Prospective Study of Serration Angioplasty in the Infrapopliteal Arteries Using the Serranator Device: PRELUDE BTK Study

2021 ◽  
pp. 152660282110599
Author(s):  
Andrew Holden ◽  
Michael Lichtenberg ◽  
Przemyslaw Nowakowski ◽  
Christian Wissgott ◽  
Klaus Hertting ◽  
...  
Keyword(s):  
Balloon Catheter ◽  
Ankle Brachial Index ◽  
Arterial Injury ◽  
Target Lesion ◽  
Transluminal Angioplasty ◽  
Balloon Inflation ◽  
The Core ◽  
Average Maximum ◽  
Artery Disease ◽  
Infrapopliteal Arteries

Purpose: The purpose was to evaluate the safety and efficacy of the Serranator percutaneous transluminal angioplasty serration balloon catheter in patients with infrapopliteal peripheral artery disease. Materials and Methods: A prospective, multicenter, single-arm feasibility study in 46 patients with claudication or chronic limb-threatening ischemia, Rutherford Clinical Category (RCC) 3 to 5, that required treatment of the infrapopliteal arteries above the tibiotalar joint. The primary efficacy outcome was device success—successful insertion, balloon inflation and deflation, and removal of the device(s) with a final diameter stenosis of <50%. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) through 30 day postprocedure. Other outcomes were change in RCC and ankle-brachial index, wound healing, and clinically-driven target lesion revascularization (CD-TLR). A subset of 9 patients were further evaluated by optical coherence tomography (OCT) or intravascular ultrasound (IVUS) for the presence of serrations in treated lesions. Patient follow-up occurred at 30 days and 6 months. Results: Forty-six patients received treatment with the Serranator device and 55 lesions were treated. Fifty-three lesions were deemed analyzable by the core lab with data and reported hereafter. Device success was 91.7% and freedom from MALE + POD through 30 days was 95.7%. Pretreatment stenosis of 82% was reduced to 21.8% and only 1 lesion (1.9%) required a bailout stent for a grade D dissection. The average maximum balloon inflation pressure was 6 atmospheres. Serrations were present in all treated lesions (n=10) in 9 patients imaged with OCT/IVUS as reviewed by the core laboratory. The RCC score improved by 1 or more level in 70% of patients at 6 months with 42% having a score of 0. The 6 month freedom from CD-TLR was 97.7%. Conclusion: Serranator treatment of infrapopliteal lesions showed excellent lumen gain with minimal evidence of arterial injury and low 6 month CD-TLR. Imaging by IVUS and OCT showed serrations without significant dissection, supporting the device’s proposed mechanism of action.

scholarly journals Association between post-balloon angioplasty dissection and primary patency in complex femoropopliteal artery disease: 2-year clinical outcomes of the AcoArt I trial

2021 ◽  
Vol 49 (4) ◽  
pp. 030006052110065
Author(s):  
Hao Ren ◽  
Jie Liu ◽  
Jiwei Zhang ◽  
Baixi Zhuang ◽  
Weiguo Fu ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Cox Regression ◽  
Target Lesion ◽  
Transluminal Angioplasty ◽  
Outcome Data ◽  
Primary Patency ◽  
Cox Regression Analysis ◽  
Femoropopliteal Artery ◽  
Artery Disease

Objective To assess the association between post-balloon angioplasty dissection and the mid-term results of the AcoArt I trial evaluating complex femoropopliteal artery disease. Methods The outcome data for 144 patients from the AcoArt 1 trial were reanalysed. These patients were randomly divided into percutaneous transluminal angioplasty (PTA) and drug-coated balloons (DCB) groups. The primary endpoint was the primary patency (PP) rate and clinically-driven target lesion revascularisation at 24 months. Results After 24 months of follow-up, the PP rate of dissection cases in the PTA group was lower vs non-dissection cases. In patients receiving a bailout stent for dissection, the PP rate in the PTA group was lower vs the DCB group. Cox regression analysis showed that dissection decreased the PP rate; mild dissection reduced the PP rate as follows: 52%, PTA group and 19%, DCB group. With severe dissection, the PP rate reduction was as follows: 75%, PTA group and 73%, DCB group. Conclusions The mid-term follow-up showed that post-balloon angioplasty dissection reduced the PP rate in the PTA group but not in the DCB group. Additionally, in patients receiving a bailout stent for dissection, the DCB group had a better PP rate than the PTA group.

The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an Unselected Patient Population

Angiology ◽  
2021 ◽  
pp. 000331972199731
Author(s):  
Ralf Langhoff ◽  
Jawed Arjumand ◽  
Matthias Waliszewski ◽  
Peter Reimer ◽  
Dirk Härtel ◽  
...  
Keyword(s):  
Balloon Catheter ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Primary Patency ◽  
Target Lesion Revascularization ◽  
Lesion Length ◽  
Multicenter Observational Study ◽  
Technical Success Rate ◽  
All Cause Mortality ◽  
Artery Disease

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)’s used was 99.6% (1.60 ± 0.79 DCB’s/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). Predictors for TLR were in-stent restenosis at baseline, vessel diameters ≤ 4.5 mm, lesion length, and post-DCB bailout stenting.

scholarly journals Basilar Artery Percutaneous Transluminal Angioplasty

2000 ◽  
Vol 6 (1_suppl) ◽  
pp. 155-158 ◽  
Author(s):  
B.Y. Sheikh ◽  
M. Ezura ◽  
A. Takahashi ◽  
T. Yoshimoto
Keyword(s):  
Basilar Artery ◽  
Balloon Catheter ◽  
Good Control ◽  
Neurological Status ◽  
Transluminal Angioplasty ◽  
Neurological Deficits ◽  
Balloon Inflation ◽  
Atherosclerotic Lesions ◽  
Single Lumen ◽  
Percutaneous Transluminal

This is a retrospective study of 15 cases with symptomatic basilar artery atherosclerotic chronic stenosis. One patient presented with reversible ischemic neurological deficits and another with completed infarction, the rest of patients presented with progressive transient neurological deficits (TIA) that was refractory to medical treatment. The protocol of PTA included the use of single lumen balloon catheter (Stealth; Boston Scientific, Boston, MT) and the pre-balloon inflation injection of Urokinase (UK). All lesions were successfully dilated except for one. Those with uncomplicated successful dilatation had good control of their neurological status with disappearance of the pre-PTA TIA. The authors conclude that PTA for basilar artery atherosclerotic lesions is possible and a promising procedure when the patients are carefully selected and the operation is performed by a team with good experience in such lesions.

Percutaneous Transluminal Angioplasty in Subclavian Steal Syndrome: Recurrent Stenosis and Retreatment in Two Patients

Neurosurgery ◽  
1982 ◽  
Vol 11 (4) ◽  
pp. 512-517 ◽  
Author(s):  
Thomas S. Moore ◽  
William F. Russell ◽  
Andrew D. Parent ◽  
Larry J. Parker ◽  
Robert R. Smith
Keyword(s):  
Balloon Catheter ◽  
Transluminal Angioplasty ◽  
Subclavian Steal Syndrome ◽  
Balloon Inflation ◽  
Recurrent Stenosis ◽  
Subclavian Steal ◽  
Factors Influencing ◽  
Percutaneous Transluminal ◽  
Steal Syndrome

Abstract Two patients with proximal subclavian artery stenosis and “subclavian steal syndrome” by clinical and arteriographic criteria were treated with percutaneous transluminal balloon catheter angioplasty. Successful dilatation was obtained, but stenoses recurred at or near the dilated segments in both cases, necessitating repeat transluminal angioplasty. One patient eventually underwent surgical carotid-subclavian grafting. Factors influencing recurrent stenosis after transluminal angioplasty are discussed, including the choice of an optimal balloon inflation diameter, the pathophysiology of angioplasty, and the role of anticoagulation. Transluminal angioplasty may be a viable therapeutic alternative to operation in selected patients with occlusive subclavian disease.

Thirty-six-month outcomes of drug-eluting balloon angioplasty in the infrapopliteal arteries

Vascular ◽  
2018 ◽  
Vol 26 (5) ◽  
pp. 457-463 ◽  
Author(s):  
Berkan Ozpak ◽  
Sahin Bozok ◽  
Mustafa Cagdas Cayir
Keyword(s):  
Balloon Angioplasty ◽  
Patency Rate ◽  
Ankle Brachial Index ◽  
Target Lesion ◽  
Primary Patency ◽  
Target Lesion Revascularization ◽  
Primary Patency Rate ◽  
Drug Eluting ◽  
Drug Eluting Balloon ◽  
Infrapopliteal Arteries

Objectives To evaluate 36-month outcomes of drug-eluting balloons in infrapopliteal (=below-the-knee) arterial segments, we made a prospective registry enrolling patients (Rutherford class 2 to 5, ankle–brachial index 0.4–0.7) who were revascularized with drug-eluting balloon from August 2011 to December 2014. Methods Three hundred and seven infrapopliteal arteries were revascularized only with drug-eluting balloon. Endpoints included target lesion revascularization, primary patency rate, and changes in ankle–brachial index and Rutherford class. Results Both ankle–brachial index improvement and Rutherford reduction were statistically significant (p < 0.001). At 36 months control, ankle–brachial index improvement was 59.3% (p = 0.032). The clinically driven target lesion revascularization rate was 28% at 36 months. Limb salvage was accomplished in 73.6% of the critical limb ischemia cases, and complete wound healing was detected in 67.8% of cases with Rutherford category 5. Overall, the 1-year primary patency rate was 32.5%. Conclusions Drug-eluting balloons have shown successful performance in infrapopliteal arteries in mid-term, and evidence regarding clinical effectiveness and safety supports drug-eluting balloon angioplasty as the first line therapy in this segment.

scholarly journals Falsely normalized ankle-brachial index despite the presence of lower-extremity peripheral artery disease: two case reports 

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Tatsuya Maruhashi ◽  
Shogo Matsui ◽  
Farina Mohamad Yusoff ◽  
Shinji Kishimoto ◽  
Masato Kajikawa ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
Lower Extremity ◽  
Peripheral Artery Disease ◽  
Ankle Brachial Index ◽  
Peripheral Artery ◽  
Cardiovascular Risk Assessment ◽  
Index Measurement ◽  
Missed Diagnosis ◽  
Artery Disease ◽  
Infrapopliteal Arteries

Abstract Background The ankle-brachial index measurement is used for screening and diagnosis of lower-extremity peripheral artery disease and cardiovascular risk assessment. However, the value is occasionally unreliable since the oscillometric ankle-brachial index can be elevated and falsely normalized despite the presence of lower-extremity peripheral artery disease because of the incompressibility of infrapopliteal arteries at the ankle, potentially leading to a missed diagnosis of lower-extremity peripheral artery disease or underestimation of cardiovascular risk. Case presentation We report two cases of lower extremity peripheral artery disease with normal ankle-brachial index (a 76-year-old Asian man and a 66-year-old Asian man). In both cases, the ankle-brachial index was within the normal range (1.00–1.40) despite the presence of lower-extremity peripheral artery disease, whereas upstroke time at the ankle calculated from the pulse volume waveform simultaneously obtained by plethysmography during the ankle-brachial index measurement was prolonged (≥ 180 milliseconds). Diagnostic imaging tests revealed the presence of occlusive arterial disease in the lower extremity and severe calcification of infrapopliteal arteries. Conclusions In both cases, the oscillometric ankle-brachial index might have been falsely normalized despite the presence of lower-extremity peripheral artery disease because of calcified incompressible infrapopliteal arteries. Sole reliance on the ankle-brachial index value may lead to a missed diagnosis of lower-extremity peripheral artery disease or underestimation of cardiovascular risk. Upstroke time at the ankle was helpful for suspecting the presence of lower-extremity peripheral artery disease in both patients with normal ankle-brachial index. In addition to history-taking and vascular examination, upstroke time at the ankle should be carefully checked for accurate diagnosis of peripheral artery disease and cardiovascular risk assessment in patients with normal ankle-brachial index.

Feasibility of ischemic leg ulcer healing using percutaneous techniques: a real-life study

2019 ◽  
Vol 61 (3) ◽  
pp. 353-360
Author(s):  
Elias Kehagias ◽  
Christos V Ioannou ◽  
Izolde Bouloukaki ◽  
Evangelia Papadaki ◽  
Nikolaos Galanakis ◽  
...  
Keyword(s):  
Lower Extremity ◽  
Limb Salvage ◽  
Percutaneous Transluminal Angioplasty ◽  
Clinical Success ◽  
Ankle Brachial Index ◽  
Real Life ◽  
Transluminal Angioplasty ◽  
Artery Disease ◽  
Percutaneous Transluminal ◽  
Lower Extremity Artery Disease

Background Percutaneous transluminal angioplasty is established as the first-line vascular procedure in patients with lower extremity artery disease. Purpose We aimed to evaluate the technical and clinical effectiveness of percutaneous transluminal angioplasty in the management of ischemic foot ulcers. Material and Methods All consecutive patients presenting with a foot ulcer at the outpatient vascular surgery clinic of our hospital between June 2009 and June 2015 were evaluated using foot pulse assessment, ankle-brachial index, and duplex scanning. If non-invasive parameters suggested lower extremity artery disease, CT angiography and/or digital subtraction angiography were performed and a percutaneous transluminal angioplasty was carried out when feasible during the same session. All patients were followed until healing, amputation, death, or for at least two years. Short- and long-term clinical success was evaluated based on ulcer size and appearance. Patients with worsening ulcers after percutaneous transluminal angioplasty underwent bypass grafting or amputation. Results Percutaneous transluminal angioplasty was performed in 161 patients (100%) with stenoses > 50%, including cases lesions > 10 cm and/or multiple/calcified lesions, 144 of which completed the study. In 88 (61.2%) patients, percutaneous transluminal angioplasty was performed in the suprapopliteal axis exclusively, in 10 (6.8%) patients in the infrapopliteal axis only, and in 46 (31.9%) in both levels. Percutaneous transluminal angioplasty was technically successful in 141 (98%) patients. After 3.1 years, the rate of healing was 68%, limb salvage 88%, overall survival 69.5%, and amputation-free survival 64%. Conclusion Our data suggest that percutaneous transluminal angioplasty for ischemic foot ulceration treatment is in the majority of patients feasible, effective, and safe with high rates of healing and limb salvage.

Klinische Langzeitergebnisse der perkutanen transluminalen Angioplastie bei Patienten mit peripherer arterieller Verschlusskrankheit

VASA ◽  
2002 ◽  
Vol 31 (1) ◽  
pp. 36-42 ◽  
Author(s):  
. Bucek ◽  
Hudak ◽  
Schnürer ◽  
Ahmadi ◽  
Wolfram ◽  
...  
Keyword(s):  
Success Rate ◽  
Clinical Stage ◽  
Ankle Brachial Index ◽  
Clinical Situation ◽  
Clinical Results ◽  
Transluminal Angioplasty ◽  
Term Outcome ◽  
Long Term Outcome

Background: We investigated the long-term clinical results of percutaneous transluminal angioplasty (PTA) in patients with peripheral arterial occlusive disease (PAOD) and the influence of different parameters on the primary success rate, the rate of complications and the long-term outcome. Patients and methods: We reviewed clinical and hemodynamic follow-up data of 166 consecutive patients treated with PTA in 1987 in our department. Results: PTA improved the clinical situation in 79.4% of patients with iliac lesions and in 88.3% of patients with femoro-popliteal lesions. The clinical stage and ankle brachial index (ABI) post-interventional could be improved significantly (each P < 0,001), the same results were observed at the end of follow-up (each P < 0,001). Major complications occurred in 11 patients (6.6%). The rate of primary clinical long-term success for suprainguinal lesions was 55% and 38% after 5 and 10 years (femoro-popliteal 44% and 33%), respectively, the corresponding data for secondary clinical long-term success were 63% and 56% (60% and 55%). Older age (P = 0,017) and lower ABI pre-interventional (P = 0,019) significantly deteriorated primary clinical long-term success for suprainguinal lesions, while no factor could be identified influencing the outcome of femoro-popliteal lesions significantly. Conclusion: Besides an acceptable success rate with a low rate of severe complications, our results demonstrate favourable long-term clinical results of PTA in patients with PAOD.

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