Calcified Lesions Research Articles

Inhibition of vascular calcification by Compound Danshen Dripping Pill through multiple mechanisms

BackgroundVascular calcification refers to the abnormal accumulation of calcium in the walls of blood vessels and is a risk factor often overlooked in cardiovascular disease. However, there is currently no specific drug for treating vascular calcification. Compound Danshen Dripping Pill (CDDP) is widely used to treat cardiovascular diseases, but its effect on vascular calcification has not been reported. PurposeWe investigated the effects of CDDP on vascular calcification in ApoE−/− mice and in vitro and elucidated its mechanism of action. Study designFirstly, we found that CDDP has the potential to improve calcification based on network pharmacology analysis. Then, we performed the following experiments: in vivo, ApoE−/− mice were fed a high-fat diet randomly supplemented with CDDP for 16 weeks. Atherosclerosis and vascular calcification were determined. In vitro, human aortic smooth muscle cells (HASMCs), human umbilical vein endothelial cells (HUVECs), and human aortic endothelial cells (HAECs) were used to determine the mechanisms for CDDP-inhibited vascular calcification. ResultsIn this study, we observed that CDDP reduced intimal calcification in atherosclerotic lesions of ApoE-deficient mice fed a high-fat diet, as well as the calcification in cultured SMCs and ECs. Mechanistically, CDDP inhibited the Wnt/β-catenin pathway by up-regulating the expression of DKK1 and LRP6, which are upstream inhibitors of Wnt, leading to a reduction in the expression of osteoblastic transition markers (ALP, OPN, BMP2, and RUNX2). Furthermore, CDDP enhanced the secretion of DKK1, which plays a role in mediating EC-SMC crosstalk in calcification. Additionally, VC contributes to vascular aging by inhibiting Sirt1 and increasing senescence parameters (SA-β-gal, p21, and p16). However, CDDP reversed these changes by activating Sirt1. CDDP also reduced the levels of pro-inflammatory cytokines and the senescence-associated secretory phenotype in vivo and in vitro. ConclusionsOur study suggests that CDDP reduces vascular calcification by regulating the DKK1/LRP6/β-catenin signaling pathway in ECs/SMCs and interactions with the crosstalk of ECs and SMCs. It also reduces the senescence of ECs/SMCs, contributing to the Sirt1 activation, indicating CDDP's novel role in ameliorating vascular calcification.

Medium-Term Outcomes of Treatment with a VIABAHN VBX Covered Stent for Aortoiliac Occlusive Lesions in Patients with Peripheral Artery Disease

Endovascular treatment (EVT) for aortoiliac (AI) occlusive lesions is now conducted worldwide, but there are challenges in EVT for complex AI lesions. The VIABAHN VBX (W.L. Gore & Associates, Flagstaff, AZ) is a next-generation balloon-expandable covered stent designed for use with complex AI lesions. The purpose of this study is to evaluate the medium-term outcomes of VIABAHN VBX for such lesions. Symptomatic patients who underwent EVT with VIABAHN VBX for an AI lesion from 2018 to 2020 at 7 Japanese centers were reviewed retrospectively. The primary endpoints were primary patency and freedom from target lesion revascularization (TLR). A total of 95 EVT procedures with VIABAHN VBX for AI occlusive lesions were performed in 71 patients. The patients had high rates of dyslipidemia (53%) and chronic kidney disease (61%), and 22% had chronic limb-threatening ischemia (CLTI). The Transatlantic Inter-Society Consensus (TASC Ⅱ) class was A in 12 patients (17%), B in 12 (17%), C in 10 (14%), and D in 37 (52%). Severe calcification (360°) of the treated lesion was present in 31 patients (33%). The median procedure time was 84 (49-158) min, with a technical success rate of 100%. The median follow-up period was 36 (32-43) months. The 3-year primary and secondary patency of VIABAHN VBX were 91% and 99%, the 3-year freedom from TLR was 92%, and the 3-year freedom from major adverse limb event (MALE) was 98%. No limbs required major amputation. Lesion severity (TASC Ⅱ C or D) and severe calcification did not affect the primary patency or freedom from TLR. Medium-term outcomes after EVT with VIABAHN VBX for AI lesions were acceptable regardless of lesion severity and calcification. These results suggest that VIABAHN VBX may be suitable for AI occlusive lesions with severe anatomical complexity and/or severe calcification.

A rare case of calcified focus discharged into the tracheal lumen in a child with tuberculosis of intrathoracic lymph nodes: a clinical case

The article presents a rare case of the isolation of a large calcified lesion in a 1-year-old child A., who was treated for tuberculosis of the intrathoracic lymph nodes, after family contact with his grandfather, a patient with fibrocavernous tuberculosis with bacterial isolation. Bronchi and lymphatic vessels are the main routes of spread of the tuberculosis process in the lungs, and in some cases reactivation of tuberculosis foci is possible. This may be due to damage and destruction of the bronchial wall. Residual tuberculous changes, caseous masses can carry a certain danger in the form of their breakthrough into the lumen of the trachea and bronchus. Aspiration of the contents contributes to the spread of tuberculosis infection; atelectasis, atelectatic pneumonia, etc. may occur. In early childhood, asphyxia with sudden death (suffocation by caseous masses) can occur. During the treatment of tuberculosis, you may encounter rare manifestations of the X-ray picture, the details of which must be assessed in time to choose the right tactics for patient management. In the presented case, the patient did not have activation of residual tuberculous changes; a large calcified lesion was coughed up due to the disintegration of dystrophic changes in the trachea in the affected area. A favorable outcome was recorded.

A novel approach for segmentation and quantitative analysis of breast calcification in mammograms.

Breast cancer is a major threat to women's health globally. Early detection of breast cancer is crucial for saving lives. One important early sign is the appearance of breast calcification in mammograms. Accurate segmentation and analysis of calcification can improve diagnosis and prognosis. However, small size and diffuse distribution make calcification prone to oversight. This study aims to develop an efficient approach for segmenting and quantitatively analyzing breast calcification from mammograms. The goal is to assist radiologists in discerning benign versus malignant lesions to guide patient management. This study develops a framework for breast calcification segmentation and analysis using mammograms. A Pro_UNeXt algorithm is proposed to accurately segment calcification lesions by enhancing the UNeXt architecture with a microcalcification detection block, fused-MBConv modules, multiple-loss-function training, and data augmentation. Quantitative features are then extracted from the segmented calcification, including morphology, size, density, and spatial distribution. These features are used to train machine learning classifiers to categorize lesions as malignant or benign. The proposed Pro_UNeXt algorithm achieved superior segmentation performance versus UNet and UNeXt models on both public and private mammogram datasets. It attained a Dice score of 0.823 for microcalcification detection on the public dataset, demonstrating its accuracy for small lesions. For quantitative analysis, the extracted calcification features enabled high malignant/benign classification, with AdaBoost reaching an AUC of 0.97 on the private dataset. The consistent results across datasets validate the representative and discerning capabilities of the proposed features. This study develops an efficient framework integrating customized segmentation and quantitative analysis of breast calcification. Pro_UNeXt offers precise localization of calcification lesions. Subsequent feature quantification and machine learning classification provide comprehensive malignant/benign assessment. This end-to-end solution can assist clinicians in early diagnosis, treatment planning, and follow-up for breast cancer patients.

Bioresorbable Scaffolds for Below-the-Knee Arterial Disease: A Literature Review of New Developments.

This review aimed to explore the therapeutic effect of bioabsorbable stents in the inferior genicular artery, from the emergence of absorbable bare metal stents to the latest technology in polymer and anti-proliferative eluting drugs mixed with coated bioresorbable vascular stents (BVSs). Currently, there are conflicting data regarding the safety and effectiveness of BVSs in infrapopliteal artery interventions, especially compared to the current generation of drug-eluting stents (DESs). This review will cover the existing data on BVSs in reconstructing the infrapopliteal arterial blood flow and active clinical trials for future iterations of BVSs. In terms of primary patency rate and target lesion revascularization rate, the available research on the effectiveness of BVSs in reconstructing the infrapopliteal arterial blood flow suggests that a BVS is compatible with current DESs within 3-12 months; long-term data have not yet been reported. The ABSORB BVS is the most studied BVS in cardiovascular disease (CAD). Initially, the ABSORB BVS showed promising results. Managing intricate regions in peripheral artery disorders, such as branching or lengthy lesions, continues to be a formidable undertaking. In contrast to the advanced narrowing of arteries seen in standard permanent stent procedures, bioabsorbable stents have the potential to promote the expansion and beneficial merging of blood channels in the latter stages. Furthermore, incorporating stents and re-establishing the endothelial function can diminish the probability of restenosis or thrombosis. Nevertheless, the extent to which bioabsorbable stents may simultaneously preserve arterial patency and guarantee their structural integrity remains uncertain. The powerful and intricate mechanical stresses exerted by the blood in the superficial femoral artery and popliteal artery can cause negative consequences on any implant inserted into the vessel, regardless of its composition, even metal. Furthermore, incorporating stents is advantageous for treating persistent occlusive lesions since it does not impact later treatments, including corrective bypass operations. Evidence is scarce about the use of bioabsorbable stents in treating infrapopliteal lesions. Utilizing bioabsorbable stents in minor infrapopliteal lesions can successfully maintain the patency of the blood vessel lumen, whereas balloon angioplasty cannot offer this benefit. The primary focus of testing these materials is determining whether bioabsorbable scaffolds can provide adequate radial force in highly calcified elongated lesions. Indeed, using "-limus" medication elution technology in conjunction with bioabsorbable stents has previously offered clinical benefits in treating the popliteal artery, as evidenced by limited trials.BVSs for peripheral arterial disease (PAD) show promise and have the potential to offer a less inflammatory and more vessel-friendly option compared to permanent metallic stents. However, current evidence does not yet allow for a universal recommendation for their use. Thus, ongoing, and future studies, such as those examining the newer generation of bioresorbable scaffolds (BRSs) with improved mechanical properties and resorption profiles, will be crucial in defining the role of BRSs in managing PAD.

A Complex Case with a Completely Percutaneous Solution: Treatment of a Severe Calcific Left Main in a Patient with Low-Flow Low-Gradient Aortic Stenosis

Background: This case study explores an integrated approach to managing a complex cardiac condition, presenting a comprehensive single-session intervention. This includes balloon valvuloplasty using a Nucleus 18 mm balloon, complex angioplasty with rotational atherectomy (rotablator) targeting calcified lesions in the left main and left anterior descending artery, and Transcatheter Aortic Valve Implantation (TAVI) with a 23 mm Sapien 3 valve, all performed on an 81-year-old woman. Furthermore, this report underscores the strategic left atrial appendage closure conducted three months post-procedure due to the patient’s elevated hemorrhagic risk. Case presentation: Facing critical coronary and valvular pathologies, the patient underwent a meticulously planned, single-session intervention. The process began with a balloon valvuloplasty using a Nucleus 18 mm balloon to address the aortic stenosis. This was followed by a high-risk angioplasty, during which the Impella CP device provided hemodynamic support and rotational atherectomy was employed to address the calcified coronary artery disease effectively. The same session saw the successful execution of TAVI using a 23 mm Sapien 3 valve. The comprehensive approach notably diminished procedural complications, illustrating the benefits of an integrated treatment pathway in managing high-risk patients. Three months later, the patient underwent a left atrial appendage closure, a critical move considering her high risk of hemorrhage. This procedure also provided an opportunity to assess the favorable outcomes of the previous angioplasty. Conclusion: This case validates the feasibility and efficacy of performing multiple advanced percutaneous interventions in a single session for high-risk cardiac patients. It underscores the crucial role of innovative and personalized treatment strategies in improving patient outcomes, particularly in complex clinical scenarios. Moreover, the case exemplifies the essential relationship between immediate, comprehensive intervention and subsequent follow-up procedures in ensuring optimal long-term patient care.

Effectiveness and Safety of a Novel Intravascular Lithotripsy System for Severe Coronary Calcification: The CALCI-CRACK Trial

BackgroundIntravascular lithotripsy is effective and safe for managing coronary calcification; however, available devices are limited, and complex lesions have been excluded in previous studies. This study aimed to investigate the effectiveness and safety of a novel intravascular lithotripsy system for severe calcification in a population with complex lesions. MethodsCALCI-CRACK (treatment of severe calcified coronary lesions with a novel intracoronary shock wave lithotripsy system) (ChiCTR2100052058) was a prospective, single-arm, multicentre study. The primary end point was the procedural success rate. Major safety end points included major adverse cardiovascular events (MACE) and target lesion failure (TLF) at 30 days and 6 months, and severe angiographic complications. Calcification morphology was assessed in the optical coherence tomography (OCT) subgroup. ResultsIn total, 242 patients from 15 high-volume Chinese centres were enrolled, including 26.45% of patients with true bifurcation lesions, 3.31% with severely tortuous vessels, and 2.48% with chronic total occlusion, respectively. The procedural success rate was 95.04% (95% confidence interval 91.50%-97.41%), exceeding the prespecified performance goal of 83.4% (P < 0.001). The 30-day and 6-month MACE rates were 4.13% and 4.55%, respectively. TLF rates at those time points were 1.24% and 1.65%, respectively. Severe angiographic complications occurred in 0.42% of patients. In the OCT subgroup (n = 93), 93.55% of calcified lesions were fractured, and minimal lumen area increased from 1.55 ± 0.55 mm2 to 4.91 ± 1.22 mm2 after stent implantation, with acute gain rate of 245 ± 102%. ConclusionsThe novel intravascular lithotripsy system is effective and safe for managing severely calcified coronary lesions in a cohort that included true bifurcation lesions, severely tortuous vessels, and chronic total occlusion. Clinical Trial RegistrationChinese Clinical Trial Registry (ChiCTR), number ChiCTR2100052058

TCTAP C-093 “Break the Calcium Rock” - A Challenging Case of Calcified Left Main Bifurcation Lesion With Rotashock and Impella Support in an Elderly Patient

TCTAP C-093 “Break the Calcium Rock” - A Challenging Case of Calcified Left Main Bifurcation Lesion With Rotashock and Impella Support in an Elderly Patient

Accurate low-energy pulse system for intravascular lithotripsy

In response to biomedical imperatives, a novel approach is presented for the endovascular management of atherosclerosis. This approach is grounded in the electrohydraulic effect of a precisely controlled low-energy pulse discharge system, coupled with sequential control within the incomplete discharge electrode, to generate shockwaves aimed at softening blood vessels and rupturing calcified plaques. Theoretical analysis encompassed circuit design, control timing, and operational processes, while experimental investigations demonstrated precise control of non-oscillation and incomplete discharge by adjusting key parameters. Utilizing a 3 kV DC high-voltage power supply, a 220 nF capacitor, and two sets of 3.3 Ω resistors in parallel, with pin–plate electrodes as the load for discharge in normal saline, resulted in a 1 kV reduction in voltage across the capacitor and a peak current of 170 A. Energy release occurred through non-oscillatory and incomplete discharge, effectively generating shockwaves with peak pressures of 5–10 MPa at distances of 1–2 mm from the discharge center to treat calcified lesions. Compared with the existing intravascular lithotripsy devices, the shockwave system realizes accurate control of discharge energy by adjusting the turn-off time of incomplete discharge so as to realize accurate control of shockwave energy. Doctors can choose different intensities of shockwaves according to different degrees of calcification in the treatment process so as to minimize the discomfort caused by shockwaves and improve safety. Valuable insights are provided for intravascular lithotripsy devices in engineering.

Binocular scleral cysts with calcification in an 86-year-old patient from China

We report a case of an 86-year-old woman from China who was admitted to the hospital for age-related cataracts in both eyes and presented binocularly light-colored, pitting, calcified lesions of the nasal sclera.

PITUITARY STONE ADENOMA ASSOCIATED WITH SEVERE HYPERPROLACTINEMIA CASE REPORT

A 35-year-old patient consulting for erectile dysfunction, with a progressive visual acuity loss. Biological assessment revealed hyperprolactinemia at 4315 ng/ml and low testosteronemia at 6.8 nmol/l. Skull X-ray showed an enlarged sellaturcica with voluminous intra- and suprasellar calcifications. A cranial CT scan revealed an intra- and suprasellar calcified mass. Transphenoidal surgery was performed. The tumor was partially removed and the piece was made of calcified grayish granular tissue. Histological examination showed adenomatous cells with large granular calcification lesions. Immunohistochemistry confirmed prolactin adenoma. Cabergoline treatment was effective on the calcified tissue remaining after surgery.

Selective assisted intravascular lithotripsy for complex aorto-iliac calcific lesions.

Intravascular lithotripsy has proven to be safe, less invasive, and effective for coronary and peripheral arteries, and the indication has been extended to the aortic district but there is still little evidence in the literature as only a few cases have been described so far. We report a case of intravascular lithotripsy of the infrarenal aorta due to coral reef, chronic occlusion using a single Shockwave M5 + balloon, followed by a covered stent deployment. The aortic bifurcation and common iliac arteries presented hemodynamic calcific lesions, which were prepared singularly with lithotripsy before aorto-iliac covered stenting in kissing configuration. The aortic length from which arises the inferior mesenteric and lumbar arteries was left uncovered preserving their patency. In this case, a single shockwave balloon was sufficient to treat successfully and safely the aortic occlusion by heavy calcific lesions. At 1 and 6 months follow-up, the patient had no clinical symptoms, and the ultrasound assessment showed a triphasic waveform at the common femoral arteries bilaterally and confirmed the patency of the stent grafts. Selective assisted lithotripsy of heavy aortic and iliac vessels is possible, but definitive outcomes have yet to be supported by the literature.

Acute and Mid-Term Results of Atherectomy in Femoropopliteal Lesions.

The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty. To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries. A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years. Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs. In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results. German Clinical Trials Register: DRKS00031245. The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials.

In-Stent Restenosis Overview: From Intravascular Imaging to Optimal Percutaneous Coronary Intervention Management.

Despite ongoing progress in stent technology and deployment techniques, in-stent restenosis (ISR) still remains a major issue following percutaneous coronary intervention (PCI) and accounts for 10.6% of all interventions in the United States. With the continuous rise in ISR risk factors such as obesity and diabetes, along with an increase in the treatment of complex lesions with high-risk percutaneous coronary intervention (CHIP), a substantial growth in ISR burden is expected. This review aims to provide insight into the mechanisms, classification, and management of ISR, with a focus on exploring innovative approaches to tackle this complication comprehensively, along with a special section addressing the approach to complex calcified lesions.

Epicardial and intra-thoracic adipose tissue and cardiovascular calcifications in type 1 diabetes (T1D) in epidemiology of diabetes Interventions and Complications (EDIC): A pilot study

ObjectiveCoronary artery, aortic valve, and descending aorta calcification (CAC, AVC, DAC) are manifestations of atherosclerosis, and cardiac epicardial adipose tissue (EAT) indicates heart adiposity. This study explored the association between cardiac adipose tissue and cardiovascular calcification in participants with long-standing T1D. MethodsEAT and intra-thoracic adipose tissue (IAT) were measured in 100 T1D subjects with cardiac computed tomography (CT) scans in the EDIC study. Volume analysis software was used to measure fat volumes. Spearman correlations were calculated between CAC, AVC, DAC with EAT, and IAT. Associations were evaluated using multiple linear and logistic regression models. ResultsParticipants ranged in age from 32 to 57. Mean EAT, and IAT were 38.5 and 50.8 mm3, respectively, and the prevalence of CAC, AVC, and DAC was 43.6 %, 4.7 %, and 26.8 %, respectively. CAC was positively correlated with age (p-value = 0.0001) and EAT (p-value = 0.0149) but not with AVC and DAC; IAT was not associated with calcified lesions. In models adjusted for age and sex, higher levels of EAT and IAT were associated with higher CAC (p-value < 0.0001 for both) and higher AVC (p-values of 0.0111 and 0.0053, respectively), but not with DAC. The associations with CAC remained significant (p-value < 0.0001) after further adjustment for smoking, systolic blood pressure, BMI, and LDL, while the associations with AVC did not remain significant. ConclusionIn participants with T1D, higher EAT and IAT levels are correlated with higher CAC scores. EAT and IAT were not independently correlated with DAC or AVC.

RotaTripsy Risk and Rewards: Findings from a Registry of Patients Undergoing Combined Rotational Atherectomy and Intravascular Lithotripsy

Background: Heavily calcified coronary artery lesions are a therapeutic challenge for interventional cardiologists worldwide. Recently, RotaTripsy has gained popularity as a calcium modification technique prior to stent implantation. In this procedure, operators employ rotational atherectomy to debulk luminal calcium alongside intravascular lithotripsy to fracture deeper concentric calcifications. Aims: To identify the demographics and outcomes of patients undergoing RotaTripsy. Methods: Baseline clinical characteristics, procedural details and in-hospital and 30-day outcomes were recorded and reported for a registry of patients in whom combined rotational atherectomy and intravascular lithotripsy were performed in one procedure at the discretion of the primary operator at one high-volume tertiary centre. Results: Over 2020–2022, 57 consecutive patients underwent RotaTripsy during percutaneous coronary intervention. In this cohort, 23 (40%) had acute coronary syndrome and three (5.3%) had an ST-elevation MI. Additionally, 10 (18%) were on dialysis, 20 (35%) had unprotected left main coronary artery/left main coronary artery equivalent lesions, seven (12%) had acute heart failure and nine (16%) required intraprocedural intra-aortic balloon pump support. Of the procedures, 51 (89.5%) were successful, defined as successful stent implantation and &lt;30% residual angiographic stenosis without in-hospital major adverse cardiac events. Complications included slow/no-reflow (six patients; 11%), cerebrovascular events (three patients; 5.3%), in-hospital MI (three patients; 5.3%) and mortality (three patients; 5.3%). The 30-day MI rate was 5.3% (three patients) and the mortality rate was 7.0% (four patients). Conclusion: RotaTripsy was successful in facilitating stent delivery and restoring flow, even in a relatively sick cohort. Nevertheless, complication rates were high, reflecting the challenge of treating these complex patients.

One-Year Outcome of Drug-Coated Balloon vs. Drug-Eluting Stent in Patients Undergoing Initial Percutaneous Coronary Intervention (PCI) for De Novo Lesion.

Drug-eluting stents (DES) are the major treatment option in percutaneous coronary intervention (PCI). Recently, drug-coated balloon (DCB) utilization has been increasing globally, leading to the expected new strategy of "stent-less PCI." This study aimed to evaluate the one-year outcome of DCB compared to DES. Patients who underwent initial PCI for de novo lesions in our institution from January 2018 to December 2021 (n=337) were subjected to retrospective analysis. Among them, 75 patients were treated with DCB, while 262 patients were treated with DES. Target lesion failure (TLF) was evaluated during the follow-up period. The proportion of PCIs for ACS was significantly lower in the DCB group (DCB, n=23, 30.7% vs. DES, n=143, 54.6%; p=0.001). The median device diameter and length in the DES group were larger than those in the DCB group (DCB, 2.60 mm vs. DES, 2.98 mm; p<0.001; DCB, 19.1 mm vs. DES, 25.2 mm; p<0.001). There was no significant difference between the DCB and DES groups in lesion calcification. The proportion of ostial lesions was significantly higher in the DCB group (DCB, n=13, 17.3% vs. DES, n=21, 8.0%; p=0.018). The cumulative rate of TLF (DCB, n=5, 6.7% vs. DES, n=18, 6.9%; p=0.951) did not significantly differ between the DCB and DES groups. DCB may be as effective a strategy as DES in the patient who underwent initial PCI for a de novo lesion.

Safety and effectiveness of the Phoenix atherectomy device for endovascular treatment of common femoral and popliteal arteries: Results of the EN-MOBILE trial.

Background: This study aimed to assess the peri- and postprocedural outcomes of atherectomy-assisted endovascular treatment of the common femoral (CFA) and popliteal arteries. Methods: Phoenix atherectomy was used for the treatment of 73 and 53 de novo CFA and popliteal artery lesions, respectively, in 122 consecutive patients. Safety endpoints encompassed perforation and peripheral embolization. Postprocedural endpoints included freedom from clinically driven target lesion revascularization (CD-TLR) and clinical success (an improvement of ⩾ 2 Rutherford category [RC]). In addition, 531 patients treated for popliteal artery stenosis or occlusion without atherectomy were used as a comparator group. Results: Procedural success (residual stenosis < 30% after treatment) was 99.2%. The need for bail-out stenting was 2 (2.7%) and 3 (5.7%) in CFA and popliteal artery lesions, respectively. Only one (1.4%) embolization occurred in the CFA, which was treated by catheter aspiration. No perforations occurred. After 1.50 (IQR = 1.17-2.20) years, CD-TLR occurred in seven (9.2%) and six (14.6%) patients with CFA and popliteal artery lesions, respectively, whereas clinical success was achieved in 62 (91.2%) and 31 (75.6%), respectively. Patients treated with atherectomy and DCB in the popliteal artery after matching for baseline RC, lesion calcification, length, and the presence of chronic total occlusion, exhibited higher freedom from CD-TLR compared to the nondebulking group (HR = 3.1; 95% CI = 1.1-8.5, p = 0.03). Conclusion: Atherectomy can be used safely and is associated with low rates of bail-out stenting in CFA and popliteal arteries. CD-TLR and clinical success rates are clinically acceptable. In addition, for the popliteal artery, atherectomy combined with DCB demonstrates lower CD-TLR rates compared to a DCB alone strategy. (German Clinical Trials Register: DRKS00016708).

Rendezvous-PIERCE technique: establishing a channel through severe calcification in infrainguinal arterial lesions using needle rendezvous

BackgroundSevere calcification often prevents device passage and balloon expansion in cases of lower extremity artery disease. To address this limitation, we introduced a novel calcium modification technique called Rendezvous-PIERCE (R-PIERCE).MethodsA needle was inserted in a retrograde manner and advanced to touch the tip of an antegrade guidewire within the lesion. Then, the guidewire was advanced into the lumen of the needle to achieve partial guidewire externalization, also known as needle rendezvous. The needle was then introduced over the externalized guidewire under wire tension and repeatedly rotated and advanced across the lesion to modify calcified intimal plaques. Notably, this technique can be applied in the opposite direction.ResultsCase 1 involved a 68-year-old male with a calcified occlusion of the anterior tibial artery. An antegrade guidewire reached the midpoint of the occlusion; however, microcatheters and balloons could not pass through the proximal calcification. Therefore, R-PIERCE was used to modify uncrossable lesions. An antegrade 2.5-mm balloon crossed and dilated the lesion, achieving hemostasis at the needle insertion site. The antegrade guidewire successfully crossed the entire lesion and was dilated by the 2.5-mm balloon. Final angiography demonstrated successful flow. In Case 2, an 80-year-old male had a calcified femoropopliteal occlusion. An antegrade guidewire was advanced into the distal superficial femoral artery (SFA); however, no device could follow it. R-PIERCE was performed to modify the calcification from the distal to the medial SFA. The antegrade balloon successfully crossed and dilated obstructed lesions. Furthermore, the antegrade guidewire crossed the entire lesion, and the antegrade balloon was dilated. Final angiography revealed a successful flow without complications.ConclusionsR-PIERCE is useful for modifying complex calcified lesions during the wiring of occlusive lesions.

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.