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Sample records for glaucoma valve implant

  1. A Novel Implantable Glaucoma Valve Using Ferrofluid

    PubMed Central

    Paschalis, Eleftherios I.; Chodosh, James; Sperling, Ralph A.; Salvador-Culla, Borja; Dohlman, Claes

    2013-01-01

    Purpose To present a novel design of an implantable glaucoma valve based on ferrofluidic nanoparticles and to compare it with a well-established FDA approved valve. Setting Massachusetts Eye & Ear Infirmary, Boston, USA. Methods A glaucoma valve was designed using soft lithography techniques utilizing a water-immiscible magnetic fluid (ferrofluid) as a pressure-sensitive barrier to aqueous flow. Two rare earth micro magnets were used to calibrate the opening and closing pressure. In-vitro flow measurements were performed to characterize the valve and to compare it to Ahmed™ glaucoma valve. The reliability and predictability of the new valve was verified by pressure/flow measurements over a period of three months and X-ray diffraction (XRD) analysis over a period of eight weeks. In vivo assessment was performed in three rabbits. Results In the in vitro experiments, the opening and closing pressures of the valve were 10 and 7 mmHg, respectively. The measured flow/pressure response was linearly proportional and reproducible over a period of three months (1.8 µl/min at 12 mmHg; 4.3 µl/min at 16 mmHg; 7.6 µl/min at 21 mmHg). X-ray diffraction analysis did not show oxidization of the ferrofluid when exposed to water or air. Preliminary in vivo results suggest that the valve is biocompatible and can control the intraocular pressure in rabbits. Conclusions The proposed valve utilizes ferrofluid as passive, tunable constriction element to provide highly predictable opening and closing pressures while maintaining ocular tone. The ferrofluid maintained its magnetic properties in the aqueous environment and provided linear flow to pressure response. Our in-vitro tests showed reliable and reproducible results over a study period of three months. Preliminary in-vivo results were very promising and currently more thorough investigation of this device is underway. PMID:23840691

  2. Ahmed glaucoma valve implant: surgical technique and complications

    PubMed Central

    Riva, Ivano; Roberti, Gloria; Oddone, Francesco; Konstas, Anastasios GP; Quaranta, Luciano

    2017-01-01

    Implantation of Ahmed glaucoma valve is an effective surgical technique to reduce intraocular pressure in patients affected with glaucoma. While in the past, the use of this device was reserved to glaucoma refractory to multiple filtration surgical procedures, up-to-date mounting experience has encouraged its use also as a primary surgery for selected cases. Implantation of Ahmed glaucoma valve can be challenging for the surgeon, especially in patients who already underwent previous multiple surgeries. Several tips have to be acquired by the surgeon, and a long learning curve is always needed. Although the valve mechanism embedded in the Ahmed glaucoma valve decreases the risk of postoperative hypotony-related complications, it does not avoid the need of a careful follow-up. Complications related to this type of surgery include early and late postoperative hypotony, excessive capsule fibrosis around the plate, erosion of the tube or plate edge, and very rarely infection. The aim of this review is to describe surgical technique for Ahmed glaucoma valve implantation and to report related complications. PMID:28255226

  3. A Review of the Ahmed Glaucoma Valve Implant and Comparison with Other Surgical Operations.

    PubMed

    Riva, Ivano; Roberti, Gloria; Katsanos, Andreas; Oddone, Francesco; Quaranta, Luciano

    2017-04-01

    The Ahmed glaucoma valve (AGV) is a popular glaucoma drainage implant used for the control of intraocular pressure in patients with glaucoma. While in the past AGV implantation was reserved for glaucoma patients poorly controlled after one or more filtration procedures, mounting evidence has recently encouraged its use as a primary surgery in selected cases. AGV has been demonstrated to be safe and effective in reducing intraocular pressure in patients with primary or secondary refractory glaucoma. Compared to other glaucoma surgeries, AGV implantation has shown favorable efficacy and safety. The aim of this article is to review the results of studies directly comparing AGV with other surgical procedures in patients with glaucoma.

  4. Outcomes of Ahmed glaucoma valve implantation in advanced primary congenital glaucoma with previous surgical failure

    PubMed Central

    Huang, Jingjing; Lin, Jialiu; Wu, Ziqiang; Xu, Hongzhi; Zuo, Chengguo; Ge, Jian

    2015-01-01

    Purpose The purpose of this study was to evaluate the intermediate surgical results of Ahmed glaucoma valve (AGV) implantation in patients less than 7 years of age, with advanced primary congenital glaucoma who have failed previous surgeries. Patients and methods Consecutive patients with advanced primary congenital glaucoma that failed previous operations and had undergone subsequent AGV implantation were evaluated retrospectively. Surgical success was defined as 1) intraocular pressure (IOP) ≥6 and ≤21 mmHg; 2) IOP reduction of at least 30% relative to preoperative values; and 3) without the need for additional surgical intervention for IOP control, loss of light perception, or serious complications. Results Fourteen eyes of eleven patients were studied. Preoperatively, the average axial length was 27.71±1.52 (25.56–30.80) mm, corneal diameter was 14.71±1.07 (13.0–16.0) mm, cup-to-disc ratio was 0.95±0.04 (0.9–1.0), and IOP was 39.5±5.7 (30–55) mmHg. The mean follow-up time was 18.29±10.96 (5–44, median 18) months. There were significant reductions in IOPs and the number of glaucoma medications (P<0.001) postoperatively. The IOPs after operation were 11.3±3.4, 13.6±5.1, 16.3±2.7, and 16.1±2.6 mmHg at 1 month, 6 months, 12 months, and 18 months, respectively. Kaplan–Meier estimates of the cumulative probability of valve success were 85.7%, 71.4%, and 71.4% at 6, 12, and 18 months, respectively. Severe surgical complications, including erosion of tube, endophthalmitis, retinal detachment, choroidal detachment, and delayed suprachoroidal hemorrhage, occurred in 28.6% cases. Conclusion AGV implantation remains a viable option for patients with advanced primary congenital glaucoma unresponsive to previous surgical intervention, despite a relatively high incidence of severe surgical complications. PMID:26082610

  5. Complication of an Ahmed glaucoma valve implant: tube exposure with methicillin-resistant Staphylococcus aureus infection

    PubMed Central

    Pansegrau, Morgan L.; Mengarelli, Eddie; Dersu, Inci Irak

    2015-01-01

    Summary Neovascular glaucoma is commonly treated surgically with implantation of glaucoma drainage devices. We report the case of a 57-year-old man who underwent an uneventful Ahmed glaucoma valve (AGV) placement for radiation-induced neovascular glaucoma but later developed early postoperative infection with tube exposure. The infection was identified 3 weeks postoperatively and antibiotic treatment was immediately initiated. However, the conjunctival melt progressed, and the AGV had to be removed. Culture of the device revealed methicillin-resistant Staphylococcus aureus (MRSA). There is a potential increased risk of postoperative infection and tube exposure following glaucoma valve implantation in patients with previous radiation therapy. To our knowledge, this is the second case in the literature of MRSA causing early postoperative infection following drainage device placement that required explantation. PMID:27330471

  6. Bilateral Ocular Decompression Retinopathy after Ahmed Valve Implantation for Uveitic Glaucoma

    PubMed Central

    Flores-Preciado, Javier; Ancona-Lezama, David Arturo; Valdés-Lara, Carlos Andrés; Díez-Cattini, Gian Franco; Coloma-González, Itziar

    2016-01-01

    Case Report We report the case of a 29-year-old man who underwent Ahmed valve implantation in both eyes as treatment for uveitic glaucoma, subsequently presenting with bilateral ocular decompression retinopathy in the postoperative period. Discussion Ocular decompression retinopathy is a rare complication of filtering surgery in patients with glaucoma; however, the course is benign in most cases, with spontaneous resolution of bleedings and improvement of visual acuity. PMID:27920718

  7. Trabeculectomy with Ex-PRESS implant versus Ahmed glaucoma valve implantation-a comparative study

    PubMed Central

    Waisbourd, Michael; Fischer, Naomi; Shalev, Hadas; Spierer, Oriel; Ben Artsi, Elad; Rachmiel, Rony; Shemesh, Gabi; Kurtz, Shimon

    2016-01-01

    AIM To compare the surgical outcomes of trabeculectomy with Ex-PRESS implant and Ahmed glaucoma valve (AGV) implantation. METHODS Patients who underwent trabeculectomy with Ex-PRESS implants or AGV implantation separately were included in this retrospective chart review. Main outcome measures were surgical failure and complications. Failure was defined as intraocular pressure (IOP) >21 mm Hg or <5 mm Hg on two consecutive visits after 3mo, reoperation for glaucoma, or loss of light perception. Eyes that had not failed were considered as complete success if they did not required supplemental medical therapy. RESULTS A total of 64 eyes from 57 patients were included: 31 eyes in the Ex-PRESS group and 33 eyes in the AGV group. The mean follow-up time was 2.6±1.1y and 3.3±1.6y, respectively. Patients in the AGV group had significantly higher baseline mean IOP (P=0.005), lower baseline mean visual acuity (VA) (P=0.02), and higher proportion of patients with history of previous trabeculectomy (P<0.0001). Crude failure rates were 16.1%, n=5/31 in the Ex-PRESS group and 24.2%, n=8/33 in the AGV group. The cumulative proportion of failure was similar between the groups, P=0.696. The proportion of eyes that experienced postoperative complications was 32.3% in the Ex-PRESS group and 60.1% in the AGV group (P=0.0229). CONCLUSION Trabeculectomy with Ex-PRESS implant and AGV implantation had comparable failure rates. The AGV group had more post-operative complications, but also included more complex cases with higher baseline mean IOP, worse baseline mean VA, and more previous glaucoma surgeries. Therefore, the results are limited to the cohort included in this study. PMID:27803857

  8. Wound Dehiscence and Device Migration after Subconjunctival Bevacizumab Injection with Ahmed Glaucoma Valve Implantation

    PubMed Central

    Miraftabi, Arezoo; Nilforushan, Naveed

    2016-01-01

    Purpose: To report a complication pertaining to subconjunctival bevacizumab injection as an adjunct to Ahmed Glaucoma Valve (AGV) implantation. Case Report: A 54-year-old woman with history of complicated cataract surgery was referred for advanced intractable glaucoma. AGV implantation with adjunctive subconjunctival bevacizumab (1.25 mg) was performed with satisfactory results during the first postoperative week. However, 10 days after surgery, she developed wound dehiscence and tube exposure. The second case was a 33-year-old man with history of congenital glaucoma and uncontrolled IOP who developed AGV exposure and wound dehiscence after surgery. In both cases, for prevention of endophthalmitis and corneal damage by the unstable tube, the shunt was removed and the conjunctiva was re-sutured. Conclusion: The potential adverse effect of subconjunctival bevacizumab injection on wound healing should be considered in AGV surgery. PMID:27195095

  9. Disorder of blood-aqueous barrier following Ahmed Glaucoma Valve implantation.

    PubMed

    Zhou, Min-Wen; Wang, Wei; Chen, Shi-da; Huang, Wen-Bin; Zhang, Xiu-Lan

    2013-03-01

    Ahmed Glaucoma Valve implantation (AGVI) is used to treat refractory glaucoma. Breakdown of the blood-aqueous barrier (BAB) has been noted after some surgical techniques. The current study was designed to assess BAB disruption after AGVI. Anterior chamber protein content was measured by the laser flare cell photometry in 22 eyes of 22 patients with refractory glaucoma before AGVI and at each postoperative visit up to 1 month. Before AGVI the mean aqueous flare values in all eyes were (15.17 ± 9.84) photon counts/ms. After AGVI, the values significantly increased at day 1, day 3, and week 1 compared to those before AGVI (all P < 0.05) with a peak at day 3. They returned to pre-operative levels at week 2, and were lower than preoperative level at month 1. Eyes with previous intraocular surgery history had greater aqueous flare values than those without previous intraocular surgery history, but there were no significant differences at all time points postoperatively (all P > 0.05). Furthermore, eyes with shallow anterior chambers had greater aqueous flare values at day 3 and week 1 (all P < 0.05). When comparing eyes with other refractory glaucoma conditions, neovascular glaucoma combined with intravitreal bevacizumab injection resulted in lower aqueous flare values after AGVI, but no significant differences were observed at all time points, postoperatively (all P > 0.05). The BAB was impaired and inflammation was present in the anterior chamber in refractory glaucomatous eyes following AGVI. However, such conditions were resolved within 1 month postoperatively. Intravitreal bevacizumab treatment in neovascular glaucoma eyes before AGVI may prevent BAB breakdown.

  10. Evaluation of Ahmed glaucoma valve implantation through a needle-generated scleral tunnel in Mexican children with glaucoma

    PubMed Central

    Albis-Donado, Oscar; Gil-Carrasco, Félix; Romero-Quijada, Rafael; Thomas, Ravi

    2010-01-01

    Purpose: To evaluate the results and extrusion rates of the Ahmed glaucoma valve (AGV) implantation through a needle-generated scleral tunnel, without a tube-covering patch, in children. Materials and Methods: A retrospective review of the charts of 106 Mexican children implanted with 128 AGVs operated between 1994 and 2002, with the needle track technique, at our institution, with at least six months follow up was done. Main outcome measures were intraocular pressure (IOP) control, tube extrusions or exposure and other complications. Results: Kaplan-Meier analysis demonstrated a 96.9% survival rate at six months, 82.4% at one year, 78.7% at two years, 70% at three years and 41.6% at four years. Total success at the last follow-up (IOP between 6 and 21 mm Hg without medications) was achieved in 30 eyes (23.5%), 58 eyes (45.3%) had qualified success (only topical hypotensive drugs) and 40 eyes (31.3%) were failures. The mean pre- and post-operative IOP at the last follow up was 28.4 mmHg (SD 9.3) and 14.5 mmHg (SD 6.3), respectively. No tube extrusions or exposures were observed. Tube-related complications included five retractions, a lens touch and a transitory endothelial touch. The risk of failure increased if the eye had any complication or previous glaucoma surgeries. Conclusion: Medium-term IOP control in Mexican children with glaucoma can be achieved with AGV implantation using a needle-generated tunnel, without constructing a scleral flap or using a patch to cover the tube. There were no tube extrusions, nor any tube exposures with this technique. PMID:20689189

  11. Intraocular Pressure Control after Implantation of an Ahmed Glaucoma Valve in Eyes with a Failed Trabeculectomy.

    PubMed

    Schimiti, Rui B; Abe, Ricardo Y; Tavares, Carla M; Vasconcellos, Jose Pc; Costa, Vital P

    2016-01-01

    To evaluate the results of Ahmed glaucoma valve (AGV) in eyes with a failed trabeculectomy. This retrospective study evaluated 61 eyes with a failed trabeculectomy that underwent implantation of an AGV due to uncontrolled intraocular pressure (IOP) on maximal medical therapy. Success was defined as IOP ≤ 21 mm Hg (criterion 1) or 20% reduction in IOP (criterion 2) with or without antiglaucoma medications. Persistent hypotony, loss of light perception, and reoperation for IOP control were defined as failure. Mean preoperative IOP and mean lOPs at 6, 12, and 24 months were 21.93 ± 6.32 mm Hg (n = 61), 14.15 ± 4.33 mm Hg (n = 59), 13.21 ± 4.44 mm Hg (n = 56), and 13.60 ± 3.27 mm Hg (n = 25) respectively. Mean number of antiglaucoma medications preoperatively and at 6, 12, and 24 months was 3.95 ± 0.85, 2.19 ± 1.38, 2.48 ± 1.44, and 2.40 ± 1.32 respectively. The reductions in the number of medications and IOP measurements were statistically significant at all time intervals (p < 0.001, Wilcoxon signed rank test). According to criterion 1, the Kaplan-Meier survival curve disclosed success rates of 75% at 12 and 24 months. According to criterion 2, the success rates were 57% at 12 months and 55% at 24 months. The most frequent complications were hypertensive phase (18%) and shallow anterior chamber (16.4%). The AGV may effectively reduce IOP in eyes that had a failed trabeculectomy. The AGV is an alternative in eyes with a failed trabeculectomy. Schimiti RB, Abe RY, Tavares CM, Vasconcellos JPC, Costa VP. Intraocular Pressure Control after Implantation of an Ahmed Glaucoma Valve in Eyes with a Failed Trabeculectomy. J Curr Glaucoma Pract 2016;10(3):97-103.

  12. Intraocular pressure control after the implantation of a second Ahmed glaucoma valve.

    PubMed

    Jiménez-Román, Jesús; Gil-Carrasco, Félix; Costa, Vital Paulino; Schimiti, Rui Barroso; Lerner, Fabián; Santana, Priscila Rezende; Vascocellos, Jose Paulo Cabral; Castillejos-Chévez, Armando; Turati, Mauricio; Fabre-Miranda, Karina

    2016-06-01

    The objective of this study is to evaluate the efficacy and safety of a second Ahmed glaucoma valve (AGV) in eyes with refractory glaucoma that had undergone prior Ahmed device implantation. This multicenter, retrospective study evaluated 58 eyes (58 patients) that underwent a second AGV (model S2-n = 50, model FP7-n = 8) due to uncontrolled IOP under maximal medical therapy. Outcome measures included IOP, visual acuity, number of glaucoma medications, and postoperative complications. Success was defined as IOP <21 mmHg (criterion 1) or 30 % reduction of IOP (criterion 2) with or without hypotensive medications. Persistent hypotony (IOP <5 mmHg after 3 months of follow-up), loss of light perception, and reintervention for IOP control were defined as failure. Mean preoperative IOP and mean IOPs at 12 and 30 months were 27.55 ± 1.16 mmHg (n = 58), 14.45 ± 0.83 mmHg (n = 42), and 14.81 ± 0.87 mmHg (n = 16), respectively. The mean numbers of glaucoma medications preoperatively at 12 and 30 months were 3.17 ± 0.16 (n = 58), 1.81 ± 0.2 (n = 42), and 1.83 ± 0.35 (n = 18), respectively. The reductions in mean IOP and number of medications were statistically significant at all time intervals (P < 0.001). According to criterion 1, Kaplan-Meier survival curves disclosed success rates of 62.9 % at 12 months and 56.6 % at 30 months. According to criterion 2, Kaplan-Meier survival curves disclosed success rates of 43.9 % at 12 months and 32.9 % at 30 months. The most frequent early complication was hypertensive phase (10.3 %) and the most frequent late complication was corneal edema (17.2 %). Second AGV implantation may effectively reduce IOP in eyes with uncontrolled glaucoma, and is associated with relatively few complications.

  13. Effect of mitomycin c and 5-flurouracil adjuvant therapy on the outcomes of Ahmed glaucoma valve implantation.

    PubMed

    Cui, Qi N; Hsia, Yen C; Lin, Shan C; Stamper, Robert L; Rose-Nussbaumer, Jennifer; Mehta, Nitisha; Porco, Travis C; Naseri, Ayman; Han, Ying

    2017-03-01

    To examine the effect of mitomycin c and 5-flurouracil on treatment outcomes following Ahmed glaucoma valve implantation. Retrospective consecutive case series. Fifty patients who received Ahmed glaucoma valve implantation from 1999 to 2013 in the San Francisco Veterans Administration Hospital. The +INJECTION group received intraoperative mitomycin c followed by postoperative mitomycin c and/or 5-flurouracil, whereas the -INJECTION group did not. Primary outcome was treatment success at 1 year post-implantation. Intraocular pressure, hypertensive phase, and the number of glaucoma medications were also examined. Twenty-six patients/eyes in the +INJECTION group and 24 patients/eyes in the -INJECTION group were included. Treatment success was higher in the +INJECTION compared with the -INJECTION group (86 vs. 58%; P = 0.04). Intraocular pressure was lower in the +INJECTION compared with the -INJECTION group at 1, 3, 6 and 12 months (P ≪ 0.00001, P = 0.00003, 0.0008 and 0.024). Hypertensive phase occurred less often in the +INJECTION compared with the -INJECTION group (3.8 vs. 54%; P = 0.021). The +INJECTION group required fewer medications compared with the -INJECTION group (P = 0.02, 0.002, 0.003 and 0.008 at 1, 3, 6 and 12 months). Complication rates were comparable between groups (46.2 and 54.2%; P = 0.63). Adjuvant treatment with antifibrotics following Ahmed glaucoma valve implantation decreased the hypertensive phase and improved surgical outcomes without impacting complication rates at 1 year. This study postulates a role for antifibrotics in the postoperative management of Ahmed glaucoma valves. © 2016 Royal Australian and New Zealand College of Ophthalmologists.

  14. Intraocular Pressure Control after Implantation of an Ahmed Glaucoma Valve in Eyes with a Failed Trabeculectomy

    PubMed Central

    Schimiti, Rui B; Abe, Ricardo Y; Tavares, Carla M; Vasconcellos, Jose PC; Costa, Vital P

    2016-01-01

    Aim To evaluate the results of Ahmed glaucoma valve (AGV) in eyes with a failed trabeculectomy. Materials and methods This retrospective study evaluated 61 eyes with a failed trabeculectomy that underwent implantation of an AGV due to uncontrolled intraocular pressure (IOP) on maximal medical therapy. Success was defined as IOP ≤ 21 mm Hg (criterion 1) or 20% reduction in IOP (criterion 2) with or without antiglaucoma medications. Persistent hypotony, loss of light perception, and reoperation for IOP control were defined as failure. Results Mean preoperative IOP and mean lOPs at 6, 12, and 24 months were 21.93 ± 6.32 mm Hg (n = 61), 14.15 ± 4.33 mm Hg (n = 59), 13.21 ± 4.44 mm Hg (n = 56), and 13.60 ± 3.27 mm Hg (n = 25) respectively. Mean number of antiglaucoma medications preoperatively and at 6, 12, and 24 months was 3.95 ± 0.85, 2.19 ± 1.38, 2.48 ± 1.44, and 2.40 ± 1.32 respectively. The reductions in the number of medications and IOP measurements were statistically significant at all time intervals (p < 0.001, Wilcoxon signed rank test). According to criterion 1, the Kaplan-Meier survival curve disclosed success rates of 75% at 12 and 24 months. According to criterion 2, the success rates were 57% at 12 months and 55% at 24 months. The most frequent complications were hypertensive phase (18%) and shallow anterior chamber (16.4%). Conclusion The AGV may effectively reduce IOP in eyes that had a failed trabeculectomy. Clinical significance The AGV is an alternative in eyes with a failed trabeculectomy. How to cite this article Schimiti RB, Abe RY, Tavares CM, Vasconcellos JPC, Costa VP. Intraocular Pressure Control after Implantation of an Ahmed Glaucoma Valve in Eyes with a Failed Trabeculectomy. J Curr Glaucoma Pract 2016;10(3):97-103. PMID:27857489

  15. Adjunctive triamcinolone acetonide for Ahmed glaucoma valve implantation: a randomized clinical trial.

    PubMed

    Yazdani, Shahin; Doozandeh, Azadeh; Pakravan, Mohammad; Ownagh, Vahid; Yaseri, Mehdi

    2017-06-26

    To evaluate the effect of intraoperative sub-Tenon injection of triamcinolone acetonide (TA) as an adjunct to Ahmed glaucoma valve (AGV) implantation. In this triple-blind randomized clinical trial, 104 eyes with refractory glaucoma were randomly assigned to conventional AGV (non-TA group) or AGV with adjunctive triamcinolone (TA group). In the TA group, 10 mg TA was injected in the sub-Tenon space around the AGV plate intraoperatively. Patients were followed for 1 year. The main outcome measure was intraocular pressure (IOP). Other outcome measures included best-corrected visual acuity (BCVA), occurrence of hypertensive phase (HP), peak IOP, number of antiglaucoma medications, and complications. A total of 90 patients were included in the final analysis. Mean IOP was lower in the TA group at most follow-up visits; however, the difference was statistically significant only at the first month (p = 0.004). Linear mixed model showed that mean IOP was 1.5 mm Hg lower in the TA group throughout the study period (p = 0.006). Peak postoperative IOP was significantly lower in the TA group (19.3 ± 4.8 mm Hg versus 29 ± 9.2 mm Hg, p = 0.032). Rates of success (defined as 6 < IOP <21 mm Hg) were similar in both groups at 12 months. There was no difference in the occurrence of the HP between the 2 groups (p = 0.123). Loss of BCVA >2 lines was more common in the non-TA group (p = 0.032). Adjunctive intraoperative TA injection during AGV implantation can blunt peak IOP levels and reduce mean IOP up to 1 year. Visual outcomes also seem to be superior to standard surgery.

  16. Application of 5-Fluorouracil-Polycaprolactone Sustained-Release Film in Ahmed Glaucoma Valve Implantation Inhibits Postoperative Bleb Scarring in Rabbit Eyes

    PubMed Central

    Bi, Xiu-Zeng; Pan, Wei-Hua; Yu, Xin-Ping; Song, Zong-Ming; Ren, Zeng-Jin; Sun, Min; Li, Cong-Hui; Nan, Kai-Hui

    2015-01-01

    This study was designed to investigate whether 5-fluorouracil (5-Fu)-polycaprolactone sustained-release film in Ahmed glaucoma valve implantation inhibits postoperative bleb scarring in rabbit eyes. Eighteen New Zealand white rabbits were randomly divided into three groups (A, B and C; n = 6 per group). Group A received combined 5-Fu-polycaprolactone sustained-release film application and Ahmed glaucoma valve implantation, group B received local infiltration of 5-Fu and Ahmed glaucoma valve implantation, and group C received Ahmed glaucoma valve implantation. Postoperative observations were made of the anterior segment, intraocular pressure, central anterior chamber depth, blebs, drainage tube, and accompanying ciliary body detachment. The pathology of the blebs and surrounding tissues were observed at month 3 postoperatively. We revealed that the 5-Fu-polycaprolactone sustained-release film maintained a release concentration range of 13.7 ± 0.12 to 37.41 ± 0.47 μg/ml over three months in vitro. Postoperatively, diffuse blebs with ridges were found in all eyes in group A, two blebs were observed in group B, and no bleb formation was present in group C. The postoperative central anterior chamber depth in group A was significantly less than that of the other two groups. The postoperative intraocular pressure of group A stabilized at 6.33–8.67 mmHg, whereas that of group C gradually remained at 7.55–10.02 mmHg. The histopathology showed that the fibrous tissue thickness of the blebs in group A was significantly thinner than that of the other groups. We conclude that the 5-Fu-polycaprolactone sustained-release film had a sustained drug release effect, which promoted the inhibition of bleb scarring after Ahmed glaucoma valve implantation. PMID:26579716

  17. Application of 5-Fluorouracil-Polycaprolactone Sustained-Release Film in Ahmed Glaucoma Valve Implantation Inhibits Postoperative Bleb Scarring in Rabbit Eyes.

    PubMed

    Bi, Xiu-Zeng; Pan, Wei-Hua; Yu, Xin-Ping; Song, Zong-Ming; Ren, Zeng-Jin; Sun, Min; Li, Cong-Hui; Nan, Kai-Hui

    2015-01-01

    This study was designed to investigate whether 5-fluorouracil (5-Fu)-polycaprolactone sustained-release film in Ahmed glaucoma valve implantation inhibits postoperative bleb scarring in rabbit eyes. Eighteen New Zealand white rabbits were randomly divided into three groups (A, B and C; n = 6 per group). Group A received combined 5-Fu-polycaprolactone sustained-release film application and Ahmed glaucoma valve implantation, group B received local infiltration of 5-Fu and Ahmed glaucoma valve implantation, and group C received Ahmed glaucoma valve implantation. Postoperative observations were made of the anterior segment, intraocular pressure, central anterior chamber depth, blebs, drainage tube, and accompanying ciliary body detachment. The pathology of the blebs and surrounding tissues were observed at month 3 postoperatively. We revealed that the 5-Fu-polycaprolactone sustained-release film maintained a release concentration range of 13.7 ± 0.12 to 37.41 ± 0.47 μg/ml over three months in vitro. Postoperatively, diffuse blebs with ridges were found in all eyes in group A, two blebs were observed in group B, and no bleb formation was present in group C. The postoperative central anterior chamber depth in group A was significantly less than that of the other two groups. The postoperative intraocular pressure of group A stabilized at 6.33-8.67 mmHg, whereas that of group C gradually remained at 7.55-10.02 mmHg. The histopathology showed that the fibrous tissue thickness of the blebs in group A was significantly thinner than that of the other groups. We conclude that the 5-Fu-polycaprolactone sustained-release film had a sustained drug release effect, which promoted the inhibition of bleb scarring after Ahmed glaucoma valve implantation.

  18. Changes in Corneal Endothelial Cell after Ahmed Glaucoma Valve Implantation and Trabeculectomy: 1-Year Follow-up

    PubMed Central

    Kim, Min Su; Kim, Kyoung Nam

    2016-01-01

    Purpose To compare changes in corneal endothelial cell density (CECD) after Ahmed glaucoma valve (AGV) implantation and trabeculectomy. Methods Changes in corneal endothelium in patients that underwent AGV implantation or trabeculectomy were prospectively evaluated. Corneal specular microscopy was performed at the central cornea using a non-contact specular microscope before surgery and 6 months and 12 months after surgery. The CECD, hexagonality of the endothelial cells, and the coefficient of variation of the cell areas were compared between the two groups. Results Forty eyes of 40 patients with AGV implantation and 28 eyes of 28 patients with trabeculectomy were studied. Intraocular pressure in the AGV implantation group was significantly higher than that in the trabeculectomy group (p < 0.001), but there was no significant difference in other clinical variables between the two groups. In the AGV implantation group, the mean CECD significantly decreased by 9.4% at 6 months and 12.3% at 12 months compared with baseline values (both, p < 0.001), while it decreased by 1.9% at 6 months and 3.2% at 12 months in the trabeculectomy group (p = 0.027 and p = 0.015, respectively). The changes at 6 months and 12 months in the AGV implantation group were significantly higher than those in the trabeculectomy group (p = 0.030 and p = 0.027, respectively). In the AGV implantation group, there was a significant decrease in the CECD between baseline and 6 months and between 6 months and 12 months (p < 0.001 and p = 0.005, respectively). However, in the trabeculectomy group, a significant decrease was observed only between baseline and 6 months (p = 0.027). Conclusions Both the AGV implantation group and the trabeculectomy group showed statistically significant decreases in the CECD 1 year after surgery. The decrease in CECD in the AVG implantation group was greater and persisted longer than that in the trabeculectomy group. PMID:27980360

  19. Intraoperative testing of opening and closing pressure predicts risk of low intraocular pressure after Ahmed glaucoma valve implantation

    PubMed Central

    Bochmann, F; Kipfer, A; Tarantino, J; Kaufmann, C; Bachmann, L; Thiel, M

    2014-01-01

    Purpose The aim of this study was to assess whether intraoperative testing of silicone Ahmed glaucoma valves (AGVs) would identify valves with an increased risk of low postoperative intraocular pressure (IOP). Methods In 30 consecutive cases of glaucoma surgery with AGV implantation, after priming the AGV, we intraoperatively measured the opening pressure A, closing pressure B, and re-opening pressure C using the active infusion pump of a phako-machine. IOP was checked postoperatively on the same day. Low IOP was defined as <5 mm Hg. Intraoperatively measured pressure characteristics of the valve function were analysed for their ability to predict postoperative IOP outcomes. Results Opening A, closing B, and re-opening C pressures (mean, (SD)) were 18.4 (5.1), 8.3 (4.7), and 11.7 (4.8)mm Hg, respectively. Ten patients (33.3%) had low IOP. An opening pressure of ≤18 mm Hg predicted low postoperative IOP with a sensitivity (10/10) of 100% (95% CI, 69.2–100) and a specificity (13/20) of 65.0% (95% CI, 40.8–84.6). Conclusions AGVs have a high variability of opening, closing, and re-opening pressures. An opening pressure of ≤18 mm Hg, a closing pressure of ≤10 mm Hg, or a re-opening pressure of ≤11 mm Hg identified all patients with low postoperative IOP. PMID:25060848

  20. Efficacy and safety of intravitreal ranibizumab with panretinal photocoagulation followed by trabeculectomy compared with Ahmed glaucoma valve implantation in neovascular glaucoma

    PubMed Central

    Sun, Jin-Tao; Liang, Hai-Jing; An, Meng; Wang, Da-Bo

    2017-01-01

    AIM To evaluate the efficacy and safety of intravitreal ranibizumab (IVR) with panretinal photocoagulation (PRP) followed by trabeculectomy compared with Ahmed glaucoma valve (AGV) implantation in neovascular glaucoma (NVG). METHODS This was a retrospective comparative study. We reviewed the cases of a total of 45 eyes from 45 NVG patients among which 23 eyes underwent AGV implantation and the other 22 underwent trabeculectomy. The causes of neovascular glaucoma included: diabetic retinopathy (25 eyes), and retinal vein occlusion (20 eyes). All patients received preoperative IVR combined with postoperative PRP. The mean best-corrected visual acuities (BCVA) were converted to the logarithms of the minimum angle of resolution (logMAR) for the statisitical analyses. Intraocular pressure (IOP), the logMAR BCVA and surgical complications were evaluated before and after surgery. The follow-up period was 12mo. RESULTS A total of 39 cases showed complete regression of iris neovascularization at 7d after injection, and 6 cases showed a small amount of residual iris neovascularization. The success rates were 81.8% and 82.6% at 12mo after trabeculectomy and AGV implantation, respectively. In the trabeculectomy group, the logMAR BCVA improved at the last follow-up in 14 eyes, remained stable in 6 eyes and decreased in 2 eyes. In 4 cases, slight hyphemas developed after trabeculectomy. A shallow anterior chamber developed in 2 cases and 2 vitreous hemorrhages. In the AGV group, the logMAR BCVA improved in 14 eyes, remained stable in 5 eyes and decreased in 4 eyes. Slight hyphemas developed in 3 cases, and a shallow anterior chamber in 3 cases. The mean postoperative IOP was significantly lower in both groups after surgery (F=545.468, P<0.05), and the mean postoperative logMAR BCVA was also significantly improved (F=10.964, P<0.05) with no significant difference between two groups. CONCLUSION It is safe and effective to treat NVG with this combined procedure, and we found

  1. Transcatheter aortic valve implantation.

    PubMed

    Oliemy, Ahmed; Al-Attar, Nawwar

    2014-01-01

    Transcatheter aortic valve implantation was developed to offer a therapeutic solution to patients with severe symptomatic aortic stenosis who are not candidates for conventional aortic valve replacement. The improvement in transcatheter aortic valve implantation outcomes is still of concern in the areas of stroke, vascular injury, heart block, paravalvular regurgitation and valve durability. Concomitantly, the progress, both technical and in terms of material advances of transcatheter valve systems, as well as in patient selection, renders transcatheter aortic valve implantation an increasingly viable treatment for more and more patients with structural heart disease.

  2. Remote actuated valve implant

    DOEpatents

    McKnight, Timothy E; Johnson, Anthony; Moise, Jr., Kenneth J; Ericson, Milton Nance; Baba, Justin S; Wilgen, John B; Evans, III, Boyd McCutchen

    2014-02-25

    Valve implant systems positionable within a flow passage, the systems having an inlet, an outlet, and a remotely activatable valve between the inlet and outlet, with the valves being operable to provide intermittent occlusion of the flow path. A remote field is applied to provide thermal or magnetic activation of the valves.

  3. Remote actuated valve implant

    DOEpatents

    McKnight, Timothy E.; Johnson, Anthony; Moise, Kenneth J.; Ericson, Milton Nance; Baba, Justin S.; Wilgen, John B.; Evans, Boyd Mccutchen

    2016-05-10

    Valve implant systems positionable within a flow passage, the systems having an inlet, an outlet, and a remotely activatable valve between the inlet and outlet, with the valves being operable to provide intermittent occlusion of the flow path. A remote field is applied to provide thermal or magnetic activation of the valves.

  4. Implants for draining neovascular glaucoma.

    PubMed Central

    Molteno, A C; Van Rooyen, M M; Bartholomew, R S

    1977-01-01

    The implant design, surgical technique, and pharmacological methods of controlling bleb fibrosis, used to treat neovascular glaucoma, are described, together with the results of 14 operations performed on 12 eyes. Images PMID:843508

  5. Double valve Implantation

    PubMed Central

    Stassano, Paolo; Mannacio, Vito; Musumeci, Antonino; Golino, Alessandro; Maida, Piero; Ferrigno, Vincenzo; Buonocore, Gaetano; Spampinato, Nicola

    1991-01-01

    From January 1976 through December 1987, 194 patients with a mean age of 43.3 ± 13.7 years (range, 11 to 74 years) underwent double (mitral and aortic) replacement of native valves with 8 types of bioprostheses: Carpentier-Edwards, 127 valves; Hancock, 76 valves; Liotta-Bioimplant, 57 valves; Ionescu-Shiley, 53 valves; Vascor, 27 valves; Carpentier-Edwards Pericardial, 22 valves; Angell-Shiley, 20 valves; and Implamedic, 6 valves. Concomitant cardiac procedures were performed in 25 patients (12.8%). There were 18 operative deaths (9.27%). Our retrospective analysis was restricted to 352 bioprostheses implanted in the 176 patients who survived surgery and were considered at risk for valve tissue failure. The overall cumulative duration of follow-up was 1,174.1 patient-years (range, 1 to 13 years). The durations of follow-up for specific valves were: Carpentier-Edwards, 920.2 valve-years; Hancock, 383.8 valve-years; Liotta-Bioimplant, 310.2 valve-years; Ionescu-Shiley, 357.7 valve-years; Vascor, 131.2 valve-years; Carpentier-Edwards Pericardial, 52.0 valve-years; Angell-Shiley, 167.0 valve-years; and Implamedic, 31.0 valve-years. Thirty patients had thromboembolic accidents, for a linearized incidence of 2.5% per patient-year. At 13 years, the actuarial freedom from thromboembolic accidents was 85.8% ± 10.7%. Nine patients had endocarditis, for a linearized incidence of 0.7% per patient-year. At 13 years, the actuarial freedom from endocarditis was 92.0% ± 1.5%. Twenty-four patients had valve tissue failure, for a cumulative linearized incidence of 1.87% per valve-year. The cumulative actuarial probability of freedom from valve tissue failure was 78.6% ± 3.7% at 10 years and 51.2% ± 10.7% at 13 years. The 24 patients with valve tissue failure all underwent reoperation: 20 of these had double valve replacement, 3 had aortic valve replacement alone, and 1 had mitral valve replacement alone. The mean interval between initial valve implantation and reoperation was

  6. The Results of the Use of Ahmed Valve in Refractory Glaucoma Surgery

    PubMed Central

    Bikbov, Mukharram Mukhtaramovich

    2015-01-01

    ABSTRACT The treatment of refractory glaucoma (RG) is challenging. The commonly adopted strategy in RG treatment is a glaucoma drainage device (GDD) implantation, which despite its radical nature may not always provide the desired intraocular pressure (IOP) levels for a long term. This review is based on the scientific literature on Ahmed glaucoma valve (AGV) implantation for refractory glaucoma. The technique of AGV implantation is described and data for both the types, FP7 and FP8 performance are presented. The outcome with adjunct antimetabolite and anti-VEGF drugs are also highlighted. An insight is given about experimental and histological examinations of the filtering bleb encapsulation. The article also describes various complications and measures to prevent them. How to cite this article: Bikbov MM, Khusnitdinov II. The Results of the Use of Ahmed Valve in Refractory Glaucoma Surgery. J Curr Glaucoma Pract 2015;9(3):86-91. PMID:26997843

  7. Angle-closure glaucoma after piggyback intraocular lens implantation.

    PubMed

    García-Feijo, J; Saenz-Frances, F; Martinez-De-La-Casa, J M; Mendez-Hernandez, C; Fernandez-Vidal, A; Elias-de-Tejada, M; Reche-Frutos, J; Garcia-Sanchez, J

    2008-01-01

    To report a case of angle closure glaucoma after piggyback intraocular lens implantation and its treatment. The authors present the case of a 75-year-old woman who was seen in the emergency department with angle closure glaucoma. Two years before she had undergone piggyback intraocular lens (IOL) implantation in order to correct a refractive error after cataract surgery. Ultrasound biomicroscopy revealed a closed angle with synechiae in 360 degrees as well as the presence of two IOLs: one in the capsular bag and the other in the ciliary sulcus. Extraction of the anterior IOL was precluded due to the poor endothelial count. Peripheral iridotomy and trabeculectomy were ineffective to lower the intraocular pressure (IOP); the authors decided to implant with an Ahmed valve and to place the valve's tube between the two IOLs to protect the endothelium. After Ahmed valve implantation, IOP maintains stable around 10-12 mmHg without medical treatment. Ahmed valve implantation is a good option in angle closure glaucoma due to piggyback. The placement of the valve's tube between the two IOLs is a good option to protect corneal endothelium.

  8. Ahmed glaucoma valve in post-penetrating-keratoplasty glaucoma: A critically evaluated prospective clinical study

    PubMed Central

    Panda, Anita; Prakash, Vadivelu Jaya; Dada, Tanuj; Gupta, Anoop Kishore; Khokhar, Sudarshan; Vanathi, Murugesan

    2011-01-01

    Aim: The aim was to evaluate the outcome of Ahmed glaucoma valve (AGV) in post-penetrating-keratoplasty glaucoma (PKPG). Materials and Methods: In this prospective study, 20 eyes of 20 adult patients with post-PKPG with intraocular pressure (IOP) >21 mmHg, on two or more antiglaucoma medications, underwent AG (model FP7) implantation and were followed up for a minimum of 6 months. Absolute success was defined as 5 implantation. The absolute success was achieved in 11 eyes and qualified success in 9. There was no significant change in best corrected visual acuity, graft clarity, or graft thickness. Six device-related complications occurred after AGV implantations which were successfully managed with medical or minor surgical therapy. Conclusions: Postkeratoplasty refractory glaucoma managed by AGV implantation revealed a satisfactory outcome up to 6 months of follow-up. PMID:21586837

  9. [New concepts for pressure-controlled glaucoma implants].

    PubMed

    Allemann, R; Stachs, O; Falke, K; Schmidt, W; Siewert, S; Sternberg, K; Chichkov, B; Wree, A; Schmitz, K-P; Guthoff, R F

    2013-08-01

    In industrialized countries glaucoma is one of the most common causes that leads to blindness. It is also the most common cause of irreversible blindness worldwide. In addition to local treatment of intraocular pressure and filtering glaucoma surgery, alloplastic implants are increasingly being used in glaucoma therapy. As long-term results published in the literature of commonly used implants are unsatisfactory, it seems useful to search for new concepts. In order to avoid the well-known short-term and long-term postoperative complications a pressure-controlled microstent with antiproliferative surface modifications was developed. Additionally, the functionality of such a microstent should be investigated using an animal glaucoma model. This paper describes the concept of a microstent which drains aquous humour from the anterior chamber into the suprachoroidal space. In addition, the glaucoma models described in the literature are discussed. Unfortunately, none of the methods could be reproduced permanently. First results show a correct implantation of a coated microstent with valve where the anti-proliferative effect could be demonstrated histologically. The promising results should lead to further investigations and the final goal will be the testing of the stent in the human eye.

  10. Implantation of a second glaucoma drainage device.

    PubMed

    Francis, Brian A; Fernandes, Rodrigo A B; Akil, Handan; Chopra, Vikas; Diniz, Bruno; Tan, James; Huang, Alex

    2017-05-01

    To evaluate success rates in controlling intraocular pressure (IOP) after implantation of a second glaucoma drainage device (GDD) with a Baerveldt glaucoma implant in patients with refractory glaucoma, with a secondary aim of reducing the need for postoperative glaucoma medications. This retrospective, noncomparative, interventional study included patients undergoing a second GDD for uncontrolled glaucoma from a tertiary care glaucoma service. Data were obtained from the medical records for the preoperative period and after the 1st, 15th, and 30th day, 3, 6, and 12 months, and then yearly until the last postoperative visit. Visual acuity, IOP, and number of glaucoma medications (NGM) from the follow-up visits were compared to baseline. Success and failure criteria were analyzed based on IOP level or need of glaucoma medications. Forty-nine patients were studied, with a mean follow-up time of 25 ± 21 months. The mean preoperative IOP was 23.7 ± 8.2 mmHg, and decreased to 14.8 ± 4.0 mmHg after 1 year, 14.4 ± 3.9 mmHg after 2 years, and 16.6 ± 8.5 mmHg after 3 years. The mean preoperative NGM was 3.4 ± 1.3, and decreased to 2.0 ± 1.8 after 1 year, 2.5 ± 1.6 after 2 years, and 2.8 ± 2.0 after 3 years. Absolute success was 9% after 1 year for a postoperative IOP between 5 and 18 mmHg, and 76% for a postoperative IOP between 5 and 21 mmHg. The qualified success was 88% at the first and second years and 83% at the third year. With up to 3 years of follow-up, a second glaucoma drainage device was successful in reducing IOP to below 21 mmHg, but not as successful below 18 mmHg. The success rate is improved with the use of glaucoma medications with up to 3 years of follow-up.

  11. Outcomes of Sequential Glaucoma Drainage Implants in Refractory Glaucoma.

    PubMed

    Hu, Wanda D; Moster, Marlene R; Zheng, Cindy X; Sabherwal, Naryan; Pequignot, Edward; Cvintal, Victor; Ekici, Feyzahan; Waisbourd, Michael

    2016-04-01

    To describe the outcomes of eyes that have undergone a second glaucoma drainage implant (GDI) surgery. A retrospective review of eyes that underwent a second GDI surgery from 2006 to 2013 was conducted. Primary outcome measures included intraocular pressure (IOP) reduction and success rates. Secondary outcome measures included glaucoma medication use, visual acuity, and number of reoperations. Success was defined as 6 ≤ IOP ≤ 21 with at least 20% IOP reduction, and no increase in the number of glaucoma medications from baseline at 3 months of follow-up or more. Sixty-five eyes (63 patients) had a mean follow-up of 22.4 ± 19.9 months. The most frequently placed second GDIs were an Ahmed FP7 (49%) or a Baerveldt 250 (26%) in the inferotemporal (46%) or inferonasal (35%) quadrant. At 3-year follow-up, IOP was reduced from 25.8 ± 7.7 to 17.4 ± 9.9 mm Hg (P = 0.004) and the number of glaucoma medications decreased from 3.6 ± 1.2 to 2.5 ± 1.4 (P = 0.01) compared with baseline. The median time to failure was 24.7 ± 5.8 months. There was no significant difference in failure rates for type of sequential GDI (P = 0.80) or plate location (P = 0.34). There was no significant difference in visual acuity between baseline and 3-year follow-up (P = 1.0). The most common postoperative complication was corneal edema (n = 9, 14%). Most eyes undergoing a second GDI achieve adequate IOP control with fewer antiglaucoma medications. Failure rates were similar regardless of quadrant selection or GDI type.

  12. Preimplantation Flow Testing of Ahmed Glaucoma Valve and the Early Postoperative Clinical Outcome.

    PubMed

    Jones, Emma; Alaghband, Pouya; Cheng, Jason; Beltran-Agullo, Laura; Sheng Lim, Kin

    2013-01-01

    The Ahmed glaucoma valve (AGV) implant is designed to prevent early postoperative hypotony. There is evidence of variation in hypotony rates in clinical trials which may be due to surgical technique variation, entry site leakage or valve defects from 'over priming'. We describe a simple preimplantation gravity driven test to assess valve function after priming that may reduce hypotony rates. Retrospective case note review. An in vivo flow test of AGVs, based on the gravity driven test was introduced prior to implantation. The onset and offset of flow through the valve was measured by altering the height of a bottle of balanced saline solution. We rejected the AGV, if there was fluid still flowing at 10 cm (7 mm Hg) or if there was no flow at 17 cm of water (12 mm Hg). The AGV implantation surgery was without mitomycin C, with a 25G needle entry tract, a corneal or scleral patch graft tube cover and without intracameral viscoelastic. Twenty Ahmed valves were implanted in 16 patients between July 2008 and October 2009. Test failure resulted in four AGV being rejected. The mean preoperative pressure was 29 mm Hg (range, 10-57 mm Hg) and the intraocular pressure (IOP) at 7 days postoperatively was 15 mm Hg (range, 3-52 mm Hg). Hypotony, defined as an IOP of less than 5 mm Hg on two consecutive assessments, was present in two eyes (10%). In vivo flow testing is an important safety check for the AGV. There are also other mechanisms after implantation that can cause an unexpected high or low IOP. How to cite this article: Jones E, Alaghband P, Cheng J, Beltran-Agullo L, Lim KS. Preimplantation Flow Testing of Ahmed Glaucoma Valve and the Early Postoperative Clinical Outcome. J Current Glau Prac 2013;7(1):1-5.

  13. Echocardiography in Transcatheter Aortic Valve Implantation and Mitral Valve Clip

    PubMed Central

    Luo, Huai

    2012-01-01

    Transcatheter aortic valve implantation and transcatheter mitral valve repair (MitraClip) procedures have been performed worldwide. In this paper, we review the use of two-dimensional and three-dimensional transesophageal echo for guiding transcatheter aortic valve replacement and mitral valve repair. PMID:23019387

  14. Glaucoma Drainage Implant Surgery – An Evidence-Based Update with Relevance to Sub-Saharan Africa

    PubMed Central

    Aminlari, Ardalan E.; Scott, Ingrid U.; Aref, Ahmad A.

    2013-01-01

    Glaucoma represents a leading cause of preventable vision loss in Sub-Saharan Africa. Recent studies evaluating outcomes of glaucoma drainage implant (GDI) surgery suggest an important role for this approach in the African patient population. The Tube Versus Trabeculectomy study demonstrated a higher success rate with non-valved GDI surgery compared to trabeculectomy with mitomycin C after five years. The Ahmed Baerveldt Comparison study showed no difference in surgical failure rates between the Ahmed Glaucoma Valve and the Baerveldt Glaucoma Implant (BGI) but better intraocular pressure outcomes with the BGI at one year. The Ahmed Versus Baerveldt study demonstrated a lower failure rate for the BGI, but also a requirement for more post-operative interventions. Further study of GDI surgery in the Sub-Saharan Africa is necessary to determine its optimal place in the treatment paradigm for glaucoma patients in the region. PMID:23741131

  15. A case of SAPIEN XT valve fallen into left ventricle during valve-in-valve transcatheter aortic valve implantation.

    PubMed

    Koizumi, Shigeki; Ehara, Natsuhiko; Nishiya, Kenta; Koyama, Tadaaki

    2017-06-24

    Late transcatheter heart valve embolization is a rare but life-threatening complication of transcatheter aortic valve implantation. Surgical intervention is performed for most cases, but some cases were treated by valve-in-valve transcatheter aortic valve implantation. We describe a patient in whom a 29-mm Edwards SAPIEN XT valve migrated into the left ventricular outflow tract 41 days after the initial implantation. We tried to perform valve-in-valve transcatheter aortic valve implantation using a transfemoral approach. As soon as the second transcatheter heart valve touched the first implanted valve, it fell into the left ventricle. Immediate surgical intervention was required. The first valve was removed, and surgical aortic valve replacement was successfully performed. In conclusion, we should choose surgical aortic valve replacement for late transcatheter heart valve embolization. Even if we need to treat by catheter intervention, transapical approach may be better.

  16. Molteno implantation for glaucoma in young patients.

    PubMed

    Hill, R A; Heuer, D K; Baerveldt, G; Minckler, D S; Martone, J F

    1991-07-01

    Seventy patients younger than 21 years of age underwent Molteno implantation for nonneovascular glaucoma. Fifty-three (76%) patients had failed angle and/or conventional filtering surgery. Final intraocular pressure less than 22 mmHg (but over 5 mmHg) was achieved in 40 (62%) of the 65 patients with at least 6-month follow-up (range, 6 to 59 months; mean +/- standard deviation, 22.7 +/- 14.1 months); however, only 22 (34%) were controlled after the initial Molteno implantation procedure, and 54 (83%) patients underwent further glaucoma and/or nonglaucoma surgical procedures. The visual acuities remained within one line of their preoperative levels or improved in 25 (68%) of the 37 patients on whom Snellen acuities were available. The most frequent complications included: tube-cornea touch (20%, transient in 3%), corneal edema (17%), retinal detachment (16%), tube block (10%), cataract (9%), chronic hypotony or phthisis (9%), pupillary or cyclitic membrane (9%), hyphema (7%), flat anterior chamber (6%), and large postoperative choroidal effusion (6%). Despite the high rates of subsequent surgical interventions and complications, Molteno implantation has been a useful approach for achieving intraocular pressure reduction in young patients with glucoma.

  17. Valve thrombosis following transcatheter aortic valve implantation: a systematic review.

    PubMed

    Córdoba-Soriano, Juan G; Puri, Rishi; Amat-Santos, Ignacio; Ribeiro, Henrique B; Abdul-Jawad Altisent, Omar; del Trigo, María; Paradis, Jean-Michel; Dumont, Eric; Urena, Marina; Rodés-Cabau, Josep

    2015-03-01

    Despite the rapid global uptake of transcatheter aortic valve implantation, valve trombosis has yet to be systematically evaluated in this field. The aim of this study was to determine the clinical characteristics, diagnostic criteria, and treatment outcomes of patients diagnosed with valve thrombosis following transcatheter aortic valve implantation through a systematic review of published data. Literature published between 2002 and 2012 on valve thrombosis as a complication of transcatheter aortic valve implantation was identified through a systematic electronic search. A total of 11 publications were identified, describing 16 patients (mean age, 80 [5] years, 65% men). All but 1 patient (94%) received a balloon-expandable valve. All patients received dual antiplatelet therapy immediately following the procedure and continued to take either mono- or dual antiplatelet therapy at the time of valve thrombosis diagnosis. Valve thrombosis was diagnosed at a median of 6 months post-procedure, with progressive dyspnea being the most common symptom. A significant increase in transvalvular gradient (from 10 [4] to 40 [12] mmHg) was the most common echocardiographic feature, in addition to leaflet thickening. Thrombus was not directly visualized with echocardiography. Three patients underwent valve explantation, and the remaining received warfarin, which effectively restored the mean transvalvular gradient to baseline within 2 months. Systemic embolism was not a feature of valve thrombosis post-transcatheter aortic valve implantation. Although a rare, yet likely under-reported complication of post-transcatheter aortic valve implantation, progressive dyspnea coupled with an increasing transvalvular gradient on echocardiography within the months following the intervention likely signifies valve thrombosis. While direct thrombus visualization appears difficult, prompt initiation of oral anticoagulation therapy effectively restores baseline valve function. Copyright © 2014

  18. Fluid Dynamics of a Novel Micro-Fistula Implant for the Surgical Treatment of Glaucoma.

    PubMed

    Sheybani, Arsham; Reitsamer, Herbert; Ahmed, Iqbal Ike K

    2015-07-01

    The purpose of this study was to describe the fluidics of a novel non-valved glaucoma implant designed to prevent hypotony and compare the fluidics of this device with two commonly used non-valved glaucoma devices. The XEN 45 micro-fistula implant was designed to limit hypotony by virtue of its length and width according to the Hagen-Poiseuille equation. Flow testing was performed using a syringe pump and pressure transducer at multiple flow rates. The pressure differentials across the XEN implant, the Ex-Press implant, and 10 mm of silicone tubing from a Baerveldt implant at a physiologic flow rate (2.5 μL/min) were extrapolated. The XEN 45 achieved a steady-state pressure calculated at 7.56 mm Hg at 2.5 μL/min. At the same flow rate, the Ex-Press device and Baerveldt tubing reached steady-state pressures of 0.09 and 0.01 mm Hg, respectively. Under flow testing, the XEN micro-fistula implant was able to maintain backpressure above numerical hypotony levels without the use of complex valve systems. This is due to the XEN implant's design, derived from the principles that dictate Newtonian fluids.

  19. Implantation of the CoreValve percutaneous aortic valve.

    PubMed

    Lamarche, Yoan; Cartier, Raymond; Denault, André Y; Basmadjian, Arsène; Berry, Colin; Laborde, Jean-Claude; Bonan, Raoul

    2007-01-01

    Surgical aortic valve replacement is the only recommended treatment for significant aortic valve stenosis. Percutaneous aortic valve replacement appears to be a novel option for high-risk patients. We report the implantation of the ReValving system (CoreValve, Paris, France) in a 64-year-old woman who was refused aortic valve replacement surgery for critical aortic stenosis and left ventricular dysfunction because of severe pulmonary fibrosis. After anesthesia, the patient was put on femorofemoral cardiopulmonary bypass, and underwent a balloon valvuloplasty with subsequent retrograde aortic valve replacement by the ReValving system. Transesophageal echocardiographic monitoring of the patient's hemodynamics showed immediate improvements of the valvular area and left ventricular ejection fraction and only traces of paravalvular leaks. The patient was easily weaned from ventilation and resumed activity soon after the surgery. A multidisciplinary approach is presently necessary to offer a reliable and safe procedure.

  20. CFD analysis of the Ahmed Glaucoma Valve and design of an alternative device.

    PubMed

    Kara, E; Kutlar, A I

    2010-12-01

    Computational fluid dynamics (CFD) modelling based on a commercial package, FLUENT, has been used in the present study. The primary aim of this study is to develop a novel implant by employing CFD techniques. Firstly, CFD analyses on the best design commercially available, which is the Ahmed Glaucoma Valve (AGV®), are accomplished. In the light of the results, the new design focus is selected as the valve. The new design is analysed using GAMBIT and FLUENT software. CFD analyses of the new design and the AGV® are compared and the strengths of the new design are revealed. The results are also compared with the experimental studies AGV® in the literature. It is deduced that the proposed model shows a nonlinear pressure drop response, which is quite similar to that of AGV®. The optimum combination would be a flow rate of 2.5 μl/min and a pressure drop of 1054.58 Pa for the proposed model.

  1. Aortic Root Enlargement or Sutureless Valve Implantation?

    PubMed Central

    Baikoussis, Nikolaos G.; Dedeilias, Panagiotis; Argiriou, Michalis

    2016-01-01

    Aortic valve replacement (AVR) in patients with a small aortic annulus is a challenging issue. The importance of prosthesis–patient mismatch (PPM) post aortic valve replacement (AVR) is controversial but has to be avoided. Many studies support the fact that PPM has a negative impact on short and long term survival. In order to avoid PPM, aortic root enlargement may be performed. Alternatively and keeping in mind that often some comorbidities are present in old patients with small aortic root, the Perceval S suturelles valve implantation could be a perfect solution. The Perceval sutureless bioprosthesis provides reasonable hemodynamic performance avoiding the PPM and providing the maximum of aortic orifice area. We would like to see in the near future the role of the aortic root enlargement techniques in the era of surgical implantation of the sutureless valve (SAVR) and the transcatheter valve implantation (TAVI). PMID:28028424

  2. Surgical Outcomes of Ahmed or Baerveldt Tube Shunt Implantation for medically Uncontrolled Traumatic Glaucoma

    PubMed Central

    Yadgarov, Arkadiy; Liu, Dan; Crane, Elliot S

    2017-01-01

    ABSTRACT Aim To describe postoperative surgical success of either Ahmed or Baerveldt tube shunt implantation for eyes with medically uncontrolled traumatic glaucoma. Materials and methods A review was carried out to identify patients with traumatic glaucoma that required tube shunt implantation between 2009 and 2015 at Rutgers University in Newark, New Jersey, USA. Seventeen eyes from 17 patients met inclusion criteria, including at least 3-month postoperative follow-up. The main outcome measure was surgical success at 1-year follow-up after tube implantation. Results Mean preoperative intraocular pressure (IOP) was 34.1 ± 8.2 mm Hg on 3.1 ± 1.6 ocular hypotensive medications. Nine eyes (53%) sustained closed globe injury. Ten eyes (59%) received an Ahmed valve shunt and seven eyes (41%) received a Baerveldt tube shunt. Surgical success rate at 1 year postoperatively was 83%. Compared to preoperative, the mean postoperative IOP was significantly lower (16.1 ± 3.5 mm Hg, p < 0.001) on significantly fewer ocular hypertensive medications (1.3 ± 1.6, p = 0.001) at a mean follow-up of 10 months. Mean IOP reduction at last follow-up was 49%. There were three cases of surgical failures: One case of hypotony, one case of tube extrusion with subsequent explan-tation, and one case requiring second tube insertion for IOP control. Conclusion Implantation of an Ahmed or Baerveldt tube shunt provided successful control of IOP in patients with medically uncontrollable traumatic glaucoma. How to cite this article Yadgarov A, Liu D, Crane ES, Khouri AS. Surgical Outcomes of Ahmed or Baerveldt Tube Shunt Implantation for medically Uncontrolled Traumatic Glaucoma. J Curr Glaucoma Pract 2017;11(1):16-21. PMID:28138213

  3. Improved technique of transapical aortic valve implantation: "the Berlin addition".

    PubMed

    Pasic, Miralem; Dreysse, Stephan; Drews, Thorsten; Buz, Semih; Unbehaun, Axel; Kukucka, Marian; Mladenow, Alexandar; Hetzer, Roland

    2010-06-01

    Transapical aortic valve implantation carries some degree of uncertainty regarding the definitive valve position. We added angiographic visualization of the aortic root while the prosthetic valve is being slowly deployed. It enables easy correction of the position of the valve so that perfect alignment can be achieved of the relationships between the prosthetic valve, aortic valve annulus, aortic cusps, and the coronary arteries.

  4. Pericardium Plug in the Repair of the Corneoscleral Fistula After Ahmed Glaucoma Valve Explantation

    PubMed Central

    Yoo, Chungkwon; Kwon, Sung Wook

    2008-01-01

    We report four cases in which a pericardium (Tutoplast®) plug was used to repair a corneoscleral fistula after Ahmed Glaucoma Valve (AGV) explantation. In four cases in which the AGV tube had been exposed, AGV explantation was performed using a pericardium (Tutoplast®) plug to seal the defect previously occupied by the tube. After debridement of the fistula, a piece of processed pericardium (Tutoplast®), measured 1 mm in width, was plugged into the fistula and secured with two interrupted 10-0 nylon sutures. To control intraocular pressure, a new AGV was implanted elsewhere in case 1, phaco-trabeculectomy was performed concurrently in case 2, cyclophotocoagulation was performed postoperatively in case 3 and anti-glaucomatous medication was added in case 4. No complication related to the fistula developed at the latest follow-up (range: 12~26 months). The pericardium (Tutoplast®) plug seems to be an effective method in the repair of corneoscleral fistulas resulting from explantation of glaucoma drainage implants. PMID:19096247

  5. Transcatheter pulmonary valve implantation: valve technology and procedural outcome.

    PubMed

    Salavitabar, Arash; Flynn, Patrick; Holzer, Ralf J

    2017-07-18

    Procedural technique and short-term outcomes of transcatheter pulmonary valve implantation (TPVI) have been widely described. The purpose of this article is to provide an update on current valve technology, and to focus on recent data surrounding TPVI in the dilated right ventricular outflow tract (RVOT), hybrid interventions, significant outcomes, and procedural costs. Transcatheter valve technology has expanded with current trials evaluating self-expandable valves that can be implanted in dilated RVOTs. Until those valves are widely available, hybrid techniques have been shown to offer a potential alternative in these patients, as well as in patients of small size. Although medium-term results of TPVI have shown 5-year freedom from reintervention or replacement of 76%, new data have underlined some concerns relating to bacterial endocarditis after the procedure. Procedural costs remain a concern, but vary greatly between institutions and healthcare systems. TPVI has emerged as one of the most innovative procedures in the treatment of patients with dysfunctional RVOT and pulmonary valves. Further device development is likely to expand the procedure to patients of smaller size and with complex, dilated RVOTs.

  6. Glaucoma

    MedlinePlus

    ... closure glaucoma; Acute glaucoma; Secondary glaucoma; Congenital glaucoma; Vision loss - glaucoma ... the optic nerve causes blind spots in your vision. Open-angle glaucoma tends to run in families. ...

  7. Transcatheter valve-in-valve implantation for failed mitral prosthesis: the first experience in Japan.

    PubMed

    Tada, Norio; Enta, Yusuke; Sakurai, Mie; Ootomo, Tatsushi; Hata, Masaki

    2017-01-01

    An 82-year-old woman had a history of mitral valve replacement with a 25-mm MOSAIC (Medtronic, USA) for severe mitral regurgitation (MR) 8 years previously. Recently, she developed heart failure due to MR secondary to prosthetic valve failure. She underwent transcatheter valve-in-valve implantation with a 23-mm SAPIEN XT (Edwards Lifesciences, USA) to the prosthetic mitral valve by transapical approach. To our knowledge, this is the first reported case of transcatheter valve implantation for failed mitral prosthetic valve using valve-in-valve technique in Japan.

  8. Percutaneous Transcatheter Aortic Disc Valve Prosthesis Implantation: A Feasibility Study

    SciTech Connect

    Sochman, Jan

    2000-09-15

    Purpose: Over the past 30 years there have been experimental efforts at catheter-based management of aortic valve regurgitation with the idea of extending treatment to nonsurgical candidates. A new catheter-based aortic valve design is described.Methods: The new catheter-delivered valve consists of a stent-based valve cage with locking mechanism and a prosthetic flexible tilting valve disc. The valve cage is delivered first followed by deployment and locking of the disc. In acute experiments, valve implantation was done in four dogs.Results: Valve implantation was successful in all four animals. The implanted valve functioned well for the duration of the experiments (up to 3 hr).Conclusion: The study showed the implantation feasibility and short-term function of the tested catheter-based aortic disc valve. Further experimental studies are warranted.

  9. Transcatheter aortic valve implantation: status and challenges.

    PubMed

    Fishbein, Gregory A; Schoen, Frederick J; Fishbein, Michael C

    2014-01-01

    Calcific aortic valve disease of the elderly is the most prevalent hemodynamically-significant valvular disease, and the most common lesion requiring valve replacement in industrialized countries. Transcatheter aortic valve implantation is a less invasive alternative to classical aortic valve replacement that can provide a therapeutic option for high-risk or inoperable patients with aortic stenosis. These devices must be biocompatible, have excellent hemodynamic performance, be easy to insert, be securely anchored without sutures, and be durable, without increased risk of thrombosis or infection. To date, complications are related to the site of entry for insertion, the site of implantation (aorta, coronary ostia, base of left ventricle), and to the structure and design of the inserted device. However, as with any novel technology unanticipated complications will develop. Goals for future development will be to make the devices more effective, more durable, safer, and easier to implant, so as to further improve outcome for patients with severe aortic stenosis. The pathologist participating in research and development, and examination of excised devices will have a critical role in improving outcome for these patients.

  10. Glaucoma

    MedlinePlus

    ... version of this page please turn Javascript on. Glaucoma What is Glaucoma? Glaucoma is a group of diseases that can ... is much greater for people over 60. How Glaucoma Develops There are several different types of glaucoma. ...

  11. Midterm outcomes after transcatheter aortic valve implantation.

    PubMed

    Lotfi, Shahram; Dohmen, Guido; Götzenich, Andreas; Haushofer, Marcus; Spillner, Jan Wilhelm; Autschbach, Rüdiger; Hoffmann, Rainer

    2014-01-01

    Transcatheter aortic valve implantation (TAVI) has become a therapeutic option for high-risk or nonoperable patients with severe symptomatic aortic valve stenosis. The best known and most frequently implanted prostheses are the CoreValve and SAPIEN prostheses. We report our experiences and analyze the results of our TAVI program. A total of 357 patients underwent transfemoral (TF) and transapical (TA) TAVI in our center between January 2008 and October 2012. The procedure was performed in 190 patients with CoreValve, in 155 patients with SAPIEN, and in 12 patients with ACURATE TA prostheses. Transfemoral access was used in 190 patients. In 167 patients, TA access was used. The mean age was 80.2 ± 6.4 years. All patients were nonoperable or had a high risk for a conventional aortic valve replacement. The mean logistic EuroSCORE I was 25.92 ± 14.51%. The TF/CoreValve (190 patients) and TA/SAPIEN (155 patients) groups showed significant difference in the patients' mean age (81.7 ± 6.3 years vs. 79.5 ± 6.6 years, P = 0.002) and in mean logistic EuroSCORE I (22.16 ± 13.05% vs. 31.04 ± 16.40, P < 0.001). The overall 30-day mortality (357 patients) was 9.80% (TF, 8.42%; TA, 11.37%); overall 1-year mortality (275 patients), 21.45% (TF, 23.74%; TA, 19.12%); overall 2-year mortality (199 patients), 29.15% (TF, 35.96%; TA, 23.64%); overall 3-year mortality (133 patients), 37.59% (TF, 43.86%; TA, 32.89%); and overall 4-year mortality (38 patients), 39.47% (TF, 45%; TA, 33.33%). The rate of pacemaker implantation after TAVI was significantly higher in the CoreValve group than in the SAPIEN group: 44.74% (85/190 patients) versus 6.45% (10/155 patients), P < 0.001. Stroke rate was higher in the TF-CoreValve group than in the TA-SAPIEN group: 4.21% versus 0.64%, P = 0.045. Outcomes after TAVI were, in our population of nonoperable and high-risk patients, encouraging. The differences in midterm outcomes between the TF-CoreValve TAVI and the TA-SAPIEN TAVI were not significant.

  12. Surgery for fulminant prosthetic valve endocarditis after transapical transcatheter aortic valve-in-valve implantation.

    PubMed

    Wilbring, Manuel; Tugtekin, Sems Malte; Matschke, Klaus; Kappert, Utz

    2014-02-01

    We report the clinical course of a patient with a history of transapical aortic "valve-in-valve" transcatheter aortic valve implantation (TAVI), actually suffering from prosthetic valve endocarditis. The patient now underwent cardiac surgery as a salvage procedure. The procedure itself was uneventful, but the patient died several days postoperative due to persisting sepsis. The present case raises the question, how to deal with high-risk patients, once considered unsuitable for cardiac surgery in presence of prosthetic valve infection? Up to now, there exists only insufficient knowledge about incidence, clinical course, and effectiveness of treatment strategies for prosthetic valve endocarditis after TAVI. A review of the available literature is given. Georg Thieme Verlag KG Stuttgart · New York.

  13. Role of Cardiac CT Before Transcatheter Aortic Valve Implantation (TAVI).

    PubMed

    Marwan, Mohamed; Achenbach, Stephan

    2016-02-01

    Catheter-based aortic valve implantation is increasingly being performed in high-risk patients with symptomatic aortic valve stenosis. For successful planning of the procedure, CT has been shown to provide crucial information concerning the aortic root as well as the peripheral access vessels. This article illustrates the increasing role of CT before transcatheter aortic valve implantation.

  14. Management of implant failure during transcatheter aortic valve implantation.

    PubMed

    Ussia, Gian Paolo; Barbanti, Marco; Immè, Sebastiano; Scarabelli, Marilena; Mulè, Massimiliano; Cammalleri, Valeria; Aruta, Patrizia; Pistritto, Anna Maria; Capodanno, Davide; Deste, Wanda; Di Pasqua, Maria Concetta; Tamburino, Corrado

    2010-09-01

    Transcatheter aortic valve implantation (TAVI) is an emerging alternative to palliative medical therapy for nonsurgical patients with severe aortic stenosis. There is a paucity of detailed data on the management and outcome of complications related to the sub-optimal deployment of the prosthesis. We appraised the incidence and management of early implant failure occurring during TAVI. Of 110 patients who underwent TAVI using the third generation 18-French CoreValve ReValving System (Medtronic, MN) in our Institution between June 2007 and January 2010, we identified those experiencing early implant failure and reported on their management and clinical outcome. The primary endpoint was the incidence of major adverse cardiovascular and cerebrovascular event (MACCE) at 30 days and mid-term follow up. Early implant failure occurred in 18 of 110 patients (16.3%). The most common cause was prosthesis under-expansion conditioning moderate to severe peri-valvular leak (44.4%). Prosthesis deployment too low or too high with respect to the aortic annulus leading to severe peri-valvular leak occurred in 22.2% and 5.5% of patients, respectively. Need of valve retrieve after the first attempt of deployment occurred in four cases (22.2%). Prosthesis embolization in the ascending aorta occurred in 5.5% of patients who experienced early implant failure. All implant failure cases were managed percutaneously with gain in aortic valve area from 0.44 ± 0.17 to 1.28 ± 0.27 cm(2) (P < 0.001), decrease of mean transaortic gradient from 55.00 ± 19.51 to 11.58 ± 5.91 mmHg (P < 0.001) and no MACCE at 30 days. After 11 ± 6 months, MACCE occurred cumulatively in two patients (11.1%). Early implant failure can complicate the TAVI procedure with the CoreValve system, but it can be managed safely and effectively with bailout transcatheter techniques, avoiding surgery, with good early and mid-term clinical and echocardiographic results.

  15. [Transcatheter aortic valve implantation (TAVI): Current perspectives].

    PubMed

    Gaede, Luise; Möllmann, Helge

    2015-08-01

    Transcatheter aortic valve implantation (TAVI) has evolved as the treatment modality of choice for elderly patients with symptomatic severe aortic stenosis who are at high risk for surgery. More than 10,000 TAVI procedures were undertaken in Germany during 2014.A mortality benefit has been shown for TAVI compared with conservative treatment in patients deemed inoperable, and the procedure was proven to be at least non-inferior to surgical aortic valve replacement in high-risk patients. Through improvements in preprocedural imaging and in valve technology as well as increasing operator and surgical team experience, TAVI has developed rapidly in the past few years. Complication rates declinded considerably and the latest study results even suggest a superiority of TAVI to surgical valve replacement in patients at intermediate operative risk. Nevertheless, the challenge to avoid procedure-specific complications influencing the outcome still remains. Therefore, making an individual decision about the approach and the valve prosthesis in an interdisciplinary heart team consisting of a cardiologist and a cardiac surgeon is indispensable for guaranteeing the best therapy for the patient.Considering the rapid developments and procedural improvements in this field, randomized trials are required to assess whether the indication for TAVI may be extended to patients at lower perioperative risk in the future.

  16. Update on Minimally Invasive Glaucoma Surgery (MIGS) and New Implants

    PubMed Central

    Brandão, Lívia M.; Grieshaber, Matthias C.

    2013-01-01

    Traditional glaucoma surgery has been challenged by the advent of innovative techniques and new implants in the past few years. There is an increasing demand for safer glaucoma surgery offering patients a timely surgical solution in reducing intraocular pressure (IOP) and improving their quality of life. The new procedures and devices aim to lower IOP with a higher safety profile than fistulating surgery (trabeculectomy/drainage tubes) and are collectively termed “minimally invasive glaucoma surgery (MIGS).” The main advantage of MIGS is that they are nonpenetrating and/or bleb-independent procedures, thus avoiding the major complications of fistulating surgery related to blebs and hypotony. In this review, the clinical results of the latest techniques and devices are presented by their approach, ab interno (trabeculotomy, excimer laser trabeculotomy, trabecular microbypass, suprachoroidal shunt, and intracanalicular scaffold) and ab externo (canaloplasty, Stegmann Canal Expander, suprachoroidal Gold microshunt). The drawback of MIGS is that some of these procedures produce a limited IOP reduction compared to trabeculectomy. Currently, MIGS is performed in glaucoma patients with early to moderate disease and preferably in combination with cataract surgery. PMID:24369494

  17. Transcatheter aortic valve implantation in aortic coarctation.

    PubMed

    Schramm, René; Kupatt, Christian; Becker, Christoph; Bombien, René; Reichart, Bruno; Sodian, Ralf; Schmitz, Christoph

    2013-06-01

    A 77-year-old male patient was scheduled for transcatheter aortic valve implantation for symptomatic and severe aortic valve stenosis. Severe multidirectional kinking of the aorta based on aortic coarctation did not allow for the transfemoral, but only for the transapical approach. The procedure was complicated because of the technically challenging retrograde passage of the transfemorally inserted pig-tail catheter required for intraoperative angiography of the aortic root. Correct positioning of the pig-tail catheter into the ascending aorta was accomplished by use of a loop snare, which was advanced into the descending aorta via the antegrade route, passing the cardiac apex, the stenotic aortic valve, and the coarctation-associated kinking. The pig-tail catheter tip was manipulated into the loop snare, pulled traverse the coarctation, and released within the proximal ascending aorta. Subsequent procedures were uneventful and followed the standardized protocol. A 29 mm Edwards Lifescience transcatheter Sapien bioprosthesis was successfully implanted. Georg Thieme Verlag KG Stuttgart · New York.

  18. Insertion of sequential glaucoma drainage implant in a piggyback manner.

    PubMed

    Välimäki, J

    2015-10-01

    This pilot study, the first of its type, was conducted to determine the clinical outcome of a sequential glaucoma drainage implant (GDI) inserted in piggyback manner, that is into the bleb of a primary GDI. This was a retrospective chart study with a minimum 1-year follow-up involving 16 eyes of 14 uncontrolled glaucoma patients who had previously undergone sequential GDI performed using a technique to convert a one-plate into a two-plate implant system. Surgical success was defined as intraocular pressure (IOP) <21 mm Hg with at least a 30% reduction in IOP from baseline on two consecutive follow-up visits, IOP >5 mm Hg on two consecutive follow-up visits, and neither reoperation of glaucoma nor loss of light perception vision. The mean ±SD baseline IOP was 29.2±5.2 mm Hg, and the mean postoperative IOP was 17.3±3.4 mm Hg, with a mean pressure drop of 39.4±10.4% (P<0.001). Life-table analysis showed an 88% success rate after 12 months of follow-up. The mean preoperative best corrected visual acuity (BCVA) was 0.2±0.2 logMAR (Snellen equivalent 6/9.5), compared with 0.3±0.3 logMAR postoperatively (Snellen equivalent 6/12; P=0.497). Postoperative complications included a flat anterior chamber and choroidal detachment (one eye), uveitis and cataract (one eye), diplopia (one eye), and worsening of pre-existing pseudophakic bullous keratopathy (one eye). In glaucoma eyes with useful vision the piggyback GDI seems to provide a significant IOP lowering with minimal complications in patients in whom an initial GDI had failed to control the IOP.

  19. Insertion of sequential glaucoma drainage implant in a piggyback manner

    PubMed Central

    Välimäki, J

    2015-01-01

    Purpose This pilot study, the first of its type, was conducted to determine the clinical outcome of a sequential glaucoma drainage implant (GDI) inserted in piggyback manner, that is into the bleb of a primary GDI. Methods This was a retrospective chart study with a minimum 1-year follow-up involving 16 eyes of 14 uncontrolled glaucoma patients who had previously undergone sequential GDI performed using a technique to convert a one-plate into a two-plate implant system. Surgical success was defined as intraocular pressure (IOP) <21 mm Hg with at least a 30% reduction in IOP from baseline on two consecutive follow-up visits, IOP >5 mm Hg on two consecutive follow-up visits, and neither reoperation of glaucoma nor loss of light perception vision. Results The mean ±SD baseline IOP was 29.2±5.2 mm Hg, and the mean postoperative IOP was 17.3±3.4 mm Hg, with a mean pressure drop of 39.4±10.4% (P<0.001). Life-table analysis showed an 88% success rate after 12 months of follow-up. The mean preoperative best corrected visual acuity (BCVA) was 0.2±0.2 logMAR (Snellen equivalent 6/9.5), compared with 0.3±0.3 logMAR postoperatively (Snellen equivalent 6/12; P=0.497). Postoperative complications included a flat anterior chamber and choroidal detachment (one eye), uveitis and cataract (one eye), diplopia (one eye), and worsening of pre-existing pseudophakic bullous keratopathy (one eye). Conclusions In glaucoma eyes with useful vision the piggyback GDI seems to provide a significant IOP lowering with minimal complications in patients in whom an initial GDI had failed to control the IOP. PMID:26113501

  20. Emergency Transcatheter Aortic Valve Implantation for Acute and Early Failure of Sutureless Perceval Aortic Valve.

    PubMed

    Durand, Eric; Tron, Christophe; Eltchaninoff, Hélène

    2015-09-01

    We report the case of a 78-year-old woman admitted for cardiogenic shock related to acute and early failure (severe aortic regurgitation) of a Perceval sutureless aortic bioprosthesis (Sorin Group, Saluggia, Italy). Clinical stability was achieved using rescue transfemoral transcatheter aortic valve-in-valve implantation with an Edwards SAPIEN 3 prosthesis (Edwards Lifesciences, Irvine, CA). To our knowledge, we report herein the first case of successful valve-in-valve implantation using a SAPIEN 3 transcatheter heart valve in a sutureless bioprosthetic aortic valve with acute and early deterioration.

  1. Coronary Obstruction Following Transcatheter Aortic Valve Implantation

    PubMed Central

    Ribeiro, Henrique Barbosa; Sarmento-Leite, Rogério; Siqueira, Dimytri A. A.; Carvalho, Luiz Antônio; Mangione, José Armando; Rodés-Cabau, Josep; Perin, Marco A.; de Brito, Fábio Sandoli

    2014-01-01

    Background Transcatheter aortic valve implantation (TAVI) was established as an important alternative for high-risk patients with severe aortic stenosis. However, there are few data in the literature regarding coronary obstruction, that although rare, is a potentially fatal complication. Objective Evaluate this complication in Brazil. Methods We evaluated all patients presenting coronary obstruction from the Brazilian Registry of TAVI. Main baseline and procedural characteristics, management of the complication, and clinical outcomes were collected from all patients. Results From 418 consecutive TAVI procedures, coronary obstruction occurred in 3 cases (incidence of 0.72%). All patients were women, without prior coronary artery bypass grafting (CABG), and with mean age of 85 ± 3 years, logistic EuroSCORE of 15 ± 6% and STS-PROM score of 9 ± 4%. All of the cases were performed with balloon-expandable Sapien XT prosthesis. In one patient, with pre-procedural computed tomography data, coronary arteries presented a low height and a narrow sinus of Valsalva. All patients presented with clinically significant severe maintained hypotension, immediately after valve implantation, and even though coronary angioplasty with stent implantation was successfully performed in all cases, patients died during hospitalization, being two periprocedurally. Conclusion Coronary obstruction following TAVI is a rare but potentially fatal complication, being more frequent in women and with the balloon-expandable prosthesis. Anatomical factors might be related with its increased occurrence, highlighting the importance of a good pre-procedural evaluation of the patients in order to avoid this severe complication. PMID:24652089

  2. Coronary obstruction following transcatheter aortic valve implantation.

    PubMed

    Ribeiro, Henrique Barbosa; Sarmento-Leite, Rogério; Siqueira, Dimytri A A; Carvalho, Luiz Antônio; Mangione, José Armando; Rodés-Cabau, Josep; Perin, Marco A; Brito, Fábio Sandoli de

    2014-01-01

    Transcatheter aortic valve implantation (TAVI) was established as an important alternative for high-risk patients with severe aortic stenosis. However, there are few data in the literature regarding coronary obstruction, that although rare, is a potentially fatal complication. Evaluate this complication in Brazil. We evaluated all patients presenting coronary obstruction from the Brazilian Registry of TAVI. Main baseline and procedural characteristics, management of the complication, and clinical outcomes were collected from all patients. From 418 consecutive TAVI procedures, coronary obstruction occurred in 3 cases (incidence of 0.72%). All patients were women, without prior coronary artery bypass grafting (CABG), and with mean age of 85 ± 3 years, logistic EuroSCORE of 15 ± 6% and STS-PROM score of 9 ± 4%. All of the cases were performed with balloon-expandable Sapien XT prosthesis. In one patient, with pre-procedural computed tomography data, coronary arteries presented a low height and a narrow sinus of Valsalva. All patients presented with clinically significant severe maintained hypotension, immediately after valve implantation, and even though coronary angioplasty with stent implantation was successfully performed in all cases, patients died during hospitalization, being two periprocedurally. Coronary obstruction following TAVI is a rare but potentially fatal complication, being more frequent in women and with the balloon-expandable prosthesis. Anatomical factors might be related with its increased occurrence, highlighting the importance of a good pre-procedural evaluation of the patients in order to avoid this severe complication.

  3. Biodegradable radioactive implants for glaucoma filtering surgery produced by ion implantation

    NASA Astrophysics Data System (ADS)

    Assmann, W.; Schubert, M.; Held, A.; Pichler, A.; Chill, A.; Kiermaier, S.; Schlösser, K.; Busch, H.; Schenk, K.; Streufert, D.; Lanzl, I.

    2007-04-01

    A biodegradable, β-emitting implant has been developed and successfully tested which prevents fresh intraocular pressure increase after glaucoma filtering surgery. Ion implantation has been used to load the polymeric implants with the β-emitter 32P. The influence of ion implantation and gamma sterilisation on degradation and 32P-fixation behavior has been studied by ion beam and chemical analysis. Irradiation effects due to the applied ion fluence (1015 ions/cm2) and gamma dose (25 kGy) are found to be tolerable.

  4. Percutaneous implantation of CoreValve aortic prostheses in patients with a mechanical mitral valve.

    PubMed

    Bruschi, Giuseppe; De Marco, Federico; Oreglia, Jacopo; Colombo, Paola; Fratto, Pasquale; Lullo, Francesca; Paino, Roberto; Frigerio, Maria; Martinelli, Luigi; Klugmann, Silvio

    2009-11-01

    Concerns exist in the field of transcatheter aortic valve implantation regarding the treatment of patients with mechanical mitral valve for possible interference between the percutaneous aortic valve and the mechanical mitral prosthesis. We report our experience with percutaneous aortic valve implantation in 4 patients with severe aortic stenosis, previously operated on for mitral valve replacement with a mechanical prosthesis. All patients underwent uneventful percutaneous retrograde CoreValve implantation (CoreValve Inc, Irvine, CA). No deformation of the nitinol tubing of the prostheses (ie, neither distortion nor malfunction of the mechanical valve in the mitral position) occurred in any of the patients. All patients are alive and asymptomatic at a mean follow-up of 171 days.

  5. Surgical outcomes of superior versus inferior glaucoma drainage device implantation

    PubMed Central

    Martino, Amy Z.; Iverson, Shawn; Feuer, William J.; Greenfield, David S.

    2013-01-01

    Purpose To compare the safety and intraocular pressure (IOP) lowering efficacy of initial glaucoma drainage device (GDD) implantation performed at the superior versus inferior limbus. Methods A retrospective chart review was conducted to identify glaucoma patients that had undergone initial Baerveldt GDD surgery at the inferior limbus for uncontrolled IOP. All eyes had a minimum of 6 months of postoperative follow-up. These eyes were frequency matched to eyes with initial Baerveldt GDD implantation performed at the superior limbus to within 5 years of age and 6 months of follow-up. Baseline demographic and clinical information, as well as preoperative and postoperative IOP, visual acuity, and number of anti-glaucoma medications were extracted. Failure was defined as IOP > 21 mmHg or not reduced by 20% below baseline on two consecutive follow-up visits after 3 months, IOP ≤ 5 mmHg on two consecutive follow-up visits after 3 months, reoperation for glaucoma, or loss of light perception vision. Statistical methods consisted of Student's t-tests, chi-squared test, and Kaplan-Meier time to failure analysis. Results Fifty eyes (17 inferior, 33 superior) of 43 patients were enrolled. Mean postoperative follow-up in both groups were similar (mean 26.2 ± 15.2 for inferior and 23.9 ± 10.43 months for superior, p=0.54). Prior trabeculectomy had been performed in 8/17 (47%) and 11/33 (33%) eyes (p=0.34) with inferior and superior implants, respectively. Mean preoperative IOP (mmHg) in the superior group (26 ± 11) was significantly higher (p=0.02) than in the inferior group (21 ± 7). Success rates were similar (p>0.05) between the inferior and superior GDD groups during the study period, with 64.7% and 75.8% classified as successful at 1-year of follow-up and 43.1% and 65.7% at 2-years of follow-up, respectively. There was no difference in cumulative proportions of eyes failing between the groups (p=0.20, log-rank test). Mean postoperative IOP and number of anti-glaucoma

  6. Aortic valve stenosis after previous coronary bypass: Transcatheter valve implantation or aortic valve replacement?

    PubMed Central

    2012-01-01

    We report a prospective comparison between transcatheter valve implantation (TAVI, n = 13) and surgical aortic valve replacement (AVR, n = 10) in patients with severe aortic valve stenosis and previous coronary bypass surgery (CABG). All patients had at least bilateral patent internal thoracic arteries bypass without indication of repeat revascularization. After a similar post-procedure outcome, despite one early death in TAVI group, the 1-year survival was 100% in surgical group and in transfemoral TAVI group, and 73% in transapical TAVI group. When previous CABG is the lone surgical risk factor, indications for a TAVI procedure have to be cautious, specially if transfemoral approach is not possible. PMID:22642844

  7. A new one-step procedure for pulmonary valve implantation of the melody valve: Simultaneous prestenting and valve implantation.

    PubMed

    Boudjemline, Younes

    2017-09-25

    To describe a new modification, the one-step procedure, that allows interventionists to pre-stent and implant a Melody valve simultaneously. Percutaneous pulmonary valve implantation (PPVI) is the standard of care for managing patients with dysfunctional right ventricular outflow tract, and the approach is standardized. Patients undergoing PPVI using the one-step procedure were identified in our database. Procedural data and radiation exposure were compared to those in a matched group of patients who underwent PPVI using the conventional two-step procedure. Between January 2016 and January 2017, PPVI was performed in 27 patients (median age/range, 19.1/10-55 years) using the one-step procedure involving manual crimping of one to three bare metal stents over the Melody valve. The stent and Melody valve were delivered successfully using the Ensemble delivery system. No complications occurred. All patients had excellent hemodynamic results (median/range post-PPVI right ventricular to pulmonary artery gradient, 9/0-20 mmHg). Valve function was excellent. Median procedural and fluoroscopic times were 56 and 10.2 min, respectively, which significantly differed from those of the two-step procedure group. Similarly, the dose area product (DAP), and radiation time were statistically lower in the one-step group than in the two-step group (P < 0.001 for all variables). After a median follow-up of 8 months (range, 3-14.7), no patient underwent reintervention, and no device dysfunction was observed. The one-step procedure is a safe modification that allows interventionists to prestent and implants the Melody valve simultaneously. It significantly reduces procedural and fluoroscopic times, and radiation exposure. © 2017 Wiley Periodicals, Inc.

  8. Boston keratoprosthesis and Ahmed glaucoma valve for visual rehabilitation in congenital anterior staphyloma

    PubMed Central

    Srinivasan, Bhaskar; Choudhari, Nikhil Shreeram; Neog, Aditya; Latka, Supriya; Iyer, Geetha K

    2012-01-01

    Congenital anterior staphyloma entails grave visual prognosis. The majority of reported patients have undergone enucleation. We report a promising result of staphylectomy with implantation of a keratoprosthesis and a glaucoma drainage device in a seven-month-old child with a large, congenital anterior staphyloma. PMID:22569392

  9. Vascular approaches for transcatheter aortic valve implantation

    PubMed Central

    Pascual, Isaac; Carro, Amelia; Hernández-Vaquero, Daniel; Díaz, Rocío; Rozado, Jose; Lorca, Rebeca; Martín, María; Silva, Jacobo; Morís, César

    2017-01-01

    Transcatheter aortic valve implantation (TAVI) is a rapidly evolving therapeutic modality currently available for patients with severe aortic stenosis (AS) that are unsuitable for surgery because of technical/anatomical issues or high-estimated surgical risk. Transfemoral approach is the preferred TAVI delivery route when possible. Alternative non-transfemoral access options include transaortic, trans-subclavian and transapical access. Other approaches are also feasible (transcarotid, transcaval, and antegrade aortic) but are restricted to operators and hospitals with experience. The peculiarities of each of the vascular approaches designed for TAVI delivery make it necessary to carefully assess patient’s atherosclerotic load and location, arterial size and tortuosity, and presence of mural thrombus. Several clinical trials are currently ongoing and in the near future the indications for these approaches will likely be better defined and extended to a broader spectrum of TAVI candidates. PMID:28616344

  10. Transcatheter mitral valve implantation: a brief review.

    PubMed

    Mylotte, Darren; Piazza, Nicolo

    2015-09-01

    In the last year transcatheter mitral valve implantation (TMVI) has seen a major jump in development. This technique offers the potential to treat a great number of elderly and/or high-risk patients with severe mitral regurgitation (MR). Such patients are declined surgical intervention either because the institutional Heart Team considers the risk of intervention to exceed the potential benefit, or because the patients and their families believe the morbidity of mitral surgery to be excessive. The advent of a less invasive transcatheter treatment could, therefore, potentially appeal to both clinicians and patients alike. In this overview paper, we describe briefly these recent developments in TVMI technologies as an introduction to the dedicated TVMI technical device parade later in this supplement.

  11. Portico Sheathless Transcatheter Aortic Valve Implantation via Distal Axillary Artery.

    PubMed

    Bruschi, Giuseppe; Colombo, Paola; Botta, Luca; Nava, Stefano; Merlanti, Bruno; Belli, Oriana; Musca, Francesco; Soriano, Francesco; Russo, Claudio F; Oliva, Fabrizio

    2017-02-01

    Transcatheter aortic valve implantation has been designed to treat older patients affected by severe aortic stenosis who are considered high-risk surgical candidates because of multiple comorbidities. The least invasive approach for transcatheter aortic valves implantation should be considered the transfemoral retrograde route, because it is minimally invasive and is feasible with local anesthesia and mild sedation. Despite significant technical improvements in recent years, the transfemoral approach is contraindicated in cases of severe peripheral artery disease. We describe the first case of a Portico transcatheter aortic valve implantation system (St. Jude Medical, Minneapolis, MN) made through the distal axillary artery in a 90-year-old patient affected by severe aortic stenosis.

  12. Transcatheter mitral valve interventions: pathophysiological considerations in choosing reconstruction versus transcatheter valve implantation.

    PubMed

    Taramasso, Maurizio; Maisano, Francesco

    2015-09-01

    Over the last few years, several surgical procedures to treat mitral regurgitation (MR) in high-risk or inoperable patients have inspired percutaneous devices, including valve repair and valve replacement technologies. As the field of transcatheter mitral valve intervention is rapidly developing, the interventional community is wondering whether valve implantation should become the leading percutaneous mitral valve therapy, and whether the introduction of reliable replacement technology will reduce the clinical value of repair approaches. Since clinical experience with transcatheter mitral valve implantation (TMVI) is at a preliminary stage and all the patients treated with this approach so far are really sick candidates with prohibitive risk, it is difficult to define properly which patients could benefit more from TMVI versus transcatheter mitral valve repair (TMVR). The specific aim of this report is to state few important clinical and pathophysiological considerations in order to clarify when and why a repair strategy should be preferred over replacement.

  13. [Emergent transcatheter aortic valve implantation in a patient with bicuspid aortic valve stenosis in cardiogenic shock].

    PubMed

    Pizzighini, S; Finet, G; Obadia, J-F; Revel, D; Bresson, D; Rioufol, G

    2015-02-01

    Transcatheter aortic valve implantation is a therapeutic option for high-risk patients with severe aortic valve stenosis and with cardiac symptoms. This procedure requires the preliminary evaluation by a "heart team" and presents some contraindications. We report the case of a 58-year-old man with severe bicuspid aortic valve stenosis and cardiogenic shock. In spite of contraindications and because of the failure of balloon aortic valvuloplasty, transcatheter aortic valve implantation was performed in emergency. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  14. Valve-in-Valve Transcatheter Valve Implantation in the Non-Aortic Position

    PubMed Central

    Ranney, David N.; Williams, Judson B.; Wang, Andrew; Gaca, Jeffrey G.

    2016-01-01

    Background Transcatheter valve-in-valve (VIV) procedures are an alternative to standard surgical valve replacement in high risk patients. Methods Cases in which a commercially approved transcatheter aortic valve replacement (TAVR) device was used for a non-aortic VIV procedure between November 2013 and September 2015 are reviewed. Clinical, echocardiographic, and procedural details, patient survival, and symptom severity by NYHA class at follow-up were assessed. Results All patients were heart-team determined high-risk for conventional redo surgery (mean STS PROM = 6.8 ± 2.2%). Five patients underwent VIV replacement in the non-aortic position, 4 for bioprosthetic mitral valve dysfunction and one for bioprosthetic tricuspid valve dysfunction. Bioprosthetic failure was due to stenosis in 3 patients and regurgitation in 2 others. A balloon-expandable device was used for all patients (Edwards Lifesciences, Irvine, CA). Transcatheter VIV replacement was accomplished by the transapical (mitral) and transfemoral venous (tricuspid) approaches. Median post-operative length of stay was 5 days (range 3-12). No deaths occurred at a mean follow-up of 21 months. NYHA class at follow-up decreased from class IV at baseline to class I or II for all patients. No paravalvular leaks greater than trivial were encountered. Median mean gradient following mitral replacement was 6.5 mmHg (range 6-13 mmHg), and following tricuspid replacement was 4 mmHg. Post-operative complications included hematuria, epistaxis, acute kidney injury, and atrial fibrillation. Conclusions Transcatheter VIV implantation in the non-aortic position for dysfunctional bioprostheses can be performed safely with favorable clinical outcomes using a balloon expandable TAVR device. PMID:27059552

  15. Effect of temporal clear corneal phacoemulsification on intraocular pressure in eyes with prior Ahmed glaucoma valve insertion.

    PubMed

    Sa, Ho-Seok; Kee, Changwon

    2006-06-01

    To evaluate the effect of temporal clear corneal phacoemulsification on intraocular pressure (IOP) in eyes after Ahmed glaucoma valve insertion. Department of Ophthalmology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea. The files of 13 patients who received phacoemulsification after Ahmed glaucoma valve insertion were reviewed in this retrospective case series. Visual acuity, IOP, and the number of glaucoma medications before phacoemulsification were used as a baseline for comparison with the values at various follow-up intervals. The mean IOP before phacoemulsification was 15.1 mm Hg +/- 3.6 (SD). Postoperatively, it was 12.8 +/- 4.5 mm Hg, 13.1 +/- 3.6 mm Hg, 16.4 +/- 5.2 mm Hg, 15.8 +/- 4.0 mm Hg, 16.1 +/- 3.9 mm Hg, 15.3 +/- 4.1 mm Hg, and 15.2 +/- 3.4 mm Hg at 1 day after 1 week, at 1, 2, 6, and 12 months, and at last visits, respectively. The mean IOP did not differ significantly from the prephacoemulsification value at any follow-up. The number of glaucoma medications increased significantly after phacoemulsification (P = .031), and 6 of 13 eyes required additional glaucoma medication because of IOP elevation at approximately 1 month. Temporal clear corneal phacoemulsification did not increase IOP significantly in eyes with prior Ahmed glaucoma valve insertion. However, some eyes experienced an IOP elevation 1 month after phacoemulsification and required glaucoma medication.

  16. Prosthetic valve endocarditis after transcatheter aortic valve implantation-diagnostic and surgical considerations

    PubMed Central

    Klaaborg, Kaj Erik; Hjortdal, Vibeke; Nørgaard, Bjarne Linde; Terkelsen, Christian Juhl; Jensen, Kaare; Christiansen, Evald Høj; Terp, Kim Allan; Andersen, Gratien; Hvitfeldt, Steen; Andersen, Henning Rud

    2016-01-01

    Prosthetic valve endocarditis (PVE) after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) is a potential life threatening complication. Better understanding of the incidence, predictors, clinical presentation, diagnostic measures, complications and management of PVE may help improve TAVI long-term outcome. We report a case of TAVI-PVE in an 80-year-old high risk patient in whom SAVR was successfully performed. We have reviewed literature regarding TAVI-PVE. PMID:27867590

  17. Transcatheter Aortic Valve Implantation: Experience with the CoreValve Device.

    PubMed

    Asgar, Anita W; Bonan, Raoul

    2012-01-01

    The field of transcatheter aortic valve implantation has been rapidly evolving. The Medtronic CoreValve first emerged on the landscape in 2004 with initial first human studies, and it is currently being studied in the Pivotal US trial. This article details the current experience with the self-expanding aortic valve with a focus on clinical results and ongoing challenges. Copyright © 2012 Elsevier Inc. All rights reserved.

  18. Transcatheter aortic valve-in-valve implantation of a CoreValve in a degenerated aortic bioprosthesis.

    PubMed

    Bruschi, Giuseppe; DeMarco, Federico; Oreglia, Jacopo; Colombo, Paola; Fratto, Pasquale; Lullo, Francesca; Paino, Roberto; Martinelli, Luigi; Klugmann, Silvio

    2010-03-01

    In recent years percutaneous aortic valve implantation has emerged as an alternative therapy to treat patients with symptomatic aortic stenosis considered to be high-risk surgical candidates. We report our experience of a percutaneous retrograde CoreValve implantation in a 77-year-old female with aortic bioprosthesis structural degeneration. The patient underwent aortic valve replacement for aortic stenosis in 1999 with the implantation of a 23 mm Carpentier-Edwards; her last echocardiography showed a severe bioprosthesis stenosis. After evaluation by cardiac surgeons and cardiologist, considering the high risk re-do surgical procedure (Logistic Euroscore 30%) and severe comorbidities (severe pulmonary hypertension, hepatocellular carcinoma and severe osteoporosis), a percutaneous aortic valve-in-valve replacement was preferred. A successful percutaneous 26 mm CoreValve prosthesis implantation was performed with the patient awake with local anesthesia and mild sedation. The patient was discharged after 10 days of hospitalization and she is in NYHA functional class I at follow-up. Our experience, characterized by a multidisciplinary approach, necessary to offer the safest conditions and care for patients, demonstrates the feasibility of a new, promising indication for the use of a transcatheter valve implantation: percutaneous treatment of a degenerated aortic bioprosthesis.

  19. Mitral valve repair and aortic valve replacement with sutureless prosthesis implantation through a right minithoracotomy.

    PubMed

    Lio, Antonio; Miceli, Antonio; Ferrarini, Matteo; Glauber, Mattia

    2016-12-14

    Little experience exists in minimally invasive treatment of double-valve disease. In this report, we present a minimally invasive approach for mitral and aortic valve disease through a minithoracotomy in the 3rd intercostal space with a sutureless aortic prosthesis implantation. © The Author 2016. Published by MMCTS on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  20. A Universal Delivery System for Percutaneous Heart Valve Implantation.

    PubMed

    Bartosch, Marco; Peters, Heiner; Spriestersbach, Hendrik; O H-Ici, Darach; Berger, Felix; Schmitt, Boris

    2016-09-01

    Transcatheter heart valve implantation is an emerging technology and an alternative to surgical valve replacement. Most existing systems consist of valves sewn into balloon-expandable stents with a delivery catheter functioning with the specific valve only. The aim of this study was to develop a universally applicable delivery system (DS) for plane stents, valves sewn into both balloon-expandable and self-expandable stents and feasible for use with different access routes. A DS was designed and manufactured in five different diameters. The requirements were derived from the implants, the implantation technique and the cardiovascular geometry of the experimental sheep. The combination of a self-expandable Nitinol stent and a jugular access point represented the major challenge as both flexibility and rigidity of the DS were required. To fulfill these contradicting mechanical properties the sheaths were comprised of a soft outer polymer tube with a stainless steel coiled spring inside. Tissue-engineered and pericardial pulmonary valves were implanted. Also polymeric and balloon-expandable stents were delivered to various positions in the vascular system. The initial success rate was 70.5%. After refinement of the DS, a success rate of 83.3% was achieved with the remaining failed implantations resulting from inadequate sizes of the prostheses.

  1. Perceval S aortic valve implantation in an achondroplastic Dwarf

    PubMed Central

    Baikoussis, Nikolaos G.; Argiriou, Michalis; Argiriou, Orestis; Dedeilias, Panagiotis

    2016-01-01

    Despite cardiovascular disease in patients with dwarfism is not rare; there is a lack of reports referring to cardiac interventions in such patients. Dwarfism may be due to achondroplasia or hormonal growth disorders. We present a 58-year-old woman with episodes of dyspnea for several months. She underwent on transthoracic echocardiography, and she diagnosed with severe aortic valve stenosis. She referred to our department for surgical treatment of this finding. In accordance of her anthropometric characteristics and her very small aortic annulus, we had the dilemma of prosthesis selection. We decided to implant a stentless valve to optimize her effective orifice area. Our aim is to present the successful Perceval S valve implantation and the descriptions of the problems coming across in operating on these special patients. To our knowledge, this is the first case patient in which a Perceval S valve is implanted according to the international bibliography. PMID:26750695

  2. [Shunt tube implantation combining amniotic membrane transplantation and implantation of Molteno implant for glaucoma after penetrating keratoplasty].

    PubMed

    Liu, Y; Li, H; Chen, J

    2000-06-01

    To investigate the therapeutic effect of aqueous humor shunt implants with amniotic membrane transplantation on intractable glaucoma. Glaucoma was induced in rabbits by the injection of alpha-chymotrypsin into the posterior chamber of the eyes. The rabbits were divided into four groups. Group A: control group, Group B: single shunt tube group, Group C: shunt tube with amniotic membrane transplantation group, Group D: shunt tube with amniotic supporter and amniotic membrane transplantation group. The intraocular pressure(IOP), histology and filterable ability of the tissue around the tubes were studied. The therapeutic effect of the three methods for the glaucoma was compared. From 1998 to 1999, 42 eyes of 41 patients with uncontrolled glacoma after penetrating keratoplasty were randomly assigned into two groups. One group (12 eyes) underwent implantation of shunt tube combining transplantation of amniotic membrane. The other group underwent implantation of a single plate Molteno implant. Clinical records were reviewed to ascertain postoperative IOP, visual acuities, number of medications. The IOP elevated after the operation and reached at the peak on the third day for all groups and then dropped slowly. The IOP was 33.34 +/- 5.54 mmHg (1 mmHg = 0.133 kPa) for Group A and 27.88 +/- 8.86 mmHg for Group B three months after the operation. There was no statistical difference between the two groups (P = 0.274). The IOP was 22.33 +/- 3.73 mmHg for Group C and there was statistical significant difference between Group C and Group A (P = 0.02) and no difference between Group C and Group B (P = 0.113). The IOP was 15.74 +/- 2.94 mmHg for Group D and there was statistical significant difference between Group D and Group A (P = 0.001) and Group B (P = 0.036). There was no difference between Group D and Group C (P = 0.09). The study of horseradish peroxidase penetrability indicated that there was peroxidase in the tissues around the tube with amniotic membrane transplantation

  3. A planning system for transapical aortic valve implantation

    NASA Astrophysics Data System (ADS)

    Gessat, Michael; Merk, Denis R.; Falk, Volkmar; Walther, Thomas; Jacobs, Stefan; Nöttling, Alois; Burgert, Oliver

    2009-02-01

    Stenosis of the aortic valve is a common cardiac disease. It is usually corrected surgically by replacing the valve with a mechanical or biological prosthesis. Transapical aortic valve implantation is an experimental minimally invasive surgical technique that is applied to patients with high operative risk to avoid pulmonary arrest. A stented biological prosthesis is mounted on a catheter. Through small incisions in the fifth intercostal space and the apex of the heart, the catheter is positioned under flouroscopy in the aortic root. The stent is expanded and unfolds the valve which is thereby implanted into the aortic root. Exact targeting is crucial, since major complications can arise from a misplaced valve. Planning software for the perioperative use is presented that allows for selection of the best fitting implant and calculation of the safe target area for that implant. The software uses contrast enhanced perioperative DynaCT images acquired under rapid pacing. In a semiautomatic process, a surface segmentation of the aortic root is created. User selected anatomical landmarks are used to calculate the geometric constraints for the size and position of the implant. The software is integrated into a PACS network based on DICOM communication to query and receive the images and implants templates from a PACS server. The planning results can be exported to the same server and from there can be rertieved by an intraoperative catheter guidance device.

  4. Direct aortic transcatheter valve implantation via mini-thoracotomy using the Medtronic CoreValve.

    PubMed

    Bruschi, Giuseppe; Botta, Luca; De Marco, Federico; Colombo, Paola; Nonini, Sandra; Klugmann, Silvio; Martinelli, Luigi

    2013-01-01

    Transcatheter aortic valve implantation using the Medtronic CoreValve is a well-established procedure. Although previously carried out only through the common femoral artery, today it is possible to perform the procedure through different arterial alternative access sites. A direct aortic approach through the ascending aorta could be carried out via a right anterior mini-thoracotomy in the second intercostal space. The pericardium is opened to expose the aorta. Two purse-string sutures are then placed on the ascending aorta and a standard retrograde CoreValve implantation is performed with the standard delivery system. Advantages, contraindications, surgical technique and results are discussed.

  5. Transapical aortic valve and mitral valve in ring prosthesis implantation - a new advance in transcatheter procedures.

    PubMed

    Neves, Paulo C; Paulo, Nelson Santos; Gama, Vasco; Vouga, Luís

    2014-08-01

    Transcatheter valve implantation offers a new treatment modality to those patients whose general condition makes conventional surgery very risky. However, the transcatheter option has only been available for the aortic valve. We describe a case of a successful implantation of two Edwards SAPIEN(®) 26 and 29 mm transapical valves, respectively, in aortic and mitral positions, on a 74-year-old patient with severe aortic and mitral stenosis. The procedure progressed uneventfully. Predischarge echocardiogram showed a peak aortic gradient of 20 mmHg, mild periprosthetic regurgitation, peak and mean mitral gradients of 12 and 4, respectively, and moderate (II/IV) periprosthetic regurgitation. Indications for transapical valve implantation will rapidly increase in the near future. It is essential to individualize the treatment be applied for each patient, in order to optimize the success of the procedure.

  6. Autopsy after transcatheter aortic valve implantation.

    PubMed

    van Kesteren, F; Wiegerinck, E M A; Rizzo, S; Baan, J; Planken, R N; von der Thüsen, J H; Niessen, H W M; van Oosterhout, M F M; Pucci, A; Thiene, G; Basso, C; Sheppard, M N; Wassilew, K; van der Wal, A C

    2017-03-01

    Autopsy after transcatheter aortic valve implantation (TAVI) is a new field of interest in cardiovascular pathology. To identify the cause of death, it is important to be familiar with specific findings related to the time interval between the procedure and death. We aimed to provide an overview of the autopsy findings in patients with TAVI in their medical history divided by the timing of death with specific interest in the added value of autopsy over a solely clinically determined cause of death. In 8 European centres, 72 cases with autopsy reports were available. Autopsies were divided according to the time interval of death and reports were analysed. In 32 patients who died ≤72 h postprocedure, mortality resulted from cardiogenic or haemorrhagic shock in 62.5 and 34.4%, respectively. In 31 patients with mortality >72 h to ≤30 days, cardiogenic shock was the cause of death in 51.6% followed by sepsis (22.6%) and respiratory failure (9.7%). Of the nine patients with death >30 days, 88.9% died of sepsis, caused by infective endocarditis in half of them. At total of 12 patients revealed cerebrovascular complications. Autopsy revealed unexpected findings in 61.1% and resulted in a partly or completely different cause of death as was clinically determined. Autopsy on patients who underwent TAVI reveals specific patterns of cardiovascular pathology that clearly relate to the time interval between TAVI and death and significantly adds to the clinical diagnosis. Our data support the role of autopsy including investigation of the cerebrum in the quickly evolving era of cardiac device technology.

  7. [Transcatheter aortic valve implantation for aortic stenosis. Initial experience].

    PubMed

    Careaga-Reyna, Guillermo; Lázaro-Castillo, José Luis; Lezama-Urtecho, Carlos Alberto; Macías-Miranda, Enriqueta; Dosta-Herrera, Juan José; Galván Díaz, José

    2016-12-09

    Aortic stenosis is a frequent disease in the elderly, and is associated with other systemic pathologies that may contraindicate the surgical procedure. Another option for these patients is percutaneous aortic valve implantation, which is less invasive. We present our initial experience with this procedure. Patients with aortic stenosis were included once selection criteria were accomplished. Under general anaesthesia and echocardiographic and fluosocopic control, a transcatheter aortic valve was implanted following s valvuloplasty. Once concluded the procedure, angiographic and pressure control was realized in order to confirm the valve function. Between November 2014 and May 2015, 6 patients were treated (4 males and 2 females), with a mean age of 78.83±5.66 years-old. The preoperative transvalvular gradient was 90.16±28.53mmHg and posterior to valve implant was 3.33±2.92mmHg (P<.05). Two patients had concomitant coronary artery disease which had been treated previously. One patient presented with acute right coronary artery occlusion which was immediately treated. However due to previous renal failure, postoperative sepsis and respiratory failure, the patient died one month later. It was concluded that our preliminary results showed that in selected patients percutaneous aortic valve implantation is a safe procedure with clinical improvement for treated patients. Copyright © 2016 Academia Mexicana de Cirugía A.C. Publicado por Masson Doyma México S.A. All rights reserved.

  8. Glaucoma

    MedlinePlus

    ... 60, especially Mexican Americans People with a family history of glaucoma There is no cure, but glaucoma can usually be controlled. Early treatment can help protect your eyes against vision loss. Treatments usually include prescription eyedrops and/or surgery. NIH: National Eye Institute

  9. Bioprosthetic Valve Fracture to Facilitate Transcatheter Valve-in-Valve Implantation.

    PubMed

    Allen, Keith B; Chhatriwalla, Adnan K; Cohen, David J; Saxon, John T; Aggarwal, Sanjeev; Hart, Anthony; Baron, Suzanne; Davis, J Russell; Pak, Alex F; Dvir, Danny; Borkon, A Michael

    2017-06-29

    Valve-in-valve transcatheter aortic valve replacement is less effective in small surgical bioprostheses. We evaluated the feasibility of bioprosthetic valve fracture with a high-pressure balloon to facilitate valve-in-valve transcatheter aortic valve replacement. In vitro bench testing on aortic tissue valves was performed on 19-mm and 21-mm Mitroflow (Sorin, Milan, Italy), Magna and Magna Ease (Edwards Lifesciences, Irvine, CA), Trifecta and Biocor Epic (St. Jude Medical, Minneapolis, MN), and Hancock II and Mosaic (Medtronic, Minneapolis, MN). High-pressure balloons Tru Dilation, Atlas Gold, and Dorado (C.R. Bard, Murray Hill, NJ) were used to determine which valves could be fractured and at what pressure fracture occurred. Mitroflow, Magna, Magna Ease, Mosaic, and Biocor Epic surgical valves were successfully fractured using high-pressures balloon 1 mm larger than the labeled valve size whereas Trifecta and Hancock II surgical valves could not be fractured. Only the internal valve frame was fractured, and the sewing cuff was never disrupted. Manufacturer's rated burst pressures for balloons were exceeded, with fracture pressures ranging from 8 to 24 atmospheres depending on the surgical valve. Testing further demonstrated that fracture facilitated the expansion of previously constrained, underexpanded transcatheter valves (both balloon and self-expanding) to the manufacturer's recommended size. Bench testing demonstrates that the frame of most, but not all, bioprosthetic surgical aortic valves can be fractured using high-pressure balloons. The safety of bioprosthetic valve fracture to optimize valve-in-valve transcatheter aortic valve replacement in small surgical valves requires further clinical investigation. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  10. Stent valve implantation in conventional redo aortic valve surgery to prevent patient-prosthesis mismatch.

    PubMed

    Ferrari, Enrico; Franciosi, Giorgio; Clivio, Sara; Faletra, Francesco; Moccetti, Marco; Moccetti, Tiziano; Pedrazzini, Giovanni; Demertzis, Stefanos

    2017-03-01

    The goal was to show the technical details, feasibility and clinical results of balloon-expandable stent valve implantation in the aortic position during conventional redo open-heart surgery in selected obese patients with a small aortic prosthesis and severe patient-prosthesis mismatch. Two symptomatic overweight patients (body mass index of 31 and 38), each with a small aortic prosthesis (a 4-year-old, 21-mm Hancock II biological valve and a 29-year-old, 23-mm Duromedic mechanical valve), increased transvalvular gradients (59/31 and 74/44 mmHg) and a reduced indexed effective orifice area (0.50 and 0.43 cm 2 /m 2 ) underwent implantation of two 26-mm balloon-expandable Sapien 3 valves during standard on-pump redo valve surgery. Using full re-sternotomy, cardiopulmonary bypass and cardioplegic arrest, the two balloon-expandable stent valves were implanted under direct view using a standard aortotomy, after prosthesis removal and without annulus enlargement. Aortic cross-clamp times were 162 and 126 min; cardiopulmonary bypass times were 178 and 180 min; total surgical times were 360 and 318 min. At discharge, echocardiograms showed transvalvular peak and mean gradients of 13/9 and 23/13 mmHg and indexed effective orifice areas of 0.64 and 1.08 cm 2 /m 2 . The 3-month echocardiographic follow-up showed transvalvular peak and mean gradients of 18/9 and 19/11 mmHg and indexed effective orifice areas of 0.78 cm 2 /m 2 and 0.84 cm 2 /m 2 , with improved symptoms (New York Heart Association class 1). Implantation of a balloon-expandable stent valve during redo aortic valve surgery is feasible in selected cases and prevents patient-prosthesis mismatch in obese patients without need for aortic annulus enlargement. Moreover, in the case of stent valve degeneration, this approach permits additional valve-in-valve procedures with large stent valves and prevents re-redo surgery.

  11. [Glaucoma].

    PubMed

    Funk, Jens

    2009-03-01

    Glaucoma is one of the most frequent causes of blindness in the world. Although there are several different subforms of glaucoma, their final common pathway is an atrophy of the optic disc leading to progressive visual field defects and finally total blindness. The loss of function in glaucoma is irreversible, i.e. early detection of the disease is the most important part of its therapy. Early detection, however, requires improved knowledge about the disease in the general population and the active help of all general practitioners, explaining their patients the insidious nature of the disease.

  12. Transcatheter Aortic Valve Implantation Despite Challenging Vascular Access

    PubMed Central

    Nascimbene, Angelo; Azpurua, Federico; Livesay, James J.; Fish, R. David

    2015-01-01

    We describe transcatheter aortic valve implantation in a patient who had severe peripheral artery disease. The patient's vascular condition required additional preliminary peripheral intervention to enable adequate vascular access. A 78-year-old man with severe aortic stenosis, substantial comorbidities, and severe heart failure symptoms was referred for aortic valve replacement. The patient's 20-mm aortic annulus necessitated the use of a 23-mm Edwards Sapien valve inserted through a 22F sheath, which itself needed a vessel diameter of at least 7 mm for percutaneous delivery. The left common femoral artery was selected for valve delivery. The left iliac artery and infrarenal aorta underwent extensive intervention to achieve an intraluminal diameter larger than 7 mm. After aortic valvuloplasty, valve deployment was successful, and the transaortic gradient decreased from 40 mmHg to less than 5 mmHg. The patient was discharged from the hospital 4 days postoperatively. We conclude that transcatheter aortic valve implantation can be successfully performed in patients with obstructed vascular access, including stenosis of the infrarenal aorta and the subclavian and coronary arteries. PMID:25873826

  13. Outcomes after Descemet stripping endothelial keratoplasty in glaucoma patients with previous trabeculectomy and tube shunt implantation.

    PubMed

    Wiaux, Christophe; Baghdasaryan, Elmira; Lee, Olivia L; Bourges, Jean-Louis; Deng, Sophie X; Yu, Fei; Aldave, Anthony J

    2011-12-01

    To describe the incidence of intraoperative and postoperative complications and visual outcomes in eyes with previous penetrating glaucoma surgery undergoing Descemet stripping endothelial keratoplasty (DSEK). A retrospective review of the first 227 cases of DSEK performed by 2 surgeons at a single institution. Data were collected regarding the performance of concurrent ocular procedures, intraoperative complications, postoperative visual outcomes, and postoperative complications, including primary graft failure, donor dislocation, endothelial rejection, and intraocular pressure (IOP) elevation. Fifty-six of the 227 DSEK procedures were performed in 52 eyes with previous trabeculectomy and/or tube shunt implantation. The percentage of procedures performed in eyes with and without a history of penetrating glaucoma surgery that resulted in primary graft failure (5.4% vs. 4.1%; P = 0.71) and donor dislocation (12.5% vs. 15.2%; P = 0.83) were not statistically significantly different. Additionally, the endothelial rejection rate was not significantly different between cases performed in eyes with (1/19.2 eye-years) and without (1/20.1 eye-years) a history of glaucoma surgery (P = 0.99). The incidence of elevated IOP (≥ 25 mm Hg) after DSEK was the highest in eyes with medically controlled glaucoma (47.4%), followed by eyes without a history of glaucoma (18.3%), and was the lowest in eyes with previous glaucoma surgery (11.5%). Postoperative corrected distance visual acuity was improved over the preoperative corrected distance visual acuity in 81%, 95%, and 88% of eyes with previous glaucoma surgery, medically controlled glaucoma, and no glaucoma, respectively. DSEK is an effective procedure to improve vision in the majority of eyes with advanced glaucoma after trabeculectomy and/or tube shunt implantation. The incidence of postoperative complications, such as donor dislocation, primary graft failure, and endothelial rejection, is not significantly higher in eyes with

  14. Left ventricular guidewire pacing for transcatheter aortic valve implantation.

    PubMed

    Guérios, Enio E; Wenaweser, Peter; Meier, Bernhard

    2013-12-01

    Previous reports prove the safety and efficacy of cardiac pacing employing a guidewire in the left ventricle as unipolar pacing electrode. We describe the use of left ventricular guidewire pacing as an alternative to conventional transvenous temporary right ventricular pacing in the context of transcatheter aortic valve implantation.

  15. Percutaneous transcatheter aortic valve replacement: first transfemoral implant in Asia.

    PubMed

    Chiam, P T; Koh, T H; Chao, V T; Lee, C Y; See Tho, V Y; Tan, S Y; Lim, S T; Hwang, N C; Sin, Y K; Chua, Y L

    2009-05-01

    Surgical aortic valve replacement (AVR) is the standard of care for patients with symptomatic severe aortic stenosis (AS), providing relief of symptoms and prolonging survival. However, many patients are either denied or not offered surgery due to high surgical risk or non-operability for open AVR. The technology of percutaneous aortic valve implantation emerged in 2002, and has since evolved rapidly with satisfactory results. Currently, almost all the procedures are performed predominantly in Europe and North America. The first-in-Asia percutaneous transcatheter aortic valve implantation via the transfemoral route is described. A 77-year-old man with symptomatic severe AS and at high surgical risk was successfully treated, with sustained clinical improvement and satisfactory haemodynamic results at 30-day follow-up.

  16. Results of Trabectome Surgery Following Failed Glaucoma Tube Shunt Implantation

    PubMed Central

    Mosaed, Sameh; Chak, Garrick; Haider, Asghar; Lin, Ken Y.; Minckler, Don S.

    2015-01-01

    Abstract To evaluate the safety and efficacy of Trabectome after failed tube shunt surgery. Twenty patients with prior failed tube shunt surgery who underwent Trabectome alone were included. All patients had at least 3 months of follow-up. Outcomes measured included intraocular pressure (IOP), glaucoma medications, and secondary glaucoma surgeries. The success for Kaplan–Meier survival analysis is defined as IOP ≤21 mm Hg, IOP reduced by at least 20% from preoperative IOP, and no secondary glaucoma surgery. Mean preoperative IOP was 23.7 ± 6.4 mm Hg and mean number of glaucoma medications was 3.2 ± 1.5. At 12 months, IOP was reduced to 15.5 ± 3.2 mm Hg (P = 0.05) and number of medications was reduced to 2.4 ± 1.5 (P = 0.44). Survival rate at 12 months was 84% and 3 patients required additional glaucoma surgery with 15 patients reaching 12 months follow-up. Other than failure of IOP control and transient hypotony (IOP < 3 mm Hg) day 1 in 2 cases, there were no adverse events. Trabecular bypass procedures have traditionally been considered an approach appropriate for early-to-moderate glaucoma; however, our study indicates benefit in refractory glaucoma as well. Eyes that are prone to conjunctival scarring and hypertrophic wound healing, such as those who have failed tube shunt surgery, may benefit from procedures that avoid conjunctival incision such as Trabectome. This study indicates potential benefits in this patient population. Trabectome was safe and effective in reducing IOP at 1-year follow-up in patients with prior failed tube shunt surgery, but not effective in reducing medication reliance in these patients. PMID:26222842

  17. Transcatheter aortic valve implantation with the Edwards Sapien 3 valve: First experiences in Turkey.

    PubMed

    Aslan, Abdullah Nabi; Baştuğ, Serdal; Kasapkara, Hacı Ahmet; Ayhan, Hüseyin; Süygün, Hakan; Keleş, Telat; Durmaz, Tahir; Akar Bayram, Nihal; Bilen, Emine; Bozkurt, Engin

    2016-12-01

    Transcatheter aortic valve implantation (TAVI) has shown promising results in patients with severe aortic stenosis (AS) at high risk for open heart surgery. We aimed to evaluate outcomes of patients who underwent TAVI with Edwards SAPIEN 3 Transcatheter Heart Valve (S3), a second-generation TAVI device. Between November 2014 and June 2016, 31 high-risk patients received balloon-expandable S3 valve at Atatürk Training and Research Hospital that has the largest case series in Turkey. Mean age of the patients was 76.1±12.6 years. Mean Society of Thoracic Surgeons and logistic European System for Cardiac Operative Risk Evaluation scores were 7.8%±3.1 and 31.4%±17.6, respectively. S3 valve was implanted in 27 patients via transfemoral approach and via trans-subclavian approach in 4 patients under local (n=29) or general (n=2) anesthesia. Procedural success rate was 100% (23 mm, n=7; 26 mm, n=16; 29 mm, n=8). Paravalvular aortic regurgitation (PAR) was absent or trivial in 29 (93.6%) patients and mild in 2 (6.4%) patients. Permanent pacemaker implantation (PPI) was required in 2 (6.4%) patients during the procedure, and in-hospital mortality occurred in 1 (3.2%) of those 2 patients. S3 valve is associated with higher rate of device success and lower incidence of PAR, peripheral vascular complications, and need for new PPI.

  18. Image-guided transapical aortic valve implantation: sensorless tracking of stenotic valve landmarks in live fluoroscopic images.

    PubMed

    Merk, Denis R; Karar, Mohamed Esmail; Chalopin, Claire; Holzhey, David; Falk, Volkmar; Mohr, Friedrich W; Burgert, Oliver

    2011-07-01

    Aortic valve stenosis is one of the most frequently acquired valvular heart diseases, accounting for almost 70% of valvular cardiac surgery. Transapical transcatheter aortic valve implantation has recently become a suitable minimally invasive technique for high-risk and elderly patients with severe aortic stenosis. In this article, we aim to automatically define a target area of valve implantation, namely, the area between the coronary ostia and the lowest points of two aortic valve cusps. Therefore, we present a new image-based tracking method of these aortic landmarks to assist in the placement of aortic valve prosthesis under live 2D fluoroscopy guidance. We propose a rigid intensity-based image registration technique for tracking valve landmarks in 2D fluoroscopic image sequences, based on a real-time alignment of a contrast image including the initialized manual valve landmarks to each image of sequence. The contrast image is automatically detected to visualize aortic valve features when the aortic root is filled with a contrast agent. Our registration-based tracking method has been retrospectively applied to 10 fluoroscopic image sequences from routine transapical aortic valve implantation procedures. Most of all tested fluoroscopic images showed a successful tracking of valve landmarks, especially for the images without contrast agent injections. A new intraoperative image-based method has been developed for tracking aortic valve landmarks in live 2D fluoroscopic images to assist transapical aortic valve implantations and to increase the overall safety of surgery as well.

  19. Percutaneous pulmonary and tricuspid valve implantations: An update

    PubMed Central

    Wagner, Robert; Daehnert, Ingo; Lurz, Philipp

    2015-01-01

    The field of percutaneous valvular interventions is one of the most exciting and rapidly developing within interventional cardiology. Percutaneous procedures focusing on aortic and mitral valve replacement or interventional treatment as well as techniques of percutaneous pulmonary valve implantation have already reached worldwide clinical acceptance and routine interventional procedure status. Although techniques of percutaneous pulmonary valve implantation have been described just a decade ago, two stent-mounted complementary devices were successfully introduced and more than 3000 of these procedures have been performed worldwide. In contrast, percutaneous treatment of tricuspid valve dysfunction is still evolving on a much earlier level and has so far not reached routine interventional procedure status. Taking into account that an “interdisciplinary challenging”, heterogeneous population of patients previously treated by corrective, semi-corrective or palliative surgical procedures is growing inexorably, there is a rapidly increasing need of treatment options besides redo-surgery. Therefore, the review intends to reflect on clinical expansion of percutaneous pulmonary and tricuspid valve procedures, to update on current devices, to discuss indications and patient selection criteria, to report on clinical results and finally to consider future directions. PMID:25914786

  20. Depth of valve implantation, conduction disturbances and pacemaker implantation with CoreValve and CoreValve Accutrak system for Transcatheter Aortic Valve Implantation, a multi-center study.

    PubMed

    Lenders, Guy D; Collas, Valérie; Hernandez, José Maria; Legrand, Victor; Danenberg, Haim D; den Heijer, Peter; Rodrigus, Inez E; Paelinck, Bernard P; Vrints, Christiaan J; Bosmans, Johan M

    2014-10-20

    Transcatheter Aortic Valve Implantation (TAVI) is now considered an indispensable treatment strategy in high operative risk patients with severe, symptomatic aortic stenosis. However, conduction disturbances and the need for Permanent Pacemaker (PPM) implantation after TAVI with the CoreValve prosthesis still remain frequent. We aimed to evaluate the implantation depth, the incidence and predictors of new conduction disturbances, and the need for PPM implantation within the first month after TAVI, using the new Accutrak CoreValve delivery system (ACV), compared to the previous generation CoreValve (non-ACV). In 5 experienced TAVI-centers, a total of 120 consecutive non-ACV and 112 consecutive ACV patients were included (n=232). The mean depth of valve implantation (DVI) was 8.4±4.0 mm in the non-ACV group and 7.1±4.0 mm in the ACV group (p=0.034). The combined incidence of new PPM implantation and new LBBB was 71.2% in the non-ACV group compared to 50.5% in the ACV group (p=0.014). DVI (p=0.002), first degree AV block (p=0.018) and RBBB (p<0.001) were independent predictors of PPM implantation. DVI (p<0.001) and pre-existing first degree AV-block (p=0.021) were identified as significant predictors of new LBBB. DVI is an independent predictor of TAVI-related conduction disturbances and can be reduced by using the newer CoreValve Accutrak delivery system, resulting in a significantly lower incidence of new LBBB and new PPM implantation. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  1. Transcatheter Aortic Valve Implantation in the Elderly: Who to Refer?

    PubMed Central

    Finn, Matthew; Green, Philip

    2015-01-01

    In recent years, experience with transcatheter aortic valve implantation has led to improved outcomes in elderly patients with severe aortic stenosis (AS) who may not have previously been considered for intervention. These patients are often frail with significant comorbid conditions. As the prevalence of AS increases, there is a need for improved assessment parameters to determine the patients most likely to benefit from this novel procedure. This review discusses the diagnostic criteria for severe AS and the trials available to aid in the decision to refer for aortic valve procedures in the elderly. PMID:25216621

  2. New styrene-b-isobutylene-b-styrene (SIBS) glaucoma drainage implant

    NASA Astrophysics Data System (ADS)

    Orozco, Marcia A.; Acosta, Ana C.; Espana, Edgar M.; Pinchuk, Leonard; Weber, Bruce; Davis, Stewart; Arrieta, Esdras; Dubovy, Sander; Fantes, Francisco; Aly, Mohamed; Zhou, Yonghua; Parel, Jean-Marie

    2006-02-01

    Purpose: To design and test the Miami-InnFocus Drainage Implant (MiDi) as a glaucoma shunt that is biocompatible, flexible, and significantly smaller than existing commercial implants in order to prevent postoperative hypotony, inflammation, scarring, erosion, and extrusion. Methods: A new biomaterial composed of styrene-b-isobutylene-b-styrene (SIBS) was used in a novel design for a glaucoma drainage implant. The implant consists of a tube 11mm long with an inner diameter of 70, 100, and 150 μm and outer diameter of 250 μm with a 1mm2 tab located 4.5mm from the proximal tip to prevent migration. The device was implanted in 15 New Zealand White rabbits for biocompatibility and efficacy testing. A similarly designed implant made of polydimethylsiloxane was implanted in 6 other animals as a pseudo-control. Typical GDI implantation technique was modified for this device. The proximal end of the new SIBS implant was inserted 2mm into the anterior chamber and the distal end placed in a subconjunctival space created by the surgeon. Biocompatibility of the device was studied by slit-lamp follow-up and intraocular pressure (IOP) measurements recorded periodically. Results: Biocompatibility of the MiDi was excellent. A low and diffuse bleb was observed with these devices. All SIBS tubes were patent 9 months after insertion. Immunostaining demonstrated non-continuous deposition of collagen with virtually no encapsulation. No macrophages or myofibroblast were visible around the SIBS polymer which was found more bioinert than the control PDMS. Conclusion: This newly designed glaucoma implant is clinically biocompatible in the rabbit model and maintained 100% patency at 9 months.

  3. Video-based measuring of quality parameters for tricuspid xenograft heart valve implants.

    PubMed

    Condurache, Alexandru Paul; Hahn, Tobias; Scharfschwerdt, Michael; Mertins, Alfred; Aach, Til

    2009-12-01

    Defective heart valves are often replaced by implants in open-heart surgery. Both mechanical and biological implants are available. Among biological implants, xenograft ones-i.e., valves grafted from animals such as pigs, are widely used. Good implants should exhibit certain typical anatomical and functional characteristics to successfully replace the native tissue. Here, we describe a video-based system for measuring quality parameters of xenograft heart valve implants, including the area of the orifice and the fluttering of the valves' leaflets, i.e., their flaps (or cusps). Our system employs automatic methods that provide a precise and reproducible way to infer the quality of an implant. The automatic analysis of both a valve's orifice and the fluttering of its leaflets offers a more comprehensive quality assessment than current, mostly manual methods. We focus on valves with three leaflets, i.e., aortic, pulmonary, and tricuspid valves.

  4. Glaucoma.

    PubMed

    Mantravadi, Anand V; Vadhar, Neil

    2015-09-01

    Glaucoma is a multifactorial degenerative optic neuropathy that can progress at variable rates and afflict all age groups. It is the second leading cause of blindness worldwide. The disease is commonly divided into 2 major subtypes, open angle and angle closure. Diagnosis of glaucoma is made by a combination of identifying characteristic changes of the optic nerve, functional testing such as visual fields, and structural imaging of the optic nerve. Management is aimed at reducing intraocular pressure (IOP). Patients with known risk factors should be referred to an ophthalmologist for complete evaluation.

  5. Correction of aortic regurgitation after transcatheter aortic valve implantation of the Medtronic CoreValveTM prosthesis due to a too-low implantation, using transcatheter repositioning.

    PubMed

    Zahn, Ralf; Schiele, Rudolf; Kilkowski, Caroline; Klein, Bärbel; Zeymer, Uwe; Werling, Christiane; Lehmann, Andreas; Gerckens, Ulrich; Saggau, Werner

    2011-01-01

    Transcatheter aortic valve implantation (TAVI) has been introduced for the treatment of severe symptomatic aortic stenosis in patients not suitable for surgical valve replacement. However, a potential problem of TAVI is the development of severe aortic insufficiency after valve implantation due to a too-low implantation of the valve. Since August 2008, a total of 33 TAVI procedures using the 18 Fr Medtronic CoreValve ReValving system has been performed at the authors' institution. Severe post-implantation aortic regurgitation occurred in three patients (9%), due to a too-low implantation. Two of these patients underwent a catheter-based repositioning of the valve using a standard snare; the third patient declined any further intervention. Both repositioning procedures were uneventful, with no significant residual regurgitation. Severe aortic regurgitation after TAVI with the Medtronic CoreValve system is not uncommon. If the valve is implanted too low, a catheter-based valve repositioning may be the method of choice to resolve the problem.

  6. Secondary glaucoma in CAPN5-associated neovascular inflammatory vitreoretinopathy

    PubMed Central

    Cham, Abdourahman; Bansal, Mayank; Banda, Himanshu K; Kwon, Young; Tlucek, Paul S; Bassuk, Alexander G; Tsang, Stephen H; Sobol, Warren M; Folk, James C; Yeh, Steven; Mahajan, Vinit B

    2016-01-01

    Objective The objective of this study was to review the treatment outcomes of patients with secondary glaucoma in cases of autosomal dominant neovascular inflammatory vitreoretinopathy (ADNIV), a hereditary autoimmune uveitis due to mutations in CAPN5. Patients and methods A retrospective, observational case series was assembled from ADNIV patients with secondary glaucoma. The main outcome measures were intraocular pressure (IOP), visual acuity, use of antiglaucoma medications, ocular surgeries, and adverse outcomes. Perimetry and optic disk optical coherence tomography (OCT) were also analyzed. Results Nine eyes of five ADNIV patients with secondary glaucoma were reviewed. Each received a fluocinolone acetonide (FA) implant for the management of posterior uveitis. Following implantation, no eyes developed neovascular glaucoma. Five eyes (in patients 1, 2, and 5) required Ahmed glaucoma valve surgery for the management of steroid-responsive glaucoma. Patient 2 also developed angle closure with iris bombe and underwent laser peripheral iridotomy. Patient 4 had both hypotony and elevated IOP that required periodic antiglaucoma medication in the FA-implanted eye. Patient 3 did not develop steroid-response glaucoma in either eye. Optic disk examinations were obscured by fibrosis and better assessed with OCT. Conclusion ADNIV patients show combined mechanism secondary glaucoma best assessed by OCT of the optic disk. The FA implants have reduced uveitic and neovascular glaucoma. Nevertheless, IOP management remains complex due to steroid-response glaucoma, angle closure glaucoma, and hypotony. PMID:27390515

  7. Results of a New Technique for Implantation of Nonrestrictive Glaucoma Devices.

    PubMed

    Ortiz Arismendi, Gabriel Enrique; Peña Valderrama, Cristina Del Pilar; Albis-Donado, Oscar

    2013-01-01

    To describe and present results of an original technique for nonvalved glaucoma implants. Thirty-five eyes of 34 patients with aggressive and/or advanced glaucomas of different causes were included. A Baerveldt implant was used in all cases, using an absorbable ligature that had been titrated to allow fow from day 1, but avoiding hypotony. Intraocular pressure (IOP) during the first 8 weeks, final IOP, visual acuity and complications were analyzed. Mean preoperative IOP was 42.8 mm Hg (range: 24-64 mm Hg). IOP was 14.4, 17.2, 18.6, 19 and 16.4 mm Hg during the 1, 2, 4, 6 and 8 postoperative weeks. Mean final IOP was 13.8 ± 4.25 mm Hg, a 67.8% reduction, after a mean follow-up time of 13 months (range: 8-29 months). Twenty-nine eyes (82.9%) had complete success, two had qualifed success (5.7%) and four were failures (11.4%). Choroidal detachments and transient tube obstructions were the most frequent complications. Titrated ligature of Baerveldt tubes was effective for controlling IOP during both the early and late postoperative phases in eyes with severe glaucomas. How to cite this article: Arismendi GEO, del Pilar Peña Valderrama C, Albis-Donado O. RESULTS of a New Technique for Implantation of Nonrestrictive Glaucoma Devices. J Current Glau Prac 2013;7(3):130-135.

  8. Results of a New Technique for Implantation of Nonrestrictive Glaucoma Devices

    PubMed Central

    Peña Valderrama, Cristina Del Pilar; Albis-Donado, Oscar

    2013-01-01

    ABSTRACT Objective: To describe and present results of an original technique for nonvalved glaucoma implants. Patients and methods: Thirty-five eyes of 34 patients with aggressive and/or advanced glaucomas of different causes were included. A Baerveldt implant was used in all cases, using an absorbable ligature that had been titrated to allow fow from day 1, but avoiding hypotony. Intraocular pressure (IOP) during the first 8 weeks, final IOP, visual acuity and complications were analyzed. Results: Mean preoperative IOP was 42.8 mm Hg (range: 24-64 mm Hg). IOP was 14.4, 17.2, 18.6, 19 and 16.4 mm Hg during the 1, 2, 4, 6 and 8 postoperative weeks. Mean final IOP was 13.8 ± 4.25 mm Hg, a 67.8% reduction, after a mean follow-up time of 13 months (range: 8-29 months). Twenty-nine eyes (82.9%) had complete success, two had qualifed success (5.7%) and four were failures (11.4%). Choroidal detachments and transient tube obstructions were the most frequent complications. Conclusion: Titrated ligature of Baerveldt tubes was effective for controlling IOP during both the early and late postoperative phases in eyes with severe glaucomas. How to cite this article: Arismendi GEO, del Pilar Peña Valderrama C, Albis-Donado O. Results of a New Technique for Implantation of Nonrestrictive Glaucoma Devices. J Current Glau Prac 2013;7(3):130-135. PMID:26997797

  9. Modified Scleral Tunnel to Prevent Tube Exposure in Patients With Refractory Glaucoma.

    PubMed

    Ma, Xiao-Hua; Du, Xiu-Juan; Liu, Bing; Bi, Hong-Sheng

    2016-11-01

    To present and evaluate modified scleral tunnel in prevention of tube exposure following Ahmed valve implantation in refractory glaucoma. In the Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine, a retrospective study was conducted in 36 eyes of 34 patients who were diagnosed with refractory glaucoma and underwent Ahmed glaucoma valve implantation. In the surgery, the modified scleral tunnel was done to prevent tube exposure. At the end of follow-up (mean 21.68±9.25 mo), there was no conjunctival tube exposure in all 36 eyes. The mean intraocular pressure was 18.3±6.79 mmHg, and 8 eyes needed 1 to 3 types of drugs to decrease intraocular pressure. The modified scleral tunnel technique in Ahmed glaucoma valve implantation is able to prevent conjunctival tube exposure in the patients with refractory glaucoma.

  10. The efficacy of Alahmady ring implantation in the management of neovascular glaucoma

    PubMed Central

    Alsmman, Alahmady H; Radwan, Gamal; Elagouz, Mohammed; Mohammed, Usama Ali

    2017-01-01

    Purpose To evaluate the efficacy and safety of Alahmady ring implantation in the management of neovascular glaucoma. Methods A total of 15 eyes of 15 patients with intractable neovascular glaucoma with intraocular pressure (IOP) ≥28 mmHg not responding to medical treatment were retrospectively analyzed. All patients had poor visual acuity and underwent Alahmady ring implantation. The ring was designed from fenestrated silicon tube used in lacrimal surgeries and was implanted subsclerally after passing it through the anterior chamber. Patients were followed up for at least 24 months. Success in this study was defined based on IOP ≥8 mmHg and <21 mmHg, with not more than 1 glaucoma drug, and improvement of patient symptoms and signs with maximum use of beta blocker as antiglaucoma drug. Results A total of 15 eyes of 15 patients (9 males [60%] and 6 females [40%]) were analyzed in this study. The mean IOP before surgery was 38.6 mmHg (standard deviation [SD]: 6.98) and it was 14.05 mmHg (SD =7.57) after surgery. The follow-up range was 24–36 months. Success of silicon drainage device was defined as an IOP <21 mmHg on the last follow-up visit. Medications included only beta-blockers and topical steroids for those who were without severe complications or for those who were not in a condition to undergo a further glaucoma surgery. Conclusion Alahmady ring implantation proves to be a good surgical option for neovascular glaucoma; however, a longer follow-up period is recommended. PMID:28356708

  11. Computed tomography assessment for transcatheter aortic valve in valve implantation: The vancouver approach to predict anatomical risk for coronary obstruction and other considerations.

    PubMed

    Blanke, Philipp; Soon, Jeanette; Dvir, Danny; Park, Jong K; Naoum, Christopher; Kueh, Shaw-Hua; Wood, David A; Norgaard, Bjarne L; Selvakumar, Kapilan; Ye, Jian; Cheung, Anson; Webb, John G; Leipsic, Jonathon

    Valve-in-valve implantation of a transcatheter heart valve into a failed bioprosthetic heart valve has emerged as a treatment alternative to repeat conventional surgery. This requires careful pre-procedural assessment using non-invasive imaging to identify patients at risk for procedure related adverse events, such as ostial coronary occlusion. Herein we report how to comprehensively assess aortic root anatomy using computed tomography prior to transcatheter valve implantation for failed bioprosthetic aortic valves.

  12. First-in-man transcatheter mitral valve-in-ring implantation with a repositionable and retrievable aortic valve prosthesis.

    PubMed

    Latib, Azeem; Ruparelia, Neil; Bijuklic, Klaudija; De Marco, Federico; Gatto, Fernando; Hansen, Lorenz; Ozbek, Cem; Greilach, Peter; Bruschi, Giuseppe; Rieß, Friedrich-Christian; Alfieri, Ottavio; Colombo, Antonio; Schofer, Joachim

    2016-02-01

    Transcatheter interventions with balloon-expandable valves have been shown to be efficacious for the treatment of mitral annuloplasty failure but are limited by the fact that there is no opportunity for post-implantation adjustment. The aim of this study was to assess the safety and efficacy of the fully repositionable and retrievable Direct Flow Medical (DFM) valve for the treatment of mitral annuloplasty failure. Patients who underwent transcatheter mitral valve-in-ring (VIR) implantation of a DFM valve for failed mitral annuloplasty deemed high risk for redo surgery were included at four institutions. Eight patients underwent transcatheter mitral VIR procedures with implantation of the DFM valve. The DFM prosthesis was successfully positioned in all patients. Two patients required retrieval of the device due to a suboptimal result, and a further patient required repositioning of the valve with an ultimately successful implantation. During the 30-day follow-up period, two patients died for reasons unrelated to the valve implantation. The four patients with successful implantation had normal valve function associated with a significant improvement in their functional status. For the first time, we demonstrate the safety, efficacy and advantages of using the DFM prosthesis for the treatment of mitral annuloplasty failure.

  13. Intraocular pressure following ECCE and IOL implantation in patients with glaucoma.

    PubMed

    Kooner, K S; Dulaney, D D; Zimmerman, T J

    1988-08-01

    Patients with glaucoma may suffer optic nerve head damage due to elevated intraocular pressure (IOP) after any intraocular procedure. We retrospectively reviewed the IOP data in 82 consecutive patients (103 eyes) with glaucoma after extracapsular cataract extraction (ECCE) and posterior chamber intraocular lens (PC-IOL) implantation. Nine eyes had previous trabeculectomy and three eyes required combined trabeculectomy with ECCE and PC-IOL. The average follow-up period is 1.5 years (range 0.5 to 6 years). The postoperative IOP rise of 8 mm Hg over baseline or above 23 mm Hg was observed in 45 eyes (49.5%). Two eyes needed argon laser trabeculoplasty and one required trabeculectomy to control postoperative IOP elevation. Most of the patients required the same or lesser number of medications for IOP control after surgery. Results suggest that ECCE with PC-IOL may be a relatively safe procedure in cataract patients with preexisting glaucoma.

  14. Quarter-Shifted Microincisional Sutureless Vitrectomy in Patients with a Glaucoma Drainage Implant or Filtering Bleb.

    PubMed

    Song, Ji Hun; Jang, Seran; Cho, Eun Hyung; Ahn, Jaehong

    2017-05-01

    When vitrectomy is performed in eyes that have undergone glaucoma surgery, the site of sclerotomy often overlaps with the previous glaucoma operation site. It can lead to serious complications such as postoperative hypotony, leakage, and/or infection. Our technique involves modification of surgeon's position and two sclerotomy sites 45° away from the original position, with an infusion cannula inserted infranasally to avoid damage to the glaucoma drainage implant or filtering bleb. The modified approach was applied to seven eyes with various indications. Vitrectomy was successfully completed, and there were no sclerotomy site complications, leakage, or hypotony in any case. Good intraocular pressure control was maintained throughout the postoperative course in all cases. © Copyright: Yonsei University College of Medicine 2017.

  15. Transcatheter aortic valve implantation with Core Valve: First Indian experience of three high surgical risk patients with severe aortic stenosis

    PubMed Central

    Seth, Ashok; Rastogi, Vishal; Kumar, Vijay; Maqbool, Syed; Mustaqueem, Arif; Sekar, V. Ravi

    2013-01-01

    The prevalence of aortic stenosis is increasing with aging population. However with multiple co-morbidities and prior procedures in this aging population, more and more patients are being declared unfit for the ‘Gold Standard’ treatment i.e. surgical aortic valve replacement (AVR). Among the patients who are unfit or high risk for aortic valve replacement (AVR) by open heart surgery, transcatheter aortic valve implantation (TAVI) has been proven to be a valuable alternative improving survival and quality of life. We report first Indian experience of Core Valve (Medtronic Inc.) implantation in three high surgical risk patients performed on 22nd and 23rd February 2012. PMID:23993000

  16. The Medtronic Melody® transcatheter pulmonary valve implanted at 24-mm diameter--it works.

    PubMed

    Cheatham, Sharon L; Holzer, Ralf J; Chisolm, Joanne L; Cheatham, John P

    2013-11-01

    We report the Melody valve implanted and/or expanded to 24-mm diameter. The Medtronic Melody valve has been implanted up to 22 mm in the pulmonary position for over a decade. A retrospective chart review was performed on 82 patients who underwent Melody valve implant. Technical implant method, pre- and postimplant echocardiographic findings, and initial follow-up were reviewed. Between 04/2008 and 12/2011, 13 Melody valves were successfully implanted in 11 patients, median age 35 years (range 16-61 years), in the pulmonary (bioprosthetic valve, right ventricle to pulmonary artery conduit, native valve) position (n = 9), tricuspid position (bioprosthetic valve n = 3), and aortic position (bioprosthetic valve n = 1). Ten valves were delivered on a 24-mm balloon in balloon catheter and three were implanted using a 22-mm Ensemble balloon delivery system, followed by postdilation using a 24-mm × 2-cm Atlas balloon catheter. Postimplant, the median peak systolic gradient across the pulmonary valve was 7 mm Hg and median gradient across the tricuspid valve was 3 mm Hg. There was no change in gradient across the Melody valve in the aortic position where valve prosthesis-patient mismatch was present. Postimplant intracardiac echocardiography demonstrated none or mild valve regurgitation. No more than mild regurgitation was noted at a median follow-up of 9.5 months. The Melody valve can be implanted at 24 mm in the stenotic/regurgitant bioprosthetic pulmonary, tricuspid, and aortic valve, dysfunctional right ventricle to pulmonary artery conduit, and the native right ventricular outflow tract, whereas the valve remains competent with only mild regurgitation. Copyright © 2013 Wiley Periodicals, Inc.

  17. 5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis.

    PubMed

    Barbanti, Marco; Petronio, Anna Sonia; Ettori, Federica; Latib, Azeem; Bedogni, Francesco; De Marco, Federico; Poli, Arnaldo; Boschetti, Carla; De Carlo, Marco; Fiorina, Claudia; Colombo, Antonio; Brambilla, Nedy; Bruschi, Giuseppe; Martina, Paola; Pandolfi, Claudia; Giannini, Cristina; Curello, Salvatore; Sgroi, Carmelo; Gulino, Simona; Patanè, Martina; Ohno, Yohei; Tamburino, Claudia; Attizzani, Guilherme F; Immè, Sebastiano; Gentili, Alessandra; Tamburino, Corrado

    2015-07-01

    The purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota). There is a paucity of evidence on long-term durability of currently available transcatheter heart valves. Starting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria. All-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p < 0.001). Late prosthesis failure occurred in 5 cases (1.4%); among these, redo TAVI was successfully carried out in 2 patients (0.6%) presenting with symptomatic prosthesis restenosis. The remaining 3 cases of prosthesis failure did not undergo further invasive interventions. Ten patients (2.8%) showed late mild stenosis with a mean transaortic gradient ranging from 20 to 40 mm Hg. No other cases of structural or nonstructural valvular deterioration were

  18. Implantation of a SAPIEN 3 Valve in a Patient with Pure Aortic Regurgitation.

    PubMed

    Minol, Jan-Philipp; Veulemans, Verena; Zeus, Tobias; Blehm, Alexander

    2016-07-01

    Transcatheter aortic valve implantation (TAVI) is an emerging treatment for high-risk patients with aortic stenosis. Aortic regurgitation is considered to be a relative contraindication for transcatheter procedures, as a non-calcified aortic annulus poses the risk of an insufficient anchoring of the transcatheter aortic valve prosthesis. Herein is described the case of a patient who suffered from recurrent aortic valve regurgitation after valve-sparing repair, and which was successfully treated by the transcatheter implantation of an Edwards SAPIEN 3™ prosthesis. This case report demonstrated the suitability of this prosthesis to treat pure aortic valve regurgitation, without excessive oversizing of the valve.

  19. Atrioventricular Conduction Changes After CoreValve Transcatheter Aortic Valve Implantation.

    PubMed

    López-Aguilera, José; Segura Saint-Gerons, José María; Mazuelos Bellido, Francisco; Suárez de Lezo, Javier; Ojeda Pineda, Soledad; Pan Álvarez-Ossorio, Manuel; Romero Moreno, Miguel Ángel; Pavlovic, Djordje; Espejo Pérez, Simona; Suárez de Lezo, José

    2016-01-01

    Conduction disturbances often occur after CoreValve transcatheter aortic valve implantation. The aim was to analyze which cardiac conduction changes occur in patients with aortic stenosis treated with this type of prosthesis. A total of 181 patients with severe aortic stenosis treated with this prosthesis and studied by electrocardiography between April 2008 and December 2013 were selected. A subgroup of 137 (75.7%) consecutive patients was studied by intracardiac electrocardiogram before and after prosthesis implantation. The primary endpoint of the study was the need for a permanent pacemaker within 72 hours after prosthesis implantation. Numerous variables to predict this possibility were analyzed. Following implantation, PR and QRS intervals were increased from 173±47 ms to 190±52ms (P < .01) and from 98±22ms to 129±24 ms (P < .01), whereas the A-H and H-V intervals were prolonged from 95±39ms to 108±41ms (P < .01) and from 54±10ms to 66±23ms (P < .01). A total of 89 (49%) patients had new-onset left bundle-branch block, and 33 (25%) required a pacemaker within the first 72hours. The independent predictors for a pacemaker were baseline right bundle-branch block and prosthetic depth. Intracardiac intervals had no predictive value. In addition, 13 patients required a pacemaker after 72 hours. CoreValve prosthesis implantation has a high incidence of conduction disturbance, with left bundle-branch block being the most common. A total of 25% of patients required a permanent pacemaker. The need for a pacemaker was related to baseline right bundle-branch block and prosthetic depth. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  20. Transfemoral implantation of CoreValve Evolut-R aortic prosthesis in patient with prior ball-cage mechanical mitral valve prosthesis.

    PubMed

    Maluenda, Gabriel; Caorsi, Carlos; Baeza, Cristian

    2016-06-01

    Transcatheter aortic valve replacement remains challenge in patients with ball-cage-type mechanical valve in mitral position. Potential under-expansion of the percutaneous valve and interaction between the mitral ball-cage mechanical valve tilted towards the left ventricular outflow tract and the percutaneous valve adds risk during and after implantation. We report a successful implantation of the novel CoreValve Evolut-R self-expanding in a patient with severe aortic stenosis and a mitral Starr-Edwards mechanical valve implanted 28years ago.

  1. Platypnea-Orthodeoxia Syndrome after Transcatheter Aortic Valve Implantation

    PubMed Central

    Garot, Jerome; Neylon, Antoinette; Sawaya, Fadi J.; Lefèvre, Thierry

    2016-01-01

    Progressive dyspnea and hypoxaemia in the subacute phase after transcatheter aortic valve implantation (TAVI) are uncommon and warrant immediate assessment of valve and prosthesis leaflet function to exclude thrombosis, as well as investigation for other causes related to the procedure, such as left ventricular dysfunction, pulmonary embolism, and respiratory sepsis. In this case, we report the observation of a patient presenting two weeks after TAVI with arterial hypoxaemia in an upright position, relieved by lying flat, and coupled with an intracardiac shunt detected on echocardiography in the absence of pulmonary hypertension, raising the suspicion of Platypnea-Orthodeoxia Syndrome (POS). Invasive intracardiac haemodynamic assessment showed a significant right-to-left shunt (Qp/Qs = 0.74), which confirmed the diagnosis, with subsequent closure of the intracardiac defect resulting in immediate relief of symptoms and hypoxaemia. To our knowledge, this is the first reported case of an interatrial defect and shunt causing Platypnea-Orthodeoxia Syndrome after transcatheter aortic valve implantation, resolved by percutaneous device closure. PMID:27610250

  2. A Review of Most Relevant Complications of Transcatheter Aortic Valve Implantation

    PubMed Central

    Michler, Robert E.

    2013-01-01

    Transcatheter aortic valve implantation (TAVI) has emerged for treating aortic stenosis in patients who are poor candidates for surgical aortic valve replacement. Currently, the balloon-expandable Edwards Sapien valve—which is usually implanted via a transfemoral or transapical approach—and the self-expanding CoreValve ReValving system—which is designed for retrograde application—are the most widely implanted valves worldwide. Although a promising approach for high-risk patients, the indication may be expanded to intermediate- and eventually low-risk patients in the future; however, doing so will require a better understanding of potential complications, risk factors for these complications, and strategies to individualize each patient to a different access route and a specific valve. This paper reviews the most relevant complications that may occur in patients who undergo catheter-based aortic valve implantation. PMID:23844292

  3. [A case of percutaneous coronary intervention after transfemoral implantation of a medtronic CoreValve System].

    PubMed

    Corcione, Nicola; Ferraro, Paolo; Polimeno, Michele; Messina, Stefano; de Rosa, Vincenzo; Giordano, Arturo

    2011-12-01

    The association between aortic valve disease and coronary atherosclerosis is common. In the recent era of transcatheter aortic valve implantation there is little experience with coronary artery intervention after valve implantation. We report a case of a 80-year-old male who underwent successful coronary artery intervention few months after a Medtronic CoreValve System percutaneous implantation for severe aortic valve stenosis. Verification of the position of the used wires (crossing from inside the self expanding frame) is of utmost importance before proceeding to coronary intervention. In this case, crossing the aortic valve, coronary angiography and percutaneous coronary intervention were successfully performed. In conclusion, percutaneous coronary intervention in patients with previous Medtronic CoreValve System implantation is feasible and safe.

  4. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement.

    PubMed

    Webb, John; Rodés-Cabau, Josep; Fremes, Stephen; Pibarot, Philippe; Ruel, Marc; Ibrahim, Reda; Welsh, Robert; Feindel, Christopher; Lichtenstein, Samuel

    2012-01-01

    Patients with severe symptomatic aortic stenosis have a poor prognosis with medical management alone, and balloon aortic valvuloplasty has failed to provide durable clinical benefit. Open surgical replacement of the aortic valve can improve symptoms and survival. Recently, transcatheter aortic valve implantation (TAVI) has been demonstrated to improve survival, quality of life, and functional status in nonoperable patients and to be a viable option for patients in whom the risk of open surgical morbidity or mortality is high. This Canadian Cardiovascular Society position statement represents the consensus of a representative group of cardiologists and cardiac surgeons as to the current, but evolving, role of this less-invasive new therapy. Specific recommendations are provided for selection of patients for TAVI vs surgical aortic valve replacement for native valves and for bioprostheses, approaches to patient evaluation for TAVI, appropriate constitution of multidisciplinary teams involved in performing TAVI, essential facilities that are needed to perform TAVI safely and effectively, and training/qualifications for TAVI operators. Cost considerations, complication rates, and the quality of the available evidence are also discussed. It is hoped that this consensus document will prove to be a useful resource for health professionals, institutions, departments, and decision-making bodies dealing with this important and rapidly evolving therapy.

  5. Persistent Hypotony Associated with Immunosuppressive Therapy in Glaucoma Drainage Implant Surgery

    PubMed Central

    Duch, Susana; Milla, Elena; Stirbu, Oana; Andreu, David

    2016-01-01

    Purpose To describe the histopathology of non-valved implant capsules in three cases of persistent postoperative hypotony after the restrictive tube ligature was released in patients receiving immunosuppressive therapy. Observations The macroscopic appearance of the capsules 3 and 4 months postoperatively was immature and loose. Microscopic examination disclosed extremely irregular thin tissue, with thicknesses ranging from 0.02 to 0.6 mm, depending on the capsular location studied. Withdrawal of immunosuppressive therapy did not facilitate rebuilding of new capsules. Replacement with a valved implant device was necessary in two cases; the third case recovered with tapering of prednisone. Conclusions and Importance The use of chronic systemic immunosuppressive therapy might interfere with capsular formation around the plates of drainage devices inducing persistent hypotony. In these cases, the use of valved implants might be safer. PMID:27790128

  6. Retrospective Comparison of Intermediate-term Efficacy of 350 mm2 Glaucoma Drainage Implants and Medium-sized 230-250 mm2 Implants

    PubMed Central

    Meyer, Alissa M; Rodgers, Cooper D; Zou, Baiming; Rosenberg, Nicole C; Webel, Aaron D

    2017-01-01

    ABSTRACT Aim To compare the intermediate-term efficacy of a large surface area Baerveldt 350 mm2 glaucoma drainage device (GDD) with medium surface area implants (Baerveldt 250 mm2 and Molteno 3, 230, or 245 mm2). Design This is a retrospective, nonrandomized comparative trial. Materials and methods A total of 94 eyes of 94 patients of mixed glaucoma diagnoses without any prior glaucoma surgical procedures and who had undergone a glaucoma drainage implant surgery with either a large Baerveldt 350 mm2 GDD or a medium-sized GDD (Baerveldt 250 mm2 or Molteno 230 or 245 mm2) were reviewed for intraocular pressure (IOP), number of glaucoma medications, and visual acuity (VA) preoperatively, and at 1, 2, and 3 years postprocedure. Results No significant differences were found in mean IOP, number of glaucoma medications used, and VA at 1, 2, and 3 years postoperatively. The rate of additional glaucoma procedures was similar between the two groups. Conclusion There is no clear evidence that a larger implant surface area beyond 230 to 250 mm2 is advantageous in providing intermediate-term IOP control. Clinical significance It may be technically easier to surgically place a GDD that does not need to have its wings placed underneath the recti muscles, and the IOP results are similar. How to cite this article Meyer AM, Rodgers CD, Zou B, Rosenberg NC, Webel AD, Sherwood MB. Retrospective Comparison of Intermediate-term Efficacy of 350 mm2 Glaucoma Drainage Implants and Medium-sized 230-250 mm2 Implants. J Curr Glaucoma Pract 2017;11(1):8-15. PMID:28138212

  7. 6-Month Aortic Valve Implantation of an Off-the-Shelf Tissue-engineered Valve in Sheep

    PubMed Central

    Syedain, Zeeshan; Reimer, Jay; Schmidt, Jillian; Lahti, Matthew; Berry, James; Bianco, Richard; Tranquillo, Robert T.

    2017-01-01

    Diseased aortic valves often require replacement, with over 30% of the current aortic valve surgeries performed in patients who will outlive a bioprosthetic valve. While many promising tissue-engineered valves have been created in the lab using the cell-seeded polymeric scaffold paradigm, none have been successfully tested long-term in the aortic position of pre-clinical model. The high pressure gradients and dynamic flow across the aortic valve leaflets require engineering a tissue that has the strength and compliance to withstand high mechanical demand without compromising normal hemodynamics. A long-term preclinical evaluation of an off-the-shelf tissue-engineered aortic valve in sheep model is presented here. The valves were made from a tube of decellularized cell-produced matrix mounted on a frame. The engineered tissue matrix is primarily composed of collagen, with strength and organization comparable to native valve leaflets. In vitro testing showed excellent hemodynamic performance with low regurgitation, low systolic pressure, and large orifice area. The implanted valves showed large-scale leaflet motion and maintained effective orifice area throughout the duration of the 6-month implant, with no calcification. After 24 weeks implantation (over 17 million cycles), the valves showed no change in tensile mechanical properties or collagen content. In addition, histology and DNA quantitation showed repopulation of the engineered matrix with interstitial-like cells and endothelialization. New extracellular matrix deposition, including elastin, further demonstrates positive tissue remodeling in addition to recellularization and valve function. Long-term implantation in the sheep model resulted in functionality, matrix remodeling, and recellularization, unprecedented results for a tissue-engineered aortic valve. PMID:26409002

  8. The expanding indications of transcatheter aortic valve implantation.

    PubMed

    Chiam, Paul T L; Ewe, See Hooi

    2016-03-01

    Transcatheter aortic valve implantation (TAVI), also known as transcatheter aortic valve replacement, is increasingly performed worldwide and is a technology that is here to stay. It has become the treatment of choice for inoperable patients and an alternative option for patients at high surgical risk with severe aortic stenosis. Early results of TAVI in intermediate-risk patients appear promising although larger randomized trial results are awaited before the widespread adoption of this technology in this big pool of patients. In patients with bicuspid aortic stenosis and degenerated surgical bioprostheses, TAVI has been shown to be feasible and relatively safe, though certain important considerations remain. Indications for TAVI are likely to grow as newer generation and improved devices and delivery systems become available.

  9. Three-year outcomes after transcatheter aortic valve implantation with the CoreValve prosthesis.

    PubMed

    Gotzmann, Michael; Czauderna, Anna; Hehnen, Tobias; Aweimer, Assem; Lind, Alexander; Kloppe, Axel; Bösche, Leif; Mügge, Andreas; Ewers, Aydan

    2014-08-15

    There is little known about the long-term results of the CoreValve prosthesis. The aim of this study was to assess the 3-year clinical and hemodynamic outcomes of the CoreValve prosthesis. One hundred fifty consecutive patients with severe aortic stenosis successfully underwent transcatheter aortic valve implantation (TAVI) with the CoreValve prosthesis. The primary study end point was death from any cause after TAVI. The secondary end points were defined as (1) cardiovascular death and (2) prosthesis-related mortality and morbidity. At 1 to 3 years, all-cause mortality rates were 25%, 32%, and 41%, respectively, and cardiovascular mortality rates were 14%, 21%, and 27%, respectively. Before TAVI, 95% of patients were in New York Heart Association class III or IV. Of the surviving patients, rates of New York Heart Association class III or IV at 1 to 3 years were 33%, 39%, and 38%, respectively. There was an annual decrease of the valve area of approximately 0.1 cm². Aortic restenosis occurred in 2 patients. Moderate or severe aortic regurgitation (AR) occurred in 15% of patients immediately after TAVI. Twenty patients (13%) had a slight worsening of AR within 3 years. New severe AR did not occur. The incidence of prosthesis-related endocarditis was 0.66% per year. Overall, 7 patients (incidence of 1.5% per year) had a clinically relevant problem of the prosthesis. In conclusion, TAVI with the CoreValve prosthesis had favorable effects on symptoms and outcomes even after 3 years. These results are clouded by side effects, such as AR and prosthesis-related mortality and morbidity.

  10. Prosthetic valve endocarditis 7 months after transcatheter aortic valve implantation diagnosed with 3D TEE.

    PubMed

    Sarı, Cenk; Durmaz, Tahir; Karaduman, Bilge Duran; Keleş, Telat; Bayram, Hüseyin; Baştuğ, Serdal; Özen, Mehmet Burak; Bayram, Nihal Akar; Bilen, Emine; Ayhan, Hüseyin; Kasapkara, Hacı Ahmet; Bozkurt, Engin

    2016-01-01

    Transcatheter aortic valve implantation (TAVI) was introduced as an alternative treatment for patients with severe symptomatic aortic stenosis for whom surgery would be high-risk. Prosthetic aortic valve endocarditis is a serious complication of surgical AVR (SAVR) with high morbidity and mortality. According to recent cases, post-TAVI prosthetic valve endocarditis (PVE) seems to occur very rarely. We present the case of a 75-year-old woman who underwent TAVI (Edwards Saphien XT) with an uneventful postoperative stay. She was diagnosed with endocarditis using three dimensional (3D) echocardiography on the TAVI device 7 months later and she subsequently underwent surgical aortic valve replacement. Little experience of the interpretation of transoesophageal echocardiography (TEE) and the clinical course and effectiveness of treatment strategies in post-TAVI endocarditis exists. We report a case of PVE in a TAVI patient which was diagnosed with three-dimensional transoesophageal echocardiography (3DTEE). Copyright © 2016 Hellenic Cardiological Society. Published by Elsevier B.V. All rights reserved.

  11. Assessment of Filtration Bleb and Endplate Positioning Using Magnetic Resonance Imaging in Eyes Implanted with Long-Tube Glaucoma Drainage Devices

    PubMed Central

    Sano, Ichiya; Tanito, Masaki; Uchida, Koji; Katsube, Takashi; Kitagaki, Hajime; Ohira, Akihiro

    2015-01-01

    Background To evaluate ocular fluid filtration and endplate positioning in glaucomatous eyes with long-tube glaucoma drainage devices (GDDs) using magnetic resonance imaging (MRI) and the effects of various factors on postoperative intraocular pressure (IOP). Methods This observational case series included 27 consecutive glaucomatous eyes (18 men, 7 women; mean age ± standard error, 63.0±2.0 years) who underwent GDD implantation (n = 8 Ahmed Glaucoma Valves [AGV] and n = 19 Baerveldt Glaucoma Implants [BGI]). Tubes were inserted into the pars plana in 23 eyes and anterior chamber in 4 eyes. Six months postoperatively, high-resolution orbital images were obtained using 3-Tesla MRI with head-array coils, and the filtering bleb volume, bleb height, and distances between the anterior endplate edge and corneal center or limbus or between the endplate and orbital wall were measured. Results In MR images obtained by three-dimensional fast imaging employing steady-state acquisition (3D-FIESTA) sequences, the shunt endplate was identified as low-intensity signal, and the filtering bleb was identified as high-intensity signals above and below the endplate in all eyes. The 6-month-postoperative IOP level was correlated negatively with bleb volume (r = -0.4510, P = 0.0182) and bleb height (r = -0.3954, P = 0.0412). The postoperative IOP was significantly (P = 0.0026) lower in BGI-implanted eyes (12.2±0.7 mmHg) than AGV-implanted eyes (16.7±1.2 mmHg); bleb volume was significantly (P = 0.0093) larger in BGI-implanted eyes (478.8±84.2 mm3) than AGV-implanted eyes (161.1±52.3 mm3). Other parameters did not differ. Conclusions The presence of intraorbital/periocular accumulation of ocular fluid affects postoperative IOP levels in eyes implanted with long-tube GDDs. Larger filtering blebs after BGI than AGI implantations explain lower postoperative IOP levels achieved with BGI than AGV. The findings will contribute to better understanding of IOP reducing mechanism of long

  12. Antithrombotic treatment in patients undergoing transcatheter aortic valve implantation (TAVI).

    PubMed

    Nijenhuis, Vincent J; Bennaghmouch, Naoual; van Kuijk, Jan-Peter; Capodanno, Davide; ten Berg, Jurriën M

    2015-04-01

    Transcatheter aortic valve implantation (TAVI) is an established treatment option for symptomatic patients with severe aortic valvular disease who are not suitable for conventional surgical aortic valve replacement. Despite improving experience and techniques, ischaemic and bleeding complications after TAVI remain prevalent and impair survival in this generally old and comorbid-rich population. Due to changing aetiology of complications over time, antiplatelet and anticoagulant therapy after TAVI should be carefully balanced. Empirically, a dual antiplatelet strategy is generally used after TAVI for patients without an indication for oral anticoagulation (OAC; e. g. atrial fibrillation, mechanical mitral valve prosthesis), including aspirin and a thienopyridine. For patients on OAC, a combination of OAC and aspirin or thienopyridine is generally used. This review shows that current registries are unfit to directly compare antithrombotic regimens. Small exploring studies suggest that additional clopidogrel after TAVI only affects bleeding and not ischemic complications. However, these studies are lack in quality in terms of Cochrane criteria. Currently, three randomised controlled trials are recruiting to gather more knowledge about the effects of clopidogrel after TAVI.

  13. Successful transfemoral aortic valve replacement in a bicuspid aortic stenotic valve: requirements for a safe implant.

    PubMed

    Maluenda, Gabriel; Araya, Mario; Ibañez-Arenas, Rodrigo

    2013-11-15

    Although transcatheter aortic valve replacement (TAVR) has been accepted as an attractive alternative for high-risk patients with severe symptomatic aortic stenosis (AS), patients with congenital bicuspid AS has been typically disqualified for this indication due to an implied risk of device dislocation, distortion, or device malfunctioning. Nonetheless, bicuspid AS is not uncommon and frequently missed by transthoracic echocardiography. We reported an interesting case of a high-risk patient with severe symptomatic bicuspid AS who underwent successful TAVR and discussed the anatomic requirements for a safe implant in patients with bicuspid AS considered candidates for TAVR. Copyright © 2013 Wiley Periodicals, Inc.

  14. The power of disruptive technological innovation: Transcatheter aortic valve implantation.

    PubMed

    Berlin, David B; Davidson, Michael J; Schoen, Frederick J

    2015-11-01

    We sought to evaluate the principles of disruptive innovation, defined as technology innovation that fundamentally shifts performance and utility metrics, as applied to transcatheter aortic valve implantation (TAVI). In particular, we considered implantation procedure, device design, cost, and patient population. Generally cheaper and lower performing, classical disruptive innovations are first commercialized in insignificant markets, promise lower margins, and often parasitize existing usage, representing unattractive investments for established market participants. However, despite presently high unit cost, TAVI is less invasive, treats a "new," generally high risk, patient population, and is generally done by a multidisciplinary integrated heart team. Moreover, at least in the short-term TAVI has not been lower-performing than open surgical aortic valve replacement in high-risk patients. We conclude that TAVI extends the paradigm of disruptive innovation and represents an attractive commercial opportunity space. Moreover, should the long-term performance and durability of TAVI approach that of conventional prostheses, TAVI will be an increasingly attractive commercial opportunity.

  15. [Transcatheter aortic valve implantation.Experience in 26 patients].

    PubMed

    Pineda, Fernando; Sarango, Byron; Sore, Loreto; Deck, Carlos; Turner, Eduardo; Parra, Víctor; Bórquez, Emiliano; Bernal, Sergio; Silva, Jorge; GonzÁlez, Soledad; Uriarte, Polentzi

    2015-12-01

    Aortic valve stenosis (AS) is the most common valvular disease. Its surgical indication is undisputed in symptomatic severe AS, however, 30% of patients are at high surgical risk or inoperable. Transcatheter Valve Implantation (TAVI) is an alternative for this group of patients. To describe the clinical outcomes of TAVI in a group of patients treated at the Instituto Nacional del Tórax, Santiago, Chile. Prospective study including all patients referred for TAVI due to their high surgical risk or being inoperable. All-cause mortality, secondary stroke, permanent pacemaker implantation, vascular complications, prosthetic and periprosthetic regurgitation, Karnosfky test and Functional Capacity (FC) were assessed as endpoints. We evaluated 26 patients with a mean age of 82 years (74% women) in whom 27 procedures were done. The mean Society of Thoracic Surgeons score was 8.8%. Overall mortality at 30 days, one and two years was 11.1, 18.5 and 29.6% respectively. Karnofsky score increased significantly from 62.3% at baseline to 83.9; 88.6 and 88.8% at six months, one and two years, respectively. Prior to the procedure, FC was 3.1 ± 0.6, decreasing significantly to 1.2; 1.3 and 1 at six months, one and two years of follow up. TAVI is an effective alternative treatment for patients with severe symptomatic AS and high surgical risk.

  16. Glaucoma Surgery in Pregnancy: A Case Series and Literature Review

    PubMed Central

    Razeghinejad, Mohammad Reza; Masoumpour, Masoumeh; Eghbal, Mohammad Hossein; Myers, Jonathan S.; Moster, Marlene R.

    2016-01-01

    Glaucoma management in pregnant patients is a real challenge, especially when the glaucoma is not controlled with medications. We report the results of 6 incisional glaucoma surgeries for the management of medically uncontrolled glaucoma patients during pregnancy. This retrospective, case series was conducted on the 6 eyes of 3pregnant patients with uncontrolled glaucoma using maximum tolerable medications. Details of the glaucoma surgical management of these patients as well as their postoperative care and pregnancy and clinical outcomes on longitudinal follow-up are discussed. All 3 patients had juvenile open-angle glaucoma and were on various anti-glaucoma medications, including oral acetazolamide. The first case described underwent trabeculectomy without antimetabolites in both eyes because of uncontrolled intraocular pressure with topical medications. The surgery was done with topical lidocaine jelly and subconjunctival lidocaine during the second and third trimesters. The second patient had an Ahmed valve implantation in both eyes during the second and third trimesters because of uncontrolled IOP with topical medications and no response to selective laser trabeculoplasty. Surgery was done with topical tetracaine and subconjunctival and sub-Tenon’s lidocaine. The third case had a Baerveldt valve implantation under general anesthesia in the second trimester. In selected pregnant glaucoma patients with medically uncontrolled intraocular pressure threatening vision, incisional surgery may lead to good outcomes for the patient with no risk for the fetus. PMID:27582594

  17. Transcatheter treatment of tricuspid regurgitation by caval valve implantation--experimental evaluation of decellularized tissue valves in central venous position.

    PubMed

    Lauten, Alexander; Laube, Adrian; Schubert, Harald; Bischoff, Sabine; Nietzsche, Sandor; Horstkötter, Kim; Poudel-Bochmann, Bhawana; Franz, Marcus; Lichtenberg, Artur; Figulla, Hans R; Akhyari, Payam

    2015-01-01

    Caval valve implantation has been suggested for transcatheter treatment of severe tricuspid regurgitation (TR). Combining the interventional technique with the promising surgical experience with decellularized valves, we sought to evaluate the functional and structural outcome of decellularized pericardial tissue valves (dTVs) in the low-pressure venous circulation in a chronic model of TR. Sixteen pericardial tissue valves were heterotopically implanted in the inferior and superior vena cava in a sheep model (54-98 kg; median 74.5 kg, n = 8) of severe TR. The devices were assembled using self-expanding nitinol stents and bovine pericardia decellularized by a detergent-based protocol (group dTV; n = 8). Glutaraldehyde-fixed pericardial tissue valves served as control (GaTV, n = 8). After 6 months, device function and structural maturation were analyzed using echocardiographic, histologic, immunohistologic, and electron microscopic approaches. After implantation, cardiac output increased significantly from 3.7 ± 1.1 l/min to 4.8 ± 1.1 l/min (P < 0.05) and competent valve function was verified by angiography. At 6 months, angiographic and echocardiographic evaluation revealed moderate to severe regurgitation in all GaTV. In contrast, five of the eight dTVs functioned well with only minor regurgitation. In these animals, autopsy revealed preserved valve structure with tender leaflets without signs of thrombosis or calcification. Conversely, GaTV showed severe degeneration with large calcification areas. Microscopic and histologic analysis confirmed endothelial repopulation in both valve types. However, additional interstitial reseeding was observed in decellularized valves. In the venous circulation in severe TR, decellularized valves show superior functional performance compared to Ga-fixed tissue valves. Macroscopic and microscopic analyses suggest preserved structural integrity and advanced endothelial and interstitial repopulation with

  18. Injectable Tissue-Engineered Pulmonary Heart Valve Implantation Into the Pig Model: A Feasibility Study

    PubMed Central

    Schlegel, Franziska; Salameh, Aida; Oelmann, Katja; Halling, Michelle; Dhein, Stefan; Mohr, Friedrich W.; Dohmen, Pascal M.

    2015-01-01

    Background Transcatheter pulmonary valve replacement is currently performed in clinical trials, but is limited by the use of glutaraldehyde-treated bioprostheses. This feasibility study was performed to evaluate delivery-related tissue distortion during implantation of tissue-engineered (TE) heart valves. Material/Methods The injectable TE heart valve was mounted on a self-expanding nitinol stent (n=7) and delivered into the pulmonary position in 7 pigs, (weight 26 to 31 kg), performing a sternotomy or limited lateral thoracotomy. Prior to implantation, the injectable TE heart valves were crimped and inserted into an applicator. Positioning of the implants was guided by fluoroscopy, and after careful deployment, angiographic examination was performed to evaluate the correct delivered position. Hemodynamic measurements were performed by epicardial echocardiography. Finally, the animals were sacrificed and the injectable TE heart valves were inspected by gross examination and histological examination. Results Orthotopic deliveries of the injectable TE heart valves were all successful performed, expect in 1 where the valve migrated due to a discrepancy between pulmonary valve annulus size and injectable TE valve size. Angiographic evaluation (n=6) showed normal valve function, supported by epicardial echocardiography in which no increased flow velocity was measured, neither trans- nor paravalvular regurgitation. Histological evaluation demonstrated absence of tissue damage from the delivery process. Conclusions Transcatheter implantation of an injectable TE heart valve seems to be possible without tissue distortion due to the delivery system. PMID:26104851

  19. Transaortic transcatheter aortic valve implantation using SAPIEN XT or SAPIEN 3 valves in the ROUTE registry†.

    PubMed

    Romano, Mauro; Frank, Derk; Cocchieri, Riccardo; Jagielak, Dariusz; Bonaros, Nikolaos; Aiello, Marco; Lapeze, Joel; Laine, Mika; Chocron, Sidney; Muir, Douglas; Eichinger, Walter; Thielmann, Matthias; Labrousse, Louis; Arne Rein, Kjell; Verhoye, Jean-Philippe; Gerosa, Gino; Baumbach, Hardy; Deutsch, Cornelia; Bramlage, Peter; Thoenes, Martin; Bapat, Vinayak

    2017-06-05

    Transaortic (TAo) access for transcatheter aortic valve implantation (TAVI) is an alternative to the conventional transfemoral or transapical routes. Data comparing the characteristics and outcomes of TAo-TAVI using the SAPIEN XT and SAPIEN 3 heart valves are scarce. The objective of the current analysis was to provide such information. ROUTE is an international, prospective, observational registry. Patients with severe calcific aortic stenosis scheduled for TAo-TAVI with an Edwards SAPIEN XT or a SAPIEN 3 heart valve were consecutively enrolled at 22 centres across Europe between February 2013 and February 2015. Periprocedural, in-hospital and 30-day complication rates were assessed. Of the 301 patients included, 126 (41.9%) received a SAPIEN 3 and 175 (58.1%) a SAPIEN XT. The SAPIEN 3 was associated with shorter procedure time (101 ± 35 vs 111 ± 40 min; P  = 0.031) and a lower quantity of contrast agent used (87 ± 43 vs 112 ± 50 ml; P  < 0.001). Balloon dilation was performed less often before (68.0% vs 78.3%; P  = 0.045) and after implantation (13.6% vs 30.1%; P  = 0.001). No statistically significant differences between the valve types were documented for overall (4.1% SAPIEN 3 vs 7.6% SAPIEN XT; P  = 0.21), TAVI-related (0.8% vs 4.7%; P  = 0.084) and cardiovascular mortality (2.4% vs 5.9%; P  = 0.158). Major vascular complications were less frequent (0.8% vs 5.3%; P  = 0.049), and there was a lower rate of moderate-to-severe paravalvular regurgitation (0.8% vs 5.1%; P  = 0.050) in the SAPIEN 3 group. Both the SAPIEN XT and SAPIEN 3 were safely implanted via the TAo route, though the SAPIEN 3 may be associated with a higher procedural success rate and improved prognosis. NCT01991431.

  20. Transaortic Transcatheter Aortic valve implantation using Edwards Sapien valve: a novel approach.

    PubMed

    Bapat, Vinayak; Khawaja, Muhammed Z; Attia, Rizwan; Narayana, Ashok; Wilson, Karen; Macgillivray, Kirsty; Young, Christopher; Hancock, Jane; Redwood, Simon; Thomas, Martyn

    2012-04-01

    To evaluate feasibility and outcome of Transoartic Transcatheter Sapien valve implantation. Transcatheter Aortic valve implantation (TAVI) using the Edwards SAPIEN device (Edwards LifeScience, Irvine, CA) is usually performed via the transfemoral (TF) or transapical (TA) routes. Some patients are not suitable for these approaches. We report our experience with the novel transaortic (TAo) approach via a partial upper sternotomy and discuss the advantages and future applications. Between January 2008 to March 2011 193 patients with severe aortic stenosis underwent TAVI with the Edwards SAPIEN bioprosthesis at the St. Thomas' Hospital, London. 108 patients were unable to undergo a TF-TAVI and of those 17 were accepted for a TAo-TAVI on the basis of anatomy, risk, LV function, and significant respiratory disease. The TAo-TAVI group (n = 17) had more prevalent respiratory disease than the TA-TAVI group (47.0% vs. 18.7%, P = 0.011). Otherwise the groups were similar in demographics and history. Despite this the 30 day mortalities were not significantly different between the groups (TAo-TAVI 4.3% at 30 days versus TA-TAVI 7.7%, P = 0.670). There were no significant differences in procedural complications. The TA-TAVI approach may not be desirable in patients with severe chest deformity, poor lung function or poor left ventricular function. TAo-TAVI via a partial sternotomy is safe and feasible in these patients. Copyright © 2011 Wiley Periodicals, Inc.

  1. Cubic Hermite Bezier spline based reconstruction of implanted aortic valve stents from CT images.

    PubMed

    Gessat, Michael; Altwegg, Lukas; Frauenfelder, Thomas; Plass, André; Falk, Volkmar

    2011-01-01

    Mechanical forces and strain induced by transcatheter aortic valve implantation are usually named as origins for postoperative left ventricular arrhythmia associated with the technique. No quantitative data has been published so far to substantiate this common belief. As a first step towards quantitative analysis of the biomechanic situation at the aortic root after transapical aortic valve implantation, we present a spline-based method for reconstruction of the implanted stent from CT images and for locally measuring the deformation of the stent.

  2. Direct Transcatheter Heart Valve Implantation Versus Implantation With Balloon Predilatation: Insights From the Brazilian Transcatheter Aortic Valve Replacement Registry.

    PubMed

    Bernardi, Fernando L M; Ribeiro, Henrique B; Carvalho, Luiz A; Sarmento-Leite, Rogerio; Mangione, José A; Lemos, Pedro A; Abizaid, Alexandre; Grube, Eberhard; Rodés-Cabau, Josep; de Brito, Fábio S

    2016-08-01

    Direct transcatheter aortic valve replacement (TAVR) is regarded as having potential advantages over TAVR with balloon aortic valve predilatation (BAVP) in reducing procedural complications, but there are few data to support this approach. Patients included in the Brazilian TAVR registry with CoreValve and Sapien-XT prosthesis were compared according to the implantation technique, with or without BAVP. Clinical and echocardiographic data were analyzed in overall population and after propensity score matching. A total of 761 consecutive patients (BAVP=372; direct-TAVR=389) were included. Direct-TAVR was possible in 99% of patients, whereas device success was similar between groups (BAVP=81.2% versus direct-TAVR=78.1%; P=0.3). No differences in clinical outcomes at 30 days and 1 year were observed, including all-cause mortality (7.6% versus 10%; P=0.25 and 18.1% versus 24.5%; P=0.07, respectively) and stroke (2.8% versus 3.8%; P=0.85 and 5.5% versus 6.8%; P=0.56, respectively). Nonetheless, TAVR with BAVP was associated with a higher rate of new onset persistent left bundle branch block with the CoreValve (47.7% versus 35.1%; P=0.01 at 1 year). Mean gradient and incidence of moderate/severe aortic regurgitation were similar in both groups at 1 year (11% versus 13.3%; P=0.57 and 9.8±5.5 versus 8.7±4.3; P=0.09, respectively). After propensity score matching analysis, all-cause mortality and stroke remained similar. By multivariable analysis, BAVP and the use of CoreValve were independent predictors of new onset persistent left bundle branch block. The 2 TAVR strategies, with or without BAVP, provided similar clinical and echocardiographic outcomes over a midterm follow-up although BAVP was associated with a higher rate of new onset persistent left bundle branch block, particularly in patients receiving a CoreValve. © 2016 American Heart Association, Inc.

  3. Comparison of complete versus incomplete stent frame expansion after transcatheter aortic valve implantation with Medtronic CoreValve bioprosthesis.

    PubMed

    Jilaihawi, Hasan; Chin, Derek; Spyt, Tomasz; Jeilan, Mohamed; Vasa-Nicotera, Mariuca; Mohamed, Noor; Bence, Johan; Logtens, Elaine; Kovac, Jan

    2011-06-15

    We sought to determine the significance of incomplete stent frame expansion after transcatheter aortic valve implantation with the Medtronic-CoreValve device. Incomplete coronary stent expansion is a well-described phenomenon. Transcatheter valves are mounted on stents; however, the incidence of incomplete stent expansion after transcatheter aortic valve implantation, its sequelae and predictors are poorly elucidated. The 18Fr CoreValve revalving system was used to treat anatomically and clinically suitable patients with severe calcific aortic stenosis. The postdeployment stent dimensions were measured on fluoroscopic images at multiple levels of the stent frame. Incomplete expansion at each was defined as <100% expected and complete expansion as ≥100%. These parameters were correlated to the hemodynamic and clinical end points. A total of 50 consecutive patients underwent transcatheter aortic valve implantation with the Medtronic-CoreValve at a single center from January 2007 to December 2008. For the inflow portion, incomplete expansion was seen in 54% of patients and was unrelated to the aortic valve area, peak or mean aortic valve gradients, or measures of aortic regurgitation, although it was paradoxically associated with a lower incidence of prosthesis-patient mismatch. Incomplete expansion of the constrained portion was seen in 62% of the patients and displayed a trend toward a greater incidence of aortic regurgitation grade 2 or greater, although this was rare. Incomplete expansion of the Medtronic CoreValve stent frame is common. For the most part, valvular hemodynamic function was satisfactory, regardless of the degree of expansion of the stent frame that carries it and a strategy of reluctant postdilation in the context of incomplete stent frame expansion was supported. Copyright © 2011 Elsevier Inc. All rights reserved.

  4. XEN Glaucoma Implant with Mitomycin C 1-Year Follow-Up: Result and Complications

    PubMed Central

    Bilgic, Alper; Eltanamly, Rasha

    2017-01-01

    Purpose. To evaluate gel microstent (XEN, Aquesys, Inc) for treatment of primary open angle glaucoma (POAG). Methods. In this prospective interventional study, 13 eyes with POAG underwent XEN implantation with subconjunctival mitomycin-C. Of those eyes, 3 were pseudophakic and 10 underwent simultaneous phacoemulsification and XEN. Patients had uncontrolled IOP, had intolerance to therapy, or had maximal therapy but undergoing cataract extraction. Follow-up visits included IOP, number of medications, vision, and complications and lasted for 1 year. Complete success was defined as IOP reduction ≥20% from preoperative baseline at 1 year without any glaucoma medications while partial success as IOP reduction of ≥20% at 1 year with medications. Results. IOP dropped from 16 ± 4 mmHg pre-op to 9 ± 5, 11 ± 6, 12 ± 5, 12 ± 4, and 12 ± 3 mmHg at 1 week, 1, 3, 6, and 12 months (p = 0.004, 0.026, 0.034, 0.01, and 0.01, Wilcoxon Signed Ranks) consecutively. BCVA (LogMAR) was 0.33 ± 0.34 and improved to 0.13 ± 0.11 at 1 year. Mean number of medications dropped from 1.9 ± 1 preoperatively to 0.3 ± 0.49 (p = 0.003) at 1 year. 42% of eyes achieved complete success and 66% qualified success. Complications included choroidal detachment in 2 eyes, and implant extrusion in 1 eye, and 2 eyes underwent trabeculectomy. Conclusion. XEN implant is an effective surgical treatment for POAG, with significant reduction in IOP and glaucoma medications at 1 year follow-up. PMID:28348884

  5. Usefulness of Predilation Before Transcatheter Aortic Valve Implantation.

    PubMed

    Pagnesi, Matteo; Jabbour, Richard J; Latib, Azeem; Kawamoto, Hiroyoshi; Tanaka, Akihito; Regazzoli, Damiano; Mangieri, Antonio; Montalto, Claudio; Ancona, Marco B; Giannini, Francesco; Chieffo, Alaide; Montorfano, Matteo; Monaco, Fabrizio; Castiglioni, Alessandro; Alfieri, Ottavio; Colombo, Antonio

    2016-07-01

    Balloon predilation is historically considered a requirement before performing transcatheter aortic valve implantation (TAVI). As the procedure has evolved, it has been questioned whether it is actually needed, but data are lacking on mid-term outcomes. The aim of this study was to evaluate the effect of balloon predilation before TAVI. A total of 517 patients who underwent transfemoral TAVI from November 2007 to October 2015 were analyzed. The devices implanted included the Medtronic CoreValve (n = 216), Medtronic Evolut R (n = 30), Edwards SAPIEN XT (n = 210), and Edwards SAPIEN 3 (n = 61). Patients were divided into 2 groups depending on whether pre-implantation balloon aortic valvuloplasty (pre-BAV) was performed (n = 326) or not (n = 191). Major adverse cardiac and cerebrovascular events (MACCE) were primarily evaluated. Propensity score matching was used to adjust for differences in baseline characteristics and potential confounders (n = 113 pairs). In the overall cohort, patients without pre-BAV had a significantly higher MACCE rate at 30 days, driven by a higher incidence of stroke (0.3% pre-BAV vs 3.7% no-pre-BAV, p <0.01). MACCE and mortality at 1 year were, however, similar in both groups. Independent predictors of MACCE at 1 year included serum creatinine, NYHA class 3 to 4, logistic European System for Cardiac Operative Risk Evaluation, and postdilation. Of note, the postdilation rate was higher in the no-pre-BAV group (21.5% pre-BAV vs 35.6% no-pre-BAV, p <0.001). After propensity score matching, there were no differences in MACCE between the 2 groups. In conclusion, this study showed that, in selected patients and with specific transcatheter valves, TAVI without pre-BAV appears to be associated with similar mid-term outcomes compared with TAVI with pre-BAV, but it may increase the need for postdilation.

  6. Conduction Abnormalities and Pacemaker Implantations After SAPIEN 3 Vs SAPIEN XT Prosthesis Aortic Valve Implantation.

    PubMed

    Husser, Oliver; Kessler, Thorsten; Burgdorf, Christof; Templin, Christian; Pellegrini, Costanza; Schneider, Simon; Kasel, Albert Markus; Kastrati, Adnan; Schunkert, Heribert; Hengstenberg, Christian

    2016-02-01

    Transcatheter aortic valve implantation is increasingly used in patients with aortic stenosis. Post-procedural intraventricular conduction abnormalities and permanent pacemaker implantations remain a serious concern. Recently, the Edwards SAPIEN 3 prosthesis has replaced the SAPIEN XT. We sought to determine the incidences of new-onset intraventricular conduction abnormalities and permanent pacemaker implantations by comparing the 2 devices. We analyzed the last consecutive 103 patients undergoing transcatheter aortic valve implantation with SAPIEN XT before SAPIEN 3 was used in the next 105 patients. To analyze permanent pacemaker implantations and new-onset intraventricular conduction abnormalities, patients with these conditions at baseline were excluded. Electrocardiograms were recorded at baseline, after the procedure, and before discharge. SAPIEN 3 was associated with higher device success (100% vs 92%; P=.005) and less paravalvular leakage (0% vs 7%; P<.001). The incidence of permanent pacemaker implantations was 12.6% (23 of 183) with no difference between the 2 groups (SAPIEN 3: 12.5% [12 of 96] vs SAPIEN XT: 12.6% [11 of 87]; P=.99). SAPIEN 3 was associated with a higher rate of new-onset intraventricular conduction abnormalities (49% vs 27%; P=.007) due to a higher rate of fascicular blocks (17% vs 5%; P=.021). There was no statistically significant difference in transient (29% [20 of 69] vs persistent 19% [12 of 64]; P=.168) left bundle branch blocks (28% [19 of 69] vs 17% [11 of 64]; P=.154) when SAPIEN 3 was compared with SAPIEN XT. We found a trend toward a higher rate of new-onset intraventricular conduction abnormalities with SAPIEN 3 compared with SAPIEN XT, although this did not result in a higher permanent pacemaker implantation rate. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  7. Alternative transarterial access for CoreValve transcatheter aortic bioprosthesis implantation.

    PubMed

    Bruschi, Giuseppe; De Marco, Federico; Modine, Thomas; Botta, Luca; Colombo, Paola; Mauri, Silvia; Cannata, Aldo; Fratto, Pasquale; Klugmann, Silvio

    2015-05-01

    Transcatheter aortic valve implantation (TAVI) is used to treat elderly patients with severe aortic stenosis who are considered extremely high-risk surgical candidates. The safety and effectiveness of TAVI have been demonstrated in numerous studies. The self-expanding CoreValve bioprosthesis (Medtronic Inc., Minneapolis, MN, USA) was the first transcatheter aortic valve to be granted the Conformité Européene (CE) mark in May 2007 for retrograde transfemoral implantation. However, TAVI patients are also often affected by severe iliofemoral arteriopathy. In these patients, the retrograde transfemoral approach carries a high risk of vascular injury, making this approach unusable. Alternative arterial access sites, such as the subclavian artery, the ascending aorta, and the carotid artery, have been used for retrograde implantation of the CoreValve bioprosthesis. In the present report, we present the procedural considerations, risks, and benefits of the different types of arterial access used to implant the CoreValve bioprosthesis.

  8. Transapical transcatheter aortic valve implantation using the J-Valve system: A 1-year follow-up study.

    PubMed

    Luo, Xiang; Wang, Xu; Li, Xuan; Wang, Xin; Xu, Fei; Liu, Mingzheng; Yu, Bing; Li, Fei; Tong, Minghui; Wang, Wei

    2017-07-01

    Transcatheter aortic valve implantation has become a routine procedure to treat screened inoperable or high-risk patients. In this study, we present the first outcome of echocardiographic midterm using a new second-generation transcatheter aortic valve implantation system, the J-Valve system (Jie Cheng Medical Technologies, Suzhou, China), in patients with aortic stenosis or aortic regurgitation. From July 2014 to June 2015, 21 patients with isolated aortic valve disease at high risk for open surgery received transapical transcatheter aortic valve implantation using the J-Valve system. The primary end point was a combined efficacy end point after 1 year, which included all-cause mortality after more than 30 days and failure of current therapy for aortic stenosis or aortic regurgitation requiring hospitalization for symptoms of valve-related cardiac decompensation or prosthetic heart valve dysfunction. Secondary end points were cardiovascular mortality, major stroke, and life-threatening, disabling, or major bleeding after 6 and 12 months. The mean age of the study cohort was 75.52 ± 5.22 years, the European System for Cardiac Operative Risk Evaluation II score was 11.33% ± 1.28%, and the mean logistic European System for Cardiac Operative Risk Evaluation I score was 31.13% ± 9.68%. Transcatheter aortic valve implantation with the J-Valve system was successfully performed in 19 of the 21 patients (90.5%). For patients with aortic stenosis, 12-month follow-up echocardiography demonstrated an increase in mean effective valve area from 0.62 ± 0.17 cm(2) to 1.52 ± 0.35 cm(2) and a decrease in transvalvular mean gradient from 61 ± 15 mm Hg to 18 ± 9 mm Hg. All surviving patients (n = 18) reported improvements in at least 1 of the New York Heart Association classes. The combined ratio of successful implantation and absence of adverse events in our cohort (n = 21) was 76.19%. The J-Valve system exhibits a convincing midterm performance and

  9. Takotsubo Cardiomyopathy Complicating Percutaneous Pulmonary Valve Implantation in a Child.

    PubMed

    Dalla Pozza, Robert; Lehner, Anja; Ulrich, Sarah; Näbauer, Michael; Haas, Nikolaus A; Heineking, B

    2017-01-01

    Takotsubo cardiomyopathy describes a sudden onset cardiomyopathy with acute impairment of left ventricular function and spontaneous resolution over time. Only a few cases of Takotsubo cardiomyopathy in childhood have been described. We report the case of a 12-year-old girl with repaired tetralogy of Fallot who experienced acute onset of left ventricular dysfunction without coronary arterial involvement, suggesting Takotsubo cardiomyopathy, during an interventional catheterization procedure. Cardiogenic shock necessitated mechanical circulatory support with extracorporeal membrane oxygenator for ten days and mechanical ventilation for 12 days. The girl recovered without sequelae. Percutaneous pulmonary valve implantation was performed four months later without complications. Unusual aspects of this case include the use of mechanical circulatory support during the recovery phase of Takotsubo cardiomyopathy in a patient with congenital heart disease.

  10. Cognitive Outcomes following Transcatheter Aortic Valve Implantation: A Systematic Review

    PubMed Central

    Lai, Ka Sing Paris; Herrmann, Nathan; Saleem, Mahwesh; Lanctôt, Krista L.

    2015-01-01

    Severe aortic stenosis is the most common valvular heart disease in the elderly in the Western world and contributes to a large proportion of all deaths over the age of 70. Severe aortic stenosis is conventionally treated with surgical aortic valve replacement; however, the less invasive transcatheter aortic valve implantation (TAVI) is suggested for those at high surgical risk. While TAVI has been associated with improved survival and favourable outcomes, there is a higher incidence of cerebral microembolisms in TAVI patients. This finding is of concern given mechanistic links with cognitive decline, a symptom highly prevalent in those with cardiovascular disease. This paper reviews the literature assessing the possible link between TAVI and cognitive changes. Studies to date have shown that global cognition improves or remains unchanged over 3 months following TAVI while individual cognitive domains remain preserved over time. However, the association between TAVI and cognition remains unclear due to methodological limitations. Furthermore, while these studies have largely focused on memory, cognitive impairment in this population may be predominantly of vascular origin. Therefore, cognitive assessment focusing on domains important in vascular cognitive impairment, such as executive dysfunction, may be more helpful in elucidating the association between TAVI and cognition in the long term. PMID:25785192

  11. Durability of prostheses for transcatheter aortic valve implantation.

    PubMed

    Arsalan, Mani; Walther, Thomas

    2016-06-01

    Transcatheter aortic valve implantation (TAVI) has become the standard of care for inoperable patients, and the preferred treatment option for high-risk patients with severe aortic stenosis. Given that this therapy was intended for elderly patients with limited life expectancy, long-term durability has not been in the focus. Now that TAVI is increasingly being used in patients with intermediate-risk and lower-risk profiles, device durability has gained importance. The available mid-term results for TAVI are promising; however, little is known about the fate of TAVI devices beyond 5 years. The experience with long-term durability of surgical valves shows that ≥10-year follow-up is required to ensure reliable durability data. In this Review, we discuss the existing studies of TAVI durability, highlight differences between surgical and transcatheter treatment of aortic stenosis that might influence durability, and present a clinical solution for failed prostheses. Furthermore, we suggest how device durability might influence the future selection of patients for TAVI.

  12. Feature identification for image-guided transcatheter aortic valve implantation

    NASA Astrophysics Data System (ADS)

    Lang, Pencilla; Rajchl, Martin; McLeod, A. Jonathan; Chu, Michael W.; Peters, Terry M.

    2012-02-01

    Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to open-heart surgery, and is critically dependent on imaging for accurate placement of the new valve. Augmented image-guidance for TAVI can be provided by registering together intra-operative transesophageal echo (TEE) ultrasound and a model derived from pre-operative CT. Automatic contour delineation on TEE images of the aortic root is required for real-time registration. This study develops an algorithm to automatically extract contours on simultaneous cross-plane short-axis and long-axis (XPlane) TEE views, and register these features to a 3D pre-operative model. A continuous max-flow approach is used to segment the aortic root, followed by analysis of curvature to select appropriate contours for use in registration. Results demonstrate a mean contour boundary distance error of 1.3 and 2.8mm for the short and long-axis views respectively, and a mean target registration error of 5.9mm. Real-time image guidance has the potential to increase accuracy and reduce complications in TAVI.

  13. US-fluoroscopy registration for transcatheter aortic valve implantation.

    PubMed

    Lang, Pencilla; Seslija, Petar; Chu, Michael W A; Bainbridge, Daniel; Guiraudon, Gerard M; Jones, Douglas L; Peters, Terry M

    2012-05-01

    Transcatheter aortic valve implantation is a minimally invasive alternative to open-heart surgery for aortic stenosis in which a stent-based bioprosthetic valve is delivered into the heart on a catheter. Limited visualization during this procedure can lead to severe complications. Improved visualization can be provided by live registration of transesophageal echo (TEE) and fluoroscopy images intraoperatively. Since the TEE probe is always visible in the fluoroscopy image, it is possible to track it using fiducial-based single-perspective pose estimation. In this study, inherent probe tracking performance was assessed, and TEE to fluoroscopy registration accuracy and robustness were evaluated. Results demonstrated probe tracking errors of below 0.6 mm and 0.2°, a 2-D RMS registration error of 1.5 mm, and a tracking failure rate of below 1%. In addition to providing live registration and better accuracy and robustness compared to existing TEE probe tracking methods, this system is designed to be suitable for clinical use. It is fully automatic, requires no additional operating room hardware, does not require intraoperative calibration, maintains existing procedure and imaging workflow without modification, and can be implemented in all cardiac centers at extremely low cost.

  14. Successful first-in-man Melody transcatheter valve implant in a dehisced mitral annuloplasty ring transapical valve-in-ring implant.

    PubMed

    Maisano, Francesco; Reser, Diana; Pavicevic, Jovana; Nietlispach, Fabian; Gämperli, Oliver; Schmid, Markus; Bettex, Dominique; Falk, Volkmar

    2014-12-01

    A "valve-in-ring" (ViR) procedure involves the transcatheter implant of a valved stent in a prosthetic mitral ring. The presence of a partial dehiscence of the prosthetic ring is a major contraindication for a ViR due to inefficacious sealing. We describe an alternative method of ViR implant to achieve proper valve sealing in the case of ring dehiscence. A 76-year-old male patient suffered from severe central mitral regurgitation due to annuloplasty ring dehiscence and leaflet tethering. ECG-gated multidetector computed tomography was used for preoperative planning. Standard transapical access was gained through a minimally invasive left thoracotomy in the 5th intercostal space. A customised Melody valve with two PTFE sutures fixed to the apex was used. The intervention was performed without complications, the patient recovered well, and transthoracic echo revealed no mitral regurgitation through the implanted valve with a transvalvular gradient of 4 mmHg. The implantation of a long covered stent such as the Melody valve allows successful sealing following a ViR even in case of partially detached annuloplasty rings. This procedure is a proof of concept that proper sealing can be achieved at the leaflet level without the use of radial force at the annular level.

  15. Transapical implantation of a self-expandable aortic valve prosthesis utilizing a novel designed positioning element.

    PubMed

    Liu, Xiaopeng; Tang, Yue; Luo, Fuliang; Tian, Yi; Li, Kai; Sun, Jiakang; Jia, Liujun; Wang, Wei

    2017-01-01

    To evaluate a new transapical system which utilizes a novel designed positioning element and a two-step positioning mechanism for easy and accurate implantation of transcatheter valves. Transcatheter aortic valve implantation is an important treatment option for non-surgical patients with severe aortic stenosis. However, accurate placement of the transcatheter valve remains challenging. Self-expandable aortic valve prosthesis with a flexibly connected, annulus-like positioning element was implanted through a transapical approach in 12 pigs. The positioning element was separated and can be released independent of the valve prosthesis. During valve implantation, firstly, the positioning element was unsheathed and fixed into the aortic sinus. Then, the prosthetic valve was guided to an anatomically oriented position and deployed. Six animals were followed up to 180 days. With the help of the positioning element, all 12 valves were successfully deployed at the anticipated site. The valve release procedure took an average of 7.3 ± 2.5 min. The mean transvalvular pressure gradient was 2.8 ± 1.1 mm Hg at valve deployment. Of the six chronic animals, the mean transvalvular pressure gradient was 3.0 ± 1.0 mm Hg on day 7, and 2.9 ± 1.6 mm Hg on day 180 (P = 0.91). No migration, embolization, or coronary obstruction was observed during surgery and at necropsy. Pathological examination showed anatomically correct positioning of the prosthetic valve without signs of thrombosis or calcification. In this study, we confirmed the feasibility of the J-Valve transapical system for transapical implantation through a two-step process. Satisfactory hemodynamic and pathological performance during a follow-up of 180 days was demonstrated. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  16. Transcatheter Aortic Valve Implantation (TAVI) for Treatment of Aortic Valve Stenosis

    PubMed Central

    Sehatzadeh, S; Doble, B; Xie, F; Blackhouse, G; Campbell, K; Kaulback, K; Chandra, K; Goeree, R

    2013-01-01

    Background One-year mortality outcomes in the PARTNER trial showed that transcatheter aortic valve implantation (TAVI) was noninferior to surgical aortic valve replacement (sAVR) in patients who were eligible for sAVR (cohort A), and superior to standard treatment in patients who were ineligible for sAVR (cohort B). Objective To update a previous report on the safety, effectiveness, and cost-effectiveness of TAVI, published in 2012. Data Sources A literature search was performed on September 11, 2012, using OVID MEDLINE, OVID MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, EBSCO Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database, for studies published from January 1, 2011, until September 11, 2012. Review Methods Randomized controlled trials investigating TAVI in comparison to sAVR or standard treatment were included for analysis. Results were summarized descriptively. Results At 2-year follow-up, mortality in cohort A was similar between the TAVI and sAVR groups. Rates of stroke/transient ischemic attack, major vascular complications, and moderate/severe paravalvular aortic regurgitation were significantly higher in the TAVI group, but rate of major bleeding was significantly higher in the sAVR group. Mortality in cohort B was significantly lower with transfemoral (TF) TAVI than with standard treatment, but rate of stroke was significantly higher with TF TAVI. TF TAVI resulted in a more rapid improvement in quality of life scores than sAVR, but this difference was not sustained at 6 and 12 months. Patients who underwent transapical TAVI did not have a greater early improvement in quality of life compared to sAVR patients. Compared to standard treatment, TF TAVI resulted in a greater improvement in quality of life scores at all time points. Incremental cost-effectiveness ratios were in favour of TAVI for inoperable patients in the base-case analysis

  17. Transcatheter Aortic Valve Implantation for Treatment of Aortic Valve Stenosis: A Health Technology Assessment

    PubMed Central

    Sehatzadeh, Shayan; Tu, Hong-Anh; Holubowich, Corinne; Higgins, Caroline

    2016-01-01

    Background Surgical aortic valve replacement (SAVR) is the gold standard for treating aortic valve stenosis. It is a major operation that requires sternotomy and the use of a heart-lung bypass machine, but in appropriately selected patients with symptomatic, severe aortic valve stenosis, the benefits of SAVR usually outweigh the harms. Transcatheter aortic valve implantation (TAVI) is a less invasive procedure that allows an artificial valve to be implanted over the poorly functioning valve. Methods We identified and analyzed randomized controlled trials that evaluated the effectiveness and safety of TAVI compared with SAVR or balloon aortic valvuloplasty and were published before September 2015. The quality of the body of evidence for each outcome was examined according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. The overall quality was determined to be high, moderate, low, or very low using a step-wise, structural methodology. We also developed a Markov decision-analytic model to assess the cost-effectiveness of TAVI compared with SAVR over a 5-year time horizon, and we conducted a 5-year budget impact analysis. Results Rates of cardiovascular and all-cause mortality were similar for the TAVI and SAVR groups in all studies except one, which reported significantly lower all-cause mortality in the TAVI group and a higher rate of stroke in the SAVR group. Trials of high-risk patients who were not suitable candidates for SAVR showed significantly better survival with TAVI than with balloon aortic valvuloplasty. Median survival in the TAVI group was 31 months, compared with 11.7 months in the balloon aortic valvuloplasty group. Compared with SAVR, TAVI was associated with a significantly higher risk of stroke, major vascular complications, paravalvular aortic regurgitation, and the need for a permanent pacemaker. SAVR was associated with a higher risk of bleeding. Transapical TAVI was associated with higher

  18. Percutaneous Transcatheter One-Step Mechanical Aortic Disc Valve Prosthesis Implantation: A Preliminary Feasibility Study in Swine

    SciTech Connect

    Sochman, Jan Peregrin, Jan H.; Rocek, Miloslav; Timmermans, Hans A.; Pavcnik, Dusan; Roesch, Josef

    2006-02-15

    Purpose. To evaluate the feasibility of one-step implantation of a new type of stent-based mechanical aortic disc valve prosthesis (MADVP) above and across the native aortic valve and its short-term function in swine with both functional and dysfunctional native valves. Methods. The MADVP consisted of a folding disc valve made of silicone elastomer attached to either a nitinol Z-stent (Z model) or a nitinol cross-braided stent (SX model). Implantation of 10 MADVPs (6 Z and 4 SX models) was attempted in 10 swine: 4 (2 Z and 2 SX models) with a functional native valve and 6 (4 Z and 2 SX models) with aortic regurgitation induced either by intentional valve injury or by MADVP placement across the native valve. MADVP function was observed for up to 3 hr after implantation. Results. MADVP implantation was successful in 9 swine. One animal died of induced massive regurgitation prior to implantation. Four MADVPs implanted above functioning native valves exhibited good function. In 5 swine with regurgitation, MADVP implantation corrected the induced native valve dysfunction and the device's continuous good function was observed in 4 animals. One MADVP (SX model) placed across native valve gradually migrated into the left ventricle. Conclusion. The tested MADVP can be implanted above and across the native valve in a one-step procedure and can replace the function of the regurgitating native valve. Further technical development and testing are warranted, preferably with a manufactured MADVP.

  19. Percutaneous transcatheter one-step mechanical aortic disc valve prosthesis implantation: a preliminary feasibility study in swine.

    PubMed

    Sochman, Jan; Peregrin, Jan H; Rocek, Miloslav; Timmermans, Hans A; Pavcnik, Dusan; Rösch, Josef

    2006-01-01

    To evaluate the feasibility of one-step implantation of a new type of stent-based mechanical aortic disc valve prosthesis (MADVP) above and across the native aortic valve and its short-term function in swine with both functional and dysfunctional native valves. The MADVP consisted of a folding disc valve made of silicone elastomer attached to either a nitinol Z-stent (Z model) or a nitinol cross-braided stent (SX model). Implantation of 10 MADVPs (6 Z and 4 SX models) was attempted in 10 swine: 4 (2 Z and 2 SX models) with a functional native valve and 6 (4 Z and 2 SX models) with aortic regurgitation induced either by intentional valve injury or by MADVP placement across the native valve. MADVP function was observed for up to 3 hr after implantation. MADVP implantation was successful in 9 swine. One animal died of induced massive regurgitation prior to implantation. Four MADVPs implanted above functioning native valves exhibited good function. In 5 swine with regurgitation, MADVP implantation corrected the induced native valve dysfunction and the device's continuous good function was observed in 4 animals. One MADVP (SX model) placed across native valve gradually migrated into the left ventricle. The tested MADVP can be implanted above and across the native valve in a one-step procedure and can replace the function of the regurgitating native valve. Further technical development and testing are warranted, preferably with a manufactured MADVP.

  20. A new percutaneous pulmonary valve implantation technique for complex right ventricular outflow tracts: the "folded melody valve".

    PubMed

    Jalal, Zakaria; Malekzadeh-Milani, Sophie; Hofbeck, Michael; Al Najashi, Khalid; Thambo, Jean-Benoit; Boudjemline, Younes

    2015-03-01

    This article sought to describe a new modification of the Melody valve that allows percutaneous pulmonary valve implantation (PPVI) in complex outflow tracts. PPVI has been validated as a valuable therapeutic option for the management of patients with dysfunctional right ventricular outflow tracts (RVOT). However, complex and unfavourable RVOT anatomy continue to limit the indications for PPVI. Between April 2012 and November 2013, PPVI was performed in 10 patients (mean age = 16, 3 ± 5 years old) using a new modification of the Melody® valve consisting in a manual shortening of the Melody by folding the two extremities of the stent. We reviewed the results of this technique. Indications were short RVOT in three patients, prevention of retrosternal compression in two patients, bioprosthetic valves in four and coronary arteries proximity in one. No complication occurred during procedures. All patients had excellent hemodynamic results [mean post PPVI RV-PA gradient was 14 ± 6 mm Hg, three patients had trivial pulmonary regurgitation (PR) and the remaining had no PR]. After a mean follow-up of 11 months (range 5-21 months), no patient had reintervention. No valve dysfunction or stent fractures were observed. The "Folded valve technique" is a safe modification of the Melody valve. By shortening the valve, this technique allowed PPVI in short and complex RVOTs with vulnerable neighborhood. © 2014 Wiley Periodicals, Inc.

  1. Does Undersizing of Transcatheter Aortic Valve Bioprostheses during Valve-in-Valve Implantation Avoid Coronary Obstruction? An In Vitro Study.

    PubMed

    Stock, Sina; Scharfschwerdt, Michael; Meyer-Saraei, Roza; Richardt, Doreen; Charitos, Efstratios I; Sievers, Hans-Hinrich; Hanke, Thorsten

    2017-04-01

    Background The transcatheter aortic valve-in-valve implantation (TAViVI) is an evolving treatment strategy for degenerated surgical aortic valve bioprostheses (SAVBs) in patients with high operative risk. Although hemodynamics is excellent, there is some concern regarding coronary obstruction, especially in SAVB with externally mounted leaflet tissue, such as the Trifecta (St. Jude Medical Inc., St. Paul, Minnesota, United States). We investigated coronary flow and hydrodynamics before and after TAViVI in a SAVB with externally mounted leaflet tissue (St. Jude Medical, Trifecta) with an undersized transcatheter aortic valve bioprosthesis (Edwards Sapien XT; Edwards Lifesciences LLC, Irvine, California, United States) in an in vitro study. Materials and Methods An aortic root model was constructed incorporating geometric dimensions known as risk factors for coronary obstruction. Investigating the validity of this model, we primarily performed recommended TAViVI with the Sapien XT (size 26 mm) in a Trifecta (size 25 mm) in a mock circulation. Thereafter, hydrodynamic performance and coronary flow (left/right coronary diastolic flow [lCF/rCF]) after TAViVI with an undersized Sapien XT (size 23 mm) in a Trifecta (size 25 mm) were investigated at two different coronary ostia heights (COHs, 8 and 10 mm). Results Validation of the model led to significant coronary obstruction (p < 0.001). Undersized TAViVI showed no significant reduction with respect to coronary flow (lCF: COH 8 mm, 0.90-0.87 mL/stroke; COH 10 mm, 0.89-0.82 mL/stroke and rCF: COH 8 mm, 0.64-0.60 mL/stroke; COH 10 mm, 0.62-0.58 mL/stroke). Mean transvalvular gradients (4-5 mm Hg, p < 0.001) increased significantly after TAViVI. Conclusions In our in vitro model, undersized TAViVI with the balloon-expandable Sapien XT into a modern generation SAVB (Trifecta) successfully avoided coronary flow obstruction. Georg Thieme Verlag KG Stuttgart · New York.

  2. Fluoroscopic guide to an ideal implant position for Sapien XT and CoreValve during a valve-in-valve procedure.

    PubMed

    Bapat, Vinnie N; Attia, Rizwan Q; Condemi, Fortunata; Visagan, Ravi; Guthrie, Maya; Sunni, Shelina; Thomas, Martyn

    2013-11-01

    This study sought to provide a guide to the fluoroscopic appearances of various valve-in-valve (VIV) combinations by deploying a transcatheter heart valve (THV) within a degenerated surgical heart valve (SHV) in an ideal position. VIV procedures are being increasingly performed with substantial experience acquired in treating degenerated SHV in the aortic position with Sapien/Sapien XT (Edwards Lifesciences Ltd., Irvine, California) and CoreValve/Evolute (Medtronic Inc., Minneapolis, Minnesota) valves. Although less invasive than conventional surgery, securing the THV in an optimal position within the SHV determines the success of this novel treatment. For VIV implantation, we selected appropriate Sapien XT and CoreValve/Evolute sizes depending on the internal diameter of the SHV. Implantation was performed in vitro. In case of the Sapien XT valve, it was deployed 4 to 5 mm below the sewing ring of the SHV, whereas the CoreValve/Evolute was deployed 5 mm below the level of the sewing ring. Photographs and fluoroscopic images of the various VIV combinations were obtained in side profile to study the ideal position and end-on profile to study the circularity of the THV. Fluoroscopic images obtained in side profile highlighted the differences in various VIV combinations, as all SHV are unique in their fluoroscopic appearances. Also, all THV implants in various VIV combinations achieved a nearly circular shape. To achieve an optimal result when considering VIV, it is important to be familiar with the structure and fluoroscopic appearances of the failed SHV, the THV used, and their combination. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. Use of the ex-press miniature glaucoma implant in a child with Sturge-Weber syndrome.

    PubMed

    Elgin, Ufuk; Simsek, Tulay; Batman, Aygen

    2007-01-01

    A two-stage antiglaucoma operation was planned for the left eye of an 11-year-old boy with bilateral Sturge-Weber syndrome to avoid intraoperative and postoperative choroidal and retinal effusion as with previous trabeculectomy. The Ex-Press miniature glaucoma implant was placed 10 days before trabeculectomy with mitomycin C. There were no complications with either procedure.

  4. Transapical implantation of a novel self-expanding sutureless aortic valve prosthesis.

    PubMed

    Stalder, Mario; Suri, Rakesh M; Kraehenbuehl, Eva S; Hellige, Gerrit; Wenaweser, Peter; Zobrist, Claudia; Schaff, Harzell V; Carrel, Thierry P

    2010-03-01

    To date, transapical aortic valve implantation has required a balloon-expandable stented valve prosthesis. More recently, a novel self-expanding sutureless stented bovine pericardial prosthesis has been developed which allows rapid aortic valve replacement via an open transaortic approach in humans. The aim of this animal study was to develop a reliable protocol to facilitate the transapical implantation of this self-expanding valve in a porcine model. Off-pump transapical aortic valve implantation was performed through a left mini-thoracotomy using a bovine pericardial valve mounted on a self-expandable nitinol stent of size 21 mm and 23 mm in 11 pigs (average weight 60 kg). The crimped valve was introduced through the left ventricular apex using a flexible and steerable delivery sheath, using a three-step technique. Biplane fluoroscopy and transesophageal echocardiography were simultaneously used for guidance. Successful adjustment of alignment along three axes prior to deployment of the valve was accomplished in each animal. Deployments were performed during a period of rapid pacing. All valves were successfully deployed and functioned normally following transapical removal of the delivery system. Paravalvular leak was documented in one case (9.1%) due to prosthetic misalignment. There was no evidence of valve migration. Correct anatomic seating was confirmed during post-procedure necropsy. Successful transapical implantation of a novel self-expandable bovine pericardial valve was accomplished in 11 animals, without cardiopulmonary bypass. A flexible, steerable delivery system with a three-step release mechanism allowed precise positioning of the valve with a low rate of paravalvular leakage, and excellent device stability.

  5. Transapical perfusion for peri-arrest salvage during transcutaneous aortic valve implantation.

    PubMed

    Göbölös, L; Tsang, G M; Curzen, N; Calver, A L; Ohri, S K

    2015-11-01

    An 80-year-old man developed severe haemodynamic instability during a transapical aortic valve implantation. He was not suitable for a conventional surgical approach due to comorbidities and patent aortocoronary bypass grafts also limited further stabilizing actions. As a bail-out procedure, we demonstrate the feasibility of transapical arterial cannulation by crossing a newly implanted TAVI valve in order to establish an emergency bypass circuit. © The Author(s) 2015.

  6. Infective endocarditis following Melody valve implantation: comparison with a surgical cohort.

    PubMed

    O'Donnell, Clare; Holloway, Rhonda; Tilton, Elizabeth; Stirling, John; Finucane, Kirsten; Wilson, Nigel

    2017-03-01

    Infective endocarditis has been reported post Melody percutaneous pulmonary valve implant; the incidence and risk factors, however, remain poorly defined. We identified four cases of endocarditis from our first 25 Melody implants. Our aim was to examine these cases in the context of postulated risk factors and directly compare endocarditis rates with local surgical valves. We conducted a retrospective review of patients post Melody percutaneous pulmonary valve implant in New Zealand (October, 2009-May, 2015) and also reviewed the incidence of endocarditis in New Zealand among patients who have undergone surgical pulmonary valve implants. In total, 25 patients underwent Melody implantation at a median age of 18 years. At a median follow-up of 2.9 years, most were well with low valve gradient (median 27 mmHg) and only mild regurgitation. Two patients presented with life-threatening endocarditis and obstructive vegetations at 14 and 26 months post implant, respectively. Two additional patients presented with subacute endocarditis at 5.5 years post implant. From 2009 to May, 2015, 178 surgical pulmonic bioprostheses, largely Hancock valves and homografts, were used at our institution. At a median follow-up of 2.9 years, four patients (2%) had developed endocarditis in this group compared with 4/25 (16%) in the Melody group (p=0.0089). Three surgical valves have been replaced. The Melody valve offers a good alternative to surgical conduit replacement in selected patients. Many patients have excellent outcomes in the medium term. Endocarditis, however, can occur and if associated with obstruction can be life threatening. The risk for endocarditis in the Melody group was higher in comparison with that in a contemporaneous surgical pulmonary implant cohort.

  7. Vascular complications with transcatheter aortic valve implantation using the 18 Fr Medtronic CoreValve System: the Rotterdam experience.

    PubMed

    Van Mieghem, Nicolas M; Nuis, Rutger-Jan; Piazza, Nicolo; Apostolos, Tzikas; Ligthart, Jurgen; Schultz, Carl; de Jaegere, Peter P; Serruys, Patrick W

    2010-01-01

    Transcatheter aortic valve implantation (TAVI) requires large bore catheters. Access site complications, therefore, can be a concern. The aim of this study is to present the 30-day incidence of major and minor vascular complications in patients treated with the third generation 18 Fr Medtronic CoreValve System. We prospectively evaluated the vascular complications occurring in all patients treated with the 18 Fr Medtronic CoreValve System between October 2006 and October 2009 in the Thoraxcenter using various proposed definitions. Ninety-nine consecutive patients were treated with TAVI using the 18 Fr Medtronic CoreValve System. Vascular events were encountered in 13 patients (13%), seven of these cases (54%) were related to incomplete arteriotomy closure with the Prostar device which is the default access closure technique in our centre. Depending on how major vascular complications were defined, the incidence varied from 4 to 13%. Blood transfusions in combination with surgical or percutaneous intervention were required in eight cases. Transcatheter aortic valve implantation with the 18 Fr Medtronic CoreValve System(R) has a 4 to 13% vascular complications' rate. More than half of the vascular events were due to incomplete Prostar arteriotomy closure, despite its use by experienced operators. Current percutaneous closure devices for these large arteriotomies seems suboptimal. Uniformity in how to define TAVI related vascular complications is needed.

  8. Endophthalmitis With Corneal Infiltrate After EX-PRESS Glaucoma Drainage Device Implantation.

    PubMed

    Cherof, Amy M; SooHoo, Jeffery R; Kahook, Malik Y; Seibold, Leonard K

    2016-03-01

    To report a case of endophthalmitis occurring shortly after EX-PRESS implantation with the formation of a corneal infiltrate overlying the EX-PRESS, requiring device removal for adequate treatment. This is a case report of a 56-year-old male with uncontrolled open-angle glaucoma who underwent right eye EX-PRESS implantation under a partial-thickness scleral flap with intraoperative application of mitomycin C. On postoperative day 16, the patient was found to have bleb-associated endophthalmitis with a corneal infiltrate adjacent to the bleb and overlying the EX-PRESS. Two days after pars plana vitrectomy with injection of intravitreal antibiotics, the corneal infiltrate was enlarging and centered on the distal end of the EX-PRESS, while the back plate of the device became partially exposed. Clinical improvement was not achieved until the device was removed and the original surgical site was reinforced with a patch graft. By week 10 after device removal, intraocular pressure was 8 mm Hg and the corneal infiltrate had resolved into an opaque, partially vascularized scar. Endophthalmitis after EX-PRESS implantation may be complicated by corneal infiltrate formation and persistent infection. Clinicians should monitor for these complications in the management of infection after EX-PRESS implantation and consider early device removal to achieve resolution.

  9. Repositionable percutaneous aortic valve implantation with the LOTUS valve: 30-day and 1-year outcomes in 250 high-risk surgical patients.

    PubMed

    Meredith, Ian T; Dumonteil, Nicolas; Blackman, Daniel J; Tchétché, Didier; Walters, Darren L; Hildick-Smith, David; Manoharan, Ganesh; Harnek, Jan; Worthley, Stephen G; Rioufol, Gilles; Lefèvre, Thierry; Modine, Thomas; Van Mieghem, Nicolas M; Feldman, Ted; Allocco, Dominic J; Dawkins, Keith D

    2017-09-20

    The REPRISE IIE trial aimed to evaluate outcomes following transcatheter aortic valve implantation of the fully repositionable and retrievable LOTUS valve with a unique seal designed to minimise paravalvular leak (PVL). This prospective, multicentre study enrolled 250 patients with severe aortic stenosis considered high-risk for surgery by a multidisciplinary Heart Team. An independent clinical events committee adjudicated events per Valve Academic Research Consortium criteria. Mean age was 84 years; 77% were in NYHA Class III/IV. LOTUS valve implantation produced significant haemodynamic improvements at one year without valve embolisation, ectopic valve deployment, or additional valve implantation. Primary endpoints were met as the 30-day mortality rate in the extended cohort (4.4%, N=250), and mean valve gradient in the main cohort (11.5±5.2 mmHg, N=120) were below (p<0.001) their predefined performance objectives. At 30 days, disabling stroke was 2.8% and new pacemaker implantation was 28.9% in all patients and 32.0% in pacemaker-naïve patients. By one year, all-cause mortality was 11.6%, disabling stroke was 3.6%, 95% of patients alive were in NYHA Class I/II, and there was no core laboratory-adjudicated moderate/severe PVL. LOTUS valve implantation produced good valve haemodynamics, minimal PVL, sustained significant improvement in functional status, and good clinical outcomes one year post implant.

  10. Bevacizumab-loaded polyurethane subconjunctival implants: effects on experimental glaucoma filtration surgery.

    PubMed

    Paula, Jayter Silva; Ribeiro, Vanessa Raquel Coimbra; Chahud, Fernando; Cannellini, Roberta; Monteiro, Tassia Cristina; Gomes, Elionai Cassiana de Lima; Reinach, Peter Sol; Rodrigues, Maria de Lourdes Veronese; Silva-Cunha, Armando

    2013-01-01

    Vascular endothelial growth factor (VEGF) may contribute to the scarring process resulting from glaucoma filtration surgery, since this cytokine may stimulate fibroblast proliferation. The aim of this study was to describe a new bevacizumab-loaded polyurethane implant (BPUI) and to evaluate its effectiveness as a new drug delivery system of anti-VEGF antibody in a rabbit model of glaucoma filtration surgery. An aqueous dispersion of polyurethane was obtained via the conventional process. Bevacizumab (1.5 mg) was then incorporated into the dispersion and was subsequently dried to form the polymeric films. Films with dimensions of 3×3×1 mm that either did (group BPUI, n=10) or did not contain bevacizumab (group PUI, n=10) were implanted in the subconjunctival space, at the surgical site in 1 eye of each rabbit. The in vitro bevacizumab release was evaluated using size-exclusion high-performance liquid chromatography (HPLC), and the in vivo effects of the drug were investigated in a rabbit experimental trabeculectomy model by examining the bleb characteristics and collagen accumulation, and by performing immunohistological analyses of VEGF expression. HPLC showed that only 10% of the bevacizumab in the implants had been released by postoperative day 5. In vivo studies demonstrated that the drug had no adverse effects; however, no significant differences in either the bleb area score or the collagen deposit intensity between the group PUI and the group that BPUI were observed. Moreover, the group BPUI presented a significantly lower proportion of VEGF-expressing fibroblasts than group PUI (0.17±0.03 vs. 0.35±0.05 cells/field, P=0.005). This study demonstrated that bevacizumab release from the BPUIs only occurred for a short time probably from the surface of the films. Nevertheless, they were well tolerated in rabbit eyes and reduced the number of VEGF-expressing fibroblasts.

  11. Bevacizumab-Loaded Polyurethane Subconjunctival Implants: Effects on Experimental Glaucoma Filtration Surgery

    PubMed Central

    Ribeiro, Vanessa Raquel Coimbra; Chahud, Fernando; Cannellini, Roberta; Monteiro, Tassia Cristina; de Lima Gomes, Elionai Cassiana; Reinach, Peter Sol; Veronese Rodrigues, Maria de Lourdes; Silva-Cunha, Armando

    2013-01-01

    Abstract Purpose Vascular endothelial growth factor (VEGF) may contribute to the scarring process resulting from glaucoma filtration surgery, since this cytokine may stimulate fibroblast proliferation. The aim of this study was to describe a new bevacizumab-loaded polyurethane implant (BPUI) and to evaluate its effectiveness as a new drug delivery system of anti-VEGF antibody in a rabbit model of glaucoma filtration surgery. Methods An aqueous dispersion of polyurethane was obtained via the conventional process. Bevacizumab (1.5 mg) was then incorporated into the dispersion and was subsequently dried to form the polymeric films. Films with dimensions of 3×3×1 mm that either did (group BPUI, n=10) or did not contain bevacizumab (group PUI, n=10) were implanted in the subconjunctival space, at the surgical site in 1 eye of each rabbit. The in vitro bevacizumab release was evaluated using size-exclusion high-performance liquid chromatography (HPLC), and the in vivo effects of the drug were investigated in a rabbit experimental trabeculectomy model by examining the bleb characteristics and collagen accumulation, and by performing immunohistological analyses of VEGF expression. Results HPLC showed that only 10% of the bevacizumab in the implants had been released by postoperative day 5. In vivo studies demonstrated that the drug had no adverse effects; however, no significant differences in either the bleb area score or the collagen deposit intensity between the group PUI and the group that BPUI were observed. Moreover, the group BPUI presented a significantly lower proportion of VEGF-expressing fibroblasts than group PUI (0.17±0.03 vs. 0.35±0.05 cells/field, P=0.005). Conclusions This study demonstrated that bevacizumab release from the BPUIs only occurred for a short time probably from the surface of the films. Nevertheless, they were well tolerated in rabbit eyes and reduced the number of VEGF-expressing fibroblasts. PMID:23391327

  12. Percutaneous paravalvular leak closure after CoreValve transcatheter aortic valve implantation using an arterio-arterial loop

    PubMed Central

    Benito-González, Tomás; Gualis, Javier; Pérez de Prado, Armando; Cuellas, Carlos; Fernandez-Vazquez, Felipe

    2017-01-01

    Significant periprosthetic aortic regurgitation after transcatheter aortic valve implantation has become a major concern of this technique given its association with impaired survival. We report the successful closure of such defect using a vascular occlusion device with the creation of an arterio-arterial loop to gain enough support to advance the delivery sheath into de the left ventricle. PMID:28275491

  13. Evaluation of an Injectable Thermosensitive Hydrogel As Drug Delivery Implant for Ocular Glaucoma Surgery

    PubMed Central

    Zhao, Feng; Zheng, Qiongjuan; Li, Xiaoning; Luo, Jing; Liu, Ji; Quan, Daping; Ge, Jian

    2014-01-01

    In this study, a biodegradable thermo-sensitive hydrogel from poly(trimethylene carbonate)15-F127-poly(trimethylene carbonate)15 (PTMC15-F127-PTMC15) was designed and evaluated as an injectable implant during ocular glaucoma filtration surgery in vivo and in vitro. Mitomycin C (MMC) was loaded into this hydrogel for controlled released to prolong the efficacy and to reduce the long-term toxicity. The properties of the hydrogel were confirmed using 1H NMR and gel permeation chromatography (GPC). Compared to the Pluronic F127 hydrogel, the PTMC15-F127-PTMC15 hydrogel showed a good solution-gel transition temperature at 37°C, a lower work concentration of 5% w/v and a longer mass loss time of more than 2 weeks. The in vitro study showed that the drug could be released from PTMC15-F127-PTMC15 (5% w/v) hydrogel for up to 16 days with only 57% of drug released in the first day. Moreover, the cell toxicity, which was tested via LDH and ANNEXIN V/PI, decreased within 72 h in human tenon's fibroblast cells (HTFs). The in vivo behavior in a rabbit glaucoma filtration surgery model indicated that this hydrogel loaded with 0.1 mg/ml MMC led to a better functional bleb with a prolonged mean bleb survival time (25.5±2.9 days). The scar tissue formation, new collagen deposition and myofibroblast generation appeared to be reduced upon histological and immunohistochemistry examinations, with no obvious side effects and inflammatory reactions. The in vitro and in vivo results demonstrated that this novel hydrogel is a safe and effective drug delivery candidate in ocular glaucoma surgery. PMID:24950176

  14. Post-market surveillance to detect adverse events associated with Melody® valve implantation.

    PubMed

    Hill, Kevin D; Goldstein, Bryan H; Angtuaco, Michael J; Chu, Patricia Y; Fleming, Gregory A

    2017-08-01

    The aim of this study was to describe previously unrecognised or under-recognised adverse events associated with Melody® valve implantation. In rare diseases and conditions, it is typically not feasible to conduct large-scale safety trials before drug or device approval. Therefore, post-market surveillance mechanisms are necessary to detect rare but potentially serious adverse events. We reviewed the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database and conducted a structured literature review to evaluate adverse events associated with on- and off-label Melody® valve implantation. Adverse events were compared with those described in the prospective Investigational Device Exemption and Post-Market Approval Melody® transcatheter pulmonary valve trials. We identified 631 adverse events associated with "on-label" Melody® valve implants and 84 adverse events associated with "off-label" implants. The most frequent "on-label" adverse events were similar to those described in the prospective trials including stent fracture (n=210) and endocarditis (n=104). Previously unrecognised or under-recognised adverse events included stent fragment embolisation (n=5), device erosion (n=4), immediate post-implant severe valvar insufficiency (n=2), and late coronary compression (n=2 cases at 5 days and 3 months after implantation). Under-recognised adverse events associated with off-label implantation included early valve failure due to insufficiency when implanted in the tricuspid position (n=7) and embolisation with percutaneous implantation in the mitral position (n=5). Post-market passive surveillance does not demonstrate a high frequency of previously unrecognised serious adverse events with "on-label" Melody® valve implantation. Further study is needed to evaluate safety of "off-label" uses.

  15. [Anesthetic management and experience in the transcatheter implantation of the CoreValve(®) self-expanding aortic valve].

    PubMed

    Fernández Suárez, F E; del Valle Fernández, R; González Alvarez, A; Sánchez Lasheras, J; Fernández Sánchez, L; Argüelles Tamargo, L

    2013-10-01

    To analyze the experience and anesthetic management in the transcatheter implantation of the CoreValve(®) self-expanding aortic valve, in a university tertiary hospital. Observational analytical review of data incorporated into a prospectively maintained database of 142 patients diagnosed with severe aortic stenosis who underwent implantation of a CoreValve(®) aortic self-expanding aortic valve between December 2007 and December 2012. The mean age of patients was 82.5±6.1 years and the logistic EuroSCORE was 14.9±11.2. General anesthesia was used in 107 patients (75.3%), with local anesthesia with sedation in 35 (24.6%). Local anesthesia and sedation was associated with a lower requirement of vasoactive drugs (P=.003) during implantation. No statistically significant differences were found between the 2 anesthetic techniques in the duration of the procedure, hospital stay, or morbimortality. The success rate was 97.1%. The most common complication was conduction disorders that required implantation of a permanent pacemaker in 46 patients (32.3%). There was no intraoperative mortality, and all-cause mortality at 30 days was 6.3%, with a one-year survival estimated by the Kaplan-Meier of 83.1%. This study confirms that in patients with severe aortic stenosis and high surgical risk, transcatheter implantation of aortic valve is a safe and effective alternative. Both, general anesthesia and local anesthesia with sedation are valid options, depending on the experience of the team. Copyright © 2013 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Published by Elsevier España. All rights reserved.

  16. A Miniature-Implantable RF-Wireless Active Glaucoma Intraocular Pressure Monitor.

    PubMed

    Chow, Eric Y; Chlebowski, Arthur L; Irazoqui, Pedro P

    2010-12-01

    Glaucoma is a detrimental disease that causes blindness in millions of people worldwide. There are numerous treatments to slow the condition but none are totally effective and all have significant side effects. Currently, a continuous monitoring device is not available, but its development may open up new avenues for treatment. This work focuses on the design and fabrication of an active glaucoma intraocular pressure (IOP) monitor that is fully wireless and implantable. Major benefits of an active IOP monitoring device include the potential to operate independently from an external device for extended periods of time and the possibility of developing a closed-loop monitoring and treatment system. The fully wireless operation is based off using gigahertz-frequency electromagnetic wave propagation, which allows for an orientation independent transfer of power and data over reasonable distances. Our system is comprised of a micro-electromechanical systems (MEMS) pressure sensor, a capacitive power storage array, an application-specific integrated circuit designed on the Texas Instruments (TI) 130 nm process, and a monopole antenna all assembled into a biocompatible liquid-crystal polymer-based tadpole-shaped package.

  17. [An experimental model of pulmonary valve implantation: a percutaneous and transventricular approach without cardiopulmonary bypass].

    PubMed

    Godart, F; Vincentelli, A; Bouzguenda, I; Juthier, F; Wautot, F; Mouquet, F; Prat, A; Rey, C; Corseaux, D; Ung, A; Jude, B

    2007-05-01

    Pulmonary valve replacement by a catheter procedure remains a therapeutic challenge. In this report, the authors demonstrate the possibility of implantation of a porcine xenograft specially prepared on an auto-expanding stent (valved stent) in a sheep model. The porcine xenograft was prepared with hypotonic non-enzymatic solutions. It was sewn onto an auto-expanding stent (Luminex Bard) and inserted into an introduction sheath of 22-24 F (Gore) calibre. In a preliminary approach, the catheter was inserted through the jugular vein. Out of 6 attempts, it was possible to position the valved stent in the pulmonary position in two cases but all the animals died of different causes: tamponade, arrhythmias, air embolism. Following this experience, two valves were implanted through the superior and inferior vena cavae. This first percutaneous approach has been modified to a mixed medico-surgical approach with a transventricular introduction without cardiopulmonary bypass. This was performed through a left thoracotomy with puncture of the pulmonary infundibulum using the same systems of introduction and valved stent. Three implantations were successfully performed. In addition, a reduction of the size of the pulmonary artery was realised to prevent embolisation of the valved stent to the pulmonary artery or one of its branches. The transventricular approach is feasible for implantation of pulmonary valve prosthesis on a stent. This technique could be adapted for correction of pulmonary regurgitation after correction of Tetralogy of Fallot associated with reduction of the pulmonary infundibulum.

  18. Radiation dose of patients undergoing transcatheter aortic valve implantation: a comparison between Edwards SAPIEN XT and Medtronic CoreValve aortic valve prostheses.

    PubMed

    Steinvil, Arie; Aviram, Galit; Konigstein, Maayan; Abramowitz, Yigal; Halkin, Amir; Arbel, Yaron; Ben-Gal, Yanai; Keren, Gad; Banai, Shmuel; Finkelstein, Ariel

    2013-10-01

    The relative radiation dose (RD) of patients undergoing transcatheter aortic valve implantation (TAVI) with either the Edwards Sapien XT (ESX) or the Medtronic CoreValve (MCV) prostheses has not been studied in depth. Our aim was to quantify RD in uncomplicated transfemoral TAVI with either prosthesis. We analyzed 248 consecutive patients undergoing uncomplicated transfemoral TAVI between March 2009 and September 2012, at a single tertiary care facility. Total air Kerma, cumulated dose area product (DAP), and fluoroscopy time were determined in each case. The ESX and MCV prostheses were implanted in 44 and 204 patients, respectively. Though mean fluoroscopy time was higher during ESX valve implantation, overall RD per total air Kerma and DAP was significantly higher during MCV implantation (P < 0.05 for both comparisons). By multivariate regression analyses, prosthesis type was an independent predictor of RD according to both total air Kerma and DAP (r(2) = 0. 498; P < 0.01 and r(2) = 0.363; P < 0.01, respectively). In uncomplicated transfemoral TAVI, RD is greater during MCV implantation than during ESX implantation. Copyright © 2013 Wiley Periodicals, Inc.

  19. The perceval S aortic valve implantation in patients with porcelain aorta; is this ideal option?

    PubMed

    Baikoussis, Nikolaos G; Dedeilias, Panagiotis; Prappa, Efstathia; Argiriou, Michalis

    2017-01-01

    We would like to present in this paper a patient with severe aortic valve stenosis referred to our department for surgical aortic valve replacement. In this patient, it was intraoperatively detected an unexpected heavily calcified porcelain ascending aorta. We present the treatment options in this situation, the difficulties affronted intraoperatively, the significance of the preoperative chest computed tomography scan and the use of the Perceval S aortic valve as ideal bioprosthesis implantation. This is a self-expanding, self-anchoring, and sutureless valve with a wide indication in all patients requiring aortic bioprosthesis.

  20. The Perceval S Aortic Valve Implantation in Patients with Porcelain Aorta; is this Ideal Option?

    PubMed Central

    Baikoussis, Nikolaos G; Dedeilias, Panagiotis; Prappa, Efstathia; Argiriou, Michalis

    2017-01-01

    We would like to present in this paper a patient with severe aortic valve stenosis referred to our department for surgical aortic valve replacement. In this patient, it was intraoperatively detected an unexpected heavily calcified porcelain ascending aorta. We present the treatment options in this situation, the difficulties affronted intraoperatively, the significance of the preoperative chest computed tomography scan and the use of the Perceval S aortic valve as ideal bioprosthesis implantation. This is a self-expanding, self-anchoring, and sutureless valve with a wide indication in all patients requiring aortic bioprosthesis. PMID:28074827

  1. Aortic sutureless bioprosthesis implantation following degeneration of a SOLO stentless valve.

    PubMed

    Vola, Marco; Gerbay, Antoine; Campisi, Salvatore; Thulane, Claire; Fuzellier, François

    2015-03-01

    A case is presented of the early degeneration of a 21 mm SOLO stentless valve concomitant with severe mitral regurgitation (MR). Transcatheter valve-in-valve implantation was considered in this high-risk case (logistic EuroSCORE 29.3%), but was dismissed because of the risk of coronary occlusion, an absence of visual landmarks, and the impossibility to treat the MR. Following the implantation of a 27 mm Medtronic Hancock II mitral bioprosthesis, the leaflets of the SOLO valve were removed, and a 19 mm 3f Enable sutureless bioprosthesis delivered into the remaining sewing belt of the stentless valve. The total cross-clamp time was 64 min. No aortic paravalvular leakage was detected at discharge and early follow up (four months); the mean and peak transvalvular aortic gradients were 13 and 23 mmHg, respectively, and the left ventricular ejection fraction 60%. A sutureless strategy simplified the management of this high-risk case.

  2. Comparative study of the safety and efficacy of the Ahmed glaucoma valve model M4 (high density porous polyethylene) and the model S2 (polypropylene) in patients with neovascular glaucoma.

    PubMed

    Gil-Carrasco, F; Jiménez-Román, J; Turati-Acosta, M; Bello-López Portillo, H; Isida-Llerandi, C G

    2016-09-01

    To prospectively evaluate the safety and efficacy of the Ahmed glaucoma valve model M4 (High density porous polyethylene plate; Medpor) compared with the model S2 (polypropylene plate). Mexican patients with neovascular glaucoma were randomly included for each group (M4 and S2). They were operated on using conventional techniques and creating a sub-episcleral tunnel to place the valve tube in the anterior chamber. After one year of follow-up, the results were evaluated with respect to a post-operative reduction in pressure, changes in visual acuity, the need for drugs, and complications, as well as the demographic characteristics of each group. Each operation using the M4 valve was performed by a single surgeon (FGC). Those operated on using the S2 model had their surgery performed by the staff surgeons at the Glaucoma Department of the Mexican Association to Prevent Blindness (APEC). Each group (M4 and S2) contained 21 eyes of 21 Mexican patients with a diagnosis of neovascular glaucoma, leading to a total of 42 patients undergoing surgery. The mean preoperative intraocular pressure (IOP) was 43.5 (±11.8), and 42.24 (±12.84) mmHg for the M4 and S2 groups, respectively. After one year of follow-up, the IOP reported was 18.9 (±9.7) mmHg for the final 18 patients in the M4 group, and 16.38 (±9.76) mmHg for the 21 patients in the S2 group. The design of a drainage valve device such as that of Ahmed has characteristics such as moderate control of IOP, thanks to the valve component in the immediate post-operative period, which makes them safer than other non-valve devices. This avoids an excess of flat chambers and the presence of low IOPs, which can lead to bleeding in the early post-operative period due to the weak desmosomal junctions of the newly formed vessels, with the advantage of maintaining suitable control of IOP from the first day after surgery. Further studies with longer follow-up with a larger number of patients are needed to evaluate the effectiveness

  3. Implantation of a Tissue-Engineered Tubular Heart Valve in Growing Lambs.

    PubMed

    Reimer, Jay; Syedain, Zeeshan; Haynie, Bee; Lahti, Matthew; Berry, James; Tranquillo, Robert

    2017-02-01

    Current pediatric heart valve replacement options are suboptimal because they are incapable of somatic growth. Thus, children typically have multiple surgeries to replace outgrown valves. In this study, we present the in vivo function and growth potential of our tissue-engineered pediatric tubular valve. The valves were fabricated by sewing two decellularized engineered tissue tubes together in a prescribed pattern using degradable sutures and subsequently implanted into the main pulmonary artery of growing lambs. Valve function was monitored using periodic ultrasounds after implantation throughout the duration of the study. The valves functioned well up to 8 weeks, 4 weeks beyond the suture strength half-life, after which their insufficiency index worsened. Histology from the explanted valves revealed extensive host cell invasion within the engineered root and commencing from the leaflet surfaces. These cells expressed multiple phenotypes, including endothelial, and deposited elastin and collagen IV. Although the tubes fused together along the degradable suture line as designed, the leaflets shortened compared to their original height. This shortening is hypothesized to result from inadequate fusion at the commissures prior to suture degradation. With appropriate commissure reinforcement, this novel heart valve may provide the somatic growth potential desired for a pediatric valve replacement.

  4. Anesthetic management for percutaneous aortic valve implantation: an overview of worldwide experiences.

    PubMed

    Ruggeri, L; Gerli, C; Franco, A; Barile, L; Magnano di San Lio, M S; Villari, N; Zangrillo, A

    2012-01-01

    Transcatheter aortic valve implantation is an emergent technique for high risk patients with aortic stenosis. Transcatheter aortic valve implantation poses significant challenges about its management, due to the procedure itself (i.e. the passage of large stiff sheaths in diseased vessels, the valve dilatation and the prosthesis positioning during a partial cardiac standstill) and the population of elder and high-risk patients who undergo the implantation. Retrograde transfemoral approach is the most popular procedure and a great number of cases is reported. Nevertheless, there is not a consensus regarding the intraoperative anesthesiological strategies, which vary in the different Centers. Sedation plus local anesthesia or general anesthesia are both valid alternatives and can be applied according to patient's characteristics and procedural instances. Most groups started the implantation program with a general anesthesia; indeed, it offers many advantages, mainly regarding the possibility of an early diagnosis and treatment of potential complications, through the use of the transesophageal echocardiography. However, after the initial experiences, many groups began to employ routinely sedation plus local anesthesia for transcatheter aortic valve implantation and their procedural and periprocedural success demonstrates that it is feasible, with many possible advantages. Many aspects about perioperative anesthetic management for transcatheter aortic valve implantation are still to be defined. Aim of this work is to clarify the different management strategies through a review of the available literature published in pubmed till June 2011.

  5. Repeat transcatheter aortic valve implantation using a latest generation balloon-expandable device for treatment of failing transcatheter heart valves.

    PubMed

    Schaefer, Andreas; Treede, Hendrik; Seiffert, Moritz; Deuschl, Florian; Schofer, Niklas; Schneeberger, Yvonne; Blankenberg, Stefan; Reichenspurner, Hermann; Schaefer, Ulrich; Conradi, Lenard

    2016-01-15

    Paravalvular leakage (PVL) is a known complication of transcatheter aortic valve implantation (TAVI) and is associated with poor outcome. Besides balloon-post-dilatation, valve-in-valve (ViV) procedures can be taken into consideration to control this complication. Herein we present initial experience with use of the latest generation balloon-expandable Edwards Sapien 3® (S3) transcatheter heart valve (THV) for treatment of failing THVs. Between 01/2014 and 12/2014 three patients (two male, age: 71-80 y, log EUROScore I: 11.89 - 32.63) with failing THVs were refered to our institution for further treatment. THV approach with secondary implantation of an S3 was chosen after mutual agreement of the local interdisciplinary heart team at an interval of 533-1119 days from the index procedure. The performed procedures consisted of: S3 in Sapien XT, JenaValve and CoreValve. Successful transfemoral implantation with significant reduction of PVL was achieved in all cases. No intraprocedural complications occurred regarding placement of the S3 with a postprocedural effective orifice area (EOA) of 1.5-2.5 cm(2) and pressure gradients of max/mean 14/6-36/16 mmHg. 30-day mortality was 0%. At the latest follow-up of 90-530 days, all patients are alive and well with satisfactory THV function. Regarding VARC-2 criteria one major bleeding and one TIA was reported. In the instance of moderate or severe aortic regurgitation after TAVI, S3 ViV deployment is an excellent option to reduce residual regurgitation to none or mild. For further assertions concerning functional outcomes long-term results have to be awaited.

  6. Bicuspid pulmonary valve implantation using polytetrafluoroethylene membrane: early results and assessment of the valve function by magnetic resonance imaging.

    PubMed

    Lee, Cheul; Lee, Chang-Ha; Kwak, Jae Gun; Song, Jin Young; Shim, Woo-Sup; Choi, Eun Young; Lee, Sang Yun; Kim, Yang Min

    2013-03-01

    The durability of bioprosthetic valves in the pulmonary position is suboptimal. The objectives of this study were to evaluate the early results of polytetrafluoroethylene (PTFE) bicuspid pulmonary valve (PV) implantation and to better define the function of this valve by magnetic resonance imaging (MRI). Fifty-six patients who underwent PTFE bicuspid PV implantation between June 2009 and August 2011 were retrospectively analysed. The median age was 17.5 years and median valve size was 26 mm. Fundamental diagnoses were tetralogy of Fallot (n = 38), pulmonary atresia with ventricular septal defect (n = 8), double outlet right ventricle (n = 7) and absent PV syndrome (n = 3). Thirty-two patients with pulmonary regurgitation (PR) underwent MRI preoperatively and 22 of them underwent follow-up MRI at a median of 6.7 months postoperatively. There was one early death. Postoperative echocardiography (n = 53) showed no or trivial PR in 49 patients and mild PR in 4. Median follow-up duration was 15.2 months. There was no late death or reoperation. Follow-up echocardiography (n = 41) performed at a median of 7.5 months postoperatively showed no or trivial PR in 33 patients and mild PR in 8 patients. Follow-up MRI showed a significant reduction in right ventricular volumes and improvement in biventricular function. The median PR fraction of this valve was 10%. Early results of bicuspid PV implantation using PTFE membrane were satisfactory. PTFE bicuspid PV demonstrated excellent performance for the short term as evidenced by echocardiography and MRI. Long-term follow-up is mandatory to determine the durability of this valve.

  7. Long-term Follow-up After Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis.

    PubMed

    Salinas, Pablo; Moreno, Raúl; Calvo, Luis; Sánchez-Recalde, Ángel; Jiménez-Valero, Santiago; Galeote, Guillermo; López-Fernández, Teresa; Ramírez, Ulises; Riera, Luis; Plaza, Ignacio; Moreno, Isidro; Mesa, José María; López-Sendón, José Luis

    2016-01-01

    Transcatheter aortic valve implantation is used as an alternative to surgical valve replacement in patients with severe aortic stenosis who are considered high-surgical-risk or inoperable. Two of the main areas of uncertainty in this field are valve durability and long-term survival. This prospective single-center registry study from a tertiary hospital included all consecutive patients who underwent percutaneous aortic valve implantation between 2008 and 2012. Clinical follow-up lasted a minimum of 2.5 years and a maximum of 6.5 years. Valve Academic Research Consortium-2 definitions were used. Seventy-nine patients were included, with an immediate success rate of 94.9%. The median survival was 47.6 months (95% confidence intervals, 37.4-57.9 months), ie, 4 years. One quarter of deaths occurred in the first month, and most were of cardiovascular cause. After the first month, most deaths were due to noncardiovascular causes. The mean values of valve gradients did not increase during follow-up. The cumulative rate of prosthetic valve dysfunction was 15.3%, with no cases of repeat valve replacement. Half of the patients with aortic stenosis who underwent transcatheter aortic valve implantation were alive 4 years after the procedure. There was a 15.3% prosthetic valve dysfunction rate in cumulative follow-up, with no cases of repeat valve replacement. Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  8. Factors associated with cardiac conduction disorders and permanent pacemaker implantation after percutaneous aortic valve implantation with the CoreValve prosthesis.

    PubMed

    Baan, Jan; Yong, Ze Yie; Koch, Karel T; Henriques, José P S; Bouma, Berto J; Vis, Marije M; Cocchieri, Riccardo; Piek, Jan J; de Mol, Bas A J M

    2010-03-01

    Cardiac conduction disorders and requirement for permanent pacemaker implantation (PPI) are not uncommon after surgical aortic valve replacement and have important clinical implications. We aimed to investigate the incidence of cardiac conduction disorders after percutaneous aortic valve implantation (PAVI) and to identify possible clinical factors associated with their development. We studied 34 patients (mean age 80 +/- 8 years, 18 male) who underwent PAVI with the CoreValve bioprosthesis (Corevalve Inc, Irvine, CA). Electrocardiographic evaluation was performed pre- and postprocedurally, and at 1-week and 1-month follow-up. Other clinical variables were obtained from the medical history, echocardiography, and angiography. After PAVI, 7 patients required PPI, all of whom developed total atrioventricular block within 3 days postprocedurally. A smaller left ventricular outflow tract diameter (20.3 +/- 0.5 vs 21.6 +/- 1.8 cm, P = .01), more left-sided heart axis (-20 degrees +/- 29 degrees vs 19 degrees +/- 36 degrees , P = .02), more mitral annular calcification (10 +/- 1 vs 5 +/- 4 mm, P = .008), and a smaller postimplantation indexed effective orifice area (0.86 +/- 0.20 vs 1.10 +/- 0.26 cm(2)/m(2), P = .04) were associated with PPI. The incidence of new left bundle-branch block (LBBB) was 65% and was associated with a deeper implantation of the prosthesis: 10.2 +/- 2.3 mm in the new-LBBB group versus 7.7 +/- 3.1 mm in the non-LBBB group (P = .02). Percutaneous aortic valve implantation with the CoreValve prosthesis results in a high incidence of total atrioventricular block requiring PPI and new-onset LBBB. Preexisting disturbance of cardiac conduction, a narrow left ventricular outflow tract, and the severity of mitral annular calcification predict the need for permanent pacing, whereas the only factor shown to be predictive for new-onset LBBB is the depth of prosthesis implantation.

  9. Dislocation of a transapically implanted aortic valve prosthesis with a functionally bicuspid aortic valve and ascending aortic aneurysm.

    PubMed

    Schroeter, T; Subramanian, S; Lehmann, S; Kempfert, J; Misfeld, M; Mohr, F W; Borger, M A

    2011-12-01

    In recent years, catheter-based aortic valve interventions have become established procedures for the treatment of high-risk and advanced age patients with aortic valve pathologies. One of the limitations of the widespread applicability of this procedure is the annulus size. Until recently, no prosthesis was available to treat patients with a large annulus. We report on a patient with high-grade aortic stenosis (AS) and a 27-mm annulus, who underwent transapical implantation (TAP) of an Edwards SAPIEN® 29-mm prosthesis (Edwards LifeScience, Irvine, CA, USA). Due to insufficient dilation of his heavily calcified, functionally bicuspid aortic valve leaflets during balloon aortic valvuloplasty (BAV), the TAP prosthesis did not anchor adequately. This was determined during follow-up as he developed progressive aortic insufficiency and orthopnea, and an echocardiography revealed that the valve had been displaced into the LVOT. A conventional aortic valve replacement and ascending aorta replacement were performed, at which time the TAP prosthesis was removed. The patient recovered uneventfully, and was discharged with a well-functioning aortic bioprosthetic valve and in good general condition. © Georg Thieme Verlag KG Stuttgart · New York.

  10. Incidence and predictors of permanent pacemaker implantation following treatment with the repositionable Lotus™ transcatheter aortic valve.

    PubMed

    Zaman, Sarah; McCormick, Liam; Gooley, Robert; Rashid, Hashrul; Ramkumar, Satish; Jackson, Damon; Hui, Samuel; Meredith, Ian T

    2017-07-01

    To determine the incidence and predictors of permanent pacemaker (PPM) requirement following transcatheter aortic valve replacement (TAVR) with the mechanically expanded Lotus(TM) Valve System (Boston Scientific). Pacemaker implantation is the most common complication following TAVR. Predictors of pacing following TAVR with the Lotus valve have not been systematically assessed. Consecutive patients with severe aortic stenosis who underwent Lotus valve implantation were prospectively recruited at a single-centre. Patients with a pre-existing PPM were excluded. Baseline ECG, echocardiographic and multiple detector computed tomography as well as procedural telemetry and depth of implantation were independently analyzed in a blinded manner. The primary endpoint was 30-day incidence of pacemaker requirement (PPM implantation or death while pacing-dependent). Multivariate analysis was performed to identify independent predictors of the primary endpoint. A total of 104 consecutive patients underwent TAVR with the Lotus valve with 9/104 (9%) with a pre-existing PPM excluded. New or worsened procedural LBBB occurred in 78%. Thirty-day incidence of the primary pacing endpoint was 28%. The most common indication for PPM implantation was complete heart block (CHB) (69%). Independent predictors of the primary endpoint included pre-existing RBBB (hazard ratio [HR] 2.8, 95% CI 1.1-7.0; P = 0.032) and depth of implantation below the noncoronary cusp (NCC) (HR 2.4, 95% CI 1.0-5.7; P = 0.045). Almost a third of Lotus valve recipients require pacemaker implantation within 30 days. The presence of pre-existing RBBB and the depth of prosthesis implantation below the NCC were significant pacing predictors. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  11. Transcatheter valve implantation can alter fluid flow fields in aortic sinuses and ascending aorta

    NASA Astrophysics Data System (ADS)

    Saikrishnan, Neelakantan; Yoganathan, Ajit

    2012-11-01

    Transcatheter aortic valves (TAVs) are valve replacements used to treat aortic stenosis. Currently, these have been used in elderly patients at high-risk for open-heart procedures. Since these devices are implanted under fluoroscopic guidance, the implantation position of the valve can vary with respect to the native aortic valve annulus. The current study characterizes the altered hemodynamics in the aortic sinus and ascending aorta under different implantation (high and low) and cardiac output (2.5 and 5.0 L/min) conditions. Two commonly used TAV designs are studied using 2-D Particle Image Velocimetry (PIV). 200 phase locked images are obtained at every 25ms in the cardiac cycle, and the resulting vector fields are ensemble averaged. High implantation of the TAV with respect to the annulus causes weaker sinus washout and weaker sinus vortex formation. Additionally, the longer TAV leaflets can also result in a weaker sinus vortex. The level of turbulent fluctuations in the ascending aorta did not appear to be affected by axial positioning of the valve, but varied with cardiac output. The results of this study indicates that TAV positioning is important to be considered clinically, since this can affect coronary perfusion and potential flow stagnation near the valve.

  12. Microparticles in patients undergoing transcatheter aortic valve implantation (TAVI).

    PubMed

    Jung, Christian; Lichtenauer, Michael; Figulla, Hans-Reiner; Wernly, Bernhard; Goebel, Bjoern; Foerster, Martin; Edlinger, Christoph; Lauten, Alexander

    2016-08-03

    Degenerative aortic stenosis (AS) is the most frequent form of acquired valvular heart disease. AS is known to entail endothelial dysfunction caused by increased mechanical shear stress leading to elevated circulatory levels of microparticles. Endothelial and platelet microparticles (EMP and PMP) are small vesicles that originate from activated cells and thrombocytes. We sought to evaluate whether transcatheter aortic valve implantation (TAVI) procedure would elicit effects on circulating EMP and PMP. 92 patients undergoing TAVI procedure for severe AS were included in this study. Samples were obtained at each visit before TAVI, 1 week post-procedure and at 1, 3 and after 6 months after TAVI and were evaluated using flow cytometry. A 12 month clinical follow-up was also performed. CD62E+ EMP concentration before TAVI was 21.11 % (±6.6 % SD) and declined to 20.99 % (±6.8 % SD) after 1 week, to 16.63 % (±5.4 % SD, p < 0.0001) after 1 month, to 17.08 % (±4.6 % SD, p < 0.0001) after 3 months and to 15.94 % (±5.4 % SD, p < 0.0001) after 6 months. CD31+/CD42b-, CD31+/Annexin+/- EMP remained unchanged. CD31+/CD41b+ PMP evidenced a slight, but statistically significant increase after TAVI and remained elevated during the entire follow-up. Apart from a procedure-related improvement in echocardiographic parameters, TAVI procedure led also to a decline in CD62E+ EMP. The reduction in pressure gradients with less hemodynamic shear stress seems also to have beneficially affected endothelial homeostasis.

  13. Sedation or general anesthesia for transcatheter aortic valve implantation (TAVI).

    PubMed

    Mayr, N Patrick; Michel, Jonathan; Bleiziffer, Sabine; Tassani, Peter; Martin, Klaus

    2015-09-01

    Transfemoral transcatheter aortic valve implantation (TAVI) is nowadays a routine therapy for elderly patients with severe aortic stenosis (AS) and high perioperative risk. With growing experience, further development of the devices, and the expansion to "intermediate-risk" patients, there is increasing interest in performing this procedure under conscious sedation (TAVI-S) rather than the previously favoured approach of general anesthesia (TAVI-GA). The proposed benefits of TAVI-S include; reduced procedure time, shorter intensive care unit (ICU) length of stay, reduced need for intraprocedural vasopressor support, and the potential to perform the procedure without the direct presence of an anesthetist for cost-saving reasons. To date, no randomized trial data exists. We reviewed 13 non-randomized studies/registries reporting data from 6,718 patients undergoing TAVI (3,227 performed under sedation). Patient selection, study methods, and endpoints have differed considerably between published studies. Reported rates of in-hospital and longer-term mortality are similar for both groups. Up to 17% of patients undergoing TAVI-S require conversion to general anesthesia during the procedure, primarily due to vascular complications, and urgent intubation is frequently associated with hemodynamic instability. Procedure related factors, including hypotension, may compound preexisting age-specific renal impairment and enhance the risk of acute kidney injury. Hypotonia of the hypopharyngeal muscles in elderly patients, intraprocedural hypercarbia, and certain anesthetic drugs, may increase the aspiration risk in sedated patients. General anesthesia and conscious sedation have both been used successfully to treat patients with severe AS undergoing TAVI with similar reported short and long-term mortality outcomes. The authors believe that the significant incidence of complications and unplanned conversion to general anesthesia during TAVI-S mandates the start-to-finish presence

  14. Improvement in Outflow Facility by Two Novel Microinvasive Glaucoma Surgery Implants

    PubMed Central

    Hays, Cassandra L.; Gulati, Vikas; Fan, Shan; Samuelson, Thomas W.; Ahmed, Iqbal Ike K.; Toris, Carol B.

    2014-01-01

    Purpose. To determine improvement in outflow facility (C) in human anterior segments implanted with a novel Schlemm's canal scaffold or two trabecular micro-bypasses. Methods. Human anterior segments were isolated from 12 pairs of eyes from donors with no history of ocular disease and then perfused at 50, 40, 30, 20, and 10 mm Hg pressures for 10 minutes each. Baseline C was calculated from perfusion pressures and flow rates. The scaffold was implanted into Schlemm's canal of one anterior segment, and two micro-bypasses were implanted three clock-hours apart in the contralateral anterior segment. Outflow facility and resistance were compared at various standardized perfusion pressures and between each device. Results. Compared to baseline, C increased by 0.16 ± 0.12 μL/min/mm Hg (74%) with the scaffold, and 0.08 ± 0.12 μL/min/mm Hg (34%) with two micro-bypasses. The scaffold increased C at perfusion pressures of 50, 40, 30, and 20 mm Hg (P < 0.005). Two micro-bypasses increased C at a perfusion pressure of 40 mm Hg (P < 0.05). Conclusions. Both implants effectively increased C in human eyes ex vivo. The scaffold increased C by a greater percentage (73% vs. 34%) and at a greater range of perfusion pressures (20 to 50 mm Hg vs. 40 mm Hg) than the two micro-bypasses, suggesting that the 8-mm dilation of Schlemm's canal by the scaffold may have additional benefits in lowering the outflow resistance. The Hydrus Microstent scaffold may be an effective therapy for increasing outflow facility and thus reducing the IOP in patients with glaucoma. PMID:24550367

  15. Minimally invasive transcatheter aortic valve implantation for the treatment of rheumatic heart disease in developing countries.

    PubMed

    Saidi, Trust; Douglas, Tania S

    2016-10-01

    The treatment of rheumatic heart disease presents a medical and surgical challenge, particularly in developing countries, where the disease is prevalent. Most of these countries find it prohibitively expensive to import heart valve prostheses that are required for treatment and are largely manufactured in the United States and Europe. Even if the valves were available, the absence of facilities to conduct open-heart surgery for valve replacement results in many people from developing countries dying needlessly of the disease. To address this problem, transcatheter aortic valve implantation, an emerging, minimally invasive, treatment strategy for rheumatic heart disease, has been proposed. Areas covered: This paper reviews the literature on current valve technologies in use globally, and focuses on a minimally invasive transcatheter aortic valve implantation device and aortic valve prosthesis that have been developed by Strait Access Technologies Holdings in South Africa. Expert commentary: This new technology holds the potential of making available heart valve replacements to millions of patients in the developing world who would otherwise have no recourse to treatment.

  16. Non-invasive and invasive predictors of paravalvular regurgitation post CoreValve® stent prosthesis implantation in aortic valves.

    PubMed

    Anger, Thomas; Bauer, Verena; Plachtzik, Claudia; Geisler, Tobias; Gawaz, Meinrad; Oberhoff, Martin; Höher, Martin

    2014-06-01

    The long-term success of CoreValve® stent prosthesis (Medtronic) implantation for severe aortic valve stenosis is limited by postprocedural paravalvular regurgitation (PVR). We have retrospectively investigated preinterventional cardiac 256-slice computed tomography (CT) scans and aortography to define predictors for mild, moderate, or severe PVR, in a blinded fashion. We investigated 100 consecutive patients with a mean aortic valve area (AVA) of 0.69 cm(2) and a mean age of 79.4 years. PVR was defined by echocardiography as mild (63), moderate (18), or severe (19). We found no differences according to AVA, left ventricular function, deployed stent size, calcification rate of the aortic valve, and stent position. Anatomically, the annular size and the angle between the left ventricular outflow tract (LVOT) and the ascending aorta demonstrated significant (P < 0.05) differences in the severity of the PVR: an LVOT: ascending aorta angle >12.6°, annulus area >8.9 cm(2) , and annulus diameter difference >3.9 mm. The multivariate analysis demonstrated that deviation angle, difference of aortic annulus (longitudinal-orthogonal), and CoreValve size were independent predictors of PVR. Our data demonstrate the feasibility of cardiac CT to evaluate predictors of PVR post-CoreValve placement. We support the aortic annulus (the area as well as the diameter differences) and the deviation of the linear slope from LVOT to ascending aorta as predictors of severe paravalvular regurgitations poststent implantation. © 2014, Wiley Periodicals, Inc.

  17. Surgical aortic-valve replacement with a transcatheter implant.

    PubMed

    Nowell, Justin L; Dewhurst, Alex; van Besouw, Jean-Pierre; Jahangiri, Marjan

    2011-04-01

    We describe a bailout procedure when surgical aortic-valve replacement was not possible due to severe calcification of the ascending aorta and the root and a very small annulus. A 21-mm CoreValve Revalving prosthesis was inserted via the aortotomy in the presence of a mitral prosthesis.

  18. Thirty-day Outcome Following CoreValve Evolut R Transcatheter Aortic Valve Implantation: An All-comers Prospective Study.

    PubMed

    Perrin, Nils; Roffi, Marco; Frei, Angela; Hachulla, Anne-Lise; Ellenberger, Christoph; Müller, Hajo; Cikirikcioglu, Mustafa; Licker, Marc; Noble, Stephane

    2017-09-01

    There are scarce clinical outcomes data on the new generation recapturable and repositionable CoreValve Evolut R. Data on all-comer patients undergoing transcatheter aortic valve implantation (TAVI) with the Evolut R for severe symptomatic aortic stenosis at a single center were prospectively collected between February 2015 and April 2016. Clinical endpoints were independently adjudicated according to the Valve Academic Research Consortium-2 criteria. Primary outcomes consisted of early safety composite endpoints and 30-day device success. The incidence of new permanent pacemaker implantation was recorded. Among the 83 patients undergoing TAVI during this period, 71 (85.5% of the population; median age, 83.0 [interquartile range, 80.0-87.0] years; Society of Thoracic Surgeons scores, 4.8±3.5%) were suitable for Evolut R implantation and were included in the analysis. Repositioning was performed in 26.8% of the procedures. The early safety composite endpoint was observed in 11.3% of patients at 30 days, with 2.8% all-cause mortality. Device success was documented in 90.1% of patients. Paravalvular leakage was less than grade II in 98.4% of patients. The mean transvalvular aortic gradient was reduced from 42.5±14.5mmHg at baseline to 7.7±4.0mmHg at discharge (P<.0001 vs baseline). New permanent pacemaker implantation was required in 23.9% of patients. The new generation Evolut R is suitable for most patients and shows high device success and acceptable mortality in an unbiased, consecutive, all-comer population at a single center performing TAVI exclusively with Medtronic valves. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  19. Polytetrafluoroethylene pulmonary valve conduit implantation for chronic pulmonary insufficiency.

    PubMed

    Quintessenza, James A

    2014-12-01

    Pulmonary valve replacement in patients with congenital cardiac disease is now being performed with more liberal indications in light of the data that chronic pulmonary insufficiency is not a benign lesion. The beneficial effects of valve replacement with low operative mortality and morbidity support this approach. Many options exist for a pulmonary valve prosthesis, which underscores the fact that there is no ideal valve available. Our efforts are focussed around a synthetic valve that avoids the bio-degeneration of a bio-prosthesis and avoids the need for life-long coumadin. We developed a bicuspid (bileaflet) polytetrafluoroethylene valve design, which has now gone through three major revisions in >200 patients over 14 years. We began the experience utilising a polytetrafluoroethylene hand-sewn bicuspid valve in the right ventricular outflow tract, initially using 0.6 mm and more recently 0.1 mm polytetrafluoroethylene. The 0.1 mm thickness material functions well as a leaflet, maintaining a relatively thin and flexible nature. It does not calcify or initiate thromboses at least for the first several years. We identified issues with dehiscence of the leaflet from the right ventricular outflow tract muscle, especially in the larger, potentially expansive right ventricular outflow tracts, and this prompted our latest design change to place the valve within a polytetrafluoroethylene tube. This current version of the polytetrafluoroethylene valve conduit has excellent short-to-intermediate-term function. Further follow-up is necessary to determine late durability and life-long valve-related procedural risk for our patients.

  20. Wireless miniature implantable devices and ASICs for monitoring, treatment, and study of glaucoma and cardiac disease

    NASA Astrophysics Data System (ADS)

    Chow, Eric Y.

    Glaucoma affects about 65 million people and is the second leading cause of blindness in the world. Although the condition is irreversible and incurable, early detection is vital to slowing and even stopping the progression of the disease. Our work focuses on the design, fabrication, and assembly of a continuous active glaucoma intraocular pressure (IOP) monitor that provides clinicians with the necessary data to more accurately diagnose and treat patients. Major benefits of an active monitoring device include the potential to develop a closed-loop treatment system and to operate independently for extended periods of time. The fully wireless operation uses gigahertzfrequency electromagnetic wave propagation, which allows for an orientation independent transfer of power and data over reasonable distances. Our system is comprised of a MEMS capacitive sensor, capacitive power storage array, ASIC, and monopole antenna assembled into a biocompatible liquid crystal polymer (LCP) package. We have performed in vivo trials on rabbits, both chronic and acute, to validate system functionality, fully wireless feasibility, and biocompatibility. Heart failure (HF) affects approximately 2% of the adult population in developed countries and 6-10% of people over the age of 65. Continuous monitoring of blood pressure, flow, and chemistry from a minimally invasive device can serve as a diagnostic and early-warning system for cardiac health. We developed a miniaturized system attached to the outer surface of an FDA approved stent, used as both the antenna for wireless telemetry/powering and structural support. The system comprises of a MEMS pressure sensor, ASIC for the sensor interface and wireless capabilities, LCP substrate, and FDA approved stent. In vivo studies on pigs validated functionality and fully wireless operation and demonstrate the feasibility of a stent-based wireless implant for continuous monitoring of blood pressure as well as other parameters including oxygen, flow

  1. Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis—Impact of Valve Size in a Single Center Experience

    PubMed Central

    Wöhrle, Jochen; Gonska, Birgid; Rodewald, Christoph; Seeger, Julia; Scharnbeck, Dominik; Rottbauer, Wolfgang

    2016-01-01

    Aims The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications. Methods and Results 235 patients with severe symptomatic aortic stenosis were prospectively enrolled. Transcatheter aortic valve implantations (TAVI) were performed without general anesthesia by transfemoral approach. Patients were followed for 30 days. Patients received 23mm (N = 77), 26mm (N = 91) or 29mm (N = 67) valve based on pre-procedural 256 multislice computer tomography. Mean oversizing did not differ between the 3 valves. There was no residual moderate or severe aortic regurgitation. Rate of mild aortic regurgitation and regurgitation index did not differ between groups. There was no switch to general anesthesia or conversion to surgery. Rate of major vascular complication was 3.0% with no difference between valve and delivery sheath sizes. Within 30 days rates of all cause mortality (2.6%) and stroke (2.1%) were low. Conclusions In patients with severe aortic stenosis transfemoral TAVI with the Edwards Sapien 3 valve without general anesthesia was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complication, mortality and stroke within 30 days with no difference between the 3 valve sizes. Trial Registration ClinicalTrials.gov NCT02162069 PMID:27003573

  2. Mitral implant of the Inovare transcatheter heart valve in failed surgical bioprostheses: a novel alternative for valve-in-valve procedures.

    PubMed

    Gaia, Diego Felipe; Braz, Ademir Massarico; Simonato, Matheus; Dvir, Danny; Breda, João Roberto; Ribeiro, Gustavo Calado; Ferreira, Carolina Baeta; Souza, José Augusto Marcondes; Buffolo, Enio; Palma, José Honório

    2017-04-01

    Reoperative procedure for the treatment of a failed mitral bioprosthesis is associated with considerable risk. In some cases, mortality is high and might contraindicate the benefit of the procedure. The minimally invasive valve-in-valve (ViV) transcatheter mitral valve implant offers an alternative less-invasive approach, reducing morbidity and mortality. The objective of this paper was to evaluate the mitral ViV approach using the Braile Inovare prosthesis. The transcatheter balloon-expandable Braile Inovare prosthesis was used in 12 cases. Procedures were performed in a hybrid operating room, under fluoroscopic and echocardiographic control. Through left minithoracotomy, the prostheses were implanted through the cardiac apex. Serial echocardiographic and clinical examinations were performed. Follow-up varied from 1 to 30 months. A total of 12 transapical mitral ViV procedures were performed. Patients had a mean age of 61.6 ± 9.9 years and 92% were women. Mean logistic EuroSCORE was 20.1%. Successful valve implantation was possible in all cases. In one case, a right lateral thoracotomy was performed for the removal of an embolized prosthesis. There was no operative mortality. Thirty-day mortality was 8.3%. Ejection fraction was preserved after the implant (66.7%; 64.8%; P  = 0.3). The mitral gradient showed a significant reduction (11 mmHg; 6 mmHg; P  < 0.001). Residual mitral regurgitation was not present. There was no left ventricular outflow tract obstruction. The mitral ViV implant in a failed bioprosthesis is an effective procedure. This possibility might alter prosthesis selection in the future initial surgical prosthesis selection, favouring bioprostheses. Further large trials should explore its safety.

  3. Tricuspid valved stent implantation: novel stent with a self-expandable super-absorbent polymer.

    PubMed

    Iino, Kenji; Lozonschi, Lucian; Metzner, Anja; Marczynski-Bühlow, Martin; Renner, Jochen; Cremer, Jochen; Lutter, Georg

    2011-08-01

    Trans-catheter aortic and pulmonary valve replacement procedures can result in favorable outcomes in selected patients. The aim of this study was to investigate the functioning of a novel self-expanding valved stent with super-absorbent polymer (SAP) for minimally invasive replacement of the tricuspid valve. A newly designed nitinol stent with SAP was specially designed for the tricuspid annulus. This device was composed of right atrial anchoring elements, a left ventricular tubular stent, and a trileaflet bovine pericardial valve. The stent was coated with a waterproof material, and a pouch containing SAP for minimizing paravalvular leakage was placed beneath the atrial element. Seven pigs underwent minimally invasive off-pump tricuspid valved stent implantation. This was performed through a lower ministernotomy using a transventricular approach under transesophageal echocardiographic guidance. After 1 and 6h, a complete echocardiographic evaluation and hemodynamics (Swan-Ganz catheter) were performed. Six of seven pigs exhibited normal hemodynamics immediately after tricuspid valved stent implantation and maintained stability for the entire period of monitoring. In one pig, a part of the atrial stent elements was deployed into the right ventricle, leading to significant paravalvular leakage, and died very soon. All subsequent animals survived with good results in the observation period. Accurate positioning of the valved stent was documented in six of seven pigs. SAP expanded and filled the gap between the stent and the native annulus in all animals. Mild paravalvular leakage was found in two of the six animals. Nevertheless, the observed leakage decreased to trace levels 6h after implantation. In the additional four pigs, only trace tricuspid regurgitation was revealed. No right ventricular outflow tract obstruction was detected. Trans-apical off-pump tricuspid valved stent implantation is feasible in an acute experimental setting, and SAP may help to reduce

  4. The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial

    PubMed Central

    2013-01-01

    Background Degenerative aortic valve (AV) stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR) has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI) can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting. Methods/Design This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA) (intervention group) compared with SAVR (control group) in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR). Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012. Discussion The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis. Trial registration ClinicalTrials.gov: NCT01057173 PMID:23302232

  5. Transcatheter aortic valve implantation in patients with severe aortic valve stenosis and large aortic annulus, using the self-expanding 31-mm Medtronic CoreValve prosthesis: first clinical experience.

    PubMed

    Nijhoff, Freek; Agostoni, Pierfrancesco; Amrane, Hafid; Latib, Azeem; Testa, Luca; Oreglia, Jacopo A; De Marco, Federico; Samim, Mariam; Bedogni, Francesco; Maisano, Francesco; Bruschi, Giuseppe; Colombo, Antonio; Van Boven, Ad J; Stella, Pieter R

    2014-08-01

    With the introduction of the 31-mm Medtronic CoreValve prosthesis, patients with large aortic annulus have become eligible for transcatheter aortic valve implantation. The aim of this study was to evaluate the feasibility, efficacy, and safety of transcatheter aortic valve implantation using the 31-mm Medtronic CoreValve in patients with severe aortic valve stenosis and large aortic annulus. Five institutions in the Netherlands and Italy participated in a retrospective multicenter registry. Clinical, procedural, and imaging data of patients treated with the 31-mm Medtronic CoreValve were retrospectively collected in accordance with the Valve Academic Research Consortium-2 criteria. Between August 2011 and November 2012, 47 patients (44 men, mean age 77.6 ± 8.9 years) received the 31-mm Medtronic CoreValve prosthesis for severe aortic stenosis. Device success (correct positioning of a single valve with intended performance and no all-cause 30-day mortality) was achieved in 31 patients (66.0%). Reasons for failing the device success criteria were significant prosthetic aortic regurgitation in 3 patients (6.4%), second valve implantation in 10 patients (21.2%) (8 cases of malpositioning with high-grade aortic regurgitation, 1 acute valve dislocation, and 1 delayed valve dislocation), 1 of whom died intrahospital, and in-hospital mortality in a further 3 patients (6.4%). Peak and mean transaortic gradients decreased significantly (P < .01). The rate of new pacemaker implantations was 41.7%. In this retrospective multicenter registry, transcatheter treatment of severe aortic valve stenosis with the 31-mm Medtronic CoreValve seemed to be challenging, even in experienced hands. If the prosthesis is properly implanted, it offers adequate valve hemodynamics and proper functioning. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  6. Biocompatibility and Pharmacokinetic Analysis of an Intracameral Polycaprolactone Drug Delivery Implant for Glaucoma

    PubMed Central

    Kim, Jean; Kudisch, Max; Mudumba, Sri; Asada, Hiroyuki; Aya-Shibuya, Eri; Bhisitkul, Robert B.; Desai, Tejal A.

    2016-01-01

    Purpose We developed polycaprolactone (PCL) implants that achieve zero-order release of a proprietary ocular hypotensive agent (DE-117) over 6 months. Methods The release rates of DE-117–loaded PCL devices were tuned based on an established predictive model and confirmed by in vitro release studies. Devices containing DE-117 and empty devices were implanted intracamerally in normotensive rabbits for up to 8 weeks' duration. Devices were retrieved after rabbits were euthanized and evaluated for tissue adherence. The drug remaining in each device was analyzed by high performance liquid chromatography. Drug distribution in ocular tissues was measured by liquid chromatography coupled with a tandem mass spectrometry (LC/MS/MS). Results In vitro release of DE-117 showed zero-order release with a release rate of 0.5 μg/day over 6 months. Implantation in rabbit eyes demonstrated that the devices were well tolerated in the intracameral space. Quantification of DE-117 and hDE-117 (the hydrolyzed active form of DE-117) in ocular tissues (cornea, iris-ciliary body, aqueous humor, and vitreous humor) indicated sustained release of DE-117 and its conversion to hDE-117 when released from the device. Analysis of drug remaining in the device found that concentration of hDE-117 was below the limit of detection, indicating the encapsulated drug was protected from hydrolysis in the device. Conclusions Proof-of-concept PCL drug delivery devices containing DE-117 show promise as a long-term glaucoma treatment based on their zero-order drug release profile in vitro, biocompatibility in vivo, and effective distribution of released drug in relevant ocular tissues. PMID:27556217

  7. Deep Sclerectomy with Nonabsorbable Implant (T-Flux) in Patients with Pseudoexfoliation Glaucoma

    PubMed Central

    Vranova, Jana; Kuchynka, Pavel; Pokorna, Jitka

    2017-01-01

    Purpose. To evaluate the effectiveness of deep sclerectomy with T-flux implant (DS T-flux) in patients with pseudoexfoliation glaucoma (PExG). Methods. 20 eyes of 18 patients with medically uncontrolled PExG have undergone DS T-flux implantation. Postoperatively we evaluated the IOP values and the frequency of complications. The minimum follow-up time was 12 months (20 eyes) and the maximum 24 months (10 eyes). Results. The mean preoperative IOP was 36.8 ± 8.7 mmHg. The IOP significantly decreased throughout all postoperative periods (P < 0.05) and reached 1 day after surgery 11.45 ± 6.6 mmHg; 3 months 13.45 ± 3.6 mmHg; 12 months 14 ± 2.8 mmHg; and 24 months 14.80 ± 2.4 mmHg. Complete success rate, defined as IOP ≤ 18 mmHg without medication, was 85% (17/20 eyes) at 12 months. Qualified success rate, defined as IOP ≤ 18 mmHg with or without medication, was 100% (20/20 eyes). The most frequent postoperative complications were mild hyphaema (9 patients, 45%), choroidal detachment (3 patients, 15%), and hypotony—IOP < 5 mmHg (2 patients, 10%). Conclusions. DS with T-flux implant is a safe and effective surgical treatment method for medically uncontrolled PExG. The number of complications is low. PMID:28182090

  8. Percutaneous pulmonary valve implantation in left pulmonary artery branch in a patient with a functional single lung.

    PubMed

    Qureshi, Athar M; Krasuski, Richard A; Prieto, Lourdes R

    2012-09-01

    Percutaneous pulmonary valve technology has had a great impact on patients with congenital and acquired heart disease. In some patients, implantation of a percutaneous pulmonary valve may not be possible due to the morphology of the existing right ventricular outflow tract. In this report, we describe implantation of a Melody transcatheter pulmonary valve in the left pulmonary artery in a patient with acquired right pulmonary artery occlusion and a large right ventricular outflow tract.

  9. Transhepatic implant of a trimmed Melody™ valved stent in tricuspid position in a 1-year-old infant.

    PubMed

    Cools, Bjorn; Rega, Filip; Gewillig, Marc

    2017-02-15

    Percutaneous valved stent implantation is precluded in small infants because large delivery sheaths and large devices. We describe a procedure in a 1-year-old boy in whom a 19 mm Epic™ valve in tricuspid position had become dysfunctional. As the internal diameter of the prosthetic valve was about 16 mm, the only available valve was the Melody™ valved stent. Technical modifications were required to address issues like venous access, the bulky delivery system, and the length of the valved stent. The Melody™ valved stent was surgically trimmed and mounted on a 16 mm Tyshak balloon, access was provided transhepatically through a short 18 Fr sheath. After deployment, the intrahepatic route was sealed with two vascular plugs (8 and 10 mm) in tandem. The procedure was uncomplicated with perfect valve function 18 months after implant. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  10. Association of aortic valve calcification severity with the degree of aortic regurgitation after transcatheter aortic valve implantation.

    PubMed

    Koos, Ralf; Mahnken, Andreas Horst; Dohmen, Guido; Brehmer, Kathrin; Günther, Rolf W; Autschbach, Rüdiger; Marx, Nikolaus; Hoffmann, Rainer

    2011-07-15

    This study sought to examine a possible relationship between the severity of aortic valve calcification (AVC), the distribution of AVC and the degree of aortic valve regurgitation (AR) after transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS). 57 patients (22 men, 81 ± 5 years) with symptomatic AS and with a logistic EuroSCORE of 24 ± 12 were included. 38 patients (67%) received a third (18F)-generation CoreValve® aortic valve prosthesis, in 19 patients (33%) an Edwards SAPIEN™ prosthesis was implanted. Prior to TAVI dual-source computed tomography for assessment of AVC was performed. To determine the distribution of AVC the percentage of the calcium load of the most severely calcified cusp was calculated. After TAVI the degree of AR was determined by angiography and echocardiography. The severity of AR after TAVI was related to the severity and distribution of AVC. There was no association between the distribution of AVC and the degree of paravalvular AR after TAVI as assessed by angiography (r = -0.02, p = 0.88). Agatston AVC scores were significantly higher in patients with AR grade ≥ 3 (5055 ± 1753, n = 3) than in patients with AR grade < 3 (1723 ± 967, p = 0.03, n = 54). Agatston AVC scores > 3000 were associated with a relevant paravalvular AR and showed a trend for increased need for second manoeuvres. There was a significant correlation between the severity of AVC and the degree of AR after AVR (r = 0.50, p < 0.001). Patients with severe AVC have an increased risk for a relevant AR after TAVI as well as a trend for increased need for additional procedures. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  11. Comparison of Systematic Predilation, Selective Predilation, and Direct Transcatheter Aortic Valve Implantation With the SAPIEN S3 Valve.

    PubMed

    Spaziano, Marco; Sawaya, Fadi; Chevalier, Bernard; Roy, Andrew; Neylon, Antoinette; Garot, Philippe; Hovasse, Thomas; Benamer, Hakim; Romano, Mauro; Unterseeh, Thierry; Bouvier, Erik; Cormier, Bertrand; Morice, Marie-Claude; Lefèvre, Thierry

    2017-02-01

    Despite previously described feasibility, direct transcatheter aortic valve implantation (TAVI) with the Edwards SAPIEN S3 device (S3-THV) (Edwards Lifesciences, Irvine, CA) has not been compared with either a systematic or a selective predilation approach. Patients undergoing predilation were divided into a systematic group (regardless of anatomic features) and a selective group (in the context of high valvular calcium burden). Both groups were matched in a 2:1 fashion to patients who underwent direct TAVI. Outcomes were assessed according to Valve Academic Research Consortium 2 (VARC-2) criteria. Two hundred eighty-one patients underwent TAVI with the S3-THV in our centre. Of these patients, 58 underwent predilation before device implantation (systematic, n = 26; selective, n = 32). Procedural success was achieved in all patients. Patients in the selective predilation group had severe valve calcification volume-more than double that of the systematic group (445 ± 306 mm(3) vs 970 ± 578 mm(3), respectively; P < 0.0001). There was a trend for less dilation after the procedure in the systematic group compared with the selective group (4% vs 19%, respectively; P = 0.09). Device malposition necessitating a second device to be implanted occurred in 3 cases of direct TAVI (5%) and in none of the patients undergoing predilation (P = not significant). Thirty-day and 1-year mortality rates were similar between the patients who underwent direct TAVI and their predilation counterparts. In patients with a moderate aortic valve calcification burden, direct TAVI appears to be feasible and safe. In those with high calcium burden, predilation should be considered after taking into account individual risk profiles. Copyright © 2016 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

  12. Phacoemulsification combined with deep sclerectomy augmented with mitomycin and amniotic membrane implantation in chronic primary open angle glaucoma with cataract

    PubMed Central

    Helmy, Hazem

    2016-01-01

    Objective The aim of this study was to determine the safety and efficacy of combined phacoemulsification plus Intraocular lens (IOL) implantation with deep sclerectomy augmented with mitomycin C (MMC) and sub-flap implantation of amniotic membrane for the management of uncontrolled, chronic, primary open-angle glaucoma patients. Methods This prospective study included 41 patients with chronic, primary, open-angle glaucoma and cataract uncontrolled with medical treatment who underwent combined phacoemulsification augmented with mitomycin C (MMC) application and amniotic membrane implantation under the scleral flap. Intraocular pressure (IOP), visual acuity, glaucoma medications, stabilization of visual field, complications, and viability of the success rate were assessed a 36-month follow-up period. Results The mean age of cases was 54.8 ± 5.3 years. Sixty-one percent of cases were males, and 39% were females. The mean IOP decreased from 23.8 ± 1.8 mmHg preoperatively to 16.8 ± 2.3 mmHg postoperatively. The overall success rate was 97.5, 95, and 92.7% in the first, second, and third year, respectively. The overall success rate was 90% in the first year, but that decreased to 85.3 and 78% in the second and third year, respectively. Qualified success was 7.5, 10, and 14.7% in the first, second, and third year, respectively. Failure was recorded as 2.5, 5, and 7.3% in the first, second, and third year, respectively. IOP reduction was sustained through the follow-up period. Visual acuity improved from 0.13 ± 0.06 to 0.9 ± 0.07 (p < 0.001). The visual field improved significantly in the first assessment, from 14.0 ± 2.7 preoperatively to 12.6 ± 2.6 at three months postoperatively (p < 0.001), after which it became stable for the remainder of the follow-up period. One hundred percent of cases were on three anti-glaucoma drugs preoperatively, while postoperatively, 12.2% were on three drugs, 4.2% were on two drugs, and 82.9% were controlled without anti-glaucoma

  13. Perceval S sutureless aortic valve prosthesis implantation via a right anterior minithoracotomy.

    PubMed

    Gilmanov, Daniyar; Farneti, Pier Andrea; Miceli, Antonio; Bevilacqua, Stefano; Glauber, Mattia

    2013-01-01

    The rapid development and refinement of techniques over the past decade have led to the realization that a minimally invasive approach enables aortic valve surgery to be performed with results, at the very least, equivalent to those of traditional (open) valve surgery done in experienced centres. Minimally invasive aortic valve replacement (MIAVR) has now evolved into a safe, efficient treatment option providing greater patient satisfaction and fewer complications. For rapidly ageing population of industrialized countries, aortic valve replacement (AVR) has become the most frequent heart valve surgery. However, transcatheter aortic valve implantation techniques and sutureless aortic valve prostheses recently introduced into clinical practice are challenging now the results of MIAVR in certain high surgical risk patients. Right anterior minithoracotomy results in excellent exposure and a safe conduct of AVR. The minithoracotomy is performed via the second intercostal space with a 6-7 cm long skin incision and no bone transection. After direct aortic and peripheral venous cannulation, aortic valve is exposed in a conventional manner, and further conduct of the intervention is not different from the sutureless AVR in median sternotomy. Herein, we discuss the indications, surgical technique and initial results of sutureless AVR through right anterior minithoracotomy.

  14. Pacemaker dependency after transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System.

    PubMed

    van der Boon, Robert M A; Van Mieghem, Nicolas M; Theuns, Dominic A; Nuis, Rutger-Jan; Nauta, Sjoerd T; Serruys, Patrick W; Jordaens, Luc; van Domburg, Ron T; de Jaegere, Peter P T

    2013-09-30

    To determine pacemaker (PM) dependency at follow-up visit in patients who underwent new permanent pacemaker implantation (PPI) following transcatheter aortic valve implantation (TAVI). Single center prospective observational study including 167 patients without previous PM implantation who underwent TAVI with the self-expanding Medtronic CoreValve System (MCS) between November 2005 and February 2011. PM dependency was defined by the presence of a high degree atrioventricular block (HDAVB; second [AV2] and third degree [AV3B]), or a slow (<30 bpm) or absent ventricular escape rhythm during follow-up PM interrogation. A total of 36 patients (21.6%) received a new PM following TAVI. The indication for PM was AV2B (n=2, 5.6%), AV3B (n=28, 77.8%), postoperative symptomatic bradycardia (n=3, 8.3%), brady-tachy syndrome (n=1, 2.8%), atrial fibrilation with slow response (n=1, 2.8%) and left bundle branch block (n=1, 2.8%). Long term follow-up was complete for all patients and ranged from 1 to 40 months (median (IQR): 11.5 (5.0-18.0 months). Of those patients with a HDAVB, 16 out of the 30 patients (53.3%) were PM independent at follow-up visit (complete or partial resolution of the AV conduction abnormality). Overall, 20 out of the 36 patients (55.6%) who received a new PM following TAVI were PM independent at follow-up. Partial and even complete resolution of peri-operative AV conduction abnormalities after MCS valve implantation occurred in more than half of the patients. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  15. Percutaneous implantation of the first repositionable aortic valve prosthesis in a patient with severe aortic stenosis.

    PubMed

    Buellesfeld, Lutz; Gerckens, Ulrich; Grube, Eberhard

    2008-04-01

    Percutaneous aortic valve replacement is a new less-invasive alternative for high-risk surgical candidates with aortic stenosis. However, the clinical experience is still limited, and the currently available 'first-generation devices' revealed technical shortcomings, such as lack of repositionability and presence of paravalvular leakages. We report the first-in-man experience with the new self-expanding Lotus Valve prosthesis composed of a nitinol frame with implemented bovine pericardial leaflets which is designed to address these issues, being repositionable and covered by a flexible membrane to seal paravalvular gaps. We implanted this prosthesis in a 93-year old patient presenting with severe symptomatic aortic stenosis (valve area: 0.6 cm(2)). Surgical valve replacement had been declined due to comorbidities. We used a retrograde approach for insertion of the 21-French Lotus catheter loaded with the valve prosthesis via surgical cut-down to the external iliac artery. Positioning of the valve was guided by transesophageal echo and supra-aortic angiograms. The prosthesis was successfully inserted and deployed within the calcified native valve. Echocardiography immediately after device deployment showed a significant reduction of the transaortic mean pressure gradient (32 to 9 mmHg; final valve area 1.7 cm(2)) without evidence of residual aortic regurgitation. The postprocedural clinical status improved from NYHA-IV to NYHA-II. These results remained unchanged up to the 3 month follow-up. Successful percutaneous aortic valve replacement can be performed using the new self-expanding and repositionable Lotus valve for treatment of high-risk patients with aortic valve stenosis. Further studies are mandatory to assess device safety and efficacy in larger patient populations. Copyright 2008 Wiley-Liss, Inc.

  16. Thrombocytopenia following implantation of the stentless biological sorin freedom SOLO valve.

    PubMed

    Gersak, Borut; Gartner, Urska; Antonic, Miha

    2011-07-01

    Stentless biological valves have proven advantages in hemodynamic performance and left ventricular function compared to stented biological valves. Following a marked postoperative fall in the platelet count of patients after implantation of the Freedom SOLO valve, the study aim was to confirm clinical observations that this effect was more severe in patients receiving Freedom SOLO valves than in those receiving St. Jude Medical (SJM) mechanical aortic valves. Preoperative and postoperative platelet counts were compared in two groups of patients who underwent aortic valve replacement (AVR) without any concomitant procedures between January and December 2007. Patients received either a Freedom SOLO valve (n = 28) or a SJM mechanical valve (n = 41). Mean values of platelet counts were compared using three multiple linear regression models. Platelet counts were significantly lower in the Freedom SOLO group than in the SJM group from the first postoperative day (POD 1) up to POD 6 (p <0.001). In three patients of the Freedom SOLO group the platelet count fell below 30x10(9)/l, while the lowest level in the SJM group was 75x10(9)/l. Based on multiple linear regression models, the type of valve implanted had a statistically significant influence on postoperative platelet counts on POD 1, POD 3, and POD 5 (p <0.001). Whilst the reason for this phenomenon is unknown, the use of consistent monitoring should prevent severe falls in platelet count from becoming dangerous for the patient. Further studies are required to investigate the phenomenon since, despite a shorter cardiopulmonary bypass time, the fall in platelet count was more profound in the Freedom SOLO group.

  17. Automated 3-dimensional aortic annular assessment by multidetector computed tomography in transcatheter aortic valve implantation.

    PubMed

    Watanabe, Yusuke; Morice, Marie-Claude; Bouvier, Erik; Leong, Tora; Hayashida, Kentaro; Lefèvre, Thierry; Hovasse, Thomas; Romano, Mauro; Chevalier, Bernard; Donzeau-Gouge, Patrick; Farge, Arnaud; Cormier, Bertrand; Garot, Philippe

    2013-09-01

    This study sought to evaluate the accuracy, reproducibility, and predictive value for post-procedural aortic regurgitation (AR) of an automated multidetector computed tomography (MDCT) post-processing imaging software, 3mensio Valves (version 5.1.sp1, 3mensio Medical Imaging BV, the Netherlands), in the assessment of patients undergoing transcatheter aortic valve implantation (TAVI). Accurate pre-operative aortic annulus measurements are crucial for patients undergoing TAVI. One hundred five patients undergoing MDCT screening before TAVI were evaluated. Aortic annular measurement was compared between automated 3mensio Valves software and manual data post-processing software on a dedicated workstation; we analyzed the discrimination value of annulus measurement for post-procedural AR in 44 recipients of a self-expanding valve. The automated 3mensio Valves software showed good concordance with manual MDCT measurements as demonstrated by Bland-Altman analysis. The automated software provided equally good reproducibility as manual measurement, especially for measurement of aortic annulus area (intraobserver intraclass correlation coefficients 0.98 vs. 0.97, interobserver 0.98 vs. 0.95). In 44 patients after implantation of a self-expanding valve, the valve diameter/CT-measured geometric mean annulus diameter ratio by automated 3mensio Valves software showed moderate and better discrimination ability in predicting post-procedural AR compared with manual measurement (p = 0.12, area under the curve 0.77, 95% confidence interval: 0.63 to 0.91, area under the curve 0.68, 95% confidence interval: 0.50 to 0.86, respectively). The automated 3mensio Valves software demonstrated reliable, reproducible aortic annulus measurement and better predictive value for post-procedural AR, suggesting important clinical implications for pre-operative assessment of patients undergoing TAVI. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights

  18. Multislice computed tomography-based prediction of the implantation plane in transcatheter aortic valve implantation: determination of the line of perpendicularity and the implanter's views.

    PubMed

    Holzamer, Andreas; Sitka, Emanuel; Hengstenberg, Christian; Schmid, Christof; Debl, Kurt; Maier, Lars; Camboni, Daniele; Husser, Oliver; Hilker, Michael

    2015-12-01

    We demonstrate a multislice computed tomography (MSCT)-based method to calculate the prediction of the so-called 'line of perpendicularity' (LOP) and the 'implanter's views' (IVs) for transcatheter aortic valve implantation (TAVI) procedures. The LOP represents all possible angiographic angulations that result in an orthogonal view to the aortic annulus plane. The IVs allow visual confirmation of correct implantation planes, and are crucial for the commissural aligned implantation of second-generation TAVI prostheses. The LOP and IVs of 335 concomitant patients were prospectively analysed using multiple plane reconstruction (MPR) of the patient's MSCT scans. Exclusion criteria were bicuspid valves (n = 18) and valve-in-valve TAVI (n = 15). In the MPRs, the aortic cusps' lowest points were marked. With the marker's three-dimensional coordinates, the graph of the LOP with the IVs was calculated and plotted using vector mathematics. In the last 244 cases, the IV with the right coronary cusp in front was chosen for the first aortic root angiogram of the TAVI procedure. The finally used angulation was confirmed by aortic angiogram prior to the valve implantation. Solid angle differences that show the combined left anterior oblique/right anterior oblique and cranio/caudal movement of the C-arm allow quantification of corrections as well as demonstrate interindividual variations. There is a broad interindividual variation of the aortic valve's topology with solid angle variations of up to 74°. The shape of the LOPs is extremely varying, especially regarding the slope of the curve that indicates differences in valve orientations. Among the 244 patients for whom we used the prediction for the procedure, the first angiogram was considered perfect for implantation without further corrections in 97% (n = 237) of them. In case of the 7 patients with subsequent corrections, the mean solid angle between the prediction and the final angiogram prior to implantation was 6.2° (±5

  19. Replacement of the left-side valves of an implanted total artificial heart.

    PubMed

    Kamohara, Keiji; Weber, Stephan; Klatte, Ryan S; Ootaki, Yoshio; Akiyama, Masatoshi; Kopcak, Michael W; Luangphakdy, Viviane; Flick, Christine R; Chen, Ji-Feng; Navia, Jose L; Smith, William A; Fukamachi, Kiyotaka

    2006-01-01

    The MagScrew total artificial heart (TAH) is under development. Despite its anticipated durability and reliability, the possibility of a bioprosthetic valve malfunction exists. As a result, the potential for valve replacement surgery, instead of device replacement, would be desirable after a TAH implant. In two of our 90-day animal experiments, we successfully replaced the left-side valves through a left thoracotomy opposite to the right-sided incision site for the initial TAH implant. The results of these cases suggest that the left-side valves could also be replaced through a left thoracotomy approach in humans. To confirm the ability to access the left-side valves in humans, four human cadaver studies were performed with the use of a mock pump designed for human application. This report describes the operative techniques for left-side valve replacement in animals and discusses the advantages of a left thoracotomy in clinical situations, based on results from the human cadaver studies.

  20. How to Perform Transcaval Access and Closure for Transcatheter Aortic Valve Implantation

    PubMed Central

    Lederman, Robert J.; Babaliaros, Vasilis C.; Greenbaum, Adam B.

    2016-01-01

    Transcaval, or caval-aortic, access is a promising approach for fully percutaneous trans-catheter aortic valve implantation in patients without good conventional access options. This tutorial review provides step-by-step guidance to planning and executing the procedure, along with approaches to remedy complications. PMID:26356244

  1. Recurrent angina from chronic coronary obstruction following transcatheter aortic valve implantation

    PubMed Central

    Kabach, Mohamad; Alrifai, Abdulah; Furlan, Stefanie; Alahdab, Fares

    2016-01-01

    Severe aortic stenosis and coronary artery disease often coexist. Coronary angiography (CA) and percutaneous coronary intervention (PCI) can be challenging in patients with prior transcatheter aortic valve implantation (TAVI). Depending on the type and position of the implanted valve, the procedure can be challenging or even unfeasible due to interference of diagnostic catheters and valve parts. The correct positioning of the TAVI prosthesis during TAVI was identified as an important factor with regard to the feasibility of subsequent CA or PCI. TAVI has been also associated with vascular, cerebrovascular and conduction complication. One is rare but life-threatening complication, coronary ostial obstruction. Coronary ostial obstruction can develop, especially if a safety check of more than 10 mm of coronary ostial height is not taken into consideration during TAVI. This complication can cause recurrent episodes of angina and can severely worsen the patient's cardiac systolic function. PMID:27390671

  2. Transcatheter aortic valve implantation with the NVT Allegra transcatheter heart valve system: first-in-human experience with a novel self-expanding transcatheter heart valve.

    PubMed

    Wenaweser, Peter; Stortecky, Stefan; Schütz, Torsten; Praz, Fabien; Gloekler, Steffen; Windecker, Stephan; Elsässer, Albrecht

    2016-05-17

    We aimed to demonstrate the feasibility and investigate the safety of a novel, self-expanding trans-catheter heart valve in a selected patient population with severe aortic stenosis. Between January and September 2013, a total of 21 patients with symptomatic severe aortic stenosis were eligible for transcatheter aortic valve implantation (TAVI) with the self-expanding NVT Allegra bioprosthesis (New Valve Technology, Hechingen, Germany) at two cardiovascular centres. Patients were elderly (age 83.8±4 years), predominantly female (95.2%), and all were considered to be at prohibitive risk for surgical aortic valve replacement (logistic EuroSCORE 30.4±11%). Procedural and device success was achieved in 95.2% and 85.7%, respectively. Echocardiographic assessment at discharge showed favourable haemodynamic results with a reduction of the mean transvalvular aortic gradient from 48.0±21 mmHg to 8.9±3 mmHg. In the majority of patients (90.5%), none or trace aortic regurgitation was recorded. Permanent pacemaker implantation was required in 23.8% of patients within the first 30 days of follow-up. Apart from one procedural death, no other serious adverse events were observed during the periprocedural period. TAVI with the NVT Allegra system was highly effective in alleviating symptoms and reducing NYHA functional class at 30-day follow-up. The first-in-human experience with the NVT Allegra transcatheter heart valve prosthesis was associated with a high rate of procedural success. Furthermore, the NVT Allegra bioprosthesis was able to achieve favourable haemodynamic results and effectively alleviate symptoms at 30-day follow-up. The larger, multicentre NAUTILUS study will provide further information on the safety and efficacy of this novel, second-generation transcatheter aortic bioprosthesis.

  3. The incidence of transcatheter aortic valve implantation-related heart block in self-expandable Medtronic CoreValve and balloon-expandable Edwards valves.

    PubMed

    Liang, Michael; Devlin, Gerard; Pasupati, Sanjeevan

    2012-04-01

    Transcatheter aortic valve implantation (TAVI) has been performed at Waikato Hospital for high-risk severe symptomatic aortic stenosis patients who are considered unsuitable for conventional cardiac surgery for the last 3 years. The Medtronic CoreValve (MCV) is a self-expandable device, while the Edwards SAPIEN valve (EV) requires the use of a balloon to expand the device. This observational study reports and compares the incidence of heart block in both Medtronic and Edwards transcatheter valves. All patients who underwent TAVI between the periods of 28 August 2008 and 27 July 2011 were included in this study. Preprocedure and daily postprocedure until discharge electrocardiograms (ECG) were obtained prospectively. New onsets of significant atrioventricular (AV) and bundle branch blocks were recorded. Patients with existing pacemaker and those who did not survive the procedure were excluded. Sixty patients underwent TAVI during the study period, of whom 40 (67%) and 20 (33%) patients had MCV and EV implanted, respectively. Seven patients were excluded from the analysis; 38 MCV and 15 EV patients fulfilled the criteria for analysis. Mean age was 80 ± 7 years, 57% were male. Five patients (9%) required permanent pacemaker (PPM) implantation, which occurred exclusively post MCV TAVI (MCV vs EV: 13% vs 0%, respectively; P=.02). The indications of PPM were complete heart block in 3 patients (60%), Mobitz II second-degree heart block in 1 patient (20%), and symptomatic sick sinus syndrome in 1 patient (20%). The incidence of left bundle branch block (LBBB) was increased after the TAVI procedure and was more significant with MCV implants (MCV vs EV: 42% vs 8%, respectively; P<.01). Of note, 2 of the 5 patients (40%) with pre-existing right bundle branch block (RBBB) who underwent TAVI required PPM (P=.01). MCV implantation is associated with a higher incidence of significant AV block requiring PPM implantation and LBBB compared to EV. The overall rate of PPM requirement

  4. Pseudomonas aeruginosa Infective Endocarditis Following Aortic Valve Implantation: A Note of Caution

    PubMed Central

    Dapás, Juan Ignacio; Rivero, Cynthia; Burgos, Pablo; Vila, Andrea

    2016-01-01

    Transcatheter aortic valve implantation (TAVI) is an alternative treatment for severe aortic valve stenosis (AS) in patients with prohibitive risk for surgical aortic valve replacement (SAVR). Prosthetic valve endocarditis (PVE) is a rare complication of this relatively novel procedure and current guidelines do not include specific recommendations for its treatment. We report a case of PVE due to Pseudomonas aeruginosa after TAVI that required SAVR, with successful outcome. PVE usually occurs during the first year after TAVI and entails a high mortality risk because patients eligible for this min-imally invasive procedure are fragile (i.e. advanced age and/or severe comorbidities). Additionally, clinical presentation may be atypical or subtle and transesophageal echocardiogram (TEE) may not be conclusive, which delays diagnosis and treatment worsening the prognosis. This case highlights that open SAVR might be ultimately indicated as part of treatment for TAVI-PVE despite a high-risk surgery score. PMID:27014375

  5. Transapical sutureless aortic valve implantation under magnetic resonance imaging guidance: Acute and short-term results.

    PubMed

    Horvath, Keith A; Mazilu, Dumitru; Cai, Junfeng; Kindzelski, Bogdan; Li, Ming

    2015-04-01

    Despite the increasing success and applicability of transcatheter aortic valve replacement, 2 critical issues remain: the durability of the valves, and the ideal imaging to aid implantation. This study was designed to investigate the transapical implantation of a device of known durability using real-time magnetic resonance imaging (MRI) guidance. A sutureless aortic valve was used that employs a self-expanding nitinol stent and is amenable to transapical delivery. MRI (1.5-T) was used to identify the anatomic landmarks in 60-kg Yucatan swine. Prostheses were loaded into an MRI-compatible delivery device with an active guidewire to enhance visualization. A series of acute feasibility experiments were conducted (n = 10). Additional animals (n = 6) were allowed to survive and had follow-up MRI scans and echocardiography at 90 days postoperatively. Postmortem gross examination was performed. The valve was MRI compatible and created no significant MRI artifacts. The 3 commissural struts were visible on short-axis view; therefore, coronary ostia obstruction was easily avoided. The average implantation time was 65 seconds. Final results demonstrated stability of the implants with preservation of myocardial perfusion and function over 90 days: the ejection fraction was 48% ± 15%; the peak gradient was 17.3 ± 11.3 mm Hg; the mean gradient was 9.8 ± 7.2 mm Hg. Mild aortic regurgitation was seen in 4 cases, trace in 1 case, and a severe central jet in 1 case. Prosthesis positioning was evaluated during gross examination. We demonstrated that a sutureless aortic valve can be safely and expeditiously implanted through a transapical approach under real-time MRI guidance. Postimplantation results showed a well-functioning prosthesis, with minimal regurgitation, and stability over time. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  6. Transapical Perceval S Sutureless Aortic Valve Implantation under MRI guidance: Acute and Short-term Results

    PubMed Central

    Horvath, Keith A.; Mazilu, Dumitru; Cai, Junfeng; Kindzelski, Bogdan; Li, Ming

    2014-01-01

    Objectives Despite the increasing success and applicability of TAVR, two critical issues remain unanswered; the durability of the valves and the ideal imaging to aid implantation. This study was designed to investigate the transapical implantation of a device of known durability using rtMRI guidance. Methods The Sorin Perceval S valve employs a self-expanding nitinol stent and is amenable to transapical delivery. A 1.5T MRI was used to identify the anatomic landmarks in 60kg Yucatan swine. Prostheses were loaded into an MRI compatible delivery device with an active guidewire to enhance visualization. A series of acute feasibility experiments were conducted (n=10). Additional animals (n=6) were allowed to survive and had follow-up MRI scans and echocardiography at 90-days postoperatively. Postmortem gross examination was then performed. Results The Perceval S valve is MRI compatible and creates no significant MRI artifacts. The three commissural struts were visible on short axis view, therefore coronary ostia obstruction was easily avoided. The average implantation time was 65 seconds. Final results demonstrated stability of the implants with preservation of myocardial perfusion and function over 90 days: EF was 48±15%; peak gradient was 17.3±11.3 mm Hg; mean gradient was 9.8±7.2 mm Hg. Mild aortic regurgitation was seen in 4 cases, trace in 1 case, and severe central jet in 1 case. Prosthesis positioning was evaluated during gross examination. Conclusions We demonstrated that the Perceval S valve can be safely and expeditiously implanted through a transapical approach under rtMRI guidance. Post-implantation results showed a well-functioning prosthesis with minimal regurgitation and stability over time. PMID:25466854

  7. Long-term efficacy and safety of ExPress implantation for treatment of open angle glaucoma

    PubMed Central

    Lee, Geun Young; Lee, Chong Eun; Lee, Kyoo Won; Seo, Sam

    2017-01-01

    AIM To compare the long-term efficacy and safety of ExPress implantation and standard trabeculectomy in patients with primary open angle glaucoma (POAG). METHODS In this retrospective study, we compared 17 eyes treated by ExPress implantation with 23 eyes treated by trabeculectomy. Efficacy was assessed according to the relevant intraocular pressure (IOP) values and success rates during the first year of follow-up. Postoperative corneal endothelial cell loss was also compared. RESULTS The number of antiglaucoma medications and the IOP reduction were similar between the 2 groups during the follow-up period. Although the mean IOP was similar, the IOP-fluctuation rate during the early postoperative period was significantly lower in the ExPress group than in the trabeculectomy group (P=0.038). A Kaplan-Meier survival curve analysis showed no significant success-rate difference between the groups (P=0.810). The corneal endothelial cell loss rate, moreover, was significantly lower in the ExPress group (P=0.05). CONCLUSION ExPress implantation compared with trabeculectomy showed similar IOP-reduction and success rates along with lower IOP fluctuation and endothelial cell loss rates. For this reason, it can be considered to be the treatment of choice for patients with advanced glaucoma or low corneal endothelial cell density. PMID:28944196

  8. Transcatheter Aortic Valve Implantation Experience with SAPIEN 3.

    PubMed

    Ohno, Y; Tamburino, C; Barbanti, M

    2015-06-01

    Based on randomized trials with first generation devices, transcatheter aortic valve replacement (TAVI) has been included into the treatment strategy for high-risk and inoperable patients with severe aortic stenosis. Procedural complications remain a concern with TAVI, including stroke, vascular complications, paravalvular leak (PVL) and conduction disturbances. Addressing these limitations will support TAVI use in lower risk populations. This review discussed features and most recent clinical evidence of the new balloon-expandable THV (SAPIEN 3, Edwards Lifescience, Irvine, CA, USA).

  9. Successful transfemoral aortic valve implantation through aortic stent graft after endovascular repair of abdominal aortic aneurysm.

    PubMed

    Kawashima, Hideyuki; Watanabe, Yusuke; Kozuma, Ken

    2017-04-01

    The patient was a 91-year-old woman presenting with severe aortic valve stenosis. Pre-procedural computed tomography scan revealed a 45-mm abdominal aortic aneurysm (AAA). Transfemoral transcatheter aortic valve implantation (TF-TAVI) was performed after endovascular aortic repair (EVAR) of the AAA. The 23-mm Edwards Sapien XT system passed through the aortic stent graft smoothly. This is the first case report showing that successful TF-TAVI can be performed through a prior abdominal aortic stent graft. TF-TAVI after EVAR of AAA is a feasible option for patients with extremely poor access.

  10. Cardiac rehabilitation after transcatheter versus surgical prosthetic valve implantation for aortic stenosis in the elderly.

    PubMed

    Russo, Nicola; Compostella, Leonida; Tarantini, Giuseppe; Setzu, Tiziana; Napodano, Massimo; Bottio, Tomaso; D'Onofrio, Augusto; Isabella, Gianbattista; Gerosa, Gino; Iliceto, Sabino; Bellotto, Fabio

    2014-11-01

    Transcatheter aortic valve implantation plays a leading role in the management of aortic stenosis in patients with comorbidities but no data are available about cardiac rehabilitation in these subjects. This study aimed to compare safety and efficacy of an early, exercise-based, cardiac rehabilitation programme in octogenarians after a traditional surgical aortic valve replacement versus transcatheter aortic valve implantation. Seventy-eight consecutive transcatheter aortic valve implantation patients were studied in order to evaluate the effect of an exercise-based cardiac rehabilitation programme in comparison to 80 of a similar age having surgical aortic valve replacement. Functional capacity was assessed by a 6 min walking test on admission and at the end of the programme. When possible, a cardiopulmonary exercise test was also performed before discharge. The two groups were similar in terms of gender and length of stay in cardiac rehabilitation; as expected, the transcatheter aortic valve implantation group had more comorbidities but no major complications occurred in either group during rehabilitation. All patients enhanced autonomy and mobility and were able to walk at least with the assistance of a stick. In those patients who were able to perform the 6 min walking test, the distance walked at discharge did not significantly differ between the groups (272.7 ± 108 vs. 294.2 ± 101 m, p = 0.42), neither did the exercise capacity assessed by cardiopulmonary exercise test (peak-VO2 12.5 ± 3.6 vs. 13.9 ± 2.7 ml/kg/min, p = 0.16). Cardiac rehabilitation is feasible, safe and effective in octogenarian patients after transcatheter aortic valve implantation as well as after traditional surgery. An early cardiac rehabilitation programme enhances independence, mobility and functional capacity and should be highly encouraged. © The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  11. Biomedical Impact in Implantable Devices-The Transcatheter Aortic Valve as an example

    NASA Astrophysics Data System (ADS)

    Anastasiou, Alexandros; Saatsakis, George

    2015-09-01

    Objective: To update of the scientific community about the biomedical engineering involvement in the implantable devices chain. Moreover the transcatheter Aortic Valve (TAV) replacement, in the field of cardiac surgery, will be analyzed as an example of contemporary implantable technology. Methods: A detailed literature review regarding biomedical engineers participating in the implantable medical product chain, starting from the design of the product till the final implantation technique. Results: The scientific role of biomedical engineers has clearly been established. Certain parts of the product chain are implemented almost exclusively by experienced biomedical engineers such as the transcatheter aortic valve device. The successful professional should have a multidisciplinary knowledge, including medicine, in order to pursue the challenges for such intuitive technology. This clearly indicates that biomedical engineers are among the most appropriate scientists to accomplish such tasks. Conclusions: The biomedical engineering involvement in medical implantable devices has been widely accepted by the scientific community, worldwide. Its important contribution, starting from the design and extended to the development, clinical trials, scientific support, education of other scientists (surgeons, cardiologists, technicians etc.), and even to sales, makes biomedical engineers a valuable player in the scientific arena. Notably, the sector of implantable devices is constantly raising, as emerging technologies continuously set up new targets.

  12. [Percutaneous catheter-based implantation of artificial pulmonary valves in patients with congenital heart defects].

    PubMed

    Wyller, Vegard Bruun; Aaberge, Lars; Thaulow, Erik; Døhlen, Gaute

    2011-07-01

    Percutaneous catheter-based implantation of artificial heart valves is a new technique that may supplement surgery and which may be used more in the future. We here report our first experience with implantation of artificial pulmonary valves in children with congenital heart defects. Eligible patients were those with symptoms of heart failure combined with stenosis and/or insufficiency in an established artificial right ventricular outflow tract. The valve was inserted through a catheter from a vein in the groin or neck. Symptoms, echocardiography, invasive measurements and angiography were assessed for evaluation of treatment effect. Our treatment results are reported for the period April 2007-September 2009. Ten patients (seven men and three women, median age 17 years) were assessed. The procedure reduced pressure in the right ventricle (p = 0.008) and resolved the pulmonary insufficiency in all patients. The median time in hospital was two days. No patients had complications that were directly associated with the implantation procedure. One patient developed a pseudoaneurysm in the femoral artery, another had a short-lasting fever two days after the procedure and one patient experienced a stent fracture that required surgery 9 months after the implantation. After 6 months all patients had a reduced pressure gradient in the right ventricular outflow tract (p = 0.008), the pulmonary insufficiency had improved (p = 0.006) and they all reported improval of symptoms. These results persisted for at least 24 months for the four patients who were monitored until then. Percutaneous catheter-based implantation of artificial pulmonary valves improves hemodynamics in the right ventricle of selected patients with congenital heart defects. A randomized controlled study should be undertaken to provide a stronger evidence-base for usefulness of this procedure.

  13. Predictors and course of high-degree atrioventricular block after transcatheter aortic valve implantation using the CoreValve Revalving System.

    PubMed

    Guetta, Victor; Goldenberg, Gustavo; Segev, Amit; Dvir, Danny; Kornowski, Ran; Finckelstein, Arik; Hay, Ilan; Goldenberg, Ilan; Glikson, Michael

    2011-12-01

    Transcatheter aortic valve implantation (TAVI) is a novel treatment for high risk or inoperable patients with symptomatic severe aortic stenosis. However, significant atrioventricular (AV) conduction system abnormalities requiring permanent pacemaker (PPM) implantation might complicate this procedure. We used best subsets logistic regression analysis to identify the independent predictors for the development of high-degree AV block (HDAVB) among 70 patients who underwent TAVI at 3 referral centers in Israel from 2008 to 2010. The mean age of the study patients was 83 ± 4.6 years. Of the 70 patients, 28 (40%) developed AV conduction abnormalities requiring PPM implantation within 14 days (median 2) of the procedure. The indications for PPM implantation were HDAVB (n = 25), new-onset left bundle branch block with PR prolongation (n = 2), and slow atrial fibrillation (n = 1). Best subsets logistic regression analysis showed that, among the 15 prespecified clinical, electrocardiographic, and echocardiographic candidate risk factors, only right bundle branch block at baseline (odds ratio 43; p = 0.002) and deep valve implantation (<6 mm from the lower edge of the noncoronary cusp to the ventricular end of the prosthesis, odds ratio 22; p <0.001) were independently associated with the development of periprocedural HDAVB. At 3 months of follow-up, HDAVB was still present in 40% of the patients who received PPM implantation for this indication. In conclusion, 40% of the patients who undergo CoreValve TAVI require PPM implantation after the procedure, with most cases (36%) associated with the development of postprocedural HDAVB. Baseline conduction abnormalities (right bundle branch block) and deep valve implantation (>6 mm) independently predicted the development of HDAVB and the need for PPM implantation after CoreValve TAVI. Copyright © 2011 Elsevier Inc. All rights reserved.

  14. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

    PubMed

    Kappetein, A Pieter; Head, Stuart J; Généreux, Philippe; Piazza, Nicolo; van Mieghem, Nicolas M; Blackstone, Eugene H; Brott, Thomas G; Cohen, David J; Cutlip, Donald E; van Es, Gerrit-Anne; Hahn, Rebecca T; Kirtane, Ajay J; Krucoff, Mitchell W; Kodali, Susheel; Mack, Michael J; Mehran, Roxana; Rodés-Cabau, Josep; Vranckx, Pascal; Webb, John G; Windecker, Stephan; Serruys, Patrick W; Leon, Martin B

    2013-01-01

    The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. Two in-person meetings (held in September 2011 in Washington, DC, and in February 2012 in Rotterdam, The Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and noninterventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiographic recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for

  15. Incidence of secondary glaucoma in behcet disease.

    PubMed

    Elgin, Ufuk; Berker, Nilufer; Batman, Aygen

    2004-12-01

    To determine the incidence of secondary glaucoma in Behcet disease. A total of 230 eyes of 129 patients with Behcet disease, were examined in uveitis and glaucoma clinics of Ankara Social Security Eye Hospital between January 1997 and September 2002. The data from all patients were investigated both retrospectively and prospectively. The mean age of 129 patients was 34.2 +/- 7.4 years (range, 18 to 55 years). In 22 patients (17%), the disease was diagnosed on the basis of the ocular findings, while in the remaining 107 patients (83%), the period between the diagnosis of Behcet disease and the onset of the ocular symptoms was 23.3 +/- 17 months (range, 1 month to 5.3 years); 122 eyes (53%) had the episodes of acute recurrent iridocyclitis, while 108 eyes (47%) developed chronic posterior uveitis, including vitreitis, retinitis, vasculitis, or optic nerve involvement. Secondary glaucoma was diagnosed in 25 eyes (10.9%); 11 eyes (44%) with steroid or inflammation induced open angle glaucoma, 6 eyes (24%) with partial angle-closure glaucoma and peripheral anterior synechiae, 5 eyes (20%) with angle closure glaucoma, peripheral anterior synechiae, and pupil block and 3 eyes (12%) with neovascular glaucoma. The treatments included YAG-laser iridotomy in 5 eyes, diode-laser cyclodestruction in 3 eyes, primary trabeculectomies with mitomycin-c in 4 eyes, secondary trabeculectomies with mitomycin-c in 2 eyes, Ahmed valve implantations in 2 eyes, and cyclocryotherapy in 3 eyes. We suggest that secondary glaucoma is a common and serious complication of Behcet disease. It develops as a result of multiple factors, generally triggered by recurrent intraocular inflammation. Early recognition and treatment of these factors have vital importance to avoid the visual morbidity.

  16. Bioengineered Human and Allogeneic Pulmonary Valve Conduits Chronically Implanted Orthotopically in Baboons: Hemodynamic Performance and Immunological Consequences

    PubMed Central

    Hopkins, Richard A.; Bert, Arthur A.; Hilbert, Stephen L.; Quinn, Rachael W.; Brasky, Kathleen M.; Drake, William B.; Lofland, Gary K.

    2012-01-01

    Objective This study assesses in a baboon model the hemodynamics and HLA immunogenicity of chronically implanted bioengineered (decellularized with collagen conditioning treatments) human and baboon heart valve scaffolds. Methods Fourteen baboons underwent pulmonary valve replacement, eight with decellularized and conditioned (bioengineered) pulmonary valves derived from either allogeneic (N=3) or xenogeneic (human) (N=5) hearts; for comparison, six baboons received clinically relevant reference cryopreserved or porcine valved conduits. Panel reactive serum antibodies (HLA Class I&II), complement fixing antibodies (C1q binding), and C-reactive protein titers were measured serially until elective sacrifice at 10 or 26 weeks. Serial transesophageal echocardiograms (TEE) measured valve function and geometry. Differences were analyzed with Kruskal-Wallis and Wilcoxon Rank Sum. P≤ 0.05 significant. Results All animals survived and thrived, exhibiting excellent immediate implanted valve function by TEE. Over time, reference valves developed smaller indexed effective orifice areas, EOAI=0.84(1.22) cm2/m2 median (range) while all bioengineered valves remained normal, EOAI=2.45 (1.35) cm2/m2; P=0.005. None of the bioengineered valves developed elevated peak transvalvular gradients, 5.5(6.0) versus 12.5(23.0) mmHg, P=0.003. Cryopreserved valves provoked the most intense antibody responses. Two of five human bioengineered and two of three baboon bioengineered valves did not provoke any Class I antibodies. Bioengineered human (but not baboon) scaffolds provoked Class II antibodies. C1q+ antibodies developed in four recipients. Conclusions Valve dysfunction correlated with markers for more intense inflammatory provocation. The tested bioengineering methods reduced antigenicity of both human and baboon valves. Bioengineered replacement valves from both species were hemodynamically equivalent to native valves. PMID:22841171

  17. Improvement of right ventricular function with transcatheter aortic valve implantation.

    PubMed

    Ayhan, Hüseyin; Durmaz, Tahir; Keleş, Telat; Sari, Cenk; Aslan, Abdullah Nabi; Kasapkara, Haci Ahmet; Bozkurt, Engin

    2014-06-01

    It has been demonstrated that right ventricular systolic dysfunction develops soon after surgical aortic valve replacement (s-AVR). While the impact of s-AVR or TAVI on the function of the left ventricle has been studied with various imaging modalities, little is known about the impact on right ventricular function (RVF). In the current study, we evaluated the impact of TAVI on RVF using conventional echocardiography parameters. Echocardiography was performed prior to 24 h, 1 month and 6 months after TAVI. RVF was assessed using (1) tricuspid annular plane systolic excursion (TAPSE); (2) RV Tissue Doppler Imaging (S'); (3) right ventricular systolic pressure (RVSP); (4) Fractional area change (FAC); and (5) RV ejection fraction (RVEF). TAVI was performed through the subclavian artery in two patients and femoral artery in 48 patients with an Edwards Sapien XT valve. TAVI was performed on 50 patients between the dates of December 2012 and June 2013. After TAVI, a statistically significant improvement was observed for all parameters related to RVF (RVSP, RVEF, TAPSE, FAC, RVTDI S'). During the 1st and 6th months this statistically significant improvement continued in TAPSE and FAC, and there was no deterioration in RVSP, RVEF, and RVTDI S during the 1st month but a statistically significant improvement continued in the 6th month. RVF assessed by conventional echocardiography did not deteriorate after TAVI in early and midterm follow-up. Further, TAVI provides improvement of RVF and can safely and efficiently be performed in patients with impaired RVF.

  18. Association between implantation depth assessed by computed tomography and new-onset conduction disturbances after transcatheter aortic valve implantation.

    PubMed

    Almeida, João Gonçalves; Ferreira, Sara Moura; Fonseca, Paulo; Dias, Tiago; Guerreiro, Cláudio; Barbosa, Ana Raquel; Teixeira, Pedro; Carvalho, Mónica; Ferreira, Wilson; Ferreira, Nuno Dias; Oliveira, Marco; Gonçalves, Helena; Braga, Pedro; Ribeiro, José; Primo, João; Ribeiro, Vasco Gama

    Transcatheter aortic valve replacement (TAVR) is often associated with intraventricular conduction disturbances. We aimed to determine the association between implantation depth assessed by multidetector computed tomography (MDCT) and new-onset conduction abnormalities after TAVR. Retrospective single-center study including patients consecutively submitted to TAVR, between August/2007 and October/2016, who underwent routine MDCT 3 months after the procedure. The endpoint of conduction disturbances included permanent pacemaker implantation and/or new-onset left bundle-branch block. Implantation depth was determined as the distance between the ventricular end of the prothesis and the native ring, at the level of the non-coronary cusp. 138 patients were included (female gender 52.2%, mean age 78.7 ± 6.9 years). The EuroSCORE II was 4.0 ± 3.9% and 57.2% were treated with self-expanding prosthesis. The endpoint of conduction abnormalities was found in 45.7% (n = 63). The implantation depth was greater in the group with conduction disturbances (7.7 vs 6.4 mm, p = 0.006). Chronic obstructive pulmonary disease, oversizing and implantation depth were independent predictors of conduction abnormalities. Implantation depth had an AUC of 0.64 (p = 0.004) for the prediction of conduction abnormalities and a cut-off value of 7.1 mm predicted the composed endpoint with a sensitivity and specificity of 65% and 70%, respectively. Implantation depth assessed by MDCT is associated with new-onset conduction disturbances after TAVR. In patients with conduction abnormalities, which do not qualify for the immediate implantation of pacemaker, the assessment of implantation depth by MDCT may be an additional marker of risk to aid decision-making. Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

  19. Use of rapid prototyping models in the planning of percutaneous pulmonary valved stent implantation.

    PubMed

    Armillotta, A; Bonhoeffer, P; Dubini, G; Ferragina, S; Migliavacca, F; Sala, G; Schievano, S

    2007-05-01

    Percutaneous replacement of the pulmonary valve is a recently developed interventional technique which involves the implantation of a valved stent in the pulmonary trunk. It relies upon careful consideration of patient anatomy for both stent design and detailed procedure planning. Medical imaging data in the form of two-dimensional scans and three-dimensional interactive graphics offer only limited support for these tasks. The paper reports the results of an experimental investigation on the use of arterial models built by rapid prototyping techniques. An analysis of clinical needs has helped to specify proper requirements for such model properties as cost, strength, accuracy, elastic compliance, and optical transparency. Two different process chains, based on the fused deposition modelling technique and on the vacuum casting of thermoset resins in rubber moulds, have been tested for prototype fabrication. The use of anatomical models has allowed the cardiologist's confidence in patient selection, prosthesis fabrication, and final implantation to be significantly improved.

  20. Aortic root remodeling with the "cuff" technique for stentless valve implantation.

    PubMed

    Massetti, M; Bruno, P; Babatasi, G; Le Page, O; Neri, E; Veron, S; Saloux, E; Khayat, A

    2001-03-01

    Aortic root and sinotubular junction dilatation and aneurysm of ascending aorta are considered relative contra-indications to implantation of a stentless valve prosthesis, because the modified aortic geometry leads to aortic incompetence and early failure of the prosthesis. Aortic root reconstruction can be performed according to various techniques. We present a surgical technique in which a tubular graft, replacing an ascending aortic aneurysm, allows sinotubular remodeling and satisfactory implantation of a stentless prosthesis. The native aorta is inserted into the vascular prosthesis at the level of the sinotubular junction which is wrapped in order to prevent commissure spreading. Sizing of the vascular and valve prosthesis is made according to annular diameter. Since October 1999, 6 patients have been operated using this technique with good results.

  1. Effects of phacoemulsification and intraocular lens implantation combined with ciliarotomy in the treatment of angle-closure glaucoma with cataract

    PubMed Central

    Li, Bo; Wang, Feng-Yun; Lv, Tai-Liang; Zhu, Yu

    2016-01-01

    The aim of the present study was to examine the effects of phacoemulsification and intraocular lens implantation combined with ciliarotomy in the treatment of angle-closure glaucoma with cataract in the elderly. A total of 68 patients were consecutively selected and divided into the control group with 33 cases (48 eyes) and the observation group with 35 cases (53 eyes). Cataract surgery combined with trabeculectomy was performed on the patients in the control group and phacoemulsification cataract extraction combined with ciliarotomy was performed on the subjects in the observation group, to compare postoperative effects and complications. Following surgery, the visual acuity of patients in the two groups significantly improved, intraocular pressure decreased, and improvement of the observation group was more evident (P<0.05). Following surgery, the depth of central anterior chamber and width of chamber angle of patients in two groups was increased, and improvement of the observation group was significantly more evident (P<0.05). Additionally, the incidence of complications, including corneal swelling, shallow of anterior chamber, fibrinous exudate in iris, and filtering bleb leaking and following cataract removal, of patients in the observation group was significantly reduced compared to the control group (P<0.05). In summary, the results of the present study show that, phacoemulsification and intraocular lens implantation combined with ciliarotomy in the treatment of angle-closure glaucoma with cataract in the elderly is a safe and effective method and should be applied in the clinic. PMID:27698750

  2. Permanent pacemaker implantation after isolated aortic valve replacement: incidence, indications, and predictors.

    PubMed

    Dawkins, Sam; Hobson, Alex R; Kalra, Paul R; Tang, Augustine T M; Monro, James L; Dawkins, Keith D

    2008-01-01

    Conducting system defects are common in patients with aortic valve disease. Aortic valve replacement may result in further conduction abnormalities and necessitate permanent pacemaker implantation (PPM). We sought to identify the contemporary incidence and predictors for early postoperative PPM in patients undergoing isolated aortic valve replacement. Data were analyzed from 354 consecutive patients undergoing isolated aortic valve replacement at a referral cardiac unit during a 30-month period; data were unavailable on 4 patients and a further 8 had undergone preoperative PPM. Results for the remaining 342 patients (97%; mean age, 67 +/- 14 years), of whom 212 were males, are presented. The major indications for aortic valve replacement were valvular stenosis (n = 224), regurgitation (n = 70), or infective endocarditis (n = 25). Preoperative conducting system disease was present in 26% of patients. In-hospital mortality was 1.8% (6 of 342 patients). Postoperatively 29 patients (8.5%) required early PPM, of which 26 were during the index admission. Patients with preoperative conducting system disease (16% versus 6%; p = 0.004) and valvular regurgitation (16% versus 7%; p = 0.01) were more likely to require PPM as opposed to those without. Preoperative conducting system disease was the only independent predictor of PPM (p < 0.01); the relative risk of PPM requirement in this group was 2.88 (95% confidence interval, 1.31 to 6.33). Permanent pacemaker implantation requirement after aortic valve replacement is a common occurrence, and should be discussed as part of the preoperative consent process. Preexisting conducting disease and preoperative aortic regurgitation were predictors of PPM requirement.

  3. Conduction disturbances after transcatheter aortic valve implantation procedures – predictors and management

    PubMed Central

    Reguła, Rafał; Bujak, Kamil; Chodór, Piotr; Długaszek, Michał; Gąsior, Mariusz

    2016-01-01

    Transcatheter aortic valve implantation (TAVI) has become a safe and efficient alternative to cardiac surgery in patients with severe aortic stenosis. In many countries the number of performed TAVI procedures equals the number of surgical implantations. Indications for TAVI are becoming more liberal, allowing a wider spectrum of patients to benefit from the advantages of transcatheter therapy. Due to its invasive nature, TAVI is associated with some complications such as conduction disturbances. Although these disturbances are usually not lethal, they have a great influence on patients’ state and long term-survival. The most relevant and common are His’ bundle branch blocks, atrioventricular blocks, and need for permanent pacemaker implantation. With the frequency at 10% to even 50%, conduction abnormalities are among the most important TAVI-related adverse events. Risk factors for conduction disturbances include age, anatomy of the heart, periprocedural factors, type of implanted valve, and comorbidities. Severity of occurring complications varies; therefore selection of a proper treatment approach is required. Considered as the most effective management, permanent pacemaker implantation turned out to negatively influence both recovery and survival. Moreover, there is no expert consensus on use of resynchronization therapy after TAVI. In this paper, the authors present a comprehensive analysis of the most common conduction disturbances accompanying TAVI, factors related to their occurrence, and treatment approach. PMID:27625682

  4. Long-term results after transcatheter aortic valve implantation: positive and side effects.

    PubMed

    Godino, C; Pavon, A G; Colombo, A

    2013-08-01

    The scientific and technological progress in the field of medicine has allowed to treat patients with severe aortic valve stenosis and with a high perioperative risk. Before the introduction of transcatheter aortic valve implantation (TAVI), patients considered at high risk for surgical treatment were managed with medical therapy or with balloon aortic valvuloplasty. With more than 50000 transcatheter aortic valves implanted in patients around the world, TAVI has demonstrated to be a valid alternative to surgical aortic valve replacement in inoperable and high-risk patients. The PARTNER trial was the first randomized controlled trial to demonstrate that TAVI is not inferior to SAVR in high-risk patients. However, despite some encouraging short-term results medium and long-term outcomes are not always so encouraging. In this review, we will present the immediate results and distinct TAVI-related drawbacks and relative impact on the long-term outcome. New technology advances promise to simplify TAVI and to improve the results by reducing the rate of TAVI-specific issues such as paravalvular aortic regurgitation, annular rupture, and conduction disturbances which may impact on the clinical outcome. Therefore, we believe that when some of these weaknesses will be overcome, even patients at lower risk might benefit from TAVI in the near future.

  5. Automatic Estimation of Optimal Deployment of Transcatheter Aortic Valve Implantation Using Computed Tomography.

    PubMed

    Kerner, Arthur; Abadi, Sobhi; Dotan, Roy; Javitt, Marcia; Aronson, Doron; Lessick, Jonathan

    2017-03-01

    A comparison was made between the accuracy of and time saved by using novel automated software for pre-procedural computed tomography (CT) planning before transcatheter aortic valve implantation (TAVI) and manual methods. Preprocedural CT to assess aortic annulus dimensions and predict the optimal C-arm implant angle before TAVI can reduce complications related to incorrect prosthesis sizing and positioning. A total of 61 consecutive patients underwent TAVI using either the SAPIEN XT or CoreValve prosthesis. Pre-procedural CT scans were analysed using three methods: automatic; semi-automatic; and manual. For each method, annular dimensions were measured and the optimal implantation angle was predicted. After TAVI the actual post-deployment angle orthogonal to the prosthesis was determined using aortic fluoroscopy. The difference between the predicted angle by CT and the measured post-deployment angle was calculated for each method. For all methods the mean angular difference with the actual post-deployment angle was similar at ~9 ± 7°. There was a significant difference between the SAPIEN XT (6.6 ± 5.8°) and CoreValve (11.5 ± 6.9°, p <0.001) prostheses due to a consistently greater left anterior oblique and caudal angulation for the CoreValve. Although the annular area correlated well among all methods, 'automatic' results were consistently larger than 'manual' results. Interobserver variability was low for all measures. The fully automatic method saved 98 s, and the semiautomatic method 40 s per case. The use of automatic software enabled a rapid and accurate prediction of implantation angles, though results differed for specific manufacturers. Annular areas were overestimated by the automatic method, and thus required manual adjustments.

  6. Transcatheter Aortic Valve Implantation in an Extremely Tortuous S-Shaped Aorta

    PubMed Central

    Toleva, Olga; Pozeg, Zlatko; Menkis, Alan

    2017-01-01

    Transcatheter aortic valve implantation (TAVI) has emerged as an alternative technique to treating aortic stenosis in patients with high surgical risk. We present a case of a successful transfemoral TAVI in a high-risk patient with an extremely tortuous iliofemoral system and a significant S-type bend in the descending aorta. With careful preprocedure planning and using all the techniques available, TAVI can be performed in the most challenging patients. PMID:28352480

  7. Transcatheter aortic valve implantation with the direct flow medical prosthesis: Impact of native aortic valve calcification degree on outcomes.

    PubMed

    D'Ancona, Giuseppe; Agma, Hüseyin U; Ince, Hüseyin; El-Achkar, Gihan; Dißmann, Martin; Ortak, Jasmin; Kische, Stephan

    2017-01-01

    We present our single center experience with the direct flow medical (DFM) prosthesis addressing the impact of native aortic valve (AV) calcification degree on outcomes. The DFM® has been introduced for transcatheter aortic valve implantation (TAVI). The valve has a nonmetallic and inflatable support structure. Patients were divided in two groups according to preoperative cardiac computed tomography (CT): group I moderate calcification and group II heavy calcification of the total AV area. We evaluated 118 patients: 53 (45%) group I and 65 (55%) group II. Preoperative trans-AV gradient and calcification extension across the aortic unit were significantly higher in group II (P = 0.008 and P < 0.0001). CT perimeter derived annular diameter (group I 24.7 ± 2.1 mm vs. group II 24.8 ± 1.9; P = 0.6) and implanted prosthesis size (group I 26.1 ± 1.5 mm vs. group II 25.7 ± 1.5; P = 0.1) were similar. Hemodynamics were similar: mean gradient 16.1 ± 5.9 mm Hg (group I) vs. 17.3 ± 6.5 mm Hg (group II) (P = 0.3). Total aortic regurgitation (AR) was mild in 5.7% in group I and 20% in group II (P = 0.03). None developed moderate/severe AR. Heavy AV calcification was the sole independent determinant for mild regurgitation (P = 0.02; OR = 7; 95% CI: 1.2-37.6). Follow-up (289 days; 40-760 days) estimated survival was 88.1% (group I) and 93.8% (group II) (P = 0.3). Independent of AV calcification degree, adequate sizing and implantation can be achieved with the DFM®. Although higher burden of calcification increases the rate of mild AR, no patient developed moderate and severe AR. Short-term estimated survival was not influenced by calcification degree. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  8. Pathophysiology, incidence and predictors of conduction disturbances during Transcatheter Aortic Valve Implantation.

    PubMed

    Barbanti, Marco; Gulino, Simona; Costa, Giuliano; Tamburino, Corrado

    2017-02-01

    Over the past decade, transcatheter aortic valve implantation (TAVI) has evolved rapidly toward an extremely reproducible, safe and effective procedure, with a marked reduction of its related complications. However, the occurrence of conduction disturbances and the need for permanent pacemaker implantation (PPI) after TAVI remains a concern. Areas covered: In this article review, we will go through the mechanisms involved in conduction disturbances after TAVI, and we will discuss the key aspects of pathophysiology, incidence and predictors of conduction disturbances following Transcatheter Aortic Valve Implantation. The evaluation of patient's valve anatomy and the selection of the most appropriate prosthesis have been proposed as a valuable options to reduce the incidence of conductions disturbances. Moreover, in recent times, a great number of new TAVI devices, so-called 'second-generation devices', have been introduced to address the limitations of the first-generation devices, including conduction disturbance, with scarce results. Expert commentary: Conduction disturbances after TAVI are increasingly recognized as an important issue in TAVI complications. Further characterization of the procedural- and patient-related factors that contribute to the development of conduction abnormalities will help to improve prosthesis designs and patient selection, making TAVI even more safer.

  9. Heidenhain variant of Creutzfeldt–Jakob disease in a patient who had bovine bioprosthetic valve implantation

    PubMed Central

    Hashoul, Jehard; Saliba, Waleed; Bloch, Irina; Jabaly-Habib, Haneen

    2016-01-01

    Creutzfeldt–Jakob disease (CJD) is a rare neurodegenerative disorder characterized by rapidly progressing dementia, general neurologic deterioration, and death. When the leading symptoms are visual disturbances, it is termed as the Heidenhain variant of CJD (HvCJD). CJD was reported following prion-contaminated pericardium transplants but never after bovine bioprosthetic cardiac valve. In this case report, we describe HvCJD in a patient who had a bovine bioprosthetic cardiac valve implant. An 82-year-old-woman was referred to neuro-ophthalmology clinic for unexplained visual loss that started 1 month previously. Medical history included aortic valve replacement with bovine bioprosthetic valve. On examination, best-corrected visual acuity was 20/120 in the right eye and 20/200 in the left eye; otherwise, the eye examination was normal. Humphrey visual fields revealed complete right homonymous hemianopsia. Magnetic resonance imaging (MRI) demonstrated nonspecific white matter changes. A week later, she was hospitalized due to memory impairment; repeated MRI and total body computed tomography scan showed no significant findings. Electroencephalography recordings and extremely elevated cerebrospinal fluid tau protein were compatible with CJD. The patient died 3 weeks later; autopsy was not performed. The patient had HvCJD. Ophthalmologists being first to see these patients should be aware of this diagnosis. Contaminated bovine bioprosthetic valve might be another source for prion disease. Further research is required to establish this issue. PMID:27905341

  10. Effect of transcatheter aortic valve implantation on intraoperative left ventricular end-diastolic pressure.

    PubMed

    Toyota, Kosaku; Ota, Takashi; Nagamine, Katsutoshi; Koide, Yasuhiro; Nomura, Takeshi; Yamanaka, Futoshi; Shishido, Koki; Tanaka, Masashi; Saito, Shigeru

    2016-12-01

    Transcatheter aortic valve implantation (TAVI) for patients with aortic stenosis is a less invasive alternative to surgical aortic valve replacement. Despite this, careful anesthetic management, especially strict control of blood pressure and fluid management, is necessary. During TAVI, normalization of left ventricular afterload due to aortic balloon valvuloplasty and prosthetic valve deployment is expected to result in rapid improvement of systolic function and consequent improvement in diastolic function. However, the early effect of TAVI on left ventricular diastolic function is less clear. We hypothesized that TAVI induces a rapid decrease in left ventricular end-diastolic pressure (LVEDP) after valve deployment. This retrospective observational study included 71 patients who had undergone TAVI using the transfemoral approach with a balloon-expandable valve under general anesthesia. Intraoperative LVEDP was measured using an intracardiac catheter. The severity of residual aortic regurgitation (AR) was assessed using the Sellers criteria. The mean (SD) LVEDP was 17.8 (5.3) mmHg just before TAVI and increased significantly to 27.3 (8.2) mmHg immediately after prosthetic valve deployment (p < 0.0001). The change in LVEDP was 8.7 (8.6) mmHg in patients with low residual AR (Sellers ≤1) and 11.0 (7.1) mmHg in those with high residual AR (Sellers ≥2); however, this difference was not significant. No correlation was found between the LVEDP change and intraoperative fluid balance. In conclusion, LVEDP increased significantly in the early period after valve deployment during TAVI, regardless of residual AR severity. It was suggested that the tolerability of fluid load could be reduced at that time.

  11. The JUPITER registry: 1-year results of transapical aortic valve implantation using a second-generation transcatheter heart valve in patients with aortic stenosis.

    PubMed

    Silaschi, Miriam; Treede, Hendrik; Rastan, Ardawan J; Baumbach, Hardy; Beyersdorf, Friedhelm; Kappert, Utz; Eichinger, Walter; Rüter, Florian; de Kroon, Thomas L; Lange, Rüdiger; Ensminger, Stephan; Wendler, Olaf

    2016-11-01

    Transcatheter aortic valve replacement (TAVR) is an established therapy for patients with aortic stenosis (AS) at high surgical risk. The JenaValve™ is a second-generation, self-expanding transcatheter heart valve (THV), implanted through transapical access (TA). During stent deployment, a specific 'clipping-mechanism' engages native aortic valve cusps for fixation. We present 1-year outcomes of the JUPITER registry, a post-market registry of the JenaValve for TA-TAVR. The JUPITER registry is a prospective, multicentre, uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV. A total of 180 patients with AS were enrolled between 2012 and 2014. End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions. The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7%. The procedure was successful in 95.0% (171/180), implantation of a second THV (valve-in-valve) was performed in 2.2% (4/180) and conversion to surgical aortic valve replacement (SAVR) was necessary in 2.8% (5/180). No annular rupture or coronary ostia obstruction occurred. Two patients required SAVR after the day of index procedure (1.1%). All-cause mortality at 30 days was 11.1% (20/180), being cardiovascular in 7.2% (13/180). A major stroke occurred in 1.1% (2/180) at 30 days, no additional major strokes were observed during 1 year. All-cause mortality after 30 days was 13.1% (21/160) and combined efficacy at 1 year was 80.8% (122/151). At 1-year follow-up, no patient presented with more than moderate paravalvular leakage, while 2 patients (3.2%) showed moderate, 12 (19.0%) mild and 49 (82.4%) trace/none paravalvular regurgitation. In a high-risk cohort of patients undergoing TA-TAVR for AS, the use of the JenaValve THV is safe and effective. In patients at higher risk for coronary ostia

  12. Timing of Onset and Outcome of New Conduction Abnormalities Following Transcatheter Aortic Valve Implantation: Role of Balloon Aortic Valvuloplasty.

    PubMed

    Campelo-Parada, Francisco; Nombela-Franco, Luis; Urena, Marina; Regueiro, Ander; Jiménez-Quevedo, Pilar; Del Trigo, María; Chamandi, Chekrallah; Rodríguez-Gabella, Tania; Auffret, Vincent; Abdul-Jawad Altisent, Omar; DeLarochellière, Robert; Paradis, Jean-Michel; Dumont, Eric; Philippon, François; Pérez-Castellano, Nicasio; Puri, Rishi; Macaya, Carlos; Rodés-Cabau, Josep

    2017-05-27

    Little is known about the timing of onset and outcome of conduction abnormalities (CA) following balloon-expandable transcatheter aortic valve implantation. The aim of this study was to examine the timing of CA and determine the impact of balloon aortic valvuloplasty (BAV) on the persistence of these abnormalities. A total of 347 patients were included. Of these, 75 had a continuous electrocardiogram recording and a 6-lead electrocardiogram at each step of the procedure. In the transcatheter aortic valve implantation population undergoing continuous electrocardiogram monitoring, new-onset left bundle branch block (LBBB) or third-degree atrioventricular block occurred in 48 (64%) and 16 (21.3%) patients, with 51.5% of CA occurring before valve implantation. Left bundle branch block persisted more frequently at hospital discharge (53.8 vs 22.7%; P=.028) and at 1-month follow-up (38.5 vs 13.6%; P=.054) when occurring before valve implantation. Balloon aortic valvuloplasty prior to valve implantation was used in 264 (76.1%) patients, and 78 (22.5%) had persistent LBBB or complete atrioventricular block requiring pacemaker implantation. Persistent LBBB or unresolved atrioventricular block at 1 month occurred more frequently in the BAV group (76.1 vs 47.6%; P=.021), and the use of BAV was associated with a lack of CA resolution (OR, 3.5; 95%CI, 1.17-10.43; P=.021). In patients undergoing a balloon-expandable transcatheter aortic valve implantation, more than half of CA occurred before valve implantation. Early occurrence of CA was associated with a higher rate of persistence at 1-month follow-up. The use of BAV was associated with an increased risk of CA persistence. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

  13. Aortic valve calcification as a predictor of location and severity of paravalvular regurgitation after transcatheter aortic valve implantation.

    PubMed

    Koh, Ezra Y; Lam, Kayan Y; Bindraban, Navin R; Cocchieri, Riccardo; Planken, R Nils; Koch, Karel T; Baan, Jan; de Mol, Bas A; Marquering, Henk A

    2015-03-01

    To determine whether the location of aortic valve calcium (AVC) influences the location of paravalvular regurgitation (PR). PR is an adverse effect of transcatheter aortic valve implantation (TAVI) with a negative effect on long-term patient survival. The relationship between AVC and the occurrence of PR has been documented. However, the relationship between the distribution of AVC and the location of PR is still sparsely studied. The purpose of this study was to correlate severity and location of AVC with PR in patients treated with TAVI. Fifty-six consecutive patients who underwent transaortic or transapical TAVI and had preoperative computed tomography scans were included in this retrospective study. The volume, mass and location of AVC was determined and compared between patients with and without PR using a non-parametric t-test. Postoperative echocardiography was performed to determine the presence and location of PR, which was associated with the cusp with highest AVC using a χ(2) test. Valve deployment was successful in all 56 patients. PR was present in 38 patients (68%) after TAVI. There was a non-significantly higher volume of AVC in the PR group [214 (70-418) vs 371 (254-606) cm(3), P = 0.15]. AVC mass was significantly higher in patients with PR than in patients without PR [282 (188-421) vs 142 (48-259) mg, respectively, P = 0.043]. The location of PR was determined in 36 of these patients. Of these 36 patients, PR occurred at the cusp with the highest AVC in 20 patients (56%, χ(2) P = 0.030). In our population, PR was associated with greater AVC mass. Moreover, the location of PR was associated with the cusp with the highest amount of AVC. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  14. Reduction of persistent air leak with endoscopic valve implants

    PubMed Central

    Toma, Tudor P; Kon, Onn Min; Oldfield, William; Sanefuji, Reina; Griffiths, Mark; Wells, Frank; Sivasothy, Siva; Dusmet, Michael; Geddes, Duncan M; Polkey, Michael I

    2007-01-01

    The standard management of air leaks due to persistent bronchopleural fistula involves chest drainage and occasionally pleurodesis, with intractable cases requiring surgical decortication or surgical repair. However, some of these patients may be at high risk for surgery, particularly if they have already had thoracic surgery or have other medical problems; for this group there is a need for less invasive methods of stopping or reducing air leaks. Emphasys endobronchial valves (EBV) are occlusive devices designed primarily for endoscopic lung volume reduction in emphysema. Because the device is a one‐way inspiratory airway blocker, it is possible that it could be used in controlling persistent air leaks while maintaining the drainage of secretions. Two cases are reported of persistent air leaks that were managed by endoscopic occlusion with EBV. In one case complete stoppage of the air leak was achieved with immediate clinical benefits. The second patient died 5 days after treatment from additional complications apparently not related to the procedure. Endobronchial blockage may be a useful salvage procedure for patients with persistent air leak for whom there is no other treatment available. PMID:17726171

  15. Reduction of persistent air leak with endoscopic valve implants.

    PubMed

    Toma, Tudor P; Kon, Onn Min; Oldfield, William; Sanefuji, Reina; Griffiths, Mark; Wells, Frank; Sivasothy, Siva; Dusmet, Michael; Geddes, Duncan M; Polkey, Michael I

    2007-09-01

    The standard management of air leaks due to persistent bronchopleural fistula involves chest drainage and occasionally pleurodesis, with intractable cases requiring surgical decortication or surgical repair. However, some of these patients may be at high risk for surgery, particularly if they have already had thoracic surgery or have other medical problems; for this group there is a need for less invasive methods of stopping or reducing air leaks. Emphasys endobronchial valves (EBV) are occlusive devices designed primarily for endoscopic lung volume reduction in emphysema. Because the device is a one-way inspiratory airway blocker, it is possible that it could be used in controlling persistent air leaks while maintaining the drainage of secretions. Two cases are reported of persistent air leaks that were managed by endoscopic occlusion with EBV. In one case complete stoppage of the air leak was achieved with immediate clinical benefits. The second patient died 5 days after treatment from additional complications apparently not related to the procedure. Endobronchial blockage may be a useful salvage procedure for patients with persistent air leak for whom there is no other treatment available.

  16. Assessment of valve haemodynamics, reverse ventricular remodelling and myocardial fibrosis following transcatheter aortic valve implantation compared to surgical aortic valve replacement: a cardiovascular magnetic resonance study

    PubMed Central

    Fairbairn, Timothy A; Steadman, Christopher D; Mather, Adam N; Motwani, Manish; Blackman, Daniel J; Plein, Sven; McCann, Gerry P; Greenwood, John P

    2013-01-01

    Objective To compare the effects of transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) on aortic valve haemodynamics, ventricular reverse remodelling and myocardial fibrosis (MF) by cardiovascular magnetic resonance (CMR) imaging. Design A 1.5 T CMR scan was performed preoperatively and 6 months postoperatively. Setting University hospitals of Leeds and Leicester, UK. Patients 50 (25 TAVI, 25 SAVR; age 77±8 years) high-risk severe symptomatic aortic stenosis (AS) patients. Main outcome measures Valve haemodynamics, ventricular volumes, ejection fraction (EF), mass and MF. Results Patients were matched for gender and AS severity but not for age (80±6 vs 73±7 years, p=0.001) or EuroSCORE (22±14 vs 7±3, p<0.001). Aortic valve mean pressure gradient decreased to a greater degree post-TAVI compared to SAVR (21±8 mm Hg vs 35±13 mm Hg, p=0.017). Aortic regurgitation reduced by 8% in both groups, only reaching statistical significance for TAVI (p=0.003). TAVI and SAVR improved (p<0.05) left ventricular (LV) end-systolic volumes (46±18 ml/m2 vs 41±17 ml/m2; 44±22 ml/m2 vs32±6 ml/m2) and mass (83±20 g/m2 vs 65±15 g/m2; 74±11 g/m2 vs 59±8 g/m2). SAVR reduced end-diastolic volumes (92±19 ml/m2 vs 74±12 ml/m2, p<0.001) and TAVI increased EF (52±12% vs 56±10%, p=0.01). MF reduced post-TAVI (10.9±6% vs 8.5±5%, p=0.03) but not post-SAVR (4.2±2% vs 4.1±2%, p=0.98). Myocardial scar (p≤0.01) and baseline ventricular volumes (p<0.001) were the major predictors of reverse remodelling. Conclusions TAVI was comparable to SAVR at LV reverse remodelling and superior at reducing the valvular pressure gradient and MF. Future work should assess the prognostic importance of reverse remodelling and fibrosis post-TAVI to aid patient selection. PMID:23749779

  17. Transapical aortic valve implantation in Rouen: four years' experience with the Edwards transcatheter prosthesis.

    PubMed

    Litzler, Pierre-Yves; Borz, Bogdan; Smail, Hassiba; Baste, Jean-Marc; Nafeh-Bizet, Catherine; Gay, Arnaud; Tron, Christophe; Godin, Matthieu; Caudron, Jerome; Hauville, Camille; Dacher, Jean-Nicolas; Cribier, Alain; Eltchaninoff, Hélène; Bessou, Jean-Paul

    2012-03-01

    The first French transapical transcatheter aortic valve implantation (TAVI) was performed in July 2007 in our department. To report 4-year outcomes of transapical implantation with the Edwards transcatheter bioprosthesis. We prospectively evaluated consecutive patients who underwent transapical implantation with an Edwards transcatheter bioprosthesis between July 2007 and October 2011. Patients were not suitable for conventional surgery (due to severe comorbidities) or transfemoral implantation (due to poor femoral access). Among 61 patients (59.0% men), mean logistic EuroSCORE was 27.5 ± 14.9% and mean age was 81.0 ± 6.8 years. Successful valve implantation was achieved in 59/61 patients (96.7%) of patients. The other two patients required conversion to conventional surgery due to prosthesis embolization and died. Six additional patients died in the postoperative period. Causes of perioperative death were two septic shocks (one of peritonitis), two multi-organ failure, one ventricular fibrillation and one respiratory insufficiency. Intraprocedural stroke was not observed in any patient. The actuarial survival rates at 1, 2 and 4 years were 73.8%, 67.2% and 41.0%. During this 4-year period, four patients died of cardiovascular events, but no impairment of transprosthesis gradient was observed. Our series of 61 patients who underwent transapical implantation of the Edwards transcatheter bioprosthesis shows satisfactory results, similar to other reports, considering the high level of severity of patients referred for this method. Transapical access is a reliable alternative method for patients that cannot benefit from a transfemoral approach. Copyright © 2012. Published by Elsevier Masson SAS.

  18. Predictors of permanent pacemaker requirement after transcatheter aortic valve implantation: insights from a Brazilian registry.

    PubMed

    Gensas, Caroline S; Caixeta, Adriano; Siqueira, Dimytri; Carvalho, Luiz A; Sarmento-Leite, Rogério; Mangione, José A; Lemos, Pedro A; Colafranceschi, Alexandre S; Caramori, Paulo; Ferreira, Maria Cristina; Abizaid, Alexandre; Brito, Fábio S

    2014-08-01

    The aim of this study is to evaluate the predictors of permanent pacemaker (PPM) implantation after TAVI. Between January 2008 and February 2012, 418 patients with severe aortic stenosis underwent TAVI and were enrolled in a Brazilian multicenter registry. After excluding patients who died during the procedure and those with a previous PPM, 353 patients were included in the analysis. At 30 days, the overall incidence of PPM implantation was 25.2%. Patients requiring PPM were more likely to be older (82.73 vs. 81.10 years, p=0.07), have pre-dilation (68.42% vs. 60.07%, p=0.15), receive CoreValve (93.68% vs. 82.55%, p=0.008), and have baseline right bundle branch block (RBBB, 25.26% vs. 6.58%, p<0.001). On multivariable analysis, CoreValve vs. Sapien XT (OR, 4.24; 95% CI, 1.56-11.49; p=0.005), baseline RBBB (OR, 4.41; 95% CI, 2.20-8.82; p<0.001), and balloon pre-dilatation (OR, 1.75; 95% CI, 1.02-3.02; p=0.04) were independent predictors of PPM implantation. PPM implantation occurred in approximately one-fourth of cases. Pre-existing RBBB, balloon pre-dilatation, and CoreValve use were independent predictors of PPM after TAVI. The type of prosthesis used and pre-balloon dilatation should be considered in TAVI candidates with baseline RBBB. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  19. Combination immunotherapy in the treatment of chronic bilateral panuveitis and uveitic glaucoma during acute dengue fever infection in the Caribbean

    PubMed Central

    Stewart, Kevin P; Tawakol, Jan B; Khan, Tasnim; Capriotti, Joseph A

    2015-01-01

    Background Ocular manifestations of the dengue fever virus include bilateral panuveitis that can occur after the acute systemic infection has resolved. In most reported cases, the inflammation resolves with topical or systemic steroid therapy. We report a case of chronic, refractory bilateral panuveitis and uveitic glaucoma that began during the acute phase of the systemic infection and required treatment with oral steroids, multiple steroid-sparing agents, and surgical therapy for glaucoma. Findings A 22-year-old male with acute systemic dengue fever presented with bilateral pain and decreased vision. Clinical examination revealed bilateral panuveitis with elevated intraocular pressures. Management required oral steroids, mycophenolate mofetil, cyclosporine, and bilateral glaucoma valve implantation. Conclusion This case highlights the fact that dengue-associated panuveitis can begin in the acute stage of systemic infection and persist long after convalescence with progression to chronic bilateral panuveitis and uveitic glaucoma. Dengue-associated chronic panuveitis with uveitic glaucoma may be effectively managed with a combination of steroid-sparing oral immunosuppression and glaucoma surgery. This is, to our knowledge, the first case of bilateral refractory dengue-associated panuveitis from the Caribbean treated with combination steroid-sparing oral immunosuppression and bilateral glaucoma valve implantation. PMID:26229512

  20. Transcatheter aortic valve-in-valve implantation for severe bioprosthetic stenosis after Bentall operation using a homograft in a patient with Behçet's disease.

    PubMed

    Joo, Hyung Joon; Hong, Soon Jun; Yu, Cheol Woong

    2015-03-01

    A 43-year-old man presented with severe aortic stenosis. Eight years previously, he had undergone primary surgical aortic valve replacement (AVR) for severe aortic regurgitation, but one year later developed cardiac arrest and complete atrioventricular block as a result of non-bacterial thrombotic endocarditis with severe valvular dehiscence. Following the diagnosis of prosthetic valve failure caused by Behçet's disease, the patient underwent a Bentall operation using 23 mm aortic homograft with permanent pacemaker implantation and coronary artery bypass grafting. Subsequently, he was stable with steroid administration and azathioprine for seven years after the second operation, but recently suffered from severe dyspnea and chest pain. Echocardiography revealed the development of severe aortic stenosis. A preprocedural evaluation demonstrated a porcelain aorta with severe calcification in the previous homograft valve on computed tomography, and critical stenosis at the ostium of the left circumflex artery on coronary angiography. After percutaneous coronary intervention for the ostium of the left circumflex artery, a transcatheter AVR was successfully performed using a 26 mm Edwards SAPIEN XT valve. The patient recovered without any complications after the procedure. This is the first report of a successful transcatheter aortic valve-in valve implantation for severe homograft aortic stenosis after a Bentall operation, using a homograft, in a patient with Behçet's disease.

  1. Development of computer-aided motion analyzing (CAMA) system for radiopaque implanted tilting disk heart valves.

    PubMed

    Ohta, Y; Horiuchi, T; Dohi, T; Sugaya, K; Matsumoto, H; Ide, H

    1990-12-01

    The newly developed semiautomatic data acquisition and processing system allows progress in quantitative evaluation of functions of implanted tilting disk valves. In the new system, data acquisition could be carried out semiautomatically by utilizing image processing methods, and the data analysis time was shortened. The system consists of a computer-controlled cinefilm loading device, a CCD camera, a frame memory, a superimposer, and CRT displays. Since series of the open- and shut-mode frames are commonly observed by turns in normal subjects, data acquisition was carried out manually at the first frame of each mode and semiautomatically from the second frame to the last. By processing the image data with the binarization method, the valve contours were detected, and an open angle and other motion properties can be obtained. Analyzing 90 frames of the cinefilm, this system analyzes data in a time period 20 min shorter than the manual procedure. With the implanted Medtronic Hall valve, a 60 to 65 degrees open angle was calculated.

  2. Baseline HV-interval predicts complete AV-block secondary to transcatheter aortic valve implantation.

    PubMed

    Shin, Dong-In; Merx, Marc W; Meyer, Christian; Kirmanoglou, Kiriakos; Hellhammer, Katharina; Ohlig, Jan; Katsani, Dimitra; Zeus, Tobias; Westenfeld, Ralf; Eickholt, Christian; Linke, Axel; Kelm, Malte

    2015-10-01

    Development of AV-block is a frequent complication associated with transcatheter aortic valve implantation (TAVI). To date little is known about the predictive value of the HV-interval prior to TAVI with respect to the risk of AV-block development. HV-interval was determined in 25 consecutive elderly patients with severe aortic valve stenosis (AS) before and immediately after TAVI. All patients subsequently underwent TAVI and 8 of these 25 patients (32%) developed complete AV-block during the TAVI procedure requiring permanent pacemaker implantation. Six of these 8 patients (75%) had marked HV prolongation (>54 ms). Pre-procedural HV-interval was significantly prolonged in the subgroup developing complete AV-block (62.1 ms±13.0 vs 49.2 ms±12.9; P=0.029). Prolongation of the HV-interval above 54 ms was associated with a higher rate of complete AV-block (sensitivity 75.0%, specificity 77.8%, P=0.01). HV-interval was prolonged in approximately one third of our elderly patients with aortic valve stenosis and associated with a high rate of complete AV-block following TAVI. HV-interval is easily obtained during TAVI screening procedures, thus facilitating identification of patients at risk for complete AV-block due to TAVI and consequently enabling bespoke risk management.

  3. [Usefulness of multidetector computed tomography in transcatheter aortic valve implantation. Advantage of a tridimentional imaging modality].

    PubMed

    Escobedo-Uribe, Carlos; Schoenhagen, Paul

    2015-01-01

    Aortic stenosis is the most common valvular disorder in the United States and Europe. Nowadays, surgical aortic valve replacement remains the standard treatment for patients with severe aortic stenosis; however, transcatheter aortic valve implantation represents a less invasive treatment option for aortic stenosis patients considered as high-risk or not suitable for surgical management. Because of the lack of direct visualization of the operative field in transcatheter aortic valve implantation, there is an increased need for precise pre-operative assessment of vascular anatomy. Therefore, in order to improve outcome and avoid complications, multidetector tomography is part of the routine evaluation of patients considered for this treatment. The data obtained covering the aorta and iliac arteries, allows the physician a precise planning prior to the intervention. In this review, we described basic aspects of the procedure, and the clinical relevance of the multidetector tomography. Copyright © 2013 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. All rights reserved.

  4. Percutaneous pulmonary valve implantation – state of the art and Polish experience

    PubMed Central

    Rużyłło, Witold; Demkow, Marcin

    2017-01-01

    Percutaneous pulmonary valve implantation (PPVI) is a relatively new method of treating patients with right ventricular outflow tract (RVOT) dysfunction after surgical repair of congenital heart disease. Since its introduction in 2000 by Bonhoeffer, more than ten thousand PPVI procedures have been performed worldwide. Indications for PPVI have been adapted from those accepted for surgical intervention. Two types of valves are being used: Melody Medtronic available in diameters 16 mm and 18 mm and the family of Edwards SAPIEN valves 23, 26 and 29. The procedure has been shown to be feasible and safe when performed in patients with full pulmonary conduit dysfunction and in selected cases of patched RVOT. The low complication rate and the reduced number of open-chest re-interventions over a patient’s lifetime are among the main advantages of the procedure. The most important problem responsible for late mortality and reinterventions is infective endocarditis. Size restrictions of the currently available valves limit deployment in the majority of patients with a wide RVOT. Newer devices are being developed to make these patients suitable for PPVI. A literature review, Polish experience and results of PPVI performed in 66 patients in the Institute of Cardiology in Warsaw are briefly reported. PMID:28344611

  5. Critical shunt-induced subdural hematoma treated with combined pressure-programmable valve implantation and endoscopic third ventriculostomy.

    PubMed

    Fukuhara, T; Vorster, S J; Luciano, M G

    2000-07-01

    The authors present 2 patients with VP shunt-induced subdural hematomas (SDH) treated with pressure-programmable valve implantation and endoscopic third ventriculostomies (TV). The first patient is an 11-year-old girl who developed a shunt-induced SDH. Revision of the shunt valve with a higher-pressure valve resulted in a prolonged deterioration of her consciousness. External ventricular drainage at low pressure led to clinical improvement. A pressure-programmable valve set at 50 mm H(2)O was implanted, and the pressure gradually increased. At a pressure of 120 mm H(2)O symptoms recurred, even though the subdural collection was beginning to decrease in size. An endoscopic TV was performed, and the valve pressure was then increased to 200 mm H(2)O without any neurological symptoms. The second patient, a 7-year-old boy with shunt-induced SDH, had recurrent SDH, even after shunt revision with placement of a higher-pressure valve, which resulted in prolonged lethargy. A pressure-programmable valve was implanted with concurrent endoscopic TV. Gradual valve pressure increases up to 200 mm H(2)O could be performed without recurrent symptoms. Eventually, the shunt system was ligated to resolve residual positional headache, and the TV has been patent for more than 3 years. In both patients, the pressure-programmable valve was useful, since the optimal CSF drainage pressure changed during the period of recovery from symptomatic subdural collections. Concurrent TV appeared to enable increasing the valve pressure gradually without any neurological symptoms. The advantages of this combined approach are discussed.

  6. Percutaneous balloon aortic valvuloplasty in the era of transcatheter aortic valve implantation: a narrative review

    PubMed Central

    Keeble, Thomas R; Khokhar, Arif; Akhtar, Mohammed Majid; Mathur, Anthony; Weerackody, Roshan; Kennon, Simon

    2016-01-01

    The role of percutaneous balloon aortic valvuloplasty (BAV) in the management of severe symptomatic aortic stenosis has come under the spotlight following the development of the transcatheter aortic valve implantation (TAVI) technique. Previous indications for BAV were limited to symptom palliation and as a bridge to definitive therapy for patients undergoing conventional surgical aortic valve replacement (AVR). In the TAVI era, BAV may also be undertaken to assess the ‘therapeutic response’ of a reduction in aortic gradient in borderline patients often with multiple comorbidities, to assess symptomatic improvement prior to consideration of definitive TAVI intervention. This narrative review aims to update the reader on the current indications and practical techniques involved in undertaking a BAV procedure. In addition, a summary of the haemodynamic and clinical outcomes, as well as the frequently encountered procedural complications is presented for BAV procedures conducted during both the pre-TAVI and post-TAVI era. PMID:28008354

  7. Percutaneous management of vascular access in transfemoral transcatheter aortic valve implantation

    PubMed Central

    Dato, Ilaria; Burzotta, Francesco; Trani, Carlo; Crea, Filippo; Ussia, Gian Paolo

    2014-01-01

    Transcatheter aortic valve implantation (TAVI) using stent-based bioprostheses has recently emerged as a promising alternative to surgical valve replacement in selected patients. The main route for TAVI is retrograde access from the femoral artery using large sheaths (16-24 F). Vascular access complications are a clinically relevant issue in TAVI procedures since they are reported to occur in up to one fourth of patients and are strongly associated with adverse outcomes. In the present paper, we review the different types of vascular access site complications associated with transfemoral TAVI. Moreover, we discuss the possible optimal management strategies with particular attention to the relevance of early diagnosis and prompt treatment using endovascular techniques. PMID:25228962

  8. Transcatheter aortic valve implantation and cerebrovascular events: the current state of the art.

    PubMed

    Hynes, Brian G; Rodés-Cabau, Josep

    2012-04-01

    Transcatheter aortic valve implantation (TAVI) has revolutionized the care of high-risk patients with severe calcific aortic stenosis. Those considered at high or prohibitive risk of major adverse outcomes with open surgical aortic valve replacement may now be offered an alternative less-invasive therapy. Despite the rapid evolution and clinical application of this new technology, recent studies have raised concerns about adverse cerebrovascular event rates in patients undergoing TAVI. In this review, we explore the current data both in relation to procedure-related silent cerebrovascular ischemic events, as well as clinically apparent stroke. The timing of neurological events and their prognostic implications are also examined. Finally, potential mechanisms of TAVI-related cerebrovascular injury are described, in addition to efforts to minimize their occurrence.

  9. Percutaneous balloon aortic valvuloplasty in the era of transcatheter aortic valve implantation: a narrative review.

    PubMed

    Keeble, Thomas R; Khokhar, Arif; Akhtar, Mohammed Majid; Mathur, Anthony; Weerackody, Roshan; Kennon, Simon

    2016-01-01

    The role of percutaneous balloon aortic valvuloplasty (BAV) in the management of severe symptomatic aortic stenosis has come under the spotlight following the development of the transcatheter aortic valve implantation (TAVI) technique. Previous indications for BAV were limited to symptom palliation and as a bridge to definitive therapy for patients undergoing conventional surgical aortic valve replacement (AVR). In the TAVI era, BAV may also be undertaken to assess the 'therapeutic response' of a reduction in aortic gradient in borderline patients often with multiple comorbidities, to assess symptomatic improvement prior to consideration of definitive TAVI intervention. This narrative review aims to update the reader on the current indications and practical techniques involved in undertaking a BAV procedure. In addition, a summary of the haemodynamic and clinical outcomes, as well as the frequently encountered procedural complications is presented for BAV procedures conducted during both the pre-TAVI and post-TAVI era.

  10. Anaesthetic management of percutaneous aortic valve implants: Results of 100 cases.

    PubMed

    Cuadrado García, A M; Hernández Antolín, R A; Almería Valera, C; López Timoneda, F

    2016-10-01

    Transfemoral transcatheter aortic-valve implantation represents a therapeutic alternative for patients with severe aortic stenosis who cannot undergo surgery due to high surgical risk. The aim of this study is to describe the anaesthetic procedure for transfemoral transcatheter aortic-valve implantation and the results on 100 patients with symptomatic severe aortic stenosis. A series of cases are presented with prospective data collected on 100 consecutive patients. The anaesthetic procedure consisted of continuous remifentanil and propofol infusions, for sedation or general anaesthetic. Almost two-thirds (65%) of the cases ended on sedation, and 35% on general anaesthetic (19% out of this total were elective and 16% were due to complications during the procedure). Complications occurred in 34% of the cases, with both vascular and complete atrioventricular block being the most frequent. Mortality within the first 24h was 5%. Implantation of transfemoral aortic prosthesis under remifentanil-propofol sedation can be considered a valid therapeutic alternative for patients with severe symptomatic aortic stenosis, and with a high surgical risk, and therefore not considered for conventional surgery. Copyright © 2016 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

  11. Replacement of the aortic valve with a bioprosthesis at the time of continuous flow ventricular assist device implantation for preexisting aortic valve dysfunction

    PubMed Central

    Chamogeorgakis, Themistokles; Mountis, Maria; Gonzalez-Stawinski, Gonzalo V.

    2015-01-01

    Left ventricular assist device (LVAD) implantation has become a mainstay of therapy for advanced heart failure patients who are either ineligible for, or awaiting, cardiac transplantation. Controversy remains over the optimal therapeutic strategy for preexisting aortic valvular dysfunction in these patients at the time of LVAD implant. In patients with moderate to severe aortic regurgitation, surgical approaches are center specific and range from variable leaflet closure techniques to concomitant aortic valve replacement (AVR) with a bioprosthesis. In the present study, we retrospectively analyzed our outcomes in patients who underwent simultaneous AVR and LVAD implantation secondary to antecedent aortic valve pathology. Between January 2004 and June 2010, 144 patients underwent LVAD implantation at a single institution. Of these, 7 patients (4.8%) required concomitant AVR. Five of the 7 patients (71%) survived to hospital discharge and suffered no adverse events in the perioperative period. One-year survival for the discharged patients was 80%, and no prosthetic valve-related adverse events were observed in long-term follow-up. Given our experience, we conclude that bioprosthetic AVR is a plausible alternative for end-stage heart failure patients at the time of LVAD implantation. PMID:26424939

  12. Efficacy and Safety of Transcatheter Aortic Valve Implantation for Bicuspid Aortic Valves: A Systematic Review and Meta-Analysis

    PubMed Central

    Xie, Xiaochuan; Shi, Xiaohan; Xun, Xiaoshuang

    2016-01-01

    Purpose: To elucidate the performance of transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BAV) patients through a systematic review and meta-analysis. Methods: A systematic literature review was performed by searching eligible articles in PubMed, Medline, EMBASE, Google Scholar and CNKI. Meta-analysis of included case-control/cohort studies was further conducted. Relative risks (RRs) and the corresponding 95% confidence intervals (CIs) were used to compare clinical outcomes of BAV patients and non-BAV patients. Results: A total of 17 articles including eight case reports, four case series and five case-control/cohort studies with 166 BAV patients were analyzed. Device success rate achieved for TAVI in this cohort of BAV patients was 95.2%. The 30-day mortality rate was 8.4%, and the medium-term (range from 6 months to 2 years) mortality rate reported was 17.9%. Overall, the performance of TAVI in BAV patients was comparable to that in non-BAV patients, as reported by the included case-control/cohort studies (30-day mortality rate: RR = 1.05, 95%CI 0.57–1.95, p = 0.87; Device success rate: RR = 1.00, 95%CI 0.95–1.05, p = 0.94; Incidence of moderate to severe paravalvular regurgitation: RR = 1.25, 95%CI 0.85–1.84, p = 0.25). Conclusion: The present study suggested that TAVI may be a feasible and safe treatment modality for BAV patients. PMID:27098769

  13. Drivers of healthcare costs associated with the episode of care for surgical aortic valve replacement versus transcatheter aortic valve implantation

    PubMed Central

    Wijeysundera, Harindra C; Li, Lindsay; Braga, Vevien; Pazhaniappan, Nandhaa; Pardhan, Anar M; Lian, Dana; Leeksma, Aric; Peterson, Ben; Cohen, Eric A; Forsey, Anne; Kingsbury, Kori J

    2016-01-01

    Objective Transcatheter aortic valve implantation (TAVI) is generally more expensive than surgical aortic valve replacement (SAVR) due to the high cost of the device. Our objective was to understand the patient and procedural drivers of cumulative healthcare costs during the index hospitalisation for these procedures. Design All patients undergoing TAVI, isolated SAVR or combined SAVR+coronary artery bypass grafting (CABG) at 7 hospitals in Ontario, Canada were identified during the fiscal year 2012–2013. Data were obtained from a prospective registry. Cumulative healthcare costs during the episode of care were determined using microcosting. To identify drivers of healthcare costs, multivariable hierarchical generalised linear models with a logarithmic link and γ distribution were developed for TAVI, SAVR and SAVR+CABG separately. Results Our cohort consisted of 1310 patients with aortic stenosis, of whom 585 underwent isolated SAVR, 518 had SAVR+CABG and 207 underwent TAVI. The median costs for the index hospitalisation for isolated SAVR were $21 811 (IQR $18 148–$30 498), while those for SAVR+CABG were $27 256 (IQR $21 741–$39 000), compared with $42 742 (IQR $37 295–$56 196) for TAVI. For SAVR, the major patient-level drivers of costs were age >75 years, renal dysfunction and active endocarditis. For TAVI, chronic lung disease was a major patient-level driver. Procedural drivers of cost for TAVI included a non-transfemoral approach. A prolonged intensive care unit stay was associated with increased costs for all procedures. Conclusions We found wide variation in healthcare costs for SAVR compared with TAVI, with different patient-level drivers as well as potentially modifiable procedural factors. These highlight areas of further study to optimise healthcare delivery. PMID:27621832

  14. Transcatheter Heart Valve Selection and Permanent Pacemaker Implantation in Patients With Pre-Existent Right Bundle Branch Block.

    PubMed

    van Gils, Lennart; Tchetche, Didier; Lhermusier, Thibault; Abawi, Masieh; Dumonteil, Nicolas; Rodriguez Olivares, Ramón; Molina-Martin de Nicolas, Javier; Stella, Pieter R; Carrié, Didier; De Jaegere, Peter P; Van Mieghem, Nicolas M

    2017-03-03

    Right bundle branch block is an established predictor for new conduction disturbances and need for a permanent pacemaker (PPM) after transcatheter aortic valve replacement. The aim of the study was to evaluate the absolute rates of transcatheter aortic valve replacement related PPM implantations in patients with pre-existent right bundle branch block and categorize for different transcatheter heart valves. We pooled data on 306 transcatheter aortic valve replacement patients from 4 high-volume centers in Europe and selected those with right bundle branch block at baseline without a previously implanted PPM. Logistic regression was used to evaluate whether PPM rate differed among transcatheter heart valves after adjustment for confounders. Mean age was 83±7 years and 63% were male. Median Society of Thoracic Surgeons score was 6.3 (interquartile range, 4.1-10.2). The following transcatheter valve designs were used: Medtronic CoreValve (n=130; Medtronic, Minneapolis, MN); Edwards Sapien XT (ES-XT; n=124) and Edwards Sapien 3 (ES-3; n=32; Edwards Lifesciences, Irvine, CA); and Boston Scientific Lotus (n=20; Boston Scientific Corporation, Marlborough, MA). Overall permanent pacemaker implantation rate post-transcatheter aortic valve replacement was 41%, and per valve design: 75% with Lotus, 46% with CoreValve, 32% with ES-XT, and 34% with ES-3. The indication for PPM implantation was total atrioventricular block in 98% of the cases. Lotus was associated with a higher PPM rate than all other valves. PPM rate did not differ between ES-XT and ES-3. Ventricular paced rhythm at 30-day and 1-year follow-up was present in 81% at 89%, respectively. Right bundle branch block at baseline is associated with a high incidence of PPM implantation for all transcatheter heart valves. PPM rate was highest for Lotus and lowest for ES-XT and ES-3. Pacemaker dependency remained high during follow-up. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by

  15. Bicuspid aortic valve increases risk of permanent pacemaker implant following aortic root replacement.

    PubMed

    Guglielmetti, Laura; Nazif, Tamim; Sorabella, Robert; Akkoc, Deniz; Kantor, Alex; Gomez, Andres; Wang, Catherine; Takayama, Hiroo; Dizon, Jose; Borger, Michael; George, Isaac

    2016-09-01

    We aimed to assess the incidence and possible differences in postoperative conduction delay after aortic root replacement (ARR) in bicuspid aortic valve (BAV) patients compared with a tricuspid aortic valve (TAV). A total of 380 patients undergoing ARR at our institution between 2005 and 2013 were included in the analysis. Patients were stratified by aortic valve anatomy: BAV, n = 191 vs TAV, n = 189. Electrocardiographic and echocardiographic data were retrospectively analysed at different time points (pre-, postoperatively and at follow-up). Primary outcome of interest was permanent pacemaker (PPM) implantation within 30 days, the composite of new PPM or new left fascicular or bundle branch block (PPM or LBBB) was the secondary outcome of interest. Age range was 24-89.5 years and incidence of preoperative moderate to severe aortic stenosis was 9.7%. BAV patients had higher incidence of PPM implantation within 30 days (5.8 vs 1.6% in TAV, P = 0.053); moreover, the composite of PPM or LBBB was also more frequent in BAV (8.4 vs 2.1%, P = 0.010). BAV was independently associated with PPM insertion (OR 4.08, P = 0.047) and also an independent predictor of PPM or LBBB in multiple regression (OR 4.96, P = 0.006). Significantly higher incidence of PPM implantation or LBBB may exist after ARR in bicuspid patients and BAV was confirmed to be an independent predictor for postoperative conduction disturbances by multivariable regression. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  16. Long-term durability of bioprosthetic aortic valves: implications from 12,569 implants.

    PubMed

    Johnston, Douglas R; Soltesz, Edward G; Vakil, Nakul; Rajeswaran, Jeevanantham; Roselli, Eric E; Sabik, Joseph F; Smedira, Nicholas G; Svensson, Lars G; Lytle, Bruce W; Blackstone, Eugene H

    2015-04-01

    Increased life expectancy and younger patients' desire to avoid lifelong anticoagulation requires a better understanding of bioprosthetic valve failure. This study evaluates risk factors associated with explantation for structural valve deterioration (SVD) in a long-term series of Carpentier-Edwards PERIMOUNT aortic valves (AV). From June 1982 to January 2011, 12,569 patients underwent AV replacement with Edwards Lifesciences Carpentier-Edwards PERIMOUNT stented bovine pericardial prostheses, models 2700PM (n = 310) or 2700 (n = 12,259). Mean age was 71 ± 11 years (range, 18 to 98 years). 93% had native AV disease, 48% underwent concomitant coronary artery bypass grafting, and 26% had additional valve surgery. There were 81,706 patient-years of systematic follow-up data available for analysis. Demographics, intraoperative variables, and 27,386 echocardiographic records were used to identify risks for explant for SVD and assess longitudinal changes in transprosthesis gradients using time-varying covariable analyses. Three hundred fifty-four explants were performed, with 41% related to endocarditis and 44% to SVD. Actuarial estimates of explant for SVD at 10 and 20 years were 1.9% and 15% overall, respectively, and in patients younger than 60 years, 5.6% and 46%, respectively. Younger age (p < 0.0001), lipid-lowering drugs (p = 0.002), prosthesis-patient mismatch (p = 0.001), and higher postoperative peak and mean AV gradients were associated with explant for SVD (p < 0.0001). The effect of gradient on SVD was greatest in patients younger than 60 years. Durability of the Carpentier-Edwards PERIMOUNT aortic valve is excellent even in younger patients. Explant for SVD is related to gradient at implantation, especially in younger patients. Strategies to reduce early postoperative AV gradients, such as root enlargement or more efficient prostheses, should be considered. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights

  17. Patient selection for transcatheter aortic valve implantation: An interventional cardiology perspective.

    PubMed

    Mylotte, Darrren; Martucci, Giuseppe; Piazza, Nicolo

    2012-07-01

    Transcatheter aortic valve implantation (TAVI) has emerged as a highly effective minimally invasive treatment symptomatic for severe calcific aortic stenosis in patients at high or prohibitive surgical risk. The success of TAVI has been determined by a number of factors, but in particular by appropriate patient selection. Appropriate patient selection involves identifying patients with the potential to benefit most from TAVI and individualizing the bioprosthesis type and size, and the vascular access site for each case. We present herein, our critical appraisal on patient selection for TAVI: an interventional cardiology perspective.

  18. Retrograde Snare Technique to Overcome Hostile Aortic Arch Anatomy During Transcatheter Aortic Valve Implantation.

    PubMed

    De Palma, Rodney; Saleh, Nawsad; Ruck, Andreas; Settergren, Magnus

    2016-07-01

    Percutaneous valve implantation is a recognized therapy for calcific aortic stenosis in those patients who are inoperable or at high surgical risk. The transfemoral approach is the most frequently used method for device delivery, but a tortuous calcific aorta and the inflexibility of large-caliber endovascular equipment can impede progress or even cause the procedure to be abandoned. Herein, the use of a technique employing a snare to safely overcome device obstruction in the aortic arch of an elderly female patient is described. The technique may be of practical value whenever any large-caliber device is obstructed in the circulation.

  19. Transcatheter implantation of self-expandable valved prosthesis in outlet right ventricle an experimental study in pigs.

    PubMed

    Guilhen, José Cícero Stocco; Palma, José Honório; Gaia, Diego Felipe; Araujo, Andre Telis Vilela de; Teles, Carlos Alberto; Branco, João Nelson; Buffolo, Enio

    2011-01-01

    Patients with congenital heart disease who underwent pulmonary valvotomy or surgery to open the pulmonary valve ring are prone to develop residual pulmonary insufficiency or stenosis that may lead to right heart failure with clinical deterioration. These children require multiple interventions throughout their lives, which impose a high rate of morbidity and mortality. To develop a less invasive technique for implantation of a valved prosthesis through the right ventricle. The valved prosthesis consists of an auto expanding metal stent built with nitinol, surrounded with polyester, where the three leaflets of bovine pericardium were mounted. Twelve pigs were used to perform the implants. Echocardiographic control was performed immediately after implantation and one, four, eight and 12 weeks. One animal showed reflux of moderate to severe and three mild reflux. Transvalvular gradients measured before implantation ranged from 3 to 6 mmHg and that soon after the implant was increased, ranging from 7 to 45 mmHg. There was a decrease in these gradients during follow up and in only four of the twelve animals the gradients were above 20 mmHg. Thrombus formation occurred in the prosthesis of six animals, and this was the most frequent complication. These findings highlight the need for studies with the use of anticoagulants and antiplatelet, an attempt to reduce this event. The study aims to contribute for the start of the use of prosthetic heart valves that could be implanted through minimally invasive techniques without the use of cardiopulmonary bypass.

  20. In-Graft Endovascular Stenting Repair for Supravalvular Stenosis From Aortic Rupture After Balloon-Expanding Transcatheter Aortic Valve Implantation.

    PubMed

    Furukawa, Nobuyuki; Scholtz, Werner; Haas, Nikolaus; Ensminger, Stephan; Gummert, Jan; Börgermann, Jochen

    2015-01-01

    An 81-year-old man with high-grade aortic valve stenosis and status post-coronary artery bypass grafting and supracoronary replacement of the ascending aorta was referred for transcatheter aortic valve implantation. He was in New York Heart Association class III and had dyspnea. After appropriate screening, we implanted a 29-mm SAPIEN XT valve (Edwards Lifesciences, Irvine, CA USA) through a transapical approach because of severe peripheral arterial occlusive disease. Postinterventional aortography revealed correct positioning and function of the valve and free coronary ostia but contrast extravasation in the vicinity of the interposed vascular prosthesis, resulting in severe luminal narrowing. We chose to manage the stenosis with an endovascular stent. After stenting, extravascular compression was markedly reduced, and the pressure gradient disappeared. The patient was discharged home on the 20th postoperative day. Three months later, computed tomography depicted correct positioning of both grafts. The patient's general health is good, and he is now in New York Heart Association class II. This case illustrates a complication of transcatheter aortic valve implantation specific for patients with an ascending aortic graft. Although stenting may be a good solution, as depicted by this case, self-expanding transcatheter aortic valves should be preferred in patients with ascending aortic grafts to avoid the described complication.

  1. Implantation of mitral, aortic, and tricuspid bioprostheses due to infective endocarditis with necessary reimplantation of the bioprosthetic aortic valve.

    PubMed

    Danielecki, Cezary; Bugajski, Paweł; Olszewski, Roman; Greberski, Krzysztof; Kalawski, Ryszard

    2016-09-01

    The patient was admitted to the Department of Cardiac Surgery of the J. Struś City Hospital in Poznan due to infective endocarditis involving the aortic, mitral, and tricuspid valves. Implantation of three biological valve prostheses proceeded without complications. Starting on day 23, the patient's general condition deteriorated, with high fever. Despite postoperative antibiotic therapy, transesophageal echocardiography revealed the presence of vegetation on the bioprosthetic aortic valve. On the 46(th) day after the initial surgery, the patient required replacement of the aortic bioprosthesis, which exhibited the presence of numerous vegetations. The bioprosthetic mitral and tricuspid valves were not affected by the degenerative process. On the 12(th) day after the reimplantation of the bioprosthetic aortic valve, the patient was discharged from the hospital in good general condition.

  2. Implantation of mitral, aortic, and tricuspid bioprostheses due to infective endocarditis with necessary reimplantation of the bioprosthetic aortic valve

    PubMed Central

    Bugajski, Paweł; Olszewski, Roman; Greberski, Krzysztof; Kalawski, Ryszard

    2016-01-01

    The patient was admitted to the Department of Cardiac Surgery of the J. Struś City Hospital in Poznan due to infective endocarditis involving the aortic, mitral, and tricuspid valves. Implantation of three biological valve prostheses proceeded without complications. Starting on day 23, the patient's general condition deteriorated, with high fever. Despite postoperative antibiotic therapy, transesophageal echocardiography revealed the presence of vegetation on the bioprosthetic aortic valve. On the 46th day after the initial surgery, the patient required replacement of the aortic bioprosthesis, which exhibited the presence of numerous vegetations. The bioprosthetic mitral and tricuspid valves were not affected by the degenerative process. On the 12th day after the reimplantation of the bioprosthetic aortic valve, the patient was discharged from the hospital in good general condition. PMID:27785140

  3. Computed tomography evaluation for transcatheter aortic valve implantation (TAVI): imaging of the aortic root and iliac arteries.

    PubMed

    Schoenhagen, Paul; Kapadia, Samir R; Halliburton, Sandra S; Svensson, Lars G; Tuzcu, E Murat

    2011-01-01

    For patients with severe aortic stenosis, open-heart surgical valve replacement remains the current clinical standard with documented, excellent long-term outcome. Over the past few years, transcatheter aortic valve implantation (TAVI) has developed into a treatment alternative for high-risk patients with severe aortic stenosis. Because transcatheter valvular procedures are characterized by lack of exposure of the operative field, image guidance is critical. This Pictorial Essay describes the role of 3-dimensional imaging with multidetector row computed tomography for detailed reconstructions of the aortic valve, aortic root, and iliac arteries in the context of TAVI.

  4. Comprehensive prospective cognitive and physical function assessment in elderly patients undergoing transcatheter aortic valve implantation.

    PubMed

    Orvin, Katia; Dvir, Danny; Weiss, Avraham; Assali, Abid; Vaknin-Assa, Hana; Shapira, Yaron; Gazit, Osnat; Sagie, Alex; Kornowski, Ran

    2014-01-01

    Transcatheter aortic valve implantation (TAVI) is occasionally associated with stroke and silent cerebral ischemia, which may affect cognitive and functional performance. The aim of this study was to evaluate the changes in cognitive performance and functional status following TAVI. We performed a comprehensive prospective functional, cognitive and quality of life (QOL) evaluation in consecutive patients who underwent TAVI using the CoreValve device (Medtronic Inc.). The evaluation was performed at baseline and 1 month after the procedure and included the 36-item Short-Form Health Survey for QOL assessment, Mini-Mental State Examination (MMSE), quantitative clock drawing test (Rouleau), color trails test, Cognistat evaluation, Barthel Index and Duke Activity Status Index. A total of 36 patients completed the full pre- and post-TAVI evaluation. Mean age was 82.2 ± 4.2 years (52.8% men); 94.5% of patients had low functional class (New York Heart Association III/IV), and 13.9% had prior stroke. After the procedure, all patients had improved functional status and valve hemodynamics. At 1 month, there was a significant improvement in the MMSE and Cognistat evaluations (from 25.9 ± 3.3 to 27.6 ± 2.4, p < 0.001, and from 5 ± 1 to 5.7 ± 0.7, p = 0.001, respectively). Our preliminary results of a comprehensive assessment of patients undergoing TAVI indicate favorable results for both functional performance and cognitive function early after the procedure.

  5. In-hospital cost comparison between percutaneous pulmonary valve implantation and surgery

    PubMed Central

    Mishra, Vinod; Lewandowska, Milena; Andersen, Jack Gunnar; Andersen, Marit Helen; Lindberg, Harald; Døhlen, Gaute; Fosse, Erik

    2017-01-01

    Abstract OBJECTIVES: Today, both surgical and percutaneous techniques are available for pulmonary valve implantation in patients with right ventricle outflow tract obstruction or insufficiency. In this controlled, non-randomized study the hospital costs per patient of the two treatment options were identified and compared. METHODS: During the period of June 2011 until October 2014 cost data in 20 patients treated with the percutaneous technique and 14 patients treated with open surgery were consecutively included. Two methods for cost analysis were used, a retrospective average cost estimate (overhead costs) and a direct prospective detailed cost acquisition related to each individual patient (patient-specific costs). RESULTS: The equipment cost, particularly the stents and valve itself was by far the main cost-driving factor in the percutaneous pulmonary valve group, representing 96% of the direct costs, whereas in the open surgery group the main costs derived from the postoperative care and particularly the stay in the intensive care department. The device-related cost in this group represented 13.5% of the direct costs. Length-of-stay-related costs in the percutaneous group were mean $3885 (1618) and mean $17 848 (5060) in the open surgery group. The difference in postoperative stay between the groups was statistically significant (P≤ 0.001). CONCLUSIONS: Given the high postoperative cost in open surgery, the percutaneous procedure could be cost saving even with a device cost of more than five times the cost of the surgical device. PMID:28007875

  6. Histological biocompatibility of new, non-absorbable glaucoma deep sclerectomy implant.

    PubMed

    Kałuzny, Jakub J; Jóźwicki, Wojciech; Wiśniewska, Halina

    2007-05-01

    We performed this study to compare the intrascleral biocompatibility of three materials: non-absorbable hydrogel contact lens polymer, non-absorbable silicone rubber, and absorbable cross-linked sodium hyaluronate. Intrascleral implantation of three different materials was performed in 13 healthy, pigmented rabbits. Implants of methacrylic hydrogel, silicone rubber, and cross-linked sodium hyaluronate were implanted in 10, 8, and 8 eyes, respectively. The animals were euthanized at 7, 30, 180, and 360 days post implantation. The eyes were enucleated and immediately fixed in 10% buffered formalin. Semithin sections were cut and stained with hematoxylin-eosin. Light microscope analysis of the specimens was performed. The least severe inflammatory reaction was observed with cross-linked sodium hyaluronate implants. The number of inflammatory cells in proximity to methacrylic hydrogel and silicone implants at all periods of follow up was similar. The thickest fibrous capsule was observed with silicone implants (average, 28.38 +/- 11.17 microm). This area was thinner with methacrylic hydrogel implants (average, 14.90 +/- 5.57 microm) and was thinnest around sodium hyaluronate implants (average, 7.21 +/- 2.33 microm). For each type of implant, the wall on the conjunctival side of the fibrous capsule was significantly thicker than the wall on the choiroidal side. The space between the implant, scleral flap, and bed was filled soon after surgery with connective tissue rich in vessels. In our study, cross-linked sodium hyaluronate had the highest intrascleral biocompatibility. Although the inflammatory responses of the sclera to methacrylic hydrogel and silicone rubber were similar in nature, a thicker fibrous capsule was generated around silicone implants.

  7. Micro-Bypass Implantation for Primary Open-Angle Glaucoma Combined with Phacoemulsification: 4-Year Follow-Up

    PubMed Central

    Fea, Antonio Maria; Consolandi, Giulia; Zola, Marta; Pignata, Giulia; Cannizzo, Paola; Lavia, Carlo; Rolle, Teresa; Grignolo, Federico Maria

    2015-01-01

    Purpose. To report the long-term follow-up results in patients with cataract and primary open-angle glaucoma (POAG) randomly assigned to cataract surgery combined with micro-bypass stent implantation or phacoemulsification alone. Methods. 36 subjects with cataract and POAG were randomized in a 1 : 2 ratio to either iStent implantation and cataract surgery (combined group) or cataract surgery alone (control group). 24 subjects agreed to be evaluated again 48 months after surgery. Patients returned one month later for unmedicated washout assessment. Results. At the long-term follow-up visit we reported a mean IOP of 15,9 ± 2,3 mmHg in the iStent group and 17 ± 2,5 mmHg in the control group (p = NS). After washout, a 14,2% between group difference in favour of the combined group was statistically significant (p = 0,02) for mean IOP reduction. A significant reduction in the mean number of medications was observed in both groups compared to baseline values (p = 0,005 in the combined group and p = 0,01 in the control group). Conclusion. Patients in the combined group maintained low IOP levels after long-term follow-up. Cataract surgery alone showed a loss of efficacy in controlling IOP over time. Both treatments reduced the number of ocular hypotensive medications prescribed. This trial is registered with: NCT00847158. PMID:26587282

  8. Evaluation of Bleb Morphology and Reduction in IOP and Glaucoma Medication following Implantation of a Novel Gel Stent

    PubMed Central

    Spinetta, Roberta; Cannizzo, Paola Maria Loredana; Consolandi, Giulia; Lavia, Carlo; Germinetti, Francesco; Rolle, Teresa

    2017-01-01

    Objective To evaluate the efficacy and safety of the Xen Gel Stent and provide a macro- and microscopic analyses of bleb morphology. Methods A prospective 12-month study on patients with primary open-angle glaucoma. Patients underwent implantation of the XEN Gel Stent (Allergan INC, Dublin, Ireland) either alone or combined with a cataract surgery. Biomicroscopy, in vivo confocal microscopy (IVCM), and anterior segment-optical coherence tomography (AS-OCT) were used to assess bleb morphology. Safety parameters were adverse events, best corrected visual acuity, visual field, and corneal endothelial cell loss. A postoperative IOP ≤ 18 mmHg without or on medications was respectively defined as complete and qualified success while an IOP ≥ 18 mmHg was defined as failure. Results Twelve eyes of 11 patients were evaluated. At one year, 5 out of 10 patients available achieved a complete success while five were qualified success. AS-OCT showed that bleb wall reflectivity was significantly higher in the failure group; IVCM revealed that stromal density was significantly lower in the success group. No safety issues were recorded. Conclusion Implantation of the XEN Gel Stent appears to be a safe and effective procedure. AS-OCT and IVCM may be helpful in bleb assessment. PMID:28751986

  9. Comparison between the EX-PRESS P-50 implant and trabeculectomy in patients with open-angle glaucoma

    PubMed Central

    Mendoza-Mendieta, María Elena; López-Venegas, Ana Paola; Valdés-Casas, Gerardo

    2016-01-01

    Purpose To evaluate the EX-PRESS P-50 implant compared to standard trabeculectomy (TBC). Methods Single-center prospective randomized study; 20 eyes of 20 patients were treated with the EX-PRESS P-50 implant, and 20 eyes of 20 patients with TBC, over a 19-month period. Records of all patients were reviewed and compared. Success was defined as intraocular pressure (IOP) <21 and >5 mmHg or a decrease of 30% of IOP. Failure was defined as >21 mmHg or decline in visual acuity. Statistical analysis was made with Student’s t-test and χ2 test analyzed with SPSS version 13.0. Results The average follow-up was 8.6 months (±4.9 months) for the EX-PRESS P-50 group and 9.6 months (±5.3 months) for the TBC group. The postoperative visual acuity and IOP were not significantly different. We report more complications in the EX-PRESS P-50 group. At 3, 6, and 12 months follow-up, the control group was found to be free of complications, whereas multiple complications were observed in the EX-PRESS P-50 group at 3 and 6 months follow-up. We found no differences in either group with respect to success. Conclusion Both procedures are equally effective for the treatment of glaucoma, with 80% success in the EX-PRESS P-50 group and 72.7% in the control group. PMID:26893540

  10. Ventricular conduction defects after transcatheter aortic valve implantation: a single-institute analysis.

    PubMed

    Kawaguchi, Akira T; D'Allessandro, Cosimo; Collet, Jean Philippe; Cluzel, Philippe; Makri, Ralouka; Leprince, Pascal

    2015-05-01

    Patients with aortic stenosis tend to develop ventricular conduction problems, which are known adverse events following transcatheter aortic valve implantation (TAVI). Changes in ventricular conduction status after TAVI were analyzed in 195 consecutive patients from a single institute registered in FRANCE2 between February 2010 and June 2012. Among the 195 patients, 29 had a prior pacemaker implantation (+PM) and 6 had acute catastrophic hemodynamics that made a full electrocardiogram (ECG) unavailable. Among the remaining 160, PM was newly required in 28 (17.5%, PM+) but not in 132 (PM-), which included 21 (13.1%) who developed new left bundle branch block (BBB), 12 (7.5%) had right BBB, and 99 (61.9%) had no change. While PM requirement had no correlation with preoperative factors, there was significant association with the development of right BBB with Edwards Sapien/XT (P = 0.003), and new left BBB (P = 0.012) and complete heart block requiring PM with CoreValve (22.6% vs. Edwards Sapien/XT, 7.4%, P = 0.016). Whereas postoperative survival regarding PM status (+PM, PM+, PM-), vascular access, valve size or type showed no difference, delayed heart block (n = 12, Day 2 or later) was associated with poor survival (P = 0.038) compared with the remaining PM+ patients with earlier onset (n = 16, Day 0 or 1). As a result, PM+ patients (n = 28) had significantly longer intensive care unit (ICU) stay and hospitalization than PM- or +PM patients. The results suggest that ventricular conduction problems requiring PM occurred more frequently after TAVI (17.5%) than with usual surgical replacement. Nonetheless, conduction problems failed to influence postoperative survival for up to 3 years on average with use of PM, but therefore did increase medical costs. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

  11. Percutaneous pulmonary valve implantation for free pulmonary regurgitation following conduit-free surgery of the right ventricular outflow tract.

    PubMed

    Cools, Bjorn; Brown, Stephen C; Heying, Ruth; Jansen, Katrijn; Boshoff, Derize E; Budts, Werner; Gewillig, Marc

    2015-01-01

    Pulmonary regurgitation (PR) following surgery of the right ventricular outflow tract (RVOT) is not innocent and leads to significant right heart dysfunction over time. Recent studies have demonstrated that percutaneous valves can be implanted in conduit free outflow tracts with good outcomes. To evaluate in patients with severe PR--anticipated to require future pulmonary valve replacement--the feasibility and safety of pre-stenting dilated non-stenotic patched conduit-free right ventricular outflow tracts before excessive dilation occurs, followed by percutaneous pulmonary valve implantation (PPVI). Twenty seven patients were evaluated, but only 23 were deemed suitable based on the presence of an adequate retention zone ≤ 24 mm defined by semi-compliant balloon interrogation of the RVOT. A 2 step procedure was performed: first the landing zone was prepared by deploying a bare stent, followed 2 months later by valve implantation. RVOT pre-stenting with an open cell bare metal stent (Andrastent XXL range) was performed at a median age of 13.0 years (range: 6.0-44.9) with a median weight of 44.3 kg (range: 20.0-88.0). Ninety six percent (22/23) of patients proceeded to PPVI a median of 2.4 months (range: 1.4-3.4) after initial pre-stent placement. Twenty one Melody valves and one 26 mm Edwards SAPIEN™ valve were implanted. Complications consisted of embolization of prestent (n = 1), scrunching (n = 4) and mild stent dislocation (n = 2). During follow-up, no stent fractures were observed and right ventricular dimensions decreased significantly. Post-surgical conduit-free non-stenotic RVOT with free pulmonary regurgitation can be treated percutaneously with a valved stent if anatomical (predominantly size) criteria are met. In experienced hands, the technique is feasible with low morbidity. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  12. Clinical outcomes of transcatheter aortic valve implantation: from learning curve to proficiency

    PubMed Central

    Lunardi, Mattia; Pesarini, Gabriele; Zivelonghi, Carlo; Piccoli, Anna; Geremia, Giulia; Ariotti, Sara; Rossi, Andrea; Gambaro, Alessia; Gottin, Leonardo; Faggian, Giuseppe; Vassanelli, Corrado; Ribichini, Flavio

    2016-01-01

    Objective The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve. Methods Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success. Margins for events acceptance were extrapolated from landmark trials that tested both balloon or self-expandable percutaneous valves. Results 30-day and 1-year survival rates were 97.2% and 89.9%, respectively. Achievement of the primary end point (number of cases needed to provide the acceptable margin of the composite end point of any death, stroke, myocardial infarction, life-threatening bleeding, major vascular complications, stage 2–3 acute kidney injury and valve-related dysfunction requiring a repeat procedure) required the performance of 54 cases, while the learning curve to achieve ‘device success’ identified 32 cases to reach the expected proficiency. In this experience, the baseline clinical risk as assessed by the Society of Thoracic Surgeons (STS) score determined the long-term survival rather than the adverse events related to the learning curve. Conclusions A relatively large number of cases are required to achieve clinical outcomes comparable to those reported in high-volume centres and controlled trials. According to our national workload standards, this represents more than 2 years of continuous activity. PMID:27621826

  13. Prediction of fluoroscopic angulations for transcatheter aortic valve implantation by CT angiography: influence on procedural parameters.

    PubMed

    Hell, Michaela M; Biburger, Lukas; Marwan, Mohamed; Schuhbaeck, Annika; Achenbach, Stephan; Lell, Michael; Uder, Michael; Arnold, Martin

    2017-05-01

    Repeated angiograms to achieve an exactly orthogonal visualization of the aortic valve plane can substantially contribute to the total contrast amount required for transcatheter aortic valve implantation (TAVI). We investigated whether pre-procedural identification of an optimal fluoroscopic projection by cardiac computed tomography (CT) can significantly reduce the amount of a procedure-related contrast agent compared with angiographic determination of suitable angulations. Eighty consecutive patients (81 ± 5 years, 55% male) with symptomatic severe aortic valve stenosis and normal renal function who underwent cardiac CT prior to TAVI were prospectively randomized. In 40 patients, a CT-predicted suitable angulation was used for the first aortic angiogram (CT cohort); in the other 40 patients, the first aortogram was acquired at LAO 10°/cranial 10 (angiography cohort). Additional aortograms were performed if no satisfactory view of the aortic valve plane was obtained. The number of aortograms needed to achieve a satisfactory fluoroscopic projection (1.2 ± 0.6 vs. 3.2 ± 1.7; P < 0.001) and the total amount of contrast agent per TAVI procedure were significantly lower in the CT cohort (95 ± 21 vs. 125 ± 36 mL; P < 0.001). Incidence of acute kidney injury was not significantly different. There was no significant difference regarding radiation dose, time of procedure, degree of post-procedural aortic regurgitation, complications and 30-day mortality between the cohorts. Pre-procedural identification of a suitable fluoroscopic projection by cardiac CT significantly reduces a procedural contrast agent volume required for TAVI.

  14. Cardiac rehabilitation programme after transcatheter aortic valve implantation versus surgical aortic valve replacement: Systematic review and meta-analysis.

    PubMed

    Ribeiro, Gustavo S; Melo, Rosangela D; Deresz, Luís F; Dal Lago, Pedro; Pontes, Mauro Rn; Karsten, Marlus

    2017-05-01

    Background Aortic stenosis is a valvular heart disease characterised by fixed obstruction of the left ventricular outflow. It can be managed by surgical aortic valve replacement (sAVR) or transcatheter aortic valve implantation (TAVI). This review aimed to describe the evidence supporting a cardiac rehabilitation programme on functional capacity and quality of life in aortic stenosis patients after sAVR or TAVI. Methods The search was conducted on multiple databases from January to March 2016. All studies were eligible that evaluated the effects of a post-interventional cardiac rehabilitation programme in aortic stenosis patients. The methodological quality was assessed using the PEDro scale. Meta-analysis was performed separately by procedure and between procedures. The walked distance during the six-minute walk test (6MWD) and Barthel index were evaluated. The analysis was conducted in Review Manager. Results Five studies were included (292 TAVI and 570 sAVR patients). The meta-analysis showed that a cardiac rehabilitation programme was associated with a significant improvement in 6MWD (0.69 (0.47, 0.91); P < 0.001) and Barthel index (0.80 (0.29, 1.30); P = 0.002) after TAVI and 6MWD (0.79 (0.43, 1.15); P < 0.001) and Barthel index (0.93 (0.67, 1.18); P < 0.001) after sAVR. In addition, the meta-analysis showed that the cardiac rehabilitation programme promoted a similar gain in 6MWD (4.28% (-12.73, 21.29); P = 0.62) and Barthel index (-1.52 points (-4.81, 1.76); P = 0.36) after sAVR or TAVI. Conclusions The cardiac rehabilitation programme improved the functional capacity and quality of life in aortic stenosis patients. Patients who underwent TAVI benefitted with a cardiac rehabilitation programme similar to sAVR patients.

  15. VALVE

    DOEpatents

    Arkelyan, A.M.; Rickard, C.L.

    1962-04-17

    A gate valve for controlling the flow of fluid in separate concentric ducts or channels by means of a single valve is described. In one position, the valve sealing discs engage opposed sets of concentric ducts leading to the concentric pipes defining the flow channels to block flow therethrough. In another position, the discs are withdrawn from engagement with the opposed ducts and at the same time a bridging section is interposed therebetween to define concentric paths coextensive with and connecting the opposed ducts to facilitate flow therebetween. A wedge block arrangement is employed with each sealing disc to enable it to engage the ducts. The wedge block arrangement also facilitates unobstructcd withdrawal of the discs out of the intervening space between the sets of ducts. (AEC)

  16. Short-term safety of dexamethasone implant for treatment of macular edema due to retinal vein occlusion, in eyes with glaucoma or treated ocular hypertension.

    PubMed

    Theodoropoulou, Sofia; Ellabban, Abdallah A; Johnston, Robert L; Cilliers, Helena; Mohamed, Quresh; Sallam, Ahmed B

    2017-04-01

    To report the short-term safety of dexamethasone implants to treat macular edema due to retinal vein occlusion (RVO), in eyes with treated glaucoma or ocular hypertension at baseline using an as-needed re-treatment regimen. Retrospective clinical database study from two centers using the same electronic medical record system. Extracted data included: intraocular pressure (IOP), visual acuity (VA), central 1 mm retinal thickness (CRT) by optical coherence tomography, phakic status, number of injections, glaucoma treatment, and peri-operative complications. Thirty-three eyes of 33 patients on IOP-lowering treatment for glaucoma or ocular hypertension (OHT) at baseline and mean IOP of 16 mmHg at baseline received one to four (mean, 1.8; median, 1) dexamethasone implants over 18 months for RVO-related macular edema. Fourteen eyes (42 %) had IOP of ≥21 mmHg, and three eyes (9 %) had IOP of ≥35 mmHg at one or more visits during the study period. Nine of 14 eyes (64 %) with raised IOP required additional topical treatment only for a mean (SE) period of 8.5 months (3.2), while the remaining five eyes (36 %) required long-term additional IOP-lowering treatment for a mean (SE) of 16 months (1.44). Surgery for IOP lowering was not required in any eye. Mean VA (SE) improved from 44 (3) ETDRS letters at baseline to 47 letters (5) at 2 months (p = 0.049), 48 (8) letters at 6 months and 46 (4) letters at 12 months. Mean CRT (SE) improved from 530 (25) μm at baseline to 323 (27) μm at 2 months (p < 0.001), 498 (76) μm at 6 months, and 359 (25) μm at 12 months (p < 0.001). The short-term IOP rise after intravitreal dexamethasone implant in eyes with glaucoma or ocular hypertension at baseline was acceptable and consistent with previous reports in patients without preexisting glaucoma. Treated OHT or glaucoma may not be a strict contraindication against the use of dexamethasone implant, but close monitoring of IOP is required.

  17. Valve

    DOEpatents

    Cho, Nakwon

    1980-01-01

    A positive acting valve suitable for operation in a corrosive environment is provided. The valve includes a hollow valve body defining an open-ended bore for receiving two, axially aligned, spaced-apart, cylindrical inserts. One insert, designated the seat insert, terminates inside the valve body in an annular face which lies within plane normal to the axis of the two inserts. An elastomeric O-ring seal is disposed in a groove extending about the annular face. The other insert, designated the wedge insert, terminates inside the valve body in at least two surfaces oppositely inclined with respect to each other and with respect to a plane normal to the axis of the two inserts. An elongated reciprocable gate, movable between the two inserts along a path normal to the axis of the two inserts, has a first flat face portion disposed adjacent and parallel to the annular face of the seat insert. The gate has a second face portion opposite to the first face portion provided with at least two oppositely inclined surfaces for mating with respective inclined surfaces of the wedge insert. An opening is provided through the gate which registers with a flow passage through the two inserts when the valve is open. Interaction of the respective inclined surfaces of the gate and wedge insert act to force the first flat face portion of the gate against the O-ring seal in the seat insert at the limits of gate displacement where it reaches its respective fully open and fully closed positions.

  18. The Ibero-American transcatheter aortic valve implantation registry with the CoreValve prosthesis. Early and long-term results.

    PubMed

    Muñoz-García, Antonio J; del Valle, Raquel; Trillo-Nouche, Ramiro; Elízaga, Jaime; Gimeno, Federico; Hernández-Antolín, Rosana; Teles, Rui; de Gama Ribeiro, Vasco; Molina, Eduardo; Cequier, Angel; Urbano-Carrillo, Cristóbal; Cruz-González, Ignacio; Payaslian, Miguel; Patricio, Lino; Sztejfman, Matías; Iñiguez, Andrés; Rodríguez, Víctor; Scuteri, Antonio; Caorsi, Carlos; López-Otero, Diego; Avanzas, Pablo; Alonso-Briales, Juan H; Hernández-García, José M; Morís, César

    2013-11-20

    Transcatheter aortic valve implantation (TAVI) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The aim of this study was to describe early experience and long-term follow-up with the CoreValve self-expanding aortic prosthesis at 42 Ibero-American hospitals. Multiple centre observational study including 1220 consecutive patients with symptomatic severe aortic stenosis who are not suitable candidates for surgery and underwent transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System between December 2007 and May 2012. The registry included 1220 consecutive patients with a mean age of 80.8 ± 6.3 years and a mean logistic euroSCORE of 17.8% ± 13%. The procedural success rate was 96.1%. Hospital mortality was 7.3% and combined end-point was 21.3%. Aortic regurgitation after TAVI was present in 24.5% (Sellers grade ≥ 2). The estimated 1-year and 2-year survival rates were 82.1% and 73.4% respectively. The following issues were significant independent risk factors for hospital mortality: acute kidney failure (odds ratio 3.55); stroke (odds ratio 5.72); major bleeding (odds ratio 2.64) and euroSCORE (odds ratio 1.02). Long-term predictors of mortality were diabetes mellitus (hazard ratio 1.59, 95% confidence interval 1.09-2.31), severe chronic obstructive pulmonary disease (hazard ratio 1.85, 95% confidence interval 1.85-2.88), and functional classes NYHA III-IV (hazard ratio 1.31, 95% confidence interval 1.01-1.70). Transcatheter aortic valve implantation constitutes a safe and viable therapeutic option for high operative risk patients with severe aortic stenosis. Long-term prognosis is conditioned by associate comorbidities. © 2013.

  19. Novel FBN1 mutation causes Marfan syndrome with bilateral ectopia lentis and refractory glaucoma.

    PubMed

    Milla, Elena; Leszczynska, Ania; Rey, Amanda; Navarro, Manuel; Larena, Concepcion

    2012-01-01

    We report the case of a 41-year-old woman with bilateral lens subluxation and medically uncontrolled glaucoma in whom Marfan syndrome (MFS) was diagnosed. The patient underwent complete clinical eye and systemic examinations and blood samples were drawn for mutational screening of fibrillin 1 gene (FBN1). The patient was diagnosed with MFS on a clinical basis and according to the Ghent criteria and the genetic testing revealed a novel heterozygous mutation in the FBN1 gene. The patient required pars plana vitrectomy with lensectomy and Ahmed valve implantation in the vitreous cavity to control her severe glaucoma. The diagnosis of a bilateral lens luxation must be followed by complete systemic examination and genetic analysis of the FBN1 gene in order to discard MFS due to its severe systemic complications. Frequently, the condition causes an aggressive secondary glaucoma that requires surgical treatment with lensectomy, vitrectomy, and drainage device implantation in order to avoid its devastating progression toward glaucomatous optic atrophy.

  20. Primary Mitral Valve Regurgitation Outcome in Patients With Severe Aortic Stenosis 1 Year After Transcatheter Aortic Valve Implantation: Echocardiographic Evaluation.

    PubMed

    Florentino, Thiago Marinho; Bihan, David Le; Abizaid, Alexandre Antonio Cunha; Cedro, Alexandre Vianna; Corrêa, Amably Pessoa; Santos, Alexandre Roginski Mendes Dos; Souza, Alexandre Costa; Bignoto, Tiago Costa; Sousa, José Eduardo Moraes Rego; Sousa, Amanda Guerra de Moraes Rego

    2017-07-10

    Mitral valve regurgitation (MR), present in up to 74% of the patients with severe aortic stenosis (AS), can be a negative prognostic factor when moderate or severe. The outcome of MR after percutaneous transcatheter aortic valve implantation (TAVI) and predictors associated with that outcome have not been well established in the literature. To assess the outcome of primary MR in patients submitted to TAVI and to identify associated factors. Observational study of patients with symptomatic severe AS submitted to TAVI from January 2009 to April 2015 at two specialized centers. Echocardiographic outcome was assessed with data collected before and 1 year after TAVI. Of the 91 patients with MR submitted to TAVI and followed up for at least 12 months, 67 (73.6%) had minimum/mild MR before the procedure and 24 (26.4%) had moderate/severe MR. Of those with minimum/mild MR, 62 (92.5%) had no change in the MR grade (p < 0.001), while 5 (7.5%) showed worsening. Of those with moderate/severe MR, 8 (33.3%) maintained the same grade and 16 (66.7%) improved it (p = 0.076). Patients with moderate/severe MR who improved MR grade had lower EuroSCORE II (p = 0.023) and STS morbidity (p = 0.027) scores, as compared to those who maintained the MR grade. MR grades change after TAVI. This study suggests a trend towards improvement in moderate/severe MR after TAVI, which was associated with lower preoperative risk scores. A insuficiência valvar mitral (IM), presente em até 74% dos pacientes com estenose aórtica (EA) grave, pode representar um fator prognóstico negativo quando moderada ou importante. A evolução da IM após implante percutâneo de valva aórtica transcateter (TAVI) e preditores associados a essa evolução não estão bem estabelecidos na literatura. Avaliar a evolução da IM primária em pacientes submetidos ao TAVI e identificar fatores associados a essa evolução. Realizou-se um estudo observacional em pacientes com EA grave sintomática, submetidos ao TAVI no

  1. Cuspal dehiscence at a post and along the stent cloth in a bovine pericardium heart valve implanted for seven years.

    PubMed

    Guidoin, Robert; Bes, Taniela Marli; Cianciulli, Tomas Francisco; Klein, Julianne; Li, Bin; Gauvin, Robert; Guzman, Randolph; Rochette-Drouin, Olivier; Germain, Lucie; Zhang, Ze

    2012-01-01

    A failing mitral valve prosthesis made from bovine pericardium was explanted from a 50-year-old patient. Preoperative transthoracic-echocardiography had confirmed severe mitral regurgitation due to structural failure of this HP Bio bovine pericardium heart valve prosthesis. The explanted device was examined macroscopically, by scanning electron microscopy (SEM), by light microscopy, and by transmission electron microscopy (TEM). Samples of unassembled patches of bovine pericardium were used as a pre-implantation control to better understand the changes that occurred in the structure of the pericardium following the 7 years of implantation. Examination confirmed complete dehiscence of a cusp along a valve post and the stent: This detached cusp was observed floating in the bloodstream at echocardiography. The fibrous pannus overgrowth was well developed along the stent and extended to the bottom of the cusps both on the inflow and the outflow sides. The fibrous panni were found to be poorly adhesive to the pericardium cusps and had become stiff, thus impairing the opening and closure of the valve. The structure of the pericardium cusps was severely deteriorated compared to the control bovine pericardium tissue samples. The collagen bundles were frequently broken and more stretched in the explanted device, lacking the wavy histological pattern of normal collagen fibers. However, the tissues were devoid of any calcification. In conclusion, the failure mode of this valve was the dehiscence of a cusp from a valve post and along the stent cloth in the absence calcification.

  2. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery.

    PubMed

    Leon, Martin B; Smith, Craig R; Mack, Michael; Miller, D Craig; Moses, Jeffrey W; Svensson, Lars G; Tuzcu, E Murat; Webb, John G; Fontana, Gregory P; Makkar, Raj R; Brown, David L; Block, Peter C; Guyton, Robert A; Pichard, Augusto D; Bavaria, Joseph E; Herrmann, Howard C; Douglas, Pamela S; Petersen, John L; Akin, Jodi J; Anderson, William N; Wang, Duolao; Pocock, Stuart

    2010-10-21

    Many patients with severe aortic stenosis and coexisting conditions are not candidates for surgical replacement of the aortic valve. Recently, transcatheter aortic-valve implantation (TAVI) has been suggested as a less invasive treatment for high-risk patients with aortic stenosis. We randomly assigned patients with severe aortic stenosis, whom surgeons considered not to be suitable candidates for surgery, to standard therapy (including balloon aortic valvuloplasty) or transfemoral transcatheter implantation of a balloon-expandable bovine pericardial valve. The primary end point was the rate of death from any cause. A total of 358 patients with aortic stenosis who were not considered to be suitable candidates for surgery underwent randomization at 21 centers (17 in the United States). At 1 year, the rate of death from any cause (Kaplan–Meier analysis) was 30.7% with TAVI, as compared with 50.7% with standard therapy (hazard ratio with TAVI, 0.55; 95% confidence interval [CI], 0.40 to 0.74; P<0.001). The rate of the composite end point of death from any cause or repeat hospitalization was 42.5% with TAVI as compared with 71.6% with standard therapy (hazard ratio, 0.46; 95% CI, 0.35 to 0.59; P<0.001). Among survivors at 1 year, the rate of cardiac symptoms (New York Heart Association class III or IV) was lower among patients who had undergone TAVI than among those who had received standard therapy (25.2% vs. 58.0%, P<0.001). At 30 days, TAVI, as compared with standard therapy, was associated with a higher incidence of major strokes (5.0% vs. 1.1%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001). In the year after TAVI, there was no deterioration in the functioning of the bioprosthetic valve, as assessed by evidence of stenosis or regurgitation on an echocardiogram. In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause

  3. Numerical analysis of the radial force produced by the Medtronic-CoreValve and Edwards-SAPIEN after transcatheter aortic valve implantation (TAVI).

    PubMed

    Tzamtzis, S; Viquerat, J; Yap, J; Mullen, M J; Burriesci, G

    2013-01-01

    A better understanding of the mechanisms producing the radial force in transcatheter heart valves is essential in order to reduce the reported cases of migration and atrio-ventricular block and improve the effectiveness of the treatment. This paper presents a numerical study of the different mechanisms responsible for the radial force exerted on the aortic annulus by self-expanding and balloon-expandable prostheses. The behavior of the Medtronic CoreValve (self-expanding) and the Edwards SAPIEN (balloon-expandable) devices, both of size 26, has been simulated and compared. The results indicate that, for both prostheses, the radial force may vary considerably within the recommended functional range for the valve implantation and is substantially higher at the smallest annular sizes. In particular, in the case of the self-expanding valve the radial force is essentially dependent on the diameter of the left ventricular outflow tract, while for the balloon-expandable valve the radial force produced is influenced by both the geometry and stiffness of the host tissue. The outcomes of this study provide a better insight into the phenomenon and useful information that could support the development of improved solutions. Copyright © 2012 IPEM. Published by Elsevier Ltd. All rights reserved.

  4. The Low Profile Bioprosthesis: Results with 491 Valves Implanted in 453 Patients for up to 5 Years

    PubMed Central

    Navia, J. A.; Gimenez, C.; Tamashiro, A.; Esper, R.; Haller, J.; Liotta, D.

    1982-01-01

    This report summarizes results of the first 453 consecutive patients who had 491 low profile bioprostheses implanted at the Italian Hospital in Buenos Aires over a 5-year period. During this time, with the goal of long-term durability, the valve mounting technique was slightly modified, whereas the materials and design of the annulus underwent more extensive changes. Images PMID:15226950

  5. Development of the Valvo pump: an axial flow pump implanted at the heart valve position.

    PubMed

    Mitamura, Y; Nakamura, H; Okamoto, E; Yozu, R; Kawada, S; Kim, D W

    1999-06-01

    Pulsatile artificial hearts having a relatively large volume are difficult to implant in a small patient, but rotary blood pumps can be easily implanted. The objective of this study was to show the feasibility of using the Valvo pump, an axial flow pump implanted at the heart valve position, in such cases. The Valvo pump consists of an impeller and a motor. The motor is waterproofed with a ferrofluidic seal. A blood flow of 5 L/min was obtained at a pressure difference of 13.3 kPa (100 mm Hg) at 7,000 rpm. The normalized index of hemolysis (NIH) was 0.030 +/- 0.003 (n = 3) for a blood flow of 5 L/min at a pressure difference of 13.3 kPa. The pressure resistance of the ferrofluidic seal was 37.5 kPa in a static condition and 26.3 kPa at 10,000 rpm. The seal exhibited no leaks for 41+ days against 20.0 kPa. The results showed that the Valvo pump can maintain systemic circulation with an acceptable level of hemolysis.

  6. Transapical Transcatheter Valve-in-Valve Implantation for Failed Mitral Bioprostheses: Gradient, Symptoms, and Functional Status in 18 High-Risk Patients Up to 5 Years.

    PubMed

    Cerillo, Alfredo Giuseppe; Gasbarri, Tommaso; Celi, Simona; Murzi, Michele; Trianni, Giuseppe; Ravani, Marcello; Solinas, Marco; Berti, Sergio

    2016-10-01

    The recourse to mitral valve-in-valve implantation is expected to rise consistently owing to the increasing use of bioprostheses and to the risks related to redo valve replacement. However, there is concern that the excellent early results of mitral valve-in-valve could be nullified by the development of significant gradients. We report our experience with mitral valve-in-valve implantation, with particular emphasis on the midterm follow-up. Eighteen patients underwent mitral valve-in-valve implantation at our institution. The mean Society of Thoracic Surgeons score was 10.3. All patients were heavily symptomatic. The mechanisms of bioprosthesis failure were stenosis (3 patients), regurgitation (4 patients) or mixed (11 patients). The mean transprosthetic gradient was 12.8 ± 5.7 mm Hg. All the procedures were transapical. Balloon predilation was never used. In the first patient, the transcatheter valve embolized in the ventricle. The patient died 2 days later of multiorgan failure. There were no other hospital deaths. Four patients died of pneumonia, endocarditis, lung cancer, and stroke at 1, 8, 18, and 46 months, postoperatively. The mean gradient at discharge was 5.1 ± 2.3 mm Hg. At follow-up (median 27 months), all surviving patients were in New York Heart Association functional class II or less. The mean transprosthetic gradient was 7 ± 1.8 mm Hg, and 1 patient had a gradient more than 10 mm Hg. Mitral valve-in-valve implantation allows good clinical and hemodynamic results. In our series, the appearance of a significant gradient at follow-up was not associated with echocardiographic signs of structural deterioration, and was possibly related to the size of the transcatheter and recipient valve. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  7. Comparison of Edwards SAPIEN 3 versus SAPIEN XT in transfemoral transcatheter aortic valve implantation: Difference of valve selection in the real world.

    PubMed

    Arai, Takahide; Lefèvre, Thierry; Hovasse, Thomas; Morice, Marie-Claude; Garot, Philippe; Benamer, Hakim; Unterseeh, Thierry; Hayashida, Kentaro; Watanabe, Yusuke; Bouvier, Erik; Cormier, Bertrand; Chevalier, Bernard

    2017-03-01

    The SAPIEN 3 (S3; Edwards Lifescience, Irvine, CA, USA) is a new-generation percutaneous aortic valve with better profile, more precise handling and positioning, designed to reduce the risk of post-procedural paravalvular aortic leak (PVL). The aim of this study was to compare the S3 valve and SAPIEN XT valve (SXT). The last 89 transfemoral transcatheter aortic valve implantation (TAVI) cases using SXT were compared to the first 111 cases using the S3. Patient age and logistic EuroSCORE were similar (83.1 years vs 83.0 years and 18.2% vs 16.6%) in the S3 and SXT groups, respectively as were other baseline characteristics. The ratio of valve diameter/calculated annulus average diameter (CAAD) by multi-detector row computed tomography was significantly lower in the S3 group (1.06 vs 1.09, p<0.001) as was the annular area oversizing percentage (11.3% vs 20.5%, p<0.001). Furthermore, a smaller valve was selected in S3 cases with borderline CAAD compared to SXT cases. Nevertheless, the frequency of paravalvular aortic leakage (PVL) ≥2 tended to be reduced in the S3 group (5% vs 9%, p=0.339). The rate of major vascular complications was significantly lower with S3 (3% vs 12%, p=0.013). In addition, 30-day mortality was significantly lower in the S3 group (0% vs 5%, p=0.044). Although TAVI using S3 tended to be carried out with a less oversized valve compared to TAVI using SXT, the frequency of post-procedural PVL ≥2 tended to be lower in the S3 group. The outcomes including vascular complications and 30-day mortality showed a trend in favor of the S3 group. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  8. Conjunctival inclusion cyst following repair of tube erosion in a child with aphakic glaucoma, leading to endophthalmitis.

    PubMed

    Roy, Avik Kumar; Senthil, Sirisha

    2015-01-01

    Glaucoma in aphakia is a major long term complication following congenital cataract surgery. Implantation of glaucoma drainage device provides an effective approach to manage refractory paediatric glaucoma. However implant surgery in young individuals is not free of complications. The prompt detection and management of tube erosion is of utmost importance to prevent devastating sequel of endophthalmitis. Implantation cyst following repair of tube erosion has not been reported so far. This case illustrates the rare occurrence of inclusion cyst following repair of tube erosion, the possible causes and its consequences. A 2-year-old child with aphakia developed intractable glaucoma. Following a failed glaucoma filtering surgery he underwent sequential Ahmed Glaucoma Valve implantation in both the eyes. Six weeks following right eye surgery, the child presented with conjunctival erosion overlying the tube, which was treated with scleral patch graft and conjunctival advancement. One month after the repair of tube erosion, the child presented with implantation cyst under the scleral patch graft, which was treated by drainage with a 29G needle. The child presented with endophthalmitis of his right eye following an episode of bilateral conjunctivitis. This was managed by an emergency pars plana vitrectomy, intraocular antibiotics and tube excision. At the last follow up visit, the IOP was 20 mmHg with 2 topical antiglaucoma medications in the right eye following a trans scleral photocoagulation. Lifelong careful follow-up of paediatric eyes with implant surgery is mandatory to look for complication such as tube erosion. It is important to place additional sutures to secure the patch graft during implantation of glaucoma drainage devices in children to prevent graft displacement and consequent tube erosion. During repair of tube erosion, it is crucial to remove all the conjunctival epithelium around the tube, thus not to incorporate epithelial tissue within the surgical

  9. Midterm clinical outcome following Edwards SAPIEN or Medtronic Corevalve transcatheter aortic valve implantation (TAVI): Results of the Belgian TAVI registry.

    PubMed

    Collas, Valérie M; Dubois, Christophe; Legrand, Victor; Kefer, Joëlle; De Bruyne, Bernard; Dens, Jo; Rodrigus, Inez E; Herijgers, Paul; Bosmans, Johan M

    2015-09-01

    To assess midterm (3 years) clinical outcomes of transcatheter aortic valve implantation (TAVI) in Belgium using the Edwards SAPIEN valve or the Medtronic CoreValve transcatheter heart valve (THV). Medium and long term follow-up data of both THVs are still relatively scarce, although of great clinical relevance for a relatively new but rapidly expanding treatment modality. Therefore, reporting mid- and long term clinical outcome data, coming from large "real world" national registries, remains contributive. Between December 2007 and March 2012, 861 "real world" patients who were not candidates for surgical aortic valve replacement as decided by the local heart teams, underwent TAVI at 23 sites. Eleven sites exclusively used SAPIEN THV (n = 460), while 12 exclusively used CoreValve THV (n = 401). Differences in clinical outcomes by valve system were assessed, according to access route and baseline EuroSCORE risk profile (<10%: low, 10-20%: intermediate and >20%: high risk). Overall cumulative survival at 3 years was 51% for SAPIEN vs. 60% for CoreValve (P = 0.021). In transfemorally treated patients, SAPIEN and CoreValve had similar survival at 3 years for each of the baseline EuroSCORE cohorts (low risk: 72% vs. 76%, P = 0.45; intermediate risk: 62% vs. 59%, P = 0.94; high risk: 48% vs. 53%, P = 0.65). Cumulative midterm 3 year survival after transfemoral TAVI in "real world" patients refused for surgery with similar baseline EuroSCORE risk profile is not different between SAPIEN or CoreValve. © 2015 Wiley Periodicals, Inc.

  10. Predictors of paravalvular aortic regurgitation following self-expanding Medtronic CoreValve implantation: the role of annulus size, degree of calcification, and balloon size during pre-implantation valvuloplasty and implant depth.

    PubMed

    Ali, O F; Schultz, C; Jabbour, A; Rubens, M; Mittal, T; Mohiaddin, R; Davies, S; Di Mario, C; Van der Boon, R; Ahmad, A S; Amrani, M; Moat, N; De Jaegere, P P T; Dalby, M

    2015-01-20

    We sought to investigate the role of balloon size during pre-implantation valvuloplasty in predicting AR and optimal Medtronic CoreValve (MCS) implantation depth. Paravalvular aortic regurgitation (AR) is common following MCS implantation. A number of anatomical and procedural variables have been proposed as determinants of AR including degree of valve calcification, valve undersizing and implantation depth. We conducted a multicenter retrospective analysis of 282 patients who had undergone MCS implantation with prior cardiac CT annular sizing between 2007 and 2011. Native valve minimum (Dmin), maximum (Dmax) and arithmetic mean (Dmean) annulus diameters as well as agatston calcium score were recorded. Nominal and achieved balloon size was also recorded. AR was assessed using contrast angiography at the end of each procedure. Implant depth was measured as the mean distance from the nadir of the non- and left coronary sinuses to the distal valve frame angiographically. 29 mm and 26 mm MCS were implanted in 60% and 39% of patients respectively. The majority of patients (N=165) developed AR <2 following MCS implantation. AR ≥3 was observed in 16% of the study population. High agatston calcium score and Dmean were found to be independent predictors of AR ≥3 in multivariate analysis (P<0.0001). Nominal balloon diameter and the number of balloon inflations did not influence AR. However a small achieved balloon diameter-to-Dmean ratio (≤0.85) showed modest correlation with AR ≥3 (P=0.04). This observation was made irrespective of the degree of valve calcification. A small MCS size-to-Dmean ratio is also associated with AR ≥3 (P=0.001). A mean implantation depth of ≥8+2mm was also associated with AR ≥3. Implantation depth of ≥12 mm was associated with small MCS diameter-to-Dmean ratio and increased 30-day mortality. CT measured aortic annulus diameter and agatston calcium score remain important predictors of significant AR. Other procedural predictors

  11. First percutaneous implantation of a completely tissue-engineered self-expanding pulmonary heart valve prosthesis using a newly developed delivery system: a feasibility study in sheep.

    PubMed

    Spriestersbach, Hendrik; Prudlo, Antonia; Bartosch, Marco; Sanders, Bart; Radtke, Torben; Baaijens, Frank P T; Hoerstrup, Simon P; Berger, Felix; Schmitt, Boris

    2017-01-01

    In a European consortium, a decellularized tissue-engineered heart valve (dTEHV) based on vessel-derived cells, a fast-degrading scaffold and a self-expanding stent has been developed. The aim of this study was to demonstrate that percutaneous delivery is feasible. To implant this valve prosthesis transcutaneously into pulmonary position, a catheter delivery system was designed and custom made. Three sheep underwent transjugular prototype implantation. Intracardiac echocardiography (ICE), angiography and computed tomography (CT) were applied to assess the position, morphology, function and dimensions of the stented dTEHV. One animal was killed 3 h after implantation and two animals were followed up for 12 weeks. Explanted valves were analyzed macroscopically and microscopically. In all animals, the percutaneous implantation of the stented dTEHV was successful. The prototype delivery system worked at first attempt in all animals. In the first implantation a 22 F system was used: the valve was slightly damaged during crimping. Loading was difficult due to valve-catheter mismatch in volume. In the second and third implantation a 26 F system was used: the valves fitted adequately and stayed intact. Following implantation, these two valves showed moderate regurgitation due to insufficient coaptation. During follow-up, regurgitation increased due to shortened leaflets. At explantation, macroscopic and microscopic analysis confirmed the second and third valve to be intact. Histology revealed autologous recellularization of the decellularized valve after 12 weeks in vivo. It was demonstrated that completely in vitro tissue-engineered heart valves are thin and stable enough to be crimped and implanted transvenously into pulmonary position.

  12. First in human experience of a new self-expandable percutaneous pulmonary valve implantation using knitted nitinol-wire and tri-leaflet porcine pericardial valve in the native right ventricular outflow tract.

    PubMed

    Kim, Gi Beom; Kwon, Bo Sang; Lim, Hong Gook

    2017-04-01

    Balloon-expandable percutaneous pulmonary valve systems using the Melody and Edwards SAPIEN transcatheter heart valves have been increasingly used instead of surgically implantable pulmonary valves. However, limited patients with right ventricular outflow tract (RVOT) lesions are suitable candidates for percutaneous pulmonary valve implantation (PPVI) using these systems after surgical correction of tetralogy of Fallot. Therefore, larger self-expandable valved-stents are being developed for native RVOT lesions. We report the first-in-human case of a new self-expandable PPVI in a patient with a native RVOT lesion using a newly made knitted nitinol-wire stent mounted with a tri-leaflet porcine pericardial valve developed in South Korea. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  13. Comparison of the effectiveness of transcatheter aortic valve implantation in patients with stenotic bicuspid versus tricuspid aortic valves (from the German TAVI Registry).

    PubMed

    Bauer, Timm; Linke, Axel; Sievert, Horst; Kahlert, Philipp; Hambrecht, Rainer; Nickenig, Georg; Hauptmann, Karl Eugen; Sack, Stefan; Gerckens, Ulrich; Schneider, Steffen; Zeymer, Uwe; Zahn, Ralf

    2014-02-01

    Patients with bicuspid aortic valves (BAVs) are considered a relative contraindication to transcatheter aortic valve implantation (TAVI). One of the main reasons is the presumed risk for residual aortic regurgitation (AR). However, case reports and small case series have suggested that TAVI can be successfully performed with acceptable clinical outcomes in high-risk patients with BAV. Within the large German TAVI Registry, we sought to evaluate TAVI in older high-risk patients with BAV. From January 2009 to June 2010, a total of 1,424 patients with severe aortic stenosis undergoing TAVI were prospectively enrolled into the German TAVI Registry. For the present analysis, patients with valve-in-valve procedures were excluded and those with BAV (n = 38, 3%) were compared with those with tricuspid aortic valve (TAV; n = 1357, 97%). Patient characteristics did not markedly differ and procedural success was very high in both groups. There was a higher rate of relevant AR (≥II) after TAVI among patients with BAV (25 vs 15%, p = 0.05), whereas pacemakers were more often implanted in patients with TAV (17% vs 35%, p = 0.02). Thirty-day mortality rate was similar in both cohorts (11% vs 11%). In a Cox proportional regression analysis, BAV was not associated with higher 1-year mortality rate (hazard ratio 0.64, 95% confidence interval 0.29 to 1.41). In selected patients with BAV, TAVI can be performed with a satisfactory clinical result. Although the risk for relevant AR seems to be greater among patients with BAV, 30-day and 1-year mortality rates were not elevated compared with patients with TAV.

  14. Red cell distribution width in anemic patients undergoing transcatheter aortic valve implantation

    PubMed Central

    Hellhammer, Katharina; Zeus, Tobias; Verde, Pablo E; Veulemanns, Verena; Kahlstadt, Lisa; Wolff, Georg; Erkens, Ralf; Westenfeld, Ralf; Navarese, Eliano P; Merx, Marc W; Rassaf, Tienush; Kelm, Malte

    2016-01-01

    AIM: To determine the impact of red blood cell distribution width on outcome in anemic patients undergoing transcatheter aortic valve implantation (TAVI). METHODS: In a retrospective single center cohort study we determined the impact of baseline red cell distribution width (RDW) and anemia on outcome in 376 patients with aortic stenosis undergoing TAVI. All patients were discussed in the institutional heart team and declined for surgical aortic valve replacement due to high operative risk. Collected data included patient characteristics, imaging findings, periprocedural in hospital data, laboratory results and follow up data. Blood samples for hematology and biochemistry analysis were taken from every patient before and at fixed intervals up to 72 h after TAVI including blood count and creatinine. Descriptive statistics were used for patient’s characteristics. Kaplan-Meier survival curves were used for time to event outcomes. A recursive partitioning regression and classification was used to investigate the association between potential risk factors and outcome variables. RESULTS: Mean age in our study population was 81 ± 6.1 years. Anemia was prevalent in 63.6% (n = 239) of our patients. Age and creatinine were identified as risk factors for anemia. In our study population, anemia per se did influence 30-d mortality but did not predict longterm mortality. In contrast, a RDW > 14% showed to be highly predictable for a reduced short- and longterm survival in patients with aortic valve disease after TAVI procedure. CONCLUSION: Age and kidney function determine the degree of anemia. The anisocytosis of red blood cells in anemic patients supplements prognostic information in addition to that derived from the WHO-based definition of anemia. PMID:26981217

  15. Effect of Hospital Volume on Outcomes of Transcatheter Aortic Valve Implantation.

    PubMed

    Badheka, Apurva O; Patel, Nileshkumar J; Panaich, Sidakpal S; Patel, Samir V; Jhamnani, Sunny; Singh, Vikas; Pant, Sadip; Patel, Nish; Patel, Nilay; Arora, Shilpkumar; Thakkar, Badal; Manvar, Sohilkumar; Dhoble, Abhijeet; Patel, Achint; Savani, Chirag; Patel, Jay; Chothani, Ankit; Savani, Ghanshyambhai T; Deshmukh, Abhishek; Grines, Cindy L; Curtis, Jeptha; Mangi, Abeel A; Cleman, Michael; Forrest, John K

    2015-08-15

    Transcatheter aortic valve implantation (TAVI) is associated with a significant learning curve. There is paucity of data regarding the effect of hospital volume on outcomes after TAVI. This is a cross-sectional study based on Healthcare Cost and Utilization Project's Nationwide Inpatient Sample database of 2012. Subjects were identified by International Classification of Diseases, Ninth Revision, Clinical Modification procedure codes, 35.05 (Trans-femoral/Trans-aortic Replacement of Aortic Valve) and 35.06 (Trans-apical Replacement of Aortic Valve). Annual hospital TAVI volumes were calculated using unique identification numbers and then divided into quartiles. Multivariate logistic regression models were created. The primary outcome was inhospital mortality; secondary outcome was a composite of inhospital mortality and periprocedural complications. Length of stay (LOS) and cost of hospitalization were assessed. The study included 1,481 TAVIs (weighted n = 7,405). Overall inhospital mortality rate was 5.1%, postprocedural complication rate was 43.4%, median LOS was 6 days, and median cost of hospitalization was $51,975. Inhospital mortality rates decreased with increasing hospital TAVI volume with a rate of 6.4% for lowest volume hospitals (first quartile), 5.9% (second quartile), 5.2% (third quartile), and 2.8% for the highest volume TAVI hospitals (fourth quartile). Complication rates were significantly higher in hospitals with the lowest volume quartile (48.5%) compared to hospitals in the second (44.2%), third (39.7%), and fourth (41.5%) quartiles (p <0.001). Increasing hospital volume was independently predictive of shorter LOS and lower hospitalization costs. In conclusion, higher annual hospital volumes are significantly predictive of reduced postprocedural mortality, complications, shorter LOS, and lower hospitalization costs after TAVI.

  16. High on-treatment platelet reactivity in transcatheter aortic valve implantation patients.

    PubMed

    Polzin, Amin; Schleicher, Mathias; Seidel, Holger; Scharf, Rüdiger E; Merx, Marc W; Kelm, Malte; Zeus, Tobias

    2015-03-15

    Dual antiplatelet therapy (DAPT) is recommended early after transcatheter aortic valve implantation (TAVI) procedure at the moment despite the lack of evidence. Two small randomized trials failed to demonstrate DAPT to be superior to aspirin alone in TAVI patients. However, it is known that there are substantial response variabilities to antiplatelet medication. We aimed to investigate high on-treatment platelet reactivity (HTPR), low on-treatment platelet reactivity (LTPR) to clopidogrel as well as HTPR to aspirin in patients undergoing TAVI procedure. We analyzed data of 140 TAVI patients in a real world observational study. Platelet function assays (clopidogrel-vasodilator-stimulated protein phosphorylation assay; aspirin-light-transmission aggregometry) have been performed during hospital course. Clinical complications were investigated during 30 days follow-up and defined using the valve academic research consortium standardized criteria. HTPR to clopidogrel occurred in 87 (62%) patients and LTPR in 9 (6.4%) patients. Aspirin antiplatelet effects were insufficient in 25 (18%) patients. Clinical complications were observed in 35 (25%) patients. Ischemic events occurred in 6 (4%), bleeding complications in 28 (20%) patients. There were no differences regarding the incidence of HTPR/LTPR in patients with overall complications, ischemic events or bleeding events. HTPR to clopidogrel is very frequent in TAVI patients. However bleeding complications are frequent and ischemic events are rare. Therefore, future clinical trials investigating the optimal antithrombotic regiment in TAVI patients should consider this high incidence of HTPR to clopidogrel and monitor clopidogrel antiplatelet effects carefully.

  17. TAVI or No TAVI: identifying patients unlikely to benefit from transcatheter aortic valve implantation.

    PubMed

    Puri, Rishi; Iung, Bernard; Cohen, David J; Rodés-Cabau, Josep

    2016-07-21

    Transcatheter aortic valve implantation (TAVI) has spawned the evolution of novel catheter-based therapies for a variety of cardiovascular conditions. Newer device iterations are delivering lower peri- and early post-procedural complication rates in patients with aortic stenosis, who were otherwise deemed too high risk for conventional surgical valve replacement. Yet beyond the post-procedural period, a considerable portion of current TAVI recipients fail to derive a benefit from TAVI, either dying or displaying a lack of clinical and functional improvement. Considerable interest now lies in better identifying factors likely to predict futility post-TAVI. Implicit in this are the critical roles of frailty, disability, and a multimorbidity patient assessment. In this review, we outline the roles that a variety of medical comorbidities play in determining futile post-TAVI outcomes, including the critical role of frailty underlying the identification of patients unlikely to benefit from TAVI. We discuss various TAVI risk scores, and further propose that by combining such scores along with frailty parameters and the presence of specific organ failure, a more accurate and holistic assessment of potential TAVI-related futility could be achieved.

  18. Surgical Management of Percutaneous Transfemoral Access to Minimize Vascular Complications Related to Transcatheter Aortic Valve' Implantation.

    PubMed

    Lareyre, Fabien; Raffort, Juliette; Dommerc, Carine; Habib, Yacoub; Bourlon, François; Mialhe, Claude

    2017-01-01

    Transcatheter aortic valve implantation (TAVI) is associated with substantial rates of vascular complications. The aim of our study is to describe the surgical management of percutaneous transfemoral access by a vascular surgeon and to report the 30-day postoperative vascular complications and mortality. Perioperative procedures to manage the femoral access site were recorded retrospectively from 220 consecutive patients who underwent TAVI. Postoperative vascular complications related to the main access were categorized according to the Valve Academic Research Consortium 2 classification. Perioperative procedures related to vascular access were performed for 56 (25.4%) patients: 6 patients required open surgical repair, 48 patients underwent endovascular stenting, and 2 patients had both procedures. The all-cause mortality was 3.6%, but no death related to a vascular complication was reported during the 30-day postoperative follow-up period. Ten (4.5%) patients developed postoperative hematomas; 2 (0.9%) of them were retroperitoneal and led to major bleeding requiring an unplanned surgical intervention. Our study underlines the utility of a multidisciplinary approach to manage the percutaneous access in TAVI for managing postoperative vascular complications.

  19. Does frame geometry play a role in aortic regurgitation after Medtronic CoreValve implantation?

    PubMed

    Rodríguez-Olivares, Ramón; El Faquir, Nahid; Rahhab, Zouhair; Geeve, Patrick; Maugenest, Anne-Marie; van Weenen, Sander; Ren, Ben; Galema, Tjebbe; Geleijnse, Marcel; Van Mieghem, Nicolas M; van Domburg, Ron; Bruining, Nico; Schultz, Carl; Lauritsch, Guenter; de Jaegere, Peter P T

    2016-07-20

    Aortic regurgitation (AR) after Medtronic CoreValve System (MCS) implantation may be explained by patient-, operator- and procedure-related factors. We sought to explore if frame geometry, as a result of a specific device-host interaction, contributes to AR. Using rotational angiography with dedicated motion compensation, we assessed valve frame geometry in 84 patients who underwent TAVI with the MCS. Aortic regurgitation was assessed by angiography (n=84, Sellers) and echocardiography at discharge (n=72, VARC-2). Twenty-two patients (26%) had AR grade ≥2 using contrast angiography, and 17 (24%) by echocardiography. Balloon predilatation and sizing and depth of implantation did not differ between the two groups. Despite more frequent balloon post-dilatation in patients with AR (40.9 vs. 9.7%, p=0.001), the frame was more elliptical at its nadir relative to the patient's annulus (6±13 vs. -1±11%, p=0.046) and occurred in a larger proportion of patients (61.9 vs. 26.8%, p=0.004). Although the Agatston score and the eccentricity of the MCS frame relative to the annulus were independent determinants of AR (odds ratio: 1.635 [1.151-2.324], p=0.006, and 4.204 [1.237-14.290], p=0.021), there was a weak association between the Agatston score and the adjusted eccentricity (Spearman's rank correlation coefficient =-0.24, p=0.046). These findings indicate that AR can be explained by a specific device-host interaction which can only partially be explained by the calcium load of the aortic root.

  20. Transcatheter Aortic Valve Implantation and Morbidity and Mortality-Related Factors: a 5-Year Experience in Brazil.

    PubMed

    Souza, André Luiz Silveira; Salgado, Constantino González; Mourilhe-Rocha, Ricardo; Mesquita, Evandro Tinoco; Lima, Luciana Cristina Lima Correia; Mattos, Nelson Durval Ferreira Gomes de; Rabischoffsky, Arnaldo; Fagundes, Francisco Eduardo Sampaio; Colafranceschi, Alexandre Siciliano; Carvalho, Luiz Antonio Ferreira

    2016-06-01

    Transcatheter aortic valve implantation has become an option for high-surgical-risk patients with aortic valve disease. To evaluate the in-hospital and one-year follow-up outcomes of transcatheter aortic valve implantation. Prospective cohort study of transcatheter aortic valve implantation cases from July 2009 to February 2015. Analysis of clinical and procedural variables, correlating them with in-hospital and one-year mortality. A total of 136 patients with a mean age of 83 years (80-87) underwent heart valve implantation; of these, 49% were women, 131 (96.3%) had aortic stenosis, one (0.7%) had aortic regurgitation and four (2.9%) had prosthetic valve dysfunction. NYHA functional class was III or IV in 129 cases (94.8%). The baseline orifice area was 0.67 ± 0.17 cm2 and the mean left ventricular-aortic pressure gradient was 47.3±18.2 mmHg, with an STS score of 9.3% (4.8%-22.3%). The prostheses implanted were self-expanding in 97% of cases. Perioperative mortality was 1.5%; 30-day mortality, 5.9%; in-hospital mortality, 8.1%; and one-year mortality, 15.5%. Blood transfusion (relative risk of 54; p = 0.0003) and pulmonary arterial hypertension (relative risk of 5.3; p = 0.036) were predictive of in-hospital mortality. Peak C-reactive protein (relative risk of 1.8; p = 0.013) and blood transfusion (relative risk of 8.3; p = 0.0009) were predictive of 1-year mortality. At 30 days, 97% of patients were in NYHA functional class I/II; at one year, this figure reached 96%. Transcatheter aortic valve implantation was performed with a high success rate and low mortality. Blood transfusion was associated with higher in-hospital and one-year mortality. Peak C-reactive protein was associated with one-year mortality.

  1. Transcatheter Aortic Valve Implantation and Morbidity and Mortality-Related Factors: a 5-Year Experience in Brazil

    PubMed Central

    Souza, André Luiz Silveira; Salgado, Constantino González; Mourilhe-Rocha, Ricardo; Mesquita, Evandro Tinoco; Lima, Luciana Cristina Lima Correia; de Mattos, Nelson Durval Ferreira Gomes; Rabischoffsky, Arnaldo; Fagundes, Francisco Eduardo Sampaio; Colafranceschi, Alexandre Siciliano; Carvalho, Luiz Antonio Ferreira

    2016-01-01

    Background Transcatheter aortic valve implantation has become an option for high-surgical-risk patients with aortic valve disease. Objective To evaluate the in-hospital and one-year follow-up outcomes of transcatheter aortic valve implantation. Methods Prospective cohort study of transcatheter aortic valve implantation cases from July 2009 to February 2015. Analysis of clinical and procedural variables, correlating them with in-hospital and one-year mortality. Results A total of 136 patients with a mean age of 83 years (80-87) underwent heart valve implantation; of these, 49% were women, 131 (96.3%) had aortic stenosis, one (0.7%) had aortic regurgitation and four (2.9%) had prosthetic valve dysfunction. NYHA functional class was III or IV in 129 cases (94.8%). The baseline orifice area was 0.67 ± 0.17 cm2 and the mean left ventricular-aortic pressure gradient was 47.3±18.2 mmHg, with an STS score of 9.3% (4.8%-22.3%). The prostheses implanted were self-expanding in 97% of cases. Perioperative mortality was 1.5%; 30-day mortality, 5.9%; in-hospital mortality, 8.1%; and one-year mortality, 15.5%. Blood transfusion (relative risk of 54; p = 0.0003) and pulmonary arterial hypertension (relative risk of 5.3; p = 0.036) were predictive of in-hospital mortality. Peak C-reactive protein (relative risk of 1.8; p = 0.013) and blood transfusion (relative risk of 8.3; p = 0.0009) were predictive of 1-year mortality. At 30 days, 97% of patients were in NYHA functional class I/II; at one year, this figure reached 96%. Conclusion Transcatheter aortic valve implantation was performed with a high success rate and low mortality. Blood transfusion was associated with higher in-hospital and one-year mortality. Peak C-reactive protein was associated with one-year mortality. PMID:27192383

  2. Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective, International, Post-Market ADVANCE-II Study.

    PubMed

    Petronio, Anna S; Sinning, Jan-Malte; Van Mieghem, Nicolas; Zucchelli, Giulio; Nickenig, Georg; Bekeredjian, Raffi; Bosmans, Johan; Bedogni, Francesco; Branny, Marian; Stangl, Karl; Kovac, Jan; Schiltgen, Molly; Kraus, Stacia; de Jaegere, Peter

    2015-05-01

    The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing. Conduction disturbances are a frequent complication of transcatheter aortic valve replacement. The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI. The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth (≤6 mm below the aortic annulus). The timing and resolution of all new-onset conduction disturbances were analyzed. A total of 194 patients were treated. The overall rate of PPI for Class I/II indications was 18.2%. An optimal depth was reached in 43.2% of patients, with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm, compared with those with deeper implants (13.3% vs. 21.1%; p = 0.14). In a paired analysis, new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4% and 39.0% of patients, respectively, and resolved spontaneously within 30 days in 43.2% and 73.9%, respectively. In patients with new PPI, the rate of intrinsic sinus rhythm increased from 25.9% at 7 days to 59.3% at 30 days (p = 0.004). Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement, compared with results reported in previous studies. (CoreValve Advance-II Study: Prospective International Post-Market Study [ADVANCE II]; NCT01624870). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  3. Polypropylene vs silicone Ahmed valve with adjunctive mitomycin C in paediatric age group: a prospective controlled study

    PubMed Central

    El Sayed, Y; Awadein, A

    2013-01-01

    Purpose To compare the results of silicone and polypropylene Ahmed glaucoma valves (AGV) implanted during the first 10 years of life. Methods A prospective study was performed on 50 eyes of 33 patients with paediatric glaucoma. Eyes were matched to either polypropylene or silicone AGV. In eyes with bilateral glaucoma, one eye was implanted with polypropylene and the other eye was implanted with silicone AGV. Results Fifty eyes of 33 children were reviewed. Twenty five eyes received a polypropylene valve, and 25 eyes received a silicone valve. Eyes implanted with silicone valves achieved a significantly lower intraocular pressure (IOP) compared with the polypropylene group at 6 months, 1 year, and 2 years postoperatively. The average survival time was significantly longer (P=0.001 by the log-rank test) for the silicone group than for the polypropylene group and the cumulative probability of survival by the log-rank test at the end of the second year was 80% (SE: 8.0, 95% confidence interval (CI): 64–96%) in the silicone group and 56% (SE: 9.8, 95% CI: 40–90%) in the polypropylene group. The difference in the number of postoperative interventions and complications between both groups was statistically insignificant. Conclusion Silicone AGVs can achieve better IOP control, and longer survival with less antiglaucoma drops compared with polypropylene valves in children younger than 10 years. PMID:23579403

  4. Polypropylene vs silicone Ahmed valve with adjunctive mitomycin C in paediatric age group: a prospective controlled study.

    PubMed

    El Sayed, Y; Awadein, A

    2013-06-01

    To compare the results of silicone and polypropylene Ahmed glaucoma valves (AGV) implanted during the first 10 years of life. A prospective study was performed on 50 eyes of 33 patients with paediatric glaucoma. Eyes were matched to either polypropylene or silicone AGV. In eyes with bilateral glaucoma, one eye was implanted with polypropylene and the other eye was implanted with silicone AGV. Fifty eyes of 33 children were reviewed. Twenty five eyes received a polypropylene valve, and 25 eyes received a silicone valve. Eyes implanted with silicone valves achieved a significantly lower intraocular pressure (IOP) compared with the polypropylene group at 6 months, 1 year, and 2 years postoperatively. The average survival time was significantly longer (P=0.001 by the log-rank test) for the silicone group than for the polypropylene group and the cumulative probability of survival by the log-rank test at the end of the second year was 80% (SE: 8.0, 95% confidence interval (CI): 64-96%) in the silicone group and 56% (SE: 9.8, 95% CI: 40-90%) in the polypropylene group. The difference in the number of postoperative interventions and complications between both groups was statistically insignificant. Silicone AGVs can achieve better IOP control, and longer survival with less antiglaucoma drops compared with polypropylene valves in children younger than 10 years.

  5. Multiple methods of surgical treatment combined with primary IOL implantation on traumatic lens subluxation/dislocation in patients with secondary glaucoma

    PubMed Central

    Wang, Rui; Bi, Chun-Chao; Lei, Chun-Ling; Sun, Wen-Tao; Wang, Shan-Shan; Dong, Xiao-Juan

    2014-01-01

    AIM To describe clinical findings and complications from cases of traumatic lens subluxation/dislocation in patients with secondary glaucoma, and discuss the multiple treating methods of operation combined with primary intraocular lens (IOL) implantation. METHODS Non-comparative retrospective observational case series. Participants: 30 cases (30 eyes) of lens subluxation/dislocation in patients with secondary glaucoma were investigated which accepted the surgical treatment by author in the Ophthalmology of Xi'an No.4 Hospital from 2007 to 2011. According to the different situations of lens subluxation/dislocation, various surgical procedures were performed such as crystalline lens phacoemulsification, crystalline lens phacoemulsification combined anterior vitrectomy, intracapsular cataract extraction combined anterior vitrectomy, lensectomy combined anterior vitrectomy though peripheral transparent cornea incision, pars plana lensectomy combined pars plana vitrectomy, and intravitreal cavity crystalline lens phacofragmentation combined pars plana vitrectomy. And whether to implement trabeculectomy depended on the different situations of secondary glaucoma. The posterior chamber intraocular lenses (PC-IOLs) were implanted in the capsular-bag or trassclerally sutured in the sulus decided by whether the capsular were present. Main outcome measures: visual acuity, intraocular pressure, the situation of intraocular lens and complications after the operations. RESULTS The follow-up time was 11-36mo (21.4±7.13). Postoperative visual acuity of all eyes were improved; 28 cases maintained IOP below 21 mm Hg; 2 cases had slightly IOL subluxation, 4 cases had slightly tilted lens optical area; 1 case had postoperative choroidal detachment; 4 cases had postoperative corneal edema more than 1wk, but eventually recovered transparent; 2 cases had mild postoperative vitreous hemorrhage, and absorbed 4wk later. There was no postoperative retinal detachment, IOL dislocation, and

  6. Long-term outcomes of glaucoma drainage devices for glaucoma post-vitreoretinal surgery with silicone oil insertion: a prospective evaluation.

    PubMed

    Gupta, Shikha; Chaurasia, Abadh K; Chawla, Rohan; Kapoor, Kulwant Singh; Mahalingam, Karthikeyan; Swamy, Deepa R; Gupta, Viney

    2016-12-01

    To evaluate long-term success of the Ahmed glaucoma valve (AGV) for refractory glaucoma after vitreoretinal surgery with silicone oil insertion. Prospective non-comparative evaluation of patients who underwent AGV insertion for management of post-vitreoretinal surgery glaucoma, post-silicone oil removal. Intraocular pressure (IOP), visual acuity, and glaucomatous neuropathy status were evaluated preoperatively and at multiple follow-up visits postoperatively. Success, using Kaplan-Meier analysis, was determined at the 12-month follow-up visit and at the last follow-up. Factors associated with failure were analysed. Twenty-seven eyes of 27 patients with a mean age of 28.3 ± 15.2 years underwent a superior AGV implantation. The average follow-up after AGV implantation was 17.11 ± 8.36 months (range: 9-60 months). Kaplan-Meier survival analysis revealed a 62 % success at 12 months and 37 % at 5 years. A 48 % rate of complications was noted, 22 % of which were vision-threatening. Factors analysed, including patient age, interval between vitreoretinal surgery and silicone oil removal, interval between vitreoretinal surgery and AGV implantation, and phakic status, were not found to be associated with higher failure rates. Long-term success of AGV implantation for glaucoma after vitreoretinal surgery with silicone oil insertion is better than that reported for trabeculectomy, though complication rates remain high.

  7. [Atrioventricular conduction disturbances after CoreValve(®) aortic prosthesis implantation. Predictive role of transesophageal echocardiography].

    PubMed

    Almería Valera, Carlos; de Agustín Loeches, Alberto; Hernández-Antolín, Rosa Ana; García Fernández, Eulogio; Pérez de Isla, Leopoldo; Fernández Pérez, Cristina; Macaya Miguel, Carlos; Zamorano Gómez, Jose Luis

    2011-12-01

    Atrioventricular conduction disorders can appear after the implantation of percutaneous aortic CoreValve(®) prostheses in patients requiring permanent pacemakers (40%-45% of these patients). The aim of our study was to detect if 2- or 3-dimensional echocardiographic variables could predict the appearance of atrioventricular conduction disorders. For this purpose, the relationship of the prosthesis with the interventricular septum was studied in 26 consecutive patients. Twelve patients (46.1%) developed atrioventricular conduction disorders. A prosthetic penetration >12 mm in the left ventricular outflow tract and a contact surface >90% between the interventricular septum and the stent of the prosthesis in diastole were strongly associated with the appearance of conduction disturbances (87.5%; P=.034). The percentage of the prosthetic stent in contact with the interventricular septum in end diastole was the only independent predictor of atrioventricular conduction disorders (odds ratio=1.12; 95% confidence interval, 1.01-1.25; P=.03). The results suggest that a higher implantation of the prosthesis and a reduced stent length might decrease the incidence of this complication. Copyright © 2011 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  8. Inverse Relationship Between Membranous Septal Length and the Risk of Atrioventricular Block in Patients Undergoing Transcatheter Aortic Valve Implantation.

    PubMed

    Hamdan, Ashraf; Guetta, Victor; Klempfner, Robert; Konen, Eli; Raanani, Ehud; Glikson, Michael; Goitein, Orly; Segev, Amit; Barbash, Israel; Fefer, Paul; Spiegelstein, Dan; Goldenberg, Ilan; Schwammenthal, Ehud

    2015-08-17

    This study sought to examine whether imaging of the atrioventricular (AV) membranous septum (MS) by computed tomography (CT) can be used to identify patient-specific anatomic risk of high-degree AV block and permanent pacemaker (PPM) implantation before transcatheter aortic valve implantation (TAVI) with self-expandable valves. MS length represents an anatomic surrogate of the distance between the aortic annulus and the bundle of His and may therefore be inversely related to the risk of conduction system abnormalities after TAVI. Seventy-three consecutive patients with severe aortic stenosis underwent contrast-enhanced CT before TAVI. The aortic annulus, aortic valve, and AV junction were assessed, and MS length was measured in the coronal view. In 13 patients (18%), high-degree AV block developed, and 21 patients (29%) received a PPM. Multivariable logistic regression analysis revealed MS length as the most powerful pre-procedural independent predictor of high-degree AV block (odds ratio [OR]: 1.35, 95% confidence interval [CI]: 1.1 to 1.7, p = 0.01) and PPM implantation (OR: 1.43, 95% CI: 1.1 to 1.8, p = 0.002). When taking into account pre- and post-procedural parameters, the difference between MS length and implantation depth emerged as the most powerful independent predictor of high-degree AV block (OR: 1.4, 95% CI: 1.2 to 1.7, p < 0.001), whereas the difference between MS length and implantation depth and calcification in the basal septum were the most powerful independent predictors of PPM implantation (OR: 1.39, 95% CI: 1.2 to 1.7, p < 0.001 and OR: 4.9, 95% CI: 1.2 to 20.5, p = 0.03; respectively). Short MS, insufficient difference between MS length and implantation depth, and the presence of calcification in the basal septum, factors that may all facilitate mechanical compression of the conduction tissue by the implanted valve, predict conduction abnormalities after TAVI with self-expandable valves. CT assessment of membranous septal anatomy provides

  9. [Left ventricular rupture of mitral valve prosthesis implantation treated using an intra-aortic balloon pump counterpulsation].

    PubMed

    García-Villarreal, Ovidio Alberto; Ramírez-González, Bertín; Saldaña-Becerra, Martín A

    2015-01-01

    Left ventricular rupture is an infrequent but potentially fatal complication of mitral valve replacement. In spite of the fact that several methods of repair have previously been described, the mortality rate remains nearly 85%. The use of the intra-aortic balloon pump counterpulsation may increase the possibilities of success in the repair of this dreaded complication. We present here three cases of left ventricular rupture associated to mitral valve prosthesis implantation successfully treated with the aid of intra-aortic balloon pump counterpulsation.

  10. Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 6-Month Results From a Phase I/II Clinical Trial.

    PubMed

    Lewis, Richard A; Christie, William C; Day, Douglas G; Craven, E Randy; Walters, Thomas; Bejanian, Marina; Lee, Susan S; Goodkin, Margot L; Zhang, Jane; Whitcup, Scott M; Robinson, Michael R

    2017-03-01

    To evaluate the safety and intraocular pressure (IOP)-lowering effect of a biodegradable bimatoprost sustained-release implant (Bimatoprost SR). Phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, open-angle glaucoma patients (n = 75) were administered Bimatoprost SR (6 μg, 10 μg, 15 μg, or 20 μg) intracamerally in the study eye; the fellow eye began topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or a single repeat treatment with implant was allowed. The primary endpoint was IOP change from baseline. The main safety measure was adverse events. Results through month 6 are reported. Bimatoprost SR provided rapid, sustained IOP lowering. Overall mean IOP reduction from baseline through week 16 in study eyes was 7.2, 7.4, 8.1, and 9.5 mm Hg with the 6-μg, 10-μg, 15-μg, and 20-μg dose strengths of implant, respectively, vs 8.4 mm Hg in topical bimatoprost-treated pooled fellow eyes (data censored at rescue/retreatment). Rescue/retreatment was not required in 91% and 71% of study eyes up to week 16 and month 6, respectively. Adverse events in study eyes usually occurred within 2 days after the injection procedure and were transient. Conjunctival hyperemia with onset later than 2 days after the injection procedure was more common with topical bimatoprost than Bimatoprost SR (17.3% vs 6.7% of eyes). Bimatoprost SR demonstrated favorable efficacy and safety through 6 months. All dose strengths were comparable to topical bimatoprost in overall IOP reduction through week 16. A single administration controlled IOP in the majority of patients for up to 6 months. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

  11. Insights into the need for permanent pacemaker following implantation of the repositionable LOTUS valve for transcatheter aortic valve replacement in 250 patients: results from the REPRISE II trial with extended cohort.

    PubMed

    Dumonteil, Nicolas; Meredith, Ian T; Blackman, Daniel J; Tchétché, Didier; Hildick-Smith, David; Spence, Mark S; Walters, Darren L; Harnek, Jan; Worthley, Stephen G; Rioufol, Gilles; Lefèvre, Thierry; Modine, Thomas; Van Mieghem, Nicolas; Houle, Vicki M; Allocco, Dominic J; Dawkins, Keith D

    2017-09-20

    This analysis aimed to evaluate the incidence and predictors of the need for permanent pacemaker (PPM) implantation following implantation of the repositionable and fully retrievable LOTUS Aortic Valve Replacement System. The prospective, single-arm, multicentre REPRISE II study with extended cohort enrolled 250 symptomatic, high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation (TAVI) with a 23 mm or 27 mm LOTUS valve. Echocardiography, computed tomography, and electrocardiography data were evaluated by independent core labs. Post TAVI, 32.0% (72/225) of pacemaker-naïve patients underwent new PPM implantation at 30 days. Most (59/72, 82%) patients were implanted for third-degree atrioventricular block, and >10% overstretch of the LVOT by area was observed in 59.7% (43/72) of PPM patients. Significant independent predictors of PPM at 30 days included baseline RBBB (odds ratio [OR] 12.7, 95% CI: 4.5, 36.2; p<0.001) and LVOT overstretch >10% (OR 3.4, 95% CI: 1.7, 6.7; p<0.001). There was a trend towards a lower 30-day PPM rate in patients with a shallower (≤5 mm) implant depth (23.9% ≤5 mm vs. 36.9% >5 mm depth from LCS; p=0.06). Careful attention to valve sizing and implant depth may help to reduce the rate of PPM with the LOTUS valve.

  12. Morphologic Study of Homograft Valves before and after Cryopreservation and after Short-Term Implantation in Patients.

    PubMed

    Goffin, Y A; de Gouveia, R H; Szombathelyi, T; Toussaint, J M; Gruys, E

    1997-01-01

    Cryopreserved heart valve homografts have been implanted in patients for the past 15 years, but controversies still exist on the survival of donor cells, matrix maintenance, and possible rejection by the host. Therefore a full morphologic study (histology, immunohistochemistry, transmission electron microscopy, and cuprolinic blue-TEM for glycosaminoglycans [GAG]) of short-term implanted uninfected grafts was done using unimplanted valves as the reference. Unimplanted tissues consisted of 5 fresh and 11 cryopreserved valves. Eight implants were recovered at reoperation [4] or autopsy [4], 4 from the right and 4 from the left ventricular outflow tract. The implantation time was 2 hours to 30 days. For unimplanted valves we found a partial preservation of the endothelium, the presence of dendritic Langerhans cells (Lc) and macrophages, and no significant damage to fibroblasts, collagen framework, and GAG pattern, except when the tissues had been ischemic for a long time. Explanted cusps exhibited (i) early disappearance of endothelium and Lc; (ii) nonspecific low-grade inflammatory cell infiltration, mostly of monocytoid type; (iii) viable degree of devitalization of fibroblasts with persistence of viable cells in some areas in most cusps; and (iv) fair preservation of collagen framework and GAGs. It is likely that, in view of the good graft preservation at implantation, humoral rejection is responsible for the earlier destruction of the endothelium and dendritic cells and the delayed devitalization of the fibroblasts and that preservation of the collagen framework and other intercellular matrix components (glycosaminoglycans) should guarantee longterm graft function. Copyright © 1997 Elsevier Science Inc. All rights reserved.

  13. Radiation Exposure and Contrast Agent Reduction During Transcatheter Aortic Valve Implantation: An Ongoing Experience.

    PubMed

    Maccagni, Davide; Godino, Cosmo; Latib, Azeem; Mancin, Morena; Chieffo, Alaide; Margonato, Alberto; Colombo, Antonio

    2016-11-01

    To determine the patient radiation exposure and contrast agent variation during transcatheter aortic valve implantation (TAVI) procedures resulting from technological improvements. TAVI procedures from January 2008 to July 2015 were analyzed in three different time periods: 1st period, when the angiography was equipped with an image intensifier technology; 2nd period, starting with the installation of a new angiography system with flat-panel detector (FPD) technology; and 3rd period, starting with the systematic use of preprocedural multidetector computed tomography (MDCT) to individualize optimal fluoroscopic projections for the aortic prosthesis implantation. Significant differences were found in contrast volume (198 ± 99 mL vs 139 ± 74 mL; P<.001), kerma area product (211 ± 135 Gy•cm² vs 147 ± 120 Gy•cm²; P<.001) and effective dose (42 ± 27 mSv vs 29 ± 24 mSv; P<.001) between the 1st and 2nd periods, respectively. The reduction continued between the 2nd and 3rd periods for contrast volume (139 ± 74 mL vs 110 ± 61 mL; P<.001), kerma area product (147 ± 120 Gy•cm² vs 111 ± 69 Gy•cm²; P<.001), and effective dose (29 ± 24 mSv vs 22 ± 11 mSv; P<.001), respectively. The present study suggests that the appropriate use of FPD technology and preprocedural MDCT to individualize fluoroscopic implant projections for TAVI temporally reduced the amount of radiation and contrast agent administered over time.

  14. The balloon-expandable Edwards Sapien 3 valve is superior to the self-expanding Medtronic CoreValve in patients with severe aortic stenosis undergoing transfemoral aortic valve implantation.

    PubMed

    Gonska, Birgid; Seeger, Julia; Baarts, Justus; Rodewald, Christoph; Scharnbeck, Dominik; Rottbauer, Wolfgang; Wöhrle, Jochen

    2017-06-01

    Residual paravalvular moderate or severe aortic regurgitation (AR) has been an independent risk factor for mortality after transcatheter aortic valve implantation (TAVI). The design of the third generation Edwards Sapien 3 (ES3; Edwards Lifesciences, Irvine, CA, USA) valve was optimized with an outer skirt to address the issue of paravalvular AR. We compared 100 consecutive patients treated with the ES3 for severe aortic stenosis with 100 patients treated with the Medtronic CoreValve (CV; Medtronic, Minneapolis, MN, USA) (Clinical Trial Registration: NCT02162069). We evaluated post-procedural AR, rate of permanent pacemaker implantation, device success, and 30-day clinical outcome according to the criteria of the Second Valve Academic Research Consortium (VARC-2). Frequency of post-procedural moderate or severe AR was significantly lower with ES3 compared to CV (0% vs. 20%, p<0.01), none or trace AR significantly higher with ES3 (69% vs. 38%, p<0.01) as well as device success (97% vs. 73%, p<0.01). There was a significantly lower need for permanent pacemaker implantation with ES3 compared with CV (14% vs. 31%, p<0.01). Cardiovascular mortality at 30 days was significantly lower with ES3 (0% vs. 6%, p=0.01), and the combined endpoint "early safety" was met significantly less with ES3 (10% vs. 21% with CV, p=0.03). Transfemoral TAVI with the ES3 compared with the CV was associated with a significantly lower rate of moderate or severe AR, significantly lower need for pacemaker implantation, and a significantly higher rate of device success according to VARC-2. Copyright © 2016 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  15. Transcatheter aortic valve implantation (TAVI) versus sutureless aortic valve replacement (SUAVR) for aortic stenosis: a systematic review and meta-analysis of matched studies

    PubMed Central

    Tsai, Yi-Chin; Niles, Natasha; Tchantchaleishvili, Vakhtang; Di Eusanio, Marco; Yan, Tristan D.; Phan, Kevin

    2016-01-01

    Background With improving technologies and an increasingly elderly populations, there have been an increasing number of therapeutic options available for patients requiring aortic valve replacement. Recent evidence suggests that transcatheter aortic valve implantation (TAVI) is one suitable option for high risk inoperable patients, as well as high risk operable patients. Sutureless valve technology has also been developed concurrently, with facilitates surgical aortic valve replacement (SUAVR) by allow resection and replacement of the native aortic valve with minimal sutures and prosthesis anchoring required. For patients amenable for both TAVI and SUAVR, the evidence is unclear with regards to the benefits and risks of either approach. The objectives are to compare the perioperative outcomes and intermediate-term survival rates of TAVI and SUAVR in matched or propensity score matched studies. Methods A systematic literature search was performed to include all matched or propensity score matched studies comparing SUAVR versus TAVI for severe aortic stenosis. A meta-analysis with odds ratios (OR) and mean differences were performed to compare key outcomes including paravalvular regurgitation and short and intermediate term mortality. Results Six studies met our inclusion criteria giving a total of 741 patients in both the SUAVR and TAVI arm of the study. Compared to TAVI, SUAVR had a lower incidence of paravalvular leak (OR =0.06; 95% CI: 0.03–0.12, P<0.01). There was no difference in perioperative mortality, however SUAVR patients had significantly better survival rates at 1 (OR =2.40; 95% CI: 1.40–4.11, P<0.01) and 2 years (OR =4.62; 95% CI: 2.62–8.12, P<0.01). Conclusions The present study supports the use of minimally invasive SUAVR as an alternative to TAVI in high risk patients requiring aortic replacement. The presented results require further validation in prospective, randomized controlled studies. PMID:28066608

  16. Outcomes after transcatheter aortic valve implantation with both Edwards-SAPIEN and CoreValve devices in a single center: the Milan experience.

    PubMed

    Godino, Cosmo; Maisano, Francesco; Montorfano, Matteo; Latib, Azeem; Chieffo, Alaide; Michev, Iassen; Al-Lamee, Rasha; Bande, Marta; Mussardo, Marco; Arioli, Francesco; Ielasi, Alfonso; Cioni, Micaela; Taramasso, Maurizio; Arendar, Irina; Grimaldi, Antonio; Spagnolo, Pietro; Zangrillo, Alberto; La Canna, Giovanni; Alfieri, Ottavio; Colombo, Antonio

    2010-11-01

    Our aim was to assess clinical outcome after transcatheter aortic valve implantation (TAVI) performed with the 2 commercially available valves with 3 delivery approaches selected in a stepwise fashion. Limited data exist on the results of a comprehensive TAVI program using different valves with transfemoral, transapical, and transaxillary approaches for treatment of severe aortic stenosis. We report 30-day and 6-month outcomes of high-risk patients consecutively treated in a single center with either the Medtronic-CoreValve (MCV) (Medtronic, Minneapolis, Minnesota) or Edwards-SAPIEN valve (ESV) (Edwards Lifesciences, Irvine, California) delivered via the transfemoral or transaxillary approaches and ESV via the transapical approach. A total of 137 patients underwent TAVI: 107 via transfemoral (46 MCV and 61 ESV), 15 via transaxillary (12 MCV and 3 ESV), and 15 via transapical approach. After the transfemoral approach, the procedural success rate was 93.5%, and major vascular complication rate was 20.6%. No intra-procedural deaths occurred. The procedural success rates of transapical and transaxillary approaches were 86.6% and 93.3%, respectively. The 30-day mortality rate was 0.9% in transfemoral group and 13.3% in transapical, and no deaths occurred after transaxillary access. Cumulative death rate at 6 months was 12.2% in transfemoral, 26.6% in transapical, and 18.2% in transaxillary groups. At multivariable analysis, logistic European System for Cardiac Operative Risk Evaluation, body surface area, and history of cerebrovascular disease were significantly associated with an increased risk of major adverse cardiac and cerebrovascular events. Routine TAVI using both MCV and ESV with a selection of approaches is feasible and allows treatment of a wide range of patients with good overall procedural success rates and 30-day and 6-month outcomes. Copyright © 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  17. Embol-X intraaortic filter and transaortic approach for improved cerebral protection in transcatheter aortic valve implantation.

    PubMed

    Etienne, Pierre-Yves; Papadatos, Spiridon; Pieters, Denis; El Khoury, Elie; Alexis, Frédéric; Price, Joel; Glineur, David

    2011-11-01

    Techniques for transcatheter aortic valve implantation involve manipulation of the native aortic valve and the aortic arch. As a result, excellent technical outcomes of this technique remain counterbalanced by a level of neurologic complications that remain unacceptably high. We present here a report of a new potential combined approach to reduce periprocedural neurologic events. After a 6-cm J-shaped upper-mini-sternotomy, 26-mm Sapien valve (Edwards Lifesciences, Irvine, CA) was deployed through a transaortic approach. In addition, the Embol-X device (Edwards Lifescience) was directly inserted in the distal ascending aorta was deployed during all the procedure. Postoperative evolution was clinically uneventful. Postoperative magnetic resonance imaging revealed no new ischemic lesions in this first patient. Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  18. Robot-assisted aortic valve replacement using a novel sutureless bovine pericardial prosthesis: proof of concept as an alternative to percutaneous implantation.

    PubMed

    Suri, Rakesh M; Burkhart, Harold M; Schaff, Hartzell V

    2010-11-01

    : Percutaneous aortic valve implantation within native valve calcium has progressed to clinical use despite the absence of data proving equivalence to complete surgical excision and prosthetic valve replacement. A novel self-expanding sutureless bovine pericardial prosthesis (Sorin Perceval) derived from a proven stented valve has been successfully used in humans recently through an open transaortic approach. We sought to develop a minimally invasive technique for native aortic valve excision and sutureless prosthetic aortic valve replacement using robot assistance. : The da Vinci S-HD system was used to open and suspend the pericardium anterior to the phrenic nerve in cadavers. A transthoracic cross-clamp was placed across the midascending aorta, following which a transverse aortotomy was made. The native aortic valve cusps were excised, and annular calcium was removed with robotic instruments. After placement of three guide sutures, the Perceval self-expanding pericardial prosthesis mounted on a flexible delivery system was inserted through a working port and lowered into the aortic annulus. : Successful implantation of all valves was possible using a 3-cm right second intercostal space working port, along with two additional 1-cm instrument ports. A standard transverse aortotomy was sufficient for examination/debridement of the native aortic valve cusps, sizing of the annulus, and deployment of the nitinol-stented, bovine pericardial prosthesis. Delivery, seating, and stability of the device were easily confirmed above and below the aortic valve annulus using the robotic camera. : Complete excision of diseased native aortic valve cusps with robot assistance facilitates accurate and reproducible aortic valve replacement using a novel self-expanding sutureless version of a proven bovine pericardial prosthesis. This approach is comparable to the current surgical gold standard and is ready for clinical use as an alternative to percutaneous aortic valve implantation.

  19. Left ventricular mass regression after sutureless implantation of the Perceval S aortic valve bioprosthesis: preliminary results

    PubMed Central

    Santarpino, Giuseppe; Pfeiffer, Steffen; Pollari, Francesco; Concistrè, Giovanni; Vogt, Ferdinand; Fischlein, Theodor

    2014-01-01

    OBJECTIVES Left ventricular (LV) hypertrophy in aortic stenosis (AS) is considered a compensatory response helping maintain systolic function, but constitutes a risk factor for cardiac morbidity and mortality. The aim of this study was to assess the degree of LV mass regression after sutureless implantation of the Perceval S aortic valve bioprosthesis (Sorin Group, Saluggia, Italy). METHODS Between March 2010 and July 2012, 78 patients with symptomatic AS underwent isolated aortic valve replacement (AVR) with the Perceval bioprosthesis. Mean age was 77.1 ± 5.3 years, 46 patients were female (59%) and mean logistic EuroSCORE was 11 ± 7.5%. Echocardiography was performed preoperatively, at discharge, and at follow-up (mean 13.5 ± 7.3 months). LV mass was calculated using the Devereux formula and indexed to body surface area. RESULTS There was 1 in-hospital non-cardiac death and 3 late deaths. LV mass index decreased from 148.4 ± 46 g/m2 at baseline to 119.7 ± 38.5 g/m2 at follow-up (P = 0.002). No significant changes were observed in LV hypertrophy and/or relative wall thickness >0.42 as well as in LV ejection fraction. Mean aortic gradient decreased from 49.5 ± 15.8 mmHg at baseline to 11.6 ± 5.1 mmHg at discharge and 8.3 ± 4.4 mmHg at follow-up (P < 0.001), resulting in significant clinical improvement. No moderate or severe paravalvular leakage was observed at discharge and at follow-up. CONCLUSIONS In AS patients, isolated AVR with the Perceval sutureless bioprosthesis is associated with significant LV mass regression at 1-year follow-up. However, longer-term follow-up is necessary to confirm these findings. PMID:24105865

  20. Association Between Blood Transfusions and 12-Month Mortality After Transcatheter Aortic Valve Implantation.

    PubMed

    Kleczynski, Pawel; Dziewierz, Artur; Bagienski, Maciej; Rzeszutko, Lukasz; Sorysz, Danuta; Trebacz, Jaroslaw; Sobczynski, Robert; Tomala, Marek; Stapor, Maciej; Dudek, Dariusz

    2017-02-07

    Blood transfusions are considered as an important predictor of adverse outcome in patients with severe aortic (AS) undergoing transcatheter aortic valve implantation (TAVI). We sought to investigate the association between blood transfusions and mortality after TAVI. We enrolled 101 consecutive patients with severe AS undergoing TAVI. Patients who required transfusion were defined as patients in whom at least one unit of packed red blood cells (PRBCs) was transfused in the perioperative period. Twelve-month outcomes were assessed based on Valve Academic Research Consortium definitions. A total of 28 (27.7%) patients required blood transfusion after TAVI. Baseline characteristics of the patients with and without a transfusion were similar. Median amount of PRBCs was 2 (interquartile range, 2-4). Twelvemonth all-cause mortality was higher in patients with than without a blood transfusion (39.3% versus 9.6%; P = 0.001). Importantly, the need for a blood transfusion after TAVI was an independent predictor of higher mortality rates after 12 months (hazard ratio (HR) 2.84 95%CI (1.06-7.63); P = 0.039; (HR for incomplete coronary revascularization 10.86, 95%CI 3.72-31.73; P < 0.001; HR for a history of stroke/TIA 3.93, 95%CI 1.39-11.07; P < 0.001). The duration of inhospital stay was longer in patients requiring transfusion (16.0 (14.0-22.0) versus 7.0 (7.0-11.5) days; P = 0.014). In conclusion, blood transfusions after TAVI were associated with higher mortality rates after 12 months, longer in-hospital stay, and were identified as an independent predictor of impaired clinical outcome.

  1. Comparison of two antiplatelet therapy strategies in patients undergoing transcatheter aortic valve implantation.

    PubMed

    Durand, Eric; Blanchard, Didier; Chassaing, Stephan; Gilard, Martine; Laskar, Marc; Borz, Bogdan; Lafont, Antoine; Barbey, Christophe; Godin, Matthieu; Tron, Christophe; Zegdi, Rachid; Chatel, Didier; Le Page, Olivier; Litzler, Pierre-Yves; Bessou, Jean-Paul; Danchin, Nicolas; Cribier, Alain; Eltchaninoff, Hélène

    2014-01-15

    Dual antiplatelet therapy is commonly used in patients undergoing transcatheter aortic valve implantation (TAVI), but the optimal antiplatelet regimen is uncertain and remains to be determined. The objective of this study was to compare 2 strategies of antiplatelet therapy in patients undergoing TAVI. A strategy using monoantiplatelet therapy (group A, n = 164) was prospectively compared with a strategy using dual antiplatelet therapy (group B, n = 128) in 292 consecutive patients undergoing TAVI. The primary end point was a combination of mortality, major stroke, life-threatening bleeding (LTB), myocardial infarction, and major vascular complications at 30 days. All adverse events were adjudicated according to the Valve Academic Research Consortium. The primary end point occurred in 22 patients (13.4%) in the group A and in 30 patients (23.4%) in the group B (hazard ratio 0.51, 95% confidence interval 0.28 to 0.94, p = 0.026). LTB (3.7% vs 12.5%, p = 0.005) and major bleedings (2.4% vs 13.3%, p <0.0001) occurred less frequently in the group A, whereas the incidence of stroke (1.2% vs 4.7%, p = 0.14) and myocardial infarction (1.2% vs 0.8%, p = 1.0) was not significantly different between the 2 groups. The benefit of a strategy using mono versus dual antiplatelet therapy persisted after multivariate adjustment and propensity score analysis (hazard ratio 0.53, 95% confidence interval 0.28 to 0.95, p = 0.033). In conclusion, a strategy using mono versus dual antiplatelet therapy in patients undergoing TAVI reduces LTB and major bleedings without increasing the risk of stroke and myocardial infarction. The results of our study question the justification of dual antiplatelet therapy and require confirmation in a randomized trial. Copyright © 2014 Elsevier Inc. All rights reserved.

  2. Catheter manipulation analysis for objective performance and technical skills assessment in transcatheter aortic valve implantation.

    PubMed

    Mazomenos, Evangelos B; Chang, Ping-Lin; Rippel, Radoslaw A; Rolls, Alexander; Hawkes, David J; Bicknell, Colin D; Desjardins, Adrien; Riga, Celia V; Stoyanov, Danail

    2016-06-01

    Transcatheter aortic valve implantation (TAVI) demands precise and efficient handling of surgical instruments within the confines of the aortic anatomy. Operational performance and dexterous skills are critical for patient safety, and objective methods are assessed with a number of manipulation features, derived from the kinematic analysis of the catheter/guidewire in fluoroscopy video sequences. A silicon phantom model of a type I aortic arch was used for this study. Twelve endovascular surgeons, divided into two experience groups, experts ([Formula: see text]) and novices ([Formula: see text]), performed cannulation of the aorta, representative of valve placement in TAVI. Each participant completed two TAVI experiments, one with conventional catheters and one with the Magellan robotic platform. Video sequences of the fluoroscopic monitor were recorded for procedural processing. A semi-automated tracking software provided the 2D coordinates of the catheter/guidewire tip. In addition, the aorta phantom was segmented in the videos and the shape of the entire catheter was manually annotated in a subset of the available video frames using crowdsourcing. The TAVI procedure was divided into two stages, and various metrics, representative of the catheter's overall navigation as well as its relative movement to the vessel wall, were developed. Experts consistently exhibited lower values of procedure time and dimensionless jerk, and higher average speed and acceleration than novices. Robotic navigation resulted in increased average distance to the vessel wall in both groups, a surrogate measure of safety and reduced risk of embolisation. Discrimination of experience level and types of equipment was achieved with the generated motion features and established clustering algorithms. Evaluation of surgical skills is possible through the analysis of the catheter/guidewire motion pattern. The use of robotic endovascular platforms seems to enable more precise and controlled

  3. Ultrasound biomicroscopy in pupillary block glaucoma secondary to ophthalmic viscosurgical device remnants in the posterior chamber after anterior chamber phakic intraocular lens implantation.

    PubMed

    Sun, Chuan-Bin; Liu, Zhe; Yao, Ke

    2010-12-01

    A 25-year-old woman developed pupillary block glaucoma in the right eye after implantation of an angle-supported phakic intraocular lens despite a preexisting moderate-sized iridectomy. Ultrasound biomicroscopy (UBM) showed ophthalmic viscosurgical device retention in the posterior chamber and a full-thickness, patent-appearing iridectomy at 12 o'clock. The intraocular pressure gradually decreased to normal after a neodymium:YAG laser iridotomy was performed midperipherally at 9 o'clock. To our knowledge, this is the first report of UBM findings of this complication.

  4. Candida and cardiovascular implantable electronic devices: a case of lead and native aortic valve endocarditis and literature review.

    PubMed

    Glavis-Bloom, Justin; Vasher, Scott; Marmor, Meghan; Fine, Antonella B; Chan, Philip A; Tashima, Karen T; Lonks, John R; Kojic, Erna M

    2015-11-01

    Use of cardiovascular implantable electronic devices (CIED), including permanent pacemakers (PPM) and implantable cardioverter defibrillators (ICD), has increased dramatically over the past two decades. Most CIED infections are caused by staphylococci. Fungal causes are rare and their prognosis is poor. To our knowledge, there has not been a previously reported case of multifocal Candida endocarditis involving both a native left-sided heart valve and a CIED lead. Here, we report the case of a 70-year-old patient who presented with nausea, vomiting, and generalised fatigue, and was found to have Candida glabrata endocarditis involving both a native aortic valve and right atrial ICD lead. We review the literature and summarise four additional cases of CIED-associated Candida endocarditis published from 2009 to 2014, updating a previously published review of cases prior to 2009. We additionally review treatment guidelines and discuss management of CIED-associated Candida endocarditis. © 2015 Blackwell Verlag GmbH.

  5. Vascular Complications and Bleeding After Transfemoral Transcatheter Aortic Valve Implantation Performed Through Open Surgical Access.

    PubMed

    Leclercq, Florence; Akodad, Mariama; Macia, Jean-Christophe; Gandet, Thomas; Lattuca, Benoit; Schmutz, Laurent; Gervasoni, Richard; Nogue, Erika; Nagot, Nicolas; Levy, Gilles; Maupas, Eric; Robert, Gabriel; Targosz, Frederic; Vernhet, Hélène; Cayla, Guillaume; Albat, Bernard

    2015-11-01

    Major vascular complications (VC) remain frequent after transcatheter aortic valve implantation (TAVI) and may be associated with unfavorable clinical outcomes. The objective of this study was to evaluate the rate of VC after transfemoral TAVI performed using an exclusive open surgical access strategy. From 2010 to 2014, we included in a monocentric registry all consecutive patients who underwent transfemoral TAVI. The procedures were performed with 16Fr to 20Fr sheath systems. VC were evaluated within 30 days and classified as major or minor according to the Valve Academic Research Consortium 2 definition. The study included 396 patients, 218 were women (55%), median age was 85 years (81 to 88), and the median logistic Euroscore was 15.2% (11 to 23). The balloon-expandable SAPIEN XT and the self-expandable Medtronic Core Valve prosthesis were used in 288 (72.7%) and 108 patients (27.3%), respectively. The total length of the procedure was 68 ± 15 minutes including 13 ± 5 minutes for the open surgical access. Major and minor VC were observed in 9 (2.3%) and 16 patients (4%), respectively, whereas life-threatening and major bleeding concerned 18 patients (4.6%). The median duration of hospitalization was 5 days (interquartile range 2 to 7), significantly higher in patients with VC (7 days [5 to 15], p <0.001). Mortality at 1-month and 1-year follow-up (n = 26, 6.6%; and n = 67, 17.2%, respectively) was not related to major or minor VC (p = 0.6). In multivariable analysis, only diabetes (odds ratio 2.5, 95% confidence interval 1.1 to 6.1, p = 0.034) and chronic kidney failure (odds ratio 3.0, 95% confidence interval 1.0 to 9.0, p = 0.046) were predictive of VC, whereas body mass index, gender, Euroscore, and lower limb arteriopathy were not. In conclusion, minimal rate of VC and bleeding can be obtained after transfemoral TAVI performed using an exclusive surgical strategy, with a particular advantage observed in high-risk bleeding patients.

  6. Impact of clinical and procedural factors upon C reactive protein dynamics following transcatheter aortic valve implantation

    PubMed Central

    Ruparelia, Neil; Panoulas, Vasileios F; Frame, Angela; Ariff, Ben; Sutaria, Nilesh; Fertleman, Michael; Cousins, Jonathan; Anderson, Jon; Bicknell, Colin; Chukwuemeka, Andrew; Sen, Sayan; Malik, Iqbal S; Colombo, Antonio; Mikhail, Ghada W

    2016-01-01

    AIM: To determine the effect of procedural and clinical factors upon C reactive protein (CRP) dynamics following transcatheter aortic valve implantation (TAVI). METHODS: Two hundred and eight consecutive patients that underwent transfemoral TAVI at two hospitals (Imperial, College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom and San Raffaele Scientific Institute, Milan, Italy) were included. Daily venous plasma CRP levels were measured for up to 7 d following the procedure (or up to discharge). Procedural factors and 30-d safety outcomes according to the Valve Academic Research Consortium 2 definition were collected. RESULTS: Following TAVI, CRP significantly increased reaching a peak on day 3 of 87.6 ± 5.5 mg/dL, P < 0.001. Patients who developed clinical signs and symptoms of sepsis had significantly increased levels of CRP (P < 0.001). The presence of diabetes mellitus was associated with a significantly higher peak CRP level at day 3 (78.4 ± 3.2 vs 92.2 ± 4.4, P < 0.001). There was no difference in peak CRP release following balloon-expandable or self-expandable TAVI implantation (94.8 ± 9.1 vs 81.9 ± 6.9, P = 0.34) or if post-dilatation was required (86.9 ± 6.3 vs 96.6 ± 5.3, P = 0.42), however, when pre-TAVI balloon aortic valvuloplasty was performed this resulted in a significant increase in the peak CRP (110.1 ± 8.9 vs 51.6 ± 3.7, P < 0.001). The development of a major vascular complication did result in a significantly increased maximal CRP release (153.7 ± 11.9 vs 83.3 ± 7.4, P = 0.02) and there was a trend toward a higher peak CRP following major/life-threatening bleeding (113.2 ± 9.3 vs 82.7 ± 7.5, P = 0.12) although this did not reach statistical significance. CRP was not found to be a predictor of 30-d mortality on univariate analysis. CONCLUSION: Careful attention should be paid to baseline clinical characteristics and procedural factors when interpreting CRP following TAVI to determine their future management. PMID

  7. Impact of clinical and procedural factors upon C reactive protein dynamics following transcatheter aortic valve implantation.

    PubMed

    Ruparelia, Neil; Panoulas, Vasileios F; Frame, Angela; Ariff, Ben; Sutaria, Nilesh; Fertleman, Michael; Cousins, Jonathan; Anderson, Jon; Bicknell, Colin; Chukwuemeka, Andrew; Sen, Sayan; Malik, Iqbal S; Colombo, Antonio; Mikhail, Ghada W

    2016-07-26

    To determine the effect of procedural and clinical factors upon C reactive protein (CRP) dynamics following transcatheter aortic valve implantation (TAVI). Two hundred and eight consecutive patients that underwent transfemoral TAVI at two hospitals (Imperial, College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom and San Raffaele Scientific Institute, Milan, Italy) were included. Daily venous plasma CRP levels were measured for up to 7 d following the procedure (or up to discharge). Procedural factors and 30-d safety outcomes according to the Valve Academic Research Consortium 2 definition were collected. Following TAVI, CRP significantly increased reaching a peak on day 3 of 87.6 ± 5.5 mg/dL, P < 0.001. Patients who developed clinical signs and symptoms of sepsis had significantly increased levels of CRP (P < 0.001). The presence of diabetes mellitus was associated with a significantly higher peak CRP level at day 3 (78.4 ± 3.2 vs 92.2 ± 4.4, P < 0.001). There was no difference in peak CRP release following balloon-expandable or self-expandable TAVI implantation (94.8 ± 9.1 vs 81.9 ± 6.9, P = 0.34) or if post-dilatation was required (86.9 ± 6.3 vs 96.6 ± 5.3, P = 0.42), however, when pre-TAVI balloon aortic valvuloplasty was performed this resulted in a significant increase in the peak CRP (110.1 ± 8.9 vs 51.6 ± 3.7, P < 0.001). The development of a major vascular complication did result in a significantly increased maximal CRP release (153.7 ± 11.9 vs 83.3 ± 7.4, P = 0.02) and there was a trend toward a higher peak CRP following major/life-threatening bleeding (113.2 ± 9.3 vs 82.7 ± 7.5, P = 0.12) although this did not reach statistical significance. CRP was not found to be a predictor of 30-d mortality on univariate analysis. Careful attention should be paid to baseline clinical characteristics and procedural factors when interpreting CRP following TAVI to determine their future management.

  8. Three-Dimensional Quantitative Micromorphology of Pre- and Post-Implanted Engineered Heart Valve Tissues

    PubMed Central

    Eckert, Chad E.; Mikulis, Brandon T.; Gottlieb, Danielle; Gerneke, Dane; LeGrice, Ian; Padera, Robert F.; Mayer, John E.; Schoen, Frederick J.; Sacks, Michael S.

    2011-01-01

    There is a significant gap in our knowledge of engineered heart valve tissue (EHVT) development regarding detailed three-dimensional (3D) tissue formation and remodeling from the point of in vitro culturing to full in vivo function. As a step toward understanding the complexities of EHVT formation and remodeling, a novel serial confocal microscopy technique was employed to obtain 3D micro-structural information of pre-implant (PRI) and post-implant for 12 weeks (POI) EHVT fabricated from PGA: PLLA scaffolds and seeded with ovine bone-marrow-derived mesenchymal stem cells. Custom scaffold fiber tracking software was developed to quantify scaffold fiber architectural features such as length, tortuosity, and minimum scaffold fiber–fiber separation distance and scaffold fiber orientation was quantified utilizing a 3D fabric tensor. In addition, collagen and cellular density of ovine pulmonary valve leaflet tissue were also analyzed for baseline comparisons. Results indicated that in the unseeded state, scaffold fibers formed a continuous, oriented network. In the PRI state, the scaffold showed some fragmentation with a scaffold volume fraction of 7.79%. In the POI specimen, the scaffold became highly fragmented, forming a randomly distributed short fibrous network (volume fraction of 2.03%) within a contiguous, dense collagenous matrix. Both PGA and PLLA scaffold fibers were observed in the PRI and POI specimens. Collagen density remained similar in both PRI and POI specimens (74.2 and 71.5%, respectively), though the distributions in the transmural direction appeared slightly more homogenous in the POI specimen. Finally, to guide future 2D histological studies for large-scale studies (since acquisition of high-resolution volumetric data is not practical for all specimens), we investigated changes in relevant collagen and scaffold metrics (collagen density and scaffold fiber orientation) with varying section spacing. It was found that a sectioning spacing up to 25

  9. Predictors of Permanent Pacemaker Implantation After Coronary Artery Bypass Grafting and Valve Surgery in Adult Patients in Current Surgical Era.

    PubMed

    Al-Ghamdi, Bandar; Mallawi, Yaseen; Shafquat, Azam; Ledesma, Alexandra; AlRuwaili, Nadiah; Shoukri, Mohamed; Khan, Shahid; Al Sanei, Aly

    2016-08-01

    Permanent pacemaker (PPM) implantation after cardiac surgery is required in 0.4-6% of patients depending on cardiac surgery type. PPM implantation in the early postoperative period may reduce morbidity and postoperative hospital stay. We performed a retrospective review of electronic medical records of adult patients with coronary artery bypass grafting (CABG), valve surgery, or both, over a 3-year period. Our aim was to identify predictors of PPM requirements and PPM dependency on follow-up in the current surgical era. After exclusion of patients with congenital heart disease, patients who already had a PPM or implantable cardioverter defibrillator (ICD), and patients with an indication for PPM or ICD before surgery, we identified 1,234 adult patients who underwent cardiac surgery between January 2007 and December 2009. A retrospective review of electronic medical records and pacemaker clinic data was performed. Patients' mean age was 46.65 ± 16 years, and 59% were males. CABG was performed in 575 (46.6%) cases, aortic valve replacement in 263 (21.3%), mitral valve replacement in 333 (27%), and tricuspid valve replacement in 76 patients (6.2%). Twenty patients (1.6%) required implantation of a PPM postoperatively. Indications for PPM implantation included complete atrioventricular (AV) block in 13 (65%), sick sinus syndrome in three (15%), and atrial fibrillation (AF) with a slow ventricular rate in four (20%). Predictors for PPM requirement by multivariate analysis were the presence of pulmonary hypertension (P-HTN), reoperation, and left bundle branch block (LBBB) (P < 0.05). Late follow-up was available in 18 patients, at 84.5 ± 30 months. Eleven patients (61%) were PPM dependent on long-term follow-up. Patients at high risk for PPM implantation after cardiac surgery include those with P-HTN, reoperation, and pre-existing LBBB. Of those receiving a PPM, about one-third will recover at least partially at long-term follow-up. We recommend preoperative

  10. Predictors of Permanent Pacemaker Implantation After Coronary Artery Bypass Grafting and Valve Surgery in Adult Patients in Current Surgical Era

    PubMed Central

    Al-Ghamdi, Bandar; Mallawi, Yaseen; Shafquat, Azam; Ledesma, Alexandra; AlRuwaili, Nadiah; Shoukri, Mohamed; Khan, Shahid; Al Sanei, Aly

    2016-01-01

    Background Permanent pacemaker (PPM) implantation after cardiac surgery is required in 0.4-6% of patients depending on cardiac surgery type. PPM implantation in the early postoperative period may reduce morbidity and postoperative hospital stay. We performed a retrospective review of electronic medical records of adult patients with coronary artery bypass grafting (CABG), valve surgery, or both, over a 3-year period. Our aim was to identify predictors of PPM requirements and PPM dependency on follow-up in the current surgical era. Methods After exclusion of patients with congenital heart disease, patients who already had a PPM or implantable cardioverter defibrillator (ICD), and patients with an indication for PPM or ICD before surgery, we identified 1,234 adult patients who underwent cardiac surgery between January 2007 and December 2009. A retrospective review of electronic medical records and pacemaker clinic data was performed. Results Patients’ mean age was 46.65 ± 16 years, and 59% were males. CABG was performed in 575 (46.6%) cases, aortic valve replacement in 263 (21.3%), mitral valve replacement in 333 (27%), and tricuspid valve replacement in 76 patients (6.2%). Twenty patients (1.6%) required implantation of a PPM postoperatively. Indications for PPM implantation included complete atrioventricular (AV) block in 13 (65%), sick sinus syndrome in three (15%), and atrial fibrillation (AF) with a slow ventricular rate in four (20%). Predictors for PPM requirement by multivariate analysis were the presence of pulmonary hypertension (P-HTN), reoperation, and left bundle branch block (LBBB) (P < 0.05). Late follow-up was available in 18 patients, at 84.5 ± 30 months. Eleven patients (61%) were PPM dependent on long-term follow-up. Conclusions Patients at high risk for PPM implantation after cardiac surgery include those with P-HTN, reoperation, and pre-existing LBBB. Of those receiving a PPM, about one-third will recover at least partially at long

  11. Psoas Muscle Area as a Predictor of Outcomes in Transcatheter Aortic Valve Implantation.

    PubMed

    Garg, Lohit; Agrawal, Sahil; Pew, Timothy; Hanzel, George S; Abbas, Amr E; Gallagher, Michael J; Shannon, Francis L; Hanson, Ivan D

    2017-02-01

    Frailty is a powerful predictor of outcomes after transcatheter aortic valve implantation (TAVI). Sarcopenia as assessed by psoas muscle area (PMA) is a validated tool to assess frailty before surgical procedures. We evaluated PMA as a predictor of outcomes after TAVI in 152 consecutive patients who underwent this procedure at our institution from 2011 to 2014. Preoperative computed tomography scans were used to measure PMA, which then was indexed to body surface area. Outcomes evaluated included (1) early poor outcome (30 days mortality, stroke, dialysis, and prolonged ventilation), (2) 1-year mortality, and (3) high-resource utilization (length of stay >7 days, discharge to rehabilitation, or readmission within 30 days). Indexed PMA (odds ratio [OR] 3.19, confidence interval [CI] 1.30 to 7.83; p = 0.012) and age (OR 1.92, CI 1.87 to 1.98; p = 0.012) predicted early poor outcome. Society of Thoracic Surgeons score predicted 1-year mortality (hazard ratio 3.07, CI 1.93 to 6.23; p = 0.011). High-resource utilization was observed more frequently in patients with PMA less than the median (73% vs 51%, OR 2.65, CI 1.32 to 5.36; p = 0.006). In conclusion, indexed PMA predicts early poor outcome and high-resource utilization after TAVI. Copyright © 2016 Elsevier Inc. All rights reserved.

  12. In-hospital and mid-term predictors of mortality after transcatheter aortic valve implantation: data from the TAVI National Registry 2010-2011.

    PubMed

    Sabaté, Manel; Cánovas, Sergio; García, Eulogio; Hernández Antolín, Rosana; Maroto, Luis; Hernández, José María; Alonso Briales, Juan H; Muñoz García, Antonio J; Gutiérrez-Ibañes, Enrique; Rodríguez-Roda, Jorge

    2013-12-01

    The treatment of severe symptomatic aortic stenosis has been revolutionized by the technique of transcatheter valve replacement. The purpose of this study was to present the outcomes and predictors of mortality in patients enrolled between 2010 and 2011 in the Transcatheter Aortic Valve Replacement National Registry. We collected 131 preprocedural, 31 periprocedural, and 76 follow-up variables, and analyzed the immediate implant success rate, the 30-day safety endpoint, and all-cause 30-day and mid-term (mean follow-up, 244 days) mortality. From January 2010 to December 2011, a total of 1416 patients were included: 806 with Edwards valves and 610 with CoreValves. The implant success and 30-day mortality rates were 94% and 8%, respectively, without differences between types of valves and approaches. The 30-day safety endpoint and mid-term mortality rates were 14% and 16%, respectively, which were also similar between groups. The presence of comorbidities (renal failure, peripheral vascular disease, ejection fraction, and atrial fibrillation), the need for conversion to surgery, and at least moderate aortic regurgitation after transcatheter aortic valve implantation were identified as independent predictors of in-hospital and mid-term mortality. The prognosis of valve implant patients could be improved by including comorbidities in patient selection and by minimizing the degree of residual aortic regurgitation to optimize the results of the procedure. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  13. Intraoperative improvement in left ventricular peak systolic velocity predicts better short-term outcome after transcatheter aortic valve implantation.

    PubMed

    Eidet, Jo; Dahle, Gry; Bugge, Jan Frederik; Bendz, Bjørn; Rein, Kjell Arne; Aaberge, Lars; Offstad, Jon Thomas; Fosse, Erik; Aakhus, Svend; Halvorsen, Per Steinar

    2016-01-01

    Left ventricular function is expected to improve after transcatheter aortic valve implantation due to the acute reduction in afterload, but does not occur in all patients. We hypothesized that the immediate intraoperative response in systolic left ventricular longitudinal motion during the procedure could be a predictor of short-term outcome. Sixty-four patients treated with transcatheter aortic valve implantation for severe aortic stenosis were included. Transoesophageal 4- and 2-chamber echocardiograms were obtained immediately prior to and ∼15 min after valve implantation. Patients were defined as responders if their average left ventricular longitudinal peak systolic velocity increased by ≥20% from the preimplantation value and was related to the 3-month outcome. Thirty-five patients were classified as responders, with an increase in the intraoperative longitudinal peak systolic velocity from an average of 2.2 ± 0.8 to 3.1 ± 1.1 cm/s (P < 0.001); the velocity was unchanged in the remaining 29 patients, who averaged 2.4 ± 1.1 cm/s. There were significantly fewer adverse cardiac events in the responder group at the 3-month follow-up (20 vs 45%, P = 0.03) and the New York Heart Association class was significantly better in the responders compared with non-responders. Responders had a significant reduction in N-terminal probrain natriuretic peptide levels [243 (113-361) vs 163 (64-273), P = 0.004] at the 3-month follow-up, whereas non-responders did not [469 (130-858) vs 289 (157-921), P = 0.48]. An immediate improvement in the longitudinal peak systolic velocity during the transcatheter aortic valve implantation procedure predicted a better short-term outcome and may be useful in identifying patients who are at risk of a less favourable outcome after transcatheter aortic valve implantation. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  14. Comparison of the Edwards SAPIEN S3 Versus Medtronic Evolut-R Devices for Transcatheter Aortic Valve Implantation.

    PubMed

    Ben-Shoshan, Jeremy; Konigstein, Maayan; Zahler, David; Margolis, Gilad; Chorin, Ehud; Steinvil, Arie; Arbel, Yaron; Aviram, Galit; Granot, Yoav; Barkagan, Michael; Keren, Gad; Halkin, Amir; Banai, Shmuel; Finkelstein, Ariel

    2017-01-15

    New generation of the most widely used devices for transcatheter aortic valve implantation have been recently introduced into practice. We compare the short-term outcomes of transcatheter aortic valve implantation with the Edwards SAPIEN S3 and the Medtronic Evolut-R. We performed a retrospective analysis from a single high-volume tertiary center. Valve Academic Research Consortium-2 criteria were used to define composite end points of device success and safety at 30 days. Study population included 232 patients implanted with the SAPIEN S3 (n = 124) and Evolut-R (n = 108). Device success reached 91.9% and 95.4% in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.289). Postprocedural echocardiography showed greater aortic valve gradients (22.8 ± 7 vs 16 ± 9 mm Hg, p <0.001) among SAPIEN S3 group. Paravalvular leak of ≥ moderate severity was observed in 2.4% and 0% in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.251). Similar rates of in-hospital complications, including major bleedings, vascular complications, and pacemaker implantations were recorded in both groups. At 30-day follow-up, the combined safety end point was reached in 5.6% and in 6.5% of patients in the SAPIEN S3 and Evolut-R groups, respectively (p = 0.790). During follow-up of 237 ± 138 days, all-cause mortality was higher in patients implanted with Evolut-R compared with SAPIEN S3 (7 vs 1 cases, respectively, p = 0.006), however, cardiovascular mortality was not significantly different between groups. In conclusions, in a single-center comparative analysis, comparable rate of device success as well as safety profile and long-term cardiovascular mortality were observed with the SAPIEN S3 and Evolut-R valves. Copyright © 2016 Elsevier Inc. All rights reserved.

  15. Cerebral embolization during percutaneous valve implantation does not occur during balloon inflation valvuloplasty: prospective diffusion-weighted brain MRI study.

    PubMed

    Astarci, Parla; Price, Joel; Glineur, David; D'Hoore, William; Kefer, Joelle; Elkhoury, Gébrine; Grandin, Cécile; Vanoverschelde, Jean-Louis

    2013-01-01

    The study aim was to define the timing of cerebral embolization events during transcatheter aortic valve implantation (TAVI), and to determine if events were more closely associated with valve implantation or with balloon inflation. Between January 2008 and November 2011, a total of 114 patients underwent TAVI at the author's institution. Of these patients, 44 had previously undergone imaging before and after TAVI, and were included in the study (26 transfemoral (TF); 18 transapical (TA)). Eleven patients who had only balloon valvuloplasty (BV) during the same period were included, as were 22 patients who had open aortic valve replacement (AVR), as controls. All 77 patients underwent neurological examination, and all had cerebral MRIs before and after their procedures. Fifty of the 77 patients who underwent postprocedural MRI had new cerebral lesions, as follows: 24/26 (92%) in TF patients; 17/18 (94%) in TA patients; 3/11 (27%) in BV patients; and 6/22 (27%) in AVR patients (TF and TA versus BV and AVR, p < 0.0001). The mean number and volume of embolic lesions per patient were respectively 5.4/438 mm3 for TF, 11.6/3414 mm3 for TA, 0.7/46 mm3 for BV, and 0.4/48 mm3 for AVR (TF versus TA and BV versus AVR, p = NS; TF and TA versus BV and AVR, p < 0.0001). No association was found between either the EuroSCORE or patient age and the number of events. In the present study, an incidence of silent cerebral embolic lesions after TAVI was identified which was significantly higher than that for BV or AVR. This indicated an association of embolism with valve implantation rather than with balloon inflation.

  16. Rationale and design of the Edwards SAPIEN-3 periprosthetic leakage evaluation versus Medtronic CoreValve in transfemoral aortic valve implantation (ELECT) trial : A randomised comparison of balloon-expandable versus self-expanding transcatheter aortic valve prostheses.

    PubMed

    Abawi, M; Agostoni, P; Kooistra, N H M; Samim, M; Nijhoff, F; Voskuil, M; Nathoe, H; Doevendans, P A; Chamuleau, S A; Urgel, K; Hendrikse, J; Leiner, T; Abrahams, A C; van der Worp, B; Stella, P R

    2017-05-01

    Periprosthetic aortic regurgitation (PPR) after transcatheter aortic valve implantation (TAVI) remains an important issue associated with impaired long-term outcomes. The current randomised study aims to evaluate potential differences between the balloon-expandable Edwards SAPIEN-3 and the self-expanding Medtronic CoreValve system with the main focus on post-TAVI PPR by means of novel imaging endpoints, and an additional focus on other clinical endpoints. The primary endpoint of this study is quantitative assessment of the severity of post-procedural PPR using cardiac magnetic resonance imaging. Several other novel imaging modalities (X-ray contrast angiography, echocardiography) are used as secondary imaging modalities for the assessment of PPR following TAVI. Secondary objectives of the study include clinical outcomes such as cerebral and kidney injury related to TAVI, and quality of life. The ELECT study is a single-centre, prospective, two-armed randomised controlled trial. For the purpose of this study, 108 consecutive adult patients suitable for transfemoral TAVI will be randomly allocated to receive the SAPIEN-3 (n = 54) or the CoreValve system (n = 54). The ELECT trial is the first randomised controlled trial to quantitatively compare the extent of post-TAVI PPR between the SAPIEN-3 and CoreValve. Furthermore, it will evaluate potential differences between the two prostheses with regard to mid-term clinical outcome and quality of life.

  17. African Americans and Glaucoma

    MedlinePlus

    ... Latinos at Increased Glaucoma Risk Glaucoma Facts and Stats Glaucoma Risk Increases in Families: Spread the Word ... Anatomy Five Common Glaucoma Tests Glaucoma Facts and Stats Glossary Symptoms of Open-Angle Glaucoma Types of ...

  18. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma

    PubMed Central

    Donnenfeld, Eric D; Solomon, Kerry D; Voskanyan, Lilit; Chang, David F; Samuelson, Thomas W; Ahmed, Iqbal Ike K; Katz, L Jay

    2015-01-01

    Purpose To evaluate 3-year safety and intraocular pressure (IOP) following two trabecular microbypass stents in phakic and pseudophakic subjects with open-angle glaucoma (OAG) not controlled on preoperative medication. Patients and methods In this prospective pilot study, phakic or pseudophakic subjects with OAG and IOP between 18 mmHg and 30 mmHg on one preoperative topical ocular hypotensive medication underwent medication washout. Thirty-nine qualified subjects with preoperative unmedicated IOP ≥22 mmHg and ≤38 mmHg received two stents. Postoperative examinations were scheduled at Day 1, Week 1, Months 1, 3, 6, and 12, and semiannually through Month 60. Ocular hypotensive medication was considered if postoperative IOP exceeded 21 mmHg. IOP, medication use, and safety were assessed at each visit. Subject follow-up through Month 36 was completed. Results Thirty-six eyes (92.3%; 95% confidence interval [CI] 79.1%, 98.4%) achieved the primary efficacy end point of Month 12 reduction in IOP ≥20% from baseline (unmedicated IOP) without ocular hypotensive medication. Four subjects required medication during the Month 36 follow-up period. Mean IOP at 36 months for subjects not taking medication was 15.2 mmHg. At 36 months, subjects sustained mean IOP decrease of 9.1±2.7 mmHg (95% CI 8.0 mmHg, 10.14 mmHg), or 37% IOP reduction, from unmedicated baseline IOP. Compared to preoperative medicated IOP, subjects had mean reduction at Month 36 of 5.5±2.7 mmHg (95% CI 4.5 mmHg, 6.6 mmHg), or 26% reduction. Both measures of IOP reduction were highly significant (P<0.001). Other than one case of early postoperative hyphema that resolved at 1 week, no postoperative adverse events were attributed to stent implantation. Conclusion In a pilot study, two trabecular microbypass stents to treat OAG subjects on one preoperative medication provided statistically significant, sustained, and safe reduction of IOP to ≤15 mmHg without medication through 36 months. PMID:26604675

  19. Puncture Versus Surgical Cutdown Complications of Transfemoral Aortic Valve Implantation (from the Spanish TAVI Registry).

    PubMed

    Hernández-Enriquez, Marco; Andrea, Rut; Brugaletta, Salvatore; Jiménez-Quevedo, Pilar; Hernández-García, José María; Trillo, Ramiro; Larman, Mariano; Fernández-Avilés, Francisco; Vázquez-González, Nicolás; Iñiguez, Andrés; Zueco, Javier; Ruiz-Salmerón, Rafael; Del Valle, Raquel; Molina, Eduardo; García Del Blanco, Bruno; Berenguer, Alberto; Valdés, Mariano; Moreno, Raúl; Urbano-Carrillo, Cristóbal; Hernández-Antolín, Rosana; Gimeno, Federico; Cequier, Ángel; Cruz, Ignacio; López-Mínguez, José Ramón; Aramendi, José Ignacio; Sánchez, Ángel; Goicolea, Javier; Albarrán, Agustín; Díaz, José Francisco; Navarro, Felipe; Moreu, José; Morist, Andrés; Fernández-Nofrerías, Eduard; Fernández-Vázquez, Felipe; Ten, Francisco; Mainar, Vicente; Mari, Belén; Saenz, Alberto; Alfonso, Fernando; Diarte, José Antonio; Sancho, Manuel; Lezáun, Román; Arzamendi, Dabit; Sabaté, Manel

    2016-08-15

    Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p <0.001) due mostly by minor vascular events (89 [15%] vs 25 [4.1%], RR 3.56, 95% CI 2.32 to 5.47, p <0.001). Bleeding rates were lower in the puncture group (18 [3%] vs 40 [6.6%], RR 0.45, 95% CI 0.26 to 0.78, p = 0.003) mainly driven by major bleeding (9 [1.5%] vs 21 [3.4%], RR 0.43, 95% CI 0.20 to 0.93, p = 0.03). At a mean follow-up of 323 days, complication rates remained significantly different between groups (minor vascular complications 90 [15%] vs 31 [5.1%], hazard ratio 2.99, 95% CI 1.99 to 4.50, p <0.001 and major bleeding 10 [1.6%] vs 21 [3.4%], hazard ratio 0.47, 95% CI 0.22 to 1.0, p = 0.04, puncture versus cutdown group, respectively). In conclusion, percutaneous approach yielded higher rates of minor vascular complications but lower rates of major bleeding compared with the surgical cutdown, both at 30-day and at mid-term follow-up in our population.

  20. Transcatheter aortic valve implantation for paradoxical low-flow low-gradient aortic stenosis patients.

    PubMed

    Debry, Nicolas; Sudre, Arnaud; Amr, Gilles; Delhaye, Cédric; Schurtz, Guillaume; Montaigne, David; Koussa, Mohamad; Modine, Thomas

    2016-03-01

    We compared the outcomes of transcatheter aortic valve implantation (TAVI) in three different aortic stenosis syndromes: paradoxical low-flow low-gradient aortic stenosis (PLFLG), high-gradient aortic stenosis (HGAS), and low ejection fraction low-gradient severe aortic stenosis (LEF-LG). Outcomes for PLFLG patients after TAVI procedure are not well known. Between 2010 and 2013, patients with severe (indexed aortic valve area iAVA≤0.6 cm(2)/m(2)) symptomatic aortic stenosis were consecutively referred to our institution for TAVI because of multiple comorbidities and excessive surgical risk. About 262 patients were split into three groups as following, PLFLG: mean gradient MG≤40 mm Hg, stroke volume index SVI≤35 mL/m(2), ejection fraction EF≥55%, valvuloarterial impedance Zva>4.5 mm Hg/mL/m(2), maximal aortic jet velocity MaxV<4 m/s; MG≤40 mm Hg, MaxV<4 m/s, EF≤50%, SVI≤35 mL/m(2); and HGAS: MaxV>4 m/s, MG>40 mm Hg, EF>55%. The primary endpoint of our study was to evaluate mid-term global and cardiovascular mortalities; secondary endpoints included recommended VARC-2 variables. PLFLG (n = 31) mid-term survival was similar to HGAS (n = 172) (mean follow-up = 13.2 months [4.6-26]). Conversely LEF-LG patients (n = 59) displayed significant higher rates of all-cause (P = 0.01) and cardiovascular mortalities (P = 0.05). Postprocedural outcomes (VARC-2 criteria) were similar in the PLFLG and HGAS groups except regarding major bleeding (P = 0.02), while the LEF-LG group had more congestive heart failure and a higher BNP before discharge (both P < 0.001) than the other groups. 30-days deaths were significantly more frequent in LEF-LG and PLFLG in comparison to HGAS (P = 0.03). As opposed to LEF-LG patients, mid-term prognosis after TAVI procedure in PLFLG patients is similar to HGAS patients despite higher perioperative mortality. © 2015 Wiley Periodicals, Inc.

  1. Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures.

    PubMed

    Milano, Carmelo; Pagani, Francis D; Slaughter, Mark S; Pham, Duc Thinh; Hathaway, David R; Jacoski, Mary V; Najarian, Kevin B; Aaronson, Keith D

    2014-09-09

    Cardiac valve procedures are commonly performed concurrently during implantation of left ventricular assist devices, but the added procedural risk has not been studied in detail. Data from patients receiving the HeartWare Ventricular Assist Device in the ADVANCE bridge to transplant (BTT) trial and continued access protocol were reviewed. Of 382 consecutive patients who completed follow-up between August 2008 and June 2013 (mean time on support 389 days, median 271 days), 262 (68.6%) underwent isolated HeartWare Ventricular Assist Device implantation, 75 (19.6%) a concurrent valve procedure, and 45 (11.8%) concurrent nonvalvular procedures. Of the concurrent valve procedures, 56 were tricuspid, 13 aortic, and 6 mitral. Survival was similar between groups (79% for concurrent valve procedures and 85% for HeartWare Ventricular Assist Device only at 1 year; P=0.33). Concurrent valve procedures were also associated with increased unadjusted early right heart failure (RHF). A multivariable analysis for death and RHF (121 total events) identified female sex (odds ratio=2.0 [95% confidence interval, 1.2-3.3; P=0.0053]) and preimplant tricuspid regurgitation severity (odds ratio=2.9 [95% confidence interval, 1.8-4.8, P<0.0001]) as independent predictors while concurrent tricuspid valve procedures (TVP) were not predictors. Furthermore, patients with significant preimplant tricuspid regurgitation who did not receive a TVP experienced an increased rate of late RHF compared with those who received TVP (0.19 versus 0.05 events per patient-year, respectively; P=0.024). Compared with HeartWare Ventricular Assist Device alone, survival was equivalent for the concurrent valve procedure group. Tricuspid regurgitation severity was the most important predictor of increased postoperative RHF, and concurrent TVP was not an independent predictor of RHF overall. Concurrent TVP may reduce the rate of late RHF for patients with significant preimplant tricuspid insufficiency. http

  2. Diplopia after glaucoma surgery.

    PubMed

    Christiansen, Stephen P

    2012-01-01

    The occurrence of strabismus and symptomatic diplopia following glaucoma surgery is becoming more common as the use of implanted setons increases. Understanding the factors contributing to the diplopia is critical to the development of treatment strategies to alleviate the patient's symptoms.

  3. Melody® pulmonary valve implantation in two teenage patients with congenitally corrected transposition of the great arteries status after Senning atrial switch operation.

    PubMed

    Rios, Rodrigo; Foerster, Susan R; Gudausky, Todd M

    2017-04-01

    The Melody® transcatheter pulmonary valve system was developed for placement within right ventricle-to-pulmonary artery conduits in patients with CHD for treatment of stenosis or regurgitation, providing an alternative to open-heart surgery. Abnormal systemic venous connections altering the catheter course to the right ventricle-to-pulmonary artery conduit may present a challenge to Melody® valve implantation. We present two such cases, in which the Melody® valve was successfully implanted in teenage patients with congenitally corrected transposition of the great arteries after Senning atrial switch operation. Despite the abnormal catheter course, the right ventricle-to-pulmonary artery was approachable via the right femoral vein allowing for deployment of the Melody® valve in the appropriate position. This suggests that systemic vein-to-left atrium baffles are not prohibitive of Melody® valve implantation. This is an important implication considering the substantial population of ageing patients with CHD who have undergone atrial switch. Melody® valve implantation can be considered as a viable option for treatment of these patients if they develop right ventricle-to-pulmonary artery conduit failure.

  4. In situ heart valve tissue engineering using a bioresorbable elastomeric implant - From material design to 12 months follow-up in sheep.

    PubMed

    Kluin, Jolanda; Talacua, Hanna; Smits, Anthal I P M; Emmert, Maximilian Y; Brugmans, Marieke C P; Fioretta, Emanuela S; Dijkman, Petra E; Söntjens, Serge H M; Duijvelshoff, Renée; Dekker, Sylvia; Janssen-van den Broek, Marloes W J T; Lintas, Valentina; Vink, Aryan; Hoerstrup, Simon P; Janssen, Henk M; Dankers, Patricia Y W; Baaijens, Frank P T; Bouten, Carlijn V C

    2017-05-01

    The creation of a living heart valve is a much-wanted alternative for current valve prostheses that suffer from limited durability and thromboembolic complications. Current strategies to create such valves, however, require the use of cells for in vitro culture, or decellularized human- or animal-derived donor tissue for in situ engineering. Here, we propose and demonstrate proof-of-concept of in situ heart valve tissue engineering using a synthetic approach, in which a cell-free, slow degrading elastomeric valvular implant is populated by endogenous cells to form new valvular tissue inside the heart. We designed a fibrous valvular scaffold, fabricated from a novel supramolecular elastomer, that enables endogenous cells to enter and produce matrix. Orthotopic implantations as pulmonary valve in sheep demonstrated sustained functionality up to 12 months, while the implant was gradually replaced by a layered collagen and elastic matrix in pace with cell-driven polymer resorption. Our results offer new perspectives for endogenous heart valve replacement starting from a readily-available synthetic graft that is compatible with surgical and transcatheter implantation procedures. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  5. Assessment of thermal effects in a model of the human head implanted with a wireless active microvalve for the treatment of glaucoma creating a filtering bleb.

    PubMed

    Schaumburg, F; Guarnieri, F A

    2017-05-07

    A 3D anatomical computational model is developed to assess thermal effects due to exposure to the electromagnetic field required to power a new investigational active implantable microvalve for the treatment of glaucoma. Such a device, located in the temporal superior eye quadrant, produces a filtering bleb, which is included in the geometry of the model, together with the relevant ocular structures. The electromagnetic field source-a planar coil-as well as the microvalve antenna and casing are also included. Exposure to the electromagnetic field source of an implanted and a non-implanted subject are simulated by solving a magnetic potential formulation, using the finite element method. The maximum SAR10 is reached in the eyebrow and remains within the limits suggested by the IEEE and ICNIRP standards. The anterior chamber, filtering bleb, iris and ciliary body are the ocular structures where more absorption occurs. The temperature rise distribution is also obtained by solving the bioheat equation with the finite element method. The numerical results are compared with the in vivo measurements obtained from four rabbits implanted with the microvalve and exposed to the electromagnetic field source.

  6. Assessment of thermal effects in a model of the human head implanted with a wireless active microvalve for the treatment of glaucoma creating a filtering bleb

    NASA Astrophysics Data System (ADS)

    Schaumburg, F.; Guarnieri, F. A.

    2017-05-01

    A 3D anatomical computational model is developed to assess thermal effects due to exposure to the electromagnetic field required to power a new investigational active implantable microvalve for the treatment of glaucoma. Such a device, located in the temporal superior eye quadrant, produces a filtering bleb, which is included in the geometry of the model, together with the relevant ocular structures. The electromagnetic field source—a planar coil—as well as the microvalve antenna and casing are also included. Exposure to the electromagnetic field source of an implanted and a non-implanted subject are simulated by solving a magnetic potential formulation, using the finite element method. The maximum SAR10 is reached in the eyebrow and remains within the limits suggested by the IEEE and ICNIRP standards. The anterior chamber, filtering bleb, iris and ciliary body are the ocular structures where more absorption occurs. The temperature rise distribution is also obtained by solving the bioheat equation with the finite element method. The numerical results are compared with the in vivo measurements obtained from four rabbits implanted with the microvalve and exposed to the electromagnetic field source.

  7. Development and validation of implantable sensors for monitoring function of prosthetic heart valves: in vitro studies.

    PubMed

    Lanning, C; Shandas, R

    2003-07-01

    The development of a 'smart' heart valve prosthesis, with the intrinsic ability to monitor thrombus formation, mechanical failure and local haemodynamics and to relay this information externally, would be of significant help to clinicians. The first step towards such a valve is development of the sensors and examination of whether sensor output provides predictive information on function. Custom-made piezo-electric sensors were mounted onto the housing of mechanical valves with various layers of simulated thrombus and bioprosthetic valves with normal and stiffened leaflets. Sensor output was examined using joint time-frequency analysis. Sensors were able to detect leaflet opening and closing with high fidelity for all types of valve. The frequency content of the closing sounds for the mechanical valves contained several peaks between 100 Hz and 10 kHz, whereas closing sounds for the bioprosthetic valve contained energy in a lower frequency range (<1 kHz). A frequency peak of 47 +/- 15 Hz was seen for the normal bioprosthetic valve; this peak increased to 115 +/- 12 Hz for the valve with visibly stiffened leaflets. Total low-frequency (80-3500 Hz) energy content diminished predictably with increasing levels of thrombus for the mechanical valves. Lastly, closing sound intensity correlated well with closing pressure dynamics (dp/dt) (y = 190x - 443; r = 0.90), indicating that the sensors also provide information on haemodynamics. These studies provide initial evidence regarding the use of embedded sensors to detect prosthetic valve function. Efforts to encapsulate these sensors with telemetry into a custom valve are currently underway.

  8. Transcatheter aortic valve implantation in very elderly patients: immediate results and medium term follow-up

    PubMed Central

    Pascual, Isaac; Muñoz-García, Antonio J; López-Otero, Diego; Avanzas, Pablo; Jimenez-Navarro, Manuel F; Cid-Alvarez, Belén; del Valle, Raquel; Alonso-Briales, Juan H; Ocaranza-Sanchez, Raimundo; Hernández, José M; Trillo-Nouche, Ramiro; Morís, César

    2015-01-01

    Objective To evaluate immediate transcatheter aortic valve implantation (TAVI) results and medium-term follow-up in very elderly patients with severe and symptomatic aortic stenosis (AS). Methods This multicenter, observational and prospective study was carried out in three hospitals. We included consecutive very elderly (> 85 years) patients with severe AS treated by TAVI. The primary endpoint was to evaluate death rates from any cause at two years. Results The study included 160 consecutive patients with a mean age of 87 ± 2.1 years (range from 85 to 94 years) and a mean logistic EuroSCORE of 18.8% ± 11.2% with 57 (35.6%) patients scoring ≥ 20%. Procedural success rate was 97.5%, with 25 (15.6%) patients experiencing acute complications with major bleeding (the most frequent). Global mortality rate during hospitalization was 8.8% (n = 14) and 30-day mortality rate was 10% (n = 16). Median follow up period was 252.24 ± 232.17 days. During the follow-up period, 28 (17.5%) patients died (17 of them due to cardiac causes). The estimated two year overall and cardiac survival rates using the Kaplan-Meier method were 71% and 86.4%, respectively. Cox proportional hazard regression showed that the variable EuroSCORE ≥ 20 was the unique variable associated with overall mortality. Conclusions TAVI is safe and effective in a selected population of very elderly patients. Our findings support the adoption of this new procedure in this complex group of patients. PMID:26345138

  9. Dynamic device properties of pulse contour cardiac output during transcatheter aortic valve implantation.

    PubMed

    Petzoldt, Martin; Riedel, Carsten; Braeunig, Jan; Haas, Sebastian; Goepfert, Matthias S; Treede, Hendrik; Baldus, Stephan; Goetz, Alwin E; Reuter, Daniel A

    2015-06-01

    This prospective single-center study aimed to determine the responsiveness and diagnostic performance of continuous cardiac output (CCO) monitors based on pulse contour analysis compared with invasive mean arterial pressure (MAP) during predefined periods of acute circulatory deterioration in patients undergoing transcatheter aortic valve implantation (TAVI). The ability of calibrated (CCO(CAL)) and self-calibrated (CCO(AUTOCAL)) pulse contour analysis to detect the hemodynamic response to 37 episodes of balloon aortic valvuloplasty enabled by rapid ventricular pacing was quantified in 13 patients undergoing TAVI. A "low" and a "high" cut-off limit were predefined as a 15 or 25 % decrease from baseline respectively. We found no significant differences between CCO(CAL) and MAP regarding mean response time [low cut-off: 8.6 (7.1-10.5) vs. 8.9 (7.3-10.8) s, p = 0.76; high cut-off: 11.4 (9.7-13.5) vs. 12.6 (10.7-14.9) s, p = 0.32] or diagnostic performance [area under the receiver operating characteristics curve (AUC): 0.99 (0.98-1.0) vs. 1.0 (0.99-1.0), p = 0.46]. But CCOCAL had a significantly higher amplitude response [95.0 (88.7-98.8) % decrease from baseline] than MAP [41.2 (30.0-52.9) %, p < 0.001]. CCOAUTOCAL had a significantly lower AUC [0.83 (0.73-0.93), p < 0.001] than MAP. Moreover, CCO(CAL) detected hemodynamic recovery significantly earlier than MAP. In conclusion, CCO(CAL) and MAP provided equivalent responsiveness and diagnostic performance to detect acute circulatory depression, whereas CCO(AUTOCAL) appeared to be less appropriate. In contrast to CCO(CAL) the amplitude response of MAP was poor. Consequently even small response amplitudes of MAP could indicate severe decreases in CO.

  10. Percutaneous Closure in Transfemoral Aortic Valve Implantation: A Single-Centre Experience.

    PubMed

    Barbier, Charlotte Ebeling; Lundin, Elin; Melki, Vilyam; James, Stefan; Nyman, Rickard

    2015-12-01

    To report the experience of a percutaneous closure device used for transfemoral transcatheter aortic valve implantation (TAVI) in an unselected patient and operator population. Eighty-two consecutive patients (32 women, 50 men) who underwent transfemoral TAVI between September 2009 and February 2014 at our hospital were retrospectively reviewed for percutaneous closure device (PCD) failure, vascular complications, and bleeding. The diameter and calcification of the common femoral artery (CFA) and the thickness of the subcutaneous fat layer in the groin were assessed on computed tomography images. The incidences of PCD failure and minor and major vascular complications were 19.5% (n = 16/82), 19.5% (n = 16/82), and 7% (n = 6/82) respectively. 8.5% (n = 7/82) had a minor perioperative bleeding, 6% (n = 5/82) had a major bleeding, and none had any life-threatening bleeding. When PCD failed, haemostasis was obtained with fascia suturing, covered stent placement, or with surgical cutdown. Thirty-day mortality and 1-year all-cause mortality were 8.5% (n = 7/82) and 19.5% (n = 16/82), respectively. In a multiple regression analysis, the CFA diameter and the presence of severe calcification were independently related to PCD failure (correlation coefficient = -0.24, p = 0.027 and correlation coefficient = 0.23, p = 0.036, respectively). PCD failure was related to a small CFA diameter and to a severely calcified CFA. Failure could largely be managed with minimally invasive techniques such as covered stents or fascia suturing.

  11. Non-Cardiovascular Computed Tomography Incidental Findings in Patients Who Underwent Transaortic Valve Implantation Procedure

    PubMed Central

    Fathala, Ahmed; Bin Saeedan, Mnahi; Zulfiqar, Ali; Al Sergani, Hani

    2017-01-01

    Background Transcatheter aortic valve implantation (TAVI) is a new treatment option for patients with severe aortic stenosis. Pre-TAVI procedure workup includes computed tomography angiography (CTA) of the heart and aorta from aortic annulus to the iliofemoral arteries. Frequently, there are a number of incidental non-cardiac findings (INCFs) in pre-TAVI CTA. However, the frequency and clinical significance of these INCFs are unknown. The aim of our study was to investigate the prevalence of INCFs and their clinical significance. Methods This was a retrospective review of 67 patients who underwent dedicated pre-TAVI CTA from 2010 till 2015. Non-cardiovascular INCFs were classified according to their clinical significance into three categories. The first category includes findings that may require urgent treatment. The second category includes findings that need further follow-up. The third category includes incidental findings that require no further follow-up or recommendation. Results The total number of patients was 67, and the mean age was 73 ± 8 years. All patients had INCFs and the total number was 248. Of the patients, 69% had chest findings, 85% had abdominal findings, and 33% had musculoskeletal findings. Results based on categorical classification were as follows: 9%, 25%, and 66% of these 248 findings belong to the first category, the second category, and the third category, respectively. Conclusion Non-cardiovascular INCFs are common in pre-TAVI CTA presumably due to increased age of such specific population. These findings have variable clinical significance and some of them might require acute treatment or additional evaluation, and should be managed properly taking into consideration patient’s life expectancy and comorbidities. PMID:28275420

  12. Incidence of Postoperative Delirium and Its Impact on Outcomes After Transcatheter Aortic Valve Implantation.

    PubMed

    Bagienski, Maciej; Kleczynski, Pawel; Dziewierz, Artur; Rzeszutko, Lukasz; Sorysz, Danuta; Trebacz, Jaroslaw; Sobczynski, Robert; Tomala, Marek; Stapor, Maciej; Dudek, Dariusz

    2017-10-01

    There are limited data on the occurrence of postoperative delirium after transcatheter aortic valve implantation (TAVI). We sought to investigate the incidence of delirium after TAVI and its impact on clinical outcomes. A total of 148 consecutive patients who underwent TAVI were enrolled. Of these patients, 141 patients survived hospital stay. The incidence of delirium was assessed in these patients for the first 4 days after the index procedure. The patients were divided into 2 groups based on the presence of delirium. Baseline characteristics, procedural and long-term outcomes, and frailty and quality-of-life indexes were compared among the groups. Of the 141 patients analyzed, 29 patients developed delirium. The transapical access was more common in patients with delirium (51.7% vs 8.9%, p <0.001). A greater median contrast volume load in the delirium group was noted (75 vs 100 ml, p = 0.001). Significantly more patients with delirium were considered as frail before TAVI. Thirty-day and 12-month all-cause mortality rates were higher in the delirium group (0.0% vs 17.2%, p <0.001; and 3.6% vs 37.9%, p <0.001, respectively). Differences in mortality were significant even after adjustment for baseline characteristics. The quality of life at 12 months, assessed by the 3-level version of the EuroQol 5-dimensional questionnaire, was similar in both groups. Despite a relatively minimally invasive character of TAVI as compared with surgery, some patients experience delirium after TAVI. Importantly, the occurrence of delirium after TAVI may help to identify patients with worse short- and long-term outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Learning Curves Among All Patients Undergoing Transcatheter Aortic Valve Implantation in Germany: A Retrospective Observational Study.

    PubMed

    Kaier, Klaus; Reinecke, Holger; Schmoor, Claudia; Frankenstein, Lutz; Vach, Werner; Hehn, Philip; Zirlik, Andreas; Bode, Christoph; Zehender, Manfred; Reinöhl, Jochen

    2017-05-15

    Transcatheter aortic valve implantation (TAVI) is a rapidly evolving technique for therapy of aortic stenosis. Previous studies report learning curves with respect to in-hospital mortality and clinical complications. We aim to determine whether observed improvements of in-hospital outcomes after TAVI are the result of improvements in procedures or due to a change in the patient population, and whether improvements differ between the transfemoral (TF) and the transapical (TA) approach. Data was analyzed using risk-adjusted regression analyses in order to track the development of clinical outcomes of all isolated TAVI procedures performed in Germany from 2008 to 2013 (N=32.436) in all German hospitals performing TAVI. Measurements include in-hospital mortality, stroke, bleeding, and mechanical ventilation. Unadjusted mortality rates decrease over time for both TA-TAVI and TF-TAVI. Reductions in mortality were smaller for TA-TAVI than for TF-TAVI. These trends could also be observed for risk-adjusted (standardized) mortality rates, indicating that time trends and differences between TA-TAVI (around 7% in 2013) and TF-TAVI (around 4% in 2013) cannot be explained by changes in the risk factor composition of the patient populations. Bleeding complications decreased for both access routes. Both unadjusted and standardized bleeding rates were substantially higher for TA-TAVI. In addition, TA-TAVI procedures were associated with an increased likelihood of requiring >48h of mechanical ventilation. Observed improvements in TAVI-related in-hospital mortality are not due to a change in patient population. The results indicate the superiority of a TF-first approach. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

  14. Incidence, Causes, and Impact of In-Hospital Infections After Transcatheter Aortic Valve Implantation.

    PubMed

    Tirado-Conte, Gabriela; Freitas-Ferraz, Afonso B; Nombela-Franco, Luis; Jimenez-Quevedo, Pilar; Biagioni, Corina; Cuadrado, Ana; Nuñez-Gil, Ivan; Salinas, Pablo; Gonzalo, Nieves; Ferrera, Carlos; Vivas, David; Higueras, Javier; Viana-Tejedor, Ana; Perez-Vizcayno, Maria Jose; Vilacosta, Isidre; Escaned, Javier; Fernandez-Ortiz, Antonio; Macaya, Carlos

    2016-08-01

    In-hospital infections (IHI) are one of the most common and serious problems after invasive procedures. Transcatheter aortic valve implantation (TAVI) is an increasingly used alternative to surgery in patients with severe symptomatic aortic stenosis. The aim of this study was to determine the incidence, origin, risk factors, and clinical outcomes of IHI after TAVI. A total of 303 consecutive patients with severe aortic stenosis who underwent transfemoral TAVI were included and followed during a median time of 21 months. We examined the occurrence, types, origin, and timing of infections during hospital stay as well as short- and long-term clinical outcomes according to the occurrence of IHI. A total of 51 patients (17%; 62 infectious episodes) experienced IHI after TAVI. Respiratory and urinary tract infections were the most frequent type of infections (44% and 34%, respectively), followed by surgical site infection (8%) and bloodstream infection (5%). Positive cultures were obtained in 74% of the samples, of which 65% were gram-negative bacilli. Modifiable factors such as bleeding (p = 0.005) and length of coronary care unit stay (p <0.001) were independently associated with an increased infection risk. Patients with IHI had a longer hospital stay (14 vs 6 days, p <0.001), an increased mortality (hazard ratio 2.48, 95% CI 1.45 to 4.23) and readmission rate (hazard ratio 2.0, 95% CI 1.27 to 3.14) during the follow-up. In conclusion, IHI is a frequent complication after TAVI with a significant impact on short- and long-term clinical outcomes. The most important risk factors associated with the development of this complication were modifiable periprocedural aspects. These results underline the importance to implement specific preventive strategies to reduce in-hospital-acquired infections after TAVI.

  15. Neurologic Complications of Unprotected Transcatheter Aortic Valve Implantation (from the Neuro-TAVI Trial).

    PubMed

    Lansky, Alexandra J; Brown, David; Pena, Constantino; Pietras, Cody G; Parise, Helen; Ng, Vivian G; Meller, Stephanie; Abrams, Kevin J; Cleman, Michael; Margolis, Pauliina; Petrossian, George; Brickman, Adam M; Voros, Szilard; Moses, Jeffrey; Forrest, John K

    2016-11-15

    Cerebral embolization during transcatheter aortic valve implantation (TAVI) can lead to a spectrum of clinically relevant manifestations, ranging from overt stroke to mild neurologic or cognitive deficits and subclinical cerebral infarcts. This study sought to determine the frequency of neurologic injury, cerebral ischemic lesions, and cognitive dysfunction in subjects undergoing contemporary commercial TAVI in the United States. Neuro-TAVR is the first prospective, multicenter study to use serial systematic neurologic and cognitive assessments and diffusion-weighted magnetic resonance imaging (at 4 ± 2 days after procedure) to investigate the incidence and severity of neurologic injury after contemporary unprotected TAVI in the United States. A total of 44 consecutive patients underwent TAVI at 5 US sites. Diffusion-weighted magnetic resonance imaging lesions were detected in 94%, with a mean of 10.4 ± 15.3 lesions per subject and a median total lesion volume of 295 mm(3) (interquartile range 71.6 to 799.6 mm(3)). New neurologic impairment (worsening in National Institutes of Health Stroke Scale score from baseline with new cerebral lesions) occurred in 22.6% (7 of 31) of subjects at discharge and 14.8% (4 of 27) at 30 days. In addition, cognitive decrements from baseline were identified by the Montreal Cognitive Assessment in 33% (12 of 36) of subjects at discharge and 41% (13 of 32) at 30 days. In conclusion, this contemporary cohort of US patients confirms that TAVI results in cerebral infarction in most patients and that 1 in 5 patients have measurable neurologic impairment and 1 in 3 patients have decrease in cognitive measures by Montreal Cognitive Assessment score after TAVI, reinforcing the need for methods to mitigate the risk of brain injury during TAVI.

  16. Simulations of Transcatheter Aortic Valve Implantation – Implications for Aortic Root Rupture

    PubMed Central

    Wang, Qian; Kodali, Susheel; Primiano, Charles; Sun, Wei

    2014-01-01

    Objectives Aortic root rupture is one of the most severe complications of transcatheter aortic valve implantation (TAVI). The mechanism of this adverse event remains mostly unknown. The purpose of this study was to obtain a better understanding of the biomechanical interaction between the tissue and stent for patients with a high risk of aortic rupture. Methods We simulated the stent deployment process of three TAVI patients with high aortic rupture risk using finite element method. The first case was a retrospective analysis of an aortic rupture case, while the other two cases were prospective studies, which ended with one cancelled procedure and one successful TAVI. Simulation results were evaluated for the risk of aortic root rupture, as well as coronary artery occlusion, and paravalvular leak. Results For Case 1, the simulated aortic rupture location was the same as clinical observations. From the simulation results, it can be seen that the large calcified spot on the interior of the left coronary sinus between coronary ostium and the aortic annulus was pushed by the stent, causing the aortic rupture. For Case 2 and Case 3, predicated results from the simulations were presented to the clinicians at pre-procedure meetings; and they were in agreement with clinician’s observations and decisions. Conclusions Our results indicated that the engineering analysis could provide additional information to help clinicians evaluate complicated, high risk aortic rupture cases. Since a systematic study of a large patient cohort of aortic rupture is currently not available (due to the low occurrence rate) to clearly understand underlying rupture mechanisms, case by case engineering analysis is recommended for evaluating patient-specific aortic rupture risk. PMID:24736808

  17. Does implantation of larger bioprosthetic pulmonary valves in young patients guarantee durability in adults? Durability analysis of stented bioprosthetic valves in the pulmonary position in patients with Tetralogy of Fallot†.

    PubMed

    Kwak, Jae Gun; Lee, Cheul; Lee, Mina; Lee, Chang-Ha; Jang, So-Ick; Lee, Sang Yun; Park, Su-Jin; Song, Mi Kyoung; Kim, Seong-Ho

    2016-04-01

    In a previous study, we identified factors affecting the durability of bioprosthetic valves in the pulmonary position following total repair of Tetralogy of Fallot (TOF). In this study, we aimed to identify factors affecting the durability of the bioprosthetic valve with regard to patient age and implanted valve size in order to guide valve choice in adolescent patients. We enrolled and analysed 108 cases of pulmonary valve replacement (PVR) with stented bioprosthetic valves in TOF patients between January 1998 and February 2014. Valvular dysfunction was defined as at least a moderate amount of pulmonary regurgitation or a peak pressure gradient of ≥40 mmHg on the most recent echocardiography. We analysed the effect of patient age and valve size on the durability of the bioprosthetic valve in the pulmonary position. There were 2 early deaths; no late deaths were observed. The follow-up duration was 92.8 ± 44.5 months. The mean age at PVR was 19.3 ± 9.1 years. The mean valve size was 24.7 ± 1.8 mm. Whereas patients ≥20 years old showed no valvular dysfunction (i.e. 100% freedom from valvular dysfunction at 10 and 14 years), patients who were adolescents and children (<20 years) showed worse durability, regardless of the z-score of valve size (68.2% at 10 years and 24.7% at 14 years). Although a larger valve with a z-score of ≥2 was implanted, patients <20 years old did not exhibit good valvular durability. The results were particularly worse in patients <10 years old, with 66.7% freedom from valvular dysfunction at 6 years and 33.3% at 8 years, compared with patients within the age range of 10 to <20 years (75.1% at 10 years, and 20.5% at 14 years). The durability of bioprosthetic valves in the pulmonary position was acceptable in patients aged ≥20 years, regardless of the z-score of valve size. However, patients who were children and adolescents did not show optimal durability of the bioprosthetic valve, irrespective of the z-score of valve size. © The

  18. The CarboMedics prosthetic heart valve: experience with 180 implants.

    PubMed

    Saito, Tsutomu; Misawa, Yoshio; Fuse, Katsuo; Konishi, Hiroaki

    2005-01-01

    At Jichi Medical School Hospital, three types of mechanical prosthetic valves (CarboMedics, Omnicarbon, Bicarbon) were used without randomization from 1991 to 2000. A retrospective study of valve replacements done between June 1991 and November 2000 utilizing 180 CarboMedics valves in 145 patients who had not previously undergone prosthetic valve replacement or aortic root and/or arch replacement was conducted to evaluate midterm patient outcomes to assess the future continuous use of CarboMedics valves. Women made up 47.6% of the patients and the mean age was 57.5 years (range 12-80 years). Preoperative New York Heart Association functional class was III or IV in 92.4% (134/145) of patients. Mean follow-up of 4.5 years (range 0-10.0 years) was 95.9% complete, with a total of 628 patient-years (PY). Early (within 30 postoperative days) mortality was 5.5% (8 of 145): 3 from hemorrhage, 3 from nonvalve-related heart failure, 1 from infection, and 1 from arrhythmia. There were 16 late deaths (2.54%/PY): 1 from hemorrhage, 4 from unknown causes/sudden death, 4 from nonvalve-related heart failure, and 7 from other noncardiac causes. A total of 121 patients (83.0%) were alive at the last follow-up, done in November 2000. The linearized death rate was 3.82%/year (including 1.11%/year for valve-related deaths). Linearized death rates from various causes were: bleeding, 0.96%/year; thromboembolism, 1.11%/year; thrombosis, 0.39%/year; perivalvular leak, 0.96%/year; endocarditis, 0%/year; hemolysis, 0%/year; and reoperation, 0.63%/year. No structural valve failure was observed. Comparative early mortality rates of valve replacement without aortic root replacement or arch replacement, excluding repeat valve replacement operations, in our institute, were 3.5% (12/307) for all valve types used contemporaneously, 2.6% (2/76) for Omnicarbon valves, and 2.3% (2/86) for Bicarbon valves. Although the CarboMedics valve had a rather high mortality rate of 5.5% (8/145) compared with the

  19. Transcatheter aortic valve implantation: a revolution in the therapy of elderly and high-risk patients with severe aortic stenosis

    PubMed Central

    Kilic, Teoman; Yilmaz, Irem

    2017-01-01

    Transcatheter aortic valve implantation (TAVI) represents a real revolution in the field of interventional cardiology for the treatment of elderly or high-risk surgical patients with severe symptomatic aortic valve stenosis. Today, TAVI seems to play a key and a reliable role in the treatment of intermediate and maybe low-risk patients with severe aortic stenosis. TAVI has also evolved from a complex and hazardous procedure into an effective and safe therapy by the development of new generation devices. This article aims to review the background and future of TAVI, clinical trials and registries with old and new generation TAVI devices and to focus on some open issues related to post-procedural outcomes. PMID:28408919

  20. Twenty-four years' implant duration of the aortic Starr-Edwards Silastic ball prosthesis: a valve of the past?

    PubMed

    Mächler, H E; Schmidt, C H; Neuner, P; Iberer, F; Anelli-Monti, M; Dacar, D; Rigler, B; Kraft-Kinz, J

    1993-01-01

    Six years after the first aortic valve replacement with the Starr-Edwards Silastic ball prosthesis at Oregon Health Sciences University, the model 1260 was implanted in a 44-year-old patient at our department. During 24 years no signs of dysfunction, thromboembolism, thrombosis, periprosthetic leaks or hemolysis were observed. Material test showed no signs of fatigue. The dimension of the Silastic poppet was found to be one millimeter less than the original specifications of these poppets and there were some lipid infiltrations. Functionally the poppet was found to be nonvariant. Histologic findings detected focal hyalinization and giant cells without signs of acute inflammation or ulceration. With regard to its reliability and durability, the Starr-Edwards valve prosthesis should not be viewed with disfavor.

  1. Short- and long-term need for permanent pacemaker after transcatheter implantation of the Edwards Sapien aortic valve prosthesis.

    PubMed

    Moreno, Raúl; Calvo, Luis; Sánchez-Recalde, Angel; Galeote, Guillermo; Jiménez-Valero, Santiago; López, Teresa; Plaza, Ignacio; González-Davia, Rosa; Ramírez, Ulises; Mesa, Jose Maria; Moreno-Gomez, Isidro; López-Sendón, José-Luis

    2015-11-01

    A permanent pacemaker is frequently needed after transcatheter aortic valve implantation, but the available data are mainly on the CoreValve system. To evaluate the need for new permanent pacemaker after implantation of the Edwards Sapien device, as well as related factors. We included the first 100 patients treated with the Edwards Sapien device at our institution. Of these, 12 had a permanent pacemaker before the procedure, and thus our study population was the remaining 88 patients. A permanent pacemaker was indicated in eight patients (9.1%) during hospitalization or at 30 days. After discharge, another four patients needed a pacemaker (at 42 days and three, 18, and 30 months). Two variables were associated with the need for pacemaker during hospitalization: previous dialysis (13% vs. 1%, p=0.042) and complete right bundle branch block before the procedure (25% vs. 5%, p=0.032). More than one month after the procedure, the characteristics associated with the need for pacemaker were plasma creatinine level (2.5±1.7 vs. 1.3±0.6 mg/dl, p=0.001) and previous myocardial infarction (50% vs. 10%, p=0.013). The rate of pacemaker implantation with the Edwards Sapien device was 9.1%. Right bundle branch block and dialysis were associated with this complication.

  2. Automatic 3D aortic annulus sizing by computed tomography in the planning of transcatheter aortic valve implantation.

    PubMed

    Queirós, Sandro; Dubois, Christophe; Morais, Pedro; Adriaenssens, Tom; Fonseca, Jaime C; Vilaça, João L; D'hooge, Jan

    Accurate imaging assessment of aortic annulus (AoA) dimension is paramount to decide on the correct transcatheter heart valve (THV) size for patients undergoing transcatheter aortic valve implantation (TAVI). We evaluated the feasibility and accuracy of a novel automatic framework for multidetector row computed tomography (MDCT)-based TAVI planning. Among 122 consecutive patients undergoing TAVI and retrospectively reviewed for this study, 104 patients with preoperative MDCT of sufficient quality were enrolled and analyzed with the proposed software. Fully automatic (FA) and semi-automatic (SA) AoA measurements were compared to manual measurements, with both automated and manual-based interobserver variability (IOV) being assessed. Finally, the effect of these measures on hypothetically selected THV size was evaluated against the implanted size, as well as with respect to manually-derived sizes. FA analysis was feasible in 92.3% of the cases, increasing to 100% if using the SA approach. Automatically-extracted measurements showed excellent agreement with manually-derived ones, with small biases and narrow limits of agreement, and comparable to the interobserver agreement. The SA approach presented a statistically lower IOV than manual analysis, showing the potential to reduce interobserver sizing disagreements. Moreover, the automated approaches displayed close agreement with the implanted sizes, similar to the ones obtained by the experts. The proposed automatic framework provides an accurate and robust tool for AoA measurements and THV sizing in patients undergoing TAVI. Copyright © 2016 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

  3. Glaucoma (image)

    MedlinePlus

    Glaucoma is a condition of increased fluid pressure inside the eye. The increased pressure causes compression of ... nerve which can eventually lead to nerve damage. Glaucoma can cause partial vision loss, with blindness as ...

  4. Impact of chronic obstructive pulmonary disease on Valve Academic Research Consortium-defined outcomes after transcatheter aortic valve implantation (from the FRANCE 2 Registry).

    PubMed

    Chopard, Romain; Meneveau, Nicolas; Chocron, Sidney; Gilard, Martine; Laskar, Marc; Eltchaninoff, Hélène; Iung, Bernard; Leprince, Pascal; Teiger, Emmanuel; Chevreul, Karine; Prat, Alain; Lievre, Michel; Leguerrier, Alain; Donzeau-Gouge, Patrick; Fajadet, Jean; Schiele, Francois

    2014-05-01

    The purposes of the present study were to determine the impact of chronic obstructive pulmonary disease (COPD) on Valve Academic Research Consortium-defined outcomes in patients undergoing transcatheter aortic valve implantation (TAVI). A total of 3,933 consecutive patients underwent TAVI from January 2010 to December 2011 in 34 centers and were included in the French national TAVI registry "FRANCE 2"; 895 (22.7%) had concomitant COPD, 3,038 (77.3%) did not. There were no significant differences in procedural characteristics or 30-day Valve Academic Research Consortium-defined outcomes between those with and without COPD. Multivariate regression analysis showed COPD to be an independent predictor of 1-year mortality and combined efficacy end point after adjustment for concomitant co-morbidities (hazard ratio 1.19, 95% confidence interval 1.005 to 1.41, p = 0.03 and hazard ratio 1.52, 95% confidence interval 1.29 to 1.79, p <0.001, respectively). The higher mortality rate at 1 year in patients with COPD was related to cardiovascular deaths (COPD 10.0% vs non-COPD 6.2%, p = 0.008). Subgroup analysis found that the effect of COPD on 1-year mortality rate was constant across different subgroups, especially the type of approach and the type of anesthesia subgroups. In conclusion, concomitant COPD in patients referred for TAVI characterizes a high-risk population. The excess in mortality is largely determined by a higher rate of cardiovascular deaths and exists regardless of the type of procedure performed and its results.

  5. Differences in recovery of left and right ventricular function following aortic valve interventions: a longitudinal echocardiographic study in patients undergoing surgical, transapical or transfemoral aortic valve implantation.

    PubMed

    Forsberg, Lena M; Tamás, Éva; Vánky, Farkas; Engvall, Jan; Nylander, Eva

    2013-11-15

    To evaluate longitudinal left and right ventricular function (LVF and RVF) after transcatheter aortic valve implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) and LVF and RVF after TAVI by the transfemoral (TF) or transapical (TA) approach. Knowledge about differences in recovery of LVF and RVF after TAVI and SAVR is scarce. Sixty patients (age 81 ± 7 years, logistic EuroSCORE 16 ± 10%), undergoing TAVI (TF: n = 35 and TA: n = 25), were examined by echocardiography including atrioventricular plane displacement (AVPD) and peak systolic velocities (PSV) by tissue Doppler at basal RV free wall, LV lateral wall and septum preprocedurally, 7 weeks and 6 months postprocedurally. Twenty-seven SAVR patients were matched to 27 TAVI patients by age, gender and LVF. Early postintervention, TAVI patients had improved longitudinal LVF. However, when analyzed separately, only TF, but not TA patients, had improved LV lateral and septal AVPD and PSV (all P ≤ 0.01). All TAVI patients, as well as the TF and TA group had unchanged longitudinal LVF between the early and late follow-ups (all P > 0.05). The SAVR group had higher septal LVF than the matched TAVI group preprocedurally, while postoperatively this difference was diminished. Longitudinal RVF was better in the TF group than in the TA group pre- and postprocedurally. Although the SAVR group had superior longitudinal RVF preoperatively, this was inferior to TAVI postoperatively. Postprocedural longitudinal LVF and RVF in patients undergoing TF-TAVI, TA-TAVI, or SAVR differ considerably. Preservation of longitudinal RVF after TAVI might influence the selection of aortic valve intervention in the future. Copyright © 2013 Wiley Periodicals, Inc.

  6. Frequency of conduction abnormalities after transcatheter aortic valve implantation with the Medtronic-CoreValve and the effect on left ventricular ejection fraction.

    PubMed

    Tzikas, Apostolos; van Dalen, Bas M; Van Mieghem, Nicolas M; Gutierrez-Chico, Juan-Luis; Nuis, Rutger-Jan; Kauer, Floris; Schultz, Carl; Serruys, Patrick W; de Jaegere, Peter P T; Geleijnse, Marcel L

    2011-01-15

    New conduction abnormalities occur frequently after transcatheter aortic valve implantation (TAVI). The relation between new conduction disorders and left ventricular (LV) systolic function after TAVI is unknown. The purpose of the present prospective, single-center study was to investigate the effect of TAVI on LV systolic function in relation to TAVI-induced conduction abnormalities. A total of 27 patients had undergone electrocardiography and transthoracic echocardiography the day before and 6 days after TAVI with the Medtronic-CoreValve system. The LV ejection fraction (EF) was calculated using the biplane Simpson method. The systolic mitral annular velocities and longitudinal strain were measured using speckle tracking echocardiography. After TAVI, 18 patients (67%) had new conduction abnormalities; 4 (15%) had a new paced rhythm and 14 patients (52%) had new left bundle branch block. In the patients with new conduction abnormalities, the EF decreased from 47 ± 12% to 44 ± 10%. In contrast, in those without new conduction abnormalities, the EF increased from 49 ± 12% to 54% ± 12%. The change in EF was significantly different among those with and without new conduction abnormalities (p <0.05). In patients without new conduction abnormalities, an improvement was found in the systolic mitral annular velocities and longitudinal strain (p <0.05). In contrast, in patients with new conduction abnormalities, the changes were not significant. In conclusion, the induction of new conduction abnormalities after TAVI with the Medtronic-CoreValve was associated with a lack of improvement in LV systolic function. Copyright © 2011 Elsevier Inc. All rights reserved.

  7. A prospective 5-year study of the frequency of arrhythmias during serial exercise testing and clinical follow-up after Melody valve implant.

    PubMed

    Priromprintr, Bryant; Silka, Michael J; Rhodes, Jonathan; Batra, Anjan S

    2016-11-01

    Although percutaneous Melody valve implant has become an accepted alternative to surgical pulmonary valve replacement in patients with congenital heart disease, the benefit regarding frequency and severity of arrhythmias remains undefined. The purpose of this study was to evaluate the impact of Melody valve implant on the type and frequency of arrhythmias during cardiopulmonary exercise testing (CPET) and subsequent clinical outcome. As part of the phase I Melody valve clinical trial, 136 patients with congenital heart disease underwent prospective serial evaluation including CPET before implant, 6 months after implant, and annually thereafter for 5 years. Arrhythmias were defined as premature ventricular complexes (PVCs) and supraventricular or ventricular tachycardia (VT). Before Melody implant, PVCs occurred in 55 patients (40%) and nonsustained ventricular tachycardia (NSVT) in 1 patient during CPET. Median age at valve implantation was 19.0 years (range 7-53 years). During median follow-up of 4.9 years (range 0.8-7.3 years), there was no significant change in the proportion of patients with PVCs during CPET at any follow-up interval (40%-45%). However, postimplant, NSVT occurred in 18 patients, including 8 during CPET. Diagnoses in the patients with NSVT were tetralogy of Fallot (11), transposition (2), and post-Ross procedure (5). Improved hemodynamic status was not associated with resolution or prevention of arrhythmias. Despite improvement in hemodynamics, Melody valve implant was not associated with resolution or prevention of arrhythmias during CPET. PVCs or VT may be related to pathologic hypertrophy, fibrosis, dilation, or possible mechanical effects of the Melody device. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

  8. A novel flexible microfluidic meshwork to reduce fibrosis in glaucoma surgery.

    PubMed

    Amoozgar, Behzad; Wei, Xiaoling; Hui Lee, Jun; Bloomer, Michele; Zhao, Zhengtuo; Coh, Paul; He, Fei; Luan, Lan; Xie, Chong; Han, Ying

    2017-01-01

    Fibrosis and hence capsule formation around the glaucoma implants are the main reasons for glaucoma implant failure. To address these issues, we designed a microfluidic meshwork and tested its biocompatibility in a rabbit eye model. The amount of fibrosis elicited by the microfluidic meshwork was compared to the amount elicited by the plate of conventional glaucoma drainage device. Six eyes from 3 New Zealand albino rabbits were randomized to receive either the novel microfluidic meshwork or a plate of Ahmed glaucoma valve model PF7 (AGV PF7). The flexible microfluidic implant was made from negative photoresist SU-8 by using micro-fabrication techniques. The overall size of the meshwork was 7 mm × 7 mm with a grid period of 100 μm. Both implants were placed in the subtenon space at the supratemporal quadrant in a standard fashion. There was no communication between the implants and the anterior chamber via a tube. All animal eyes were examined for signs of infection and implant erosion on days 1, 3, 7, and 14 and then monthly. Exenterations were performed in which the entire orbital contents were removed at 3 months. Histology slides of the implant and the surrounding tissues were prepared and stained with hematoxylin-eosin. Thickness of the fibrous capsules beneath the implants were measured and compared with paired student's t-test between the two groups. The gross histological sections showed that nearly no capsule formed around the microfluidic meshwork in contrast to the thick capsule formed around the plate of AGV PF7. Thickness of the fibrotic capsules beneath the AGV PF7 plate from the 3 rabbit eyes was 90μm, 82μm, and 95 μm, respectively. The thickness at the bottom of fibrotic capsules around the new microfluidic implant were 1μm, 2μm, and 1μm, respectively. The difference in thickness of capsule between the two groups was significant (P = 0.002). No complications were noticed in the 6 eyes, and both implants were tolerated well by all rabbits

  9. A novel flexible microfluidic meshwork to reduce fibrosis in glaucoma surgery

    PubMed Central

    Hui Lee, Jun; Bloomer, Michele; Zhao, Zhengtuo; Coh, Paul; He, Fei; Luan, Lan; Xie, Chong

    2017-01-01

    Purpose/Relevance Fibrosis and hence capsule formation around the glaucoma implants are the main reasons for glaucoma implant failure. To address these issues, we designed a microfluidic meshwork and tested its biocompatibility in a rabbit eye model. The amount of fibrosis elicited by the microfluidic meshwork was compared to the amount elicited by the plate of conventional glaucoma drainage device. Methods Six eyes from 3 New Zealand albino rabbits were randomized to receive either the novel microfluidic meshwork or a plate of Ahmed glaucoma valve model PF7 (AGV PF7). The flexible microfluidic implant was made from negative photoresist SU-8 by using micro-fabrication techniques. The overall size of the meshwork was 7 mm × 7 mm with a grid period of 100 μm. Both implants were placed in the subtenon space at the supratemporal quadrant in a standard fashion. There was no communication between the implants and the anterior chamber via a tube. All animal eyes were examined for signs of infection and implant erosion on days 1, 3, 7, and 14 and then monthly. Exenterations were performed in which the entire orbital contents were removed at 3 months. Histology slides of the implant and the surrounding tissues were prepared and stained with hematoxylin-eosin. Thickness of the fibrous capsules beneath the implants were measured and compared with paired student’s t-test between the two groups. Results The gross histological sections showed that nearly no capsule formed around the microfluidic meshwork in contrast to the thick capsule formed around the plate of AGV PF7. Thickness of the fibrotic capsules beneath the AGV PF7 plate from the 3 rabbit eyes was 90μm, 82μm, and 95 μm, respectively. The thickness at the bottom of fibrotic capsules around the new microfluidic implant were 1μm, 2μm, and 1μm, respectively. The difference in thickness of capsule between the two groups was significant (P = 0.002). No complications were noticed in the 6 eyes, and both implants

  10. Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

    PubMed

    Stortecky, Stefan; Stefanini, Giulio G; Pilgrim, Thomas; Heg, Dik; Praz, Fabien; Luterbacher, Fabienne; Piccolo, Raffaele; Khattab, Ahmed A; Räber, Lorenz; Langhammer, Bettina; Huber, Christoph; Meier, Bernhard; Jüni, Peter; Wenaweser, Peter; Windecker, Stephan

    2015-09-25

    The Valve Academic Research Consortium (VARC) has proposed a standardized definition of bleeding in patients undergoing transcatheter aortic valve interventions (TAVI). The VARC bleeding definition has not been validated or compared to other established bleeding definitions so far. Thus, we aimed to investigate the impact of bleeding and compare the predictivity of VARC bleeding events with established bleeding definitions. Between August 2007 and April 2012, 489 consecutive patients with severe aortic stenosis were included into the Bern-TAVI-Registry. Every bleeding complication was adjudicated according to the definitions of VARC, BARC, TIMI, and GUSTO. Periprocedural blood loss was added to the definition of VARC, providing a modified VARC definition. A total of 152 bleeding events were observed during the index hospitalization. Bleeding severity according to VARC was associated with a gradual increase in mortality, which was comparable to the BARC, TIMI, GUSTO, and the modified VARC classifications. The predictive precision of a multivariable model for mortality at 30 days was significantly improved by adding the most serious bleeding of VARC (area under the curve [AUC], 0.773; 95% confidence interval [CI], 0.706 to 0.839), BARC (AUC, 0.776; 95% CI, 0.694 to 0.857), TIMI (AUC, 0.768; 95% CI, 0.692 to 0.844), and GUSTO (AUC, 0.791; 95% CI, 0.714 to 0.869), with the modified VARC definition resulting in the best predictivity (AUC, 0.814; 95% CI, 0.759 to 0.870). The VARC bleeding definition offers a severity stratification that is associated with a gradual increase in mortality and prognostic information comparable to established bleeding definitions. Adding the information of periprocedural blood loss to VARC may increase the sensitivity and the predictive power of this classification. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

  11. Five-year follow-up after transcatheter aortic valve implantation for symptomatic aortic stenosis.

    PubMed

    Zahn, Ralf; Werner, Nicolas; Gerckens, Ulrich; Linke, Axel; Sievert, Horst; Kahlert, Philipp; Hambrecht, Rainer; Sack, Stefan; Abdel-Wahab, Mohamed; Hoffmann, Ellen; Zeymer, Uwe; Schneider, Steffen

    2017-07-06

    Transcatheter aortic valve implantation (TAVI) has been implemented into the care of elderly patients suffering from severe symptomatic aortic stenosis. However, data on long-term follow-up are sparse and predictors of long-term mortality need to be evaluated to better select patients. Therefore, we aimed to analyse predictors of 5-year mortality after TAVI. We analysed data from the German Transcatheter Aortic Valve Interventions-Registry. Each of the 27 participating hospitals agreed to include all consecutive TAVI patients at their institution. Out of 1444 patients treated with TAVI, 1378 patients had a follow-up of at least 4.5 years (completeness 95.4%). Endpoint for this analysis was 5-year survival. Cox regression analysis was used to determine risk factors associated with this endpoint. Patients who died were compared with survivors. The two groups showed multiple differences in patient characteristics, indications for interventions, preinterventional, as well as interventional characteristics and postinterventional events. Calculated 1-year mortality was 21.8% and 5-year mortality 59.1%. A higher logistic EuroScore was associated with a lower 5-year survival, being 45.5% in patients with a logistic EuroScore of <20%, 34.5% in those with 20% to 40% and 28.4% in patients with a logistic EuroScore >40%. Cox proportional hazard analysis revealed the following independent predictors of 5-year mortality: female gender (HR (HR)=0.66, 95% CI 0.56 to 0.77, p<0.0001), renal failure (HR=1.43, 95% CI 1.22 to 1.69, p<0.0001), prior mitral regurgitation ≥II° (HR=1.42, 95% CI 1.21 to 1.65, p<0.0001), residual aortic regurgitation ≥II° (HR=1.52, 95% CI 1.24 to 1.85, p<0.0001), atrial fibrillation (HR=1.38, 95% CI 1.18 to 1.64, p=0.0001), low gradient aortic stenosis (HR=1.48, 95% CI 1.19 to 1.84, p=0.0004), prior decompensation (HR=1.32, 95% CI 1.13 to 1.54, p=0.0006), frailty (HR=1.31, 95% CI 1.09 to 1.58, p=0.004), surgical TAVI (HR=1.42, 95%

  12. Percutaneous Implantation of the self-expanding valve Prosthesis a patient with homozygous familial hypercholesterolemia severe aortic stenosis and porcelain aorta.

    PubMed

    Sahiner, Levent; Asil, Serkan; Kaya, Ergün Baris; Ozer, Necla; Aytemir, Kudret

    2016-10-01

    Transcatheter aortic valve implantation (TAVI) has shown favorable outcomes in patients with severe symptomatic aortic valve stenosis who are at high surgical risk or inappropriate for open heart surgery. However, concerns exist over treating patients who have porcelain aorta and familial hypercholesterolemia, due to the potential complications of aortic root and aortic annulus. In this case report, we present a patient with familial hypercholesterolemia, symptomatic severe aortic stenosis, previous coronary artery bypass grafting and porcelain aorta, who was successfully treated with TAVI using a CoreValve.

  13. A comparative study between propofol and dexmedetomidine as sedative agents during performing transcatheter aortic valve implantation.

    PubMed

    Khalil, Mohamed; Al-Agaty, Ahmed; Asaad, Osama; Mahmoud, Mohsen; Omar, Amr S; Abdelrazik, Ahmed; Mostafa, Mohamed

    2016-08-01

    The type of sedative drugs could play a major role in providing hemodynamic stability which is crucial during transcatheter aortic valve implantation (TAVI) procedure. The aim of this study is to compare propofol with dexmedetomidine for conscious sedation during TAVI. A prospective randomized pilot study. Fifty patients with a mean age of 74years, American Society of Anesthesiologists 3-4, complaining from severe aortic stenosis were enrolled in this study to undergo TAVI. The propofol group (group P; n=25) received a bolus dose of 0.5mg/kg propofol followed by a continuous intravenous infusion of propofol at a rate of 30 to 50μg kg(-1) min(-1), and the dexmedetomidine group (group D; n=25) received dexmedetomidine at a loading dose of 1μg/kg and then a continuous intravenous infusion of dexmedetomidine at a rate of 0.5μg kg(-1) h(-1). Heart rate, mean arterial blood pressure, number of phenylephrine boluses, oxygen saturation, sedation, and satisfaction scores were measured just after the start of infusion of the sedation drugs and at the end of the procedure. Postoperative complications were also recorded. There was a statistically significant reduction in the heart rate in group D in comparison to group P where it was 67.28±6.9beats/min in the first group in comparison to 78±6.9beats/min in the last one (P<.001). The mean arterial blood pressure was statistically significant lower in group D in comparison to group P (58.12±5.4mm Hg in group D vs 68.24±11.4mm Hg in group P; P<.001). Also, the number of phenylephrine boluses was higher in group D than in group P (36.5±7.17 in group D vs 20.6±2.07 in group p; P<.001). No difference between the 2 groups regarding oxygen saturation, sedation, pain, satisfaction scores, and postoperative complications. During TAVI, dexmedetomidine may be associated with significant hypotension and bradycardia rather than propofol. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Frailty is associated with delirium and mortality after transcatheter aortic valve implantation

    PubMed Central

    Assmann, Patricia; Kievit, Peter; van der Wulp, Kees; Verkroost, Michel; Noyez, Luc; Bor, Hans; Schoon, Yvonne

    2016-01-01

    Objective We hypothesised that frailty assessment is of additional value to predict delirium and mortality after transcatheter aortic valve implantation (TAVI). Methods Observational study in 89 consecutive patients who underwent TAVI. Inclusion from November 2012 to February 2014, follow-up until April 2014. Measurement of the association of variables from frailty assessment and cardiological assessment with delirium and mortality after TAVI, respectively. Results Incidence of delirium after TAVI: 25/89 (28%). Variables from frailty assessment protectively associated with delirium were: Mini Mental State Examination, (OR 0.79; 95% CI 0.65 to 0.96; p=0.02), Instrumental Activities of Daily Living (OR 0.79; 95% CI 0.63 to 0.99; p=0.04) and gait speed (OR 0.05; 95% CI 0.01 to 0.50; p=0.01). Timed Up and Go was predictively associated with delirium (OR 1.14; 95% CI 1.03 to 1.26; p=0.01). From cardiological assessment, pulmonary hypertension was protectively associated with delirium (OR 0.34; 95% CI 0.12 to 0.98; p=0.05). Multivariate logistic analysis: Nagelkerke R2=0.359, Mini Mental State Examination was independently associated with delirium. Incidence of mortality: 11/89 (12%). Variables predictively associated with mortality were: the summary score Frailty Index (HR 1.66, 95% CI 1.06 to 2.60; p=0.03), European System for Cardiac Operative Risk Evaluation (EuroSCORE) II (HR 1.14, 95% CI 1.06 to 1.22; p<0.001) and complications (HR 4.81, 95% CI 1.03 to 22.38; p=0.05). Multivariate Cox proportional hazards analysis: Nagelkerke R2=0.271, Frailty Index and EuroSCORE II were independently associated with mortality. Conclusions Delirium frequently occurs after TAVI. Variables from frailty assessment are associated with delirium and mortality, independent of cardiological assessment. Thus, frailty assessment may have additional value in the prediction of delirium and mortality after TAVI. PMID:28008356

  15. Clinical and prognostic implications of atrial fibrillation in patients undergoing transcatheter aortic valve implantation

    PubMed Central

    Salinas, Pablo; Moreno, Raúl; Calvo, Luis; Jiménez-Valero, Santiago; Galeote, Guillermo; Sánchez-Recalde, Angel; López-Fernández, Teresa; Garcia-Blas, Sergio; Iglesias, Diego; Riera, Luis; Moreno-Gómez, Isidro; Mesa, Jose María; Plaza, Ignacio; Ayala, Rocio; Gonzalez, Rosa; López-Sendón, José-Luis

    2012-01-01

    AIM: To study a cohort of consecutive patients undergoing transcatheter aortic valve implantation (TAVI) and compare the outcomes of atrial fibrillation (AF) patients vs patients in sinus rhythm (SR). METHODS: All consecutive patients undergoing TAVI in our hospital were included. The AF group comprised patients in AF at the time of TAVI or with history of AF, and were compared with the SR group. Procedural, echocardiographic and follow-up variables were compared. Likewise, the CHA2DS2-VASC stroke risk score and HAS-BLED bleeding risk score and antithrombotic treatment at discharge in AF patients were compared with that in SR patients. RESULTS: From a total of 34 patients undergoing TAVI, 17 (50%) were allocated to the AF group, of whom 15 (88%) were under chronic oral anticoagulation. Patients in the AF group were similar to those in the SR group except for a trend (P = 0.07) for a higher logistic EuroSCORE (28% vs 19%), and a higher prevalence of hypertension (82% vs 53%) and chronic renal failure (17% vs 0%). Risk of both stroke and bleeding was high in the AF group (mean CHA2DS2-VASC 4.3, mean HAS-BLED 2.9). In the AF group, treatment at discharge included chronic oral anticoagulation in all except one case, and in association with an antiplatelet drug in 57% of patients. During a mean follow-up of 11 mo (maximum 32), there were only two strokes, none of them during the peri-procedural period: one in the AF group at 30 mo and one in the SR group at 3 mo. There were no statistical differences in procedural success, and clinical outcome (survival at 1 year 81% vs 74% in AF and SR groups, respectively, P = NS). CONCLUSION: Patients in AF undergoing TAVI show a trend to a higher surgical risk. However, in our cohort, patients in AF did not have a higher stroke rate compared to the SR group, and the prognosis was similar in both groups. PMID:22279599

  16. Early- and mid-term outcomes after transcatheter aortic valve implantation. Data from a single-center registry

    PubMed Central

    Bagienski, Maciej; Dziewierz, Artur; Rzeszutko, Lukasz; Sorysz, Danuta; Trebacz, Jaroslaw; Sobczynski, Robert; Tomala, Marek; Stapor, Maciej; Gackowski, Andrzej; Dudek, Dariusz

    2016-01-01

    Introduction Transcatheter aortic valve implantation (TAVI) is a less invasive treatment option for elderly, high-risk patients with symptomatic severe aortic stenosis (AS) than aortic valve replacement. More importantly, TAVI improves survival and quality of life as compared to medical treatment in inoperable patients. Aim To assess early- and mid-term clinical outcomes after TAVI. Material and methods All consecutive high-risk patients with severe symptomatic AS undergoing TAVI from November 2008 to August 2014 were enrolled. The clinical and procedural characteristics, as well as clinical outcomes including mortality during 12-month follow-up, were assessed. Results A total of 101 consecutive patients underwent TAVI for native aortic valve stenosis (100%). Patients were elderly, with a median age of 81.0 (76.0–84.0) years, 60.4% were female and 83.2% presented with NYHA III/IV. Median baseline EuroSCORE I and STS scores were 14.0 (10.0–22.5)% and 12.0 (5.0–24.0)%, respectively. The main periprocedural and in-hospital complications were minor vascular complications, bleeding requiring blood transfusions, and the need for a permanent pacemaker. In-hospital, 30-day, 6-month and 12-month mortality rates were 6.9%, 10.9%, 15.8% and 17.8%, respectively. Conclusions A mortality rate of < 20% after 12 months seems acceptable given the high-risk population enrolled. PMID:27279871

  17. Automatic segmentation of the aortic root in CT angiography of candidate patients for transcatheter aortic valve implantation.

    PubMed

    Elattar, M A; Wiegerinck, E M; Planken, R N; Vanbavel, E; van Assen, H C; Baan, J; Marquering, H A

    2014-07-01

    Transcatheter aortic valve implantation is a minimal-invasive intervention for implanting prosthetic valves in patients with aortic stenosis. Accurate automated sizing for planning and patient selection is expected to reduce adverse effects such as paravalvular leakage and stroke. Segmentation of the aortic root in CTA is pivotal to enable automated sizing and planning. We present a fully automated segmentation algorithm to extract the aortic root from CTA volumes consisting of a number of steps: first, the volume of interest is automatically detected, and the centerline through the ascending aorta and aortic root centerline are determined. Subsequently, high intensities due to calcifications are masked. Next, the aortic root is represented in cylindrical coordinates. Finally, the aortic root is segmented using 3D normalized cuts. The method was validated against manual delineations by calculating Dice coefficients and average distance error in 20 patients. The method successfully segmented the aortic root in all 20 cases. The mean Dice coefficient was 0.95 ± 0.03, and the mean radial absolute error was 0.74 ± 0.39 mm, where the interobserver Dice coefficient was 0.95 ± 0.03 and the mean error was 0.68 ± 0.34 mm. The proposed algorithm showed accurate results compared to manual segmentations.

  18. Tricuspid Valve Annular Dilation as a Predictor of Right Ventricular Failure After Implantation of a Left Ventricular Assist Device.

    PubMed

    Goldraich, Livia; Kawajiri, Hiroyuki; Foroutan, Farid; Braga, Juarez; Billia, Phyllis; Misurka, Jimmy; Stansfield, William E; Yau, Terrence; Ross, Heather J; Rao, Vivek

    2016-02-01

    Tricuspid annular (TA) dilation has been suggested as a more reliable marker of concomitant advanced right ventricular failure (RVF) than severity of tricuspid regurgitation (TR). Our objective was to examine the impact of TA dilation on occurrence of RVF and in-hospital mortality following left ventricular assist device (LVAD) implant. Consecutive patients undergoing implantation of a continuous-flow LVAD implant were grouped according to the presence or absence of preoperative dilated TA. Clinical characteristics, hemodynamics, and short-term postoperative outcomes were compared between groups. RVF was defined as unplanned right ventricular assist device (RVAD) or postoperative use of inotropes for >14 days. Linear and logistic regressions were used to explore associations of TA with occurrence of RVF and duration of inotrope use. We included 69 patients who had continuous-flow LVAD implanted between 2006 and 2013 (50 ± 13 years old; 69% males; 37% ischemic etiology; 69% bridge-to-transplant LVAD; 18% INTERMACS 1-2; 48% with significant TR). RVF occurred in nine cases, and overall in-hospital mortality rate was 14%. Tricuspid valve repair was performed in ten cases. Dilated TA (OR 4.86; 95% CI 1.05-22.33; p = 0.04) was associated with RVF. In an adjusted multivariable analysis, indexed TA was an independent predictor of increased days of inotrope use (0.8-day increase in inotrope use for every 1 mm/m2 increase; p = 0.04). In this cohort, TA dilation was a predictor of RVF after LVAD implant. The potential benefit of concomitant TVR in selected patients with a dilated TA undergoing LVAD implantation remains to be determined. © 2016 Wiley Periodicals, Inc.

  19. Quality-of-life in elderly patients one year after transcatheter aortic valve implantation for severe aortic stenosis.

    PubMed

    Ussia, Gian Paolo; Barbanti, Marco; Cammalleri, Valeria; Scarabelli, Marilena; Mulè, Massimiliano; Aruta, Patrizia; Pistritto, Anna Maria; Immè, Sebastiano; Capodanno, Davide; Sarkar, Kunal; Gulino, Simona; Tamburino, Corrado

    2011-09-01

    Transcatheter aortic valve implantation (TAVI) is an emerging alternative to medical therapy reserved to a limited population with severe aortic stenosis. Quality-of-life (QoL) is a critical measure of effectiveness of TAVI in this patient population. In this prospective study, we sought to assess one year changes in QoL in patients who underwent TAVI. From June 2007 to July 2010, 149 consecutive patients underwent TAVI using the 18 Fr CoreValve (Medtronic Inc, Minneapolis, MN, USA) or the Edwards SAPIEN XT heart valve (Edwards Lifescience, Irvine, CA, USA) at our institution. Of these, 143 patients with successful prosthesis implantation comprised the study population. The SF-12v2 Health-Survey questionnaire provides scales for physical (physical component summary [PCS]) and mental (mental component summary [MCS]) health. Among patients included in the present analysis, device success was obtained in 138 patients (96.5%). Mean preprocedural SF-12v2 scores showed an important upgrading after TAVI: PCS improved from 28.3 to 44.0 at five months and 42.4 at 12 months (p<0.001). MCS increased from 38.0 to 47.3 at five months and 48.2 at 12 months (p<0.001). Both the physical and mental score summaries at follow-up of these post-TAVI patients were not significantly different from the anticipated thresholds of the general Italian population over the age of 75 years. NYHA functional class improvement was reported in all patients. Our results showed a marked mid-term improvement in functional status and physical and mental health in patients who underwent TAVI.

  20. Quality of life after transcatheter aortic valve implantation and surgical replacement in high-risk elderly patients.

    PubMed

    Kala, Petr; Tretina, Martin; Poloczek, Martin; Ondrasek, Jiri; Malik, Petr; Pokorny, Petr; Parenica, Jiri; Spinar, Jindrich; Jarkovsky, Jiri; Littnerova, Simona; Nemec, Petr

    2013-03-01

    The aim of this study was to compare the quality of life after transcatheter aortic valve implantation (TAVI) and surgical replacement (SAVR) at one year. The study included 45 consecutive high-risk patients (average age 82.0 years; logistic Euroscore 22.3%) with symptomatic severe aortic stenosis allocated to TAVI transfemoral, TAVI transapical using the Edwards-Sapien valve or SAVR with the Edwards Perimount bioprosthesis (n=15 in each). The pre-operative characteristics were similar except for more myocardial infarctions in TAVI. The quality of life was assessed using the standardized EQ-5D questionnaire at baseline and on days 30, 90 and 360. The protocol was approved by the local ethics committee and an informed consent was signed. A total of 7 patients (15.5%) died during follow-up. At baseline no significant differences in any of the quality-of-life parameters were found except for usual activities described as "best" (46.7% in SAVR vs. 10.0% in TAVI; P=0.002). At 30 and 90 days surviving patients were similar and at 360 days only the anxiety/depression score was "best" in 83.3% SAVR vs. 59.1% (P=0.046). Functional status improved in all patients (NYHA class I-II in 13.3% at baseline vs. 78.9% at 360-days) and the general health median significantly improved in TAVI patients (from 50 to 67; P=0.001) with a positive trend in SAVR patients (P=0.060). At one year, the general quality of life of high-risk patients had significantly improved after transcatheter aortic valve implantation with a positive trend in surgically treated patients.

  1. SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve.

    PubMed

    Wendler, Olaf; Schymik, Gerhard; Treede, Hendrik; Baumgartner, Helmut; Dumonteil, Nicolas; Neumann, Franz-Josef; Tarantini, Giuseppe; Zamorano, José Luis; Vahanian, Alec

    2017-06-12

    Transcatheter aortic valve implantation (TAVI) has developed from a procedure for patients with aortic stenosis inoperable or high risk for surgery, into a treatment option even for intermediate risk elderly patients. This development has been facilitated by the clinical learning curve and constant improvements of transcatheter heart valves used. We present total 1-year results of SOURCE 3, the European post-approval multicentre registry of the latest generation balloon expandable SAPIEN 3TM (Edwards Lifesciences, Irvine, CA, USA). Participating centres have submitted their consecutive experience with the SAPIEN 3, dependent on patients consent. Data were prospectively collected and all end point-related outcomes adjudicated according to VARC-2 definitions by an independent committee. Between July 2014 and October 2015, in total 1946 patients (mean age 81.6 ± 6.7 years, 52% male) were enrolled in 80 centres from 10 European countries. At 1 year, all-cause mortality was 12.6%, cardiovascular mortality 8.0%, stroke 3.1%, disabling stroke 1.4%, and rate of new pacemakers 13.2%. Causes of death were 62.0% cardiovascular and 38.0% non-cardiovascular, with heart failure (13.4%) and pulmonary complications (12.7%) being the main reasons for fatal outcomes. Multivariable analysis identified New York Heart Association Class IV and renal insufficiency as predictors of mortality, while higher BMI's improved survival. Severe (zero) and moderate paravalvular leakage (2.6%) was rare at 1 year. In SOURCE 3, we observe a low complication rate and mortality at 1 year. Given the low incidence of higher degree paravalvular leakages, this variable did no longer affect outcome. Clinicaltrial.gov number: NCT02698956.

  2. Evaluation of the learning curve for transcatheter aortic valve implantation via the transfemoral approach.

    PubMed

    Arai, Takahide; Lefèvre, Thierry; Hovasse, Thomas; Hayashida, Kentaro; Watanabe, Yusuke; O'Connor, Stephen A; Benamer, Hakim; Garot, Philippe; Cormier, Bertrand; Bouvier, Erik; Morice, Marie-Claude; Chevalier, Bernard

    2016-01-15

    The aim of this study was to evaluate the learning curve in performing transfemoral TAVI (TF-TAVI). Between October 2006 and October 2013, 312 consecutive TF-TAVI cases performed by 6 interventional cardiologists, using the Edwards Sapien valve and 104 using the CoreValve, were included in the present analysis. Cumulative sum (CUSUM) failure analysis of combined 30-day safety endpoint was used to evaluate learning curves. The CUSUM analysis revealed a learning curve regarding the occurrence of 30-day adverse events with an improvement after the initial 86 cases using the Edwards valve and 40 cases using the CoreValve. We divided the Edwards valve cases into two groups (early experience: Cases 1 to 86; late experience: Cases 87 to 312). The rate of 30-day mortality and 1-year mortality significantly decreased in the late experience group (17% to 7%, p=0.019; 34% to 21%, p=0.035, respectively). We divided the CoreValve cases into two groups (early experience: Cases 1 to 40; late experience: Cases 41 to 104). The rate of 30-day mortality and 1-year mortality significantly decreased in the late experience group (20% to 6%, p=0.033; 38% to 15%, p=0.040, respectively). The groups including both valves were also analyzed after propensity-matching (early [n=52] vs late [n=52]). This model also showed that 30-day and 1-year mortality rates were significantly lower in the late experience group (13% to 1%, p=0.028; 34% to 20%, p=0.042, respectively). An appropriate level of experience is needed to reduce the complication rate and mortality in TF-TAVI. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  3. Guide to prosthetic cardiac valves

    SciTech Connect

    Morse, D.; Steiner, R.M.; Fernandez, J.

    1985-01-01

    This book contains 10 chapters. Some of the chapter titles are: The development of artificial heart valves: Introduction and historical perspective; The radiology of prosthetic heart valves; The evaluation of patients for prosthetic valve implantation; Pathology of cardiac valve replacement; and Bioengineering of mechanical and biological heart valve substitutes.

  4. Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve: The ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) Randomized Clinical Trial.

    PubMed

    Rodés-Cabau, Josep; Masson, Jean-Bernard; Welsh, Robert C; Garcia Del Blanco, Bruno; Pelletier, Marc; Webb, John G; Al-Qoofi, Faisal; Généreux, Philippe; Maluenda, Gabriel; Thoenes, Martin; Paradis, Jean-Michel; Chamandi, Chekrallah; Serra, Vicenç; Dumont, Eric; Côté, Mélanie

    2017-07-10

    The aim of this study was to compare aspirin plus clopidogrel with aspirin alone as antithrombotic treatment following transcatheter aortic valve replacement (TAVR) for the prevention of ischemic events, bleeding events, and death. Few data exist on the optimal antithrombotic therapy following TAVR. This was a randomized controlled trial comparing aspirin (80 to 100 mg/day) plus clopidogrel (75 mg/day) (dual antiplatelet therapy [DAPT]) versus aspirin alone (single-antiplatelet therapy [SAPT]) in patients undergoing TAVR with a balloon-expandable valve. The primary endpoint was the occurrence of death, myocardial infarction (MI), stroke or transient ischemic attack, or major or life-threatening bleeding (according to Valve Academic Research Consortium 2 definitions) within the 3 months following the procedure. The trial was prematurely stopped after the inclusion of 74% of the planned study population. A total of 222 patients were included, 111 allocated to DAPT and 111 to SAPT. The composite of death, MI, stroke or transient ischemic attack, or major or life-threatening bleeding tended to occur more frequently in the DAPT group (15.3% vs. 7.2%, p = 0.065). There were no differences between groups in the occurrence of death (DAPT, 6.3%; SAPT, 3.6%; p = 0.37), MI (DAPT, 3.6%; SAT, 0.9%; p = 0.18), or stroke or transient ischemic attack (DAPT, 2.7%; SAPT, 0.9%; p = 0.31) at 3 months. DAPT was associated with a higher rate of major or life-threatening bleeding events (10.8% vs. 3.6% in the SAPT group, p = 0.038). There were no differences between groups in valve hemodynamic status post-TAVR. This small trial showed that SAPT (vs. DAPT) tended to reduce the occurrence of major adverse events following TAVR. SAPT reduced the risk for major or life-threatening events while not increasing the risk for MI or stroke. Larger studies are needed to confirm these results. (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation: The ARTE

  5. Determinants and outcomes of acute transcatheter valve-in-valve therapy or embolization: a study of multiple valve implants in the U.S. PARTNER trial (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve).

    PubMed

    Makkar, Raj R; Jilaihawi, Hasan; Chakravarty, Tarun; Fontana, Gregory P; Kapadia, Samir; Babaliaros, Vasilis; Cheng, Wen; Thourani, Vinod H; Bavaria, Joseph; Svensson, Lars; Kodali, Susheel; Shiota, Takahiro; Siegel, Robert; Tuzcu, E Murat; Xu, Ke; Hahn, Rebecca T; Herrmann, Howard C; Reisman, Mark; Whisenant, Brian; Lim, Scott; Beohar, Nirat; Mack, Michael; Teirstein, Paul; Rihal, Charanjit; Douglas, Pamela S; Blackstone, Eugene; Pichard, Augusto; Webb, John G; Leon, Martin B

    2013-07-30

    This study investigated the determinants and outcomes of acute insertion of a second transcatheter prosthetic valve (TV) within the first (TV-in-TV) or transcatheter valve embolization (TVE) after transcatheter aortic valve replacement (TAVR). TAVR failure can occur with both TV-in-TV and TVE as a consequence of TAVR malpositioning. Only case reports and limited series pertaining to these complications have been reported to date. Patients undergoing TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve) randomized trial (cohorts A and B) and accompanying registries were studied. Data were dichotomized for those with and without TV-in-TV or TVE, respectively. From a total of 2,554 consecutive patients, 63 (2.47%) underwent TV-in-TV and 26 (1.01%) TVE. The indication for TV-in-TV was significant aortic regurgitation in most patients, often due not only to malpositioning but also to leaflet dysfunction. Despite similar aortic valve function on follow-up echoes, TV-in-TV was an independent predictor of 1-year cardiovascular mortality (hazard ratio [HR]: 1.86, 95% confidence interval [CI]: 1.03 to 3.38, p = 0.041), with a nonsignificant trend toward greater all-cause mortality (HR: 1.43, 95% CI: 0.88 to 2.33, p = 0.15). Technical and anatomical reasons accounted for most cases of TVE. A multivariable analysis found TVE to be an independent predictor of 1-year mortality (HR: 2.68, 95% CI: 1.34 to 5.36, p = 0.0055) but not cardiovascular mortality (HR: 1.30, 95% CI: 0.48 to 3.52, p = 0.60). Acute TV-in-TV and TVE are serious sequelae of TAVR, often resulting in multiple valve implants. They carry an excess of mortality and are caused by anatomic and technical factors, which may be avoidable with judicious procedural planning. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  6. The angiotensin II type 1 receptor blocker losartan attenuates bioprosthetic valve leaflet calcification in a rabbit intravascular implant model.

    PubMed

    Shin, Hong Ju; Kim, Dae-Hyun; Park, Han Ki; Park, Young Hwan

    2016-12-01

    There is evidence that angiotensin II type I receptor blocker (ARB) could reduce structural valve deterioration. However, the anticalcification effect on the bioprosthetic heart valve (BHV) has not been investigated. Thus, we investigated the effects of losartan (an ARB) on calcification of implanted bovine pericardial tissue in a rabbit intravascular implant model. A total of 16 male New Zealand White rabbits (20 weeks old, 2.98-3.34 kg) were used in this study. Commercially available BHV leaflet of bovine pericardium was trimmed to the shape of a 3-mm triangle and implanted to both external jugular veins of the rabbit. The ARB group (n = 8) was given 25 mg/kg of powdered losartan daily until 6 weeks after surgery by direct administration in the buccal pouch of the animals. The control group (n = 8) was given 5 ml of normal saline by the same method. After 6 weeks, quantitative calcium determination, histological evaluation and western blot analysis of interleukin-6 (IL-6), osteopontin and bone morphogenetic protein 2 (BMP-2) were performed to investigate the mechanisms of the anticalcification effect of losartan. No deaths or complications such as infection or haematoma were recorded during the experiment. All animals were euthanized on the planned date. The calcium measurement level in the ARB group (2.28 ± 0.65 mg/g) was significantly lower than that in the control group (3.68 ± 1.00 mg/g) (P = 0.0092). Immunohistochemistry analyses revealed that BMP-2-positive reactions were significantly attenuated in the ARB group. Western blot analysis showed that losartan suppressed the expression of IL-6, osteopontin and BMP-2. Our results indicate that losartan significantly attenuates postimplant degenerative calcification of a bovine pericardial bioprosthesis in a rabbit intravascular implant model. Further studies are required to assess the effects of ARBs on BHV tissue in orthotopic implantations using a large animal model. © The Author 2016. Published by Oxford

  7. Combined venoarterial extracorporeal membrane oxygenation and transcatheter aortic valve implantation for the treatment of acute aortic prosthesis dysfunction in a high-risk patient.

    PubMed

    Pergolini, Amedeo; Zampi, Giordano; Tinti, Maria Denitza; Polizzi, Vincenzo; Pino, Paolo Giuseppe; Pontillo, Daniele; Musumeci, Francesco; Luzi, Giampaolo

    2016-01-01

    We describe the case of a patient with acute bioprosthesis dysfunction in cardiogenic shock, in whom hemodynamic support was provided by venoarterial extracorporeal membrane oxygenation, and successfully treated by transcatheter aortic valve implantation. Copyright © 2016 Sociedade Portuguesa de Cardiologia. Publicado por Elsevier España, S.L.U. All rights reserved.

  8. Aortic valve conduit implantation in the descending thoracic aorta in a sheep model: The outcomes of pre-seeded scaffold.

    PubMed

    Kajbafzadeh, Abdol-Mohammad; Ahmadi Tafti, Seyed Hossein; Mokhber-Dezfooli, Mohammad-Reza; Khorramirouz, Reza; Sabetkish, Shabnam; Sabetkish, Nastaran; Rabbani, Shahram; Tavana, Hamid; Mohseni, Mohammad Javad

    2016-04-01

    We evaluated the outcomes of implanting pre-seeded decellularized aortic valve conduit (AVC) with bone marrow-derived mesenchymal stem cells (MSCs) in a sheep model. Eight sheep AVCs were obtained under sterile conditions and decellularized by using detergent-based methods. Decellularized AVCs were seeded with autologous bone marrow-derived MSCs in a dynamic bioreactor system. Pre-seeded AVCs were implanted in the descending thoracic aorta in a sheep model. In all sheep, a decellularized pericardial patch was also anastomosed to the proximal part in order to reduce the incidence of rupture. Pathological evaluations, echocardiography, multislice computed tomography (CT), and CT angiography were performed for the evaluation of implanted AVCs. The longest survival period was 19 months in pre-seeded animals with complete recellularization at the long-term follow-up. Immunohistochemical staining for desmin, smooth muscle actin, and cytokeratin was significantly positive in the pre-seeded samples and reached near normal ranges. CT angiography revealed no intimal tearing after 18 months of follow-up. Pre-seeded AVCs with bone marrow-derived MSCs may have satisfactory results in postoperative cell seeding capabilities with promising functional potentiality. This modality may be beneficial and may provide a new era of biological grafts in cardiovascular surgery. Copyright © 2016 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  9. Concomitant tricuspid valve repair or replacement during left ventricular assist device implant demonstrates comparable outcomes in the long term.

    PubMed

    Deo, Salil V; Hasin, Tal; Altarabsheh, Salah E; McKellar, Stephen H; Shah, Ishan K; Durham, Lucian; Stulak, John M; Daly, Richard C; Park, Soon J; Joyce, Lyle D

    2012-11-01

    Severe tricuspid regurgitation (TR) is present in nearly half the patients undergoing implant of a left ventricular assist device (LVAD) and its correction confers better long-term outcome. To compare the early and late results of tricuspid valve repair (TVrpr) or replacement (TVR) with LVAD implant. Sixty-four from a cohort of 126 patients had a concomitant tricuspid valve procedure; 48 (75%) underwent a TVrpr whereas 16 (25%) had TVR. All preoperative hemodynamic parameters including the mean TR grade (TVrpr; 3.6 vs. TVR; 3.7) were comparable (p = 0.7). The mean TR grade was 1.6 ± 1.5 for the remaining 62 patients who did not have a concomitant tricuspid valve procedure, with 4/62 (6%) having severe TR (p < 0.0001). Cardiopulmonary bypass time was longer for patients undergoing TVR (p = 0.01). There was a significant reduction in right atrial pressure for the entire cohort (p < 0.01) and the postoperative right atrial pressure was not statistically different between TVrpr (13.6 ± 4.6) and TVR (11.6 ± 4.3; p = 0.6. Postoperative intensive care unit stay was comparable as was the duration of inotropic support (p = 0.5) or need for temporary right ventricular mechanical support. In-hospital mortality (12%) was not different between groups. The mean time for LVAD support was 12.3 ± 9.71 months and the last transthoracic echocardiographic examination was performed at mean intervals of 13.8 ± 10.8 months (TVrpr) and 11.8 ± 7.6 months (TVR; p = 0.47). Reduction in TR grade was similar between groups (p = 0.27). Late mortality (p = 1.00) was comparable in both groups. Using log-rank analysis, there was no significant difference in the estimated survival between TVrpr and TVR (p = 0.88). TVrpr repair at the time of LVAD implant is effective in correcting TR even at the end of one year of follow-up. The choice to repair or replace does not affect the clinical outcome. © 2012 Wiley Periodicals, Inc.

  10. Incidence, predictors, origin and prevention of early and late neurological events after transcatheter aortic valve implantation (TAVI): a comprehensive review of current data.

    PubMed

    Kahlert, Philipp; Al-Rashid, Fadi; Plicht, Björn; Hildebrandt, Heike; Patsalis, Polykarpos; Chilali, Karim El; Wendt, Daniel; Thielmann, Matthias; Bergmann, Lars; Kottenberg, Eva; Schlamann, Marc; Eggebrecht, Holger; Jakob, Heinz; Heusch, Gerd; Konorza, Thomas; Erbel, Raimund

    2013-05-01

    Transcatheter aortic valve implantation (TAVI) is a novel treatment option for patients with severe, symptomatic aortic valve stenosis considered inoperable or at high risk for surgical aortic valve replacement. Despite rapid adoption of this technology into clinical application, however, recent randomized controlled clinical trials have raised safety concerns regarding an increased risk of neurological events with TAVI compared to both medical treatment and conventional, surgical aortic valve replacement. Moreover, neuro-imaging studies have revealed an even higher incidence of new, albeit clinically silent cerebral lesions as a surrogate for procedural embolization. In this article, we review currently available data on the incidence, timing, predictors, prognostic implications and potential mechanisms of neurological events after TAVI.

  11. Embolic capture with updated intra-aortic filter during coronary artery bypass grafting and transaortic transcatheter aortic valve implantation: first-in-human experience.

    PubMed

    Ye, Jian; Webb, John G

    2014-12-01

    We report our first-in-human clinical experience in the use of the new version of the EMBOL-X intra-aortic filter (Edwards Lifesciences Corporation, Irvine, Calif) to capture embolic material during transaortic transcatheter aortic valve implantation and cardiac surgery. Five patients were enrolled into the first-in-human clinical assessment of the new version of the EMBOL-X intra-aortic filter. Three patients underwent coronary artery bypass grafting, and 2 patients underwent transaortic transcatheter aortic valve implantation. During coronary artery bypass grafting, the filter was deployed before clamping of the aorta and removal of the aortic clamp. In contrast, the filter was deployed before aortic puncture for transaortic transcatheter aortic valve implantation and kept in the aorta throughout the entire procedure. The filter introducer sheath and filter were easily placed and removed without difficulty. There were no complications related to the use of the filter. Postoperative examination of the retrieved filters revealed the presence of multiple microemboli in the filters from all 5 cases. Histologic study revealed various kinds of tissue and thrombus. This first-in-human clinical experience has demonstrated the safety and feasibility of using the new version of the EMBOL-X intra-aortic filter during either cardiac surgery or transaortic transcatheter aortic valve implantation. We believe that the combination of the transaortic approach without aortic arch manipulation and the use of the EMBOL-X filter with a high capture rate is a promising strategy to reduce the incidence of embolic complications during transcatheter aortic valve implantation. Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  12. Phacoemulsification versus phacoemulsification with micro-bypass stent implantation in primary open-angle glaucoma: randomized double-masked clinical trial.

    PubMed

    Fea, Antonio M

    2010-03-01

    To compare phacoemulsification alone and phacoemulsification with micro-bypass stent implantation in eyes with primary open-angle glaucoma. Instituto di Fisiopatologia Clinica, Clinica Oculistica, Universita' di Torino, Torino, Italy. In this prospective double-masked randomized clinical trial, patients had phacoemulsification alone (control group) or phacoemulsification with iStent implantation (combined group). Primary outcomes were intraocular pressure (IOP) and reduction in medication use over 15 months and IOP after a 1-month washout of ocular hypotensive agents (ie, 16 months postoperatively). The baseline IOP was similar between groups (combined group: 17.9 mm Hg +/- 2.6 [SD]; control group: 17.3 +/- 3.0 mm Hg) (P = .512). Three patients in the control group were lost to follow-up. The mean IOP was 14.8 +/- 1.2 mm Hg in the combined group and 15.7 +/- 1.1 mm Hg in the control group at 15 months and 16.6 +/- 3.1 mm Hg and 19.2 +/- 3.5 mm Hg, respectively, after washout; the IOP was statistically significantly lower in the combined group than in the control group at both time points (P = .031 and P = .042, respectively). At 15 months, the mean number of medications was lower in the combined group than in the control group (0.4 +/- 0.7 and 1.3 +/- 1.0, respectively; P = .007), as was the proportion of patients on ocular hypotensive medication (33% and 76%, respectively). Phacoemulsification with stent implantation was more effective in controlling IOP than phacoemulsification alone; the safety profiles were similar. Copyright 2010 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

  13. The valvo-pump, an axial blood pump implanted at the heart valve position: concept and initial results.

    PubMed

    Yamazaki, K; Okamoto, E; Yamamoto, K; Mitamura, Y; Tanaka, T; Yozu, R

    1992-06-01

    The valvo-pump, an axial nonpulsatile blood pump implanted at the heart valve position, has been developed. The valvo-pump consists of an impeller and a motor, which are encased in a housing. An impeller with 5 vanes (22.0 mm in diameter) is used. The impeller is connected to a samarium-cobalt-rare earth magnet direct current (DC) brushless motor measuring 21.3 mm in diameter and 18.5 mm in length. Sealing is achieved by means of a ferrofluidic seal. A pump flow of 10.5 L/min was obtained at a pump differential pressure of 3.3 kPa (25 mm Hg), and a flow of 4.9 L/min was obtained at 7.0 kPa (53 mm Hg). Sealing was kept perfect against a pressure of 29.3 kPa (220 mm Hg) at 9,000 rpm.

  14. Commissural detachment and Valsalva sinus dilatation after implantation of Prima Plus stentless valve with full root technique.

    PubMed

    Ohira, Suguru; Doi, Kiyoshi; Okawa, Kazunari; Yaku, Hitoshi

    2016-06-01

    The stentless aortic bioprosthesis has been used because of its excellent hemodynamics and few valve-related complications. We report a case of redo aortic root replacement for severe aortic regurgitation and dilatation of the Valsalva sinus 7 years after the implantation of a Prima Plus aortic root bioprosthesis (Edwards LifeScience, Irvine, CA, USA) using a full root technique. Intraoperative findings showed the complete detachment of the commissure between the left and non-coronary cusps, and Valsalva sinus dilatation of the porcine aortic root bioprosthesis. Redo aortic root replacement with a 23-mm porcine bioprosthesis and 28-mm straight graft was performed. There were no findings of intimal tear, suture dehiscence, degeneration, and perforation of the bioprosthesis. Such complications associated with the Edwards Prima Plus aortic root bioprosthesis were rarely reported. Commissural detachment of a porcine stentless aortic bioprosthesis can occur; thus, careful follow-up involving echocardiography and computed tomography is necessary.

  15. Pulmonary annulus preservation lowers the risk of late postoperative pulmonary valve implantation after the repair of tetralogy of Fallot.

    PubMed

    Kim, Gwan Sic; Han, Seungbong; Yun, Tae-Jin

    2015-02-01

    The long-term benefits of pulmonary annulus preservation in tetralogy of Fallot (ToF) repair in patients with a marginally small pulmonary annulus are controversial. We sought to determine whether pulmonary annulus preservation (AP) is superior to transannular patching (TAP) in lowering the risk of pulmonary valve implantation (PVI) long after the repair of ToF. Of the 255 patients who underwent total correction of ToF during infancy between January 1989 and December 2005, 114 patients (AP group = 57, TAP group = 57) were selected by propensity score matching for various preoperative variables, such as age and body weight at operation, sex, pulmonary artery size, pre-repair palliation, anatomical types of ventricular septal defect, and Z-score of pulmonary valve annulus diameter (PVA-Z). The PVA-Z of the AP and TAP groups were -2.3 ± 1.3 and -2.1 ± 1.3, respectively (p = 0.547). The time to PVI was compared between the two groups. The median follow-up duration was 146 months (AP group: 141 months, TAP group: 147 months; p = 0.191). During the follow-up periods, there were 12 reoperations for the relief of right ventricular outflow tract obstruction (RVOTO), eight PVIs, and three late deaths. While freedom from reoperation for RVOTO was comparable between the two groups (p = 0.182), freedom from PVI at postoperative 15 years was significantly lower in the TAP group than in the AP group (74 and 100 %, p = 0.015). In repairing ToF with marginally small pulmonary valve annulus, AP is associated with a lower risk of late postoperative PVI.

  16. Percutaneous Aortic Balloon Valvuloplasty and Intracardiac Adrenaline in Electromechanical Dissociation as Bridge to Transcatheter Aortic Valve Implantation.

    PubMed

    Chaara, Jawad; Meier, Pascal; Ellenberger, Christophe; Gasche, Yvan; Bendjelid, Karim; Noble, Stephane; Roffi, Marco

    2015-07-01

    This report describes an emergent balloon aortic valvuloplasty (BAV) procedure performed under cardiopulmonary resuscitation in a 79-year-old man with severe symptomatic aortic stenosis (mean gradient 78 mm Hg, valve area 0.71 cm, and left ventricular ejection fraction 40%) awaiting surgery and who was admitted for heart failure rapidly evolving to cardiogenic shock and multiorgan failure. Decision was made to perform emergent BAV. After crossing the valve with a 6 French catheter, the patient developed an electromechanical dissociation confirmed at transesophageal echocardiography and cardiac arrest. Manual chest compressions were initiated along with the application of high doses of intravenous adrenaline, and BAV was performed under ongoing resuscitation. Despite BAV, transoesophageal echocardiography demonstrated no cardiac activity. At this point, it was decided to advance a pigtail catheter over the wire already in place in the left ventricle and to inject intracardiac adrenaline (1 mg, followed by 5 mg). Left ventricular contraction progressively resumed and, in the absence of aortic regurgitation, an intraaortic balloon pump was inserted. The patient could be weaned from intraaortic balloon pump and vasopressors on day 1, extubated on day 6, and recovered from multiorgan failure. In the absence of neurologic deficits, he underwent uneventful transcatheter aortic valve implantation on day 12 and was discharged to a cardiac rehabilitation program on day 30. At 3-month follow-up, he reported dyspnea NYHA class II as the only symptom.This case shows that severe aortic stenosis leading to electromechanical dissociation may be treated by emergent BAV and intracardiac administration of high-dose adrenaline. Intracardiac adrenaline may be considered in case of refractory electromechanical dissociation occurring in the cardiac catheterization laboratory.

  17. The Polish Interventional Cardiology TAVI Survey (PICTS): adoption and practice of transcatheter aortic valve implantation in Poland.

    PubMed

    Parma, Radosław; Dąbrowski, Maciej; Ochała, Andrzej; Witkowski, Adam; Dudek, Dariusz; Siudak, Zbigniew; Legutko, Jacek

    2017-01-01

    Few studies have assessed the development of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in 2008, and data on current TAVI activity or practice are missing. To assess the dynamics of TAVI adoption in Poland and to detect differences among Polish centres in TAVI practice and decision-making. The Polish Interventional Cardiology TAVI Survey (PICTS) was approved by the Polish Association of Cardiovascular Interventions and presented to all 21 national TAVI centres. Between 2008 and 2015 the cumulative number of TAVI performed in Poland was 2189. The annual number of TAVI rose from 8 in 2008 to 670 in 2015 (0.21 to 17.4 implants per million inhabitants, respectively). The median TAVI experience per centre was 80 procedures (95% CI: 38.1-154.6). In 2015 the TAVI penetration rate reached 5.12% of the estimated eligible Polish population. Inoperable and high-risk patients are treated with TAVI in all centres, with 52% of Heart Teams also qualifying medium-risk patients. The rate of transfemoral implantations increased to 83.2% of all procedures in 2015, while transapical implantations decreased to 12%. The frequency of subclavian, direct aortic or transcarotid routes in 2015 was below 3% each. The PICTS survey observed a positive but slow rate of adoption of TAVI in Poland. When compared to Western European countries, our findings highlight a significant treatment gap in high or prohibitive surgical risk patients with severe aortic stenosis. Remarkable variations in TAVI practices among Polish TAVI centres warrant publication of joint national guidelines and recommendations.

  18. The Polish Interventional Cardiology TAVI Survey (PICTS): adoption and practice of transcatheter aortic valve implantation in Poland

    PubMed Central

    Parma, Radosław; Dąbrowski, Maciej; Ochała, Andrzej; Witkowski, Adam; Dudek, Dariusz; Siudak, Zbigniew

    2017-01-01

    Introduction Few studies have assessed the development of transcatheter aortic valve implantation (TAVI) in Poland since its introduction in 2008, and data on current TAVI activity or practice are missing. Aim To assess the dynamics of TAVI adoption in Poland and to detect differences among Polish centres in TAVI practice and decision-making. Material and methods The Polish Interventional Cardiology TAVI Survey (PICTS) was approved by the Polish Association of Cardiovascular Interventions and presented to all 21 national TAVI centres. Between 2008 and 2015 the cumulative number of TAVI performed in Poland was 2189. The annual number of TAVI rose from 8 in 2008 to 670 in 2015 (0.21 to 17.4 implants per million inhabitants, respectively). Results The median TAVI experience per centre was 80 procedures (95% CI: 38.1–154.6). In 2015 the TAVI penetration rate reached 5.12% of the estimated eligible Polish population. Inoperable and high-risk patients are treated with TAVI in all centres, with 52% of Heart Teams also qualifying medium-risk patients. The rate of transfemoral implantations increased to 83.2% of all procedures in 2015, while transapical implantations decreased to 12%. The frequency of subclavian, direct aortic or transcarotid routes in 2015 was below 3% each. Conclusions The PICTS survey observed a positive but slow rate of adoption of TAVI in Poland. When compared to Western European countries, our findings highlight a significant treatment gap in high or prohibitive surgical risk patients with severe aortic stenosis. Remarkable variations in TAVI practices among Polish TAVI centres warrant publication of joint national guidelines and recommendations. PMID:28344612

  19. Impact of optimising fluoroscopic implant angles on paravalvular regurgitation in transcatheter aortic valve replacements - utility of three-dimensional rotational angiography.

    PubMed

    Poon, Karl K; Crowhurst, James; James, Christopher; Campbell, Douglas; Roper, Damian; Chan, Jonathan; Incani, Alexander; Clarke, Andrew; Tesar, Peter; Aroney, Constantine; Raffel, Owen Christopher; Walters, Darren L

    2012-09-01

    The clinical value of optimising implant angles during transcatheter aortic valve replacements (TAVR) remains undefined. The Aortic Valve Guide (AVG) is a proprietary software that provides structured analysis of three-dimensional images from rotational angiography (DynaCT). This study compares AVG with preprocedural multislice computed tomography (MSCT) and DynaCT in optimal implant angle prediction for TAVR, and evaluates if an optimised implant angle is associated with reduced paravalvular regurgitation (PVR). One hundred and six consecutive patients were included, comprising three groups. Group 1 (n=19) underwent no preprocedural MSCT or DynaCT (or AVG); Group 2 (n=44) underwent periprocedural DynaCT, without AVG; Group 3 (n=43) had DynaCT with AVG. Implant angles yielded were graded as excellent, satisfactory or poor. Group 3 were more likely than Groups 2 and 1 to have excellent implant angles (83.7% vs. 52.3% vs. 42.1%, respectively, p=0.001). In 100 patients who had 30-day transthoracic echocardiogram follow-up, an excellent implant angle was significantly more likely to be associated with no PVR than a non-excellent angle (41.3% vs. 21.6%, respectively, p=0.045), independent of operator experience and THV used. Optimising implant angles may be important in reducing PVR. This is significantly more likely to be achieved with AVG rotational angiography.

  20. Intravenous Recombinant Tissue Plasminogen Activator Therapy for Acute Basilar Artery Ischemic Stroke Following Transfemoral Transcatheter Aortic Valve Implantation.

    PubMed

    Montarello, Nicholas J; Nelson, Adam J; Sidharta, Samuel L; Worthley, Stephen G

    2016-01-01

    Transcatheter aortic valve implantation (TAVI) can now be considered a standard of care for inoperable and high-risk surgical patients with severe aortic stenosis, and its uptake worldwide is rapidly increasing. Indeed, many centers performing the procedure have now moved towards treating intermediate-risk patients with TAVI rather than referring them for surgical aortic valve replacement. Although the incidence of peri-procedural acute and subacute stroke following TAVI has fallen to 2-5%, its occurrence can be life-threatening and life-changing, and every effort must be made to improve patient outcome should stroke occur. Many cardiologists would not instinctively consider the use of thrombolytic therapy for post-transfemoral TAVI ischemic stroke because of concern about the risk of major bleeding from the access site, despite it being a standard of care for ischemic stroke in other circumstances. The present case highlights the benefit of using intravenous thrombolytic therapy for an acute basilar artery thrombotic stroke after transfemoral TAVI (TF-TAVI) that would otherwise have almost certainly resulted in the patient's death. The case may also prompt interventional cardiologists to consider performing TF-TAVI under conscious sedation rather than general anesthesia, as this can result in an earlier detection of acute stroke and allow an earlier intervention with thrombolytic agents, with an improved outcome.