Intravascular Lithotripsy for Treatment of Calcified Infrapopliteal Lesions: Results from the Disrupt PAD III Observational Study

2021 ◽  
pp. 152660282110329
Author(s):  
George Adams ◽  
Peter A. Soukas ◽  
Anderson Mehrle ◽  
Barry Bertolet ◽  
Ehrin J. Armstrong
Keyword(s):  
Observational Study ◽  
Real World ◽  
De Novo ◽  
Academic Research ◽  
Limb Ischemia ◽  
Vessel Diameter ◽  
Lesion Length ◽  
Residual Stenosis ◽  
Below The Knee ◽  
Infrapopliteal Arteries

Purpose: To evaluate the safety and effectiveness of the Shockwave S4 intravascular lithotripsy (IVL) catheter in an “all-comers” cohort of patients with calcified infrapopliteal lesions. Materials and Methods: The Disrupt PAD III Observational Study (NCT02923193) is a prospective, nonrandomized, multicenter single-arm study designed to assess the “real-world” acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of de novo calcified, stenotic peripheral arteries. Patients were eligible for enrollment if they had claudication or critical limb ischemia (CLI) and at least moderate calcification as assessed by angiography. This subanalysis includes consecutive patients enrolled with angiographic core lab-assessed treatment of infrapopliteal arteries using the Shockwave S4 IVL catheter. Results From July 2018 to August 2020, 101 patients with 114 calcified infrapopliteal arteries treated with the S4 IVL catheter were enrolled at 15 sites in 3 countries. CLI was present in 69.3% of patients. The anterior tibial and tiboperoneal trunk were the most commonly treated vessels with an overall mean reference vessel diameter (RVD) of 3.1±0.8 mm, minimum lumen diameter (MLD) of 0.5±0.6 mm, and a corresponding diameter stenosis of 83.4%±15.8% by core lab assessment. Mean lesion length was 64.7±54.7 mm with moderate to severe calcification in 69.3% of lesions by the Peripheral Academic Research Consortium (PARC) criteria. Adjunctive calcium-modifying technology, defined as scoring or cutting balloon and/or atherectomy, was used in 22.7% of procedures. The average acute gain at the end of the procedure was 2.0±0.7 mm with a residual stenosis <50% achieved in 99.0% of lesions and a mean residual stenosis of 23.3±12.5%. There were no flow-limiting dissection, embolization, slow flow/no-reflow, or abrupt closure events at the end of the procedure. Conclusion This subanalysis of the PAD III Observational Study represents the largest report to-date of IVL treatment of heavily calcified below-the-knee (BTK) lesions in a “real-world” patient cohort. The use of S4 IVL demonstrated consistent acute safety and effectiveness outcomes consistent with prior IVL peripheral studies. These consistent outcomes were achieved with the initial use of the S4 IVL catheter for treatment of complex BTK lesions.

scholarly journals PRELUDE Prospective Study of the Serranator Device in the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Popliteal Arteries

2018 ◽  
Vol 26 (1) ◽  
pp. 18-25 ◽  
Author(s):  
Andrew Holden ◽  
Andrew Hill ◽  
Andrew Walker ◽  
Brendan Buckley ◽  
Stephen Merrilees ◽  
...  
Keyword(s):  
De Novo ◽  
Balloon Catheter ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Lesion Length ◽  
Chronic Total Occlusions ◽  
The Core ◽  
Safety Endpoint ◽  
Exciting Potential ◽  
Primary Safety Endpoint

Purpose: To evaluate the safety and efficacy of the Serranator Alto PTA Serration Balloon Catheter in subjects with peripheral artery disease in the superficial femoral and popliteal arteries. Materials and Methods: A prospective, multicenter, single-arm feasibility study enrolled 25 patients (mean age 66 years; 18 men) to evaluate Serranator inflation and postinflation effects under monitoring by independent core laboratories. Inclusion criteria were claudication or ischemic rest pain, de novo lesions or native artery restenosis, >70% stenosis, lesion length <10 cm, and a reference vessel diameter of 4 to 6 mm. Chronic total occlusions (CTO) up to 6 cm in length were allowed (n=8). The primary safety endpoint was 30-day major adverse events. Primary efficacy outcome was device success with final diameter stenosis <50%. The secondary objective was to confirm the presence of serrations across the lesions using optical coherence tomography (OCT) or intravascular ultrasound (IVUS) following treatment in a subset of 10 subjects. Follow-up evaluations were conducted at 30 days and 6 months. Results: Technical success of device delivery and retrieval was 100%. The primary safety endpoint was met, with no patients experiencing a major adverse event in the first 30 days. Pretreatment stenosis of 88% was reduced to 23%. One stent was implanted for grade D dissection in a CTO. The core laboratory–adjudicated primary patency was 100% at 1 month and 64% at 6 months. Serrations were confirmed in all 10 OCT/IVUS images reviewed by the core laboratory. The Rutherford category showed significant and sustained improvement at 6 months. Conclusion: The Serranator is a safe and efficacious angioplasty balloon catheter system. This new design provides an exciting potential for optimizing vessel preparation and aiding drug delivery.

Endovascular first strategy for de novo TransAtlantic Inter-Society Consensus C and D femoro-popliteal disease: Mid-term outcomes from a single tertiary referral center

Vascular ◽  
2014 ◽  
Vol 23 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Jeffrey Lorne Grenville ◽  
Kong Teng Tan ◽  
Hadas Moshonov ◽  
Dheeraj Kumar Rajan
Keyword(s):  
De Novo ◽  
Ankle Brachial Index ◽  
Limb Ischemia ◽  
Transluminal Angioplasty ◽  
Study Patient ◽  
Lesion Length ◽  
Secondary Patency ◽  
Tertiary Referral Center ◽  
Patient Demographics ◽  
The Mean

Purpose: Describe outcomes after endovascular intervention of TransAtlantic Inter-Society Consensus C and D femoro-popliteal disease. Materials and methods: Retrospective cohort study. Patient demographics, ankle-brachial indices, and lesion details were analyzed from a prospectively maintained database. In all, 980 limbs treated with percutaneous transluminal angioplasty ± stenting of the femoro-popliteal segment between 2005 and 2012 were reviewed. Seventy-six patients representing 83 limbs with de novo TransAtlantic Inter-Society Consensus C and D lesions measuring ≥15 cm continuously were identified (mean age 71.3 ± 12.1 years, 62% male). Results: Twenty-five (30.1%) limbs were treated for severe claudication and 58 (69.9%) for critical limb ischemia. The mean pre-procedural ankle-brachial index was 0.47 ± 0.19. The mean lesion length was 22.9 ± 4.82 cm. Seventy patients representing 77 limbs were available for a mean follow-up length of 19.5 months (range 0–79). The mean post-procedural ankle-brachial index was 0.71 ± 0.28. Primary, assisted-primary, and secondary patency rates were 68.1%, 72.7%, and 83.3% at 6 months, 55.3%, 63.6%, and 58.3% at 12 months, and 38.2%, unavailable, and 10.4% at 24 months, respectively. Conclusions: Angioplasty-first strategy for TransAtlantic Inter-Society Consensus C and D lesions of the femoro-popliteal artery can be safely performed. However, patency drastically decreases after 12 months suggesting further improvements are required to achieve longer-term clinical benefit.

scholarly journals Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study

2020 ◽  
Vol 27 (3) ◽  
pp. 473-480 ◽  
Author(s):  
George Adams ◽  
Nicolas Shammas ◽  
Sarang Mangalmurti ◽  
Nelson L. Bernardo ◽  
William E. Miller ◽  
...  
Keyword(s):  
Observational Study ◽  
Real World ◽  
Thrombotic Event ◽  
Arterial Stenosis ◽  
Arterial Calcification ◽  
Distal Embolization ◽  
Residual Stenosis ◽  
Type D ◽  
Artery Disease ◽  
Drug Coated Balloon

Purpose: To evaluate the performance of peripheral intravascular lithotripsy (IVL) in a real-world setting during endovascular treatment of multilevel calcified peripheral artery disease (PAD). Materials and Methods: The Disrupt PAD III Observational Study ( ClinicalTrials.gov identifier NCT02923193) is a prospective, nonrandomized, multicenter, single-arm observational study assessing the acute safety and effectiveness of the Shockwave Peripheral IVL System for the treatment of calcified, stenotic lower limb arteries. Patients were eligible if they had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. Between November 2017 and August 2018, 200 patients (mean age 72.5±8.7 years; 148 men) were enrolled across 18 sites and followed through hospital discharge. Results: In the 220 target lesions, IVL was more commonly used in combination with other balloon-based technologies (53.8%) and less often with concomitant atherectomy or stenting (19.8% and 29.9%, respectively). There was a 3.4-mm average acute gain at the end of procedure; the final mean residual stenosis was 23.6%. Angiographic complications were rare, with only 2 type D dissections and a single perforation following drug-coated balloon inflation (unrelated to the IVL procedure). There was no abrupt closure, distal embolization, no reflow, or thrombotic event. Conclusion: Use of peripheral IVL to treat severely calcified, stenotic PAD in a real-world study demonstrated low residual stenosis, high acute gain, and a low rate of complications despite the complexity of disease.

Neointimal Healing Evaluated by Optical Coherence Tomography after Drug-Eluting Absorbable Metal Scaffold Implantation in de novo Native Coronary Lesions: Rationale and Design of the Magmaris-OCT Study

Cardiology ◽  
2017 ◽  
Vol 137 (4) ◽  
pp. 225-230 ◽  
Author(s):  
Pasi Karjalainen ◽  
Tuomas Paana ◽  
Jussi Sia ◽  
Wail Nammas
Keyword(s):  
Optical Coherence Tomography ◽  
De Novo ◽  
Quantitative Coronary Angiography ◽  
Vessel Diameter ◽  
Target Lesion ◽  
Lesion Length ◽  
Optical Coherence ◽  
Flow Reserve ◽  
Coronary Lesions

Objectives: We sought to explore neointimal healing assessed by optical coherence tomography (OCT) following implantation of the Magmaris sirolimus-eluting absorbable metal scaffold. Methods: The Magmaris-OCT is a prospective, multicenter, single-arm observational clinical study, intended to enrol 60 consecutive patients with up to 2 de novo native coronary lesions, each located in different major epicardial vessels, with a reference vessel diameter of 2.5-3.5 mm, and a maximum lesion length of 20 mm. Patients will undergo Magmaris scaffold implantation in the target lesion, according to the standard practice. Clinical follow-up will take place at 30 days, and at 3, 6, 9, and 12 months. For invasive-imaging follow-up, patients will be classified into 3 groups: cohort A will be scheduled for follow-up at 3 months, cohort B at 6 months, and cohort C at 12 months. Invasive imaging will include quantitative coronary angiography, OCT evaluation, and coronary flow reserve measurement. The primary end point will be the percentage of uncovered scaffold struts assessed by OCT at the prespecified follow-up. Conclusions: This study will provide insight into the short- and mid-term healing properties following Magmaris scaffold implantation, with special emphasis on the neointimal coverage of scaffold struts.

Drug-Coated Balloon Angioplasty in Atherosclerosis Patients With Popliteal Artery Involvement

2018 ◽  
Vol 25 (5) ◽  
pp. 581-587 ◽  
Author(s):  
Tomoharu Dohi ◽  
Andrej Schmidt ◽  
Dierk Scheinert ◽  
Yvonne Bausback ◽  
Daijiro Kabata ◽  
...  
Keyword(s):  
Popliteal Artery ◽  
De Novo ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Lesion Length ◽  
Endovascular Interventions ◽  
Long Term Follow Up ◽  
Drug Coated Balloon

Purpose: To investigate outcomes of drug-coated balloon (DCB) angioplasty in endovascular interventions including or restricted to the popliteal artery. Methods: A retrospective analysis was conducted of 266 patients [median age 72 years, interquartile range (IQR) 62, 78; 166 men] treated with DCB angioplasty in 281 de novo lesions including the popliteal artery between December 2011 and January 2015 at a single center. The median lesion length was 270 mm (IQR 150, 373). The study outcomes were primary patency and predictors of restenosis [reported as the hazard ratio (HR) with 95% confidence interval (CI)]. Results: The primary patency was 77.4% at a median 12.2 months (IQR 5.7, 18.8). Independent variables associated with restenosis included baseline Rutherford category (HR 1.36, 95% CI 1.05 to 1.77, p=0.02), reference vessel diameter (HR 0.77, 95% CI 0.63 to 0.95, p=0.02), dissection (HR 1.69, 95% CI 1.022.79, p=0.04), and standard nitinol stent use (HR 2.08, 95% CI 1.14 to 3.79, p=0.02). Conclusion: Outcomes after DCB angioplasty in lesions including the popliteal artery were acceptable compared with previous studies. Further investigation with long-term follow-up is needed to confirm these results.

Optimal Vessel Sizing and Understanding Dissections in Infrapopliteal Interventions: Data From the iDissection Below the Knee Study

2020 ◽  
Vol 27 (4) ◽  
pp. 575-580 ◽  
Author(s):  
Nicolas W. Shammas ◽  
W. John Shammas ◽  
Susan Jones-Miller ◽  
James T. Torey ◽  
Ehrin J. Armstrong ◽  
...  
Keyword(s):  
Vessel Diameter ◽  
Accurate Estimate ◽  
Transluminal Angioplasty ◽  
Lesion Length ◽  
Internal Elastic Lamina ◽  
Post Intervention ◽  
Blood Institute ◽  
Below The Knee ◽  
Orbital Atherectomy ◽  
Vascular Angiography

Purpose: To investigate if imaging with intravascular ultrasound (IVUS) yields a more accurate estimate of vessel diameter and the presence of dissections than angiography after intervention in the infrapopliteal arteries. Materials and Methods: A prospective, single-center study enrolled 20 consecutive patients (mean age 74.1±12.4 years; 12 women) with infrapopliteal disease who were treated with percutaneous transluminal angioplasty (PTA; n=10) or orbital atherectomy (OA) followed by PTA (n=10). The majority of patients were hypertensive and half were diabetic. The overall lesion length was 7.3±6.3 cm, and the diameter stenosis was 80.3%±22.1%. The baseline characteristics did not differ between the groups. Vessel diameters were measured using IVUS from the internal elastic lamina (IEL) to the IEL. IVUS was performed at baseline, post PTA or OA, and post OA+PTA. Quantitative vascular angiography (QVA) and IVUS were analyzed by a core laboratory. Dissections on cine images were categorized based on the National Heart Lung and Blood Institute (NHLBI) classification, while the arc and depth were used to characterize dissections on IVUS images. Results: Mean vessel diameter by QVA was 2.9±0.6 vs 4.0±1.0 mm by IVUS according to the core laboratory (mean difference 1.1±0.9, p<0.001). On angiography, there were 7 dissections after PTA (6 C, 1 D), 1 dissection after OA (1 B), and 2 dissections after OA+PTA (1 A, 1 B; p=0.028 vs post PTA). IVUS uncovered 3.8 times more dissections than seen on angiography. There were 23 dissections after PTA (18 intima, 3 media, 2 adventitia), 12 dissections after OA (8 intima, 1 media, 3 adventitia), and 11 dissections following OA+PTA (7 intima, 1 media, 3 adventitia; p=0.425 vs PTA). Bailout stenting (all due to angiographic dissections ≥C) was necessary in 6 of the PTA cohort and none of the OA+PTA group. Conclusion: In addition to underestimating the infrapopliteal vessel diameter by ~25%, angiography underappreciated the presence and severity of post-intervention dissections vs IVUS, particularly in the OA+PTA group.

scholarly journals Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 12-month interim results of the BIOLUX P-III registry first year of enrolment

2017 ◽  
Vol 16 (4) ◽  
pp. 276-284 ◽  
Author(s):  
Marianne Brodmann ◽  
Thomas Zeller ◽  
Johnny Christensen ◽  
Christoph Binkert ◽  
Lubomir Spak ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Limb Amputation ◽  
Lesion Length ◽  
Infrainguinal Arteries ◽  
Artery Disease ◽  
Major Adverse Events

Abstract Background Endovascular management of atherosclerotic infrainguinal arteries recently shifted towards drug eluting devices, designed to locally prevent the restenosis process. Numerous clinical studies report an advantage of drug coated balloons over uncoated balloon angioplasty in treating lower extremity peripheral artery disease. However, as coating and balloon platforms are different, each device requires dedicated clinical evaluations. Objective The aim of the study is to further investigate the safety and effectiveness of a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries in a real-world setting. Methods 203 patients out of a final sample of 882 were enrolled in this prospective multicenter, observational, all-comers registry during the first 12 months. The primary endpoints were major adverse events (defined as procedure or device related death within 30 days post index procedure, clinically-driven target lesion revascularization or major target limb amputation) at 6 months and freedom from clinically-driven target lesion revascularization at 12 months. Both endpoints were adjudicated by a Clinical Events Committee. Results Mean patient age was 70.2±10.4 years (60.1% male). 47.3% of the patients were diabetic and 67.5% had a history of smoking. Severe claudication was reported in 37.4% and 40% had critical limb ischemia. 257 lesions, including 13.2% in the infrapopliteal territory, were treated with Passeo-18 Lux (mean lesion length 75.1 mm±69.4, 20% occlusions, 76.3% calcified). At 6 months, the rate of major adverse events was 5.5% (95%CI 3.1-9.7). Freedom from clinically-driven target lesion revascularization at 12 months was 93.2% (95%CI 89.1-95.8). All causes mortality was 6.5% (95%CI 3.8-11.0) and overall amputation rate was 4.2% (95%CI 2.1-8.3) at 12 months. Conclusion In a real-world environment, the BIOLUX P-III registry preliminary results confirm the safety and efficacy of the Paclitaxel-Coated Passeo-18 Lux balloon as a stand-alone treatment option for atherosclerotic infrainguinal arteries.

scholarly journals Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry

2020 ◽  
Author(s):  
Gunnar Tepe ◽  
Thomas Zeller ◽  
Matej Moscovic ◽  
Jean-Marc Corpataux ◽  
Johnny Kent Christensen ◽  
...  
Keyword(s):  
Real World ◽  
Large Population ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Lesion Length ◽  
Complication Rates ◽  
Full Cohort ◽  
Infrainguinal Arteries ◽  
And Performance

Abstract Purpose After promising small randomized trials, the aim of BIOLUX P-III was to further investigate the safety and performance of the Passeo-18 lx drug-coated balloon in infrainguinal arteries under real-world conditions. Methods BIOLUX P-III is a global prospective single-arm study with follow-up at 6, 12 and 24 months. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months. The primary performance endpoint was freedom from clinically driven target lesion revascularization (TLR) within 12 months. Results 877 patients/1084 lesions were enrolled. Diabetes mellitus was present in 47.7%, and 42.1% had critical limb ischemia (CLI). The mean lesion length was 89.0 mm with 76.1% of calcified lesions, and 24.9% occluded. At 24 months, freedom from MAE was 83.1% in the full cohort; 84.9% in the femoropopliteal population (592 patients, 691 lesions); 77.7% for long lesions (187 subjects/192 lesions); and 72.5% in the in-stent restenosis (ISR) subgroup (103 subjects/116 lesions). Twenty-four-month freedom from clinically driven TLR was 88.1% in the full cohort; 88.9% in the femoropopliteal population; 80.3% for the long lesions; and 78.4% for ISR. Twenty-four-month all-cause mortality was 12.0% in the full cohort, 10.2% in the femoropopliteal population, 14.8% for the long lesions and 12.0% for ISR. There was no device- or procedure-related death up to 24-month follow-up. Conclusion The BIOLUX P-III 24-month outcomes confirm the safety and performance of Passeo-18 lx in infrainguinal arteries in a large population treated under real-world conditions with low complication rates and good clinical outcomes (NCT02276313).

Lumen Loss at 1 Year After Bare Nitinol Stent Implantation in the Superficial Femoral Artery

2020 ◽  
pp. 152660282095026
Author(s):  
Nobuhiro Ito ◽  
Mitsuyoshi Takahara ◽  
Yoshimitsu Soga ◽  
Seiichi Hiramori ◽  
Kaoru Hirose ◽  
...  
Keyword(s):  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Failure Time ◽  
De Novo ◽  
Vessel Diameter ◽  
Accelerated Failure Time Model ◽  
Lesion Length ◽  
Time Model ◽  
Nitinol Stent ◽  
The Mean

Purpose To investigate lumen loss (LL) at 1 year after bare nitinol stent (BNS) implantation for de novo superficial femoral artery (SFA) lesions. Materials and Methods The subjects were 701 consecutive patients (mean age 74±9 years; 492 men) with 817 de novo SFA lesions treated with BNS implantation between January 2004 and September 2015. The mean lesion length was 141±88 mm and the mean vessel diameter was 5.4±0.9 mm. The endpoint was LL at 1 year after BNS implantation. Secondary outcomes were restenosis and target lesion revascularization (TLR) estimated using the Kaplan-Meier method; estimates are reported with the 95% confidence interval (CI). LL was defined as the minimum lumen diameter immediately after BNS implantation minus that at 1 year measured by angiographic quantitative vessel analysis. The distribution of LL in the overall population was estimated using an accelerated failure time model. Results Mean LL at 1 year was estimated to be 1.74±1.28 mm (95% CI 1.63 to 1.84). Current smoking was positively associated with LL (p=0.015), whereas lack of cilostazol use was correlated with an increase in LL (p=0.001). Reference vessel diameter and lesion length did not have any significant association with LL at 1 year. The 1-year cumulative estimate of restenosis was 25% (95% CI 22% to 28%); the corresponding value for TLR was 18% (95% CI 15% to 21%). Conclusion Mean LL progressed by at least 1.6 mm at 1 year after BNS implantation. The risk factors for increased LL were current smoker and lack of cilostazol use.

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