Catheterization and Cardiovascular Interventions

Transcription

1 Recanalization of Popliteal and Infrapopliteal Chronic Total Occlusions using Viance and CrossBoss Crossing Catheters: a Multicenter Experience from the XLPAD Registry Journal: Manuscript ID: CCI--0 Wiley - Manuscript type: Original Studies Keywords: LIC - Limb Ischemia, Critical, PAD - Peripheral Arterial Disease, SEND - Surgery, Endovascular

2 Page of Recanalization of Popliteal and Infrapopliteal Chronic Total Occlusions using Viance and CrossBoss Crossing Catheters: a Multicenter Experience from the XLPAD Registry Salil Sethi, Atif Mohammad, S. Hinan Ahmed,Samir Germanwala, Rahul Thomas, Omar Hadidi, Karan Sarode, Carolina Ortiz-Lopez, Nicolas W Shammas, Anna Sanchez, Robert N. Bertoldo, Subhash Banerjee, and Anand Prasad University of Texas Health Science Center, San Antonio, TX, VA North Texas Health Care System, Dallas, TX, Longview Regional Medical Center, Longview, TX, Midwest Cardiovascular Research Foundation, Genesis Heart Institute, Davenport, IA Word Count:, Corresponding author: Anand Prasad, MD, FACC, FSCAI University of Texas Health Science Center San Antonio Department of Medicine, Division of Cardiology 0 Floyd Curl Drive San Antonio, Texas -00 anandprasadmd@gmail.com Brief title: Viance crossing catheter use in popliteal and infrapopliteal CTO. Keywords: Chronic total occlusion, Viance crossing catheter, peripheral arterial disease

3 Page of Abstract Background: Chronic total occlusions (CTOs) are reported in up to 0% of patients with symptomatic peripheral arterial disease. The Viance Crossing catheter (Covidien, Mansfield, MA) and the CrossBoss (Boston Scientific, Natick, MA) are novel devices, which facilitates either true lumen or subintimal navigation across CTOs. The purpose of this study was to examine the acute procedural success of these devices for below the knee (BTK) CTOs. Methods: Clinical and procedural outcome data between Sept 0 and October 0 was analyzed from the ongoing multicenter XLPAD registry. Technical success was defined as true lumen passage of the catheter while procedural success was defined as successful vessel revascularization inclusive of subintimal recanalization. Results: patients underwent procedures in which lesions were treated with the Viance and CrossBoss catheters. Mean age of the group was. ±. years and patients were males (0%). All patients (0%) had hypertension, diabetes was present in % and % were active smokers. % of the cases were performed for CLI with mean Rutherford class of. for the entire cohort. Target CTOs included anterior tibial, posterior tibial, peroneal, tibioperoneal trunk, and popliteal artery lesions. Mean lesion length was ± mm; lesions (%) were extensively calcified. True lumen passage was obtained in lesions (% technical success). Subintimal entry was achieved in lesions (%). Procedural success was achieved in lesions (0%). Procedural failure was related to longer lesion length (mean length of failed lesion ± mm, P<0.00). Conclusions: The Viance/Crossboss catheters were associated with an overall 0% procedural success with true lumen crossing in a BTK CTO cohort. CTO length remains an important determinant of device success.

4 Page of Introduction Due in large part to the rising prevalence of diabetes and peripheral arterial disease (PAD) in the United States, critical limb ischemia (CLI) is a growing epidemic. Approximately 00,000 non-traumatic amputations are performed annually in US with substantial morbidity and mortality(). Endovascular therapy is a key component in the management of CLI patients. With advances in equipment and techniques, non-surgical therapies are often the first choice for treatment of below the knee (BTK) atherosclerotic disease. The anatomical challenges associated with BTK disease treatment include the frequent presence of vascular calcification, a high prevalence of chronic total occlusions (CTOs), and diffuse atherosclerosis. CTOs in particular are present in as many as 0% of patients presenting with CLI. The presence of a CTO has been associated with a lower procedural success with endovascular therapy as well as increased procedural times, radiation dose, and contrast load. () Failure to cross the occlusion is the primary method of failure in the majority of unsuccessful cases. () The use of a wire coupled with a support catheter has been documented to cross infrainguinal CTOs in 0-0% of cases (). With the advent of subintimal passage and re-entry with hydrophilic guidewires, the success rates has increased to over 0% - though this statistic is largely limited to above the knee occlusions. (,) Success rates for smaller caliber infrapopliteal vessels are lower with treatment failure in about % cases. () Subintimal tracking and re-entry remain challenging in BTK arteries. These factors are the rationale for developing novel peripheral CTO crossing catheters. We present a multicenter experience with the Viance and CrossBoss crossing catheters - novel CTO crossing devices when used for popliteal and BTK lesions. Our aim was to define the variables which are associated with acute procedural success for CTO revascularization in this context.

5 Page of Methods Clinical and Procedural Data Clinical and procedural outcome data on Viance and CrossBoss catheter use between Sept 0 and October 0 was analyzed from the ongoing multicenter XLPAD registry.() The Viance catheter is a stainless steel hydrophilic tipped 0.0 wire compatible catheter with a cm working length. The CrossBoss catheter is a similar catheter indicated for coronary CTO revascularization and has a cm working length otherwise both catheters function identically. The Viance catheter is labeled for a PAD revascularization indication, while the use of the CrossBoss catheter in this context is off-label. Chart review was performed, to collect demographical, clinical and procedural information on popliteal and below the knee peripheral CTO lesions when the Viance or Crossboss catheter was used either as an initial crossing strategy or following failed guidewire and crossing catheter technique. Procedural information was collected after reviewing the peripheral angiograms and procedural notes by an experienced individual blinded to the clinical details. CTO length, degree of calcification, choice of anticoagulation, access site and catheter Fr size were noted. CTO length was defined as the distance between the proximal and distal caps on angiography. Intraprocedural complications (flow limiting dissections, perforations, distal embolization) and acute post-procedural complications (bleeding) were recorded. Data on the use and success of re-entry devices either with the Outback catheter (Cordis, Bridgewater NJ) or Enteer Re-entry System (Covidien, Mansfield, MA) was noted. The Enteer system is a 0.0 or 0.0 compatible self-orienting flat balloon tipped catheter, which allows direction of a stiff tipped wire to gain access to the true lumen from the subintimal space and subsequent passage of a workhorse wire into the target vessel.

6 Page of A single CTO was defined based on the presence of a single occlusion or multiple sequential occlusions separated by cm in the popliteal arteries and a single occlusion or sequential occlusion separated by cm with a patent distal runoff in the BTK vessels. Vascular calcification was classified as none, mild, moderate and severe or extensive based on the presence of either an isolated focus of calcification (mild), a contiguous segments of calcification on one or alternating sides of the vessel (moderate) or contiguous calcification on both sides of the vessel (severe) visible on angiographic views prior to contrast injection. The presence of collaterals at the proximal and distal ends of the CTO was assessed in a semi-quantitative method (none, poorly developed, or well developed). The presence or absence of a clearly visible distal target reconstituted vessel was also noted. Outcome definitions Technical success was defined as placement of a guidewire beyond the distal CTO cap into the true lumen of the target vessel, confirmed by angiographic contrast injection into the distal vessel. The need for a re-entry device was deemed as technical failure of the primary crossing device. Procedural success was defined as successful revascularization of the CTO. Statistical analysis Continuous parameters are reported as mean ± standard deviation, and discrete variables are reported as a percent (%). Continuous variables were compared using Student s T-test and non-parametric analyses were performed using Spearman Rank Order Correlation. Multivariable logistic regression models were used to determine independent predictors of procedural and technical success. A p-value of <0.0 was considered statistically significant. Given the small overall sample size both the univariable and multivariable analyses were

7 Page of considered exploratory and hypothesis generating. All statistics were performed using SigmaStat/Plot version..0. (Systat, Chicago, IL). Results patients were identified who underwent endovascular procedures for CTO lesions with the use of the Viance (n=) or Crossboss catheter (n=). patients had separate CTO revascularization procedures for both limbs. Four patients had CTO lesions attempted and patient had CTO lesions attempted on the same index procedure. Baseline demographic data are reported in Table. Procedural data are shown in Table. The majority of patients were male (0%) with a mean age of. ±. years. All procedures were performed on patients with severe claudication or CLI with mean Rutherford class of. ±.. patients (%) had evidence of tissue loss. lesions (%) were noted to be in the anterior tibial artery, (%) in the posterior tibial artery, (%) in the peroneal artery distribution, (%) in the tibioperitoneal trunk and the remaining (%) in popliteal artery. Only lesion had been attempted to be crossed before at a separate setting with a support catheter and guidewire technique and all remaining were de novo attempts. (%) lesions were extensively calcified, (%) lesion had moderate and lesions (%) had mild calcification. Average CTO length was measured to be ± mm (-0 mm). Most of the proximal caps and distal caps were well defined (% and %, respectively). lesions (%) had extensive collateral development. Bivalirudin was used for anticoagulation in procedures (%) and unfractionated heparin in the other 0 (%) cases with a mean peak activated clotting time of ± 0. A multitude of 0.0 guidewires were used inside the Viance for the various cases, including hydrophilic coated, heavy tipped CTO wires, supportive body wires, and workhorse wires with no correlation between wire type and technical success.

8 Page of The Viance was successful in true lumen passage in lesions accounting for a % technical success. Subintimal entry occurred in lesions (%). The Enteer system was used in of these lesions and was unsuccessful in achieving re-entry in the distal true lumen. The Outback catheter was used for other lesion which achieving successful reentry. A support catheter along with multiple wire attempts was used for subintimal tracking and re-entry in lesion when the Enteer had failed, resulting in successful distal true lumen access. Thus, procedural success was achieved in lesions (0%) with successful placement of a wire in distal true lumen. When several lesions were attempted on the same procedure, often times the attempt to cross the second CTO was curtailed to prevent further contrast load and radiation exposure. patients (0%) had at least one infrapopliteal CTO that was successfully recanalized, resulting in establishment of at least one in line flow to the foot. On further analysis, lesions were noted to be less than 0 mm and the Viance was able to traverse of them via true lumen and lesion subintimally accounting for % technical and % procedural success. Atherectomy was performed in lesions (0%) and distal embolization protection with a filter device was used in lesions (%). Balloon angioplasty was performed in all treated lesions. Post procedure stenosis in these lesions was reduced to an average of.0 ± %. Stents were used post balloon angioplasty in only lesions. ± ml of contrast was used with ± minutes of fluoroscopy time in these procedures. The total average procedure time recorded was ± minutes. There was no correlation of the lesion length with the fluoroscopy time and total procedure time. There was one intraprocedural complication which was the development of thrombus within the posterior tibial artery managed with eptifibatide infusion without subsequent clinical sequelae.

9 Page of Univariable correlates with technical success included shorter lesion length (r=-0., p=0.00), and a well defined distal CTO cap (r=0., P<0.00). Correlates with procedural success included shorter lesion length (r=-0., p<0.00), a well defined distal cap (r=0.0, p<0.00), and successful true lumen passage of the Viance catheter (r=0., p<0.00). Procedural success was also associated with lower Rutherford scores (r=-0., p=0.00). Lesion calcification was not related to technical success (r=0., p=0.) or procedural success (r=0., p=0.0) but was related to longer procedural times (r=0., p=0.00). No demographic variable including the presence of diabetes, age, presence of CKD, or current smoking was related to technical or procedural success. In a multivariable logistic model which included lesion characteristics, lesion length was the only independent predictor of technical (OR 0. [0.-.00], p=0.0) or procedural success (OR 0. [0.-0.], P=0.0). Discussion In the present study, the Viance and CrossBoss catheters were able to achieve % technical and 0% procedural success rates in recanalizing popliteal and infrapopliteal CTOs. These data are also consistent with the finding that infrapopliteal CTO procedural outcomes tend to be poorer than those for femoro-popliteal CTOs. However, when the initial target lesion was only included the present analysis, the procedural success rate was 0% - suggesting that for selected lesions the efficacy of this device may be higher. To date, the largest evaluation of the Viance catheter has been the Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions (PFAST-CTOs) study.() In this study patients underwent CTO recanalization with the Viance catheter with or without the Enteer system. The majority of patients had Rutherford - claudication, and the target lesion was the superficial femoral artery in.%. The use of the catheter in the popliteal vessel was.% and in the tibial vessels.%. The perforation rate was.% ( case). The technical success in crossing the CTO with

10 Page of the Viance only was % ( cases) and with the assistance of the Enteer device % ( cases). Approximately % of all lesions were reported to be moderate or severely calcified. Our present series represents the largest evaluation of the Viance device for popliteal and infrapopliteal disease. Our lower success rates likely reflect the challenges associated with BTK endovascular therapy particularly therapy in smaller diffusely diseased vessels. Role of crossing device technology Failure to cross into the true distal lumen is the most common reason for procedural failure in the context of CTO revascularization. (,) CTO recanalization has traditionally been achieved by the use of a support catheter technique and wire (often with a weighted and/or hydrophilic tip) with either negotiation of the true lumen or subintimal passage and re-entry.() Given the challenges associated with re-entry in the smaller BTK vessels and risk of damage to runoff vessels, dedicated crossing technologies are being developed to maintain true lumen position during recanalization. In theory, devices which facilitate true lumen crossing have several advantages over traditional methods including reductions in procedural and radiation exposure times, reduced risk of vessel damage, and may result in a more attractive substrate for atherectomy. These potential benefits remain to be tested and are uncertain largely due to a lack of randomized controlled data. Several of the available tools to facilitate intraluminal crossing for both above and below the knee CTOs are summarized in Table. The Frontrunner XP catheter (Cordis Endovascular, Miami, FL) employs blunt micro-dissection to displace plaque.() The Crosser catheter (Bard Peripheral Vascular, Tempe, AZ) uses high frequency vibrations propagated by a stainless steel tip to facilitate penetration of hard and calcified lesions.() The Wildcat catheter (Avinger, Redwood City, CA) has a rotatable tip equipped with distal spiral wedges that can be used to

11 Page of bore a track into the CTO cap that facilitates guide-wire placement distally. () Ocelot catheter (Avinger, Redwood City, CA) uses similar mechanism as the wildcat catheter, however it uses real time optical coherence tomography for direct visualization to direct intravascular orientation. (,) The Safe-Cross system (Intra-luminal Therapeutics, Carlsbad, CA) combines an optical coherence reflectometer with radiofrequency energy delivered from the wire tip to help the operator remain intraluminal. () TruePath (,) (Boston Scientific, Natick, MA) CTO device features a rotating diamond-coated tip designed to break through plaque in peripheral lesions. As noted by Table, the majority of studies examining the utility of dedicated crossing devices have focused on above the knee lesions primarily in the superficial femoral artery. It should be noted that to date there are no peer-reviewed published papers available for dedicated BTK crossing technology. Viance catheter: design, tips, and techniques In contrast to the devices described above, the Viance catheter is an over the wire 0.0 guidewire compatible, cm long multi-wire coiled shaft that has a 0.0 inch atraumatic distal tip. It has a hydrophilic stainless steel distal coating and is compatible through Fr sheath. It is designed to deliver a guidewire via true lumen or subintimal pathways. The catheter is advanced to the proximal CTO cap and manually spun using the torqueable handle. The torque device should be placed close to the entry of the catheter into the sheath with approximately < cm of separation. Spinning of the torque device should be performed in a rapid fashion in a single direction, this fast spin technique allows the device to find microchannels through the occlusion. Upon finding a channel, the device tip will move forward often relatively suddenly. The temptation to apply forward pressure should be avoided while the device tip probes the cap/channel as this may increase subintimal passage. In our experience

12 Page of several minutes (up to minutes) of spinning may be required prior to visible forward movement of the device. If torque transmission is hindered then an audible clicking will occur and in this case spinning of the device in the opposite direction may be required. If failure of torque transmission does occur it is an important troubleshooting step to ensure that the catheter is straight on the field and not looped or coiled and that there is not wrapping of sterile towels or drapes along the shaft of the device. The Viance catheter shaft/tip is minimally shapeable making altering its direction in a vessel challenging. If the catheter is migrating into an unwanted direction then spinning the opposite direction may bring it into a different plane/direction. Though there are no published data, the wire characteristics/choice used with the Viance catheter may impact its performance. Again in our experience, we have noted the following wire techniques in combination with the Viance: ) placing a curve on the tip of the guidewire and leading with the curved wire may help redirect the device in the desired direction, ) leading with a heavy tipped CTO wire may allow the device to initially engage the cap of the CTO, ) the use of a stiff shaft wire for example, the MailMan wire, helps maintain a straight orientation of the catheter, and ) the distance of the wire from the distal end of the Viance appears to impact the freedom of movement of the Viance tip such that maintaining the guidewire - cm proximal from the tip allows for greater probing movement of the Viance. Study Limitations There are numerous study limitations, which must be considered. Since the data were collected as part of a prospective registry, the patients were non-randomized. Therefore, the role of selection bias cannot be underestimated as the decision to use the Viance catheter on a given case was left up to the individual operators. It is unclear whether the successful Viance cases might have been also successful with alternative crossing tools. Calcification is classically

13 Page of associated with poor success rates in crossing CTOs. Calcification was not significantly related to treatment failure in the present study. Assessment of calcification severity can be difficult in the infrapopliteal circulation as delineating intraluminal calcium from medial calcification can be challenging. Of note, calcification was associated with longer overall procedural times. In addition, the assessment of adjunctive tools for subintimal to true lumen re-entry particularly the role of the Enteer device cannot be deciphered from the present study given the small number of cases. The sample size also limits any statistical analysis to hypothesis generating data. Conclusions In the present series, the Viance and CrossBoss crossing catheters appeared to be safe devices with acceptable efficacy in crossing popliteal and infrapopliteal occlusions. Lesion length appears to be the strongest predictor failure. Further larger registry and randomized data will be needed to better understand the role of this device in peripheral CTO therapy.

14 Page of Figure Legends Figure : Viance Device Description and Use: Viance catheter is an over the wire 0.0 guidewire compatible, cm long multi-wire coiled shaft that has a 0.0 inch atraumatic distal tip. It has a hydrophilic stainless steel distal coating and is compatible through Fr sheath. Figure : Revascularization of Posterior tibial Chronic Total Occlusion with Viance: Left Posterior tibial artery intervention (a) Baseline angiogram showing chronic total occlusion (b) Viance catheter being advanced through the occlusion over a 0.0 guidewire (c) True lumen distal guidewire placement (d) Balloon angioplasty being performed (e) Final angiogram showing minimal residual stenosis.

15 Page of References:. Bell D. Peripheral arterial disease overview. Podiatry Management 00(April/May 00):0-.. Javed U, Laird JR. Specialty Crossing Devices: Understanding the Learning Curve. Endovascular today 0:-.. Bolia A, Miles KA, Brennan J, Bell PR. Percutaneous transluminal angioplasty of occlusions of the femoral and popliteal arteries by subintimal dissection. Cardiovasc Intervent Radiol 0;():-.. Markose G, Miller FN, Bolia A. Subintimal angioplasty for femoro-popliteal occlusive disease. J Vasc Surg 0;():0-.. London NJ, Srinivasan R, Naylor AR, Hartshorne T, Ratliff DA, Bell PR, Bolia A. Subintimal angioplasty of femoropopliteal artery occlusions: the long-term results. Eur J Vasc Surg ;():-.. Banerjee S. Multi-Center Registry for Peripheral Arterial Disease Interventions and Outcomes (XLPAD). ClinicalTrials.gov Identifier : NCT00 July 0.. Gray W. Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions (pfast - CTO). Presented in the Vascular Interventional Advances (VIVA) Conference, Las Vegas, Nevada 0.. Mossop PJ, Amukotuwa SA, Whitbourn RJ. Controlled blunt microdissection for percutaneous recanalization of lower limb arterial chronic total occlusions: a single center experience. Catheter Cardiovasc Interv 00;():0-.. Adams GL, Gardner SJ, Gardner J, Mustapha JA. Exotic Access, Techniques, and Devices for Infrapopliteal CTOs. Endovascular today 0;May:-.. Shetty R, Vivek G, Thakkar A, Prasad R, Pai U, Nayak K. Safety and efficacy of the frontrunner XP catheter for recanalization of chronic total occlusion of the femoropopliteal arteries. J Invasive Cardiol 0;():-.. Gandini R, Volpi T, Pipitone V, Simonetti G. Intraluminal recanalization of long infrainguinal chronic total occlusions using the Crosser system. J Endovasc Ther 00;():-.. Pigott JP, Raja ML, Davis T, Connect Trial I. A multicenter experience evaluating chronic total occlusion crossing with the Wildcat catheter (the CONNECT study). J Vasc Surg 0;():-.. Selmon M. CONNECT II study. Presented in the Vascular Interventional Advances (VIVA) Conference, Las Vegas, Nevada 0.. Cawich I, Marmagkiolis K, Cilingiroglu M. Ocelot catheter for the treatment of long SFA occlusion. Catheter Cardiovasc Interv 0.. Kirvaitis RJ, Parr L, Kelly LM, Reese A, Kamineni R, Heuser RR. Recanalization of chronic total peripheral arterial occlusions using optical coherent reflectometry with guided radiofrequency energy: a single center experience. Catheter Cardiovasc Interv 00;(): TruePath CTO Device ReOpen study data. Boston Scientific.. George JC. Revascularization of Calcified Infrapopliteal Chronic Total Occlusion. Vascular disease management 0;():-.

16 Page of Table : Baseline Characteristics Clinical Variables (n=) Data Age (years). ±. Male (0%) Hypertension (0%) Diabetes mellitus (%) Tobacco use Active (%) Former (%) Chronic kidney disease (%) Coronary artery disease (%) Rutherford category (%) Rutherford category (%) Rutherford category (%) Rutherford category (%) Baseline ABI 0. ± 0. Aspirin (%) Clopidogrel (%) Warfarin (%) Lesion characteristics (n=) Data Popliteal n (%) (.%) Anterior Tibial n (%) (.%) Posterior tibial n (%) (.%) Tibio-peroneal n (%) (.%) Peroneal n (%) (.%) Denovo lesions (%) Prior attempt (%) Heavily calcified (%) Mean CTO length (mm) ± mm

17 Page of Number of run off vessels. ± 0. Data presented as (mean ± SD) or (n, %)

18 Page of Table : Procedural Data Procedural details Data Contralateral access (%) Ipsilateral access (%) True lumen entry (%) Sub-intimal angioplasty (%) Successful distal re-entry (%) Distal embolization protection (%) Atherectomy (0%) Number of lesions stented (%) Technical success (%) Procedural success (0%) Complications (.%) Fluoroscopy time (min) ± Total contrast (ml) ± Procedure duration (min) ± Data presented as (mean ± SD) or (n, %)

19 Page of Table : CTO devices published data for efficacy and lesion characteristics Device Author/Year Lesions Lesion distribution Lesion length (mm) Success rate Safe Cross Kirvaitis et al. 00 CIA Crosser Joye et al. 00 PATRIOT trial EIA SFA Pop SFA ±.0 0% Pop Infra pop Frontrunner Shetty et al. 0 SFA 0 Pop Wildcat Pigott et al.0 SFA SFA/Pop Pop True Path ReOpen 0 SFA SFA/Pop Pop Tibial.% 0 ± % ± % 0% Ocelot CONNECT II 0 0 SFA and Pop <00 % Viance Gray et al. 0 PFast-CTOs SFA Infrapop ± % (CIA Common Iliac artery, EIA External Iliac artery, SFA Superficial femoral artery, Pop Popliteal artery, Infrapop Infrapopliteal arteries)

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