From the SIR Residents and Fellows Section (RFS)

Teaching Topic: Transradial Approach for Noncoronary Interventions: A Single-Center Review of Safety and Feasibility in the First 1,500 Cases

Posham R, Biederman DM, Patel RS, Kim E, Tabori NE, Nowakowski FS, Lookstein RA, Fischman AM. J Vasc Interv Radiol 2016; 27:159-66.

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Transradial access (TRA) is an increasingly common method of performing percutaneous intravascular interventions. Although the interventional cardiology literature has described the benefits of TRA in large prospective studies, the data for TRA in noncoronary interventions is sparse. In this study, a retrospective analysis was performed on 946 patients for 1,531 consecutive procedures using transradial access for noncoronary interventions. Exclusion criteria included sheath sizes >6Fr, Barbeau D waveform, radial artery <2mm, known severe aortic tortuosity, dialysis, and radial artery occlusion. Reported results included success rates of 98.2% with minor and major complication rates of 2.38% and 0.13%, respectively. Endoleak repair and renal/visceral intervention were the only significant predictors of cross over to transfemoral access (TFA). Limitations were stated to be non-randomization of the population, operator proficiency bias, and subclinical complications.

Clinical Pearls

What is the Barbeau classification of pulse waveform and how is it used in selecting eligible patients for TRA?

Radial access is a theoretically feasible approach due to the vascular anatomy of the hand. The hand is supplied by both the ulnar and radial artery. There is collateral flow between arteries via the deep and superficial arches as well as the interosseous collaterals. The Barbeau classification of pulse wave forms is an objective test (adaption of the modified Allen test), which indirectly assess the integrity of the collateral circulation between both arteries. To perform this test, a pulse oximetry device is placed on the thumb and the morphology of a plethysmography tracing is noted. The examiner subsequently occludes the radial artery and observes the waveform over a two minute period (see Figure 1 of article).

· A type A response does not demonstrate a change in the waveform (uninterrupted arterial filling) after occlusion.

· A type B response does not demonstrate interrupted arterial filling, however, there is decreased amplitude of the waveform with adaption and restoration of the previous (unconcluded) waveform by two minutes.

· A type C response demonstrates interrupted arterial filling (cessation of pulsatile waveform) with subsequent delayed appearance of a pulsatile waveform. This is thought to be secondary to recruitment of collaterals.

· A type D response demonstrates interrupted arterial filling, however, there is no restoration of visualized pulsatile collateral flow at two minutes.

What is the standard radial access technique?

Topical nitroglycerine and lidocaine are applied to the wrist 30 minutes prior to cannulation. Preferentially, the left wrist is cannulated. A wrist towel roll is places beneath the wrist to allow for adequate hyperextension. Patient can be positioned prone or supine. Pulse oximeter is applied to the ipsilateral thumb or index finger. After radial access is obtained, a hydrophilic sheath is placed (4-7Fr with preference for smaller sheaths). Catheter lengths of 110 cm with standard 0.035-in access wire are used for engaging the mesenteric vessels. Microcatheters are typically 150 cm. Nonocclusive hemostasis is utilized to decrease risk of radial artery occlusion at the conclusion of the procedure.

Questions to Consider

What are the proposed benefits of TRA versus TFA?

The RIFLE study demonstrated a decrease in access site-related bleeding, net adverse events (in PCI), and decreased length of hospital stays. The RIVAL study, a multicenter prospective randomized controlled trial, showed a decrease in major vascular complications in the TRA arm. TRA also provides for easier hemostasis, the option of earlier ambulation, and increased reported patient satisfaction. Finally, TRA has also been shown in one study to be overall more cost effective.

What complications should be specifically mentioned in the consent process when considering TRA?

Radial artery occlusion (RAO) is a known complication of TRA thought to be secondary to intimal disruption which is reversible and asymptomatic in most subjects. Symptomatic RAO has been reported at 0.2% with digital ischemia being a severe presentation of such. The radial artery is also subject to spasm. The risk of cerebrovascular infection is theoretically increased (although debated) due to proximity to the vertebral artery and necessary aortic arch manipulation. However, this is mediated by preferentially cannulating the left wrist to decrease arch manipulation. Other complications include hematoma, pain, pseudoaneurysm, perforation, and dissection which are also risks of TFA.

Additional References:
Kotowycz MA, Dzavík V. Advances in Interventional Cardiology. Circ Cardiovasc Interv. 2012 Feb 1;5(1):127-33.

Fischman AM, Swinburne NC, Patel RS. A Technical Guide Describing the Use of Transradial Access Technique for Endovascular Interventions. Tech Vasc Interv Radiol. 2015 Jun;18(2):58-65

Post Author:
Lindsay Karr Thornton, MD
SIR RFS Clinical Education Chair
University of Florida

5-Year Results of Laser-Assisted Vena Cava Filter Removal

Inferior vena cava (IVC) filters with prolonged implantation are associated with increased risk of filter-related complications. Prolonged dwell time is also associated with an increased risk of the filter embedding in the vessel wall increasing the likelihood of failed retrieval using standard retrieval methods. Kuo et al. recently published their 5-year results of laser-assisted removal of embedded IVC filters in the journal CHEST. A total of 251 patients were enrolled prospectively in the study after failure of standard retrieval methods. Indications for filter retrieval included symptomatic IVC thrombosis, chronic IVC occlusion, pain from filter penetration and/or reduction of risk from prolonged implantation. Success was defined as complete filter detachment and removal. Major procedure-related complications were assessed. Laser-assisted retrieval was successful in 249/251 (99.2%) with a mean dwell time of 979 days (range 37-9098). Less measured force was needed for laser-assisted retrieval compared to failed standard retrieval attempts (3.8 lbs compared to 6.7 lbs). They report a major complication rate of 1.6%. This included 2 patients who developed IVC thrombus during the procedure that was successfully treated with catheter-directed thrombolysis and 2 patients who suffered IVC injury with retroperitoneal hemorrhage and hypotension requiring endovascular stentgraft placement. Retrieval permitted a cessation of anticoagulation in 45/46 (98%) patients. Filter associated morbidity was relieved in 55/57 (96%) patients. Authors conclude the excimer laser-sheath technique is safe and effective for removing embedded IVC filters that have failed standard retrieval attempts.

Commentary

This article reports favorable results for the use of the excimer laser sheath for IVC filter retrieval that has failed standard techniques. The laser sheath is FDA approved for removal of embedded venous pacemaker leads and any use for embedded IVC filters is off-label. Failed laser-assisted retrieval occurred with cylindrical-shaped filters (1 Optease and 1 Trapease) that contained a large amount of chronic thrombus that could not be captured within the sheath. In subsequent cases, authors reduced large amounts of chronic thrombus with a separate atherectomy catheter and/or angioplasty balloon allowing for laser-assisted filter removal. Not included in the major complications were 25 patients that developed a small (<2.5 cm) pseudoaneursym and 3 patients with small focal hemorrhage. All were self-limited or treated with temporary occlusion balloon inflation with resolution on immediate follow-up venography. Pseudoaneurysms larger than 2.5 cm were followed with cross sectional imaging and found to be resolved within 2-3 months. Data for this study was collected over a 5-year time period and authors do admit to a learning curve with laser sheath usage. Prior to routine force gauge use there were 4 cases of laser sheath cracking external to the patient with application of excessive force. Additionally, the major complications reported occurred earlier in their experience. The encouraging overall safety and efficacy, therefore, may not be transferable to early experience.

Click here for abstract

Kuo WT, Odegaard JI, Rosenberg JK, Hofmann LV, Laser-Assisted Removal of Embedded Vena Cava Filters: A 5-Year First-in-Human Study, CHEST (2016), doi: 10.1016/j.chest.2016.09.029.

Post Author:
Jennifer Montgomey, MD, PhD
Assistant Professor
Cleveland Clinic

From the SIR Residents and Fellows Section (RFS)

Teaching Topic: The Influence of Statin Therapy on Restenosis in Patients Undergoing Nitinol Stent Implantation for de Novo Femoropopliteal Artery Disease

Kim W, Gandhi RT, Peña CS, Herrera RE, Schernthaner MB, Acuña JM, Becerra VN, Katzen BT. The Influence of Statin Therapy on Restenosis in Patients Who Underwent Nitinol Stent Implantation for de Novo Femoropopliteal Artery Disease: Two-Year Follow-up at a Single Center. J Vasc Interv Radiol 2016; 27:1494–1501

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Peripheral artery disease (PAD), including femoropopliteal artery disease, has been proposed as a “coronary heart disease risk equivalent” in the National Cholesterol Education Program Adult Treatment Panel III. Patients with femoropopliteal arterial disease are strong candidates for statin therapy. The effect of statin therapy on femoropopliteal arterial disease has received relatively little attention in the literature. This manuscript evaluated 135 limbs in 135 patients in whom nitinol stents were placed in femoropopliteal occlusions and found that the incidence of binary restenosis was significantly lower in the statin group than in the nonstatin group.

Clinical Pearls

What are the TransAtlantic Inter-Society Concensus (TASC) II classifications of femoral popliteal lesions?
The following diagram illustrates the TASC II classification of femoropoliteal disease as described by Norgren et al. in the Journal of Vascular Surgery in January of 2007.



This study aimed for goals of a residual pressure gradient of less than 10 mm Hg, residual stenosis of less than 30%, or no flow-limiting dissection after nitinol stent implantation according to TASC II. 91.1% of lesions treated in this study were TASC II type C or D.


What are the American College of Cardiology and American Heart Association guidelines for intensity of statin therapy?

The “2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults” established algorithms to decide initiation and dosing of statin therapy.  

Click here for the complete report

What are the pharmacologic effects of statins?

Statins have potent pleiotropic effects in addition to their lipid-lowering effects, such as reducing inflammatory response and oxidative stress, protecting vascular endothelial function, inhibiting the proliferation and migration of vascular smooth muscle cells, and inhibiting neointimal hyperplasia.

Morning Report Questions

What were the methods to follow-up patients after femoropopliteal revascularization with nitinol stenting?

The authors in this study evaluated patients for follow-up within 30 days of the index procedure, which included an assessment of the patient’s clinical improvement as well as interval ankle-brachial index (ABI) and duplex ultrasound (US) scanning. Follow-up was then conducted every 3–6 months during the first postoperative year and every 6–12 months thereafter. In cases of suspected restenosis based on the clinical evaluation and arterial noninvasive examination, lower-extremity computed tomographic angiography could be performed at the discretion of the operator. The primary endpoint of the study was binary restenosis (angiographic luminal narrowing > 50% in diameter anywhere within the stent or within the 5-mm proximal or distal border of the stent or peak systolic velocity ratio of > 2.54 by duplex US) at 1 year. Secondary endpoints were primary patency at 1 year, binary restenosis at 2 years, and target lesion revascularization (TLR; repeat revascularization of the target lesion secondary to restenosis of more than 50% within the stent or 5 mm proximal or distal to the stent) at 2 years

In the present study, a total of 135 limbs (91.1% TASC II type C or D lesions) of 135 patients were included in the analysis. 91 (67.4%) received statin therapy and 44 (32.6%) did not. Equivalent proportions of patients in each group were treated with aspirin, thienopyridine derivatives, and cilostazol. The total stent implanted length and mean stent diameter did not differ between groups. The mean follow-up duration was 16.9 months. There were significant differences in the incidence of binary restenosis between groups at 1 year (45.5% for the nonstatin group vs 28.6% for the statin group; P = .05) and 2 years. Primary patency rates at 1 year were 50.5% in the nonstatin group and 72.5% in the statin group (P = .01). The 2-year TLR rates were 54.5% in the nonstatin group and 35.2% in the statin group (P = .03). The odds of binary restenosis at 1 year were not affected after adjustment for age, sex, and other cardiovascular risk factors.

What is the mechanism of cilostazol and how might it have confounded the study?

Cilostazol is a phosphodiesterase (PDE) III inhibitor with vasodilator, metabolic, and antiplatelet activity. The TASC II analysis reported benefits of cilostazol over placebo in treadmill performance and quality of life measures with side effects of headache, diarrhea, and palpitations. Because it is a PDE III inhibitor, it should not be given to patients with congestive heart failure. Recent studies have demonstrated that that long-term cilostazol therapy was able to reduce restenosis after endovascular therapy in symptomatic patients with femoropopliteal artery disease. Although the use of cilostazol was statistically equivalent between the two groups in the present study, the rates of binary restenosis and TLR might be affected according to the proportion of patients receiving cilostazol therapy.

How may future studies be affected by increasing statin use?

Some patients in the nonstatin group of this study included those with hypertension, CAD, or a history of percutaneous coronary intervention. It is possible that these and other patients with transient ischemic attack or minimal coronary artery stenosis may have been followed up without the use of statins, even though that is not considered the standard of care. The Reduction of Atherothrombosis for Continued Health Registry showed that the rate of statin use at baseline was only 62.2% in patients with PAD, and one third of the nonstatin group had a history of CAD or cerebrovascular disease. They observed differences in statin use based on physician subspecialty or patient age. The use of statins has become more common, but a high prevalence of statin use among patients with PAD in the future will make it challenging to design clinical studies to evaluate the role of statin therapy as an inhibitor of restenosis after nitinol stent implantation in patients with femoropopliteal artery disease.

Additional Citations:
Norgren et al. Inter-Society Concensus for the Management of Peripheral Arterial Disease (TASC II). Journal of Vascular Surgery. 2007 January; 45(1): S5A-S67A

Stone NJ, Robinson JG, Lichtenstein AH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation 2014; 129(25 Suppl 2):S1–45.

Post Author:
Rajat Chand, MD
Diagnostic Radiology Resident, PGY-2
John H. Stroger Hospital of Cook County

Meta-analysis of Prostate Artery Embolization

There is increasing data on outcomes of prostate artery embolization (PAE) for benign prostatic hyperplasia (BPH), but there remains a need for more robust evaluation of this new intervention. Uflacker et al performed a meta-analysis of available PAE studies, including studies which reported standardized urologic and clinical outcomes, and excluding studies which included redundant cases. Six of 268 studies met these criteria, and were analyzed for primary outcomes of International Prostate Symptom Score (IPSS) and Quality of Life (QoL) score. At 1, 3, 6, and 12-months post PAE, there were significant decreases in both scores from baseline values (p < 0.001); the IPSS scores decreased 12.93, 14.98, 15.00 and 20.39 points and the QoL scores decreased 2.17, 2.18, 2.15, and 2.49 points at the respective times points. Secondary outcomes included changes in prostate volume (PV), post void residual (PVR) and International Index of Erectile Function (IIEF) score. Prostate volumes demonstrated significant progressive decreases from baseline, including 62.0 mL at 1-month (p < 0.004) and 85.5 mL at 12-months (p < 0.001) post PAE. Qmax also demonstrated durable improvement, of 4.7 mL/s at 1-month, and 5.4 mL/s at 12-months post PAE (p < 0.001). There was no significant change in the IIEF score at the various time points, up to 12=months post PAE. Complications were also analyzed from nine studies, which revealed a 32.9% complication rate, nearly all of which were minor complications (216/218). The two major complications were severe urinary tract infection and bladder ischemia.

Commentary

As the authors highlighted in their introduction, there have been numerous challenges to interpreting previous meta-analyses on PAE literature, due to the inclusion of studies with redundant cases. The efforts in this study design to avoid those confounding factors and attain patient-level data, when possible, afforded a cleaner, potentially more valid, evaluation of existing PAE data. The improvements in the primary endpoints of IPSS and QoL as well as secondary endpoints including Qmax seen at up to 12-months after PAE, across the analyzed studies supported the efficacy and durability of PAE, while the exceedingly low rate of major complications also suggested a favorable safety profile. There are numerous limitations to the meta-analysis results, which the authors described in the discussion, including heterogeneity in patient populations and technical approaches between studies, as well as drop-offs in data for the longer post-PAE time points (i.e. 12-month versus 1-month). These factors precluded reliable elucidation of controversial issues including optimal embolic size/agent and unilateral versus bilateral embolization. Outcome comparisons with existing urologic interventions for BPH including transurethral resection of the prostate (TURP) and transurethral holmium laser enucleation (HoLEP) were also not addressed by this meta-analysis. Ongoing and future randomized controlled trials and registries will be essential to provide definitive answers to these questions and delineate the optimal role of PAE in BPH management. Nonetheless, this meta-analysis provides an improved evaluation of currently available evidence on this promising intervention for BPH.

Click here for abstract

Uflacker A, Haskal ZJ, Bilhim T, Patrie J, Huber T, Pisco JM. Meta-Analysis of Prostatic Artery Embolization for Benign Prostatic Hyperplasia. J Vasc Interv Radiol. 2016; 27: 1686-1697.

Post Authors:
Jeffrey Forris Beecham Chick, MD, MPH, DABR
Assistant Professor of Vascular and Interventional Radiology
Vice Quality Assurance and Safety Officer
University of Michigan Health Systems

James X. Chen, MD
Resident in Radiology
Hospital of the University of Pennsylvania