Clinical Outcomes of Additional Below-The-Ankle Intervention Compared to Below-The-Knee Intervention Alone: A Post-Hoc Analysis of a Prospective Multicenter Study.

PURPOSE: To investigate the clinical implication of additional below-the-ankle (BTA) intervention in patients with chronic limb-threatening ischemia (CLTI) undergoing below-the-knee (BTK) intervention. MATERIALS AND METHODS: A sub-analysis was performed using data from the LIBERTY trial (ClinicalTrials.gov identifier NCT01855412), a prospective, observational, core-laboratory adjudicated, multicenter study of endovascular intervention in 1204 patients. Patients with CLTI (Rutherford Classification 4-6) who underwent BTK intervention were included in this sub-analysis. Participants were then stratified into 2 treatment groups according to whether at least one lesion intervened on was BTA (n=66) or not (n=273). The decision on whether and where to intervene was made during the procedure. The main outcome measures included major amputation, target vessel revascularization (TVR), major adverse events (MAE), survival, amputation-free survival, major adverse limb events or peri-operative death (MALE-POD), and all-cause death. Other outcome measures included procedural success, procedural complications, and wound healing rate. RESULTS: There were no differences in procedural success or severe angiographic complications between the 2 groups. At 1-year post-procedure, patients in the BTK group had a higher rate of freedom from major amputation (95.0% vs. 86.9%, respectively; HR: 2.87, 95% CI: 1.17-7.03), a higher rate of freedom from TVR (80.1% vs. 66.9%, respectively; HR: 1.94, 95% CI: 1.14-3.32), a higher rate of freedom from MALE-POD (94.6% vs. 86.9%, respectively; HR: 2.65, 95% CI: 1.10-6.41), and a higher rate of freedom from MAE at both 1 (76.0% vs. 60.1%, respectively; HR: 2.00, 95% CI: 1.24-3.22) and 3 years post procedure (67.5% vs. 55.8%, respectively; HR: 1.69, 95% CI: 1.08-2.65). There was a significantly lower rate of survival in the BTK group at 3 years (74.3% vs. 91.1%, respectively; HR: 0.35, 95% CI: 0.14-0.87). After risk adjustment, there was a higher rate of all-cause death in the BTK group at 3 years (19.4% vs. 9.1%, respectively; p=0.023) post-intervention. CONCLUSION: Patients with disease requiring intervention to BTA lesions have a potential increased amputation rate in the short term, but BTA intervention carries a potential survival benefit in the long term when compared to BTK intervention alone.

Endovascular Treatment of a Popliteal Artery Aneurysm Via Transpedal Approach: A Case Report.

Popliteal artery aneurysm (PAA) has been increasingly treated with endovascular intervention in recent years. However, whether transpedal access can be utilized to treat PAA has not been widely reported. We report a case of successful treatment of a PAA with a covered stent via retrograde transpedal approach in an 80-year male with prohibitive surgical risk who initially failed antegrade approach. This case demonstrates the feasibility of treating PAA via a retrograde transpedal access in selected patients.

Transradial Endovascular Intervention: Results From the Radial accEss for nAvigation to Your CHosen Lesion for Peripheral Vascular Intervention (REACH PVI) Study.

BACKGROUND/PURPOSE: The transradial approach has been proposed as an alternative to traditional transfemoral access for diagnostic and therapeutic purposes in several catheterization procedures. Historically, extended length devices for lower limb endovascular interventions have been limited. The aim of this study was to investigate the acute clinical outcomes of orbital atherectomy (OA) via transradial access (TRA) for the treatment of lower extremity peripheral artery disease (PAD). METHODS/MATERIALS: REACH PVI was a multicenter, prospective, observational study (NCT03943160) including subjects with PAD and target lesion morphology appropriate for OA. All patients were followed post-procedure through the first standard of care follow-up visit. RESULTS: A total of 50 patients were enrolled. In most cases the indication for intervention was disabling claudication (74.0%). Overall, 50 target lesions were treated, 92.0% of lesions were femoropopliteal and 8.0% were infrapopliteal. The average lesion length was 98.3 ± 87.5 mm and 78.0% of the lesions were severely calcified. Balloon angioplasty was performed in 98.0% of target lesions, while a stent was deployed in 16.0%. Treatment success was 98.0%; in only one case the result was sub-optimal (>30% stenosis with stent placement) and a significant dissection was reported. No serious distal embolization, serious thrombus formation or serious acute vessel closure were observed intra- or post-procedurally. CONCLUSIONS: Transradial OA followed by percutaneous transluminal angioplasty for lower extremity PAD is feasible and demonstrates a favorable safety profile. Extended length devices such as the Extended Length Orbital Atherectomy System could further facilitate transradial endovascular procedures by increasing its spectrum of application.

Transpedal approach for femoral-popliteal chronic total occlusions using the outback® elite re-entry device.

BACKGROUND: Transpedal access is increasingly utilized for the treatment of peripheral artery disease (PAD). Femoral-popliteal artery chronic total occlusions (CTOs) are some of the most difficult lesion subsets that sometimes require the use of re-entry support devices during percutaneous intervention. Limited data is available on the use of re-entry devices when treating femoral-popliteal CTOs via transpedal access. The aim of this study was to demonstrate the feasibility of using the Outback® Elite re-entry device for the treatment of femoral-popliteal CTOs via the transpedal approach in an outpatient based lab setting. METHODS: Seventeen patients presented with femoral-popliteal CTOs in which treatment required the use of the Outback® Elite re-entry device. All procedures were performed in a single outpatient based lab. Patients were followed at 1 week and 1 month post-procedure, with lower extremity arterial duplex ultrasound assessment during the 1 month follow-up. RESULTS: The average patient age was 78 years-old, with 71% being males. Most patients presented with Rutherford class IV symptoms. Procedural success was achieved in all patients with no requirement to convert to femoral artery access in any of the cases. No immediate post-procedural complications nor at any time during follow-up were observed. Ultrasonography at 1 month follow-up showed patent intervention sites and access site vessels in all patients. CONCLUSION: The use of the Outback® Elite re-entry device for the treatment of femoral-popliteal CTOs via transpedal access is a feasible option and may have potential benefits by avoiding risks associated with traditional femoral artery access.

Dual alternate access sites for the treatment of an ostial left common iliac artery chronic total occlusion.

Growing endovascular strategies with TASC D lesions in aortoiliac disease reflect increasing technical success with evidenced safety and efficacy. In cases of failed transfemoral access, revascularization of iliac chronic total occlusions has prompted the utilization of other alternate access sites (e.g. transradial and transbrachial approaches) as important options in aortoiliac TASC D lesions. We describe a case of successful revascularization of an occluded ostial left common iliac artery in an 81-year-old man using a dual ulnar and tibioperoneal approach (absent radial artery). A Controlled Antegrade and Retrograde Tracking technique was performed where a balloon was advanced from the peroneal artery into the distal cap of the chronic total occlusion in the proximal common femoral artery. Balloon inflation was performed and a glidewire from transulnar access was advanced and re-entered into the true lumen in the common femoral artery. The wire was then snared and externalized out the transpedal access site creating a continuous true lumen from the ulnar artery to the peroneal artery. To reconstruct the aortic bifurcation, kissing balloon inflations were performed from the peroneal as well as the ulnar artery approaches. A 10 mm × 59 mm balloon expandable stent was placed in the ostial left common iliac artery and a 8 mm × 60 mm self-expanding stent was placed in the left external iliac artery successfully.

Delayed Presentation of a Large Pseudoaneurysm in the Common Femoral Artery After an Electrophysiology Study.

We describe a rare case of an exceptionally large pseudoaneurysm that developed in the right common femoral artery 6 months after an electrophysiological study. Surgical and other conventional methods to treat his pseudoaneurysm were not feasible. Therefore, the pseudoaneurysm was successfully treated via an endovascular approach with a covered stent. (Level of Difficulty: Beginner.).

Development and treatment of two distinct pseudoaneurysms following transradial coronary catheterization in a patient with high bleeding risk: a case report.

BACKGROUND: A pseudoaneurysm is a rare but serious complication after transradial coronary catheterization. Although different treatment modalities have been proposed to treat post-catheterization pseudoaneurysm, only limited data are available to guide the treatment approach. CASE PRESENTATION: We report a rare case of two distinct pseudoaneurysms complicating transradial percutaneous coronary intervention in a 75-year-old Hispanic woman being treated with dual antiplatelet agents for myocardial infarction and warfarin for atrial fibrillation. The pseudoaneurysms were diagnosed with ultrasound and were successfully treated with a series of Terumo Corporation (TR) band compressions. CONCLUSIONS: This case demonstrates the efficacy of compression therapy in managing post-catheterization radial artery pseudoaneurysm in patients with high bleeding risk.

Treatment of an external iliac artery chronic total occlusion using alternate access sites.

BACKGROUND: With the advent of endovascular techniques, alternate sites such as the pedal and radial arteries can now be accessed when treating peripheral arterial disease to reduce procedural complications, shorten recovery time, and improve patient comfort. However, a paucity of literature exists on the availability of support devices that can be utilized during challenging cases. CASE PRESENTATION: A 70 year-old female patient presented for evaluation of severe lifestyle-limiting left-sided claudication refractory to maximal medical therapy. Angiography revealed a chronic total occlusion of the left external iliac artery, which was treated successfully by percutaneous intervention via a primary transpedal approach and with the assistance of the Outback® Elite re-entry device. The patient was discharged 2 h after the procedure and reported significant symptom improvement at follow-up. CONCLUSION: This case highlights a newly adopted endovascular approach through an alternate access site and illustrates how the Outback® Elite device can be used as an adjunctive tool in the treatment of complex lower-extremity vascular lesions.

Pseudoaneurysm after transpedal arterial access for evaluation and treatment of peripheral arterial disease.

BACKGROUND: There has been an increasing use of transpedal arterial access (TPA) for evaluation and treatment of peripheral arterial disease (PAD) over a transfemoral approach (TFA). TPA, it is expected to be associated with better patient comfort, less recovery time and possibly less access site complications compared to standard TFA. Access site complications and pseudoaneurysm (PSA) associated with the TPA have not been previously reported. OBJECTIVE: Here we report a series of pedal artery PSA related to access site complicating TPA catheterization. METHODS: We studied 1460 patients with symptomatic PAD who underwent 2236 peripheral diagnostic and/or interventional procedures between 06/2014 and 01/2016 via TPA. Hemostasis was achieved using patent hemostasis technique by a radial artery compression device for 2h. PSA related to the access site were suspected clinically and confirmed with arterial duplex ultrasound. RESULTS: The incidence of PSA related to any access site was 0.002%. In this series all PSA occurred only in the posterior tibial artery, after an interventional procedure. All patients were treated successfully with thrombin injection with no residual complications. CONCLUSIONS: PSA associated with TPA is extremely rare and seems to occur exclusively after posterior tibial artery access. It is easily treatable by thrombin injection.

Transpedal approach for iliac artery stenting: A pilot study.

OBJECTIVE: To demonstrate the safety and feasibility of the transpedal approach as an alternate arterial access site for iliac artery intervention. BACKGROUND: The common femoral artery is the traditional access site for the endovascular treatment of iliac artery stenoses. However, this approach is associated with complication rates as high as 2%, including retroperitoneal bleeding which carries high patient morbidity and mortality. Furthermore, the standard femoral approach is associated with longer recovery times and longer time to ambulation which are important considerations especially when performing procedures in an ambulatory setting. METHODS: Twelve patients were prospectively followed after treatment for symptomatic iliac artery stenosis via transpedal access. Under ultrasound guidance, one of the pedal arteries was visualized and accessed, and stenting of the iliac arteries were performed as per protocol. The patient was monitored immediately post procedure and clinical follow up was performed at one week and one month later. RESULTS: The average age of the patients was 71years old. 58% were male. Most patients had Rutherford class III symptoms. Successful stent placement was achieved in all 12 patients via transpedal access. No conversion to femoral access was required. No complications immediately post procedure nor at any time period during follow up were noted. Lower extremity arterial duplex at one month showed patent stents and patent pedal access site vessels in all patients. CONCLUSION: Transpedal arterial access may be a safe and feasible approach for iliac artery stenting. Given the possible benefits of avoiding femoral artery access, larger studies should be conducted directly comparing the different approaches.

Comparison of TR Band™ and VasoStat™ Hemostasis Devices following Transpedal Catheterization for Lower Extremity Revascularization for Peripheral Arterial Disease.

BACKGROUND: Transpedal access is increasingly utilized for peripheral vascular catheterization. There is a paucity of data on the use of radial hemostasis devices as an alternative to manual compression for achievement of hemostasis after this approach. OBJECTIVE: To compare safety and efficacy of two hemostasis devices following transpedal catheterization for lower extremity revascularization for peripheral arterial disease. METHODS: A consecutive cohort of patients with bilateral Rutherford 2-5 disease who underwent transpedal catheterization for peripheral vascular interventions were retrospectively analyzed. In each patient, retrograde tibial artery access was obtained, a 4 French sheath was placed, and all revascularization was performed via tibial access. In all patients, a TR Band™ (Terumo Medical, n = 215) and/or VasoStat™ (Forge Medical, n = 99) were used to apply puncture site compression, following removal of the tibial sheath until hemostasis was achieved. Safety and efficacy of each device was compared. RESULTS: Puncture site hemostasis was achieved in all patients within 2 hours of sheath removal facilitating early discharge. Two access site pseudoaneurysms occurred within 30 days of revascularization, one of which followed TR Band™ placement and the other following VasoStat™ placement (P = 0.53). Each patient was successfully treated with ultrasound-guided thrombin injection. Loss of access site patency by duplex ultrasound occurred in 2 patients following the TR Band™ and a single patient following the VasoStat™ (P = 1.0). CONCLUSION: Both the TR Band™ and the VasoStat™ were effective in achieving hemostasis following transpedal catheterization with low rates of complications.

Superficial Femoral Artery Intervention by Single Transpedal Arterial Access.

BACKGROUND: Atherosclerotic disease of the superficial femoral artery (SFA) is frequently seen and can be treated with percutaneous interventions, traditionally via femoral artery access. There are limited reports of transpedal artery access for peripheral artery interventions, but none to date describing routine primary transpedal artery approach for SFA stenting. METHODS: In this preliminary study, we report 4 patients who underwent successful endovascular SFA stenting using a single transpedal artery access via a new ultra-low profile 6 Fr sheath (Glidesheath Slender; Terumo Corporation). RESULTS: All patients underwent successful SFA stenting without complication. Procedure time varied from 51 to 72 minutes. The mean contrast amount used was 56 mL; mean fluoroscopy time was 21 minutes; mean radiation dose was 91 mGy. At 1-month follow-up, duplex ultrasonography showed that all pedal arteries had remained patent. CONCLUSIONS: Transpedal artery approach as a primary approach to SFA stenting appears feasible and safe. Comparative trials with standard percutaneous femoral approach are warranted.

Safety and Feasibility of the Coronary Orbital Atherectomy System via the Transradial Approach.

Technological innovations have enabled higher success rates with percutaneous coronary intervention (PCI) of complex coronary lesions via the transradial approach. The orbital atherectomy system (OAS; Cardiovascular Systems, Inc) is the most recent innovation that abrades plaque using a rotation device for the facilitation of stent placement in heavily calcified lesions. Fifty patients with classic anginal symptoms and an abnormal stress test demonstrating ischemia underwent PCI using the coronary OAS. In all, 46 out of 50 patients received stents in the target lesion after orbital atherectomy. At follow-up, there were no major adverse cardiovascular events, including cardiac death, myocardial infarction, and need for target-vessel revascularization. Radial artery occlusion rate was 6% at 30 days. The use of the OAS via the radial approach may be a safe and feasible option to assist in the treatment of heavily calcified coronary lesions.

Feasibility and Safety of Routine Transpedal Arterial Access for Treatment of Peripheral Artery Disease.

OBJECTIVE: To demonstrate the feasibility and safety of transpedal arterial access for lower-extremity angiography and intervention. BACKGROUND: Traditionally, the femoral artery is chosen for the initial access site in symptomatic peripheral artery disease (PAD), but this approach carries a substantial portion of the entire procedural complication risk. METHODS: 80 patients were prospectively evaluated for the treatment of PAD between May and July 2014. All patients underwent peripheral angiography, and intervention if necessary. A pedal artery was the initial access site for all patients. Under ultrasound guidance, one of the pedal arteries was visualized and accessed, and a 4 Fr Glidesheath was inserted. Retrograde orbital atherectomy and balloon angioplasty were performed with a 4 Fr sheath or upsizing to a 6 Fr Glidesheath Slender (Terumo) for stenting as needed. Clinical and ultrasound assessment of the pedal arteries were performed before the procedure and at 1-month follow-up. RESULTS: Diagnostic transpedal peripheral angiography was performed in all 80 patients. 43 out of 51 patients (84%) who required intervention were successful using a pedal artery as the sole access site. No immediate or delayed access-site complications were detected. Clinical follow-up was achieved in 77 patients (96%) and access artery patency was demonstrated by ultrasound at 1 month in 100% of patients. CONCLUSION: The routine use of a transpedal approach for the treatment of PAD may be feasible and safe. Pedal artery access may also avoid many of the complications associated with the traditional femoral approach, but further study is needed.

Tips and tricks for antegrade recanalization of chronic total occlusions using the CrossBoss catheter.

OBJECTIVES: To provide new strategies and techniques for the successful recanalization of chronic total occlusions (CTOs) with the sole use of the CrossBoss catheter. In addition, some common CTO scenarios are illustrated in detail. BACKGROUND: CTOs are one of the most challenging complex coronary lesion subsets to intervene upon. Even with the innovation of specialized catheters, the success rate of antegrade recanalization remains low. METHODS: Between June and December 2013, a retrospective analysis of 50 consecutive patients who presented with a planned percutaneous intervention (PCI) of a CTO was performed. In all patients, the CrossBoss catheter was used. No additional reentry devices were necessary. Procedural success was defined as <20% residual stenosis and TIMI-3 distal blood flow of the treated vessel at the end of the procedure. RESULTS: The majority of the patients were male (72%), with an average age of 68 years. Thirty percent of patients presented with prior CTO-PCI failure. The average fluoroscopy time was 45.9 minutes and the average amount of contrast use was 273.8 mL. No patient suffered a coronary perforation from the CrossBoss catheter. CONCLUSIONS: With increased experience using the CrossBoss catheter, the antegrade success rate of CTOs can be improved. Some tips include identifying the likely course of the artery with the aid of retrograde injection, proper guidewire selection and manipulation, and redirecting the CrossBoss catheter if there is substantial deviation from the original path.

The utility of extension catheters in transradial percutaneous coronary intervention.

OBJECTIVES: To evaluate the use of extension catheters in transradial intervention of complex coronary lesions. BACKGROUND: Complex percutaneous coronary intervention (PCI) via transradial approach remains a challenge for many interventionalists, primarily due to the difficulty in obtaining adequate guide catheter support. METHODS: A retrospective case series identified 54 patients who presented for PCI of complex coronary lesions. A lesion was defined as complex if it contained severe calcification, proximal tortuosity, chronic total occlusion, or was located distal to a previously implanted stent. After identifying the complex lesions, a conversion to femoral approach was considered, but an attempt via the transradial approach with the use of an extension catheter was chosen as the initial strategy. Specific cases highlighting this approach are illustrated in detail. RESULTS: The average age of the patients was 72 years old, with male predominance (55%). The success rate of completing the transradial intervention with the help of an extension catheter was 96%. Stent delivery failed due to severe tortuosity and calcification in only 2 cases. The coronary artery involved was either the left anterior descending (n = 25), the left circumflex (n = 10), the right coronary artery (n = 14), or a saphenous vein graft (n = 5). There were no coronary dissections evident from use of the extension catheter. CONCLUSION: In the treatment of complex coronary lesions via the transradial approach, the use of an extension catheter may assist in improving successful intervention and decrease the frequency of crossover to a femoral approach.

Mortality in the coronary care unit.

OBJECTIVES: Currently, there are limited data on mortality or predictors of survival for patients admitted to the coronary care unit (CCU). The purpose of this study was to provide data on mortality in the modern-day CCU and to better define factors influencing patient survival. METHODS: A survey was conducted of all patients admitted to CCUs in New York City metropolitan academic hospitals in 2011, followed by a retrospective analysis comparing clinical data from 59 nonsurvivors with those from 897 survivors at two representative institutions. RESULTS: The weighted average mortality in the CCU across all hospitals was 5.6% (range 2.2-9.2%). The average age of the patients admitted to the CCU was 67 years, with 68% being male. Acute coronary syndromes accounted for 57% of all CCU admissions. Survival was worse in patients admitted for cardiac arrest (P=0.000), sepsis (P=0.002), primary respiratory failure (P=0.031), and systolic heart failure (P=0.003). Excluding patients who were made 'do not resuscitate' during their CCU stay, patients receiving treatments such as defibrillation after in-CCU cardiac arrest, right heart invasive monitoring, mechanical ventilation, inotropic support, emergent dialysis, or placement of an intra-aortic balloon pump had higher rates of in-CCU mortality. The most frequent causes of death were intractable cardiogenic shock, brain death, respiratory failure, multiorgan failure, or hypotension. CONCLUSION: This study provides additional mortality information for the modern-day CCU and should help identify factors that may predict survival.

Transulnar catheterization in patients with ipsilateral radial artery occlusion.

BACKGROUND: The transradial approach to percutaneous coronary intervention (PCI) has recently gained popularity among interventionalists. However, radial artery occlusion (RAO) limits the ability for repeat catheterization. In current practice, transulnar catheterization is thought to be a contraindication in patients with ipsilateral RAO. METHODS: Seventeen consecutive patients undergoing transulnar catheterization and PCI were reviewed. Each of the patients had clinical follow-up post-procedure at days 1, 7, and 30. RESULTS: We successfully performed 17 ulnar catheterizations in patients with ipsilateral RAO. All patents were subsequently found to have adequate collaterals from the anterior interosseous branch. One patient developed ulnar artery spasm and another patient developed a forearm hematoma. Overall, no patient suffered any ulnar nerve injury. The ulnar artery was patent both by palpation and by the presence of an adequate plethysmographic signal during follow-up at days 1, 7, and 30. No patients developed with any signs or symptoms of hand ischemia during follow-up. CONCLUSION: In patients with RAO, ipsilateral transulnar catheterization may not be an absolute contraindication. Our results suggest that extensive collaterals from the anterior interosseous artery may be the reason for protection against hand ischemia in the setting of RAO.

Balloon-assisted sheathless transradial intervention (BASTI) using 5 Fr guiding catheters.

BACKGROUND: The sheathless approach to transradial percutaneous coronary intervention (PCI) has recently gained popularity among interventionalists. However, technical problems and lack of approved equipment in the United States has limited its applicability. We describe a new approach, balloon-assisted sheathless transradial intervention (BASTI) that can ease the use of 5 Fr sheathless guiding catheters and decrease complication rates. METHODS: Twenty-seven consecutive patients undergoing staged elective PCI were enrolled. Radial artery access was obtained using the BASTI method - inflation of a compliant coronary balloon at the tip of the guiding catheter was used to ease the transition of the catheter into the skin. The guidewire and coronary balloon were reused during the PCI. Each of the patients had clinical postprocedure follow-up at radial compression device release, and at 1 day, 7 days, and 30 days. Major adverse cardiac events and access-site complications, including radial artery occlusion (RAO), were documented. RESULTS: In this consecutive series, we successfully attempted (27/27) BASTIs. There were no difficulties in obtaining radial artery access with the 5 Fr sheathless guiding catheter. Two patients had balloon rupture during initial radial artery access, but were successfully re-attempted with a higher balloon inflation pressure. All patients then underwent successful coronary intervention. There were no adverse events or procedure-related complications at any time period during follow-up. CONCLUSION: BASTI is a feasible alternative to conventional techniques and may reduce vascular access-site complications and patient morbidity in a cost-effective manner.

A novel technique in the use of fractional flow reserve in coronary artery bifurcation lesions.

The side branch (SB) in bifurcation lesions is a frequently encountered challenge that interventional cardiologists must face. There is great interest in determining fractional flow reserve (FFR) in the SB to help guide treatment decisions; however, difficulty with the pressure guidewire limits its widespread use. We propose a novel technique that will ease the incorporation of FFR in routine evaluation of bifurcation lesions, and allow better assessment of provisional stenting and need for SB intervention. Conventionally, to measure SB FFR, the jailed SB is re-crossed through the stent strut using a pressure wire. Our technique involves the use of a microcatheter and wire exchange within the SB, thereby alleviating some of the technical difficulties associated with the FFR wire. In light of the difficulties and clinical concerns associated with bifurcation lesions, we propose an innovative method to ease the incorporation of FFR to allow better assessment of provisional stenting and need for SB intervention.