomy devices, which may create some degree of confusion regarding the suitable application of each instrument. The aim of this review is to cover this vital topic from different aspects. First, we tried to provide an overview on the pathophysiology and types of coronary calcification and its risk factors. Then, we outlined the available imaging modalities for the evaluation of calcified coronary lesions, highlighting the points of strength and weakness of each of them. A comprehensive discussion of calcium-modifying techniques was elaborated, summarizing their mechanism of action, pros and cons, and possible complications. Finally, an integrated algorithm was proposed for the best management of calcified coronary lesions.

Cutting balloon septotomy for repair of right common iliac artery aneurysm in the setting of type B aortic dissection.

We report a case of using cutting balloon septotomy for a 5-cm right common iliac artery aneurysm repair in a patient with a chronic type B aortic dissection after open repair 10 years before. This technique uses intravenous ultrasound to facilitate deployment of a cutting balloon to shear through the dissection flap, allowing for optimization of the landing zone for endovascular repair of a right common iliac artery aneurysm. Various methods are available for performing septotomy, and the use of a cutting balloon is one that helps with stent placement and position.

An analysis of published cases of cutting balloon use in spontaneous coronary artery dissection.

Introduction: SCAD involves a sudden tear or separation within the layers of the coronary artery wall, resulting in blood flow obstruction and subsequent myocardial ischemia. Materials and methods: A comprehensive literature search was conducted to identify relevant published cases of cutting balloon use in patients diagnosed with spontaneous coronary artery dissection. Electronic databases including PubMed, MEDLINE, Embase, Cochrane Library and Google Scholar were systematically searched from inception until the present using terms "cutting balloon," "SCAD," "acute coronary syndrome," "intramural hematoma," and "angioplasty." Results: A total of 32 published cases of cutting balloon use in spontaneous coronary artery dissection were analyzed in this study. The majority of the patients included in the analysis were female without prior history of cardiovascular disease. The median age of the SCAD population was approximately 46 years. The most frequently affected artery in SCAD cases was the Left Anterior Descending artery. Intravascular ultrasound was utilized more frequently than other modalities of adjunctive imaging techniques. The most frequent complication was the distal propagation of hematoma. Despite the successful dilation achieved with the cutting balloon, in some cases stenting was required to provide additional support. Conclusion: The results of this analysis demonstrate that cutting balloon use in SCAD cases yields favorable outcomes.

Comparison of peripheral cutting balloon angioplasty with conventional balloon angioplasty for recurrent hemodialysis vascular access stenosis: A prospective randomized controlled trial.

PURPOSE: This study aimed to compare the efficacy and safety of cutting balloon angioplasty (CBA) and conventional balloon angioplasty (control group) for recurrent vascular access stenosis in arteriovenous fistulas. MATERIALS AND METHODS: This prospective, randomized single-center clinical trial included patients with hemodynamically significant recurrent vascular access stenosis of an arteriovenous fistula. The Kaplan-Meier method was used to assess primary patency, whereas the log-rank test was used to evaluate differences in patency between groups. Functional evaluations were performed using Doppler ultrasonography. RESULTS: Patients (n = 122) were randomly assigned to undergo CBA or conventional balloon angioplasty between December 2012 and November 2017. The clinical success rate was 100% in both groups. The anatomical success rates were 65% and 56% in the CBA and control groups, respectively. The primary patency of the target lesion was significantly better in the CBA group (33.3%) than in the control group (16.1%) at 6 months (hazard ratio, 0.50; 95% confidence interval, 0.33-0.77; p = 0.00171). The stenosis percentage decreased significantly after angioplasty in the CBA group (Δ-50.7%) compared with the control group (Δ-41.9%) (p = 0.0008). Access flow, measured using duplex Doppler ultrasonography, improved after angioplasty in both groups (300-526 ml/min in the control group and, 268-546 ml/min in the CBA group). Change in access flow (Δ + 278 ± 162) in the CBA group tended to be greater than that in the control group (Δ + 226 ± 151) (p = 0.07). However, the difference was not statistically significant. CONCLUSION: In patients with recurrent vascular access stenosis of the arteriovenous fistula CBA is effective and superior to conventional angioplasty.

Comparative efficacy and safety of four common balloon angioplasty techniques for an arteriovenous fistula or graft stenosis: a systematic review and network meta-analysis of randomized controlled trials.

Background: Balloon angioplasty could decrease restenosis of hemodialysis vascular access. The present study investigated the comparative effects and safety of commonly available balloon angioplasty techniques for treating patients with failing autogenous arteriovenous fistulas (AVFs) and grafts (AVGs) stenosis. Methods: A comprehensive literature search, including an updated search of PubMed and Embase (via Ovid) and screening of published meta-analyses, was conducted. Primary patency at 6 and 12 months was the primary outcome, and the incidence of complications was the secondary outcome. The random-effects model was used to conduct all statistical analyses, which were performed using RevMan 5.3 and ADDIS 1.16.8. Results: A total of 20 eligible studies involving four balloon angioplasty techniques were entered into the final analysis. Although the direct meta-analysis indicated that cutting balloon angioplasty (CtBA) significantly improved primary patency at 6 [odds ratio (OR), 1.91; 95% confidence interval (CI): 1.27 to 2.86] and 12 (OR, 1.56; 95% CI: 1.13 to 2.15) months compared with conventional balloon angioplasty (CBA), this was not supported by network meta-analysis, which suggested that CtBA was associated with a higher risk of complications compared with drug-coated balloon angioplasty (DcBA) [OR, 0.05; 95% credible interval (CrI): 0.00 to 0.83], high-pressure balloon angioplasty (HBA) (OR, 0.04; 95% CrI: 0.00 to 0.69), and CBA (OR, 0.11; 95% CrI: 0.02 to 0.59). Subgroup analysis of AVFs did not detect any significant differences. Conclusions: In failing AVF and AVG stenosis, HBA might be a preferential option as it is related to a lower risk of complications and has numerically higher primary patency than DcBA and CBA. Further studies are needed to confirm these findings.

Cutting balloon for femoral arterial and venus obstructions due to suture-based closure devices: Case series.

Suture-based vascular closure devices have been shown to be effective in hemostasis for procedures with vascular access. However, iatrogenic vascular occlusion may occur. The cutting balloon (CB) is a noncompliant balloon wrapped with 3-4 microsurgical blades that are intended to modify vascular lesions, but it may also be utilized to cut and release endovascular sutures. We report two cases in which the CB was employed as a bailout strategy to alleviate suture-related vascular occlusion after transcatheter aortic valve replacement. The CB can be effectively utilized to resolve suture-related vascular occlusion.

Propensity score-matched analysis of six-month outcomes of paclitaxel-coated balloons combined with UltraScore balloons versus conventional scoring balloons for femoropopliteal lesions.

PURPOSE: Combination angioplasty with paclitaxel-coated balloons (PCBs) and conventional scoring balloons for femoropopliteal lesions has demonstrated satisfactory results, even for complex lesions. The UltraScore balloon (Becton Dickinson, New Jersey, USA), which has a maximum length of 300 mm, has two longitudinal 0.010-inch stainless steel wires and is a new treatment option for complex femoropopliteal lesions. However, no studies have evaluated the effect of the UltraScore balloon on femoropopliteal lesions. This study aimed to compare the clinical efficacy of angioplasty over a six-month period using UltraScore balloons versus conventional scoring balloons for the treatment of atherosclerotic femoropopliteal lesions with PCBs. METHODS: A retrospective single-center observational study enrolled 272 patients who underwent PCB angioplasty combined with an UltraScore balloon (n = 58) or conventional scoring balloon (n = 214) without bailout stenting. Propensity score matching was used to minimize intergroup differences in baseline characteristics, and six-month outcomes were compared between the two groups. The primary endpoint was a technical success (i.e., residual angiographic stenosis of <30% with non-severe dissection). The secondary endpoints were the incidences of periprocedural complications, restenosis, and target lesion revascularization (TLR). RESULTS: After propensity score matching, 50 matched pairs of patients were selected for analysis. The UltraScore group had a significantly longer vessel length (192.8 ± 94.9 versus 36.6 ± 7.9 mm, P < 0.001), a lower frequency of non-compliant balloon (26.0% versus 56.0%, P = 0.002), and a smaller PCB diameter (5.32 ± 0.65 versus 5.66 ± 0.52 mm, P = 0.002) compared with the scoring group. The primary endpoint of technical success was significantly higher in the UltraScore group than in the scoring group (76.0% versus 56.0%, P = 0.035). There were no significant differences in periprocedural complications (4.0% versus 2.0%, P = 0.562), six-month restenosis (4.0% versus 8.0%, P = 0.339), and TLR (2.0% versus 4.0%, P = 0.500) between both groups. The multivariate logistic regression analysis showed that UltraScore use was independently associated with an increase in technical success (odds ratio: 2.58; 95% confidence interval: 1.05-6.36, P = 0.040). CONCLUSION: The use of an UltraScore balloon during PCB angioplasty for femoropopliteal lesions significantly improved technical success compared with conventional scoring balloons. UltraScore use was an independent predictor of technical success, indicating its potential advantages in peripheral intervention procedures.

Combined treatment of dysfunctional dialysis access with cutting balloon and paclitaxel-coated balloon in real world.

Background: Dysfunction in arteriovenous (AV) access is a common reason for subsequent intervention. To evaluate the results of endovascular treatment of AV access lesions using cutting balloon (CB) and drug-coated balloon (DCB) angioplasty compared to standard treatment using plain-old balloon angioplasty (POBA). Patients and methods: Patients who retrospectively were selected from a prospectively maintained database. Primary endpoint was primary patency rate at the target lesion up to 12 months after index procedure. Secondary endpoints were the acute treatment success, the "bail out" stent rate, primary patency at 6 months, freedom from target lesion revascularization (TLR), AV access replacement and surgical revision during a follow-up period up to 12 months, and all-cause mortality rate stratified to patients treated with and without DCB. Results: One hundred and eighty-four patients met the inclusion criteria. POBA as stand alone or combined with DCB angioplasty was performed in 71 patients (38.6%), CB in 54 patients (29.3%), and in 59 patients (32.1%), both CB and DCB were used. Primary patency rate at 12 months was 31.6% for the POBA/DCB-group, 52.3% for the CB-group, and 64.8% for the CB/DCB-group, respectively. In total, 80 patients (51.6%) had a TLR including endovascular or surgical revision, or a shunt replacement. All-cause mortality at 12 months was 7.2% in the DCB group and 9.1% in the group of patients treated without a DCB (p=0.747). Conclusions: The use of CB seems to be crucial for a better outcome. The combination of CB and DCB achieves the best patency results at mid-term.

A study of balloon type on calcified coronary lesion predilation: A finite element analysis.

Calcified coronary lesions have been one of the more difficult types of lesion for interventional treatment, and angioplasty is required to break the calcification before stent implantation so that the stent can expand smoothly, however, it remains unclear which type of angioplasty is optimal for different calcified lesions. In this study, a finite element approach was used to model normal balloons, cutting balloons, and AngioSculpt balloons. In addition, calcified lesions of different degrees, thicknesses, and lengths were modeled according to Intravascular ultrasound (IVUS) calcification grade. The above three balloons were used to pretreat calcified lesions, and the brittle fracture module for calcification was used to detect fracture success, to facilitate virtual stent implantation after predilation. The simulation results showed that with a thickness of less than 0.3 mm, balloons were unable to deal with calcified plaques in lesions of less than 120°, for 180° calcified lesions the cutting balloon fractured the calcified material at 1.2 MPa, the AngioSculpt balloon produced multiple fractures at 0.8 MPa for 270° calcified plaques, but was unable to fracture calcified lesions with a thickness of 0.4 mm. Based on these results, we conclude that the length of the lesion did not affect calcification fracture, while the thickness of the lesion did. In calcified lesions of approximately 180°, the cutting balloon showed the best predilation results, while the AngioSculpt balloon was optimal for 270°. In annular calcification, all three balloons were unable to fracture the lesion.

Cutting balloon to optimize predilation for stent implantation: The COPS randomized trial.

OBJECTIVES: The objective of this study is to investigate the use of cutting balloon (CB) inflated at high pressure compared with noncompliant balloon (NCB) for the treatment of calcified coronary lesions. BACKGROUND: No data are available regarding the safety and efficacy of CB inflated at high pressure in coronary artery calcifications. METHODS: Patients with calcified lesions (more than 100° of calcium demonstrated at baseline intravascular ultrasound) were randomized. Primary endpoint of the study was the final minimal stent area (MSA) and stent symmetry in the calcific segment. Secondary endpoints included rate of device failure and the 1-year rate of target lesion revascularization, target vessel revascularization, and major adverse cardiovascular events. RESULTS: From September 2019 to June 2021, a total of 100 patients were included and randomized; 13 patients were excluded for major protocol deviations. Lesions were complex (type B2/C n = 61 [71.2%]) with a mean arch of calcium of 266 ± 84°, a calcium length of 12 ± 6.6 mm. CB was inflated at comparable atmospheres when compared with NCB (18.3 ± 5 vs. 19 ± 4.5, p = 0.46). In the per-protocol population, the final MSA at the level of the calcium site was significantly higher in the CB group (8.1 ± 2 vs. 7.3 ± 2.1, p = 0.035) with a higher eccentricity index achieved in the CB group (0.84 ± 0.07 vs. 0.8 ± 0.08, p = 0.013). Three device failure occurred in the CB group. One-year follow-up outcomes were comparable. CONCLUSIONS: Treatment of calcified lesions with high-pressure CB has a good safety profile and is associated with a larger MSA and higher eccentricity of the stent at the level of the calcium site compared with NCB.

Pretreatment Effects of Cutting Balloon on Coronary Artery Calcification Based on Finite Element Analysis / 医用生物力学

Objective To investigates the applicability of cutting balloon in the pretreatment of superficial coronary artery calcified lesions, so as to decrease the occurrence of serious consequences in the treatment of calcified lesions. Methods The effect of cutting balloon on calcified plaques with different curvatures, thickness, and length was analyzed using the finite element method, with normal balloon as a control. The thickness of calcified plaque was set to 0.3 mm and 0.4 mm, and the length was set to 2 mm and 4 mm. The calcification degree was set to 120°, 180°, 270°and 360° according to the intravenous ultrasound (IVUS) calcification severity grading, with a total of 16 types of calcified plaques. The brittle fracture module was used to simulate calcification fracture of calcified plaques, and virtual stent implantation was carried out based on pretreatment simulation. The effect of pretreatment was evaluated by calcification fracture condition and stent roundness. Results For superficial calcification lesions, in lesions less than 120°, the balloon could not remove the calcification plaque obstruction, and the stent roundness rate was 82.75%. In 180° calcified lesions with thickness of less than 0.3 mm, the calcification was broken by cutting balloon under 1 215.9 kPa expansion pressure, and the post-stent roundness rate was 74.42%; normal balloon could not cause calcification fracture under safe expansion pressure (1 418.55 kPa). In 270°calcified lesions with thickness less than 0.3 mm, the normal balloon produced 3 fractures under 1 013.25 kPa expansion pressure. The cutting balloon produced 2 fractures under 1 013.25 kPa expansion pressure, and the balloon could not fracture the circular calcified lesions with thickness of 0.3 mm. Conclusions Cutting balloon is recommended for 180°calcified lesions with thickness less than 0.3 mm, the normal balloon is recommended for 270°calcified lesions, and balloon pretreatment is not recommended for annular lesions with thickness greater than 0.3 mm.

Efficacy and safety of drug-coated balloon combined with cutting balloon for side branch of true coronary bifurcation lesions: Study protocol for a multicenter, prospective, randomized controlled trial.

Background: Coronary bifurcation lesions are common of percutaneous coronary intervention (PCI), and the optimal interventional therapy strategy is still a matter of debate and remains a challenge for interventional cardiologists. The provisional stenting technique is still a preferred method for most bifurcation lesions, but restenosis of the side branch (SB) occurs in approximately 17-19% of cases. Therefore, the dilemma of reducing SB restenosis still exists, and further research on strategies to reduce restenosis for SB is necessary. Drug-coated balloon (DCB) can reduce clinical events in small vessel disease and in-stent restenosis. The efficacy and safety of DCB for SB of true coronary bifurcation lesions have not been fully investigated. A randomized comparison of DCB combined with cutting balloon angioplasty vs. cutting balloon angioplasty for SB has never been published. Methods and design: The purpose of this study is to explore the superiority of DCB combined with cutting balloon vs. cutting balloon angioplasty for SB after main vessel (MV) drug-eluting stent implantation of true coronary bifurcation lesions. This study is a multicenter, prospective, randomized controlled trial including 140 patients with true coronary bifurcation lesions. Patients will be randomized in a 1:1 manner to receive either DCB combined with cutting balloon or cutting balloon angioplasty for SB after MV drug-eluting stent implantation. The primary endpoint is the evaluation of late lumen loss (LLL) of SB at the 9-month follow-up. The secondary endpoints include procedural success during initial hospitalization, LLL of MV at the 9-month follow-up, binary angiographic restenosis in MV and SB at the 9-month follow-up, the proportion of patients with a final post-PCI quantitative flow ratio result ≤ 0.80 for SB at the 9-month follow-up, and major adverse cardiac events during the 24-month follow-up. Conclusions: This clinical trial will provide evidence as to whether DCB combined with cutting balloon for SB of true coronary bifurcation lesions is a superior treatment approach. Trial Registration Number: ChiCTR2000040475. Dissemination: The results of this clinical trial will be published in a peer-reviewed journal.

Combined rotational atherectomy and cutting balloon angioplasty prior to drug-eluting stent implantation in severely calcified coronary lesions: The PREPARE-CALC-COMBO study.

OBJECTIVES: To evaluate the safety and efficacy of lesion preparation using rotational atherectomy (RA) with consecutive cutting balloon angioplasty (Rota-Cut). BACKGROUND: Whether the Rota-Cut combination improves stent performance in severely calcified coronary lesions is unknown. METHODS: PREPARE-CALC-COMBO is a single-arm prospective trial in which 110 patients were treated with a Rota-Cut strategy before implantation of sirolimus-eluting stents and compared with patients treated with modified balloon (MB, scoring or cutting) or RA from a historical cohort (the randomized PREPARE-CALC trial). The study had two primary endpoints: in-stent acute lumen gain (ALG) by quantitative angiographic analysis and stent expansion (SE) on optical coherence tomography. RESULTS: In-stent ALG was significantly higher with Rota-Cut compared to RA or MB alone (1.92 ± 0.45 mm vs. 1.74 ± 0.45 mm with MB vs. 1.70 ± 0.42 mm with RA; p = 0.001 and p < 0.001, respectively). SE was comparable between groups (75.1 ± 13.8% vs. 73.5 ± 13.3 with MB vs. 73.1 ± 12.2 with RA; p = 0.19 and p = 0.39, respectively). The Rota-Cut combination resulted in higher minimal stent area (MSA) (7.1 ± 2.2mm2 vs. 6.1 ± 1.7mm2  with MB vs. 6.2 ± 1.9mm2 with RA; p = 0.003 and p = 0.004, respectively). In-hospital death occurred in one patient. Target vessel failure at 9 months was low and comparable between groups (8.2% vs. 8% with MB vs. 6% with RA; p = 1 and p = 0.79, respectively). CONCLUSION: Rota-Cut combination resulted in higher ALG and larger MSA compared with historical control of RA or MB alone, but was not associated with higher SE. Despite extensive lesion preparation, this strategy is safe, feasible, and associated with favorable clinical outcome at 9 months.

Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions.

BACKGROUND: The comparative efficacy of percutaneous techniques for the preparation of calcified lesions before stenting remains poorly studied. OBJECTIVES: This study sought to compare the performance of up-front rotational atherectomy (RA) or balloon-based techniques before drug-eluting stent implantation in severely calcified coronary lesions as assessed by angiography and optical coherence tomography (OCT). METHODS: Patient-level data from the PREPARE-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) and ISAR-CALC (Comparison of Strategies to Prepare Severely Calcified Coronary Lesions) randomized trials were pooled. The primary endpoint was stent expansion as assessed by OCT imaging. The secondary endpoints included stent eccentricity, stent asymmetry, angiographic acute lumen gain, strategy success and in-hospital occurrence of cardiac death, target vessel myocardial infarction, and repeat revascularization. RESULTS: Among 274 patients originally randomized, 200 participants with available OCT data after lesion preparation with RA (n = 63), a modified balloon (MB, n = 103), or a super high-pressure balloon (n = 34) before stenting were analyzed. The use of RA versus MB or a super high-pressure balloon led to comparable stent expansion (73.2% ± 11.6% vs 70.8% ± 13.6% vs 71.8% ± 12.2%, P = 0.49) and stent asymmetry (P = 0.83). Compared with RA or MB, a super high-pressure balloon was associated with less stent eccentricity (P = 0.03) with a numerically higher acute lumen gain, albeit not significantly different (P = 0.08). Strategy success was more frequent with RA versus MB (P = 0.002) and numerically more frequent with RA versus a super high-pressure balloon (P = 0.06). Clinical outcomes did not differ between groups. CONCLUSIONS: In patients with severely calcified lesions undergoing drug-eluting stent implantation, lesion preparation with RA, MB, or a super high-pressure balloon was associated with comparable stent expansion. A super high-pressure balloon is associated with less stent eccentricity, whereas strategy success is more frequent with RA.

Use of a Cutting Balloon Reduces the Incidence of Distal Embolism in Acute Coronary Syndrome Requiring Predilatation Before Stenting.

Background: Acute coronary syndrome (ACS) patients with solid lesions often require predilatation before stenting. Predilatation with high pressure may increase the risk of distal embolism, whereas direct stenting increases the risk of stent underexpansion. We recently reported that, in severely calcified lesions, using a cutting balloon (CB) can provide greater acute gain compared with other scoring balloons. Therefore, we hypothesized that predilatation with CB may reduce the incidence of distal embolism in ACS patients with solid lesions. Methods and Results: This study retrospectively analyzed data for 175 ACS patients who required predilatation, either with a conventional balloon (n=136) or CB (n=39). The occurrence of distal embolism was significantly lower in the CB than conventional balloon group (10.3% vs 32.4%, respectively; P=0.007). Multivariate analysis showed that the occurrence of distal embolism was positively associated with Thrombolysis in Myocardial Infarction (TIMI) grade and the presence of attenuated plaque, but negatively associated with the use of a CB. To support this clinical observation, we compared thrombus dispersal using a CB and non-compliant balloon in an ex vivo experimental model using a pseudo-thrombus. In this model, pseudo-thrombus dispersal was significantly smaller when a CB rather than non-compliant balloon was used (1.8±1.0% vs 2.6±1.2%, respectively; n=20, for each; P=0.002). Conclusions: In ACS patients with solid lesions that require predilatation, predilatation with a CB may reduce the incidence of distal embolism.

Multi-vessel spontaneous coronary artery dissection in a patient with aortic dissection: a case report.

Background: Spontaneous coronary artery dissection (SCAD) is a rare cause of acute coronary syndrome that is often misdiagnosed. Case summary: We describe a case of multi-vessel SCAD in a 73-year-old patient with no evidence of fibromuscular dysplasia that is presented with Type A aortic dissection after undergoing an ascending aorta and aortic arch replacement with stent placement in the abdominal aorta. The use of percutaneous coronary intervention with cutting balloons and drug-eluting stent implantation helped wean the patient off extracorporeal membrane oxygenation successfully. Discussion: To our knowledge, this is the first reported case of multi-vessel SCAD presenting concomitantly with aortic dissection. More research is needed to help understand the pathophysiology of the two conditions as well as possible links between them.