Conventional Implantation Research Articles

Abstract 17539: Conventional vs. Transcatheter Aortic Valve Replacement - Propensity Score Adjusted Comparison of 3,751 Unselected Patients

Background and Hypothesis: Transcatheter aortic valve replacement (TAVR) is an established method in high-risk patients. Two aspects of this procedure are currently under discussion: 1.) Do the data acquired from randomized studies and registers justify expansion of the procedure to include younger and healthier patients? 2.) Is the transfemoral approach superior to the transapical approach with regard to mortality and periprocedural complications? Against this background we examined the mortality and morbidity of all patients who received an isolated conventional, transapical or transfemoral aortic valve replacement in accordance with the criteria of the Valve Academic Research Consortium (VARC)-2. Methods: A prospective register was taken from a single center recording all conventional (CONV, n=2,881), transapical (TAVR-TA, n=363) and transfemoral (TAVR-TF, n=570) aortic valve implantations during the period from 07/2009 to 10/2014. Using propensity score (PS) matching, first CONV and TAVRall (TA+TF) and then TAVR-TA and TAVR-TF were paired on the basis of 21 risk variables, creating comparable groups. Results: 393 pairs CONV vs. TAVRall within a moderate risk could be created (EuroSCORE 18.7 vs. 18.5; STS 5.0 vs. 5.4). Comparison revealed no difference for 30d mortality (4.6% CONV vs. 5.1% TAVRall, p=0.74), stroke (2.8% vs. 2.0%, p=0.48) or myocardial infarction (0.0 vs. 0.3%, p=0.50). Bleeding complications were significantly more frequent in the CONV, SM implantations and vascular complications in the TAVRall group. In the PS-adjusted comparison TAVR-TA vs. TAVR-TF (289 pairs; EuroSCORE 25.1 vs. 22.1; STS 6.8 vs. 6.7) there was also no difference in the hard endpoints (30d mortality 4.9% TA vs. 4.2% TF, p=0.70; stroke 3.1% vs. 2.8%, p=0.81; myocardial infarction 0.4% vs. 0.4%, p=1.00). Here bleeding complications were significantly more frequent in the TA group, SM implantations and vascular complications in the TF group. Subgroup analyses show an advantage of the TAVR procedure in patients with high STS or low LVEF. Conclusions: These data show that 1.) conventional aortic valve replacement and TAVR are comparable in the moderate risk group, and 2.) the two approaches, transapical and transfemoral, produce comparable results.

The Efficiency of Hydrogen-Doping as a Function of Implantation Temperature

– For a conventional proton implantation doping process applied to crystalline silicon comprising proton implantation and subsequent furnace annealing the effect of the substrate temperature set during implantation is examined for temperatures between 50 °C and 200 °C. The formation efficiency of the hydrogen related donors in the maximum of the related doping profiles is shown to linearly increase with the implantation temperature. Regarding the dose rate, a reverted effect is found. The appearing effects are explained by considering the evolution of the initial implantation damage towards a vacancy related precursor species of the hydrogen related donor. Additional information about the implantation temperature dependent defect distribution is gained from Fourier-DLTS results.

Comparison of genitourinary and gastrointestinal toxicity among four radiotherapy modalities for prostate cancer: Conventional radiotherapy, intensity-modulated radiotherapy, and permanent iodine-125 implantation with or without external beam radiotherapy

PurposeTo compare late genitourinary (GU) and gastrointestinal (GI) toxicity following different prostate cancer treatment modalities. Materials and methodsThis study included 1084 consecutive prostate cancer patients treated with conventional radiotherapy, intensity-modulated radiotherapy (IMRT), permanent iodine-125 implantation (PI) alone, and PI combined with external beam radiotherapy (PI+EBRT). The effects of treatment- and patient-related factors on late grade⩾2 (G2+) GU/GI toxicity risk were assessed. ResultsThe median follow-up was 43months (range, 12–97months). Compared to the PI+EBRT, there was significantly less G2+ GU toxicity in the conventional radiotherapy (hazard ratio [HR]=0.39; 95% CI, 0.20–0.77) and the IMRT (HR=0.45, 95% CI, 0.27–0.73). Compared to the PI+EBRT, there was significantly more G2+ GI toxicity in the IMRT (HR=2.38; 95% CI, 1.16–4.87). In PI-related groups, prostate equivalent dose in 2Gy fractions was a significant predictor of G2+ GU toxicity (p=0.001), and the rectal volume receiving more than 100% of the prescribed dose was a significant predictor of G2+ GI toxicity (p=0.001). ConclusionThe differences in the late G2+ GU/GI risk cannot be explained by the differences in treatment modalities themselves, but by the total radiation dose to the GU/GI tract, which had a causal role in the development of late G2+ GU/GI toxicity across all treatment modality groups.

Geographic miss with aorto-ostial coronary stent implantation: insights from high-resolution coronary computed tomography angiography

Accurate positioning of aorto-ostial coronary stents is challenging. Coronary CT angiography (CCTA) allows detailed imaging of the coronary sinuses and implanted stents. We utilised CCTA to evaluate the accuracy of aorto-ostial stenting and to assess the efficacy of conventional angiography for guiding these procedures. We analysed 256-row CCTA scans in 23 patients who had undergone aorto-ostial stenting. Optimal stent positioning was defined as presence of the entire circumference of the proximal stent edge within an aorto-ostial landing zone (AOLZ), located within 1 mm of the aorto-ostial plane. Geographic miss was diagnosed when at least a section of the proximal stent edge was located proximal or distal to the AOLZ. CCTA findings were compared with review of the conventional two-dimensional implantation angiogram (two experienced operators). By CCTA, the entire circumference of the proximal stent edge was located within the AOLZ in only three (13%) cases, with geographic miss in the remainder. Conversely, conventional coronary angiography suggested complete lesion coverage to be present in 95% of cases and optimal location of the proximal stent edge within the AOLZ in 76%. Geographic miss was common in aorto-ostial stenting and was underestimated by conventional two-dimensional angiography.

An Alternative Approach for Perioperative Extracorporeal Life Support Implantation.

Central veno-arterial extracorporeal membrane oxygenation (ECMO) is traditionally implanted using direct cannulation of the aorta and right atrium. We aim to summarize the outcome of patients who underwent perioperative central ECMO implantation using an alternative surgical approach, which allows sternum closure and does not require resternotomy at the time of explantation. We retrospectively reviewed patients who required veno-arterial ECMO support at our institution between January 2013 and July 2014. Inclusion criteria were patients undergoing central ECMO implantation using the above-mentioned implantation technique. Nine patients (65 ± 14 years) were supported using this technique. Four patients underwent coronary bypass surgery as a primary surgery and the other five patients had combined coronary and valve surgeries. The average duration of ECMO support was 9 ± 7 days (range 1-24 days). The dominant postoperative complication was renal failure, which occurred in eight patients (89%). In four patients (44%), the ECMO was successfully removed. Survival rate to discharge was 22%. In conclusion, this study showed the feasibility of this alternative ECMO implantation technique. No technical issues were encountered. Extended support duration and reducing resternotomy risks may be the main advantages of this technique compared with conventional ECMO implantation methods.

Cardiac Resynchronization Therapy Delivered Via a Multipolar Left Ventricular Lead is Associated with Reduced Mortality and Elimination of Phrenic Nerve Stimulation: Long-Term Follow-Up from a Multicenter Registry.

Lower Mortality and Eliminated PNS Associated with Quadripolar LeadsIntroductionCardiac resynchronization therapy (CRT) using quadripolar left ventricular (LV) leads provides more pacing vectors compared to bipolar leads. This may avoid phrenic nerve stimulation (PNS) and allow optimal lead placement to maximize biventricular pacing. However, a long‐term improvement in patient outcome has yet to be demonstrated.MethodsA total of 721 consecutive patients with conventional CRTD criteria implanted with quadripolar (n = 357) or bipolar (n = 364) LV leads were enrolled into a registry at 3 UK centers. Lead performance and mortality was analyzed over a 5‐year period.ResultsPatients receiving a quadripolar lead were of similar age and sex to those receiving a bipolar lead, although a lower proportion had ischemic heart disease (62.6% vs. 54.1%, P = 0.02). Both groups had similar rates of procedural success, although lead threshold, impedance, and procedural radiation dose were significantly lower in those receiving a quadripolar lead. PNS was more common in those with quadripolar leads (16.0% vs. 11.6%, P = 0.08), but was eliminated by switching pacing vector in all cases compared with 60% in the bipolar group (P < 0.001). Furthermore, LV lead displacement (1.7% vs. 4.6%, P = 0.03) and repositioning (2.0% vs. 5.2%, P = 0.03) occurred significantly less often in those with a quadripolar lead. All‐cause mortality was also significantly lower in the quadripolar compared to bipolar lead group in univariate and multivariate analysis (13.2% vs. 22.5%, P < 0.001).ConclusionsIn a large, multicenter experience, the use of quadripolar LV leads for CRT was associated with elimination of PNS and lower overall mortality. This has important implications for LV pacing lead choice.

Young age is a positive prognostic factor for residual hearing preservation in conventional cochlear implantation.

To investigate the prognostic significance of various factors in hearing preservation after traditional cochlear implantation (CI). Retrospective case review. Academic tertiary referral center. A total of 153 implantations with mean patient age at implantation of 36 years (from 10 mo to 83 yr) and residual hearing at the frequencies 250, 500, and 1,000 Hz on the unaided preoperative pure-tone audiometry were included. CI with a conventional full-length electrode. The changes on the residual hearing 3 months after implantation were analyzed regarding patients' demographic factors, shape of the preoperative threshold curve, type of the electrode carrier, and approach of electrode insertion in the cochlea. Preservation of residual hearing was defined as measurable postoperative threshold at the frequencies 250, 500, and 1,000 Hz. Preservation of residual hearing was observed in almost half of the cases (47%). In more than half of these patients (54%), a maximal to complete hearing preservation (0-10 dB loss) was achieved. About one-third of these implantations (29%) showed a moderate preservation of residual hearing (11-20 dB loss). In the remaining 17%, the preservation of hearing was marginal (>21 dB loss). Hearing preservation and its extent were significantly better in children and adolescents compared with those in adults. The preservation of residual hearing after conventional CI is possible. Young age seems to have a positive impact on hearing preservation.

Optical coherence tomography evaluation of overlapping everolimus-eluting bioresorbable vascular scaffold implantation guided by enhanced stent visualization system

In a porcine model, implantation of overlapping everolimus-eluting bioresorbable vascular scaffolds (BVS, Abbott Vascular, Santa Clara, California) resulted in delayed strut coverage and higher neointimal response [1] that might lead to important clinical consequences (scaffold thrombosis; in-scaffold restenosis). According to this, any effort to minimize BVS overlap area and the number of overlapping struts is desirable. A bench testing in an in vitro phantom model has shown how to minimize BVS overlap utilizing the platinum markers located at each BVS edge, where the ideal overlap should be achieved when BVS edge markers positioned at 90° to each other, causing the majority of the overlapped struts to be positioned in the cell area between the struts [2]. In the same paper [2], authors stated that trying to intentionally achieve a minimum overlap is highly difficult and that the correct positioning of the BVS markers is practically unachievable during conventional PCI. In fact, the achievement of minimum BVS overlap in daily clinical practice may be difficult mainly because BVS edge markers are poorly visible at normal fluoroscopy. Therefore, the risk of “geographical miss” or long overlap remains high. Enhanced stent visualization (ESV) system guidance has beenwell validated during conventional stent implantation [3]. ESV systems might significantly improve

Comparison of vault after implantation of posterior chamber phakic intraocular lens with and without a central hole

To compare the vault after implantation of a posterior chamber phakic intraocular lens (pIOL) (Visian Implantable Collamer Lens) with and without a central artificial hole for moderate to high ametropia. Department of Ophthalmology, Kitasato University, Kanagawa, Japan. Retrospective comparative study. The study comprised eyes of patients who had central hole pIOL implantation in 1 eye and conventional pIOL implantation in the fellow eye. The time course of the postoperative pIOL vault was quantitatively assessed using a rotating Scheimpflug camera (Pentacam HR). Twenty-three patients (46 eyes) (mean age 31.3 years ± 7.4 [SD]) were enrolled in the study. The amount of vault with the central hole pIOL was 603 ± 276 μm, 552 ± 261 μm, 539 ± 258 μm, 520 ± 240 μm, and 482 ± 245 μm, at 1 week, 1 month, 3 months, 6 months, and 1 year postoperatively, respectively. The amount with the conventional pIOL vault was 585 ± 252 μm, 550 ± 269 μm, 514 ± 253 μm, 485 ± 233 μm, and 459 ± 239 μm, respectively. There was no significant association between the pIOL vault and the refractive accuracy 1 year postoperatively (Spearman correlation coefficient r = 0.18, P = 0.41 for central hole pIOL and r = 0.07, P = .76 for conventional pIOL). The vault of the new central hole pIOL appeared to be essentially equivalent to the vault of the conventional pIOL, suggesting that the presence of the central hole did not significantly affect the vault or the refractive accuracy. Dr. Shimizu is a consultant to Staar Surgical Co. and has assisted with the development of patented technologies. No other author has a financial or proprietary interest in any material or method mentioned.

Tissue-engineered heart valve with a tubular leaflet design for minimally invasive transcatheter implantation.

Transcatheter aortic valve implantation of (nonviable) bioprosthetic valves has been proven a valid alternative to conventional surgical implantation in patients at high or prohibitive mortality risk. In this study we present the in vitro proof-of-principle of a newly developed tissue-engineered heart valve for minimally invasive implantation, with the ultimate aim of adding the unique advantages of a living tissue with regeneration capabilities to the continuously developing transcatheter technologies. The tube-in-stent is a fibrin-based tissue-engineered valve with a tubular leaflet design. It consists of a tubular construct sewn into a self-expandable nitinol stent at three commissural attachment points and along a circumferential line so that it forms three coaptating leaflets by collapsing under diastolic back pressure. The tubular constructs were molded with fibrin and human umbilical vein cells. After 3 weeks of conditioning in a bioreactor, the valves were fully functional with unobstructed opening (systolic phase) and complete closure (diastolic phase). Tissue analysis showed a homogeneous cell distribution throughout the valve's thickness and deposition of collagen types I and III oriented along the longitudinal direction. Immunohistochemical staining against CD31 and scanning electron microscopy revealed a confluent endothelial cell layer on the surface of the valves. After harvesting, the valves underwent crimping for 20 min to simulate the catheter-based delivery. This procedure did not affect the valvular functionality in terms of orifice area during systole and complete closure during diastole. No influence on the extracellular matrix organization, as assessed by immunohistochemistry, nor on the mechanical properties was observed. These results show the potential of combining tissue engineering and minimally invasive implantation technology to obtain a living heart valve with a simple and robust tubular design for transcatheter delivery. The effect of the in vivo remodeling on the functionality of the tube-in-stent valve remains to be tested.

Alternative right ventricular assist device implantation technique for patients with perioperative right ventricular failure

ObjectivesTemporary right ventricular assist devices (RVADs) may be required to support patients with perioperative refractory right ventricular failure (RVF). We report on our experience using a different technique of RVAD implantation that does not necessitate resternotomy at the time of RVAD removal. MethodsPatients with perioperative RVF who underwent temporary RVAD implantation between January 2010 and February 2014 were reviewed. A dacron graft was attached to the pulmonary artery and passed through a subxiphoid exit, where the RVAD outflow cannula was inserted. The inflow cannula was percutaneously cannulated in the femoral vein, and the sternum was primarily closed. On the day of RVAD explantation, the outflow graft of the RVAD was pulled and ligated, and the insertion site was secondarily closed. The RVAD inflow cannula was removed, and direct pressure was applied. ResultsTwenty-one patients (age 58 ± 14 years) were supported. Seventeen patients (81%) had RVF after left ventricular assist device implantation, and 4 patients developed postcardiotomy RVF. The median duration of RVAD support was 9 days (range: 2-88 days). Eleven patients (52%) were successfully weaned from the RVAD. Two patients were bridged to transplantation. Eight patients died on left ventricular assist device and/or RVAD support. The survival rates to discharge or heart transplantation, and to 1-year, were 62% and 52%, respectively. ConclusionsNo technical issues were encountered in this large series of RVAD implantations using the described technique for various forms of postoperative RVF. Extended support duration and reduction of resternotomy risks may be the main advantages of this technique compared with conventional RVAD implantation methods.

Jarvik 2000: evolution of surgical implantation from conventional to minimally invasive technique.

The Jarvik 2000 is a continuous axial flow left ventricular assist device (LVAD) with an impeller type pump. It has a unique power delivery system, which is tunneled to a retro-auricular skull pedestal in order to minimize driveline infections (1). Conventional implantation of the Jarvik 2000 is performed off-pump through a left postero-lateral thoracotomy, with the outflow conduit anastomosed to the descending aorta. An alternative technique is performed through a full sternotomy, on cardiopulmonary bypass, with the outflow graft anastomosed to the ascending aorta (1-3). In both cases, the pump is implanted at the left ventricular apex. We describe an evolution of the Jarvik 2000 implantation technique, using a less invasive approach to surgery and perfusion (4) (Video 1). Video 1 Jarvik 2000: evolution of surgical implantation from conventional to minimally invasive technique. Case 1—Conventional implantation via postero-lateral thoracotomy Clinical vignette A 62-year-old man presented with primary dilated cardiomyopathy, severe left ventricular dysfunction, severe pulmonary hypertension, high pulmonary vascular resistance, and was graded as INTERMACS class 2. A Jarvik 2000 was implanted as a bridge to transplant.

8 * Submammary device implantation: long-term results

Conventional pacemaker and ICD implantation in women can be disfiguring with adverse psychological and social effects. The submammary position, between breast capsule and pre-pectoral fascia, allows devices to be hidden with good tissue cover. Implantation is by a small infraclavicular incision for vein access and lead fixation; a second incision lateral or inferior to the breast gives acces to the submammary plane for creation of the pocket. The lead(s) are tunnelled to the pocket and the device implanted in a central retromammary position. The lower incision is closed in 4 layers and the upper in 2. Details of the technique are discussed. The results of 131 consecutive single-operator procedures on 74 women, age 15–79 (mean 42) years between 1986 and 2013 are reported. The devices were pacemakers (118), ICDs (11) and Internal loop recorders (2). The initial procedures were primary implants (70) and revision or replacement of existing systems (5). Further procedures were generator replacement (35), lead revision, replacement or addition (11), pocket revision (6), system replacement (2) and system removal (2). Early complications were small pneumothorax (2) and lead displacement (5). There was no loss of sensation in the breast and no persistant discomfort or limitation of movement except in some cases of device migration. Average follow-up from initial procedure is over 12 years (3–327 months, mean 145). Late complications were device migration (7), skin erosion and infection (3) and lead failure (3). Further procedures were undertaken by other operators: device replacement (4) lead revision (1) and upgrade to ICD (1). Four patients have died from non-device-related causes. Present follow-up status is unknown for 4 patients. Submammary device implantation is a safe and successful procedure. Developments in technique over the study period have reduced complications especially lead displacement and device migration.

Characteristics of GaN-Based Bipolar Transistors on Sapphire Substrates With the n-Type Emitter Region Formed Using Si-Ion Implantation

We have investigated the possibility of being able to create gallium nitride bipolar junction transistors (GaN BJTs) whose n-type emitter region is formed using a conventional Si-ion implantation technology. The thermal stability of the p-GaN layer, which was the most important technique in creating GaN BJTs, was found to be maintained even after annealing at 1100 °C. A Hall-effect measurement revealed that the n-type emitter region, which was formed using 2.0 × 10 <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">15</sup> cm <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">-2</sup> Si-ion implantation within the p-GaN base layer, has a sheet carrier density of 1.59 × 10 <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">14</sup> cm <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">-2</sup> (i.e., a carrier activation ratio of 8%), an electron mobility of 41.0 cm <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">2</sup> /Vs, and a sheet resistance of 958 Q/sq. The fabricated GaN BJTs had a maximum dc current gain of 160 and a maximum differential current gain of 238. These results show that Si-ion implantation is a promising technique for forming an n-type emitter of GaN BJTs. However, some of the transistor characteristics were found to be limited possibly by the Si-ion implantation-induced large base resistance.

Plasma Doping of InGaAs at Elevated Substrate Temperature for Reduced Sheet Resistance and Defect Formation

Plasma doping (PLAD), a high-throughput ion implantation technique capable of achieving ultrashallow junctions and conformal doping of 3-D structures such as fin field-effect transistors, is investigated as an alternative to conventional beam-line ion implantation for InGaAs at advanced technology nodes. The PLAD at an elevated substrate temperature (ET-PLAD) is studied and reported for InGaAs for the first time. The ET-PLAD can give lower sheet resistance than room-temperature PLAD due to enhanced dopant incorporation. More crucially, an ET can help to prevent amorphization. After dopant activation anneal, residual corner defects are observed in small fins that are amorphized during plasma ion implantation, whereas fins that remain crystalline during plasma ion implantation are free of corner defects.

Bone‐Anchored Hearing Aid Implantation Using the Cochlear BA400 System: Early Experience and Patient‐Reported Outcomes

Objectives: Several contemporary bone-anchored hearing aid (BAHA) surgical techniques have been described with the common goal of minimizing soft-tissue reduction, which may benefit patients, surgeons, and audiologists alike. Recently, the hydroxyapatite coated Cochlear BA400 abutment was introduced, the first designed specifically for soft tissue preservation. We present our early experience of this system with corresponding patient-reported outcomes. Methods: Data were collected prospectively on the first 25 patients implanted with the BA400 system at our institution (February-September 2013). The Glasgow Benefit Inventory (GBI) was subsequently used to evaluate patient-perceived quality of life in all patients 4 months following sound processor fitting. Results: Mean patient age was 61 years (range, 23-91 years). BAHA was indicated for single-sided deafness in 6 cases (24%) and for conductive or mixed loss when a conventional aid was contraindicated in the remainder. Procedures were performed under local anaesthetic in all but 1 case. Mean operating time was 14 minutes (range, 9-22 minutes). Four patients (16%) suffered implant site soft tissue reactions which were all successfully managed conservatively and graded as follows: Holger’s grade 1 (n = 2), 2 (n = 1), and 3 (n = 1). No other complications were observed. Respective overall, general health, social support, and physical health GBI benefit mean scores were +33 (95% confidence interval [CI]; 27-39), +46 (95% CI; 37-55), +15 (95% CI; 5-25), and 0 (95% CI; –8 to 8). Conclusions: Our data support use of the soft tissue preserving Cochlear BA400 implant system, with shorter operating times, comparable soft-tissue outcomes, and favorable patient-reported quality-of-life when compared with conventional BAHA implantation techniques.

Direct Drug-Eluting Stenting to Reduce Stent Restenosis: A Randomized Comparison of Direct Stent Implantation to Conventional Stenting With Pre-Dilation or Provisional Stenting in Elective PCI Patients

The aim was to investigate whether a strategy of direct drug-eluting stent (DES) implantation without pre-dilation is associated with a reduced incidence of restenosis compared with CS with pre-dilation or provisional stenting (PS). Previous studies were performed comparing direct stenting (DS) with conventional stenting (CS) after pre-dilation; however, none of these in the DES era. Therefore, the STRESSED (direct Stenting To reduce REStenosis in Stent Era with Drug elution) study was designed and carried out. A total of 600 patients with angina pectoris or recent myocardial infarction were randomized to a DS, CS, or PS strategy. The primary endpoint was the mean minimal lumen diameter at 9-month follow-up angiography. Secondary endpoints were clinical procedural success defined as angiographic success without in-hospital major adverse cardiac events (MACE), and MACE at 9-month and 2-year follow-up. Stent implantation in the DS group was 98%, 99% in the CS group, and 77% in the PS group. Percutaneous coronary intervention success was 99% in all groups. The minimal lumen diameter at 9-month follow-up was 2.12 ± 0.58 mm (DS), 2.17 ± 0.67 mm (CS), and 1.99 ± 0.69 mm (PS), p= 0.556 for comparison of DS with CS, p= 0.073 for comparison of DS with PS. The absolute difference was-0.05 (DS to CS), 95% confidence interval:-0.19 to-0.09, p= 0.48 and 0.13 (DS to PS), confidence interval:-0.02 to-0.27, p= 0.087. Restenosis was found in 3.4% (DS), 6.7% (CS), and 11.5% (PS), p=0.025. At 9-month and 2-year follow-up, MACE occurred in 6.8% and 11.5% (DS), 4.6% and 10.3% (CS), and 7.6% and 13.8% (PS) (p= 0.439 and 0.536), respectively. Direct DES implantation compared with conventional DES implantation did not reduce restenosis. Provisional stenting, however, was associated with a higher rate of restenosis. This did not translate into a difference in the rate of MACE. (STRESSED study: direct Stenting To reduce REStenosis in Stent Era with Drug elution; ISRCTN41213536).

Prostaglandin therapy during the proliferative phase improves pregnancy rates following frozen embryo transfer in a hormone replacement cycle

To determine the efficacy of prostaglandin administration during the proliferative phase in order to improve pregnancy rates following frozen embryo transfer during a hormone replacement cycle (HRC). From September 2010 through March 2012, patients (n = 135) were recruited who had undergone oocyte retrieval during a stimulation cycle with clomiphene and had deferred fresh embryo transfer (ET) due to a thin uterine endometrium. All patients were less than 40 years of age and underwent thawed ET following all embryo cryopreservation, and were randomly divided into two groups for thawed ET using a conventional hormone replacement cycle with or without prostaglandin derivatives (prostaglandin or conventional group). Prostaglandin derivatives were administrated during the proliferative phase. Pregnancy and implantation rates following frozen ET were compared between the two groups. Although the endometrial thickness on the day of ET was similar for the prostaglandin and conventional groups, the pregnancy and implantation rates for the prostaglandin group were 40.0% and 22.0%, respectively, which was significantly higher than the rates for the conventional group (P < 0.01). Among patients who avoided fresh ET due to a thin endometrium, the pregnancy rate following a thawed cycle was low. However, it was improved when prostaglandin derivatives were used during the proliferative phase.

In vivo high-content evaluation of three-dimensional scaffolds biocompatibility.

While developing tissue engineering strategies, inflammatory response caused by biomaterials is an unavoidable aspect to be taken into consideration, as it may be an early limiting step of tissue regeneration approaches. We demonstrate the application of flat and flexible films exhibiting patterned high-contrast wettability regions as implantable platforms for the high-content in vivo study of inflammatory response caused by biomaterials. Screening biomaterials by using high-throughput platforms is a powerful method to detect hit spots with promising properties and to exclude uninteresting conditions for targeted applications. High-content analysis of biomaterials has been mostly restricted to in vitro tests where crucial information is lost, as in vivo environment is highly complex. Conventional biomaterials implantation requires the use of high numbers of animals, leading to ethical questions and costly experimentation. Inflammatory response of biomaterials has also been highly neglected in high-throughput studies. We designed an array of 36 combinations of biomaterials based on an initial library of four polysaccharides. Biomaterials were dispensed onto biomimetic superhydrophobic platforms with wettable regions and processed as freeze-dried three-dimensional scaffolds with a high control of the array configuration. These chips were afterward implanted subcutaneously in Wistar rats. Lymphocyte recruitment and activated macrophages were studied on-chip, by performing immunocytochemistry in the miniaturized biomaterials after 24 h and 7 days of implantation. Histological cuts of the surrounding tissue of the implants were also analyzed. Localized and independent inflammatory responses were detected. The integration of these data with control data proved that these chips are robust platforms for the rapid screening of early-stage in vivo biomaterials' response.

O150 Long term efficacy and safety of transseptal endocardial left ventricular lead implantation in failed conventional CRT implantations

O150 Long term efficacy and safety of transseptal endocardial left ventricular lead implantation in failed conventional CRT implantations