Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study.

OBJECTIVE: Endovascular therapy of lower extremity peripheral artery disease (PAD) is associated with higher complication rates and worse outcomes in women vs men. Although intravascular lithotripsy (IVL) has shown similarly favorable outcomes in men and women in calcified coronary arteries, there is no published safety and effectiveness data of peripheral IVL differentiated by sex. This study aims to evaluate sex-specific acute procedural safety and effectiveness following IVL treatment of calcified PAD. METHODS: We performed a secondary analysis of the multicenter Disrupt PAD III Observational Study, which assessed short-term procedural outcomes of patients undergoing treatment of symptomatic calcified lower extremity PAD with the Shockwave peripheral IVL system. Adjudicated acute safety and efficacy outcomes were compared by sex using univariate analysis performed with the χ2 test or Fisher exact test, as appropriate. RESULTS: A total of 1262 patients (29.9% women) were included, with >85% having moderate to severe lesion calcification. Women were older (74 vs 71 years; P < .001), had lower ankle-brachial index (0.7 vs 0.8; P = .003), smaller reference vessel size (5.3 vs 5.6 mm; P = .009), and more severe stenosis at baseline vs men (82.3% vs 79.8%; P = .012). Rates of diabetes, renal insufficiency, chronic limb-threatening ischemia, lesion length, and atherectomy use were similar in both groups. Residual stenosis after IVL alone was significantly reduced in both groups. Final residual stenosis was 21.9% in women and 24.7% in men (P = .001). Serious angiographic complications were infrequent and similar in both groups (1.4% vs 0.6%; P = .21), with no abrupt vessel closure, distal embolization, or thrombotic events during any procedure. CONCLUSIONS: The use of IVL to treat calcified PAD in this observational registry demonstrated favorable acute safety and effectiveness in both women and men.

Solid state, pulsed-wave 355 nm UV laser atherectomy debulking in the treatment of infrainguinal peripheral arterial disease: The Pathfinder Registry.

BACKGROUND: Atherectomy is an important option for debulking atherosclerotic plaque from diseased arteries in patients with infrainguinal arterial disease. Laser atherectomy uses a high-powered laser to remove the plaque from the arteries to restore blood flow. AIMS: The Pathfinder multicenter registry was initiated to evaluate the safety and efficacy of the 355 nm laser atherectomy system in a real-world setting for the treatment of de novo, re-stenotic and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with peripheral artery disease (PAD). METHODS: The study was a prospective, single-arm, multicenter, open-label registry study for patients treated with the 355 nm laser system. Clinical and lesion characteristics, procedural safety and efficacy data, and baseline, 6-, and 12-month outcomes data, including Ankle Brachial Index (ABI), Rutherford class, and Walking Impairment Questionnaires (WIQ), were collected. The primary efficacy endpoint was the achievement of ≤30% final residual stenosis at the index lesion postatherectomy and adjunctive therapy evaluated by an angiographic Core Lab. The primary safety endpoint was the percentage of subjects who did not experience periprocedural major adverse events (PPMAEs) before discharge. RESULTS: One hundred and two subjects with 121 lesions treated with the 355 nm laser device at 10 centers were included in the analysis. Mean age was 68.4 ± 10.21 years, 61.8% of subjects were male, 44.6% had critical limb ischemia (CLI), and 47.3% had tibial lesions. The mean residual stenosis at the end of the procedure was 24.4 ± 15.5 with 69 lesions (69.0%) achieving technical procedural success (<30% stenosis); similar rates were observed for subjects with ISR (25.5 ± 14.9), chronic total occlusion (CTO) (28.1 ± 17.0), and severe calcification (36.5 ± 21.6) lesions. Mean ABI, Rutherford, and WIQ scores were improved at both 6 and 12 months. Ninety-seven of 102 subjects (95.1%) met the primary safety endpoint of not experiencing a PPMAE before discharge. CONCLUSIONS: The initial data from the Pathfinder Registry demonstrates the 355 nm laser system is safe and effective in a real-world setting for performing atherectomy in patients with infrainguinal PAD.

Intravascular Lithotripsy for Treatment of Severely Calcified Common Femoral Artery Disease: Results From the Disrupt PAD III Observational Study.

BACKGROUND: Surgical endarterectomy is currently considered the front-line therapy for the treatment of calcified lesions in the common femoral artery (CFA). Endovascular interventions have evolved, and their use is increasing in frequency. Intravascular lithotripsy (IVL) has shown promising safety and effectiveness in calcified CFA lesions in a small pilot study, but "real-world" evidence from a larger cohort is lacking. METHODS: The Disrupt PAD III Observational Study (NCT02923193) was a prospective, multicenter registry designed to assess the acute safety and effectiveness of IVL treatment for calcified peripheral arterial disease. Any concomitant treatment with other calcium-modifying technologies as well as definitive treatment strategies was at the discretion of the operators. Patients with CFA lesions were evaluated for acute angiographic safety and effectiveness outcomes following IVL treatment as determined by an independent angiographic core lab. RESULTS: Common femoral artery treatment was indicated in 177 patients (n=163 could be analyzed based on core-laboratory data) enrolled at 23 sites. Characteristics for 164 treated lesions included moderate-severe calcification 95.1%, diameter stenosis 74.8±17.7%, and lesion length 53.6±53.1 mm. Concomitant calcium-modifying therapy was used in 32.3% of lesions. Final therapy included drug-coated balloons in 68.9% and stenting in 16.5% of lesions. Post-IVL and final residual stenoses were 29.2±16.5%and 23.6±11.5%, respectively. No vascular complications (flow-limiting dissections, perforations, embolization, slow or no reflow, or abrupt closure) were present at the end of the procedure by core-laboratory assessment, with 1 (0.8%) flow-limiting dissection initially occurring immediately following IVL treatment. CONCLUSION: This study represents the largest real-world experience of IVL treatment in heavily calcified CFA lesions. Intravascular lithotripsy treatment showed significant stenosis reduction and favorable periprocedural safety in this challenging patient population. CLINICAL IMPACT: In this study we show that calcified common femoral artery disease can be safely and effectively treated with shockwave balloon angioplasty with high procedural success and low complication rates and in clinical practice can now be offered as an alternative to surgical treatment in those patients reluctant to or high risk for vascular surgery. This opens another option for clinicians to treat calcified common femoral artery disease without the risk of dissection, perforation or distal embolization that are associated with atherectomy. This study shows that shockwave lithoplasty offers an innovative plaque modification technology to tackle calcified disease in the common femoral artery.

Endovascular Treatment and Outcomes for Femoropopliteal In-Stent Restenosis: Insights from the XLPAD Registry.

Background: There is limited "real-world" evidence examining treatment modalities and outcomes in patients with symptomatic peripheral arterial disease undergoing endovascular treatment of femoropopliteal (FP) in-stent restenosis (ISR). Materials and Methods: We compared outcomes in 2,895 patients from the XLPAD registry (NCT01904851) between 2006 and 2019 treated for FP ISR (n = 347) and non-ISR (n = 2,548) lesions. Primary endpoint included major adverse limb events (MALE) at 1 year, a composite of all-cause death, target limb repeat revascularization, or major amputation. Results: ISR patients were more frequently on antiplatelet (94.5% vs 89.4%, p=0.007) and statin (68.9% vs 60.3%, p=0.003) therapies. Lesion length was similar (ISR: 145 ± 99 mm vs. non-ISR: 142 ± 99 mm, p=0.55). Fewer treated ISR lesions were chronic total occlusions (47.3% vs. 53.7%, p=0.02) and severely calcified (22.4% vs. 44.7%, p < 0.001). Atherectomy (63.5% vs. 45.0%, p < 0.001) and drug-coated balloons (DCB; 4.7% vs. 1.7%, p < 0.001) were more frequently used in ISR lesions. The distal embolization rate was higher in ISR lesions (2.4% vs. 0.9%, p=0.02). Repeat revascularization (21.5% vs. 16.7%, p=0.04; Figure) was higher and freedom from MALE at 1 year was significantly lower (87% vs. 92.5%, p < 0.001) in the ISR group. Conclusion: Atherectomy and DCB are more frequently used to treat FP ISR lesions. Patients with FP ISR have more intraprocedural distal embolization, higher repeat revascularization procedures, and lower freedom from MALE at 1 year.

Intravascular Ultrasound Assessment and Correlation With Angiographic Findings of Arterial Dissections Following Auryon Laser Atherectomy and Adjunctive Balloon Angioplasty: Results of the iDissection Auryon Laser Study.

BACKGROUND: Femoropopliteal arterial angiographic dissections with the use of the Auryon laser atherectomy system (previously the B-laser) have been infrequent and non-flow limiting. However, the pattern of these dissections (depth and arc) using intravascular ultrasound remains unknown. MATERIALS AND METHODS: We prospectively enrolled 29 patients in the iDissection Auryon study. The primary objective was to define the occurrence of new adventitial injury with intravascular ultrasound (IVUS). Secondary objectives included distal embolization and bailout stenting as judged by the operator because of 30% or more residual narrowing and/or NHLBI (National Heart, Lung, and Blood Institute) angiographic dissection C and higher. Core laboratory analysis was carried on all cases except for 1 patient (that crossed over to Jetstream atherectomy). Dissections were classified according to the iDissection classification as involving the intima (A), media (B), and adventitia (C) and ≤ 180-° arc (1) or >180-° arc (2). Overall, 22 of 29 patients had an embolic filter (per protocol). RESULTS: Median lesion and treated lengths were 100.0 and 150.0 mm, respectively. Vessel diameter by IVUS was 6.5 ± 1.5 mm. Chronic total occlusion (CTO) was present in 24.1% of cases. The arc of calcium was: no calcium in 27.6%, <90° in 13.8%, 90° to 180° in 20.7%, and >180° in 34.4%. Lesion severity was reduced to a median of 14% post laser and adjunctive percutaneous transluminal angioplasty (PTA) from a baseline of 76%. Bailout stenting occurred in 6 of 28 (21.4%) patients (3 for dissections, 2 for residual >30%, and 1 for both) and primary stenting in 1 of 28 (3.6%). By IVUS, there were 9 new dissections post laser (1 adventitial; 3≥180°) and 21 new dissections post laser and PTA (3 adventitial; 1≥180°). No distal embolization requiring treatment was seen and no macrodebris ≥2 mm was recovered in the filters. CONCLUSION: The Auryon laser atherectomy system had minimal rate of adventitial injury despite complex disease with relatively low bailout stent rate and no clinically significant macrodebris.

JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study.

PURPOSE: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). MATERIALS AND METHODS: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). RESULTS: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. CONCLUSION: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

Education of Self-Radial Pulse Palpation and Atrial Fibrillation Signs and Symptoms.

The purpose of this evidence-based education initiative was to increase A Fib detection in a cardiovascular diseased population in which participants were taught radial pulse palpation and signs/symptoms of A Fib. Participants were evaluated after initial education on performance of radial pulse palpation and teach back of signs/symptoms of the arrhythmia and again at three weeks on adherence to daily self-screening and recall of signs/symptoms of A Fib. Post initial education, 88% of eligible participants learned pulse-palpation and 93% could verbalize at minimum one sign/symptom. After three weeks, 94.7% reported daily self-screening, but only 44.7% could verbalize at minimum one sign/symptom. This indicated that participants were continuing to self-screen, but in need of booster education sessions. Educating individuals on self-screening and signs/symptoms of A Fib is clinically feasible.

Comparative Outcomes of Supera Interwoven Nitinol vs Bare Nitinol Stents for the Treatment of Femoropopliteal Disease: Insights From the XLPAD Registry.

Purpose: To report a propensity score analysis comparing outcomes of the Supera interwoven nitinol stent to bare nitinol stents (BNS) in the femoropopliteal segment. Materials and Methods: A retrospective study was conducted utilizing data extracted from the Excellence in Peripheral Artery Disease (XLPAD) registry (ClinicalTrials.gov identifier NCT01904851) on 871 patients (mean age 65.1 years; 713 men) who underwent femoropopliteal balloon angioplasty with either Supera stent implantation in 118 limbs or other contemporary BNS in 753 limbs between January 2006 and December 2016. All patients in both groups were matched for baseline demographic and clinical characteristics in a 1:1 propensity score matching using the nearest neighbor method to create the 118-patient matched BNS cohort. One-year outcomes included all-cause mortality, target vessel revascularization (TVR), and target limb revascularization (TLR). An additional core laboratory analysis was conducted to measure the deployed length of Supera stents. Results: In unmatched data, the Supera stent group had a numerically lower rate of TVR (7.6% vs 13.4%, p=0.08) and a significantly lower 1-year TLR rate (7.6% vs 16.2%, p=0.02) compared to the BNS group. Both groups had similar 1-year mortality (2.5% vs 2.7%, p=0.9). Kaplan-Meier analysis demonstrated that the Supera group had a significantly lower risk of TVR (p=0.02) and TLR (p=0.002) than the BNS group. After propensity matching, the 1-year TVR estimate was lower for Supera stents (7.6% vs 12.7%, p=0.08) and significantly lower for TLR (7.6% vs 13.6%, p=0.04) than the BNS group. There was no statistically significant association between Supera stent elongation (>10% of the labeled stent length) and 1-year risk of TLR (p=0.6). Conclusion: Supera stent usage in femoropopliteal intervention was associated with reduced risk of 1-year repeat target limb revascularization compared with BNS treatment in both unmatched and matched cohorts.

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

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.

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry.

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.