Atherectomy Device Research Articles

Assessment of safety, efficacy and learning curve of intravascular lithotripsy in real world practice within a high volume calcium modification centre

Abstract Background There has been a rapid uptake in the use of intravascular lithotripsy (IVL) for calcium modification during percutaneous coronary intervention (PCI) due to its ease of use and excellent safety profile, particularly when compared to atherectomy devices. Purpose To review the adoption and safety of IVL in a high volume centre with established use of alternative calcium modification techniques Methods This was a retrospective analysis of all patients undergoing PCI from the introduction of IVL in January 2019 until December 2023. Patient demographics, comorbidity, procedure details and procedural complications were compared between IVL and non-IVL cases. Line charts were created to demonstrate the uptake and use of IVL per quarter compared with other established calcium modification strategies. A further line chart was created to compare the frequency of IVL use per quarter in more complex cases (left main intervention, ST elevation, treatment of in stent restenosis and in combination with rotational/orbital atherectomy). Results In the analysis timeframe there were 7,843 PCI cases performed, of which there were 301 IVL cases, 263 rotational/orbital atherectomy cases and 77 excimer laser atherectomy. IVL cases were older, more likely to have previous revascularisation (PCI (40.8% vs 57.1 % (p<0.001)) or bypass grafts 4.8% vs 8.0% (p=0.012)), diabetes mellitus (22.7% vs 33.6% (p<0.001)) and hypertension (45.4% vs 56.5% (p<0.001)). From a procedural perspective, treatment of left main and restenosis were more common with IVL compared with the rest of the cohort (7.0% vs 27.6% (p<0.001) and 8.3% vs 28.9% (p<0.001) respectively). IVL cases were more frequently guided by intracoronary imaging (intravascular ultrasound 35.9% vs 70.4% (p<0.001), optical coherence tomography 3.7% vs 18.9% (p<0.001)). Atherectomy was more frequent in IVL cases (excimer laser atherectomy 0.7% vs 7.3% (p<0.001) and rotational/orbital atherectomy 2.6% vs 22.9% (p<0.001)). Figure 1 shows the frequency of IVL use compared with other established calcium modification strategies per quarter and demonstrates the rapid and sustained uptake in IVL usage. Interestingly the use of other atherectomy techniques does not appear to have reduced. Figure 2 shows that IVL was quickly utilised in more complex calcification cases and again this has remained consistent since the introduction. Both figures demonstrate the short learning curve associated with IVL. Finally, there was no significant increase in perforation or slow/no reflow with IVL use (0.5% vs 0.7% (p=0.647) and 1.1% vs 1.3% (p=0.675) respectively) consistent with the published literature. There was an increase in documented coronary dissection with uncertain impact (3.4% vs 6.5% p=0.017). Conclusions IVL has become an essential tool within the calcium modification algorithm as a result of its ease of use, efficacy and excellent safety profile.Calcium modification per quarterFrequency of complex IVL cases

Technical aspects of the new BYCROSSTM atherectomy device - preliminary results after 28 patients.

Purpose: Technical aspects are crucial for the planning and performing of the atherectomy to treat peripheral arterial disease. This report illustrates the use of a novel atherectomy device and investigates the feasibility, efficacy, and safety procedures involved in performing the atherectomy on 28 patients. We performed a prospective analysis of patients who underwent an atherectomy with the BYCROSSTM Atherectomy device between August 2022 and September 2023 at a tertiary referral centre. Patients with a lesion below the aortic bifurcation (vessel diameter ≥ 3mm) having a de novo or restenotic (stent-included) present were recruited. Major adverse events (MAE) are defined as amputation, death, myocardial infarction, or angiographic distal embolization that require a separate intervention. Of the 28 patients treated with the BYCROSS device, 23 were men with a mean age of 65.6 ± 9,6 years and a mean BMI of 24,6 ± 3.9 kg/m2. Most patients had a typical atherogenic risk profile as well as multiple preexisting comorbidities. In all patients, a symptomatic peripheral arterial disease (PAD) was the main reason for an intervention. The most common Rutherford category was 5 (12/28). The most common lesion region was the femoropopliteal segment (25/28) with 23 de novo stenosis. Mean lesion length was 218,0 ± 93,7 mm. The mean PACCS Score was 3,0 ± 1,0. Stenosis grade was by mean 99,3 ± 3,7%. Ankle Brachial Index (ABI) increased significantly after BYCROSS atherectomy (pre- 0,44 ± 0,43 vs. post-procedure 0,84 ± 0,30 P<0,001. Target lesion/vessel revascularization (TLR/TVR) within the first 30 days was 3,6% (1/28). 30-day MAE rate was 14,3% (vessel perforation in 3/28 patients, embolism in 1/28). There were no deaths, index limb amputations, or myocardial infarctions. The BYCROSSTM atherectomy system is a new device with numerous advantages in treating high-grade, calcifying stenosis and occlusion processes in PAD. Based on the above findings, the BYCROSSTM Atherectomy device represents a feasible, safe, and effective method for endovascular treatment of peripheral arterial disease.

TCT-382 Dual-Prep Registry: Atherectomy Devices and Intravascular Lithotripsy for the Preparation of Heavy Calcified Coronary Lesion Registry

TCT-382 Dual-Prep Registry: Atherectomy Devices and Intravascular Lithotripsy for the Preparation of Heavy Calcified Coronary Lesion Registry

Combination Tools for Calcium Modification from RASER to Orbitalshock.

Coronary artery calcification is frequently encountered during percutaneous coronary intervention and its presence is associated with a higher risk of stent under-expansion which has been associated with long-term risk of stent failure. There are several different calcium modification strategies available, whether they be balloon-based devices (cutting/scoring and intravascular lithotripsy) or atherectomy devices (orbital atherectomy, rotational atherectomy, excimer laser coronary atherectomy) that are established for the modification of coronary calcification. Each strategy applies a different mechanism of action for calcium modulation and consequently the potential to combine modifying tools may offer synergistic advantages over device monotherapy. This article will focus on reviewing the evidence for the use of multiple calcium modification techniques and examine whether there really is any such synergistic effect of combining these tools.

Staged strategy of combined rotational atherectomy and intravascular lithotripsy for severely calcified lesions: an evaluation using multimodality intracoronary imaging—a case report

Abstract Background Severely calcified lesions are the most significant challenge for percutaneous coronary intervention, exhibiting poor clinical outcomes. Some severely calcified lesions remain untreatable with conventional balloons or even atherectomy devices. Intravascular lithotripsy is a new option for treating severe calcification. Case summary Herein, we describe a case of ischaemic cardiomyopathy with a thick, circumferential calcified lesion in the proximal and mid-segments of the left anterior descending coronary artery. In the first session, high-pressure balloons, cutting balloons, and rotational atherectomy failed to disrupt the calcification. In the staged additional treatment that was subsequently planned, eight cycles of intravascular lithotripsy created multiple fractures in the deep calcification, resulting in successful stent deployment. The effect of intravascular lithotripsy was observed mainly in calcified areas with lipid components detected using near-infrared spectroscopy-intravascular ultrasound. Discussion Our report suggests the efficacy of employing a combined strategy of rotational atherectomy with small burrs and intravascular lithotripsy in the treatment of severe calcification with a minimal risk of complications. Our study introduces a novel aspect by utilizing near-infrared spectroscopy-intravascular ultrasound to evaluate calcified lesions before performing intravascular lithotripsy. To our knowledge, there have been no similar reports to date. The effect of intravascular lithotripsy on calcified lesions may be related to the distribution of lipid components and/or heterogeneity within the calcification.

Successful treatment of chronic venous in-stent restenosis using a Phoenix atherectomy device.

Although endovascular treatment of venous obstruction with percutaneous transluminal angioplasty (PTA) and stenting is a safe and effective alternative to conservative treatment, the overall prevalence of in-stent restenosis (ISR) remains high in this patient population. This study reports a novel treatment option for patients with chronic ISR (C-ISR). At our center, all patients with ISR were treated based on the time since the initial intervention. Acute in-stent restenosis (A-ISR) was preferably treated with catheter-directed thrombolysis or a pharmacomechanical peripheral thrombectomy device and PTA. Selected patients with chronic ISR (C-ISR) (greater than 30 days) were treated with a catheter- guided unidirectional atherectomy in addition to PTA, under the assumption of a non-thrombotic mechanism in the development of C-ISR. We demonstrate a safe and practical treatment option for chronic ISR using a catheter- guided technical approach with the Phoenix atherectomy device in four patients. Technical success was achieved in every case, and mid-term patency was restored in three out of four patients. Restenosis following venous stenting is highly complex. Patients must be treated individually, with a focus on anticoagulation and antiplatelet therapy regimens, as well as the appropriate interventional treatment. Catheter- guided atherectomy is a viable option for this heterogeneous group of patients. Further studies are required to understand the etiology of chronic ISR.

Innovative nomogram for predicting 1-year clinically driven revascularization outcomes in endovascular femoropopliteal disease.

Femoropopliteal artery disease (FPAD) is a common vascular disease that usually requires surgical treatment. The aim of this study was to apply predictive modeling to develop predictive models for predicting clinically driven target revascularization (CD-TLR) events 1 year after intervention in patients with FPAD. In this study, clinical data were collected from a total of 484 patients who underwent FPAD endovascular intervention from 2014 to 2019. According to the inclusion and exclusion criteria, 400 patients will be finally included and assigned to the training cohort and test cohort in the ratio of 7:3. By analyzing these data through statistical methods, we will explore the effects of different factors on target revascularization events 1 year after intervention in FPAD patients, and build the corresponding prediction model of the column line graph. The final nomogram model consisted of 5 independent predictors: history of cerebrovascular disease, lesion length >15 cm, no atherectomy device used, no medicated balloon used and procedure time. The C-index of the model was 0.766 and 0.726 for the training cohort and validation cohort, respectively. The calibration curves also showed that the model had satisfactory agreement in both cohorts. The newly developed prediction model can accurately predict clinically driven target revascularization events at 1 year in patients with FPAD, providing valuable information for the development of individualized treatment plans.

Injury of the superficial femoral artery and posterior tibial artery associated with an atherectomy device.

Rotational atherectomy can offer a viable treatment for occlusive peripheral artery disease; maintaining the minimal invasiveness of an endovascular procedure, while allowing for a more complete lesion debridement compared with balloon angioplasty. This case report outlines a complication of guidewire entrapment associated with rotational atherectomy in the superficial femoral artery (SFA). A 57-year-old male underwent an atherectomy with Rotorex for left lower limb foot pain. During the procedure, the guidewire was suctioned into the atherectomy device, preventing any further advancement of the device and damaging the SFA and posterior tibial artery (PTA). The atherectomy device was withdrawn and a new vascular access site was gained in the left PTA. A covered stent was inserted to treat the original SFA lesion, and balloon angioplasty was used to repair the device-induced damaged to the PTA. While guidewire complications have been previously reported, this case report details the first reported case, to our knowledge, of guidewire entrapment while using a rotational atherectomy device. Knowledge of this possible complication of rotational atherectomy can aid in clinical decision making when choosing between treatments for peripheral vascular disease.

Consensus of National Heart Center and the Saudi Arabian Cardiac Interventional Society on the Current Landscape of the Management of Intracoronary Calcification in Saudi Arabia.

We aimed to develop a streamlined algorithm for the management of intracoronary calcification that includes guidance on intracoronary imaging and the appropriate selection of atherectomy devices. National experts representing both the National Heart Center (NHC) and the Saudi Arabian Cardiac Interventional Society (SACIS) met to develop a consensus document on the assessment and management of intracoronary calcification in Saudi Arabia. The nominal group technique was utilized; a number of statements on the assessment and management of coronary artery calcification were developed based on a systematic review of the literature. The authors discussed the developed statements until a consensus was reached. Twenty statements were discussed and agreed upon. Invasive and non-invasive imaging modalities in the assessment of coronary artery calcification, and management of intracoronary calcification using calcium ablation techniques, excimer laser coronary atherectomy, ballon-based techniques, and shockwave lithotripsy; were all thoroughly discussed in light of scientific evidence and the experts' clinical practice. We present a national consensus on the assessment and the multifaceted management of intracoronary calcification in Saudi Arabia.

Practice patterns in utilization of atherectomy and embolic protection devices in inpatient and outpatient treatment settings

ObjectiveThe frequency of atherectomy in lower extremity arterial disease has increased substantially over the past several years, specifically in the office-based laboratory (OBL) setting, yet the efficacy compared with other interventions and the consequences of distal embolization remain unknown. Embolic protection devices (EPDs) have been used at varying rates depending on physician and practice setting. Previous studies have described lesion characteristics to consider when weighing the benefits and drawbacks associated with device use. Our study focuses on the use of atherectomy and EPDs in femoropopliteal arterial disease to better characterize resource use trends and postoperative outcomes in the inpatient and OBL interventional settings. MethodsWe conducted a retrospective analysis on endovascular interventions performed for femoral-popliteal occlusive disease that were entered into the Vascular Quality Initiative data registry between 2017 and 2021. A one:one greedy match, adjusted analysis based on inpatient or OBL location of procedure was used to compare the groups. Hierarchical logistical regression with selective use of principal component analysis was used to further explore the differences in EPD use and immediate postoperative outcomes. A proportional hazard model was used to demonstrate differences in reintervention rates up to 2 years postoperatively between patients who underwent atherectomy in the inpatient vs OBL treatment setting. Results2849 matched pairs were inlcuded in the final analysis. In our cohort, there was 22% EPD use overall, 40% in the hospital setting and 4.4% in the OBL setting (P < .001). Among the patients with available follow-up information, OBL intervention setting increased probability of reintervention by 18% at 2 years postoperatively compared with the inpatient setting; however, there was no difference associated with EPD placement and rate of reintervention. ConclusionsUse of EPDs in the OBL setting compared with the hospital setting is dramatically decreased; however, no increased incidence of postoperative complications was seen compared to procedures performed in the hospital setting when controlling for patient and lesion characteristics. Patients with available follow-up data were more likely to undergo ipsilateral reintervention between 6 months and 2 years postoperatively if atherectomy was done in the OBL setting. Dedicated studies are encouraged to ensure patient safety, effective resource allocation, and long-term efficacy of OBL atherectomy as an ever-growing number of peripheral arterial procedures are transitioned to the OBL setting.

Intravascular Ultrasound Assessment of Arterial Dissections Following Rotarex Atherectomy: Results of the iDissection Rotarex Study

BackgroundThere are limited data on the mechanism of the Rotarex Rotational Excisional Atherectomy System in treating femoropopliteal arterial disease. The Rotarex iDissection study is a prospective, single center study evaluating the extent of excision and dissection in de novo and restenotic (not in-stent) lesions of the femoropopliteal arteries in symptomatic peripheral arterial disease patients. MethodsConsecutive patients with symptomatic peripheral arterial disease were prospectively enrolled in the Rotarex iDissection study at a single US center after obtaining informed consent. The study was approved by a central ethics committee. Quantitative vascular angiography and intravascular ultrasound images were analyzed by an independent core laboratory. The Eagle Eye Platinum ST intravascular ultrasound (Phillips) was used to identify the depth (A, B, C for intima, media, and adventitia, respectively) and arc of dissections (1 and 2 for <180° and ≥180°, respectively) using the iDissection classification. Statistical significance was determined by a P value <.05. ResultsA total of 19 patients (20 procedures) were enrolled by 1 endovascular specialist. There were 57.9% men with mean age of 71.1 ± 9.6 years. Of the patients, 31.6% had diabetes mellitus, and 84.2% were current or past smokers. Thirty percent of treated vessels were chronic total occlusions. A total of 10 patients received stents (2 covered stents due to perforation, 6 due to National Heart, Lung, and Blood Institute Type C dissections, and 2 were primary stenting). Two distal embolizations occurred; one was attributed to the Rotarex, and both were treated with no adverse consequences. Angiographic baseline stenosis was 74.7% ± 25.6%; after Rotarex, 48.7% ± 14.8%; and after percutaneous transluminal angioplasty (PTA), 16.0% ± 6.2%. Baseline minimal lumen diameter was 1.0 ± 1.0 mm; after Rotarex, 2.4 ± 1.1 mm; and after PTA, 4.4 ± 1.0 mm. Angiographically, there was 1 type A dissection at baseline; 1 A, 1 B, and 2 C after Rotarex, and 3 A and 5 C after final adjunctive PTA. Intravascular ultrasound revealed a reference diameter of 6.2 ± 1.0 mm; 70% of patients had adventitial dissections. The mean arc of calcium was 221° ± 39.4° (moderate to severe calcium). ConclusionsThe Rotarex device is an effective atherectomy device in treating complex femoropopliteal arterial disease. A high frequency of adventitial dissections is seen with the Rotarex. The long-term outcomes of this finding need to be further studied.

Treatment of Complex Femoropopliteal Lesions Using Jetstream Atherectomy Device and Ranger Drug-Coated Balloon Without Embolic Protection: 12-Month Results of the ELLIPSE Multicenter Study

Treatment of Complex Femoropopliteal Lesions Using Jetstream Atherectomy Device and Ranger Drug-Coated Balloon Without Embolic Protection: 12-Month Results of the ELLIPSE Multicenter Study

The efficacy of atherectomy combined with percutaneous transluminal angioplasty (PTA)/drug-coated balloon (DCB) compared with PTA/DCB for infrapopliteal arterial diseases: A systematic review and meta-analysis.

With the development of endovascular therapies, some studies have indicated a therapeutic potential for infrapopliteal arterial revascularization with atherectomy (AT). This study was designed to perform a meta-analysis to investigate the efficacy of AT combined with percutaneous transluminal angioplasty (PTA) or drug-coated balloon (DCB) compared with PTA or DCB for infrapopliteal arterial diseases. This is a systematic review and meta-analysis. The Pubmed, Web of Science, and Cochrane Library were systematically searched for articles published up to November 2022, reporting using atherectomy devices for infrapopliteal arterial patients. Randomized controlled trials and retrospective studies were included, and clinical characteristic outcomes were extracted and pooled. Then, we analyzed the efficacies of the AT (AT + PTA or DCB) group and the non-AT (DCB or PTA) group for infrapopliteal arterial patients. We identified 6 studies with 1269 patients included in this meta-analysis. The risk ratios (RRs) of primary patency for patients treated with atherectomy group compared to non-atherectomy group at 6months was 1.03 (95% confidence intervals (CIs) 0.86-1.23, p = .74), at 12months was 1.05 (95% CIs 0.84-1.30, p = .66), in the subgroup analysis between AT combined with DCB and DCB alone, the RRs of primary patency was 1.56 (95% CIs 1.02-2.39, p = .04). The RRs of freedom from target lesion revascularization (TLR) at 6 months was 1.04 (95% CIs 0.93-1.17, p = .45), at 12 months was 1.20 (95% CIs 0.83-1.75, p = .33). The RRs of mortality at 6 months was 0.57 (95% CIs 0.29-1.11, p = .10), and at 12 months was 0.79 (95% CI 0.50-1.25, p = .31). The RRs of limb salvage at 12 months was 0.99 (95% CIs 0.92-1.07, p = .87). The standardized mean difference (SMD) of (Ankle-brachial index) ABI at 12months was 0.16 (95% CIs 0.06-0.26, p = .001). According to this systematic review and meta-analysis, no significant advantages were found with the addition of atherectomy to balloon angioplasty in the below-the-knee segment. Only in the analysis of a small subgroup of atherectomy + DCB versus DCB alone was the primary patency rate at six months significantly higher when adding atherectomy. No further significant differences were found related to 12months of primary patency, TLR, limb salvage, and mortality among groups.

Combined Treatment of Native Femoropopliteal Occlusions in Chronic Limb-Threatening Ischemia Using Atherectomy Debulking and a New Sirolimus Drug-Coated Balloon (SELUTION SLR)

Abstract Objective The aim of this study was to report the primary outcomes of a pilot study investigating the safety and efficacy of sirolimus drug-coated balloons (SELUTION) for endovascular postatherectomy treatment of native occluded femoropopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods This study analyzes a cohort of CLTI patients with femoropopliteal artery occlusions treated with combined rotational atherectomy and postatherectomy angioplasty using the SELUTION device. The primary outcome measures were amputation-free survival (AFS) defined as time to major limb (above ankle) amputation of the index leg or death from any cause. Secondary outcome measures included technical success, overall survival, major amputation of the index leg, major adverse limb event (MALE) defined as major amputation or any further major revascularization intervention of the treated segment during the follow-up period and primary patency at 12 months. Results Between April 2021 and January 2022, nine patients (mean age: 64.0 ± 8.4, 66.7% male) with femoropopliteal occlusive lesions (mean lesion length: 141.1mm, range: 40–400) were treated with the above-combined approach. Technical success was 100%. At 12 months, the AFS was 88.9%, with one death and zero major amputations (88.9% survival and 100% limb salvage, respectively); only two patients (22.2%) suffered a MALE; primary patency was 75%. No adverse events related to the sirolimus drug-coated balloon nor to the atherectomy device were observed. Conclusion Combining sirolimus drug-coated balloon and atherectomy for treatment of femoropopliteal occlusions in CLTI patients is a safe and effective approach achieving satisfactory patency and adverse event rates.

Safety and Feasibility of the BYCROSS® Atherectomy Device for the Treatment of Femoropopliteal Arterial Obstructions: Single-Center Short-Term Outcomes.

Background: Endovascular techniques have gained preference over peripheral arterial bypass surgery due to their minimally invasive nature; however, endovascular treatments often show limited efficacy in arterial segments with a high atherosclerotic load. The use of atherectomy devices enables the removal of calcified plaque material and may promote arterial wall remodeling. This study assessed the technical success, safety, and feasibility of the BYCROSS® atherectomy device in femoropopliteal lesions. Methods: This single-center, retrospective cohort study analyzed elective patients undergoing BYCROSS® atherectomy for chronic peripheral arterial disease from March 2022 to May 2023. Patient data, procedural details, and outcomes were retrospectively collected from electronic patient records. The primary performance endpoints of this study were technical success, complications, and patency rates. Primary safety endpoints included 30-day and short-term major adverse limb events (MALEs), major adverse cardiovascular events (MACEs), and mortality rate. Results: The study included 19 patients (median age, 71 years; 63% male) with Fontaine class IIb (26%), III (21%), or IV (53%). The BYCROSS® atherectomy device was used to treat 22 limbs in the femoropopliteal tract, of which 11 lesions (50%) were occlusions and 11 were stenoses, with a median length of 24 cm (interquartile range: 17-38). Technical success was achieved in all cases: 4.5% required atherectomy only, 50% required additional balloon angioplasties, 41% required balloon angioplasties and stenting, and 4.5% required segments only stenting. Additional treatment of below-the-knee arteries was performed in 12 patients. Procedurally related complications (not limited to the use of the BYCROSS® device) occurred in 23% of limbs, including distal embolization and laceration. At 30 days, mortality was 5%, the MACE rate was 11%, and the MALE rate was 0%. The observed mortality rate was not directly related to the procedure. Patency (<50% restenosis at duplex ultrasound) was 83% at 30 days. Conclusions: The use of the BYCROSS® atherectomy device for the treatment of femoropopliteal lesions appears to be safe and feasible, with high technical success and low MALE and MACE rates in a challenging population with long-segment femoropopliteal lesions. Long-term follow-up in larger patient series is needed to confirm these findings and to determine the durability of this technique.

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).

A Cost-Effective Approach to Resistant AV Fistula Stenosis: Successful Treatment Using Coronary OPN NC® Balloon in a Low-Income Setting.

Stenosis in the anastomotic site or venous limb of an arteriovenous fistula (AVF) is the most frequent cause of AVF failure. Percutaneous angioplasty with a standard or high-pressure balloon is the first-line treatment for AVF stenosis due to its higher technical success rate (90%) and lower complication rate (4%). Almost 20% of stenosis cases are resistant or undilatable by regular-pressure balloon angioplasty due to fibrosis, leading to technical failure or restenosis. Alternative therapies, such as atherectomy devices or cutting balloons, are expensive and difficult to obtain in low-income developing countries. We successfully treated resistant AVF stenosis with a coronary OPN-NC® ultra-high-pressure balloon and produced a good angiographic result with technical success. Coronary hardware is easily available and relatively cheaper compared to dedicated peripheral balloons or devices in our country due to reuse, which can be a boon in such type of cases. According to the standard hospital protocol, Cathlab hardware was reused.

Procedural characteristics and cardiovascular outcomes in patients undergoing drug-coated balloon angioplasty for de novo lesions in large coronary arteries: an observational study.

Limited data exist regarding drug-coated balloon (DCB) treatment in de novo large coronary arteries. We sought to demonstrate procedural characteristics, residual stenosis, and clinical outcomes following DCB angioplasty for de novo lesions in large versus small coronary arteries. The study included 184 consecutive patients with 223 de novo coronary lesions undergoing paclitaxel DCB angioplasty between January 2019 and August 2020, who were divided according to whether the DCB diameter was ≥ 3.0mm (large group, n = 58) or < 3.0mm (small group, n = 125). The large group had a higher proportion of acute coronary syndrome more commonly with ostial, bifurcation, and calcified lesions in large vessels and received lesion preparation with more frequent use of scoring or cutting balloons and atherectomy devices compared to the small group. Postprocedural angiographic diameter stenosis was smaller in the large group compared to the small group (31% [22-37] vs. 35% [26-42], p = 0.032), and intravascular ultrasound revealed no significant difference in postprocedural area stenosis between the groups (66.2 ± 7.7% vs. 67.9 ± 7.8%; p = 0.26). The median follow-up duration was 995days. The incidence of a composite of all-cause death, myocardial infarction, stroke, or target lesion revascularization was similar between the groups (log-rank p = 0.41) and was influenced by the presence of acute coronary syndrome and anemia but not by DCB diameter. The rate of cardiovascular outcomes after DCB treatment was comparable in de novo large and small coronary arteries. Notably, well-planned lesion preparation with intravascular imaging guidance was prevalent in large vessels.

Coronary intravascular lithotripsy in contemporary practice: challenges and opportunities in coronary intervention.

Percutaneous coronary intervention (PCI) of calcified coronary arteries is associated with poor outcomes. Poorly modified calcified lesion hinders the stent delivery, disrupts drug-carrying polymer, impairs drug elution kinetics and results in under-expanded stent (UES). UES is the most common cause of acute stent thrombosis and in-stent restenosis after PCI of calcified lesions. Angiography has poor sensitivity for recognition and quantification of coronary calcium, thereby mandating the use of intravascular imaging. Intravascular imaging, like intravascular ultrasound and optical coherence tomography, has the potential to accurately identify and quantify the coronary calcium and to guide appropriate modification device before stent placement. Available options for the modification of calcified plaque include modified balloons (cutting balloon, scoring balloon and high-pressure balloon), atherectomy devices (rotational atherectomy and orbital atherectomy) and laser atherectomy. Coronary intravascular lithotripsy (IVL) is the newest addition to the tool box for calcified plaque modification. It produces the acoustic shockwaves, which interact with the coronary calcium to cause multiplanar fractures. These calcium fractures increase the vessel compliance and result in desirable minimum stent areas. Coronary IVL has established its safety and efficacy for calcified lesion in series of Disrupt CAD trials. Its advantages over atherectomy devices include ease of use on workhorse wire, ability to modify deep calcium, no debris embolization causing slow flow or no-flow and minimal thermal injury. It is showing promising results in modification of difficult calcified lesion subsets such as calcified nodule, calcified left main bifurcation lesions and chronic total occlusion. In this review, authors will summarize the mechanism of action for IVL, its role in contemporary practice, evidence available for its use, its advantages over atherectomy devices and its imaging insight in different calcified lesion scenarios.

Impact of a Less Than 50% Residual Stenosis Following Vessel Preparation in Femoropopliteal Drug-Coated Balloon Angioplasty.

Drug-coated balloon (DCB) has been established as first-line therapy in femoropopliteal (FP) intervention, and successful vessel preparation (VP) is considered a key element. However, the clinical impact of successful VP remains unknown. This retrospective study examined the clinical impact of successful VP in DCB FP intervention. In total, 268 patients (308 limbs) who underwent successful FP intervention using DCB without atherectomy devices for symptomatic lower extremity artery disease between March 2018 and December 2019 were included in this study (high-dose DCB: 69.8%; low-dose DCB: 30.2%). Successful VP was defined as <50% residual stenosis and <dissection grade D before DCB (the successful VP group). The primary outcome measure was primary patency, and its associated factors were evaluated. The median follow-up period was 2.1 (interquartile range=1.1-2.7) years. Successful VP was achieved in 163 patients (60.8%). Primary patency and freedom from clinically-driven target lesion revascularization (CD-TLR) were significantly higher in the successful VP group than in the nonsuccessful VP group (54.2% vs 33.0%, p<0.001; 69.9% vs 57.7%, p=0.047). In the successful VP group, high-dose DCB and low-dose DCB were comparable in primary patency and freedom from CD-TLR (53.2% vs 53.6%, p=0.48; 68.7% vs 70.9%, p=0.69). In nonsuccessful VP group, high-dose DCB demonstrated numerically higher primary patency but not statistically significant than low-dose DCB (44.5% vs 16.0%, p=0.06), whereas no significant difference in freedom from CD-TLR was observed (56.0% vs 58.9%, p=0.29). On multivariate analysis, successful VP and preballoon size to reference vessel diameter ratio were significantly associated with primary patency. Achieving successful VP before DCB was independently associated with primary patency in DCB FP intervention. This study revealed that the successful vessel preparation (VP) before DCB and preballoonsize to reference vessel diameter ratio were independently associated with primary patency in DCB femoropopliteal intervention. When successful VP was achieved only before DCB treatment, the clinical outcomes were comparable between high-dose DCB and low-dose DCB at midterm follow-up.To maximized DCB efficacy, successful VP is very important in daily clinical practice.