Prostar XL Research Articles

TCT-427 Safety and Efficacy of The ProStar XL Percutaneous Vascular Closure System for Transfemoral Transcatheter Aortic Valve Replacement (TAVR): a Single Center Six-year Experience

TCT-427 Safety and Efficacy of The ProStar XL Percutaneous Vascular Closure System for Transfemoral Transcatheter Aortic Valve Replacement (TAVR): a Single Center Six-year Experience

Percutaneous interventions in aortic disease.

Percutaneous access techniques for diagnostic and therapeutic approaches to the coronary and aortic branch vessels have been the mainstay of cardiovascular interventions for several decades. The development of catheter-based technologies to treat traumatic and degenerative pathology of the thoracic and abdominal aorta initially required the use of direct femoral access via open incisions because of the size of the devices and their delivery sheaths. Although the endovascular repair of infrarenal aortic aneurysms (EVAR)1 ushered in an entirely new concept for managing aortic pathology, there was a concomitant development of a new series of complications associated with open vascular access. Of the devices approved by the US Food and Drug Administration, the profiles of the currently available components ranges from 9F to 25F inner diameter, which correlates to 11F to 27F outer diameter. In particular, delivery systems for thoracic endografts have 22F to 27F outer diameter and are traditionally placed via femoral artery cut-down or surgically created conduits. With the evolution of devices with smaller sheaths, the development of closure devices, and noninvasive imaging studies to assess the suitability of arteries for percutaneous access, there have been major changes in the approach and timing of aortic interventions. Over the years, many closure devices have been marketed to decrease the need for manual compression or reversal of anticoagulation after transfemoral percutaneous diagnostic or therapeutic interventions. To date, only suture-mediated closure devices have been used to manage larger catheter-based percutaneous interventions. Two suture-mediated percutaneous closure devices currently are available for potential off-label use in the closure of endograft access sites: Perclose Prostar XL and Perclose ProGlide (Abbott Vascular, Redwood City, CA). The Perclose Prostar XL device comes in 2 different sizes. The Prostar XL 8 is designed for closure of 6.5F to 8F access sites, and Prostar XL 10 is for closure …

0219 : Outcomes of patients undergoing femoral covered stent graft during percutaneous transcatheter aortic valve implantation

Although vascular complications are frequent after percutaneous transcatheter aortic valve implantation (TAVI), they can be managed percutaneously most of the time by implanting a covered stent graft in the femoral artery. To evaluate the characteristics of patients who required femoral stent implantation after TAVI and to determine the long-term impact of stent placement in the femoral position. Between January 2011 and December 2013, 320 patients underwent transfemoral TAVI in our center using the Edwards Sapien XT valve. After gaining vascular access, a pre-closure technique was performed with a 10-F ProStar XL closure device followed by16 to 20-F sheath insertion for 23, 26 or 29mm valve implantation. After valve implantation and sheath removal, access site was closed with the ProStar device. An ilio-femoral angiography was performed via the contralateral femoral artery to assess final result and a self-expandable covered stent graft was placed at the level of vessel injury in case of persistent bleeding despite prolonged manual compression or balloon occlusion. Follow-up was performed by phone call and duplex ultrasonography of the access site. 29 (9%) patients required emergency femoral covered stent graft implantation. Patients characteristics were comparable to those of patients who did not require stent implantation except for previous anticoagulant therapy which was significantly associated with stent implantation (44.8% vs 27.1%, p = 0.045). Despite stent implantation, 2 patients underwent surgery for persistent bleeding. Stent implantation did not affect survival (p=0.456). At a median follow-up of 23 months, only 1 patient complained of groin discomfort impacting his daily life. Neither stent fracture nor occlusion was noted by ultrasonography. Vascular complications after TAVI can be safely treated percutaneously by femoral covered stent graft with minimal long-term functional impairment and no impact on survival.

0473: Abdominal aortic aneurysms repair by entirely percutaneous endovascular approach using closure suture-based device. Prospective study of safety, feasibility and efficiency

Endovascular repair of abdominal aortic anevrysms (AAA) is a well documented option. This approach is usually performed by surgical cut down of the common femoral arteries (CFA). Total percutaneous access for endovascular aortic anevrysm repair (« preclose technique ») has been reported. However high bleeding risk obese patients are still considered as bad candidates for this method. We describe our experience of the entirely percutaneous vascular approach using the Prostar XL system, in our obese population in particular. We analyzed 164 consecutive patients treated for AAA by endovascular percutaneous route between January 2007 and February 2012. Mean age of our patients was 76 years old. 25.8%of our population were obese (mean body mass index = 36). All patients were treated with a bifurcated endoprosthesis. The diameter of the introducer was 18-French (F) for the main femoral access and 12F for the controlateral access. The success rate of the procedure has been described elsewhere. A total of non-surgical 328 femoral access sites were closed with the Prostar XL system. The success rate of the entirely percutaneous vascular approach procedure was 94,5% and reached 100% in obese population, with a mean delay to hospital discharge of 6 days. Nine procedure failures were deplored. All procedure failures occurred on the 18F side while the success rate was 100% with 12F introducers (p=0.002). Re-hospitalization rate due to vascular access complication (haematoma, false anevrysm, femoral abscess) was 2.4% after a mean follow-up of 23 months, but no difference between obese and non-obese patients was found. Our results indicate that even in obese patients, usually considered as relatively contra-indicated to this strategy, the entirely percutaneous approach using the Prostar device for endovascular treatment of infrarenal AAA is safe.

Commentary on ‘Predictors of Failure of Closure in Percutaneous EVAR Using the Prostar XL Percutaneous Vascular Surgery Device’

Actual outer diameter corresponding to the size given by the manufacturer in mm Size in Fr given by manufacturer 12F 14F 16F 18F 20F 22F In their paper, Rijkee et al. evaluated predictors of failure of closure in percutaneous endovascular aneurysm repair (P-EVAR) using the Prostar XL Percutaneous Vascular Surgery Device (Abbot Vascular, Santa Clara, CA, USA) in a consecutive series of 154 percutaneous accesses performed in 84 patients over a 40 month period. The team was experienced: P-EVAR was performed in 69% of the population treated. The pre-operative status of the common femoral artery (CFA) was properly evaluated on computed tomography (CT) scan, and puncture was systematically performed under per-operative ultrasound guidance to control the site of puncture and to avoid severe calcifications and atheromatous plaques. The authors demonstrated that the use of the Prostar XL device in P-EVAR was safe and feasible, with a success rate of 93.5% in a selected population excluding patients with circumferentially calcified femoral access sites or CFA stenosis. Failure to close access sites was defined as the need for conversion to conventional femoral cutdown to stop bleeding or correct vessel obstruction. In an attempt to predict failures, two potential new factors: (i) a specific calcification and location score system, and (ii) the SA-ratio (the ratio between sheath and CFA diameters) were proposed. This newly introduced calcification quantity and location score system evaluated the degree of arterial wall calcification on CT angiography, which was defined in a percentage of total wall circumference: grade I ( 50%, except circumferentially calcifications). Calcification location was classified as none or posterior, scattered anterior, and fully anterior, but this classification failed to predict failure. This result is probably related to the fact that the authors did the right thing by excluding patients with circumferentially calcified and stenotic CFAs, and puncturing under ultrasound guidance avoiding calcifications and then favoring femoral cut down in non-favorable CFAs. The other indicator was the SA ratio. The SA ratio was demonstrated to be a significant predictor of failure with a

Commentary on ‘A Randomized Controlled Trial of the Fascia Suture Technique Compared with a Suture-mediated Closure Device for Femoral Arterial Closure After Endovascular Aortic Repair’

Several techniques exist for EVAR access closure: 1) open surgical technique with cutdown onto the femoral artery, 2) modified open technique with fascia suture technique (FST), and 3) strictly percutaneous pre-suturing technique with suture-mediated closure device (SMCD). There is no consensus on which technique should be used. In Sweden, cutdown was used in 21% of all EVAR in 2013, FST in 37%, and SMCD in 42%. 1 In this issue, Larzon and colleagues present the results of a randomized controlled trial comparing FST with SMCD (Prostar XL) for femoral artery closure after EVAR. 2 Based on achievability, time was chosen as the primary outcome. Consequently, the main finding was that FST is faster compared with Prostar. With a median difference of 7 minutes in favor of FST, the clinical relevance of this finding can be questioned. A more desirable and relevant study design would have been technical failure and major complications as primary outcome, with time and cost as secondary endpoints. The authors argue, however, that such a study is not feasible because of the large sample size required. Operator experience is a strong predictor of technical success for SMCD, 3 and excellent results have been reported for experienced operators. 4 In the present study, experience of 15 cases was used to define the basic level, and of 60 procedures the experienced level. Notably, experienced operators had a technical failure rate of 4% for FST and 7% for Prostar, while corresponding rates for the basic level operators were 27% and 30%, respectively. This indicates that the learning curve is of great importance in both techniques. Prostar was until recently the only available SMCD for large access sites. ProGlide (Abbot Vascular, Redwood City, CA, USA) is a simplified SMCD recently approved for closure of up to 21F vascular access sites. Ultimately, a complete percutaneous approach is desirable, and with easier-tolearn closure devices and delivery systems getting ever smaller, this is a likely development. Although FST is more invasive than SMCD, the lack of preclosure preparation of the access site is an advantage, particularly in the emergency situation. Furthermore, as demonstrated by this investigation, FST can work as a bailout procedure for a failed Prostar XL suture, and may be a cheaper option than Prostar XL.

Predictors of Failure of Closure in Percutaneous EVAR Using the Prostar XL Percutaneous Vascular Surgery Device

To identify predictors of failure in percutaneous endovascular aneurysm repair (P-EVAR) using the Prostar XL Percutaneous Vascular Surgery Device (Abbot Vascular, Santa Clara, CA, USA) and the need for conversion to conventional femoral cutdown (O-EVAR). Consecutive patients who underwent P-EVAR with the Prostar XL device between January 2009 and April 2012 were included in this series. Patients with a circular calcified common femoral artery (CFA) oncomputed tomography angiography were operated using O-EVAR and were therefore excluded. To identify predictors of success of closure in P-EVAR, artery characteristics, sheath size used, and comorbidities were analyzed in a univariate logistic regression model. Percutaneous access was achieved in 154 femoral access sites with conversion to O-EVAR was needed in10 (6.5%). Significant predictors of conversion included sheath size (continuous, relative risk [RR] 1.50, p < .03)and the ratio between sheath size and CFA diameter >0.75 (RR 8.93, p < .01). Variables such as calcification quantity scores, CFA diameter, body mass index, and comorbidities were not significant. The data demonstrate that sheath size, in particular, combined with CFA diameter predicts failure of closure in P-EVAR using the Prostar XL device. This ratio can be utilized to help in decision making with regard to the EVAR approach. A ratio of >0.75 would favor a primary open groin approach.

TCT-783 Less access-site related vascular complications with double versus single Prostar closure device in patients with transfemoral Transcatheter Aortic Valve Implantation

Serious vascular complications have been reported to occur in 6% of the transfemoral TAVI patients. The aim was to report access site related complications using Single (SP) versus Double (DP) Prostar XL for closure of 18F femoral arterial access in TAVI. 134 patients included in our prospective

A single-centre experience of 200 consecutive unselected patients in percutaneous EVAR

This study evaluated the feasibility and safety of percutaneous endovascular aneurysm repair (P-EVAR) in an "unselected" population of patients using Prostar XL closure device, comparing our results with the literature data reported for open EVAR (O-EVAR) and P-EVAR in selected populations. We prospectively enrolled 200 patients with abdominal aortic aneurysms to be treated with the P-EVAR procedure, without any selection criteria. Four hundred percutaneous femoral accesses using the Prostar XL closure device were performed. The early follow-up protocol consisted of a Doppler ultrasound (US) examination. Later evaluations were performed with US and computed tomography. Technical success was achieved in all percutaneous accesses (100 %). Ten early complications related to access site were recorded (10/400; 2.5 %): four pseudoaneurysms and six cases of lower limb ischaemia. Five of ten complications occurred in patients presenting calcification of the common femoral arteries, whereas 4/10 were in patients with "complex" groin anatomy. Eight of ten complications occurred at the access site of the main body of the prosthesis using a sheath size >20 Fr. Percutaneous endovascular aneurysm repair in "unselected" patients is safe and efficient, with a very low risk of access-related complications, comparable to P-EVAR in selected populations and to the best O-EVAR series.

A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial)

The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair (PEVAR) with use of a 21F endovascular stent graft system and either an 8 F or 10 F suture-mediated closure system (the PEVAR trial, NCT01070069). A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure. Between 2010 and 2012, 20 U.S. institutions participated in a prospective, Food and Drug Administration-approved randomized trial to evaluate percutaneous femoral artery access and closure by a "preclose" technique in conjunction with endovascular abdominal aortic aneurysm repair. A total of 151 patients were allocated by a 2:1 design to percutaneous access/closure (n = 101) or open femoral exposure (n = 50 [FE]). PEVAR procedures were performed with either the 8 F Perclose ProGlide (n = 50 [PG]) or the 10 F Prostar XL (n = 51 [PS]) closure devices. All endovascular abdominal aortic aneurysm repair procedures were performed with the Endologix 21 F profile (outer diameter) sheath-based system. Patients were screened by computed tomography with three-dimensional reconstruction and independent physician review for anatomic suitability and adequate femoral artery anatomy for percutaneous access. The primary trial end point (treatment success) was defined as procedural technical success and absence of major adverse events and vascular complications at 30 days. An independent access closure substudy evaluated major access-related complications. Clinical utility and procedural outcomes, ankle-brachial index, blood laboratory analyses, and quality of life were also evaluated with continuing follow-up to 6 months. Baseline characteristics were similar among groups. Procedural technical success was 94% (PG), 88% (PS), and 98% (FE). One-month primary treatment success was 88% (PG), 78% (PS), and 78% (FE), demonstrating noninferiority vs FE for PG (P = .004) but not for PS (P = .102). Failure rates in the access closure substudy analyses demonstrated noninferiority of PG (6%; P = .005), but not of PS (12%; P = .100), vs FE (10%). Compared with FE, PG and PS yielded significantly shorter times to hemostasis and procedure completion and favorable trends in blood loss, groin pain, and overall quality of life. Initial noninferiority test results persist to 6 months, and no aneurysm rupture, conversion to open repair, device migration, or stent graft occlusion occurred. Among trained operators, PEVAR with an adjunctive preclose technique using the ProGlide closure device is safe and effective, with minimal access-related complications, and it is noninferior to standard open femoral exposure. Training, experience, and careful application of the preclose technique are of paramount importance in ensuring successful, sustainable outcomes.

Haemostasis for 568 large femoral artery access sites - outcomes and predictors of success

The introduction of stent grafts for thoracic and abdominal aorta (T / EVAR) has raised the demand for percutaneous closure devices for larger femoral arterial access sites. The aim of our study was to evaluate the success and complication rate of completely percutaneous T / EVAR with Prostar XL® and surgical haemostasis over a 50- month period. Between December 16th 2005 and February 17th 2010 T / EVAR was performed in 306 patients with 568 arterial access sites with diameters of 12 to 24 Fr. The exclusion criteria for percutaneous haemostasis were a calcified anterior wall at the puncture site and / or a stenotic common femoral artery, seen on computed tomographic angiography. Surgical haemostasis was performed in 184 (32.4 %, o-T / EVAR group) while percutaneous haemostasis was attempted at 384 sites (67.6 %, p-T / / EVAR group). Most of the procedures were elective; five of twelve emergency patients had percutaneous haemostasis that was successful in all. Percutaneous haemostasis failed at 23 sites. No data about follow-up was recorded for 54 sites (9,5 %). The technical success rate of percutaneous haemostasis was 93.6 % (338 / 361 sites). A larger size of the access site resulted in significantly more complications of haemostasis in both groups (p-T / EVAR group p = 0.019; o-T / EVAR group p = 0.003). p-T / EVAR caused more mild complications compared to o-T / EVAR (p = 0.03). No deaths as consequence of failed haemostasis were recorded. Complete percutaneous T / EVAR is technically feasible and safe in a majority of patients. Good patient selection based on adequate pre-procedural imaging and technical expertise of the operators are key to success. Surgical back-up is strongly recommended to assist in those patients in whom p-T / EVAR fails.

Closure of femoral artery puncture site with antegrade placement of Prostar XL vascular closure device

Groin compression and patient stabilization are the conventional methods of achieving hemostasis following angiographic interventions performed by means of common femoral artery (CFA) punctures, but these methods are rather uncomfortable, and they necessitate longer hospital stays. Another disadvantage of these post-interventional measures is that they bear the risk of development of several serious complications including hematoma at the puncture site, retroperitoneal hemorrhage, and pseudoaneurysm and arteriovenous fistula formation. The Prostar XL vascular closure kit has been developed with the purpose of implanting surgical sutures at the CFA puncture site, following both diagnostic and interventional procedures. Here, we report a case of closure of femoral artery puncture site with antegrade placement of Prostar XL vascular closure device instead of the retrograde entry as it is commonly used.

The use of human cadavers and virtual reality simulation in endovascular training: A questionnaire of patient and professional opinion

s / International Journal of Surgery 11 (2013) 686e745 737 ABSTRACTS 0544: THE USE OF HUMAN CADAVERS AND VIRTUAL REALITY SIMULATION IN ENDOVASCULAR TRAINING: A QUESTIONNAIRE OF PATIENT AND PROFESSIONAL OPINION Stuart Maitland , Craig Nesbitt , Roger Searle , Gerard Stansby . 1 Freeman Hospital, NUT, Newcastle Upon Tyne, UK; Newcastle University, NUT, Newcastle Upon Tyne, UK. Aim: To establish the opinion of patients and clinicians on the use of virtual reality simulators (VRS) and human cadavers (HC) for endovascular training. Methods: Experts in interventional cardiology, radiology and vascular surgery rated their agreement to statements regarding endovascular simulation (HC and VRS) through an online questionnaire. Patients' views on endovascular simulation training were also sought. Results: 100 professionals completed questionnaires. < 25% were aware of endovascular HC training, none had first hand experience, five (5.6%) disagreed with its use. All candidates were aware of VRS, 80.9% had first hand experience. Many expressed interest in HC stating concerns regarding the realism of VRS. 107 patients (50 non-vascular, 57 vascular*) responded. All patients agreed with HC training. Patients declared greater confidence in doctors trained on HC versus VRS (p1⁄40.000). Conclusion: These are the first recorded opinions of professionals and patients regarding endovascular simulation training. Endovascular professionals question the suitability, appropriateness and feasibility of endovascular HC training, yet few are wholly satisfied with VRS. Patients appreciate the need for adjunctive simulation training, but harbor mistrust in computer technology. Enhanced patient education is required to maintain confidence and trust. * non-vascular patients have no history of vascular disease 0547: TYPE II ENDOLEAKS: LOW RISK OF RUPTURE AND HIGH RISK OF TREATMENT FAILURE David Sidloff, Philip Stather, Eddie Choke, Matt Bown, Robert Sayers. University of Leicester, Leicester, UK. Aim: To assess the risk of rupture and determine the benefits of intervention for the treatment of type II endoleaks after endovascular abdominal aortic aneurysm repair. Method: A systematic review was performed according to PRISMA guidelines. Outcome data including incidence, spontaneous resolution, sac expansion, interventions, success, and complications were recorded. Results: 32 non-randomised retrospective studies were included, totalling 21,728 patients, 1515 type II endoleaks and 392 interventions. This analysis reveals type II endoleaks have an incidence of 10% with 32.3% spontaneously resolving. 14 ruptures were reported (incidence 0.9%), from which 43% did not have concurrent sac expansion. Analysing interventions, 28% were unsuccessful. Translumbar embolization had a higher success rate compared to transarterial embolization (TL81% v TA62.5% P1⁄40.024) with fewer persistent endoleaks (TA36% Vs TL19% P1⁄40.0396). Transarterial embolizations had a higher associated number of complications (TA10% Vs TL0% P1⁄40.0426). Conclusion: This review has revealed that rupture secondary to an isolated type II endoleak is rare (<1%) and that over a third occur in the absence of sac expansion. Nearly a third of all interventions for the treatment of type II endoleaks fail, however a translumbar intervention has a higher success rate with a lower risk of complications. 0555: AN EVALUATION OF OUR EARLY EXPERIENCE OF PERCUTANEOUS EVAR USING THE PROSTAR XL DEVICE David Ormesher, Jenna Godfrey, Andrew Schiro, David Murray, Ferdinand Serracino-Inglott. Department of Vascular and Endovascular Surgery, Manchester Royal Infirmary, Manchester, UK. Introduction: There is a trend towards less invasive procedures in all areas of surgery. It is suggested that the use of percutaneous closure devices for endovascular procedures that require larger seat sizes may have a positive impact on patient outcomes. Methods: A retrospective review of our endovascular logbook was undertaken from which all patients who received a Prostar XL device were identified and data collected. Results: 96 Prostar XL devices were deployed. Mean skin to common femoral artery (CFA) depth was 31.3mm, all but 5 patients had some degree of CFA calcification. The median length of stay was 4 days. 4 patients went on to develop groin haematomas postoperatively; all of these were treated conservatively. The Prostar XL cut through the CFA in one patient and this required repair. 80% of complications were in the first 15 cases. Conclusion: No long-term complications in our series can be attributed to the percutaneous approach for EVAR. We believe that US-guided puncture can overcome problems associated with CFA calcification and that the depth from skin to CFA has no impact on morbidity. The use of low profile devices ( 16F) and operator experience have a positive impact on outcomes with the Prostar XL device. 0564: TEMPORAL ARTERY BIOPSY e TOO MANY TOO LATE? Ruth Graham, Lourdusamy Selvam. West Wales General Hospital,

Commentary Regarding “Percutaneous Closure of Large Femoral Artery Access with ProStar XL in Thoracic Endovascular Aortic Repair”

Commentary Regarding “Percutaneous Closure of Large Femoral Artery Access with ProStar XL in Thoracic Endovascular Aortic Repair”

Percutaneous Closure of Large Femoral Artery Access with Prostar XL in Thoracic Endovascular Aortic Repair

To investigate the technical success rate of Prostar XL for closure of large (≥20F) femoral vascular access sites in thoracic endovascular aortic repair (TEVAR) procedures. This was a single-center consecutive case series. All TEVAR procedures at Uppsala University Hospital 2006-2010 were registered prospectively. Reoperations and cases with open closure technique were excluded. Primary (early) technical failure was defined as closure failure requiring immediate (on-table) open surgical repair; late access-related complication occurred thereafter. The medical records, pre- and postoperative computed tomography images were reviewed retrospectively. A total of 164 TEVAR procedures were identified, of which 118 (71%) had a median 22F (range 20-26F) access site sealed with tandem Prostar XL. The indications for TEVAR were dissection (47%), aneurysm (42%), trauma (8%), and miscellaneous (3%). Median follow-up time was 10 months (range 1-62). Primary technical failure occurred in 10 of 118 (8%). These cases were converted to cut-downs and surgical repair (n = 7), femoral fascia suturing (n = 2), and external compression with the Femo-Stop device (n = 1). Hypertension was associated with primary failure (p = .005), and a trend was observed for high age (p = .078) and increased groin subcutaneous fat layer (p = .077). Late access-related complications included pseudo-aneurysms (n = 12), small hematomas (n = 7), superficial groin infections (n = 2), and deep venous thrombosis (n = 1). None of the late complications required surgical treatment. The access closure technique with tandem Prostar XL for large access sites during TEVAR is safe, in experienced hands. Few technical failures and few late complications occur, and they are usually benign.

Safety and feasibilty of transfemoral aortic valve implantation (CoreValve) in local anesthesia

Background: After its introduction, transfemoral aortic valve implantation (TAVI) was mostly performed under general anesthesia (GA) or in deep sedation (DS). Due to the increased experience of the technique, device improvement, reduction of the size of the femoral delivery sheaths and the use of percutaneous arterial closure system, one could imagine that it is feasible to perform TAVI in local anesthesia (LA). Aim of the study: The aim of this study was to investigate the safety and feasibilty of TAVI in LA without deep sedation and without anesthesiological standby. Methods: From April 2010 until November 2012 in 247 pts underwent transfemoral TAVI in LA at our hospital using the CoreValve system (26/29/31mm). There was no anesthesiological assistance present, but a cardiology fellow with experience in intensive care. For LA 20 ml of 1% lidocaine was injected sc into the groin. The CoreValve prothesis was inserted retrogradely via an 18 F sheath. Before introducing the 18-F-sheath, 2-7,5mg of Piritramid was given iv for analgesia. Closure of the arterial access site was done using the ProStar XL 10F- percutaneous suture device. Results: At our hospital 247 pts (age 81.2±0.4 years, 129 male) with severe AS (pmax 74.8±1.4 mmHg, pmean 44.2±0.9 mmHg, ava 0.6±0.01 cm2, LVEF 51.1±0.7%, logistic Euroscore 24.3±0.8) underwent the TAVI procedure in LA. Only one pt had to be converted to GA because of the development of a pulmonary edema due to a intermittent postinterventional aortic insuffiency grade III, which could be successfully treated by post-dilatation with a 28mm Balloon. Only 4 pts needed conversion to DS using midazolame/Propofol. There were no in-lab deaths and no in-lab strokes or TIAs. Mean intervention time was 74±3.4 min, the mean fluoroscopy time 13.3 min and the amount of contrast was 167±5.3 ml. In-Lab vascular complications occurred in 8 pts (3.2%); 1 vessel closure (VC) of the arteria femoralis communis (AFC) due to the Prostar system, 4 sheath induced dissections of the iliac artery treated by stenting, two iliac perforations treated with covered stents and 1 unremovable Solopath sheath. Two of these 8 pts (Prostar VC, unremovable sheath) needed surgical repair. Thirty–day all-cause mortality was 4.9% (n=12;cardiac mortality 41.6%) and long-term all-cause mortality (1-year) 14.6% (n=36; cardiac mortality 41.7%). There were 2 strokes during 30 days resulting in a stroke rate of 0.8% and 4 TIAs (1.6%). Conclusion: TAVI in LA represents a feasible and safe option with low (0%) In-Lab stroke/TIA rate. Acute-, intermediate and longterm-outcome is excellent.

Transcatheter implantation of self-expanding valve for failed stentless aortic root bioprosthesis

Although repeat aortic valve replacement (AVR) remains the standard treatment for failed bioprostheses, the feasibility of transcatheter aortic valve implantation (TAVI) has also been demonstrated. We report the successful implantation of a CoreValveTM self expanding aortic prosthesis (Medtronic, Inc) in a patient with a degenerated BioConduitTM stentless valve conduit (Shelhigh, Inc). A 63 year-old man was admitted due to NYHA class IV heart failure symptoms. He had a history of triple percutaneous coronary intervention followed by AVR plus LIMA to LAD grafting. Two years after the first surgery, acute dissection of the ascending aorta occurred and the mechanical valve along with the proximal ascending aorta were replaced by a stentless 25 mm valve conduit. Postoperative mediastinitis and atrio-ventricular block warranted sternum refixation and pacemaker implantation. Another year later, the patient underwent conservative treatment for prosthetic valve endocarditis. On current admission, transthoracic and transoesophageal echocardiography (TTE, TEE) revealed left ventricle (LV) end-diastolic diameter (EDD) of 62 mm and ejection fraction (EF) of 25%. Bioprosthetic cusps were opening well but seemed perforated and had attached two additional structures of ultrasound intensity, irregular shape and high mobility corresponding to organised bacterial vegetations. Consequently, severe aortic regurgitation (AR) was present. On coronary angiography, the arterial graft was occluded and no revascularisation within native coronaries was required. The unfavourable anatomical environment expected after mediastinitis accompanied by high STS scoring (16%) and wide peripheral arteries contributed to a decision to reject reoperation in favour of the transcatheter approach. On multi-detector computed tomography (MDCT), the prosthesis length was 45 mm with significant angulation of neighbouring ascending aorta and coronaries reimplanted 12 mm and 17 mm above the valve (Fig. 1). Laboratory findings excluded active infective endocarditis. After induction of general anaesthesia, a Prostar XL (Abbott) device was introduced into the right common femoral artery. Next, a 26 mm CoreValve prosthesis (the size had been selected according to the inner BioConduit diameter of 22 mm by TEE, standard delivery system) was positioned and deployed in a retrograde manner. Lack of fluoroscopy markers such as calcifications or rigid ring rendered the procedure more TEE-dependent. After completion, no transprosthetic gradient was measured and residual paravalvular AR was trivial. Nevertheless, deficient expansion of the stent frame distal part within the non-pliable BioConduit was noted. The time from arterial puncture to closure was 65 min with 22 min of fluoroscopy, and 180 mL of contrast agent was used. The post-procedural course was uneventful and the patient remained asymptomatic at 12-month follow-up. A remarkable improvement in LV performance was noted, with EDD of 54 mm and EF of 56% by TTE. Repeated MDCT visualised uncompromised coronaries ostia and persistent distal stent frame deformation. Proximal circularity remained however unaffected, which corresponded to the valve’s excellent function (Figs. 2, 3). Initial balloon valvuloplasty may optimise transcatheter valve stent alignment at the expense of degenerated bioprosthesis fragmentation and peripheral embolisation. The anticipated fragility of the thin-walled bioprosthetic cuff further added to our refraining from the manoeuvre. Lack of natural aorta sinus widening in patients with full root prostheses renders coronary flow impairment during TAVI more likely. This was avoided by careful positioning of the CoreValve sealing skirt below the coronaries’ ostia.

Safety and Efficacy of the Prostar XL Vascular Closing Device for Percutaneous Closure of Large Arterial Access Sites

Purpose. The purpose of this study is to retrospectively evaluate the efficacy and safety of the Prostar XL device for percutaneous large access site closure in an unselected patient and operator collective. Materials and Methods. All patients (n = 50) who had received percutaneous vascular closing with the Prostar XL device in our institution with follow-up data of at least 6 months were retrospectively included. Primary (freedom from surgical conversion) and continued (freedom from groin surgery in further course) technical success and major (deviations from expected outcome requiring surgery) and minor (other deviations from expected outcome) complications were assessed. Success and complications rates were correlated with delivery system size (Mann-Whitney Rank Sum Tests) and operator experience (paired samples t-test). Results. Rates of primary and continued technical success as well as major and minor complications were 93.6%, 89.7%, 10.3%, and 10.3% (groin based) and 90.0%, 84.0%, 16.0%, and 16.0% (patient based), respectively. No correlation of success and complications rate was found with delivery system sizes and operator experience. Conclusions. Application of the Prostar XL device for percutaneous closure of large arterial access sites is safe with a relatively high rate of technical success and low rate of major complications. Sizes of the delivery systems and the experience of the operator did not influence the results.

Application of gelatin sponge sandwich as a hemostatic aid to percutaneous suture-mediated arteriotomy closure

Suture-mediated closure devices are increasingly used for closure of large arteriotomies, such as those required for endovascular aortic repair. One of the commonly encountered situations is persistent arteriotomy oozing after successful closure requiring manual compression. The purpose of this report is to describe a simple adjunctive technique that allows a hemostatic agent (such as gelatin sponge) to be "railroaded" onto the arteriotomy site over the sutures of the closure device, thus facilitating hemostasis.

Predicting the learning curve and failures of total percutaneous endovascular aortic aneurysm repair

Percutaneous endovascular aneurysm repair (PEVAR) has been shown to be feasible; however, technical success is variable, reported to be between 46.2% and 100%. The objective of this study was to quantify the learning curve of the PEVAR closure technique and identify predictors of closure failure. We reviewed patient- and procedure-related characteristics in 99 consecutive patients who underwent PEVAR over a 30-month period in a single academic institution. A suture-mediated closure device (Proglide or Prostar XL) was used. Forward stepwise logistic regression was used to investigate associations between the failure of the closure technique and a number of patient and operative characteristics. To ensure objective assessment of the learning curve, a time-dependent covariate measuring time in calendar quarters was introduced in the model. Poisson regression was used to model the trend of observed failure events of the percutaneous technique over time. Overall PEVAR technical success was 82%. Type of closure device (P<.35), patient's body mass index (P<.86), type of anesthesia (P<.95), femoral artery diameter (P<.09), femoral artery calcification (P<.56), and sheath size as measured in Fr (P<.17) did not correlate with closure failure rates. There was a strong trend for a decreasing number of failure events over time (P<.007). The average decrease in the odds of technical failure was 24% per calendar quarter. The predicted probability of closure failure decreased from 45% per patient at the time of the initiation of our PEVAR program to 5% per patient at the end of the 30-month period. There were two postoperative access-related complications that required surgical repair. Need for surgical cutdown in the event of closure failure prolonged the operative time by a mean of 45 minutes (P<.001). No groin infections were seen in the percutaneous group or the failed group. Technical failure can be reduced as the surgeon gains experience with the suture-mediated closure device utilized during PEVAR. Previous experience with the Proglide device does not seem to influence the learning curve.