Radial access for peripheral vascular intervention: the S.M.A.R.T. RADIANZ Vascular Stent System.

INTRODUCTION: Radial access is the standard of care for nearly all cardiac catheterization procedures. It improves patient satisfaction, reduces the length of stay, and is associated with fewer complications. However, few devices and tools are available for the treatment of peripheral arterial disease via a transradial approach (TRA). The S.M.A.R.T. RADIANZ Vascular Stent System is among the RADIANZ suite of products, which is aimed at expanding the portfolio of devices to treat peripheral arterial disease. AREAS COVERED: In this Expert review, the following areas will be covered: (1) Current Landscape of peripheral vascular intervention (PVI) using TRA (2) Detailed description of the S.M.A.R.T. RADIANZ Vascular Stent System. (3) Ongoing clinical trials to evaluate safety of this approach. (4) Future directions and current regulatory status. EXPERT OPINION: TRA for PVI is a promising approach. It holds the possibility of substantially improving the care of patients with peripheral arterial disease (PAD). Numerous challenges must be overcome to realize the full potential of a radial-to-peripheral (RTP) approach. The length of devices and the small sheath size are the main constraints of this approach. The results of the ongoing RADIANCY trial will demonstrate the safety, in selected patients, of the RADIANZ suite of products.

Systematic review of atherectomy of inguinal arteries for atherosclerotic lesions.

INTRODUCTION: Surgical endarterectomy represents the gold standard for the treatment of atherosclerotic lesions of the groin vessels. Endovascular treatment such as atherectomy with or without drug coated angioplasty (DCA) of the so called no stenting zones, i.e. inguinal and popliteal vessels, is gaining growing acceptance as alternative option to open surgery. This systematic review aims to scrutiny the current clinical evidence regarding atherectomy and DCA for the common artery (CFA). EVIDENCE ACQUISITION: We conducted an exhaustive research in multiple platforms (Medline, PubMed, Cochrane, Google Scholar, Embase) on studies over atherectomy and angioplasty for inguinal atherosclerotic lesions published between 2000 and 2021. As search strategy we used a wide list of MeSH items, words, synonyms. Bibliographies of review articles were checked for further relating studies regarding atherectomy of CFA. A qualitative and quantitative data analysis was carried out. EVIDENCE SYNTHESIS: Fifteen studies were included in the qualitative review. Not all studies were focused only on atherectomy of inguinal vessels, despite including such treatment. Hence, data regarding this treatment were not exhaustive. A fairly homogeneous data analysis was possible in 7 of 15 studies. The remaining 8 studies were qualitatively analyzed but not included in the statistical analysis. In all 7 included studies directional atherectomy and DCA under filter protection were carried out. In this subgroup, overall, 497 patients were treated with atherectomy. Sixty-eight percent of the patients were males. Rutherford class from 1-3 dominated against 4-6 (63% vs. 37%). Mean technical success rate was 96%, with a primary and secondary patency rate of 92% and 98% respectively at one year. Procedure related vascular complications ranged from 1% to 6%. CONCLUSIONS: Current literature about atherectomy for inguinal arteries is scant, data are inhomogeneous and so are treatment modalities. Nevertheless, the results of this systematic review suggest that this endovascular strategy is feasible with good short and midterm results. Prospective trials with larger patient cohorts are necessary to confirm these preliminary results.

Safety and Feasibility of Intravascular Lithotripsy for Treatment of Common Femoral Artery Stenoses.

PURPOSE: To evaluate the safety and feasibility of treating calcified, stenotic common femoral arteries (CFAs) using the Peripheral Intravascular Lithotripsy (IVL) System. METHODS: An analysis was performed of 21 patients (mean age 71.9±10.1 years; 16 men) across 3 sites with calcified CFA stenoses treated with the Peripheral IVL System. The outcomes of interest were the ability to deliver IVL to the target lesion, the increase in acute gain, the reduction in diameter stenosis, the rate of provisional stenting, and angiographically defined complications. RESULTS: Access to the target lesion and delivery of treatment by the IVL catheter were successful in all 21 patients. Post treatment mean diameter stenosis was 21.3%, representing an acute mean lumen gain of 3.1±1.3 mm (range 0.7-5.2). Vascular complications were minimal, with only 5 type B (non-flowing-limiting) dissections reported. The profunda femoris artery was patent in all patients following IVL, and none of the subjects experienced a perforation, distal embolization, thrombus, no reflow, or abrupt closure. CONCLUSION: These early results demonstrate that calcified, stenotic CFA lesions can be safely and successfully treated using the Peripheral IVL System.

Effectiveness of Intra-Arterial Aneurysm Sac Embolization for Type Ia Endoleak after Endovascular Aneurysm Repair.

PURPOSE: To evaluate the effectiveness and durability of intra-arterial aneurysm sac embolization for the treatment of type Ia endoleak after endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: From February 2011 to December 2016, 22 patients underwent embolization of a type Ia endoleak after EVAR. Four patients (18%) were treated during the index EVAR and 18 (82%) in follow-up. Five patients (23%) were treated urgently and 17 (77%) electively. The embolization was performed with the use of liquid embolic agent, coils, and/or plugs. Adjunctive neck procedures were performed in 55% (n = 12) of the patients. The primary endpoint of this study was freedom from sac enlargement. Key secondary endpoints were technical success and freedom from endoleak-related reinterventions. RESULTS: Technical success was 100%. The 30-day mortality was 5% (n = 1; acute coronary syndrome). At a mean follow-up of 15.4 months (range 0.1-65.4) the freedom from sac enlargement rate was 76% (16 out of 21). Reintervention-free survival rates at 6, 12, and 24 months were 80%, 68% and 68%, respectively. CONCLUSIONS: In patients with persistent type Ia endoleak the embolization of the aneurysm sac with or without adjunctive neck procedures can be safely performed, leading to acceptable clinical and radiologic outcomes.

Optical coherence tomography guided directional atherectomy with antirestenotic therapy for femoropopliteal arterial disease.

BACKGROUND: Optical coherence tomography (OCT)-guided directional atherectomy enables a real-time visualization of the arterial wall during plaque debulking and might optimize vessel preparation prior to drug-coated balloon (DCB) angioplasty. Nonetheless there is a paucity of data reporting on the outcomes of OCT-guided directional atherectomy with antirestenotic therapy (DAART). Aim of this study was to evaluate the performance of OCT-guided DAART in the treatment of femoropopliteal atherosclerosis. METHODS: Patients treated by OCT-guided DAART for femoropopliteal occlusive disease between January 2015 and December 2016 were included into this retrospective, single-center, single-arm analysis. The primary measure outcome of this study was primary patency rate (PPR). Secondary outcomes were technical success rate (TSR), secondary patency rate (SPR) and freedom from target lesion revascularization (TLR). RESULTS: Thirty-three patients (N.=33, mean age 67±8 years) and 37 lesions were included into this analysis. The median follow-up time was 15 months (interquartile ratio (IQR): 4-21). The majority of patients presented with lifestyle limiting claudication (N.=25, 75%) and de novo atherosclerotic disease (N.=25, 68%). Median lesion length was 70 mm (IQR: 27-104), while 35% (N.=13) of the lesions were chronic total occlusions. Vessel wall calcification was present in 22% (N.=8) of the treated vessels. The mean luminal gain after atherectomy was 52±17% and the median gain after DAART amounted to 68% (IQR: 58-91). The TSR was 95%. The overall 12 months PPR was 93% whereas the SPR and the freedom from TLR at 12 months were 95% and 100% respectively. A single target vessel perforation (N.=1, 3%) and 2 peripheral embolizations (N.=2, 5%) were observed. The bailout stenting rate was 3% (N.=1) and the final angiography did not reveal any flow limiting dissection. An aneurysmatic degeneration of the target vessel was observed in 2 lesions (5%). CONCLUSIONS: In this study, OCT-guided DAART was associated with sufficient luminal gain, low rates of bailout stenting and perioperative adverse events and led to very promising 12-month outcomes.

Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II.

OBJECTIVE: DISRUPT PAD II was designed to evaluate the safety and performance of intravascular lithotripsy (IVL), a novel approach using pulsatile sonic pressure waves, to modify intimal and medial calcium in stenotic peripheral arteries. BACKGROUND: Vascular calcification restricts vessel expansion, increases the risk of vascular complications, and may impair the effect of anti-proliferative therapy. METHODS: Disrupt PAD II was a non-randomized, multi-center study that enrolled 60 subjects with complex, calcified peripheral arterial stenosis at eight sites. Patients were treated with IVL and followed to 12-months. The primary safety endpoint was major adverse events (MAE) through 30 days. The primary effectiveness endpoint was patency at 12 months as adjudicated by duplex ultrasonography (DUS). Key secondary endpoints included acute procedure success, freedom from re-intervention, and functional outcomes. RESULTS: Between June 2015 and December 2015, subjects with moderate or severe calcified arterial lesions were enrolled. The final residual stenosis was 24.2%, with an average acute gain of 3.0 mm. The 30-day MAE rate was 1.7% with one grade D dissection that resolved following stent placement. Primary patency at 12 months was 54.5%, and clinically driven TLR at 12 months was 20.7%. Optimal IVL technique defined by correct balloon sizing and avoiding therapeutic miss, improved 12-month primary patency and TLR outcomes to 62.9% and 8.6%, respectively. CONCLUSIONS: IVL demonstrated compelling safety with minimal vessel injury, and minimal use of adjunctive stents in a complex, difficult to treat population.

Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Common Femoral Artery Atherosclerotic Disease.

PURPOSE: To report an experience using directional atherectomy (DA) with antirestenotic therapy (DAART) in the form of drug-coated balloon (DCB) angioplasty vs DCB angioplasty alone in common femoral artery (CFA) occlusive lesions. METHODS: A retrospective review was conducted of 47 consecutive patients (mean age 71 years; 26 men) treated between October 2011 and July 2016 using either DCB angioplasty alone (n=26) or DAART (n=21) for CFA lesions. The majority of patients had lifestyle-limiting claudication (14 DCB and 15 DAART). Mean lesion length (39±14 mm DCB and 34±16 mm DAART) and vessel calcification (17/26 DCB and 11/21 DAART) were comparable between the groups. There were 4 chronic total occlusions, all in the DAART group. The main outcome measure was primary patency. Key secondary outcomes were technical success, secondary patency, and freedom from clinically-driven target lesion revascularization (TLR). RESULTS: Technical success rates were 89% following DCB angioplasty and 95% for DAART (p=0.41). The 88% 12-month primary patency and 89% freedom from TLR for DAART were higher than the 68% and 75% estimates following DCB angioplasty alone, but neither difference was statistically significant. However, the secondary patency estimate at 12 months was significantly higher in the DAART group (100% vs 81% for DCB, p=0.03). Bailout stenting (1 DCB vs 1 DAART), vessel perforation (1 DCB vs 0 DAART), access site complications (4 DCB vs 3 DAART), and distal embolization (0 DCB vs 1 DAART) were comparable, whereas DCB angioplasty had more non-flow-limiting dissections (8 vs 1 for DAART, p=0.02). CONCLUSION: Preparation of the atherosclerotic CFA with directional atherectomy was not associated with statistically significantly higher primary patency or freedom from TLR compared to DCB angioplasty alone at 12 months. Nonetheless, both modalities had promising outcomes in a primarily surgically treated vascular territory.

Outcome After Crossing Femoropopliteal Chronic Total Occlusions Based on Optical Coherence Tomography Guidance.

AIMS: The crossing of chronic total occlusions (CTOs) is the key step for an endovascular treatment. The Ocelot system is a novel device that combines a steerable drilling tip with optical coherence tomography (OCT) technology. It provides intraluminal imaging to help the crossing of CTOs in the femoropopliteal segment. Aim of the study was to determine early and midterm results after recanalization with this device. METHODS AND RESULTS: During a period of 16 months, 84 CTOs were treated using the Ocelot system and prospectively registered. The primary end points were technical success and the primary and secondary patency of the lesion. Risk factors associated with early and midterm results were also analyzed. In all, 58 (69.0%) lesions were treated for intermittent claudication, 26 (31.0%) for critical limb ischemia, 34 (40.5%) were classified as Trans-Atlantic Inter-Society Consensus II D lesions, and 22 (26.2%) showed severe calcifications. The technical success rate was 72.6%. During 36 months of follow-up (mean 25.9), there were 10 reinterventions. The primary and secondary patency at 36 months were 54.2% and 68.1%, respectively. CONCLUSIONS: In our experience, the Ocelot system would appear to be a safe and effective tool for increasing the applicability of endovascular techniques. However, the midterm results did not show drastic improvement.

Initial Experience With the 6-F and 8-F Indigo Thrombectomy System for Acute Renovisceral Occlusive Events.

PURPOSE: To examine the safety and effectiveness of the new large-bore Indigo thrombectomy catheters to treat patients with acute renovisceral occlusion without the need of thrombolytic agents. METHODS: Between November 2015 and 2016, 7 consecutive patients (mean age 65±5 years; 5 men) with acute renovisceral artery occlusion were treated with the new large-bore (6-F and 8-F) vacuum-assisted thrombectomy catheters. The occluded vessels were 6 renal arteries and 3 superior mesenteric arteries (SMAs); 5 of the 9 thromboses were in bridging stent-grafts associated with branched endografts. Mean lesion length was 63±36 mm. For the SMA and all bridging stent-grafts, 8-F catheters are routinely used through a brachial access, whereas 6-F aspiration catheters were used in native renal arteries. Technical success was defined as restoration of antegrade blood flow without the need of lysis or alternative thrombectomy/revascularization strategies. Safety endpoints were any in-hospital major adverse events. Pre- and postoperative hemoglobin and hematocrit levels were compared. RESULTS: Technical success was 100% with no major adverse events or fatal bleeding. The mean amount of aspirated blood was 219±97 mL. The mean hemoglobin and hematocrit values were 13.1±2.1 g/dL and 39%±6% prior to and 11.6±2.2 g/dL (p=0.001) and 34%±6% (p<0.0001) directly after the intervention, respectively. CONCLUSION: The first assessment of the new large-bore Indigo thrombectomy catheters showed them to be an effective and safe lysis-free frontline therapy for acute renovisceral artery occlusion in a small cohort of patients. New users should be fully aware of the potential blood loss during aspiration.

Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study.

PURPOSE: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. METHODS: The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. RESULTS: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. CONCLUSION: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.

Endovascular treatment of occluded and stenotic visceral vessels in patients with chronic mesenteric ischemia.

Objective Current evidence in the literature about endovascular treatment (ET) of visceral vessels in patients with chronic mesenterial ischemia (CMI) based on morphological characteristics is limited. The aim of this study was the evaluation of ET in occluded and stenotic visceral vessels. Methods Patients undergoing ET for CMI between November 2000 and November 2012 were included in this retrospective study. Primary measure outcome was the symptom-free survival (SFS). Secondary outcomes were primary (PPR), secondary patency (SPR) rates and technical success rate (TSR). A Cox-regression analysis identified risk factors for the primary and secondary measure outcomes. Results Forty patients were included in the present study (men: 21, mean age: 68). The overall number of vessels with intention-to-treat was 62. Fifty-two visceral arteries (18 occlusions and 34 stenoses) were successfully treated by endovascular means. The overall TSR was 84%. Visceral vessel occlusions and atherosclerotic disease of the superior mesenteric artery (SMA) were identified as independent risk factors for poorer TSR ( p < 0.05). The 12-month SFS was 60%. The overall 12-month PPR and SPR were 71% and 94%, respectively. No significant differences were observed between occluded and stenotic vessels ( p > 0.05) concerning the PPR. On the other hand, the subgroup analysis revealed higher SPR among occluded visceral vessels ( p < 0.001) and coeliac axis lesions ( p < 0.001). Conclusions ET was associated with high incidence of symptoms recurrence despite the satisfying patency rates in both occluded and stenotic vessels. Additionally, visceral vessel occlusion and presence of atherosclerotic lesions in the SMA were associated with poorer TSR.

Directional Atherectomy With Antirestenotic Therapy vs Drug-Coated Balloon Angioplasty Alone for Isolated Popliteal Artery Lesions.

PURPOSE: To report a single-center study comparing drug-coated balloon (DCB) angioplasty vs directional atherectomy with antirestenotic therapy (DAART) for isolated lesions of the popliteal artery. METHODS: Seventy-two patients were treated with either DCB angioplasty alone (n=31) or with DAART (n=41) for isolated popliteal artery stenotic disease between October 2009 and December 2015. The majority of patients presented with lifestyle-limiting claudication (74% vs 86%, respectively). Vessel calcification (29% vs 29%, respectively), mean lesion length (47 vs 42 mm, respectively), and number of runoff vessels were comparable between the groups. The primary outcome measure was primary patency; secondary outcomes were technical success (<30% residual stenosis or bailout stenting), secondary patency, and freedom from clinically driven target lesion revascularization (TLR). RESULTS: The technical success rate following DCB was 84% vs 93% (p=0.24) after DAART. The 12-month primary patency rate was significantly higher in the DAART group (65% vs 82%; hazard ratio 2.64, 95% confidence interval 1.09 to 6.37, p=0.021), while freedom from TLR did not differ between the 2 treatment strategies (82% vs 94%, p=0.072). Secondary patency at 12 months was identical for both groups (96% vs 96%). Although not statistically significant, bailout stenting was more common after DCB angioplasty (16% vs 5% for DAART, p=0.13) and aneurysmal degeneration of the popliteal artery was seen more often after DAART (7% vs 0% for DCB alone, p=0.25). Popliteal artery injury was observed in 2 patients treated using DAART (5% vs 0% for DCB alone, p=0.5), whereas distal embolization rates were comparable between the groups (3% for DCB alone vs 5% for DAART, p=0.99). CONCLUSION: In this study, the use of DAART was associated with a higher primary patency rate compared with DCB angioplasty for isolated popliteal lesions. Nonetheless, both treatment options were associated with excellent 12-month secondary patency. Aneurysmal degeneration of the popliteal artery and increased bailout stenting could compromise the outcomes of DAART and DCB, respectively.

Results of primary stent therapy for femoropopliteal peripheral arterial disease at 7 years.

OBJECTIVE: Primary stenting is a well-established treatment option for femoropopliteal arterial disease. However, there is a paucity of data concerning the performance of this modality at ≥5 years. This study evaluated the long-term clinical and radiologic outcomes of primary stent therapy in patients with femoropopliteal arterial disease. METHODS: A prospective data collection and analysis was conducted in patients undergoing primary stent placement in femoropopliteal lesions between September 2006 and September 2007. The EverFlex (Medtronic/Covidien, Plymouth, Minn) bare-metal stent was used. The primary outcome of this study was the primary patency rate. Secondary outcomes were secondary patency rate, amputation-free-survival (AFS), and freedom from target lesion revascularization (TLR). A Cox regression analysis identified risk factors for the primary and the secondary measure outcomes. RESULTS: Included were 89 patients (102 stents). The prevalence of critical limb ischemia was 34% (n = 30). The initial angiography revealed a TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D lesion in 31 patients (35%). Occlusions were present in 49 patients (55%), and the mean lesion length was 116 ± 33 mm. Popliteal artery disease was present in 39 treated limbs (35%). The primary patency rate at 1, 3, 5, and 7 years was 73%, 64%, 47%, and 33% respectively. At 7 years, secondary patency rate was 67%, freedom from TLR was 47%, and the AFS was 73%. Cox regression analysis revealed a decreased AFS among diabetic patients (hazard ratio [HR], 2.6; 95% confidence interval [CI], 1.08-6.28; P = .03), whereas secondary endovascular interventions showed a protective effect for AFS (HR, 0.14; 95% CI, 0.03-0.65; P = .01). Popliteal artery disease was identified as independent risk factor for secondary interventions (HR, 2.07; 95% CI, 1.05-4.06; P = .04) and TLR (HR, 1.99; 95% CI, 1.03-3.83; P = .04). Critical limb ischemia was associated with an increased incidence of surgical conversion owing to endovascular treatment failure (HR, 5.46; 95% CI, 2.44-12.17; P < .001). CONCLUSIONS: This study found primary stenting was associated with acceptable clinical and radiologic long-term outcomes. Diabetes was associated with poor AFS, and popliteal artery involvement correlated with an increased need for reinterventions. AFS was better among patients undergoing secondary procedures.

Efficacy and Safety of Transbrachial Access for Iliac Endovascular Interventions.

PURPOSE: To evaluate the use of a brachial artery access for endovascular treatment of iliac artery disease. METHODS: A retrospective review was conducted of 201 patients (mean age 73 years; 147 men) treated via a brachial artery access for iliac artery stenosis. The majority (n=141, 70%) presented with lifestyle-limiting claudication (Rutherford category 3), whereas the incidence of critical limb ischemia (Rutherford categories 4-6) was 30% (n=70). Diagnostic angiography revealed a TransAtlantic Inter-Society Consensus II (TASC) C/D lesion in 114 (57%) patients. The primary outcome was technical success achieved exclusively with a brachial artery access. Secondary outcomes were secondary technical success (adjunctive transfemoral access), access site complications, and stroke/transient ischemic attack (TIA). RESULTS: In 17 (8%) patients, lesion crossing was unsuccessful, while an adjunctive transfemoral approach was necessary to restore iliac vessel patency in 23 (11%) cases. Thus, the primary and secondary technical success rates were 81% and 92%, respectively. Local hematomas (9, 4%) dominated the access site complications, followed by pseudoaneurysms (8, 4%), late brachial artery bleeding (4, 2%), brachial artery occlusion (2, 1%), and puncture site infection (2, 1%). No transient or permanent median nerve dysfunction was observed. The stroke/TIA rate was 2% (n=4). A single patient died due to acute coronary syndrome (0.5% mortality). TASC II class (p=0.58), sex (p=0.66), and target vessel (p>0.3 for all locations) had no effect on technical success. Female gender unfavorably influenced the incidence of access site complications (hazard ratio 6.7, 95% confidence interval 2.7 to 15, p<0.001), but sheath size did not (p=0.22). CONCLUSION: Brachial artery access enables endovascular treatment of iliac artery disease in the majority of patients, although an adjunctive transfemoral access may be required. However, the high incidences of access site complications and cerebral events remain a significant limitation of the transbrachial approach.

Validation of the Wound, Ischemia, foot Infection (WIfI) classification system in nondiabetic patients treated by endovascular means for critical limb ischemia.

BACKGROUND: The Society for Vascular Surgery Lower Extremity Guidelines Committee developed the Wound, Ischemia, foot Infection (WIfI) a classification system to predict the amputation risk in patients with critical limb ischemia (CLI). A number of published studies have already evaluated its prognostic value. However, most of the included patients were diabetic, and the validation was done independent of the revascularization procedure. This single-center study evaluated the prognostic value of WIfI stages in nondiabetic patients treated by endovascular means. METHODS: A retrospective analysis was performed of prospectively collected data of nondiabetic patients treated by endovascular means between January 2013 and September 2014. All patients were classified according to their wound status, ischemia index, and extent of foot infection to four classes: very low risk, low risk, moderate risk, and high risk. Comorbidities and vascular lesions for each group were analyzed. The prognostic value of WIfI was analyzed based on the amputation-free survival, overall survival rate, and freedom from amputation at 12 months. RESULTS: Data from 302 CLI patients treated in the study period were reviewed. A total of 219 patients (73%) underwent an endovascular intervention, and among them, 126 nondiabetic patients (58%) were enrolled in this study. Most patients were classified as low risk (33%), and the prevalence of very low-risk, moderate-risk, and very high-risk patients was 23%, 23%, and 21%, respectively. The modified Edifoligide for the Prevention of Infrainguinal Vein Graft Failure (PREVENT III) score was statistically significantly higher in the high-risk group (5.2 ± 2.4) than in the very low-risk, low-risk, and moderate-risk groups (4.3 ± 2.5, 3.5 ± 2.3, 4.5 ± 2.2, respectively; P = .048). One major amputation (1%) was performed during the hospital stay in a high-risk patient. Mean follow-up was 14 ± 8 months. The amputation-free survival at 12 months was 87%, 81%, 81%, and 62%, in the very low-risk, low-risk, moderate risk, and very high-risk groups, respectively (P = .106). The difference was statistically significant between the very low-risk and high-risk groups (hazard ratio, 3.4; 95% confidence interval, 1.1-10.3; P = .029). A similar trend was also observed for 1-year survival between the very low-risk and the high-risk groups (87%, 84%, 81%, 65%; P = .166). The amputation rate during the follow-up time was 0%, 2% (n = 6), 3% (n = 5), and 12% (n = 9) for the very low-risk, low-risk, moderate-risk, and very high-risk groups, respectively (P = .033). CONCLUSIONS: The WIfI classification system predicted the amputation risk and survival in this highly selected group of nondiabetic CLI patients treated by endovascular means, with a statistically significant difference between very low-risk and high-risk patients already at 1 year.

Combined Directional Atherectomy and Drug-Eluting Balloon Angioplasty for Isolated Popliteal Artery Lesions in Patients With Peripheral Artery Disease.

PURPOSE: To evaluate the midterm results of combined directional atherectomy (DA) and drug-eluting balloon (DEB) angioplasty for atherosclerotic lesions of the popliteal artery. METHODS: In a single-arm, prospective study, 21 patients (mean age 63±16 years; 16 men) with isolated popliteal artery lesions were enrolled and underwent treatment with combined DA and DEB angioplasty under filter protection between October 2009 and February 2014. The majority (18, 86%) presented with lifestyle-limiting intermittent claudication and 3 with critical limb ischemia. Fifteen (71%) target sites were de novo lesions; 4 were occlusions. The main outcome was primary patency; secondary outcomes were technical success, secondary patency, and early and midterm morbidity and mortality. RESULTS: The TurboHawk atherectomy device was used in 15 (71%) patients and the SilverHawk peripheral plaque excision system in the remaining 6 patients. The In.Pact Admiral/Pacific DEB was used in the majority of cases (15, 71%). The technical success rate was 90% (n=19). One flow-limiting dissection was treated with bailout stenting. Complications included a perforation of the popliteal artery and 2 puncture site hematomas; there was no distal embolic event. The mean follow-up was 18±12 months. Two restenoses were retreated successfully. Kaplan-Meier estimates of primary patency at 12 and 18 months were 95% and 90%, respectively; the secondary patency was 100%. One (5%) patient died in follow-up. None of the patients had an amputation. CONCLUSION: In this prospective single-arm study, the combined therapy of DA and DEB angioplasty for popliteal artery lesions showed promising midterm performance. The combination of DA and DEB may, in highly selected patients, overcome the challenges presented by the mobility of the knee joint.

Use of parallel grafts to save failed prior endovascular aortic aneurysm repair and type Ia endoleaks.

OBJECTIVE: The aim of this study was the evaluation of the clinical and radiologic outcomes of parallel grafts in the treatment of patients with failed prior endovascular aneurysm repair and type Ia endoleak. METHODS: Prospectively collected clinical and radiologic data of consecutive patients with prior endovascular aneurysm repair and evidence of type Ia endoleak were analyzed. All patients were treated between January 2009 and November 2014 by use of parallel grafts, ie, chimney/snorkel or periscope grafts and abdominal endovascular devices. Primary outcome of the study was the technical success. Secondary outcomes were patency of the chimney grafts and shrinkage of aneurysm morphology. RESULTS: Technical success was 94.4% (17 of 18). One patient showed evidence of persistent type Ia endoleak after triple chimney graft placement and treated by Onyx embolization (Covidien, Plymouth, Minn) successfully. The mean preoperative and postoperative aneurysm diameters were 7.1 ± 1.7 and 7.0 ± 2 cm. Primary patency of the chimney grafts was 96.7% and assisted patency was 100% after successful retrograde recanalization of an acute occlusion of the superior mesenteric artery from the celiac trunk and the gastroduodenal artery. One patient who had undergone the sandwich technique with transfemoral placement of the flexible Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) due to impossible catheterization of the target vessel from the upper extremity presented with contained rupture caused by gutter-associated endoleak and underwent urgent embolization with Onyx successfully. No procedure-related death or open conversion was observed in the entire follow-up period. CONCLUSIONS: Use of parallel grafts showed midterm safety and feasibility with low incidence of persistent endoleaks requiring intervention or progression of aneurysm diameter. Reproducible results from other vascular centers will establish the chimney technique in the treatment of type I endoleaks as a viable endovascular modality.

Twelve-month results of the rapid renal sympathetic denervation for resistant hypertension using the OneShotTM ablation system (RAPID) study.

AIMS: Renal denervation has emerged as a treatment option for patients with drug-resistant hypertension. This study was designed to assess the safety and effectiveness of the OneShotª Renal Denervation System. METHODS AND RESULTS: RAPID is a prospective, multicentre, single-arm study which enrolled 50 patients at 11 clinical sites in Europe and New Zealand. Eligible patients had an office systolic blood pressure (SBP) ≥160 mmHg and were on a stable regimen of ≥3 antihypertensive medications including a diuretic. The primary safety endpoints were acute procedural safety at discharge and chronic procedural safety at six months. The primary effectiveness endpoint was the rate of office SBP reduction ≥10 mmHg at six months compared to baseline. While not a predefined endpoint, change in 24-hour ambulatory BP was evaluated. The mean baseline office SBP and diastolic BP measurements were 181.6±20.8 and 95.5±15.5 mmHg, respectively. Patients were on a mean of 5.1 antihypertensive medications at baseline. The mean office BP decreased by -20/-8 mmHg (p<0.0001/p=0.0002), and -22/-8 mmHg (p<0.0001/p=0.0014), from baseline to six and 12 months, respectively. The 24-hour ABPM was also significantly reduced by -11/-6 mmHg at six months compared to baseline (p=0.0085/p=0.037). There were no serious adverse events (SAE) at discharge related to groin and vascular access complication or renal artery injury or SAE/adverse device effects at six months. CONCLUSIONS: The results of the RAPID study demonstrate safe delivery of RF energy by the OneShot Renal Denervation System for renal sympathetic denervation and sustained efficacy, as evidenced by a significant reduction in office and 24-hour ABPM for six months, which was sustained up to 12 months. ClinicalTrials.gov Identifier: NCT01520506.

Use of iliac branch devices for endovascular repair of aneurysmal distal seal zones after EVAR.

PURPOSE: To assess the feasibility and midterm outcomes of iliac branch devices (IBD) for the treatment of aneurysmal distal seal zones after endovascular aneurysm repair (EVAR). METHODS: Between January 2005 and January 2014, 188 patients with aortic aneurysms involving the iliac bifurcation underwent IBD implantation; of these, 18 consecutive patients (17 men; mean age 70±10 years) were treated for aneurysmal degeneration of 22 distal seal zones (mean 36±6-mm diameter) after EVAR. The main outcome measure was technical success. Further outcomes were primary and assisted primary patency of the internal iliac branch, types Ib/III endoleaks, reintervention, and all-cause mortality. RESULTS: The technical success rate was 100%. The primary patency rate was 100% over a median follow-up of 15 months (interquartile range 4-25). None of the patients developed type Ib or III endoleak. During surveillance, two device-related reinterventions were performed (thrombectomy of an occluded external iliac artery and angioplasty with stenting of a stenotic common iliac artery). One patient died due to metastatic prostate cancer. CONCLUSION: Iliac side branch endografting showed excellent feasibility and encouraging midterm outcomes for the challenging endovascular repair of aneurysmal distal seal zones post EVAR.

Final results of the Chronic Total Occlusion Crossing With the Ocelot System II (CONNECT II) study.

PURPOSE: To evaluate the safety and effectiveness of the optical coherence tomography-guided Ocelot catheter to cross femoropopliteal chronic total occlusions (CTOs). METHODS: The CONNECT II study was a prospective, multicenter, non-randomized single-arm study of the safety and effectiveness of the Ocelot catheter in CTO crossing. Key inclusion criteria were a 99% to 100% stenosed femoropopliteal segment, lesion length between 1 and 30 cm, and resistance to guidewire crossing. The main exclusion criterion was a severely calcified target vessel. The primary safety endpoint was 30-day major adverse events (MAE), while the primary effectiveness endpoint was successful CTO crossing (i.e., guidewire placement in the distal true lumen) with the Ocelot catheter. Endpoint analysis was based on pre-specified objective performance criteria. Between February and June 2012, 100 patients (55 men; mean age 69 years) were enrolled. Most of the CTOs (94%) were in the superficial femoral artery (SFA); mean lesion length was 16.6±9.3 cm. RESULTS: Through 30 days, 2 patients experienced MAE (significant perforations) related to the Ocelot catheter. The Ocelot catheter successfully crossed 97% of target CTOs either alone (72%), in conjunction with an assist device (18%), or in conjunction with a re-entry device (7%). Both primary safety and effectiveness endpoints were met. CONCLUSION: The Ocelot catheter with optical coherence tomography guidance offers physicians a reliable option for crossing femoral and popliteal chronic total occlusions with low MAE rates.